Public record
Losartan: 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 losartan
The FDA label read for losartan (COZAAR, application NDA020386) was last revised on 2026-01-20. It carries a boxed warning headed "WARNING: FETAL TOXICITY". Of the 4 population sections checked, 4 are present: pregnancy, lactation, pediatric use, geriatric use.
| Measure | Value | Note |
|---|---|---|
| Label revision date | 2026-01-20 | |
| Label read | COZAAR | NDA020386, brand-name application |
| Boxed warning | Yes | heading as printed: "WARNING: FETAL TOXICITY" |
| 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 losartan from an original manufacturer
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 losartan
The earliest FDA approval on file for a losartan product is 1995-04-14. Drugs@FDA lists 27 applications for it and 213 approved supplements, the most recent on 2026-09-25.
| Measure | Value | Note |
|---|---|---|
| Earliest FDA approval on file | 1995-04-14 | |
| Applications with an approval on file | 27 | |
| New drug applications (NDA) | 2 | |
| Generic applications (ANDA) | 25 | |
| Approved supplements | 213 | label, manufacturing and efficacy changes |
| Most recent supplement approval | 2026-09-25 | |
| Sponsoring companies | 27 |
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 losartan 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 losartan
The FDA Orange Book lists 25 approved generic applications for losartan, the first approved on 2010-04-06. 3 listed patents on specific brand products have not yet expired, the last on 2041-10-07; generics of other versions are already approved.
| Measure | Value | Note |
|---|---|---|
| Brand-name applications (NDA) | 2 | |
| Approved generic applications (ANDA) | 25 | first approved 2010-04-06 |
| Companies with a generic not marked discontinued | 16 | |
| Listed patents not yet expired | 3 | |
| Latest listed patent expiry | 2041-10-07 | on any product; may cover only one brand formulation |
| Earliest approval date on file | 1995-04-14 | |
| Products not marked discontinued | 52 of 79 |
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 losartan 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 spending on losartan
Medicare Part D spending on losartan products was $359.5M in 2024 across 36,252,456 claims, compared with $491.9M in 2023 (-26.9%). Average spending per claim was $9.92, before rebates.
| Measure | Value | Note |
|---|---|---|
| Total spending, 2024 | $359.5M | |
| Total spending, 2023 | $491.9M | |
| Change in spending, 2023 to 2024 | -26.9% | |
| Claims (prescription fills), 2024 | 36,252,456 | |
| Average spending per claim, 2024 | $9.92 | |
| Losartan Potassium: spending, 2024 | $355.2M | 36,240,406 claims |
| Cozaar: spending, 2024 | $4.4M | 12,050 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 losartan product in Part D (Losartan Potassium, Cozaar), 2024.
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.
Adverse event reports
Most reported events in FDA adverse event reports for losartan
Through 2026-10-28, FDA had received 181,632 adverse event reports for losartan, 113,112 of them marked serious by the reporter. The symptom terms named most often were fatigue (13,097), diarrhoea (11,049) and nausea (10,014).
| Measure | Value | Note |
|---|---|---|
| All reports received | 181,632 | |
| Reports the reporter marked serious | 113,112 | death, hospitalisation, disability or similar outcome |
| Fatigue | 13,097 reports | |
| Diarrhoea | 11,049 reports | |
| Nausea | 10,014 reports | |
| Dyspnoea | 9,050 reports | |
| Headache | 8,738 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 drug ineffective) were left out of the list.
Reports where FDA recorded losartan 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 losartan
FDA enforcement reports list 101 drug recall entries naming losartan from 2014 to 2023-07-12. 85 of them are for compounded or other unlisted products and 16 for products FDA lists under a label. The most common stated reason was impurities or nitrosamines (84 of 101).
| Measure | Value | Note |
|---|---|---|
| Recall entries on record | 101 | |
| For products FDA lists under an approved or registered label | 16 | |
| For compounded or other unlisted products | 85 | matched by the name in the product description |
| Class I (most serious) | 0 | |
| Class II | 101 | |
| Class III | 0 | |
| Most recent recall reported | 2023-07-12 | |
| Most common stated reason | impurities or nitrosamines | 84 of 101 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 losartan 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 losartan
ClinicalTrials.gov lists 456 registered studies that name losartan as an intervention as of 2026-11-11. Of these, 28 are recruiting, 273 are completed and 93 are phase 3 studies.
| Measure | Value |
|---|---|
| Registered studies | 456 |
| Recruiting now | 28 |
| Not yet recruiting | 10 |
| Completed | 273 |
| Terminated, withdrawn or suspended | 57 |
| Phase 3 (including phase 2/3) | 93 |
| Phase 2 (including phase 1/2) | 78 |
| Phase 1 | 76 |
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 losartan, 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 Losartan
- Losartan Dosage for Adults - Starting Dose and Titration
- Stopping Losartan: Check Which Treatment Goal Needs Replacing
- What to Do When You Miss a Dose of Losartan
- Losartan Monitoring for Older Adults (50 to 64): Labs, Schedule, and Clinical Checkpoints
- Losartan Safety Signals and FDA Actions: What Prescribers and Patients Should Know
- Losartan Monitoring for Young Adults (18 to 29): Lab Schedules, Safety Checks, and What Your Doctor Should Track