Saxenda prescribing information describes a daily liraglutide shot for weight management, including who it fits and when treatment needs another look. Its adult and teenage dose checks differ. The numbers describe Saxenda, not a schedule for a different medicine.
Saxenda prescribing information: which version?
As of November 5, 2026, the day this article was written, DailyMed's Saxenda record says “Revised: 6/2026.” The FDA PDF's medical highlights say “Revised: 02/2026”; its pen instructions say “Revised: 06/2026.” The newest FDA action, a June 2, 2026 supplement, changed only the pen instructions. DailyMed's highlights carry that June date, while FDA's own PDF keeps February 2026, the month the suicidal-behavior warning was removed, on its highlights.
The label records removal of the suicidal-behavior warning in February 2026. FDA's January 13, 2026 safety communication reported no increased risk of suicidal thoughts or behavior after a comprehensive review. FDA still tells patients to contact their health care professional about new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior, and to call or text 988 for immediate support.
Section 1: who Saxenda is for
The label covers people aged 12 and older who have obesity and weigh more than 60 kilograms. It also covers adults with overweight and at least one weight-related condition. Treatment accompanies a reduced-calorie diet and increased activity.
Liraglutide copies GLP-1, a gut hormone involved in fullness and blood sugar. The label advises against combining Saxenda with another liraglutide product or another medicine acting on the GLP-1 signal.
Section 14 describes the supporting studies. In SCALE Obesity and Prediabetes, 3,731 adults without diabetes received liraglutide or placebo, an inactive comparison treatment, plus lifestyle counseling. Average weight loss at 56 weeks was 8.4 kilograms versus 2.8 kilograms (Pi-Sunyer and colleagues, New England Journal of Medicine, 2015). Those are study averages.
Semaglutide is a separate molecule
Semaglutide acts on the same hormone signal but is a different molecule with its own dosing and evidence. The liraglutide versus semaglutide comparison explains the head-to-head trials. A switch requires a prescriber's plan; Saxenda's milligram amounts do not establish a semaglutide dose.
Sections 2–3: dosing as a label fact
Section 2 describes gradual dose increases, which the label says lower the risk of stomach and bowel side effects. The prescriber sets the actual dose and pace.
| Label week | Saxenda daily dose |
|---|---|
| 1 | 0.6 mg |
| 2 | 1.2 mg |
| 3 | 1.8 mg |
| 4 | 2.4 mg |
| 5 onward | 3 mg |
The adult maintenance dose, meaning the ongoing treatment dose, is 3 mg; lower doses are for the gradual increase. The label calls for stopping if 3 mg isn't tolerated. It also calls for stopping when weight loss is below 4% after 16 weeks from the start.
For children, increases may take up to eight weeks. A 2.4 mg maintenance dose is an option when 3 mg isn't tolerated. The label calls for stopping if 2.4 mg isn't tolerated either. The response check is different: at least a 1% reduction in BMI after 12 weeks on maintenance. BMI, or body mass index, measures weight relative to height.
Sections 4–5: contraindications and warnings
A contraindication is a reason the label says the medicine must not be used. Section 4 lists:
- A personal or family history of medullary thyroid carcinoma, a particular thyroid cancer.
- Multiple endocrine neoplasia type 2, an inherited condition that causes tumors in hormone-making glands.
- A serious allergic reaction to liraglutide or another Saxenda ingredient.
The boxed warning, the label's most prominent warning, concerns thyroid tumors found in rats and mice. Whether Saxenda causes these tumors in humans is unknown.
Section 5 also covers inflammation of the pancreas, gallbladder disease, low blood sugar, faster resting heartbeat, dehydration-related kidney injury, and serious allergic reactions. Severe gastroparesis, unusually slow stomach emptying, is a reason Saxenda isn't recommended.
The label describes food or fluid entering the lungs during anesthesia or deep sedation, medicines that make someone unconscious or deeply sleepy. Planned procedures therefore belong in the prescribing conversation. Section 7 also notes that slower stomach emptying can affect medicines taken by mouth.
Why tirzepatide needs its own review
Tirzepatide acts on GLP-1 and GIP, another gut hormone involved in blood-sugar regulation. Its separate development program includes SURMOUNT-1, reported in the New England Journal of Medicine in 2022. It isn't a version of liraglutide. Saxenda's dose ladder and response deadlines cannot establish a tirzepatide treatment plan.
Section 6: the side-effect table
About four in ten adults receiving Saxenda reported nausea. The label's pooled adult table includes 3,384 Saxenda participants and 1,941 placebo participants:
| Recorded reaction | Saxenda | Placebo |
|---|---|---|
| Nausea | 39.3% | 13.8% |
| Diarrhea | 20.9% | 9.9% |
| Constipation | 19.4% | 8.5% |
| Vomiting | 15.7% | 3.9% |
These are selected reactions, not the complete list. The label cautions against comparing percentages from separate drugs' trials directly.
As of November 5, 2026, the day this article was written, an updated review published online September 1, 2026 brought together 38 trials of GLP-1 medicines and related drugs in adults with overweight or obesity who did not have diabetes. Stomach and bowel problems remained common. Safety reporting was inconsistent across trials, limiting how neatly the findings can be compared.
Section 8: pregnancy, children, and other histories
Pregnancy is addressed here rather than in section 4. The label says Saxenda may cause fetal harm, based on animal studies, and that weight loss offers no benefit during pregnancy; it calls for stopping Saxenda when pregnancy is recognized. Human breastfeeding data are absent. Experience in people with kidney or liver impairment is limited, and relatively few trial participants were 75 or older.
The adolescent evidence came from a 251-participant, 56-week trial (Kelly and colleagues, New England Journal of Medicine, 2020). Estimated proportions reaching at least a 5% BMI reduction were about four in ten with liraglutide and two in ten with placebo: 43.3% versus 18.7%.
That was a different study from STEP TEENS, which tested semaglutide. Saxenda's label doesn't establish its safety and effectiveness below age 12 or in children with type 2 diabetes.
Section 16: branded pens and storage
Saxenda comes in a prefilled 3 mL pen containing 6 mg/mL liraglutide. These details describe the branded product.
Its storage section specifies refrigeration at 36–46°F before first use. After first use, the pen's limit is 30 days, refrigerated or at 59–86°F. Freezing makes it unsuitable for use. Protection from excessive heat and sunlight also matters. These storage limits cannot establish another preparation's usable life.
What this means for compounded semaglutide
Saxenda's label cannot establish a compounded semaglutide preparation's dose, storage limits, safety, or effectiveness. The actual prescription and dispensing pharmacy's directions matter.
Semaglutide and tirzepatide prescribed through Promise are dispensed by a licensed U.S. compounding pharmacy as compounded medications, each different from an FDA-approved product: the formulation offered here is not FDA-approved. FDA explains that compounded drugs don't undergo its review for safety, effectiveness, or quality before marketing.
A licensed provider may still prescribe — that decision is between you and your doctor.
What the provider still needs to know
The conversation includes current medicines, prior reactions, family thyroid-cancer history, pregnancy plans, and planned procedures. At Promise, a licensed provider reviews every request, and not everyone qualifies.
