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 This drug is indicated for the treatment of major depressive disorder and its associated symptoms.[FDA label] Mirtazapine has been used off-label for a variety of conditions including panic disorder, generalized anxiety disorder, dysthymia, tension headaches, hot flushes, post-traumatic stress disorder (PTSD), sleep disorders, substance abuse disorders, and sexual disorders, among others.[A177811,A177946]
Marketing Status approved
ATC Code N06AX11
DrugBank ID DB00370
KEGG ID D00563
MeSH ID D000078785
PubChem ID 4205
TTD Drug ID D05ZIK
NDC Product Code 76483-111; 78206-156; 0904-6519; 65862-032; 65977-0137; 13107-003; 50090-1057; 50090-2558; 55154-8145; 57237-007; 57237-011; 61919-153; 63187-554; 63629-2366; 65862-003; 68084-121; 68788-7754; 71335-0441; 71610-475; 76483-110; 38779-3076; 60312-0095; 43353-378; 45865-137; 55154-8335; 57664-501; 63629-5086; 63629-9255; 63739-099; 68071-2784; 68788-7251; 70518-0180; 70518-1309; 71335-1055; 71610-100; 71610-523; 71610-713; 0615-8078; 80425-0305; 45865-382; 51079-086; 57237-009; 57237-010; 60687-584; 63629-2368; 65862-021; 68084-119; 68084-120; 68788-7492; 70518-1838; 70518-2453; 71610-121; 0615-8268; 63187-206; 63629-2367; 63739-098; 66993-606; 68788-8459; 71610-115; 71610-717; 72578-105; 76483-112; 78206-160; 65862-031; 70600-004; 71052-108; 57237-012; 60505-0247; 61919-154; 63629-5085; 70518-1293; 70518-2582; 71205-481; 71335-1534; 72578-103; 72578-104; 12860-0030; 53296-0047; 60870-0117; 65862-001; 65862-023; 13107-001; 51407-351; 53002-1712; 53002-2712; 55700-249; 57664-500; 60505-0248; 63629-3346; 68071-2635; 68788-7324; 70518-2058; 71335-0286; 71335-0717; 12860-0076; 13107-032; 50090-2800; 57237-013; 63187-403; 68071-2884; 71335-0664; 42291-494; 51407-350; 60505-0249; 70518-1397; 70518-2581; 70518-2819; 71335-0964; 78206-161; 70600-037; 13107-031; 51407-352; 0378-3515; 0378-3545; 71335-1332; 0615-8269; 78206-158; 78206-159; 65862-022; 51079-087; 51079-088; 53002-1474; 55154-5355; 55154-7297; 57237-008; 57664-499; 63187-471; 63629-5537; 0378-3530; 12860-0077; 58032-0121; 60312-0096; 49999-629; 57664-510
UNII A051Q2099Q
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
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)
Anxiety19.06.02.0020.004193%
Apathy19.04.04.0020.000496%-
Aphasia19.21.01.001; 17.02.03.0010.000296%
Aphthous ulcer07.05.06.002---
Aplastic anaemia01.03.03.002---
Apnoea22.02.01.0010.000080%
Areflexia17.02.01.0010.000320%-
Arrhythmia02.03.02.0010.000456%-
Arrhythmia supraventricular02.03.03.001---
Arthralgia15.01.02.0010.001232%
Arthritis15.01.01.001--
Arthropathy15.01.01.003---
Ascites02.05.04.002; 09.01.05.003; 07.07.01.0010.000160%
Aspartate aminotransferase increased13.03.04.011--
Asphyxia22.02.02.001; 12.01.08.011---
Aspiration22.02.07.0070.000160%
Asthenia08.01.01.001---
Asthma10.01.03.010; 22.03.01.002---
Ataxia17.02.02.001; 08.01.02.004--
Atrioventricular block02.03.01.0020.000080%-
Back pain15.03.04.005--
Benign prostatic hyperplasia21.04.02.0010.000080%-
Binge eating19.09.01.0010.000200%-
Bladder pain20.02.02.001---
Blepharitis23.03.04.012; 06.04.04.001---
Blepharospasm17.17.02.001; 06.05.01.0010.000160%-
Blister12.01.06.002; 23.03.01.001---
Blood acid phosphatase increased13.04.02.008---
Blood cholesterol increased13.12.01.002--
Blood triglycerides increased13.12.03.001---
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