Saxenda Long-Term Side Effects: What Years of Data Show
Saxenda has been sold in the US since 2014. The long-term label warnings are thyroid C-cell tumors (seen in rodents), pancreatitis, gallbladder disease and kidney injury from fluid loss.
- Sold in the US since
- 2014
- Most common
- Nausea 39.3%
- Same on placebo
- 13.8%
- Stopped because of side effects
- 9.8%
Key facts about Saxenda
Its half-life is about 13 hours. Half is gone by 13 h, and about 3% remains once five half-lives have passed (2.7 d).
SCALE Obesity and Prediabetes, 56 weeks showed 7.4% of body weight, while placebo showed 3%.
Sources: FDA label (DailyMed).
Serious warnings explained simply
- Thyroid C-cell tumors: boxed warning It caused thyroid C-cell tumors in rodents, but it is not known whether this happens in people. Do not use it if you or a family member has had medullary thyroid cancer (MTC), or if you have MEN 2.
- Pancreatitis. It can cause inflammation of the pancreas. If severe stomach pain does not go away and sometimes spreads to your back, stop taking it and get care.
- Disease affecting the gallbladder. You may develop gallstones or inflammation of the gallbladder. Report a fever, yellow skin or eyes, or belly pain in the upper right area.
- Blood sugar that is too low. The risk of low blood sugar rises when you use it with insulin or a sulfonylurea, and those doses may need to be lowered.
- A quicker heart rateIt may raise your resting heart rate. Tell your doctor if your heartbeat races or pounds while you are at rest.
- Kidney injury caused by fluid loss. Kidney injury may follow fluid loss caused by vomiting or diarrhea. Have fluids and report a large loss of fluid.
- Severe reactions in the stomach and gut Side effects in the stomach and gut are common and may be severe. Severe gastroparesis means this medicine is not recommended.
- Allergic reactions that are serious. Reports include serious allergic reactions with swelling of the face, lips, or throat. If these reactions happen, stop taking it and get help right away.
- During anesthesia or sedation, food can reach the lungs. Food can remain in the stomach for longer, and this matters during anesthesia or deep sedation. Let your care team know before any procedure.
Source: FDA label (DailyMed).
Source: FDA label (DailyMed).
Saxenda long term side effects: label rates vs placebo
From its placebo-controlled trials, the FDA label includes 24 common Saxenda side effects. Each row's last column shows how much more often that effect occurred than with placebo.
| Side effect | Placebo | Saxenda Saxenda | More than placebo |
|---|---|---|---|
| Nausea | 13.8% | 39.3% | +25.5 points |
| Diarrhea | 9.9% | 20.9% | +11 points |
| Constipation | 8.5% | 19.4% | +10.9 points |
| Vomiting | 3.9% | 15.7% | +11.8 points |
| Injection Site Reaction | 10.5% | 13.9% | +3.4 points |
| Headache | 12.6% | 13.6% | +1 points |
| Hypoglycemia in T2DM | 6.6% | 12.6% | +6 points |
| Dyspepsia | 2.7% | 9.6% | +6.9 points |
| Fatigue | 4.6% | 7.5% | +2.9 points |
| Dizziness | 5% | 6.9% | +1.9 points |
| Abdominal Pain | 3.1% | 5.4% | +2.3 points |
| Increased Lipase | 2.2% | 5.3% | +3.1 points |
| Upper Abdominal Pain | 2.7% | 5.1% | +2.4 points |
| Gastroenteritis | 3.2% | 4.7% | +1.5 points |
| Gastroesophageal Reflux Disease | 1.7% | 4.7% | +3 points |
| Abdominal Distension | 3% | 4.5% | +1.5 points |
| Eructation | 0.2% | 4.5% | +4.3 points |
| Urinary Tract Infection | 3.1% | 4.3% | +1.2 points |
| Flatulence | 2.5% | 4% | +1.5 points |
| Viral Gastroenteritis | 1.6% | 2.8% | +1.2 points |
| Insomnia | 1.7% | 2.4% | +0.7 points |
| Dry Mouth | 1% | 2.3% | +1.3 points |
| Asthenia | 0.8% | 2.1% | +1.3 points |
| Anxiety | 1.6% | 2% | +0.4 points |
Source: FDA label (DailyMed).