65/100 · Elevated
Manufactured by Organon LLC
Moderate Safety Concerns with Losartan Potassium
146,739 FDA adverse event reports analyzed
Last updated: 2026-05-12
LOSARTAN POTASSIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Organon LLC. Based on analysis of 146,739 FDA adverse event reports, LOSARTAN POTASSIUM has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for LOSARTAN POTASSIUM 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 POTASSIUM.
Losartan Potassium has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 146,739 adverse event reports for this medication, which is primarily manufactured by Organon Llc.
The most commonly reported adverse events include Fatigue, Diarrhoea, Nausea. Of classified reports, 60.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue, dizziness, and headache are common, with a significant number of reports indicating serious adverse events.
There is a notable increase in cardiovascular and renal issues, including congestive heart failure and renal failure. Drug interactions and hyperkalemia are potential concerns, especially in elderly patients.
Patients taking Losartan Potassium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Losartan Potassium can interact with other drugs, leading to hyperkalemia. Patients should avoid certain medications and closely monitor potassium levels. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Losartan Potassium received a safety concern score of 65/100 (elevated concern). This is based on a 60.9% serious event ratio across 75,103 classified reports. The score accounts for 146,739 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: 42,755, Male: 28,217, Unknown: 67. The most frequently reported age groups are age 70 (1,493 reports), age 72 (1,445 reports), age 69 (1,427 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 75,103 classified reports for LOSARTAN POTASSIUM:
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 Potassium can interact with other drugs, leading to hyperkalemia. Patients should avoid certain medications and closely monitor potassium levels.
If you are taking Losartan Potassium, 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 serious adverse events such as renal failure and congestive heart failure. Be aware of potential drug interactions and hyperkalemia, especially in elderly patients. 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.
The FDA continues to monitor the safety of Losartan Potassium, and updates will be provided as necessary. Patients should report any adverse events to their healthcare provider.
The FDA has received approximately 146,739 adverse event reports associated with Losartan Potassium. 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 Potassium include Fatigue, Diarrhoea, Nausea, Drug Ineffective, Dyspnoea. By volume, the top reported reactions are: Fatigue (5,517 reports), Diarrhoea (4,462 reports), Nausea (4,381 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 Potassium.
Out of 75,103 classified reports, 45,724 (60.9%) were classified as serious and 29,379 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 Potassium break down by patient sex as follows: Female: 42,755, Male: 28,217, Unknown: 67. 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 Potassium adverse events are: age 70: 1,493 reports, age 72: 1,445 reports, age 69: 1,427 reports, age 71: 1,422 reports, age 73: 1,395 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 Potassium adverse event reports is Organon Llc. 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 Potassium include: Dizziness, Headache, Pain, Asthenia, 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 Potassium 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 Potassium has a safety concern score of 65 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. Fatigue, dizziness, and headache are common, with a significant number of reports indicating serious adverse events.
Key safety signals identified in Losartan Potassium's adverse event data include: Serious adverse events such as renal failure and congestive heart failure are reported frequently.. A high number of reports indicate dizziness and fatigue, suggesting a potential impact on daily functioning.. There are multiple reports of drug interactions and hyperkalemia, indicating a need for caution.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Losartan Potassium can interact with other drugs, leading to hyperkalemia. Patients should avoid certain medications and closely monitor potassium levels. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Losartan Potassium.
Monitor for signs of serious adverse events such as renal failure and congestive heart failure. Be aware of potential drug interactions and hyperkalemia, especially in elderly patients.
Losartan Potassium has 146,739 adverse event reports on file with the FDA. There is a notable increase in cardiovascular and renal issues, including congestive heart failure and renal failure. The volume of reports for Losartan Potassium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Losartan Potassium, and updates will be provided as necessary. Patients should report any adverse events to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Organon LLC and compare their safety profiles:
The following drugs share commonly reported adverse reactions with LOSARTAN POTASSIUM:
Drugs related to LOSARTAN POTASSIUM based on therapeutic use, drug class, or shared indications: