Public record
Semaglutide: the public record
Each table is computed from the named federal dataset as of its data date; the method is under each one.
Label
FDA label facts for semaglutide
The FDA label read for semaglutide (OZEMPIC, application NDA213051) was last revised on 2026-01-30. It carries a boxed warning headed "WARNING: RISK OF THYROID C-CELL TUMORS". Of the 4 population sections checked, 4 are present: pregnancy, lactation, pediatric use, geriatric use.
| Measure | Value | Note |
|---|---|---|
| Label revision date | 2026-01-30 | |
| Label read | OZEMPIC | NDA213051, brand-name application |
| Boxed warning | Yes | heading as printed: "WARNING: RISK OF THYROID C-CELL TUMORS" |
| Pregnancy section | Present | |
| Lactation section | Present | |
| Pediatric use section | Present | |
| Geriatric use section | Present |
How this was calculated
Selected the most recently revised prescription label for this single ingredient from an original manufacturer, preferring a brand-name application. Checked which sections exist and quoted headings and sentences exactly as printed.
One label: the newest prescription label for single-ingredient semaglutide from an original manufacturer, not specific to Wegovy
Read from one label. Labels for other brands, strengths or forms of the same ingredient can differ. A missing section heading does not mean there is no guidance. Read the full label before relying on it.
Approvals
FDA approval history for semaglutide
The earliest FDA approval on file for a semaglutide product is 2017-12-05. Drugs@FDA lists 6 applications for it and 47 approved supplements, the most recent on 2026-08-27.
| Measure | Value | Note |
|---|---|---|
| Earliest FDA approval on file | 2017-12-05 | |
| Applications with an approval on file | 6 | |
| New drug applications (NDA) | 5 | |
| Generic applications (ANDA) | 1 | |
| Approved supplements | 47 | label, manufacturing and efficacy changes |
| Most recent supplement approval | 2026-08-27 | |
| Sponsoring companies | 3 |
How this was calculated
Selected applications with a product whose only active ingredient is this substance, then counted approved original and supplemental submissions. The earliest approved original submission is the first approval.
Applications with a single-ingredient semaglutide product in Drugs@FDA, all sponsors and strengths
Older approvals can be missing dates, and tentative approvals are not counted. An approved application does not mean the product is currently marketed.
Patents and generics
Patents and generic approvals for semaglutide
The FDA Orange Book lists 0 approved generic applications for semaglutide across 29 listed products. 30 listed patents have not yet expired, the last on 2041-02-17.
| Measure | Value | Note |
|---|---|---|
| Brand-name applications (NDA) | 4 | |
| Approved generic applications (ANDA) | 0 | |
| Listed patents not yet expired | 30 | |
| Latest listed patent expiry | 2041-02-17 | |
| Latest listed exclusivity expiry | 2029-03-19 | exclusivity code NS |
| Earliest approval date on file | 2017-12-05 | |
| Products not marked discontinued | 28 of 29 |
How this was calculated
Selected Orange Book products whose only active ingredient is this substance, then counted applications by type and the distinct patents and exclusivities listed against them. Expired patents are left out.
All single-ingredient semaglutide products in the Orange Book, every brand and strength, files dated 2026-10-09
An approved generic or an expired patent does not show that a generic is on sale. Launch timing also depends on litigation, settlements and supply. Biologics and compounded products are not in the Orange Book.
Medicare Part D
Medicare Part D claims for semaglutide by age group
Of 11,876,226 Medicare Part D claims for semaglutide in 2024, 9,247,488 (77.9%) were for enrollees aged 65 and over and 2,628,738 were for enrollees under 65.
| Measure | Value | Note |
|---|---|---|
| All Part D claims, 2024 | 11,876,226 | |
| Claims for enrollees aged 65 and over | 9,247,488 | |
| Claims for enrollees under 65 | 2,628,738 | mostly people who qualify through disability |
| Share of claims for enrollees aged 65 and over | 77.9% | share of claims, not of patients |
How this was calculated
Summed the national rows for every brand and generic row with this generic name. Claims under 65 are total claims minus claims for enrollees 65 and over.
National Part D claims for single-ingredient semaglutide products, 2024, split at age 65
Medicare mostly covers people 65 and over, so this split describes Medicare enrollees and not use in the general population.
Medicare Part D
Medicare Part D claims for semaglutide by state
California had the most Medicare Part D claims for semaglutide in 2024 (1,176,301), followed by Texas (1,023,411) and New York (837,399). Prescribers in 59 states and territories wrote 11,876,178 claims in all.
| Measure | Value | Note |
|---|---|---|
| All states and territories, 2024 | 11,876,178 claims | |
| States and territories with reported claims | 59 | |
| California | 1,176,301 claims | $1.36B gross drug cost |
| Texas | 1,023,411 claims | $1.35B gross drug cost |
| New York | 837,399 claims | $1.10B gross drug cost |
| Florida | 815,754 claims | $1.06B gross drug cost |
| Pennsylvania | 538,950 claims | $674.4M gross drug cost |
How this was calculated
Summed claims and drug cost by prescriber state over every brand and generic row with this generic name. Combination products excluded. Rows CMS suppressed for small counts are left out.
Part D claims for single-ingredient semaglutide products by the prescriber's state, 2024; all brands, not only Ozempic
State counts follow population size and where the prescriber practises. They are not per-person rates and do not show any state's coverage rules.
Medicare Part D
Medicare Part D spending on semaglutide
Medicare Part D spending on semaglutide products was $15.16B in 2024 across 11,880,490 claims, compared with $10.86B in 2023 (+39.6%). Average spending per claim was $1,276, before rebates.
| Measure | Value | Note |
|---|---|---|
| Total spending, 2024 | $15.16B | |
| Total spending, 2023 | $10.86B | |
| Change in spending, 2023 to 2024 | +39.6% | |
| Claims (prescription fills), 2024 | 11,880,490 | |
| Average spending per claim, 2024 | $1,276 | |
| Ozempic: spending, 2024 | $12.97B | 10,417,182 claims |
| Rybelsus: spending, 2024 | $1.89B | 1,251,733 claims |
| Wegovy: spending, 2024 | $301.3M | 211,575 claims |
How this was calculated
Summed total spending and claims over every brand and generic row with this generic name in the CMS file, using the Overall manufacturer rows. Combination products excluded. Average per claim is spending divided by claims.
Every single-ingredient semaglutide product in Part D (Ozempic, Rybelsus, Wegovy), 2024. Not limited to Wegovy.
Gross drug cost before manufacturer rebates, so net cost is lower. Part D excludes some uses by law (for example erectile dysfunction, weight loss and hair growth), so claims reflect covered uses only. Compounded products are not included.
Medicaid
Medicaid prescriptions for semaglutide by state
State Medicaid programmes paid for 5,889,063 semaglutide prescriptions in 2025, with $6.61B reimbursed before rebates. California reported the most (2,000,880), followed by New York (488,820) and Pennsylvania (485,053); 52 states and territories reported any.
| Measure | Value | Note |
|---|---|---|
| Prescriptions paid by Medicaid, 2025 | 5,889,063 | |
| Total reimbursed before rebates, 2025 | $6.61B | |
| States and territories reporting | 52 | with at least one count CMS did not suppress |
| California | 2,000,880 prescriptions | $2.33B reimbursed |
| New York | 488,820 prescriptions | $579.2M reimbursed |
| Pennsylvania | 485,053 prescriptions | $573.2M reimbursed |
| North Carolina | 363,890 prescriptions | $454.8M reimbursed |
| Michigan | 284,140 prescriptions | $344.0M reimbursed |
How this was calculated
Matched each Medicaid product code to the FDA NDC Directory by labeler and product code, kept finished single-ingredient products, then summed prescriptions and reimbursement by state. National roll-up and suppressed rows dropped.
All single-ingredient semaglutide products in the FDA NDC Directory, fee-for-service and managed care, 2025
Counts under 11 are suppressed by CMS and left out, so totals are a floor. Amounts are before rebates. Differences between states reflect programme size and coverage rules. Compounded products are not included.
Pharmacy cost
Pharmacy acquisition cost (NADAC) for semaglutide
Retail pharmacies paid an average of $332.02 per mL for OZEMPIC 0.25-0.5 MG/DOSE (2 MG/3 ML) PEN as of 2026-11-11, compared with $322.33 twelve months earlier (+3.0%). This is a pharmacy purchase cost, not a patient price.
| Measure | Value | Note |
|---|---|---|
| OZEMPIC 0.25-0.5 MG/DOSE (2 MG/3 ML) PEN | $332.02 per mL | 12 months earlier $322.33 (+3.0%) |
| OZEMPIC 1 MG/DOSE (4 MG/3 ML) PEN | $331.94 per mL | 12 months earlier $322.31 (+3.0%) |
| OZEMPIC 2 MG/DOSE (8 MG/3 ML) PEN | $332.00 per mL | 12 months earlier $322.25 (+3.0%) |
| OZEMPIC 1.5 MG TABLET | $33.15 per unit | no price on file 12 months earlier |
| OZEMPIC 4 MG TABLET | $33.19 per unit | no price on file 12 months earlier |
| OZEMPIC 9 MG TABLET | $33.19 per unit | no price on file 12 months earlier |
How this was calculated
Matched NADAC product codes to the FDA NDC Directory, kept finished single-ingredient products, and listed the product descriptions with the most package codes. The earlier price is the same package code in the file one year before.
Brand-name product of semaglutide in the weekly NADAC file of 2026-11-11, compared with the file of 2025-11-12
NADAC is the average invoice price retail pharmacies pay, from a voluntary survey. It leaves out rebates, dispensing fees and markups, and it is not what a patient or insurer pays. Compounded products are not surveyed.
Adverse event reports
FDA adverse event reports naming burping and semaglutide
Through 2026-10-28, FDA had received 1,524 adverse event reports for semaglutide that name burping (eructation), out of 111,027 reports for the drug in all. 894 of these reports concerned female patients and 531 male patients.
| Measure | Value | Note |
|---|---|---|
| Reports naming burping (eructation) | 1,524 | |
| All reports for semaglutide | 111,027 | |
| Share of this drug's reports naming it | 1.4% | share of reports received, not of people taking the drug |
| Of those: female patients | 894 | reflects who takes the drug and who files reports |
| Of those: male patients | 531 | |
| Of those: sex not recorded | 99 |
How this was calculated
Counted FAERS reports listing this active substance and at least one of these reaction terms: eructation. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.
Reports where FDA recorded semaglutide as a single-ingredient active substance (any brand, not only Ozempic), MedDRA term eructation
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Adverse event reports
FDA adverse event reports naming constipation and semaglutide
Through 2026-10-28, FDA had received 6,473 adverse event reports for semaglutide that name constipation, out of 111,027 reports for the drug in all. 4,213 of these reports concerned female patients and 1,771 male patients.
| Measure | Value | Note |
|---|---|---|
| Reports naming constipation | 6,473 | |
| All reports for semaglutide | 111,027 | |
| Share of this drug's reports naming it | 5.8% | share of reports received, not of people taking the drug |
| Of those: female patients | 4,213 | reflects who takes the drug and who files reports |
| Of those: male patients | 1,771 | |
| Of those: sex not recorded | 489 |
How this was calculated
Counted FAERS reports listing this active substance and at least one of these reaction terms: constipation. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.
Reports where FDA recorded semaglutide as a single-ingredient active substance (any brand, not only Wegovy), MedDRA term constipation
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Adverse event reports
FDA adverse event reports naming diarrhoea and semaglutide
Through 2026-10-28, FDA had received 8,785 adverse event reports for semaglutide that name diarrhoea, out of 111,027 reports for the drug in all. 5,159 of these reports concerned female patients and 2,917 male patients.
| Measure | Value | Note |
|---|---|---|
| Reports naming diarrhoea | 8,785 | |
| All reports for semaglutide | 111,027 | |
| Share of this drug's reports naming it | 7.9% | share of reports received, not of people taking the drug |
| Of those: female patients | 5,159 | reflects who takes the drug and who files reports |
| Of those: male patients | 2,917 | |
| Of those: sex not recorded | 709 |
How this was calculated
Counted FAERS reports listing this active substance and at least one of these reaction terms: diarrhoea. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.
Reports where FDA recorded semaglutide as a single-ingredient active substance (any brand, not only Ozempic), MedDRA term diarrhoea
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Adverse event reports
FDA adverse event reports naming gallstones or gallbladder inflammation and semaglutide
Through 2026-10-28, FDA had received 1,382 adverse event reports for semaglutide that name gallstones or gallbladder inflammation, out of 111,027 reports for the drug in all. 852 of these reports concerned female patients and 417 male patients.
| Measure | Value | Note |
|---|---|---|
| Reports naming gallstones or gallbladder inflammation | 1,382 | |
| All reports for semaglutide | 111,027 | |
| Share of this drug's reports naming it | 1.2% | share of reports received, not of people taking the drug |
| Of those: female patients | 852 | reflects who takes the drug and who files reports |
| Of those: male patients | 417 | |
| Of those: sex not recorded | 113 |
How this was calculated
Counted FAERS reports listing this active substance and at least one of these reaction terms: cholelithiasis, cholecystitis, cholecystitis acute. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.
Reports with semaglutide as a single-ingredient active substance (any brand), 3 MedDRA terms for gallstones or gallbladder inflammation
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Adverse event reports
FDA adverse event reports naming injection site reactions and semaglutide
Through 2026-10-28, FDA had received 2,506 adverse event reports for semaglutide that name injection site reactions, out of 111,027 reports for the drug in all. 1,811 of these reports concerned female patients and 525 male patients.
| Measure | Value | Note |
|---|---|---|
| Reports naming injection site reactions | 2,506 | |
| All reports for semaglutide | 111,027 | |
| Share of this drug's reports naming it | 2.3% | share of reports received, not of people taking the drug |
| Of those: female patients | 1,811 | reflects who takes the drug and who files reports |
| Of those: male patients | 525 | |
| Of those: sex not recorded | 170 |
How this was calculated
Counted FAERS reports listing this active substance and at least one of these reaction terms: injection site reaction, injection site pain, injection site erythema, injection site swelling, injection site pruritus. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.
Reports with semaglutide as a single-ingredient active substance (any brand), 5 MedDRA terms for injection site reactions
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Adverse event reports
FDA adverse event reports naming low blood sugar and semaglutide
Through 2026-10-28, FDA had received 785 adverse event reports for semaglutide that name low blood sugar (hypoglycaemia), out of 111,027 reports for the drug in all. 492 of these reports concerned female patients and 214 male patients.
| Measure | Value | Note |
|---|---|---|
| Reports naming low blood sugar (hypoglycaemia) | 785 | |
| All reports for semaglutide | 111,027 | |
| Share of this drug's reports naming it | 0.7% | share of reports received, not of people taking the drug |
| Of those: female patients | 492 | reflects who takes the drug and who files reports |
| Of those: male patients | 214 | |
| Of those: sex not recorded | 79 |
How this was calculated
Counted FAERS reports listing this active substance and at least one of these reaction terms: hypoglycaemia. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.
Reports where FDA recorded semaglutide as a single-ingredient active substance (any brand, not only Ozempic), MedDRA term hypoglycaemia
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Adverse event reports
FDA adverse event reports naming nausea and semaglutide
Through 2026-10-28, FDA had received 15,568 adverse event reports for semaglutide that name nausea, out of 111,027 reports for the drug in all. 10,572 of these reports concerned female patients and 3,718 male patients.
| Measure | Value | Note |
|---|---|---|
| Reports naming nausea | 15,568 | |
| All reports for semaglutide | 111,027 | |
| Share of this drug's reports naming it | 14.0% | share of reports received, not of people taking the drug |
| Of those: female patients | 10,572 | reflects who takes the drug and who files reports |
| Of those: male patients | 3,718 | |
| Of those: sex not recorded | 1,278 |
How this was calculated
Counted FAERS reports listing this active substance and at least one of these reaction terms: nausea. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.
Reports where FDA recorded semaglutide as a single-ingredient active substance (any brand, not only Ozempic), MedDRA term nausea
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Adverse event reports
FDA adverse event reports naming pancreatitis and semaglutide
Through 2026-10-28, FDA had received 2,201 adverse event reports for semaglutide that name pancreatitis, out of 111,027 reports for the drug in all. 1,147 of these reports concerned female patients and 872 male patients.
| Measure | Value | Note |
|---|---|---|
| Reports naming pancreatitis | 2,201 | |
| All reports for semaglutide | 111,027 | |
| Share of this drug's reports naming it | 2.0% | share of reports received, not of people taking the drug |
| Of those: female patients | 1,147 | reflects who takes the drug and who files reports |
| Of those: male patients | 872 | |
| Of those: sex not recorded | 182 |
How this was calculated
Counted FAERS reports listing this active substance and at least one of these reaction terms: pancreatitis, pancreatitis acute. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.
Reports where FDA recorded semaglutide as a single-ingredient active substance (any brand, not only Ozempic), MedDRA terms pancreatitis, pancreatitis acute
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Adverse event reports
FDA adverse event reports naming vomiting and semaglutide
Through 2026-10-28, FDA had received 10,351 adverse event reports for semaglutide that name vomiting, out of 111,027 reports for the drug in all. 6,763 of these reports concerned female patients and 2,755 male patients.
| Measure | Value | Note |
|---|---|---|
| Reports naming vomiting | 10,351 | |
| All reports for semaglutide | 111,027 | |
| Share of this drug's reports naming it | 9.3% | share of reports received, not of people taking the drug |
| Of those: female patients | 6,763 | reflects who takes the drug and who files reports |
| Of those: male patients | 2,755 | |
| Of those: sex not recorded | 833 |
How this was calculated
Counted FAERS reports listing this active substance and at least one of these reaction terms: vomiting. A report can name several reactions and several drugs. Counts by year use the date FDA received the report.
Reports where FDA recorded semaglutide as a single-ingredient active substance (any brand, not only Wegovy), MedDRA term vomiting
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Adverse event reports
Most reported events in FDA adverse event reports for semaglutide
Through 2026-10-28, FDA had received 111,027 adverse event reports for semaglutide, 55,901 of them marked serious by the reporter. The symptom terms named most often were nausea (15,568), vomiting (10,351) and diarrhoea (8,785).
| Measure | Value | Note |
|---|---|---|
| All reports received | 111,027 | |
| Reports the reporter marked serious | 55,901 | death, hospitalisation, disability or similar outcome |
| Nausea | 15,568 reports | |
| Vomiting | 10,351 reports | |
| Diarrhoea | 8,785 reports | |
| Constipation | 6,473 reports | |
| Decreased appetite | 6,098 reports |
How this was calculated
Counted FAERS reports listing this active substance, then the reaction terms named most often. A report can name several reactions, and a term can describe the illness being treated and not an effect of the drug. Terms about product use or complaints rather than symptoms (for example off label use) were left out of the list.
Reports where FDA recorded semaglutide as a single-ingredient active substance (any brand), all years to 2026-10-28
FAERS reports are unverified and do not prove the drug caused the event. Reporting rises with use, publicity and lawsuits, so these counts cannot give rates or risks and cannot be compared between drugs.
Recalls
FDA drug recalls naming semaglutide
FDA enforcement reports list 57 drug recall entries naming semaglutide from 2021 to 2026-10-14. 56 of them are for compounded or other unlisted products and 1 for products FDA lists under a label. The most common stated reason was lack of sterility assurance (30 of 57).
| Measure | Value | Note |
|---|---|---|
| Recall entries on record | 57 | |
| For products FDA lists under an approved or registered label | 1 | |
| For compounded or other unlisted products | 56 | matched by the name in the product description |
| Class I (most serious) | 0 | |
| Class II | 57 | |
| Class III | 0 | |
| Most recent recall reported | 2026-10-14 | |
| Most common stated reason | lack of sterility assurance | 30 of 57 entries |
How this was calculated
Counted enforcement report entries matched by FDA's listed active substance, or by the name in the product description where FDA lists none. Reasons were grouped by keywords in FDA's stated reason.
Recalls of single-ingredient semaglutide products, plus compounded or unlisted products whose description names it
Each recall covers specific lots from one firm and is not a statement about every product with this ingredient. One event can appear as several entries, one per product.
Clinical studies
Registered clinical studies of semaglutide
ClinicalTrials.gov lists 802 registered studies that name semaglutide as an intervention as of 2026-11-11. Of these, 179 are recruiting, 356 are completed and 186 are phase 3 studies.
| Measure | Value |
|---|---|
| Registered studies | 802 |
| Recruiting now | 179 |
| Not yet recruiting | 107 |
| Completed | 356 |
| Terminated, withdrawn or suspended | 25 |
| Phase 3 (including phase 2/3) | 186 |
| Phase 2 (including phase 1/2) | 139 |
| Phase 1 | 125 |
How this was calculated
Searched the ClinicalTrials.gov intervention field for the name, downloaded every matching record and counted by overall status and phase. Combined phases are counted under the higher phase. Phase not applicable covers observational, device and behavioural studies.
Studies whose intervention field matches semaglutide, any condition, any country, all statuses
A registered study is not a result. Counts include studies where the drug is a comparator or background treatment, and studies that never finished or reported.
Articles on Semaglutide
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