FDA Adverse Events Reports (FAERS) Summary for PACERONE

These tables and charts are based on 2,033 total reports for PACERONE (AMIODARONE HYDROCHLORIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 1,921 pharmaceutical company-submitted and non-U.S. FAERS reports and 112 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 112 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch PACERONE summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	SHORTNESS OF BREATH	235
2	LACK OF STRENGTH AND ENERGY (ASTHENIA)	187
3	FATIGUE	182
4	ATRIAL FIBRILLATION	170
5	DIZZINESS	146
6	CONGESTIVE HEART FAILURE	136
7	PNEUMONIA	131
8	GASTROINTESTINAL BLEEDING	130
9	NAUSEA	124
10	DEATH	116
11	FALL	113
12	CHEST PAIN	106
13	COUGH	98
14	LOW BLOOD PRESSURE	93
15	DIARRHEA	92
16	ANEMIA	87
17	HEADACHE	83
18	PAIN	76
19	KIDNEY FAILURE	73
20	HIGH BLOOD PRESSURE	71
21	VOMITING	70
22	ACUTE KIDNEY INJURY	69
23	HEART ATTACK (MYOCARDIAL INFARCTION)	68
24	LUNG INFECTION	68
25	WEIGHT DECREASED	67
26	TREMOR	64
27	DECREASED APPETITE	58
28	CONSTIPATION	57
29	ANXIETY	56
30	RESPIRATORY FAILURE	56
31	DRUG INEFFECTIVE	52
32	ECONOMIC PROBLEM	52
33	GAIT DISTURBANCE	52
34	PAIN IN EXTREMITY	52
35	PRODUCT USE IN UNAPPROVED INDICATION	52
36	BACK PAIN	51
37	INSOMNIA	51
38	SWELLING OF LIMBS	50
39	PULMONARY TOXICITY	50
40	STROKE	49
41	CORONARY ARTERY DISEASE	49
42	DEHYDRATION	49
43	WHEEZING	49
44	DEPRESSION	48
45	JOINT PAIN	47
46	MALAISE	47
47	BALANCE DISORDER	45
48	BREATHLESSNESS	45
49	URINARY TRACT INFECTION	45
50	INJURY	44
51	OFF LABEL USE	43
52	RENAL FAILURE ACUTE	43
53	HAIR LOSS	42
54	ARRHYTHMIA	42
55	FAINTING	42
56	BLINDNESS	41
57	PALPITATIONS	41
58	PLEURAL EFFUSION	41
59	CHRONIC KIDNEY DISEASE	40
60	MUSCULAR WEAKNESS	40
61	WEIGHT INCREASED	39
62	ADVERSE DRUG REACTION	38
63	PRODUCT PRESCRIBING ERROR	38
64	CHRONIC OBSTRUCTIVE PULMONARY DISEASE	37
65	BLEEDING	37
66	MITRAL VALVE INCOMPETENCE	37
67	SWELLING	37
68	HEART RATE LOW (BRADYCARDIA)	35
69	CARDIAC DISORDER	35
70	NOSEBLEED	35
71	UNEVALUABLE EVENT	35
72	ABDOMINAL PAIN	34
73	ACUTE RESPIRATORY FAILURE	33
74	CHEST DISCOMFORT	33
75	CONFUSIONAL STATE	33
76	FEVER	33
77	ABDOMINAL PAIN UPPER	32
78	BLOOD GLUCOSE INCREASED	32
79	HEART FAILURE	32
80	HEART RATE DECREASED	32
81	PINS AND NEEDLES	32
82	BLOOD PRESSURE DECREASED	31
83	CARDIAC ARREST	31
84	DRUG INTERACTION	31
85	HEART RATE INCREASED	31
86	MUSCLE SPASMS	31
87	PLATELET COUNT DECREASED	31
88	RECTAL BLEEDING	31
89	SEPSIS	31
90	VISION BLURRED	31
91	BRUISE	30
92	RASH	30
93	NUMBNESS	29
94	HYPOTHYROIDISM	29
95	INTERNATIONAL NORMALISED RATIO INCREASED	29
96	LUNG CONGESTION	29
97	THROMBOCYTOPENIA	29
98	VENTRICULAR TACHYCARDIA	29
99	CARDIOMYOPATHY	28
100	CELLULITIS	28

Latest Known Outcomes for Reactions Reported for PACERONE

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	792
2	Patient recovered	357
3	Patient has not recovered/symtoms have not resolved	315
4	Patient died	215
5	Patient is recovering/symptoms resolving	172
6	Patient has recovered but has consequent health issues	12

Search all MedWatch and FAERS by keyword:

PACERONE Total Reports

Male	Female	Unknown	Total
1157	807	69	2,033

Top Countries Reporting

	Country	Number of Reports
1	United States	1379
2	Egypt	1
3	France	1

Outcomes for Reports

Serious: 1578
Not Serious: 455
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

Top Companies Reporting

Safety-Related FDA Updates

FDA Approval Date: 1998-04-30

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 PACERONE 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.