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)
Libido decreased21.03.02.005; 19.08.03.001--
Libido increased21.03.02.007; 19.08.03.002--
Malaise08.01.01.003--
Mania19.16.02.002--
Micturition disorder20.02.02.005--Not Available
Muscle rigidity17.05.02.005; 15.05.04.001--Not Available
Mydriasis17.02.11.003; 06.05.03.004--Not Available
Myocardial infarction24.04.04.009; 02.02.02.007--
Nasal congestion22.04.04.001--
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Neuroleptic malignant syndrome15.05.04.015; 12.03.01.003; 08.05.01.005; 17.05.02.003--Not Available
Neuropathy peripheral17.09.03.003--Not Available
Nightmare19.02.03.003--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Pain08.01.08.004--
Palpitations02.11.04.012--
Paraesthesia23.03.03.094; 17.02.06.005--
Parotid gland enlargement07.06.03.001--Not Available
Petechiae24.07.06.004; 23.06.01.003; 01.01.03.002--Not Available
Photosensitivity reaction23.03.09.003--
Pollakiuria20.02.02.007--
Pruritus23.03.12.001--
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Restlessness17.02.05.021; 19.11.02.002--
Seizure17.12.03.001--
Serotonin syndrome17.05.02.004; 15.05.04.016; 12.03.01.041--Not Available
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