GANIRELIX ACETATE

Generic: GANIRELIX ACETATE

Fresenius Kabi USAManufacturer
SUBCUTANEOUSRoute
GANIRELIX ACETATEActive Substance
2023-02-28Original Approval

GANIRELIX ACETATE is FDA application ANDA215658, sponsored by GLAND. 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 II2025-11-13
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Man

Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acr

Top Reported Reactions

1
OVARIAN HYPERSTIMULATION SYNDROME
222 reports
2
ASCITES
44 reports
3
NAUSEA
35 reports
4
DYSPNOEA
29 reports
5
ABDOMINAL PAIN
26 reports
6
DRUG INEFFECTIVE
26 reports
7
HEADACHE
25 reports
8
ABDOMINAL DISTENSION
20 reports
9
FATIGUE
20 reports
10
MATERNAL EXPOSURE BEFORE PREGNANCY
19 reports