Risperidone 4 mg Tablets — Generic For Risperdal — SOLCO

These highlights do not include all the information needed to use RISPERIDONE TABLETS safely and effectively. See full prescribing information for RISPERIDONE TABLETS.

RISPERIDONE tablets, for oral use

Initial U.S. Approval: 1993

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

See full prescribing information for complete boxed warning.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Risperidone is not approved for use in patients with dementia-related psychosis. (5.1)

Recent Major Changes

Warnings and Precautions (5.6) 01/2025

Indications And Usage

Risperidone is an atypical antipsychotic indicated for:

Dosage And Administration

Initial DoseTarget DoseEffective Dose Range

Schizophrenia: adults (2.1)

2 mg

4 to 8 mg

4 to 16 mg

Schiophrenia: adolescents (2.1)

0.5 mg

3 mg

1 to 6 mg

Bipolar mania: adults (2.2)

2 to 3 mg

1 to 6 mg

1 to 6 mg

Bipolar mania in children and adolescents (2.2)

0.5 mg

1 to 2.5 mg

1 to 6 mg

Irritability associated with autistic disorder (2.3)

0.25 mg

(Weight <20 kg)

0.5 mg

(Weight ≥20 kg)

0.5 mg (<20 kg)

1 mg (≥20 kg)

0.5 to 3 mg

Dosage Forms And Strengths

Contraindications

Warnings And Precautions

• (5.6) 01/2025 INDICATIONS AND USAGE Risperidone is an atypical antipsychotic indicated for:
• Treatment of schizophrenia (1.1)
• As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2)
• Treatment of irritability associated with autistic disorder (1.3) DOSAGE AND ADMINISTRATION
• Recommended daily dosage: Initial Dose Target Dose Effective Dose Range Schizophrenia: adults (2.1) 2 mg 4 to 8 mg 4 to 16 mg Schiophrenia: adolescents (2.1) 0.5 mg 3 mg 1 to 6 mg Bipolar mania: adults (2.2) 2 to 3 mg 1 to 6 mg 1 to 6 mg Bipolar mania in children and adolescents (2.2) 0.5 mg 1 to 2.5 mg 1 to 6 mg Irritability associated with autistic disorder (2.3) 0.25 mg (Weight <20 kg) 0.5 mg (Weight ≥20 kg) 0.5 mg (<20 kg) 1 mg (≥20 kg) 0.5 to 3 mg
• Severe Renal or Hepatic Impairment in Adults: Use a lower starting dose of 0.5 mg twice daily. May increase to dosages above 1.5 mg twice daily at intervals of at least one week. (2.4) DOSAGE FORMS AND STRENGTHS
• Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (3) CONTRAINDICATIONS
• Known hypersensitivity to risperidone, paliperidone, or to any excipients in risperidone tablets. (4) WARNINGS AND PRECAUTIONS

• (5.6) 01/2025 INDICATIONS AND USAGE Risperidone is an atypical antipsychotic indicated for:
• Treatment of schizophrenia (1.1)
• As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2)
• Treatment of irritability associated with autistic disorder (1.3) DOSAGE AND ADMINISTRATION
• Recommended daily dosage: Initial Dose Target Dose Effective Dose Range Schizophrenia: adults (2.1) 2 mg 4 to 8 mg 4 to 16 mg Schiophrenia: adolescents (2.1) 0.5 mg 3 mg 1 to 6 mg Bipolar mania: adults (2.2) 2 to 3 mg 1 to 6 mg 1 to 6 mg Bipolar mania in children and adolescents (2.2) 0.5 mg 1 to 2.5 mg 1 to 6 mg Irritability associated with autistic disorder (2.3) 0.25 mg (Weight <20 kg) 0.5 mg (Weight ≥20 kg) 0.5 mg (<20 kg) 1 mg (≥20 kg) 0.5 to 3 mg
• Severe Renal or Hepatic Impairment in Adults: Use a lower starting dose of 0.5 mg twice daily. May increase to dosages above 1.5 mg twice daily at intervals of at least one week. (2.4) DOSAGE FORMS AND STRENGTHS
• Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (3) CONTRAINDICATIONS
• Known hypersensitivity to risperidone, paliperidone, or to any excipients in risperidone tablets. (4) WARNINGS AND PRECAUTIONS

Adverse Reactions

The most common adverse reactions in clinical trials (>5% and twice placebo) were parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Drug Interactions

Use In Specific Populations

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2026