Ozempicsemaglutide
According to the FDA label: RYBELSUS and OZEMPIC tablets are indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.
62,885 adverse event reports submitted to the FDA (2013–2026)
Top Reported Adverse Events
The most frequently reported events in association with Ozempic in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Nausea 9,384 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 6,339 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Vomiting 6,203 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 5,743 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Decreased Appetite 4,169 reports
Constipation 4,053 reports
Difficulty passing stool, or having fewer bowel movements than usual.
Full definition in the glossary → See all drugs reporting this event →Weight Decreased 3,832 reports
Fatigue 2,865 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Product Use in Unapproved Indication 2,841 reports
Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Full definition in the glossary →Headache 2,807 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Blood Glucose Increased 2,781 reports
A blood test result showing a higher than normal blood sugar level.
Full definition in the glossary →- Impaired Gastric Emptying 2,775 reports
Abdominal Pain Upper 2,565 reports
Pain in the upper part of the belly, above the navel.
Full definition in the glossary →Wrong Technique in Product Usage Process 2,527 reports
A report that the medication was used or administered with the wrong technique, such as an incorrect injection or inhaler method. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →Dizziness 2,356 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 36,762 |
| Male | 20,525 |
| Unknown | 29 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 174 |
| 18-34 | 1,594 |
| 35-49 | 5,353 |
| 50-64 | 13,165 |
| 65-74 | 10,409 |
| 75+ | 4,986 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Ozempic. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 28,751 |
| Other Serious | 25,169 |
| Hospitalization | 14,053 |
| Life-Threatening | 1,535 |
| Disability | 1,415 |
| Death | 1,237 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Ozempic. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2013 | 1 |
| 2014 | 4 |
| 2015 | 8 |
| 2016 | 17 |
| 2017 | 16 |
| 2018 | 1,159 |
| 2019 | 1,751 |
| 2020 | 3,203 |
| 2021 | 4,056 |
| 2022 | 5,784 |
| 2023 | 9,361 |
| 2024 | 14,309 |
| 2025 | 20,415 |
| 2026 (partial) | 2,801 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Ozempic
In FDA adverse event reports that mention Ozempic, these medications appeared most often in the same report.
- Metformin (9,405 reports)
- Insulin Glargine (3,659 reports)
- Aspirin (3,334 reports)
- Empagliflozin (3,228 reports)
- Ergocalciferol (2,879 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026