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)
Pneumothorax22.05.02.003--
Pollakiuria20.02.02.0070.000200%
Polydipsia14.05.02.001; 05.03.03.0020.000080%Not Available
Polydipsia psychogenic14.05.02.002; 19.24.01.0040.000080%Not Available
Polyneuropathy17.09.03.0120.000120%Not Available
Polyuria20.02.03.002--Not Available
Posture abnormal15.03.05.029; 17.02.05.0330.000080%Not Available
Pre-eclampsia24.08.07.002; 20.01.08.002; 18.02.03.0020.000200%Not Available
Pregnancy18.08.02.0040.000080%Not Available
Premature baby18.04.02.0010.000480%Not Available
Premature delivery18.07.01.0060.000160%
Premature separation of placenta24.07.03.019; 18.02.01.0040.000080%Not Available
Presyncope02.11.04.013; 24.06.02.010; 17.02.05.0090.000160%
Priapism24.04.12.007; 21.03.01.0050.000656%Not Available
Pruritus23.03.12.001--
Psychomotor hyperactivity19.11.02.003; 17.01.02.0110.000640%Not Available
Psychomotor retardation19.15.02.0020.000280%Not Available
Psychotic behaviour19.03.01.0030.000080%Not Available
Pulmonary congestion22.01.03.002; 02.05.02.002; 24.03.08.001--Not Available
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Pulmonary oedema02.05.02.003; 22.01.03.003--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rash pruritic23.03.13.0300.000320%Not Available
Rebound effect08.06.02.0090.000080%Not Available
Respiratory arrest22.02.01.0090.000320%Not Available
Respiratory disorder22.02.07.002--Not Available
Respiratory distress22.02.01.0120.000280%Not Available
Restlessness19.11.02.002; 17.02.05.0210.000672%
Retching07.01.07.0020.000120%Not Available
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