IVABRADINE

N/A

Manufactured by Amgen Inc

12,129 FDA adverse event reports analyzed

Last updated: 2026-04-15

About IVABRADINE

IVABRADINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amgen Inc. The most commonly reported adverse reactions for IVABRADINE include OFF LABEL USE, DYSPNOEA, HYPOTENSION, DIZZINESS, CARDIAC FAILURE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IVABRADINE.

Top Adverse Reactions

OFF LABEL USE1,295 reports
DYSPNOEA460 reports
HYPOTENSION413 reports
DIZZINESS350 reports
CARDIAC FAILURE324 reports
FATIGUE317 reports
DRUG INTERACTION308 reports
DRUG INEFFECTIVE270 reports
NAUSEA253 reports
BRADYCARDIA248 reports
HEADACHE231 reports
CHEST PAIN195 reports
MALAISE185 reports
PALPITATIONS174 reports
ASTHENIA162 reports
SYNCOPE156 reports
DIARRHOEA153 reports
OEDEMA PERIPHERAL152 reports
DEATH142 reports
HEART RATE INCREASED142 reports
ACUTE KIDNEY INJURY141 reports
TACHYCARDIA134 reports
FALL133 reports
VOMITING133 reports
FEELING ABNORMAL125 reports
COUGH117 reports
PNEUMONIA117 reports
PYREXIA109 reports
PULMONARY OEDEMA107 reports
CONDITION AGGRAVATED104 reports
VISUAL IMPAIRMENT102 reports
EJECTION FRACTION DECREASED101 reports
PAIN99 reports
WEIGHT INCREASED97 reports
ANAEMIA96 reports
ARTHRALGIA95 reports
RASH95 reports
WEIGHT DECREASED95 reports
ELECTROCARDIOGRAM QT PROLONGED93 reports
ATRIAL FIBRILLATION92 reports
ANGINA PECTORIS90 reports
HYPERTENSION90 reports
COVID 1989 reports
HEART RATE DECREASED87 reports
CARDIAC FAILURE CHRONIC85 reports
DECREASED APPETITE85 reports
PHOTOPSIA85 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS81 reports
HOSPITALISATION78 reports
PRODUCT USE ISSUE78 reports
DYSPNOEA EXERTIONAL77 reports
GENERAL PHYSICAL HEALTH DETERIORATION77 reports
PRESYNCOPE77 reports
CHEST DISCOMFORT75 reports
PRURITUS75 reports
ANXIETY74 reports
BLOOD PRESSURE DECREASED72 reports
SOMNOLENCE72 reports
VISION BLURRED71 reports
BLOOD PRESSURE INCREASED70 reports
PAIN IN EXTREMITY69 reports
ARRHYTHMIA68 reports
CONFUSIONAL STATE66 reports
MUSCLE SPASMS66 reports
TREMOR66 reports
URTICARIA66 reports
HYPERHIDROSIS64 reports
HYPERKALAEMIA64 reports
MYALGIA64 reports
PRODUCT DOSE OMISSION ISSUE64 reports
BLOOD CREATININE INCREASED63 reports
CONSTIPATION63 reports
PRODUCT USE IN UNAPPROVED INDICATION63 reports
TORSADE DE POINTES63 reports
CARDIAC DISORDER62 reports
INSOMNIA62 reports
INTENTIONAL OVERDOSE62 reports
CONTRAINDICATED PRODUCT ADMINISTERED61 reports
MIGRAINE61 reports
RENAL FAILURE61 reports
VENTRICULAR TACHYCARDIA61 reports
CARDIAC ARREST60 reports
CONTUSION60 reports
PERIPHERAL SWELLING60 reports
TOXICITY TO VARIOUS AGENTS60 reports
ABDOMINAL PAIN UPPER59 reports
MYOCARDIAL INFARCTION59 reports
PSORIASIS59 reports
SEPSIS59 reports
DEPRESSION58 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION58 reports
OVERDOSE57 reports
SINUS BRADYCARDIA57 reports
URINARY TRACT INFECTION56 reports
ACUTE MYOCARDIAL INFARCTION55 reports
FLUID RETENTION55 reports
LOSS OF CONSCIOUSNESS55 reports
SINUS TACHYCARDIA55 reports
CARDIAC FAILURE CONGESTIVE53 reports
ANGIOEDEMA52 reports

Report Outcomes

Out of 6,540 classified reports for IVABRADINE:

Serious 71.6%Non-Serious 28.4%

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

Female3,218 (57.6%)
Male2,365 (42.3%)
Unknown6 (0.1%)

Reports by Age

Age 68130 reports
Age 70124 reports
Age 67119 reports
Age 69113 reports
Age 60108 reports
Age 51103 reports
Age 62103 reports
Age 77103 reports
Age 7299 reports
Age 5692 reports
Age 5991 reports
Age 6190 reports
Age 6589 reports
Age 5488 reports
Age 5587 reports
Age 6386 reports
Age 5385 reports
Age 7184 reports
Age 4683 reports
Age 6483 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 IVABRADINE?

This profile reflects 12,129 FDA FAERS reports that mention IVABRADINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for IVABRADINE?

Frequently reported terms in FAERS include OFF LABEL USE, DYSPNOEA, HYPOTENSION, DIZZINESS, CARDIAC FAILURE, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures IVABRADINE?

Labeling and FAERS entries often list Amgen Inc in connection with IVABRADINE. 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.