No black box warning on record for Risperidone

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

Other warnings & precautions

Elderly Patients with Dementia-Related Psychosis — Black Box Warning: Risperidone (and all antipsychotics) carry a black box warning for elderly patients with dementia. These patients have a significantly increased risk of death (primarily from cardiovascular events and infections like pneumonia) when treated with antipsychotics. The FDA-approved indications do not include dementia-related behavioral symptoms. If used off-label for this purpose, the risks must be explicitly discussed with the patient's family/caregivers, and the lowest effective dose for the shortest duration should be used.
Hyperprolactinemia: Risperidone causes the most prolactin elevation of any atypical antipsychotic. Clinical effects in women: menstrual irregularities, amenorrhea, galactorrhea, decreased libido, infertility. In men: gynecomastia, galactorrhea, sexual dysfunction, decreased libido. Long-term hyperprolactinemia may increase risk of osteoporosis and, theoretically, hormone-sensitive tumors (though this is not clearly established clinically).
Tardive Dyskinesia: Long-term antipsychotic use risks development of TD — involuntary, repetitive movements typically of the face (lip smacking, tongue movements) or extremities. Risk increases with duration and dose. If TD develops, consider discontinuing or switching to a lower-risk agent (clozapine, quetiapine). Valbenazine and deutetrabenazine are FDA-approved treatments for TD.
Metabolic Syndrome Monitoring: All patients on atypical antipsychotics require baseline and periodic monitoring of: weight/BMI, waist circumference, fasting glucose, HbA1c, lipid panel, blood pressure. Schedule monitoring at baseline, 12 weeks, then annually.
Dose-Dependent EPS: Unlike many other atypical antipsychotics, risperidone has significant dose-dependent extrapyramidal side effects — especially above 6–8mg/day. Keeping doses at or below 6mg/day significantly reduces EPS risk while maintaining antipsychotic efficacy.

Other warnings & precautions

Elderly Patients with Dementia-Related Psychosis — Black Box Warning: Risperidone (and all antipsychotics) carry a black box warning for elderly patients with dementia. These patients have a significantly increased risk of death (primarily from cardiovascular events and infections like pneumonia) when treated with antipsychotics. The FDA-approved indications do not include dementia-related behavioral symptoms. If used off-label for this purpose, the risks must be explicitly discussed with the patient's family/caregivers, and the lowest effective dose for the shortest duration should be used.

Hyperprolactinemia: Risperidone causes the most prolactin elevation of any atypical antipsychotic. Clinical effects in women: menstrual irregularities, amenorrhea, galactorrhea, decreased libido, infertility. In men: gynecomastia, galactorrhea, sexual dysfunction, decreased libido. Long-term hyperprolactinemia may increase risk of osteoporosis and, theoretically, hormone-sensitive tumors (though this is not clearly established clinically).

Tardive Dyskinesia: Long-term antipsychotic use risks development of TD — involuntary, repetitive movements typically of the face (lip smacking, tongue movements) or extremities. Risk increases with duration and dose. If TD develops, consider discontinuing or switching to a lower-risk agent (clozapine, quetiapine). Valbenazine and deutetrabenazine are FDA-approved treatments for TD.

Metabolic Syndrome Monitoring: All patients on atypical antipsychotics require baseline and periodic monitoring of: weight/BMI, waist circumference, fasting glucose, HbA1c, lipid panel, blood pressure. Schedule monitoring at baseline, 12 weeks, then annually.

Dose-Dependent EPS: Unlike many other atypical antipsychotics, risperidone has significant dose-dependent extrapyramidal side effects — especially above 6–8mg/day. Keeping doses at or below 6mg/day significantly reduces EPS risk while maintaining antipsychotic efficacy.

Risperidone Black Box Warning

No black box warning on record for Risperidone

Other warnings & precautions

Risperidone Black Box Warning

No black box warning on record for Risperidone

Other warnings & precautions