EDOXABAN TOSYLATE

N/A

Manufactured by Daiichi Sankyo Inc.

9,635 FDA adverse event reports analyzed

Last updated: 2026-04-15

About EDOXABAN TOSYLATE

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

Top Adverse Reactions

ANAEMIA290 reports
OFF LABEL USE270 reports
RENAL IMPAIRMENT268 reports
CARDIAC FAILURE243 reports
DYSPNOEA243 reports
CEREBRAL INFARCTION239 reports
NAUSEA218 reports
PNEUMONIA195 reports
ATRIAL FIBRILLATION191 reports
FALL188 reports
GASTROINTESTINAL HAEMORRHAGE182 reports
DIARRHOEA180 reports
FATIGUE178 reports
DIZZINESS174 reports
ACUTE KIDNEY INJURY173 reports
DECREASED APPETITE160 reports
PYREXIA145 reports
DRUG INTERACTION140 reports
HAEMATURIA140 reports
MALAISE139 reports
HYPOTENSION137 reports
VOMITING137 reports
ASTHENIA136 reports
DEATH132 reports
GENERAL PHYSICAL HEALTH DETERIORATION128 reports
DEHYDRATION123 reports
CEREBROVASCULAR ACCIDENT121 reports
EPISTAXIS121 reports
HEADACHE117 reports
OEDEMA PERIPHERAL114 reports
INTERSTITIAL LUNG DISEASE112 reports
RASH110 reports
HAEMORRHAGE95 reports
SYNCOPE94 reports
PLEURAL EFFUSION91 reports
DRUG INEFFECTIVE90 reports
MELAENA87 reports
HYPONATRAEMIA84 reports
CEREBRAL HAEMORRHAGE83 reports
CONSTIPATION83 reports
ARTHRALGIA82 reports
COVID 1980 reports
URINARY TRACT INFECTION79 reports
HAEMOGLOBIN DECREASED77 reports
LOSS OF CONSCIOUSNESS77 reports
HYPERTENSION76 reports
ABDOMINAL PAIN73 reports
BACK PAIN73 reports
EMBOLIC STROKE73 reports
WEIGHT DECREASED73 reports
PLATELET COUNT DECREASED72 reports
PRURITUS72 reports
GAIT DISTURBANCE71 reports
RENAL FAILURE70 reports
BLOOD PRESSURE DECREASED69 reports
PNEUMONIA ASPIRATION68 reports
C REACTIVE PROTEIN INCREASED66 reports
CARDIAC FAILURE ACUTE66 reports
PAIN IN EXTREMITY66 reports
COUGH64 reports
PERIPHERAL SWELLING64 reports
FEBRILE NEUTROPENIA63 reports
HAEMATOCHEZIA61 reports
MALIGNANT NEOPLASM PROGRESSION61 reports
SEPSIS61 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS57 reports
CONTUSION56 reports
INCORRECT DOSE ADMINISTERED56 reports
MYOCARDIAL INFARCTION56 reports
RECTAL HAEMORRHAGE56 reports
BLOOD CREATININE INCREASED55 reports
CHEST PAIN54 reports
CONDITION AGGRAVATED54 reports
PAIN54 reports
PULMONARY EMBOLISM54 reports
ARRHYTHMIA53 reports
BRADYCARDIA53 reports
THROMBOSIS53 reports
ABDOMINAL DISCOMFORT52 reports
PULMONARY HYPERTENSION52 reports
DEEP VEIN THROMBOSIS50 reports
HEPATIC FUNCTION ABNORMAL50 reports
MYALGIA50 reports
PRESYNCOPE50 reports
MITRAL VALVE INCOMPETENCE48 reports
ABDOMINAL PAIN UPPER47 reports
NO ADVERSE EVENT47 reports
HYPOKALAEMIA46 reports
PALPITATIONS46 reports
HYPERKALAEMIA45 reports
INFECTION45 reports
SHOCK HAEMORRHAGIC44 reports
UNDERDOSE44 reports
CARDIAC FAILURE CHRONIC43 reports
CARDIAC FAILURE CONGESTIVE43 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION43 reports
RESPIRATORY FAILURE43 reports
TRICUSPID VALVE INCOMPETENCE43 reports
VISUAL IMPAIRMENT43 reports
BRAIN OEDEMA42 reports

Report Outcomes

Out of 6,051 classified reports for EDOXABAN TOSYLATE:

Serious 88.9%Non-Serious 11.1%

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

Male2,770 (52.1%)
Female2,545 (47.9%)

Reports by Age

Age 85195 reports
Age 78193 reports
Age 77190 reports
Age 82185 reports
Age 80180 reports
Age 83161 reports
Age 74160 reports
Age 84160 reports
Age 81156 reports
Age 86147 reports
Age 76143 reports
Age 72140 reports
Age 79139 reports
Age 75138 reports
Age 73122 reports
Age 88114 reports
Age 69109 reports
Age 71104 reports
Age 68100 reports
Age 70100 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 EDOXABAN TOSYLATE?

This profile reflects 9,635 FDA FAERS reports that mention EDOXABAN TOSYLATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for EDOXABAN TOSYLATE?

Frequently reported terms in FAERS include ANAEMIA, OFF LABEL USE, RENAL IMPAIRMENT, CARDIAC FAILURE, DYSPNOEA, CEREBRAL INFARCTION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures EDOXABAN TOSYLATE?

Labeling and FAERS entries often list Daiichi Sankyo Inc. in connection with EDOXABAN TOSYLATE. 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.