GLP-1 Drugs and Suicidal Thoughts: Why FDA Removed the Warning and What the Evidence Shows

On 13 January 2026 FDA asked the makers of Wegovy, Zepbound and Saxenda to remove the warning about suicidal thoughts and behaviour from their labels. A review of 91 placebo-controlled trials and a cohort of more than two million people did not find an increased risk. Large studies from Europe, the UK and the US point the same way. The change does not mean mood changes can be ignored: anyone who notices new or worsening depression or suicidal thoughts should tell their prescriber.

If you are thinking about suicide, contact your local emergency number or a crisis line now. In the US, call or text 988.

This article explains what the warning said and why it was there, what FDA reviewed, what independent studies show and where their limits are. It covers approved GLP-1 medicines such as semaglutide, liraglutide and tirzepatide. For other effects of these drugs outside weight loss, see GLP-1 drugs beyond weight loss.

The short version

• What changed. FDA requested removal of the suicidal behaviour and ideation section from the Warnings and Precautions of three weight-loss medicines: Saxenda (liraglutide), Wegovy (semaglutide) and Zepbound (tirzepatide).¹
• Why the warning existed. It was not based on a finding about GLP-1 drugs. Similar wording appears in other weight-loss medicine labels and comes from reports seen with a variety of older weight-loss medicines. GLP-1 medicines approved for type 2 diabetes never carried it.¹
• What FDA reviewed. A meta-analysis of 91 placebo-controlled trials with 107,910 patients and a claims-data study of 2,243,138 people with type 2 diabetes. Neither showed an increased risk.¹
• Other regulators and researchers agree. Europe's medicines safety committee reached the same conclusion in April 2024, and cohort studies from Sweden, Denmark, the UK and the US found no increase after accounting for differences between patients.²³⁴⁵
• What it doesn't mean. No study can rule out a reaction in a particular person. FDA still tells patients to report new or worsening depression, suicidal thoughts or unusual mood changes.¹

What the warning said, and why it was there

When Saxenda, Wegovy and Zepbound were approved for weight reduction, each label included information about a potential risk of suicidal ideation and behaviour in its Warnings and Precautions section. FDA says that wording mirrors the labels of other weight-loss medicines and is based on reports from a variety of older medicines used or studied for weight loss.¹

The same molecules, sold for type 2 diabetes, did not have this warning. FDA says removing it gives "consistent messaging across the labeling for all FDA-approved GLP-1 RA medications."¹

How the review unfolded

What FDA looked at

• Clinical trials. Because each trial had only a handful of such events, FDA pooled 91 placebo-controlled trials across GLP-1 development programmes: 60,338 people on a GLP-1 medicine and 47,572 on placebo. The meta-analysis found no increased risk of suicidal ideation or behaviour, or of anxiety, depression, irritability or psychosis.¹
• Real-world data. In FDA's Sentinel system, 1,161,983 people with type 2 diabetes who started a GLP-1 medicine were compared with 1,081,155 who started an SGLT2 inhibitor, another diabetes drug class, between October 2015 and September 2023. After adjusting for differences at baseline, intentional self-harm was not more common with GLP-1 medicines, including in people who also had obesity.¹
• Published studies. FDA concluded that "the totality of these studies does not support a causal relationship."¹

What independent studies found

HR (hazard ratio) and RR (risk ratio) compare rates between groups; 1 means no difference. The range in brackets is the 95% confidence interval. Our guide to statistical and clinical significance explains how to read them.

Teenagers

GLP-1 medicines are increasingly prescribed to adolescents with obesity.¹⁰ A 2026 meta-analysis of 11 studies with 10,175 adolescents found no higher rate of suicidal behaviour or depression with GLP-1 medicines, and a possibly lower rate of suicidal ideation (RR 0.73, 0.54 to 0.99), which the authors say should be read cautiously.⁹ A 2026 health-records study of 9,222 matched pairs also found no increase, but no difference when GLP-1 users were compared with adolescents taking metformin.¹⁰

Why the early reports looked worrying

Reports to safety databases come from patients and clinicians who suspect a link. They are useful for spotting a possible problem, but they cannot show how often something happens or whether the drug caused it. A 2024 analysis of the World Health Organization's global database found disproportionate reporting of suicidal ideation with semaglutide (107 suicidal or self-injurious reports) and called for urgent clarification.¹¹ The larger studies above were the follow-up that question needed.

The UK study shows why adjustment matters. Before accounting for differences between patients, people starting a GLP-1 medicine had about twice the rate of suicidality of people starting a DPP-4 inhibitor. Once the researchers accounted for those differences, the gap disappeared.⁴ Our guide to correlation and causation explains this kind of confounding.

The limits of the evidence

• Rare outcomes are hard to measure. In the Swedish and Danish study, 77 suicide deaths occurred among GLP-1 users. The results are compatible with an absolute increase of no more than 0.16 deaths per 1,000 person-years, but a very small effect cannot be excluded completely.³
• Observational studies rely on records. They can only count what was recorded, and people who receive one drug may differ from those who receive another. Researchers adjust for these differences, but adjustment cannot remove every one.⁴¹⁰
• "Lower risk" findings need caution. Some studies found fewer suicidal thoughts with GLP-1 medicines. That does not make them a treatment for depression; the authors themselves warn about selection bias.⁵¹⁰
• These studies are of approved medicines. They say nothing about the safety of unapproved or "research use only" products sold under the same names. See approved versus unapproved peptide products.

What this means if you use a GLP-1 medicine

• Keep taking your medicine as prescribed, and discuss any worries with your prescriber. Don't stop or change treatment on your own.¹
• Tell your health professional if you notice new or worsening depression, suicidal thoughts, or unusual changes in mood or behaviour, whatever their cause.¹
• If you have a history of depression, tell your prescriber. In a large study of people with type 2 diabetes treated for depression, starting a GLP-1 medicine did not increase recorded suicidality.⁷
• Report side effects to FDA MedWatch or your national medicines regulator.¹

Frequently asked questions

Do Wegovy, Zepbound or Ozempic cause suicidal thoughts?

The evidence reviewed by FDA and by independent researchers does not show that they do. FDA's pooled analysis of 91 placebo-controlled trials and its study of more than two million people found no increased risk, and large studies from Sweden, Denmark, the UK and the US agree.¹³⁴⁸ A small effect in rare individual cases cannot be ruled out completely.³

Why did the warning appear only on the weight-loss versions?

The wording came from the labels of older weight-loss medicines, not from a finding about GLP-1 drugs. The same molecules sold for type 2 diabetes never carried it.¹

Is it safe to use a GLP-1 medicine if I have depression?

That is a decision for you and your prescriber. In a large US study of people with type 2 diabetes already treated for depression, starting a GLP-1 medicine did not increase recorded suicidality.⁷ Tell your prescriber about your history and about any change in mood.¹

What about teenagers?

A 2026 meta-analysis of studies in adolescents found no higher rate of suicidal behaviour or depression with GLP-1 medicines.⁹ The evidence is smaller than for adults, so mood changes should still be reported.¹¹⁰