Risperidone 0.25 mg Tablets — Generic For Risperdal — Ajanta

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 tablets are not approved for use in patients with dementia-related psychosis. (5.1)

Recent Major Changes

Warnings and Precautions (5.6) 1/2025

Indications And Usage

Risperidone tablets are 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

Schizophrenia: 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

Cerebrovascular events, including stroke, in elderly patients with dementia-related psychosis: Risperidone tablets are not approved for use in patients with dementia-related psychosis (5.2)

Neuroleptic Malignant Syndrome: Manage with immediate discontinuation of risperidone tablets and close monitoring. (5.3)

Tardive dyskinesia: Consider discontinuing risperidone tablets if clinically indicated. (5.4)

Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular / cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain. (5.5)

Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes. (5.5)

Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. (5.5)

Weight Gain: Significant weight gain has been reported. Monitor weight gain. (5.5)

Hyperprolactinemia: Prolactin elevations occur and persist during chronic administration. (5.6)

Orthostatic hypotension: For patients at risk, consider a lower starting dose and slower titration. (5.7)

Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts in patients with a history of clinically significant low white blood cell count (WBC). Consider discontinuing risperidone tablets if a clinically significant decline in WBC occurs in the absence of other causative factors. (5.9)

Potential for cognitive and motor impairment: Use caution when operating machinery. (5.10)

Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold. (5.11)

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 Ajanta Pharma USA Inc. at 855-664-7744 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Drug Interactions

Carbamazepine and other enzyme inducers decrease plasma concentrations of risperidone. Increase the risperidone tablets dose up to double the patient’s usual dose. Titrate slowly. (7.1)

Fluoxetine, paroxetine, and other CYP 2D6 enzyme inhibitors increase plasma concentrations of risperidone. Reduce the initial dose. Do not exceed a final dose of 8 mg per day of risperidone tablets. (7.1)

Use In Specific Populations

Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. (8.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2025