Pemoline Side Effects

It is possible that some side effects of pemoline may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to pemoline: oral tablet, oral tablet chewable

Along with its needed effects, pemoline 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.

If any of the following side effects occur while taking pemoline, check with your doctor immediately:

Rare
  • Dark urine
  • yellow eyes or skin

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

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 pemoline side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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 taking this drug, it is possible that you may still experience side effects that need medical attention. If you notice any of the following side effects check with your doctor immediately:

  • 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

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

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.

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

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.

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

Dermatologic

Dermatologic side effects have included skin rash.

Cardiovascular

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

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

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.)

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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