This is one label's record. It reads the OZEMPIC (semaglutide) injection prescribing information (Novo Nordisk, NDA 209637, SPL version 20, effective 1 June 2026) as published by the manufacturer on DailyMed and read on 24 September 2026. A search of the FDA label database by brand name returns repackagers' older copies of this label first, some from 2020–2023; this page uses Novo Nordisk's current one.
Ozempic is semaglutide approved for type 2 diabetes, not for weight management; that indication belongs to Wegovy, whose record is on Wegovy's own side-effect page. Every number here comes from adults with diabetes, most on other diabetes medicines. The class-wide picture is on our GLP-1 side effects page. A tablet sold under the Ozempic name has its own separate label and is not covered here.
Nothing here tells anyone what to do about a symptom. Where the label addresses prescribers or patients, that is reported as what the label says.
The counted reactions, with placebo subtracted
The label's Table 1 pools two placebo-controlled trials — one of Ozempic alone and one added to basal insulin. 521 people received Ozempic for a mean of 32.9 weeks; their mean age was 56 and they had had diabetes for 8.8 years. The label prints only the 0.5 mg and 1 mg doses here. The last column is our arithmetic.
| Reaction | Placebo | 0.5 mg | 1 mg | Excess at 1 mg |
|---|---|---|---|---|
| Nausea | 6.1% | 15.8% | 20.3% | +14.2 |
| Vomiting | 2.3% | 5.0% | 9.2% | +6.9 |
| Diarrhoea | 1.9% | 8.5% | 8.8% | +6.9 |
| Abdominal pain | 4.6% | 7.3% | 5.7% | +1.1 |
| Constipation | 1.5% | 5.0% | 3.1% | +1.6 |
Below the 5% line: indigestion (up to 3.5% against 1.9%), burping (up to 2.7% against 0%), reflux (up to 1.9% against 0%), flatulence and gastritis. The label adds fatigue, altered taste and dizziness as associated reactions above 0.4%, without a table.
The label prints no 2 mg column. The 2 mg dose was studied in a separate 40-week trial of 959 people on 1 mg or 2 mg (no placebo). The label reports one number from it: gastrointestinal reactions in 34% on 2 mg against 30.8% on 1 mg, and "no new safety signals".
Stomach effects: common, and a small share who stop
Any gastrointestinal reaction was reported by 32.7% on 0.5 mg and 36.4% on 1 mg, against 15.3% on placebo. Those who stopped because of one: 3.1% and 3.8%, against 0.4%. The label says most nausea, vomiting and diarrhoea came during dose escalation.
Severe gastrointestinal reactions were 0.4% on 0.5 mg and 0.8% on 1 mg, against 0% on placebo. The label says Ozempic is not recommended in severe gastroparesis.
Placebo matters on this label more than most: roughly one in seven people injecting nothing reported a stomach complaint. Of the 36.4% on 1 mg, about 21 points are the drug's plausible share.
The eye warning, worked through
This is the axis that sets the Ozempic label apart, and the one the headline tables leave out. Section 5.3 reports what happened in SUSTAIN 6, a 2-year trial of 3,297 adults with type 2 diabetes and high cardiovascular risk:
| Diabetic retinopathy complications | Placebo | Ozempic | Excess (points) | Ratio |
|---|---|---|---|---|
| All patients | 1.8% | 3.0% | +1.2 | 1.7× |
| History of retinopathy at baseline | 5.2% | 8.2% | +3.0 | 1.6× |
| No known history | 0.4% | 0.7% | +0.3 | 1.75× |
The last two columns are our arithmetic on the label's percentages. They show what a single "Ozempic raises retinopathy risk" line hides: the relative increase is about the same in both groups, but the absolute increase is ten times larger in people who already have the disease. Roughly three extra complications per hundred people with a history of retinopathy over two years, against three per thousand without.
The label's explanation is not a toxic effect on the eye. It says "rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy". It also says "the effect of long-term glycemic control with semaglutide on diabetic retinopathy complications has not been studied". Its instruction is to prescribers: patients with a history of diabetic retinopathy "should be monitored for progression". How and how often is a decision for the prescriber and the eye specialist.
Three limits on this table: SUSTAIN 6 was a cardiovascular trial, not designed to study eyes; "complications" is a composite (the label does not split it here); and the subgroup figures come from one trial of about 1,650 people per arm. The Mounjaro and Zepbound labels carry a similar warning without a trial rate; our Mounjaro side effects page sets that label out.
Low blood sugar depends on what Ozempic is added to
The label's Table 2 uses two thresholds — documented symptoms at 70 mg/dL or below, and a confirmed reading at 56 mg/dL or below — so its figures cannot be lined up against labels that use 54 mg/dL.
| 30 weeks | Placebo | 0.5 mg | 1 mg |
|---|---|---|---|
| Alone: severe | 0% | 0% | 0% |
| Alone: documented symptomatic (≤70 mg/dL) | 0% | 1.6% | 3.8% |
| Alone: severe or confirmed ≤56 mg/dL | 1.6% | 0% | 0% |
| With basal insulin: severe | 0% | 0% | 1.5% |
| With basal insulin: documented symptomatic (≤70 mg/dL) | 15.2% | 16.7% | 29.8% |
| With basal insulin: severe or confirmed ≤56 mg/dL | 5.3% | 8.3% | 10.7% |
With a sulfonylurea, the label reports severe episodes in 0.8% and 1.2% on 0.5 and 1 mg, documented symptomatic episodes in 17.3% and 24.4%, and severe-or-confirmed in 6.5% and 10.4%. A "severe" episode is one that needed another person's help. The label tells prescribers to consider a lower dose of the insulin or sulfonylurea when Ozempic is started — a prescribing decision, not one a reader can make from this table.
The outcome trials behind two of the three indications
Ozempic carries three indications, all in adults with type 2 diabetes. The second and third rest on these trials:
| Trial | Population | Primary outcome | Placebo | Ozempic | Hazard ratio (95% CI) |
|---|---|---|---|---|---|
| SUSTAIN 6 (median 2.1 years) | 3,297 with cardiovascular disease or high risk | Heart attack, stroke or cardiovascular death | 8.9% | 6.6% | 0.74 (0.58–0.95) |
| FLOW | 3,533 with chronic kidney disease | ≥50% kidney-function decline, kidney failure, or kidney or cardiovascular death | 23.2% | 18.7% | 0.76 (0.66–0.88) |
In SUSTAIN 6 the reduction came from non-fatal strokes (1.6% against 2.7%) and heart attacks; cardiovascular death was 2.7% against 2.8%. In FLOW, all-cause death was 12.8% against 15.8%, and the label notes the benefit "was not evident in patients taking SGLT2 inhibitors at baseline, but there were few events in these patients". FLOW collected only serious adverse events and pre-selected categories, and the label says no new serious reactions were identified. Our Trulicity and Ozempic comparison and Mounjaro and Ozempic comparison cover how these sit against other diabetes drugs.
Laboratory changes and rarer counts
- Pancreatic enzymes. Mean amylase up 13% and lipase up 22% from baseline on Ozempic; no change on placebo.
- Acute pancreatitis. 7 adjudicated cases in the glucose-control trials — 0.3 per 100 patient-years against 0.2 on comparators. Pancreatitis page.
- Gallstones. 1.5% on 0.5 mg and 0.4% on 1 mg; none on placebo. Gallbladder page.
- Heart rate. Mean rise of 2 to 3 beats per minute; placebo fell by 0.3.
- Injection-site reactions. 0.2% of Ozempic patients.
The warnings, and where each is covered
- Thyroid C-cell tumours (boxed warning, from rodent studies) — thyroid cancer page.
- Acute pancreatitis, including necrotising pancreatitis sometimes resulting in death (postmarketing).
- Diabetic retinopathy complications — above.
- Never share an Ozempic pen, even with a new needle.
- Low blood sugar with insulin or a sulfonylurea — above.
- Acute kidney injury from dehydration.
- Severe gastrointestinal reactions.
- Hypersensitivity, including anaphylaxis and angioedema.
- Acute gallbladder disease.
- Pulmonary aspiration during anaesthesia or deep sedation — our surgery page.
The postmarketing list adds ileus, bowel obstruction, faecal impaction, cholecystitis, headache, dysesthesia and hair loss — from voluntary reports "from a population of uncertain size", so without rates. Hair loss is covered on our hair loss page.
What this page cannot tell you
- What any one person will experience. These are group rates from trials with regular visits.
- How Ozempic compares with another drug. The label says rates from different trials "cannot be directly compared".
- Anything about children. The label states safety and efficacy have not been established in paediatric patients.
Anyone experiencing a side effect, or with diabetic eye disease and weighing these figures, should take it to the person who prescribed the medicine. How side effects change as the dose climbs, across the class, is on our dose and side effects page; the semaglutide trial record beyond safety is in our semaglutide review.
Sources
- OZEMPIC (semaglutide) injection, prescribing information, Novo Nordisk, NDA 209637, SPL version 20, effective 2026-06-01 — DailyMed setid adec4fd2-6858-4c99-91d4-531f5f2a2d79, read 2026-09-24: boxed warning, sections 1, 5, 6.1, 6.2, 8.4, 8.5, 14.2 and 14.3.
- SUSTAIN 6 NCT01720446 (label section 5.3 and Table 9); FLOW NCT03819153 (label Table 10).