PREMARIN for Atrophic vulvovaginitis: Side Effects & Safety Data
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There are 16 adverse event reports in the FDA FAERS database where PREMARIN was used for Atrophic vulvovaginitis.
Most Reported Side Effects for PREMARIN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Breast cancer female | 89 | 13.1% | 5 | 14 |
| Drug ineffective | 47 | 6.9% | 0 | 0 |
| Invasive ductal breast carcinoma | 41 | 6.0% | 1 | 2 |
| Hot flush | 37 | 5.5% | 0 | 1 |
| Malaise | 29 | 4.3% | 0 | 3 |
| Breast cancer | 26 | 3.8% | 3 | 1 |
| Drug effect incomplete | 23 | 3.4% | 0 | 0 |
| Headache | 22 | 3.2% | 0 | 2 |
| Product quality issue | 21 | 3.1% | 0 | 1 |
| Pain | 20 | 3.0% | 0 | 3 |
| Feeling abnormal | 19 | 2.8% | 0 | 0 |
| Drug hypersensitivity | 18 | 2.7% | 0 | 0 |
| Insomnia | 17 | 2.5% | 0 | 1 |
| Dizziness | 15 | 2.2% | 0 | 2 |
| Vulvovaginal discomfort | 15 | 2.2% | 0 | 0 |
Other Indications for PREMARIN
Hormone replacement therapy (222)
Menopausal symptoms (43)
Vulvovaginal dryness (36)
Oestrogen replacement therapy (26)
Hot flush (17)
Dyspareunia (8)
Menopause (6)
Product used for unknown indication (6)
Other Drugs Used for Atrophic vulvovaginitis
ESTRADIOL (1,139)
ESTROGENS, CONJUGATED (483)
PRASTERONE (214)
OSPEMIFENE (169)
OSPHENA (25)
ESTRADIOL\NORETHINDRONE (11)
ESTRING (11)
ESTROGENS, CONJUGATED\MEDROXYPROGESTERONE (8)
ESTRIOL (6)
DUPILUMAB (5)