DIPHENHYDRAMINE
Generic: DIPHENHYDRAMINE HYDROCHLORIDE
Fresenius Kabi USAManufacturer
INTRAMUSCULAR, INTRAVENOUSRoute
DIPHENHYDRAMINE HYDROCHLORIDEActive Substance
2002-05-28Original Approval
DIPHENHYDRAMINE is FDA application ANDA040466, sponsored by APP PHARMS. 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.
Recalls
Class II2022-04-13
Diphenhydramine HCl oral solution, USP, 25 mg/10 mL UD, packaged in a) 10 mL unit dose cups (NDC 0121-0978-10), b) 100-ccGMP deviations: Temperature abuse
Class II2021-03-15
Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Top Reported Reactions
1
OFF LABEL USE
11,372 reports
2
FATIGUE
8,610 reports
3
HEADACHE
8,095 reports
4
DRUG INEFFECTIVE
8,087 reports
5
NAUSEA
7,347 reports
6
PAIN
7,100 reports
7
INFUSION RELATED REACTION
6,159 reports
8
ARTHRALGIA
5,852 reports
9
TOXICITY TO VARIOUS AGENTS
5,567 reports
10
DYSPNOEA
5,456 reports