Does ACETAMINOPHEN\IBUPROFEN Cause Product use in unapproved indication? 1,730 Reports in FDA Database

Q: Does ACETAMINOPHEN\IBUPROFEN cause Product use in unapproved indication?

1,730 reports of Product use in unapproved indication have been filed with the FDA for ACETAMINOPHEN\IBUPROFEN, representing 57.6% of all ACETAMINOPHEN\IBUPROFEN adverse event reports.

Q: How dangerous is Product use in unapproved indication from ACETAMINOPHEN\IBUPROFEN?

Of 1,730 reports, 12 (0.7%) resulted in death and 14 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 1,730 reports of Product use in unapproved indication have been filed in association with ACETAMINOPHEN\IBUPROFEN. This represents 57.6% of all adverse event reports for ACETAMINOPHEN\IBUPROFEN.

1,730

Reports of Product use in unapproved indication with ACETAMINOPHEN\IBUPROFEN

57.6%

of all ACETAMINOPHEN\IBUPROFEN reports

Deaths

Hospitalizations

How Dangerous Is Product use in unapproved indication From ACETAMINOPHEN\IBUPROFEN?

Of the 1,730 reports, 12 (0.7%) resulted in death, 14 (0.8%) required hospitalization, and 13 (0.8%) 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 ACETAMINOPHEN\IBUPROFEN. However, 1,730 reports have been filed with the FAERS database.

What Other Side Effects Does ACETAMINOPHEN\IBUPROFEN Cause?

Drug effective for unapproved indication (1,620) Drug ineffective (397) Drug effect less than expected (163) Therapeutic product effect incomplete (159) Drug ineffective for unapproved indication (97) Therapeutic response unexpected (91) Abdominal discomfort (76) Incorrect dose administered (53) Abdominal pain upper (52) Hypersensitivity (48)

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 ACETAMINOPHEN\IBUPROFEN Alternatives Have Lower Product use in unapproved indication Risk?

ACETAMINOPHEN\IBUPROFEN vs ACETAMINOPHEN\METHOCARBAMOL ACETAMINOPHEN\IBUPROFEN vs ACETAMINOPHEN\OPIUM ACETAMINOPHEN\IBUPROFEN vs ACETAMINOPHEN\OXYCODONE ACETAMINOPHEN\IBUPROFEN vs ACETAMINOPHEN\OXYCODONE\OXYCODONE ACETAMINOPHEN\IBUPROFEN vs ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE

ACETAMINOPHEN\IBUPROFEN Full Profile All Product use in unapproved indication Reports All Drugs Causing Product use in unapproved indication ACETAMINOPHEN\IBUPROFEN Demographics