72/100 · Elevated
Manufactured by Organon LLC
Safety Profile of Losartan Potassium and Hydrochlorothiazide: Common Reactions and Serious Events
22,797 FDA adverse event reports analyzed
Last updated: 2026-05-12
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Organon LLC. Based on analysis of 22,797 FDA adverse event reports, LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE 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 POTASSIUM AND HYDROCHLOROTHIAZIDE include NAUSEA, DRUG INEFFECTIVE, FATIGUE, DIZZINESS, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE.
Losartan Potassium And Hydrochlorothiazide 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 22,797 adverse event reports for this medication, which is primarily manufactured by Organon Llc.
The most commonly reported adverse events include Nausea, Drug Ineffective, Fatigue. Of classified reports, 64.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions include nausea, fatigue, and dizziness, with a serious event rate of 64.9%.
Reports of cardiovascular events, renal failure, and drug interactions are notable. The majority of reports are from older adults, with the highest number of reports from those aged 65-75. Serious adverse events such as myocardial infarction, renal failure, and death are reported but less frequent. Drug ineffectiveness and hypertension are also commonly reported.
Patients taking Losartan Potassium And Hydrochlorothiazide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other antihypertensive drugs and diuretics are common, and patients should be monitored for adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Losartan Potassium And Hydrochlorothiazide received a safety concern score of 72/100 (elevated concern). This is based on a 64.9% serious event ratio across 11,443 classified reports. The score accounts for 22,797 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: 7,139, Male: 3,909, Unknown: 9. The most frequently reported age groups are age 68 (269 reports), age 65 (267 reports), age 70 (255 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 11,443 classified reports for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE:
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.
Interactions with other antihypertensive drugs and diuretics are common, and patients should be monitored for adverse effects.
If you are taking Losartan Potassium And Hydrochlorothiazide, here are important things to know. The most commonly reported side effects include nausea, drug ineffective, fatigue, dizziness, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing and do not alter the regimen without medical advice. 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 oversight is ongoing, with regular updates on safety concerns and recommendations for patient monitoring.
The FDA has received approximately 22,797 adverse event reports associated with Losartan Potassium And Hydrochlorothiazide. 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 And Hydrochlorothiazide include Nausea, Drug Ineffective, Fatigue, Dizziness, Headache. By volume, the top reported reactions are: Nausea (769 reports), Drug Ineffective (734 reports), Fatigue (675 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 And Hydrochlorothiazide.
Out of 11,443 classified reports, 7,427 (64.9%) were classified as serious and 4,016 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 And Hydrochlorothiazide break down by patient sex as follows: Female: 7,139, Male: 3,909, Unknown: 9. 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 And Hydrochlorothiazide adverse events are: age 68: 269 reports, age 65: 267 reports, age 70: 255 reports, age 71: 237 reports, age 69: 236 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 And Hydrochlorothiazide 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 And Hydrochlorothiazide include: Diarrhoea, Pain, Dyspnoea, Arthralgia, Asthenia. 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 And Hydrochlorothiazide 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 And Hydrochlorothiazide 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. The most common reactions include nausea, fatigue, and dizziness, with a serious event rate of 64.9%.
Key safety signals identified in Losartan Potassium And Hydrochlorothiazide's adverse event data include: Myocardial infarction and renal failure are key serious safety signals.. Drug ineffectiveness and hypertension are frequent, indicating potential efficacy concerns.. A high number of reports involve drug interactions, highlighting the need for caution.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other antihypertensive drugs and diuretics are common, and patients should be monitored for adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Losartan Potassium And Hydrochlorothiazide.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing and do not alter the regimen without medical advice.
Losartan Potassium And Hydrochlorothiazide has 22,797 adverse event reports on file with the FDA. Reports of cardiovascular events, renal failure, and drug interactions are notable. The volume of reports for Losartan Potassium And Hydrochlorothiazide reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with regular updates on safety concerns and recommendations for patient monitoring. 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 AND HYDROCHLOROTHIAZIDE:
Drugs related to LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE based on therapeutic use, drug class, or shared indications: