55/100 · Moderate
Manufactured by Novo Nordisk
Semaglutide Adverse Events: Nausea, Vomiting, and Weight Loss Predominate
146,328 FDA adverse event reports analyzed
Last updated: 2026-05-12
SEMAGLUTIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novo Nordisk. Based on analysis of 146,328 FDA adverse event reports, SEMAGLUTIDE has a safety score of 55 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 SEMAGLUTIDE include NAUSEA, VOMITING, OFF LABEL USE, DIARRHOEA, DECREASED APPETITE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SEMAGLUTIDE.
Semaglutide has a safety concern score of 55 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 146,328 adverse event reports for this medication, which is primarily manufactured by Novo Nordisk.
The most commonly reported adverse events include Nausea, Vomiting, Off Label Use. Of classified reports, 51.7% 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 like nausea and vomiting, which affect a significant portion of users.
Weight loss is a frequent side effect, with reports of decreased appetite and weight decreased. Serious adverse events, including cardiovascular and neurological issues, account for nearly 52% of all reports.
Patients taking Semaglutide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Semaglutide can cause gastrointestinal disturbances, and patients should be warned about the risk of dehydration and electrolyte imbalances. Drug interactions are not well-documented, but patients should avoid using it with other drugs that affect bl This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Semaglutide received a safety concern score of 55/100 (elevated concern). This is based on a 51.7% serious event ratio across 72,076 classified reports. The score accounts for 146,328 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 43,872, Male: 21,741, Unknown: 39. The most frequently reported age groups are age 60 (1,184 reports), age 65 (1,174 reports), age 67 (1,158 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 72,076 classified reports for SEMAGLUTIDE:
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.
Semaglutide can cause gastrointestinal disturbances, and patients should be warned about the risk of dehydration and electrolyte imbalances. Drug interactions are not well-documented, but patients should avoid using it with other drugs that affect bl
If you are taking Semaglutide, here are important things to know. The most commonly reported side effects include nausea, vomiting, off label use, diarrhoea, decreased appetite. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of dehydration and electrolyte imbalances, especially in patients with pre-existing conditions. Discuss potential weight changes with your healthcare provider, as this can be a significant side effect. 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 semaglutide, and updates will be provided as more data becomes available. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 146,328 adverse event reports associated with Semaglutide. 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 Semaglutide include Nausea, Vomiting, Off Label Use, Diarrhoea, Decreased Appetite. By volume, the top reported reactions are: Nausea (10,666 reports), Vomiting (6,913 reports), Off Label Use (6,532 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Semaglutide.
Out of 72,076 classified reports, 37,279 (51.7%) were classified as serious and 34,797 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 Semaglutide break down by patient sex as follows: Female: 43,872, Male: 21,741, Unknown: 39. 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 Semaglutide adverse events are: age 60: 1,184 reports, age 65: 1,174 reports, age 67: 1,158 reports, age 69: 1,134 reports, age 64: 1,133 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 Semaglutide adverse event reports is Novo Nordisk. 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 Semaglutide include: Constipation, Weight Decreased, Fatigue, Headache, Product Use In Unapproved Indication. 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 Semaglutide 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.
Semaglutide has a safety concern score of 55 out of 100 (elevated 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 like nausea and vomiting, which affect a significant portion of users.
Key safety signals identified in Semaglutide's adverse event data include: Gastrointestinal issues such as nausea, vomiting, and diarrhea are the most frequently reported adverse events.. Serious adverse events, including cardiovascular and neurological issues, are concerning given their high frequency.. There are reports of weight loss and decreased appetite, which may be beneficial for some but concerning for others.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Semaglutide can cause gastrointestinal disturbances, and patients should be warned about the risk of dehydration and electrolyte imbalances. Drug interactions are not well-documented, but patients should avoid using it with other drugs that affect bl Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Semaglutide.
Monitor for signs of dehydration and electrolyte imbalances, especially in patients with pre-existing conditions. Discuss potential weight changes with your healthcare provider, as this can be a significant side effect.
Semaglutide has 146,328 adverse event reports on file with the FDA. Weight loss is a frequent side effect, with reports of decreased appetite and weight decreased. The volume of reports for Semaglutide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of semaglutide, and updates will be provided as more data becomes available. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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