PYGEUM: 34 Adverse Event Reports & Safety Profile
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34
Total FAERS Reports
2 (5.9%)
Deaths Reported
24
Hospitalizations
34
As Primary/Secondary Suspect
First Report: 20100106 · Latest Report: 20220429
What Are the Most Common PYGEUM Side Effects?
#1 Most Reported
Agranulocytosis
9 reports (26.5%)
#2 Most Reported
Thrombocytopenia
7 reports (20.6%)
#3 Most Reported
Anaemia
7 reports (20.6%)
All PYGEUM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Agranulocytosis | 9 | 26.5% | 1 | 8 |
| Anaemia | 7 | 20.6% | 0 | 7 |
| Thrombocytopenia | 7 | 20.6% | 0 | 7 |
| Photosensitivity reaction | 5 | 14.7% | 0 | 0 |
Who Reports PYGEUM Side Effects? Age & Gender Data
Gender: 0.0% female, 100.0% male. Average age: 73.3 years. Most reports from: FR. View detailed demographics →
Is PYGEUM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 1 | 1 | 1 |
| 2012 | 5 | 0 | 5 |
| 2015 | 1 | 0 | 0 |
| 2016 | 1 | 0 | 0 |
| 2017 | 1 | 0 | 1 |
| 2018 | 10 | 1 | 9 |
| 2019 | 5 | 0 | 0 |
| 2020 | 4 | 0 | 2 |
| 2022 | 6 | 0 | 6 |
What Is PYGEUM Used For?
| Indication | Reports |
|---|---|
| Benign prostatic hyperplasia | 17 |
| Prostatomegaly | 8 |
Official FDA Label for PYGEUM
Official prescribing information from the FDA-approved drug label.