Drug side effects
dofetilide Side Effects
The reactions most often reported to the FDA for dofetilide (also sold as Tikosyn), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 10,302
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of dofetilide come from 10,302 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 10,302 reports to the FDA Adverse Event Reporting System (FAERS) for dofetilide (Tikosyn): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
10,302
Reports Mentioning Death
799
7.8% of reports — not proof the medicine caused the death
Hospitalizations
2,960
28.7% of reports
Top Indication
Atrial Fibrillation
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 799 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 478 |
| CARDIAC ARREST | 39 |
| CARDIAC FAILURE CONGESTIVE | 34 |
| DYSPNOEA | 33 |
| MYOCARDIAL INFARCTION | 32 |
| ATRIAL FIBRILLATION | 31 |
| PNEUMONIA | 27 |
| CARDIAC FAILURE | 25 |
| RENAL FAILURE | 23 |
| CARDIAC DISORDER | 22 |
| COMPLETED SUICIDE | 20 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 19 |
| FATIGUE | 19 |
| SEPSIS | 17 |
| HYPOTENSION | 16 |
| VENTRICULAR TACHYCARDIA | 16 |
| RESPIRATORY FAILURE | 15 |
| WEIGHT DECREASED | 15 |
| ASTHENIA | 14 |
Reactions in Hospitalization Reports
Top reactions in 2,960 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| ATRIAL FIBRILLATION | 504 |
| DYSPNOEA | 278 |
| DIZZINESS | 173 |
| ELECTROCARDIOGRAM QT PROLONGED | 169 |
| FATIGUE | 155 |
| PNEUMONIA | 150 |
| FALL | 130 |
| HEART RATE INCREASED | 121 |
| ASTHENIA | 120 |
| CARDIAC DISORDER | 112 |
| ARRHYTHMIA | 110 |
| DIARRHOEA | 110 |
| HEADACHE | 109 |
| NAUSEA | 108 |
| CARDIAC FAILURE CONGESTIVE | 105 |
| VENTRICULAR TACHYCARDIA | 103 |
| HOSPITALISATION | 101 |
| CONDITION AGGRAVATED | 100 |
| CHEST PAIN | 97 |
Nearby, Related Medications
What the FAERS Data Reveals About dofetilide Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 10,302 voluntary reports linked to dofetilide and its brand equivalents (Tikosyn), spanning 2004 through 2025. Of those, 799 (7.8%) listed death as an outcome and 2,960 (28.7%) involved hospitalization. The most common indication reported alongside adverse events was Atrial Fibrillation.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 48% were female and 51% male; age distribution skews toward 75+, with 2,423 reports in that bracket. The single most reported reaction is atrial fibrillation with 1,058 submissions, followed by dyspnoea and dizziness.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to dofetilide's 10,302.
Read our methodology - how this data is sourced, computed, and verified.