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 →
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.
How to Take It
Your doctor will decide the right dose for you. You will likely start with a high dose (800 to 1600 mg per day) until your heart rhythm is better. This usually takes 1 to 3 weeks. Then, your doctor will lower the dose to 600 to 800 mg per day for one month, and then to a maintenance dose of 400 mg per day.
This is a plain-language summary of amiodarone's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
This medicine can harm your unborn baby. It can cause thyroid problems, slow heart rate, and brain development issues. Do not breastfeed while taking this medicine.
This is a plain-language summary of amiodarone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of amiodarone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature (68° to 77°F) in a closed container that protects the medicine from light.
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
- Difficulty breathing
Difficulty breathing
1,158 reports
- Weakness
Weakness
975 reports
- Tiredness
Tiredness
893 reports
- Feeling sick to your stomach
Feeling sick to your stomach
605 reports
- Coughing
Coughing
597 reports
- Irregular heartbeat in the upper chambers of the heart
Irregular heartbeat in the upper chambers of the heart
593 reports
- Feeling lightheaded or unsteady
Feeling lightheaded or unsteady
572 reports
- Lung infection
Lung infection
539 reports
- Low blood pressure
Low blood pressure
477 reports
- Throwing up
Throwing up
465 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) 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.
What to do: Your doctor should limit your dose of ezetimibe and simvastatin to no more than 10 mg/20 mg daily.
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.
What to do: Your daily dose of VYTORIN should not exceed 10/20 mg if you are taking amiodarone.
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.
What to do: Do not take these two medications together. Your doctor will need to find an alternative treatment to avoid dangerous heart issues.
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.
What to do: If you are taking amiodarone, your daily dose of simvastatin should not go above 20 mg.
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.
What to do: Your doctor should monitor your heart rhythm closely if you must take these medications together.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
Is amiodarone safe during pregnancy?
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 →
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: February 2, 2024
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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