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Drug ReportsAmitriptyline
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
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
mental disordersD001523
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Amitriptyline (discontinued: Amitid, Amitril, Amitriptyline, Elavil, Endep)
Combinations
Chlordiazepoxide 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
ELAVILAstraZenecaN-012703 DISCN1982-01-01
6 products, RLD
ELAVILAstraZenecaN-012704 DISCN1982-01-01
1 products
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Amitriptyline hydrochloride
+
Perphenazine
Tradename
Company
Number
Date
Products
TRIAVIL 2-25New River PharmaceuticalsN-014715 DISCN1982-01-01
1 products
TRIAVIL 4-10New River PharmaceuticalsN-014715 DISCN1982-01-01
1 products
TRIAVIL 2-10New River PharmaceuticalsN-014715 DISCN1982-01-01
1 products
TRIAVIL 4-25New River PharmaceuticalsN-014715 DISCN1982-01-01
1 products
TRIAVIL 4-50New River PharmaceuticalsN-014715 DISCN1982-01-01
1 products
ETRAFON-AMerck & CoN-014713 DISCN1982-01-01
1 products
ETRAFON 2-25Merck & CoN-014713 DISCN1982-01-01
1 products
ETRAFON-FORTEMerck & CoN-014713 DISCN1982-01-01
1 products
ETRAFON 2-10Merck & CoN-014713 DISCN1982-01-01
1 products
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Amitriptyline hydrochloride
+
Chlordiazepoxide
Tradename
Company
Number
Date
Products
LIMBITROLChartwell PharmaceuticalsN-016949 DISCN1982-01-01
1 products, RLD
LIMBITROL DSChartwell PharmaceuticalsN-016949 DISCN1982-01-01
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
amitriptylineANDA2009-10-22
amitriptyline hclANDA2025-05-13
amitriptyline hydrochlorideANDA2025-10-04
chlordiazepoxide & amitriptyline hydrochloride2007-02-12
chlordiazepoxide and amitriptyline hydrochlorideANDA2025-07-07
chlordiazepoxide and amitriptyline hydrochloride chlordiazepoxide and amitriptyline hydrochlorideANDA2025-06-11
elavilANDA2021-08-31
elavil 25 mgANDA2016-04-13
perphenazine and amitriptyline hydrochlorideANDA2025-08-30
sentravil pm-25unapproved drug other2011-08-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
painEFO_0003843D010146R52
psychotic affective disorders—D000341F39
depressive disorderEFO_1002014D003866F32.A
substance withdrawal syndromeEFO_0005800D013375—
vomiting—D014839R11.1
nausea—D009325R11.0
torticollis—D014103F45.8
tourette syndromeEFO_0004895D005879F95.2
huntington diseaseOrphanet_399D006816G10
schizophreniaEFO_0000692D012559F20
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Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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
140 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FibromyalgiaD005356EFO_0005687M79.1———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Major depressive disorderD003865EFO_0003761F22——1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAmitriptyline
INNamitriptyline
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 classantidepressants (dibenzol[a,d]cycloheptane derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN(C)CCC=C1c2ccccc2CCc2ccccc21
Identifiers
PDB—
CAS-ID50-48-6
RxCUI—
ChEMBL IDCHEMBL629
ChEBI ID2666
PubChem CID2160
DrugBankDB00321
UNII ID1806D8D52K (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
ORM2
ORM2
Organism
Homo sapiens
Gene name
ORM2
Gene synonyms
AGP2
NCBI Gene ID
5005
Protein name
alpha-1-acid glycoprotein 2
Protein synonyms
AGP 2, alpha-1-acid glycoprotein, type 2, OMD 2, Orosomucoid-2
Uniprot ID
Q6IB74
Mouse ortholog
—
—
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Amitriptyline
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Amitriptyline
+
Chlordiazepoxide
Total medical expenditures per year (USD, in millions)
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Price per prescription (USD)
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Amitriptyline
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Perphenazine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 23,015 documents
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Safety
Black-box Warning
Black-box warning for: Amitriptyline, Amitriptyline hcl, 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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28,874 adverse events reported
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