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)
Mental disability26.01.01.001--Not Available
Mental impairment19.21.02.003; 17.03.03.002--Not Available
Migraine17.14.02.001; 24.03.05.003--Not Available
Mood altered19.04.02.007--Not Available
Movement disorder17.01.02.010--Not Available
Multiple sclerosis10.04.10.008; 17.16.01.001--Not Available
Muscle rigidity17.05.02.005; 15.05.04.001--Not Available
Muscle spasms15.05.03.004--
Muscle twitching15.05.03.005--Not Available
Myalgia15.05.02.0010.000048%
Mydriasis17.02.11.003; 06.05.03.0040.000048%Not Available
Myocardial infarction24.04.04.009; 02.02.02.007--
Nausea07.01.07.0010.000218%
Nervousness19.06.02.003--Not Available
Neuralgia17.02.07.005--
Neuroleptic malignant syndrome17.05.02.003; 15.05.04.015; 12.03.01.003; 08.05.01.005--Not Available
Neuropathy peripheral17.09.03.003--Not Available
Nightmare19.02.03.003--Not Available
Obsessive-compulsive disorder19.06.05.002--Not Available
Oedema08.01.07.006; 14.05.06.010--Not Available
Oedema peripheral08.01.07.007; 02.05.04.007; 14.05.06.011--
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Osteoarthritis15.01.04.001--Not Available
Pain in extremity15.03.04.0100.000073%
Pallor24.03.04.001; 23.03.03.031; 08.01.03.032--Not Available
Palpitations02.11.04.012--
Pancytopenia01.03.03.003--Not Available
Paraesthesia17.02.06.005; 23.03.03.0940.000048%
Paresis17.01.04.008--Not Available
Parotid gland enlargement07.06.03.001--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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