No black box warning on record for Varenicline

As of the latest FDA labeling reviewed, Varenicline (VARENICLINE) does not carry a black box warning. Standard warnings and precautions still apply — see the full Varenicline medicine page for the complete safety profile.

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Neuropsychiatric Adverse Events: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed su

No black box warning on record for Varenicline

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS Neuropsychiatric Adverse Events: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed su

Varenicline Black Box Warning

No black box warning on record for Varenicline

Other warnings & precautions

Varenicline Black Box Warning

No black box warning on record for Varenicline

Other warnings & precautions