Saxenda is an FDA-approved weight loss drug that works by curbing hunger, but it has links to serious side effects and health risks. The drug faces growing legal action and regulatory scrutiny over claims it causes stomach paralysis and other injuries.
Saxenda (liraglutide) is a prescription medication used to help people manage their weight. It is part of a group of drugs called GLP-1 receptor agonists.
The U.S. Food and Drug Administration (FDA) initially approved liraglutide under the brand name Victoza for the treatment of type 2 diabetes. However, in 2014, the FDA approved Saxenda, a higher-dose form of liraglutide to treat adults with obesity or those who are overweight and have related health issues. Novo Nordisk manufactures both Saxenda and Victoza.
Did You Know?
Saxenda was the first FDA-approved GLP-1 agonist drug for weight loss.
Saxenda works by reducing feelings of hunger and slowing the rate at which food moves through the stomach, which helps people eat less.
Patients administer Saxenda through a daily injection and increase the dose gradually over several weeks until reaching 3 mg per day.
“While Saxenda offers promise for weight loss within obesity treatment regimens, its daily dosing and lower overall weight loss results, as compared to other injectable medications, make it less commonly used.”
While patients must take Saxenda daily, semaglutide-based Wegovy, another GLP-1 drug approved for weight management, requires only one injection per week. Ozempic is another semaglutide drug that only requires weekly dosing.
Saxenda Side Effects and Health Risks
Saxenda’s label carries a black box warning — the FDA’s most serious warning — for a possible risk of thyroid C-cell tumors. People who have a personal or family history of certain cancers, such as medullary thyroid cancer (MTC), should not take Saxenda. The warning is based on animal studies.
The most common side effects of Saxenda are typically minor. Researchers identified these side effects in clinical trials before the medication’s FDA approval.
Common Saxenda Side Effects
Abdominal pain
Constipation
Diarrhea
Dizziness
Dyspepsia (indigestion)
Fatigue
Gastroenteritis (inflammation of the stomach and intestines)
Headache
Hypoglycemia (low blood sugar)
Increased lipase (higher levels of a pancreatic enzyme)
Injection site reactions
Nausea
Pyrexia (increased body temperature or fever)
Vomiting
Common side effects were those observed in 5% or more of the people participating in clinical trials.
Severe Side Effects of Saxenda
Acute Pancreatitis
Your doctor may have you stop taking Saxenda if you show symptoms of pancreatitis.
Allergic Reactions
Some people have reported serious allergic reactions with Saxenda. Seek help if you notice any severe reactions.
Gallbladder Issues
If you have signs of gallbladder problems, your doctor may recommend tests.
Low Blood Sugar
Individuals may experience low blood sugar, especially when taking Saxenda with certain diabetes medications. Be aware of the signs of low blood sugar.
Increased Heart Rate
Saxenda can raise your heart rate, so it’s essential to have it checked regularly.
Kidney Problems
Some patients report kidney issues associated with Saxenda. Speak to your doctor if you have kidney problems.
Suicidal Behavior and Ideation
Monitor your mental health and inform your doctor if you feel depressed or have thoughts of self-harm.
Always consult your healthcare provider with any concerns. You should never stop taking Saxenda without first talking to your doctor.
What To Do if You’re Experiencing Side Effects
If you experience mild side effects from Saxenda, monitor them and discuss them with your doctor at your next visit. Don’t stop taking it without consulting your doctor, as this could affect your weight management.
If you have serious side effects while taking Saxenda, it’s essential to act fast and contact your doctor. Some side effects can be dangerous and may require you to stop using the medication right away.
Symptoms of Saxenda Side Effects Requiring Immediate Medical Attention
A lump or swelling in your neck, hoarseness, trouble swallowing or shortness of breath (possible thyroid cancer)
A racing or pounding heartbeat that lasts for several minutes (possible heart rate issues)
Nausea, vomiting or diarrhea that won’t stop and makes it hard to drink fluids (possible dehydration and kidney problems)
New or worsening mood changes, sadness or thoughts of self-harm (possible mental health concerns)
Pain in your upper abdomen, yellowing of your skin or eyes, fever or clay-colored stools (possible gallbladder problems)
Severe stomach pain that doesn’t go away, with or without vomiting (possible pancreatitis)
Shakiness, sweating, dizziness or confusion (possible low blood sugar, especially in people with type 2 diabetes)
Swelling of your face, lips, tongue or throat, trouble breathing, difficulty swallowing or a severe rash (possible serious allergic reaction)
Before starting Saxenda, tell your doctor about your personal and family history of thyroid cancer or hormone-related issues. In addition, mention any other medications you’re taking, as Saxenda can interact with them.
You can report any adverse reactions you experience to the FDA’s MedWatch program.
Emerging Lawsuits Against Saxenda
People who experienced severe gastrointestinal injuries have filed Saxenda lawsuits. These lawsuits argue that Novo Nordisk knew or should have known that Saxenda could cause gastroparesis and other gastrointestinal injuries, but didn’t do enough to warn doctors and patients about the risks.
In December 2024, a federal panel added Saxenda to a multidistrict litigation (MDL) involving five other GLP-1 medications. MDLs enable the consolidation of several similar lawsuits into a single litigation to expedite the legal process.
The Saxenda MDL in an Eastern Pennsylvania federal court claims that GLP-1 drugs have caused gastroparesis, intestinal blockages and other gastrointestinal injuries. In addition to Saxenda lawsuits, Novo Nordisk is a defendant in Wegovy, Rybelsus and Ozempic lawsuits. Eli Lilly and Company faces Trulicity and Mounjaro lawsuits in the same MDL.
As of July 2025, there were 1,997 lawsuits in the MDL. No trials, verdicts or settlements have been announced.
If you experienced injuries from a severe gastrointestinal side effect, you may be able to file a Saxenda lawsuit. You should gather your medical records related to Saxenda and your injuries. Drugwatch works with leading national law firms that specialize in lawsuits over harmful prescription drugs. We can help connect you with an attorney experienced in Saxenda and other GLP-1 medication lawsuits.
Regulatory Oversight and Cancer Warnings
The FDA keeps a close eye on Saxenda because of concerns about its possible links to cancer. The FDA required Novo Nordisk to include Saxenda’s black box warning about thyroid tumors found in animal tests before the manufacturer could sell the medication in the U.S.
Some users have reported a rare form of cancer called medullary thyroid cancer (MTC) after taking Saxenda. Because of this risk, the FDA advises that people with a personal or family history of MTC — or a genetic disorder called multiple endocrine neoplasia type 2 (MEN2) — should not use this drug.
FDA Regulatory Timeline for Saxenda
December 23, 2014
The FDA approved Saxenda, a medication for adults struggling with weight. The approval came with additional requirements, including:
Novo Nordisk had to maintain a Risk Evaluation and Mitigation Strategy (REMS) with the FDA to inform healthcare providers about serious risks, like the potential for thyroid tumors.
Novo Nordisk had to create a registry to monitor medullary thyroid cancer cases for 15 years. The FDA also ordered Novo Nordisk to complete further studies to investigate the potential risk of breast cancer.
December 4, 2018
The FDA lifted the REMS requirement for Saxenda.
December 4, 2020
The FDA approved Saxenda for children aged 12 and older with obesity who weigh over 132 pounds. Saxenda became the first medication in its class approved for helping teenagers manage their weight.
November 1, 2024
Novo Nordisk updated Saxenda's label, adding the risk of pulmonary aspiration during surgery for patients taking the medication. Pulmonary aspiration occurs when people inhale food, liquid or vomit into their airways and lungs.
May 28, 2025
The FDA approved a label change for Saxenda, strengthening warnings around pancreatic, gastrointestinal and kidney risks.
As of March 31, 2025, the FDA Adverse Events Reporting System (FAERS) Public Dashboard indicated that the agency had received a total of 6,013 reports related to Saxenda. Of those, the FDA categorized 2,627 reports as serious, including 70 deaths.
The most frequent serious side effect reported was pancreatitis (211 cases), while the most frequent common side effect was nausea (1,066 cases).
Off-Label Weight Loss Use Raises Concerns
Saxenda is FDA-approved for adults with a BMI of 30 or higher, or a BMI of at least 27 with weight-related health issues. The FDA has also approved Saxenda for children aged 12 and older meeting specific obesity criteria. It is not approved for general weight loss in people who don’t meet these criteria, and it also lacks FDA approval to treat type 2 diabetes.
However, some people may use Saxenda for unapproved reasons via off-label usage. Off-label prescribing happens when a doctor prescribes a medication for a purpose that isn’t FDA-approved. For example, if someone who doesn’t meet the FDA’s BMI requirements for Saxenda takes it for weight loss, that would qualify as off-label use.
It’s unclear how widely doctors have prescribed Saxenda off-label. However, the Massachusetts Health Policy Commission reported that, from 2018 through September 2023, the use of GLP-1 medications for long-term weight loss increased significantly, rising from 6% to 40% of all GLP-1 prescriptions. The Commission also noted that the 40% rate is probably lower than the actual rate due to off-label usage.
Saxenda’s label states that its safety and effectiveness haven’t been thoroughly tested in combination with other weight-loss products or in unapproved groups. Using it off-label may pose risks, including unknown drug interactions and side effects.
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