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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

OSPHENA: 205 Adverse Event Reports & Safety Profile

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205
Total FAERS Reports
0
Deaths Reported
4
Hospitalizations
205
As Primary/Secondary Suspect
2
Life-Threatening
1
Disabilities

First Report: 2013 · Latest Report: 20140606

What Are the Most Common OSPHENA Side Effects?

#1 Most Reported
Off label use
35 reports (17.1%)
#2 Most Reported
Hot flush
34 reports (16.6%)
#3 Most Reported
Muscle spasms
20 reports (9.8%)

All OSPHENA Side Effects by Frequency

Side Effect Reports % of Total 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
Dizziness 5 2.4% 0 0
Drug ineffective 5 2.4% 0 0
Fatigue 5 2.4% 0 0
Pain in extremity 5 2.4% 0 0
Swollen tongue 5 2.4% 0 0

Who Reports OSPHENA Side Effects? Age & Gender Data

Average age: 60.0 years. Most reports from: US. View detailed demographics →

Is OSPHENA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2013 53 0 2
2014 82 0 2

View full timeline →

What Is OSPHENA Used For?

IndicationReports
Dyspareunia 95
Product used for unknown indication 71
Off label use 34
Vulvovaginal dryness 32
Atrophic vulvovaginitis 25

OSPHENA vs Alternatives: Which Is Safer?

OSPHENA vs OVINE DIGOXIN IMMUNE FAB OSPHENA vs OXACILLIN OSPHENA vs OXALIPLATIN OSPHENA vs OXAPROZIN OSPHENA vs OXAZEPAM OSPHENA vs OXCARBAZEPINE OSPHENA vs OXITRIPTAN OSPHENA vs OXOMEMAZINE OSPHENA vs OXY TAB OSPHENA vs OXYBATE

Official FDA Label for OSPHENA

Official prescribing information from the FDA-approved drug label.