Does IBUPROFEN Cause Off label use? 3,556 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 3,556 reports of Off label use have been filed in association with IBUPROFEN (equate ibuprofen). This represents 4.1% of all adverse event reports for IBUPROFEN.
3,556
Reports of Off label use with IBUPROFEN
4.1%
of all IBUPROFEN reports
296
Deaths
1,354
Hospitalizations
How Dangerous Is Off label use From IBUPROFEN?
Of the 3,556 reports, 296 (8.3%) resulted in death, 1,354 (38.1%) required hospitalization, and 432 (12.1%) 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 IBUPROFEN. However, 3,556 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)
Product use in unapproved indication (3,596)
Toxicity to various agents (3,584)
Intentional overdose (3,185)
Headache (3,010)
Dyspnoea (2,906)
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 IBUPROFEN Alternatives Have Lower Off label use Risk?
IBUPROFEN vs IBUPROFEN LYSINE
IBUPROFEN vs IBUPROFEN UNKNOWN PRODUCT
IBUPROFEN vs IBUPROFEN\IBUPROFEN
IBUPROFEN vs IBUPROFEN\PHENYLEPHRINE
IBUPROFEN vs IBUPROFEN\PSEUDOEPHEDRINE