Common Side Effects and Reports to the FDA
The most common side effects of Bydureon and Byetta occurred in 5 percent or more of clinical trial participants. Side effects may occur more frequently when people take higher doses of the drugs or take them with other antidiabetic drugs or insulin.
Nausea, for example, occurred in 8 percent of people who took Byetta during clinical trials compared to 0 percent of patients who took placebo. Combining the drug with metformin increased that number to 44 percent, according to AstraZeneca’s Byetta website, compared to 18 percent with placebo.
Common side effects include:
- Nausea
- Dizziness
- Vomiting
- Diarrhea
- Headache
- Dizziness
- Injection site reactions (Bydureon)
- Jittery feelings
- Indigestion
- Constipation
- Hypoglycemia (low blood sugar)
- Weakness or lack of energy
- Gastroesophageal reflux disease
An October
2016 study in Diabetes Care found gastrointestinal side effects of exenatide were mild to moderate in severity and mostly went away within a few days. In some people, diarrhea, nausea and vomiting peaked by the eighth week of treatment.
Since the drugs hit the market, drugmakers have received reports of additional possible side effects. These are called postmarketing side effects, and some of them are serious.
Reports include hypersensitivity reactions (skin rashes, difficulty breathing and swelling), abdominal pain, hair loss, kidney problems and severe pancreatitis. One desirable side effect for patients in a 2009 study was a small weight loss of about 7 pounds to 13 pounds over 52 weeks, according to researchers at Oregon Health and Science University.
People report many of these postmarketing events to the FDA’s Adverse Events Reporting System (FAERS) database. From 2005 to Sept. 30, 2019, people reported 48,174 adverse events related to Byetta. The most reported adverse events in FAERS include increased blood sugar, weight loss and nausea.