Amiodarone Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 15, 2024.

Applies to amiodarone: oral tablet.

Other dosage forms:

• intravenous solution

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Amiodarone oral tablet is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity.

Amiodarone 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 therapy is initiated.

Repeat history, physical exam, and chest X-ray every 3 to 6 months.

Amiodarone 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 if the patient experiences signs or symptoms of clinical liver injury.

Amiodarone can exacerbate arrhythmias.

Initiate in a clinical setting where continuous electrocardiograms and cardiac resuscitation are available.

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 immediately if any of the following side effects occur while taking amiodarone:

More common side effects

• 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 side effects

• 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 side effects

• 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

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:

More common side effects

• constipation
• headache
• loss of appetite
• nausea
• vomiting

Less common side effects

• 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

For healthcare professionals

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

General adverse events

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

Amiodarone side effects can vary depending on the individual. 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.

Medical Disclaimer