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Pacerone Side Effects

Generic name: amiodarone

Medically reviewed by Last updated on Sep 18, 2023.

Note: This document contains side effect information about amiodarone. Some dosage forms listed on this page may not apply to the brand name Pacerone.

Applies to amiodarone: oral tablet. Other dosage forms:


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 Pacerone

Along with its needed effects, amiodarone (the active ingredient contained in Pacerone) 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

Less common


Incidence not known

Other side effects of Pacerone

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

Less common

For Healthcare Professionals

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


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


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]


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]


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]


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]


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]


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

Frequency not reported: Vivid dreams, chronic anxiety

Postmarketing reports: Hallucination[Ref]


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

Frequency not reported: Vomiting, dysgeusia, diarrhea

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


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


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]


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

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


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]


Common (1% to 10%): Muscle weakness

Frequency not reported: Back pain

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


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


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

Postmarketing reports: Epididymitis[Ref]


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]


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]


1. Product Information. Cordarone (amiodarone). Wyeth-Ayerst Laboratories. 2002;PROD.

2. Product Information. Cordarone (amiodarone). Apothecon Inc. 2022.

3. Cerner Multum, Inc. UK Summary of Product Characteristics.

4. Cerner Multum, Inc. Australian Product Information.

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.