DESLORATADINE ORAL SOLUTION

Generic: DESLORATADINE

INA PharmaceuticsManufacturer
ORALRoute
DESLORATADINEActive Substance
2016-05-26Original Approval

DESLORATADINE ORAL SOLUTION is FDA application ANDA202936, sponsored by TARO. 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 II2023-12-20
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manu

CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.

Top Reported Reactions

1
FATIGUE
375 reports
2
DRUG INEFFECTIVE
358 reports
3
DYSPNOEA
341 reports
4
NAUSEA
329 reports
5
PRURITUS
322 reports
6
DIARRHOEA
296 reports
7
OFF LABEL USE
286 reports
8
HEADACHE
281 reports
9
RASH
281 reports
10
VOMITING
279 reports