REGADENOSON

N/A

Manufactured by Astellas Pharma US, Inc.

8,610 FDA adverse event reports analyzed

Last updated: 2026-04-15

About REGADENOSON

REGADENOSON is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Astellas Pharma US, Inc.. The most commonly reported adverse reactions for REGADENOSON include NAUSEA, DYSPNOEA, INJECTION SITE EXTRAVASATION, VOMITING, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for REGADENOSON.

Top Adverse Reactions

NAUSEA509 reports
DYSPNOEA408 reports
INJECTION SITE EXTRAVASATION361 reports
VOMITING357 reports
HEADACHE315 reports
HYPOTENSION312 reports
CARDIAC ARREST283 reports
DIZZINESS272 reports
SEIZURE251 reports
CHEST PAIN230 reports
BLOOD PRESSURE DECREASED207 reports
BRADYCARDIA195 reports
TREMOR182 reports
LOSS OF CONSCIOUSNESS181 reports
UNRESPONSIVE TO STIMULI160 reports
DIARRHOEA155 reports
PAIN IN EXTREMITY143 reports
HEART RATE INCREASED128 reports
CHEST DISCOMFORT108 reports
SYNCOPE106 reports
MALAISE105 reports
HEART RATE DECREASED100 reports
INJECTION SITE PAIN95 reports
HYPERHIDROSIS86 reports
BLOOD PRESSURE INCREASED84 reports
HYPERTENSION80 reports
INCORRECT PRODUCT ADMINISTRATION DURATION79 reports
BACK PAIN77 reports
ATRIOVENTRICULAR BLOCK76 reports
FEELING ABNORMAL76 reports
ABDOMINAL DISCOMFORT75 reports
ATRIOVENTRICULAR BLOCK COMPLETE74 reports
CEREBROVASCULAR ACCIDENT74 reports
PRESYNCOPE70 reports
ABDOMINAL PAIN69 reports
FATIGUE68 reports
MYOCARDIAL INFARCTION68 reports
FLUSHING67 reports
MUSCLE SPASMS67 reports
ASTHENIA65 reports
PAIN64 reports
OFF LABEL USE63 reports
INFUSION SITE EXTRAVASATION58 reports
ABDOMINAL PAIN UPPER56 reports
ATRIAL FIBRILLATION56 reports
CONVULSION56 reports
RASH56 reports
HYPOAESTHESIA54 reports
DEATH52 reports
INCORRECT DRUG ADMINISTRATION DURATION52 reports
NO ADVERSE EVENT51 reports
URTICARIA50 reports
HYPERSENSITIVITY49 reports
MYALGIA47 reports
EXTRAVASATION46 reports
ATRIOVENTRICULAR BLOCK SECOND DEGREE44 reports
WHEEZING44 reports
ANXIETY43 reports
PARAESTHESIA42 reports
ACUTE MYOCARDIAL INFARCTION41 reports
TACHYCARDIA41 reports
SINUS ARREST40 reports
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION39 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS39 reports
CARDIO RESPIRATORY ARREST36 reports
DRUG HYPERSENSITIVITY36 reports
RESPIRATORY ARREST36 reports
RETCHING35 reports
DRUG INEFFECTIVE34 reports
ERYTHEMA34 reports
APHASIA33 reports
LETHARGY33 reports
ANAPHYLACTIC REACTION32 reports
BRONCHOSPASM32 reports
CHILLS31 reports
ELECTROCARDIOGRAM ST SEGMENT ELEVATION30 reports
PALLOR30 reports
ARTHRALGIA29 reports
VENTRICULAR EXTRASYSTOLES29 reports
PRURITUS28 reports
MENTAL STATUS CHANGES27 reports
MIGRAINE27 reports
VISION BLURRED27 reports
DRUG ADMINISTRATION ERROR26 reports
BURNING SENSATION25 reports
MUSCULOSKELETAL PAIN25 reports
NODAL RHYTHM25 reports
PRODUCT QUALITY ISSUE25 reports
THROAT TIGHTNESS25 reports
VENTRICULAR TACHYCARDIA25 reports
ELECTROCARDIOGRAM ABNORMAL24 reports
INFUSION SITE PAIN24 reports
SPEECH DISORDER24 reports
SUPRAVENTRICULAR TACHYCARDIA24 reports
DISCOMFORT23 reports
MUSCULOSKELETAL STIFFNESS23 reports
PALPITATIONS23 reports
PULSE ABSENT23 reports
SEIZURE LIKE PHENOMENA23 reports
SYRINGE ISSUE23 reports

Report Outcomes

Out of 4,708 classified reports for REGADENOSON:

Serious 55.6%Non-Serious 44.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female2,270 (56.6%)
Male1,518 (37.8%)
Unknown223 (5.6%)

Reports by Age

Age 6794 reports
Age 7091 reports
Age 6882 reports
Age 6577 reports
Age 6976 reports
Age 773 reports
Age 6071 reports
Age 7870 reports
Age 5569 reports
Age 6669 reports
Age 7569 reports
Age 7167 reports
Age 8067 reports
Age 6166 reports
Age 7266 reports
Age 7466 reports
Age 6265 reports
Age 7364 reports
Age 7764 reports
Age 7963 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with REGADENOSON?

This profile reflects 8,610 FDA FAERS reports that mention REGADENOSON. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for REGADENOSON?

Frequently reported terms in FAERS include NAUSEA, DYSPNOEA, INJECTION SITE EXTRAVASATION, VOMITING, HEADACHE, HYPOTENSION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures REGADENOSON?

Labeling and FAERS entries often list Astellas Pharma US, Inc. in connection with REGADENOSON. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.