Label Changes for:
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)
- Cardiac disorders: symptomatic hypotension (addition)
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.
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