MYCOPHENOLIC ACID

Generic: MYCOPHENOLIC ACID

Slate Run PharmaceuticalsManufacturer
ORALRoute
MYCOPHENOLATE SODIUMActive Substance
2021-02-10Original Approval

MYCOPHENOLIC ACID is FDA application ANDA214376, sponsored by YICHANG HUMANWELL. 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 II2024-09-03
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratori

Failed Dissolution Specifications

Top Reported Reactions

1
OFF LABEL USE
2,225 reports
2
DRUG INEFFECTIVE
1,498 reports
3
DIARRHOEA
1,055 reports
4
ACUTE KIDNEY INJURY
901 reports
5
COVID-19
802 reports
6
PRODUCT USE IN UNAPPROVED INDICATION
758 reports
7
NAUSEA
755 reports
8
PYREXIA
749 reports
9
DRUG INTERACTION
732 reports
10
DEATH
703 reports