methadone
Brand names: Dolophine
Methadone Hydrochloride Injection is a strong pain medicine. It is also used to treat opioid dependence temporarily when you cannot take medicine by mouth.
Drug Pricing (NADAC)
Generic Price
$0.10/unit
Generic Available
Yes (22 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine is used to manage severe, ongoing pain that needs a strong opioid medicine when other pain medicines don't work well enough.
Common side effects
Lightheadedness, Dizziness, Sedation
Key warnings
Methadone Hydrochloride Injection can cause serious and life-threatening risks, including addiction, abuse, and misuse.
How It Works
Methadone works by attaching to opioid receptors in the brain and body. This changes how your body feels pain. It can also help reduce withdrawal symptoms if you are opioid dependent.
How to Take It
Methadone Hydrochloride Injection will be given to you by a healthcare provider. They will inject it into a vein, muscle, or under your skin. The dose will be based on your pain and how you respond to the medicine. Your doctor will use the lowest effective dose for the shortest amount of time needed.
Pregnancy & Breastfeeding
Using Methadone Hydrochloride Injection during pregnancy can cause withdrawal symptoms in the newborn. Talk to your doctor about the risks and benefits of using this medicine if you are pregnant or plan to become pregnant. It is not known if methadone passes into breast milk, so talk to your doctor before breastfeeding.
Missed Dose
Since a healthcare provider is giving you this medicine, you are not likely to miss a dose. Call your doctor if you think you missed a dose.
Storage
This medicine should be stored at room temperature, away from light, and in its original carton.
Side Effects (from patient reports)
Based on 34,762 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 41,632 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
41,632
Death-Related Reports
13,420
Hospitalization Reports
11,019
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG DEPENDENCE | 5,614 |
| 2 | TOXICITY TO VARIOUS AGENTS | 5,213 |
| 3 | DRUG ABUSE | 4,797 |
| 4 | OVERDOSE | 3,840 |
| 5 | PAIN | 3,671 |
| 6 | DEATH | 3,519 |
| 7 | EMOTIONAL DISTRESS | 2,385 |
| 8 | DRUG WITHDRAWAL SYNDROME | 2,343 |
| 9 | DRUG INEFFECTIVE | 1,722 |
| 10 | FOETAL EXPOSURE DURING PREGNANCY | 1,659 |
| 11 | NAUSEA | 1,601 |
| 12 | DRUG INTERACTION | 1,592 |
| 13 | ANXIETY | 1,336 |
| 14 | DRUG WITHDRAWAL SYNDROME NEONATAL | 1,334 |
| 15 | FATIGUE | 1,300 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Methadone Hydrochloride Injection can cause serious and life-threatening risks, including addiction, abuse, and misuse. It can also cause life-threatening breathing problems, especially when you first start taking it or after a dose increase. Using methadone during pregnancy can cause withdrawal symptoms in the newborn. Using methadone with benzodiazepines or other drugs that can cause drowsiness, including alcohol, can cause severe sedation, breathing problems, coma, and death. Methadone can also cause a serious heart problem called QT prolongation.
Known Drug Interactions
Analgesics Methadone Contraindicated during and 2 weeks after itraconazole treatment.
Mechanism: Itraconazole prevents your body from clearing methadone, which can lead to a dangerous buildup and breathing issues.
What to do: Do not use these medications together, and wait two weeks after your last dose of itraconazole before taking methadone.
7.2 Opioid Drugs Because serious, sometimes fatal reactions have been precipitated with concomitant use of opioid drugs (e.g., meperidine and its derivatives, methadone, propoxyphene, or tramadol) and MAOIs, including selective MAO-B inhibitors, concomitant use of these drugs is contraindicated [see Warnings and Precautions (5.2) ] .
Mechanism: Taking these together can cause a very serious and potentially fatal reaction in the brain and nervous system.
What to do: Do not use these two drugs together.
John’s Wort, Phenobarbital Benzodiazepines and other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death (see WARNINGS ).
Mechanism: Both drugs slow down the central nervous system, and taking them together makes this effect much stronger. This can lead to dangerous breathing problems, extreme sleepiness, or even death.
What to do: Avoid taking these drugs together if possible. If they must be used together, your doctor will need to monitor you very closely for signs of breathing trouble.
Product Clinical Comment on Concomitant Use [See Contraindications (4.1)] ; Predominant Effect/Risk [Hypertensive Reaction (HR) [See Warnings and Precautions (5.3)] ; or Serotonin Syndrome (SS) [See Warnings and Precautions (5.7)] ] Altretamine Use with caution If not otherwise specified in this table, consider avoiding concomitant use (see also information on medication-free intervals , use agent at the lowest appropriate dose, monitor for effects of the interaction, advise the patient to report potential effects, and be prepared to discontinue the agent and treat effects of the interactio...
Mechanism: This combination can lead to life-threatening issues like extremely high blood pressure or serotonin syndrome. These drugs interfere with the way the body processes chemicals that regulate pain, mood, and heart rate.
What to do: It is best to avoid taking these drugs together. If they are necessary, your doctor will need to monitor you very closely for any signs of a bad reaction and use the lowest effective doses.
Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol.
Mechanism: Both of these medicines can slow down your brain activity and breathing, which increases the risk of dangerous sleepiness.
What to do: Avoid driving or using heavy machinery until you know how this combination affects you, and watch for slow breathing.
Common Questions
Can I take this medicine for any type of pain?
Can I drive while taking this medicine?
What should I do if I feel like the medicine is not working anymore?
Can I drink alcohol while taking this medicine?
What should I tell my doctor before taking this medicine?
Is this medicine addictive?
What are the symptoms of an overdose?
Can I stop taking this medicine suddenly?
What are the symptoms of withdrawal?
How long does this medicine stay in my system?
What are the common side effects of methadone?
Does methadone interact with other medications?
What drug class is methadone?
Is methadone safe during pregnancy?
Related Medications in Opioid Agonist
Other drugs grouped near methadone — same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
Compare with methadone →
alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with methadone →
amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
Compare with methadone →
amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
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aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with methadone →
Medication Guides
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What the FDA Data Shows for methadone
The FDA label for methadone (sold under brand names such as Dolophine) classifies it as a prescription-only medication in the Opioid Agonist class. This medicine is used to manage severe, ongoing pain that needs a strong opioid medicine when other pain medicines don't work well enough. Official labeling lists 6 commonly reported side effects, including Lightheadedness, Dizziness, Sedation.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 34,762 voluntary reports. The database also lists 41 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.10.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: December 31, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages