Does ACETAMINOPHEN\IBUPROFEN Cause Exostosis? 5 Reports in FDA Database

Q: Does ACETAMINOPHEN\IBUPROFEN cause Exostosis?

5 reports of Exostosis have been filed with the FDA for ACETAMINOPHEN\IBUPROFEN, representing 0.2% of all ACETAMINOPHEN\IBUPROFEN adverse event reports.

Q: How dangerous is Exostosis from ACETAMINOPHEN\IBUPROFEN?

Of 5 reports, 5 (100.0%) resulted in death and 5 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 5 reports of Exostosis have been filed in association with ACETAMINOPHEN\IBUPROFEN. This represents 0.2% of all adverse event reports for ACETAMINOPHEN\IBUPROFEN.

Reports of Exostosis with ACETAMINOPHEN\IBUPROFEN

0.2%

of all ACETAMINOPHEN\IBUPROFEN reports

Deaths

Hospitalizations

How Dangerous Is Exostosis From ACETAMINOPHEN\IBUPROFEN?

Of the 5 reports, 5 (100.0%) resulted in death, 5 (100.0%) required hospitalization, and 5 (100.0%) were considered life-threatening.

Is Exostosis Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for ACETAMINOPHEN\IBUPROFEN. However, 5 reports have been filed with the FAERS database.

What Other Side Effects Does ACETAMINOPHEN\IBUPROFEN Cause?

Product use in unapproved indication (1,730) Drug effective for unapproved indication (1,620) Drug ineffective (397) Drug effect less than expected (163) Therapeutic product effect incomplete (159)