Cylert Side Effects

Please note - some side effects for Cylert may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Cylert Side Effects - for the Professional

Cylert

The following are adverse reactions in decreasing order of severity within each category associated with Cylert:

Hepatic

There have been reports of hepatic dysfunction, ranging from asymptomatic reversible increases in liver enzymes to hepatitis, jaundice and fatal hepatic failure, in patients taking Cylert.

Hematopoietic

There have been isolated reports of aplastic anemia.

Central Nervous System

The following CNS effects have been reported with the use of Cylert: convulsive seizures; literature reports indicate that Cylert may precipitate attacks of Gilles de la Tourette syndrome; hallucinations; dyskinetic movements of the tongue, lips, face and extremities; abnormal oculomotor function including nystagmus and oculogyric crisis; mild depression; dizziness; increased irritability; headache; and drowsiness.

Insomnia is the most frequently reported side effect of Cylert; it usually occurs early in therapy prior to an optimum therapeutic response. In the majority of cases it is transient in nature or responds to a reduction in dosage.

Gastrointestinal

Anorexia and weight loss may occur during the first weeks of therapy. In the majority of cases it is transient in nature; weight gain usually resumes within three to six months.

Nausea and stomach ache have also been reported.

Genitourinary

A case of elevated acid phosphatase in association with prostatic enlargement has been reported in a 63 year old male who was treated with Cylert for sleepiness. The acid phosphatase normalized with discontinuation of Cylert and was again elevated with rechallenge.

Miscellaneous

Suppression of growth has been reported with the long-term use of stimulants in children. Skin rash has been reported with Cylert.

If adverse reactions are of a significant or protracted nature, dosage should be reduced or the drug discontinued.

Side Effects by Body System

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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