FDA label dfd50b2e-a32e-4ac3-b899-ee77d6bb9a6d

WARNINGS Decrements in the predicted growth (i.e., weight gain and/or height) rate have been reported with the long-term use of stimulants in children. Therefore, patients requiring long-term therapy should be carefully monitored.

ADVERSE REACTIONS 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 (see BOXED WARNING and PRECAUTIONS ). 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. (See WARNINGS .) 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.