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)
Skin burning sensation23.03.03.021; 17.02.06.009--Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.003--Not Available
Paraesthesia oral07.05.05.035; 17.02.06.008--Not Available
Pulseless electrical activity02.03.04.0200.000073%Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Antinuclear antibody positive13.06.01.003--Not Available
Inflammation10.02.01.089; 08.01.05.007--Not Available
Limb discomfort15.03.04.014--Not Available
Therapeutic reaction time decreased08.06.01.015--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.001--
Ill-defined disorder08.01.03.049--Not Available
Sensation of foreign body08.01.09.002--Not Available
Drug intolerance08.06.01.013--Not Available
Psychotic disorder19.03.01.002--
Poor quality sleep19.02.05.005; 17.15.04.002--Not Available
Bone marrow failure01.03.03.005--
Oropharyngeal pain22.12.03.016; 07.05.05.004--
Multiple organ dysfunction syndrome08.01.03.0570.000048%
Depersonalisation/derealisation disorder19.14.01.004--Not Available
Alcohol interaction08.06.03.003--Not Available
Concomitant disease aggravated08.01.03.063--Not Available
Sleep disorder due to general medical condition, insomnia type19.02.04.004--Not Available
Drug effective for unapproved indication12.09.02.001; 08.06.01.0370.000106%Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.038--Not Available
Gait inability08.01.02.011; 17.02.05.069--Not Available
Therapeutic product ineffective08.06.01.057--Not Available
Therapeutic response shortened08.06.01.062--Not Available
Therapy partial responder08.06.01.064--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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