Liraglutide Label Updates 2020 to 2026: Every FDA Change Explained

What is the key documented liraglutide label change since 2020?

The key documented change is the removal of Saxenda's suicidal behavior and ideation warning. The Saxenda label dated January 26, 2024 carried a Warnings and Precautions item titled Suicidal Behavior and Ideation, directing clinicians to monitor for depression or suicidal thoughts and to discontinue Saxenda if symptoms developed [8]. That item is no longer in the Saxenda prescribing information effective February 25, 2026 [2].

On January 13, 2026 the FDA issued a Drug Safety Communication asking the application holders for Saxenda, Wegovy and Zepbound to remove suicidal ideation and behavior (SI/B) information from their labeling [1]. The agency said it reviewed a meta-analysis of 91 placebo-controlled GLP-1 receptor agonist trials covering 107,910 patients (60,338 on a GLP-1 drug, 47,572 on placebo), a claims cohort of 2,243,138 new users, and published studies, and found no increased risk of SI/B [1].

The Saxenda prescribing information effective February 25, 2026 reflects that. Warnings and Precautions run from 5.1, thyroid C-cell tumors, to 5.9, pulmonary aspiration during general anesthesia or deep sedation, with no SI/B section, and the word suicid does not appear anywhere in the label text [2]. One trace remains: depression appears as an adverse reaction in the pediatric trial table at 4% with Saxenda versus 2.4% with placebo [2].

The FDA request named Saxenda, Wegovy and Zepbound; Victoza was not named [1]. FDA noted that GLP-1 labels for type 2 diabetes did not include SI/B information in the first place [1].

What was added: the December 2020 adolescent indication

On December 4, 2020 the FDA approved a supplemental indication for Saxenda in patients aged 12 and older who are obese, defined by BMI cut-offs for age and sex that correspond to a BMI of 30 or higher in adults, and who weigh more than 60 kg (132 pounds) [3]. The current label states it as adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity [2].

The supporting study was a 56-week, double-blind, placebo-controlled trial in 251 patients aged 12 to 17 [3][9]. The primary endpoint was change in BMI standard-deviation score: an average reduction of 0.23 with Saxenda versus no reduction with placebo [3], an estimated difference of -0.22 (95% CI -0.37 to -0.08; P=0.002) [9]. As a secondary endpoint not tested for statistical significance, Saxenda patients lost a mean 2.65% of body weight while placebo patients gained 2.37% [3].

At the time, the FDA's approval notice said patients should be monitored for depression and suicidal thoughts, citing one suicide in the trial's Saxenda group [3]; the investigator judged that event unlikely related to treatment [9]. The 2026 communication later removed that labeling language [1][2].

The pediatric safety figures carried into the current label are nausea 42.4% versus 14.3%, vomiting 34.4% versus 4%, symptomatic hypoglycemia with glucose below 70 mg/dL in 15.2% versus 4%, and discontinuation for adverse reactions in 10.4% versus 0% [2].

What the current Saxenda label warns about

The boxed warning says liraglutide causes dose- and duration-dependent thyroid C-cell tumors in rats and mice at clinically relevant exposures, human relevance is unknown, Saxenda is contraindicated with a personal or family history of medullary thyroid carcinoma or MEN 2, and routine serum calcitonin or thyroid ultrasound is of uncertain value for early detection [2].

The nine current Warnings and Precautions items are thyroid C-cell tumors, acute pancreatitis, acute gallbladder disease, hypoglycemia with insulin or an insulin secretagogue, heart rate increase, acute kidney injury from volume depletion, severe gastrointestinal reactions, hypersensitivity, and pulmonary aspiration [2]. Several carry numbers:

• Heart rate: mean resting increases of 2 to 3 beats per minute; rises of more than 10 bpm at two consecutive visits in 34% versus 19% with placebo; more than 20 bpm in 5% versus 2%; at least one reading above 100 bpm in 6% versus 4%. The label instruction is to monitor heart rate at regular intervals [2].
• Gallbladder: cholelithiasis reported in 2.2% versus 0.8% and cholecystitis in 0.8% versus 0.4%; gallbladder studies are indicated if either is suspected [2].
• Hypoglycemia: among adults with type 2 diabetes taking a sulfonylurea, glucose below 54 mg/dL with or without symptoms occurred in 28.2% on Saxenda versus 12.7% on placebo, with sulfonylurea doses cut 50% at the start of that trial; the label says the risk may be lowered by reducing the dose of the insulin secretagogue or insulin [2].

Pregnancy information is in Section 8 of the label rather than the warning list. The label says to use Saxenda during pregnancy only if the potential benefit justifies the potential risk to the fetus, that weight loss offers no benefit in pregnancy, and that Saxenda should be discontinued when pregnancy is recognized [2].

What the current Victoza label covers

Victoza is indicated as an adjunct to diet and exercise for glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease; it is not approved for weight loss [4]. Dosing tops out at 1.8 mg daily, and the label says to give it as a separate injection from insulin, never mixed [4].

In the LEADER trial, 9,340 adults with type 2 diabetes and high cardiovascular risk were followed for a median 3.8 years. The composite of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke occurred in 13.0% on liraglutide versus 14.9% on placebo (hazard ratio 0.87, 95% CI 0.78 to 0.97) [10].

What the current dosing sections specify

The Saxenda schedule in the current label runs 0.6 mg daily for one week, then 1.2, 1.8 and 2.4 mg at weekly intervals, reaching 3 mg daily from week 5; the lower doses are for titration only, and the label directs discontinuation if 3 mg is not tolerated [2]. The label specifies the abdomen, thigh or upper arm, at any time of day and regardless of meals [2]. For adults, the label directs evaluating weight at 16 weeks and stopping if less than 4% of baseline body weight has been lost [2]. For adolescents, the label says escalation may take up to 8 weeks and the dose may be lowered to 2.4 mg daily if 3 mg is not tolerated [2].

The Saxenda prescribing information says to resume the next scheduled daily dose without doubling; if more than 3 days have passed since the last dose, it says to restart at 0.6 mg and re-titrate [2]. The Victoza label starts adults at 0.6 mg for one week, which it notes is not effective for glycemic control, then 1.2 mg, with 1.8 mg if more control is needed after at least another week [4].

Generic liraglutide: more than one label now

FDA-approved generic liraglutide exists. Generics referencing Saxenda include Teva (ANDA 214568), Biocon (ANDA 217063) and Cipla (ANDA 217234); generics referencing Victoza include Hikma (ANDA 215503, approved December 23, 2024), Lupin, Meitheal/NorthStar and a Teva authorized generic [6]. A Saxenda-referencing generic carries weight-management labeling, while a Victoza-referencing generic carries type 2 diabetes labeling [6].

Compounded liraglutide in 2026

On April 30, 2026 the FDA proposed excluding semaglutide, tirzepatide and liraglutide from the list of bulk drug substances that outsourcing facilities may use in compounding, finding no clinical need to compound these three from bulk substances [7]. FDA invited comments through June 29, 2026 and said it would consider them before making a final determination [7]; a final decision was not found. The FDA Commissioner is quoted in the announcement saying that when FDA-approved drugs are available, outsourcing facilities cannot lawfully compound from bulk substances unless there is a clear clinical need [7].