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U.S. Department of Health and Human Services

Safety

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Risperdal (risperidone) tablets, Risperdal (risperidone) oral solution, and Risperdal M-Tab (risperidone) oral disintegrating tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2010 

Summary View

WARNINGS and PRECAUTIONS

Priapism
  • Priapism has been reported during postmarketing surveillance

ADVERSE REACTIONS

Postmarketing Experience
  • hypothermia
  • priapism
  • sleep apnea syndrome
  • urinary retention
  • diabetes mellitus
  • hypoglycemia
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