Medication Guide App

Ergamisol Side Effects

Generic Name: levamisole

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

Not all side effects for Ergamisol may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to levamisole: oral tablet

In addition to its needed effects, some unwanted effects may be caused by levamisole (the active ingredient contained in Ergamisol). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking levamisole:

Less common
  • Fever or chills
  • unusual feeling of discomfort or weakness
Rare
  • Black, tarry stools
  • blood in urine or stools
  • cough or hoarseness
  • lower back or side pain
  • painful or difficult urination
  • pinpoint red spots on skin
  • unusual bleeding or bruising

If any of the following side effects occur while taking levamisole, check with your doctor or nurse as soon as possible:

Less common
  • Sores in mouth and on lips
Rare
  • Blurred vision
  • confusion
  • convulsions (seizures)
  • lip smacking or puffing
  • numbness, tingling, or pain in face, hands, or feet
  • paranoia (feelings of persecution)
  • puffing of cheeks
  • rapid or worm-like movements of tongue
  • trembling or shaking
  • trouble in walking
  • uncontrolled movements of arms and legs

Some of the side effects that can occur with levamisole may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Diarrhea
  • metallic taste
  • nausea
Less common
  • Anxiety or nervousness
  • dizziness
  • headache
  • mental depression
  • nightmares
  • pain in joints or muscles
  • skin rash or itching
  • trouble in sleeping
  • unusual tiredness or sleepiness
  • vomiting

Levamisole may cause a temporary loss of hair in some people. After treatment has ended, normal hair growth should return.

For Healthcare Professionals

Applies to levamisole: oral tablet

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.[Ref]

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]

Dermatologic

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

Other

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

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

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

4. 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

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

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