Methadone Hydrochloride
According to the FDA label: Methadone Hydrochloride Tablets are indicated for the: 1. Management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.
42,086 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Methadone Hydrochloride in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Dependence 5,634 reports
A report that the body or mind has come to rely on a medication, so that stopping it causes difficulty. The term describes a physical or psychological state, not a judgment about the person.
Full definition in the glossary →Toxicity to Various Agents 5,253 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Drug Abuse 4,851 reports
A report that a medication was used in a way other than prescribed, or for non-medical reasons. The term describes a pattern of use, not a judgment about the person.
Full definition in the glossary →Overdose 3,857 reports
Taking more of a medication than intended or recommended. This can be accidental.
Full definition in the glossary →Pain 3,689 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Death 3,569 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Emotional Distress 2,387 reports
A report of emotional suffering such as upset, worry, or anguish. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Drug Withdrawal Syndrome 2,353 reports
The set of symptoms that can occur when a medication the body has gotten used to is stopped or reduced.
Full definition in the glossary →Drug Ineffective 1,752 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Foetal Exposure During Pregnancy 1,668 reports
A report noting that a developing baby was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself. Also spelled fetal in American English.
Full definition in the glossary →Nausea 1,617 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Drug Interaction 1,606 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Anxiety 1,347 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Drug Withdrawal Syndrome Neonatal 1,347 reports
Withdrawal symptoms in a newborn whose mother took certain medications during pregnancy.
Full definition in the glossary →Fatigue 1,314 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 20,809 |
| Female | 16,588 |
| Unknown | 174 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 1,560 |
| 18-34 | 6,306 |
| 35-49 | 8,569 |
| 50-64 | 7,100 |
| 65-74 | 2,130 |
| 75+ | 726 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Methadone Hydrochloride. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 22,031 |
| Death | 13,531 |
| Hospitalization | 11,193 |
| Non-Serious | 5,767 |
| Life-Threatening | 2,231 |
| Disability | 1,948 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Methadone Hydrochloride. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2003 | 1 |
| 2004 | 85 |
| 2005 | 290 |
| 2006 | 202 |
| 2007 | 83 |
| 2008 | 76 |
| 2009 | 498 |
| 2010 | 833 |
| 2011 | 700 |
| 2012 | 899 |
| 2013 | 1,896 |
| 2014 | 2,163 |
| 2015 | 2,720 |
| 2016 | 2,142 |
| 2017 | 2,403 |
| 2018 | 3,491 |
| 2019 | 2,699 |
| 2020 | 4,481 |
| 2021 | 5,415 |
| 2022 | 3,379 |
| 2023 | 2,749 |
| 2024 | 2,411 |
| 2025 | 2,042 |
| 2026 (partial) | 428 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Methadone Hydrochloride
In FDA adverse event reports that mention Methadone Hydrochloride, these medications appeared most often in the same report.
- Oxycodone (6,291 reports)
- Diazepam (4,746 reports)
- Gabapentin (4,523 reports)
- Diazepam Concentrate (4,083 reports)
- Pregabalin (4,018 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026