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Medically reviewed by Drugs. Last updated on Dec 20, Applies to methadone : oral solution, oral tablet, oral tablet for suspension. Deaths due to too-rapid titration, drug interactions, or cardiac and respiratory side effects have occurred with methadone use for opioid dependence. Respiratory depression is the main hazard associated with methadone administration. QT interval prolongation and serious arrhythmias torsades de pointes have been observed during treatment with methadone. Only approved hospitals and pharmacies can dispense oral methadone for the treatment of narcotic addiction. Methadone hydrochloride tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Serious, life-threatening, or fatal respiratory depression may occur with use of methadone hydrochloride tablets. The peak respiratory depressant effect of methadone occurs later, and persists longer than the peak analgesic effect, especially during the initial dosing period or following a dose increase. Monitor for respiratory depression, especially during initiation of methadone hydrochloride tablets or following a dose increase. Proper dosing and titration are essential and methadone hydrochloride should only be prescribed by healthcare professionals who are knowledgeable in the use of methadone for toxification and maintenance treatment of opioid addiction. Accidental ingestion of even one dose of methadone hydrochloride tablets, especially by children, can result in a fatal overdose of methadone. Life-Threatening QT Prolongation: QT interval prolongation and serious arrhythmia torsades de pointes have occurred during treatment with methadone. Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction. Closely monitor patients with risk factors for development of prolonged QT interval, a history of cardiac conduction abnormalities, and those taking medications affecting cardiac conduction for changes in cardiac rhythm during initiation and titration of methadone hydrochloride tablets. Neonatal opioid withdrawal syndrome NOWS is an expected and treatable outcome of use of methadone hydrochloride tablets during pregnancy. NOWS may be life-threatening if not recognized and treated in the neonate. Advise the patient of the risk of NOWS so that appropriate planning for management of the neonate can occur. Cytochrome P InteractionThe concomitant use of methadone hydrochloride tablets with all cytochrome P 3A4, 2B6, 2C19, 2C9 or 2D6 inhibitors may result in an increase in methadone plasma concentrations, which could cause potentially fatal respiratory depression. In addition, discontinuation of concomitantly used cytochrome P 3A4, 2B6, 2C19, or 2C9 inducers may also result in an increase in methadone plasma concentration. Follow patients closely for respiratory depression and sedation, and consider dosage reduction with any changes of concomitant medications that can result in an increase in methadone levels. Concomitant use of opioids with benzodiazepines or other central nervous system CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of methadone and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. If the patient is visibly sedated, evaluate the cause of sedation, and consider delaying or omitting the daily methadone dose. Along with its needed effects, methadone 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 methadone:. Some side effects of methadone 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 methadone: compounding powder, injectable solution, intravenous solution, oral concentrate, oral solution, oral tablet, oral tablet dispersible. Frequency not reported : Headache, seizures, confusion, disorientation, lightheadedness \\\\\\\\\\[ Ref \\\\\\\\\\]. Cases of QT interval prolongation and Torsades de pointes have occurred during treatment; these cases appear to be more commonly associated with higher dose treatment greater than mg per day. In vivo studies have confirmed this drug effects the QT interval and in vitro studies have shown it inhibits cardiac potassium channels. Uncommon 0. Rare less than 0. Frequency not reported : Arrhythmias, bigeminal rhythms, cardiomyopathy, ECG abnormalities, extrasystoles, heart failure , phlebitis, QT interval prolongation, syncope, T-wave inversion, tachycardia , ventricular fibrillation , ventricular tachycardia \\\\\\\\\\[ Ref \\\\\\\\\\]. Constipation often persists during chronic administration; nausea, and vomiting appear to be more frequent after oral administration. Frequency not reported : Abdominal pain , anorexia, biliary tract spasm \\\\\\\\\\[ Ref \\\\\\\\\\]. Frequency not reported : Anaphylaxis \\\\\\\\\\[ Ref \\\\\\\\\\]. Anaphylaxis has been reported with ingredients contained in methadone products. Frequency not reported : Agitation, dysphoria, insomnia , mood changes \\\\\\\\\\[ Ref \\\\\\\\\\]. Hypogonadism, decreased serum testosterone, and reproductive effects are thought to be related to chronic opioid use. Frequency not reported : Urinary hesitancy, ureteric spasm \\\\\\\\\\[ Ref \\\\\\\\\\]. Frequency not reported : Pulmonary edema \\\\\\\\\\[ Ref \\\\\\\\\\]. Frequency not reported : Reversible thrombocytopenia , lymphocytosis \\\\\\\\\\[ Ref \\\\\\\\\\]. Reversible thrombocytopenia has been described in opioid addicts with chronic hepatitis. The major adverse reaction of this drug is respiratory depression; to a lesser degree, systemic hypotension, respiratory arrest, shock, cardiac arrest , and death have occurred. The most commonly observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. Frequency not reported : Hypokalemia , hypomagnesemia \\\\\\\\\\[ Ref \\\\\\\\\\]. Frequency not reported : Visual disturbances \\\\\\\\\\[ Ref \\\\\\\\\\]. Sweating often persists during chronic administration. Frequency not reported : Local tissue reactions pain, erythema , swelling particularly with continuous subcutaneous infusion \\\\\\\\\\[ Ref \\\\\\\\\\]. Diskets methadone. Dolophine methadone. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Some side effects may not be reported. You may report them to the FDA. Other brands: Dolophine , Methadose , Methadone Diskets. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices. Subscribe to Drugs. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. We comply with the HONcode standard for trustworthy health information - verify here. Skip to Content. Methadone Side Effects Medically reviewed by Drugs. Warning Oral route Tablet for Suspension Deaths due to too-rapid titration, drug interactions, or cardiac and respiratory side effects have occurred with methadone use for opioid dependence. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of methadone hydrochloride tablets. Accidental Ingestion Accidental ingestion of even one dose of methadone hydrochloride tablets, especially by children, can result in a fatal overdose of methadone. Closely monitor patients with risk factors for development of prolonged QT interval, a history of cardiac conduction abnormalities, and those taking medications affecting cardiac conduction for changes in cardiac rhythm during initiation and titration of methadone hydrochloride tablets Neonatal Opioid Withdrawal Syndrome Neonatal opioid withdrawal syndrome NOWS is an expected and treatable outcome of use of methadone hydrochloride tablets during pregnancy. Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. References 1. Cerner Multum, Inc. Drug Status Rx. Availability Prescription only. Akorn, Inc. Mallinckrodt Inc. Mylan Pharmaceuticals Inc. Drug Class. Narcotic analgesics. Related Drugs. Methadone Images. Explore Apps. About About Drugs. All rights reserved.
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