Cordaroneamiodarone
According to the FDA label: Pacerone is indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. Pacerone is an antiarrhythmic indicated for: Recurrent ventricular fibrillation. ( 1 ) Recurrent hemodynamically unstable ventricular tachycardia. ( 1 )
10,887 adverse event reports submitted to the FDA (2000–2026)
Top Reported Adverse Events
The most frequently reported events in association with Cordarone in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Dyspnoea 1,174 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Asthenia 990 reports
Physical weakness or lack of strength.
Full definition in the glossary →Fatigue 911 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 868 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Drug Ineffective 733 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Product Use in Unapproved Indication 672 reports
Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Full definition in the glossary →Nausea 619 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Atrial Fibrillation 611 reports
An irregular, often rapid heart rhythm.
Full definition in the glossary →Cough 607 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Dizziness 583 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 551 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Hypotension 487 reports
Vomiting 473 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Drug Interaction 458 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →- Pulmonary Toxicity 407 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 6,090 |
| Female | 3,942 |
| Unknown | 7 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 147 |
| 18-34 | 131 |
| 35-49 | 369 |
| 50-64 | 1,419 |
| 65-74 | 2,103 |
| 75+ | 3,441 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Cordarone. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 6,199 |
| Hospitalization | 5,411 |
| Death | 1,885 |
| Non-Serious | 1,543 |
| Life-Threatening | 1,335 |
| Disability | 497 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Cordarone. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2000 | 2 |
| 2004 | 110 |
| 2005 | 156 |
| 2006 | 139 |
| 2007 | 130 |
| 2008 | 104 |
| 2009 | 188 |
| 2010 | 202 |
| 2011 | 241 |
| 2012 | 433 |
| 2013 | 220 |
| 2014 | 243 |
| 2015 | 332 |
| 2016 | 349 |
| 2017 | 666 |
| 2018 | 606 |
| 2019 | 755 |
| 2020 | 702 |
| 2021 | 935 |
| 2022 | 1,012 |
| 2023 | 1,003 |
| 2024 | 1,104 |
| 2025 | 1,079 |
| 2026 (partial) | 176 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Cordarone
In FDA adverse event reports that mention Cordarone, these medications appeared most often in the same report.
- Furosemide (2,866 reports)
- Aspirin (1,529 reports)
- Metoprolol (1,270 reports)
- Acetaminophen (1,117 reports)
- Spironolactone (1,076 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026