Label Changes for:
Pepcid (famotidine) Tablet
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)
- addition of rhabdomyolysis
- Prolonged QT interval has been reported very rarely in patients with impaired renal function whose dose/dosing interval of famotidine may not have been adjusted appropriately
- Prolonged QT interval, in patients with impaired renal function, has been reported very rarely