Dronedarone

Common brands: Multaq, Metoprolol, Metoprolol Tartrate, Bayer Low Dose, Ecotrin

Top reporter: Sanofi-Aventis U.S. Llc

Antiarrhythmic [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Loop Diuretic [EPC]Platelet Aggregation Inhibitor [EPC]HMG-CoA Reductase Inhibitor [EPC]
10,013
Total Reports
2,128
Serious Reports
665
Death Reports
30
Reported Reactions
Death Report Ratio: High (6.64%)

Patient Demographics

Male
4,264
Female
4,858

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Dronedarone.

# Reaction Reports % of Total
1 ATRIAL FIBRILLATION 1,422
13.8%
2 DYSPNOEA 842
8.2%
3 FATIGUE 619
6.0%
4 OFF LABEL USE 483
4.7%
5 DIARRHOEA 482
4.7%
6 NAUSEA 473
4.6%
7 DRUG INTERACTION 469
4.5%
8 DIZZINESS 451
4.4%
9 GASTROINTESTINAL HAEMORRHAGE 421
4.1%
10 ASTHENIA 381
3.7%
11 DRUG INEFFECTIVE 328
3.2%
12 BLOOD CREATININE INCREASED 311
3.0%
13 HEADACHE 231
2.2%
14 CARDIAC FAILURE 223
2.2%
15 MALAISE 220
2.1%
16 OEDEMA PERIPHERAL 218
2.1%
17 COUGH 215
2.1%
18 PALPITATIONS 213
2.1%
19 RASH 212
2.1%
20 CARDIAC FAILURE CONGESTIVE 210
2.0%
21 DEATH 199
1.9%
22 ANAEMIA 196
1.9%
23 PNEUMONIA 194
1.9%
24 WEIGHT INCREASED 193
1.9%
25 INTERNATIONAL NORMALISED RATIO INCREASED 191
1.9%
26 RENAL FAILURE 190
1.8%
27 HYPOTENSION 189
1.8%
28 VOMITING 184
1.8%
29 CONDITION AGGRAVATED 182
1.8%
30 WEIGHT DECREASED 179
1.7%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.