MID-VOLUME · HOSP-MID
dofetilide Side Effects
dofetilide (also sold as Tikosyn) sits MID-VOLUME #312 of 524 by FAERS report count. Lead signal: HOSP-MID - 28.7% mention hospitalization (2,960 reports). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 10,302
- FAERS reports
FDA Adverse Event Reporting System extract for dofetilide. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-MID. How figures are compiled.
dofetilide: 28.7% mention hospitalization (2,960 reports). Death stamp DEATH-HEAVY; volume band MID-VOLUME #312 of 524 by FAERS report count.
Mid-book FAERS page for dofetilide (Tikosyn) (10,302 reports). Signature HOSP-MID. Dominant age band on file: 75+. Educational reference only.
Counts from the openFDA FAERS extract (2004–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ATRIAL FIBRILLATION leads 1,058 of 10,302 reports
Who reports · age peak 75+ (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 75+ (2,423 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (799 reports, 7.8%). Top co-reported reactions in that subset - voluntary, not causal.
| 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
Hospitalization mid-share (2,960, 28.7%). Co-reported reactions:
| 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 |
How to read dofetilide FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-MID)
FAERS holds 10,302 voluntary reports linked to dofetilide (Tikosyn), 2004-2025. Death is listed on 799 (7.8%). Hospitalization appears on 2,960 (28.7%). Top co-reported indication: Atrial Fibrillation.
Mid-volume extract - treat DEATH-HEAVY · HOSP-MID as signal-detection rates next to 28.7% mention hospitalization (2,960 reports).
Read with dofetilide
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 10,248 FAERS cases (Δ 54 lighter vs dofetilide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 10,243 FAERS cases (Δ 59 lighter vs dofetilide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 10,232 FAERS cases (Δ 70 lighter vs dofetilide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 10,228 FAERS cases (Δ 74 lighter vs dofetilide); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 54.4 pp vs dofetilide's DEATH-HEAVY): CASELOAD · HOSP-MID.
dofetilide stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.