Saxenda® (liraglutide) and mood changes

Three countries, three wordings

When Saxenda® was approved for weight management, its US warnings included a possible risk of suicidal behaviour and ideation. The FDA explains that this language came from reports seen with several older weight-loss medicines rather than from a specific finding with GLP-1 medicines. ^[4] On 13 January 2026 the FDA asked the makers of Saxenda®, Wegovy® and Zepbound® to remove it, and the current Saxenda® label records the removal in its list of recent major changes. ^[1][4]

The documents in other regions read differently, and they are updated on their own timelines.

What the FDA review found

The 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 analysis showed no increased risk of suicidal ideation or behaviour, or of anxiety, depression, irritability or psychosis. ^[4] A separate claims-data study of more than 2.2 million people with type 2 diabetes found no higher risk of intentional self-harm with GLP-1 medicines than with SGLT2 inhibitors. ^[4]

The FDA concluded that published observational and pooled studies, taken together, do not support a causal link, and asked patients to keep taking their medicine as prescribed while discussing any concerns with their clinician. ^[4]

What liraglutide trials and studies measured

A pooled post hoc analysis of all phase 2 and 3a liraglutide 3 mg weight-management trials, 3,384 people on the medicine and 1,941 on placebo, found depression at 2.1 events per 100 person-years in both groups and anxiety at 1.9 versus 1.7. Nine people (0.3%) on liraglutide and two (0.1%) on placebo reported suicidal ideation or behaviour as an adverse event, a small numerical imbalance, but questionnaires given to everyone showed no difference: 1.0% in each group on a standard suicide-risk scale. ^[5] The Canadian monograph cites the same nine and two cases. ^[3]

In the adolescent trial, one young person on liraglutide died by suicide; the investigator judged it unlikely to be related to treatment. ^[6] Depression was recorded in 4% of teens on Saxenda® and 2.4% on placebo. ^[1] A 2026 health-records study of more than 9,000 matched adolescents found that GLP-1 or GIP/GLP-1 treatment was associated with fewer suicide-related events and no more depression or anxiety than lifestyle treatment, though the authors caution about selection bias. ^[7]

Reporting databases give a less reassuring signal: one analysis found liraglutide linked with depression reports in the Canadian adverse reaction database. ^[8] Such reports can reflect awareness and other factors and cannot show cause.

Mood changes that have another explanation

• Low blood sugar: the Medication Guide lists anxiety, irritability or mood changes among its signs, alongside sweating, shakiness and confusion. This matters most for people with type 2 diabetes using insulin or a sulfonylurea, and for teenagers, who had more low blood sugar on Saxenda® in trials. ^[1]
• Poor sleep: insomnia is a listed Saxenda® reaction, and MedlinePlus counts sleep changes, tiredness and irritability among depression symptoms. ^[1][10]
• Eating much less: MedlinePlus notes that eating far less or more than usual can be a sign of depression. ^[10]
• Everything else: MedlinePlus explains that depression has genetic, biological, environmental and psychological causes, is more common in women and often accompanies conditions such as diabetes and heart disease; some medicines and thyroid problems can mimic it. ^[10]

If you are in crisis

If you are having thoughts of suicide or feel you cannot keep yourself safe, get help immediately. In the US, call or text 988 or chat at 988lifeline.org, available 24 hours a day; in life-threatening situations call 911. ^[11][12] In Canada, call or text 9-8-8, or 9-1-1 if your safety is at immediate risk. ^[13] Elsewhere, call your local emergency number (112 in Türkiye and across the EU) or go to the nearest emergency department.

The 988 Lifeline also supports people who are worried about someone else, which matters for parents of teenagers on Saxenda®. ^[12]

What the guidance asks of you

The FDA asks patients to tell their health care professional about new or worsening depression, suicidal thoughts or unusual changes in mood or behaviour, and not to stop the medicine on their own. ^[4] The Canadian patient information asks you to tell your healthcare professional before starting Saxenda® if you have or have had depression or suicidal thoughts. ^[3]

MedlinePlus advises talking to a health care or mental health provider if low mood or loss of interest lasts most of the day, nearly every day, for two weeks or more, and notes that regular exercise, a consistent sleep schedule and managing stress support mental health. ^[10]

Saxenda® and Wegovy® are registered trademarks of Novo Nordisk A/S. Zepbound® is a registered trademark of Eli Lilly and Company. PepLabo is not affiliated with or endorsed by Novo Nordisk or Eli Lilly.

When to get help