AVODART: 97 Adverse Event Reports & Safety Profile
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97
Total FAERS Reports
14 (14.4%)
Deaths Reported
32
Hospitalizations
97
As Primary/Secondary Suspect
2
Life-Threatening
6
Disabilities
First Report: 2004 · Latest Report: 20140505
What Are the Most Common AVODART Side Effects?
#1 Most Reported
Death
9 reports (9.3%)
#2 Most Reported
Prostate cancer
7 reports (7.2%)
#3 Most Reported
Erectile dysfunction
7 reports (7.2%)
All AVODART Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 9 | 9.3% | 9 | 1 |
| Erectile dysfunction | 7 | 7.2% | 0 | 0 |
| Prostate cancer | 7 | 7.2% | 0 | 0 |
| Anxiety | 6 | 6.2% | 0 | 4 |
| Depressed mood | 5 | 5.2% | 0 | 4 |
| Dyspnoea | 5 | 5.2% | 0 | 2 |
| Suicide attempt | 5 | 5.2% | 0 | 5 |
Who Reports AVODART Side Effects? Age & Gender Data
Average age: 66.6 years. Most reports from: US. View detailed demographics →
Is AVODART Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2004 | 1 | 0 | 1 |
| 2006 | 1 | 0 | 1 |
| 2007 | 2 | 0 | 1 |
| 2008 | 1 | 0 | 1 |
| 2010 | 7 | 0 | 2 |
| 2011 | 2 | 0 | 1 |
| 2012 | 6 | 0 | 4 |
| 2013 | 17 | 1 | 5 |
| 2014 | 15 | 0 | 10 |
What Is AVODART Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 50 |
| Benign prostatic hyperplasia | 27 |
Official FDA Label for AVODART
Official prescribing information from the FDA-approved drug label.