Prescription medicine
Amiodarone Brand names: Nexterone, Pacerone; first approved as Cordarone
Amiodarone (Pacerone) is a prescription medicine with an FDA approval on record since 1985. FDA's NDC Directory lists it from 32 generic labelers, and pharmacies paid $0.122 per amiodarone HCl 200 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the amiodarone FDA label on DailyMed (effective December 9, 2025, Chartwell RX, LLC); the NDA 18972 record on Drugs@FDA; every amiodarone label on DailyMed.
Highlights of the record
FDA label of December 9, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
PULMONARY, HEPATIC AND CARDIAC TOXICITY.
Amiodarone hydrochloride is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity [see Indications and Usage (1) ]. Amiodarone hydrochloride can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. Pulmonary toxicity has been fatal about 10% of the time. Obtain a baseline chest X-ray and pulmonary-function tests, including diffusion capacity, when amiodarone hydrochloride therapy is initiated. Repeat history, physical exam, and chest X-ray every 3 to 6 months [see Warnings and Precautions (5.2) ]. Amiodarone hydrochloride can cause hepatoxicity, which can be fatal. Obtain baseline and periodic liver transaminases and discontinue or reduce dose if the increase exceeds three times normal, or doubles in a patient with an elevated baseline. Discontinue amiodarone hydrochloride if the patient experiences signs or symptoms of clinical liver injury [see Warnings and Precautions (5.3) ]. Amiodarone hydrochloride can exacerbate arrhythmias. Initiate amiodarone hydrochloride in a clinical setting where continuous electrocardiograms and cardiac resuscitation are available [see Warnings and Precautions (5.4) ]. […]
Used for
From the label: indications and usageAmiodarone hydrochloride 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.
Forms and strengths
- 100 mg
- 200 mg
- 300 mg
- 400 mg
- 1.5 mg/ml
- 1.8 mg/ml
- 50 mg/ml
- 150 mg/3ml
- 450 mg/9ml
- 900 mg/18ml
Tablet; injection (solution).
On the market
- Earliest approval on file
- December 24, 1985 Cordarone, Wyeth Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 31 first April 30, 1998; 16 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 33 of which 32 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- February 27, 2033 Nexterone injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.122 per tablet Amiodarone HCl 200 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 7 since 2014 2 Class I among all firms' recalls; latest August 6, 2026; 1 more by firms not listed as its makers
- FAERS reports
- 11,139 through July 30, 2026
What is amiodarone used for?
From the label: indications and usageAmiodarone hydrochloride 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. Amiodarone hydrochloride is an antiarrhythmic indicated for: Recurrent ventricular fibrillation. ( 1 ) Recurrent hemodynamically unstable ventricular tachycardia.
FDA pharmacologic class: Antiarrhythmic.
Source: FDA drug label (Amiodarone Hydrochloride), Chartwell RX, LLC, effective December 9, 2025 (SPL set 5520f11d-968d-4f4f-bf57-d14369c0d746), via openFDA; the full label on DailyMed
What does the patient leaflet for amiodarone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about amiodarone hydrochloride tablets?Amiodarone hydrochloride tablets can cause serious side effects that can lead to death, including: lung problems liver problems worsening of heartbeat problems Call your healthcare provider or get medical help right away if you have any of the following symptoms during treatment with amiodarone hydrochloride tablets: trouble breathing, wheezing, shortness of breath, coughing chest pain, spitting up of blood, or fever nausea or vomiting, brown or dark-colored urine, feel more tired than usual, yellowing of your skin or the whites of your eyes (jaundice), or right upper stomach-area pain heart pounding, skipping a beat, beating fast or slowly, feel light-headed, or if you faint vision problems, including blurred vision, see halos, or your eyes become sensitive to light. You should have regular eye exams before and during treatment with amiodarone hydrochloride tablets. Amiodarone hydrochloride tablets should be started in a hospital so that your medical condition can be carefully monitored. Amiodarone hydrochloride tablets should only be used to treat people who have been diagnosed with life-threatening heartbeat problems called ventricular arrhythmias, when other treatments did not work or you cannot tolerate them. Amiodarone hydrochloride tablets can cause other serious side effects. See “What are the possible side effects of amiodarone hydrochloride tablets?” If you get serious side effects during treatment you may need to stop amiodarone hydrochloride tablets, have your dose changed, or get medical treatment. Talk with your healthcare provider before you stop taking amiodarone hydrochloride tablets. You may still have side effects after stopping amiodarone hydrochloride tablets because the medicine stays in your body for months after treatment is stopped. […]
From the patient leaflet: What should I avoid while taking amiodarone hydrochloride tablets?Avoid drinking grapefruit juice during treatment with amiodarone hydrochloride tablets. Drinking grapefruit juice with amiodarone hydrochloride tablets may increase the amount of amiodarone in your blood, and this may lead to side effects. Amiodarone hydrochloride tablets can make your skin sensitive to sunlight. You could get severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin to help protect you if you must be in sunlight. Talk to your healthcare if you get a sunburn. See "Skin problems" in the Medication Guide section "What are the possible side effects of amiodarone hydrochloride tablets?" below.
From the patient leaflet: How should I store amiodarone hydrochloride tablets?Store amiodarone hydrochloride tablets at room temperature between 20° to 25°C (68° to 77°F). Keep amiodarone hydrochloride tablets in a tightly closed container, and keep amiodarone hydrochloride tablets out of the light. Keep amiodarone hydrochloride tablets and all medicines out of the reach of children.
Source: FDA drug label (Amiodarone Hydrochloride), Chartwell RX, LLC, effective December 9, 2025 (SPL set 5520f11d-968d-4f4f-bf57-d14369c0d746), via openFDA; the full label on DailyMed
Is there a generic for amiodarone (Pacerone)?
The FDA approved the first generic amiodarone on April 30, 1998. 31 generic applications are approved; 16 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists amiodarone from 32 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 6 patents for Nexterone injection, the last expiring on February 27, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1985 earliest approval on file
- 1998 first generic approved
- 2033 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for amiodarone (Pacerone)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.122 per Amiodarone HCl 200 mg tablet, up 4% from $0.117 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Amiodarone HCl 200 mg tablet (generic)
- Pacerone 200 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Amiodarone 150 mg/3 mL vial | Generic | $0.521 per mL | $1.56 per vial | n/a |
| Amiodarone HCl 100 mg tablet | Generic | $0.376 per tablet | $11.28 | -37% |
| Amiodarone HCl 200 mg tablet | Generic | $0.122 per tablet | $3.65 | +4% |
| Amiodarone HCl 400 mg tablet | Generic | $0.500 per tablet | $14.99 | +27% |
| Pacerone 100 mg tablet | Brand | $0.776 per tablet | $23.29 | -7% |
| Pacerone 200 mg tablet | Brand | $0.125 per tablet | $3.75 | -16% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has amiodarone been recalled?
The FDA's Enforcement Report lists 8 recalls naming amiodarone since 2014: 2 Class I (the most serious), 3 Class II, 3 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of amiodarone and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 6, 2026 | Class II | Baxter Healthcare Corporation | CGMP Deviations |
| August 17, 2020 | Class I | Mylan Institutional LLC | Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled … |
| November 11, 2019 | Class III | AuroMedics Pharma LLC | Crystallization: Presence of visible particulate matter. |
| November 10, 2017 | Class I | Baxter Healthcare Corporation | Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which … |
| August 10, 2017 | Class II | SSM Health Care St. Louis DBA SSM St. Clare Health Center not a listed maker | Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. … |
| September 12, 2014 | Class II | Mckesson | Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the amiodarone label say about other medicines?
The amiodarone label names 23 other medicines in its interaction, contraindication or warning sections. The labels of 46 other medicines name amiodarone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amphotericin b | warnings and precautions | Give special attention to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhea or receiving drugs affecting electrolyte levels, such as diuretics, laxatives, systemic corticosteroids, or amphotericin B. … |
| Atorvastatin | drug interactions | Concomitant Drug/Class/Name: HMG-CoA Reductase Inhibitors; Examples: simvastatin, lovastatin, atorvastatin; Clinical Comment: Increased plasma concentration of HMG- CoA reductase inhibitor. Limit the dose of lovastatin to 40 mg. Limit the coadministered dose of simvastatin to 20 mg. … |
| Cholestyramine | drug interactions | Concomitant Drug/Class/Name: Cholestyramine; Examples: Reduced amiodarone serum levels. |
| Cimetidine | drug interactions | Concomitant Drug/Class/Name: CYP450 Inhibitors; Examples: grapefruit juice, certain fluoroquinolone and macrolide antibiotics, azole antifungals, cimetidine, certain protease inhibitors; Clinical Comment: Increased exposure of amiodarone. Avoid concomitant use. |
| Clonidine | drug interactions | Concomitant Drug/Class/Name: Negative Chronotropes; Examples: digoxin, beta blockers, verapamil, diltiazem, clonidine, ivabradine; Clinical Comment: Potentiates the electrophysiologic and hemodynamic effects of amiodarone, resulting in bradycardia, sinus arrest, and AV block. Monitor heart rate. |
| Cyclosporine | drug interactions | Concomitant Drug/Class/Name: Cyclosporine; Examples: Increased plasma levels of cyclosporine have been reported resulting in elevated creatinine, despite reduction of cyclosporine dose. Monitor cyclosporine drug levels and renal function with concomitant use. |
| Digoxin | drug interactions | Concomitant Drug/Class/Name: Negative Chronotropes; Examples: digoxin, beta blockers, verapamil, diltiazem, clonidine, ivabradine; Clinical Comment: Potentiates the electrophysiologic and hemodynamic effects of amiodarone, resulting in bradycardia, sinus arrest, and AV block. Monitor heart rate. |
| Diltiazem | drug interactions | Concomitant Drug/Class/Name: Negative Chronotropes; Examples: digoxin, beta blockers, verapamil, diltiazem, clonidine, ivabradine; Clinical Comment: Potentiates the electrophysiologic and hemodynamic effects of amiodarone, resulting in bradycardia, sinus arrest, and AV block. Monitor heart rate. |
| Fentanyl | drug interactions | CYP3A Substrate fentanyl Fentanyl in combination with amiodarone may cause hypotension, bradycardia, and decreased cardiac output. |
| Flecainide | drug interactions | Concomitant Drug/Class/Name: Antiarrhythmics; Examples: quinidine, procainamide, flecainide; Clinical Comment: Reserve concomitant use for patients who are unresponsive to a single agent. Antiarrhythmic metabolism inhibited by amiodarone. … |
| Ivabradine | drug interactions | Concomitant Drug/Class/Name: Negative Chronotropes; Examples: digoxin, beta blockers, verapamil, diltiazem, clonidine, ivabradine; Clinical Comment: Potentiates the electrophysiologic and hemodynamic effects of amiodarone, resulting in bradycardia, sinus arrest, and AV block. Monitor heart rate. |
| Ledipasvir and sofosbuvir | warnings and precautions | Postmarketing cases of symptomatic bradycardia, some requiring pacemaker insertion and at least one fatal, have been reported when ledipasvir/sofosbuvir or sofosbuvir with simeprevir were initiated in patients on amiodarone. |
| Lidocaine | drug interactions | CYP3A Substrate lidocaine Sinus bradycardia has been reported with oral amiodarone in combination with lidocaine given for local anesthesia. Monitor heart rate. |
| Lithium | drug interactions | Concomitant Drug/Class/Name: QT Prolonging Drugs; Examples: class I and III antiarrhythmics, lithium, certain phenothiazines, tricyclic antidepressants, certain fluoroquinolone and macrolide antibiotics, azole antifungals, halogenated inhalation anesthetic agents; … |
Every other medicine the amiodarone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Lovastatin | drug interactions | Concomitant Drug/Class/Name: HMG-CoA Reductase Inhibitors; Examples: simvastatin, lovastatin, atorvastatin; Clinical Comment: Increased plasma concentration of HMG- CoA reductase inhibitor. … |
| Phenytoin | drug interactions | Concomitant Drug/Class/Name: Phenytoin; Examples: Increased steady-state levels of phenytoin. Monitor phenytoin levels. |
| Prednisone | warnings and precautions | Prednisone 40 to 60 mg/day tapered over several weeks may be helpful in treating pulmonary toxicity. |
| Procainamide | drug interactions | Concomitant Drug/Class/Name: Antiarrhythmics; Examples: quinidine, procainamide, flecainide; Clinical Comment: Reserve concomitant use for patients who are unresponsive to a single agent. … |
| Quinidine | drug interactions | Concomitant Drug/Class/Name: Antiarrhythmics; Examples: quinidine, procainamide, flecainide; Clinical Comment: Reserve concomitant use for patients who are unresponsive to a single agent. … |
| Simvastatin | drug interactions | Concomitant Drug/Class/Name: HMG-CoA Reductase Inhibitors; Examples: simvastatin, lovastatin, atorvastatin; Clinical Comment: Increased plasma concentration of HMG- CoA reductase inhibitor. … |
| Sofosbuvir | drug interactions | Concomitant Drug/Class/Name: Hepatitis C Direct Acting Antiviral; Examples: sofosbuvir; Clinical Comment: Cases of symptomatic bradyarrhythmia requiring pacemaker insertion have been reported in … |
| Verapamil | drug interactions | Concomitant Drug/Class/Name: Negative Chronotropes; Examples: digoxin, beta blockers, verapamil, diltiazem, clonidine, ivabradine; … |
| Warfarin | drug interactions | Concomitant Drug/Class/Name: Warfarin; Examples: Potentiates anticoagulant response and can result in serious or fatal bleeding. Coadministration increases prothrombin time by 100% after 3 to 4 days. … |
Other labels that name amiodarone
- Afatinib
- Anagrelide
- Artemether and lumefantrine
- Asenapine
- Atazanavir
- Atenolol
- Azithromycin
- Betaxolol
- Bosentan
- Carvedilol
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clozapine
- Cobicistat
- Codeine
- Cyclophosphamide
- Dabigatran
- Darunavir
- Dronabinol
- Dronedarone
- Eliglustat
- Erythromycin
- Etrasimod arginine
- Etravirine
- Ezetimibe
- Fluconazole
- Fluoxetine
- Fosamprenavir
- Foscarnet
- Haloperidol
- Iloperidone
- Letermovir
- Levofloxacin
- Levothyroxine
- Liothyronine
- Lomitapide
- Macimorelin
- Macitentan
- Meloxicam
- Metronidazole
- Milsaperidone
- Moxifloxacin
- Naldemedine
- Nateglinide
- Nelfinavir
- Nevirapine
- Orlistat
- Ozanimod
- Paliperidone
- Pimavanserin
- Ponesimod
- Propafenone
- Propranolol
- Quinine
- Rimegepant
- Ritonavir
- Ropivacaine
- Sertraline
- Siponimod
- Sotalol
- Tacrolimus
- Talazoparib
- Terbinafine
- Tetrabenazine
- Thalidomide
- Tizanidine
- Tolterodine
- Toremifene
- Torsemide
- Tramadol
- Trazodone
- Vandetanib
- Vardenafil
Source: FDA drug label (Amiodarone Hydrochloride), Chartwell RX, LLC, effective December 9, 2025 (SPL set 5520f11d-968d-4f4f-bf57-d14369c0d746), via openFDA; the full label on DailyMed
What do FAERS reports show for amiodarone?
The FDA Adverse Event Reporting System holds 11,139 reports that list amiodarone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,934 are coded as a death and 5,523 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Alternatives to amiodarone
- medicines labeled for the same conditions
- Other antiarrhythmics
- the pharmacologic class, with prices and generics
- Amiodarone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other