Amitriptylinoxide
Amitriptyline, Amitriptyline / (amitriptylinoxide) is a small molecule pharmaceutical. Amitriptylinoxide was first approved as Elavil on 1982-01-01.
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Commercial
Therapeutic Areas
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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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 | 2025-08-08 |
| chlordiazepoxide & amitriptyline hydrochloride | 2007-02-12 | |
| chlordiazepoxide and amitriptyline hydrochloride | ANDA | 2025-07-07 |
| 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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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 |
Show 38 more
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 |
Show 28 more
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 |
Show 25 more
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 |
Show 11 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Amitriptylinoxide |
| INN | amitriptylinoxide |
| Description | Amitriptylinoxide is an organic tricyclic compound. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[N+](C)([O-])CCC=C1c2ccccc2CCc2ccccc21 |
Identifiers
| PDB | — |
| CAS-ID | 4317-14-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL627 |
| ChEBI ID | — |
| PubChem CID | 20313 |
| DrugBank | DB13114 |
| UNII ID | TYR2U59WMA (ChemIDplus, GSRS) |
Target
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Variants
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Trends
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Additional graphs summarizing 82 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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15 adverse events reported
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