IBUPROFEN PM

Generic: IBUPROFEN AND DIPHENHYDRAMINE CITRATE

KROGER COMPANYManufacturer
ORALRoute
IBUPROFENActive Substance
2022-05-31Original Approval

IBUPROFEN PM is FDA application ANDA216204, sponsored by AUROBINDO PHARMA. 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
59 reports
2
OFF LABEL USE
57 reports
3
UNDERDOSE
46 reports
4
PRODUCT NAME CONFUSION
44 reports
5
SOMNOLENCE
35 reports
6
EXPIRED PRODUCT ADMINISTERED
32 reports
7
INCORRECT DOSE ADMINISTERED
26 reports
8
DIZZINESS
23 reports
9
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS
23 reports
10
ACCIDENTAL OVERDOSE
21 reports