ACETAMINOPHEN AND IBUPROFEN
Generic: ACETAMINOPHEN AND IBUPROFEN
AMERISOURCE BERGENManufacturer
ORALRoute
IBUPROFENActive Substance
2023-08-01Original Approval
ACETAMINOPHEN AND IBUPROFEN is FDA application ANDA216999, sponsored by BIONPHARMA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Top Reported Reactions
1
DRUG INEFFECTIVE
48 reports
2
DRUG EFFECTIVE FOR UNAPPROVED INDICATION
30 reports
3
THERAPEUTIC PRODUCT EFFECT INCOMPLETE
27 reports
4
DRUG EFFECT LESS THAN EXPECTED
15 reports
5
UNDERDOSE
13 reports
6
OVERDOSE
10 reports
7
INCORRECT DOSE ADMINISTERED
9 reports
8
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION
8 reports
9
HYPERSENSITIVITY
7 reports
10
OFF LABEL USE
7 reports