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U.S. Department of Health and Human Services

Safety

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Risperdal (risperidone) tablets, oral solution, Risperdal M-Tab (risperidone) orally disintegrating tablets, and Risperdal Consta (risperidone) long-acting injection.

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

 

April 2014

Summary View

6 ADVERSE REACTIONS

6.2 Postmarketing Experience 
  • added ..... ileus
6.8 Postmarketing Experience [for Risperdal Consta ]
  • added: Very rarely, cases of anaphylactic reaction after injection with RISPERDAL CONSTA have been reported during postmarketing experience in patients who have previously tolerated oral risperidone. 

 

September 2011

Summary View

WARNINGS and PRECAUTIONS

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    

 

ADVERSE DRUG REACTIONS

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