PROGRAF

Generic: TACROLIMUS

Astellas Pharma USManufacturer
ORALRoute
TACROLIMUSActive Substance
2018-05-24Original Approval

PROGRAF is FDA application NDA210115, sponsored by ASTELLAS. 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 I2024-12-23
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

Top Reported Reactions

1
OFF LABEL USE
14,791 reports
2
DRUG INEFFECTIVE
10,239 reports
3
DRUG INTERACTION
6,290 reports
4
PRODUCT USE IN UNAPPROVED INDICATION
6,286 reports
5
ACUTE KIDNEY INJURY
5,967 reports
6
DIARRHOEA
5,792 reports
7
TRANSPLANT REJECTION
4,823 reports
8
DEATH
4,812 reports
9
PYREXIA
4,795 reports
10
CYTOMEGALOVIRUS INFECTION
4,526 reports