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Label Changes for:

Risperdal (risperidone) tablets, oral solutionRisperdal M-Tab (risperidone) orally disintegrating tabletsRisperdal Consta (risperidone) long-acting injection

September 2011

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)


September 2011


Metabolic Changes
  • Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.
Weight Gain
  • Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.


June 2011

Summary View    



Commonly-Observed Adverse Reactions in Double-Blind, Placebo- Controlled Clinical Trials - Autistic Disorder
  • In another study with patients treated for irritability associated with autistic disorder, headache (6%), epistaxis (6%) and pyrexia (6%) were also observed in Risperdal-treated pediatric subjects.
Other Adverse Reactions Observed During the Clinical Trial Evaluation of Risperidone
  • Blood and Lymphatic System Disorders: neutropenia
  • Nervous System Disorders: head titubation
Postmarketing Experience
  • blood cholesterol increased, blood triglycerides increased
  • drug withdrawal syndrome neonatal, dysgeusia