Prescription medication · Opioid Agonist
methadone
Also sold as Dolophine. This medicine is used to manage severe, ongoing pain that needs a strong opioid medicine when other pain medicines don't work well enough.
Data updated 2026-05-15
- 41,632
- FDA reportsOften reported
- 41
- InteractionsMany interactions
- $0.10
- Generic price (NADAC)
What the data shows
methadone (Dolophine) is a prescription Opioid Agonist, reported at a middle-of-the-pack volume (41,632 FDA reports), with 41 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
methadone (Dolophine) is a prescription Opioid Agonist. This medicine is used to manage severe, ongoing pain that needs a strong opioid medicine when other pain medicines don't work well enough.
Methadone Hydrochloride Injection is a strong pain medicine. It is also used to treat opioid dependence temporarily when you cannot take medicine by mouth.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from methadone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of methadone's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of methadone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of methadone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed 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 41,632 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for methadone, by number of reports
- Addiction to the drug
Addiction to the drug
5,614 reports
- Harmful effects from different substances
Harmful effects from different substances
5,213 reports
- Misuse of the drug
Misuse of the drug
4,797 reports
- Taking too much of the drug
Taking too much of the drug
3,841 reports
- Pain
Pain
3,669 reports
- Death
Death
3,519 reports
- Emotional upset
Emotional upset
2,385 reports
- Symptoms when stopping the drug
Symptoms when stopping the drug
2,343 reports
- Baby exposed to drug during pregnancy 1,659
Baby exposed to drug during pregnancy
1,659 reports
- Feeling sick to your stomach 1,602
Feeling sick to your stomach
1,602 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for methadone each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where methadone sits
methadone has more FDA adverse-event reports than 70% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is methadone; the line is the median (50th percentile).
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
Reports Mentioning Death
13,420
32.2% of reports — not proof of cause
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 |
| 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 |
| 17 | VOMITING | 1,253 |
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...
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 41,632 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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