METHYLPREDNISOLONE SODIUM SUCCINATE

Generic: METHYLPREDNISOLONE

Amneal Pharmaceuticals LLCManufacturer
INTRAMUSCULAR, INTRAVENOUSRoute
METHYLPREDNISOLONE SODIUM SUCCINATEActive Substance
2016-11-09Original Approval

METHYLPREDNISOLONE SODIUM SUCCINATE is FDA application ANDA207549, sponsored by AMNEAL. 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 III2020-01-14
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA

Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to recons

Top Reported Reactions

1
OFF LABEL USE
21,508 reports
2
DRUG INEFFECTIVE
15,486 reports
3
FATIGUE
7,210 reports
4
PAIN
6,746 reports
5
NAUSEA
6,658 reports
6
HEADACHE
6,616 reports
7
PYREXIA
6,425 reports
8
PNEUMONIA
6,329 reports
9
ARTHRALGIA
5,876 reports
10
INFUSION RELATED REACTION
5,692 reports