Colchicine is an oral, plant-based prescription alkaloid derived from the dried seeds of the autumn crocus or meadow saffron (Colchicum autumnale) that, depending on the brand or generic, may be used to:

• treat and prevent gout flares in adults (Colcrys, generics)
• prevent gout flares in adults and children aged 16 years and older (Colcrys, Gloperba, Mitigare, generics)
• treat symptoms of Behçet disease (BD), such as redness, swelling, or pain) (generics)
• treat familial Mediterranean fever (FMF) in adults and children 4 years of age or older (Colcrys)
• reduce the risk of heart attack, stroke, and cardiovascular death in adults with heart disease or at high risk of developing it (Lodoco tablets).

Colchicine is not an analgesic medication and should not be used to treat pain from other causes.

How colchicine works is not fully understood. However, it’s believed the mechanism of action (MOA) of colchicine is to reduce the inflammatory reaction to urate crystals by interfering with a process in white blood cells that triggers inflammation and prevents their migration to areas of inflammation. Colchicine does not affect uric acid production or excretion.

Colchicine was initially approved in 1961 and developed before federal regulations requiring FDA review of all marketed drug products. Colchicine may also be used for purposes not listed here.

Colchicine uses

Colcrys tablets 0.6 mg are FDA-approved to:

• treat or prevent gout in adults (FDA-approval October 22, 2009)
• treat a genetic condition called Familial Mediterranean Fever in adults and children who are at least 4 years old (FDA-approval July 31,  2009).

Mitigare capsules 0.6 mg are FDA-approved to prevent gout flares in adults (FDA-approval September 26, 2014).

Gloperba oral solution (0.6 mg/5mL) is FDA-approved to prevent gout attacks (FDA-approval January 30, 2019).

Lodoco tablets 0.5 mg are FDA-approved to lower the risk of heart attack, stroke, and cardiovascular death in adults with heart disease or at high risk of developing it (FDA-approval June 16, 2023). 

Generic forms of colchicine (colchicine 0.6 mg) have been used to treat or prevent attacks of gout, or to treat symptoms of Behcet’s syndrome (such as swelling, redness, warmth, and pain).

Colchicine is not a cure for gouty arthritis or Behcet’s syndrome, and it will not prevent these diseases from progressing.

Colchicine side effects

The most common side effects of colchicine are gastrointestinal symptoms, including diarrhea, nausea, vomiting, and abdominal (stomach) pain

Serious side effects and warnings

Do not take colchicine if you have liver or kidney problems and you take certain other medicines. Serious side effects, including death, have been reported in these patients even when taken as directed.

Blood problems (such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia) have been reported (have happened in some people taking colchicine. Get medical help right away if you have a pale or gray color to your lips, tongue, or palms of your hands; feel weak or tired; unusual bleeding or bruising; or increased infections

Muscle weakness has happened in some people taking colchicine. Get medical help right away if you have any of these symptoms muscle weakness or pain, numbness, or tingling in your fingers or toes.

Colchicine can cause serious side effects or death if levels of colchicine are too high in your body. Get medical help right away if you have:

• Muscle weakness or pain
• Numbness or tingling in your fingers or toes
• Unusual bleeding or bruising
• Increased infections
• Feel weak or tired
• Pale or gray color to your lips, tongue, or palms of your hands
• Severe diarrhea or vomiting.

These are not all of the possible side effects of colchicine For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

Before taking

Do not take colchicine if you have liver or kidney problems and you take certain other medicines. Serious side effects, including death, have been reported in these patients even when taken as directed.

Before you take colchicine, tell your healthcare provider about all your medical conditions, including if you:

• have liver or kidney problems
• take other medications, including ones that are only taken for a short time, such as antibiotics, because they may interact with colchicine
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Your dose of colchicine may need to be changed.

Colchicine may rarely and transiently impair fertility in males who can father children.

Pregnancy

 It is not known if colchicine will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.

Breastfeeding

Colchicine passes into your breast milk. You and your healthcare provider should decide if you will take colchicine or breastfeed. If you take colchicine and breastfeed, you should talk to your child’s healthcare provider about how to watch for side effects in your child.

How should I take colchicine?

Take colchicine exactly as your healthcare provider tells you to take it. If you are not sure about your dosing, call your healthcare provider.

• Colchicine tablets, capsules, or the solution can be taken with or without food.
• Measure Gloperba liquid with an accurate milliliter measuring device. A household teaspoon is not an accurate measuring device. Ask your pharmacist to recommend a measuring device and for instructions on how to measure the correct dose.

Gastrointestinal symptoms, such as diarrhea, are often the first sign of colchicine toxicity. Contact your healthcare provider immediately if new symptoms develop.

If you have a gout flare while taking colchicine daily, report this to your healthcare provider.

Do not stop taking colchicine even if you start to feel better unless your healthcare provider tells you.

Colchicine dosage

Dosage adjustments may be needed in patients with kidney or liver disease, younger patients, or when colchicine is taken with certain other medications.

• Your healthcare provider may do blood tests while you take colchicine.

How to take colchicine for gout flares in adults

Colcrys: 1.2 mg (two tablets) at the first sign of a gout flare followed by 0.6 mg (one tablet) one hour later.

• The maximum recommended dose of colchicine for the treatment of gout flares is 1.8 mg over one hour.
• Do not repeat this course for at least 3 days.
• Colchicine is taken to ease the pain of a gout attack.
• After taking the colchicine dose to treat a gout attack (flare), wait 12 hours and then resume the preventive dose.
• If you are already taking colchicine to prevent gout flares, talk to your healthcare provider about what you should take during a gout flare. 

How to take colchicine to prevent gout flares in adults

Colcrys: 0.6 mg once or twice daily in adults and adolescents older than 16 years. Maximum dose 1.2 mg/day.

Mitigare: 0.6 mg once or twice daily.  Maximum dose 1.2 mg per day.

Gloperba: 0.6 mg (5 mL) once or twice daily. Maximum dose 1.2 mg/day.

Colchicine dosage for Familial Mediterranean fever (FMF)

Colcrys:

• Adults and children older than 12 years: 1.2 – 2.4 mg
• Children 6 to 12 years: 0.9 – 1.8 mg
• Children 4 to 6 years: 0.3 – 1.8 mg.

Give the total daily dose in one or two divided doses.

Increase or decrease the dose as indicated and as tolerated in increments of 0.3 mg/day, not to exceed the maximum recommended daily dose

Colchicine dosage for Behçet disease (BD)

Generic colchicine: Experimental doses ranged from colchicine 0.6 mg/day to 2 mg/day in divided doses.

Colchicine dosage to reduce the risk of heart attack, stroke, and cardiovascular death

Lodoco tablets: 0.5 mg (1 tablet) daily.

Colchicine poisoning

Colchicine is extremely dangerous if too much is taken. Even small amounts can be fatal, especially in children. The difference between a safe dose and an overdose is very small. Many people have died after accidentally taking too much colchicine. Handle and store colchicine carefully.

What happens if I miss a dose?

If you take colchicine daily and you miss a dose, then take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take two doses at the same time.

What happens if I overdose?

 If you take too much colchicine, go to the nearest hospital emergency room right away.

 Fatal overdoses have been reported with colchicine in adults and children. Keep out of the reach of children.

What should I avoid while taking colchicine?

Avoid eating grapefruit or drinking grapefruit juice while taking colchicine. It can increase your chances of getting serious side effects.

Colchicine interacts with many other medications. Do not start a new medication without asking your healthcare provider first if it interacts with colchicine.

What other drugs can affect colchicine?

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Taking certain medicines with colchicine can cause your level of colchicine to become too high, especially if you have kidney or liver problems.

Even medicines that you take for a short period, such as antibiotics, can interact with colchicine and cause serious side effects or death. Especially tell your healthcare provider if you take:

• atazanavir sulfate (Reyataz)                
• clarithromycin (Biaxin)
• cyclosporine (Neoral, Gengraf, Sandimmune)
• darunavir (Prezista)
• digoxin
• fosamprenavir (Lexiva) with or without  ritonavir
• indinavir (Crixivan)                    
• itraconazole (Sporanox)
• ketoconazole (Nizoral)                           
• lopinavir/ritonavir (Kaletra)
• nefazodone (Serzone)                            
• nelfinavir mesylate (Viracept)
• ritonavir (Norvir)                         
• saquinavir mesylate (Invirase)
• telithromycin (Ketek)               
• tipranavir (Aptivus).

Using colchicine with HMG CoA reductase inhibitors (such as simvastatin, atorvastatin, or pravastatin), gemfibrozil, and fenofibric acid or cyclosporine may potentiate the development of muscle problems, including muscles weakness, or fatigue.

Co-administration of colchicine with dual CYP3A4 and P-gp inhibitors (such as clarithromycin or cyclosporine) has resulted in life-threatening interactions and death.

Grapefruit and grapefruit juice may also interact and should not be consumed during colchicine treatment.

Ask your healthcare provider or pharmacist if you are not sure if you take any of the medicines listed above. This is not a complete list of all the medicines that can interact with Colchicine. See the colchicine prescribing information for a complete list. Do not start a new medicine without talking to your healthcare provider.

Colchicine storage

Store colchicine tablets and liquid at room temperature between 68°F and 77°F (20°C and 25°C).

Keep in a tightly closed container, away from light.

Keep out of the reach of children.

Colchicine ingredients

Colcrys 0.6 mg tablets

Active Ingredient: colchicine 0.6 mg             

Inactive Ingredients: carnauba wax, FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin.

Mitigare 0.6 mg capsule

Active Ingredient: colchicine 0.6 mg             

Inactive Ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate,

microcrystalline cellulose and sodium starch glycolate.

The capsule shell contains gelatin, purified water, titanium dioxide, erythrosine, Brilliant Blue FCF, and Quinoline Yellow.

Lodoco 0.5 mg tablets

Active Ingredient: colchicine 0.5 mg             

Inactive Ingredients: gelatin, lactose monohydrate, magnesium stearate, potato starch, and talc.

Gloperba 0.6 mg/5 mL oral solution

Active Ingredient: colchicine 0.6 mg/5 mL oral solution

Inactive Ingredients: benzyl alcohol, FD&C Red No. 40, artificial cherry flavor, anhydrous citric acid, dibasic sodium phosphate, glycerin, propylene glycol, sucralose, xanthan gum, and purified water.

Generic colchicine 0.6 mg tablets

Refer to the manufacturer’s medication guide.

Generic colchicine 0.6 mg capsules

Refer to the manufacturer’s medication guide.

Who makes colchicine?

Takeda Pharmaceuticals U.S.A., Inc. makes Colcrys.

West-Ward Columbus Inc. makes Mitigare capsules for Hikma Americas Inc.

Agepha Pharma USA, LLC. distributes Lodoco.

Gloperba is manufactured for Scilex Pharmaceuticals, Inc.

Various manufacturers make generic colchicine 0.6 mg tablets including Camber Pharmaceuticals, Inc., Ascend Laboratories, LLC., and Actavis Pharma, Inc.

Various manufacturers make generic colchicine 0.6 mg capsules including Par Pharmaceuticals, Inc., Aurobindo Pharma Limited, and Hikma Pharmaceuticals USA Inc.

What is allopurinol?

Allopurinol belongs to a class of medications called xanthine oxidase inhibitors. It works by reducing the production of uric acid in the body. High levels of uric acid may cause gout attacks or kidney stones.

Allopurinol is used to treat gout (a type of arthritis in which uric acid, a naturally occurring substance in the body, builds up in the joints and causes sudden attacks of redness, swelling, pain, and heat in one or more joints). Allopurinol is used to prevent gout attacks, not to treat them once they occur. Allopurinol does not need to be stopped during an acute flare.

Allopurinol is also used to treat high levels of uric acid that builds up in the blood as tumors break down in people with certain types of cancer who are being treated with chemotherapy medications. It is also used to treat kidney stones that have come back in people who have high levels of uric acid in their urine.

Warnings

You should not use this medicine if you have ever had an allergic reaction to allopurinol.

Allopurinol can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

In rare cases, allopurinol may cause a severe allergic reaction. Stop taking this medicine and call your doctor right away if you have painful urination, blood in your urine, burning in your eyes, swelling in your face or throat, skin redness or a rash that spreads and causes blistering and peeling.

Avoid drinking alcohol. It can make your condition worse. Allopurinol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Before taking this medicine

You should not use allopurinol if you are allergic to it.

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

• diabetes;
• congestive heart failure;
• high blood pressure;
• if you are receiving chemotherapy;
• if you have a gene variation called HLA-B*58:01 allele (your doctor can test you for this);
• liver disease; or
• kidney disease.

Allopurinol may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

How should I use allopurinol?

Take allopurinol exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take the tablets with a full glass of water. To reduce your risk of kidney stones, drink 8 to 10 full glasses of fluid every day, unless your doctor tells you otherwise.

Take with food if allopurinol tablets upsets your stomach.

Allopurinol injection is injected into a vein by a healthcare provider. The injection is usually only used if you are unable to take medicine by mouth.

You may need frequent medical tests while using this medicine, even if you have no symptoms.

Your kidney and liver function may also need to be tested. Your doctor may change your dose if your kidney function changes.

You may have gout attacks when you first start taking allopurinol tablets. Your doctor may recommend another gout medication to take with allopurinol. Keep taking the medicine as directed.

Your symptoms may not improve for up to 2 to 6 weeks. Call your doctor if your symptoms do not improve after 6 weeks.

You may need to follow a special diet to help prevent kidney stones. Follow all instructions of your doctor or dietitian. Learn about the foods you should eat or avoid.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take allopurinol 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.

Call your doctor for instructions if you miss an appointment for your allopurinol injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using allopurinol?

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

Avoid drinking alcohol.

Allopurinol side effects

Get emergency medical help if you have signs of an allergic reaction to allopurinol (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.

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

• any skin rash, no matter how mild;
• painful urination, blood in the urine;
• inflammation of your blood vessels – numbness or tingling, skin rash, fever, headache, body aches, night sweats, weight loss, feeling or weak or tired;
• signs of infection – fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or
• liver problems – loss of appetite, weight loss, stomach pain (upper right side), itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common allopurinol side effects may include:

• an increase in gout attacks when you first start taking this medicine;
• rash;
• drowsiness;
• abnormal liver function tests;
• nausea, vomiting, diarrhea; or
• kidney problems – swelling, urinating less, feeling tired or short of breath.

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 allopurinol?

Tell your doctor about all your other medicines, especially:

• azathioprine or mercaptopurine;
• chlorpropamide;
• cyclosporine;
• cancer medicine;
• other gout medications;
• an antibiotic such as ampicillin or amoxicillin;
• a blood thinner such as warfarin, Coumadin, Jantoven; or
• a diuretic or “water pill”.