Cylert Side Effects

Generic Name: pemoline

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

Not all side effects for Cylert 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 pemoline: oral tablet, oral tablet chewable

Along with its needed effects, pemoline (the active ingredient contained in Cylert) may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others by doing certain tests.

Pemoline may cause some serious side effects, including liver problems. Also, medicines like pemoline, when used for a long time, have been reported to slow the growth rate of children. Some doctors recommend medicine-free periods during treatment with pemoline. Pemoline may also cause unwanted effects on behavior in children with severe mental illness.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pemoline:

Rare
  • Dark urine
  • yellow eyes or skin

Check with your doctor as soon as possible if any of the following side effects occur while taking pemoline:

Rare
  • Convulsions (seizures)
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • nausea and vomiting
  • shortness of breath, troubled breathing, wheezing, or tightness in chest
  • skin rash
  • sores, ulcers, or white spots on lips or in mouth
  • swollen or painful glands
  • uncontrolled movements of eyes, tongue, lips, face, arms, or legs
  • unusual bleeding or bruising
  • unusual tiredness
  • vocal sounds you cannot control
Symptoms of overdose
  • Agitation
  • confusion
  • convulsions (seizures)—may be followed by coma
  • false sense of well-being
  • fast heartbeat
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • headache (severe)
  • high blood pressure
  • high fever
  • large pupils
  • muscle trembling or twitching
  • restlessness
  • sweating
  • vomiting

This medicine may also cause the following side effects that your doctor will watch for:

Rare
  • Liver problems
  • slow growth in children

Some side effects of pemoline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Loss of appetite
  • trouble in sleeping
  • weight loss
Less common
  • Dizziness
  • drowsiness
  • headache
  • increased irritability
  • mental depression
  • stomachache

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Abdominal pain
  • convulsions (seizures)
  • headache
  • mental depression
  • nausea
  • unusual behavior
  • unusual tiredness or weakness
  • vomiting

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 (the active ingredient contained in Cylert) 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 (the active ingredient contained in Cylert) and elevated again on rechallenge.)

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