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 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 D00809
MeSH ID D000639
PubChem ID 11065
TTD Drug ID D0Y5UG
NDC Product Code 0781-1491; 0904-0202; 0904-7185; 76420-017; 16729-172; 29300-421; 50090-2553; 51655-969; 53002-3391; 53002-4910; 60760-212; 61919-117; 64330-630; 64330-632; 67296-1816; 67544-085; 70518-2570; 71335-0040; 71335-9635; 71335-9685; 72888-069; 72888-071; 0781-1486; 76420-239; 15894-0033; 17337-0501; 46438-0630; 54154-021; 63275-9936; 16571-108; 16714-260; 16714-449; 16714-450; 29300-419; 29300-423; 45865-648; 50090-6315; 50268-041; 55700-643; 57664-691; 63187-260; 63187-359; 63629-1368; 64330-634; 67296-0932; 67296-1279; 69844-063; 70518-1505; 70771-1177; 70934-071; 71335-9633; 0781-1489; 76420-238; 36974-0019; 16714-257; 16714-262; 16714-448; 29300-422; 43063-836; 55700-619; 57664-687; 60687-433; 60760-556; 61919-289; 63187-408; 68071-2843; 68071-4405; 70771-1176; 71335-0306; 71335-9710; 55289-124; 55700-600; 64330-635; 67296-0388; 68071-2796; 69306-050; 69844-060; 69844-062; 71205-466; 71335-0366; 71335-9668; 0904-7184; 38779-0189; 67763-104; 16571-106; 16571-110; 16714-261; 16714-446; 16729-174; 50090-3564; 51655-632; 51655-639; 61919-076; 67296-1509; 68788-6432; 68788-6825; 70518-1633; 70518-3654; 70710-1225; 71335-0173; 71335-0566; 72888-068; 72888-072; 0781-1488; 76420-237; 80425-0285; 80425-0287; 49452-0460; 16729-175; 16729-176; 43063-822; 50090-6179; 50268-039; 55700-689; 60687-444; 63187-156; 63187-637; 63629-8987; 68071-2931; 68071-2955; 68788-8218; 70518-1538; 70518-2258; 70518-3691; 70756-203; 70756-205; 70771-1178; 71610-695; 71610-710; 72789-305; 46438-0038; 71554-001; 29300-420; 50268-037; 51655-084; 55154-7898; 60760-181; 61919-374; 63187-229; 63629-2123; 64330-633; 67544-253; 68071-4238; 68071-4519; 70518-3621; 70934-607; 71335-9637; 71610-711; 0781-1487; 70859-013; 16571-105; 16714-258; 29300-424; 51655-121; 63629-2120; 68788-8339; 68788-8363; 70518-1484; 70518-3641; 70756-204; 70771-1174; 70934-703; 71610-703; 0904-0201; 83008-003; 83008-004; 51927-1603; 50268-038; 50268-040; 57664-689; 57664-690; 60760-367; 68788-6320; 70756-201; 70771-1175; 70934-428; 72189-309; 66577-038; 79572-002; 16571-107; 16714-259; 16729-171; 16729-173; 45865-432; 55700-660; 63187-155; 64330-631; 68071-4348; 68071-5220; 68788-6899; 68788-7061; 68788-8346; 68788-8380; 69844-058; 69844-059; 69844-061; 70710-1226; 70710-1227; 70710-1228; 70710-1229; 70710-1230; 70756-202; 70756-206; 70771-1173; 71335-0395; 71335-1254; 71335-1256; 72888-067; 72888-070; 0781-1490; 68981-015; 16571-109; 16714-447; 16714-451; 43063-863; 50090-2840; 50090-6313; 50090-6418; 51655-334; 57664-688; 57664-692
UNII 26LUD4JO9K
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
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 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--
Syncope02.11.04.015; 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--
Vasculitis24.12.04.027; 10.02.02.006--
Vision blurred06.02.06.007; 17.17.01.010--
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 syndrome15.06.02.004; 10.04.03.003; 23.03.02.004--Not Available
Inappropriate antidiuretic hormone secretion05.03.03.001; 14.05.07.001--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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