Byetta Side Effects
Byetta may cause constipation, diarrhea, upset stomach, headache and hypoglycemia. Some patients may experience severe side effects such as kidney disorders, pancreatitis and gallstones. Serious allergic reactions can cause anaphylaxis.
Most Recent Byetta Side Effects Information
As of September 30, 2024, the most common Byetta side effects reported to the FDA were hyperglycemia, weight loss, low blood sugar and gastrointestinal upset (nausea, vomiting and diarrhea). These symptoms are often mild, but changes to blood sugar levels can become serious.
Dizziness and headache were additional mild side effects reported frequently to the FDA. Pancreatitis, while not common, happens often enough to appear in the FDA’s Adverse Events Reporting System (FAERS). Byetta packaging includes a warning about the risk of developing pancreatitis and pre-cancerous pancreatic cells.
Total cases reported | 48,948 |
Serious cases (including deaths) | 12,448 |
Deaths | 1,572 |
Disclaimer: Reports sent to the FDA don’t necessarily mean the drug caused an adverse event. Consult a health care professional before stopping or changing medication.
The annual number of adverse effects reported to the FDA for Byetta has decreased steadily since 2014. Among the millions of Byetta prescriptions written since 2005, fewer than 50,000 total cases have resulted in adverse events.
However, it’s important to note that about 25% of reported Byetta cases have involved serious side effects. If you have concerns about taking Byetta, talk to your doctor about the benefits and risks.
Byetta FDA Warnings
The FDA requires a warning on Byetta packaging alerting patients about the risk of developing acute pancreatitis. While rare, this serious side effect can lead to bleeding in or around the pancreas, necrosis of the pancreas, or even death.
As of 2021, the FDA also required an updated warning about the risk of hypoglycemia, including severe hypoglycemia, in patients using Byetta in combination with insulin or other drugs that increase insulin levels. Patients should be made aware of the risk and the warning signs of severe hypoglycemia before taking Byetta.
Common Byetta Side Effects
Gastrointestinal symptoms including nausea, vomiting and diarrhea, are among the most common Byetta side effects. Some patients also report low blood sugar, although this symptom is usually mild.
- Low blood sugar
- Nausea
- Upset stomach
- Vomiting
Clinical study data reported in Byetta patient information shows that low blood sugar, or hypoglycemia, is more likely to occur if you take Byetta in combination with other medications that affect insulin, including metformin and sulfonylurea. The risk of hypoglycemia increases with higher doses of Byetta as an add-on to metformin and sulfonylurea combination therapy.
Mild Byetta Side Effects
Many Byetta side effects are mild. Symptoms like dizziness, feeling jittery, gastrointestinal distress (nausea, vomiting, diarrhea, indigestion and constipation), headaches and general weakness usually resolve on their own as your body adjusts to the medication. However, you should notify your doctor if your symptoms do not improve or if they become severe.
Most occurrences of hypoglycemia are mild, but tell your doctor if you experience serious symptoms such as confusion, severe dizziness, drowsiness, headache, hunger, a rapid heartbeat or sweating. These symptoms could indicate extremely low blood sugar levels, a potentially serious condition.
Rare But Serious Byetta Side Effects
Pancreatitis and kidney problems were the most frequently reported severe side effects of Byetta. While taking Byetta or other GLP-1 receptor agonist drugs, you may have a higher risk of developing gallstones or gallbladder inflammation.
Some patients and study participants have experienced severe allergic reactions to Byetta. In rare cases, severe allergic reactions can result in anaphylaxis, a potentially fatal condition. If you notice symptoms such as a rash, hives, difficulty breathing or swelling of the face or throat, seek immediate medical attention.
- Allergic reaction
- Dehydration
- Gallbladder problems
- Pancreatitis
While serious Byetta side effects are rare, they can be life-threatening. You should report any symptoms of a severe adverse reaction to your doctor immediately.
Acute Kidney Injury
In rare cases, patients taking Byetta have experienced impaired kidney function that can lead to kidney failure. Symptoms of kidney injury may include persistent nausea, vomiting and diarrhea that does not improve over time.
Notify your doctor if these symptoms last for more than a few days or if you have trouble taking liquids by mouth, as this could put you at an increased risk for kidney problems.
“Byetta may cause new or worse problems with kidney function, including kidney failure. Dialysis or kidney transplant may be needed.”
According to a 2022 study published in Frontiers in Endocrinology, the risk of acute kidney injury is higher in patients taking liraglutide compared to exenatide, the active ingredient in Byetta. However, anyone with a history of kidney disease should carefully consider the risks of kidney failure associated with any GLP-1 receptor agonist drugs.
Pancreatitis
The Byetta label includes a warning about an increased risk of hemorrhagic or necrotizing pancreatitis, a condition involving inflammation of the pancreas that can become fatal.
Chronic pancreatitis can cause permanent damage to the pancreas. Symptoms include abdominal pain, upset stomach, fever and weight loss. If you have a history of pancreatitis, an alternative antidiabetic medication might be a safer choice.
If you notice any of these symptoms while taking Byetta, you should consult a medical professional to see if you need to discontinue the medication. However, you should not stop taking your medication unless your doctor advises you to.
Byetta Gastrointestinal Side Effects Case Study
Pancreatitis Risk With Byetta
A 44-year-old woman with Type 1 diabetes and kidney problems received a transplant procedure to help the new kidney produce insulin on its own. Doctors prescribed a medication called Byetta (exenatide) to help control the woman’s blood sugar levels, according to a letter to the editor published in the New England Journal of Medicine.
Digestive Complications
After 11 months of treatment, the woman experienced severe stomach problems including nausea and vomiting. Doctors found a tightly packed mass of undigested food in the stomach and removed it.
The doctors temporarily stopped the woman’s Byetta treatment, but when they restarted it on a lower dose, the same problems returned within three months. After the second occurrence, the doctors decided to stop use of Byetta entirely.
Risks With Gastroparesis
The authors wrote that while Byetta may help stabilize blood sugar levels, the medication can worsen a stomach condition called gastroparesis, which can lead to serious problems like pancreatitis.
As a result, the authors recommended that patients with a history of gastroparesis should think carefully about whether Byetta is right for them.
Byetta Alternatives
If you are concerned about possible Byetta side effects, you may consider taking alternative Type 2 diabetes medications, including other GLP-1 receptor agonists. Several drugs within this class, including Bydureon BCise®, Mounjaro™, Ozempic® and Trulicity®, are potential options.
Keep in mind that these Byetta alternatives may also cause serious side effects, especially the newer medications. A 2024 review published in Cureus shows that newer drugs within the GLP-1 receptor agonist class have higher rates of serious adverse reactions compared to older GLP-1 receptor agonists like Byetta.
- DPP-4 inhibitors
- Finerenone
- Other GLP-1 receptor agonists
- SGLT2 inhibitors
Dipeptidyl peptidase-4 (DPP-4) inhibitors are usually well tolerated and can help lower A1C levels without causing hypoglycemia. Sodium-glucose co-transporter 2 (SGLT2) inhibitors are another class of diabetes drugs that can effectively lower blood sugar levels. They also help preserve kidney function in some patients with kidney disease.
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