72/100 · Elevated
Manufactured by Waylis Therapeutics LLC
Dutasteride Adverse Events: High Serious Event Rate, Diverse Reactions
39,892 FDA adverse event reports analyzed
Last updated: 2026-05-12
DUTASTERIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Waylis Therapeutics LLC. Based on analysis of 39,892 FDA adverse event reports, DUTASTERIDE 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 DUTASTERIDE include DRUG INEFFECTIVE, DYSPNOEA, FATIGUE, DIZZINESS, ASTHENIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DUTASTERIDE.
Dutasteride 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 39,892 adverse event reports for this medication, which is primarily manufactured by Waylis Therapeutics Llc.
The most commonly reported adverse events include Drug Ineffective, Dyspnoea, Fatigue. Of classified reports, 63.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Dutasteride reports show a high percentage of serious adverse events, particularly respiratory and cardiovascular issues.
A wide variety of reactions are reported, indicating potential for diverse side effects. The most common reactions include dyspnea, fatigue, and dizziness, which may affect patient quality of life.
Patients taking Dutasteride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Dutasteride can cause drug interactions, particularly with other cardiovascular medications, and warnings are issued for patients with pre-existing conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dutasteride received a safety concern score of 72/100 (elevated concern). This is based on a 63.7% serious event ratio across 20,678 classified reports. The score accounts for 39,892 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: 18,325, Female: 653, Unknown: 34. The most frequently reported age groups are age 72 (634 reports), age 74 (560 reports), age 77 (538 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 20,678 classified reports for DUTASTERIDE:
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.
Dutasteride can cause drug interactions, particularly with other cardiovascular medications, and warnings are issued for patients with pre-existing conditions.
If you are taking Dutasteride, here are important things to know. The most commonly reported side effects include drug ineffective, dyspnoea, fatigue, dizziness, asthenia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for serious adverse events, especially respiratory and cardiovascular issues. Follow healthcare provider’s advice regarding potential drug interactions. 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.
Regulatory oversight is ongoing, with frequent updates to the drug’s safety profile based on new reports.
The FDA has received approximately 39,892 adverse event reports associated with Dutasteride. 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 Dutasteride include Drug Ineffective, Dyspnoea, Fatigue, Dizziness, Asthenia. By volume, the top reported reactions are: Drug Ineffective (1,402 reports), Dyspnoea (1,234 reports), Fatigue (1,142 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Dutasteride.
Out of 20,678 classified reports, 13,174 (63.7%) were classified as serious and 7,504 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 Dutasteride break down by patient sex as follows: Male: 18,325, Female: 653, Unknown: 34. 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 Dutasteride adverse events are: age 72: 634 reports, age 74: 560 reports, age 77: 538 reports, age 79: 529 reports, age 75: 520 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 Dutasteride adverse event reports is Waylis Therapeutics 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 Dutasteride include: Diarrhoea, Fall, Off Label Use, Nausea, Malaise. 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 Dutasteride 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.
Dutasteride 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. Dutasteride reports show a high percentage of serious adverse events, particularly respiratory and cardiovascular issues.
Key safety signals identified in Dutasteride's adverse event data include: High percentage of serious events (63.7%). Diverse range of reactions, including cardiovascular and respiratory issues. Reported deaths and severe conditions like pulmonary embolism and sepsis. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Dutasteride can cause drug interactions, particularly with other cardiovascular medications, and warnings are issued for patients with pre-existing conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dutasteride.
Monitor for serious adverse events, especially respiratory and cardiovascular issues. Follow healthcare provider’s advice regarding potential drug interactions.
Dutasteride has 39,892 adverse event reports on file with the FDA. A wide variety of reactions are reported, indicating potential for diverse side effects. The volume of reports for Dutasteride reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with frequent updates to the drug’s safety profile based on new reports. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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