Amiodarone Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 18, 2023.

Applies to amiodarone: intravenous solution. Other dosage forms:

• oral tablet

Serious side effects of Amiodarone

Along with its needed effects, amiodarone 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 or nurse immediately if any of the following side effects occur while taking amiodarone:

More common

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• sweating
• unusual tiredness or weakness

Less common

• Black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• chest pain, tightness, or discomfort
• chills
• cold, clammy skin
• cough
• decreased urine output
• diarrhea
• difficulty with breathing
• dilated neck veins
• dizziness
• fainting
• fast, pounding, or irregular heartbeat or pulse
• fast, weak pulse
• fever
• irregular heartbeat recurrent
• itching
• joint or muscle pain
• lightheadedness, dizziness, or fainting
• no blood pressure or pulse
• pinpoint red spots on the skin
• red, irritated eyes
• red skin lesions, often with a purple center
• slow or irregular heartbeat
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stopping of the heart
• swelling of the face, fingers, feet, or lower legs
• trouble breathing
• unconsciousness
• unusual bleeding or bruising
• weight gain

Incidence not known

• Agitation
• back, leg, or stomach pains
• bleeding gums
• bloating
• blurred or double vision
• clay-colored stools
• coma
• confusion about identity, place, and time
• cough or hoarseness
• coughing or spitting up blood
• cracks in the skin
• dark-colored urine
• decreased frequency or amount of urine
• decreased urine output
• depression
• difficulty swallowing
• eye pain
• fever with or without chills
• general body swelling
• headache
• high fever
• hives
• holding false beliefs that cannot be changed by fact
• hostility
• increased blood pressure
• increased thirst
• indigestion
• inflamed tissue from infection
• irritability
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lethargy
• light-colored stools
• loss of appetite
• loss of heat from the body
• lower back or side pain
• muscle pain, stiffness, cramps, spasms, twitching, tenderness, wasting, or weakness
• noisy breathing
• nosebleeds
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• persistent non-healing sore
• pink growth
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• rash
• red, swollen skin
• reddish patch or irritated area
• redness, soreness, or itching skin
• scaly skin
• seeing, hearing, or feeling things that are not there
• seizures
• severe headache
• shiny bump
• sores, welting, or blisters
• stomach pain
• stupor
• swollen or painful glands
• unexplained bleeding or bruising
• unpleasant breath odor
• unusual excitement, nervousness, or restlessness
• upper right abdominal or stomach pain
• vomiting
• vomiting of blood
• weakness
• white, yellow, or waxy scar-like area
• yellow eyes and skin

Other side effects of Amiodarone

Some side effects of amiodarone 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:

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For Healthcare Professionals

Applies to amiodarone: compounding powder, intravenous solution, oral tablet.

General

The most common adverse reactions were corneal microdeposits, hypotension, and photosensitivity.^[Ref]

Cardiovascular

Very common (10% or more): Hypotension (up to 20.2%)

Common (1% to 10%): Bradycardia, blood pressure decreased, congestive heart failure, heart arrest, ventricular tachycardia, cardiac arrhythmia, sinoatrial node dysfunction, flushing

Uncommon (0.1% to 1%): Conduction disturbances

Very rare (less than 0.01%): Marked bradycardia, sinus arrest, vasculitis, hot flushes

Frequency not reported: Torsade de pointes, collapse, atrial fibrillation, nodal arrhythmia, QT interval prolonged, sinus bradycardia, ventricular fibrillation, shock, asystole, pulseless electrical activity, cardiogenic shock, atrioventricular block, severe hypotension

Postmarketing reports: Sinoatrial block, intraventricular conduction disorders, bundle branch block, infra-His block, ventricular extrasystole, antegrade conduction via an accessory pathway^[Ref]

Hepatic

Common (1% to 10%): Acute liver disorders with high serum transaminases and/or jaundice including hepatic failure, liver function tests abnormal, nonspecific hepatic disorder

Very rare (less than 0.01%): Pseudo alcoholic hepatitis, cirrhosis, serum transaminases increased

Frequency not reported: ALT increased, AST increased

Postmarketing reports: Cholestatic hepatitis, cholestasis, jaundice, alkaline phosphatase increased, blood lactate dehydrogenase increased, hepatitis^[Ref]

Respiratory

Common (1% to 10%): Pulmonary toxicity, pulmonary inflammation or fibrosis, adult respiratory distress syndrome

Very rare (less than 0.01%): Bronchospasm, interstitial pneumonitis, severe respiratory complications, apnea

Frequency not reported: Pulmonary hemorrhage, lung edema, respiratory disorder, alveolar pneumonitis

Postmarketing reports: Possibly fatal respiratory disorder, bronchiolitis obliterans organizing pneumonia, dyspnea, cough, hemoptysis, wheezing, hypoxia, pulmonary infiltrates, pulmonary mass, pleuritis, pulmonary phospholipidosis, pleural effusion, eosinophilic pneumonia, acute respiratory distress syndrome^[Ref]

Ocular

Very common (10% or more): Corneal microdeposits (up to 90% or more)

Common (1% to 10%): Visual disturbance

Very rare (less than 0.01%): Optic neuropathy/neuritis

Frequency not reported: Permanent blindness, papilledema, corneal degeneration, eye discomfort, scotoma, lens opacities, macular degeneration, keratopathy, gritty eyes, itching, burning

Postmarketing reports: Visual field defect, blurred vision^[Ref]

Dermatologic

Very common (10% or more): Photosensitivity (up to 10%)

Common (1% to 10%): Slate-gray or bluish pigmentations of light-exposed skin

Very rare (less than 0.01%): Erythema, rash, exfoliative dermatitis, alopecia, sweating

Frequency not reported: Granuloma, angioedema, urticaria, Stevens-Johnson syndrome, spontaneous ecchymosis, pustular psoriasis enhanced

Postmarketing reports: Toxic epidermal necrolysis, erythema multiforme, skin cancer, pruritus, bullous dermatitis, drug rash with eosinophilia and systemic symptoms (DRESS), eczema^[Ref]

Nervous system

Common (1% to 10%): Extrapyramidal symptoms, extrapyramidal tremor, tremor/abnormal involuntary movement, lack of coordination, gait abnormal/ataxia, dizziness, paresthesia, headache, abnormal taste and smell

Uncommon (0.1% to 1%): Peripheral sensorimotor neuropathy

Very rare (less than 0.01%): Cerebellar ataxia, benign intracranial hypertension, vertigo

Frequency not reported: Peripheral neuropathy, demyelinating polyneuropathy, nerve conduction abnormal, neurolipidosis, neuromyopathy, parosmia

Postmarketing reports: Confusional state, disorientation, delirium, intracranial pressure increased, hypoesthesia, Parkinsonian symptoms^[Ref]

Psychiatric

Common (1% to 10%): Nightmare, sleep disorders, libido decreased, insomnia, sleep disturbance

Frequency not reported: Vivid dreams, chronic anxiety

Postmarketing reports: Hallucination^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, constipation, abdominal pain, salivation abnormal

Frequency not reported: Vomiting, dysgeusia, diarrhea

Postmarketing reports: Pancreatitis, acute pancreatitis, dry mouth^[Ref]

Other

Common (1% to 10%): Fever, malaise, fatigue^[Ref]

Endocrine

Very common (10% or more): Hypothyroidism (up to 10%)

Common (1% to 10%): Hyperthyroidism

Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone secretion

Frequency not reported: Thyroid function tests abnormal

Postmarketing reports: Thyroid nodules/cancer^[Ref]

Metabolic

Common (1% to 10%): Anorexia, edema

Frequency not reported: Weight gain, symptomatic hypercalcemia, appetite decreased^[Ref]

Hematologic

Common (1% to 10%): Coagulation abnormalities

Very rare (less than 0.01%): Hemolytic anemia, aplastic anemia, thrombocytopenia

Frequency not reported: Bone marrow granuloma, bone marrow depression

Postmarketing reports: Pancytopenia, neutropenia, agranulocytosis, granulocytosis^[Ref]

Musculoskeletal

Common (1% to 10%): Muscle weakness

Frequency not reported: Back pain

Postmarketing reports: Myopathy, rhabdomyolysis, muscle spasm, lupus-like syndrome^[Ref]

Local

Common (1% to 10%): Injection site reactions^[Ref]

Genitourinary

Very rare (less than 0.01%): Epididymo-orchitis, impotence

Postmarketing reports: Epididymitis^[Ref]

Immunologic

Very rare (less than 0.01%): Anaphylactic shock

Frequency not reported: Hypersensitivity reaction, positive antinuclear antibodies, immunoglobulin level increased

Postmarketing reports: Anaphylactic/anaphylactoid reaction^[Ref]

Renal

Very rare (less than 0.01%): Blood creatinine increased

Frequency not reported: Kidney function abnormal, chronic renal failure worsened

Postmarketing reports: Renal impairment, renal insufficiency, acute renal failure^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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