- colchicine (Colcrys, Mitigare)
- Are you currently using colchicine?
- Effects and safety of long-term use of colchicine on heart disease
- Help put out today’s gout attack and prevent tomorrow’s gout flare with COLCRYS
- What you should know about colchicine
- Fatal Overdose
- Blood Dyscrasias
- Interactions With CYP3A4 And P-Gp Inhibitors
- Neuromuscular Toxicity
- Patient Counseling Information
- Nonclinical Toxicology
- Carcinogenesis, Mutagenesis, Impairment Of Fertility
- Use In Specific Populations
- Use In Pregnancy
- Labor And Delivery
- Use In Nursing Mothers
- Pediatric Use
- Geriatric Use
- Renal Impairment
- Hepatic Impairment
- Colchicine Toxicity Prompts Dosage Change
- 6mg maximum dose in acute gout
- 3mg maximum dose for at risk patients
- Intensive regimen should not be repeated for 3 days
- Dose reduction based on published evidence of toxicity
- Steroids recommended for colchicine therapeutic failures
- Co-administration of NSAIAs with colchicine should be avoided
- Hospitalisation essential for suspected overdose
- About colchicine
- Before taking colchicine
- How to take colchicine
- Getting the most from your treatment
- Can colchicine cause problems?
- How to store colchicine
- Important information about all medicines
- Colchicine Side Effects
- In Summary
- For the Consumer
- For Healthcare Professionals
- Further information
- More about colchicine
colchicine (Colcrys, Mitigare)
Brand Names: Colcrys, Mitigare
Generic Name: colchicine
- What is colchicine (Colcrys, Mitigare)?
- What are the possible side effects of colchicine (Colcrys, Mitigare)?
- What is the most important information I should know about colchicine (Colcrys, Mitigare)?
- What should I discuss with my healthcare provider before taking colchicine (Colcrys, Mitigare)?
- How should I take colchicine (Colcrys, Mitigare)?
- What happens if I miss a dose (Colcrys, Mitigare)?
- What happens if I overdose (Colcrys, Mitigare)?
- What should I avoid while taking colchicine (Colcrys, Mitigare)?
- What other drugs will affect colchicine (Colcrys, Mitigare)?
- Where can I get more information (Colcrys, Mitigare)?
What is colchicine (Colcrys, Mitigare)?
Colchicine affects the way the body responds to uric acid crystals, which reduces swelling and pain.
Because colchicine was developed prior to federal regulations requiring FDA review of all marketed drug products, not all uses for colchicine have been approved by the FDA.
The Colcrys brand of colchicine is FDA-approved to treat or prevent gout in adults, and to treat a genetic condition called Familial Mediterranean Fever in adults and children who are at least 4 years old.
The Mitigare brand of colchicine is FDA-approved to prevent gout flares in adults.
Generic forms of colchicine have been used to treat or prevent attacks of gout, or to treat symptoms of Behcets syndrome (such as swelling, redness, warmth, and pain).
Colchicine is not a cure for gouty arthritis or Behcets syndrome, and it will not prevent these diseases from progressing. Colchicine should not be used as a routine pain medication for other conditions.
Colchicine may also be used for purposes not listed in this medication guide.
capsule, blue/light blue, imprinted with West ward, 118
capsule, purple, imprinted with AR 374
capsule, purple, imprinted with AR 374
Colchicine 0.6 mg 009046732
capsule, blue/light blue, imprinted with West-ward, 118
Colchicine 0.6 mg-URL
round, white, imprinted with EP 104
Colchicine 0.6 mg-WAT
round, white, imprinted with 944, DAN
Colchicine 0.6 mg-WES
round, white, imprinted with west-ward 201
What are the possible side effects of colchicine (Colcrys, Mitigare)?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- muscle pain or weakness;
- numbness or tingly feeling in your fingers or toes;
- pale or gray appearance of your lips, tongue, or hands;
- severe or ongoing vomiting or diarrhea;
- fever, chills, body aches, flu symptoms; or
- easy bruising, unusual bleeding, feeling weak or tired.
Common side effects may include:
- nausea, vomiting, stomach pain; or
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 at 1-800-FDA-1088.
What is the most important information I should know about colchicine (Colcrys, Mitigare)?
Serious drug interactions can occur when certain medicines are used together with colchicine. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.
Are you currently using colchicine?
Read the Medication Guide provided by your pharmacist before you start taking colchicine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually once or twice a day. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
The dosage is based on your medical condition, other drugs/foods you may be taking, and response to treatment. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To decrease your risk for serious side effects, do not increase your dose, take it more often, or take it for a longer time than directed by your doctor. Serious side effects may occur even at usual prescribed doses.
If your doctor directs you to take colchicine regularly, take it regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.
Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.
Effects and safety of long-term use of colchicine on heart disease
Colchicine is a very old, inexpensive treatment. It has strong effects against inflammation and is widely used in inflammatory diseases like gout. There are many studies on colchicine in inflammatory diseases. Inflammation is also an important component for the development of heart attacks or strokes. Some recent studies have shown that colchicine may have positive effects on heart disease.
We aimed to review all available studies evaluating longer-term use of colchicine. We wanted to describe the benefits and harms for people with or without established coronary heart disease. We looked at all studies that lasted at least six months, that included adults, and that compared health effects of colchicine use with the use of any other treatment. We took a closer look at people with previous heart issues.
We included 39 trials with 4992 participants in our analyses. Four trials included 1230 participants in total with heart disease. Colchicine treatment had no effect on death from any cause. There is uncertainty around the effect of colchicine on cardiovascular (heart-related) death. Results showed that cardiovascular death may be reduced, but this was not clear because some of our analyses showed a reduced risk while others did not. The risk for myocardial infarctions (heart attacks) was reduced, but this finding was based on only two studies and a total of 22 events. Colchicine did not clearly increase the risk of total harms but colchicine increased the risk for gastrointestinal intolerance, which was typically described as mild and short-lived. We found no clear effects on strokes, heart failure, emergency hospitalisations or unplanned invasive cardiac treatments.
Four of the 39 studies reported that they systematically looked for serious side effects linked to use of colchicine. Serious side effects can be life-threatening or require hospitalisation. No participant in these four studies was reported to have such a serious side effect. This means that possible serious side effects seem to be relatively rare: for example, the results indicate that among 800 people who are treated for one year, none would suffer a serious side effect. However, we have some concerns about the certainty of this result, because the reporting of serious harms in the studies was not ideal; for example, because the definitions of serious adverse events differed between studies, and it was not always clear what would be considered a serious adverse event. We found no difference in effects of colchicine in people at high cardiovascular risk.
The evidence is current to January 2015.
Overall, we found that further research would probably change our assessment of the benefits and harms of colchicine. Our findings should therefore be interpreted with caution. However, new treatments in heart diseases are urgently needed. Although there is much uncertainty around the benefits and harms of colchicine treatment, it may be associated with cardiovascular benefits, especially on myocardial infarction. We therefore think that large high-quality clinical trials should be conducted to further investigate colchicine in heart disease.
Help put out today’s gout attack and prevent tomorrow’s gout flare with COLCRYS
COLCRYS can cause serious side effects or death if levels of COLCRYS are too high in your body. Taking certain medicines with COLCRYS can cause your level of COLCRYS to be too high, even at recommended doses, especially if you have kidney or liver problems.,Tell your healthcare provider about all your medical conditions and all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements, and if you consume grapefruit juice.,Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. Keep COLCRYS out of the reach of children.,COLCRYS can also cause serious muscle problems and blood disorders even when taken as directed. You have a higher chance for muscle problems if you are elderly, are taking certain other medicines with COLCRYS, or have kidney problems.,Tell your healthcare provider if you have any side effect that bothers you or that does not go away.,The most common side effects in people who have gout flares are diarrhea (23%) and throat pain (3%).
COLCRYS (colchicine, USP) 0.6 mg tablet is a prescription medicine used in adults to prevent and treat gout flares.,COLCRYS is not a pain medicine and should not be taken to treat pain related to other conditions.
Colchicine is a medicine used to help prevent gout flares in adults.1 Gout is a form of inflammatory arthritis that occurs when too much uric acid builds up in the joints, leading to chronic swelling and often intense pain.2,3
There are several stages of gout. The most serious involves frequent gout flares, which develop in people whose uric acid levels have been high for many years.4 Once infrequent, flares begin to occur regularly, and the pain increases in severity and duration.4 Joint damage may also occur, which can lead to loss of mobility.4
What you should know about colchicine
If you suffer with gout flares, here are three important things to know about colchicine 0.6 mg capsules:
1. Colchicine has been used for centuries to prevent gout attacks5
Colchicine was originally derived from a plant called the autumn crocus (Colchicum autumnale).5 The drug was prescribed for gout flare prevention for many years before manufacturers were required to have formal approval from the U.S. Food and Drug Administration (FDA).6 Until this time, patients had grown accustomed to paying approximately 10 cents a pill for this daily medication.6
2. Colchicine, a once-affordable drug, became too costly for many patients6
In 2009, the FDA approved the first branded version of colchicine.6 All other formulations, which had not gone through FDA’s review process, were removed from the market at that time.6 Patients who tried to refill their prescriptions found that their long-used colchicine medications were no longer available.6
The only colchicine option at this time was a newly branded drug offered by a pharmaceutical company that charged $5 per pill—50 times the price of colchicine pills previously available.6
In response, West-Ward Pharmaceuticals Corp. pursued the development of a colchicine capsule product and secured FDA approval for and introduced Mitigare® (colchicine) 0.6 mg Capsules in 2014.7 The company began offering their authorized generic, colchicine 0.6 mg capsules, shortly thereafter.7 West-Ward was the first manufacturer to provide an authorized generic, offering significant potential savings for patients.7
As of today, West-Ward remains the only manufacturer offering colchicine therapy in capsule form.
3. Color matters
Mitigare® (colchicine) 0.6 mg Capsules, and its authorized generic, colchicine 0.6 mg capsules, are a distinctive two-tone blue color. This pop of color may help adult patients distinguish these capsules from other medications they take.8,9
The True Blue Savings program helps qualified patients save money on their Mitigare® or Generic Colchicine 0.6 mg Capsules prescriptions. With the Mitigare® True Blue Savings Card, eligible patients can receive Mitigare® (colchicine) or Generic Colchicine 0.6 mg Capsules for as little as $0 for the first 30 days and get $5 refills.*
*For all eligible patients 18 years or older who are legal residents of the United States or Puerto Rico. First 30 days are as little as $0 only for eligible patients. Maximum savings of $65 on the first fill and $50 on refills. Please see complete Terms and Conditions available at Mitigare.com.
Mitigare® is indicated for prophylaxis of gout flares in adults. The safety and effectiveness of Mitigare for acute treatment of gout flares during prophylaxis has not been studied. Mitigare® is not an analgesic medication and should not be used to treat pain from other causes.
Important Safety Information
Colchicine 0.6 mg capsules are contraindicated in patients with renal or hepatic impairment who are currently prescribed drugs that inhibit both P-gp and CYP3A4.Combining one of these dual inhibitors, or a medication that inhibits either P-gp or CYP3A4, with colchicine has resulted in life-threatening or fatal colchicine toxicity. Patients with both renal and hepatic impairment should not use Mitigare®. The safety and effectivenes of Mitigare® for acute treatment of gout flares during prophylaxis has not been studied. Mitigare® is not an analgesic medication and should not be used to treat pain from other causes.
Fatal overdoses have been reported with colchicine in adults and children. Keep Mitigare® out of the reach of children. Blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia and aplastic anemia have been reported with colchicine use. Monitor for toxicity and if present consider temporary interruption or discontinuation of colchicine.
NOTE: This article was not written by a medical professional and is not intended to substitute the guidance of a physician. These are not West-Ward’s recommendations for gout flare prevention, but rather facts and data collected from various reliable medical sources. For a list of resources and their attributing links, see below.
Included as part of the “PRECAUTIONS” Section
Fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine . Colchicine capsules should be kept out of the reach of children.
Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia have been reported with colchicine used in therapeutic doses.
Interactions With CYP3A4 And P-Gp Inhibitors
Because colchicine is a substrate for both the CYP3A4 metabolizing enzyme and the P-glycoprotein efflux transporter, inhibition of either of these pathways may lead to colchicine-related toxicity. Inhibition of both CYP3A4 and P-gp by dual inhibitors such as clarithromycin has been reported to produce life-threatening or fatal colchicine toxicity due to significant increases in systemic colchicine levels. Therefore, concomitant use of colchicine capsules and inhibitors of CYP3A4 or P-glycoprotein should be avoided . If avoidance is not possible, reduced daily dose should be considered and the patient should be monitored closely for colchicine toxicity. Use of colchicine capsules in conjunction with drugs that inhibit both P-gp and CYP3A4 is contraindicated in patients with renal or hepatic impairment .
Neuromuscular toxicity and rhabdomyolysis have been reported from chronic treatment with colchicine in therapeutic doses, especially in combination with other drugs known to cause this effect. Patients with impaired renal function and elderly patients (even those with normal renal and hepatic function) are at increased risk. Once colchicine treatment is ceased, the symptoms generally resolve within 1 week to several months.
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
If a dose of colchicine capsules is missed, advise the patient to take the dose as soon as possible and then return to the normal dosing schedule. However, if a dose is skipped, the patient should not double the next dose.
Advise the patient that fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. Colchicine capsules should be kept out of the reach of children.
Advise patients that bone marrow depression with agranulocytosis, aplastic anemia, and thrombocytopenia may occur with colchicine capsules.
Drug And Food Interactions
Advise patients that many drugs or other substances may interact with colchicine capsules and some interactions could be fatal. Therefore, patients should report to their healthcare provider all of the current medications they are taking, and check with their healthcare provider before starting any new medications, including short-term medications such as antibiotics. Patients should also be advised to report the use of non-prescription medication or herbal products. Grapefruit and grapefruit juice may also interact and should not be consumed during treatment with colchicine capsules.
Advise patients that muscle pain or weakness, tingling or numbness in fingers or toes may occur with colchicine capsules alone or when it is used with certain other drugs. Patients developing any of these signs or symptoms must discontinue colchicine capsules and seek medical evaluation immediately.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Carcinogenicity studies of colchicine have not been conducted. Due to the potential for colchicine to produce aneuploid cells (cells with an unequal number of chromosomes), colchicine presents a theoretical increased risk of malignancy.
Published studies demonstrated that colchicine was negative for mutagenicity in the bacterial reverse mutation assay. However, in vitro chromosomal aberration assays demonstrated the formation of micronuclei following colchicine treatment. Because published studies demonstrated that colchicine induces aneuploidy through the process of mitotic nondisjunction without structural DNA changes, colchicine is not considered clastogenic, although micronuclei are formed.
Impairment Of Fertility
There were no studies of the effects of colchicine capsules on fertility. However, published nonclinical studies have demonstrated that colchicine-induced disruption of microtubule formation affects meiosis and mitosis. Published reproductive studies with colchicine reported abnormal sperm morphology and reduced sperm counts in males, and interference with sperm penetration, second meiotic division, and normal cleavage in females.
Case reports and epidemiology studies in human male subjects on colchicine therapy indicate that infertility from colchicine is rare. A case report indicated that azoospermia was reversed when therapy was stopped. Case reports and epidemiology studies in female subjects on colchicine therapy have not established a clear relationship between colchicine use and female infertility.
Use In Specific Populations
Use In Pregnancy
Pregnancy Category C
There are no adequate and well-controlled studies with colchicine capsules in pregnant women. Colchicine crosses the human placenta. Developmental studies in animals were not conducted with colchicine capsules, however published animal reproduction and development studies with colchicine demonstrated embryofetal toxicity, teratogenicity, and altered postnatal development at exposures within or above the clinical therapeutic range. Colchicine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor And Delivery
The effect of colchicine on labor and delivery is unknown.
Use In Nursing Mothers
Colchicine is excreted into human milk. Limited information suggests that infants exclusively breastfed receive less than 10 percent of the maternal weight-adjusted dose. While there are no published reports of adverse effects in breast-feeding infants of mothers taking colchicine, colchicine can affect gastrointestinal cell renewal and permeability. Caution should be exercised and breastfeeding infants should be observed for adverse effects when colchicine capsules is administered to a nursing woman.
Gout is rare in pediatric patients; the safety and effectiveness of colchicine capsules in pediatric patients has not been evaluated in controlled studies.
Because of the increased incidence of decreased renal function in the elderly population, and the higher incidence of other co-morbid conditions in the elderly population requiring the use of other medications, reducing the dosage of colchicine when elderly patients are treated with colchicine should be carefully considered.
No dedicated pharmacokinetic study has been conducted using colchicine capsules in patients with varying degrees of renal impairment. Colchicine is known to be excreted in urine in humans and the presence of severe renal impairment has been associated with colchicine toxicity. Urinary clearance of colchicine and its metabolites may be decreased in patients with impaired renal function. Dose reduction or alternatives should be considered for the prophylaxis of gout flares in patients with severe renal impairment. Colchicine is not effectively removed by hemodialysis. Patients who are undergoing hemodialysis should be monitored carefully for colchicine toxicity.
No dedicated pharmacokinetic study using colchicine capsules has been conducted in patients with varying degrees of hepatic impairment. Colchicine is known to be metabolized in humans and the presence of severe hepatic impairment has been associated with colchicine toxicity. Hepatic clearance of colchicine may be significantly reduced and plasma half-life prolonged in patients with chronic hepatic impairment.
Dose reduction or alternatives should be considered for the prophylaxis of gout flares in patients with severe hepatic impairment.
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Published: December 1998
Colchicine Toxicity Prompts Dosage Change
This article is more than five years old. Some content may no longer be current.
Prescriber Update 17: 9-–11
Medsafe Editorial Team
The maximum dose of colchicine in an acute attack of gout should be 6mg (10 tablets). Colchicine should be taken at an initial dose of 1.2mg followed by 1 tablet every 2 hours until the gouty pain is relieved, gastrointestinal symptoms develop, or the maximum dose is reached. In elderly patients, those who weigh less than 50kg and those with co-existing renal or hepatic disease, alternative therapy should be used or a maximum dose of 3mg colchicine observed. Patients with suspected overdose should be admitted to a hospital with intensive supportive facilities.
The dosage instructions for colchicine have recently been changed to reflect the fact that it is possible to take a fatal dose before gaining relief from the symptoms of gout or developing diarrhoea.
6mg maximum dose in acute gout
The approved dosage instructions for colchicine in the treatment of acute gout now recommend a starting dose of 1.2mg (two 0.6mg tablets), followed by 1 tablet 2-hourly until the pain is relieved or diarrhoea or other gastrointestinal symptoms develop, up to a maximum dose of 6mg (10 tablets).
3mg maximum dose for at risk patients
In elderly patients, those who weigh less than 50kg and those with renal or hepatic impairment, other treatments such as a non-steroidal anti-inflammatory agent (NSAIA) or high dose (20-40mg) short duration oral prednisone or prednisolone should be considered. If colchicine is prescribed for these patients the maximum total dose should be 3mg.
Intensive regimen should not be repeated for 3 days
An intensive regimen of colchicine therapy should not be repeated until an interval of at least three days has elapsed between courses. Nevertheless, maintenance therapy of one tablet daily may be commenced the day following treatment for an acute attack.
Dose reduction based on published evidence of toxicity
The two major changes in the dosage instructions relate to frequency of administration and maximum dose.
Previously no maximum was stated in the approved dosage instructions. The maximum recommended dose has been set by reference to the following:
- Standard textbooks such as Avery’s Drug Treatment which advises a maximum of 6mg;1
- Published cases of death occurring after doses of 6 or 7 mg;2
- Sources which indicate survival may follow excessive ingestion of up to 0.5 mg/kg with intensive supportive care;3,4
- Maximum approved doses in other countries, for example the United Kingdom where 10mg is the recommended maximum;5 and
- Advice from the New Zealand Rheumatology Association which reviewed the literature and agreed that 6mg was a suitable maximum dose.6
The recommended frequency of administration has been halved, to further reduce the chance of serious toxicity occurring. The new frequency is similar to that recommended in Australia and the United Kingdom.
Steroids recommended for colchicine therapeutic failures
For a patient who has not gained adequate pain relief from the maximum dose of colchicine, alternatives are intramuscular corticotrophin 40-80IU or oral prednisone 20-50 mg/day for 3 days.1
Co-administration of NSAIAs with colchicine should be avoided
While either a NSAIA or colchicine can be used as first line therapy for acute gout, they should not be co-prescribed as both medicines compete for excretion at the same site in the kidney. In addition to competition for excretion, use of NSAIAs is associated with decreased renal blood flow. Increased colchicine toxicity, due to delayed renal excretion, is the end result of these pharmacodynamic effects.
Hospitalisation essential for suspected overdose
If there is a high probability of colchicine toxicity, for example because of intentional overdose or dose in excess of 6mg in high risk patients, prompt admission to a facility with access to intensive supportive treatment is essential.
In overdose, early use of activated charcoal will minimise absorption. Repeated doses of charcoal will assist with the elimination of colchicine reabsorbed into the intestines through enterohepatic recycling. Diarrhoea should not be treated as it is the primary route of elimination. The period 24-72 hours after ingestion is critical and multisystem organ failure may occur. The key to patient management is full supportive care.
Serious toxicity with colchicine is an adverse reaction of current concern. Please report all New Zealand cases to the New Zealand Centre for Adverse Reactions Monitoring.
- Brooks PM. Rheumatic disorders. In Speight TM, Holford NHG (Eds). Avery’s Drug Treatment 4th Ed, Adis International, Auckland, 1997, p.1151.
- Macleod JG, Phillips L. Hypersensitivity to colchicine. Ann Rheum Dis 1947;6:224-9.
- Murray SS, Kramlinger KG, McMichan JC, Mohr DN. Acute toxicity after excessive ingestion of colchicine. Mayo Clin Proc 1983;58:528-32.
- Dodds AJ, Lawrence PJ, Biggs JC. Colchicine overdose. Med J Aust 1978;2:91-2.
- Brit Nat Formulary, British Medical Association and Royal Pharmaceutical Society of Great Britain, No. 35, March 1998, p.441-2.
- Personal Communication, Dr JP Petrie, Secretary, New Zealand Rheumatology Association, Feb 1998.
Medical Editor: John P. Cunha, DO, FACOEP
Last reviewed on RxList 12/17/2018
Colchicine (Brand: Colcrys) is an alkaloid used to prevent or treat gout attacks (flares), and is also used to prevent attacks of pain in the abdomen, chest, or joints caused by a certain inherited disease (familial Mediterranean fever). Common side effects of Colchicine include:
- abdominal pain, and
Contact your doctor if you experience rare but serious side effects of colchicine including:
- unusual bleeding/bruising,
- severe diarrhea or vomiting,
- muscle weakness or pain,
- numbness/tingling in your fingers or toes,
- pale or gray color of the lips/tongue/palms of hands,
- signs of infection (such as fever, persistent sore throat),
- unusual weakness or tiredness,
- fast heartbeat,
- shortness of breath, or
- changes in the amount of urine.
To treat acute gouty arthritis the usual dose of colchicine to relieve or abort an attack is 1 to 1.2 mg (two 0.5 mg granules or two 0.6 mg tablets). This dose may be followed by one unit of either preparation (granule or tablet) every hour, or two units every two hours, until pain is relieved or until diarrhea ensues. Colchicine may interact with azole antifungals, cyclosporine, HIV medications, antibiotics, telithromycin, verapamil, atorvastatin, digoxin, gemfibrozil, fenofibrate, pravastatin, or simvastatin. Tell your doctor all medications and supplements you use. During pregnancy, colchicine should be used only when prescribed. This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breastfeeding.
Our Colchicine (Brand: Colcrys) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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 at 1-800-FDA-1088.
|Type of medicine||An anti-inflammatory medicine for gout|
|Used for||Gout attacks|
Gout causes attacks of painful inflammation in one or more of your joints. It is caused by a build-up of a naturally occurring chemical in your blood, called uric acid (urate). From time to time, the level of uric acid in your blood may become too high and tiny grit-like crystals may form, which typically collect in your joints and tendons. The crystals irritate the tissues of the joint to cause inflammation, swelling and pain.
The most commonly prescribed treatment for a gout attack is an anti-inflammatory painkiller, although not everyone is able to take this kind of medicine. Colchicine is an alternative treatment for gout attacks for those people who cannot take anti-inflammatory painkillers. It works by reducing the number of white blood cells which travel into the inflamed areas. This helps break the cycle of inflammation and reduces the swelling and pain of the gout attack.
Before taking colchicine
Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking colchicine it is important that your doctor knows:
- If you are pregnant, trying for a baby or breastfeeding.
- If you have any problems with the way your heart or liver works, or any problems with the way your kidneys work.
- If you have any problems with your digestive system.
- If you have a blood disorder.
- If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
- If you have ever had an allergic reaction to a medicine.
How to take colchicine
- Before you start the treatment, read the manufacturer’s printed information leaflet from inside the pack. It will give you more information about colchicine and will provide you with a full list of the side-effects which you may experience from taking it.
- You must take colchicine exactly as your doctor tells you to. Most doctors will recommend that when a gout attacks starts, you should take one tablet 2-4 times a day until the pain eases. It is important that you do not take more than 12 tablets of colchicine as a course of treatment during any one gout attack. It is also important that you leave at least three days between courses of colchicine. If you find you are having frequent attacks of gout, please let your doctor know about this.
- If you have recently been prescribed a medicine to prevent gout attacks (such as allopurinol, febuxostat, or sulfinpyrazone) and you have been given colchicine to prevent a flare-up attack of gout, the usual dose for this is one tablet twice each day.
- Take colchicine tablets with a drink of water.
- If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose, in which case leave out the missed dose. Do not take two doses together to make up for a forgotten dose.
Getting the most from your treatment
- Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress.
- Do not drink grapefruit juice while you are on colchicine. This is because grapefruit juice increases the risk that you will experience side-effects from the colchicine.
- Colchicine tablets are taken in short courses of treatment to relieve the pain of a gout attack. If you have frequent attacks of gout, let your doctor know as your he/she may prescribe another medicine for you to take every day to help prevent the attacks from occurring.
- There are a number of lifestyle changes that you can make to help reduce the risk of having a gout attack. These include losing weight (if you are overweight), eating a healthy diet and not drinking much alcohol or sugar-sweetened soft drinks. Your doctor will advise you about the changes which could benefit you.
- Never take more than the prescribed dose. Taking too much colchicine can cause serious problems. If you suspect that someone has taken an overdose of colchicine or has swallowed some by accident, you must contact a doctor straightaway. Alternatively, go to the accident and emergency department of a local hospital. Do not delay. Take the container with you, even if it is empty. This is so the doctor knows what has been taken.
Can colchicine cause problems?
Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with colchicine. You will find a full list in the manufacturer’s information leaflet supplied with your medicine. Speak with your doctor or pharmacist if any of the following continue or become troublesome.
|Common colchicine side-effects||What can I do if I experience this?|
|Feeling sick (nausea) or being sick (vomiting), pain in your tummy (abdomen)||Stop your course of tablets and let your symptoms settle. If the sickness continues or is severe, speak with your doctor|
|Diarrhoea||Stop your course of tablets and let your symptoms settle. If this is severe or contains blood, speak with your doctor straightaway|
If you experience any other symptoms which you think may be due to the tablets, speak with your doctor or pharmacist for further advice.
How to store colchicine
- Keep all medicines out of the reach and sight of children.
- Store in a cool, dry place, away from direct heat and light.
Important information about all medicines
This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.
If you buy any medicines ‘over-the-counter’, always check with a pharmacist that they are suitable for you to take alongside your other medicines.
If you are having an operation or any dental treatment, tell the person carrying out the treatment which medicines you are taking.
Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.
If you have any questions about this medicine ask your pharmacist.
Colchicine Side Effects
Medically reviewed by Drugs.com. Last updated on Nov 1, 2018.
- Side Effects
Commonly reported side effects of colchicine include: diarrhea and nausea. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to colchicine: oral capsule, oral tablet
Along with its needed effects, colchicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking colchicine:
- nausea or vomiting
- stomach pain
- Black, tarry stools
- blood in the urine or stools
- burning, “crawling”, or tingling feeling in the skin
- difficulty with breathing when exercising
- fever with or without chills
- large, hive-like swellings on the face, eyelids, mouth, lips, or tongue
- muscle weakness
- numbness in the fingers or toes (usually mild)
- peeling of the skin
- pinpoint red spots on the skin
- skin rash or hives
- sores, ulcers, or white spots on the lips or in the mouth
- sore throat
- unusual bleeding or bruising
- unusual tiredness or weakness
Get emergency help immediately if any of the following symptoms of overdose occur while taking colchicine:
Symptoms of overdose
- burning feeling in the stomach, throat, or skin
- convulsions (seizures)
- diarrhea (severe or bloody)
- fast, shallow breathing
- muscle weakness (very severe)
- nausea, stomach pain, or vomiting (severe)
Some side effects of colchicine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Hair loss
- loss of appetite
For Healthcare Professionals
Applies to colchicine: compounding powder, intravenous solution, oral capsule, oral tablet
The most common adverse reactions have included gastrointestinal symptoms and pharyngolaryngeal pain.
Very common (10% or more): Diarrhea (23%)
Common (1% to 10%): Abdominal cramping, abdominal pain, nausea, vomiting
Frequency not reported: Lactose intolerance, gastrointestinal hemorrhage, paralytic ileus, stomatitis
Gastrointestinal events including diarrhea, nausea, vomiting, and abdominal pain are the most common adverse reactions reported with use of this drug. These events are often the first signs of toxicity and may indicate the need for dose reduction or therapy discontinuation.
Rare (less than 0.1%): Agranulocytosis, thrombocytopenia, aplastic anemia
Postmarketing reports: Myelosuppression, disseminated intravascular coagulation
Rare (less than 0.1%): Peripheral neuritis
Frequency not reported: Sensory motor neuropathy
Rare (less than 0.1%): Myopathy, rhabdomyolysis
Frequency not reported: Elevated CPK, myotonia, muscle weakness, muscle pain
Very rare (less than 0.01%): Hypersensitivity including angioedema
Frequency not reported: Renal damage, bladder spasm, anuria, oliguria
Frequency not reported: elevated AST, elevated ALT, elevated alkaline phosphatase, hepatic damage
Common (1% to 10%): Pharyngolaryngeal pain
Postmarketing reports: Adult respiratory distress syndrome
There have been reports of corneal ulcers refractory to conventional treatment and delayed corneal wound healing following strabismus surgery in patients receiving colchicine. Discontinuation of colchicine therapy resulted in satisfactory wound healing within several days.
Frequency not reported: Delayed corneal wound healing
Rare (less than 0.1%): Alopecia
Very rare (less than 0.01%): Nonthrombocytopenic purpura rashes, rashes, urticaria, dermatoses, dermatitis
Frequency not reported: Maculopapular rash
Frequency not reported: Hypothyroidism
Rare (less than 0.1%): Azoospermia, oligospermia
Frequency not reported: Amenorrhea, dysmenorrhea, hematuria
Frequency not reported: Loss of appetite
1. “Product Information. Colcrys (colchicine).” AR Scientific Inc, Philadelphia, PA.
2. “Product Information. Mitigare (colchicine).” Hikma Americas, Inc, Memphis, TN.
3. Cerner Multum, Inc. “Australian Product Information.” O 0
4. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
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- Drug class: antigout agents
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