Amiodarone (Oral)

Generic name: Amiodarone
Drug class: Group III antiarrhythmics

Usage of Amiodarone (Oral)

Amiodarone is used to treat life-threatening heart rhythm problems called ventricular arrhythmias. This medicine is used in patients who have already been treated with other medicines that did not work well.

Amiodarone belongs to the group of medicines known as antiarrhythmics. It works directly on the heart tissue and will slow the nerve impulses in the heart. This helps keep your heart rhythm normal.

This medicine is available only with your doctor's prescription.

Amiodarone (Oral) side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Cough

dizziness, lightheadedness, or fainting

fever (slight)

numbness or tingling in the fingers or toes

painful breathing

sensitivity of the skin to sunlight

trembling or shaking of the hands

trouble with walking

unusual and uncontrolled movements of the body

weakness of the arms or legs

Less common

Blue-gray coloring of the skin on the face, neck, and arms

blurred vision or blue-green halos seen around objects

coldness

dry eyes

dry, puffy skin

fast or irregular heartbeat

nervousness

pain and swelling in the scrotum

sensitivity of the eyes to light

sensitivity to heat

slow heartbeat

sweating

swelling of the feet or lower legs

trouble with sleeping

unusual tiredness

weight gain or loss

Rare

Skin rash

yellow eyes or skin

Incidence not known

Agitation

back, leg, or stomach pains

bleeding gums

blistering, peeling, or loosening of the skin

bloating

blood in the urine

bloody, black, or tarry stools

blue lips, fingernails, or skin

blurred or double vision

chest pain

chills

clay-colored stools

confusion

confusion as to time, place, or person

coughing or spitting up blood

cracks in the skin

dark urine

decreased awareness or responsiveness

decreased urine output

depression

diarrhea

difficult or labored breathing

difficult urination

dry cough

eye pain

fast heartbeat

general body swelling

high fever

holding false beliefs that cannot be change by facts

hostility

inability to have or keep an erection

indigestion

irregular, fast or slow, or shallow breathing

irritability

itching

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

loss in sexual ability, desire, drive, or performance

loss of consciousness

loss of heat from the body

lower back or side pain

mood or mental change

muscle cramps, spasms, twitching, pain, or stiffness

no breathing

noisy breathing

nosebleeds

pain in the abdomen, groin, or scrotum

pain or burning with urination

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

pinpoint red spots on the skin

rapid weight gain

red skin lesions, often with a purple center

red, irritated eyes

red, swollen skin

scaly skin

seeing, hearing, or feeling things that are not there

seizures

severe headache

severe sleepiness

sneezing

sore throat

sores, ulcers, or white spots on the lips or in mouth

stomach pain

swelling of the face, ankles, or hands

swelling of the scrotum

swollen or painful glands

tightness in the chest

troubled breathing

unpleasant breath odor

unusual bleeding or bruising

unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

unusual excitement, nervousness, or restlessness

vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Constipation

headache

loss of appetite

nausea

vomiting

Less common

Bitter or metallic taste

decrease in sexual interest

decreased sexual ability in males

feeling of warmth

redness of the face, neck, arms and occasionally, upper chest

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Amiodarone (Oral)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of amiodarone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amiodarone in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving amiodarone.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Atazanavir

Bepridil

Cisapride

Colchicine

Dronedarone

Fezolinetant

Fingolimod

Fluconazole

Grepafloxacin

Indinavir

Ketoconazole

Levoketoconazole

Levomethadyl

Mesoridazine

Nelfinavir

Nirmatrelvir

Pimozide

Piperaquine

Posaconazole

Ritonavir

Saquinavir

Sparfloxacin

Terfenadine

Thioridazine

Tipranavir

Vernakalant

Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abametapir

Abiraterone Acetate

Acecainide

Adagrasib

Afatinib

Agalsidase Alfa

Alfentanil

Alfuzosin

Alprazolam

Amisulpride

Amitriptyline

Amprenavir

Anagrelide

Apalutamide

Apixaban

Apomorphine

Aprepitant

Aripiprazole

Aripiprazole Lauroxil

Armodafinil

Arsenic Trioxide

Artemether

Asenapine

Astemizole

Azimilide

Azithromycin

Bedaquiline

Bendamustine

Benzhydrocodone

Berotralstat

Betrixaban

Boceprevir

Bretylium

Buprenorphine

Buserelin

Carbamazepine

Carvedilol

Cenobamate

Ceritinib

Chloral Hydrate

Chloroquine

Chlorpromazine

Cilostazol

Cimetidine

Ciprofloxacin

Citalopram

Clarithromycin

Clofazimine

Clomipramine

Clopidogrel

Clothiapine

Clozapine

Cobicistat

Codeine

Conivaptan

Crizotinib

Cyclobenzaprine

Dabigatran Etexilate

Dabrafenib

Daclatasvir

Darunavir

Dasabuvir

Dasatinib

Deferasirox

Degarelix

Delamanid

Delavirdine

Desipramine

Deslorelin

Deutetrabenazine

Dexamethasone

Dexmedetomidine

Digoxin

Dihydrocodeine

Diltiazem

Disopyramide

Docetaxel

Dofetilide

Dolasetron

Domperidone

Donepezil

Doxepin

Doxorubicin

Doxorubicin Hydrochloride Liposome

Droperidol

Ebastine

Efavirenz

Elagolix

Eliglustat

Encainide

Encorafenib

Enflurane

Entrectinib

Enzalutamide

Eribulin

Erlotinib

Erythromycin

Escitalopram

Eslicarbazepine Acetate

Etrasimod

Etravirine

Famotidine

Fedratinib

Felbamate

Fentanyl

Fexinidazole

Finerenone

Flecainide

Fluoxetine

Fluvoxamine

Formoterol

Fosamprenavir

Fosaprepitant

Foscarnet

Fosnetupitant

Fosphenytoin

Fostemsavir

Galantamine

Gatifloxacin

Gemfibrozil

Gemifloxacin

Gepirone

Ginkgo Biloba

Glasdegib

Goldenseal

Gonadorelin

Goserelin

Granisetron

Halofantrine

Haloperidol

Halothane

Histrelin

Hydrocodone

Hydroquinidine

Hydroxychloroquine

Hydroxyzine

Ibutilide

Idelalisib

Iloperidone

Imatinib

Imipramine

Indecainide

Inotuzumab Ozogamicin

Iohexol

Isoflurane

Isradipine

Itraconazole

Ivabradine

Ivacaftor

Ivosidenib

Lacosamide

Lapatinib

Larotrectinib

Ledipasvir

Lefamulin

Lemborexant

Lenvatinib

Letermovir

Leuprolide

Levofloxacin

Lidocaine

Lofexidine

Lomitapide

Lopinavir

Loratadine

Lorlatinib

Lovastatin

Lumacaftor

Lumefantrine

Macimorelin

Macitentan

Mavacamten

Mefloquine

Meperidine

Methadone

Methotrexate

Methotrimeprazine

Metronidazole

Mexiletine

Mibefradil

Miconazole

Mifepristone

Mirtazapine

Mitotane

Mizolastine

Mobocertinib

Modafinil

Moricizine

Morphine

Morphine Sulfate Liposome

Moxifloxacin

Nafarelin

Nafcillin

Nefazodone

Netupitant

Nevirapine

Nilotinib

Norfloxacin

Octreotide

Ofloxacin

Olanzapine

Omaveloxolone

Ombitasvir

Ondansetron

Osilodrostat

Osimertinib

Ospemifene

Oxaliplatin

Oxcarbazepine

Oxycodone

Ozanimod

Paclitaxel

Pacritinib

Palbociclib

Paliperidone

Panobinostat

Papaverine

Paritaprevir

Paroxetine

Pasireotide

Pazopanib

Pentamidine

Pentazocine

Perphenazine

Pexidartinib

Phenobarbital

Phenytoin

Pimavanserin

Pipamperone

Pitolisant

Pixantrone

Ponesimod

Pralsetinib

Prednisone

Prilocaine

Primidone

Probucol

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Quizartinib

Ranitidine

Ranolazine

Regorafenib

Relugolix

Ribociclib

Rifabutin

Rifampin

Rimegepant

Risperidone

Selpercatinib

Sematilide

Sertindole

Sertraline

Sevoflurane

Simeprevir

Simvastatin

Siponimod

Sirolimus

Sirolimus Protein-Bound

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Sofosbuvir

Solifenacin

Sorafenib

Sotalol

Spiramycin

St John's Wort

Sufentanil

Sulfamethoxazole

Sulpiride

Sultopride

Sunitinib

Tacrolimus

Talazoparib

Tamoxifen

Tedisamil

Telaprevir

Telavancin

Telithromycin

Tenofovir Alafenamide

Teriflunomide

Tetrabenazine

Ticagrelor

Tocainide

Tolterodine

Topotecan

Toremifene

Tramadol

Trazodone

Triclabendazole

Trifluoperazine

Trimethoprim

Trimipramine

Triptorelin

Ubrogepant

Vandetanib

Vardenafil

Vemurafenib

Venetoclax

Venlafaxine

Verapamil

Vilanterol

Vincristine

Vincristine Sulfate Liposome

Vinflunine

Voclosporin

Voriconazole

Vorinostat

Voxelotor

Warfarin

Zileuton

Zolmitriptan

Zolpidem

Zotepine

Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abarelix

Acenocoumarol

Atorvastatin

Clonazepam

Cyclosporine

Dicumarol

Digitoxin

Ibrutinib

Rifapentine

Rivaroxaban

Rosuvastatin

Theophylline

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice

Relate drugs

How to use Amiodarone (Oral)

You will receive your first dose of this medicine in the hospital. Your doctor will watch you closely after you take this medicine to make sure you do not have any serious side effects.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not miss any doses. It may also take 1 to 3 weeks before your body responds to this medicine.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food, but take it the same way each time.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For ventricular arrhythmias:

Adults—At first, 800 to 1600 milligrams (mg) per day taken in divided doses. Your doctor may adjust your dose as needed and tolerated.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Warnings

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Tell your doctor right away if you are having difficulty breathing, chest tightness, or any type of breathing problem while using this medicine.

This medicine can cause changes in your heart rhythm, such as a condition called QT prolongation. It may cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as a fast, pounding, or irregular heartbeat.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you have burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

You may need to carry a medical identification card or bracelet showing that you are using this medicine. Ask your doctor about this.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

Amiodarone increases the sensitivity of your skin to sunlight. Too much sun exposure could cause a serious sunburn. Your skin may continue to be sensitive to sunlight for several months after treatment is stopped. Use a sunscreen when you are outdoors. Wear protective clothing and hats. Avoid sunlamps and tanning beds.

After you have taken this medicine for a long time, it may cause a blue-gray color to appear on your skin, especially in areas exposed to the sun, such as your face, neck, and arms. This color will usually fade after treatment with amiodarone has ended, although it may take several months. Check with your doctor if this color change occurs.

Grapefruit and grapefruit juice may increase the side effects of amiodarone by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

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