FDA Adverse Events Reports (FAERS) Summary for MULTAQ

These tables and charts are based on 9,029 total reports for MULTAQ (DRONEDARONE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 8,800 pharmaceutical company-submitted and non-U.S. FAERS reports and 229 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 229 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch MULTAQ summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with MULTAQ (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	ATRIAL FIBRILLATION	1294
2	SHORTNESS OF BREATH	751
3	FATIGUE	569
4	OFF LABEL USE	459
5	NAUSEA	444
6	DIARRHEA	437
7	DIZZINESS	409
8	LACK OF STRENGTH AND ENERGY (ASTHENIA)	364
9	GASTROINTESTINAL BLEEDING	358
10	DRUG INEFFECTIVE	293
11	BLOOD CREATININE INCREASED	283
12	DRUG INTERACTION	267
13	HEADACHE	222
14	HEART FAILURE	204
15	MALAISE	203
16	COUGH	201
17	SWELLING OF LIMBS	200
18	RASH	199
19	CONGESTIVE HEART FAILURE	184
20	DEATH	180
21	PALPITATIONS	178
22	WEIGHT DECREASED	174
23	PNEUMONIA	173
24	WEIGHT INCREASED	173
25	CONDITION AGGRAVATED	172
26	INTERNATIONAL NORMALISED RATIO INCREASED	172
27	VOMITING	171
28	ANEMIA	170
29	ITCHING	168
30	HEART RATE INCREASED	163
31	PAIN	163
32	KIDNEY FAILURE	162
33	FALL	154
34	FEELING ABNORMAL	152
35	LOW BLOOD PRESSURE	151
36	ARRHYTHMIA	149
37	JOINT PAIN	148
38	HEART RATE DECREASED	146
39	ABDOMINAL DISCOMFORT	133
40	DECREASED APPETITE	132
41	ABDOMINAL PAIN UPPER	131
42	CHEST PAIN	129
43	HEART RATE LOW (BRADYCARDIA)	126
44	GAIT DISTURBANCE	123
45	INSOMNIA	120
46	RENAL FAILURE ACUTE	120
47	PAIN IN EXTREMITY	117
48	TREMOR	115
49	BRUISE	113
50	BLEEDING	112
51	NOSEBLEED	110
52	ABDOMINAL PAIN	106
53	ALT LIVER ENZYME INCREASED	105
54	FEVER	102
55	LOWER LIMBS SWELLING	100
56	RECTAL BLEEDING	97
57	VENTRICULAR TACHYCARDIA	97
58	HAIR LOSS	95
59	CHEST DISCOMFORT	94
60	FAINTING	93
61	MUSCLE SPASMS	92
62	BACK PAIN	90
63	CONSTIPATION	90
64	ANXIETY	89
65	ASPARTATE AMINOTRANSFERASE INCREASED	89
66	ATRIAL FLUTTER	89
67	ELEVATED LIVER ENZYMES	89
68	BLOOD PRESSURE INCREASED	88
69	URINARY TRACT INFECTION	87
70	STROKE	86
71	MUSCLE PAIN	85
72	DIFFICULTY SWALLOWING	82
73	SKIN REDNESS	82
74	BLOOD PRESSURE DECREASED	81
75	INCORRECT DOSE ADMINISTERED	80
76	CARDIAC ARREST	79
77	HAEMORRHAGIC ANAEMIA	79
78	JOINT SWELLING	79
79	ACUTE KIDNEY INJURY	78
80	CARDIAC DISORDER	78
81	HIGH BLOOD PRESSURE	78
82	UPPER GASTROINTESTINAL HAEMORRHAGE	76
83	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	76
84	HAEMOGLOBIN DECREASED	75
85	HEART RATE IRREGULAR	75
86	VISION BLURRED	75
87	INDIGESTION	73
88	UNDERDOSE	73
89	BLOOD CLOTTING DISORDER	69
90	BLOOD IN URINE	69
91	MUSCULAR WEAKNESS	69
92	KIDNEY IMPAIRMENT	69
93	ELECTROCARDIOGRAM QT PROLONGED	68
94	DRUG DOSE OMISSION	67
95	RAPID HEART RATE (TACHYCARDIA)	67
96	DEHYDRATION	66
97	GASTROINTESTINAL DISORDER	65
98	INTERSTITIAL LUNG DISEASE	65
99	PLEURAL EFFUSION	65
100	DROWSINESS	65

Latest Known Outcomes for Reactions Reported for MULTAQ

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	3929
2	Patient has not recovered/symtoms have not resolved	1434
3	Patient recovered	1409
4	Patient is recovering/symptoms resolving	594
5	Patient died	340
6	Patient has recovered but has consequent health issues	49

Search all MedWatch and FAERS by keyword:

MULTAQ Total Reports

Male	Female	Unknown	Total
3816	4411	802	9,029

Top Countries Reporting

	Country	Number of Reports
1	United States	5192
2	Germany	285
3	Sweden	149
4	Spain	49
5	United Kingdom	32
6	Norway	30
7	Canada	27
8	Italy	27
9	South Korea	26
10	Israel	21

Outcomes for Reports

Serious: 6232
Not Serious: 2797
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Atrial fibrillation
Product used for unknown indication
Diabetes mellitus
Atrial flutter

Top Companies Reporting

SANOFI AVENTIS

Safety-Related FDA Updates

FDA Approval Date: 2009-07-01

MULTAQ (DRONEDARONE HYDROCHLORIDE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with MULTAQ? Rate MULTAQ at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

This report, created by AskaPatient.com, is derived from the cases for MULTAQ reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.