What changed in 2026
When Saxenda®, Wegovy® and Zepbound® were first approved for weight reduction, their Warnings and Precautions sections included the potential risk of suicidal behavior and ideation. The FDA notes that similar language appears in the labels of other types of weight-loss medicines and rests on reports seen with several older drugs that were used, or tested, for weight loss [1].
On 13 January 2026 the FDA published a Drug Safety Communication requesting removal of this warning from the three labels. The current versions list it as removed under Recent Major Changes: the Wegovy® label in 01/2026, the Saxenda® label in 02/2026, and the Zepbound® label in a 2026 revision. The labels of GLP-1 medicines approved for type 2 diabetes, such as Ozempic® and Mounjaro®, never carried this warning, and the Foundayo™ label does not include it [1][2][3][4].
What the FDA review looked at
- A meta-analysis of 91 placebo-controlled GLP-1 trials with 107,910 participants: 60,338 on a GLP-1 medicine and 47,572 on placebo. It did not show an increased risk of suicidal thoughts or behavior, nor a rise in anxiety, depression, irritability, psychosis or similar psychiatric events [1].
- A study in the FDA Sentinel claims database of more than 2.2 million people with type 2 diabetes starting a GLP-1 medicine or an SGLT2 inhibitor between 2015 and 2023. After adjusting for baseline differences, it found no increased risk of intentional self-harm with GLP-1 medicines, including in people with both diabetes and obesity [1].
- Published observational and pooled studies, which the FDA concluded do not support a causal link [1].
What a pooled trial analysis measured
A post hoc analysis published in JAMA Internal Medicine in 2024 pooled the STEP 1, 2 and 3 trials of semaglutide 2.4 mg (3,377 adults, 68 weeks) and checked the results against STEP 5 (304 adults, 104 weeks). Depressive symptoms were measured with a standard questionnaire (PHQ-9) and suicidal thoughts and behavior with the Columbia rating scale [10].
Scores were low at the start and stayed low. At week 68 the semaglutide group scored slightly lower than placebo, a difference the authors did not consider clinically meaningful, and people on semaglutide were less likely to move into a more severe depression category. Suicidal ideation or behavior was reported by 1% or fewer, with no difference between groups, and psychiatric adverse events were generally balanced [10].
Two limits matter. The trials excluded people with known major psychiatric illness, so the results do not describe that group, and several authors were employees of the manufacturer. The authors themselves conclude that people with obesity should be monitored for mental health concerns [10].
Why the Canadian information reads differently
Regulators do not always change wording at the same time. The Canadian Zepbound® product monograph, revised in June 2026, still has a Suicidal Ideation and Behaviour section: it asks prescribers to monitor for new or worsening depression, suicidal thoughts or unusual changes in mood or behaviour, to stop the medicine if suicidal thoughts appear, and to avoid it in people with a history of suicide attempts or active suicidal thoughts [6]. The Canadian Mounjaro® monograph has a similar monitoring paragraph, and both patient sections ask you to call your healthcare professional right away about thoughts of harming yourself or mental health changes that are new, worse or worrying [7].
The European product information for semaglutide, tirzepatide and liraglutide contains no suicidality warning in the versions we checked [8][9]. If your leaflet says something different from this page, follow the leaflet for your country and ask your prescriber or pharmacist.
What the labels still contain
Individual table rows remain. The Saxenda® adolescent trial table lists depression in 4% on liraglutide versus 2.4% on placebo, and its adult table lists anxiety in 2% versus 1.6% and insomnia in 2.4% versus 1.7%. The Wegovy® adolescent table lists anxiety in 4% versus 2%. These are single-trial counts of reported events that cleared the table threshold; the FDA’s pooled review, across far more people, is what informed the label change [2][3].
Mood also appears in a different context. The Ozempic®, Wegovy® and Saxenda® Medication Guides list anxiety, irritability or mood changes among the signs of low blood sugar, together with sweating, shakiness, dizziness, headache and confusion. For someone using insulin or a sulfonylurea, a sudden change in mood can be a blood sugar question [2][3][5].
Why mood can shift, and what else to consider
No label links appetite loss or weight change itself to depression, so treat any such link as unproven. What the sources agree on is that a lasting change in mood deserves attention, whatever its cause.
- What the labels support: low blood sugar can show up as anxiety, irritability or a mood change, mainly with insulin or a sulfonylurea [2][5].
- What general sources describe: MedlinePlus explains that depression can come from genetic, biological, environmental and psychological factors, that stressful life events raise the risk, and that sometimes there is no clear cause. NIMH adds that depression is linked with conditions such as diabetes and heart disease [12][13].
- What can look like depression: MedlinePlus lists changes in appetite, sleeping too much or too little, tiredness, and aches or digestive problems among its symptoms, several of which overlap with expected GLP-1 effects. It also notes that some medicines and conditions, such as thyroid disorders, can cause symptoms that resemble depression, and that a diagnosis needs symptoms most of the day, nearly every day, for at least two weeks [12].
Older pages may still show the old wording
Information online does not update all at once. The MedlinePlus page on liraglutide, last revised in December 2025, before the Saxenda® label changed, still puts depression that is new or getting worse, unusual shifts in mood or behavior, and thoughts of self-harm on its list of serious symptoms. Patient leaflets, pharmacy printouts and articles written before 2026 can also show the earlier warning [11].
When two sources disagree, check the revision date and the country. The current prescribing information on the manufacturer’s site for your country is the reference for what the label says now.
What the FDA asks patients to do
- Keep taking the medicine as prescribed and discuss any concerns with your health care professional [1].
- Let your clinician know about depression that is new or getting worse, about any thoughts of suicide, and about mood or behavior that feels unusual for you.
- Health care professionals are asked to refer anyone who discloses suicidal thoughts or behavior to mental health professionals for evaluation.
If you are in crisis
If you are having thoughts of harming yourself or feel you cannot keep yourself safe, get help now. In the US, call or text 988, the Suicide and Crisis Lifeline, available 24 hours a day; the FDA communication points to 988lifeline.org. Outside the US, call your local emergency number or go to the nearest emergency department.
A change in label wording does not change the fact that depression is common and treatable, whatever its cause.
What helps, according to public health sources
- Speak early: MedlinePlus says getting help at the earliest sign of a problem can help manage symptoms, and suggests talking to your health care provider or a mental health provider if you think you have depression [12].
- Do not stop on your own: the FDA asks patients to keep taking the medicine as prescribed and raise concerns with their clinician, and the Canadian monographs ask you to call right away about worrying changes [1][6].
- Involve people around you: the Canadian patient information asks you to pay attention to changes in mood, behaviour, feelings or thoughts; family members often notice these first, and 988 also supports people calling about someone else [6][14].
- Use the support that exists: NIMH points to 988 by call, text or chat for anyone struggling or having thoughts of suicide, and to 911 in life-threatening situations [13].
Keeping notes on mood
Mood is easier to discuss with a record. A short daily note on mood, sleep, appetite and energy, next to your doses, shows whether a change began with a new medicine, a dose increase, poor sleep or something else in life, and helps your clinician judge it.
Ozempic®, Wegovy® and Saxenda® are registered trademarks of Novo Nordisk A/S. Mounjaro® and Zepbound® are registered trademarks of Eli Lilly and Company, and Foundayo™ is a trademark of Eli Lilly and Company. PepLabo is not affiliated with or endorsed by Novo Nordisk or Eli Lilly.
When to get help
| Sign | Who to contact | How fast | Source |
|---|---|---|---|
| Thoughts of harming or killing yourself, or feeling you cannot keep yourself safe | Call or text 988 in the US, or your local emergency number; go to the nearest emergency department | Emergency | FDA [1]; NIMH [13]; 988 Lifeline [14] |
| A life-threatening situation | Call 911 or your local emergency number | Emergency | NIMH [13] |
| Depression that is new or getting worse, or changes in mood or behaviour that are unusual or worrying | Your prescriber or another health care professional | Today | FDA [1]; Canadian monographs [6][7] |
| A sudden mood change with shakiness, sweating or confusion if you use insulin or a sulfonylurea | Follow your low blood sugar plan, then tell your prescriber | Today | Medication Guides [2][5] |
| A depressed mood or lost interest in things, lasting for two weeks or more on nearly every day | Your health care provider or a mental health provider | At your next appointment | MedlinePlus [12] |
