ZITHROMAX

Generic: AZITHROMYCIN DIHYDRATE

Pfizer Laboratories Div Pfizer IncManufacturer
ORALRoute
AZITHROMYCIN DIHYDRATEActive Substance
1996-07-18Original Approval

ZITHROMAX is FDA application NDA050711, sponsored by PFIZER. 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 III2014-01-02
Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion only, No latex, No preservative

Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specifi

Top Reported Reactions

1
DRUG HYPERSENSITIVITY
1,996 reports
2
DYSPNOEA
1,451 reports
3
DRUG INEFFECTIVE
1,197 reports
4
NAUSEA
1,128 reports
5
PAIN
1,086 reports
6
DIARRHOEA
1,033 reports
7
FATIGUE
1,007 reports
8
OFF LABEL USE
1,005 reports
9
PNEUMONIA
982 reports
10
HEADACHE
947 reports