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Mitigare Side Effects

Generic Name: colchicine

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.[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

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.[Ref]

Frequency not reported: Delayed corneal wound healing[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]

References

1. "Product Information. Colcrys (colchicine)." AR Scientific Inc, Philadelphia, PA.

2. "Product Information. Mitigare (colchicine)." Hikma Americas, Inc, Memphis, TN.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. Cerner Multum, Inc. "Australian Product Information." O 0

Some side effects of Mitigare may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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