Prescription medication · Angiotensin II Receptor Blocker (ARB)
losartan
Also sold as Cozaar. Losartan is used to treat high blood pressure in adults and children over 6 years old.
Data updated 2026-05-15
- 165,585
- FDA reportsHeavily reported
- 10
- InteractionsSeveral interactions
- 99% less
- Generic vs brandHuge savings
- 19
- Recall records
What the data shows
losartan (Cozaar) is a prescription Angiotensin II Receptor Blocker (ARB), more reported than roughly 9 in 10 tracked drugs (165,585 FDA reports), whose generic costs a fraction of the brand (about 99% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
losartan (Cozaar) is a prescription Angiotensin II Receptor Blocker (ARB). Losartan is used to treat high blood pressure in adults and children over 6 years old.
Losartan is a medicine that lowers blood pressure. It can also help prevent strokes in some people with high blood pressure and an enlarged heart.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$5.59/unit
Generic Price
$0.05/unit
Generic Savings
99%
Generic Available
Yes (24 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: LOSARTAN POTASSIUM 100 MG TAB
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -13.2% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| February 21, 2024 | $0.0556/EA | - | 3 |
| December 18, 2024 | $0.0483/EA | -13.2% | 42 |
What it does
Losartan is used to treat high blood pressure in adults and children over 6 years old.
Common side effects
Dizziness, Upper respiratory infection, Nasal congestion
Key warnings
Losartan can harm your unborn baby, even causing death.
The sections below are summarized in plain English from losartan's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Losartan blocks a substance in your body that tightens blood vessels. This helps blood vessels relax, which lowers blood pressure. It also helps the kidneys work better in people with diabetes.
Side Effects (from patient reports)
Based on 165,585 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for losartan, by number of reports
- Fatigue
Fatigue
11,852 reports
- Diarrhoea
Diarrhoea
9,870 reports
- Nausea
Nausea
9,207 reports
- Dyspnoea
Dyspnoea
8,439 reports
- Dizziness
Dizziness
7,999 reports
- Headache
Headache
7,815 reports
- Pain
Pain
7,325 reports
- Arthralgia
Arthralgia
6,302 reports
- Malaise
Malaise
5,919 reports
- Asthenia
Asthenia
5,867 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for losartan each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where losartan sits
losartan has more FDA adverse-event reports than 92% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is losartan; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 165,585 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2001–2025.
Total Reports
165,585
Reports Mentioning Death
12,034
7.3% of reports — not proof of cause
Hospitalization Reports
48,929
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 11,852 |
| 2 | DIARRHOEA | 9,870 |
| 3 | NAUSEA | 9,207 |
| 5 | DYSPNOEA | 8,439 |
| 6 | DIZZINESS | 7,999 |
| 7 | HEADACHE | 7,815 |
| 8 | PAIN | 7,325 |
| 10 | ARTHRALGIA | 6,302 |
| 11 | MALAISE | 5,919 |
| 12 | ASTHENIA | 5,867 |
| 13 | COUGH | 5,353 |
| 14 | FALL | 5,234 |
| 15 | VOMITING | 5,173 |
| 16 | PRURITUS | 4,829 |
| 17 | PAIN IN EXTREMITY | 4,738 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Losartan can harm your unborn baby, even causing death. If you are pregnant or plan to become pregnant, tell your doctor right away. Stop taking losartan as soon as you know you are pregnant.
Known Drug Interactions
7.4 Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Do not coadminister aliskiren with losartan potassium in patients with diabetes. Avoid use of aliskiren with losartan potassium in patients with renal impairment (GFR <60 mL/min).
Mechanism: Taking these two drugs together can over-block the system that controls blood pressure, potentially causing fainting or kidney failure.
(7.1) • Lithium: Risk of lithium toxicity. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use.
Mechanism: Losartan can make it harder for your body to get rid of lithium. This can cause lithium to build up to dangerous levels in your blood.
Losartan : Fluconazole inhibits the metabolism of losartan to its active metabolite (E-31 74) which is responsible for most of the angiotensin II-receptor antagonism which occurs during treatment with losartan.
Mechanism: Fluconazole prevents losartan from changing into its active form that helps lower blood pressure. This can make the blood pressure medicine work less effectively.
7.5 Drugs with No Observed Clinically Significant Interactions with MAVYRET No dose adjustment is required when MAVYRET is coadministered with the following medications: abacavir, amlodipine, caffeine, dextromethorphan, dolutegravir, elvitegravir/ cobicistat, emtricitabine, ethinyl estradiol of 20 mcg or less, felodipine, lamivudine, lamotrigine, losartan, midazolam, norethindrone or other progestin-only contraceptives, omeprazole, raltegravir, rilpivirine, sofosbuvir, tacrolimus, tenofovir alafenamide, tenofovir disoproxil fumarate, tolbutamide, and valsartan.
Mechanism: There are no known significant interactions between these two medications.
The VA NEPHRON trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 ml/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years. Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end state renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury...
Mechanism: Combining these types of blood pressure medicines can increase the risk of kidney damage and high potassium levels.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I take losartan if I have diabetes?
Can I drink alcohol while taking losartan?
How long does it take for losartan to lower blood pressure?
Can I stop taking losartan if my blood pressure is normal?
Are there any foods I should avoid while taking losartan?
Can losartan cause weight gain?
Can losartan cause hair loss?
Is it safe to take losartan with other medications?
What should I do if I experience side effects from losartan?
Can children take Losartan?
What are the common side effects of losartan?
Does losartan interact with other medications?
What drug class is losartan?
Is there a generic version of losartan?
What pregnancy or breastfeeding source fields are listed for losartan?
Has losartan been recalled?
Active Recalls
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Teva Pharmaceuticals USA
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Teva Pharmaceuticals USA
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Torrent Pharma Inc.
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Teva Pharmaceuticals USA
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
AVKARE Inc.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Torrent Pharma Inc.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Torrent Pharma Inc.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Torrent Pharma Inc.
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Legacy Pharmaceutical Packaging LLC
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Legacy Pharmaceutical Packaging LLC
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Camber Pharmaceuticals Inc
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Camber Pharmaceuticals Inc
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Torrent Pharma Inc.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Torrent Pharma Inc.
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Camber Pharmaceuticals Inc
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Torrent Pharma Inc.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Torrent Pharma Inc.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Torrent Pharma Inc.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Sandoz, Inc
Related Medications in Angiotensin II Receptor Blocker (ARB)
Other drugs grouped near losartan - same-class peers and common alternatives.
acebutolol
Sectral
Acebutolol is a medicine that helps lower blood pressure and control irregular heartbeats.
Compare with losartan →
aliskiren
Tekturna
Tekturna is a medicine used to treat high blood pressure.
Compare with losartan →
amiloride
Midamor
Amiloride is a water pill that helps your body hold onto potassium.
Compare with losartan →
amlodipine
Norvasc
Amlodipine (Norvasc) is a drug that lowers blood pressure and treats chest pain.
Compare with losartan →
amlodipine/benazepril
Lotrel
Lotrel is a combination medicine that contains amlodipine and benazepril.
Compare with losartan →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for losartan: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 165,585.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 7.27%.
- phenazopyridine Δ 0.02 pts · 3,599 reports · Urinary Analgesic 7.25%death share
- brinzolamide Δ 0.03 pts · 8,461 reports · Carbonic Anhydrase Inhibitor (Ophthalmic) 7.23%death share
- fenofibrate Δ 0.05 pts · 48,091 reports · Fibrate 7.22%death share
- deutetrabenazine Δ 0.07 pts · 6,445 reports · VMAT2 Inhibitor 7.20%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for losartan
The FDA label for losartan (sold under brand names such as Cozaar) classifies it as a prescription-only medication in the Angiotensin II Receptor Blocker (ARB) class. Losartan is used to treat high blood pressure in adults and children over 6 years old. Official labeling lists 4 commonly reported side effects, including Dizziness, Upper respiratory infection, Nasal congestion.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 165,585 voluntary reports. The database also lists 10 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.05 versus $5.59 for the brand - a 99% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 19 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: October 22, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages