Ergamisol Side Effects

Please note - some side effects for Ergamisol 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 by Body System

Hematologic

One analysis of 267 reports representing 6,217 patients, found that patients treated for rheumatic disorders (n=1131) reported a significantly higher rate of leukopenia and agranulocytosis (4.9%). The majority of these patients (4.5%) discontinued therapy. Leukopenia is usually not prodromal to agranulocytosis.

Reports show some indication that agranulocytosis is due to a type II reaction (Coombs' classification). Management of levamisole-induced agranulocytosis includes early diagnosis, discontinuation of treatment, and prevention of infection. Agranulocytosis is spontaneously reversible when treatment is discontinued.

Hematologic toxicity primarily involves (sometimes fatal) agranulocytosis. Leukopenia has been reported in 2% (over 4,000/mm3), 4% (2,000 to 4,000/mm3), and less than 1% (less than 2,000/mm3). Transient granulocytopenia has been reported in up to 20% of treated patients. Recovery is usually spontaneous. In patients with thrombocytopenia, 1% of patients show platelet counts over 130,000/mm3, and 1% show platelet counts between 50,000 and 130,000/mm3.

Dermatologic

One analysis of 267 reports representing 6,217 patients, found that patients treated for rheumatic disorders (n=1131) reported a significantly high percentage of idiosyncratic or allergic reactions. These included skin rash (14.8%). Half of the patients experiencing skin rash discontinued therapy (7%).

Dermatologic side effects include dermatitis (8%), alopecia (3%), pruritus (1%) and urticaria (<1%).

Other

Fever may be a symptom of infection associated with agranulocytosis, but often it is not.

Flu-like symptoms including fatigue (6%), fever (3%), rigors (3%), myalgia, and malaise have been reported.

Gastrointestinal

Gastrointestinal side effects include nausea (22%), diarrhea (13%), vomiting (6%), stomatitis (3%), anorexia (2%), abdominal pain (2%), and constipation (2%). Flatulence and dyspepsia have also been reported.

Cardiovascular

Cardiac dysfunction leading to edema (1%) and chest pain (<1%) have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (5%) and myalgia (3%) have been reported.

Nervous system

Nervous system side effects including dizziness (3%), headache (3%), paresthesia (2%), taste perversion (8%), and an altered sense of smell (1%) have been reported.

Psychiatric

Psychiatric side effects including somnolence (3%), depression (1%), nervousness (1%), insomnia (1%), and anxiety (1%) have been reported. Confusion, hallucinations, impaired concentration, nightmares, and an encephalopathy-like syndrome have also been reported. A case has been reported of a psychotic episode which was believed to be caused by prolonged levamisole use.

Ocular

Ocular side effects including blurred vision (1%) and conjunctivitis (<1%) have been reported. Periorbital edema has also been reported.

Immunologic

Infection (5%) has been reported.

Hepatic

Hyperbilirubinemia and increased alkaline phosphatase have been reported rarely.

Renal

Renal failure and elevated serum creatinine have been reported rarely. One case report of syndrome of inappropriate antidiuretic hormone has been reported.

Other

Other adverse reactions including vaginal bleeding and anaphylaxis have been reported.

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