REGADENOSON

Generic: REGADENOSON

Meitheal Pharmaceuticals Inc.Manufacturer
INTRAVENOUSRoute
REGADENOSONActive Substance
2022-04-11Original Approval

REGADENOSON is FDA application ANDA212806, sponsored by MEITHEAL. 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 II2024-10-30
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Ph

Labeling: Missing Label

Top Reported Reactions

1
HYPOTENSION
59 reports
2
NAUSEA
57 reports
3
DYSPNOEA
52 reports
4
HEADACHE
42 reports
5
CHEST PAIN
35 reports
6
DIZZINESS
34 reports
7
UNRESPONSIVE TO STIMULI
29 reports
8
CARDIAC ARREST
26 reports
9
BRADYCARDIA
25 reports
10
SEIZURE
24 reports