Mitigare Side Effects
Generic name: colchicine
Medically reviewed by Drugs.com. Last updated on Aug 29, 2023.
Note: This document provides detailed information about Mitigare.
Applies to colchicine: oral capsule, oral solution, oral tablet Side Effects associated with colchicine. Some dosage forms listed on this page may not apply specifically to the brand name Mitigare.
Applies to colchicine: oral capsule, oral solution, oral tablet.
Precautions
If you must take colchicine (the active ingredient contained in Mitigare) for a long time (preventive treatment), it is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not use this medicine together with atazanavir (Reyataz®), clarithromycin (Klaricid®), cyclosporine (Gengraf®), darunavir/ritonavir (Prezista®), indinavir (Crivixan®), itraconazole (Sporanox®), ketoconazole (Nizoral), lopinavir/ritonavir (Kaletra®), nefazodone (Serzone®), nelfinavir (Viracept®), ranolazine (Ranexa®), ritonavir (Norvir®), saquinavir (Invirase®), telithromycin (Ketek®), tipranavir/ritonavir (Aptivus®).
Stomach problems may be more likely to occur if you drink large amounts of alcoholic beverages while using colchicine. Also, drinking too much alcohol may increase the amount of uric acid in your blood. This may lessen the effects of colchicine when it is used to prevent gout attacks. Therefore, people who use colchicine should be careful to limit the amount of alcohol they drink.
For patients taking small amounts of colchicine regularly (preventive treatment):
- Attacks of gout or other problems caused by inflammation may continue to occur during treatment. However, the attacks or other problems should occur less often, and they should not be as severe as they were before you started taking colchicine. Even if you think the colchicine is not working, do not stop taking it and do not increase the dose. Check with your doctor instead.
Colchicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
If your doctor tells you to increase the amount of medicine you are taking or if you are just starting this medicine, make sure you tell the doctor right away if you get muscle pain, tenderness, or weakness.
If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become temporarily infertile (unable to have children).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects of Mitigare
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:
More common side effects
- diarrhea
- nausea
- stomach pain
- vomiting
Rare side effects
- 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
- headache
- large, hive-like swellings on the face, eyelids, mouth, lips, or tongue
- muscle weakness
- numbness in the fingers or toes (usually mild)
- pain
- peeling of the skin
- pinpoint red spots on the skin
- redness of the skin
- skin rash or hives
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swelling
- tenderness
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- bleeding gums
- chest pain or tightness
- cough
- dark urine
- headache
- high fever
- muscle cramps, spasms, or stiffness
- muscular pain, tenderness, or wasting
- painful or difficult urination
- pale skin
- sensation of pins and needles
- stabbing pain
- swollen or painful glands
Get emergency help immediately if any of the following symptoms of overdose occur while taking colchicine:
Symptoms of overdose
- bleeding
- burning feeling in the stomach, throat, or skin
- chest pain or discomfort
- chills
- cold, clammy, pale skin
- confusion
- cough
- diarrhea (severe or bloody)
- dizziness
- eye pain
- fever
- general feeling of illness
- headache
- irregular heartbeat
- irregular, fast, slow, or shallow breathing
- muscle weakness (very severe)
- nausea, stomach pain, or vomiting (severe)
- seizures
- slow heart rate
- sore throat
- unusual tiredness
Other side effects of Mitigare
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:
Less common side effects
- hair loss or thinning of hair
- loss of appetite
Incidence not known
- stomach bloating from increased gas
- stomach cramping
For healthcare professionals
Applies to colchicine: compounding powder, intravenous solution, oral capsule, oral liquid, oral tablet.
General adverse events
The most common adverse reactions have included gastrointestinal symptoms and pharyngolaryngeal pain.[Ref]
Gastrointestinal
- 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[Ref]
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.[Ref]
Hematologic
- Rare (less than 0.1%): Agranulocytosis, thrombocytopenia, aplastic anemia
- Postmarketing reports: Myelosuppression, disseminated intravascular coagulation[Ref]
Nervous system
- Rare (less than 0.1%): Peripheral neuritis
- Frequency not reported: Sensory motor neuropathy[Ref]
Musculoskeletal
- Rare (less than 0.1%): Myopathy, rhabdomyolysis
- Frequency not reported: Elevated CPK, myotonia, muscle weakness, muscle pain[Ref]
Hypersensitivity
- Very rare (less than 0.01%): Hypersensitivity including angioedema[Ref]
Renal
- Frequency not reported: Renal damage, bladder spasm, anuria, oliguria[Ref]
Hepatic
- Frequency not reported: elevated AST, elevated ALT, elevated alkaline phosphatase, hepatic damage[Ref]
Respiratory
- Common (1% to 10%): Pharyngolaryngeal pain
- Postmarketing reports: Adult respiratory distress syndrome[Ref]
Ocular
- Frequency not reported: Delayed corneal wound healing[Ref]
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.[Ref]
Dermatologic
- Rare (less than 0.1%): Alopecia
- Very rare (less than 0.01%): Nonthrombocytopenic purpura rashes, rashes, urticaria, dermatoses, dermatitis
- Frequency not reported: Maculopapular rash[Ref]
Endocrine
- Frequency not reported: Hypothyroidism[Ref]
Genitourinary
- Rare (less than 0.1%): Azoospermia, oligospermia
- Frequency not reported: Amenorrhea, dysmenorrhea, hematuria[Ref]
Metabolic
- Frequency not reported: Loss of appetite[Ref]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2009) "Product Information. Colcrys (colchicine)." AR Scientific Inc
4. (2016) "Product Information. Mitigare (colchicine)." Hikma Americas, Inc
Frequently asked questions
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Other brands
Colcrys, Gloperba, Lodoco, Colcigel Gel
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Further information
Mitigare side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.