Losartan: What to Know Before You Take It
Also sold as Cozaar
FDA Boxed Warning
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue losartan potassium 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 losartan potassium as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)
What Losartan Is Used For
1 INDICATIONS AND USAGE Losartan potassium tablets are 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 Losartan potassium tablets are 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, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Losartan potassium tablets may be administered with other antihypertensive agents. 1.2 Hypertensive Patients with Left Ventricular Hypertrophy Losartan potassium tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ]. 1.3 Nephropathy in Type 2 Diabetic Patients Losartan potassium tablets are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.3) ].
Warnings
5 WARNINGS AND PRECAUTIONS • Hypotension: Correct volume or salt depletion prior to administration of losartan potassium. (5.2) • Monitor renal function and potassium in susceptible patients. (5.3 , 5.4) 5.1 Fetal Toxicity Losartan potassium 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 losartan potassium 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 losartan potassium. Correct volume or salt depletion prior to administration of losartan potassium [see Dosage and Administration (2.1) ]. 5.3 Renal Function Deterioration Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on losartan potassium. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on losartan potassium [see Drug Interactions (7.3) and Use in Specific Populations (8.7) ]. 5.4 Hyperkalemia Monitor serum potassium periodically and treat appropriately. Dosage reduction or discontinuation of losartan potassium may be required [see Adverse Reactions (6.1) ]. Concomitant use of other drugs that may increase serum potassium may lead to hyperkalemia [see Drug Interactions (7.1) ].
Contraindications
4 CONTRAINDICATIONS Losartan potassium 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)
Losartan Drug Interactions (4)
Check Losartan against your full medication list in our free Interaction Checker
Most-Reported Side Effects
Based on 206,980 reports in the FDA Adverse Event Reporting System (FAERS). Reports do not prove the drug caused the effect.
Explore full Losartan safety data in our free FDA Safety Explorer
FDA Recalls (showing 12 of 20)
Presence of foreign substance: plastic-like substance.
Recalling firm: MACLEODS PHARMA USA, INC
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Recalling firm: Strides Pharma Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Macleods Pharma Usa Inc
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: PD-Rx Pharmaceuticals, Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: PD-Rx Pharmaceuticals, Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: PD-Rx Pharmaceuticals, Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Strides Pharma Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Strides Pharma Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Strides Pharma Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Recalling firm: Direct Rx
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Recalling firm: Direct Rx
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Recalling firm: Direct Rx
This information is educational — not medical advice.
This page is provided for general educational purposes and summarizes publicly available data from sources such as the U.S. Food & Drug Administration. It is not a substitute for the judgment of a licensed clinician and should not be used to start, stop, or change any medication. It may be incomplete or out of date, and individual circumstances vary. Always talk with your prescriber or pharmacist about your specific medications and health conditions. If you think you may have a medical emergency, call 911.