DRONEDARONE for Arrhythmia prophylaxis: Side Effects & Safety Data
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There are 16 adverse event reports in the FDA FAERS database where DRONEDARONE was used for Arrhythmia prophylaxis.
Most Reported Side Effects for DRONEDARONE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Atrial fibrillation | 309 | 11.3% | 8 | 99 |
| Dyspnoea | 235 | 8.6% | 8 | 75 |
| Fatigue | 206 | 7.5% | 4 | 34 |
| Off label use | 189 | 6.9% | 8 | 7 |
| Drug interaction | 176 | 6.4% | 11 | 93 |
| Nausea | 151 | 5.5% | 5 | 24 |
| Diarrhoea | 141 | 5.2% | 7 | 34 |
| Dizziness | 136 | 5.0% | 1 | 36 |
| Drug ineffective | 128 | 4.7% | 2 | 25 |
| Asthenia | 101 | 3.7% | 5 | 25 |
| Palpitations | 87 | 3.2% | 0 | 33 |
| Rash | 77 | 2.8% | 3 | 8 |
| Heart rate decreased | 76 | 2.8% | 1 | 14 |
| Pruritus | 75 | 2.7% | 1 | 9 |
| Blood creatinine increased | 72 | 2.6% | 4 | 11 |
Other Indications for DRONEDARONE
Atrial fibrillation (1,370)
Product used for unknown indication (319)
Atrial flutter (68)
Arrhythmia (58)
Supraventricular tachycardia (35)
Cardiac disorder (20)
Ventricular extrasystoles (20)
Heart rate irregular (19)
Cardiovascular disorder (11)
Ventricular tachycardia (11)
Other Drugs Used for Arrhythmia prophylaxis
AMIODARONE (122)
RIVAROXABAN (64)
DABIGATRAN ETEXILATE (31)
WARFARIN (29)
PROPAFENONE (16)
METOPROLOL (15)
FLECAINIDE (14)
SOTALOL (14)
TINZAPARIN (12)
APIXABAN (11)