EudraVigilance analysis compares suicide and self-injury reports across GLP-1 drugs

A new analysis of Europe's adverse event database has compared reports of suicide and self-injury across three GLP-1 based medicines, finding differences in how often these events were reported for each drug. The study, published in Frontiers in Pharmacology, looked at reports submitted to EudraVigilance, the European Union's pharmacovigilance system, between January 1, 2021, and December 31, 2025 ^[1].

Researchers reviewed 42,941 total adverse event reports involving liraglutide (sold as Saxenda and Victoza), semaglutide (sold as Ozempic, Wegovy, and Rybelsus), and tirzepatide (sold as Mounjaro and Zepbound), where the reported use was for type 2 diabetes or weight management ^[1]. Most reports overall involved semaglutide, followed by tirzepatide and then liraglutide ^[1]. Gastrointestinal problems were the most common adverse events reported across all three drugs, followed by injury and administration site issues ^[1].

Within that larger pool, suicide or self-injury events made up a small share of total reports: 37 cases for liraglutide, 141 for semaglutide, and 47 for tirzepatide ^[1]. To compare reporting frequency, the authors calculated reporting odds ratios, a statistical measure used in pharmacovigilance to see how often an event shows up for one drug compared with another. Using tirzepatide as the reference point, the reporting odds ratio was 2.54 for liraglutide (95% confidence interval, 1.60 to 4.01) and 2.69 for semaglutide (95% confidence interval, 1.91 to 3.83) ^[1]. In plain terms, suicide and self-injury events were reported roughly two and a half times more often for liraglutide and semaglutide than for tirzepatide in this database, though the researchers stress this is a comparison of reporting patterns, not a measurement of actual risk ^[1].

The study's authors are explicit that their findings do not establish a causal link between these medicines and suicide or self-injury events ^[1]. They describe the results as a comparative analysis of "disproportionality," a method used to flag possible safety signals worth further study, not proof that the drugs themselves are causing harm ^[1]. The authors also note that their findings do not contradict existing conclusions from European and U.S. regulators, who have not confirmed a causal relationship between these drugs and suicidality ^[1].

The authors caution that spontaneous reporting systems like EudraVigilance have real limitations. Reports come from doctors, patients, and others voluntarily, so the database can be affected by underreporting, overreporting driven by media attention, or missing information about a patient's other health conditions ^[1]. Because of this, the researchers say the results should be interpreted with caution ^[1].

Why it matters for patients

For people currently using or considering GLP-1 medications, this study adds a data point to an ongoing safety conversation rather than a settled answer. The numbers show that suicide and self-injury reports remain a small fraction of all adverse events tied to these drugs, and the study's own authors say their work does not prove these medicines cause such events ^[1]. At the same time, the differences in reporting frequency between drugs are large enough that the researchers call for continued monitoring, especially as more people use these medications for weight management rather than diabetes ^[1]. Patients weighing which GLP-1 medicine to use, or whether to continue one, may want to know that regulators in both the U.S. and Europe have so far not confirmed a causal link between these drugs and suicidality, a point the study's authors repeat ^[1].

What happens next

The authors call for continued pharmacovigilance, meaning ongoing collection and review of real-world safety reports, particularly as GLP-1 drug use for weight management keeps growing ^[1]. The study does not give a specific timeline for further research or regulatory review, and it is not yet known whether this analysis will prompt any change from the FDA or European Medicines Agency.