DRONEDARONE for Prophylaxis: Side Effects & Safety Data
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There are 6 adverse event reports in the FDA FAERS database where DRONEDARONE was used for 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)
Arrhythmia prophylaxis (16)
Cardiovascular disorder (11)
Other Drugs Used for Prophylaxis
PEGFILGRASTIM (7,424)
HUMAN C1-ESTERASE INHIBITOR (5,950)
DENOSUMAB (4,541)
SULFAMETHOXAZOLE\TRIMETHOPRIM (3,197)
ASPIRIN (2,083)
VALACYCLOVIR (1,574)
PANTOPRAZOLE (1,502)
VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN (1,444)
CLOPIDOGREL BISULFATE (1,296)
ENOXAPARIN (1,278)