Drug Safety Information for CORDARONE (Amiodarone hydrochloride)

Safety-related Labeling Changes for CORDARONE (AMIODARONE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for NEXTERONE (AMIODARONE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for CORDARONE* (Amiodarone hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with CORDARONE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug interaction2006
2Atrial fibrillation1900
3Dyspnoea*1876
4Renal failure1437
5Renal failure acute1373
6Asthenia1332
7Hypotension1262
8Fall1202
9International normalised ratio increased1180
10Nausea*1114
11Cardiac failure congestive1072
12Anaemia1065
13Dizziness*1018
14Bradycardia1002
15Pain994
16Pneumonia971
17Fatigue*933
18Cardiac failure904
19Death859
20Vomiting846

* This side effect also appears in "Top 10 Side Effects of CORDARONE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking CORDARONE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Atrial fibrillation*19116
2Product used for unknown indication13209
3Arrhythmia*6105
4Ventricular tachycardia*2325
5Atrial flutter2023
6Cardiac disorder1786
7Supraventricular tachycardia821
8Heart rate irregular637
9Tachycardia*613
10Ventricular fibrillation609

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for CORDARONE

Total Reports Filed with FDA: 140783


Number of FDA Adverse Event Reports by Patient Age for CORDARONE

Total Reports Filed with FDA: 140783*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Amiodarone hydrochloride (Nexterone, Amiodarona, Amiodarone hcl, Trangorex, Aratac, Cordarex, Amiobeta, Amiohexal, Corbionax, Pacerone, Cordarone)

Charts are based on 140783 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and CORDARONE Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on CORDARONE's side effects.