What did the FDA find in 2024?
The FDA’s first look found no evidence that GLP-1 medicines cause suicidal thoughts or actions. The agency began investigating in July 2023 after receiving postmarketing reports, and in a January 2024 update it said the reports, trial data and observational studies did not show a clear link.
It added an important caveat. Because suicidal thoughts and actions were rare in both treated and comparison groups, the FDA said it could not definitively rule out a small risk and planned a larger analysis. That analysis is what settled the question for the agency two years later.
What did the larger 2026 analysis show?
On January 13, 2026, the FDA reported that a much larger review found no increased risk and asked the makers of Saxenda, Wegovy and Zepbound to remove the suicidal behavior and ideation warning from their labels.
| What was studied | Size | Finding |
|---|---|---|
| Placebo-controlled clinical trials | 91 trials, 107,910 patients (60,338 on a GLP-1, 47,572 on placebo) | No increased risk of suicidal thoughts or behavior |
| Other psychiatric events in those trials | Same trials | No increased risk of anxiety, depression, irritability or psychosis |
| Real-world insurance claims cohort (FDA Sentinel System, 2015 to 2023) | 1,161,983 new GLP-1 users compared with 1,081,155 new SGLT2 inhibitor users | No increased risk of intentional self-harm after adjusting for baseline differences |
| Published observational and pooled studies | Many | Taken together, do not support a causal link |
The change has reached the label. The current Wegovy label lists its former suicidal behavior and ideation section as removed in February 2026.
Why was the warning on the label in the first place?
It was inherited rather than discovered. The FDA explains that Saxenda, Wegovy and Zepbound carried the caution from their original approvals because similar language appears across weight-loss medicines, based on reports with a variety of older drugs used or studied for weight loss. GLP-1 medicines approved for type 2 diabetes, such as Ozempic, never carried it.
So the warning reflected the history of the drug category more than a signal from semaglutide itself. The 2026 analysis tested that signal directly in semaglutide’s own data and in the class as a whole.
Which mood changes still need a call?
The FDA still asks patients on these medicines to tell their health care professional about new or worsening depression, suicidal thoughts, or unusual changes in mood or behavior. No large study makes an individual immune to depression, and weight loss can coincide with job stress, poor sleep or a hard life event.
MedlinePlus lists signs of depression that are worth tracking. A few overlap with expected GLP-1 effects, such as eating less or feeling tired, so focus on the ones the medicine does not explain:
- feeling sad, empty or hopeless most days;
- losing interest in things you usually enjoy;
- pulling away from family and friends;
- drinking more or using drugs to cope;
- thoughts of death or suicide.
If you are thinking about harming yourself, do not wait for an appointment. Call or text 988 to reach the 988 Suicide and Crisis Lifeline, available 24 hours a day. If you are in immediate danger, call 911.
Could something else explain feeling low on semaglutide?
Yes, and it is worth checking before blaming the medicine or yourself. Eating far less than your body needs can leave you drained and short-tempered; our answer on feeling tired on semaglutide covers that. In men with diabetes who also take insulin or a sulfonylurea, the Wegovy label lists irritability and mood changes among the symptoms of low blood sugar.
Hormones matter too. Low testosterone can bring mood changes, irritability and low motivation. Our page on depression or low testosterone explains how the two are told apart, and irritability and mood swings in men covers other causes.
How Ultimate Male looks after mood during weight loss
Every plan in our medical weight loss program starts with a medical evaluation, and your mood history belongs in it. Tell your provider about any past depression, anxiety or medicines for them; it does not rule you out, and it helps your provider know what to watch for at each check-in.
If mood changes during treatment, your provider can review your eating, sleep and labs, adjust the plan, and coordinate with your primary care doctor or a mental health professional when that is the right next step. Our page on who should not take semaglutide covers the conditions that do rule it out. To talk through your history before booking, start with the free 10-minute call.
