Ozempic FDA Adverse Event Reports (2026): FAERS Data Summary
Latest update (2026-01)
- FDA enforcement record (Ongoing): Presence of Particulate Matter: Hair was found in a prefilled syringe. [source]
How many Ozempic adverse event reports has the FDA received
As of July 21, 2026, the FDA Adverse Event Reporting System (FAERS) contains 82,911 public reports in which Ozempic (semaglutide) is listed as a suspect or concomitant drug. Of these, 44,539 reports (53.7%) were classified as serious, and 1,485 involved a reported death outcome. These figures come directly from the openFDA public API and update as new reports are processed.
Ozempic FAERS reports by year
Recent yearly report volumes for Ozempic (semaglutide) in FAERS: . Report counts reflect when the FDA received each report, not when the adverse event occurred, so recent years may still rise as processing continues.
What side effects are most reported for Ozempic
The most frequently reported reaction terms for Ozempic in FAERS are: Nausea (12,084 reports); Vomiting (7,988 reports); Off Label Use (7,322 reports); Diarrhoea (6,943 reports); Decreased Appetite (4,963 reports); Constipation (4,952 reports); Weight Decreased (4,353 reports); Fatigue (3,745 reports). Reaction terms follow MedDRA coding as submitted by reporters, and a single report may list multiple reactions.
Do FAERS reports prove the drug caused the injury
No. FAERS is a spontaneous reporting system: anyone can submit a report, reports are not verified for causation, and the existence of a report does not establish that the drug caused the event. Report volumes are also influenced by publicity and litigation activity. FAERS data is best used as a signal, alongside clinical studies and regulatory findings.
How to cite this data
Source: U.S. FDA Adverse Event Reporting System (FAERS), retrieved via the openFDA API on July 21, 2026. Query: reports listing semaglutide. You are welcome to cite the figures on this page with a link back to this summary; the underlying raw data is public at open.fda.gov.
References
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