Tablet: Eyes: Microdeposits at the anterior surface of the cornea are found in almost every patient, are usually limited to the area below the pupil and may occasionally lead to visual disturbances (blurring of vision, visual halos). They usually regress 6-12 months after discontinuation of amiodarone HCl. Some cases of optic neuritis, which caused permanent blindness in isolated cases, have been reported. During treatment with amiodarone HCl, regular ophthalmic examinations (including fundoscopy and examinations by means of a slit-lamp) are therefore indicated.
Skin: Occasionally, photosensitization with increased tendency to sunburns may occur, which can lead to erythema and rash. During longer-term treatment, especially body areas exposed to sunlight, may become hyperpigmented with black-violet to slate-grey discoloration of the skin (pseudocyanosis). The discoloration slowly recedes within 1-4 years after discontinuing the preparation. Cases of erythematous development on radiation therapy have been reported. Cases of erythema nodosum and rarely specific exanthemas including rare cases of exfoliative dermatitis have been reported. (For preventive measures see Precautions.)
Thyroid Gland: Amiodarone HCl inhibits the transformation of T4 into T3 and may lead to increased T4 values, as well as to decreased T3 values in clinically inconspicuous (euthyroid) patients. Occasionally, thyroid dysfunctions (hyperthyroidism or hypothyroidism) occur.
The following symptoms may point to thyroid dysfunction: In Hypothyroidism: Weight gain, exhaustion, extreme bradycardia exceeding the effect expected on amiodarone HCl.
In Hyperthyroidism: Weight loss, tachycardia, tremor, nervousness, increased diaphoresis and heat intolerance, recurrence of arrhythmias or angina pectoris, cardiac insufficiency.
Severe hyperthyroidism, in isolated cases leading to death, has been described.
For examinations during the course of therapy, diagnostic and therapeutic measures (see Warnings and Precautions).
Lung: As a result of the pulmonary toxicity of amiodarone HCl, atypical pneumonia as symptom of a hypersensitivity reaction (hypersensitivity pneumonitis), alveolar or interstitial pneumonitis or fibroses, pleuritis, bronchiolitis obliterans with pneumonia/BOOP may occur. If amiodarone HCl is discontinued in good time, the previously mentioned pulmonary alterations subside. Isolated cases with lethal course have been reported. Mostly after surgical procedures, several cases of shock lung acute respiratory distress syndrome (ARDS), which were fatal in isolated cases, occurred.
For examinations during the course of therapy, diagnostic and therapeutic measures (see Precautions).
Gastrointestinal Tract/Liver: Nausea and vomiting frequently occur. Occasionally, abdominal pain, sensation of repletion, constipation and anorexia occur.
Occasionally, isolated increases in serum transaminases occur, which are usually not very pronounced.
Rare cases of acute hepatitis (in isolated cases leading to death), cholestatic icterus or hepatocirrhosis have been described. In cases of persistent clinically relevant increases in liver enzymes, cholestetic icterus or hepatomegalia, discontinuation of amiodarone HCl should be taken into consideration.
Heart: As a result of the pharmacological effect of amiodarone HCl, sinus bradycardia, which may be more pronounced in elderly patients or in cases of disturbed sinus node function, or in exceptional cases, sinus node arrest may occur. The ECG shows the following alterations: QT prolongation, occurrence of U-wave, prolongation or deformation of the T-wave. Therapy must be withdrawn if pronounced bradycardia or sinus node arrest occurs.
In rare cases, conduction disturbances occurred (SA block, AV block); in isolated cases, the occurrence of asystole has been observed. Pro-arrhythmic effects in the form of alterations or aggravations of arrhythmias have been observed which can lead to highly impaired cardiac activity with the possible consequence of cardiac arrest. Isolated cases of torsades de pointes and ventricular fibrillation/flutter have been described.
Other Adverse Reactions: Occasionally, fatigue, headache, dyssomnia, nightmares, vertigo, diminished libido, myasthenia, tremor, impaired coordination, paresthesia, peripheral neuropathy or ataxia occur.
Rarely, dysgeusia, as well as reversible alopecia occur.
Rarely, hypersensitivity reactions as well as vasculitis, thrombocytopenia, transiently impaired renal function and epididymitis may occur.
Isolated cases of hemolytic or aplastic anemia, as well as intracranial increase in pressure (cerebral pseudo-tumor) have been reported.
Isolated cases of a syndrome of inappropriate (increased) secretion of antidiuretic hormone (SIADH) with hyponatremia have been described in connection with amiodarone.
Injection: The most important adverse effects of amiodarone IV were hypotension, asystole/cardiac arrest/electromechanical dissociation (EMD), cardiogenic shock, congestive heart failure (CHF), bradycardia, liver function test abnormalities, ventricular tachycardia (VT) and AV block.
The most common treatment-emergent adverse events during amiodarone IV therapy which are considered to be possibly drug-related are as follows. Body as a Whole: Fever.
Cardiovascular System: Bradycardia, CHF, heart arrest, hypotension (sometimes fatal), VT, atrial fibrillation, nodal arrhythmia, prolonged QT interval, shock, sinus bradycardia, ventricular fibrillation, sinus arrest, angioedema.
Digestive System: Abnormal liver function tests, nausea, abnormal kidney function, diarrhea, increased alanine transaminase (ALT), increased aspartate aminotransferase (AST), vomiting, hepatitis, cirrhosis, pancreatitis.
Respiratory: Lung edema, respiratory disorder, bronchospasm, possibly fatal respiratory disorders (including distress, failure, arrest, and ARDS), bronchiolitis obliterans organizing pneumonia (possibly fatal), dyspnea, cough, hemoptysis, wheezing, hypoxia, pulmonary infiltrates and/or mass, pleuritis.
Gastrointestinal: Nausea, vomiting, constipation, abdominal pain, abnormal salivation, anorexia, epigastric burning or fullness, and pancreatitis.
Dermatologic: Stevens-Johnson syndrome, toxic epidermal necrolysis (sometimes fatal), erythema multiforme, exfoliative dermatitis, skin cancer, pruritus, injection site reactions (pain, erythema, edema, pigment changes, venous thrombosis, phlebitis, thrombophlebitis, cellulitis, necrosis and skin sloughing).
Neurologic: Hallucination, confusional state, disorientation, delirium.
Hematologic: Thrombocytopenia, hemolytic anemia, aplastic anemia, pancytopenia, neutropenia, agranulocytosis.
Thyroid: Thyroid nodules/thyroid cancer.
Others: Anaphylactic/anaphylactoid reaction (including shock), renal impairment, renal insufficiency, acute renal failure, pseudotumor cerebri, syndrome of inappropriate antidiuretic hormone secretion (SIADH), vasculitis, granuloma, myopathy, muscle weakness, rhabdomyolysis, epididymitis and impotence.