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U.S. Department of Health and Human Services

Safety

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Tyvaso (Treprostinil) Inhalation Solution

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013

Summary View

 

ADVERSE REACTIONS

Adverse Reactions Identified in Clinical Trials
  • …2.3 years, with a maximum exposure of 5.4 years. Eighty-nine (89%) percent of patients achieved the target dose of nine breaths, four times daily. Forty-two (42%) percent achieved a dose of 12 breaths four times daily.
  • Adverse Reactions Identified in Post-Marketing Experience - The following adverse reaction has been identified during the postapproval use of Tyvaso: Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure: Angioedema.