Semaglutide Prescribing Information: All Labels
Semaglutide is sold under 3 labels: Ozempic, Wegovy, Rybelsus. Each carries the same boxed warning for thyroid C-cell tumors but lists different approved uses.
- Boxed warning
- Thyroid C-cell tumors
- Approved uses
- 3
- Warnings
- 9
- First approved
- 2017
Wegovy in short
Its half-life is about 1 week: after 7 d half is gone, and after five half-lives (35 d) about 3% is left.
STEP 1 covered 68 weeks: 14.9% of body weight, compared with 2.4% on placebo.
Monthly prices in US dollars include the list price and self-pay offers, with each figure read from the maker's price page.
Sources: FDA label (DailyMed), healthsystemtracker.org, prnewswire.com 1 2.
The 3 semaglutide labels
| Label | Main approved use | Form | Full label |
|---|---|---|---|
 Ozempic | It lowers blood sugar in adults with type 2 diabetes, together with diet and exercise. | weekly injection | DailyMed |
 Wegovy | It lowers the risk of a heart attack, a stroke, or death related to the heart in adults who have heart disease and also have obesity, or are overweight (both injection and tablets). | weekly injection or daily tablet | DailyMed |
 Rybelsus | It lowers blood sugar in adults with type 2 diabetes, together with diet and exercise. | daily tablet | DailyMed |
Sources: FDA label (DailyMed), FDA label.
What the Ozempic black box says
In rodents, it caused thyroid C-cell tumors; whether this happens in people remains unknown, as the boxed warning states. Do not use it if you or your family have a history of medullary thyroid cancer (MTC), or if you have MEN 2.
Words from the label
“In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including medullary”
Source: FDA label (DailyMed).
Indications
It lowers blood sugar in adults with type 2 diabetes, together with diet and exercise.
Words from the label
“as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. •to reduce the risk of major adverse”
Source: FDA label (DailyMed).
Among adults with type 2 diabetes and heart disease, taking it reduces the risk of heart attack, stroke, or heart-related death.
Words from the label
“to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and”
Source: FDA label (DailyMed).
For adults with type 2 diabetes and chronic kidney disease, it reduces the risk of kidney disease getting worse, kidney failure, and heart-related death.
Words from the label
“to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.”
Source: FDA label (DailyMed).
Contraindications
Medullary thyroid cancer (MTC) in your own or family history, or MEN 2.
Words from the label
“personal or family history of MTC or in patients with MEN 2”
Source: FDA label (DailyMed).
A past serious allergic reaction to semaglutide or any ingredient in the product.
Words from the label
“A serious hypersensitivity reaction to semaglutide or to any of the excipients in OZEMPIC. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with”
Source: FDA label (DailyMed).
Warnings and precautions you should know
Thyroid C-cell tumors. In rodents, it caused thyroid C-cell tumors, but whether it does so in people is not known. Do not use it if you have had medullary thyroid cancer (MTC) or if a family member has. Do not use it if you have MEN 2.
Words from the label
“In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at”
Source: FDA label (DailyMed).
Pancreatitis. It can cause the pancreas to become inflamed. Severe stomach pain that continues requires you to stop taking it and get care.
Words from the label
“Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including OZEMPIC [see Adverse Reactions”
Source: FDA label (DailyMed).
Diabetic eye disease getting worse If you have type 2 diabetes, diabetic eye disease may get worse. A fast drop in blood sugar makes this more likely. Eye checks matter when diabetic eye disease is already present.
Words from the label
“In a 2-year trial involving patients with type 2 diabetes and high cardiovascular risk, more events of diabetic retinopathy complications occurred in patients treated with”
Source: FDA label (DailyMed).
Low blood sugar. Low blood sugar becomes more likely when it is combined with insulin or a sulfonylurea. The doses of those drugs may need to be reduced.
Words from the label
“Patients receiving OZEMPIC in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia [see Adverse”
Source: FDA label (DailyMed).
Kidney damage from fluid loss. Vomiting or diarrhea can lead to fluid loss, and that fluid loss can injure your kidneys. If you lose a lot of fluid, report it and drink fluids.
Words from the label
“There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with semaglutide. The majority of the reported events”
Source: FDA label (DailyMed).
Severe stomach and gut reactions. Stomach and gut side effects are common and can be severe. Severe gastroparesis is a reason not to recommend this medicine.
Words from the label
“Use of OZEMPIC has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions ( 6 )] . In OZEMPIC clinical trials, severe gastrointestinal”
Source: FDA label (DailyMed).
Allergic reactions that are severe. Reports have described serious allergic reactions, some with swelling in the face, lips or throat. Stop taking it and seek medical care right away.
Words from the label
“Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with OZEMPIC. If hypersensitivity reactions occur, discontinue use of OZEMPIC; treat promptly per”
Source: FDA label (DailyMed).
Gallbladder disease. You can get gallstones and inflammation of the gallbladder. Report belly pain on the upper right side, fever, or yellow skin or eyes.
Words from the label
“Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was”
Source: FDA label (DailyMed).
Food in your lungs during anesthesia or sedation. Food can stay in the stomach longer, and this matters during deep sedation or anesthesia. Tell your care team before any procedure.
Words from the label
“OZEMPIC delays gastric emptying [see Clinical Pharmacology (12.2)]. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective”
Source: FDA label (DailyMed).
Source: FDA label (DailyMed).
Adverse reactions table
For each dose group, the label trials show the side effects reported most often, with placebo as the comparison.
| Side effect | Placebo | Ozempic 0.5 mg | Ozempic 1 mg | More than placebo, 1 mg |
|---|---|---|---|---|
| Nausea | 6.1% | 15.8% | 20.3% | +14.2 points |
| Vomiting | 2.3% | 5% | 9.2% | +6.9 points |
| Diarrhea | 1.9% | 8.5% | 8.8% | +6.9 points |
| Abdominal pain | 4.6% | 7.3% | 5.7% | +1.1 points |
| Constipation | 1.5% | 5% | 3.1% | +1.6 points |
Taken from: Ozempic label (DailyMed).
Drug interactions
Taken with insulin, or with a sulfonylurea such as glipizide or glimepiride, it raises the risk of low blood sugar. Your doctor may lower those doses.
Words from the label
“When initiating OZEMPIC, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings”
Source: FDA label (DailyMed).
Because it slows stomach emptying, other pills can be absorbed differently.
Words from the label
“OZEMPIC causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials,”
Source: FDA label (DailyMed).
Pregnancy and breastfeeding
If you plan a pregnancy, stop taking it at least 2 months ahead of time; the pregnancy data are limited.
Words from the label
“Discontinue OZEMPIC in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide [see Use in Specific Populations”
Source: FDA label (DailyMed).
It is not known if the medicine passes into breast milk in humans.
Words from the label
“There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. Semaglutide”
Source: FDA label (DailyMed).
Storage and patient counselling
Put new pens in the fridge. After the first use, a pen can remain in the fridge or at room temperature for 56 days. Do not freeze it.
Words from the label
“After first use of the OZEMPIC pen, the pen can be stored for 56 days at controlled room temperature 15°C to 30°C (59°F to 86°F)”
Source: FDA label (DailyMed).
How this label compares with other GLP-1 labels
| Label | Boxed warning | Warnings | Interaction lines | Named beyond insulin and pills |
|---|---|---|---|---|
| Ozempic | Yes | 9 | 2 | Not listed |
| Wegovy | Yes | 10 | 3 | Levothyroxine |
| Rybelsus | Yes | 9 | 3 | Levothyroxine |
 Mounjaro | Yes | 9 | 4 | Birth control pills, Warfarin and narrow-range drugs |
 Zepbound | Yes | 9 | 4 | Birth control pills, Warfarin and narrow-range drugs |
 Foundayo | Yes | 9 | 6 | Strong CYP3A4 inhibitors, Simvastatin, Birth control pills, Strong CYP3A4 inducers |
 Trulicity | Yes | 9 | 3 | Warfarin and narrow-range drugs |
 Saxenda | Yes | 9 | 2 | Not listed |
 Victoza | Yes | 8 | 2 | Not listed |
| Byetta | No | 9 | 4 | Antibiotics and Birth control pills, along with Warfarin and narrow-range drugs |
Labels used: Ozempic label (DailyMed), Wegovy label (DailyMed), Rybelsus label (DailyMed), Mounjaro label (DailyMed), Zepbound label (DailyMed), Foundayo label (DailyMed), Trulicity label (DailyMed), Saxenda label (DailyMed), Victoza label (DailyMed), Byetta label (DailyMed).
Read the full Ozempic label
The complete prescribing information is available on DailyMed, the National Library of Medicine label site.