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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.

FLUMETHASONE PIVALATE: 3,468 Adverse Event Reports & Safety Profile

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3,468
Total FAERS Reports
2,481 (71.5%)
Deaths Reported
2,754
Hospitalizations
3,468
As Primary/Secondary Suspect
2,864
Life-Threatening
2,872
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status

FDA Application: 016379 ·

First Report: 19910101 · Latest Report: 20200710

What Are the Most Common FLUMETHASONE PIVALATE Side Effects?

#1 Most Reported
Systemic lupus erythematosus
1,847 reports (53.3%)
#2 Most Reported
Glossodynia
1,839 reports (53.0%)
#3 Most Reported
Rheumatoid arthritis
1,814 reports (52.3%)

All FLUMETHASONE PIVALATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Systemic lupus erythematosus 1,847 53.3% 1,309 1,398
Glossodynia 1,839 53.0% 1,314 1,396
Rheumatoid arthritis 1,814 52.3% 1,267 1,392
Infusion related reaction 1,803 52.0% 1,272 1,357
Hand deformity 1,795 51.8% 1,278 1,391
Synovitis 1,788 51.6% 1,264 1,356
Fatigue 1,762 50.8% 1,219 1,389
Joint swelling 1,760 50.8% 1,231 1,365
Hepatic enzyme increased 1,757 50.7% 1,234 1,362
Wound 1,754 50.6% 1,238 1,366
Rash 1,738 50.1% 1,226 1,346
Swelling 1,729 49.9% 1,229 1,359
Off label use 1,718 49.5% 1,172 1,401
Helicobacter infection 1,684 48.6% 1,244 1,335
Alopecia 1,681 48.5% 1,108 1,289
Pemphigus 1,670 48.2% 1,111 1,253
Duodenal ulcer perforation 1,651 47.6% 1,204 1,297
General physical health deterioration 1,637 47.2% 1,280 1,368
Abdominal discomfort 1,634 47.1% 1,095 1,275
Psoriatic arthropathy 1,629 47.0% 1,273 1,361

Who Reports FLUMETHASONE PIVALATE Side Effects? Age & Gender Data

Gender: 100.0% female, 0.0% male. Average age: 43.8 years. Most reports from: CA. View detailed demographics →

Is FLUMETHASONE PIVALATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 9 0 9
2008 2 2 2
2011 1 1 1
2012 1 0 0
2015 29 21 28
2017 7 6 6
2018 7 0 7
2020 3 0 0

View full timeline →

What Is FLUMETHASONE PIVALATE Used For?

IndicationReports
Rheumatoid arthritis 1,771
Product used for unknown indication 1,743
Foetal exposure during pregnancy 66
Exposure during pregnancy 27
Drug ineffective 14

FLUMETHASONE PIVALATE vs Alternatives: Which Is Safer?

FLUMETHASONE PIVALATE vs FLUMETHASONE\SALICYLIC ACID FLUMETHASONE PIVALATE vs FLUNARIZINE FLUMETHASONE PIVALATE vs FLUNISOLIDE FLUMETHASONE PIVALATE vs FLUNITRAZEPAM FLUMETHASONE PIVALATE vs FLUOCINOLONE FLUMETHASONE PIVALATE vs FLUOCINOLONE ACETONIDE FLUMETHASONE PIVALATE vs FLUOCINOLONE ACETONIDE\HYDROQUINONE\TRETINOIN FLUMETHASONE PIVALATE vs FLUOCINONIDE FLUMETHASONE PIVALATE vs FLUORESCEIN FLUMETHASONE PIVALATE vs FLUOROMETHOLONE

Official FDA Label for FLUMETHASONE PIVALATE

Official prescribing information from the FDA-approved drug label.