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MediZYour medication guide

From the FDA-approved label

Ozempic

semaglutide · 1.34 mg/1 mL injection, solution · subcutaneous

Will be updated when more information is available.

Strength
1.34 mg/1 mL
Form
injection, solution
Route
subcutaneous
FDA application
NDA209637

What this page covers

This page is about semaglutide 1.34 mg/1 mL injection, solution. The same FDA label also covers 7 other products at different strengths or in different forms. Those are taken differently. Do not use this page for them.

Patient summaries are still being prepared. Available source text is in the label’s own words. This page does not show doses. Follow your prescription and ask your pharmacist or prescriber about dosing.

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FDA Boxed Warning

FDA Boxed Warning: important safety information

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 )] . WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 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). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 ).

More detail

Will be updated when more information is available.

Sources (1)
  • BOXED WARNINGBoxed Warning
    “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 )] . WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 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). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors ( 4 , 5.1 ).”

    From the FDA-approved label for Ozempic, version 20, effective 2026-06-01. Read this section on DailyMed

What is this medication?

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Sources

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    What is it approved to treat?

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      Important limitations: what it does not do

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        Common side effects

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          Serious risks to understand

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            Who should not take it, and drug interactions

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              Pregnancy, children, and older adults

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                How it is taken (as described in the label)

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                  Reporting a side effect

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                    Where this comes from

                    Product
                    Ozempic · SEMAGLUTIDE 1.34 mg/mL · INJECTION, SOLUTION
                    NDC
                    0169-4130
                    Labeler
                    Novo Nordisk Pharmaceutical Industries, LP
                    Document
                    SPL set adec4fd2… version 20
                    Label effective
                    2026-06-01
                    Published (DailyMed)
                    Jun 10, 2026
                    Retrieved on
                    Sun, 20 Sep 2026 05:15:54 GMT
                    Clinically reviewed
                    No clinical review has been performed. “Retrieved” means downloaded from a public FDA source. It does not mean a clinician checked it.
                    Source APIs (3)
                    • openFDA Drug Label API

                      U.S. Food & Drug Administration

                      Source last updated: 2026-09-18

                    • openFDA NDC Directory API

                      U.S. Food & Drug Administration

                      Source last updated: 2026-09-18

                    • DailyMed SPL Service v2

                      U.S. National Library of Medicine

                      Source last updated: Sep 18, 2026 08:28:07PM EST

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