Oral budesonide is used to treat the following conditions with inflammation as a symptom:

• Eosinophilic esophagitis (EoE) in adults and children 11 years and older for up to 12 weeks (Eohilia [budesonide oral suspension 2 mg/10 mL])
• Active, mild to moderate Crohn’s disease (CD) that involves the ileum and/or ascending colon in adults and children 8 years and older who weigh at least 55 pounds (25 kg). Also used in adults for up to 3 months to maintain clinical remission in CD (Entocort EC, generic, and Ortikos [budesonide extended-release capsules 3 mg, 6 mg, 9 mg])
• Active, mild to moderate ulcerative colitis in adults, to help induce remission (Uceris and generic [budesonide extended-release tablets 9 mg])
• Primary immunoglobulin A nephropathy (IgAN) to reduce the loss of kidney function in those who are at risk for disease progression (Tarpeyo [budesonide delayed release capsules 4 mg])

Budesonide works by preventing the activation of inflammatory cells (such as mast cells, eosinophils, and neutrophils) and blocking inflammatory mediators such as histamine and cytokines, which are involved in allergic responses. Exactly how it works for EoE is not fully understood, but inflammation plays a key role in EoE development. It belongs to the drug class called corticosteroids.

Budesonide is a potent anti-inflammatory corticosteroid, 200 times stronger than cortisol and 15 times stronger than prednisolone. It has high glucocorticoid effects (strong effects on inflammation, immune system, wound healing, and intermediary metabolism) and weak mineralocorticoid effects (less effects on water, salt, and mineral metabolism).

Budesonide oral FDA approvals are as follows:

• Eohilia (budesonide oral suspension 2 mg/10 mL; February 9, 2024). No generic.
• Entocort EC (budesonide extended-release capsule 3 mg; October 2, 2001). Generic available.
• Ortikos (budesonide extended-release capsule 6 mg, 9 mg; June 13, 2019 [discontinued]).  
• Uceris (budesonide extended-release tablet 9 mg; January 14, 2013). Generic available.
• Tarpeyo (budesonide delayed-release capsule 4 mg; December 15, 2021). No generic. 

Budesonide side effects

The most common side effects of budesonide oral suspension (Eohilia) are:

• respiratory tract infection
• sore throat
• fungal infections of the mouth, throat, and esophagus (thrush)
• adrenal suppression
• headache
• acid-related damage to the lining of the esophagus (erosive esophagitis)
• infection of the stomach and intestine (gastroenteritis).

The most common side effects of budesonide extended-release capsules (Entocort EC, Ortikos, generic) are:

• headache
• infection in your air passages (respiratory infection)
• nausea
• back pain
• indigestion 
• dizziness
• stomach area (abdominal) pain
• gas
• vomiting
• tiredness
• pain.

The most common side effects of budesonide delayed-release capsules (Tarpeyo) are:

• swelling of the lower legs, ankles, and feet
• high blood pressure
• muscle spasms
• acne
• headache
• upper respiratory tract infection
• swelling of the face
• weight increase
• indigestion
• irritation or inflammation of the skin
• joint pain
•  increased white blood cell count

The most common side effects of budesonide extended release tablets (Uceris, generic) are:

• headache
• nausea
• decreased blood cortisol levels
• stomach-area pain
• tiredness
• stomach or intestinal gas
• bloating
• acne
• urinary tract infection
• joint pain
• constipation.

Serious side effects and warnings

Budesonide (oral) may cause the following serious side effects:

• Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-term use of budesonide may cause you to have elevated levels of corticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms:
  • acne
  • thicker body hair and facial hair
  • bruise easily
  • a fatty pad or hump between your shoulders (buffalo hump)
  • rounding of your face
  • pink or purple stretch marks on the skin of your abdomen, thighs, breasts, and arms
  • ankle swelling.
• Adrenal suppression. Long-term use of budesonide can cause a condition in which the adrenal glands do not make enough steroid hormones (adrenal suppression). Tell your healthcare provider if you are under stress or if you have any of the following signs or symptoms:
  • tiredness
  • nausea and vomiting
  • weakness
  • low blood pressure.
• Decreased ability of your body to fight infections (immunosuppression) and increased risk of infection. Corticosteroid medicines, including budesonide, lower the ability of your immune system to fight infections and increase the risk of infections caused by viruses, bacteria, fungi, protozoans, or certain parasites. Corticosteroid medicines, including budesonide, can also:
  • make current infections worse
  • increase the risk of infections spreading (disseminated)
  • increase the risk of making infections active again or making infections worse that have not been active (latent)
  • hide (mask) some signs of infection

These infections can be mild, but can also be severe and lead to death. Your healthcare provider should check you closely for signs and symptoms of an infection while taking budesonide. Tell your healthcare provider right away about any signs or symptoms of a new or worsening infection while taking budesonide, including flu-like symptoms such as:

• • fever
  • cough
  • chills
  • pain
  • stomach area (abdominal) pain
  • feeling tired
  • aches 
  • nausea and vomiting
  • diarrhea.
• Tuberculosis: If you have inactive (latent) tuberculosis, your tuberculosis may become active again while taking budesonide. Your healthcare provider should check you closely for signs and symptoms of tuberculosis while taking budesonide.
• Chicken pox and measles: People taking corticosteroid medicines, including budesonide, who have not had chicken pox or measles, should avoid contact with people who have these diseases. Tell your healthcare provider right away if you come in contact with anyone who has chicken pox or measles.
• Hepatitis B virus (HBV) reactivation: If you are a carrier of HBV, the virus can become an active infection again while taking budesonide. Your healthcare provider will test you for HBV before you start taking budesonide.
• Amebiasis: Inactive (latent) amebiasis may become an active infection while taking budesonide. Your healthcare provider should check you for amebiasis before you start taking budesonide if you have spent time in the tropics or have unexplained symptoms.
• Fungal infections of the mouth (thrush), throat, and esophagus in patients using budesonide may occur. Symptoms of infection include
  • white spots in the mouth, a burning or painful sensation in your mouth, redness inside of your mouth, difficulty with eating or
  • swallowing, loss of taste, and a feeling like cotton is in your mouth. Tell your healthcare provider if any of the above symptoms occur.
• Erosive esophagitis. Budesonide can cause acid-related damage to the lining of the esophagus. Tell your healthcare provider if you notice any new or worsening signs or symptoms such as:
  • heartburn
  • chest pain
  • trouble swallowing.
• Effect on growth. Taking corticosteroids can affect your child’s growth. Tell your healthcare provider if you are worried about your child’s growth. Your healthcare provider may monitor the growth of your child while taking budesonide.
• Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to budesonide may cause your allergies to come back. These allergies may include a skin condition called eczema or inflammation inside your nose (rhinitis). Tell your healthcare provider if any of your allergies become worse while taking budesonide.
• Kaposi’s sarcoma: Kaposi’s sarcoma has happened in people who receive corticosteroid therapy, most often for treatment of long-lasting (chronic) conditions.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

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

Before taking this medicine

You should not use budesonide if you are allergic to budesonide, Eohilia, Ortikos, Tarpeyo, Uceris, Entocort EC, or any of the excipients in oral budesonide products.

Before you take budesonide tell your healthcare provider if you have any other medical conditions including if you:

• have liver problems
• are planning to have surgery
• have chicken pox or measles, or have recently been near anyone with chicken pox or measles
• have certain kinds of infections that have not been treated, including fungal infections, bacterial infections, and viral infections
• parasitic infections, including threadworm (Strongyloides) infections
• herpes simplex infection of the eye (ocular herpes simplex)
• have or had tuberculosis
• have malaria of the brain (cerebral malaria)
• have an infection of the mouth, throat, or esophagus
• have diabetes or glaucoma, or have a family history of diabetes or glaucoma
• have cataracts
• have high blood pressure (hypertension)
• have low bone mineral density or osteoporosis
• have stomach ulcers
• have a weak immune system
• have unexplained diarrhea
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Steroids can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have. Tell your doctor about any recent, active, or chronic illness, especially any type of infection caused by bacteria, virus, fungus, or parasites, including threadworm.

Pregnancy

Budesonide may harm your unborn baby. Talk to your healthcare provider about the possible risk to your unborn baby if you take budesonide when you are pregnant. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during your treatment with budesonide.

Breastfeeding

It is not known if budesonide passes into your breast milk or if it will affect your baby. Talk to your healthcare provider about the best way to feed your baby if you take budesonide.

The Tarpeyo Prescribing information recommends routine monitoring of linear growth in infants with long-term use of budesonide in women who are breastfeeding.

How should I take budesonide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

How you take budesonide depends on your condition and the formulation or brand you are prescribed.

Budesonide oral suspension

Eohilia stick packs

See the detailed Instructions for Use that comes with Eohilia for information about how to prepare and take Eohilia and how to properly store and throw away (dispose of) used Eohilia stick packs. Take Eohilia exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Eohilia to take.

• Eohilia is taken 2 times a day (1 time in the morning and 1 time in the evening).
• Shake the stick pack for at least 10 seconds before opening. After opening the top, squeeze the stick pack from bottom to top to dispense contents directly into the mouth.
• Repeat this 2 to 3 times until the stick pack is empty. Swallow all of the suspension and avoid eating or drinking anything for 30 minutes.
• After 30 minutes, rinse your mouth with water and spit out the contents without swallowing.

Do not mix Eohilia with food or liquid.

Do not eat or drink at the same time as taking Eohilia. Wait to eat or drink at least 30 minutes after taking Eohilia.

Your healthcare provider may change your dose if needed. Do not change your dose or stop taking Eohilia unless your healthcare provider tells you.

Budesonide extended-release capsules

Entocort EC extended-release capsules and generic

Take Entocort EC exactly as your healthcare provider tells you. Your healthcare provider will tell you how many Entocort EC capsules to take. Your healthcare provider may change your dose if needed.

• Take Entocort EC 1 time each day in the morning.
• Swallow the capsules whole. Do not chew or crush the capsules before swallowing.

For patients unable to swallow a whole capsule, Entocort EC capsules can be opened and administered as follows:

1. Place 1 tablespoonful of applesauce into a clean container, such as an empty bowl. The applesauce used should not be hot and should be soft enough to be swallowed without chewing.
2. Open the capsule. You may need to use more than 1 Entocort EC capsule for the dose prescribed by your healthcare provider.
3. Carefully empty all of the granules inside the capsule on the applesauce.
4. Stir the granules with the applesauce.
5. Swallow the applesauce and granules mixture within 30 minutes after preparing it. Follow the applesauce and granules immediately with a glass (8 ounces) of cool water to help with complete swallowing of the granules. Do not chew or crush the granules.
6. Do not save the applesauce and granules for later use.

Ortikos extended-release capsules

Take Ortikos exactly as your healthcare provider tells you. Your healthcare provider will tell you how many capsules to take. Your healthcare provider may change your dose if needed.

• Take Ortikos 1 time each day, in the morning.
• Swallow the capsules whole. Do not chew or crush the capsules before swallowing.

Budesonide extended-release tablets

Uceris extended-release tablets and generic

Take Uceris extended-release tablets exactly as your healthcare provider tells you to take them.

• Take Uceris 1 time each day in the morning with or without food.
• Swallow the tablets whole with water. Do not chew, crush, or break the tablets before swallowing.

Budesonide delayed-release capsules

Tarpeyo delayed-release capsules

Take Tarpeyo exactly as your healthcare provider tells you. Your healthcare provider will decide how long you should take Tarpeyo. Do not stop taking Tarpeyo without first talking with your healthcare provider.

• Take Tarpeyo 1 time each day in the morning, at least 1 hour before a meal.
• Swallow Tarpeyo capsules whole. Do not open, chew, crush, or break Tarpeyo capsules before swallowing.

Dosing information

The dosage of budesonide depends on your condition and the formulation or brand you are prescribed.

Budesonide oral suspension 2 mg/10 mL

Dosage for EOS (Eohilia): 2 mg twice daily for 12 weeks.

• 2mg is contained in one Eohilia stick pack.

Budesonide extended-release capsules

Dosage for the treatment of Crohn’s disease (Entocort EC, Ortikos, generic):

• Adults: 9 mg once daily for up to 8 weeks
• Repeat 8-week courses with recurring episodes of active disease
• Children 8 through 17 years (weight > 25 kg): 9 mg once daily for up to 8 weeks followed by 6 mg once daily for 2 weeks.

Dosage for the maintenance of clinical remission of Crohn’s disease (Entocort EC, Ortikos, generic):

• Adults: 6 mg once daily for up to 3 months.
• Taper to complete cessation after 3 months.
• Continued treatment for more than 3 months has not been shown to provide substantial clinical benefit.
• When switching from oral prednisolone, begin tapering prednisolone concomitantly with initiating Ortikos.

Budesonide delayed-release tablets 

Dosage for ulcerative colitis (Uceris, generic)

• 9 mg once daily in the morning with or without food for up to 8 weeks.

Budesonide delayed-release capsules

Dosage for the treatment of IgAN in adults (Tarpeyo)

• 16 mg once daily
• Take in the morning at least 1 hour before food.
• The recommended duration of therapy is 9 months.
• When discontinuing, reduce the dosage to 8 mg once daily for the last 2 weeks.

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.

If you take budesonide for primary immunoglobulin A nephropathy, skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I take too much budesonide?

If you take too much budesonide, call your healthcare provider right away or go to the nearest hospital emergency room.

What should I avoid while taking budesonide?

Grapefruit may interact with budesonide and cause side effects. Avoid consuming grapefruit products.

Avoid receiving a “live” vaccine and being near people who are sick or have infections. The vaccine may not work as well while you are using budesonide. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). Also call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using budesonide.

What other drugs will affect budesonide?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially if you use stomach acid reducers.

This list is not complete. Other drugs may affect budesonide, including prescription and over-the-counter medicines, vitamins, and herbal products.

Storage

Eohilia: Store between 36°F to 77°F (2°C to 25°C). May be refrigerated. Do not freeze.

Entocort EC and generic: Store at room temperature between 68°F to 77°F (20°C to 25°C).

Ortikos: Store at room temperature between 68° to 77°F (20° to 25°C). Keep in a tightly closed container.

Uceris and generic: Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed.

Tarpeyo: Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed.

Keep all medicines out of the reach of children.

Ingredients

Eohilia ingredients

Active ingredient: budesonide

Inactive ingredients: acesulfame potassium, ascorbic acid, Avicel® RC-591, cherry flavor, citric acid, dextrose, disodium ethylenediaminetetraacetic acid (EDTA), glycerin, Magnasweet® 110, maltodextrin, polysorbate 80, potassium sorbate, sodium ascorbate, sodium benzoate, sodium citrate, and purified water. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

Entocort EC ingredients

Active ingredient: budesonide

Inactive ingredients: ethylcellulose, acetyltributyl citrate, methacrylic acid copolymer type C, triethyl citrate, antifoam M, polysorbate 80, talc, and sugar spheres.

The capsule shell contains: gelatin, iron oxide, and titanium dioxide.

Ortikos ingredients

Active ingredient: budesonide

Inactive ingredients: acetyl tributyl citrate, corn starch, ethylcellulose aqueous dispersion, methacrylic acid and ethyl acrylate copolymer dispersion, polysorbate 80, simethicone emulsion, sucrose, talc, and triethyl citrate.

Capsule shell contains gelatin, iron oxide black (for 6 mg), iron oxide red, iron oxide yellow, sodium lauryl sulphate, and titanium dioxide.

The imprinting ink contains black iron oxide, potassium hydroxide, and shellac.

Uceris ingredients

Active Ingredient: budesonide

Inactive ingredients: stearic acid, lecithin, microcrystalline cellulose, hydroxypropyl cellulose, lactose, silicon dioxide, magnesium stearate, methacrylic acid copolymer types A and B, talc, triethyl citrate, and titanium dioxide.

Tarpeyo ingredients

Active ingredient: budesonide

Inactive ingredients: sugar spheres (sucrose and starch), hypromellose, polyethylene glycol, citric acid monohydrate, ethyl cellulose, medium chain triglycerides and oleic acid.

The capsules contain: hypromellose and titanium oxide (E171).

The printing ink on the capsules contains: shellac, propylene glycol and black iron oxide (E172).

The enteric coating on the capsules contains: methacrylic acid and methacrylate copolymer, talc and dibutyl sebacate.

Who makes budesonide?

Budesonide is made by various manufacturers.

Budesonide oral suspension (2 mg/10 mL, Eohilia) is made by Takeda Pharmaceuticals America, Inc., in Lexington, MA.

Budesonide extended-release oral capsules (3 mg, Entocort EC brand) are made by Perrigo. They acquired the rights to this medication from AstraZeneca in 2015. Perrigo is headquartered in Dublin, Ireland, with U.S. operations based in Michigan, USA.

• A generic Entocort 3mg delayed-release oral capsule 3 mg is available manufactured by Aurobindo Pharma USA, Zydus Pharma, Amneal Pharma, Dr Reddys Labs SA, and Rising.

Budesonide extended-release oral capsules (6 mg, 9 mg, Ortikos brand) were made by Sun Pharmaceutical Industries Ltd., in Gujarat, India.

Budesonide extended-release oral tablets (9 mg, Uceris brand) are made by Bausch Health Companies Inc. (formerly known as Valeant Pharmaceuticals). Salix Pharmaceuticals is the specific division or subsidiary of Bausch Health Companies that markets and distributes Uceris tablets.

• A generic Uceris extended-release oral tablet 9 mg is made by Actavis Labs FL Inc., and Mylan.

Budesonide delayed release capsules (4mg, Tarpeyo) are made by Calliditas Therapeutics AB, with headquarters in Stockholm, Sweden.

The Colazal brand of balsalazide is used to treat mild to moderate active ulcerative colitis in adults and children who are at least 5 years old.

The Giazo brand of balsalazide is used to treat mild to moderate active ulcerative colitis in men who are at least 18 years old.

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

Balsalazide side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Balsalazide may cause serious side effects. Call your doctor at once if you have:

• pain or burning when you urinate;
• worsening colitis symptoms–fever, stomach pain, cramps, or bloody diarrhea;
• kidney problems–little or no urinating, swelling, rapid weight gain;
• liver problems–upper stomach pain, loss of appetite, 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.

Common side effects of balsalazide may include:

• headache;
• mild or occasional nausea, vomiting, stomach pain, diarrhea;
• joint pain;
• fever; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use balsalazide if you are allergic to balsalazide or mesalamine, or to aspirin or other salicylates (including Kaopectate, Pamprin, Pepto-Bismol, Tricosal, Trilisate, and others).

Tell your doctor if you have ever had:

• kidney disease;
• liver disease; or
• a stomach condition called pyloric stenosis.

Balsalazide tablets contain sodium. Talk to your doctor before using this form of balsalazide if you are on a low salt diet.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether balsalazide will harm an unborn baby. However, having active ulcerative colitis during pregnancy may cause premature delivery or low birth weight. The benefit of treating ulcerative colitis may outweigh any risks to the baby.

If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby.

Balsalazide capsules should not be given to a child younger than 5 years old. Balsalazide tablets should not be given to anyone under 18 years old.

How should I take balsalazide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Balsalazide can be taken with or without food.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away. Medicine from the capsule may stain your teeth or tongue yellow/orange when mixed with food. Do not save the mixture for later use.

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

Balsalazide is usually taken only for a short time (8 to 12 weeks). Follow your doctor’s dosing instructions very carefully.

Store at room temperature away from moisture and heat.

Balsalazide dosing information

Usual Adult Dose for Ulcerative Colitis — Active:

Oral capsules:
Usual dose: Three 750 mg capsules orally 3 times a day for up to 8 weeks
-Some patients in the clinical trials required up to 12 weeks of treatment.
-Safety and efficacy beyond 12 weeks have not been established.

GIAZO(R) tablets; male patients:
Three 1.1 gram tablets orally twice a day, with or without food, for up to 8 weeks
-Effectiveness in female patients was not demonstrated in clinical trials.
-Safety and efficacy beyond 8 weeks have not been established.

Use(s): Treatment of mildly to moderately active ulcerative colitis.

Usual Pediatric Dose for Ulcerative Colitis — Active:

5 years and older, oral capsules:
Three 750 mg capsules orally 3 times a day for up to 8 weeks
OR
One 750 mg capsule orally 3 times a day for up to 8 weeks

Comments:
-Safety and efficacy beyond 8 weeks have not been established

Use(s): Treatment of mildly to moderately active ulcerative colitis.

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 balsalazide?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Bactroban is an antibiotic that prevents bacteria from growing on your skin.

Bactroban topical (for use on the skin) is used to treat skin infections such as impetigo or a “Staph” infection of the skin.

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

Warnings

Use Bactroban cream or ointment for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed. Avoid your eyes, nose, mouth, and lips when applying Bactroban. If medication gets in any of these areas, wash with water.

Watch for signs of improvement in 3 to 5 days. If your condition gets worse or does not improve, see your doctor.

A separate formulation, Bactroban nasal ointment, is available for nasal use.

Before taking this medicine

You should not use Bactroban cream or ointment if you are allergic to mupirocin.

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

• kidney disease.

Do not use Bactroban on a child without medical advice. The cream should not be used on a child younger than 3 months old. The ointment may be used on a child as young as 2 months old.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether mupirocin topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. If you apply this medicine to your breast or nipple, wash the areas thoroughly before nursing your baby.

How should I use Bactroban?

Use Bactroban cream or ointment exactly as directed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Bactroban is for use only on the skin. If this medicine gets in your eyes, nose, or mouth, rinse with water.

Wash your hands before and after applying Bactroban.

Clean and dry the affected skin area. Use a cotton swab or gauze pad to apply a small amount of Bactroban cream or ointment as directed.

Do not spread Bactroban over large areas of skin.

Bactroban is usually applied 3 times per day for 10 days. Use only a small amount of the cream or ointment.

Use only a sterile gauze pad to cover the treated skin. Do not cover treated areas with a bandage, plastic wrap, or other covering that does not allow air to circulate.

Call your doctor if your symptoms do not improve within 3 to 5 days, or if your skin condition gets worse.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Store at room temperature away from moisture and heat. Do not freeze. Keep the medicine tube tightly closed when not in use.

What happens if I miss a dose?

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

What happens if I overdose?

An overdose of Bactroban cream or ointment is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line if anyone has accidentally swallowed the medication.

What should I avoid while using Bactroban?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid getting this medicine in your eyes, mouth, or nose. A separate product called Bactroban nasal is made for use in the nose. Bactroban topical is for use only on the skin.

Avoid using other medications on the areas you treat with Bactroban unless your doctor tells you to.

Bactroban side effects

Get emergency medical help if you have signs of an allergic reaction to Bactroban: hives; dizziness, fast or pounding heartbeats; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• severe itching, rash, or other irritation of treated skin;
• unusual skin blistering or peeling; or
• any signs of a new skin infection.

Common Bactroban side effects may include:

• burning, stinging;
• itching; or
• pain.

What is Azulfidine?

Azulfidine is used to treat ulcerative colitis (UC), and to decrease the frequency of UC attacks. This medicine will not cure ulcerative colitis, but it can reduce the number of attacks you have.

Azulfidine is also used to treat rheumatoid arthritis in children and adults who have used other arthritis medicines that did not work or have stopped working.

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

Azulfidine 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.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sore throat;
• mouth sores, red or swollen gums;
• pale skin, easy bruising, unusual bleeding; or
• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Also call your doctor at once if you have:

• fever with headache, rash, and vomiting;
• a skin rash, no matter how mild;
• severe nausea or vomiting when you first start taking Azulfidine;
• little or no urination, urine that looks foamy;
• puffy eyes, swelling in your ankles or feet, weight gain; or
• liver problems–loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of Azulfidine may include:

• nausea, vomiting, upset stomach, loss of appetite;
• headache;
• rash; or
• low sperm count in men.

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

Warnings

You should not use Azulfidine if you have porphyria, a blockage in your bladder or intestines, or if you are allergic to sulfa drugs, aspirin, or similar medicines called salicylates.

Before taking this medicine

You should not use Azulfidine if you are allergic to it, or if you have:

• a blockage in your bladder or intestines;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• an allergy to sulfa drugs; or
• an allergy to aspirin or other salicylates (such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others).

Tell your doctor if you have ever had:

• frequent infections;
• asthma;
• low blood cell counts; or
• liver or kidney disease.

Tell your doctor if you are pregnant. Taking Azulfidine can make it harder for your body to absorb folic acid, and folic acid helps prevent major birth defects of the baby’s brain or spine. You may need to take folic acid supplements if you take this medicine during pregnancy. Follow your doctor’s instructions.

Sulfasalazine can pass into breast milk and may cause diarrhea or bloody stools in a nursing baby. Tell your doctor if you are breast-feeding.

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

How should I take Azulfidine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Azulfidine after a meal.

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

You will need frequent medical tests.

Drink plenty of liquids to keep your kidneys working properly while you are taking Azulfidine.

Azulfidine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Azulfidine may cause your skin or urine to appear orange-yellow in color. Call your doctor if you also have yellowing of your eyes, brown urine, or stomach pain. These may be signs of liver problems.

If you are treating arthritis, do not stop using any of your other arthritis medicines until your doctor tells you to. Azulfidine may not improve your symptoms right away, and you may still need your other medicines for awhile.

Azulfidine is only part of a complete treatment for rheumatoid arthritis that may also include rest and physical therapy. Follow your doctor’s instructions very closely.

What is azathioprine?

Azathioprine weakens your body’s immune system, to help keep it from “rejecting” a transplanted organ such as a kidney. Organ rejection happens when the immune system treats the new organ as an invader and attacks it.

Azathioprine is used to prevent your body from rejecting a transplanted kidney. Azathioprine is also used to treat symptoms of rheumatoid arthritis.

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

Azathioprine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Azathioprine may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Stop using azathioprine and call your doctor right away if you have any of these symptoms of lymphoma:

• fever, swollen glands, body aches, night sweats, not feeling well;
• pale skin, rash, easy bruising or bleeding;
• cold hands and feet, feeling light-headed or short of breath;
• pain in your upper stomach that may spread to your shoulder; or
• feeling full after eating only a small amount, weight loss.

Also call your doctor at once if you have:

• signs of infection (fever, chills, weakness, flu symptoms, sore throat, cough, pain or burning when you urinate);
• severe nausea, vomiting, or diarrhea;
• easy bruising, unusual bleeding;
• rapid heartbeats, shortness of breath;
• pale skin, cold hands and feet; or
• dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of azathioprine may include:

• nausea, diarrhea, stomach pain;
• hair loss; or
• skin rash.

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

Warnings

Azathioprine may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis.

Before taking this medicine

You should not take azathioprine if you are allergic to azathioprine.

You should not use azathioprine to treat rheumatoid arthritis if you are pregnant. This medicine can harm an unborn baby. Use effective birth control to prevent pregnancy while using this medicine.

Azathioprine may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

While taking azathioprine, you may have a higher risk of developing skin cancer. Ask your doctor about skin symptoms to watch for.

Tell your doctor if you have ever had:

• kidney disease, or a kidney transplant (if you are using azathioprine for rheumatoid arthritis);
• any type of viral, bacterial, or fungal infection;
• liver disease; or
• chemotherapy with medications like cyclophosphamide, chlorambucil, melphalan, busulfan, and others.

You should not breast-feed while you are using azathioprine.

How should I take azathioprine?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using azathioprine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

When given for kidney transplant, azathioprine is usually given right before or on the day of transplant. For rheumatoid arthritis, azathioprine is taken on a daily basis.

It may take up to 8 weeks before your symptoms improve. Keep using azathioprine as directed and tell your doctor if your symptoms have not improved after 12 weeks of use.

Take with food if azathioprine upsets your stomach.

You may not be able to continue taking other arthritis medications together with azathioprine. Do not change your dose or dosing schedule without your doctor’s advice.

Azathioprine affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Store at room temperature away from moisture, heat, and light. Keep the bottle 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 azathioprine?

Avoid sunlight or tanning beds. Azathioprine can increase your risk of developing skin cancer. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.