This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue COZAAR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) ] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue COZAAR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2 ) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3 ) 1.1 Hypertension COZAAR ® is indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, ...
is contraindicated: In patients who are hypersensitive to any component of this product. For coadministration with aliskiren in patients with diabetes. Hypersensitivity to any component. ( 4 ) Coadministration with aliskiren in patients with diabetes. ( 4 )
Hypotension: Correct volume or salt depletion prior to administration of COZAAR. ( 5.2 ) Monitor renal function and potassium in susceptible patients. ( 5.3 , 5.4 ) 5.1 Fetal Toxicity COZAAR can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue COZAAR as soon as possible [see Use in Specific Populations (8.1) ] . 5.2 Hypotension in Volume- or Salt-Depleted Patients In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with COZAAR. Correct volume or salt depletion prior to administration of COZAAR [see Dosage and Administration (2.1) ] . 5.3 Renal Function Deterioration Changes in renal ...
Most common adverse reactions (incidence ≥2% and greater than placebo) are: dizziness, upper respiratory infection, nasal congestion, and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Hypertension COZAAR has been evaluated for safety in more than 3300 adult patients treated for essential hypertension and 4058 patients/subjects overall. Over 1200 patients were treated for over 6 months and more than 800 for over one year. Treatment with COZAAR was well-tolerated with an overall incidence of adverse events similar to that of placebo. In controlled clinical trials, discontinuation of therapy for adverse events occurred in 2.3% of patients treated with COZAAR and 3.7% of patients given placebo. In 4 clinical trials involving over 1000 patients on various doses (10-15...
Source: FDA SPL label for COZAAR (Organon LLC), effective 20260120. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 19,151 | 16,151 | 14,174 | 13,268 | 13,698 | 12,242 | 14,359 | 7,927 |
947 reports blaming this drug for every million Medicare prescriptions filled, which is 0.3× the typical drug on this site. (34,316 reports in 2024–2026, against 36,252,456 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 06/2023 | Class II | Strides Pharma Inc. | Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet. |
| 06/2022 | Class II | PD-Rx Pharmaceuticals, Inc. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| 06/2022 | Class II | PD-Rx Pharmaceuticals, Inc. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| 06/2022 | Class II | PD-Rx Pharmaceuticals, Inc. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| 05/2022 | Class II | Strides Pharma Inc. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| 05/2022 | Class II | Strides Pharma Inc. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| 05/2022 | Class II | Strides Pharma Inc. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| 04/2022 | Class II | Macleods Pharma Usa Inc | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| 04/2022 | Class II | Macleods Pharma Usa Inc | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| 04/2022 | Class II | Macleods Pharma Usa Inc | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| 03/2022 | Class II | Lupin Pharmaceuticals Inc. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
| 03/2022 | Class II | Lupin Pharmaceuticals Inc. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Losartan Potassium | 36,240,406 | $10 |
| Cozaar | 12,050 | $362 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.