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Pemoline Side Effects

Applies to pemoline: oral tablet, oral tablet chewable

Hepatic

As of October 2005, hepatic failure resulting in liver transplant or death, usually within 4 weeks of onset of signs and symptoms of hepatic failure, has been reported in at least 13 patients receiving pemoline. The reporting rate for hepatic failure with pemoline is 10 to 25 times greater than the background rate of hepatic failure in the general population.[Ref]

Hepatic side effects have included asymptomatic reversible increases in liver enzymes, hepatitis, jaundice, and life threatening hepatic failure.[Ref]

General

Insomnia tends to occur early in therapy. Most cases are transient and respond to a reduction in dosage.[Ref]

General side effects have included insomnia which has been reported to be the most frequent side effect with the use of pemoline. Growth suppression has been associated with the long term use of stimulants in children.[Ref]

Hematologic

Hematologic side effects including aplastic anemia have been reported.[Ref]

Nervous system

Nervous system side effects including seizures, hallucinations, dyskinetic movements of the tongue, lips, face, and extremities, mild depression, dizziness, increased irritability, headache, and drowsiness have been reported.[Ref]

Ocular

Ocular side effects have included nystagmus and oculogyric crisis.[Ref]

Gastrointestinal

Gastrointestinal side effects including anorexia, weight loss, nausea, and stomach ache have been reported.[Ref]

Anorexia and weight loss tend to occur during the first weeks of therapy. Most cases are transient. Weight gain usually resumes within 3 to 6 months.[Ref]

Dermatologic

Dermatologic side effects have included skin rash.[Ref]

Cardiovascular

Cardiovascular side effects including a case of severe hypotension have been reported.[Ref]

The case of severe hypotension was reported in a patient receiving pemoline during general anesthesia.[Ref]

Other

Other side effects including ototoxicity have been reported.[Ref]

Genitourinary

Genitourinary side effects have included an isolated case of elevated serum acid phosphatase in one man with prostatic enlargement. (The serum acid phosphatase normalized upon discontinuation of pemoline and elevated again on rechallenge.)[Ref]

References

1. Sterling MJ, Kane M, Grace ND "Pemoline-induced autoimmune hepatitis." Am J Gastroenterol 91 (1996): 2233-4

2. "Product Information. Cylert (pemoline)." Abbott Pharmaceutical, Abbott Park, IL.

3. Berkovitch M, Pope E, Phillips J, Koren G "Pemoline-associated fulminant liver failure: testing the evidence for causation." Clin Pharmacol Ther 57 (1995): 696-8

4. Shuster J "Adverse drug reaction. Pemoline and dyskinesia." Nursing 29 (1999): 24

5. Bohringer CH, Jahr JS, Rowell S, Mayer K "Severe hypotension in a patient receiving pemoline during general anesthesia." Anesth Analg 91 (2000): 1131-3

6. "Multum Information Services, Inc. Expert Review Panel"

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