FDA Warnings

Adzenys XR-ODT (amphetamine – Adderall XR)

FDA-approved label for Adzenys XR-ODT, an amphetamine bioequivalent of Adderall XR, warns: “Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed.”

Chantix (varenicline)

FDA-approved label warns of postmarketing reports of serious neuropsychiatric symptoms, including homicidal ideation, in patients being treated with Chantix.

Effexor (venlafaxine hydrochloride)

FDA-approved label warns that homicidal ideation was a reported adverse event during the premarketing evaluation of Effexor and Effexor XR.

Luvox (fluvoxamine maleate)

FDA-approved label warns patients to call their healthcare provider or 911 if “acting on dangerous impulses” or “acting aggressive or violent.”

Savella (milnacipran hydrochloride)

FDA-approved label warns patients of reported adverse events including “aggression, anger, delirium, hallucination, homicidal ideation.”

Trazodone Hydrochloride

FDA-approved label warns patients to call their healthcare provider or 911 if “acting on dangerous impulses” or “acting aggressive or violent.”

Vyvanse (lisdexamfetamine)

FDA-approved label warns “Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been seen.”

Wellbutrin (bupropion hydrochloride)

FDA-approved label warns: “Serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation. These have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide.”