"The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of "...
(Generic versions may still be available.)
Cylert Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Cylert (pemoline) is used to treat attention deficit hyperactivity disorder (ADHD). It is a central nervous system stimulant. The brand name Cylert is no longer available in the U.S. Generic versions may be available. Common side effects include insomnia (difficulty sleeping), nervousness, headache, or drowsiness, mild depression, or nausea, decreased appetite, or weight loss. In rare cases, pemoline has caused severe liver damage resulting in death or liver transplant. Notify your doctor if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, itching, clay-colored stools, or dark urine. These symptoms may be early signs of liver damage.
The recommended starting dose of pemoline is 37.5 mg/day, taken as a single dose once each morning. The effective daily dose for most patients ranges from 56.25 to 75 mg. The maximum recommended daily dose of pemoline is 112.5 mg. There may be an increased risk of seizures when pemoline is taken with antiepileptic medications. Other drugs may interact with pemoline. Tell your doctor all prescription or over-the-counter medicines you use. Tell your doctor if you are pregnant before taking pemoline. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.
Our Cylert (pemoline) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Cylert FDA Prescribing Information: Side Effects
The following are adverse reactions in decreasing order of severity within each category associated with CYLERT (pemoline) :
Hepatic: There have been reports of hepatic dysfunction, ranging from asymptomatic reversible increases in liver enzymes to hepatitis, jaundice and life- threatening hepatic failure, in patients taking CYLERT (see PRECAUTIONS and WARNINGS).
Hematopoietic: There have been isolated reports of aplastic anemia.
Central Nervous System: The following CNS effects have been reported with the use of CYLERT (pemoline) : convulsive seizures: literature reports indicate that CYLERT (pemoline) may precipitate attacks of Gilles de la Tourette syndrome; hallucinations; dyskinetic movements of the tongue, lips, face and extremities: abnorrnal 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 (pemoline) , 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.
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 (pemoline) for sleepiness. The acid phosphatase normalized with discontinuation of CYLERT (pemoline) and was again elevated with rechallenge.
Mild adverse reactions appearing early during the course of treatment with CYLERT (pemoline) often remit with continuing therapy. If adverse reactions are of a significant or protracted nature, dosage should be reduced or the drug discontinued.
DRUG ABUSE AND DEPENDENCE
Controlled Substance: CYLERT (pemoline) is subject to control under DEA schedule IV.
Abuse: CYLERT (pemoline) failed to demonstrate a potential for self- administration in primates. However, the pharmacologic similarity of pemoline to other psychostimulants with known dependence liability suggests that psychological and/ or physical dependence might also occur with CYLERT (pemoline) . There have been isolated reports of transient psychotic symptoms occurring in adults following the long- term misuse of excessive oral doses of pemoline. CYLERT (pemoline) should be given with caution to emotionally unstable patients who may increase the dosage on their own initiative.
Read the entire FDA prescribing information for Cylert (Pemoline) »
Additional Cylert Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.