Colchicine/Probenecid Side Effects

Please note - some side effects for Colchicine/Probenecid 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/Probenecid - 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.

Side Effects by Body System

Nervous system

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

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

Nervous system side effects of probenecid have included headache and dizziness.

Gastrointestinal

Gastrointestinal side effects of colchicine have included nausea, vomiting, abdominal pain, and diarrhea in nearly 80% of treated patients. These symptoms can be indicative 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 therapy.

Gastrointestinal side effects of probenecid have included vomiting, nausea, anorexia, and sore gums.

Renal

Renal side effects of colchicine 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.

Renal side effects of probenecid have included nephrotic syndrome, with or without renal failure, urinary frequency, uric acid stones with or without hematuria, and renal colic.

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

Adequate hydration, to result in urine output of 2 liters/day, if possible, and alkalinization of the urine may reduce the risk of stone formation. Probenecid is contraindicated in patients who are overproducers of uric acid (i.e. 24-hour urinary uric acid excretion of greater than 750 mg).

Hematologic

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

Hematologic side effects of probenecid have rarely included leukopenia, aplastic anemia, leukopenia, hemolytic anemia, and anemia.

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 of colchicine 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.

Glucose-6-phosphate dehydrogenase (G-6-PD) deficiency may increase the risk of probenecid-induced hemolytic anemia in some patients. However, probenecid has also been implicated in at least two cases of immune-mediated hemolytic anemia. In both cases. serum antibodies reacted with red blood cells only in the presence of probenecid. In one patient, a generalized rash, fever, malaise, and anorexia were also present.

Hepatic

Hepatic side effects of probenecid have included hepatic necrosis.

Hypersensitivity

Hypersensitivity side effects of colchicine have included urticaria.

Hypersensitivity side effects of probenecid have included anaphylaxis, fever, urticaria, rash, and pruritus.

Dermatologic

Dermatologic side effects of colchicine and probenecid have included dermatitis, purpura, alopecia after intoxification or long-term usage, and toxic epidermal necrolysis with concomitant ethanol use.

Metabolic

Metabolic side effects of probenecid have included precipitation of gouty arthritis.

Musculoskeletal

Musculoskeletal side effects of colchicine have included myopathy, muscular weakness, paralysis, and costovertebral pain.

Genitourinary

Genitourinary side effects of probenecid have included urinary frequency and azoospermia.

A case of 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.

Other

At toxic doses, other side effects associated with colchicine have included severe diarrhea, generalized vascular damage, and renal damage with hematuria and oliguria.

Respiratory

Respiratory side effects including respiratory distress syndrome have been reported.

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