What adverse events have been reported to the FDA related to compounded tirzepatide, and which compounding pharmacies were involved?
Executive summary
Compounded tirzepatide has been linked in FDA reporting to hundreds of adverse event reports—most commonly gastrointestinal complaints, dosing-error–related harms, and some hospitalizations and deaths—while the agency has identified specific problematic compounders and fraudulent labels but has not published a comprehensive public list tying every report to named pharmacies [1] [2] [3].
1. What adverse events have been reported to the FDA related to compounded tirzepatide?
The FDA and academic summaries show a consistent pattern: nausea, vomiting, diarrhea, abdominal pain and constipation are repeatedly reported among adverse events associated with compounded tirzepatide, and more severe complications — including dehydration, fainting, acute pancreatitis, gallbladder disease and hospitalizations — have also been described in submitted reports [2] [1] [4]. Independent analyses of post‑marketing surveillance and FAERS data indicate medication errors and dosing mistakes (patients administering many times their intended dose) are a frequent proximate cause of these harms, which can escalate gastrointestinal side effects into serious outcomes requiring emergency care [1] [5]. Industry and advocacy summaries additionally note that some reports recorded deaths among combined compounded semaglutide/tirzepatide cases, a figure the National Association of Manufacturers cited from FDA databases as 17 deaths among more than 900 total adverse‑event entries for both drugs combined as of late 2024 [3].
2. How large is the reporting signal — numbers and trends the FDA has disclosed
As of April 2025 the FDA’s tally cited in clinical and professional summaries was roughly 480 adverse event reports specifically concerning compounded tirzepatide, and approximately 520 for compounded semaglutide — figures that regulators and clinicians warn understate the true burden because state‑licensed compounders and consumers do not always submit reports to federal systems [1] [4]. The agency has emphasized that many reports involve dosing beyond approved-label schedules or errors with multi‑dose vials, and that some incidents led to hospitalization [2] [6].
3. Which compounding pharmacies have been named or implicated in FDA actions?
FDA public enforcement documents and coverage identify several named targets and problem actors: Aequita Pharmacy (Kirkland, WA) is cited in a recall notice involving compounded semaglutide/tirzepatide combination vials and associated quality concerns [7]. The agency has also issued warning letters to online vendors and compounders such as GLP‑1 Solution and Healthy Male for offering unapproved compounded tirzepatide products and making misleading claims, signaling those operations as implicated in the enforcement response [8] [9]. Broader FDA campaigns in 2025–2026 included dozens of warning letters to more than 50 compounding or manufacturing entities tied to semaglutide and tirzepatide distribution, though many of those letters are to companies without a public one‑to‑one mapping to specific adverse‑event reports in the agency’s summaries [10].
4. How the FDA characterizes the role of counterfeit or falsely‑labeled compound products
The FDA warns that some vials labeled as “compounded tirzepatide” were fraudulent — bearing the names of pharmacies that did not make them or listing compounders that do not exist — and the agency has said it is aware of at least one adverse event reported with a product labeled as compounded tirzepatide that came from a pharmacy that, based on FDA inquiry, did not actually compound the product [2]. This complicates attribution: harms reported to FDA may come from legitimately compounded but improperly dosed products, from contaminated or mismanufactured batches, or from counterfeit items sold under false pharmacy names [2] [6].
5. Agency action, root causes, and outstanding uncertainties
The FDA’s responses — public safety communications, a “green list” of acceptable API suppliers, recalls, and multiple warning letters — focus on three root issues: dosing errors (especially with multi‑dose vials), product quality/sterility failures, and illegal marketing/counterfeiting of unapproved GLP‑1s [6] [7] [8]. While the data reported by FDA and summarized by academic and professional groups make the safety signal clear, the agency’s public materials do not provide a fully transparent mapping of each adverse event to an identified compounding pharmacy, and underreporting and fraudulent labeling mean the precise origin of many incidents remains uncertain [1] [2].