Does OSPEMIFENE Cause Off label use? 387 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 387 reports of Off label use have been filed in association with OSPEMIFENE (Osphena). This represents 18.9% of all adverse event reports for OSPEMIFENE.
387
Reports of Off label use with OSPEMIFENE
18.9%
of all OSPEMIFENE reports
0
Deaths
11
Hospitalizations
How Dangerous Is Off label use From OSPEMIFENE?
Of the 387 reports, 11 (2.8%) required hospitalization, and 3 (0.8%) were considered life-threatening.
Is Off label use Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for OSPEMIFENE. However, 387 reports have been filed with the FAERS database.
What Other Side Effects Does OSPEMIFENE Cause?
Hot flush (319)
Headache (171)
Muscle spasms (164)
No adverse event (160)
Vaginal haemorrhage (127)
Vaginal discharge (112)
Labelled drug-drug interaction medication error (104)
Hyperhidrosis (95)
Nausea (79)
Drug ineffective (69)
What Other Drugs Cause Off label use?
RITUXIMAB (39,751)
INFLIXIMAB (34,801)
DENOSUMAB (34,612)
METHOTREXATE (24,020)
VEDOLIZUMAB (21,017)
ETANERCEPT (20,178)
TOCILIZUMAB (18,256)
PREDNISONE (17,867)
LENALIDOMIDE (17,017)
ADALIMUMAB (16,417)
Which OSPEMIFENE Alternatives Have Lower Off label use Risk?
OSPEMIFENE vs OSPHENA
OSPEMIFENE vs OVINE DIGOXIN IMMUNE FAB
OSPEMIFENE vs OXACILLIN
OSPEMIFENE vs OXALIPLATIN
OSPEMIFENE vs OXAPROZIN