Is Ozempic Safe? Warnings, Who Should Not Take It, Long-Term Data
Ozempic has been FDA-approved since 2017 and was tested in 8,709 people across 3 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
- 8,709
- Longest follow-up
- 3.4 years (median follow-up)
- Boxed warning
- Thyroid C-cell tumors
Ozempic overview
Its half-life is about 1 week: after 7 d, half is gone, while about 3% remains after five half-lives (35 d).
In SUSTAIN 1, people with type 2 diabetes lost 4.7 kg over 30 weeks, compared with 1.2 kg on placebo.
Monthly prices in US dollars include the list price and self-pay offers, with each amount taken from the manufacturer's price page.
Sources: FDA label (DailyMed), healthsystemtracker.org, prnewswire.com 1 2.
Boxed warning
Boxed warning: the medicine caused thyroid C-cell tumors in rodents, but whether it causes them in people is not known. People must not use this medicine if they have MEN 2 or a personal or family history of medullary thyroid cancer (MTC).
Source: label from FDA on DailyMed.
Who should not take Ozempic?
- A personal or family history of medullary thyroid cancer (MTC), or MEN 2.
- If semaglutide or any ingredient in the product caused a serious allergic reaction, do not use it.
Source: label from FDA on DailyMed.
Source: label from FDA on DailyMed.
Rates of serious side effects
These rates come from the trials in the label, shown beside placebo from those same trials.
Source: Ozempic label (DailyMed).
Additional label warnings for Ozempic
- Thyroid C-cell tumors. It caused thyroid C-cell tumors in rodents; whether it does the same in people is not known. It is not for you if medullary thyroid cancer (MTC) appears in your personal or family history, or if you have MEN 2.
- Pancreatitis. It may cause the pancreas to become inflamed. Get care and stop taking it when severe stomach pain stays and sometimes spreads to your back.
- Diabetic eye disease may get worse. In people with type 2 diabetes, diabetic eye disease may worsen, particularly when blood sugar falls quickly. Eye checks are important if you already have diabetic eye disease.
- Low blood sugar Combining this medicine with insulin or a sulfonylurea raises the risk of low blood sugar. Those doses may need to be lowered.
- Kidney injury from fluid loss Vomiting or diarrhea can cause fluid loss that leads to kidney injury. Report heavy fluid loss; drink fluids.
- Severe stomach and gut reactions. Common side effects affect the stomach and gut, and some can be severe. For severe gastroparesis, this medicine is not recommended.
- Allergic reactions that are severe Reports include serious allergic reactions, such as swelling of the face, lips or throat. Get help right away and stop it if they happen.
- Gallbladder disease. You may develop gallstones and inflammation of the gallbladder. Report fever, yellow skin or eyes, or upper-right belly pain.
- Food getting into your lungs during anesthesia or sedation. When you receive anesthesia or deep sedation, food may remain in the stomach longer, and this matters. Tell your care team before you have any procedure.
Source: label from FDA on DailyMed.
Long-term safety data
The longest Ozempic trials had a median follow-up period of 3.4 years. What they measured was hard outcomes rather than weight alone.
| Trial | What it measured | Result | Compared with | Length |
|---|---|---|---|---|
| SUSTAIN-6 | Heart attack, stroke or death from heart disease | 6.6% vs 8.9% 26% lower risk | Placebo | 104 weeks |
| FLOW | Kidney failure, a major drop in kidney function, or death from kidney or heart causes | 24% lower risk | Placebo | 3.4 years (median follow-up) |
Sources: SUSTAIN-6 (PubMed), FLOW (PubMed).