72/100 · Elevated
Manufactured by Granules India Ltd
High Incidence of Serious Adverse Reactions with Losartan
321,944 FDA adverse event reports analyzed
Last updated: 2026-05-12
LOSARTAN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Granules India Ltd. Based on analysis of 321,944 FDA adverse event reports, LOSARTAN has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for LOSARTAN include FATIGUE, DIARRHOEA, NAUSEA, DRUG INEFFECTIVE, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LOSARTAN.
Losartan has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 321,944 adverse event reports for this medication, which is primarily manufactured by Granules India Ltd.
The most commonly reported adverse events include Fatigue, Diarrhoea, Nausea. Of classified reports, 63.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse reactions, such as acute kidney injury and renal failure, are reported frequently.
A wide range of reactions, including cardiovascular and gastrointestinal issues, are common. The majority of reported reactions are serious, indicating a high risk profile.
Patients taking Losartan should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Losartan can interact with other drugs, and patients should be warned about potential drug interactions and the importance of correct dosage administration. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Losartan received a safety concern score of 72/100 (elevated concern). This is based on a 63.6% serious event ratio across 165,450 classified reports. The score accounts for 321,944 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 92,093, Male: 61,269, Unknown: 132. The most frequently reported age groups are age 70 (3,637 reports), age 71 (3,542 reports), age 72 (3,540 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 165,450 classified reports for LOSARTAN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Losartan can interact with other drugs, and patients should be warned about potential drug interactions and the importance of correct dosage administration.
If you are taking Losartan, here are important things to know. The most commonly reported side effects include fatigue, diarrhoea, nausea, drug ineffective, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of kidney dysfunction, such as changes in urine output or swelling, and report them to your healthcare provider. Follow prescribed dosing instructions carefully to avoid drug interactions and other adverse effects. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory bodies continue to monitor Losartan for safety, and patients should report any adverse reactions to their healthcare provider.
The FDA has received approximately 321,944 adverse event reports associated with Losartan. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Losartan include Fatigue, Diarrhoea, Nausea, Drug Ineffective, Dyspnoea. By volume, the top reported reactions are: Fatigue (11,851 reports), Diarrhoea (9,871 reports), Nausea (9,205 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Losartan.
Out of 165,450 classified reports, 105,210 (63.6%) were classified as serious and 60,240 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Losartan break down by patient sex as follows: Female: 92,093, Male: 61,269, Unknown: 132. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Losartan adverse events are: age 70: 3,637 reports, age 71: 3,542 reports, age 72: 3,540 reports, age 65: 3,482 reports, age 73: 3,473 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Losartan adverse event reports is Granules India Ltd. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Losartan include: Dizziness, Headache, Pain, Off Label Use, Arthralgia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Losartan to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Losartan has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Serious adverse reactions, such as acute kidney injury and renal failure, are reported frequently.
Key safety signals identified in Losartan's adverse event data include: Acute kidney injury and renal failure are key safety signals.. Cardiovascular issues like hypertension and hypotension are frequently reported.. Respiratory issues, including pneumonia and chronic kidney disease, are also significant.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Losartan can interact with other drugs, and patients should be warned about potential drug interactions and the importance of correct dosage administration. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Losartan.
Monitor for signs of kidney dysfunction, such as changes in urine output or swelling, and report them to your healthcare provider. Follow prescribed dosing instructions carefully to avoid drug interactions and other adverse effects.
Losartan has 321,944 adverse event reports on file with the FDA. A wide range of reactions, including cardiovascular and gastrointestinal issues, are common. The volume of reports for Losartan reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory bodies continue to monitor Losartan for safety, and patients should report any adverse reactions to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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