DRONEDARONE for Atrial fibrillation: Side Effects & Safety Data
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There are 1,370 adverse event reports in the FDA FAERS database where DRONEDARONE was used for Atrial fibrillation.
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
Product used for unknown indication (319)
Atrial flutter (68)
Arrhythmia (58)
Supraventricular tachycardia (35)
Cardiac disorder (20)
Ventricular extrasystoles (20)
Heart rate irregular (19)
Arrhythmia prophylaxis (16)
Cardiovascular disorder (11)
Ventricular tachycardia (11)
Other Drugs Used for Atrial fibrillation
RIVAROXABAN (52,584)
DABIGATRAN ETEXILATE (20,492)
APIXABAN (10,500)
AMIODARONE (9,083)
WARFARIN (8,680)
EDOXABAN (3,855)
ASPIRIN (2,993)
DOFETILIDE (2,439)
PRADAXA (2,325)
METOPROLOL (1,542)