Colchicine Side Effects

Please note - some side effects for Colchicine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Colchicine - for the consumer

Colchicine/Probenecid

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Colchicine/Probenecid:

Diarrhea; dizziness; flushing; hair loss; headache; loss of appetite; nausea; sore gums; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; chills; dark urine; decreased or increased urination; fever; infection; lower back, lower stomach, genital, or inner thigh pain; muscle weakness; numbness or tingling; severe diarrhea; severe or persistent nausea or vomiting; sore throat; tiredness; unusual bleeding or bruising; weakness; worsening gout; yellowing of the eyes or skin.

Colchicine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Colchicine:

Diarrhea; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever; infection; numbness or tingling; severe diarrhea; sore throat; tiredness; unusual bleeding or bruising; weakness.

By body system

Gastrointestinal side effects

Gastrointestinal side effects may occur with either oral or intravenous administration.

Gastrointestinal side effects have included diarrhea, nausea, vomiting, and abdominal pain in nearly 80% of treated patients, and can be indicative of acute colchicine toxicity. Anorexia, electrolyte disturbance, pancreatitis, and paralytic ileus may also occur, and steatorrhea and enzyme inhibition have been reported in patients on long-term colchicine prophylaxis.

Hematologic side effects

Hematologic side effects have included thrombocytopenia, pancytopenia, leukopenia, agranulocytosis, bone marrow failure, bone marrow depression, disseminated intravascular coagulation, and aplastic anemia in patients on long-term therapy and are most common in cases of overdose or intoxication. Heinz-body hemolytic anemia has been reported in 3 cases.

A case of fatal pancytopenia developed in a patient treated with 10 mg of colchicine over a 5 day period.

Thrombocytopenia is a rare side effect and is usually associated with myelotoxicity.

Fatal marrow aplasia was reported in a 70-year-old who was given 10 mg of colchicine intravenously over a 5 day period.

Nervous system side effects

Nervous system side effects have rarely included myopathy, seizures, mental status changes, and neuropathy in patients with impaired renal function, and are sometimes reversible with drug discontinuation. Neuromyopathy occurrence has been reported with or without elevated muscle enzymes.

Colchicine-induced neuromyopathy often presents with a pattern of general muscle weakness, elevated creatinine phosphokinase, a diffuse myositic pattern on EMG, and noninflammatory vacuolar changes on muscle biopsy.

Renal side effects

Acute renal failure with a fatal outcome has been reported in a 78-old-man after a 10 day course of colchicine 0.5 mg three times a day.

Chronic renal failure has been reported in two Sepharad patients after 20 years of appropriate colchicine therapy for familial Mediterranean fever.

Renal side effects have included acute renal failure and rare cases of rapid progressive glomerulonephritis. Chronic renal failure and acute renal failure with a fatal outcome following colchicine toxicity have been reported.

Dermatologic side effects

Dermatologic side effects have included urticaria, alopecia after intoxication or long-term usage, toxic epidermal necrolysis with concomitant ethanol use, fixed drug eruption, dermatitis, and purpura.

Local side effects

Local side effects have included venous irritation following intravenous administration of colchicine. Tissue irritation or damage may result if extravasation occurs.

Genitourinary side effects

Genitourinary side effects have rarely included azoospermia.

A case of reversible azoospermia has been reported in a patient treated with colchicine. The patient's sperm count returned to normal when colchicine was discontinued, and decreased on reintroduction of the drug. The patient fathered two apparently normal children while not receiving the drug. One study of six patients treated with colchicine showed moderate oligospermia in two patients, but no effect in any of the treated patients.

Hepatic side effects

Hepatic side effects have occasionally been reported.

Respiratory side effects

Respiratory side effects including adult respiratory distress syndrome have been reported.

Musculoskeletal side effects

Musculoskeletal side effects have been reported the most frequently. These have included myopathy, manifested as weakness, neuropathy, and paralysis.

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