Amiodarone
Amiodarone is a heart rhythm medicine (antiarrhythmic) used for life-threatening ventricular arrhythmias, as tablets by mouth or as an intravenous (IV) injection in a hospital setting.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 29 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Amiodarone is a powerful, specialist heart rhythm medicine for life-threatening ventricular fibrillation and ventricular tachycardia, given as tablets or hospital IV when other drugs have failed; it slows the heart's electrical signals and lengthens the reset between beats, and, on the market since about 1985, it is available generically. Nausea and a slower pulse are the usual complaints, mostly during the higher-dose start. Its boxed warning covers lung, liver and heart toxicity, so report a new cough, breathlessness, yellow skin or eyes, or a new irregular heartbeat promptly. It can also affect the thyroid and eyes, so expect blood tests, chest X-rays and eye exams, and report vision changes.
Clinical pearls
- Avoid grapefruit juice, which raises amiodarone levels, and take each dose the same way with respect to meals every day.
- If you take warfarin or digoxin, expect lower doses and closer checks of your clotting test (INR) or digoxin level.
- It lingers in the body for weeks to months, so side effects and interactions can continue after stopping it.
- Tell every prescriber you take it, especially before starting simvastatin, a beta blocker, or the hepatitis C drug sofosbuvir.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Amiodarone can cause life-threatening lung, liver and heart rhythm problems. It is meant only for dangerous ventricular arrhythmias, and other treatments should be tried first.
- Lungs: Lung inflammation or scarring can occur with the tablets and has been fatal in about 10% of those cases. Watch for new cough, shortness of breath or fever. You should have a chest X-ray and lung tests before starting, and an exam and chest X-ray every 3 to 6 months.
- Liver: Liver injury can be fatal. Liver blood tests are done before and during treatment. Yellow skin or eyes, or dark urine, need urgent attention.
- Heart: It can make arrhythmias worse. Treatment should start where continuous heart monitoring and resuscitation are available.
Patient information guide A plain-language walkthrough of Amiodarone, written from its FDA label.
What Amiodarone is used for
▾
Amiodarone treats life-threatening ventricular rhythm problems.
- Recurrent ventricular fibrillation: tablets, including Pacerone, in adults who have not responded to or cannot tolerate other antiarrhythmics.
- Recurrent hemodynamically unstable ventricular tachycardia: tablets, including Pacerone, with the same conditions.
- Injection (Nexterone and Amiodarone Hydrochloride/HCl injection): starting treatment and preventing frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.
- Amiodarone Hydrochloride and Amiodarone HCl injection: also for patients who need oral amiodarone but cannot take it by mouth.
How Amiodarone works
▾
Amiodarone is mainly a class III antiarrhythmic, but it also has effects of the other classes. It blocks potassium channels, which lengthens the time heart cells take to reset between beats. It also blocks sodium and calcium channels and dampens adrenaline-type signals. Together, these effects slow conduction and steady the heart rhythm.
It also relaxes blood vessels, which can reduce the heart's workload and oxygen use.
Amiodarone dosage
▾
Tablets are taken by mouth, starting with a higher loading phase and then a lower maintenance amount. Take them consistently with regard to meals. Split doses with meals may be suggested for higher totals or an upset stomach.
The injection is given through an IV by a healthcare team, starting with a fast infusion, then slower ones. Follow your prescriber and the label. Missed-dose guidance is not covered here, so ask your pharmacist.
Dosing details from the FDA-approved label
From the Amiodarone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Starting dose, first 24 hours (IV amiodarone)
- About 1000 mg over the first 24 hours: First Rapid loading infusion 150 mg over the FIRST 10 minutes (15 mg/min)
- Followed by Slow loading infusion 360 mg over the NEXT 6 hours (1 mg/min)
- Then Maintenance Infusion 540 mg over the REMAINING 18 hours (0.5 mg/min)
- Maximum: Mean daily doses above 2100 mg were associated with an increased risk of hypotension; do not exceed an initial infusion rate of 30 mg/min
- First 24-hour dose may be individualized for each patient
- Maintenance infusion after the first 24 hours
- Continue 0.5 mg/min (720 mg per 24 hours) at a concentration of 1 mg/mL to 6 mg/mL
- Rate may be increased to achieve effective arrhythmia suppression
- Maximum: Up to 0.5 mg/min can be continued for 2 to 3 weeks
- Use a central venous catheter for concentrations greater than 2 mg/mL; applies regardless of age, renal function, or left ventricular function
- Breakthrough episodes of VF or hemodynamically unstable VT
- 150 mg supplemental infusions of amiodarone (mixed in 100 mL of D5W and infused over 10 minutes)
- Infuse over 10 minutes to minimize the potential for hypotension
- Intravenous to oral transition
- Patients whose arrhythmias have been suppressed may be switched to oral amiodarone
- Optimal dose depends on the IV dose already administered and the bioavailability of oral amiodarone
- Clinical monitoring recommended, particularly for elderly patients; do not drink grapefruit juice during oral treatment
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Dosage must be individualized based on severity of arrhythmia and response. Use the lowest effective dose. Obtain baseline chest x-ray, pulmonary function tests, thyroid function tests, and liver aminotransferases. Correct hypokalemia, hypomagnesemia, and hypocalcemia before initiating treatment. Initiate treatment with a loading doses of 800 to 1600 mg/day until initial therapeutic response occurs (usually 1 to 3 weeks). Once adequate arrhythmia control is achieved, or if side effects become prominent, reduce amiodarone hydrochloride tablets dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day. ( 2 ) Recommended Dosage: Initiate treatment with a loading doses of 800 to 1600 mg/day until initial therapeutic response occurs (usually 1 to 3 weeks). Once adequate arrhythmia control is achieved, or if side effects become prominent, reduce amiodarone hydrochloride tablets dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day. Administration: Administer amiodarone hydrochloride tablets consistently with regard to meals [see Clinical Pharmacology (12.3) ] . Administration of amiodarone hydrochloride tablets in divided doses with meals is suggested for total daily doses of 1000 mg or higher, or when gastrointestinal intolerance occurs.
Read the full Dosage and Administration section on DailyMed →
Amiodarone side effects
▾
Side effects depend on the form. These were most common with the IV injection:
Common side effects
- Low blood pressure (most common with IV use)
- Slow heart rate
- Nausea
- Fever
- Abnormal liver blood tests
- Heart failure symptoms or worsening
- Heart arrest or other rhythm changes (IV use)
When to get medical help
- Trouble breathing, new cough, wheezing, fever or coughing up blood, which may signal lung damage
- Yellow skin or eyes, dark urine, or severe stomach pain, which may signal liver injury
- Fainting, a very slow pulse, or new or worsening irregular heartbeats
- Changes in vision, blurred vision, or reduced side vision
- Signs of an overactive or underactive thyroid, such as new rhythm problems
- Severe allergic reaction: rash, swelling, flushing, sweating, or low blood pressure
- Severe skin reactions, such as blistering or peeling skin
- Pain, redness or swelling at the IV site
Amiodarone warnings and precautions
▾
- Lung toxicity: can be fatal; regular chest X-rays and lung tests are needed.
- Liver injury: can be fatal; liver tests are done regularly.
- Worsened rhythm problems: treatment starts where heart monitoring is available.
- Thyroid problems: both overactive and underactive thyroid can occur.
- Vision loss: optic nerve problems have been reported; eye exams are advised.
- Long-lasting effects: the drug stays in the body for months.
- IV use: low blood pressure, slow heart rate and allergic reactions.
Amiodarone interactions
▾
Amiodarone interacts with many medicines, and effects can last after stopping it.
- Warfarin: greatly increases bleeding risk.
- Digoxin: raises digoxin levels.
- QT-prolonging drugs: raise the risk of dangerous rhythms.
- Beta blockers, verapamil, diltiazem, clonidine: can slow the heart too much.
- Ledipasvir/sofosbuvir and similar hepatitis C drugs: serious slow heart rate.
- Simvastatin, lovastatin: dose limits apply.
- Grapefruit juice: raises amiodarone levels.
- Cyclosporine, phenytoin, lidocaine: levels can rise.
Interactions listed in the FDA-approved label
From the Amiodarone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Drugs prolonging the QT interval (class I and III antiarrhythmics, lithium, certain phenothiazines, tricyclic antidepressants, certain fluoroquinolone and macrolide antibiotics, azole antifungals, halogenated inhalation anesthetics): Increases the risk of Torsade de Pointes. In general, avoid concomitant use of drugs that prolong the QT interval.
- Drugs that slow heart rate (digoxin, beta blockers, verapamil, diltiazem, ivabradine, clonidine): Can potentiate the electrophysiologic and hemodynamic effects of amiodarone, resulting in bradycardia, sinus arrest, and AV block. Monitor heart rate.
- Grapefruit juice: Increased amiodarone AUC by 50% and Cmax by 84% in healthy volunteers, increasing plasma levels of amiodarone. Avoid grapefruit juice while taking amiodarone.
- Quinidine, procainamide, flecainide (antiarrhythmics): Their metabolism can be inhibited by amiodarone; quinidine serum concentration increased by 33% after two days. Initiate any added antiarrhythmic at a lower than usual dose and monitor carefully; reduce previous antiarrhythmic doses by 30% to 50% several days after adding oral amiodarone.
- Digoxin: Oral amiodarone increases serum digoxin concentration (by 70% after one day). Reduce dose of digoxin by half or discontinue digoxin; if continued, monitor serum levels closely and observe for toxicity.
- HMG-CoA reductase inhibitors (simvastatin, lovastatin, atorvastatin): Amiodarone may increase plasma concentrations of these drugs. Limit simvastatin to 20 mg daily and lovastatin to 40 mg daily; lower starting and maintenance doses of other CYP3A4 substrates may be required.
- Warfarin-type anticoagulants: Potentiation of anticoagulant response is almost always seen and can result in serious or fatal bleeding; INR increases by 100% after 3 to 4 days. Reduce the anticoagulant dose by one-third to one-half and monitor INR closely.
- Cyclosporine: Persistently elevated cyclosporine plasma concentrations resulting in elevated creatinine, despite dose reduction. Monitor cyclosporine levels and renal function.
- Phenytoin: Increased steady-state phenytoin levels have been reported. Monitor phenytoin levels.
- Ledipasvir/sofosbuvir or sofosbuvir with simeprevir: Serious symptomatic bradycardia, some requiring pacemaker insertion and at least one fatal, has been reported. Monitor heart rate when starting antiviral treatment in patients taking or recently discontinuing amiodarone.
Read the label’s full interactions text
7 DRUG INTERACTIONS Because of amiodarone’s long half-life, expect drug interactions to persist for weeks to months after discontinuation of amiodarone. Drug interactions with amiodarone are described in Table 1 below. 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. Avoid concomitant use. Negative Chronotropes digoxin, beta blockers, verapamil, diltiazem, clonidine, ivabradine Potentiates the electrophysiologic and hemodynamic effects of amiodarone, resulting in bradycardia, sinus arrest, and AV block. Monitor heart rate. Pharmacokinetic Interactions CYP450 Inhibitors grapefruit juice, certain fluoroquinolone and macrolide antibiotics, azole antifungals, cimetidine, certain protease inhibitors Increased exposure of amiodarone. Avoid concomitant use. CYP450 Inducers St. John’s Wort Reduced amiodarone serum levels. Cyclosporine 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. Cholestyramine Reduced amiodarone serum levels. Antiarrhythmics quinidine, procainamide, flecainide Reserve concomitant use for patients who are unresponsive to a single agent. Antiarrhythmic metabolism inhibited by amiodarone. Initiate antiarrhythmic at a lower than usual dose and monitor patient carefully. Reduce dose levels of previously administered antiarrhythmic by 30 to 50% for several days after transitioning to oral amiodarone. Evaluate continued need for antiarrhythmic. Digoxin Increased digoxin concentration. Reduce digoxin by half or discontinue. If continued, monitor for evidence of toxicity.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Amiodarone
▾
- Do not use with an allergy to amiodarone or iodine.
- Do not use with cardiogenic shock, marked slow heart rate, or second- or third-degree AV block without a working pacemaker.
- Pregnancy: it can harm the baby.
- Breastfeeding is not recommended.
- It may reduce female and male fertility; whether this is reversible is unknown.
- Children: safety and effectiveness have not been established.
- Older adults: dosing usually starts low.
- Tell your doctor about lung, liver, thyroid or eye problems, and before surgery or laser eye surgery.
Amiodarone overdose
▾
Overdose has been reported, some cases fatal. IV overdose can cause low blood pressure, cardiogenic shock, slow heart rate, AV block and liver damage. Treatment includes slowing the infusion, supportive medicines, temporary pacing if needed, and close liver monitoring. Dialysis does not remove amiodarone.
What Amiodarone does in the body
▾
Amiodarone slows the sinus rate by about 15 to 20% and lengthens the PR and QT intervals by about 10%. These changes show the drug is working. Effects on rhythm usually take 1 to 3 weeks with tablets, and can last weeks or months after stopping.
How your body processes Amiodarone
▾
Tablets are absorbed slowly and variably, with about 50% bioavailability. Food increases absorption. Amiodarone builds up in fat and organs like the liver and lungs. It is broken down by the liver (CYP3A and CYP2C8) into an active metabolite, DEA. Its half-life averages about 53 days, so effects and interactions can last long after stopping. Little is cleared in urine.
How to store Amiodarone
▾
Store at 20° to 25°C (68° to 77°F) . Protect from light. Dispense in a light-resistant, tight container.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Amiodarone
210 supplements and herbal products have documented interactions with Amiodarone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 11
- Moderate · 163
- Minor · 36
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Amiodarone: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Amiodarone — the kind of thing our pharmacy team would talk through with you at the counter.
What is amiodarone for?
▾
How should I take the tablets?
▾
What side effects should I call about?
▾
Can I drink grapefruit juice?
▾
Why do I need so many tests?
▾
Is it safe in pregnancy?
▾
Is Amiodarone available over the counter?
▾
When was Amiodarone first available?
▾
Who makes Amiodarone?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Amiodarone on HelloPharmacist
Amiodarone forms and strengths (how it comes)
Amiodarone is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Pacerone and Amiodarone Hydrochloride tablets are used for documented, life-threatening recurrent ventricular fibrillation in adults.
- Pacerone and Amiodarone Hydrochloride tablets are used for life-threatening recurrent hemodynamically unstable ventricular tachycardia in adults who have not responded to other antiarrhythmics or cannot tolerate them.
- Pacerone tablets should be taken consistently with regard to meals.
- Pacerone tablets may be split into divided doses with meals for higher daily totals or stomach upset.
- Pacerone treatment usually starts with a loading phase, then a lower maintenance amount, individualized by your prescriber.
- Amiodarone Hydrochloride tablets are taken consistently with regard to meals, following the same schedule.
Injection
How this form is used
- Amiodarone Hydrochloride injection and Nexterone are used to start treatment and prevent frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.
- Amiodarone Hydrochloride injection can also be used for patients who need oral amiodarone but cannot take it by mouth.
- Nexterone is a ready-to-use premixed bag given by IV; no further dilution is needed.
- Nexterone should be given, whenever possible, through a dedicated central venous catheter with an in-line filter.
- Amiodarone Hydrochloride injection starts with a rapid infusion, then a slower one, then a maintenance infusion, with close monitoring.
- Amiodarone Hydrochloride injection is usually needed for 48 to 96 hours, and patients may later move to oral amiodarone.
Amiodarone on the U.S. market: products, makers and brands
How Amiodarone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
32 companies list 70 Amiodarone product records with the FDA, mostly as tablet, injection; the earliest marketing or approval year on record is 1985. Brand names on the directory include Cordarone, Pacerone, Nexterone and 1 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Amiodarone is used (Medicaid data)
A general measure of how commonly Amiodarone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Amiodarone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Amiodarone prescribed? Of the 1,601 medications we measure, Amiodarone ranks #384 by Medicaid prescriptions — more than 76% of them.
Utilization by Amiodarone product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
amiodarone hydrochloride 200 MG Oral Tablet Most dispensed
Summed across the 14 of 107 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 833528
amiodarone hydrochloride 100 MG Oral Tablet
Summed across the 5 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835956
amiodarone hydrochloride 400 MG Oral Tablet
Summed across the 4 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 834348
200 ML amiodarone hydrochloride 1.8 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 849876
100 ML amiodarone hydrochloride 1.5 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1046406
3 ML amiodarone hydrochloride 50 MG/ML Injection
Summed across the 2 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1663224
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Amiodarone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 27 of 172 listed Amiodarone NDCs with Medicaid activity.
Compare Amiodarone products
A representative set of FDA-listed product records for Amiodarone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 150 mg/3 mL | Intravenous | AuroMedics Pharma LLC | ANDA | View NDC → |
| 450 mg/9 mL | Intravenous | AuroMedics Pharma LLC | ANDA | View NDC → |
| 900 mg/18 mL | Intravenous | AuroMedics Pharma LLC | ANDA | View NDC → |
| 1.5 mg/mL | Intravenous | Baxter Healthcare Corporation | NDA | View NDC → |
| 1.8 mg/mL | Intravenous | Baxter Healthcare Corporation | NDA | View NDC → |
| 50 mg/mL | Intravenous | Fresenius Kabi USA, LLC × 3 listings | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Gland Pharma Limited | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Henry Schein, Inc. | ANDA | View NDC → |
| 50 mg/mL | Intravenous | HF Acquisition Co LLC, DBA HealthFirst × 3 listings | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Medical Purchasing Solutions, LLC × 3 listings | ANDA | View NDC → |
| 150 mg/3 mL | Intravenous | Medical Purchasing Solutions, LLC | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Medical Purchasing Solutions, LLC. | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Mylan Institutional LLC × 2 listings | ANDA | View NDC → |
| 50 mg/mL | Intravenous | ProPharma Distribution | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Remedyrepack Inc. | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Slate Run Pharmaceuticals | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Zhejiang Poly Pharm. Co., Ltd. × 3 listings | ANDA | View NDC → |
| 💊Tablet | ||||
| 200 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 100 mg | Oral | Advagen Pharma Limited | ANDA | View NDC → |
| 200 mg | Oral | Advagen Pharma Limited | ANDA | View NDC → |
| 400 mg | Oral | Advagen Pharma Limited | ANDA | View NDC → |
| 200 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 200 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC | ANDA | View NDC → |
| 200 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 100 mg | Oral | AvPAK | ANDA | View NDC → |
| 100 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 200 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | Cardinal Health 107, LLC × 2 listings | ANDA | View NDC → |
| 100 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 200 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 400 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 100 mg | Oral | Dr. Reddy's Labratories Inc. | ANDA | View NDC → |
| 200 mg | Oral | Dr. Reddy's Labratories Inc. | ANDA | View NDC → |
| 200 mg | Oral | Major Pharmaceuticals × 2 listings | ANDA | View NDC → |
| 100 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 200 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 200 mg | Oral | Redpharm Drug | ANDA | View NDC → |
| 200 mg | Oral | Remedyrepack Inc. × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | Safecor Health LLC | ANDA | View NDC → |
| 100 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 200 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 300 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 400 mg | Oral | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 200 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
| 100 mg | Oral | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
| 200 mg | Oral | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
| 400 mg | Oral | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
| 100 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 200 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 400 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 100 mg | Oral | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 200 mg | Oral | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 400 mg | Oral | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
Showing 70 of 70 products — FDA National Drug Code Directory. See every product, package size and price: browse all 70 Amiodarone NDCs →
Amiodarone side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Amiodarone — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Amiodarone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Amiodarone FDA approval history
How Amiodarone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Amiodarone recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Amiodarone recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Mad… Lots: Lot # NC177832, Exp Date: 12/31/2026; Lot # NC185417, NC185455, Exp Date: 08/31/2027; Lot # NC188593, Exp Date: 11/30/2027; Lot # NC188647, NC188685, NC188807, NC188838, NC188920, Exp Date: 12/31/2027; Lot # NC193603, NC193726, NC193788, N… FDA record D-0814-2026 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 703 4 dose forms · 11 strengths
-
Dose form (SCDF) Injectable Solution RxCUI 377132In current FDA listingsClinical drug / strength (SCD) hydrochloride 50 MG/MLRxCUI 833532 -
Dose form (SCDF) Injection RxCUI 1663223In current FDA listingsClinical drug / strength (SCD) 3 ML amiodarone hydrochloride 50 MG/MLRxCUI 16632249 ML amiodarone hydrochloride 50 MG/MLRxCUI 166324418 ML amiodarone hydrochloride 50 MG/MLRxCUI 1663248100 ML amiodarone hydrochloride 1.5 MG/MLRxCUI 1046406200 ML amiodarone hydrochloride 1.8 MG/MLRxCUI 849876 -
Dose form (SCDF) Oral Tablet RxCUI 370568In current FDA listingsClinical drug / strength (SCD) hydrochloride 100 MGRxCUI 835956hydrochloride 200 MGRxCUI 833528hydrochloride 300 MGRxCUI 835960hydrochloride 400 MGRxCUI 834348 -
Dose form (SCDF) Prefilled Syringe RxCUI 727379No current FDA listingClinical drug / strength (SCD) 3 ML amiodarone hydrochloride 50 MG/MLRxCUI 834357
Look up RxCUI 703 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Amiodarone supply and shortage status
Whether Amiodarone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Amiodarone costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 200 mg | $0.125 per tablet | NDC details & price history |
| Tablet · Oral | 100 mg | $0.776 per tablet | NDC details & price history |
| Tablet · Oral | 400 mg | $0.719 per tablet | NDC details & price history |
| Injection, Solution · Intravenous | 50 mg/mL | $0.521 per mL | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Amiodarone brand names
Amiodarone is sold under 4 brand names in the FDA directory — Cordarone, Pacerone, Nexterone, Amiodarone Hci. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Amiodarone: manufacturers and labelers
32 companies list Amiodarone products with the FDA. By number of product records, the largest are Medical Purchasing Solutions, LLC, Bryant Ranch Prepack, Remedyrepack Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 8 more on the FDA NDC directory.
Amiodarone drug class (RxNorm)
Amiodarone belongs to the Antiarrhythmic class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Amiodarone page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Cardinal Health 107, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →