DIPHENHYDRAMINE HYDROCHLORIDE
Generic: DIPHENHYDRAMINE HYDROCHLORIDE
Armas Pharmaceuticals Inc.Manufacturer
INTRAMUSCULAR, INTRAVENOUSRoute
DIPHENHYDRAMINE HYDROCHLORIDEActive Substance
2018-08-22Original Approval
DIPHENHYDRAMINE HYDROCHLORIDE is FDA application ANDA205723, sponsored by MICRO LABS. 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
FATIGUE
3,563 reports
2
OFF LABEL USE
3,208 reports
3
PAIN
3,183 reports
4
HEADACHE
3,169 reports
5
DRUG INEFFECTIVE
2,868 reports
6
INFUSION RELATED REACTION
2,804 reports
7
NAUSEA
2,760 reports
8
ARTHRALGIA
2,755 reports
9
NASOPHARYNGITIS
2,438 reports
10
PNEUMONIA
2,375 reports