Colchicine Side Effects

Brand Names: Colcrys

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.

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; dark urine; decreased or increased urination; fever, chills, or persistent sore throat; lower back, lower stomach, genital, or inner thigh pain; muscle pain, tenderness, or weakness; numbness, burning, or tingling; severe diarrhea; severe or persistent nausea or vomiting; unusual bleeding or bruising; unusual tiredness or weakness; unusually pale skin; worsening gout; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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; mild sore throat; nausea; stomach pain or cramping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); muscle pain, tenderness, or weakness (with or without fever or fatigue); numbness or tingling in the fingers or toes; pale or gray color of the lips, tongue, or palms of the hands; severe or persistent diarrhea, nausea, stomach pain, or vomiting; signs of infection (eg, fever, chills, severe or persistent sore throat); unusual bleeding or bruising; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

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

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.

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.

Nervous system

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.

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.

Renal

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

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.

Genitourinary

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.

Genitourinary side effects have rarely included azoospermia.

Hepatic

Hepatic side effects have occasionally been reported.

Respiratory

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

Musculoskeletal

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

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