No black box warning on record for Quetiapine

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

Other warnings & precautions

Increased Mortality in Elderly Patients with Dementia (Boxed Warning): Atypical antipsychotics increase the risk of death in elderly patients treated for dementia-related psychosis. Not FDA-approved for this indication.
Suicidality (Boxed Warning): Antidepressants increase the risk of suicidal thinking in children and young adults. Quetiapine is used adjunctively for MDD — monitor closely for suicidality.
Metabolic Effects: Quetiapine causes significant weight gain (average 2–3 kg in acute trials; more with long-term use), hyperglycemia, and dyslipidemia. Monitor weight, fasting glucose, and lipids at baseline and regularly during treatment. Counsel patients on diet and exercise.
QTc Prolongation: Monitor ECG in patients at risk. Avoid combination with other QTc-prolonging medicines.
Off-Label Sleep Use: Quetiapine is widely prescribed at low doses (25–100mg) for insomnia without FDA approval for this indication. This practice exposes patients to metabolic, cardiovascular, and tardive dyskinesia risks even at low doses. Evidence for efficacy at low doses is limited. Consider evidence-based insomnia treatments (CBT-I, FDA-approved sleep agents) first.

No black box warning on record for Quetiapine

Other warnings & precautions

Increased Mortality in Elderly Patients with Dementia (Boxed Warning): Atypical antipsychotics increase the risk of death in elderly patients treated for dementia-related psychosis. Not FDA-approved for this indication.
Suicidality (Boxed Warning): Antidepressants increase the risk of suicidal thinking in children and young adults. Quetiapine is used adjunctively for MDD — monitor closely for suicidality.
Metabolic Effects: Quetiapine causes significant weight gain (average 2–3 kg in acute trials; more with long-term use), hyperglycemia, and dyslipidemia. Monitor weight, fasting glucose, and lipids at baseline and regularly during treatment. Counsel patients on diet and exercise.
QTc Prolongation: Monitor ECG in patients at risk. Avoid combination with other QTc-prolonging medicines.
Off-Label Sleep Use: Quetiapine is widely prescribed at low doses (25–100mg) for insomnia without FDA approval for this indication. This practice exposes patients to metabolic, cardiovascular, and tardive dyskinesia risks even at low doses. Evidence for efficacy at low doses is limited. Consider evidence-based insomnia treatments (CBT-I, FDA-approved sleep agents) first.

Quetiapine Black Box Warning

No black box warning on record for Quetiapine

Other warnings & precautions

Quetiapine Black Box Warning

No black box warning on record for Quetiapine

Other warnings & precautions