Generic name: ibuprofen [ EYE-bue-PROE-fen ]
Brand names: Advil, Advil Migraine, Children’s Advil, Children’s Ibuprofen Berry
Drug class: Nonsteroidal anti-inflammatory drugs 

What is Ibu?

Ibu is a nonsteroidal anti-inflammatory drug (NSAID).

Ibu is used to reduce fever and treat pain or inflammation caused by many conditions such as headache, toothache, back pain, arthritis, menstrual cramps, or minor injury. Ibu is used in adults and children who are at least 6 months old.

Ibu may also be used for purposes not listed in this medication guide.

Ibu side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Ibu may cause serious side effects. Stop using Ibu and call your doctor at once if you have:

• changes in your vision;
• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• a skin rash, no matter how mild;
• signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems–nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low red blood cells (anemia)–pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
• kidney problems–little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects of Ibu may include:

• nausea, vomiting, gas;
• bleeding; or
• dizziness, headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Ibu can increase your risk of fatal heart attack or stroke. Do not use Ibu just before or after heart bypass surgery (coronary artery bypass graft, or CABG). This medicine may also cause stomach or intestinal bleeding, which can be fatal.

Before taking this medicine

Ibu can increase your risk of fatal heart attack or stroke, even if you don’t have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibu may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

You should not use Ibu if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Ask a doctor or pharmacist if this medicine is safe to use if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• liver or kidney disease;
• asthma; or
• if you take aspirin to prevent heart attack or stroke.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

If you are pregnant, you should not take Ibu unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Do not give Ibu to a child younger than 6 months old without the advice of a doctor.

How should I take Ibu?

Use exactly as directed on the label, or as prescribed by your doctor. Use the lowest dose that is effective in treating your condition.

An Ibu overdose can damage your stomach or intestines. The maximum amount of ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses).

A child’s dose of ibuprofen is based on the age and weight of the child. Carefully follow the dosing instructions provided with children’s Ibu for the age and weight of your child. Ask a doctor or pharmacist if you have questions.

Take Ibu with food or milk to lessen stomach upset.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

You must chew the chewable tablet before you swallow it.

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

What happens if I miss a dose?

Since Ibu is used when needed, you may not be on a dosing schedule. Skip any missed dose if it’s almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What should I avoid while taking Ibu?

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to Ibu (such as aspirin, this medicine, ketoprofen, or naproxen).

Avoid taking aspirin unless your doctor tells you to.

If you also take aspirin to prevent stroke or heart attack, taking Ibu can make aspirin less effective in protecting your heart and blood vessels. If you take both medicines, take this medicine at least 8 hours before or 30 minutes after you take aspirin (non-enteric coated form).

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

What other drugs will affect Ibu?

Ask your doctor before using Ibu if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist before using Ibu with any other medications, especially:

• cyclosporine;
• lithium;
• methotrexate;
• a blood thinner (warfarin, Coumadin, Jantoven);
• heart or blood pressure medication, including a diuretic or “water pill”; or
• steroid medicine (such as prednisone).

What is ibuprofen?

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Ibuprofen is used to reduce fever and treat pain or inflammation caused by many conditions such as headache, toothache, back pain, arthritis, menstrual cramps, or minor injury.

Ibuprofen is used in adults and children who are at least 6 months old.

Warnings

Ibuprofen can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

Do not take more than your recommended dose. An ibuprofen overdose can damage your stomach or intestines. Use only the smallest amount of medication needed to get relief from your pain, swelling, or fever.

Before taking this medicine

You should not use ibuprofen if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Ask a doctor or pharmacist if this medicine is safe to use if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• liver or kidney disease;
• asthma; or
• if you take aspirin to prevent heart attack or stroke.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

If you are pregnant, you should not take ibuprofen unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Do not give ibuprofen to a child younger than 6 months old without the advice of a doctor.

How should I take ibuprofen?

Use ibuprofen exactly as directed on the label, or as prescribed by your doctor. Use the lowest dose that is effective in treating your condition.

An ibuprofen overdose can damage your stomach or intestines. The maximum amount of ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses).

A child’s dose is based on the age and weight of the child. Carefully follow the dosing instructions provided with children’s ibuprofen for the age and weight of your child. Ask a doctor or pharmacist if you have questions.

Take ibuprofen with food or milk to lessen stomach upset.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

You must chew the chewable tablet before you swallow it.

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

What happens if I miss a dose?

Since ibuprofen is used when needed, you may not be on a dosing schedule. Skip any missed dose if it’s almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What to avoid

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to ibuprofen (such as aspirin, ketoprofen, or naproxen).

Avoid taking aspirin unless your doctor tells you to.

If you also take aspirin to prevent stroke or heart attack, taking ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you take both medicines, take ibuprofen at least 8 hours before or 30 minutes after you take aspirin (non-enteric coated form).

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Ibuprofen side effects

Get emergency medical help if you have signs of an allergic reaction to ibuprofen (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using this medicine and call your doctor at once if you have:

• changes in your vision;
• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• a skin rash, no matter how mild;
• signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems – nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low red blood cells (anemia) – pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
• kidney problems – little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common ibuprofen side effects may include:

• nausea, vomiting, gas;
• bleeding; or
• dizziness, headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect ibuprofen?

Ask your doctor before using ibuprofen if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist before using ibuprofen with any other medications, especially:

• cyclosporine;
• lithium;
• methotrexate;
• a blood thinner (warfarin, Coumadin, Jantoven);
• heart or blood pressure medication, including a diuretic or “water pill”; or
• steroid medicine (such as prednisone).

What is indomethacin?

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) that is used in adults and children at least 14 years old to treat signs and symptoms caused by certain types of arthritis such as moderate to severe osteoarthritis, rheumatoid arthritis, gouty arthritis, or ankylosing spondylitis.

Indomethacin is also used to treat shoulder pain caused by bursitis or tendonitis.

Extended-release indomethacin should not be used to treat gouty arthritis.

Indomethacin may also be used for purposes not listed in this medication guide.

Indomethacin side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using indomethacin and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Indomethacin may cause serious side effects. Stop using indomethacin and call your doctor at once if you have:

• a skin rash, no matter how mild;
• changes in your vision;
• flu-like symptoms;
• neurological problems–tremors or shaking, seizures, new or worsening depression, confusion, or psychosis, drowsiness;
• high blood pressure–severe headache, blurred vision, pounding in your neck or ears;
• kidney or heart problems–swelling, urinating less, rapid weight gain, feeling tired or short of breath;
• signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems–loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• high blood potassium–nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or
• low red blood cells (anemia)–pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.

Indomethacin may also worsen asthma attacks in people who have asthma. Talk with your doctor about your own risk.

Older adults may be more likely to have serious stomach problems while taking medicine that contains an NSAID.

Common side effects of indomethacin may include:

• headache; dizziness;
• heartburn, stomach pain, gas; or
• nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Indomethacin can increase your risk of fatal heart attack or stroke. Do not use indomethacin just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Indomethacin may also cause stomach or intestinal bleeding, which can be fatal.

Before taking this medicine

Indomethacin can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Indomethacin may also cause stomach or intestinal bleeding, which can be fatal. This can occur without warning, especially in older adults.

You should not use indomethacin if you are allergic to it, or if you have ever had an asthma attack, hives or a severe allergic reaction after taking aspirin or an NSAID.

Tell your doctor if you have or have ever had:

• congestive heart failure, heart disease, high blood pressure, high cholesterol, diabetes, smoking;
• a heart attack, stroke, or blood clot;
• bleeding problems;
• stomach ulcers or bleeding;
• depression, mood changes;
• seizures, epilepsy, Parkinson’s disease;
• asthma;
• fluid retention; or
• liver or kidney disease.

It may be harder for you to get pregnant while you are using this medicine.

Do not use indomethacin during pregnancy unless your doctor tells you to. Using an NSAID in the last 20 weeks can harm the unborn baby or cause pregnancy complications.

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take indomethacin?

Follow all directions on your prescription label and read all medication guides. Use the lowest dose that is effective in treating your condition.

Your dose needs may change if you switch to a different brand, strength, or form of indomethacin. Avoid medication errors by using only the form and strength your doctor prescribes.

Take this medicine with food or milk if it upsets your stomach.

You may be given other medications to help prevent certain side effects. Keep taking these medicines for as long as your doctor has prescribed.

Swallow the extended-release capsule whole and do not crush, chew, break, or open it.

Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

You may need medical tests to check your heart and kidney function. Your blood pressure will need to be checked often.

Tell your doctor if you have a planned surgery.

Call your doctor if your symptoms do not improve, or if they get worse. Indomethacin is not meant to be used long-term.

This medicine may affect the results of certain medical tests. Tell any doctor who treats you that you are using indomethacin.

Store at room temperature away from moisture and heat. Store the liquid medicine tightly closed away from light. Do not allow the liquid medicine to freeze.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking indomethacin?

Avoid taking aspirin or other NSAIDs unless your doctor tells you to.

Avoid smoking and drinking alcohol. It may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to indomethacin (such as aspirin, ibuprofen, ketoprofen, or naproxen).

Avoid driving or hazardous activity until you know how indomethacin will affect you. Your reactions could be impaired.

What other drugs will affect indomethacin?

Ask your doctor before using indomethacin if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Indomethacin can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, high blood pressure, pain, or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your other medicines, especially:

• aspirin;
• probenecid;
• a blood thinner–warfarin, Coumadin, Jantoven;
• medicine used to prevent blood clots–alteplase, clopidogrel, dipyridamole, ticlopidine, and others; or
• steroid medicine (such as prednisone).

What is ketoprofen?

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat signs and symptoms caused by certain types of arthritis and for short-term pain relief.

Ketoprofen immediate-release capsule can also be used to treat menstrual pain.

Ketoprofen extended-release capsule is only used for treating arthritis. This brand form of ketoprofen will not work fast enough to treat acute (immediate) pain.

Ketoprofen may also be used for purposes not listed in this medication guide.

Ketoprofen side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Ketoprofen may cause serious side effects. Stop using ketoprofen and call your doctor at once if you have:

• diarrhea, gas, heartburn, flu-like symptoms;
• a skin rash, no matter how mild;
• high blood pressure–severe headache, blurred vision, pounding in your neck or ears;
• kidney or heart problems–swelling, urinating less, rapid weight gain, feeling tired or short of breath;
• signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems–loss of appetite, nausea, vomiting, stomach pain (upper right side), itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low red blood cells (anemia)–pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Ketoprofen may also worsen asthma attacks in people who have asthma. Talk with your doctor about your own risk.

Older adults may be more likely to have serious stomach problems while taking medicine that contains an NSAID.

Common side effects of ketoprofen may include:

• heartburn, stomach pain, gas, nausea;
• headache, kidney problems;
• diarrhea, constipation; or
• insomnia, nervousness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Ketoprofen can increase your risk of fatal heart attack or stroke. Do not use ketoprofen just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Ketoprofen may also cause stomach or intestinal bleeding, which can be fatal.

Before taking this medicine

Ketoprofen can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ketoprofen may also cause stomach or intestinal bleeding, which can be fatal. This can occur without warning, especially in older adults.

You should not use ketoprofen if you are allergic to it, or if you have ever had an asthma attack, hives or a severe allergic reaction after taking aspirin or an NSAID.

Tell your doctor if you have or have ever had:

• heart disease, high blood pressure, high cholesterol, smoking, diabetes;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• asthma;
• fluid retention; or
• liver or kidney disease.

Do not use ketoprofen during pregnancy unless your doctor tells you to. Using an NSAID in the last 20 weeks can harm the unborn baby or cause pregnancy complications.

Ask a doctor if it is safe to breastfeed while using this medicine.

Ketoprofen is not approved for use by anyone younger than 18 years old.

How should I take ketoprofen?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the lowest effective dose for your condition. Do not use ketoprofen more often than prescribed.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using exactly as directed on the label, or as prescribed by your doctor.

Take this medicine with food or milk if it upsets your stomach.

Swallow the capsule whole and do not crush, chew, break, or open it.

You may be given other medications to help prevent certain side effects. Keep taking these medicines for as long as your doctor has prescribed.

You may need medical tests to check your heart and kidney function. Your blood pressure will need to be checked often.

Call your doctor if your symptoms do not improve, or if they get worse.

Store at room temperature away from moisture, heat, and light. Keep tightly closed when not in use.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking ketoprofen?

Do not take ketoprofen immediate-release capsules and extended-release capsules at the same time.

Avoid smoking and drinking alcohol. It may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to ketoprofen (such as aspirin, ibuprofen, or naproxen).

What other drugs will affect ketoprofen?

Ask your doctor before using ketoprofen if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Ketoprofen can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your other medicines, especially:

• aspirin;
• probenecid;
• a blood thinner–warfarin, Coumadin, Jantoven;
• medicine used to prevent blood clots–alteplase, clopidogrel, dipyridamole, ticlopidine, and others; or
• steroid medicine (such as prednisone).

What is meloxicam?

Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause pain, fever, and inflammation in the body.

Meloxicam is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints).

Meloxicam is also used to relieve the pain, tenderness, swelling, and stiffness caused by juvenile rheumatoid arthritis (a type of arthritis that affects children) in children 2 years of age and older.

The Anjeso brand of this medicine is used to treat moderate to severe pain in adults.

Vivlodex is for use only in adults. Qmiiz ODT is for adults and children weighing at least 132 pounds (60 kilograms).

Warnings

Meloxicam can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Meloxicam may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Avoid smoking and drinking alcohol as they also increase your risk of stomach bleeding.

Before taking this medicine

Meloxicam can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Meloxicam may also cause stomach or intestinal bleeding, which can be fatal.

Meloxicam may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

You should not use meloxicam if you are allergic to it, or if you ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure meloxicam is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a heart attack, stroke, or blood clot;
• ulcers or stomach bleeding;
• asthma;
• kidney disease (or if you are on dialysis);
• liver disease; or
• fluid retention.

If you are pregnant, you should not take meloxicam unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Meloxicam may cause a delay in ovulation (the release of an egg from an ovary). You should not take this medicine if you are undergoing fertility treatment, or are otherwise trying to get pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Meloxicam is not approved for use by anyone younger than 2 years old.

How is meloxicam given?

Take Meloxicam exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the lowest effective dose for your condition.

Meloxicam oral is taken by mouth.

Meloxicam injection is given as an infusion into a vein. A healthcare provider will give you this injection.

Your dose needs may change if you switch to a different brand, strength, or form of meloxicam. Avoid medication errors by using only the medicine your doctor prescribes.

Meloxicam doses are based on weight (especially in children and teenagers). Your dose needs may change if you gain or lose weight.

If you use this medicine long-term, you may need frequent medical tests.

Store oral suspension, tablets or capsules at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use.

Dosing Information

Usual Adult Dose for Osteoarthritis:

Oral Tablets and Oral Disintegrating Tablets:
-Initial dose: 7.5 mg orally once a day
-Maintenance dose: 15 mg orally once a day in patients requiring additional analgesia
-Maximum dose: 15 mg orally once a day

Oral Capsules:
-Initial dose: 5 mg orally once a day
-Maintenance dose: 10 mg orally once a day in patients requiring additional analgesia
-Maximum dose: 10 mg orally once a day.

Use: For the relief of signs and symptoms of osteoarthritis pain

Usual Adult Dose for Rheumatoid Arthritis:

Oral Tablets and Oral Disintegrating Tablets:
-Initial dose: 7.5 mg orally once a day
-Maintenance dose: 15 mg orally once a day in patients requiring additional analgesia
-Maximum dose: 15 mg orally once a day.

Use: For the relief of signs and symptoms of rheumatoid arthritis

Usual Adult Dose for Pain:

30 mg IV bolus (over 15 seconds) once a day

Comments:
-Median time to meaningful pain relief was 2 to 3 hours in clinical trials; a non-NSAID with a rapid onset may be needed; some patients may not experience adequate analgesia for the first 24-hours.
-The lowest effective dose for the shortest duration possible consistent with individual treatment goals should be used.

Use: For the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:

2 years or older:
Oral Tablets and Oral Disintegrating Tablets:
Weight: 60 kg or greater: 7.5 mg orally once a day
-No additional benefit has been demonstrated with doses above 7.5 mg/day.

Comments:
-Oral formulations have not shown equivalent systemic exposure and are not considered interchangeable
-The oral tablets should not be used in children who weigh less than 60 kg.

Use: For the relief of signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving meloxicam?

Drinking alcohol may increase your risk of stomach bleeding.

Avoid taking aspirin while you are taking meloxicam, unless your doctor tells you to.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to meloxicam (such as aspirin, ibuprofen, ketoprofen, or naproxen).

Meloxicam side effects

Get emergency medical help if you have signs of an allergic reaction to meloxicam (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Meloxicam may cause serious side effects. Stop using this medicine and call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild;
• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems – nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed, cold hands and feet; or
• kidney problems – little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Common meloxicam side effects may include:

• stomach pain, nausea, vomiting, heartburn;
• diarrhea, constipation, gas;
• dizziness; or
• cold symptoms, flu symptoms.

What is Mobic?

Mobic is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause pain, fever, and inflammation in the body.

Mobic is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints).

Mobic is also used to relieve the pain, tenderness, swelling, and stiffness caused by juvenile rheumatoid arthritis (a type of arthritis that affects children) in children 2 years of age and older.

Warnings

Mobic can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Mobic may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Avoid smoking and drinking alcohol as they also increase your risk of stomach bleeding.

Before taking this medicine

Mobic can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Mobic may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using meloxicam, especially in older adults.

You should not use Mobic if you are allergic to meloxicam, or if you ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure Mobic is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a heart attack, stroke, or blood clot;
• ulcers or stomach bleeding;
• asthma;
• kidney disease (or if you are on dialysis);
• liver disease; or
• fluid retention.

If you are pregnant, you should not take Mobic unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Mobic may cause a delay in ovulation (the release of an egg from an ovary). You should not take Mobic if you are undergoing fertility treatment, or are otherwise trying to get pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Mobic tablets are not approved for use in children weighing less than 132 lb (60 kg).

How is Mobic given?

Take Mobic exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the lowest effective dose for your condition.

If you use Mobic long-term, you may need frequent medical tests.

Store Mobic tablets at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use.

Dosing Information

Usual Adult Dose for Osteoarthritis:

Oral Tablets:
-Initial dose: 7.5 mg orally once a day
-Maintenance dose: 15 mg orally once a day in patients requiring additional analgesia
-Maximum dose: 15 mg orally once a day.

Usual Adult Dose for Rheumatoid Arthritis:

Oral Tablets:
-Initial dose: 7.5 mg orally once a day
-Maintenance dose: 15 mg orally once a day in patients requiring additional analgesia
-Maximum dose: 15 mg orally once a day.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:
2 years or older:

Oral Tablets:
Weight: 60 kg or greater: 7.5 mg orally once a day
-No additional benefit has been demonstrated with doses above 7.5 mg/day.

Comments:
-Oral formulations have not shown equivalent systemic exposure and are not considered interchangeable
-The oral tablets should not be used in children who weigh less than 60 kg.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving Mobic?

Drinking alcohol may increase your risk of stomach bleeding.

Avoid taking aspirin while you are taking Mobic, unless your doctor tells you to.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to Mobic (such as aspirin, ibuprofen, ketoprofen, or naproxen).

Mobic side effects

Get emergency medical help if you have signs of an allergic reaction to Mobic (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Meloxicam may cause serious side effects. Stop using Mobic and call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild;
• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems – nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed, cold hands and feet; or
• kidney problems – little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Common Mobic side effects may include:

• stomach pain, nausea, vomiting, heartburn;
• diarrhea, constipation, gas;
• dizziness; or
• cold symptoms, flu symptoms.

What is nabumetone?

Nabumetone is a nonsteroidal anti-inflammatory drug (NSAID). Nabumetone works by reducing hormones that cause inflammation and pain in the body.

Nabumetone is used to relieve the symptoms of rheumatoid arthritis or osteoarthritis.

Nabumetone may also be used for purposes not listed in this medication guide.

Nabumetone side effects

Get emergency medical help if you have signs of an allergic reaction (hives, sneezing, runny or stuffy nose, wheezing, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Nabumetone may cause serious side effects. Stop using nabumetone and call your doctor at once if you have:

• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• the first sign of any skin rash, no matter how mild;
• signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems–nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems–little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
• low red blood cells (anemia)–pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects of nabumetone may include:

• stomach pain, indigestion, nausea;
• diarrhea, constipation, gas;
• swelling in your hands and feet;
• headache, dizziness;
• itching, skin rash; or
• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA

Warnings

Nabumetone can increase your risk of fatal heart attack or stroke. Do not use nabumetone just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Nabumetone may also cause stomach or intestinal bleeding, which can be fatal.

Before taking this medicine

Nabumetone can increase your risk of fatal heart attack or stroke, even if you don’t have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Nabumetone may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using nabumetone, especially in older adults.

You should not use nabumetone if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Tell your doctor if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• asthma;
• liver or kidney disease; or
• fluid retention.

If you are pregnant, you should not take nabumetone unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

You should not breastfeed while using this medicine.

Nabumetone is not approved for use by anyone younger than 18 years old.

How should I take nabumetone?

Follow all directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Use the lowest dose that is effective in treating your condition.

You may take nabumetone with or without food.

If you use nabumetone long-term, you may need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Nabumetone dosing information

Usual Adult Dose for Osteoarthritis:

Initial dose: 1000 mg orally once a day
Maintenance dose: 1500 to 2000 mg orally per day in 1 or 2 divided doses
Maximum dose: 2000 mg/day

Comments:
-Patients weighing less than 50 kg may be less likely to require dosages beyond 1000 mg.
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient’s treatment goals.

Use: For the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.

Usual Adult Dose for Rheumatoid Arthritis:

Initial dose: 1000 mg orally once a day
Maintenance dose: 1500 to 2000 mg orally per day in 1 or 2 divided doses
Maximum dose: 2000 mg/day

Comments:
-Patients weighing less than 50 kg may be less likely to require dosages beyond 1000 mg.
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient’s treatment goals.

Use: For the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking nabumetone?

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to nabumetone (such as aspirin, ibuprofen, ketoprofen, or naproxen).

What is Naprosyn?

Naprosyn is a nonsteroidal anti-inflammatory drug (NSAID). Naproxen works by reducing hormones that cause inflammation and pain in the body.

Naprosyn is used to treat pain or inflammation caused by conditions such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

Naprosyn delayed-release tablets are slower-acting forms of naproxen that are used only for treating chronic conditions such as arthritis or ankylosing spondylitis. These forms of naproxen will not work fast enough to treat acute pain.

Warnings

You should not use Naprosyn if you have a history of allergic reaction to aspirin or other NSAID (nonsteroidal anti-inflammatory drug).

Naproxen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use Naprosyn just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

Before taking this medicine

Naprosyn may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Naprosyn, especially in older adults.

You should not use Naprosyn if you are allergic to naproxen, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Ask a doctor before giving naproxen to a child younger than 12 years old.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a history of heart attack, stroke, or blood clot;
• a history of stomach ulcers or bleeding;
• asthma;
• liver or kidney disease;
• fluid retention: or
• if you take aspirin to prevent heart attack or stroke.

If you are pregnant, you should not take Naprosyn unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

It may not be safe to breastfeed while using Naprosyn. Ask your doctor about any risk.

Naprosyn is not approved for use by anyone younger than 2 years old. Do not give this medicine to a child without medical advice.

How should I take Naprosyn?

Use Naprosyn exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If you change brands, strengths, or forms of naproxen, your dosage needs may change. Ask your pharmacist if you have any questions about the kind of naproxen you are using.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Naproxen doses are based on weight in children, and any changes may affect your child’s dose.

If you use Naprosyn long-term, you may need frequent medical tests.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Naprosyn.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

What happens if I miss a dose?

Since Naprosyn is sometimes used only when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

What to avoid

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin or other NSAIDs unless your doctor tells you to.

Ask your doctor before taking any other medication for pain, arthritis, fever, or swelling. Many medicines available over the counter contain aspirin, salicylates, or other medicines similar to naproxen (such as ibuprofen or ketoprofen). Taking certain products together can cause you to get too much of this type of medication.

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb naproxen.

Naprosyn side effects

Get emergency medical help if you have signs of an allergic reaction to Naprosyn (runny or stuffy nose, wheezing or trouble breathing, hives, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using Naprosyn and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using Naprosyn and call your doctor at once if you have:

• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• the first sign of any skin rash, no matter how mild;
• signs of stomach bleeding – blood in the stools or dark, tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems – nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems – little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
• low red blood cells (anemia) – fatigue, pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
• severe skin reaction – fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Naprosyn side effects may include:

• indigestion, heartburn, stomach pain, nausea;
• headache, dizziness, drowsiness;
• bruising, itching, rash;
• swelling; or
• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect Naprosyn?

Ask your doctor before using Naprosyn if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist if it is safe for you to use Naprosyn if you are also using any of the following drugs:

• cholestyramine;
• cyclosporine;
• digoxin;
• lithium;
• methotrexate;
• pemetrexed;
• phenytoin or similar seizure medications;
• probenecid;
• warfarin (Coumadin, Jantoven) or similar blood thinners;
• a diuretic or “water pill”;
• heart or blood pressure medication; or
• insulin or oral diabetes medicine.

What is naproxen?

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Naproxen is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps. It can also be used to treat acute pain caused by other conditions not listed in this medication guide.

The delayed-release or extended-release tablets are slower-acting forms of naproxen that are used only for treating chronic conditions such as arthritis or ankylosing spondylitis. These forms will not work fast enough to treat acute pain.

Naproxen is also available in combination with other medications under the following brand names: Aleve PM, Aleve-D Sinus and Cold, Treximet, and Vimovo

Naproxen side effects

Common naproxen side effects

Common naproxen side effects may include indigestion, heartburn, stomach pain, nausea, headache, dizziness, drowsiness, bruising, itching, rash, swelling or ringing in your ears.

Serious naproxen side effects

Get emergency medical help if you have signs of an allergic reaction to naproxen (runny or stuffy nose, wheezing or trouble breathing, hives, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using naproxen and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using naproxen and call your doctor at once if you have:

• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• the first sign of any skin rash, no matter how mild;
• signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems – nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems – little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
• low red blood cells (anemia) – pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
• severe skin reaction – fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

You should not use naproxen if you have a history of allergic reaction to aspirin or other NSAID (nonsteroidal anti-inflammatory drug).

Naproxen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have swelling of the face or throat, chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance. Stop taking naproxen and notify your physician if you notice stomach pain, tiredness or weakness, yellow skin or eyes, nausea, vomiting, bloody or black and sticky bowel movements, skin rash, unexplained weight loss or weight gain, or swelling of the hands and feet.

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

Before taking this medicine

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

You should not use naproxen if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Ask a doctor before giving naproxen to a child younger than 12 years old.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a history of heart attack, stroke, or blood clot;
• a history of stomach ulcers or bleeding;
• asthma;
• liver or kidney disease;
• fluid retention: or
• if you take aspirin to prevent heart attack or stroke.

If you are pregnant, you should not take naproxen unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

It may not be safe to breastfeed while using naproxen. Ask your doctor about any risk.

Naproxen is not approved for use by anyone younger than 2 years old. Do not give this medicine to a child without medical advice.

How should I take naproxen?

Use naproxen exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If you change brands, strengths, or forms of this medicine, your dosage needs may change. Ask your pharmacist if you have any questions about the kind of naproxen you are using.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Doses are based on weight in children, and any changes may affect your child’s dose.

If you use this medicine long-term, you may need frequent medical tests.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using naproxen.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

What happens if I miss a dose?

Since naproxen is sometimes used only when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin or other NSAIDs unless your doctor tells you to.

Ask your doctor before taking any other medication for pain, arthritis, fever, or swelling. Many medicines available over the counter contain aspirin, salicylates, or other medicines similar to naproxen (such as ibuprofen or ketoprofen). Taking certain products together can cause you to get too much of this type of medication.

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb naproxen.

What other drugs will affect naproxen?

Ask your doctor before using naproxen if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you are also using any of the following drugs:

• cholestyramine;
• cyclosporine;
• digoxin;
• lithium;
• methotrexate;
• pemetrexed;
• phenytoin or similar seizure medications;
• probenecid;
• warfarin (Coumadin, Jantoven) or similar blood thinners;
• a diuretic or “water pill”;
• heart or blood pressure medication; or
• insulin or oral diabetes medicine.

What is Relafen?

Relafen is a nonsteroidal anti-inflammatory drug (NSAID). Nabumetone works by reducing hormones that cause inflammation and pain in the body.

Relafen is used to relieve the symptoms of rheumatoid arthritis or osteoarthritis.

Relafen may also be used for purposes not listed in this medication guide.

Warnings

Relafen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Relafen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Relafen, especially in older adults.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to Relafen (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking Relafen. Alcohol can increase the risk of stomach bleeding caused by nabumetone. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Relafen can make your skin more sensitive to sunlight and sunburn may result.

Before taking this medicine

Relafen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Relafen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Relafen, especially in older adults.

You should not use Relafen if you are allergic to nabumetone, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure Relafen is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• asthma;
• liver or kidney disease; or
• fluid retention.

If you are pregnant, you should not take Relafen unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Relafen is not FDA-approved for use by anyone younger than 18 years old.

How should I take Relafen?

Take Relafen exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

You may take Relafen with or without food.

If you use this medicine long-term, you may need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Dosing information

Usual Adult Dose for Osteoarthritis:

Initial: 1000 mg orally once a day at bedtime.
Maintenance: 1500 to 2000 mg orally in 1 to 2 divided doses, to a maximum daily dose of 2000 mg.

Usual Adult Dose for Rheumatoid Arthritis:

Initial: 1000 mg orally once a day at bedtime.
Maintenance: 1500 to 2000 mg orally in 1 to 2 divided doses, to a maximum daily dose of 2000 mg.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid drinking alcohol and smoking. It may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to Relafen. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Avoid exposure to sunlight or tanning beds. Relafen can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Relafen side effects

Get emergency medical help if you have signs of an allergic reaction to Relafen: (hives, sneezing, runny or stuffy nose, wheezing, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using Relafen and call your doctor at once if you have:

• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• the first sign of any skin rash, no matter how mild;
• signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems – nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems – little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
• low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common Relafen side effects may include:

• stomach pain, indigestion, nausea;
• diarrhea, constipation, gas;
• swelling in your hands and feet;
• headache, dizziness;
• itching, skin rash; or
• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Relafen?

Ask your doctor before using Relafen if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• lithium;
• methotrexate;
• a blood thinner (examples: warfarin, Coumadin, Jantoven, apixaban, dabigatran, rivaroxaban);
• heart or blood pressure medication, including a diuretic or “water pill”; or
• steroid medicine (such as prednisone).