Nexterone Side Effects

Generic name: amiodarone

Medically reviewed by Drugs.com. Last updated on Sep 21, 2024.

Note: This document provides detailed information about Nexterone Side Effects associated with amiodarone. Some dosage forms listed on this page may not apply specifically to the brand name Nexterone.

Applies to amiodarone: oral tablet.

Other dosage forms:

• intravenous solution

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Tell your doctor right away if you are having difficulty breathing, chest tightness, or any type of breathing problem while using this medicine.

This medicine can cause changes in your heart rhythm, such as a condition called QT prolongation. It may cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as a fast, pounding, or irregular heartbeat.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you have burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

You may need to carry a medical identification card or bracelet showing that you are using this medicine. Ask your doctor about this.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

Amiodarone increases the sensitivity of your skin to sunlight. Too much sun exposure could cause a serious sunburn. Your skin may continue to be sensitive to sunlight for several months after treatment is stopped. Use a sunscreen when you are outdoors. Wear protective clothing and hats. Avoid sunlamps and tanning beds.

After you have taken this medicine for a long time, it may cause a blue-gray color to appear on your skin, especially in areas exposed to the sun, such as your face, neck, and arms. This color will usually fade after treatment with amiodarone (the active ingredient contained in Nexterone) has ended, although it may take several months. Check with your doctor if this color change occurs.

Grapefruit and grapefruit juice may increase the side effects of amiodarone by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of Nexterone

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:

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:

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]

See also:

Further information

Nexterone 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer