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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.001459%
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal dreams19.02.03.001; 17.15.02.0010.003101%Not Available
Abnormal faeces07.01.03.0010.000365%Not Available
Abnormal weight gain14.03.02.0100.000730%Not Available
Abortion missed18.01.01.0020.000365%Not Available
Abortion spontaneous18.01.04.001--Not Available
Accommodation disorder06.02.04.001--Not Available
Acne23.02.01.001--Not Available
Acute abdomen07.01.06.015--Not Available
Acute hepatic failure09.01.03.0010.000190%Not Available
Acute psychosis19.03.01.0010.000912%Not Available
Ageusia07.14.03.003; 17.02.07.0010.000730%Not Available
Aggression19.05.01.0010.004012%Not Available
Agitation19.06.02.001; 17.02.05.0120.009849%
Agranulocytosis01.02.03.0010.000285%Not Available
Akathisia19.06.02.006; 17.01.02.0020.003465%
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Altered state of consciousness19.07.01.003; 17.02.04.0010.005472%Not Available
Amblyopia06.02.01.001--Not Available
Amenorrhoea21.01.02.001; 05.05.01.002--
Amnesia19.20.01.001; 17.03.02.0010.001459%
Anaemia01.03.02.001--
Anaesthetic complication pulmonary22.02.07.005; 12.02.12.0070.000547%Not Available
Anger19.04.02.0010.002736%Not Available
Angina pectoris02.02.02.002; 24.04.04.002--
Angioedema10.01.05.009; 23.04.01.0010.002736%Not Available
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