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 Amitriptyline, a tertiary amine tricyclic antidepressant, is structurally related to both the skeletal muscle relaxant cyclobenzaprine and the thioxanthene antipsychotics such as thiothixene. It is extremely sedating, and thus improvement of sleep patterns can be the first benefit of treatment. Amitriptyline exhibits strong anticholinergic activity, cardiovascular effects including orthostatic hypotension, changes in heart rhythm and conduction, and a lowering of the seizure threshold. As with other antidepressants, several weeks of therapy may be required in order to realize the full clinical benefit of amitriptyline. Although not a labelled indication, amitriptyline is widely used in the management of chronic nonmalignant pain (e.g., post-herpetic neuralgia, fibromyalgia).
Marketing Status Prescription; Discontinued
ATC Code N06AA09
DrugBank ID DB00321
KEGG ID D07448
MeSH ID D000639
PubChem ID 2160
TTD Drug ID D0Y5UG
NDC Product Code 51927-0198
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
ArrhythmiaCytochrome P450 2D6P10635T5739210772431; 15748098; 10983742
ArrhythmiaCytochrome P450 2D6P10635T57392Not Available
Atrioventricular blockCytochrome P450 3A4P08684T3784811903482; 9435993; 8941495; 11952767
Blood creatinine increasedCytochrome P450 3A4P08684T3784811903482; 9435993; 8941495; 11952767
HaemorrhageCytochrome P450 2C19P33261Not Available395826; 803187
HypotensionCytochrome P450 3A4P08684T3784811903482; 9435993; 8941495; 11952767
Platelet aggregation abnormalCytochrome P450 3A4P08684T3784811903482; 9435993; 8941495; 11952767
RhabdomyolysisCytochrome P450 3A4P08684T3784811903482; 9435993; 8941495; 11952767
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Disturbance in attention19.21.02.002; 17.03.03.001--
Dizziness17.02.05.003; 02.01.02.004; 24.06.02.0070.000321%
Drug hypersensitivity10.01.01.0010.000321%Not Available
Drug withdrawal syndrome19.07.02.011; 08.06.02.004--Not Available
Dry mouth07.06.01.0020.000428%
Dysarthria19.19.03.001; 17.02.08.001--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyskinesia17.01.02.006--
Dyspepsia07.01.02.001--
Dyspnoea22.02.01.004; 02.01.03.0020.000214%
Electrocardiogram QRS complex13.14.05.034--Not Available
Electrocardiogram QT prolonged13.14.05.004--
Eosinophilia01.02.04.001--
Extrapyramidal disorder17.01.02.007--
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Galactorrhoea21.05.02.002; 05.03.04.002--Not Available
Gastrointestinal disorder07.11.01.0010.000642%Not Available
Gynaecomastia21.05.04.003; 05.05.02.003--
Hallucination19.10.02.0020.000214%
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Hepatitis09.01.07.004--Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hyperpyrexia08.05.02.002--Not Available
Hypertension24.08.02.001--
Hypoaesthesia17.02.06.023--Not Available
Hypomania19.16.02.001--Not Available
Hypotension24.06.03.002--
Ileus paralytic07.02.05.001--Not Available
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