Ozempic prescribing information, also called the package insert or label, is the official document for Novo Nordisk's once-weekly semaglutide injection, and the current version is dated May 2026. In plain terms: Ozempic is labeled for adults with type 2 diabetes, to lower blood sugar and to cut the risk of certain heart and kidney events. It starts at 0.25 mg a week and tops out at 2 mg. It carries a boxed warning about thyroid tumors seen in rodents. Weight loss isn't one of its labeled uses.
Below is that label, section by section, in everyday words. Its doses are facts about a document, not a plan; a prescriber sets the actual dose.
What's current in the Ozempic prescribing information
As of September 23, 2026, the day this article was written, the Ozempic injection label on DailyMed reads Revised: 5/2026. That revision traces to an FDA letter signed May 5, 2026, which added single-dose prefilled syringes and put necrotizing pancreatitis (a severe, tissue-destroying form), sometimes fatal, on the list of problems reported after launch. The newest letter, signed August 27, 2026, changed only the carton. The patient Medication Guide at the back still prints Revised: 01/2025; each part is revised on its own schedule.
The name now covers two products. An FDA letter of January 30, 2026 renamed a newer Rybelsus formulation as Ozempic tablets, taken daily, with a separate label. Everything below is the injection; oral semaglutide covers the pills.
What Ozempic is labeled to treat
An indication is a use written into the label after the evidence was reviewed. Ozempic injection has three, all in adults with type 2 diabetes:
- Alongside diet and exercise, improving blood-sugar control.
- Lowering the risk of heart attack, stroke or cardiovascular death in people with established cardiovascular disease.
- Lowering the risk of lasting kidney decline, kidney failure and cardiovascular death in people with chronic kidney disease.
The heart use rests on SUSTAIN-6, a two-year trial of 3,297 adults at high cardiovascular risk. A first heart attack, stroke or cardiovascular death happened to 6.6% on semaglutide and 8.9% on placebo (Marso et al., New England Journal of Medicine 2016).
The kidney use, added January 28, 2025, rests on FLOW: 3,533 adults with type 2 diabetes and kidney disease, followed for a median 3.4 years. Kidney failure, a fall of at least half in eGFR (the blood-test estimate of kidney filtering), or death from kidney or heart causes occurred in 331 people on semaglutide and 410 on placebo (Perkovic et al., New England Journal of Medicine 2024).
Weight management isn't on this label. The same molecule carries that use under the Wegovy name; Wegovy's prescribing information walks that document.
The Ozempic dosing guide, as a label fact
This schedule reports the label. It isn't a set of instructions.
| Label step | Once-weekly dose | When the label allows it |
|---|---|---|
| Start | 0.25 mg | Weeks 1–4, to ease stomach side effects |
| First step | 0.5 mg | From week 5 |
| More control needed | 1 mg | After at least 4 weeks at 0.5 mg |
| More control needed | 2 mg | After at least 4 weeks at 1 mg; the maximum |
For the kidney use, the maintenance dose is 1 mg. The 2 mg step comes from SUSTAIN FORTE, a 40-week trial of 961 adults in which HbA1c, a blood test of average sugar over about three months, fell 2.1 points on 2 mg and 1.9 on 1 mg (Frías et al., Lancet Diabetes & Endocrinology 2021).
The label's missed-dose rule turns on five days: within five days the dose is given; after that it's skipped and the regular day resumes.
The Ozempic boxed warning and contraindications
A boxed warning is a label's most prominent caution. Ozempic's concerns thyroid C-cell tumors: semaglutide caused them in mice and rats, and the label says it's unknown whether it causes them in people, including medullary thyroid carcinoma (MTC), a rare thyroid cancer. Routine calcitonin tests or thyroid ultrasounds are "of uncertain value" for catching it early.
A contraindication is a reason the drug must not be used. The current label states: “OZEMPIC is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2.” The other contraindication is a past serious allergic reaction to semaglutide or an ingredient. Tell the prescriber about any family history of MEN 2, too.
Ozempic warnings and precautions, in plain language
Past the thyroid box, the label numbers nine more:
- Pancreatitis, an inflamed pancreas, with persistent severe belly pain as the pattern.
- Diabetic retinopathy complications, eye damage from diabetes. In SUSTAIN-6: 3.0% on Ozempic, 1.8% on placebo, concentrated in people who already had it (8.2% against 5.2%).
- Never sharing a pen, even with a new needle.
- Low blood sugar alongside insulin or a sulfonylurea, a pill that pushes the pancreas to release insulin.
- Kidney injury from dehydration after vomiting or diarrhea.
- Severe stomach and bowel reactions, 0.4% to 0.8% against 0% on placebo; not recommended in severe gastroparesis, a stomach that empties very slowly.
- Serious allergic reactions, including anaphylaxis.
- Gallbladder disease: gallstones in 0.4% to 1.5%, none on placebo.
- Pulmonary aspiration, stomach contents entering the lungs under anesthesia or deep sedation, which is why the label asks that planned procedures be raised with the care team.
One thing isn't there. As of September 23, 2026, the day this article was written, the US label doesn't mention NAION, a sudden loss of blood flow to the optic nerve. Europe's medicines regulator concluded in June 2025 that NAION is a very rare side effect of semaglutide, affecting up to 1 in 10,000 people. Federal lawsuits claiming GLP-1 drugs caused it, 216 pending on September 1, 2026 according to the Judicial Panel on Multidistrict Litigation, are allegations, not findings. Semaglutide and vision weighs the evidence.
Side effects in the Ozempic package insert
Adverse reactions are side effects recorded in trials. This is the label's pool of two placebo-controlled trials, listing reactions in at least 5% of people on Ozempic:
| Reaction | Placebo | 0.5 mg | 1 mg |
|---|---|---|---|
| Nausea | 6.1% | 15.8% | 20.3% |
| Vomiting | 2.3% | 5.0% | 9.2% |
| Diarrhea | 1.9% | 8.5% | 8.8% |
| Abdominal pain | 4.6% | 7.3% | 5.7% |
| Constipation | 1.5% | 5.0% | 3.1% |
Most nausea, vomiting and diarrhea came while doses were rising. Stopping over stomach side effects ran 3.1% at 0.5 mg and 3.8% at 1 mg, against 0.4% on placebo. Resting heart rate rose 2 to 3 beats a minute on average. Reports after launch add ileus (a bowel that stops moving), hair loss and headache.
An October 2026 nail-detachment survey found an association with GLP-1 use, while U.S. labels list no nail disorders.
Interactions, pregnancy and other groups
With insulin or a sulfonylurea, the label suggests considering lower doses of those. Because Ozempic slows stomach emptying, it may change how pills are absorbed.
Human pregnancy data are limited and animal studies suggest possible fetal harm. The label says to discontinue Ozempic at least two months before a planned pregnancy because semaglutide clears slowly. There are no data on semaglutide in human milk, it isn't established for children, and no dose change is listed for kidney or liver impairment.
How Ozempic is supplied and stored
Multi-dose pens are refrigerated until first use, then good for 56 days refrigerated or at 59°F to 86°F. The newer single-dose syringes, at 0.25, 0.5 or 1 mg, may spend up to 28 days at 46°F to 86°F. Neither may be frozen.
What the Ozempic label does not say about compounded semaglutide
The Ozempic label belongs to the branded product. It doesn't set the ingredients, strength, container or directions of a compounded preparation, and its heart and kidney uses come from trials of Ozempic itself. Through Promise, semaglutide is dispensed as a compounded medication, which is different from an FDA-approved product: the formulation offered here is not FDA-approved. The FDA says it doesn't verify the safety, effectiveness or quality of compounded drugs before they're marketed.
The molecule is the same, so the label's screening questions still matter: thyroid cancer history, pancreatitis, diabetic eye disease, pregnancy plans, other medicines. A licensed provider may still prescribe a compounded formulation; that decision is between you and your doctor. At Promise, a licensed provider reviews every request, and not everyone qualifies. Compounded semaglutide explains the rest.
