45/100 · Moderate
Manufactured by Novo Nordisk
Oral Semaglutide Adverse Events: Mostly Mild to Moderate, with Serious Events Noting Gastrointestinal and Metabolic Issues
125,550 FDA adverse event reports analyzed
Last updated: 2026-05-12
ORAL SEMAGLUTIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novo Nordisk. Based on analysis of 125,550 FDA adverse event reports, ORAL SEMAGLUTIDE 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 ORAL SEMAGLUTIDE include NAUSEA, OFF LABEL USE, VOMITING, DIARRHOEA, DECREASED APPETITE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ORAL SEMAGLUTIDE.
Oral Semaglutide 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 125,550 adverse event reports for this medication, which is primarily manufactured by Novo Nordisk.
The most commonly reported adverse events include Nausea, Off Label Use, Vomiting. Of classified reports, 50.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are mild to moderate, with nausea, vomiting, and diarrhea being the most common.
Serious adverse events, though not frequent, include gastrointestinal issues and metabolic changes. Weight loss and decreased appetite are common, but weight increase is also reported. Drug interactions and misuse are noted, with warnings about incorrect technique and dose issues.
Patients taking Oral Semaglutide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Oral Semaglutide can cause gastrointestinal issues and metabolic changes. Patients should follow the prescribed dosing and usage instructions carefully to avoid adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Oral Semaglutide received a safety concern score of 45/100 (moderate concern). This is based on a 50.4% serious event ratio across 60,716 classified reports. The score accounts for 125,550 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: 35,682, Male: 19,970, Unknown: 18. The most frequently reported age groups are age 67 (1,078 reports), age 69 (1,064 reports), age 65 (1,062 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 60,716 classified reports for ORAL 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.
Oral Semaglutide can cause gastrointestinal issues and metabolic changes. Patients should follow the prescribed dosing and usage instructions carefully to avoid adverse effects.
If you are taking Oral Semaglutide, here are important things to know. The most commonly reported side effects include nausea, off label use, vomiting, 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. Follow the prescribed dosing and usage instructions carefully to avoid gastrointestinal and metabolic issues. Report any serious adverse events to your healthcare provider immediately. 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 profile of Oral Semaglutide. Healthcare providers should be vigilant about potential serious adverse events and manage patient care accordingly.
The FDA has received approximately 125,550 adverse event reports associated with Oral 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 Oral Semaglutide include Nausea, Off Label Use, Vomiting, Diarrhoea, Decreased Appetite. By volume, the top reported reactions are: Nausea (9,141 reports), Off Label Use (5,920 reports), Vomiting (5,842 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Oral Semaglutide.
Out of 60,716 classified reports, 30,605 (50.4%) were classified as serious and 30,111 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 Oral Semaglutide break down by patient sex as follows: Female: 35,682, Male: 19,970, Unknown: 18. 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 Oral Semaglutide adverse events are: age 67: 1,078 reports, age 69: 1,064 reports, age 65: 1,062 reports, age 60: 1,058 reports, age 68: 1,052 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 Oral 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 Oral Semaglutide include: Constipation, Weight Decreased, Blood Glucose Increased, Product Use In Unapproved Indication, 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 Oral 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.
Oral Semaglutide 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 majority of adverse events are mild to moderate, with nausea, vomiting, and diarrhea being the most common.
Key safety signals identified in Oral Semaglutide's adverse event data include: Gastrointestinal issues like nausea, vomiting, and diarrhea are frequent.. Metabolic changes, including blood glucose increases and decreases, are reported.. Serious events include dehydration, hypoglycemia, and acute kidney injury.. There are reports of cardiovascular issues, including chest pain and palpitations.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Oral Semaglutide can cause gastrointestinal issues and metabolic changes. Patients should follow the prescribed dosing and usage instructions carefully to avoid adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Oral Semaglutide.
Follow the prescribed dosing and usage instructions carefully to avoid gastrointestinal and metabolic issues. Report any serious adverse events to your healthcare provider immediately.
Oral Semaglutide has 125,550 adverse event reports on file with the FDA. Serious adverse events, though not frequent, include gastrointestinal issues and metabolic changes. The volume of reports for Oral Semaglutide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety profile of Oral Semaglutide. Healthcare providers should be vigilant about potential serious adverse events and manage patient care accordingly. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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