Does IBUPROFEN Cause Product use in unapproved indication? 3,596 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 3,596 reports of Product use in unapproved indication have been filed in association with IBUPROFEN (equate ibuprofen). This represents 4.1% of all adverse event reports for IBUPROFEN.
3,596
Reports of Product use in unapproved indication with IBUPROFEN
4.1%
of all IBUPROFEN reports
143
Deaths
516
Hospitalizations
How Dangerous Is Product use in unapproved indication From IBUPROFEN?
Of the 3,596 reports, 143 (4.0%) resulted in death, 516 (14.3%) required hospitalization, and 190 (5.3%) were considered life-threatening.
Is Product use in unapproved indication Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for IBUPROFEN. However, 3,596 reports have been filed with the FAERS database.
What Other Side Effects Does IBUPROFEN Cause?
Drug ineffective (9,352)
Drug hypersensitivity (5,269)
Nausea (4,129)
Vomiting (4,116)
Acute kidney injury (3,639)
Toxicity to various agents (3,584)
Off label use (3,556)
Intentional overdose (3,185)
Headache (3,010)
Dyspnoea (2,906)
What Other Drugs Cause Product use in unapproved indication?
DUPILUMAB (33,452)
DICLOFENAC (12,197)
METHOTREXATE (8,930)
PREDNISONE (7,625)
RITUXIMAB (7,519)
MYCOPHENOLATE MOFETIL (5,910)
ACETAMINOPHEN (5,819)
CYCLOPHOSPHAMIDE (5,750)
RISPERIDONE (5,551)
TACROLIMUS (5,057)
Which IBUPROFEN Alternatives Have Lower Product use in unapproved indication Risk?
IBUPROFEN vs IBUPROFEN LYSINE
IBUPROFEN vs IBUPROFEN UNKNOWN PRODUCT
IBUPROFEN vs IBUPROFEN\IBUPROFEN
IBUPROFEN vs IBUPROFEN\PHENYLEPHRINE
IBUPROFEN vs IBUPROFEN\PSEUDOEPHEDRINE