85/100 · Critical
Manufactured by Sarfez Pharmaceuticals Inc
Torsemide Adverse Events: High Serious Reaction Rate and Renal Concerns
74,224 FDA adverse event reports analyzed
Last updated: 2026-05-12
TORSEMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Sarfez Pharmaceuticals Inc. Based on analysis of 74,224 FDA adverse event reports, TORSEMIDE 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 TORSEMIDE include DYSPNOEA, FATIGUE, NAUSEA, DIARRHOEA, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TORSEMIDE.
Torsemide 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 74,224 adverse event reports for this medication, which is primarily manufactured by Sarfez Pharmaceuticals Inc.
The most commonly reported adverse events include Dyspnoea, Fatigue, Nausea. Of classified reports, 81.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Torsemide reports show a high rate of serious adverse events, particularly involving renal function and cardiovascular issues.
The most common reactions include dyspnea, fatigue, and nausea, with a significant number of reports involving acute kidney injury and death. Renal failure and deterioration in general physical health are notable concerns, with a high number of reports indicating these issues. Cardiac failure and pneumonia are also frequently reported, highlighting the need for careful monitoring in patients.
Patients taking Torsemide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Torsemide can interact with other drugs, potentially leading to adverse effects such as hypotension, hypokalemia, and renal impairment. Warnings are issued for patients with pre-existing renal or cardiac conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Torsemide received a safety concern score of 85/100 (high concern). This is based on a 81.5% serious event ratio across 31,073 classified reports. The score accounts for 74,224 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: 15,666, Male: 13,621, Unknown: 20. The most frequently reported age groups are age 73 (730 reports), age 70 (715 reports), age 78 (711 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 31,073 classified reports for TORSEMIDE:
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.
Torsemide can interact with other drugs, potentially leading to adverse effects such as hypotension, hypokalemia, and renal impairment. Warnings are issued for patients with pre-existing renal or cardiac conditions.
If you are taking Torsemide, here are important things to know. The most commonly reported side effects include dyspnoea, fatigue, nausea, diarrhoea, dizziness. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of renal impairment and cardiac failure, especially in elderly patients. Regularly check electrolyte levels, particularly potassium, and adjust dosages as needed. Be cautious when co-administering Torsemide with other diuretics or drugs that affect renal function. 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 Torsemide for safety, particularly for serious renal and cardiac events. Healthcare providers should be vigilant and adjust dosages as necessary to mitigate risks.
The FDA has received approximately 74,224 adverse event reports associated with Torsemide. 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 Torsemide include Dyspnoea, Fatigue, Nausea, Diarrhoea, Dizziness. By volume, the top reported reactions are: Dyspnoea (3,305 reports), Fatigue (2,066 reports), Nausea (1,926 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Torsemide.
Out of 31,073 classified reports, 25,321 (81.5%) were classified as serious and 5,752 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 Torsemide break down by patient sex as follows: Female: 15,666, Male: 13,621, Unknown: 20. 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 Torsemide adverse events are: age 73: 730 reports, age 70: 715 reports, age 78: 711 reports, age 79: 703 reports, age 82: 689 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 Torsemide adverse event reports is Sarfez Pharmaceuticals Inc. 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 Torsemide include: Acute Kidney Injury, Death, General Physical Health Deterioration, Oedema Peripheral, Fall. 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 Torsemide 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.
Torsemide 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. Torsemide reports show a high rate of serious adverse events, particularly involving renal function and cardiovascular issues.
Key safety signals identified in Torsemide's adverse event data include: Acute kidney injury and renal failure are key safety signals, with a high number of reports indicating these issues.. Cardiac failure and death are also significant safety signals, with a notable number of serious reports.. Renal impairment and deterioration in general physical health are other key signals, with a high volume of reports.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Torsemide can interact with other drugs, potentially leading to adverse effects such as hypotension, hypokalemia, and renal impairment. Warnings are issued for patients with pre-existing renal or cardiac conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Torsemide.
Monitor patients for signs of renal impairment and cardiac failure, especially in elderly patients. Regularly check electrolyte levels, particularly potassium, and adjust dosages as needed. Be cautious when co-administering Torsemide with other diuretics or drugs that affect renal function.
Torsemide has 74,224 adverse event reports on file with the FDA. The most common reactions include dyspnea, fatigue, and nausea, with a significant number of reports involving acute kidney injury and death. The volume of reports for Torsemide reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Torsemide for safety, particularly for serious renal and cardiac events. Healthcare providers should be vigilant and adjust dosages as necessary to mitigate risks. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with TORSEMIDE:
Drugs related to TORSEMIDE based on therapeutic use, drug class, or shared indications: