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Mitigare

Generic Name: colchicine (KOL chi seen)
Brand Name: Colcrys, Mitigare
Physician reviewed Mitigare patient information - includes Mitigare description, dosage and directions.
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Drug Information:
Mitigare affects the way the body responds to uric acid crystals, which reduces swelling and pain. Because Mitigare was developed prior to federal regulations requiring FDA review of all marketed drug products, not all uses for this medicine 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. Learn more

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Mitigare Side Effects

Note: This document contains side effect information about colchicine. Some of the dosage forms listed on this page may not apply to the brand name Mitigare.

For the Consumer

Applies to colchicine: oral capsule, oral tablet

Along with its needed effects, colchicine (the active ingredient contained in Mitigare) 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

  • Diarrhea
  • nausea or vomiting
  • stomach pain

Rare

  • 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
  • skin rash or hives
  • sores, ulcers, or white spots on the lips or in the mouth
  • sore throat
  • swelling
  • tenderness
  • 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

  • Bleeding
  • 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:

Less common

  • Hair loss
  • loss of appetite

For Healthcare Professionals

Applies to colchicine: compounding powder, intravenous solution, oral capsule, oral tablet

General

The most common adverse reactions have included gastrointestinal symptoms and pharyngolaryngeal pain.

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

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.

Hematologic

Rare (less than 0.1%): Agranulocytosis, thrombocytopenia, aplastic anemia

Postmarketing reports: Myelosuppression, disseminated intravascular coagulation

Nervous system

Rare (less than 0.1%): Peripheral neuritis

Frequency not reported: Sensory motor neuropathy

Musculoskeletal

Rare (less than 0.1%): Myopathy, rhabdomyolysis

Frequency not reported: Elevated CPK, myotonia, muscle weakness, muscle pain

Hypersensitivity

Very rare (less than 0.01%): Hypersensitivity including angioedema

Renal

Frequency not reported: Renal damage, bladder spasm, anuria, oliguria

Hepatic

Frequency not reported: elevated AST, elevated ALT, elevated alkaline phosphatase, hepatic damage

Respiratory

Common (1% to 10%): Pharyngolaryngeal pain

Postmarketing reports: Adult respiratory distress syndrome

Ocular

There have been reports of corneal ulcers refractory to conventional treatment and delayed corneal wound healing following strabismus surgery in patients receiving colchicine (the active ingredient contained in Mitigare) Discontinuation of colchicine therapy resulted in satisfactory wound healing within several days.

Frequency not reported: Delayed corneal wound healing

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

Endocrine

Frequency not reported: Hypothyroidism

Genitourinary

Rare (less than 0.1%): Azoospermia, oligospermia

Frequency not reported: Amenorrhea, dysmenorrhea, hematuria

Metabolic

Frequency not reported: Loss of appetite

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Mitigare (www.drugs.com/mtm/mitigare.html).