Skip to the main content
LongevityGLP1
Safety

How safe is Ozempic? What the label and two outcomes trials show

Ozempic's side effects with their placebo rates, the ten warnings on its label, what its heart and kidney trials found, and the people the label rules out.

Marisol Keane

How this page is paid for: LongevityGLP1 links to telehealth programs, and a few of them pay us. No link on this page pays us, and nothing here was ordered by who pays. How we make money

The short answer

For adults with type 2 diabetes, Ozempic has a well-studied safety record. Its common side effects are digestive and mostly early. Its serious risks (pancreatitis, gallbladder disease, kidney injury from dehydration, eye complications in people with retinopathy, and a thyroid tumor warning based on rodent studies) are uncommon but worth knowing. It is not approved for weight loss.

Key takeaways

  • Nausea affected 15.8% (0.5 mg) and 20.3% (1 mg) of people on Ozempic against 6.1% on placebo, and most stomach effects came while the dose was rising.
  • Two outcomes trials are on the label: SUSTAIN 6 cut major heart events (hazard ratio 0.74) and FLOW cut kidney decline and related deaths (0.76).
  • Don't use it with a personal or family history of medullary thyroid cancer or MEN 2, or after a serious allergic reaction to semaglutide.
  • The label says to stop Ozempic at least 2 months before a planned pregnancy.
  • Ozempic isn't approved for weight loss; its safety data come from people with type 2 diabetes.

Ozempic is FDA-approved for adults with type 2 diabetes, and its label carries real, specific risks. The answer depends on who is taking it and why. The numbers below come from the current US prescribing information, dated June 2026 [1]. For what Ozempic is, see our Ozempic guide.

Ozempic is approved for type 2 diabetes and two of its complications

The label gives Ozempic three uses, all in adults with type 2 diabetes [1]:

  • To improve blood sugar, along with diet and exercise.
  • To lower the risk of heart attack, stroke and heart-related death in people who also have heart disease.
  • To lower the risk of kidney decline, kidney failure and heart-related death in people who also have chronic kidney disease.

That's the whole list. Weight loss isn't on it. The semaglutide brand approved for weight is Wegovy, which has its own label and dose range; see our Wegovy guide.

Digestive side effects are the most common, and they rise with dose

The label's main table pools two placebo-controlled trials in people with type 2 diabetes, about 260 people per group, for an average of 33 weeks on Ozempic [1]. About one person in three on Ozempic had a digestive side effect: 32.7% at 0.5 mg and 36.4% at 1 mg, against 15.3% on placebo.

Ozempic side effects in placebo-controlled trials (% of people)
Side effectPlaceboOzempic 0.5 mgOzempic 1 mg
Nausea6.115.820.3
Vomiting2.35.09.2
Diarrhea1.98.58.8
Abdominal pain4.67.35.7
Constipation1.55.03.1
Indigestion (dyspepsia)1.93.52.7
Burping (eructation)02.71.1
Heartburn and reflux (GERD)01.91.5
Gas (flatulence)0.80.41.5
Gastritis0.80.80.4
Any digestive side effect15.332.736.4

Ozempic prescribing information, DailyMed version 20, June 2026, Table 1 and §6.1. The label also lists fatigue, taste changes (dysgeusia) and dizziness at more than 0.4%, and injection-site reactions in 0.2%.

Nausea in Ozempic's placebo-controlled trials
Placebo
6.1%[1]
Ozempic 0.5 mg
15.8%[1]
Ozempic 1 mg
20.3%[1]

Low blood sugar depends mostly on what else you take. On Ozempic alone, severe episodes were 0% in the label's monotherapy trial. With a sulfonylurea, severe low blood sugar reached 0.8% at 0.5 mg and 1.2% at 1 mg [1]. If you use insulin or a sulfonylurea, your prescriber may lower that dose when Ozempic starts.

Other side effects have their own pages: bruising, itching and rash, thirst, urination and dry mouth, and the facial changes people call "Ozempic face".

Most nausea, vomiting and diarrhea came while the dose was rising

The majority of reports of nausea, vomiting, and/or diarrhea occurred during dose escalation.[1]

Ozempic starts at 0.25 mg a week and allows up to 2 mg; the label says that slow start is there "to reduce the risk of gastrointestinal adverse reactions" [1]. Your prescriber decides the dose steps. In the trials, 3.1% at 0.5 mg and 3.8% at 1 mg stopped because of digestive side effects, against 0.4% on placebo. For each stomach symptom in detail, see Ozempic's stomach side effects.

The label lists ten warnings, and most of them are rare

Serious risks on the Ozempic label and what they look like
RiskHow often (label)Signs the label listsSection
Thyroid C-cell tumorsSeen in rodents; unknown in peopleLump or swelling in the neck, hoarseness, trouble swallowing, shortness of breathBoxed, 5.1
Acute pancreatitis0.3 vs 0.2 cases per 100 patient-years (vs comparators)Severe stomach pain that won't go away, sometimes into the back, with or without vomiting5.2
Eye complications (diabetic retinopathy)3.0% vs 1.8% over 2 years; 8.2% vs 5.2% with prior retinopathyChanges in vision5.3
Low blood sugar with insulin or a sulfonylureaSevere: 0.8 to 1.2% with a sulfonylureaShakiness, sweating, confusion, fast heartbeat5.5
Kidney injury from dehydrationPostmarketing reports, some needing dialysisFollows vomiting, diarrhea or nausea that doesn't stop5.6
Severe digestive reactions0.4% (0.5 mg) and 0.8% (1 mg) vs 0%Stomach problems that are severe or won't go away5.7
Serious allergic reactionsReported; rate not givenSwelling of face, lips, tongue or throat; trouble breathing; severe rash; very fast heartbeat5.8
Gallstones1.5% (0.5 mg) and 0.4% (1 mg) vs 0%Upper belly pain, fever, yellow skin or eyes, clay-colored stools5.9
Food in the lungs under anesthesiaRare postmarketing reportsTell the surgical team you take Ozempic5.10
Pen sharingNot a rate; a ruleNever share a pen, even with a new needle5.4

Ozempic prescribing information, DailyMed version 20, June 2026. The label also says Ozempic is not recommended for people with severe gastroparesis (§5.7).

The boxed warning is the one people ask about. In mice and rats, semaglutide caused thyroid C-cell tumors; the label says it is "unknown" whether Ozempic does this in people [1]. The human evidence is in semaglutide and thyroid cancer. Wegovy is the same molecule, so that page applies to Ozempic too.

In people with diabetes and heart disease, Ozempic cut major heart events by about a quarter

Two large trials on the label measured hard outcomes, not just blood sugar. Both were funded by Novo Nordisk, which makes Ozempic [2] [3].

Outcomes trials on the Ozempic label
TrialWhoFollow-upResultSafety note
SUSTAIN 63,297 adults with type 2 diabetes and heart diseaseMedian 2.1 yearsHeart attack, stroke or heart death: 6.6% vs 8.9% (hazard ratio 0.74)More diabetic eye complications (3.0% vs 1.8%)
FLOW3,533 adults with type 2 diabetes and chronic kidney diseaseMedian 41 monthsKidney decline, kidney failure or kidney or heart death: 18.7% vs 23.2% (hazard ratio 0.76)No new serious adverse reactions identified

Ozempic prescribing information §14.2 Table 9 and §14.3 Table 10, June 2026. A hazard ratio of 0.74 means about 26% fewer events over the trial.

In SUSTAIN 6, non-fatal strokes were also lower (1.6% vs 2.7%). The eye signal came from the same trial, so the benefit and the retinopathy risk travel together for people who already have diabetic eye disease [1].

The label rules Ozempic out for two groups and urges caution for several more

  • Do not use with a personal or family history of medullary thyroid carcinoma, or with MEN 2.
  • Do not use after a serious allergic reaction to semaglutide or any ingredient in Ozempic.
  • Not recommended with severe gastroparesis (very slow stomach emptying).
  • Pregnancy: stop at least 2 months before a planned pregnancy, because semaglutide takes a long time to leave the body.
  • Tell your prescriber about past pancreas problems, diabetic retinopathy, kidney disease, or a history of anaphylaxis or angioedema with another GLP-1 drug.

The first two are contraindications in §4. The rest come from §5, §8.3 and the Medication Guide [1].

Ozempic isn't approved for weight loss, so its label data come from people with diabetes

Some people are prescribed Ozempic off-label for weight. Its label can't tell you how safe that is, because every trial on it enrolled people with type 2 diabetes. Semaglutide for weight has been studied as Wegovy, at higher doses, with its own side-effect tables. See is Wegovy safe? for that evidence.

Compounded semaglutide sold for weight is a third thing again: it is not FDA-approved, and FDA does not check its safety, effectiveness or quality before it ships [5]. See is compounded semaglutide safe?

The longest data on the label run about two to three and a half years

SUSTAIN 6 followed people for a median of 2.1 years and FLOW for a median of 41 months [1]. Evidence beyond that comes from observational studies, which can't prove cause and effect. Stopping has its own effects: in a one-year follow-up after semaglutide 2.4 mg for weight, people regained about two-thirds of the weight they had lost [4]. If you plan to stay on Ozempic for many years, that is a fair question to raise with your prescriber.

Tell your prescriber about thyroid, pancreas, gallbladder, kidney and eye history

The Medication Guide asks you to mention pancreas problems, diabetic retinopathy, severe stomach problems such as gastroparesis, planned surgery or sedation, and pregnancy or breastfeeding plans. List every medicine you take, including insulin, sulfonylureas, vitamins and supplements, because Ozempic slows stomach emptying and may affect how other pills are absorbed [1].

Cost is a separate decision. See does Medicare cover Ozempic? and what Ozempic costs without insurance. For the pill form of semaglutide, see oral semaglutide.

Weighing programs on price? The brand Wegovy and Zepbound self-pay programs lineup sets 21 of them side by side, each with its true monthly cost.

Providers that offer Semaglutide

  • SnagRxPartner

    You want compounded semaglutide or tirzepatide at one flat price for every dose, with the pharmacies named, and you're happy to pay month to month or commit to a longer plan up front.

    SnagRx review →
  • altRx

    You want compounded semaglutide or tirzepatide at one flat monthly price that doesn't rise with your dose, and you're settled enough on treatment that a no-refund policy won't bite.

    altRx review →
  • EmbodyPartner

    You're sure you want a compounded GLP-1, you like a price that holds at every dose, and you want the pharmacies and the doctor network named before you start.

    Embody review →
  • EdenPartner

    You want a compounded GLP-1 at one flat price that won't rise with your dose, with labs and round-the-clock messaging included and no membership.

    Eden review →
  • Pepti

    You want to see every dose's price before you commit, like a named pharmacy, and are comfortable with an online-only physician review and 28-day billing.

    Pepti review →

See all 88 providers on the compounded semaglutide lineup →

Frequently asked

What are the most serious side effects of Ozempic?
The label's serious risks are pancreatitis, diabetic eye complications, low blood sugar with insulin or a sulfonylurea, kidney injury from dehydration, severe digestive reactions, serious allergic reactions, gallbladder disease and aspiration under anesthesia. Most are rare. The boxed warning covers thyroid tumors seen in rodents.
Is Ozempic addictive?
The Ozempic label has no section on drug abuse or dependence, which is where the FDA puts that information when it applies. Nothing on the label describes Ozempic as habit-forming.
Does Ozempic cause cancer?
The label's boxed warning says semaglutide caused thyroid C-cell tumors in rodents, and that it is unknown whether it does so in people. Ozempic is not for anyone with a personal or family history of medullary thyroid cancer or MEN 2. Report a lump in the neck, hoarseness or trouble swallowing to your prescriber.
What happens when you stop Ozempic?
The Ozempic label doesn't describe it. In the STEP 1 trial extension of semaglutide 2.4 mg for weight (Wegovy's dose), people regained about two-thirds of the weight they had lost within a year of stopping, and most heart and metabolic improvements moved back toward where they started. Stopping is a conversation to have with your prescriber.
Can you take Ozempic if you don't have diabetes?
Only off-label. Ozempic is approved for adults with type 2 diabetes, and its safety data come from that group. Wegovy is the semaglutide brand approved for weight management in people with or without diabetes.

Sources

  1. [1] OZEMPIC (semaglutide) injection, prescribing information and Medication Guide (DailyMed, version 20, June 2026) (2026). DailyMed label
  2. [2] Marso SP. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes (2016). PMID 27633186
  3. [3] Perkovic V. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes (2024). PMID 38785209
  4. [4] Wilding JPH. Weight regain and cardiometabolic effects after withdrawal of semaglutide: The STEP 1 trial extension (2022). PMID 35441470
  5. [5] FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (content current as of October 1, 2026) (2026). FDA

Picked for the same drugs and questions as this page.

  • ResearchOzempic storage: the fridge before first use, then 56 days

    The answer changes once you've used the pen. Here is the label's rule before and after first use, the different rule for the prefilled syringe and the tablets, and what freezing or heat means for your medicine.

  • Drug guideOzempic: what it is, what it's approved for, and what it costs

    Ozempic is a weekly semaglutide injection from Novo Nordisk, approved for adults with type 2 diabetes to lower blood sugar and reduce heart and kidney risks. It is not FDA-approved for weight loss, although people lose weight on it; Wegovy is the same drug approved for weight management. A prescription is required.

  • Side by sideIs compounded semaglutide the same as Ozempic? Not as a product

    The name on the vial is the same molecule. Almost everything else differs: who checks it, what else is in it, how it's dosed and what evidence stands behind it. Here is each difference, with current prices for both.

  • ResearchHow much weight people lost on Ozempic in its diabetes trials

    Ozempic isn't approved for weight loss, but its label reports how much weight people lost in every major diabetes trial. Here are those numbers, how they compare with Wegovy, and why the two differ.