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Ergamisol Side Effects

Generic name: levamisole

Medically reviewed by Last updated on May 28, 2023.

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

Applies to levamisole: oral tablet.


Serious side effects have been reported with the use of levamisole including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function or blood problems (fever or chills; or signs of infection); nervous system problems (confusion or loss of consciousness, extreme fatigue, memory loss, muscle weakness, numbness or tingling; seizure, speech disturbances); and others. Talk to your doctor about the possible side effects from treatment with levamisole.

If you experience any of the following serious side effects from levamisole (the active ingredient contained in Ergamisol) seek emergency medical attention or contact your doctor immediately:

Other, less serious side effects may be more likely to occur. Continue taking levamisole and talk to your doctor if you experience:

Other side effects have also been reported. Discuss with your doctor any side effect that occurs during treatment with levamisole.

For Healthcare Professionals

Applies to levamisole: oral tablet.


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]


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]


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 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]


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


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


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


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


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


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


1. 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. 1990;322:352-8.

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

3. Mutch RS, Hutson PR. Levamisole in the adjuvant treatment of colon cancer. Clin Pharm. 1991;10:95-109.

4. Product Information. Ergamisol (levamisole). Janssen Pharmaceuticals. 2001;PROD.

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

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

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

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.