78/100 · Elevated
Manufactured by Organon LLC
Simvastatin Adverse Events: High Serious Reaction Rate
452,850 FDA adverse event reports analyzed
Last updated: 2026-05-12
SIMVASTATIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Organon LLC. Based on analysis of 452,850 FDA adverse event reports, SIMVASTATIN has a safety score of 78 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 SIMVASTATIN include FATIGUE, NAUSEA, DYSPNOEA, DIARRHOEA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SIMVASTATIN.
Simvastatin has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 452,850 adverse event reports for this medication, which is primarily manufactured by Organon Llc.
The most commonly reported adverse events include Fatigue, Nausea, Dyspnoea. Of classified reports, 72.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Simvastatin reports include a high percentage of serious adverse events, particularly related to muscle and kidney issues.
The most common reactions are fatigue, nausea, and dyspnoea, indicating a broad range of mild to moderate side effects. Drug interactions and renal failure are significant safety concerns, especially in older adults.
Patients taking Simvastatin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Simvastatin can cause drug interactions, particularly with other statins and fibrates, leading to increased risk of myopathy and rhabdomyolysis. Regular monitoring of renal function is advised. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Simvastatin received a safety concern score of 78/100 (high concern). This is based on a 72.9% serious event ratio across 245,710 classified reports. The score accounts for 452,850 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: 118,884, Male: 113,306, Unknown: 597. The most frequently reported age groups are age 71 (5,651 reports), age 74 (5,437 reports), age 70 (5,427 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 245,710 classified reports for SIMVASTATIN:
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.
Simvastatin can cause drug interactions, particularly with other statins and fibrates, leading to increased risk of myopathy and rhabdomyolysis. Regular monitoring of renal function is advised.
If you are taking Simvastatin, here are important things to know. The most commonly reported side effects include fatigue, nausea, dyspnoea, diarrhoea, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for muscle pain, weakness, or dark urine, which may indicate rhabdomyolysis. Regularly check kidney function, 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.
Simvastatin is subject to strict FDA oversight due to its potential for severe side effects, especially in higher doses or in combination with other drugs.
The FDA has received approximately 452,850 adverse event reports associated with Simvastatin. 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 Simvastatin include Fatigue, Nausea, Dyspnoea, Diarrhoea, Drug Ineffective. By volume, the top reported reactions are: Fatigue (13,576 reports), Nausea (12,947 reports), Dyspnoea (12,427 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Simvastatin.
Out of 245,710 classified reports, 179,015 (72.9%) were classified as serious and 66,695 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 Simvastatin break down by patient sex as follows: Female: 118,884, Male: 113,306, Unknown: 597. 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 Simvastatin adverse events are: age 71: 5,651 reports, age 74: 5,437 reports, age 70: 5,427 reports, age 73: 5,340 reports, age 75: 5,309 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 Simvastatin 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 Simvastatin include: Dizziness, Fall, Asthenia, Pain, Headache. 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 Simvastatin 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.
Simvastatin has a safety concern score of 78 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. Simvastatin reports include a high percentage of serious adverse events, particularly related to muscle and kidney issues.
Key safety signals identified in Simvastatin's adverse event data include: Muscle-related issues like rhabdomyolysis and myalgia are frequent and serious.. Renal failure and acute kidney injury are also common, highlighting the need for careful monitoring.. Serious cardiovascular events such as myocardial infarction and cerebrovascular accident are reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Simvastatin can cause drug interactions, particularly with other statins and fibrates, leading to increased risk of myopathy and rhabdomyolysis. Regular monitoring of renal function is advised. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Simvastatin.
Monitor for muscle pain, weakness, or dark urine, which may indicate rhabdomyolysis. Regularly check kidney function, especially in elderly patients.
Simvastatin has 452,850 adverse event reports on file with the FDA. The most common reactions are fatigue, nausea, and dyspnoea, indicating a broad range of mild to moderate side effects. The volume of reports for Simvastatin reflects both the drug's usage level and the vigilance of the reporting community.
Simvastatin is subject to strict FDA oversight due to its potential for severe side effects, especially in higher doses or in combination with other drugs. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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