Amitriptyline
Amitriptyline, Amitriptyline / (amitriptyline) is a small molecule pharmaceutical. Amitriptyline was first approved as Elavil on 1982-01-01. It is used to treat depressive disorder, pain, and psychotic affective disorders in the USA. The pharmaceutical is active against muscarinic acetylcholine receptor M2, muscarinic acetylcholine receptor M4, muscarinic acetylcholine receptor M5, muscarinic acetylcholine receptor M3, muscarinic acetylcholine receptor M1, histamine H1 receptor, sodium-dependent serotonin transporter, and sodium-dependent noradrenaline transporter. In addition, it is known to target 5-hydroxytryptamine receptor 2A, 5-hydroxytryptamine receptor 7, 5-hydroxytryptamine receptor 2C, lysophosphatidic acid receptor 1, 5-hydroxytryptamine receptor 6, G protein-activated inward rectifier potassium channel 4, and G protein-activated inward rectifier potassium channel 2.
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Commercial
Trade Name
FDA
EMA
Amitriptyline (discontinued: Amitid, Amitril, Amitriptyline, Elavil, Endep)
CombinationsChlordiazepoxide amitriptyline, Perphenazine amitriptyline (discontinued: Chlordiazepoxide amitriptyline, Etrafon, Limbitrol, Perphenazine amitriptyline, Triavil)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amitriptyline hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ELAVIL | AstraZeneca | N-012703 DISCN | 1982-01-01 | 6 products, RLD |
| ELAVIL | AstraZeneca | N-012704 DISCN | 1982-01-01 | 1 products |
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Amitriptyline hydrochloride
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Perphenazine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TRIAVIL 2-25 | New River Pharmaceuticals | N-014715 DISCN | 1982-01-01 | 1 products |
| TRIAVIL 4-10 | New River Pharmaceuticals | N-014715 DISCN | 1982-01-01 | 1 products |
| TRIAVIL 2-10 | New River Pharmaceuticals | N-014715 DISCN | 1982-01-01 | 1 products |
| TRIAVIL 4-25 | New River Pharmaceuticals | N-014715 DISCN | 1982-01-01 | 1 products |
| TRIAVIL 4-50 | New River Pharmaceuticals | N-014715 DISCN | 1982-01-01 | 1 products |
| ETRAFON-A | Merck & Co | N-014713 DISCN | 1982-01-01 | 1 products |
| ETRAFON 2-25 | Merck & Co | N-014713 DISCN | 1982-01-01 | 1 products |
| ETRAFON-FORTE | Merck & Co | N-014713 DISCN | 1982-01-01 | 1 products |
| ETRAFON 2-10 | Merck & Co | N-014713 DISCN | 1982-01-01 | 1 products |
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Amitriptyline hydrochloride
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Chlordiazepoxide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LIMBITROL | Chartwell Pharmaceuticals | N-016949 DISCN | 1982-01-01 | 1 products, RLD |
| LIMBITROL DS | Chartwell Pharmaceuticals | N-016949 DISCN | 1982-01-01 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amitriptyline | ANDA | 2009-10-22 |
| amitriptyline hcl | ANDA | 2025-05-13 |
| amitriptyline hydrochloride | ANDA | 2025-06-27 |
| chlordiazepoxide & amitriptyline hydrochloride | 2007-02-12 | |
| chlordiazepoxide and amitriptyline hydrochloride | ANDA | 2025-06-13 |
| chlordiazepoxide and amitriptyline hydrochloride chlordiazepoxide and amitriptyline hydrochloride | ANDA | 2025-06-11 |
| elavil | ANDA | 2021-08-31 |
| elavil 25 mg | ANDA | 2016-04-13 |
| perphenazine and amitriptyline hydrochloride | ANDA | 2025-03-15 |
| sentravil pm-25 | unapproved drug other | 2011-08-01 |
Indications
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Agency Specific
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Patent Expiration
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ATC Codes
N: Nervous system drugs
— N06: Psychoanaleptics
— N06A: Antidepressants
— N06AA: Non-selective monoamine reuptake inhibitors
— N06AA09: Amitriptyline
— N06C: Psycholeptics and psychoanaleptics in combination
— N06CA: Antidepressants in combination with psycholeptics
— N06CA01: Amitriptyline and psycholeptics
HCPCS
Code | Description |
|---|---|
| J1320 | Injection, amitriptyline hcl, up to 20 mg |
Clinical
Clinical Trials
154 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Migraine disorders | D008881 | EFO_0003821 | G43 | 1 | 2 | 5 | 4 | 7 | 19 |
| Depression | D003863 | — | F33.9 | 3 | 1 | 3 | 3 | 5 | 15 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | 1 | 5 | 4 | 4 | 3 | 14 |
| Headache | D006261 | — | R51 | — | 2 | 4 | 2 | 6 | 14 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | 1 | 4 | 3 | 4 | 3 | 13 |
| Pain | D010146 | EFO_0003843 | R52 | — | 4 | 6 | 4 | 2 | 13 |
| Neuralgia | D009437 | EFO_0009430 | — | 1 | 3 | 4 | 3 | 1 | 12 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | 1 | 2 | 2 | 3 | 9 |
| Chronic pain | D059350 | — | — | — | — | — | 4 | 3 | 7 |
| Syndrome | D013577 | — | — | — | — | — | 3 | 3 | 6 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Peripheral nervous system diseases | D010523 | — | G64 | — | 8 | 6 | — | 1 | 11 |
| Neoplasms | D009369 | — | C80 | — | — | 3 | — | — | 3 |
| Tension-type headache | D018781 | — | G44.2 | — | — | 1 | — | 2 | 3 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | 2 | 2 | — | 1 | 3 |
| Interstitial cystitis | D018856 | EFO_1000869 | N30.1 | — | — | 2 | — | 1 | 3 |
| Cystitis | D003556 | EFO_1000025 | N30 | 1 | — | 2 | — | — | 3 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | 1 | — | 1 | 2 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | 1 | — | — | 2 |
| Plasma cell neoplasms | D054219 | — | — | — | 1 | 1 | — | — | 2 |
| Neurotoxicity syndromes | D020258 | — | G92 | — | — | 2 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intervertebral disc displacement | D007405 | EFO_1001800 | — | — | 1 | — | — | 2 | 3 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | 1 | 2 |
| Nervous system diseases | D009422 | — | G00-G99 | — | 1 | — | — | 1 | 2 |
| Pruritus | D011537 | — | L29 | — | 1 | — | — | 1 | 2 |
| Fibrosis | D005355 | — | — | — | 2 | — | — | — | 2 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 2 | — | — | — | 2 |
| Infections | D007239 | EFO_0000544 | — | — | 2 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | — | 1 | — | — | — | 1 |
| Female genital neoplasms | D005833 | — | — | — | 1 | — | — | — | 1 |
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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 | — | — | — | 4 | — | — | — | 2 | 6 |
| Enuresis | D004775 | — | R32 | 1 | — | — | — | — | 1 |
| Neuritis | D009443 | — | — | 1 | — | — | — | — | 1 |
| Radiation injuries | D011832 | — | T66 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Radiculopathy | D011843 | — | M54.1 | — | — | — | — | 3 | 3 |
| Taste disorders | D013651 | — | — | — | — | — | — | 3 | 3 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 2 | 2 |
| Hernia | D006547 | — | K40-K46 | — | — | — | — | 2 | 2 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | — | — | — | 1 | 1 |
| Synovitis | D013585 | EFO_0008997 | M67.5 | — | — | — | — | 1 | 1 |
| Spasm | D013035 | — | M62.83 | — | — | — | — | 1 | 1 |
| Gout | D006073 | EFO_0004274 | M10 | — | — | — | — | 1 | 1 |
| Sciatica | D012585 | — | M54.3 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Amitriptyline |
| INN | amitriptyline |
| Description | Amitriptyline is an organic tricyclic compound that is 10,11-dihydro-5H-dibenzo[a,d][7]annulene substituted by a 3-(dimethylamino)propylidene group at position 5. It has a role as an adrenergic uptake inhibitor, an antidepressant, an environmental contaminant, a xenobiotic and a tropomyosin-related kinase B receptor agonist. It is a tertiary amine and a carbotricyclic compound. It derives from a hydride of a dibenzo[a,d][7]annulene. |
| Classification | Small molecule |
| Drug class | antidepressants (dibenzol[a,d]cycloheptane derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN(C)CCC=C1c2ccccc2CCc2ccccc21 |
Identifiers
| PDB | — |
| CAS-ID | 50-48-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL629 |
| ChEBI ID | 2666 |
| PubChem CID | 2160 |
| DrugBank | DB00321 |
| UNII ID | 1806D8D52K (ChemIDplus, GSRS) |
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Amitriptyline
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Amitriptyline
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Chlordiazepoxide
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Amitriptyline
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Perphenazine
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Additional graphs summarizing 22,403 documents
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Safety
Black-box Warning
Black-box warning for: Amitriptyline, Amitriptyline hcl, Amitriptyline hydrochloride, Chlordiazepoxide & amitriptyline hydrochloride, Chlordiazepoxide and amitriptyline hydrochloride, Chlordiazepoxide and amitriptyline hydrochloride chlordiazepoxide and amitriptyline hydrochloride, Elavil 25 mg, Perphenazine and amitriptyline hydrochloride, Sentravil pm-25
Adverse Events
Top Adverse Reactions
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28,321 adverse events reported
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