Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Amitriptyline
Drug ID BADD_D00118
Description Amitriptyline hydrochloride, also known as _Elavil_, is a tricyclic antidepressant (TCA) with analgesic properties, widely used to treat depression and neuropathic pain [A174658]. It was originally approved by the FDA in 1977 and manufactured by Sandoz [L5308].
Indications and Usage This drug in indicated for the following conditions [FDA label]: Major depressive disorder in adults Management of neuropathic pain in adults Prophylactic treatment of chronic tension-type headache (CTTH) in adults Prophylactic treatment of migraine in adults Treatment of nocturnal enuresis in children aged 6 years and above when organic pathology, including spina bifida and related disorders, have been excluded and no response has been achieved to all other non-drug and drug treatments, including antispasmodics and vasopressin-related products. This product should only be prescribed by a healthcare professional with expertise in the management of persistent enuresis [FDA label] Off-label uses: irritable bowel syndrome, sleep disorders, diabetic neuropathy, agitation, fibromyalgia, and insomnia
Marketing Status approved
ATC Code N06AA09
DrugBank ID DB00321
KEGG ID D07448
MeSH ID D000639
PubChem ID 2160
TTD Drug ID D0Y5UG
NDC Product Code 51927-0198
UNII 1806D8D52K
Synonyms Amitriptyline | Tryptine | Amineurin | Amitrip | Amitriptylin Beta | Amitriptylin Desitin | Desitin, Amitriptylin | Amitriptylin RPh | RPh, Amitriptylin | Amitriptylin-Neuraxpharm | Amitriptylin Neuraxpharm | Amitriptyline Hydrochloride | Amitrol | Anapsique | Apo-Amitriptyline | Apo Amitriptyline | Damilen | Domical | Laroxyl | Lentizol | Novoprotect | Saroten | Sarotex | Syneudon | Triptafen | Endep | Tryptizol | Elavil | Tryptanol
Chemical Information
Molecular Formula C20H23N
CAS Registry Number 50-48-6
SMILES CN(C)CCC=C1C2=CC=CC=C2CCC3=CC=CC=C31
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.0020.000048%
Abnormal dreams19.02.03.001; 17.15.02.001---
Accommodation disorder06.02.04.001---
Acne23.02.01.001---
Ageusia07.14.03.003; 17.02.07.001---
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001---
Akathisia19.06.02.006; 17.01.02.002--
Alopecia23.02.02.001--
Amnesia19.20.01.001; 17.03.02.001--
Anaemia01.03.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.002---
Anger19.04.02.001---
Ankylosing spondylitis15.01.09.001; 10.04.04.004---
Anxiety19.06.02.002--
Aphthous ulcer07.05.06.002---
Arrhythmia02.03.02.001---
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Asthenia08.01.01.001---
Asthma22.03.01.002; 10.01.03.010---
Ataxia17.02.02.001; 08.01.02.004--
Atrioventricular block02.03.01.002---
Blister12.01.06.002; 23.03.01.001---
Body temperature increased13.15.01.001---
Bradycardia02.03.02.0020.000097%-
Breast enlargement21.05.04.001---
Bundle branch block02.03.01.009---
Cardiac arrest02.03.04.0010.000194%
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ADReCS-Target
Drug Name ADR Term Target
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