85/100 · Critical
Manufactured by VistaPharm, LLC
High Safety Concerns with Methadone Use
88,944 FDA adverse event reports analyzed
Last updated: 2026-05-12
METHADONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by VistaPharm, LLC. Based on analysis of 88,944 FDA adverse event reports, METHADONE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for METHADONE include DRUG DEPENDENCE, TOXICITY TO VARIOUS AGENTS, DRUG ABUSE, OVERDOSE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for METHADONE.
Methadone has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 88,944 adverse event reports for this medication, which is primarily manufactured by Vistapharm, Llc.
The most commonly reported adverse events include Drug Dependence, Toxicity To Various Agents, Drug Abuse. Of classified reports, 86.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Methadone is associated with a high risk of serious adverse events, including overdose, death, and cardiac arrest.
The drug is frequently reported to cause drug dependence and withdrawal symptoms, both in adults and neonates. Methadone use is linked to significant respiratory depression and respiratory failure, posing a critical risk.
Patients taking Methadone should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Methadone can interact with other drugs, potentially leading to increased toxicity or reduced efficacy. Warnings include interactions with drugs that affect the QT interval and central nervous system depressants. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Methadone received a safety concern score of 85/100 (high concern). This is based on a 86.3% serious event ratio across 41,635 classified reports. The score accounts for 88,944 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 20,594, Female: 16,434, Unknown: 174. The most frequently reported age groups are age 55 (693 reports), age 39 (655 reports), age 47 (642 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 41,635 classified reports for METHADONE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Methadone can interact with other drugs, potentially leading to increased toxicity or reduced efficacy. Warnings include interactions with drugs that affect the QT interval and central nervous system depressants.
If you are taking Methadone, here are important things to know. The most commonly reported side effects include drug dependence, toxicity to various agents, drug abuse, overdose, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should strictly follow prescribed dosages and avoid self-adjustment of medication. Regular monitoring by healthcare providers is essential to manage potential side effects and adjust treatment as necessary. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA closely monitors methadone use due to its high safety concerns. Healthcare providers should be vigilant in monitoring patients for signs of adverse reactions and adjust dosages accordingly.
The FDA has received approximately 88,944 adverse event reports associated with Methadone. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Methadone include Drug Dependence, Toxicity To Various Agents, Drug Abuse, Overdose, Pain. By volume, the top reported reactions are: Drug Dependence (5,614 reports), Toxicity To Various Agents (5,213 reports), Drug Abuse (4,797 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Methadone.
Out of 41,635 classified reports, 35,937 (86.3%) were classified as serious and 5,698 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Methadone break down by patient sex as follows: Male: 20,594, Female: 16,434, Unknown: 174. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Methadone adverse events are: age 55: 693 reports, age 39: 655 reports, age 47: 642 reports, age 37: 641 reports, age 32: 640 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Methadone adverse event reports is Vistapharm, Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Methadone include: Death, Emotional Distress, Drug Withdrawal Syndrome, Drug Ineffective, Foetal Exposure During Pregnancy. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Methadone to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Methadone has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Methadone is associated with a high risk of serious adverse events, including overdose, death, and cardiac arrest.
Key safety signals identified in Methadone's adverse event data include: Overdose and death are the most serious adverse events, with high report volumes.. Cardiac arrest and respiratory depression are critical safety signals, indicating potential life-threatening risks.. Neonatal withdrawal syndrome is a key safety signal, highlighting the risks to infants exposed to methadone during pregnancy.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Methadone can interact with other drugs, potentially leading to increased toxicity or reduced efficacy. Warnings include interactions with drugs that affect the QT interval and central nervous system depressants. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Methadone.
Patients should strictly follow prescribed dosages and avoid self-adjustment of medication. Regular monitoring by healthcare providers is essential to manage potential side effects and adjust treatment as necessary.
Methadone has 88,944 adverse event reports on file with the FDA. The drug is frequently reported to cause drug dependence and withdrawal symptoms, both in adults and neonates. The volume of reports for Methadone reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors methadone use due to its high safety concerns. Healthcare providers should be vigilant in monitoring patients for signs of adverse reactions and adjust dosages accordingly. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with METHADONE:
Drugs related to METHADONE based on therapeutic use, drug class, or shared indications: