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U.S. Department of Health and Human Services

Safety

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MoviPrep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution)

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

 

December 2013

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • Cardiovascular: Tachycardia, palpitations, hypertension, arrhythmia, atrial fibrillation, peripheral edema.
  • Nervous system: Syncope, tremor, seizure.
  • Renal: Renal impairment and/or failure.
     

 

September 2013

Summary View

17 PATIENT COUNSELING INFORMATION

  • changes to the administration instructions (see PI for details)