Methadone
Methadone, Methadose (methadone) is a small molecule pharmaceutical. Methadone was first approved as Dolophine hydrochloride on 1982-01-01. It is used to treat intractable pain and opioid-related disorders in the USA. The pharmaceutical is active against mu-type opioid receptor. In addition, it is known to target kappa-type opioid receptor and delta-type opioid receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Methadone, Methadose (discontinued: Dolophine, Methadone, Methadose, Westadone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 2-oak mix, red/white pollen 3-oak mix, black/blackjack/post pollen 3-ragweed mix, giant/short/western pollen 4-pine mix, austrian/loblolly/scotch/w... | Biologic Licensing Application | 2011-03-11 |
| a mold mixture absidia ramosa acrothecium robustum alternaria alternata aspergillus flavus aspergillus fumigatus aspergillus mixture aspergillus ni... | Biologic Licensing Application | 2009-11-17 |
| all physical sunscreen broad spectrum spf 50 | OTC monograph not final | 2021-10-15 |
| animi-3 | unapproved drug other | 2013-02-06 |
| anticholium | unapproved drug for use in drug shortage | 2024-11-08 |
| attitude oceanly phyto-sun kit spf 30 | C200263 | 2024-04-01 |
| attitude oceanly phyto-sun lip balm spf 30 baby rose | C200263 | 2024-04-01 |
| attitude oceanly phyto-sun lip balm spf 30 peachy shell | C200263 | 2024-04-01 |
| attitude oceanly phyto-sun lip balm spf 30 terracotta | C200263 | 2024-04-01 |
| attitude oceanly phyto-sun tinted - spf 15 - broad spectrum sunscreen | C200263 | 2025-01-08 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| opioid-related disorders | EFO_0005611 | D009293 | F11 |
| intractable pain | — | D010148 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N02: Analgesics
— N02A: Opioid analgesics
— N02AC: Diphenylpropylamine derivative analgesics
— N02AC52: Methadone, combinations excl. psycholeptics
— N07: Other nervous system drugs in atc
— N07B: Drugs used in addictive disorders
— N07BC: Drugs used in opioid dependence
— N07BC02: Methadone
HCPCS
Code | Description |
|---|---|
| G2067 | Medication assisted treatment, methadone; weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing, if performed (provision of the services by a medicare-enrolled opioid treatment program) |
| G2078 | Take-home supply of methadone; up to 7 additional day supply (provision of the services by a medicare-enrolled opioid treatment program); list separately in addition to code for primary procedure |
| H0020 | Alcohol and/or drug services; methadone administration and/or service (provision of the drug by a licensed program) |
| J1230 | Injection, methadone hcl, up to 10 mg |
| S0109 | Methadone, oral, 5 mg |
Clinical
Clinical Trials
538 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 28 | 42 | 26 | 15 | 98 | 201 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 10 | 14 | 6 | 7 | 44 | 79 |
| Postoperative pain | D010149 | — | G89.18 | 2 | 5 | 5 | 20 | 9 | 40 |
| Pain | D010146 | EFO_0003843 | R52 | 10 | 10 | 7 | 4 | 11 | 38 |
| Chronic pain | D059350 | — | — | 7 | 6 | 3 | 5 | 14 | 32 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 7 | 4 | 3 | 7 | 11 | 31 |
| Hepatitis c | D006526 | — | B19.2 | 5 | 3 | 3 | 6 | 14 | 31 |
| Cocaine-related disorders | D019970 | — | F14 | 6 | 14 | 3 | 1 | 8 | 30 |
| Hepatitis | D006505 | — | K75.9 | 1 | 3 | 1 | 8 | 13 | 26 |
| Heroin dependence | D006556 | EFO_0004240 | — | 1 | 4 | 2 | 4 | 14 | 24 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cancer pain | D000072716 | — | G89.3 | 1 | 2 | 4 | — | 5 | 11 |
| Substance withdrawal syndrome | D013375 | EFO_0005800 | — | 3 | 1 | 3 | — | 4 | 10 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | 1 | — | 3 | 4 |
| Opiate substitution treatment | D058850 | — | — | — | — | 2 | — | 2 | 4 |
| Acute pain | D059787 | — | R52 | 1 | — | 2 | — | 1 | 4 |
| Peripheral nervous system diseases | D010523 | — | G64 | — | 3 | 1 | — | — | 3 |
| Syphilis | D013587 | EFO_0007504 | A53.9 | — | — | 1 | — | 2 | 3 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 1 | 1 | — | 1 | 3 |
| Intractable pain | D010148 | — | — | — | — | 1 | — | 1 | 2 |
| Herpes simplex | D006561 | — | B00 | — | — | 1 | — | 1 | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parasomnias | D020447 | — | G47.5 | 1 | 1 | — | — | 2 | 4 |
| Hyperalgesia | D006930 | — | — | 1 | 1 | — | — | 2 | 4 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | 1 | — | — | 2 | 3 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | — | 1 | — | — | 1 | 2 |
| Hypogonadism | D007006 | — | E23.0 | 1 | 1 | — | — | 1 | 2 |
| Dyssomnias | D020920 | — | — | — | 1 | — | — | 1 | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 1 | — | — | 1 | 2 |
| Esophageal neoplasms | D004938 | — | C15 | 1 | 1 | — | — | 1 | 2 |
| Central nervous system neoplasms | D016543 | — | — | 1 | 1 | — | — | 1 | 2 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | 1 | — | — | 1 | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 7 | — | — | — | 1 | 8 |
| Recurrence | D012008 | — | — | 2 | — | — | — | 2 | 4 |
| Sleep wake disorders | D012893 | — | G47 | 1 | — | — | — | 3 | 4 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | — | — | — | 1 | 2 |
| Drug interactions | D004347 | — | — | 2 | — | — | — | — | 2 |
| Bronchiolitis | D001988 | — | — | 1 | — | — | — | — | 1 |
| Hepacivirus | D016174 | — | — | 1 | — | — | — | — | 1 |
| Kyphosis | D007738 | — | M40.20 | 1 | — | — | — | — | 1 |
| Intervertebral disc degeneration | D055959 | — | — | 1 | — | — | — | — | 1 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 10 | 10 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | — | — | — | 5 | 5 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | — | — | — | 4 | 4 |
| Traumatic stress disorders | D040921 | — | — | — | — | — | — | 3 | 3 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | — | — | — | 3 | 3 |
| Drug overdose | D062787 | — | — | — | — | — | — | 3 | 3 |
| Retention in care | D000076522 | — | — | — | — | — | — | 3 | 3 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 2 | 2 |
| Leukemia | D007938 | — | C95 | — | — | — | — | 2 | 2 |
| Risk-taking | D012309 | — | — | — | — | — | — | 2 | 2 |
Show 68 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Methadone |
| INN | methadone |
| Description | Methadone is a racemate comprising equimolar amounts of dextromethadone and levomethadone. It is a opioid analgesic which is used as a painkiller and as a substitute for heroin in the treatment of heroin addiction. It has a role as an opioid analgesic, a mu-opioid receptor agonist, a xenobiotic, an environmental contaminant, a NMDA receptor antagonist and a serotonin uptake inhibitor. It contains a levomethadone and a dextromethadone. |
| Classification | Small molecule |
| Drug class | Opioid |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 76-99-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL651 |
| ChEBI ID | 6807 |
| PubChem CID | 4095 |
| DrugBank | DB00333 |
| UNII ID | UC6VBE7V1Z (ChemIDplus, GSRS) |
Target
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Financial
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Estimated US medical usage
Methadone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
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Additional graphs summarizing 64,365 documents
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Safety
Black-box Warning
Black-box warning for: 2-oak mix, red/white pollen 3-oak mix, black/blackjack/post pollen 3-ragweed mix, giant/short/western pollen 4-pine mix, austrian/loblolly/scotch/w..., A mold mixture absidia ramosa acrothecium robustum alternaria alternata aspergillus flavus aspergillus fumigatus aspergillus mixture aspergillus ni..., Diskets, Methadone, Methadone hydrochloride, Methadone hydrochloride methadose, Methadone hydrochloride methadose dispersible, Methadone hydrocloride, Methadose, Methadose methadose, Methadose methadose sugar-free, Physicians ez use m-pred, Vitamin k1, Vitamin k1 - phytonadione, Vitamin k1 phytonadione
Adverse Events
Top Adverse Reactions
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50,237 adverse events reported
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