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)
Cerebral haematoma17.08.01.014; 24.07.04.0060.000200%Not Available
Depressive symptom19.15.02.0030.000080%Not Available
Affect lability19.04.01.001--Not Available
Skin burning sensation17.02.06.009; 23.03.03.0210.000080%Not Available
Cerebral disorder17.02.10.0170.000080%Not Available
Foetal death08.04.01.011; 18.01.02.0030.000120%
Colitis microscopic07.08.01.0110.000080%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.000216%Not Available
Paraesthesia oral07.05.05.035; 17.02.06.0080.000160%Not Available
Cognitive disorder19.21.02.001; 17.03.03.003--
Major depression19.15.01.003--Not Available
Toxic skin eruption12.03.01.073; 10.01.01.008; 23.03.05.0030.000160%Not Available
Ocular icterus06.08.03.009; 01.06.04.007; 09.01.01.0070.000176%Not Available
Dysgraphia17.02.03.0060.000080%Not Available
Nuchal rigidity17.05.02.006; 15.05.04.005--Not Available
Thyroid mass05.02.01.0030.000080%Not Available
Muscle relaxant therapy25.16.01.001--Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.001248%Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Gastrointestinal toxicity12.03.01.019; 07.08.03.0060.000080%Not Available
Angiopathy24.03.02.007--Not Available
Urine output increased13.13.03.002--Not Available
Hot flush21.02.02.001; 08.01.03.027; 24.03.01.0050.000456%
Neurological symptom17.02.05.0100.000216%Not Available
Adverse event08.06.01.010--Not Available
Appetite disorder19.09.01.002; 14.03.01.0040.000176%Not Available
Cardiac disorder02.11.01.003--Not Available
Electrocardiogram change13.14.05.014--Not Available
Embolism24.01.01.009--
Infarction24.04.02.0170.000080%Not Available
The 19th Page    First    Pre   19 20 21 22 23    Next   Last    Total 23 Pages