Ozempic
Generic name: semaglutide injection · Brand names: Ozempic, Wegovy (listed as another brand of semaglutide injection)
Quick facts
Drug class
GLP-1 Receptor Agonist [EPC] (openFDA openfda.pharm_class_epc); label Highlights: 'OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist'
Rx or otc
Rx (DailyMed: HUMAN PRESCRIPTION DRUG LABEL)
Forms and strengths
- Single-patient-use pens (Section 3 / 16): 2 mg / 3 mL (0.68 mg/mL), 4 mg / 3 mL (1.34 mg/mL), 8 mg / 3 mL (2.68 mg/mL); Highlights: 2 mg/3 mL for 4 doses of 0.25 mg and 2 doses of 0.5 mg or 4 doses of 0.5 mg, 4 mg/3 mL for 4 doses of 1 mg, and 8 mg/3 mL for 4 doses of 2 mg
- Single-dose prefilled syringes: 0.25 mg / 0.5 mL, 0.5 mg / 0.5 mL, 1 mg / 0.5 mL (Section 3 / 16)
Common use one line
Used with diet and exercise to improve blood sugar control in adults with type 2 diabetes (DailyMed Section 1).
What it is used for
Used with diet and exercise to improve blood sugar control in adults with type 2 diabetes. It is also used to lower the risk of major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, and to lower the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.
Section
1
Source
DailyMed label
Source text (exact source wording)
OZEMPIC is indicated:
• 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 cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
• 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.
• 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 cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
• 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.
How it works
Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. It acts as a GLP-1 receptor agonist that binds to and activates the GLP-1 receptor. Binding to albumin gives it a long half-life.
Section
12.1
Source
DailyMed label
Source text (exact source wording)
Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1.
GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors.
The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme.
GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors.
The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme.
Dosage: adults
Start with 0.25 mg injected under the skin once weekly for 4 weeks. After 4 weeks, increase to 0.5 mg once weekly. For glycemic control, the dose may be increased to 1 mg once weekly after at least 4 weeks on 0.5 mg, then to 2 mg once weekly after at least 4 weeks on 1 mg. The maximum recommended dosage is 2 mg once weekly. For type 2 diabetes with chronic kidney disease, increase to 1 mg once weekly after at least 4 weeks on 0.5 mg. Give it on the same day each week, at any time of day, with or without meals.
Section
2.1/2.2
Source
DailyMed label
Source text (exact source wording)
2.1 Important Administration Instructions
• Administer OZEMPIC once weekly, on the same day each week, at any time of the day, with or without meals.
• Inject OZEMPIC subcutaneously in the abdomen, thigh, or upper arm. Instruct patients to use a different injection site each week when injecting in the same body region.
• When using OZEMPIC with insulin, instruct patients to administer as separate injections and to never mix the products. It is acceptable to inject OZEMPIC and insulin in the same body region, but the injections should not be adjacent to each other.
• The day of weekly administration can be changed if necessary as long as the time between two doses is at least 2 days (>48 hours).
2.2 Recommended Dosage
Initiate OZEMPIC with a dosage of 0.25 mg injected subcutaneously once weekly for 4 weeks. Follow the dosage escalation below to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions (5.7), Adverse Reactions (6.1)].
After 4 weeks on the 0.25 mg dosage, increase the dosage to 0.5 mg once weekly.
Recommended Maintenance and Maximum Dosages for Glycemic Control
The recommended maintenance dosage is 0.5 mg, 1 mg, or 2 mg, injected subcutaneously once weekly, based on glycemic control.
If additional glycemic control is needed after at least 4 weeks on the:
• 0.5 mg dosage, the dosage may be increased to 1 mg once weekly.
• 1 mg dosage, the dosage may be increased to 2 mg once weekly.
The maximum recommended dosage is 2 mg once weekly.
Recommended Maintenance Dosage in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease
Increase the dosage to the maintenance dosage, 1 mg once weekly, after at least 4 weeks on the 0.5 mg dosage.
• Administer OZEMPIC once weekly, on the same day each week, at any time of the day, with or without meals.
• Inject OZEMPIC subcutaneously in the abdomen, thigh, or upper arm. Instruct patients to use a different injection site each week when injecting in the same body region.
• When using OZEMPIC with insulin, instruct patients to administer as separate injections and to never mix the products. It is acceptable to inject OZEMPIC and insulin in the same body region, but the injections should not be adjacent to each other.
• The day of weekly administration can be changed if necessary as long as the time between two doses is at least 2 days (>48 hours).
2.2 Recommended Dosage
Initiate OZEMPIC with a dosage of 0.25 mg injected subcutaneously once weekly for 4 weeks. Follow the dosage escalation below to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions (5.7), Adverse Reactions (6.1)].
After 4 weeks on the 0.25 mg dosage, increase the dosage to 0.5 mg once weekly.
Recommended Maintenance and Maximum Dosages for Glycemic Control
The recommended maintenance dosage is 0.5 mg, 1 mg, or 2 mg, injected subcutaneously once weekly, based on glycemic control.
If additional glycemic control is needed after at least 4 weeks on the:
• 0.5 mg dosage, the dosage may be increased to 1 mg once weekly.
• 1 mg dosage, the dosage may be increased to 2 mg once weekly.
The maximum recommended dosage is 2 mg once weekly.
Recommended Maintenance Dosage in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease
Increase the dosage to the maintenance dosage, 1 mg once weekly, after at least 4 weeks on the 0.5 mg dosage.
Dosage: children
Safety and efficacy have not been established in children.
Section
8.4
Source
DailyMed label
Source text (exact source wording)
Safety and efficacy of OZEMPIC have not been established in pediatric patients.
Dosage adjustments
Drug interaction caps
The risk of hypoglycemia may be lowered by reducing the dose of a sulfonylurea (or other insulin secretagogue) or insulin. When starting Ozempic, consider reducing the dose of these medicines.
Section
5.5
Source
DailyMed label
Source text (exact source wording)
5.5 ... The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
7.1 ... 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 and Precautions (5.5), Adverse Reactions (6)].
7.1 ... 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 and Precautions (5.5), Adverse Reactions (6)].
Kidney
No dose change is recommended for people with kidney impairment.
Section
8.6
Source
DailyMed label
Source text (exact source wording)
No dose adjustment of OZEMPIC is recommended for patients with renal impairment. In subjects with renal impairment including kidney failure, no clinically relevant change in semaglutide pharmacokinetics (PK) was observed [see Clinical Pharmacology (12.3)].
Liver
No dose change is recommended for people with liver impairment.
Section
8.7
Source
DailyMed label
Source text (exact source wording)
No dose adjustment of OZEMPIC is recommended for patients with hepatic impairment. In a study in subjects with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics (PK) was observed [see Clinical Pharmacology (12.3)].
Elderly
No overall differences in safety or efficacy were detected between older and younger patients.
Section
8.5
Source
DailyMed label
Source text (exact source wording)
In the pool of placebo- and active-controlled glycemic control trials, 744 (23.6%) OZEMPIC-treated patients were 65 years of age and over and 102 OZEMPIC-treated patients (3.2%) patients were 75 years of age and over. In SUSTAIN 6, the cardiovascular outcome trial, 788 (48%) OZEMPIC-treated patients were 65 years of age and over and 157 OZEMPIC-treated patients (9.6%) patients were 75 years of age and over.
No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Missed dose
If a dose is missed, give it as soon as possible within 5 days after the missed dose. If more than 5 days have passed, skip it and give the next dose on the regular day. Do not take a double dose.
Section
2.1
Source
DailyMed label; MedlinePlus agrees for diabetes (5 days)
Source text (exact source wording)
DailyMed 2.1: If a dose is missed, administer OZEMPIC as soon as possible within 5 days after the missed dose. If more than 5 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once-weekly dosing schedule.
MedlinePlus: if you are taking this medication to control diabetes, inject the missed dose as soon as you remember it within 5 days after the missed dose. However, if more than 5 days have passed, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
MedlinePlus: if you are taking this medication to control diabetes, inject the missed dose as soon as you remember it within 5 days after the missed dose. However, if more than 5 days have passed, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Overdose
In an overdose, supportive treatment should be started based on signs and symptoms. A prolonged period of observation and treatment may be necessary because the half-life is approximately 1 week. Poison control: 1-800-222-1222.
Section
10; MedlinePlus Overdose
Source
DailyMed label; MedlinePlus
Source text (exact source wording)
DailyMed 10: In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of OZEMPIC of approximately 1 week.
MedlinePlus: In case of overdose, call the poison control helpline at 1-800-222-1222.
MedlinePlus: In case of overdose, call the poison control helpline at 1-800-222-1222.
Storage
Before first use, keep the pen in a refrigerator between 2°C to 8°C (36°F to 46°F) and do not freeze it. After first use, the pen can be kept 56 days at 15°C to 30°C (59°F to 86°F) or in a refrigerator. The prefilled syringe is kept refrigerated at 2°C to 8°C (36°F to 46°F) and, if needed, can be kept from 8°C to 30°C (46°F to 86°F) up to 28 days.
Section
16.2 (Novo Nordisk labeler-specific)
Source
DailyMed label
Source text (exact source wording)
Prior to first use, the OZEMPIC pen should be stored in a refrigerator between 2°C to 8°C (36°F to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze OZEMPIC and do not use OZEMPIC if it has been frozen. OZEMPIC must be kept in the original carton until time of administration.
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) or in a refrigerator 2°C to 8°C (36°F to 46°F). Do not freeze. Keep the pen cap on when not in use. OZEMPIC should be protected from excessive heat and sunlight.
Single-dose prefilled syringes: Store the OZEMPIC prefilled syringe refrigerated at 2°C to 8°C (36°F to 46°F). If needed, the syringe can be kept from 8°C to 30°C (46°F to 86°F) up to 28 days. Do not freeze OZEMPIC and do not use OZEMPIC if it has been frozen. Protect OZEMPIC from light. OZEMPIC must be kept in the original carton until time of administration. Discard the OZEMPIC syringe after use.
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) or in a refrigerator 2°C to 8°C (36°F to 46°F). Do not freeze. Keep the pen cap on when not in use. OZEMPIC should be protected from excessive heat and sunlight.
Single-dose prefilled syringes: Store the OZEMPIC prefilled syringe refrigerated at 2°C to 8°C (36°F to 46°F). If needed, the syringe can be kept from 8°C to 30°C (46°F to 86°F) up to 28 days. Do not freeze OZEMPIC and do not use OZEMPIC if it has been frozen. Protect OZEMPIC from light. OZEMPIC must be kept in the original carton until time of administration. Discard the OZEMPIC syringe after use.
Boxed warning
The label has a boxed warning about thyroid C-cell tumors. In rodents, semaglutide caused thyroid C-cell tumors. It is unknown whether the medicine causes them, including medullary thyroid carcinoma (MTC), in humans. It must not be used by people with a personal or family history of MTC or with MEN 2. Patients should be told about the risk and about symptoms of thyroid tumors such as a mass in the neck, dysphagia, dyspnea and persistent hoarseness.
Section
Boxed Warning
Source
DailyMed label
Source text (exact source wording)
WARNING: RISK OF THYROID C-CELL TUMORS
• 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 thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions (5.1), Nonclinical Toxicology (13.1)].
• OZEMPIC is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications (4)]. Counsel patients regarding the potential risk for MTC with the use of OZEMPIC and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with OZEMPIC [see Contraindications (4), Warnings and Precautions (5.1)].
• 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 thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions (5.1), Nonclinical Toxicology (13.1)].
• OZEMPIC is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications (4)]. Counsel patients regarding the potential risk for MTC with the use of OZEMPIC and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with OZEMPIC [see Contraindications (4), Warnings and Precautions (5.1)].
Contraindications
People who have had medullary thyroid carcinoma (MTC), or who have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or who have a personal or family history of MTC, should not use it.
Name
Personal or family history of MTC or MEN 2
Section
4 Contraindications
Source text (exact source wording)
OZEMPIC is contraindicated in patients with: • A personal or family history of MTC or in patients with MEN 2 [see Warnings and Precautions (5.1)].
People who have had a serious allergic reaction to semaglutide or to any other ingredient in the product should not use it. Serious reactions including anaphylaxis and angioedema have been reported.
Name
Serious hypersensitivity reaction
Section
4 Contraindications
Source text (exact source wording)
• 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 OZEMPIC [see Warnings and Precautions (5.8)].
Warnings and precautions
The label says it is not known whether this medicine causes thyroid C-cell tumors, including MTC, in people.
Heading
5.1 Risk of Thyroid C-Cell Tumors
Section
5.1
Source text (exact source wording)
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 clinically relevant plasma exposures [see Nonclinical Toxicology (13.1)]. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including MTC, in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.
Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.
OZEMPIC is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of OZEMPIC and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).
Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with OZEMPIC. Such monitoring may increase the risk of unnecessary procedures, due to the low-test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.
OZEMPIC is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of OZEMPIC and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).
Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with OZEMPIC. Such monitoring may increase the risk of unnecessary procedures, due to the low-test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
Acute pancreatitis, including fatal and non-fatal forms, has been observed.
Heading
5.2 Acute Pancreatitis
Section
5.2
Source text (exact source wording)
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 (6)].
After initiation of OZEMPIC, observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back), and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue OZEMPIC and initiate appropriate management.
After initiation of OZEMPIC, observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back), and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue OZEMPIC and initiate appropriate management.
In a trial, more events of diabetic retinopathy complications happened in people treated with this medicine (3.0%).
Heading
5.3 Diabetic Retinopathy Complications
Section
5.3
Source text (exact source wording)
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 OZEMPIC (3.0%) compared to placebo (1.8%). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline (OZEMPIC 8.2%, placebo 5.2%) than among patients without a known history of diabetic retinopathy (OZEMPIC 0.7%, placebo 0.4%).
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. The effect of long-term glycemic control with semaglutide on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. The effect of long-term glycemic control with semaglutide on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
Pens must never be shared between people, even if the needle is changed.
Heading
5.4 Never Share an OZEMPIC Pen Between Patients
Section
5.4
Source text (exact source wording)
OZEMPIC pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens.
People who also use insulin secretagogues or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia.
Heading
5.5 Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
Section
5.5
Source text (exact source wording)
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 Reactions (6.1), Drug Interactions (7)].
The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
There have been reports of acute kidney injury, in some cases needing hemodialysis.
Heading
5.6 Acute Kidney Injury Due to Volume Depletion
Section
5.6
Source text (exact source wording)
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 occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea [see Adverse Reactions (6.1)]. Monitor renal function in patients reporting adverse reactions to OZEMPIC that could lead to volume depletion, especially during dosage initiation and escalation of OZEMPIC.
Stomach and bowel side effects have been linked to use, and they are sometimes severe.
Heading
5.7 Severe Gastrointestinal Adverse Reactions
Section
5.7
Source text (exact source wording)
Use of OZEMPIC has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6)]. In OZEMPIC clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving OZEMPIC (0.5 mg 0.4%, 1 mg 0.8%) than placebo (0%). Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists.
OZEMPIC is not recommended in patients with severe gastroparesis.
OZEMPIC is not recommended in patients with severe gastroparesis.
Serious allergic reactions such as anaphylaxis and angioedema have been reported.
Heading
5.8 Hypersensitivity Reactions
Section
5.8
Source text (exact source wording)
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 standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous hypersensitivity to OZEMPIC [see Contraindications (4), Adverse Reactions (6.2)].
Anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to anaphylaxis with OZEMPIC.
Anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to anaphylaxis with OZEMPIC.
Acute gallbladder problems such as cholelithiasis or cholecystitis have been reported.
Heading
5.9 Acute Gallbladder Disease
Section
5.9
Source text (exact source wording)
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 reported in 1.5% and 0.4% of patients-treated with OZEMPIC 0.5 mg and 1 mg, respectively. Cholelithiasis was not reported in placebo-treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.
There have been rare reports of pulmonary aspiration in people receiving GLP-1 receptor agonists.
Heading
5.10 Pulmonary Aspiration During General Anesthesia or Deep Sedation
Section
5.10
Source text (exact source wording)
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 surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.
Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking OZEMPIC, including whether modifying preoperative fasting recommendations or temporarily discontinuing OZEMPIC could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking OZEMPIC.
Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking OZEMPIC, including whether modifying preoperative fasting recommendations or temporarily discontinuing OZEMPIC could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking OZEMPIC.
Pregnancy and breastfeeding
The label says to use it in pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no data on semaglutide in human milk or its effects on the breastfed infant. Stop it at least 2 months before a planned pregnancy.
Section
8.1, 8.2, 8.3; MedlinePlus Precautions
Source
DailyMed label; MedlinePlus
Source text (exact source wording)
DailyMed 8.1: There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see Clinical Considerations). Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. OZEMPIC should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
DailyMed 8.2: 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 was present in the milk of lactating rats, however, due to species-specific differences in lactation physiology, the clinical relevance of these data are not clear (see Data). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OZEMPIC and any potential adverse effects on the breastfed infant from OZEMPIC or from the underlying maternal condition.
DailyMed 8.3: 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 (8.1)].
MedlinePlus: tell your doctor if you are pregnant or are breastfeeding. If you become pregnant while taking semaglutide injection, call your doctor immediately.tell your doctor if you plan to become pregnant. Your doctor will tell you to stop using semaglutide injection for 2 months before a planned pregnancy.
DailyMed 8.2: 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 was present in the milk of lactating rats, however, due to species-specific differences in lactation physiology, the clinical relevance of these data are not clear (see Data). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OZEMPIC and any potential adverse effects on the breastfed infant from OZEMPIC or from the underlying maternal condition.
DailyMed 8.3: 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 (8.1)].
MedlinePlus: tell your doctor if you are pregnant or are breastfeeding. If you become pregnant while taking semaglutide injection, call your doctor immediately.tell your doctor if you plan to become pregnant. Your doctor will tell you to stop using semaglutide injection for 2 months before a planned pregnancy.
Side effects
Common
The label lists nausea, vomiting, diarrhea, abdominal pain and constipation as reactions reported in at least 5% of patients treated with Ozempic. Nausea was 15.8% with 0.5 mg and 20.3% with 1 mg, compared with 6.1% with placebo.
Section
6.1 Table 1; Highlights
Source
DailyMed label
Source text (exact source wording)
Highlights: The most common adverse reactions reported in ≥5% of patients treated with OZEMPIC are: nausea, vomiting, diarrhea, abdominal pain and constipation. (6.1)
6.1: Table 1 shows common adverse reactions, excluding hypoglycemia, associated with the use of OZEMPIC in the pool of placebo-controlled trials. These adverse reactions occurred more commonly on OZEMPIC than on placebo and occurred in at least 5% of patients treated with OZEMPIC.
Table 1. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of OZEMPIC-Treated Patients with Type 2 Diabetes Mellitus (Placebo N=262 / OZEMPIC 0.5 mg N=260 / OZEMPIC 1 mg N=261, %): Nausea 6.1 / 15.8 / 20.3; Vomiting 2.3 / 5 / 9.2; Diarrhea 1.9 / 8.5 / 8.8; Abdominal pain 4.6 / 7.3 / 5.7; Constipation 1.5 / 5 / 3.1
6.1: Table 1 shows common adverse reactions, excluding hypoglycemia, associated with the use of OZEMPIC in the pool of placebo-controlled trials. These adverse reactions occurred more commonly on OZEMPIC than on placebo and occurred in at least 5% of patients treated with OZEMPIC.
Table 1. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of OZEMPIC-Treated Patients with Type 2 Diabetes Mellitus (Placebo N=262 / OZEMPIC 0.5 mg N=260 / OZEMPIC 1 mg N=261, %): Nausea 6.1 / 15.8 / 20.3; Vomiting 2.3 / 5 / 9.2; Diarrhea 1.9 / 8.5 / 8.8; Abdominal pain 4.6 / 7.3 / 5.7; Constipation 1.5 / 5 / 3.1
Less common
Reactions below 5% include dyspepsia (1.9%, 3.5%, 2.7% for placebo, 0.5 mg, 1 mg), eructation, flatulence, gastroesophageal reflux disease and gastritis. Injection site reactions were reported in 0.2% of treated patients. Fatigue, dysgeusia and dizziness occurred at a frequency of more than 0.4%.
Section
6.1
Source
DailyMed label
Source text (exact source wording)
In addition to the reactions in Table 1, the following gastrointestinal adverse reactions with a frequency of <5% were associated with OZEMPIC (frequencies listed, respectively, as: placebo; 0.5 mg; 1 mg): dyspepsia (1.9%, 3.5%, 2.7%), eructation (0%, 2.7%, 1.1%), flatulence (0.8%, 0.4%, 1.5%), gastroesophageal reflux disease (0%, 1.9%, 1.5%), and gastritis (0.8%, 0.8%, 0.4%).
Injection Site Reactions: In placebo-controlled trials, injection site reactions (e.g., injection-site discomfort, erythema) were reported in 0.2% of OZEMPIC-treated patients.
Fatigue, Dysgeusia and Dizziness: Other adverse reactions with a frequency of >0.4% were associated with OZEMPIC include fatigue, dysgeusia and dizziness.
Injection Site Reactions: In placebo-controlled trials, injection site reactions (e.g., injection-site discomfort, erythema) were reported in 0.2% of OZEMPIC-treated patients.
Fatigue, Dysgeusia and Dizziness: Other adverse reactions with a frequency of >0.4% were associated with OZEMPIC include fatigue, dysgeusia and dizziness.
Serious
Label postmarketing and warnings
Postmarketing reports include pancreatitis (sometimes fatal), ileus, intestinal obstruction, anaphylaxis, angioedema, cholecystitis, pulmonary aspiration, acute kidney injury and alopecia. See the warnings list for other serious problems.
Section
6.2; 5
Source
DailyMed label
Source text (exact source wording)
6.2 Postmarketing Experience: The following adverse reactions have been reported during post-approval use of semaglutide, the active ingredient of OZEMPIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal: acute pancreatitis and necrotizing pancreatitis, sometimes resulting in death; ileus, intestinal obstruction, severe constipation including fecal impaction
Hypersensitivity:anaphylaxis, angioedema, rash, urticaria
Hepatobiliary:cholecystitis, cholecystectomy
Neurologic:dysesthesia, headache
Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation.
Renal: acute kidney injury
Skin and Subcutaneous Tissue:alopecia
See Warnings and Precautions 5.1-5.10 (full text above).
Gastrointestinal: acute pancreatitis and necrotizing pancreatitis, sometimes resulting in death; ileus, intestinal obstruction, severe constipation including fecal impaction
Hypersensitivity:anaphylaxis, angioedema, rash, urticaria
Hepatobiliary:cholecystitis, cholecystectomy
Neurologic:dysesthesia, headache
Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation.
Renal: acute kidney injury
Skin and Subcutaneous Tissue:alopecia
See Warnings and Precautions 5.1-5.10 (full text above).
Medlineplus
MedlinePlus says to call your doctor immediately or get emergency medical treatment for ongoing pain in the upper left or middle of the stomach that may spread to the back, rash, itching, fainting or dizziness, swelling of the eyes, face, mouth, tongue or throat, difficulty breathing or swallowing, decreased urination, swelling of legs, ankles or feet, vision changes, pain in upper stomach with yellowing of skin or eyes, fever or clay-colored stools, rapid or pounding heartbeat, or severe stomach or intestinal problems.
Source
MedlinePlus Semaglutide Injection (Last Revised - 05/15/2026)
Source text (exact source wording)
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNINGS section, call your doctor immediately or get emergency medical treatment:
ongoing pain that begins in the upper left or middle of the stomach but may spread to the back, with or without vomiting
rash; itching; fainting or dizziness; swelling of the eyes, face, mouth, tongue, or throat; or difficulty breathing or swallowing
decreased urination; or swelling of legs, ankles, or feet
vision changes
pain in upper stomach; yellowing of skin or eyes; fever; or clay-colored stools
rapid or pounding heartbeat
severe stomach or intestinal problems
ongoing pain that begins in the upper left or middle of the stomach but may spread to the back, with or without vomiting
rash; itching; fainting or dizziness; swelling of the eyes, face, mouth, tongue, or throat; or difficulty breathing or swallowing
decreased urination; or swelling of legs, ankles, or feet
vision changes
pain in upper stomach; yellowing of skin or eyes; fever; or clay-colored stools
rapid or pounding heartbeat
severe stomach or intestinal problems
Led to discontinuation
More patients on 0.5 mg (3.1%) and 1 mg (3.8%) stopped treatment because of stomach and bowel side effects than patients on placebo (0.4%).
Section
6.1
Source
DailyMed label
Source text (exact source wording)
In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving OZEMPIC than placebo (placebo 15.3%, OZEMPIC 0.5 mg 32.7%, OZEMPIC 1 mg 36.4%). The majority of reports of nausea, vomiting, and/or diarrhea occurred during dose escalation. More patients receiving OZEMPIC 0.5 mg (3.1%) and OZEMPIC 1 mg (3.8%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.4%).
Interactions
Drugs
Used with an insulin secretagogue (for example a sulfonylurea) or insulin, it may increase the risk of hypoglycemia, including severe hypoglycemia. When starting it, consider reducing the dose of those medicines.
Name
Insulin secretagogue or insulin
Section
7.1
Source text (exact source wording)
OZEMPIC stimulates insulin release in the presence of elevated blood glucose concentrations. Patients receiving OZEMPIC in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia.
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 and Precautions (5.5), Adverse Reactions (6)].
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 and Precautions (5.5), Adverse Reactions (6)].
It delays gastric emptying, which could affect absorption of oral medicines. In clinical pharmacology trials it did not affect absorption of orally administered medications to any clinically relevant degree, but caution should be used.
Name
Oral medications
Section
7.2
Source text (exact source wording)
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, semaglutide did not affect the absorption of orally administered medications to any clinically relevant degree [see Clinical Pharmacology (12.3)]. Nonetheless, caution should be exercised when oral medications are concomitantly administered with OZEMPIC.
Food and alcohol
Name
Alcohol
Section
MedlinePlus
It can be taken with or without meals.
Name
Food
Section
2
Source text (exact source wording)
Administer OZEMPIC once weekly, on the same day each week, at any time of the day, with or without meals.
Other
Never share a pen, even if the needle is changed.
Name
Pen sharing
Section
5.4
Source text (exact source wording)
OZEMPIC pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens.
Patient tips
Label patient information
Section
17
Source
DailyMed label
Medlineplus
Follow your doctor's exercise and diet advice. Store pens in the refrigerator (36°F to 46°F, 2°C to 8°C) and do not freeze. Continue even if you feel well and do not stop without talking to your doctor. Never reuse needles or share needles or pens. Inject in the upper arm, thigh or stomach area and use a different site each time. Tell your doctor or dentist about the medicine before surgery.
Source
MedlinePlus Semaglutide Injection (Last Revised - 05/15/2026), https://medlineplus.gov/druginfo/meds/a618008.html
Source text (exact source wording)
Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian.
Store semaglutide pens in the refrigerator (36°F to 46°F [2°C to 8°C]). Do not freeze.
tell your doctor if you are pregnant or are breastfeeding.
Continue to use semaglutide injection even if you feel well. Do not stop using semaglutide injection without talking to your doctor.
Never reuse needles and never share needles or pens.
Inject semaglutide in your upper arm, thigh, or stomach area. Use a different site for each injection.
If you are having surgery, including dental surgery, tell the doctor or dentist that you are using semaglutide injection.
Store semaglutide pens in the refrigerator (36°F to 46°F [2°C to 8°C]). Do not freeze.
tell your doctor if you are pregnant or are breastfeeding.
Continue to use semaglutide injection even if you feel well. Do not stop using semaglutide injection without talking to your doctor.
Never reuse needles and never share needles or pens.
Inject semaglutide in your upper arm, thigh, or stomach area. Use a different site for each injection.
If you are having surgery, including dental surgery, tell the doctor or dentist that you are using semaglutide injection.
Alternatives
Class
GLP-1 Receptor Agonist [EPC]
Class source
openFDA label API openfda.pharm_class_epc for semaglutide (api.fda.gov/drug/label.json)
Indication source
DailyMed Section 1 (type 2 diabetes mellitus)
Note
No recommendation of one drug over another.
Frequently asked questions
Question
What is Ozempic (semaglutide) used for?
Answer
It is used with diet and exercise to improve blood sugar control in adults with type 2 diabetes. It is also used to lower the risk of major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, and to lower the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.
Quote
OZEMPIC is indicated:
• 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 cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
• 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.
• 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 cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
• 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 section
1 Indications and Usage
Source
DailyMed label (Novo Nordisk, set ID adec4fd2-6858-4c99-91d4-531f5f2a2d79)
Question
Can I take it with food?
Answer
Yes. It is given once a week, on the same day each week, at any time of day, with or without meals.
Quote
Administer OZEMPIC once weekly, on the same day each week, at any time of the day, with or without meals.
Source section
2 Dosage and Administration
Source
DailyMed label (Novo Nordisk, set ID adec4fd2-6858-4c99-91d4-531f5f2a2d79)
Question
What if I miss a dose?
Answer
The label says to give the missed dose as soon as possible within 5 days after the missed dose.
Quote
If a dose is missed, administer OZEMPIC as soon as possible within 5 days after the missed dose. If more than 5 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day.
Source section
2 Dosage and Administration
Source
DailyMed label (Novo Nordisk, set ID adec4fd2-6858-4c99-91d4-531f5f2a2d79)
Question
What are the most common side effects?
Answer
The label lists nausea, vomiting, diarrhea, abdominal pain and constipation as reactions reported in at least 5% of treated patients with type 2 diabetes.
Quote
Highlights: The most common adverse reactions reported in ≥5% of patients treated with OZEMPIC are: nausea, vomiting, diarrhea, abdominal pain and constipation. (6.1)
6.1: Table 1 shows common adverse reactions, excluding hypoglycemia, associated with the use of OZEMPIC in the pool of placebo-controlled trials. These adverse reactions occurred more commonly on OZEMPIC than on placebo and occurred in at least 5% of patients treated with OZEMPIC.
Table 1. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of OZEMPIC-Treated Patients with Type 2 Diabetes Mellitus (Placebo N=262 / OZEMPIC 0.5 mg N=260 / OZEMPIC 1 mg N=261, %): Nausea 6.1 / 15.8 / 20.3; Vomiting 2.3 / 5 / 9.2; Diarrhea 1.9 / 8.5 / 8.8; Abdominal pain 4.6 / 7.3 / 5.7; Constipation 1.5 / 5 / 3.1
6.1: Table 1 shows common adverse reactions, excluding hypoglycemia, associated with the use of OZEMPIC in the pool of placebo-controlled trials. These adverse reactions occurred more commonly on OZEMPIC than on placebo and occurred in at least 5% of patients treated with OZEMPIC.
Table 1. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of OZEMPIC-Treated Patients with Type 2 Diabetes Mellitus (Placebo N=262 / OZEMPIC 0.5 mg N=260 / OZEMPIC 1 mg N=261, %): Nausea 6.1 / 15.8 / 20.3; Vomiting 2.3 / 5 / 9.2; Diarrhea 1.9 / 8.5 / 8.8; Abdominal pain 4.6 / 7.3 / 5.7; Constipation 1.5 / 5 / 3.1
Source section
6 Adverse Reactions
Source
DailyMed label (Novo Nordisk, set ID adec4fd2-6858-4c99-91d4-531f5f2a2d79)
Question
Can I use it during pregnancy or while breastfeeding?
Answer
The label says to use it in pregnancy only if the potential benefit justifies the potential risk to the fetus, and to stop it at least 2 months before a planned pregnancy. There are no data on semaglutide in human milk, its effects on the breastfed infant, or on milk production.
Quote
DailyMed 8.1: There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see Clinical Considerations). Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. OZEMPIC should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
DailyMed 8.2: 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 was present in the milk of lactating rats, however, due to species-specific differences in lactation physiology, the clinical relevance of these data are not clear (see Data). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OZEMPIC and any potential adverse effects on the breastfed infant from OZEMPIC or from the underlying maternal condition.
DailyMed 8.3: 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 (8.1)].
MedlinePlus: tell your doctor if you are pregnant or are breastfeeding. If you become pregnant while taking semaglutide injection, call your doctor immediately.tell your doctor if you plan to become pregnant. Your doctor will tell you to stop using semaglutide injection for 2 months before a planned pregnancy.
DailyMed 8.2: 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 was present in the milk of lactating rats, however, due to species-specific differences in lactation physiology, the clinical relevance of these data are not clear (see Data). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OZEMPIC and any potential adverse effects on the breastfed infant from OZEMPIC or from the underlying maternal condition.
DailyMed 8.3: 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 (8.1)].
MedlinePlus: tell your doctor if you are pregnant or are breastfeeding. If you become pregnant while taking semaglutide injection, call your doctor immediately.tell your doctor if you plan to become pregnant. Your doctor will tell you to stop using semaglutide injection for 2 months before a planned pregnancy.
Source section
8 Use in Specific Populations
Source
DailyMed label (Novo Nordisk, set ID adec4fd2-6858-4c99-91d4-531f5f2a2d79)
Question
What should I not combine with it?
Answer
Used with insulin secretagogues (such as sulfonylureas) or insulin, it may increase the risk of hypoglycemia. It delays gastric emptying, so caution should be used with oral medicines. Pens must never be shared between people.
Quote
OZEMPIC stimulates insulin release in the presence of elevated blood glucose concentrations. Patients receiving OZEMPIC in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia.
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 and Precautions (5.5), Adverse Reactions (6)].
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, semaglutide did not affect the absorption of orally administered medications to any clinically relevant degree [see Clinical Pharmacology (12.3)]. Nonetheless, caution should be exercised when oral medications are concomitantly administered with OZEMPIC.
OZEMPIC pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens.
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 and Precautions (5.5), Adverse Reactions (6)].
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, semaglutide did not affect the absorption of orally administered medications to any clinically relevant degree [see Clinical Pharmacology (12.3)]. Nonetheless, caution should be exercised when oral medications are concomitantly administered with OZEMPIC.
OZEMPIC pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens.
Source section
5 Warnings and Precautions; 7 Drug Interactions
Source
DailyMed label (Novo Nordisk, set ID adec4fd2-6858-4c99-91d4-531f5f2a2d79)
Question
Who should not use it?
Answer
People with a personal or family history of MTC, people with MEN 2, and people who have had a serious hypersensitivity reaction to semaglutide or any ingredient should not use it.
Quote
OZEMPIC is contraindicated in patients with:
• A personal or family history of MTC or in patients with MEN 2 [see Warnings and Precautions (5.1)].
• 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 OZEMPIC [see Warnings and Precautions (5.8)].
• A personal or family history of MTC or in patients with MEN 2 [see Warnings and Precautions (5.1)].
• 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 OZEMPIC [see Warnings and Precautions (5.8)].
Source section
4 Contraindications
Source
DailyMed label (Novo Nordisk, set ID adec4fd2-6858-4c99-91d4-531f5f2a2d79)
Question
How should I store the pen?
Answer
Before first use, store the pen in a refrigerator between 2°C to 8°C (36°F to 46°F) and do not freeze it. After first use, the pen can be stored for 56 days at 15°C to 30°C (59°F to 86°F) or in a refrigerator.
Quote
Prior to first use, the OZEMPIC pen should be stored in a refrigerator between 2°C to 8°C (36°F to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze OZEMPIC and do not use OZEMPIC if it has been frozen. OZEMPIC must be kept in the original carton until time of administration.
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) or in a refrigerator 2°C to 8°C (36°F to 46°F). Do not freeze. Keep the pen cap on when not in use. OZEMPIC should be protected from excessive heat and sunlight.
Single-dose prefilled syringes: Store the OZEMPIC prefilled syringe refrigerated at 2°C to 8°C (36°F to 46°F). If needed, the syringe can be kept from 8°C to 30°C (46°F to 86°F) up to 28 days. Do not freeze OZEMPIC and do not use OZEMPIC if it has been frozen. Protect OZEMPIC from light. OZEMPIC must be kept in the original carton until time of administration. Discard the OZEMPIC syringe after use.
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) or in a refrigerator 2°C to 8°C (36°F to 46°F). Do not freeze. Keep the pen cap on when not in use. OZEMPIC should be protected from excessive heat and sunlight.
Single-dose prefilled syringes: Store the OZEMPIC prefilled syringe refrigerated at 2°C to 8°C (36°F to 46°F). If needed, the syringe can be kept from 8°C to 30°C (46°F to 86°F) up to 28 days. Do not freeze OZEMPIC and do not use OZEMPIC if it has been frozen. Protect OZEMPIC from light. OZEMPIC must be kept in the original carton until time of administration. Discard the OZEMPIC syringe after use.
Source section
16.2 Recommended Storage
Source
DailyMed label (Novo Nordisk, set ID adec4fd2-6858-4c99-91d4-531f5f2a2d79)
Sources
- DailyMed Ozempic (Novo Nordisk Pharmaceutical Industries, LP)
Set id: adec4fd2-6858-4c99-91d4-531f5f2a2d79 · Label effective or revised date: Revised: 5/2026 (Highlights). Medication Guide Revised: 01/2025. Instructions for Use (pens) Revised: June/2026; prefilled syringe Approved: 05/2026 · Dailymed version date: Updated June 1, 2026 (page header); API published_date Jun 10, 2026 · Fetched at: 2026-11-02 · Sections used: Highlights incl. Boxed Warning, 1-8, 10, 12.1 (first 3 paragraphs), 16, 17 opening; Medication Guide NOT CAPTURED. Captured verbatim via get_page_text on printer-friendly page. - MedlinePlus Semaglutide Injection
Label effective or revised date: Last Revised - 05/15/2026 · Fetched at: 2026-11-02 · Sections used: all (captured verbatim via get_page_text) - openFDA drug label API (pharmacologic class)
Label effective or revised date: NOT FOUND · Fetched at: 2026-11-02 · Sections used: openfda.pharm_class_epc, pharm_class_moa, pharm_class_cs - Drugs@FDA
Label effective or revised date: NOT FOUND · Fetched at: 2026-11-02 · Sections used: not searched; NOT FOUND
Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug