Prescription medication · Class III Antiarrhythmic
amiodarone
Also sold as Cordarone, Pacerone. This medicine treats very fast, irregular heartbeats in the ventricles (lower chambers of the heart).
Data updated 2026-05-15
- 10,687
- FDA reportsModerately reported
- 42
- InteractionsMany interactions
- $0.63
- Generic price (NADAC)
What the data shows
amiodarone (Cordarone) is a prescription Class III Antiarrhythmic, reported less often than most tracked drugs (10,687 FDA reports), with 42 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
amiodarone (Cordarone) is a prescription Class III Antiarrhythmic. This medicine treats very fast, irregular heartbeats in the ventricles (lower chambers of the heart).
Amiodarone (Pacerone) is a medicine used to treat life-threatening, irregular heartbeats. It helps to restore a normal heart rhythm when other medicines don't work or can't be used.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.63/unit
Generic Available
Yes (15 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: AMIODARONE HCL 100 MG TABLET
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -21.1% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| February 21, 2024 | $0.7960/EA | - | 1 |
| December 18, 2024 | $0.6281/EA | -21.1% | 8 |
What it does
This medicine treats very fast, irregular heartbeats in the ventricles (lower chambers of the heart).
Common side effects
Low thyroid levels (hypothyroidism), High thyroid levels (hyperthyroidism), Heart failure
Key warnings
This medicine can cause serious problems with your lungs, liver, and heart.
The sections below are summarized in plain English from amiodarone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Amiodarone affects the electrical signals in your heart. It slows down these signals, which helps your heart beat normally. This medicine can help prevent dangerous, fast heart rhythms.
Side Effects (from patient reports)
Based on 10,687 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for amiodarone, by number of reports
- Dyspnoea
Dyspnoea
1,158 reports
- Asthenia
Asthenia
975 reports
- Fatigue
Fatigue
895 reports
- Nausea
Nausea
606 reports
- Cough
Cough
597 reports
- Atrial Fibrillation
Atrial Fibrillation
594 reports
- Dizziness
Dizziness
572 reports
- Pneumonia
Pneumonia
539 reports
- Hypotension
Hypotension
477 reports
- Vomiting
Vomiting
467 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for amiodarone each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where amiodarone sits
amiodarone has more FDA adverse-event reports than 41% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is amiodarone; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 10,687 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2000–2025.
Total Reports
10,687
Reports Mentioning Death
1,847
17.3% of reports — not proof of cause
Hospitalization Reports
5,301
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DYSPNOEA | 1,158 |
| 2 | ASTHENIA | 975 |
| 3 | FATIGUE | 895 |
| 7 | NAUSEA | 606 |
| 8 | COUGH | 597 |
| 9 | ATRIAL FIBRILLATION | 594 |
| 10 | DIZZINESS | 572 |
| 11 | PNEUMONIA | 539 |
| 12 | HYPOTENSION | 477 |
| 13 | VOMITING | 467 |
| 14 | DRUG INTERACTION | 453 |
| 15 | PULMONARY TOXICITY | 407 |
| 16 | DEATH | 393 |
| 17 | PULMONARY FIBROSIS | 390 |
| 18 | ANAEMIA | 380 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This medicine can cause serious problems with your lungs, liver, and heart. Lung problems can be fatal. Your doctor will check your lungs with X-rays and breathing tests. Liver problems can also be fatal. Your doctor will check your liver with blood tests. This medicine can also make irregular heartbeats worse. You will likely start this medicine in the hospital where your heart can be monitored.
Known Drug Interactions
Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with ezetimibe and simvastatin. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed ezetimibe and simvastatin 10 mg/20 mg daily [see Dosage and Administration ( 2.3 )].
Mechanism: Taking these drugs together can cause the cholesterol medicine to build up in your body, which increases the risk of serious muscle damage.
Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with VYTORIN. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed VYTORIN 10/20 mg daily [see Dosage and Administration (2.3) ] .
Mechanism: Amiodarone slows the removal of simvastatin from your system, which increases the risk of muscle injury.
Antiarrhythmics amiodarone, dronedarone, flecainide, propafenone, quinidine ↑ antiarrhythmic Co-administration contraindicated due to potential for cardiac arrhythmias [see Contraindications (4) ] .
Mechanism: Ritonavir slows down how the body breaks down amiodarone, causing the heart medicine to build up to dangerous levels. This increase can lead to serious and life-threatening heart rhythm problems.
Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with ezetimibe and simvastatin. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed ezetimibe and simvastatin 10 mg/20 mg daily [see Dosage and Administration ( 2.3 )].
Mechanism: Amiodarone interferes with how your body breaks down simvastatin, leading to higher levels of the medicine in your blood. This makes muscle damage more likely to happen.
Table 1: Amiodarone Drug Interactions Concomitant Drug Class/Name Examples Clinical Comment Pharmacodynamic Interactions QT Prolonging Drugs class I and III antiarrhythmics, lithium, certain phenothiazines, tricyclic antidepressants, certain fluoroquinolone and macrolide antibiotics, azole antifungals, halogenated inhalation anesthetic agents Increased risk of Torsade de Pointes.
Mechanism: Both drugs can affect the electrical rhythm of your heart. Taking them together increases the risk of a dangerous and irregular heartbeat.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I stop taking this medicine suddenly?
Will this medicine cure my irregular heartbeats?
What tests will I need while taking this medicine?
Can I drink grapefruit juice while taking this medicine?
Can I take other medicines with this?
What should I do if I have side effects?
How long does this medicine stay in my body?
Can this medicine affect my vision?
Can this medicine make my skin sensitive to the sun?
What if I need surgery?
What are the common side effects of amiodarone?
Does amiodarone interact with other medications?
What drug class is amiodarone?
What pregnancy or breastfeeding source fields are listed for amiodarone?
Related Medications in Class III Antiarrhythmic
Other drugs grouped near amiodarone - same-class peers and common alternatives.
adenosine
Adenocard
Adenosine (Adenocard) is a medicine used to treat certain types of irregular heartbeats.
Compare with amiodarone →
atropine
AtroPen
Atropine is a medicine that can temporarily block severe effects on your body.
Compare with amiodarone →
bumetanide
Bumex
Bumetanide is a water pill (diuretic).
Compare with amiodarone →
carvedilol
Coreg
Carvedilol is a medicine that lowers blood pressure and helps your heart work better.
Compare with amiodarone →
digoxin
Lanoxin
Digoxin (Lanoxin) is a medicine that helps your heart pump better.
Compare with amiodarone →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for amiodarone: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 10,687.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 17.28%.
- valganciclovir Δ 0.07 pts · 18,056 reports · Antiviral (Nucleoside Analog) 17.35%death share
- ceftriaxone Δ 0.08 pts · 31,340 reports · Third-Generation Cephalosporin 17.20%death share
- chlorpheniramine Δ 0.14 pts · 6,221 reports · First-Generation Antihistamine 17.42%death share
- bisacodyl Δ 0.22 pts · 13,500 reports · Stimulant Laxative 17.50%death share
Medication Guides
Understanding Drug Interactions
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Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for amiodarone
The FDA label for amiodarone (sold under brand names such as Cordarone, Pacerone) classifies it as a prescription-only medication in the Class III Antiarrhythmic class. This medicine treats very fast, irregular heartbeats in the ventricles (lower chambers of the heart). Official labeling lists 33 commonly reported side effects, including Low thyroid levels (hypothyroidism), High thyroid levels (hyperthyroidism), Heart failure.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 10,687 voluntary reports. The database also lists 42 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.63.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: February 2, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages