Pacerone

Last reviewed on RxList: 7/12/2019
Pacerone Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/12/2019

Pacerone (amiodarone HCl) is an antiarrhythmic drug indicated for treatment of recurrent ventricular fibrillation and recurrent hemodynamically unstable ventricular tachycardia only when these conditions have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated. Common side effects of Pacerone include:

Side effects of Pacerone can be serious and may include:

Because of the serious nature of the arrhythmia and the lack of predictable time course of effect, a loading dose of Pacerone should be performed in a hospital setting. Loading doses of 800 to 1,600 mg/day are required for 1 to 3 weeks (occasionally longer) until initial therapeutic response occurs. Pacerone may interact with other antiarrhythmics, lithium, phenothiazines, tricyclic antidepressants, fluoroquinolone and macrolide antibiotics, IV pentamidine, azole antifungals, digoxin, beta blockers, verapamil, diltiazem, clonidine, protease inhibitors, loratadine, cimetidine, trazodone, rifampin, St. John's wort, grapefruit juice, cyclosporine, “statin” drugs, lidocaine, anticoagulants, clopidogrel, dabigatran, fentanyl, phenytoin, and dextromethorphan. Tell your doctor all medications and supplements you use. During pregnancy, Pacerone should be used only if prescribed. It may harm a fetus. Pacerone passes into breast milk. Breastfeeding while using Pacerone is not recommended.

Our Pacerone (Amiodarone HCl) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

In the U.S., 1 in every 4 deaths is caused by heart disease. See Answer
Pacerone Consumer Information

3 pharmacies near 20147 have coupons for Pacerone (Brand Names:Pacerone for 200MG)

CVS Pharmacy
CVS Pharmacy
$173.89

Est. Regular Price

$451.03

with free coupon

View Coupon
Costco
Costco
$173.89

Est. Regular Price

$453.51

with free coupon

View Coupon
Walgreens
Walgreens
$173.89

Est. Regular Price

$457.33

with free coupon

View Coupon

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Amiodarone takes a long time to completely clear from your body. You may continue to have side effects from amiodarone after you stop using it.

Call your doctor at once if you have any of these side effects, even if they occur up to several months after you stop using amiodarone:

  • wheezing, cough, chest pain, cough with bloody mucus, fever;
  • a new or a worsening irregular heartbeat pattern (fast, slow, or pounding heartbeats);
  • a light-headed feeling, like you might pass out;
  • blurred vision, seeing halos around lights (your eyes may be more sensitive to light);
  • liver problems--nausea, vomiting, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes);
  • nerve problems--loss of coordination, muscle weakness, uncontrolled muscle movement, or a prickly feeling in your hands or lower legs;
  • signs of overactive thyroid--weight loss, thinning hair, feeling hot, increased sweating, tremors, feeling nervous or irritable, irregular menstrual periods, swelling in your neck (goiter); or
  • signs of underactive thyroid--weight gain, tiredness, depression, trouble concentrating, feeling cold.

Common side effects may include:

  • nausea, vomiting, loss of appetite; or
  • constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Pacerone (Amiodarone HCl Tablets)

IMAGES

See Images
Pacerone Professional Information

SIDE EFFECTS

Adverse reactions have been very common in virtually all series of patients treated with amiodarone for ventricular arrhythmias with relatively large doses of drug (400 mg/day and above), occurring in about three-fourths of all patients and causing discontinuation in 7 to 18%. The most serious reactions are pulmonary toxicity, exacerbation of arrhythmia and rare serious liver injury (see “WARNINGS”), but other adverse effects constitute important problems. They are often reversible with dose reduction or cessation of amiodarone treatment. Most of the adverse effects appear to become more frequent with continued treatment beyond six months, although rates appear to remain relatively constant beyond one year. The time and dose relationships of adverse effects are under continued study.

Neurologic problems are extremely common, occurring in 20 to 40% of patients and including malaise and fatigue, tremor and involuntary movements, poor coordination and gait, and peripheral neuropathy; they are rarely a reason to stop therapy and may respond to dose reductions or discontinuation (see “PRECAUTIONS”). There have been spontaneous reports of demyelinating polyneuropathy.

Gastrointestinal complaints, most commonly nausea, vomiting, constipation and anorexia, occur in about 25% of patients but rarely require discontinuation of drug. These commonly occur during high-dose administration (i.e., loading dose) and usually respond to dose reduction or divided doses.

Ophthalmic abnormalities including optic neuropathy and/or optic neuritis, in some cases progressing to permanent blindness, papilledema, corneal degeneration, photosensitivity, eye discomfort, scotoma, lens opacities and macular degeneration have been reported (see “WARNINGS”).

Asymptomatic corneal microdeposits are present in virtually all adult patients who have been on drug for more than 6 months. Some patients develop eye symptoms of halos, photophobia and dry eyes. Vision is rarely affected and drug discontinuation is rarely needed.

Dermatological adverse reactions occur in about 15% of patients, with photosensitivity being most common (about 10%). Sunscreen and protection from sun exposure may be helpful, and drug discontinuation is not usually necessary. Prolonged exposure to amiodarone occasionally results in a blue-gray pigmentation. This is slowly and occasionally incompletely reversible on discontinuation of drug but is of cosmetic importance only.

Cardiovascular adverse reactions, other than exacerbation of the arrhythmias, include the uncommon occurrence of congestive heart failure (3%) and bradycardia. Bradycardia usually responds to dosage reduction but may require a pacemaker for control. CHF rarely requires drug discontinuation. Cardiac conduction abnormalities occur infrequently and are reversible on discontinuation of drug.

The following side-effect rates are based on a retrospective study of 241 patients treated for 2 to 1,515 days (mean 441.3 days).

The following side effects were each reported in 10 to 33% of patients:

Gastrointestinal: Nausea and vomiting.

The following side effects were each reported in 4 to 9% of patients:

Dermatologic: Solar dermatitis/photosensitivity.

Neurologic: Malaise and fatigue, tremor/abnormal involuntary movements, lack of coordination, abnormal gait/ataxia, dizziness, paresthesias.

Gastrointestinal: Constipation, anorexia.

Ophthalmologic: Visual disturbances.

Hepatic: Abnormal liver-function tests.

Respiratory: Pulmonary inflammation or fibrosis.

The following side effects were each reported in 1 to 3% of patients:

Thyroid: Hypothyroidism, hyperthyroidism.

Neurologic: Decreased libido, insomnia, headache, sleep disturbances.

Cardiovascular: Congestive heart failure, cardiac arrhythmias, SA node dysfunction.

Gastrointestinal: Abdominal pain.

Hepatic: Nonspecific hepatic disorders.

Other: Flushing, abnormal taste and smell, edema, abnormal salivation, coagulation abnormalities.

The following side effects were each reported in less than 1% of patients:

Blue skin discoloration, rash, spontaneous ecchymosis, alopecia, hypotension and cardiac conduction abnormalities.

In surveys of almost 5,000 patients treated in open U.S. studies and in published reports of treatment with amiodarone, the adverse reactions most frequently requiring discontinuation of amiodarone included pulmonary infiltrates or fibrosis, paroxysmal ventricular tachycardia, congestive heart failure and elevation of liver enzymes. Other symptoms causing discontinuations less often included visual disturbances, solar dermatitis, blue skin discoloration, hyperthyroidism and hypothyroidism.

Postmarketing Reports

In postmarketing surveillance, hypotension (sometimes fatal), sinus arrest, anaphylactic/anaphylactoid reaction (including shock), angioedema, urticaria, eosinophilic pneumonia, hepatitis, cholestatic hepatitis, cirrhosis, pancreatitis, acute pancreatitis, renal impairment, renal insufficiency, acute renal failure, acute respiratory distress syndrome in the post-operative setting, bronchospasm, possibly fatal respiratory disorders (including distress, failure, arrest, and ARDS), bronchiolitis obliterans organizing pneumonia (possibly fatal), fever, dyspnea, cough, hemoptysis, wheezing, hypoxia, pulmonary infiltrates and/or mass, pulmonary alveolar hemorrhage, pleural effusion, pleuritis, pseudotumor cerebri, parkinsonian symptoms such as akinesia and bradykinesia (sometimes reversible with discontinuation of therapy), syndrome of inappropriate antidiuretic hormone secretion (SIADH), thyroid nodules/thyroid cancer, toxic epidermal necrolysis (sometimes fatal), erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, bullous dermatitis, drug rash with eosinophilia and systemic symptoms (DRESS), eczema, skin cancer, vasculitis, pruritus, hemolytic anemia, aplastic anemia, pancytopenia, neutropenia, thrombocytopenia, agranulocytosis, granuloma, myopathy, muscle weakness, rhabdomyolysis, demyelinating polyneuropathy, hallucination, confusional state, disorientation, delirium, epididymitis, impotence and dry mouth, also have been reported with amiodarone therapy.

Read the entire FDA prescribing information for Pacerone (Amiodarone HCl Tablets)

SLIDESHOW

Heart Disease: Symptoms, Signs, and Causes See Slideshow

© Pacerone Patient Information is supplied by Cerner Multum, Inc. and Pacerone Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors