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Mitigare Side Effects

Generic name: colchicine

Medically reviewed by Drugs.com. Last updated on Oct 29, 2022.

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

Applies to colchicine: oral capsule, oral solution, oral tablet.

Serious side effects of Mitigare

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

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 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

  • 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

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

Gastrointestinal

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]

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]

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]

Frequently asked questions

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Colcrys (colchicine). AR Scientific Inc. 2009.

4. Product Information. Mitigare (colchicine). Hikma Americas, Inc. 2016.

Further information

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.

Medical Disclaimer