Ozempic Prescribing Information, Explained Section by Section
The Ozempic label carries a boxed warning for thyroid c-cell tumors, 9 other warnings and 2 drug interaction lines. It is approved for 3 uses.
- Boxed warning
- Tumors of thyroid C-cells
- Approved uses
- 3
- Warnings
- 9
- First approved
- 2017
A quick look at Ozempic
Its half-life is about 1 week: after 7 d, half of it is gone, and after five half-lives (35 d) about 3% is left.
In SUSTAIN 1, a 30-week trial in type 2 diabetes, people lost 4.7 kg compared with 1.2 kg on placebo.
Monthly prices in US dollars: the list price and the self-pay offers, each taken from the maker's price page.
Sources: FDA label (DailyMed), healthsystemtracker.org, prnewswire.com 1 2.
Ozempic's boxed warning
Boxed warning: it caused thyroid C-cell tumors in rodents; whether it does in people is not known. Do not use it if medullary thyroid cancer (MTC) appears in your personal or family history, 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
When used with diet and exercise, it lowers blood sugar for adults who have type 2 diabetes.
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).
For adults who have type 2 diabetes and heart disease, it lowers the risk of a heart attack, a 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).
In adults who have type 2 diabetes and chronic kidney disease, this medicine lowers the risk of kidney failure and heart-related death. It also lowers the risk that kidney disease gets worse.
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 your family's history, or MEN 2.
Words from the label
“personal or family history of MTC or in patients with MEN 2”
Source: FDA label (DailyMed).
Any earlier serious allergic reaction to semaglutide or to an 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 to know about
Tumors of thyroid C-cells. It caused thyroid C-cell tumors in rodents; whether it does in people is not known. Do not use it if medullary thyroid cancer (MTC) appears in your personal or family history, or 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 may cause inflammation of the pancreas. If severe stomach pain does not go away, stop taking it and get care. The pain may spread to your back.
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 can get worse. Diabetic eye disease can worsen in people with type 2 diabetes, especially when blood sugar falls quickly. If you already have this condition, eye checks are important.
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).
Blood sugar too low. Taking it with insulin or a sulfonylurea makes low blood sugar more likely. Those doses may need to be lowered.
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 injury caused by fluid loss. Vomiting or diarrhea can cause fluid loss that harms the kidneys. You need to drink fluids and report heavy fluid loss.
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 gut and stomach reactions. Common stomach and gut side effects may be severe. It is not recommended for people with severe gastroparesis.
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).
Severe allergic reactions Reports include serious allergic reactions, some with swelling of the face, lips or throat. If these reactions happen, stop taking it and get help 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).
Disease of the gallbladder. You may develop gallstones or inflammation of the gallbladder. Report upper right belly pain, 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 getting into the lungs during anesthesia or sedation. During anesthesia or deep sedation, it matters because food can stay in the stomach longer. Let your care team know 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 in a table
The label trials list the most common side effects by dose group beside placebo.
| 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 |
Source: Ozempic label (DailyMed).
Interactions with other drugs
Low blood sugar is more likely if you use it with insulin, or with a sulfonylurea such as glipizide or glimepiride. Your doctor may lower the doses of those medicines.
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).
It slows stomach emptying, and that can change how other pills are absorbed.
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).
Use during pregnancy and breastfeeding
If you plan a pregnancy, stop at least 2 months before it. Data on pregnancy 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).
Whether it passes into human breast milk is not known.
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 advice
New pens go in the fridge; once a pen has been used, it can stay in the fridge or at room temperature for 56 days. Never 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).
Comparing the label 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 | Simvastatin, Strong CYP3A4 inhibitors, Strong CYP3A4 inducers, Birth control pills |
 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 | Birth control pills and antibiotics, Warfarin and narrow-range drugs |
The sources are: 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 complete Ozempic label
You can find the complete prescribing information at DailyMed, the National Library of Medicine label site.