DOFETILIDE

N/A

Manufactured by Pfizer Laboratories Div Pfizer Inc

17,040 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DOFETILIDE

DOFETILIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. The most commonly reported adverse reactions for DOFETILIDE include ATRIAL FIBRILLATION, DRUG INEFFECTIVE, DYSPNOEA, DIZZINESS, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DOFETILIDE.

Top Adverse Reactions

ATRIAL FIBRILLATION1,057 reports
DRUG INEFFECTIVE1,025 reports
DYSPNOEA602 reports
DIZZINESS552 reports
FATIGUE522 reports
DEATH478 reports
ELECTROCARDIOGRAM QT PROLONGED443 reports
HEADACHE387 reports
MALAISE319 reports
DIARRHOEA316 reports
DRUG INTERACTION297 reports
NAUSEA288 reports
HEART RATE INCREASED286 reports
ASTHENIA285 reports
ARRHYTHMIA265 reports
CARDIAC DISORDER249 reports
OFF LABEL USE238 reports
COUGH223 reports
PALPITATIONS222 reports
CONDITION AGGRAVATED217 reports
FALL215 reports
CHEST PAIN213 reports
WEIGHT DECREASED199 reports
PNEUMONIA195 reports
FEELING ABNORMAL186 reports
PAIN182 reports
VENTRICULAR TACHYCARDIA172 reports
INSOMNIA171 reports
URINARY TRACT INFECTION168 reports
TORSADE DE POINTES164 reports
HYPERTENSION156 reports
RASH156 reports
CARDIAC ARREST155 reports
CEREBROVASCULAR ACCIDENT155 reports
CARDIAC FAILURE CONGESTIVE152 reports
PRURITUS151 reports
PAIN IN EXTREMITY150 reports
HYPOTENSION146 reports
ARTHRALGIA145 reports
NASOPHARYNGITIS143 reports
HEART RATE IRREGULAR136 reports
DRUG HYPERSENSITIVITY134 reports
WEIGHT INCREASED134 reports
GAIT DISTURBANCE132 reports
BACK PAIN131 reports
BLOOD PRESSURE INCREASED125 reports
MYOCARDIAL INFARCTION124 reports
ANXIETY123 reports
HEART RATE DECREASED115 reports
MUSCLE SPASMS114 reports
VOMITING114 reports
DECREASED APPETITE112 reports
HOSPITALISATION108 reports
TACHYCARDIA107 reports
CONSTIPATION103 reports
CHEST DISCOMFORT102 reports
HYPOACUSIS99 reports
LOSS OF CONSCIOUSNESS99 reports
OEDEMA PERIPHERAL99 reports
MEMORY IMPAIRMENT98 reports
ATRIAL FLUTTER96 reports
ABDOMINAL DISCOMFORT92 reports
GASTROINTESTINAL HAEMORRHAGE92 reports
DYSPHAGIA90 reports
TREMOR89 reports
SINUSITIS88 reports
SYNCOPE86 reports
BRONCHITIS85 reports
HYPERHIDROSIS84 reports
CARDIAC FAILURE83 reports
EPISTAXIS82 reports
ABDOMINAL PAIN UPPER81 reports
PERIPHERAL SWELLING79 reports
VISUAL IMPAIRMENT79 reports
PYREXIA78 reports
BLOOD POTASSIUM DECREASED77 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE77 reports
PRODUCT PRESCRIBING ERROR77 reports
BLOOD PRESSURE DECREASED75 reports
FLUID RETENTION75 reports
INCORRECT DOSE ADMINISTERED75 reports
PRODUCT USE IN UNAPPROVED INDICATION74 reports
VENTRICULAR FIBRILLATION74 reports
BRADYCARDIA73 reports
CONFUSIONAL STATE73 reports
DEPRESSION73 reports
INFLUENZA73 reports
MYALGIA73 reports
HYPOAESTHESIA72 reports
RENAL FAILURE72 reports
PARAESTHESIA71 reports
SOMNOLENCE71 reports
HYPERSENSITIVITY70 reports
ANAEMIA69 reports
DRUG DOSE OMISSION69 reports
INFECTION69 reports
BLOOD GLUCOSE INCREASED68 reports
DYSPEPSIA68 reports
DYSPNOEA EXERTIONAL68 reports
BALANCE DISORDER66 reports

Report Outcomes

Out of 10,301 classified reports for DOFETILIDE:

Serious 59.7%Non-Serious 40.3%

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

Male4,743 (50.7%)
Female4,502 (48.2%)
Unknown101 (1.1%)

Reports by Age

Age 75284 reports
Age 74262 reports
Age 71236 reports
Age 77231 reports
Age 76226 reports
Age 67214 reports
Age 72212 reports
Age 73212 reports
Age 79204 reports
Age 70203 reports
Age 78202 reports
Age 80200 reports
Age 69192 reports
Age 68187 reports
Age 81183 reports
Age 66173 reports
Age 65163 reports
Age 82158 reports
Age 83154 reports
Age 64144 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 DOFETILIDE?

This profile reflects 17,040 FDA FAERS reports that mention DOFETILIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DOFETILIDE?

Frequently reported terms in FAERS include ATRIAL FIBRILLATION, DRUG INEFFECTIVE, DYSPNOEA, DIZZINESS, FATIGUE, DEATH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DOFETILIDE?

Labeling and FAERS entries often list Pfizer Laboratories Div Pfizer Inc in connection with DOFETILIDE. 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.