GLP-1 Receptor Agonist · Brand: Ozempic, Rybelsus + 2 more

Semaglutide Side Effects: Common, Serious & FDA Warnings

Creator: MedivaScan
Published: 2026-05-28T04:28:23.927087+00:00

Verified from FDA on May 28, 2026Refreshes every 6 hoursFDA-Sourced

FDA-Approved For

Quick answer

Based on 82,000+ FDA adverse event reports, the most-reported semaglutide reactions include nausea, vomiting, and diarrhoea. FDA reports 3 active Class II recalls of semaglutide, primarily for failed dissolution specifications. The FDA-approved label carries a boxed warning.

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.

FDA Boxed 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 RYBELSUS and OZEMPIC tablets cause 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 )] . • RYBELSUS and OZEMPIC tablets are 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 RYBELSUS or OZEMPIC tablets 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 RYBELSUS or OZEMPIC tablets [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 RYBELSUS and OZEMPIC tablets cause 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 ). • RYBELSUS and OZEMPIC tablets are 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 ).

Common Side Effects of Semaglutide

The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for semaglutide. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.

Reaction	Reports	% of total
Nausea	12,084	14.6%
Vomiting	7,988	9.6%
Diarrhoea	6,943	8.4%
Constipation	4,952	6.0%
Decreased Appetite	4,963	6.0%
Weight Decreased	4,353	5.3%
Fatigue	3,745	4.5%
Headache	3,568	4.3%
Abdominal Pain Upper	3,169	3.8%
Blood Glucose Increased	3,156	3.8%

Source: FDA FAERS·Updated May 28, 2026·n=82,911+·verify on FDA →·Methodology

Serious Outcomes and FDA Warnings

FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.

Outcome flag	Reports	% of total
Serious reports (any flag)	—	—
Hospitalization	—	—

From the FDA-approved label, Section 5.1: Risk of Thyroid C-Cell

Tumors 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 RYBELSUS and OZEMPIC tablets cause 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.
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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. RYBELSUS and OZEMPIC tablets are 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 RYBELSUS or OZEMPIC tablets 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 RYBELSUS or OZEMPIC tablets. 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.

From the FDA-approved label, Section 5.4: Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin Patients receiving RYBELSUS

or OZEMPIC tablets 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 dosage 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.

Source: DailyMed (semaglutide label)·Updated May 28, 2026

Semaglutide Recalls

FDA enforcement actions matched to semaglutide via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.

Date	Reason	Class	Quantity	Status
2026-01-07	Presence of Particulate Matter: Hair was found in a prefilled syringe Novo Nordisk Inc.	Class II	N/A	Ongoing
2026-01-07	Presence of Particulate Matter: Hair was found in a prefilled syringe Novo Nordisk Inc.	Class II	N/A	Ongoing
2025-05-07	Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released. Cardinal Health Inc.	Class II	48 Cartons	Ongoing

Source: FDA Drug Enforcement Reports·Updated May 28, 2026·Refreshes every 6 hours·verify on FDA →

Show 2 closed recalls (2021 to 2021)

Includes resolved and terminated recalls matched to semaglutide. Most recent first.

Date	Reason	Class	Quantity	Status
2021-06-02	CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc.	Class II	1189 cartons	Terminated
2021-04-21	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors. Novo Nordisk Inc	Class II	N/A	Terminated

Semaglutide Shortages

FDA-listed shortages of semaglutide products. Strength and dosage-form level detail.

No active or recent shortages of semaglutide are listed. We refresh this view daily.

Source: FDA Drug Shortages·Updated May 28, 2026

Is Semaglutide Safe?

Semaglutide is FDA-approved. The label's Warnings and Precautions section covers risk of thyroid c-cell (Section 5.1), acute pancreatitis (Section 5.2), diabetic retinopathy (Section 5.3), hypoglycemia with concomitant use of insulin secretagogues or insulin patients receiving rybelsus (Section 5.4), acute kidney injury due to volume depletion (Section 5.5), severe gastrointestinal adverse reactions (Section 5.6), hypersensitivity reactions (Section 5.7), acute gallbladder disease (Section 5.8), pulmonary aspiration during general anesthesia or deep sedation rybelsus and (Section 5.9).

As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.

Source: DailyMed (semaglutide label)·Updated May 28, 2026

FDA-Approved Indications

Semaglutide is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.

RYBELSUS and OZEMPIC tablets are 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 (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. RYBELSUS and OZEMPIC tablets are glucagon-like peptide-1 (GLP-1) receptor agonists indicated: • as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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( 1 ) • 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 who are at high risk for these events. ( 1 )

Source: DailyMed (semaglutide label)·Updated May 28, 2026·Section 1 (Indications and Usage)

Frequently Asked Questions

What are the most-reported side effects of semaglutide?

Nausea, vomiting, and diarrhoea are among the most-reported reactions in FDA FAERS data for semaglutide. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.

Is semaglutide the same as Ozempic?

Semaglutide is the generic name; Ozempic is a brand name for the same active ingredient. Other brand names include Rybelsus, Wegovy, and Wegovy Hd. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.

Has semaglutide been recalled?

Yes. Semaglutide has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by contamination or foreign material, mislabeling, and CGMP deviations. See the recalls table on this page for current counts, firm names, dates, and lot quantities.

What are semaglutide's current ongoing recalls about?

Active semaglutide recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reasons across these recalls are contamination or foreign material and mislabeling. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.

What do FDA recall classes mean?

Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.

Does semaglutide have an FDA boxed warning?

Yes. The FDA-approved label for semaglutide carries a boxed warning. Boxed warnings are the FDA's strongest cautions. See the "FDA Boxed Warning" section above for the verbatim warning text.

Data Sources & Methodology

How each section of this page is sourced, and how often the data is refreshed.

Source	Endpoint	Refresh
FAERS reactions	openFDA `/drug/event.json` count API. Aggregated per drug per reaction term; we do not store individual reports.	Daily
Recalls	openFDA `/drug/enforcement.json`. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here.	6 hours
Shortages	FDA Drug Shortages list.	Daily
Boxed warnings & label sections	openFDA `/drug/label.json`. Labels are stable; monthly cadence is sufficient.	Monthly
Condition categories	Synonym-mapped from drug_labels.indications. Methodology at /methodology/.	Per-drug

What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.