Seroquel XR
FDA Black Box Warning

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

See full prescribing information for complete boxed warning. Antipsychotic drugs are associated with an increased risk of death.
Seroquel XR is not approved for elderly patients with Dementia-Related Psychosis.

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder and other psychiatric disorders.