82/100 · Critical
Manufactured by Pfizer Laboratories Div Pfizer Inc
Spirochlorate Adverse Reactions: High Serious Event Rate and Renal Concerns
279,694 FDA adverse event reports analyzed
Last updated: 2026-05-12
SPIRONOLACTONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. Based on analysis of 279,694 FDA adverse event reports, SPIRONOLACTONE has a safety score of 82 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 SPIRONOLACTONE include DYSPNOEA, FATIGUE, NAUSEA, DIARRHOEA, ACUTE KIDNEY INJURY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SPIRONOLACTONE.
Spironolactone has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 279,694 adverse event reports for this medication, which is primarily manufactured by Pfizer Laboratories Div Pfizer Inc.
The most commonly reported adverse events include Dyspnoea, Fatigue, Nausea. Of classified reports, 78.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Spirochlorate reports show a high rate of serious adverse events, particularly respiratory and renal issues.
The most common reactions include dyspnea, fatigue, and nausea, indicating a broad range of potential side effects. Renal injury and hyperkalemia are significant safety concerns, with multiple reports of acute kidney injury and hyperkalemia.
Patients taking Spironolactone should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Spirochlorate can cause drug interactions, particularly with other potassium-sparing diuretics, and warnings are issued for patients with renal impairment. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Spironolactone received a safety concern score of 82/100 (high concern). This is based on a 78.9% serious event ratio across 133,891 classified reports. The score accounts for 279,694 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: 73,421, Male: 51,523, Unknown: 171. The most frequently reported age groups are age 69 (2,617 reports), age 73 (2,580 reports), age 70 (2,578 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 133,891 classified reports for SPIRONOLACTONE:
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.
Spirochlorate can cause drug interactions, particularly with other potassium-sparing diuretics, and warnings are issued for patients with renal impairment.
If you are taking Spironolactone, here are important things to know. The most commonly reported side effects include dyspnoea, fatigue, nausea, diarrhoea, 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 patients for signs of renal dysfunction, particularly in those with pre-existing kidney conditions. Be cautious when combining Spirochlorate with other potassium-sparing agents to avoid hyperkalemia. 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 Spirochlorate for safety, with ongoing reviews and updates to the drug label.
The FDA has received approximately 279,694 adverse event reports associated with Spironolactone. 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 Spironolactone include Dyspnoea, Fatigue, Nausea, Diarrhoea, Acute Kidney Injury. By volume, the top reported reactions are: Dyspnoea (10,389 reports), Fatigue (8,181 reports), Nausea (7,817 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Spironolactone.
Out of 133,891 classified reports, 105,695 (78.9%) were classified as serious and 28,196 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 Spironolactone break down by patient sex as follows: Female: 73,421, Male: 51,523, Unknown: 171. 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 Spironolactone adverse events are: age 69: 2,617 reports, age 73: 2,580 reports, age 70: 2,578 reports, age 74: 2,518 reports, age 72: 2,489 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 Spironolactone adverse event reports is Pfizer Laboratories Div Pfizer 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 Spironolactone include: Dizziness, Headache, Hypotension, Off Label Use, Drug Ineffective. 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 Spironolactone 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.
Spironolactone has a safety concern score of 82 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. Spirochlorate reports show a high rate of serious adverse events, particularly respiratory and renal issues.
Key safety signals identified in Spironolactone's adverse event data include: Acute kidney injury is a key safety signal, with 6,785 reports.. Hyperkalemia is another critical signal, with 4,928 reports.. Renal failure and renal impairment are also frequent, with 3,662 and 2,444 reports respectively.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Spirochlorate can cause drug interactions, particularly with other potassium-sparing diuretics, and warnings are issued for patients with renal impairment. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Spironolactone.
Monitor patients for signs of renal dysfunction, particularly in those with pre-existing kidney conditions. Be cautious when combining Spirochlorate with other potassium-sparing agents to avoid hyperkalemia.
Spironolactone has 279,694 adverse event reports on file with the FDA. The most common reactions include dyspnea, fatigue, and nausea, indicating a broad range of potential side effects. The volume of reports for Spironolactone reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Spirochlorate for safety, with ongoing reviews and updates to the drug label. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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