LUPRON DEPOT

Generic: LEUPROLIDE ACETATE

AbbVie Inc.Manufacturer
1989-01-26Original Approval

LUPRON DEPOT is FDA application NDA019732, sponsored by ABBVIE ENDOCRINE INC. 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 II2014-03-10
Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syring

Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective

Class II2014-03-10
Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syring

Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defecti

Class II2014-03-10
Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit with prefilled dual-chamber syring

Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective

Class II2014-03-10
LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber sy

Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective

Class II2014-03-10
Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syring

Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective

Top Reported Reactions

1
HOT FLUSH
3,514 reports
2
DEATH
2,344 reports
3
FATIGUE
1,950 reports
4
HEADACHE
1,505 reports
5
PAIN
1,316 reports
6
DRUG INEFFECTIVE
1,245 reports
7
NAUSEA
1,209 reports
8
ARTHRALGIA
1,103 reports
9
ASTHENIA
1,001 reports
10
OFF LABEL USE
987 reports