45/100 · Moderate
Manufactured by AstraZeneca Pharmaceuticals LP
Exenatide Safety Profile: Common Gastrointestinal and Metabolic Effects
130,422 FDA adverse event reports analyzed
Last updated: 2026-05-12
EXENATIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AstraZeneca Pharmaceuticals LP. Based on analysis of 130,422 FDA adverse event reports, EXENATIDE has a safety score of 45 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for EXENATIDE include BLOOD GLUCOSE INCREASED, WEIGHT DECREASED, NAUSEA, DECREASED APPETITE, BLOOD GLUCOSE DECREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for EXENATIDE.
Exenatide has a safety concern score of 45 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 130,422 adverse event reports for this medication, which is primarily manufactured by Astrazeneca Pharmaceuticals Lp.
The most commonly reported adverse events include Blood Glucose Increased, Weight Decreased, Nausea. Of classified reports, 28.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common adverse events are gastrointestinal issues such as nausea, vomiting, and diarrhea, which are expected given the drug's mechanism of action.
Weight loss is a significant benefit for patients with type 2 diabetes, but it is also associated with a notable number of reports. Pancreatitis is a key safety concern, with a relatively high number of reports, indicating a need for careful monitoring.
Patients taking Exenatide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Exenatide can cause gastrointestinal side effects such as nausea, vomiting, and diarrhea, and patients should be monitored for signs of pancreatitis. Drug interactions are not well-documented, but patients should inform their healthcare provider of a This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Exenatide received a safety concern score of 45/100 (moderate concern). This is based on a 28.0% serious event ratio across 52,304 classified reports. The score accounts for 130,422 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 32,748, Male: 18,370, Unknown: 209. The most frequently reported age groups are age 58 (1,416 reports), age 59 (1,413 reports), age 63 (1,404 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 52,304 classified reports for EXENATIDE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Exenatide can cause gastrointestinal side effects such as nausea, vomiting, and diarrhea, and patients should be monitored for signs of pancreatitis. Drug interactions are not well-documented, but patients should inform their healthcare provider of a
If you are taking Exenatide, here are important things to know. The most commonly reported side effects include blood glucose increased, weight decreased, nausea, decreased appetite, blood glucose decreased. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be educated on the common side effects of exenatide, including gastrointestinal symptoms, and how to manage them. Regular monitoring for signs of pancreatitis is recommended, especially in patients with a history of pancreatitis. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of exenatide, and the drug is generally considered safe for use in patients with type 2 diabetes. However, patients should report any serious adverse events to their healthcare provider immediately.
The FDA has received approximately 130,422 adverse event reports associated with Exenatide. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Exenatide include Blood Glucose Increased, Weight Decreased, Nausea, Decreased Appetite, Blood Glucose Decreased. By volume, the top reported reactions are: Blood Glucose Increased (15,472 reports), Weight Decreased (12,120 reports), Nausea (12,041 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Exenatide.
Out of 52,304 classified reports, 14,624 (28.0%) were classified as serious and 37,680 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Exenatide break down by patient sex as follows: Female: 32,748, Male: 18,370, Unknown: 209. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Exenatide adverse events are: age 58: 1,416 reports, age 59: 1,413 reports, age 63: 1,404 reports, age 60: 1,364 reports, age 62: 1,343 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Exenatide adverse event reports is Astrazeneca Pharmaceuticals Lp. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Exenatide include: Vomiting, Diarrhoea, Dizziness, Drug Ineffective, Headache. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Exenatide to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Exenatide has a safety concern score of 45 out of 100 (moderate concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The most common adverse events are gastrointestinal issues such as nausea, vomiting, and diarrhea, which are expected given the drug's mechanism of action.
Key safety signals identified in Exenatide's adverse event data include: Pancreatitis is a key safety signal, with 2010 reports, indicating a potential risk that requires monitoring.. Gastrointestinal symptoms like nausea, vomiting, and diarrhea are frequent, suggesting a need for patient education on managing these side effects.. There is a notable number of serious adverse events (14,624 out of 52,304, or 28%) which include conditions like renal failure and death.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Exenatide can cause gastrointestinal side effects such as nausea, vomiting, and diarrhea, and patients should be monitored for signs of pancreatitis. Drug interactions are not well-documented, but patients should inform their healthcare provider of a Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Exenatide.
Patients should be educated on the common side effects of exenatide, including gastrointestinal symptoms, and how to manage them. Regular monitoring for signs of pancreatitis is recommended, especially in patients with a history of pancreatitis.
Exenatide has 130,422 adverse event reports on file with the FDA. Weight loss is a significant benefit for patients with type 2 diabetes, but it is also associated with a notable number of reports. The volume of reports for Exenatide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of exenatide, and the drug is generally considered safe for use in patients with type 2 diabetes. However, patients should report any serious adverse events to their healthcare provider immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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