Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Trazodone hydrochloride
Drug ID BADD_D02267
Description Trazodone is triazolopyridine derivative from the serotonin receptor antagonists and reuptake inhibitors (SARIs) class of antidepressants.[A181180] It is used in adults and has been shown to be comparable in efficacy to other drugs such as tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), and serotonin-norepinephrine receptor inhibitor (SNRIs) in the treatment of depression.[T646] A unique feature of this drug is that it does not promote the anxiety symptoms, sexual symptoms, or insomnia, which are commonly associated with SSRI and SNRI therapy.[T646] Trazodone acts on various receptors, including certain histamine, serotonin, and adrenergic receptors, distinguishing it from other antidepressants that cover a narrow range of neurotransmitters.[T646] It was initially granted FDA approval in 1981.[L3484]
Indications and Usage Trazodone is indicated for the treatment of major depressive disorder (MDD).[L3484] It has been used off-label for adjunct therapy in alcohol dependence, and off-label to treat anxiety and insomnia.[L3484] It may also be used off-label to treat symptoms of dementia, Alzheimer’s disease, schizophrenia, eating disorders, and fibromyalgia due to its effects on various neurotransmitter receptors.[A31634]
Marketing Status approved; investigational
ATC Code N06AX05
DrugBank ID DB00656
KEGG ID D00820
MeSH ID D014196
PubChem ID 62935
TTD Drug ID D00USF
NDC Product Code 16729-299; 53002-1105; 60505-2654; 60687-454; 61919-613; 68071-2822; 69584-884; 70518-2793; 70518-2973; 0555-0711; 70934-818; 71610-514; 82982-047; 0904-6869; 59651-704; 59651-706; 13668-331; 16729-302; 42291-869; 50111-450; 50111-560; 53002-4105; 55154-8087; 57664-053; 60760-806; 63187-680; 68071-2996; 68788-7137; 70518-3403; 71205-630; 71335-1575; 71610-530; 0615-8386; 13668-330; 13668-333; 51655-662; 53489-511; 60505-2653; 68071-4410; 68788-7118; 70771-1129; 70771-1131; 71205-505; 71335-1630; 55700-739; 68382-806; 69584-885; 70771-1130; 71335-0742; 71335-2084; 72789-079; 50090-4825; 50090-6121; 53002-1132; 55700-810; 57664-014; 60505-2655; 60687-443; 61919-386; 61919-473; 61919-631; 63187-133; 67296-2049; 68071-5187; 68382-805; 70518-3426; 70518-3756; 71205-551; 71205-815; 71335-0705; 71335-1483; 71610-529; 0615-8371; 80425-0298; 51927-0215; 45865-431; 51655-366; 51655-986; 55700-844; 60687-432; 67296-1438; 68071-2959; 68382-808; 70518-1204; 70518-2929; 70518-3479; 70771-1128; 70934-817; 71205-568; 71335-0730; 80425-0302; 0904-7212; 13107-081; 13107-082; 16729-301; 50090-2373; 53002-3132; 55154-8085; 70518-2180; 0615-8339; 72789-168; 82053-002; 13107-080; 13668-332; 16729-300; 42291-868; 50111-561; 51655-658; 63187-377; 71610-511; 38779-0559; 59651-707; 62207-019; 13107-079; 53002-2132; 53489-510; 55700-957; 60505-2659; 68382-807; 70518-3082; 71610-525; 72789-154; 80425-0326; 0904-6868; 24823-911; 46014-1118; 59651-705; 50090-4283; 50090-5218; 55700-855; 63187-086; 68788-7166; 70518-3290; 71205-574; 71610-513; 71610-537; 58159-072; 65015-602; 65085-0014; 42291-829; 43353-973; 43353-974; 50090-2374; 50268-776; 53489-517; 55700-921; 57664-026
UNII 6E8ZO8LRNM
Synonyms Trazodone | Tradozone | AF-1161 | AF 1161 | AF1161 | Deprax | Desyrel | Gen-Trazodone | Gen Trazodone | Molipaxin | Novo-Trazodone | Novo Trazodone | Trittico | PMS-Trazodone | PMS Trazodone | Ratio-Trazodone | Ratio Trazodone | RatioTrazodone | Thombran | Trazodon Hexal | Trazodon-Neuraxpharm | Trazodon Neuraxpharm | TrazodonNeuraxpharm | Trazodone Hydrochloride | Trazon | Apo-Trazodone | Apo Trazodone | Nu-Trazodone | Nu Trazodone
Chemical Information
Molecular Formula C19H23Cl2N5O
CAS Registry Number 25332-39-2
SMILES C1CN(CCN1CCCN2C(=O)N3C=CC=CC3=N2)C4=CC(=CC=C4)Cl.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)
Coordination abnormal17.02.02.004--Not Available
Death08.04.01.001--
Delusion19.10.01.001--
Diarrhoea07.02.01.001--
Diplopia17.17.01.005; 06.02.06.002--Not Available
Disorientation19.13.01.002; 17.02.05.015--Not Available
Disturbance in attention19.21.02.002; 17.03.03.001--
Dizziness24.06.02.007; 17.02.05.003; 02.11.04.006--
Dry mouth07.06.01.002--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Dysuria20.02.02.002--
Electrocardiogram QT prolonged13.14.05.004--
Enlarged clitoris21.08.02.001; 05.05.01.004--Not Available
Extrapyramidal disorder17.01.02.007--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.002--
Gastrointestinal disorder07.11.01.001--Not Available
Generalised tonic-clonic seizure17.12.01.002--Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.006--
Haemolytic anaemia01.06.03.002--Not Available
Hallucination19.10.04.003--
Headache17.14.01.001--
Hirsutism23.02.04.001; 05.05.01.005--
Hostility19.05.01.003--Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.003--Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
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