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Label Changes for:

Opsumit (macitentan)

June 2016

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

June 2016

ADVERSE REACTIONS

Postmarketing Experience
  • Cardiac disorders: symptomatic hypotension (addition)

 

February 2016

ADVERSE REACTIONS

Postmarketing

General disorders and administration site conditions: edema/fluid retention

  • Cases of edema and fluid retention occurred within weeks of starting Opsumit, some requiring intervention with a diuretic, fluid management or hospitalization for decompensated heart failure.

 

April 2015

ADVERSE REACTIONS

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of OPSUMIT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Immune system disorders: hypersensitivity reactions (angioedema, pruritus and rash)
  • Respiratory, thoracic and mediastinal disorders: nasal congestion

 

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