OSPEMIFENE for Atrophy: Side Effects & Safety Data
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There are 20 adverse event reports in the FDA FAERS database where OSPEMIFENE was used for Atrophy.
Most Reported Side Effects for OSPEMIFENE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 387 | 18.9% | 0 | 11 |
| Hot flush | 319 | 15.6% | 0 | 0 |
| Headache | 171 | 8.4% | 0 | 4 |
| Muscle spasms | 164 | 8.0% | 0 | 1 |
| No adverse event | 160 | 7.8% | 0 | 0 |
| Vaginal haemorrhage | 127 | 6.2% | 0 | 2 |
| Vaginal discharge | 112 | 5.5% | 0 | 0 |
| Labelled drug-drug interaction medication error | 104 | 5.1% | 0 | 2 |
| Hyperhidrosis | 95 | 4.6% | 0 | 0 |
| Nausea | 79 | 3.9% | 0 | 3 |
| Drug ineffective | 69 | 3.4% | 0 | 2 |
| Therapeutic response unexpected | 68 | 3.3% | 0 | 0 |
| Pain in extremity | 63 | 3.1% | 0 | 2 |
| Weight increased | 63 | 3.1% | 0 | 0 |
| Rash | 62 | 3.0% | 0 | 0 |
Other Indications for OSPEMIFENE
Product used for unknown indication (946)
Dyspareunia (601)
Off label use (346)
Vulvovaginal dryness (282)
Atrophic vulvovaginitis (169)
Urinary tract infection (18)
Vulvovaginal pain (15)
Vulvovaginal burning sensation (14)
Vulvovaginal discomfort (13)
Menopausal symptoms (10)