Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Mirtazapine
Drug ID BADD_D01476
Description Mirtazapine is a tetracyclic _piperazino-azepine_ antidepressant agent that was initially approved for the treatment of major depressive disorder (MDD) in the Netherlands in 1994.[A177946] This drug was first manufactured by Organon Inc., and received FDA approval in 1997 for the treatment of major depressive disorder.[T595, L6157] The effects of this drug may be observed as early as 1 week after beginning therapy.[A178144,L6160] In addition to its beneficial effects in depression, mirtazapine has been reported to be efficacious in the off-label management of various other conditions. It may improve the symptoms of neurological disorders, reverse weight loss caused by medical conditions, improve sleep, and prevent nausea and vomiting after surgery.[A177811]
Indications and Usage For the treatment of major depressive disorder.
Marketing Status Prescription; Discontinued
ATC Code N06AX11
DrugBank ID DB00370
KEGG ID D00563
MeSH ID D000078785
PubChem ID 4205
TTD Drug ID D05ZIK
NDC Product Code 78206-156; 38779-3076; 68084-121; 63187-471; 43353-963; 55154-5355; 71052-108; 70600-004; 57664-510; 63187-403; 72969-049; 57237-009; 68071-4989; 57237-007; 63629-2367; 71335-1534; 68071-4972; 65862-001; 58032-0121; 65862-021; 57237-008; 0904-6519; 57237-011; 50090-4643; 58118-0052; 53002-2712; 43353-378; 60687-584; 12860-0076; 70518-1397; 68084-119; 53296-0047; 43353-962; 13107-003; 50090-5296; 65862-003; 68788-7754; 55154-7297; 50090-4222; 71610-115; 49999-629; 68071-2635; 51407-350; 13107-031; 17856-0101; 71610-475; 63629-3346; 43353-535; 51407-351; 50090-1057; 53002-1474; 71610-523; 57237-013; 57237-012; 13107-001; 57237-010; 0378-3545; 0615-8078; 65862-032; 68788-7324; 65862-022; 68084-120; 78206-160; 71335-0542; 65862-031; 71610-121; 0378-3515; 0615-8268; 78206-159; 63187-554; 63629-2366; 70518-2453; 78206-158; 70518-2819; 55154-8145; 55154-8335; 57664-499; 71610-369; 71335-0664; 60312-0096; 63739-098; 65862-023; 71335-0441; 68071-4379; 50090-2140; 70518-2582; 68788-7492; 51407-352; 50090-2558; 0615-8269; 43353-536; 57664-500; 71335-0964; 71610-100; 51079-088; 63739-099; 53002-1712; 13107-032; 70518-1838; 55700-249; 71335-0372; 12860-0077; 60870-0117; 50090-2800; 51079-086; 60505-0247; 70518-1293; 71335-0286; 78206-161; 51079-087; 45865-382; 68071-4752; 60505-0249; 12860-0030; 68071-4239; 63629-2368; 68071-4539; 70518-1309; 63629-5537; 63629-5086; 57664-501; 71335-0122; 63187-206; 45865-137; 71335-1332; 50090-4123; 0378-3530; 60312-0095; 71205-481; 71335-0717; 60505-0248
Synonyms Mirtazapine | 6-Azamianserin | 6 Azamianserin | ORG 3770 | ORG-3770 | ORG3770 | Rexer | Remeron | Norset | Remergil | Zispin | Esmirtazapine | (S)-Mirtazapine | Org 50081 | (N-Methyl-11C)mirtazapine
Chemical Information
Molecular Formula C17H19N3
CAS Registry Number 85650-52-8
SMILES CN1CCN2C(C1)C3=CC=CC=C3CC4=C2N=CC=C4
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Hypertransaminasaemia09.01.02.0050.000365%Not Available
Oropharyngeal discomfort22.02.05.027; 07.05.05.008--Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.0040.001459%
Acute kidney injury20.01.03.016--
Foetal growth restriction18.03.01.0020.000365%
Slow speech17.02.08.016; 19.19.02.0040.000547%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.000912%Not Available
Lacrimal structural disorder06.06.04.013--Not Available
Drug reaction with eosinophilia and systemic symptoms10.01.01.021; 23.03.05.0050.002189%Not Available
Candida infection11.03.03.021--
Mouth swelling10.01.05.020; 07.05.04.007; 23.04.01.0200.000365%Not Available
Multiple organ dysfunction syndrome08.01.03.057--
Liver function test increased13.03.01.044--Not Available
Depersonalisation/derealisation disorder19.14.01.004--Not Available
Bone cancer15.09.03.012; 16.29.02.0020.000143%Not Available
Coeliac disease14.02.01.007; 10.04.04.012; 07.17.01.0080.000365%Not Available
Convulsive threshold lowered17.12.03.0230.000730%Not Available
Drop attacks17.05.02.016; 15.05.04.0180.000365%Not Available
Impulsive behaviour19.18.01.0010.000547%Not Available
Maternal drugs affecting foetus18.03.03.009; 12.03.03.0060.002371%Not Available
Neonatal asphyxia22.11.02.006; 18.04.15.0050.000547%Not Available
Neonatal respiratory distress syndrome22.11.02.010; 18.04.10.0030.000547%Not Available
Persecutory delusion19.10.01.0070.000547%Not Available
Slow response to stimuli17.02.05.0630.000547%Not Available
Small for dates baby18.04.02.0020.000547%Not Available
Thrombocytopenia neonatal18.04.03.005; 01.08.01.0100.000730%Not Available
Violence-related symptom19.05.01.0220.000365%Not Available
Feeling guilty19.15.02.0100.000365%Not Available
Consciousness fluctuating17.02.04.0190.000730%Not Available
Non-alcoholic steatohepatitis14.08.04.024; 09.01.07.0350.000547%Not Available
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