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)
Angle closure glaucoma06.03.01.001--Not Available
Anosmia22.04.03.006; 17.04.04.0010.000730%
Anuria20.01.03.0020.000365%Not Available
Anxiety19.06.02.0020.012767%
Apathy19.04.04.0020.001641%Not Available
Aphasia19.21.01.001; 17.02.03.0010.000730%
Aphthous ulcer07.05.06.002--Not Available
Aplastic anaemia01.03.03.002--Not Available
Arrhythmia02.03.02.0010.001094%Not Available
Arrhythmia supraventricular02.03.03.001--Not Available
Arthralgia15.01.02.0010.004560%
Arthritis15.01.01.001--
Arthropathy15.01.01.003--Not Available
Ascites02.05.04.002; 09.01.05.003; 07.07.01.0010.000730%
Aspartate aminotransferase increased13.03.01.006--
Asphyxia22.02.02.001; 12.01.08.011--Not Available
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Ataxia17.02.02.001; 08.01.02.004--
Atrial fibrillation02.03.03.002--
Atrial septal defect03.07.02.002; 02.04.02.0090.000912%Not Available
Atrioventricular block02.03.01.0020.000365%Not Available
Back pain15.03.04.005--
Benign prostatic hyperplasia21.04.02.0010.000365%Not Available
Binge eating19.09.01.0010.001094%Not Available
Bladder pain20.02.02.001--Not Available
Blepharitis23.03.04.012; 06.04.04.001--Not Available
Blister23.03.01.001; 12.01.06.002--Not Available
Blood acid phosphatase increased13.04.02.008--Not Available
Blood albumin decreased13.09.01.0010.000730%Not Available
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