Victoza Side Effects: FDA-Labelled Risks of Daily Liraglutide
Victoza (liraglutide) is a once-daily injectable GLP-1 receptor agonist approved by the FDA for adults and paediatric patients aged 10 years and older with type 2 diabetes, and to reduce major adverse cardiovascular events in adults with established cardiovascular disease. Per the FDA prescribing information, the most common adverse reactions are gastrointestinal and the label carries a boxed warning for thyroid C-cell tumours.
Victoza (Liraglutide) is an FDA-approved once-daily glp-1 receptor agonist. The most common adverse reactions per the FDA label are gastrointestinal. The label carries a boxed warning for thyroid C-cell tumours and lists pancreatitis, kidney injury, gallbladder disease, and hypoglycaemia with insulin or sulfonylureas as serious risks. This page summarises label and EMA information; it is not medical advice.
Key Takeaways
- Victoza is the once-daily injectable form of liraglutide. The same molecule at a higher dose is sold as Saxenda for weight management.
- FDA boxed warning for thyroid C-cell tumours. Contraindicated in personal or family history of MTC or MEN2.
- Per the FDA label the most common adverse reactions are nausea, diarrhoea, vomiting, decreased appetite, dyspepsia, and constipation.
- Labelled serious risks include pancreatitis, gallbladder disease, acute kidney injury, hypersensitivity, severe hypoglycaemia with insulin or sulfonylureas, and increased heart rate.
- Approved for adults and paediatric patients aged 10 and older, which distinguishes Victoza from many other GLP-1 receptor agonists.
What is Victoza, and what is it approved for?
Victoza is FDA-approved for type 2 diabetes glycaemic control in adults and paediatric patients aged 10 years and older, and to reduce major adverse cardiovascular events (MACE) in adults with T2DM and established cardiovascular disease. The LEADER trial demonstrated the cardiovascular benefit. The Saxenda brand (liraglutide 3 mg daily) is the higher-dose, weight-management indication.
| Property | Detail |
|---|---|
| Generic name | Liraglutide |
| Brand | Victoza (Novo Nordisk) |
| Drug class | GLP-1 receptor agonist |
| Route | Subcutaneous injection, once daily |
| Approved indications (FDA) | Type 2 diabetes (adults and ≥10 years); MACE reduction in T2DM with CV disease |
| Boxed warning | Thyroid C-cell tumours |
| Common adverse reactions per FDA label | Nausea, diarrhoea, vomiting, decreased appetite, dyspepsia, constipation |
| Half-life | ~13 hours |
How does Victoza work?
Liraglutide is a long-acting GLP-1 receptor agonist produced by recombinant DNA technology in yeast. According to the FDA label, a single amino acid substitution and the attachment of a fatty acid side chain enable albumin binding and resistance to dipeptidyl peptidase-4 (DPP-4) cleavage, extending the half-life to approximately 13 hours. Liraglutide enhances glucose-dependent insulin secretion, suppresses glucagon, slows gastric emptying, and reduces appetite.
What side effects has Victoza been linked to in trials?
The following summary is drawn from the FDA prescribing information and EMA product information. It is for general information and does not replace advice from your prescriber.
| Category | Listed reactions / risks | Source |
|---|---|---|
| Boxed warning | Thyroid C-cell tumours (animal data) | FDA label |
| Pancreatitis | Severe, persistent abdominal pain; advise discontinuation and urgent assessment | FDA label |
| Acute kidney injury | Usually secondary to dehydration from GI side effects | FDA label |
| Severe hypoglycaemia | Risk increases with insulin or insulin secretagogues; dose reduction usually required | FDA label |
| Gallbladder disease | Cholelithiasis and cholecystitis reported | FDA label |
| Common GI reactions | Nausea, diarrhoea, vomiting, constipation, abdominal pain | FDA label, EMA EPAR |
| Hypersensitivity | Rash, urticaria, angioedema, anaphylaxis | FDA label |
| Aspiration risk during anaesthesia | Delayed gastric emptying may retain food in the stomach during sedation | ASA / multi-society guidance |
Taking Victoza alongside other medications?
Allmeds scans the widest interaction database for free, so you can talk to your doctor with a clear picture.
Common Questions About Victoza
Both contain liraglutide and are made by Novo Nordisk. Victoza is approved by the FDA for type 2 diabetes at doses up to 1.8 mg daily; Saxenda is approved for chronic weight management at a higher dose of 3 mg daily. The boxed warning and major label warnings are similar across both.
Per the FDA prescribing information, the most common adverse reactions in clinical trials were nausea, diarrhoea, vomiting, decreased appetite, dyspepsia, and constipation. These were typically most pronounced during the first weeks of treatment and after each dose increase.
Yes. The FDA label carries a boxed warning for thyroid C-cell tumours based on rodent studies. Victoza is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
Per the FDA label, Victoza is approved for paediatric patients aged 10 years and older with type 2 diabetes. The label notes that suicidal thoughts have been reported in paediatric clinical trials. Any paediatric use should be initiated and managed by a qualified specialist.
Yes. GLP-1 receptor agonists slow gastric emptying. The American Society of Anesthesiologists and other bodies have issued guidance noting that GLP-1 medicines may leave food in the stomach during sedation. Discuss any planned procedure with both your prescriber and the anaesthetic service.
References
- U.S. Food & Drug Administration. Victoza (liraglutide) prescribing information. Source.
- European Medicines Agency. Victoza EPAR product information. Source.
- Marso SP et al. Liraglutide and cardiovascular outcomes in type 2 diabetes (LEADER). N Engl J Med. 2016;375:311-322. Source.
- Therapeutic Goods Administration (Australia). Australian Register of Therapeutic Goods (ARTG). Source.