Reporting patterns of suicide- and self-injury-related events involving liraglutide, semaglutide, and tirzepatide: data from the European pharmacovigilance database
- Design
- Pharmacovigilance · Unknown outcome
- Match to healthy normal-weight adults aged 55–75
- Different population[Auto] Participants had type 2 diabetes (age/BMI not reported in abstract).
- Could weight loss explain it?
- Unknown[Auto] Harm signal; weight-loss mediation not the relevant question, but consider whether harms relate to rapid weight loss or reduced intake.
- Study tier
- Study tier 4[Auto] Hypothesis-generating design (auto-provisional).
- Assessment
- Version 1 · automatic, not yet reviewed by a person · Sep 13, 2026
Study facts come from the paper. Population match, weight-loss explanation and study tier are our judgments, made against the reference group of healthy normal-weight adults aged 55–75.
[Auto, unreviewed; quoted from abstract conclusions] These findings do not establish a causal link between GLP-1 and GLP-1/GIP RAs and suicide or self-injury events but simply provide a comparative analysis of disproportionality. Overall, the results do not contradict regulatory conclusions. They should be interpreted with caution, as spontaneous reporting systems have limitations. Continued pharmacovigilance is warranted, especially as use for weight management increases.
01Findings
What the study reported
- Drugs
- Semaglutide, Liraglutide, Tirzepatide
- Comparator
- tirzepatide
- Primary outcome
- Not extracted
- Effect
- Not extracted
- 95% confidence interval
- Not extracted
- Follow-up
- Not stated
- Adverse events
- Not extracted
- Limitations
- Auto-classified from abstract only; effect estimates, adverse events and limitations not extracted. Requires manual review.
Who was studied
- Diabetes status
- type 2 diabetes present (all or most)
Study quality details
- Study design
- Pharmacovigilance analysis
- Sample size
- not extracted
- Randomization
- no
- Blinding
- not stated
- Comparator
- not stated
- Follow up duration
- not stated
- Outcome type
- unknown
- Replication
- not assessed (auto)
- Consistency with other evidence
- not assessed (auto)
- Population applicability
- INDIRECT
- Statistical precision
- CI reported: 95% confidence intervals, were calculated to compare the frequency of suicide and s
- Risk of bias
- not assessed (auto)
- Funding conflicts
- unclear
- Peer review status
- yes
02Funding
Funding and conflicts
- Funding
- not reported in abstract
- Industry funded
- Unclear
- Manufacturer
- None identified
- Sponsor role
- not reported in abstract
- Author conflicts
- The author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
- Independent replication
- unknown
Funding is shown on every study and never used to score it.
04Source
The source, as retrieved
Abstract
[INTRODUCTION] Glucagon-like peptide-1 (GLP-1) and GIP receptor agonists (RAs) are increasingly used for treating type 2 diabetes mellitus and for chronic weight management. As their use expands, more attention is being paid to potential safety concerns, especially psychiatric adverse events. So far, European and United States regulatory agencies have not confirmed a causal relationship between these drugs and suicidality. Continued post-marketing monitoring remains warranted, given their growing use for weight management. [METHODS] This study aimed to provide an updated pharmacovigilance analysis of suicide or self-injury-related events reported with liraglutide, semaglutide, and tirzepatide. Individual Case Safety Reports listing liraglutide, semaglutide, or tirzepatide as suspected drugs were retrieved from EudraVigilance. The period covered was 1 January 2021 to 31 December 2025. Reports were included if the indication was consistent with type 2 diabetes mellitus or weight management. Suicide and self-injury events were identified using Preferred Terms from the Standardised MedDRA Query "Suicide/self-injury." Report characteristics were described. Reporting odds ratio (RORs), along with 95% confidence intervals, were calculated to compare the frequency of suicide and self-injury events across the three drugs. [RESULTS] We included 42,941 eligible reports. Most reports involved semaglutide, then tirzepatide and liraglutide. Gastrointestinal disorders were the most frequent adverse events, followed by injury, poisoning and procedural complications, and general disorders and administration site conditions. Suicide/self-injury events made up a small portion, with 37 cases for liraglutide, 141 for semaglutide, and 47 for tirzepatide. Compared with tirzepatide, the reporting frequency of these events was higher for liraglutide (ROR 2.54, 95% CI 1.60-4.01) and semaglutide (ROR 2.69, 95% CI 1.91-3.83). [CONCLUSIONS] These findings do not establish a causal link between GLP-1 and GLP-1/GIP RAs and suicide or self-injury events but simply provide a comparative analysis of disproportionality. Overall, the results do not contradict regulatory conclusions. They should be interpreted with caution, as spontaneous reporting systems have limitations. Continued pharmacovigilance is warranted, especially as use for weight management increases.
Where this record came from
| Source | Retrieved | Identifier |
|---|---|---|
| pubmed | Sep 13, 2026 | 42723821 first ingestion |