mirtazapine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
psychoactive 1816 85650-52-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • mirtazapine
  • mepirzapin
  • mepirzepine
  • mirtabene
  • mirtazepine
  • mirtazipine
A piperazinoazepine tetracyclic compound that enhances the release of NOREPINEPHRINE and SEROTONIN through blockage of presynaptic ALPHA-2 ADRENERGIC RECEPTORS. It also blocks both 5-HT2 and 5-HT3 serotonin receptors and is a potent HISTAMINE H1 RECEPTOR antagonist. It is used for the treatment of depression, and may also be useful for the treatment of anxiety disorders.
  • Molecular weight: 265.36
  • Formula: C17H19N3
  • CLOGP: 2.81
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 0
  • TPSA: 19.37
  • ALOGS: -2.38
  • ROTB: 0

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
30 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 2.83 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 4.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 8 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.15 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 15 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 14, 1996 FDA ORGANON USA INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 1832.93 37.28 545 5444 20489 2331607
Toxicity to various agents 1783.33 37.28 592 5397 32162 2319934
Drug abuse 1078.47 37.28 320 5669 11706 2340390
Suicide attempt 842.30 37.28 261 5728 11021 2341075
Somnolence 769.03 37.28 293 5696 23192 2328904
Overdose 759.87 37.28 278 5711 19629 2332467
Intentional overdose 704.06 37.28 228 5761 11093 2341003
Sopor 635.34 37.28 167 5822 3828 2348268
Hyponatraemia 632.42 37.28 219 5770 13106 2338990
Serotonin syndrome 606.38 37.28 157 5832 3383 2348713
Fall 587.69 37.28 298 5691 46801 2305295
Drug interaction 580.79 37.28 255 5734 28908 2323188
Confusional state 537.22 37.28 229 5760 24115 2327981
Electrocardiogram QT prolonged 512.22 37.28 164 5825 7650 2344446
Intentional self-injury 507.93 37.28 141 5848 3986 2348110
Coma 445.14 37.28 153 5836 8903 2343193
Agitation 415.36 37.28 153 5836 10898 2341198
Depression 402.92 37.28 196 5793 27936 2324160
Suicidal ideation 374.60 37.28 142 5847 10945 2341151
Inappropriate antidiuretic hormone secretion 368.94 37.28 97 5892 2212 2349884
Tachycardia 343.53 37.28 149 5840 16260 2335836
Cardiac arrest 333.65 37.28 142 5847 14788 2337308
Cardio-respiratory arrest 311.90 37.28 118 5871 9028 2343068
Hypotension 306.21 37.28 171 5818 32265 2319831
Tremor 304.57 37.28 147 5842 20514 2331582
Anxiety 291.35 37.28 160 5829 29199 2322897
Poisoning 277.49 37.28 81 5908 2739 2349357
Loss of consciousness 265.87 37.28 130 5859 18637 2333459
Drug ineffective 263.06 37.28 243 5746 101381 2250715
Depressed level of consciousness 255.16 37.28 97 5892 7507 2344589
Seizure 249.93 37.28 136 5853 24330 2327766
Insomnia 248.71 37.28 138 5851 25649 2326447
Neuroleptic malignant syndrome 232.52 37.28 66 5923 2014 2350082
Dizziness 228.98 37.28 178 5811 58487 2293609
Restless legs syndrome 213.57 37.28 63 5926 2208 2349888
Weight increased 211.06 37.28 118 5871 22219 2329877
Condition aggravated 208.56 37.28 133 5856 31846 2320250
Respiratory arrest 200.68 37.28 77 5912 6101 2345995
Sedation 189.23 37.28 63 5926 3299 2348797
Disorientation 187.77 37.28 74 5915 6298 2345798
Hyperhidrosis 183.48 37.28 95 5894 15327 2336769
Vomiting 182.22 37.28 170 5819 71432 2280664
Decreased appetite 173.13 37.28 114 5875 28777 2323319
Intentional product misuse 162.50 37.28 75 5914 9414 2342682
Disturbance in attention 160.41 37.28 64 5925 5621 2346475
Rhabdomyolysis 160.23 37.28 67 5922 6637 2345459
Death 158.25 37.28 167 5822 81301 2270795
Constipation 156.03 37.28 96 5893 21533 2330563
Restlessness 152.19 37.28 58 5931 4505 2347591
Muscle rigidity 151.37 37.28 46 5943 1785 2350311
Syncope 148.05 37.28 85 5904 16790 2335306
Dysarthria 147.31 37.28 62 5927 6240 2345856
Dyskinesia 145.92 37.28 57 5932 4732 2347364
Urinary retention 145.68 37.28 53 5936 3614 2348482
Accidental overdose 145.21 37.28 54 5935 3918 2348178
Agranulocytosis 144.59 37.28 52 5937 3430 2348666
Exposure during pregnancy 140.13 37.28 95 5894 25124 2326972
Aggression 138.92 37.28 55 5934 4731 2347365
Nausea 136.48 37.28 181 5808 112008 2240088
Nightmare 134.18 37.28 50 5939 3647 2348449
Psychotic disorder 133.11 37.28 53 5936 4626 2347470
Delirium 130.86 37.28 54 5935 5169 2346927
Oedema peripheral 130.78 37.28 89 5900 23674 2328422
Psychomotor retardation 130.04 37.28 32 5957 551 2351545
Fatigue 128.71 37.28 153 5836 84720 2267376
Depressed mood 127.72 37.28 53 5936 5145 2346951
Mania 126.50 37.28 43 5946 2397 2349699
Acute kidney injury 126.25 37.28 93 5896 28029 2324067
Myoclonus 125.76 37.28 43 5946 2440 2349656
Intestinal pseudo-obstruction 125.43 37.28 24 5965 112 2351984
Paraesthesia 124.57 37.28 84 5905 22004 2330092
Foetal exposure during pregnancy 123.83 37.28 52 5937 5200 2346896
Palpitations 121.05 37.28 74 5915 16382 2335714
Malaise 118.58 37.28 120 5869 55465 2296631
Mydriasis 118.55 37.28 40 5949 2179 2349917
General physical health deterioration 118.07 37.28 69 5920 14070 2338026
Akathisia 117.06 37.28 37 5952 1637 2350459
Generalised tonic-clonic seizure 116.08 37.28 50 5939 5322 2346774
Depressive symptom 112.09 37.28 28 5961 514 2351582
Drug hypersensitivity 111.14 37.28 107 5882 46536 2305560
Headache 110.83 37.28 138 5851 80041 2272055
Asthenia 110.59 37.28 107 5882 46819 2305277
Maternal exposure during pregnancy 109.72 37.28 67 5922 14796 2337300
Pyrexia 109.18 37.28 113 5876 53595 2298501
Abnormal dreams 106.90 37.28 38 5951 2420 2349676
Product use in unapproved indication 105.12 37.28 59 5930 11141 2340955
Feeling abnormal 101.33 37.28 76 5913 23505 2328591
Sleep disorder 100.87 37.28 48 5941 6441 2345655
Acute motor-sensory axonal neuropathy 99.31 37.28 17 5972 35 2352061
Hallucination 99.10 37.28 51 5938 8097 2343999
Abnormal behaviour 98.57 37.28 43 5946 4717 2347379
Dissociation 96.41 37.28 24 5965 434 2351662
Psychomotor hyperactivity 96.21 37.28 33 5956 1889 2350207
Withdrawal syndrome 95.59 37.28 38 5951 3299 2348797
Drug withdrawal syndrome 95.59 37.28 47 5942 6774 2345322
Product prescribing error 92.85 37.28 36 5953 2924 2349172
Dysphagia 92.64 37.28 57 5932 12748 2339348
Status epilepticus 91.68 37.28 34 5955 2444 2349652
Medication error 91.18 37.28 44 5945 6087 2346009
Alanine aminotransferase increased 90.32 37.28 58 5931 13974 2338122
Rheumatoid factor negative 89.31 37.28 14 5975 11 2352085
Muscle spasms 87.10 37.28 67 5922 21499 2330597
Neutropenia 84.96 37.28 66 5923 21482 2330614
Dyspnoea 83.30 37.28 119 5870 78614 2273482
Speech disorder 83.07 37.28 42 5947 6422 2345674
Off label use 81.93 37.28 114 5875 73484 2278612
Hepatocellular injury 81.90 37.28 36 5953 4019 2348077
Hypertonia 81.10 37.28 26 5963 1204 2350892
Ventricular fibrillation 80.69 37.28 30 5959 2171 2349925
Irritability 80.37 37.28 41 5948 6386 2345710
Orthostatic hypotension 79.73 37.28 32 5957 2847 2349249
Mood swings 79.15 37.28 33 5956 3236 2348860
Cognitive disorder 78.15 37.28 38 5951 5343 2346753
Fracture 77.87 37.28 31 5958 2700 2349396
Respiratory failure 75.11 37.28 51 5938 13477 2338619
Weight decreased 74.95 37.28 69 5920 28302 2323794
Gamma-glutamyltransferase increased 73.99 37.28 37 5952 5525 2346571
Dry mouth 73.43 37.28 42 5947 8211 2343885
Miosis 73.08 37.28 24 5965 1200 2350896
Tardive dyskinesia 72.79 37.28 26 5963 1678 2350418
Unresponsive to stimuli 72.51 37.28 35 5954 4841 2347255
Circulatory collapse 71.82 37.28 32 5957 3688 2348408
Incoherent 71.40 37.28 22 5967 893 2351203
Maternal drugs affecting foetus 71.39 37.28 25 5964 1522 2350574
Vertigo 70.99 37.28 43 5946 9341 2342755
Hypokalaemia 70.92 37.28 45 5944 10609 2341487
Gestational diabetes 70.14 37.28 24 5965 1363 2350733
Hallucination, visual 68.53 37.28 29 5960 2950 2349146
Sudden death 66.89 37.28 25 5964 1835 2350261
Anger 66.44 37.28 27 5962 2480 2349616
Hepatic steatosis 66.42 37.28 29 5960 3184 2348912
Thinking abnormal 65.84 37.28 25 5964 1917 2350179
Product complaint 65.75 37.28 32 5957 4506 2347590
Sleep paralysis 65.74 37.28 14 5975 121 2351975
Coma scale abnormal 65.24 37.28 20 5969 798 2351298
Incontinence 65.19 37.28 23 5966 1431 2350665
Parkinsonism 64.42 37.28 23 5966 1482 2350614
Hepatic enzyme increased 64.24 37.28 41 5948 9761 2342335
Dehydration 62.34 37.28 56 5933 22239 2329857
Asphyxia 61.20 37.28 20 5969 984 2351112
Liver function test abnormal 61.01 37.28 36 5953 7454 2344642
Loss of personal independence in daily activities 60.98 37.28 32 5957 5279 2346817
Affective disorder 60.25 37.28 19 5970 833 2351263
Gait disturbance 59.84 37.28 55 5934 22490 2329606
Abnormal weight gain 59.79 37.28 15 5974 280 2351816
Caesarean section 59.79 37.28 29 5960 4052 2348044
Dystonia 59.41 37.28 24 5965 2170 2349926
Blood creatine phosphokinase increased 59.13 37.28 31 5958 5105 2346991
Altered state of consciousness 58.27 37.28 28 5961 3832 2348264
Swollen tongue 57.97 37.28 31 5958 5312 2346784
Hypertonia neonatal 56.52 37.28 11 5978 57 2352039
Hypothermia 56.46 37.28 23 5966 2125 2349971
Non-Hodgkin's lymphoma recurrent 56.21 37.28 11 5978 59 2352037
Drug intolerance 56.18 37.28 43 5946 13674 2338422
Chills 53.50 37.28 44 5945 15508 2336588
Heart rate increased 52.61 37.28 38 5951 11067 2341029
Intestinal obstruction 51.95 37.28 27 5962 4366 2347730
Aphasia 51.81 37.28 28 5961 4900 2347196
Memory impairment 51.80 37.28 40 5949 12883 2339213
White blood cell count decreased 51.41 37.28 46 5943 18162 2333934
Agitation neonatal 51.35 37.28 11 5978 98 2351998
Drug level increased 50.69 37.28 23 5966 2764 2349332
Diarrhoea 50.11 37.28 98 5891 83466 2268630
Paranoia 50.09 37.28 21 5968 2086 2350010
Angioedema 49.81 37.28 33 5956 8363 2343733
Cerebral ventricle dilatation 49.75 37.28 12 5977 189 2351907
Pulmonary embolism 49.70 37.28 45 5944 18038 2334058
Arrhythmia 49.16 37.28 29 5960 5999 2346097
Bradykinesia 48.98 37.28 15 5974 596 2351500
Night sweats 48.66 37.28 24 5965 3476 2348620
Arthralgia 48.60 37.28 76 5913 54209 2297887
Hypophagia 48.49 37.28 25 5964 3975 2348121
Shock 48.47 37.28 25 5964 3979 2348117
Blood sodium decreased 48.35 37.28 23 5966 3077 2349019
Wound 48.00 37.28 22 5967 2706 2349390
Abdominal distension 47.89 37.28 35 5954 10376 2341720
Delusion 47.15 37.28 20 5969 2045 2350051
Depersonalisation/derealisation disorder 47.00 37.28 12 5977 241 2351855
Selective eating disorder 46.74 37.28 13 5976 366 2351730
Pyelonephritis 46.46 37.28 20 5969 2121 2349975
Aspartate aminotransferase increased 46.15 37.28 37 5952 12575 2339521
Panic attack 45.88 37.28 24 5965 3932 2348164
Motor dysfunction 45.80 37.28 17 5972 1223 2350873
Aspergillus test positive 45.72 37.28 9 5980 50 2352046
Opisthotonus 45.64 37.28 10 5979 100 2351996
Skull malformation 45.37 37.28 10 5979 103 2351993
Cardiac hypertrophy 44.70 37.28 11 5978 189 2351907
Tachyphrenia 44.70 37.28 12 5977 295 2351801
Bradyphrenia 44.04 37.28 16 5973 1083 2351013
Hypertension 44.00 37.28 51 5938 27310 2324786
Sinus tachycardia 43.86 37.28 22 5967 3303 2348793
Jaundice 43.61 37.28 26 5963 5482 2346614
Drug reaction with eosinophilia and systemic symptoms 43.56 37.28 26 5963 5492 2346604
Myalgia 43.53 37.28 47 5942 23286 2328810
Increased appetite 43.33 37.28 17 5972 1423 2350673
Spina bifida 43.31 37.28 10 5979 129 2351967
Persecutory delusion 43.26 37.28 13 5976 484 2351612
Breast discomfort 43.10 37.28 10 5979 132 2351964
Hyperthermia 43.01 37.28 17 5972 1451 2350645
Ventricular tachycardia 42.91 37.28 21 5968 2990 2349106
Enterococcus test positive 42.68 37.28 10 5979 138 2351958
Cogwheel rigidity 42.49 37.28 11 5978 234 2351862
Feeling of despair 42.01 37.28 12 5977 373 2351723
Swelling face 41.60 37.28 31 5958 9462 2342634
Self-injurious ideation 41.42 37.28 13 5976 561 2351535
Pneumonia aspiration 41.40 37.28 22 5967 3720 2348376
Pain 41.30 37.28 76 5913 61781 2290315
Vision blurred 41.28 37.28 37 5952 14631 2337465
Compulsive sexual behaviour 40.38 37.28 7 5982 16 2352080
Product administration error 40.32 37.28 22 5967 3921 2348175
Polydipsia 40.10 37.28 13 5976 623 2351473
Abortion spontaneous 40.00 37.28 35 5954 13410 2338686
Cellulitis orbital 39.89 37.28 9 5980 104 2351992
Orgasm abnormal 39.43 37.28 8 5981 53 2352043
Lethargy 39.36 37.28 29 5960 8701 2343395
Premature rupture of membranes 39.35 37.28 14 5975 892 2351204
Salivary hypersecretion 38.76 37.28 15 5974 1210 2350886
Feeling of body temperature change 38.75 37.28 13 5976 694 2351402
Musculoskeletal stiffness 38.69 37.28 33 5956 12214 2339882
Chemical burn of oral cavity 38.68 37.28 6 5983 4 2352092
Urinary tract infection bacterial 38.66 37.28 12 5977 499 2351597
Pancytopenia 38.54 37.28 32 5957 11420 2340676
Oral candidiasis 38.23 37.28 17 5972 1948 2350148
Hyperkinesia 38.22 37.28 10 5979 222 2351874
Mental impairment 37.74 37.28 18 5971 2422 2349674
Septic shock 37.72 37.28 26 5963 7028 2345068
Parkinson's disease 37.61 37.28 15 5974 1311 2350785
Panic reaction 37.39 37.28 13 5976 774 2351322
Encephalopathy 37.33 37.28 22 5967 4539 2347557

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxicity to various agents 1558.41 40.43 551 4070 28590 1713570
Completed suicide 1284.21 40.43 414 4207 15898 1726262
Intentional overdose 670.71 40.43 212 4409 7458 1734702
Overdose 641.89 40.43 250 4371 16451 1725709
Drug abuse 634.34 40.43 235 4386 13454 1728706
Suicide attempt 554.78 40.43 182 4439 7199 1734961
Serotonin syndrome 533.96 40.43 142 4479 2646 1739514
Confusional state 479.19 40.43 218 4403 21060 1721100
Agitation 468.75 40.43 178 4443 10848 1731312
Drug interaction 466.63 40.43 233 4388 27725 1714435
Somnolence 403.32 40.43 180 4441 16559 1725601
Depression 359.50 40.43 166 4455 16503 1725657
Intentional self-injury 331.73 40.43 97 4524 2576 1739584
Anxiety 329.60 40.43 153 4468 15374 1726786
Sopor 326.83 40.43 90 4531 1911 1740249
Insomnia 307.40 40.43 148 4473 16128 1726032
Fall 296.00 40.43 171 4450 27043 1715117
Restlessness 278.01 40.43 95 4526 4226 1737934
Hyponatraemia 255.91 40.43 109 4512 8891 1733269
Pneumonia aspiration 248.53 40.43 92 4529 5174 1736986
Suicidal ideation 244.93 40.43 104 4517 8414 1733746
Coma 243.65 40.43 99 4522 7163 1734997
Respiratory arrest 242.86 40.43 93 4528 5746 1736414
Tremor 237.38 40.43 116 4505 13015 1729145
Aggression 233.03 40.43 99 4522 8016 1734144
Restless legs syndrome 219.22 40.43 57 4564 960 1741200
Cardiac arrest 216.18 40.43 116 4505 15814 1726346
Poisoning 208.06 40.43 67 4554 2465 1739695
Rhabdomyolysis 200.40 40.43 98 4523 10992 1731168
Drug ineffective 199.88 40.43 189 4432 63612 1678548
Cardio-respiratory arrest 198.03 40.43 92 4529 9201 1732959
Electrocardiogram QT prolonged 194.16 40.43 78 4543 5467 1736693
Myoclonus 189.66 40.43 61 4560 2234 1739926
Tachycardia 182.61 40.43 96 4525 12532 1729628
Neuroleptic malignant syndrome 182.18 40.43 64 4557 3084 1739076
Logorrhoea 168.39 40.43 40 4581 454 1741706
Blood creatine phosphokinase increased 165.12 40.43 80 4541 8776 1733384
Nightmare 162.54 40.43 57 4564 2730 1739430
Hallucination, visual 154.95 40.43 54 4567 2538 1739622
Mania 145.27 40.43 49 4572 2084 1740076
Seizure 139.80 40.43 96 4525 20345 1721815
Hallucination 137.93 40.43 69 4552 8101 1734059
Delirium 135.44 40.43 63 4558 6299 1735861
Condition aggravated 134.51 40.43 95 4526 21055 1721105
Intentional product misuse 132.68 40.43 65 4556 7293 1734867
Psychomotor hyperactivity 130.93 40.43 44 4577 1849 1740311
Accidental overdose 130.04 40.43 54 4567 4110 1738050
Disturbance in attention 129.17 40.43 54 4567 4180 1737980
Extrapyramidal disorder 128.63 40.43 46 4575 2331 1739829
Sedation 126.23 40.43 50 4571 3367 1738793
Dizziness 118.99 40.43 108 4513 34253 1707907
Hyperhidrosis 118.21 40.43 72 4549 12416 1729744
Altered state of consciousness 114.77 40.43 47 4574 3450 1738710
Pulmonary oedema 112.23 40.43 56 4565 6530 1735630
Hypotension 108.12 40.43 96 4525 29558 1712602
Depressed level of consciousness 106.31 40.43 54 4567 6538 1735622
Delusion 101.50 40.43 38 4583 2193 1739967
Weight increased 101.14 40.43 63 4558 11294 1730866
Depressed mood 100.55 40.43 41 4580 2975 1739185
Abnormal behaviour 99.50 40.43 51 4570 6291 1735869
Loss of consciousness 94.86 40.43 67 4554 14808 1727352
Hepatic steatosis 92.59 40.43 37 4584 2547 1739613
Psychotic disorder 92.09 40.43 45 4576 5011 1737149
Disorientation 91.67 40.43 46 4575 5423 1736737
Death 88.15 40.43 147 4474 87296 1654864
Inappropriate antidiuretic hormone secretion 87.70 40.43 32 4589 1716 1740444
Acute pulmonary oedema 86.95 40.43 29 4592 1188 1740972
Dyskinesia 84.90 40.43 39 4582 3780 1738380
Drug withdrawal syndrome 84.58 40.43 41 4580 4484 1737676
Product use in unapproved indication 83.18 40.43 52 4569 9370 1732790
Muscle twitching 83.08 40.43 31 4590 1771 1740389
Poisoning deliberate 80.36 40.43 25 4596 817 1741343
Sleep disorder 79.53 40.43 38 4583 4025 1738135
Pulmonary congestion 79.39 40.43 30 4591 1775 1740385
Epilepsy 77.41 40.43 37 4584 3922 1738238
Akathisia 76.75 40.43 27 4594 1301 1740859
Headache 76.33 40.43 85 4536 34291 1707869
Priapism 74.18 40.43 27 4594 1437 1740723
Accidental death 73.61 40.43 20 4601 400 1741760
Apathy 73.57 40.43 26 4595 1270 1740890
Hypersomnia 73.16 40.43 28 4593 1715 1740445
Urinary retention 72.13 40.43 39 4582 5356 1736804
Bezoar 71.60 40.43 16 4605 135 1742025
Oesophageal obstruction 71.59 40.43 15 4606 90 1742070
Progressive multifocal leukoencephalopathy 71.21 40.43 27 4594 1612 1740548
Speech disorder 69.64 40.43 36 4585 4512 1737648
Circulatory collapse 69.60 40.43 33 4588 3434 1738726
Mood swings 69.40 40.43 28 4593 1974 1740186
Bradyphrenia 68.80 40.43 21 4600 643 1741517
Muscle spasms 68.66 40.43 50 4571 11571 1730589
Syncope 68.34 40.43 54 4567 14115 1728045
Major depression 67.32 40.43 21 4600 692 1741468
Unresponsive to stimuli 66.19 40.43 35 4586 4594 1737566
Dysgraphia 65.84 40.43 17 4604 277 1741883
Dysarthria 64.73 40.43 36 4585 5223 1736937
Muscle rigidity 64.59 40.43 26 4595 1822 1740338
Foetal exposure during pregnancy 63.53 40.43 38 4583 6321 1735839
Gait disturbance 62.62 40.43 49 4572 12621 1729539
Agranulocytosis 62.62 40.43 31 4590 3545 1738615
On and off phenomenon 62.06 40.43 16 4605 259 1741901
Off label use 60.48 40.43 80 4541 38491 1703669
Irritability 60.36 40.43 35 4586 5497 1736663
Selective eating disorder 59.79 40.43 17 4604 404 1741756
Alcohol use 59.68 40.43 20 4601 831 1741329
Vestibular disorder 58.34 40.43 14 4607 166 1741994
Illness anxiety disorder 58.14 40.43 11 4610 35 1742125
Parkinson's disease psychosis 57.85 40.43 9 4612 3 1742157
Mental status changes 57.32 40.43 35 4586 6040 1736120
Mental disorder 56.87 40.43 27 4594 2816 1739344
Liver function test abnormal 56.63 40.43 34 4587 5692 1736468
Illusion 56.46 40.43 14 4607 192 1741968
Asphyxia 54.96 40.43 20 4601 1063 1741097
Persecutory delusion 54.54 40.43 16 4605 426 1741734
Psychomotor retardation 54.22 40.43 16 4605 435 1741725
Macrophages increased 54.20 40.43 9 4612 9 1742151
Parkinsonism 53.92 40.43 21 4600 1348 1740812
Brain oedema 53.77 40.43 24 4597 2172 1739988
Paraesthesia 52.89 40.43 41 4580 10410 1731750
Hallucinations, mixed 52.78 40.43 16 4605 478 1741682
Bradykinesia 52.10 40.43 16 4605 500 1741660
Malaise 52.08 40.43 65 4556 29500 1712660
Nausea 51.21 40.43 86 4535 51110 1691050
Sinus tachycardia 50.50 40.43 24 4597 2508 1739652
Respiratory depression 50.08 40.43 23 4598 2224 1739936
Withdrawal syndrome 49.69 40.43 23 4598 2265 1739895
Blood sodium decreased 49.53 40.43 23 4598 2281 1739879
Ataxia 49.07 40.43 23 4598 2330 1739830
Dehydration 48.57 40.43 49 4572 17609 1724551
Myalgia 47.80 40.43 46 4575 15612 1726548
Drug-induced liver injury 47.76 40.43 25 4596 3212 1738948
Paranoia 47.60 40.43 22 4599 2159 1740001
Cardiometabolic syndrome 46.45 40.43 13 4608 291 1741869
Maternal drugs affecting foetus 46.25 40.43 18 4603 1153 1741007
Antipsychotic drug level above therapeutic 45.99 40.43 12 4609 204 1741956
Electrocardiogram QRS complex prolonged 45.70 40.43 16 4605 759 1741401
Hypernatraemia 45.44 40.43 17 4604 977 1741183
Coordination abnormal 45.29 40.43 19 4602 1478 1740682
Substance abuse 45.29 40.43 17 4604 986 1741174
Alanine aminotransferase increased 45.09 40.43 40 4581 12238 1729922
Mood altered 45.05 40.43 21 4600 2101 1740059
Depressive symptom 43.89 40.43 13 4608 358 1741802
Alcohol poisoning 43.85 40.43 14 4607 498 1741662
Urine sodium decreased 43.43 40.43 8 4613 21 1742139
Anger 43.39 40.43 22 4599 2644 1739516
Product prescribing error 42.50 40.43 21 4600 2389 1739771
Hypertriglyceridaemia 42.21 40.43 17 4604 1192 1740968
Miosis 42.19 40.43 18 4603 1460 1740700
Bipolar disorder 42.15 40.43 15 4606 747 1741413
Hallucination, auditory 42.01 40.43 20 4601 2097 1740063
Vomiting 41.82 40.43 67 4554 38248 1703912
Treatment noncompliance 41.61 40.43 27 4594 5174 1736986
Hepatitis acute 41.56 40.43 17 4604 1240 1740920
Hyperreflexia 41.20 40.43 14 4607 607 1741553
Hepatic fibrosis 41.09 40.43 14 4607 612 1741548
Obsessive-compulsive disorder 40.93 40.43 15 4606 813 1741347
Feeling guilty 40.58 40.43 9 4612 73 1742087

Pharmacologic Action:

SourceCodeDescription
ATC N06AX11 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Other antidepressants
MeSH PA D018663 Adrenergic Agents
MeSH PA D058669 Adrenergic alpha-2 Receptor Antagonists
MeSH PA D000317 Adrenergic alpha-Antagonists
MeSH PA D018674 Adrenergic Antagonists
CHEBI has role CHEBI:37890 alpha-adrenergic antagonist
CHEBI has role CHEBI:48279 serotonergic antagonist
CHEBI has role CHEBI:37956 histamine antagonist
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:37955 H1-receptor antagonist
CHEBI has role CHEBI:146270 oneirogen
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D000928 Antidepressive Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D058830 Serotonin 5-HT2 Receptor Antagonists
MeSH PA D058831 Serotonin 5-HT3 Receptor Antagonists
MeSH PA D018490 Serotonin Agents
MeSH PA D012702 Serotonin Antagonists
MeSH PA D014149 Tranquilizing Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Major depressive disorder indication 370143000
Posttraumatic stress disorder off-label use 47505003 DOID:2055
Suicidal thoughts contraindication 6471006
Weight gain finding contraindication 8943002
Hypercholesterolemia contraindication 13644009
Myocardial infarction contraindication 22298006 DOID:5844
Hypovolemia contraindication 28560003
Orthostatic hypotension contraindication 28651003
Dehydration contraindication 34095006
Low blood pressure contraindication 45007003
Cerebrovascular disease contraindication 62914000 DOID:6713
Hyponatremia contraindication 89627008
Seizure disorder contraindication 128613002
Liver function tests abnormal contraindication 166603001
Bipolar affective disorder, current episode manic contraindication 191618007
Angina pectoris contraindication 194828000
Impaired renal function disorder contraindication 197663003
Cerebrovascular accident contraindication 230690007
Disease of liver contraindication 235856003 DOID:409
Akathisia contraindication 285145004
Hypertriglyceridemia contraindication 302870006
Neutropenic disorder contraindication 303011007 DOID:1227
Serotonin syndrome contraindication 371089000
Obesity contraindication 414916001 DOID:9970
Acute Thromboembolic Stroke contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.67 Basic
pKa2 2.91 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
5-hydroxytryptamine receptor 2C GPCR ANTAGONIST Ki 7.41 CHEMBL CHEMBL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 7.16 CHEMBL CHEMBL
5-hydroxytryptamine receptor 7 GPCR Ki 6.58 CHEMBL
Alpha-2B adrenergic receptor GPCR ANTAGONIST IC50 6.65 CHEMBL
Alpha-2C adrenergic receptor GPCR ANTAGONIST Ki 7.74 CHEMBL
5-hydroxytryptamine receptor 3A Ion channel Ki 5.54 CHEMBL
5-hydroxytryptamine receptor 1A GPCR Kd 5.30 CHEMBL
Alpha-2A adrenergic receptor GPCR ANTAGONIST Ki 7.70 CHEMBL
Alpha-1A adrenergic receptor GPCR IC50 5.50 CHEMBL
Muscarinic acetylcholine receptor M2 GPCR WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR WOMBAT-PK
Histamine H1 receptor GPCR Ki 8.80 WOMBAT-PK
Sodium-dependent noradrenaline transporter Transporter Ki 5.34 PDSP
D(1A) dopamine receptor GPCR Ki 5.38 PDSP
D(2) dopamine receptor GPCR Ki 5.26 PDSP
D(3) dopamine receptor GPCR Ki 5.24 CHEMBL
D(1A) dopamine receptor GPCR Ki 5.38 CHEMBL
D(2) dopamine receptor GPCR Ki 5.84 CHEMBL
Transporter Transporter Ki 5.79 CHEMBL
5-hydroxytryptamine receptor 2C GPCR Ki 8.26 CHEMBL
Adrenergic receptor alpha-1 GPCR Ki 6.22 CHEMBL
5-hydroxytryptamine receptor 2A GPCR Ki 8.70 CHEMBL

External reference:

IDSource
D000078785 MESH_DESCRIPTOR_UI
4020978 VUID
N0000148449 NUI
C0049506 UMLSCUI
D00563 KEGG_DRUG
108430001 SNOMEDCT_US
006054 NDDF
46110 MMSL
15996 RXNORM
386847004 SNOMEDCT_US
d04025 MMSL
5120 MMSL
4020978 VANDF
A051Q2099Q UNII
6481 INN_ID
CHEBI:6950 CHEBI
CHEMBL654 ChEMBL_ID
DB00370 DRUGBANK_ID
4205 PUBCHEM_CID
7241 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-0105 TABLET, FILM COATED 15 mg ORAL NDA 19 sections
REMERONSOLTAB HUMAN PRESCRIPTION DRUG LABEL 1 0052-0106 TABLET, ORALLY DISINTEGRATING 15 mg ORAL NDA 19 sections
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-0107 TABLET, FILM COATED 30 mg ORAL NDA 19 sections
REMERONSOLTAB HUMAN PRESCRIPTION DRUG LABEL 1 0052-0108 TABLET, ORALLY DISINTEGRATING 30 mg ORAL NDA 19 sections
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-0109 TABLET, FILM COATED 45 mg ORAL NDA 19 sections
REMERONSOLTAB HUMAN PRESCRIPTION DRUG LABEL 1 0052-0110 TABLET, ORALLY DISINTEGRATING 45 mg ORAL NDA 19 sections
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-4364 TABLET, FILM COATED 15 mg ORAL NDA 19 sections
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-4365 TABLET, FILM COATED 30 mg ORAL NDA 19 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0115-1653 TABLET, ORALLY DISINTEGRATING 15 mg ORAL ANDA 15 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0115-1654 TABLET, ORALLY DISINTEGRATING 30 mg ORAL ANDA 15 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0115-1656 TABLET, ORALLY DISINTEGRATING 45 mg ORAL ANDA 15 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3515 TABLET, FILM COATED 15 mg ORAL ANDA 18 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3530 TABLET, FILM COATED 30 mg ORAL ANDA 18 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3545 TABLET, FILM COATED 45 mg ORAL ANDA 18 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-5527 TABLET 45 mg ORAL ANDA 14 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-5572 TABLET, FILM COATED 15 mg ORAL ANDA 14 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-5573 TABLET, FILM COATED 30 mg ORAL ANDA 14 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-7870 TABLET, FILM COATED 7.50 mg ORAL ANDA 14 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8078 TABLET 7.50 mg ORAL ANDA 14 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8268 TABLET, FILM COATED 15 mg ORAL ANDA 14 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8269 TABLET, FILM COATED 30 mg ORAL ANDA 14 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0904-6519 TABLET, FILM COATED 15 mg ORAL ANDA 14 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 13107-001 TABLET, FILM COATED 7.50 mg ORAL ANDA 14 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 13107-003 TABLET, FILM COATED 30 mg ORAL ANDA 14 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 13107-031 TABLET, FILM COATED 15 mg ORAL ANDA 14 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 13107-032 TABLET, FILM COATED 45 mg ORAL ANDA 14 sections
MIRTAZAPINE HUMAN PRESCRIPTION DRUG LABEL 1 16590-153 TABLET, FILM COATED 15 mg ORAL ANDA 14 sections
MIRTAZAPINE HUMAN PRESCRIPTION DRUG LABEL 1 16590-154 TABLET, FILM COATED 30 mg ORAL ANDA 14 sections
MIRTAZAPINE HUMAN PRESCRIPTION DRUG LABEL 1 16590-155 TABLET, FILM COATED 45 mg ORAL ANDA 14 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 16714-706 TABLET 7.50 mg ORAL ANDA 14 sections