PRASTERONE for Vaginal disorder: Side Effects & Safety Data
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There are 19 adverse event reports in the FDA FAERS database where PRASTERONE was used for Vaginal disorder.
Most Reported Side Effects for PRASTERONE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 653 | 43.1% | 0 | 15 |
| Application site discharge | 111 | 7.3% | 0 | 1 |
| Drug ineffective | 105 | 6.9% | 0 | 1 |
| Vaginal discharge | 82 | 5.4% | 0 | 0 |
| Vulvovaginal burning sensation | 71 | 4.7% | 0 | 0 |
| Headache | 59 | 3.9% | 0 | 20 |
| Rash | 57 | 3.8% | 0 | 33 |
| Alopecia | 55 | 3.6% | 0 | 1 |
| Product dose omission issue | 55 | 3.6% | 0 | 2 |
| Therapeutic response unexpected | 52 | 3.4% | 0 | 0 |
| Product administration error | 47 | 3.1% | 0 | 0 |
| Underdose | 45 | 3.0% | 0 | 0 |
| Insomnia | 44 | 2.9% | 0 | 1 |
| Product physical issue | 43 | 2.8% | 0 | 0 |
| Vaginal haemorrhage | 43 | 2.8% | 0 | 1 |
Other Indications for PRASTERONE
Product used for unknown indication (587)
Vulvovaginal dryness (268)
Dyspareunia (259)
Atrophic vulvovaginitis (214)
Vulvovaginal pain (37)
Urinary tract infection (32)
Menopause (31)
Menopausal symptoms (24)
Vulvovaginal discomfort (22)
Vulvovaginal burning sensation (17)