OSPHENA for Off label use: Side Effects & Safety Data
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There are 34 adverse event reports in the FDA FAERS database where OSPHENA was used for Off label use.
Most Reported Side Effects for OSPHENA
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 35 | 17.1% | 0 | 2 |
| Hot flush | 34 | 16.6% | 0 | 0 |
| Muscle spasms | 20 | 9.8% | 0 | 0 |
| Vaginal discharge | 16 | 7.8% | 0 | 0 |
| Headache | 15 | 7.3% | 0 | 0 |
| No adverse event | 13 | 6.3% | 0 | 0 |
| Vaginal haemorrhage | 13 | 6.3% | 0 | 0 |
| Rash | 11 | 5.4% | 0 | 0 |
| Abdominal pain | 10 | 4.9% | 0 | 0 |
| Night sweats | 8 | 3.9% | 0 | 0 |
| Hyperhidrosis | 7 | 3.4% | 0 | 0 |
| Nausea | 7 | 3.4% | 0 | 0 |
| Anxiety | 6 | 2.9% | 0 | 0 |
| Labelled drug-drug interaction medication error | 6 | 2.9% | 0 | 0 |
| Rash generalised | 6 | 2.9% | 0 | 0 |
Other Indications for OSPHENA
Dyspareunia (95)
Product used for unknown indication (71)
Vulvovaginal dryness (32)
Atrophic vulvovaginitis (25)
Other Drugs Used for Off label use
LENALIDOMIDE (5,767)
ECULIZUMAB (3,550)
CERTOLIZUMAB PEGOL (2,256)
ABOBOTULINUMTOXINA (2,170)
LEVETIRACETAM (2,161)
APREMILAST (1,995)
PROPRANOLOL (1,576)
CETIRIZINE (1,416)
HUMAN IMMUNOGLOBULIN G (1,129)
THALIDOMIDE (1,033)