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U.S. Department of Health and Human Services

Safety

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Trental (pentoxifylline) Extended-Release Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2012

 

Summary View

 

PRECAUTIONS

General
  • At the first sign of anaphylactic/anaphylactoid reaction, TRENTAL must be discontinued
Drug Interactions
  • Postmarketing cases of increased anticoagulant activity have been reported in patients concomitantly treated with pentoxifylline and vitamin K antagonists. Monitoring of anticoagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed.

ADVERSE REACTIONS

  • Cholestasis
  • Immune system disorders - anaphylactic reaction, anaphylactoid reaction, anaphylactic shock