Pemoline Side Effects

Some side effects of pemoline may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to pemoline: oral tablet, oral tablet chewable

If you experience any of the following serious side effects, stop taking pemoline and seek emergency medical attention or notify your doctor immediately:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

• liver damage (nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, itching, clay-colored stools, or dark urine)

• seizures;

• unusual behavior, confusion, or hallucinations; or

• unusual movements of the tongue, lips, face, or arms and legs.

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

• insomnia (difficulty sleeping);

• nervousness, headache, or drowsiness;

• mild depression; or

• nausea, decreased appetite, or weight loss.

Pemoline is habit forming and may cause drug dependence. Do not stop taking it suddenly.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to pemoline: oral tablet, oral tablet chewable

Hepatic

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

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.

General

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.

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

Hematologic

Hematologic side effects including aplastic anemia have been reported.

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.

Ocular

Ocular side effects have included nystagmus and oculogyric crisis.

Gastrointestinal

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

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.

Dermatologic

Dermatologic side effects have included skin rash.

Cardiovascular

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

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

Other

Other side effects including ototoxicity have been reported.

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.)

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