Is Semaglutide Safe? Trial Risk Rates, Long-Term Data, Compounded
Semaglutide has been FDA-approved since 2017 and was tested in 44,905 people across 13 major trials. Its label carries a boxed warning for thyroid C-cell tumors and 9 other warnings. 2 groups should not take it.
- FDA-approved since
- 2017
- People in its major trials
- 44,905
- Longest follow-up
- 3.4 years (median follow-up)
- Boxed warning label
- Tumors: Thyroid C-cell tumors
A quick look at Wegovy
Half-life is about 1 week: after 7 d, half is gone, and about 3% remains after five half-lives (35 d).
In STEP 1, over 68 weeks, the placebo result was 2.4%, compared with 14.9% of body weight.
The maker's price page lists monthly price points in US dollars for list prices and self-pay offers.
Sources: FDA label (DailyMed), healthsystemtracker.org, prnewswire.com 1 2.
Boxed warning label
Boxed warning: it caused thyroid C-cell tumors in rodents, and whether it does in people is not known. Avoid it if medullary thyroid cancer (MTC) is in your personal or family history, or if you have MEN 2.
Source: FDA label (DailyMed).
Who should not take semaglutide?
- Your personal or family history of Medullary thyroid cancer (MTC), or MEN 2.
- In the past, semaglutide or one of the product's ingredients caused a serious allergic reaction in you.
Source: FDA label (DailyMed).
Source: FDA label (DailyMed).
How often do serious side effects happen?
Label trial rates, shown next to placebo from those same trials.
Sources: Ozempic label (DailyMed), Wegovy label (DailyMed), Rybelsus label (DailyMed).
The Ozempic label lists other warnings
- Tumors: Thyroid C-cell tumors It caused thyroid C-cell tumors in rodents; whether it does in people is not known. Do not take it if medullary thyroid cancer (MTC) is in your personal or family history, or if you have MEN 2.
- Pancreatitis. It can lead to inflammation of the pancreas. Severe stomach pain that will not go away can sometimes spread to your back.
- Diabetic eye disease getting worse. People with type 2 diabetes can find that diabetic eye disease gets worse, especially when blood sugar drops fast. If you already have diabetic eye disease, eye checks matter.
- Low blood sugar. Low blood sugar risks. Combining this medicine with insulin or a sulfonylurea raises the chance of low blood sugar. Those doses may need lowering.
- Kidney injury from fluid loss. Fluid loss caused by vomiting or diarrhea can lead to kidney injury. Drink fluids. Report heavy fluid loss. Drink fluids, and report if you are losing a lot of fluid.
- Severe stomach and gut reactions. Side effects in the stomach and gut are common, and some can be severe. It is not advised for people with severe gastroparesis.
- Allergic reactions: serious cases. Some reports include serious allergic reactions with swelling affecting the face, lips, or throat. If these reactions happen, stop taking the medicine and seek help right away.
- Gallbladder disease. You can get gallstones, and the gallbladder can also become inflamed. Gallstones and gallbladder inflammation may occur. Report fever, yellow skin or eyes, or any upper right belly pain.
- Food reaching the lungs while you are under anesthesia or sedation. Food that enters the lungs during anesthesia or sedation. It can remain in your stomach longer, which matters during anesthesia or deep sedation. Tell the care team before any procedure.
Source: FDA label (DailyMed).
Long-term safety data
The longest semaglutide trials tracked people across 3.4 years (median follow-up). Hard outcomes were measured here, rather than weight alone.
| Trial | What it measured | Result | Compared with | Length |
|---|---|---|---|---|
| SELECT | Heart attack, stroke or death from heart disease | 6.5% vs 8% 20% lower risk | Placebo | 39.8 months (mean follow-up) |
| SUSTAIN-6 | Heart attack, stroke or death from heart disease | 6.6% vs 8.9% 26% lower risk | Placebo | 104 weeks |
| PIONEER 6 | Heart attack, stroke or death from heart disease | 3.8% vs 4.8% 21% lower risk | Placebo | Not listed |
| SOUL | Heart attack, stroke or death from heart disease | 12% vs 13.8% 14% lower risk | Placebo | 47.5 months (mean follow-up) |
| FLOW | Death caused by kidney or heart problems, Kidney failure, or a large drop in kidney function | 24% lower risk | Placebo | 3.4 years (median follow-up) |
| ESSENCE | MASH resolved without worse scarring | 62.9% vs 34.3% | Placebo | 72 weeks (interim analysis) |
Sources: SELECT (PubMed), SELECT (FDA label (DailyMed)), SUSTAIN-6 (PubMed), PIONEER 6 (PubMed), SOUL (PubMed), FLOW (PubMed), ESSENCE (PubMed).
Because of side effects, how many people stopped?
Sources: STEP 1 (FDA label (DailyMed)), STEP 1 (PubMed), SELECT (PubMed).