PRASTERONE for Vulvovaginal dryness: Side Effects & Safety Data
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There are 268 adverse event reports in the FDA FAERS database where PRASTERONE was used for Vulvovaginal dryness.
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)
Dyspareunia (259)
Atrophic vulvovaginitis (214)
Vulvovaginal pain (37)
Urinary tract infection (32)
Menopause (31)
Menopausal symptoms (24)
Vulvovaginal discomfort (22)
Vaginal disorder (19)
Vulvovaginal burning sensation (17)
Other Drugs Used for Vulvovaginal dryness
ESTRADIOL (2,109)
ESTROGENS, CONJUGATED (762)
OSPEMIFENE (282)
PREMARIN (36)
ESTRADIOL\NORETHINDRONE (34)
OSPHENA (32)
ESTROGENS, CONJUGATED\MEDROXYPROGESTERONE (22)
ESTRING (12)
ESTRADIOL\PROGESTERONE (7)
PROGESTERONE (7)