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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.

HYDROCORTISONE PROBUTATE: 506 Adverse Event Reports & Safety Profile

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506
Total FAERS Reports
415 (82.0%)
Deaths Reported
411
Hospitalizations
506
As Primary/Secondary Suspect
410
Life-Threatening
404
Disabilities
Feb 28, 1997
FDA Approved
Discontinued
Status

FDA Application: 020453 ·

First Report: 20100806 · Latest Report: 20160908

What Are the Most Common HYDROCORTISONE PROBUTATE Side Effects?

#1 Most Reported
Maternal exposure during pregnancy
239 reports (47.2%)
#2 Most Reported
Hypertension
237 reports (46.8%)
#3 Most Reported
Hand deformity
233 reports (46.0%)

All HYDROCORTISONE PROBUTATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Maternal exposure during pregnancy 239 47.2% 206 195
Hypertension 237 46.8% 237 228
Fibromyalgia 233 46.1% 233 224
Hand deformity 233 46.1% 233 223
Dry mouth 232 45.9% 232 222
Folliculitis 229 45.3% 229 219
Osteoarthritis 227 44.9% 227 218
Lower respiratory tract infection 226 44.7% 226 216
Duodenal ulcer perforation 224 44.3% 224 214
Pemphigus 224 44.3% 224 213
Glossodynia 223 44.1% 223 213
Type 2 diabetes mellitus 223 44.1% 223 213
Hypoaesthesia 222 43.9% 222 213
Impaired healing 221 43.7% 221 211
Helicobacter infection 220 43.5% 220 211
Liver injury 220 43.5% 220 209
Confusional state 218 43.1% 218 208
Mobility decreased 214 42.3% 214 205
Psoriatic arthropathy 214 42.3% 214 203
Infusion related reaction 213 42.1% 212 204

Who Reports HYDROCORTISONE PROBUTATE Side Effects? Age & Gender Data

Gender: 97.4% female, 2.6% male. Average age: 42.4 years. Most reports from: CA. View detailed demographics →

Is HYDROCORTISONE PROBUTATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2010 1 0 0
2015 5 5 5
2016 1 0 0

View full timeline →

What Is HYDROCORTISONE PROBUTATE Used For?

IndicationReports
Rheumatoid arthritis 273
Product used for unknown indication 194
Foetal exposure during pregnancy 51

HYDROCORTISONE PROBUTATE vs Alternatives: Which Is Safer?

HYDROCORTISONE PROBUTATE vs HYDROCORTISONE\HYDROCORTISONE HYDROCORTISONE PROBUTATE vs HYDROCORTISONE\NEOMYCIN\POLYMYXIN B HYDROCORTISONE PROBUTATE vs HYDROCORTISONE\PRAMOXINE HYDROCORTISONE PROBUTATE vs HYDROGEN PEROXIDE HYDROCORTISONE PROBUTATE vs HYDROMORPHONE HYDROCORTISONE PROBUTATE vs HYDROQUINONE HYDROCORTISONE PROBUTATE vs HYDROXOCOBALAMIN HYDROCORTISONE PROBUTATE vs HYDROXYCHLOROQUINE HYDROCORTISONE PROBUTATE vs HYDROXYCHLOROQUINE DIPHOSPHATE HYDROCORTISONE PROBUTATE vs HYDROXYETHYL STARCH 130/0.4

Official FDA Label for HYDROCORTISONE PROBUTATE

Official prescribing information from the FDA-approved drug label.