Does ACETAMINOPHEN Cause Product use in unapproved indication? 5,819 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 5,819 reports of Product use in unapproved indication have been filed in association with ACETAMINOPHEN (Hydrocodone Bitartrate and Acetaminophen). This represents 4.3% of all adverse event reports for ACETAMINOPHEN.
5,819
Reports of Product use in unapproved indication with ACETAMINOPHEN
4.3%
of all ACETAMINOPHEN reports
1,145
Deaths
1,785
Hospitalizations
How Dangerous Is Product use in unapproved indication From ACETAMINOPHEN?
Of the 5,819 reports, 1,145 (19.7%) resulted in death, 1,785 (30.7%) required hospitalization, and 1,328 (22.8%) 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. However, 5,819 reports have been filed with the FAERS database.
What Other Side Effects Does ACETAMINOPHEN Cause?
Drug ineffective (17,522)
Toxicity to various agents (16,128)
Off label use (9,410)
Vomiting (9,055)
Pain (8,573)
Fatigue (8,202)
Overdose (7,917)
Nausea (7,245)
Rash (7,107)
Headache (7,084)
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)
CYCLOPHOSPHAMIDE (5,750)
RISPERIDONE (5,551)
TACROLIMUS (5,057)
CYCLOSPORINE (5,019)
Which ACETAMINOPHEN Alternatives Have Lower Product use in unapproved indication Risk?
ACETAMINOPHEN vs ACETAMINOPHEN AND OR DEXTROMETHORPHAN AND OR DIPHENHYDRAMINE AND OR GUAIFENESIN AND OR PHENYLEPHRINE AND OR PSEUDOEPHEDRINE
ACETAMINOPHEN vs ACETAMINOPHEN W/HYDROCODONE
ACETAMINOPHEN vs ACETAMINOPHEN\ASPIRIN\CAFFEINE
ACETAMINOPHEN vs ACETAMINOPHEN\ASPIRIN\CAFFEINE\SALICYLAMIDE
ACETAMINOPHEN vs ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM