AZITHROMYCIN

Generic: AZITHROMYCIN

Sun Pharmaceutical IndustriesManufacturer
INTRAVENOUSRoute
AZITHROMYCIN MONOHYDRATEActive Substance
2013-04-02Original Approval

AZITHROMYCIN is FDA application ANDA090923, sponsored by SUN PHARM INDS LTD. 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
Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-174-10

cGMP deviations: Temperature abuse

Top Reported Reactions

1
OFF LABEL USE
4,384 reports
2
DRUG INEFFECTIVE
4,188 reports
3
DYSPNOEA
3,414 reports
4
NAUSEA
2,465 reports
5
PAIN
2,351 reports
6
PNEUMONIA
2,343 reports
7
COUGH
2,291 reports
8
DIARRHOEA
1,995 reports
9
FATIGUE
1,959 reports
10
HEADACHE
1,872 reports