What the FDA label warns about
These come from the Saxenda prescribing information published on DailyMed.
Boxed warning: risk of thyroid C-cell tumours
The label carries a boxed warning — the most serious kind. Liraglutide caused thyroid C-cell tumours in both male and female rats and mice, and the effect increased with higher doses and longer treatment.
Saxenda must not be used if you or a family member has had medullary thyroid carcinoma, or if you have Multiple Endocrine Neoplasia syndrome type 2. It is also contraindicated if you have had a serious allergic reaction to liraglutide or anything else in the injection.
Other warnings and precautions on the label:
- Acute pancreatitis
- Acute gallbladder disease
- Low blood sugar, particularly alongside insulin or a sulfonylurea
- Increased heart rate
- Acute kidney injury caused by dehydration from vomiting or diarrhoea
- Severe gastrointestinal reactions
- Hypersensitivity reactions
- Food entering the lungs during general anaesthesia or deep sedation — tell your anaesthetist you take it
The label numbers, against placebo
The FDA label reports these adult adverse reaction rates for Saxenda against placebo (n=1,941). They are close to, but not identical to, the trial figures above.
| Reaction | Saxenda (n=3,384) | Placebo |
|---|---|---|
| Nausea | 39.3% | 13.8% |
| Diarrhoea | 20.9% | 9.9% |
| Constipation | 19.4% | 8.5% |
| Vomiting | 15.7% | 3.9% |
| Headache | 13.6% | 12.6% |
| Indigestion | 9.6% | 2.7% |
How many people stopped because of side effects
of adults in the trials stopped Saxenda early because of an adverse reaction, compared with 4.3% on placebo. The most common reasons were nausea (2.9%), vomiting (1.7%) and diarrhoea (1.4%).
Rare but serious — when to call your doctor
Call your doctor immediately if you have:
- Severe abdominal pain, with or without vomiting, that may spread to your back (possible pancreatitis)
- Pain in the upper right of your abdomen, fever, or yellowing of the skin or eyes (possible gallbladder problems)
- Shakiness, sweating, confusion or dizziness, especially if you also take insulin or a sulfonylurea (low blood sugar)
- A lump or swelling in the neck, hoarseness, trouble swallowing or shortness of breath (thyroid symptoms listed on the label)
- Vomiting or diarrhoea you cannot stay on top of, which can lead to dehydration and kidney injury
- Swelling of the face, lips or tongue, or difficulty breathing (allergic reaction)
What actually helps
Strategies that work best, based on trial and community experience.
Smaller, slower meals
The drug slows how quickly your stomach empties. Smaller portions eaten slowly are the most commonly suggested way to reduce nausea.
Keep fluids up
The label lists dehydration from vomiting or diarrhoea as a cause of acute kidney injury. Sipping through the day matters more than drinking a lot at once.
Tell your anaesthetist
The label warns about food entering the lungs during general anaesthesia or deep sedation. Mention Saxenda before any procedure or dental sedation.
Flag other medicines
If you take insulin or a sulfonylurea, the label warns about low blood sugar. Your prescriber may adjust those doses.
When to push through vs. talk to your doctor
You can push through if...
- Mild nausea that is settling week by week
- You are still able to eat and drink normally
- Constipation that responds to fluids and fibre
- You are keeping up with fluids
Talk to your doctor if...
- Severe abdominal pain, or pain that spreads to your back
- Vomiting or diarrhoea you cannot keep on top of
- A lump or swelling in your neck, or trouble swallowing
- Symptoms of low blood sugar if you also take insulin or a sulfonylurea
- Any symptom you are unsure about
Common questions
Written and maintained by one person · Built with agentic AI tools · Every number checked against the cited trial · Not medical advice
Sources for Liraglutide side effect data
Side effect frequencies come from the SCALE Obesity and Prediabetes trial. The boxed warning, warnings and precautions, adverse reaction table and discontinuation rates come from the Saxenda FDA prescribing information published on DailyMed.
- SCALE Obesity and Prediabetes — Liraglutide: 3,731 adults with obesity or overweight with comorbidities, 56 weeks. New England Journal of Medicine, 2015. View source ↗
- SAXENDA (liraglutide) injection FDA prescribing information — DailyMed View source ↗
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