What were the most common adverse events with BYETTA in clinical trials?
The most common treatment-emergent adverse events associated with BYETTA (vs placebo) in three 30-week placebo-controlled clinical trials were nausea (44% vs 18%), vomiting (13% vs 4%), diarrhea (13% vs 6%), feeling jittery (9% vs 4%), dizziness (9% vs 6%), headache (9% vs 6%), and dyspepsia (6% vs 3%). In a 16-week study of patients receiving BYETTA with a thiazolidinedione, the incidence and type of other adverse events observed were similar. Postmarketing experience reports include nausea, vomiting, and/or diarrhea resulting in dehydration with some reports associated with increased serum creatinine/acute renal failure (that may be reversible if treated appropriately), acute pancreatitis, and rare cases of anaphylactic reaction. For complete safety profile, see the Prescribing Information.
