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

Applies to amiodarone: oral tablet. Other dosage forms:

• intravenous solution

Serious side effects of Nexterone

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

• 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

Other side effects of Nexterone

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

• 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

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]