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U.S. Department of Health and Human Services

Safety

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Relpax (eletriptan) Tablets

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

 

October 2013

Summary View

CONTRAINDICATIONS

  • Hypersensitivity to Relpax (angioedema and anaphylaxis seen)

WARNINGS AND PRECAUTIONS

Increase in Blood Pressure
  • Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with Relpax. Relpax is contraindicated in patients with uncontrolled hypertension
Anaphylactic/Anaphylactoid Reactions
  • There have been reports of anaphylaxis, anaphylactoid, and hypersensitivity reactions including angioedema in patients receiving Relpax. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. Relpax is contraindicated in patients with a history of hypersensitivity reaction to Relpax.

 

 

April 2011

Summary View

 

ADVERSE REACTIONS

Other Events Observed During Postmarketing Use
  • ...vomiting...