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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.

Does IBUPROFEN Cause Product label issue? 99 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 99 reports of Product label issue have been filed in association with IBUPROFEN (equate ibuprofen). This represents 0.1% of all adverse event reports for IBUPROFEN.

99
Reports of Product label issue with IBUPROFEN
0.1%
of all IBUPROFEN reports
8
Deaths
12
Hospitalizations

How Dangerous Is Product label issue From IBUPROFEN?

Of the 99 reports, 8 (8.1%) resulted in death, 12 (12.1%) required hospitalization, and 9 (9.1%) were considered life-threatening.

Is Product label issue Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for IBUPROFEN. However, 99 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) Off label use (3,556) Intentional overdose (3,185) Headache (3,010)

What Other Drugs Cause Product label issue?

RIVAROXABAN (379) ACETAMINOPHEN (276) GUSELKUMAB (177) USTEKINUMAB (164) DIMETHICONE\LOPERAMIDE (154) CETIRIZINE (138) GOLIMUMAB (76) POLYETHYLENE GLYCOL 3350 (76) FENTANYL (72) LOPERAMIDE (72)

Which IBUPROFEN Alternatives Have Lower Product label issue Risk?

IBUPROFEN vs IBUPROFEN LYSINE IBUPROFEN vs IBUPROFEN UNKNOWN PRODUCT IBUPROFEN vs IBUPROFEN\IBUPROFEN IBUPROFEN vs IBUPROFEN\PHENYLEPHRINE IBUPROFEN vs IBUPROFEN\PSEUDOEPHEDRINE

Related Pages

IBUPROFEN Full Profile All Product label issue Reports All Drugs Causing Product label issue IBUPROFEN Demographics