Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Amitriptyline hydrochloride
Drug ID BADD_D00119
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 D00809
MeSH ID D000639
PubChem ID 11065
TTD Drug ID D0Y5UG
NDC Product Code 43353-164; 63187-229; 50090-3985; 68788-6432; 53002-3390; 63629-8022; 0603-2216; 79572-002; 29300-420; 29300-419; 55154-7898; 70518-2258; 43353-163; 16714-260; 70518-1538; 63629-2120; 70771-1177; 63629-2122; 60687-433; 63187-637; 60687-444; 63187-408; 61919-289; 16714-257; 50090-3784; 70756-201; 60760-212; 68071-4519; 63629-1368; 15894-0033; 57664-689; 0781-1490; 0603-2212; 70859-013; 0832-1225; 50090-5015; 63275-9936; 68071-4092; 68071-4108; 0781-1489; 16714-259; 76420-017; 55700-643; 61919-076; 16714-261; 0904-7185; 70710-1230; 16714-446; 43063-836; 55700-619; 61919-117; 70710-1229; 63629-2115; 63187-155; 63629-2121; 16714-258; 63187-156; 54154-021; 50090-2553; 16714-449; 0781-1488; 29300-421; 0603-2214; 16714-447; 61919-374; 55700-600; 71335-0366; 70518-1484; 68071-4408; 72189-309; 55700-660; 70771-1174; 16714-448; 51655-121; 0832-1221; 0904-0201; 57664-687; 63187-359; 66577-038; 45865-648; 63629-2117; 69306-050; 0832-1220; 63187-260; 55289-124; 60760-181; 29300-424; 70518-1505; 67296-1279; 68071-4104; 0832-1223; 53002-3391; 49452-0460; 70934-428; 16729-172; 0395-8048; 57664-688; 70756-206; 16714-451; 70518-2570; 68788-6899; 70771-1176; 67296-1509; 16714-262; 0603-2217; 55700-689; 43063-822; 50090-3026; 68071-5220; 70934-607; 16729-175; 50090-5754; 57664-690; 70934-703; 68788-7061; 68071-4720; 63629-2118; 46438-0630; 67296-0932; 71554-001; 46438-0038; 67544-085; 16729-171; 57664-691; 70518-0493; 70756-203; 63629-2119; 66577-011; 67296-0388; 71335-1254; 67763-104; 70771-1178; 71335-0173; 16714-450; 71335-0306; 71335-0395; 50090-2840; 70518-1633; 36974-0019; 50090-4005; 68071-4405; 70756-202; 71335-0040; 45865-432; 67296-1816; 70934-430; 68788-6320; 71335-1256; 70756-205; 16729-176; 70710-1227; 70934-071; 0832-1222; 63629-3597; 68071-4348; 0603-2213; 71205-466; 51927-1603; 63629-8987; 17337-0501; 60760-367; 70771-1175; 29300-422; 53002-4910; 0603-2215; 50090-0031; 50090-3986; 43353-306; 68981-015; 63629-2116; 68788-6825; 67544-253; 0832-1224; 0781-1487; 68071-4238; 70771-1173; 0904-0202; 70710-1228; 43063-863; 70756-204; 71335-0566; 0904-7184; 50090-3564; 70710-1225; 0781-1486; 29300-423; 57664-692; 16729-173; 63629-2123; 16729-174; 70710-1226; 0781-1491; 38779-0189
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 C20H24ClN
CAS Registry Number 549-18-8
SMILES CN(C)CCC=C1C2=CC=CC=C2CCC3=CC=CC=C31.Cl
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
ArrhythmiaCytochrome P450 2D6P10635T57392Not Available
Atrioventricular blockCytochrome P450 3A4P08684T37848Not Available
Blood creatinine increasedCytochrome P450 3A4P08684T37848Not Available
HaemorrhageCytochrome P450 2C19P33261Not AvailableNot Available
HypotensionCytochrome P450 3A4P08684T37848Not Available
Platelet aggregation abnormalCytochrome P450 3A4P08684T37848Not Available
RhabdomyolysisCytochrome P450 3A4P08684T37848Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Skin exfoliation23.03.07.003--Not Available
Skin irritation23.03.04.009--Not Available
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Stomatitis07.05.06.005--
Syncope02.01.02.008; 24.06.02.012; 17.02.04.008--
Tachycardia02.03.02.007--Not Available
Tardive dyskinesia17.01.02.012--Not Available
Testicular swelling21.13.01.003--Not Available
Thrombocytopenia01.08.01.002--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Tongue discolouration07.14.02.006--Not Available
Tongue oedema23.04.01.009; 10.01.05.008; 07.14.02.007--Not Available
Tremor17.01.06.002--
Urinary retention20.02.02.011--
Urinary tract disorder20.08.01.001--Not Available
Urinary tract malformation20.08.03.002; 03.06.02.003--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Vasculitis24.05.02.001; 10.02.02.006--
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Mental status changes19.07.01.001--Not Available
Application site dryness23.03.03.024; 12.07.01.011; 08.02.01.011--Not Available
Lupus-like syndrome23.03.02.004; 15.06.02.004; 10.04.03.003--Not Available
Inappropriate antidiuretic hormone secretion14.05.07.001; 05.03.03.001--Not Available
Application site discolouration23.03.03.023; 12.07.01.030; 08.02.01.030--Not Available
Electrocardiogram change13.14.05.014--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
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