Avodartdutasteride
According to the FDA label: AVODART is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: ( 1.1 ) • improve symptoms, • reduce the risk of acute urinary retention, and • reduce the risk of the need for BPH-related surgery. AVODART in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
20,873 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Avodart in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 1,410 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Dyspnoea 1,242 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Fatigue 1,158 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Dizziness 997 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Asthenia 942 reports
Physical weakness or lack of strength.
Full definition in the glossary →Diarrhoea 913 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Fall 818 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Off Label Use 801 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Nausea 711 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Malaise 668 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Death 653 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Headache 624 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Pruritus 616 reports
Cough 614 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Arthralgia 600 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 18,490 |
| Female | 657 |
| Unknown | 34 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 114 |
| 18-34 | 161 |
| 35-49 | 275 |
| 50-64 | 1,946 |
| 65-74 | 4,432 |
| 75+ | 6,633 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Avodart. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 8,293 |
| Non-Serious | 7,537 |
| Hospitalization | 6,488 |
| Death | 1,983 |
| Life-Threatening | 845 |
| Disability | 567 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Avodart. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 235 |
| 2005 | 414 |
| 2006 | 708 |
| 2007 | 979 |
| 2008 | 1,075 |
| 2009 | 898 |
| 2010 | 939 |
| 2011 | 953 |
| 2012 | 884 |
| 2013 | 826 |
| 2014 | 918 |
| 2015 | 1,082 |
| 2016 | 999 |
| 2017 | 931 |
| 2018 | 1,171 |
| 2019 | 1,014 |
| 2020 | 999 |
| 2021 | 983 |
| 2022 | 1,120 |
| 2023 | 1,407 |
| 2024 | 1,202 |
| 2025 | 949 |
| 2026 (partial) | 187 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Avodart
In FDA adverse event reports that mention Avodart, these medications appeared most often in the same report.
- Aspirin (3,202 reports)
- Furosemide (2,584 reports)
- Atorvastatin (1,632 reports)
- Simvastatin (1,599 reports)
- Ergocalciferol (1,553 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026