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
- Diarrhea
- nausea
- stomach pain
- vomiting
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
- 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
- tightness in the chest
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]
