Questions about Ozempic and depression grew after reports of suicidal thoughts in people taking semaglutide and related drugs reached regulators in 2023. FDA has since completed its review, and the answer it reached changed the labels.
This page covers what FDA said at each step, what the labels say now, and what the trials and one large cohort measured. The drug itself is covered in the semaglutide guide.
What FDA said in January 2024
FDA began looking into the question in July 2023, after it received postmarketing reports [2]. Its first public update came in January 2024 [1].
That update said the preliminary evaluation “has not found evidence that use of these medicines causes suicidal thoughts or actions.” The case reports were often limited and could be influenced by other factors.
FDA was careful about the limit. Because so few events occurred in the trials, “we cannot definitively rule out that a small risk may exist.” It announced a meta-analysis of trials and a study in its Sentinel data network.
What FDA found in January 2026
On 13 January 2026, FDA published the result. It “found no increased risk of SI/B,” meaning suicidal ideation or behavior, “with the use of GLP-1 RA medications” [2].
The meta-analysis pooled 91 placebo-controlled trials with 107,910 patients: 60,338 on a GLP-1 drug and 47,572 on placebo. It “did not show an increased risk for SI/B.”
It also found no increased risk of “other relevant psychiatric adverse events such as anxiety, depression, irritability, or psychosis.” That is the most direct answer FDA has given on depression.
The Sentinel study compared 1,161,983 people with type 2 diabetes starting a GLP-1 drug with 1,081,155 starting an SGLT2 inhibitor. After adjustment, FDA found no increased risk of intentional self-harm.
FDA also reviewed published observational studies. It concluded that together they do “not support a causal relationship” between these drugs and suicidal thoughts or behavior.
| Analysis | Who | Result reported by FDA |
|---|---|---|
| Meta-analysis of 91 placebo-controlled trials | 107,910 patients (60,338 GLP-1, 47,572 placebo) | No increased risk of SI/B, anxiety, depression, irritability or psychosis |
| Sentinel claims cohort, 2015 to 2023 | 2,243,138 people with type 2 diabetes, GLP-1 vs SGLT2 inhibitor | No increased risk of intentional self-harm |
| Review of published observational studies | Not stated as one population | Does not support a causal relationship |
What the labels say now
FDA asked the application holders for Saxenda, Wegovy and Zepbound to remove the warning [2]. Those are the versions of liraglutide, semaglutide and tirzepatide approved for weight reduction.
FDA explains where the warning came from. It was based on “reports of such events observed with a variety of older medicines used or studied for weight loss,” not on a finding specific to GLP-1 drugs.
The current Wegovy label lists the change in its summary of recent changes: “Suicidal Behavior and Ideation (5.10) (Removed) 02/2026” [3].
The Ozempic label contains no suicidal-thoughts or depression warning [4]. FDA says labeling for the diabetes versions “does not currently include” this information, so the removal makes the class consistent [2].
The other warnings on these labels are covered in semaglutide side effects, tirzepatide side effects and liraglutide side effects.
What the semaglutide trials measured
A pooled analysis of the STEP 1, 2, 3 and 5 weight-loss trials tested mood directly [5]. It used the PHQ-9 depression questionnaire and a standard suicide-risk rating scale.
The trials compared semaglutide 2.4 mg weekly with placebo in adults with overweight or obesity, for 68 or 104 weeks. They enrolled people “without known major psychopathology,” so people with serious mental illness were not studied.
Across 3,377 people in STEP 1, 2 and 3, PHQ-9 scores at week 68 were 2.0 on semaglutide and 2.4 on placebo. Both are in the range for no or minimal depression.
People on semaglutide were less likely to move into a more severe depression category (odds ratio 0.63, 95% CI 0.50 to 0.79). The authors called the small score difference “not considered clinically meaningful.”
Suicidal thoughts or behavior were reported by 1% or fewer, with no difference between groups. Three of the nine authors reported employment with the drug’s maker.
A separate 2025 meta-analysis pooled 27 randomized trials of GLP-1 drugs for diabetes or obesity [6]. Suicide and self-harm events were rare in both groups: 0.047 per 100 person-years on the drugs, 0.042 on placebo.
The rate ratio was 0.76 (95% CI 0.48 to 1.21), which was not a statistically significant difference.
What a large cohort found
A 2024 study used U.S. electronic health records from 240,618 people with overweight or obesity [7]. It compared semaglutide with other weight-loss drugs over six months.
Semaglutide was associated with a lower risk of suicidal ideation, including recurrent ideation (hazard ratio 0.44, 95% CI 0.32 to 0.60). The finding repeated in 1,589,855 people with type 2 diabetes.
The authors concluded the data “do not support higher risks of suicidal ideation with semaglutide.” An observational association like this cannot show that the drug protects against these thoughts.
What is still not known
The trials that measured mood left out people with major psychiatric illness. The pooled STEP analysis therefore does not answer how semaglutide affects someone already living with depression.
Sleep on semaglutide is covered in semaglutide and insomnia. The label’s boxed warning is covered in Ozempic and thyroid cancer.