GLP-1 Adverse Event Reports in FDA's FAERS Database: What the Numbers Actually Say

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No Ozempic or other GLP-1 lawsuit has been settled, and no court or jury has found that these medications caused anyone's injury — the litigation is ongoing, with major expert-evidence rulings still ahead. Whether any individual has a claim depends on their own medical records and the law of their state. Do not stop, start, or change any prescribed medication because of anything on this page. Those decisions belong with your prescriber. Attorney Advertising.

As of data retrieved August 7, 2026, FDA’s Adverse Event Reporting System (FAERS) held 82,911 reports naming semaglutide, 160,663 naming tirzepatide, 88,160 naming dulaglutide, and 50,705 naming liraglutide. Reports submitted to FDA are not verified and do not establish causation. These are counts of complaints filed, not counts of injuries proven, and they cannot be used to calculate how often anything happens.

FAERS is a passive surveillance system. Anyone — a patient, a family member, a physician, a manufacturer — can submit a report, and FDA publishes what is submitted. Nobody adjudicates whether the medication caused the event described. Duplicate reports exist. Reporting rises with media attention and with litigation. A drug that is prescribed more generates more reports for that reason alone. Every figure on this page inherits all of those limitations.

We publish the numbers anyway, with their caveats attached, because the alternative in this market is worse: figures circulating with no source, no retrieval date, and no explanation of what a “report” is.

Headline counts by drug

Every figure above is a count of reports submitted to FDA. Reports submitted to FDA are not verified and do not establish causation. “Serious” is a reporting classification applied at submission, not a medical or legal finding. Tirzepatide’s total exceeding semaglutide’s despite a shorter time on the market illustrates the point: report volume tracks prescribing volume, market attention, and reporting behavior, not risk.

The coding nuance that matters most: FAERS does not say “gastroparesis”

This surprises almost everyone who goes looking. Adverse events in FAERS are coded to MedDRA preferred terms, and for these medications the term that carries the stomach-paralysis reports is “impaired gastric emptying,” not “gastroparesis.” Searching FAERS for the word patients and lawyers actually use returns far less than the underlying reporting.

• Semaglutide, impaired gastric emptying: 3,558 reports. Reports submitted to FDA are not verified and do not establish causation.
• Dulaglutide, impaired gastric emptying: 1,829 reports. Reports submitted to FDA are not verified and do not establish causation.
• “Gastroparesis” as an exact term: not present in semaglutide’s 100 most-reported terms, where the hundredth-ranked term still carried 417 reports; not present in the top 200 terms for tirzepatide, dulaglutide, or liraglutide. The exact count is therefore below that cutoff and was not verified.

Anyone quoting a FAERS “gastroparesis count” for these drugs should be asked which term they queried.

The same problem on the vision side: NAION is coded “optic ischaemic neuropathy”

Non-arteritic anterior ischemic optic neuropathy does not appear in FAERS under that name either. The MedDRA preferred term carrying these reports is “optic ischaemic neuropathy” — that exact word order. The differently ordered string “ischaemic optic neuropathy” is a distinct term and did not appear in the top 100 semaglutide reaction terms.

The 631 semaglutide reports stand out against the other three ingredients, where the term did not surface within each drug’s 200 most-reported terms. That is directionally consistent with the published literature focusing on semaglutide specifically. It is not a measure of relative risk: raw counts are confounded by prescribing volume, time on market, and reporting stimulated by news coverage and litigation. Reports submitted to FDA are not verified and do not establish causation.

Gastrointestinal and vision terms, side by side

“Not in top 200” means the term did not appear among that drug’s 200 most-frequently-reported reaction terms; the true count is below that cutoff and was not separately verified rather than estimated. Reports submitted to FDA are not verified and do not establish causation.

Methodology

• Source: openFDA’s public FAERS endpoint, api.fda.gov/drug/event.json, queried by active ingredient.
• Retrieved: August 7, 2026. The openFDA data-update stamp observed at retrieval was July 30, 2026 for most queries.
• Method: total counts read from the result metadata; reaction counts from term-frequency queries capped at the 100 or 200 most-reported terms per drug.
• Verification: each figure was checked for internal consistency — no reaction count exceeds its drug’s total, and no figure was included that could not be reproduced. Values that could not be retrieved reliably are reported as not verified rather than estimated.
• Not included: we do not publish a fatality count. Death-coded reaction terms exist in the data but are an imprecise proxy for the fatal-outcome flag and would mislead.
• What these numbers cannot do: they cannot establish causation, they cannot produce an incidence rate (there is no denominator of treated patients), and they cannot be compared between drugs to rank risk.

FDA’s own guidance on this data is blunt: do not rely on it to make decisions about medical care, and assume all results are unvalidated. Reports submitted to FDA are not verified and do not establish causation.

Common questions

The data: FAERS reports by injury, the FAERS methodology, the US vs. EU warning-label gap, and the lawsuit tracker.