Increased risk of suicidality and associated behaviors in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders. May worsen psychosis or precipitate a shift to mania or hypomania in bipolar disorder. Not approved for treatment of bipolar depression. May cause anticholinergic effects (constipation, xerostomia, blurred vision, urinary retention) or extrapyramidal symptoms (pseudoparkinsonism, acute dystonic reactions, akathisia and tardive dyskinesia). Use may be associated with neuroleptic malignant syndrome (risk may be increased in Parkinson’s disease or Lewy body dementia). May cause orthostatic hypotension or sedation. Use with caution in cardiovascular disease (previous myocardial infarction, stroke, tachycardia, or conduction abnormalities), hepatic impairment, renal impairment, seizure disorder (head trauma, brain damage, alcoholism, or concurrent therapy with medications which may lower seizure threshold), hyperthyroidism or those receiving thyroid supplementation. Effects may be potentiated when used with other sedative drugs or ethanol. May increase risks associated with electroconvulsive therapy.