PRASTERONE for Atrophic vulvovaginitis: Side Effects & Safety Data
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There are 214 adverse event reports in the FDA FAERS database where PRASTERONE was used for Atrophic vulvovaginitis.
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)
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 Atrophic vulvovaginitis
ESTRADIOL (1,139)
ESTROGENS, CONJUGATED (483)
OSPEMIFENE (169)
OSPHENA (25)
PREMARIN (16)
ESTRADIOL\NORETHINDRONE (11)
ESTRING (11)
ESTROGENS, CONJUGATED\MEDROXYPROGESTERONE (8)
ESTRIOL (6)
DUPILUMAB (5)