GLP-1 suicidal ideation and depression warning: what the labels say

Short answer: the US Suicidal Behavior and Ideation Warnings and Precautions section that used to appear on Wegovy, Saxenda and Zepbound was removed in February 2026 after FDA's January 13, 2026 Drug Safety Communication found no increased risk of suicidal ideation or behavior with GLP-1 receptor agonists. US labels for the diabetes-indicated products (Ozempic, Rybelsus, Mounjaro, Victoza, Trulicity) never carried that dedicated section. Several Canadian monographs still keep Psychiatric / Suicidal Ideation wording for Wegovy, Saxenda, Zepbound and Mounjaro. Below is the honest product-by-product picture, cited to DailyMed, FDA and Health Canada monographs — not a reason to change a dose on your own.

On this page: FDA 2026 removal · US labels (all 8) · Former US warning text · Canada · Crisis help · What to log

FDA January 2026: remove the SI/B warning

On January 13, 2026, FDA published a Drug Safety Communication requesting that application holders remove information about suicidal ideation and behavior (SI/B) from the labeling of GLP-1 RA medications that still included it: Saxenda, Wegovy and Zepbound. DailyMed "Recent Major Changes" for those three products list Suicidal Behavior and Ideation as (Removed) 02/2026.

FDA's evaluation included a meta-analysis of 91 placebo-controlled GLP-1 RA trials with 107,910 patients (60,338 on a GLP-1 RA and 47,572 on placebo) that did not show an increased risk of SI/B or of anxiety, depression, irritability or psychosis, plus a Sentinel retrospective cohort study of more than 2.2 million new users that did not find increased intentional self-harm versus SGLT2 inhibitors. FDA concluded the totality of evidence does not support a causal relationship between GLP-1 RAs and SI/B, and that removing the language keeps messaging consistent with diabetes-indicated GLP-1 RA labels that never carried it.

FDA still tells patients and caregivers to talk with a health care professional about new or worsening depression, suicidal thoughts, or unusual mood or behavior changes, and points to the US 988 Suicide & Crisis Lifeline.

US labels for all 8 products (checked November 6, 2026)

Status from current DailyMed pages. "Removed" means the Warnings and Precautions section is gone after the FDA request; "Not listed" means that product's US label did not have a dedicated SI/B Warnings and Precautions section.

Medication	US §5 SI/B status	Current action	Notes (former text or class context)
Ozempic (semaglutide injection)	Not listed	No dedicated §5 SI/B warning (diabetes label)	FDA DSC: glycemic-control GLP-1 RA labels did not include SI/B Warnings and Precautions language
Wegovy (semaglutide)	Removed 02/2026 (was 5.10)	Section removed per FDA request	Former text: SI/B reported in trials with other weight-management products; monitor depression/suicidal thoughts/behavior; discontinue if present; avoid with history of attempts or active ideation
Rybelsus / Ozempic tablets	Not listed	No dedicated §5 SI/B warning (diabetes label)	Same class note as Ozempic
Mounjaro (tirzepatide)	Not listed	No dedicated §5 SI/B warning (diabetes label)	FDA DSC: glycemic-control products did not carry the weight-management SI/B Warnings and Precautions language
Zepbound (tirzepatide)	Removed 02/2026 (was 5.9)	Section removed per FDA request	Former text: SI/B reported in trials with other weight-management products; monitor; discontinue if present; avoid with history of attempts or active ideation
Saxenda (liraglutide 3 mg)	Removed 02/2026 (was 5.9)	Section removed per FDA request	Former adult rates: suicidal ideation 0.3% (9/3384) vs 0.1% (2/1941) placebo; 1 attempt on Saxenda; pediatric death by suicide 1/125 with insufficient info for causality; monitor; discontinue; avoid with history
Victoza (liraglutide)	Not listed	No dedicated §5 SI/B warning (diabetes label)	Same class note as other glycemic-control GLP-1 RAs
Trulicity (dulaglutide)	Not listed	No dedicated §5 SI/B warning (diabetes label)	Same class note as other glycemic-control GLP-1 RAs

This table is about labeling, not about whether mood symptoms can happen for other reasons. If mood changes worry you, contact your clinician or crisis services — do not wait for an app or a web page.

What the former US warnings said (pre-removal)

For historical context only — these sections are no longer on the current DailyMed labels for Wegovy, Saxenda and Zepbound:

Wegovy (former 5.10) and Zepbound (former 5.9): Suicidal behavior and ideation have been reported in clinical trials with other weight management products. Monitor for emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue if suicidal thoughts or behaviors occur. Avoid in patients with a history of suicidal attempts or active suicidal ideation.
Saxenda (former 5.9): Same monitoring / discontinue / avoid language, plus the adult trial rates (0.3% vs 0.1% placebo for suicidal ideation; one attempt on Saxenda) and the pediatric trial note (1 of 125 Saxenda-treated patients died by suicide; insufficient information to establish causality).

Canada: monograph Psychiatric / SI wording (checked November 6, 2026)

Health Canada product monographs are updated on a different schedule from US DailyMed. As of the PDFs linked below, several Canadian monographs still include a Psychiatric suicidal-ideation section even though the matching US section was removed.

Monograph	Suicidal ideation / Psychiatric summary
Ozempic	Not listed — no suicidal-ideation / Psychiatric warning section found in the Canadian monograph we checked (Nov 6, 2026).
Wegovy	Psychiatric — Suicidal Behaviour and Ideation: patients with history of suicidal behaviour, major depressive disorder, or recent suicidal ideation were excluded from trials; do not use in patients with history of suicidal attempts or active suicidal ideation; monitor for emergence or worsening of depression, suicidal thoughts or behaviour, or unusual mood changes; discontinue if suicidal thoughts or behaviours occur.
Rybelsus	Not listed — no suicidal-ideation warning section found in the Canadian monograph we checked (Nov 6, 2026).
Mounjaro	Psychiatric — Suicidal Ideation and Behaviour: monitor for emergence or worsening of depression, suicidal thoughts or behaviours, or unusual mood changes; consider benefits and risks before initiating or continuing therapy in patients with suicidal thoughts or behaviours or a history of suicidal attempts.
Zepbound	Psychiatric — Suicidal Ideation and Behaviour: SI/B have been reported with products that induce weight loss; monitor for emergence or worsening of depression, suicidal thoughts or behaviours, or unusual mood changes; discontinue if suicidal thoughts or behaviours occur; avoid in patients with history of suicidal attempts or active suicidal ideation.
Saxenda	Psychiatric — Suicidal Behavior and Ideation: adult trials 0.3% (9/3384) vs 0.1% (2/1941) placebo reported suicidal ideation; one Saxenda-treated patient attempted suicide; pediatric trial 1/125 Saxenda-treated death by suicide (investigator assessed unrelated) and 1 attempt each on Saxenda and placebo in off-drug follow-up; monitor; discontinue if suicidal thoughts or behaviours; avoid with history of attempts or active ideation.
Victoza	No dedicated SI/B warning section in the Canadian monograph we checked; Psychiatric Disorders appears under adverse reactions (e.g. depression, anxiety, insomnia) rather than as a Warnings and Precautions SI/B section.
Trulicity	Not listed — no suicidal-ideation warning section found; Psychiatric Disorders in adverse reactions lists insomnia in the copy we checked (Nov 6, 2026).

Canada vs US takeaway: US weight-management labels dropped the dedicated SI/B Warnings and Precautions section in February 2026; Canadian Wegovy, Saxenda, Zepbound and Mounjaro monographs we checked still instruct clinicians to monitor mood and to discontinue or reconsider therapy if suicidal thoughts or behaviours appear. Always use the monograph version supplied with your prescription.

Crisis help

US: call or text 988 (Suicide & Crisis Lifeline), or visit 988lifeline.org.
Canada: call or text 988 where the Suicide Crisis Helpline is available, or use Health Canada's get-help page for local resources.
Emergency: call 911.

What to log and tell your prescriber

Dates of new or worsening depression symptoms, mood swings, irritability, or unusual behavior changes.
Any suicidal thoughts — tell a clinician or crisis line promptly; a tracker is for appointment notes, not crisis care.
Sleep changes, anxiety, or other psychiatric symptoms your prescriber asked you to watch.
History of depression, suicidal ideation or attempts (relevant to Canadian Wegovy / Saxenda / Zepbound / Mounjaro monograph cautions).
Other medicines that affect mood, if your clinician asked you to track them.

For the other class warnings, see thyroid warning and contraindications, tracking side effects, pregnancy and breastfeeding, heart rate and hypersensitivity, hypoglycemia and severe GI adverse reactions.

Sources

This page summarizes official product labels and FDA communications as general information. It is not medical advice. Do not start, stop or change any medication based on this page. Labels and monographs are updated; check the current version for your product. If you are in crisis, call or text 988 (US or Canada where available) or call 911.

Frequently asked questions

Do Ozempic, Wegovy, Mounjaro and Zepbound still carry a suicidal ideation warning in the US?

As of February 2026, DailyMed shows the Suicidal Behavior and Ideation Warnings and Precautions section as Removed for Wegovy, Saxenda and Zepbound. FDA's January 13, 2026 Drug Safety Communication requested that removal after a review that found no increased risk of suicidal ideation or behavior (SI/B) with GLP-1 receptor agonists. Ozempic, Rybelsus, Mounjaro, Victoza and Trulicity US labels for glycemic control never carried a dedicated SI/B Warnings and Precautions section.

What did the old US Wegovy, Saxenda and Zepbound warnings say?

Before removal, each told clinicians to monitor for emergence or worsening of depression, suicidal thoughts or behavior, and unusual mood changes; to discontinue if suicidal thoughts or behaviors occur; and to avoid the drug in people with a history of suicidal attempts or active suicidal ideation. Saxenda also listed adult trial rates (0.3% vs 0.1% placebo for suicidal ideation) and a pediatric trial death by suicide with insufficient information for causality. Wegovy and Zepbound noted that SI/B had been reported in trials with other weight-management products.

Why did FDA remove the warning?

FDA's January 13, 2026 communication describes a meta-analysis of 91 placebo-controlled GLP-1 RA trials (107,910 patients) that did not show an increased risk of SI/B or of other psychiatric adverse events such as anxiety, depression, irritability or psychosis, plus a Sentinel claims study that did not find increased intentional self-harm vs SGLT2 inhibitors. FDA concluded the totality of evidence does not support a causal relationship and asked sponsors to remove the language from Saxenda, Wegovy and Zepbound so messaging is consistent across GLP-1 RA labeling.

Do Canadian monographs still warn about suicidal ideation?

Yes for several weight-management and some diabetes products checked November 6, 2026. Wegovy, Saxenda, Zepbound and Mounjaro Canadian monographs still have a Psychiatric / Suicidal Ideation (or Behaviour) section telling clinicians to monitor mood and to discontinue (or avoid / consider benefits and risks) when suicidal thoughts or behaviours are present. Ozempic, Rybelsus and Trulicity Canadian monographs we checked do not list a suicidal-ideation warning section. Victoza lists depression/anxiety under Psychiatric adverse reactions but not a dedicated SI/B warning section in the copy we reviewed.

Which products historically had the US section 5 warning?

FDA named Saxenda (liraglutide), Wegovy (semaglutide) and Zepbound (tirzepatide) — the GLP-1 RA products approved for weight reduction that included SI/B language in Warnings and Precautions. Labeling for GLP-1 RAs approved to improve glycemic control in type 2 diabetes did not include that SI/B Warnings and Precautions language.

What trial numbers did Saxenda's (former) US label give?

Adult trials: 9 of 3384 Saxenda-treated patients (0.3%) and 2 of 1941 placebo-treated patients (0.1%) reported suicidal ideation; one Saxenda-treated patient attempted suicide. Pediatric trial: 1 of 125 Saxenda-treated patients (0.8%) died by suicide; the label said there was insufficient information to establish a causal relationship. The Canadian Saxenda monograph reports the same adult rates and notes the pediatric death was assessed as unrelated to treatment by the investigator, with one attempt each on Saxenda and placebo in the off-drug follow-up period.

Should I stop my GLP-1 if my mood changes?

That is your prescriber's decision. FDA's 2026 review found no increased SI/B risk with GLP-1 RAs, but Canadian monographs for Wegovy, Saxenda, Zepbound and Mounjaro still tell clinicians to monitor mood and to discontinue (or reconsider therapy) if suicidal thoughts or behaviours appear. Tell your healthcare professional about new or worsening depression, suicidal thoughts, or unusual mood or behavior changes. Glidedose does not suggest doses or when to stop.

Where can I get crisis help in the US or Canada?

In the US, call or text 988 (Suicide & Crisis Lifeline) or visit 988lifeline.org. In Canada, call or text 988 (Suicide Crisis Helpline) where available, or go to https://www.canada.ca/en/public-health/services/mental-health-services/mental-health-get-help.html for local resources. In an emergency call 911.

What should I log in a GLP-1 tracker?

Mood changes with dates, new or worsening depression symptoms, any suicidal thoughts (share with your clinician — do not rely on an app for crisis care), sleep changes, and other psychiatric symptoms your prescriber asked you to watch. Never log a dose change suggested by an app — Glidedose is a GLP-1 tracker for dates and symptoms so you can show your prescriber.

Is this medical advice?

No. This page summarizes FDA Drug Safety Communications, DailyMed labels and Health Canada product monographs as general information. It is not medical advice. Do not start, stop or change any medication based on this page. Labels and monographs are updated; check the current version for your product.

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