SIROLIMUS
Generic: SIROLIMUS
NORTHSTAR RX LLCManufacturer
ORALRoute
SIROLIMUSActive Substance
2020-10-16Original Approval
SIROLIMUS is FDA application ANDA208691, sponsored by GLENMARK PHARMS 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 III2024-05-01
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08Failed Impurities/Degradation Specifications
Class III2021-05-12
Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American HealFailed Impurities/Degradation Specifications
Class III2016-06-03
Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5Failed impurities/degradation: out of specification result for impurity secorapamycin.
Top Reported Reactions
1
OFF LABEL USE
2,004 reports
2
DRUG INEFFECTIVE
1,106 reports
3
PRODUCT USE IN UNAPPROVED INDICATION
778 reports
4
PYREXIA
522 reports
5
DIARRHOEA
513 reports
6
PNEUMONIA
486 reports
7
DRUG INTERACTION
448 reports
8
ACUTE KIDNEY INJURY
434 reports
9
THROMBOTIC MICROANGIOPATHY
376 reports
10
TRANSPLANT REJECTION
372 reports