85/100 · Critical
Manufactured by Validus Pharmaceuticals LLC
Furosemide Adverse Events: High Serious Reaction Rate
777,645 FDA adverse event reports analyzed
Last updated: 2026-05-12
FUROSEMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Validus Pharmaceuticals LLC. Based on analysis of 777,645 FDA adverse event reports, FUROSEMIDE has a safety score of 85 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 FUROSEMIDE include DYSPNOEA, FATIGUE, DIARRHOEA, NAUSEA, ACUTE KIDNEY INJURY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FUROSEMIDE.
Furosemide has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 777,645 adverse event reports for this medication, which is primarily manufactured by Validus Pharmaceuticals Llc.
The most commonly reported adverse events include Dyspnoea, Fatigue, Diarrhoea. Of classified reports, 81.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Furosemide reports show a high rate of serious adverse events, particularly respiratory and renal issues.
Fatigue, nausea, and diarrhea are common, but not as serious as other reported reactions. Death and acute kidney injury are among the most frequent and severe reactions.
Patients taking Furosemide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Furosemide can interact with other diuretics, causing hypokalemia and hyponatremia. It is important to monitor electrolyte levels and avoid concurrent use with other nephrotoxic drugs. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Furosemide received a safety concern score of 85/100 (high concern). This is based on a 81.4% serious event ratio across 387,800 classified reports. The score accounts for 777,645 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 200,788, Male: 161,112, Unknown: 454. The most frequently reported age groups are age 77 (8,175 reports), age 75 (8,147 reports), age 76 (8,122 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 387,800 classified reports for FUROSEMIDE:
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.
Furosemide can interact with other diuretics, causing hypokalemia and hyponatremia. It is important to monitor electrolyte levels and avoid concurrent use with other nephrotoxic drugs.
If you are taking Furosemide, here are important things to know. The most commonly reported side effects include dyspnoea, fatigue, diarrhoea, nausea, acute kidney injury. 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 dehydration, electrolyte imbalances, and renal or respiratory issues, especially in elderly patients. Follow prescribed dosages and avoid overuse or off-label use. 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 closely monitors furosemide's safety profile, and any new or severe adverse events should be reported promptly.
The FDA has received approximately 777,645 adverse event reports associated with Furosemide. 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 Furosemide include Dyspnoea, Fatigue, Diarrhoea, Nausea, Acute Kidney Injury. By volume, the top reported reactions are: Dyspnoea (29,107 reports), Fatigue (20,389 reports), Diarrhoea (19,937 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Furosemide.
Out of 387,800 classified reports, 315,848 (81.4%) were classified as serious and 71,952 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 Furosemide break down by patient sex as follows: Female: 200,788, Male: 161,112, Unknown: 454. 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 Furosemide adverse events are: age 77: 8,175 reports, age 75: 8,147 reports, age 76: 8,122 reports, age 74: 8,078 reports, age 78: 7,874 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 Furosemide adverse event reports is Validus Pharmaceuticals 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 Furosemide include: Death, Fall, Pneumonia, Asthenia, Hypotension. 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 Furosemide 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.
Furosemide has a safety concern score of 85 out of 100 (high 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. Furosemide reports show a high rate of serious adverse events, particularly respiratory and renal issues.
Key safety signals identified in Furosemide's adverse event data include: Acute kidney injury and death are the most critical safety signals.. Respiratory issues like pneumonia and dyspnea are also significant.. Renal failure and fluid retention are common and can be severe.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Furosemide can interact with other diuretics, causing hypokalemia and hyponatremia. It is important to monitor electrolyte levels and avoid concurrent use with other nephrotoxic drugs. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Furosemide.
Monitor for signs of dehydration, electrolyte imbalances, and renal or respiratory issues, especially in elderly patients. Follow prescribed dosages and avoid overuse or off-label use.
Furosemide has 777,645 adverse event reports on file with the FDA. Fatigue, nausea, and diarrhea are common, but not as serious as other reported reactions. The volume of reports for Furosemide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors furosemide's safety profile, and any new or severe adverse events should be reported promptly. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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