PlainMeds provides educational information only. This is not medical advice. Always consult your doctor or pharmacist.

losartan

Verify with FDA → · CMS NADAC pricing →

Brand names: Cozaar

Angiotensin II Receptor Blocker (ARB) Rx

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.

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 →

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.

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.

How to Take It

Take losartan once a day, with or without food. The usual starting dose for adults is 50 mg. Your doctor may increase the dose up to 100 mg daily if needed. For children, the starting dose is based on weight. Follow your doctor's instructions carefully.

Pregnancy & Breastfeeding

Do not take losartan if you are pregnant. It can cause serious harm or death to the developing fetus. If you are breastfeeding, talk to your doctor about whether losartan is right for you.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store losartan at room temperature (68°F to 77°F) and protect it from light.

Side Effects (from patient reports)

Based on 85,155 FDA adverse event reports.

Tiredness
11,852
Diarrhea
9,868
Feeling sick to your stomach
9,206
The medicine is not working
9,195
Difficulty breathing
8,439
Feeling lightheaded
7,999
Head pain
7,815
Aches
7,326
Using the medicine for something it is not approved for
7,153
Joint pain
6,302

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

Death-Related Reports

12,034

Hospitalization Reports

48,929

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 92,090 (60%)
Male 61,269 (40%)

Age Distribution

0–17 811
18–44 6,341
45–64 37,385
65–74 34,185
75+ 32,356

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 FATIGUE 11,852
2 DIARRHOEA 9,870
3 NAUSEA 9,207
4 DRUG INEFFECTIVE 9,195
5 DYSPNOEA 8,439
6 DIZZINESS 7,999
7 HEADACHE 7,815
8 PAIN 7,325
9 OFF LABEL USE 7,154
10 ARTHRALGIA 6,302
11 MALAISE 5,919
12 ASTHENIA 5,867
13 COUGH 5,353
14 FALL 5,234
15 VOMITING 5,173

Reactions in Death Reports

DEATH 4,651
COMPLETED SUICIDE 908
PNEUMONIA 655
ACUTE KIDNEY INJURY 531
DYSPNOEA 510
RENAL FAILURE 445
CHRONIC KIDNEY DISEASE 435
CARDIAC ARREST 431
OFF LABEL USE 411
FATIGUE 410

Reactions in Hospitalization Reports

DYSPNOEA 3,495
PNEUMONIA 3,299
DIARRHOEA 3,116
FATIGUE 3,042
FALL 2,861
NAUSEA 2,719
ACUTE KIDNEY INJURY 2,518
ASTHENIA 2,440
VOMITING 2,358
DIZZINESS 2,319

Source: FDA FAERS (Adverse Event Reporting System) 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.

What to do: You should not use these drugs together if you have diabetes or poor kidney function.

moderate lithium

(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.

What to do: Your doctor should monitor your lithium blood levels closely while you take these drugs together. Watch for signs of too much lithium, like tremors or feeling very thirsty.

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.

What to do: Your doctor may need to monitor your blood pressure and adjust your treatment if it is not controlled.

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.

What to do: You can continue taking both medications at your current doses.

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 comp...

Mechanism: Combining these types of blood pressure medicines can increase the risk of kidney damage and high potassium levels.

What to do: Your doctor should monitor your kidney function and potassium levels closely if these drugs are used together.

Check all your medications →

Common Questions

Can I take losartan if I have diabetes?
Yes, losartan can be used to treat kidney problems caused by diabetes.
Can I drink alcohol while taking losartan?
Talk to your doctor about drinking alcohol while taking losartan.
How long does it take for losartan to lower blood pressure?
It may take a few weeks for losartan to fully lower your blood pressure.
Can I stop taking losartan if my blood pressure is normal?
Do not stop taking losartan without talking to your doctor first.
Are there any foods I should avoid while taking losartan?
Talk to your doctor about any dietary restrictions while taking losartan.
Can losartan cause weight gain?
Weight gain is not a common side effect of losartan.
Can losartan cause hair loss?
Hair loss is not a common side effect of losartan.
Is it safe to take losartan with other medications?
Tell your doctor about all the medications you take, including over-the-counter drugs and supplements.
What should I do if I experience side effects from losartan?
Tell your doctor if you experience any bothersome or persistent side effects.
Can children take Losartan?
Losartan can be used in children 6 years and older.
What are the common side effects of losartan?
The most commonly reported side effects of losartan include Dizziness, Upper respiratory infection, Nasal congestion, Back pain. Based on 85,155 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does losartan interact with other medications?
Yes, losartan has 10 known drug interactions. Notable interactions include aliskiren, lithium, fluconazole. Always inform your doctor about all medications you are taking.
What drug class is losartan?
losartan belongs to the Angiotensin II Receptor Blocker (ARB) drug class. It requires a prescription (Rx). Losartan is used to treat high blood pressure in adults and children over 6 years old.
Is there a generic version of losartan?
Yes, generic losartan is available from 24 manufacturers. The generic costs $0.05 per unit compared to $5.59 for the brand version, saving approximately 99%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
Is losartan safe during pregnancy?
Do not take losartan if you are pregnant. It can cause serious harm or death to the developing fetus. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has losartan been recalled?
There are 19 recalls associated with losartan products. CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. Check the recalls section below for full details and affected products.

Active Recalls

Class II March 25, 2020

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

Class II March 25, 2020

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

Class II September 19, 2019

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.

Class II June 6, 2019

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

Class II April 24, 2019

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.

Class II April 18, 2019

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.

Class II April 18, 2019

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.

Class II April 18, 2019

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.

Class II March 1, 2019

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Legacy Pharmaceutical Packaging LLC

Class II March 1, 2019

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Legacy Pharmaceutical Packaging LLC

Class II February 28, 2019

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Camber Pharmaceuticals Inc

Class II February 28, 2019

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Camber Pharmaceuticals Inc

Class II February 28, 2019

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.

Class II February 28, 2019

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.

Class II February 28, 2019

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Camber Pharmaceuticals Inc

Class II February 28, 2019

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.

Class II December 20, 2018

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.

Class II December 20, 2018

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.

Class II November 1, 2018

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.

Compare losartan vs acebutolol side-by-side →

Medication Guides

Related Health & Safety Data

Save on losartan

Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.

Disclosure: This link may earn us a commission at no extra cost to you. See our terms.

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 85,155 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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

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. Always consult a healthcare professional before making medication decisions.

Last updated: October 22, 2025

All federal data sources used on this page