Rybelsussemaglutide
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.
6,782 adverse event reports submitted to the FDA (2016–2026)
Top Reported Adverse Events
The most frequently reported events in association with Rybelsus 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.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Nausea 977 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Vomiting 682 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 531 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 409 reports
Off Label Use 394 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 →Constipation 370 reports
Difficulty passing stool, or having fewer bowel movements than usual.
Full definition in the glossary → See all drugs reporting this event →Blood Glucose Increased 331 reports
A blood test result showing a higher than normal blood sugar level.
Full definition in the glossary →Weight Decreased 326 reports
Headache 284 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Fatigue 276 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Abdominal Pain 263 reports
Pain in the belly or stomach area.
Full definition in the glossary → See all drugs reporting this event →Dizziness 258 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →- Impaired Gastric Emptying 249 reports
Abdominal Pain Upper 245 reports
Pain in the upper part of the belly, above the navel.
Full definition in the glossary →Asthenia 214 reports
Physical weakness or lack of strength.
Full definition in the glossary →
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 | 3,710 |
| Male | 2,559 |
| Unknown | 3 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 125 |
| 18-34 | 119 |
| 35-49 | 524 |
| 50-64 | 1,481 |
| 65-74 | 1,072 |
| 75+ | 658 |
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 Rybelsus. 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 | 2,985 |
| Other Serious | 2,709 |
| Hospitalization | 1,564 |
| Disability | 195 |
| Life-Threatening | 177 |
| Death | 161 |
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 Rybelsus. 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 |
|---|---|
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 7 |
| 2020 | 487 |
| 2021 | 841 |
| 2022 | 1,039 |
| 2023 | 1,065 |
| 2024 | 1,519 |
| 2025 | 1,567 |
| 2026 (partial) | 252 |
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 Rybelsus
In FDA adverse event reports that mention Rybelsus, these medications appeared most often in the same report.
- Metformin (1,141 reports)
- Empagliflozin (472 reports)
- Aspirin (358 reports)
- Dapagliflozin (312 reports)
- Insulin Glargine (291 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