Adverse reactions : תופעות לוואי

6 ADVERSE REACTIONS
The following serious adverse reactions are described, or described in greater detail, in other sections:
•   Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] •   Life Threatening Respiratory Depression [see Warnings and Precautions (5.3)] •   QT Prolongation [see Warnings and Precautions (5.4)]
•   Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5)] •   Interactions with Benzodiazepines and other CNS Depressants [see Warnings and Precautions (5.7)]
•   Serotonin Syndrome [see Warnings and Precautions (5.9)]
•   Adrenal Insufficiency [see Warnings and Precautions (5.10)]
•   Severe Hypotension [see Warnings and Precautions (5.11)]
•   Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.13)] •   Seizures [see Warnings and Precautions (5.14)]
•   Withdrawal [see Warnings and Precautions (5.15)]
The following adverse reactions associated with the use of methadone were identified in clinical studies or post-marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The major hazards of methadone is respiratory depression and, to a lesser degree, systemic hypotension. Respiratory arrest, shock, cardiac arrest, and death have occurred.
The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients and in those who are not suffering severe pain. In such individuals, lower doses are advisable.
Other adverse reactions include the following:
Body as a Whole: asthenia (weakness), edema, headache
Cardiovascular: arrhythmias, bigeminal rhythms, bradycardia, cardiomyopathy, ECG abnormalities, extrasystoles, flushing, heart failure, hypotension, palpitations, phlebitis, QT interval prolongation, syncope, T-wave inversion, tachycardia, torsades de pointes, ventricular fibrillation, ventricular tachycardia
Central Nervous System: agitation, confusion, disorientation, dysphoria, euphoria, insomnia, hallucinations, seizures, visual disturbances, congenital oculomotor disorders (nystagmus, strabismus)
Endocrine: hypogonadism, decreased testosterone
Gastrointestinal: abdominal pain, anorexia, biliary tract spasm, constipation, dry mouth, glossitis
Hematologic: reversible thrombocytopenia has been described in opioid addicts with chronic hepatitis
Metabolic: hypoglycemia, hypokalemia, hypomagnesemia, weight gain
Renal: antidiuretic effect, urinary retention or hesitancy
Reproductive: amenorrhea, reduced libido and/or potency, reduced ejaculate volume, reduced seminal vesicle and prostate secretions, decreased sperm motility, abnormalities in sperm morphology
Respiratory: pulmonary edema, respiratory depression
Skin and Subcutaneous Tissue: pruritus, urticaria, other skin rashes, and rarely, hemorrhagic urticaria
Hypersensitivity: Anaphylaxis has been reported with ingredients contained in Methadone solution.
Serotonin Syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal Insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Androgen Deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see Clinical Pharmacology (12.2)].