Saxenda Side Effects: What the FDA Label Lists
[Side effects · Saxenda]

Saxenda side effects

liraglutide · once-daily injection · Label checked

Short answer: In the label's placebo-controlled trials in adults, nausea was the most common side effect of Saxenda: 39.3% against 13.8% on placebo. Diarrhea (20.9% vs 9.9%), constipation (19.4% vs 8.5%) and vomiting (15.7% vs 3.9%) followed. The label says nausea became less common as treatment continued. It carries a boxed warning about thyroid C-cell tumors seen in rodents.

What Saxenda is approved for: The label says Saxenda is approved, with a reduced-calorie diet and more physical activity, to reduce excess body weight and keep it off long term in adults and children 12 and older with obesity and a body weight over 60 kg, and in adults with overweight who have at least one weight-related medical condition.

Source
SAXENDA (liraglutide) injection, for subcutaneous use, prescribing information and Medication Guide. Novo Nordisk. DailyMed, version published June 15, 2026. DailyMed setid 3946d389-0926-4f77-a708-0acb8153b143

Does Saxenda have a boxed warning?

Boxed warning

WARNING: RISK OF THYROID C-CELL TUMORS

Liraglutide caused thyroid C-cell tumors in rats and mice, and it is not known whether Saxenda causes these tumors, including medullary thyroid carcinoma (MTC), in people. Saxenda must not be used by people with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). The label lists a lump in the neck, trouble swallowing, shortness of breath and lasting hoarseness as possible thyroid tumor symptoms.

What are the most common Saxenda side effects?

These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Saxenda.

Table 2. Adverse Reactions Occurring in ≥2% of SAXENDA-treated Adult Patients and More Frequently than Placebo [Section 6.1]
Adverse reactionPlacebo N=1941 %Saxenda N=3384 %
Nausea13.839.3
Diarrhea9.920.9
Constipation8.519.4
Vomiting3.915.7
Injection Site Reaction10.513.9
Headache12.613.6
Hypoglycemia in T2DM6.612.6
Dyspepsia2.79.6
Fatigue4.67.5
Dizziness56.9
Abdominal Pain3.15.4
Increased Lipase2.25.3
Upper Abdominal Pain2.75.1
Gastroenteritis3.24.7
Gastroesophageal Reflux Disease1.74.7
Abdominal Distension34.5
Eructation0.24.5
Urinary Tract Infection3.14.3
Flatulence2.54
Viral Gastroenteritis1.62.8
Insomnia1.72.4
Dry Mouth12.3
Asthenia0.82.1
Anxiety1.62

Five placebo-controlled trials in 3,384 adults with overweight or obesity treated for up to 56 weeks (mean 46 weeks), alongside diet and activity counseling. Hypoglycemia in T2DM is blood sugar below 54 mg/dL in people with type 2 diabetes not on insulin (Study 2).

Table 3. Adverse Reactions Occurring in ≥3% of SAXENDA-treated Pediatric Patients and More Frequently than Placebo in a 56 Week Clinical Trial [Section 6.1]
Adverse reactionPlacebo N=126 %Saxenda N=125 %
Nausea14.342.4
Vomiting434.4
Diarrhea14.322.4
Hypoglycemia415.2
Gastroenteritis4.812.8
Dizziness3.210.4
Pyrexia7.18
Abdominal discomfort0.84.8
Constipation2.44.8
Dyslipidemia3.24.8
Fatigue3.24.8
Cough3.24
Depression2.44
Dyspepsia2.44
Pain in extremity2.44
Injection site pain3.23.2
Flatulence03.2
Increased Blood Creatine Kinase2.43.2
Increased Lipase0.83.2
Rash03.2

One 56-week placebo-controlled trial in children aged 12 and older with obesity (125 on Saxenda, 126 on placebo). Hypoglycemia here means blood sugar below 70 mg/dL with symptoms; these children did not have type 2 diabetes.

Other numbers in the Adverse Reactions section

  • Section 6.1

    Stopping treatment because of side effects: 9.8% on Saxenda and 4.3% on placebo in adults. The top reasons were nausea (2.9% vs 0.2%), vomiting (1.7% vs less than 0.1%) and diarrhea (1.4% vs 0%).

  • Section 6.1

    Stomach and gut problems overall: about 68% on Saxenda and 39% on placebo, with severe reactions in 4.8% and 1.4%. 6.2% on Saxenda versus 0.8% on placebo stopped because of them.

  • Section 6.1

    In the trial in children 12 and older, 8% on Saxenda versus none on placebo stopped because of stomach and gut side effects, mostly vomiting (4.8%) and nausea (3.2%).

  • Section 6.1

    In adults with type 2 diabetes taking a sulfonylurea, blood sugar below 54 mg/dL occurred in 28.2% on Saxenda and 12.7% on placebo; severe low blood sugar occurred in 0.7% on Saxenda.

  • Section 6.1

    Breast cancer was reported in 0.7% of women on Saxenda versus 0.2% on placebo; the label says there were too few cases to tell whether they were related to Saxenda.

What serious risks does the Saxenda label warn about?

The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.

  • Section 5.1

    Risk of thyroid C-cell tumors. Liraglutide caused thyroid C-cell tumors in rats and mice, and cases of MTC have been reported after marketing. People with a personal or family history of MTC or with MEN 2 must not use Saxenda.

  • Section 5.2

    Acute pancreatitis. Inflammation of the pancreas, including fatal cases, has been seen with GLP-1 drugs including liraglutide. The label says to stop Saxenda if pancreatitis is suspected.

  • Section 5.3

    Gallbladder disease. Gallstones were reported in 2.2% on Saxenda versus 0.8% on placebo, and gallbladder inflammation in 0.8% versus 0.4%. Most people with these events needed gallbladder removal. The excess was seen even after accounting for weight loss.

  • Section 5.4

    Low blood sugar. Adults with type 2 diabetes on a sulfonylurea or insulin may have a higher risk of low blood sugar, and the label says to check blood sugar before and during treatment. In children without diabetes, blood sugar below 54 mg/dL occurred in 1.6% on Saxenda versus 0.8% on placebo.

  • Section 5.5

    Heart rate increase. Resting heart rate rose by a mean of 2 to 3 beats per minute in adults and 3 to 7 in children. The label says to check heart rate regularly and to stop Saxenda if resting heart rate stays raised.

  • Section 5.6

    Kidney injury from fluid loss. Acute kidney injury, sometimes needing dialysis, has been reported, mostly in people who became dehydrated from nausea, vomiting or diarrhea. The label says to monitor kidney function in these people, especially when starting or raising the dose.

  • Section 5.7

    Severe stomach and gut side effects. Severe stomach and gut side effects were reported in 4.8% on Saxenda against 1.4% on placebo. Saxenda is not recommended in people with severe gastroparesis.

  • Section 5.8

    Allergic reactions. Serious allergic reactions such as anaphylaxis and angioedema have been reported. The label says the patient should stop Saxenda and other suspect medicines and promptly seek medical advice.

  • Section 5.9

    Food or liquid in the lungs during anesthesia. Saxenda slows stomach emptying. Rare reports describe food entering the lungs during procedures with general anesthesia or deep sedation. The label says to tell your providers you take Saxenda before any planned procedure.

When does the label say to call your doctor?

From the Medication Guide that comes with Saxenda:

  • A lump or swelling in the neck, hoarseness, trouble swallowing or shortness of breath: tell your healthcare provider (possible thyroid tumor symptoms).
  • Severe stomach pain that will not go away, with or without nausea or vomiting, sometimes felt through to the back: stop using Saxenda and call your healthcare provider right away.
  • Signs of low blood sugar such as dizziness, sweating, confusion, shakiness, fast heartbeat or hunger, in adults with type 2 diabetes or in children 12 and older: talk with your provider about how to recognize and treat it.
  • A racing or pounding heart at rest that lasts for several minutes: tell your healthcare provider.
  • Nausea, vomiting or diarrhea that does not go away: tell your healthcare provider right away, because fluid loss can cause kidney problems.
  • Stomach problems that are severe or will not go away: tell your healthcare provider.
  • Swelling of the face, lips, tongue or throat, trouble breathing or swallowing, severe rash or itching, fainting or a very rapid heartbeat: stop using Saxenda and get medical help right away.
  • Pain in the upper stomach, fever, yellowing of the skin or eyes, or clay-colored stools: call your healthcare provider (possible gallbladder problems).
  • A planned surgery or procedure with anesthesia or deep sedation: tell all your healthcare providers you take Saxenda beforehand.

How do I keep track of side effects in Dose Track?

Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.

This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.

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Frequently asked questions

What is the most common side effect of Saxenda?+
Nausea. In the label's adult trials, 39.3% of people on Saxenda reported nausea compared with 13.8% on placebo. The label says the share of people reporting nausea declined as treatment continued, and most stomach and gut events were mild or moderate.
How many people stopped Saxenda because of side effects?+
In the adult trials, 9.8% of people on Saxenda and 4.3% on placebo stopped early because of side effects. The most common reasons were nausea (2.9% vs 0.2%), vomiting (1.7% vs less than 0.1%) and diarrhea (1.4% vs 0%).
Are injection site reactions common with Saxenda?+
The label lists injection site reactions in 13.9% on Saxenda versus 10.5% on placebo. The most common, each reported by 1% to 2.5% of people on Saxenda, were redness, itching and rash at the injection site.
Are side effects different in teenagers on Saxenda?+
In the trial in children 12 and older, nausea was 42.4% versus 14.3% on placebo and vomiting 34.4% versus 4%. Low blood sugar with symptoms (below 70 mg/dL) was 15.2% versus 4%. The Medication Guide also lists fever and gastroenteritis as extra common side effects in children.
When do tiredness and dizziness happen on Saxenda?+
The label says weakness, fatigue, feeling unwell, taste changes and dizziness were mainly reported in the first 12 weeks of treatment and were often reported together with nausea, vomiting or diarrhea.