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)
Generalised tonic-clonic seizure17.12.01.002--Not Available
Guillain-Barre syndrome17.09.01.001; 11.07.01.001; 10.04.10.0050.000048%
Gynaecomastia21.05.04.003; 05.05.02.003--
Hallucination19.10.04.0030.000048%
Hallucination, auditory19.10.04.004--Not Available
Hallucination, visual19.10.04.007--Not Available
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Hepatitis09.01.07.004--Not Available
Hyperhidrosis08.01.03.028; 23.02.03.004--
Hyperpyrexia08.05.02.002--Not Available
Hypertension24.08.02.001--
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Hypomania19.16.02.001--Not Available
Hypotension24.06.03.0020.000266%
Ileus paralytic07.02.05.001--Not Available
Influenza like illness08.01.03.010--
Injection site haemorrhage24.07.01.010; 12.07.03.005; 08.02.03.005--Not Available
Insomnia19.02.01.002; 17.15.03.0020.000106%
Intraocular pressure increased13.07.04.002--Not Available
Irritability19.04.02.013; 08.01.03.011--
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.004--Not Available
Joint stiffness15.01.02.003--Not Available
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.008--
Leukopenia01.02.02.001--Not Available
Libido decreased21.03.02.005; 19.08.03.001--
Loss of consciousness17.02.04.004--Not Available
Malaise08.01.01.003--
Mania19.16.02.002--
Memory impairment19.20.01.003; 17.03.02.003--
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ADReCS-Target
Drug Name ADR Term Target
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