Colcrys 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 Colcrys.

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

For the Consumer

Applies to colchicine: intravenous solution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking colchicine (the active ingredient contained in Colcrys) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• muscle pain or weakness;

• numbness or tingly feeling in your fingers or toes;

• pale or gray appearance of your lips, tongue, or hands;

• severe vomiting or diarrhea;

• easy bruising or bleeding, feeling weak or tired;

• fever, chills, body aches, flu symptoms;

• blood in your urine; or

• urinating less than usual or not at all.

Less serious side effects of colchicine may include:

• mild nausea or vomiting, stomach pain; or

• mild diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to colchicine: compounding powder, intravenous solution, oral tablet

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 (the active ingredient contained in Colcrys) 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 (the active ingredient contained in Colcrys) 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 (the active ingredient contained in Colcrys) 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 active ingredient contained in Colcrys) 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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