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Ergamisol Side Effects

Generic name: levamisole

Note: This document contains side effect information about levamisole. Some of the dosage forms listed on this page may not apply to the brand name Ergamisol.

Applies to levamisole: oral tablet

Hematologic

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.[Ref]

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.[Ref]

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%).[Ref]

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

Other

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

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

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.[Ref]

Cardiovascular

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

Musculoskeletal

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

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.[Ref]

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 (the active ingredient contained in Ergamisol) use.[Ref]

Ocular

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

Immunologic

Infection (5%) has been reported.[Ref]

Hepatic

Hyperbilirubinemia and increased alkaline phosphatase have been reported rarely.[Ref]

Renal

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

Other

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

Medically reviewed by Drugs.com. Last updated on Nov 2, 2020.

More about Ergamisol (levamisole)

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References

1. "Product Information. Ergamisol (levamisole)." Janssen Pharmaceutica, Titusville, NJ.

2. Symoens J, Veys E, Mielants M, Pinals R "Adverse reactions to levamisole." Cancer Treat Rep 62 (1978): 1721-30

3. Moertel CG, Fleming TR, Macdonald JS, Haller DG, Laurie JA, Goodman PJ, Ungerleider JS, Emerson WA, Tormey DC, Glick JH, et al "Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma." N Engl J Med 322 (1990): 352-8

4. Mutch RS, Hutson PR "Levamisole in the adjuvant treatment of colon cancer." Clin Pharm 10 (1991): 95-109

5. Jeffries JJ, Cammisuli S "Psychosis secondary to long-term levamisole therapy." Ann Pharmacother 32 (1998): 134-5

6. Arora SK, Singh G, Sen PC "Side effects of levamisole." Indian J Med Sci 40 (1986): 6-8

7. Tweedy CR, Silverberg DA, Scott L "Levamisole-induced syndrome of inappropriate antidiuretic hormone." N Engl J Med 326 (1992): 1164

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.