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)
Blood bilirubin increased13.03.01.008--
Blood cholesterol increased13.12.01.002--
Blood cortisol decreased13.10.09.0040.000365%Not Available
Blood creatine phosphokinase increased13.04.01.0010.001641%
Blood creatinine increased13.13.01.0040.001094%
Blood lactic acid increased13.02.01.0150.000547%Not Available
Blood potassium increased13.11.01.0110.000365%Not Available
Blood pressure abnormal13.14.03.0010.000365%Not Available
Blood pressure decreased13.14.03.0020.001277%Not Available
Blood pressure increased13.14.03.005--Not Available
Blood pressure systolic increased13.14.03.0060.000365%Not Available
Blood triglycerides increased13.12.03.0010.000912%Not Available
Body temperature increased13.15.01.0010.000365%Not Available
Bone disorder15.02.04.004--Not Available
Bone pain15.02.01.001--
Bradycardia02.03.02.0020.001824%Not Available
Bradykinesia17.01.02.0040.001459%Not Available
Bradypnoea22.02.01.0020.000547%Not Available
Breast engorgement21.05.05.002; 18.08.02.001--Not Available
Breast enlargement21.05.04.001--Not Available
Breast feeding26.05.01.001--Not Available
Breast pain21.05.05.0030.000365%
Bronchitis22.07.01.001; 11.01.09.001--
Bundle branch block right02.03.01.0110.000365%Not Available
Burning sensation17.02.06.001; 08.01.09.0290.001277%Not Available
Bursitis15.04.01.001--Not Available
C-reactive protein increased13.09.01.0070.000730%Not Available
Cardiac arrest02.03.04.0010.000619%
Cardio-respiratory arrest22.02.06.007; 02.03.04.002--Not Available
Cardiomegaly02.04.02.001--Not Available
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