Peptide basics

"Off label use" is one of the most-reported FAERS terms. It is not an injury.

This page explains one coded term and what its prominence does and does not indicate. It is not a claim that off-label use is safe or unsafe, and it is not guidance about anyone's own use — that requires someone who can examine you.

What the term is

Adverse event reports are coded with MedDRA, a standardised dictionary whose preferred terms cover more than symptoms and diagnoses. Some terms describe the circumstances of use — how a product was taken, in what setting, for what purpose. OFF LABEL USE is one of these.⁸

Off-label use itself means prescribing or using an approved product for an indication, population or context the approved labelling does not cover. FDA describes it as lawful medical practice: the agency regulates approval and marketing, not the practice of medicine, and health care providers may prescribe an approved product for an unapproved use.⁶

Where it ranks

In the extract dated 28 April 2026, ranking reaction terms for reports naming SEMAGLUTIDE put OFF LABEL USE fourth with 426 reports, behind nausea, vomiting and diarrhoea. That is a count of reports mentioning the term, not a count of people and not a share of anyone.¹

For OZEMPIC in the same extract it ranked second at 5,944 reports, with PRODUCT USE IN UNAPPROVED INDICATION separately at 2,740 — again counts of reports, with no denominator and no causal assessment behind them.²

For MOUNJARO it ranked fourth at 7,394 reports. All three of these are counts of what reporters wrote; none supports a statement about how much off-label use occurs among people taking these products.³

Why its prominence is less informative than it looks

The term is not rare or specific to these products. Across the whole adverse event database it appears in 835,571 reports. A term that common is part of the background of the dataset, and finding it near the top of a drug's list is partly a property of how reports are coded generally.⁴

Its trajectory also follows the same market history as everything else in these files. Ozempic reports carrying the term went 90 (2018), 267 (2020), 460 (2022), 917 (2023), 1,342 (2024) and 2,306 (2025) — a curve that coincides with the product's uptake and its coverage in the press, both of which raise report volume independently of anything happening to anyone.⁵⁷

What it does tell you

It tells you what a body of reports is about. A drug approved for type 2 diabetes accumulating thousands of reports coded as off-label use is a record of a product that moved into a different use than its own labelling describes, and that is a real, documented feature of this market rather than an inference.²⁶

It also marks the boundary of what the label can answer. The approved prescribing information for a product describes the population studied for the indication it carries; where a report describes use outside that, the labelled adverse-reaction table was not derived from people using the product that way.¹⁰

That boundary is why FDA has published separately about unapproved and compounded versions of GLP-1 products, describing products that are not FDA-approved and for which the agency has not evaluated safety, effectiveness or quality.⁹

Semaglutide's US labelling covers specific approved indications. Reports coded as off-label use are, by construction, reports about use the labelled evidence does not describe.

Common questions