72/100 · Elevated
Manufactured by Organon LLC
Finasteride Adverse Events Show High Incidence of Sexual and Psychological Side Effects
103,583 FDA adverse event reports analyzed
Last updated: 2026-05-12
FINASTERIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Organon LLC. Based on analysis of 103,583 FDA adverse event reports, FINASTERIDE 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 FINASTERIDE include FATIGUE, ERECTILE DYSFUNCTION, DEPRESSION, ANXIETY, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FINASTERIDE.
Finasteride 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 103,583 adverse event reports for this medication, which is primarily manufactured by Organon Llc.
The most commonly reported adverse events include Fatigue, Erectile Dysfunction, Depression. Of classified reports, 65.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Finasteride reports include a high frequency of sexual dysfunction and psychological adverse events.
The most common reactions are fatigue, erectile dysfunction, and depression, indicating a significant impact on quality of life. Serious adverse events, such as death and respiratory issues, are also reported but less frequently. A large number of reports involve drug ineffectiveness and adverse drug reactions, suggesting variability in patient responses.
Patients taking Finasteride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Finasteride can cause sexual dysfunction and may interact with other drugs, so patients should inform their healthcare provider of all medications they are taking. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Finasteride received a safety concern score of 72/100 (elevated concern). This is based on a 65.1% serious event ratio across 56,533 classified reports. The score accounts for 103,583 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: Male: 50,207, Female: 1,461, Unknown: 71. The most frequently reported age groups are age 76 (1,233 reports), age 77 (1,228 reports), age 79 (1,180 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 56,533 classified reports for FINASTERIDE:
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.
Finasteride can cause sexual dysfunction and may interact with other drugs, so patients should inform their healthcare provider of all medications they are taking.
If you are taking Finasteride, here are important things to know. The most commonly reported side effects include fatigue, erectile dysfunction, depression, anxiety, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Inform your healthcare provider about any sexual or psychological side effects you experience while taking Finasteride. Do not stop taking Finasteride without consulting your doctor, as it is used to treat serious conditions. 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 Finasteride's safety profile, and regulatory actions may be taken based on ongoing data analysis.
The FDA has received approximately 103,583 adverse event reports associated with Finasteride. 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 Finasteride include Fatigue, Erectile Dysfunction, Depression, Anxiety, Drug Ineffective. By volume, the top reported reactions are: Fatigue (3,948 reports), Erectile Dysfunction (3,933 reports), Depression (3,499 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Finasteride.
Out of 56,533 classified reports, 36,817 (65.1%) were classified as serious and 19,716 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 Finasteride break down by patient sex as follows: Male: 50,207, Female: 1,461, Unknown: 71. 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 Finasteride adverse events are: age 76: 1,233 reports, age 77: 1,228 reports, age 79: 1,180 reports, age 75: 1,142 reports, age 78: 1,137 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 Finasteride 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 Finasteride include: Dizziness, Sexual Dysfunction, Diarrhoea, Death, 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 Finasteride 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.
Finasteride 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. Finasteride reports include a high frequency of sexual dysfunction and psychological adverse events.
Key safety signals identified in Finasteride's adverse event data include: Sexual dysfunction (erectile dysfunction, decreased libido) is a key safety signal.. Psychological adverse events (depression, anxiety) are frequently reported.. Drug ineffectiveness and adverse drug reactions are significant safety signals.. There is a notable number of reports involving falls and balance disorders, particularly in older adults.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Finasteride can cause sexual dysfunction and may interact with other drugs, so patients should inform their healthcare provider of all medications they are taking. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Finasteride.
Inform your healthcare provider about any sexual or psychological side effects you experience while taking Finasteride. Do not stop taking Finasteride without consulting your doctor, as it is used to treat serious conditions.
Finasteride has 103,583 adverse event reports on file with the FDA. The most common reactions are fatigue, erectile dysfunction, and depression, indicating a significant impact on quality of life. The volume of reports for Finasteride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Finasteride's safety profile, and regulatory actions may be taken based on ongoing data analysis. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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