Saxenda Side Effects and Results: What the Label and Trials Show
How much weight people actually lost on liraglutide 3 mg in the trials behind Saxenda's approval, how common nausea and vomiting really are, what the label's 16-week stopping rule means, and what happens after you stop.
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Search “Saxenda before and after” and you get transformation photos. Search the prescribing information and you get numbers. This article uses the numbers, because they are the only honest answer to “what will happen to me” — and because generic liraglutide carries exactly the same label, so everything here applies whether your box says Saxenda, Teva, Cipla, Orbicular or Biocon.
Saxenda is liraglutide 3 mg, injected under the skin once a day. It was the first GLP-1 receptor agonist the FDA approved for weight management. The FDA’s discontinuation database carries a Novo Nordisk notice, posted August 25, 2026, that the brand will be available until discontinuation in January 2027 — a date that comes from the FDA record, since no corresponding Novo Nordisk press release could be found in the company’s US news archive as of September 14, 2026 [12]. Generic liraglutide approved against Saxenda is a separate set of approvals and stays on the market.
This is not medical advice. It reports what the FDA-approved label and the published trials say. Where it describes doses, escalation, storage or stopping, it is summarizing the prescribing information and the Instructions for Use; follow your own prescription and your provider’s directions.
How much weight did people actually lose?
The Saxenda label reports three 56-week randomized, double-blind, placebo-controlled trials. In all of them, everyone — including the placebo group — got a roughly 500-calorie-per-day deficit diet and counseling to add at least 150 minutes a week of physical activity [1].
Study 1 — 3,731 adults with obesity, or overweight plus a weight-related condition, without type 2 diabetes. Mean starting weight 106.2 kg (about 234 pounds), mean BMI 38.3.
| Outcome at 56 weeks | Saxenda (n=2,487) | Placebo (n=1,244) |
|---|---|---|
| Average weight change | −7.4% | −3.0% |
| Lost at least 5% | 62.3% | 34.4% |
| Lost more than 10% | 33.9% | 15.4% |
Study 2 — 635 adults who had type 2 diabetes along with overweight or obesity.
| Outcome at 56 weeks | Saxenda (n=423) | Placebo (n=212) |
|---|---|---|
| Average weight change | −5.4% | −1.7% |
| Lost at least 5% | 49.0% | 16.4% |
| Lost more than 10% | 22.4% | 5.5% |
Study 3 — 422 adults who had already lost at least 5% during a 12-week low-calorie run-in, then continued for 56 more weeks.
| Outcome at 56 weeks | Saxenda (n=212) | Placebo (n=210) |
|---|---|---|
| Average weight change | −4.9% | +0.3% |
| Lost at least 5% | 44.2% | 21.7% |
Three things to take from this. Weight loss is smaller in people with type 2 diabetes — a pattern seen across the GLP-1 class. The placebo groups lost weight too, 1.7% to 3.0%, because the diet and activity program was real. And in Study 3, people who had already lost weight kept losing on Saxenda while the placebo group crept back up, which is the maintenance case for the drug.
The published pivotal trial, SCALE Obesity and Prediabetes, gives the figures in kilograms: an average loss of 8.4 kg on liraglutide versus 2.8 kg on placebo, a difference of 5.6 kg. About 92% of the liraglutide group lost some weight, versus 65% on placebo [2][3].
What happens after a year?
The Saxenda label includes a 160-week extension in the subgroup of Study 1 who had abnormal blood glucose at randomization [1]:
| Milestone | Saxenda (n=1,505) | Placebo (n=749) |
|---|---|---|
| Known to have lost at least 5% at week 56 | 817 (56%) | 182 (25%) |
| Known to have lost at least 5% at week 160 | 424 (28%) | 102 (14%) |
| Known to have lost at least 5% at both points | 391 (26%) | 74 (10%) |
By week 160, 47% of the Saxenda group and 55% of the placebo group had discontinued study drug, and only half the Saxenda group had a weight measurement at all. So those percentages are a floor, not a precise estimate. But the shape is clear: a minority of people are still carrying a 5% loss three years in.
An independent Cochrane review published in October 2025 pooled 24 randomized trials and 9,937 participants. It rated the evidence that liraglutide increases the proportion of people achieving at least 5% weight loss as moderate certainty (risk ratio 2.10, 95% CI 1.80 to 2.45), while rating the evidence on percentage weight change itself as very low certainty. It also noted that 22 of 24 trials were funded by the manufacturer [4].
How does this compare to the newer drugs?
Directly, in one trial. STEP 8 randomized 338 adults to weekly semaglutide 2.4 mg or daily liraglutide 3.0 mg for 68 weeks. Average weight change was −15.8% on semaglutide versus −6.4% on liraglutide, a difference of 9.4 percentage points [5].
That is the context for everything in this article. Liraglutide works. It works considerably less well than what came after it.
What are the side effects, in numbers?
Saxenda was evaluated for safety in five double-blind placebo-controlled trials covering 3,384 adults treated for up to 56 weeks, plus one 56-week trial in 125 pediatric patients [1].
Adults
| Reaction | Saxenda | Placebo |
|---|---|---|
| Nausea | 39.3% | 13.8% |
| Diarrhea | 20.9% | 9.9% |
| Constipation | 19.4% | 8.5% |
| Vomiting | 15.7% | 3.9% |
| Injection site reaction | 13.9% | 10.5% |
| Headache | 13.6% | 12.6% |
| Low blood sugar in people with type 2 diabetes | 12.6% | 6.6% |
| Indigestion | 9.6% | 2.7% |
| Fatigue | 7.5% | 4.6% |
| Dizziness | 6.9% | 5.0% |
| Abdominal pain | 5.4% | 3.1% |
| Increased lipase | 5.3% | 2.2% |
| Acid reflux | 4.7% | 1.7% |
| Bloating | 4.5% | 3.0% |
| Burping | 4.5% | 0.2% |
Adolescents aged 12 to 17
| Reaction | Saxenda | Placebo |
|---|---|---|
| Nausea | 42.4% | 14.3% |
| Vomiting | 34.4% | 4.0% |
| Diarrhea | 22.4% | 14.3% |
| Low blood sugar | 15.2% | 4.0% |
| Gastroenteritis | 12.8% | 4.8% |
| Dizziness | 10.4% | 3.2% |
| Fever | 8.0% | 7.1% |
Two things stand out in the adolescent column. Vomiting is far more common than in adults — more than a third of young patients, against 15.7% of adults. And low blood sugar occurred in 15.2% of liraglutide-treated adolescents even though none of them had type 2 diabetes [1]. That is why the label tells prescribers to inform all patients about hypoglycemia and teach them the signs.
In the 56-week adult trials, about 10% of Saxenda patients and 4% of placebo patients stopped because of an adverse reaction, and most of those exits happened in the first few months [1]. In the 160-week trial the figures were 13% and 6%.
What are the serious risks?
Every liraglutide product carries the same boxed warning: liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both sexes of rats and mice. Whether it does so in humans is unknown. Cases of medullary thyroid carcinoma have been reported after marketing, but the label states the data are insufficient to establish or exclude a causal relationship. Liraglutide is contraindicated in anyone with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2. Routine calcitonin testing or thyroid ultrasound is described as being of uncertain value [1].
The current label’s other warnings and precautions [1]:
- Acute pancreatitis — discontinue if pancreatitis is suspected
- Acute gallbladder disease — gallstones and cholecystitis; the label directs gallbladder studies if suspected
- Hypoglycemia — especially when combined with insulin or a sulfonylurea
- Increased resting heart rate — monitor at regular intervals
- Acute kidney injury from volume depletion — driven by vomiting and diarrhea; monitor kidney function if these occur
- Severe gastrointestinal adverse reactions — added to the label in October 2025, with a statement that liraglutide is not recommended in people with severe gastroparesis
- Serious hypersensitivity reactions — anaphylaxis and angioedema reported after marketing
- Pulmonary aspiration during general anesthesia or deep sedation — the label directs prescribers to inform patients to disclose their use of the drug before any planned surgery or procedure
Two label changes are worth flagging because older consumer pages still get them wrong. The formal pregnancy contraindication was removed in May 2025; pregnancy is now handled in Use in Specific Populations, where the label says to discontinue Saxenda when a pregnancy is recognized and that weight loss offers no benefit during pregnancy and may cause fetal harm. And the Suicidal Behavior and Ideation subsection was removed in February 2026 [1][6].
On that last point, a pharmacovigilance analysis published in August 2026 compared reports of suicide and self-injury in the European EudraVigilance database across liraglutide, semaglutide and tirzepatide. Such events were a small share of 42,941 total reports: 37 cases for liraglutide, 141 for semaglutide, 47 for tirzepatide. Reporting frequency was higher for liraglutide and semaglutide than for tirzepatide. The authors emphasize this does not establish causation and does not contradict regulatory conclusions [7].
Also new in 2026: a PLOS ONE systematic review of GLP-1-associated gastroparesis identified 13 reported cases across the class, with onset commonly after a dose increase or an incorrect restart, and with symptoms resolving when the drug was stopped in every reported case [8]. And a meta-analysis in Drugs covering more than 1.25 million people found no effect on bone density or fractures, but a consistent reduction in lean body mass with GLP-1 receptor agonists, driven mainly by liraglutide and semaglutide, at low certainty [9].
What does the label say about dosing and stopping?
This section summarizes the FDA-approved prescribing information and the Instructions for Use that come in the carton. It is a description of those documents, not instructions for you. Dosing decisions belong to your prescriber, and the prescription you were given plus the Instructions for Use in your own box are what govern what you actually do. All of the following is what the label directs clinicians to do [1].
Escalation. Week 1: 0.6 mg daily. Week 2: 1.2 mg. Week 3: 1.8 mg. Week 4: 2.4 mg. Week 5 and onward: 3 mg. If a patient does not tolerate a step, the label says to consider delaying the next increase by about a week. For adolescents, escalation may take up to 8 weeks.
The maintenance dose. For adults, 3 mg daily; lower doses are described as “for titration only,” and the label says to discontinue if the patient cannot tolerate 3 mg. For adolescents, 3 mg with a permitted reduction to 2.4 mg if 3 mg is not tolerated, and discontinuation if 2.4 mg is not tolerated either.
That bears on a question that comes up constantly in patient forums: whether a person can simply stay at a lower dose that feels manageable [10]. The approved label does not describe a lower maintenance dose for adults. That is a statement about the label, not a judgment about any individual — off-label maintenance at a lower dose is a decision a prescriber can legitimately make, and it is theirs to make, not this page’s to endorse or rule out.
Missed doses. The label directs that when a dose is missed, the once-daily regimen resumes with the next scheduled dose and no extra dose is given to make up for it. When more than three days have elapsed since the last dose, the prescriber-facing section directs reinitiation at 0.6 mg and re-escalation, to reduce gastrointestinal reactions on reinitiation. The patient-facing Medication Guide in the same label is more cautious: it tells patients who have missed doses for three days or more to call their healthcare provider about how to restart. If that is your situation, the phone call is the step, not a self-directed restart.
The stopping rules. These are unusual and worth knowing, and both are written as directions to the prescriber:
- Adults: the label directs evaluating the change in body weight 16 weeks after initiation and discontinuing if the patient has not lost at least 4% of baseline body weight, “since it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.”
- Ages 12 to 17: the label directs evaluating the change in BMI after 12 weeks on the maintenance dose and discontinuing if BMI has not fallen at least 1% from baseline.
Injection practicalities, as the label and Instructions for Use describe them. Once daily, at any time of day, with or without food, into the abdomen, thigh or upper arm, with sites rotated within the same region to reduce the risk of a skin condition called cutaneous amyloidosis. Before first use the pen is refrigerated at 36 to 46 degrees Fahrenheit and not frozen. After first use it is described as usable for 30 days at controlled room temperature (59 to 86 degrees) or refrigerated. The needle is removed and discarded after each injection and the pen is stored with no needle attached.
What happens when you stop?
The adolescent trial gives the cleanest signal. In SCALE Teens, after treatment ended, BMI standard-deviation score rose more in the liraglutide group than in the placebo group — an estimated difference of 0.15 (95% CI 0.07 to 0.23) [11]. In other words, stopping brought some of the effect back.
The adult 160-week data point the same way: the proportion known to be holding at least a 5% loss fell from 56% at week 56 to 28% at week 160, during a period when nearly half the group had come off treatment [1].
This is a chronic-condition medicine, and the label frames it that way — the indication is to reduce excess body weight and maintain weight reduction long term. Plans for stopping, tapering or switching are decisions to make with a healthcare provider, ideally before you start, not after a pharmacy tells you the refill is out of stock.
The realistic picture
If the label numbers were a weather forecast, they would read: most people who stay on liraglutide 3 mg for a year lose somewhere in the range of 5% to 8% of their starting weight, roughly one in three loses more than 10%, roughly two in five have nausea, about one in ten stops because of side effects, and keeping the loss past three years is the hard part.
That is less than the weekly drugs deliver, and it is a great deal more than nothing — particularly for someone whose alternative is no GLP-1 at all because of what the alternatives cost.
Whether this medicine fits your situation is a question for a healthcare provider. Two label checkpoints are worth bringing to that conversation, because a lot of patients have never been told they exist: the adult review at 16 weeks against a 4% weight-loss threshold, and the adolescent review after 12 weeks on the maintenance dose against a 1% BMI reduction.
Sources
- SAXENDA (liraglutide) injection, solution — prescribing information, DailyMed, updated 2026-02-25
- Pi-Sunyer X et al. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. New England Journal of Medicine, 2015
- SCALE Obesity and Prediabetes — PubMed record, PMID 26132939
- Meza N et al. Liraglutide for adults living with obesity. Cochrane Database of Systematic Reviews, 2025-10-30
- STEP 8 Randomized Clinical Trial — JAMA, January 2022
- SAXENDA prescribing information PDF — Novo Nordisk, revised 02/2026
- Scavone C et al. Reporting patterns of suicide- and self-injury-related events involving liraglutide, semaglutide, and tirzepatide. Frontiers in Pharmacology, 2026-08-27
- Olubodun T et al. Gastroparesis induced by GLP-1 receptor agonists: a systematic review. PLOS ONE, 2026
- Beaudart C et al. GLP-1 Receptor Agonists and Musculoskeletal Outcomes. Drugs, 2026-09-12
- r/liraglutide — “Do you REALLY have to go all the way up to 3mg??”, 2026-08-16
- Kelly AS et al. A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity. New England Journal of Medicine, 2020
- FDA Drug Shortages — Liraglutide Injection, discontinuation record, retrieved 2026-09-14
Questions people ask
What are the most common side effects of Saxenda?
In the label's pooled adult trials, nausea occurred in 39.3% of people on Saxenda versus 13.8% on placebo, diarrhea in 20.9% versus 9.9%, constipation in 19.4% versus 8.5%, and vomiting in 15.7% versus 3.9%. About 10% of people stopped because of a side effect, mostly in the first few months.
How much weight do people lose on Saxenda?
In the largest 56-week trial in the label, average weight change was −7.4% on Saxenda versus −3.0% on placebo. 62.3% lost at least 5% of body weight and 33.9% lost more than 10%. Results were smaller in people with type 2 diabetes.
How long does nausea last on Saxenda?
The label does not give a duration, but it reports that most people who stopped because of a side effect did so during the first few months, and it instructs prescribers to consider delaying the next dose increase by about a week if a step is not tolerated. Report persistent or severe symptoms to your provider.
What is the Saxenda 16-week rule?
The label tells prescribers to check body weight 16 weeks after starting and discontinue if the person has not lost at least 4% of their baseline weight, because it is then unlikely they will achieve and sustain meaningful weight loss. For patients 12 to 17, the check is BMI after 12 weeks on the maintenance dose, with a 1% threshold.
Do you regain weight after stopping Saxenda?
The adolescent trial found that BMI standard-deviation score rose more after stopping liraglutide than after stopping placebo, an estimated difference of 0.15. In the 160-week adult extension, only 28% of the liraglutide group and 14% of the placebo group were known to have kept off at least 5% at week 160.
Does Saxenda cause thyroid cancer?
Liraglutide caused thyroid C-cell tumors in rats and mice, which is why every liraglutide product carries a boxed warning. Whether it causes them in humans is unknown. It is contraindicated for anyone with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2.
Is Saxenda safe in pregnancy?
The label says there may be risks to the fetus based on animal studies, that weight loss offers no benefit during pregnancy and may cause fetal harm, and that Saxenda should be discontinued when a pregnancy is recognized. Talk to a healthcare provider if you are pregnant, could become pregnant, or are breastfeeding.
Do I have to go all the way up to 3 mg?
The label says 3 mg is the recommended adult dose and that lower doses are for titration only, and it directs discontinuation if 3 mg cannot be tolerated. Adolescents who cannot tolerate 3 mg may have the maintenance dose reduced to 2.4 mg. Any change to your dose is a decision for your prescriber.
This article summarizes FDA labeling, published research and company information current as of September 14, 2026. It is not medical advice and does not replace a conversation with your own healthcare provider. How we research and verify.