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
Intentional overdose 595.33 10.21 675 88323 64269 46532795
Intentional self-injury 500.52 10.21 395 88603 23771 46573293
Serotonin syndrome 450.96 10.21 372 88626 23848 46573216
Suicide attempt 426.29 10.21 525 88473 54511 46542553
Toxicity to various agents 425.37 10.21 1116 87882 210650 46386414
Drug abuse 415.94 10.21 557 88441 62851 46534213
Sopor 376.34 10.21 308 88690 19520 46577544
Electrocardiogram QT prolonged 315.50 10.21 437 88561 50888 46546176
Suicidal ideation 302.51 10.21 450 88548 55932 46541132
Drug interaction 299.87 10.21 959 88039 202135 46394929
Completed suicide 295.57 10.21 772 88226 145148 46451916
Rheumatoid arthritis 274.85 10.21 61 88937 240154 46356910
Overdose 261.41 10.21 591 88407 101388 46495676
Hyponatraemia 246.20 10.21 575 88423 100757 46496307
Agitation 209.96 10.21 378 88620 55037 46542027
Somnolence 209.21 10.21 715 88283 155806 46441258
Confusional state 187.68 10.21 700 88298 159192 46437872
Depressed level of consciousness 171.97 10.21 318 88680 47251 46549813
Inappropriate antidiuretic hormone secretion 154.16 10.21 161 88837 13941 46583123
Depression 140.44 10.21 669 88329 169435 46427629
Drug ineffective 137.49 10.21 747 88251 677091 45919973
Muscle rigidity 135.30 10.21 128 88870 9833 46587231
Tremor 134.50 10.21 505 88493 115134 46481930
Neuroleptic malignant syndrome 134.34 10.21 134 88864 10988 46586076
Coma 131.75 10.21 322 88676 58027 46539037
Disorientation 129.91 10.21 244 88754 36674 46560390
Tachycardia 129.37 10.21 451 88547 99171 46497893
Restlessness 124.48 10.21 195 88803 25329 46571735
Depressed mood 115.73 10.21 219 88779 33100 46563964
Disturbance in attention 115.31 10.21 212 88786 31348 46565716
Fall 112.47 10.21 1037 87961 328060 46269004
Treatment failure 111.77 10.21 21 88977 93066 46503998
Anxiety 105.61 10.21 650 88348 181307 46415757
Joint swelling 103.94 10.21 98 88900 165975 46431089
Sinusitis 102.58 10.21 60 88938 129708 46467356
Akathisia 98.85 10.21 96 88902 7618 46589446
Drug hypersensitivity 98.24 10.21 198 88800 243627 46353437
Rash 96.65 10.21 352 88646 356160 46240904
Mydriasis 90.32 10.21 106 88892 10447 46586617
Aggression 88.45 10.21 157 88841 22587 46574477
Restless legs syndrome 84.23 10.21 126 88872 15717 46581347
Infusion related reaction 82.55 10.21 45 88953 101163 46495901
Injection site pain 81.25 10.21 52 88946 107100 46489964
Dysarthria 80.46 10.21 203 88795 37295 46559769
General physical health deterioration 79.10 10.21 432 88566 115337 46481727
Pain 78.99 10.21 559 88439 476389 46120675
Nasopharyngitis 78.77 10.21 107 88891 153891 46443173
Nightmare 78.42 10.21 125 88873 16473 46580591
Hallucination 78.13 10.21 241 88757 49710 46547354
Urinary retention 78.05 10.21 161 88837 25900 46571164
Rheumatoid factor negative 78.05 10.21 32 88966 525 46596539
Dissociation 77.63 10.21 47 88951 1830 46595234
Systemic lupus erythematosus 77.61 10.21 15 88983 65165 46531899
Arthralgia 77.34 10.21 395 88603 364208 46232856
Parkinsonism 75.05 10.21 84 88914 7864 46589200
Dyskinesia 72.16 10.21 166 88832 28759 46568305
Arthropathy 71.53 10.21 36 88962 84664 46512400
Depersonalisation/derealisation disorder 71.35 10.21 36 88962 974 46596090
Withdrawal syndrome 70.29 10.21 125 88873 18009 46579055
Pemphigus 70.06 10.21 4 88994 45270 46551794
Pleurothotonus 69.31 10.21 37 88961 1128 46595936
Alopecia 68.74 10.21 128 88870 162286 46434778
Sedation 67.98 10.21 141 88857 22769 46574295
Urticaria 67.56 10.21 75 88923 117817 46479247
Myoclonus 66.32 10.21 107 88891 14245 46582819
Depressive symptom 64.43 10.21 49 88949 2787 46594277
Drug withdrawal syndrome 62.71 10.21 152 88846 27232 46569832
Hallucination, visual 62.69 10.21 118 88880 17755 46579309
Delirium 62.34 10.21 184 88814 37044 46560020
Poisoning 61.51 10.21 102 88896 13892 46583172
Peripheral swelling 61.37 10.21 131 88867 157940 46439124
Swelling 61.18 10.21 89 88909 124422 46472642
Seizure 61.17 10.21 423 88575 122631 46474433
Contraindicated product administered 60.32 10.21 39 88959 79908 46517156
Tardive dyskinesia 60 10.21 73 88925 7470 46589594
Hyperhidrosis 58.14 10.21 329 88669 88979 46508085
Gastric pH decreased 57.73 10.21 23 88975 349 46596715
Psychotic disorder 56.62 10.21 130 88868 22491 46574573
Injection site erythema 53.88 10.21 38 88960 74389 46522675
Intestinal pseudo-obstruction 53.74 10.21 26 88972 641 46596423
Feeling of despair 51.97 10.21 36 88962 1769 46595295
Abdominal discomfort 51.70 10.21 134 88864 151031 46446033
Extrapyramidal disorder 50.69 10.21 83 88915 11185 46585879
Cough 50.12 10.21 247 88751 230002 46367062
Loss of consciousness 49.67 10.21 365 88633 107873 46489191
Mania 48.94 10.21 80 88918 10766 46586298
Headache 48.62 10.21 632 88366 477720 46119344
Injection site pruritus 47.61 10.21 9 88989 39734 46557330
Drug intolerance 47.54 10.21 134 88864 146915 46450149
Psychomotor retardation 46.70 10.21 43 88955 3190 46593874
Pruritus 46.64 10.21 271 88727 242081 46354983
Asphyxia 46.41 10.21 54 88944 5272 46591792
Drug dependence 45.07 10.21 110 88888 19791 46577273
Sleep disorder 44.44 10.21 192 88806 46603 46550461
Hallucination, auditory 44.09 10.21 76 88922 10680 46586384
Hypertonia 43.54 10.21 48 88950 4418 46592646
Pain in extremity 43.25 10.21 302 88696 258378 46338686
Sleep paralysis 42.97 10.21 20 88978 451 46596613
Hyperkinesia 42.70 10.21 32 88966 1780 46595284
Progressive multifocal leukoencephalopathy 42.42 10.21 77 88921 11269 46585795
Accidental overdose 42.38 10.21 108 88890 19958 46577106
Psoriasis 41.81 10.21 53 88945 78551 46518513
Therapeutic product effect decreased 41.59 10.21 58 88940 82543 46514521
Cogwheel rigidity 41.22 10.21 29 88969 1461 46595603
Hypertonia neonatal 41.14 10.21 16 88982 227 46596837
Synovitis 40.62 10.21 34 88964 61041 46536023
Polydipsia 40.50 10.21 40 88958 3239 46593825
Arthritis 40.23 10.21 53 88945 77263 46519801
Psoriatic arthropathy 40.00 10.21 10 88988 36369 46560695
Psychomotor hyperactivity 39.50 10.21 68 88930 9545 46587519
Product dose omission issue 38.86 10.21 177 88821 168343 46428721
Glossodynia 38.76 10.21 18 88980 44355 46552709
Nasal congestion 38.34 10.21 22 88976 48091 46548973
Hypersensitivity 38.28 10.21 152 88846 150169 46446895
Device expulsion 38.22 10.21 4 88994 27538 46569526
Acute motor-sensory axonal neuropathy 37.63 10.21 17 88981 357 46596707
Abnormal dreams 37.47 10.21 69 88929 10210 46586854
Major depression 36.70 10.21 54 88944 6636 46590428
Erythema 36.63 10.21 144 88854 142676 46454388
Dystonia 36.63 10.21 72 88926 11185 46585879
Abnormal behaviour 36.13 10.21 105 88893 20953 46576111
Back pain 35.69 10.21 244 88754 209795 46387269
Galactorrhoea 35.62 10.21 40 88958 3757 46593307
Derealisation 35.53 10.21 21 88977 782 46596282
Rhabdomyolysis 35.33 10.21 166 88832 41743 46555321
Product prescribing error 33.47 10.21 99 88899 19948 46577116
Delusion 33.35 10.21 69 88929 11119 46585945
Persecutory delusion 33.12 10.21 32 88966 2523 46594541
Fracture 33.08 10.21 87 88911 16384 46580680
Opisthotonus 32.90 10.21 15 88983 322 46596742
Panic attack 32.89 10.21 99 88899 20143 46576921
Off label use 32.83 10.21 518 88480 379323 46217741
Cognitive disorder 32.50 10.21 148 88850 36735 46560329
Altered state of consciousness 32.27 10.21 108 88890 23240 46573824
Abulia 32.24 10.21 15 88983 338 46596726
Gestational diabetes 32.24 10.21 53 88945 7166 46589898
Unresponsive to stimuli 32.09 10.21 134 88864 32040 46565024
Bradypnoea 31.97 10.21 34 88964 3005 46594059
Anger 31.76 10.21 70 88928 11782 46585282
Product administration error 31.73 10.21 96 88902 19585 46577479
Asthma 31.39 10.21 81 88917 91461 46505603
Histrionic personality disorder 30.55 10.21 9 88989 50 46597014
Orthostatic hypotension 30.55 10.21 110 88888 24548 46572516
Injection site bruising 30.29 10.21 15 88983 35621 46561443
Herpes zoster 30.02 10.21 52 88946 67820 46529244
Paranoia 30.01 10.21 64 88934 10533 46586531
Injection site swelling 29.97 10.21 20 88978 40307 46556757
Coma scale abnormal 29.79 10.21 42 88956 4964 46592100
Cardiac arrest 29.78 10.21 283 88715 90116 46506948
C-reactive protein abnormal 29.74 10.21 3 88995 21267 46575797
Incontinence 29.61 10.21 61 88937 9801 46587263
Pallor 29.26 10.21 104 88894 23062 46574002
Rhonchi 29.20 10.21 28 88970 2187 46594877
Drooling 28.74 10.21 33 88965 3176 46593888
Product use issue 28.58 10.21 89 88909 94555 46502509
Miosis 28.56 10.21 48 88950 6609 46590455
Dysphagia 28.50 10.21 248 88750 77064 46520000
Self-injurious ideation 28.30 10.21 28 88970 2272 46594792
Intentional product misuse 28.30 10.21 170 88828 46958 46550106
Schizophrenia 28.12 10.21 55 88943 8513 46588551
Affective disorder 28.06 10.21 40 88958 4775 46592289
Generalised tonic-clonic seizure 27.86 10.21 114 88884 27008 46570056
Fatigue 27.86 10.21 917 88081 607780 45989284
Ventricular fibrillation 27.60 10.21 65 88933 11431 46585633
Urinary hesitation 27.40 10.21 25 88973 1833 46595231
Ballismus 26.81 10.21 9 88989 81 46596983
Chemical burn of oral cavity 26.43 10.21 9 88989 85 46596979
Skull malformation 26.24 10.21 13 88985 338 46596726
Therapeutic product effect incomplete 26.15 10.21 70 88928 78083 46518981
Language disorder 25.46 10.21 22 88976 1501 46595563
Helplessness 25.31 10.21 11 88987 210 46596854
Knee arthroplasty 25.08 10.21 7 88991 23658 46573406
Agitation neonatal 24.44 10.21 14 88984 491 46596573
Salivary hypersecretion 24.42 10.21 44 88954 6401 46590663
Upper respiratory tract infection 24.36 10.21 53 88945 63503 46533561
Fungal infection 24.24 10.21 13 88985 29507 46567557
H1N1 influenza 23.93 10.21 21 88977 1463 46595601
Irritability 23.92 10.21 114 88884 28832 46568232
Tonic clonic movements 23.91 10.21 19 88979 1153 46595911
Norepinephrine increased 23.83 10.21 8 88990 72 46596992
Diarrhoea 23.73 10.21 851 88147 558751 46038313
Blood prolactin increased 23.60 10.21 29 88969 2998 46594066
Panic reaction 23.52 10.21 32 88966 3657 46593407
Breast discomfort 23.47 10.21 12 88986 334 46596730
Social avoidant behaviour 23.44 10.21 28 88970 2811 46594253
Speech disorder 23.35 10.21 133 88865 36034 46561030
Circulatory collapse 23.10 10.21 92 88906 21532 46575532
CYP3A4 polymorphism 23.09 10.21 8 88990 80 46596984
Non-cardiogenic pulmonary oedema 23.01 10.21 14 88984 550 46596514
Pyelonephritis 22.99 10.21 73 88925 15284 46581780
Facial nerve disorder 22.85 10.21 14 88984 557 46596507
Personality disorder 22.80 10.21 29 88969 3104 46593960
Infection 22.76 10.21 155 88843 133437 46463627
Impaired healing 22.58 10.21 22 88976 36721 46560343
Neonatal hypoxia 22.36 10.21 13 88985 469 46596595
Mood swings 22.30 10.21 75 88923 16177 46580887
Maternal exposure during pregnancy 22.28 10.21 110 88888 102439 46494625
Epilepsy 22.23 10.21 97 88901 23641 46573423
Orgasm abnormal 22.16 10.21 8 88990 91 46596973
Myocardial infarction 22.13 10.21 103 88895 97425 46499639
Cerebral ventricle dilatation 22.06 10.21 17 88981 986 46596078
Giant cell arteritis 21.89 10.21 22 88976 1819 46595245
Injection site reaction 21.76 10.21 36 88962 47813 46549251
Alkalosis hypochloraemic 21.71 10.21 9 88989 152 46596912
Incoherent 21.34 10.21 34 88964 4478 46592586
Euphoric mood 21.32 10.21 33 88965 4239 46592825
Tachycardia paroxysmal 21.17 10.21 11 88987 317 46596747
Pneumonia 21.14 10.21 551 88447 375769 46221295
Hypophagia 21.09 10.21 111 88887 29195 46567869
Insomnia 21.05 10.21 436 88562 164488 46432576
Agranulocytosis 21.04 10.21 91 88907 22094 46574970
Osteoporosis 20.95 10.21 28 88970 40580 46556484
Feeling jittery 20.95 10.21 57 88941 10951 46586113
Respiratory distress 20.93 10.21 18 88980 31898 46565166
Platelet count decreased 20.76 10.21 109 88889 99915 46497149
Apathy 20.70 10.21 44 88954 7224 46589840
Neuropathy peripheral 20.62 10.21 96 88902 90797 46506267
Injection site haemorrhage 20.38 10.21 7 88991 20702 46576362
Immune reconstitution inflammatory syndrome 20.33 10.21 38 88960 5687 46591377
Mutism 20.17 10.21 18 88980 1282 46595782
Autonomic nervous system imbalance 20.15 10.21 24 88974 2402 46594662
Product quality issue 20.05 10.21 23 88975 35625 46561439
Hyperthermia 19.99 10.21 46 88952 7968 46589096
Suicidal behaviour 19.97 10.21 24 88974 2424 46594640
Cataract 19.89 10.21 35 88963 45380 46551684
Thinking abnormal 19.87 10.21 52 88946 9762 46587302
Aphasia 19.74 10.21 107 88891 28460 46568604
Impulsive behaviour 19.68 10.21 19 88979 1496 46595568
Cardiac failure congestive 19.59 10.21 99 88899 91651 46505413
Thymus disorder 19.58 10.21 9 88989 197 46596867
Purple glove syndrome 19.54 10.21 9 88989 198 46596866
Parosmia 19.44 10.21 31 88967 4085 46592979
Bradyphrenia 19.25 10.21 39 88959 6191 46590873
Visceral congestion 19.22 10.21 10 88988 289 46596775
Merycism 19.20 10.21 8 88990 137 46596927
Drug dose titration not performed 19.15 10.21 11 88987 388 46596676
Reduced facial expression 19.14 10.21 17 88981 1203 46595861
Thirst 19.09 10.21 55 88943 10921 46586143
Natural killer cell count decreased 19.07 10.21 6 88992 43 46597021
Respiratory arrest 19.05 10.21 120 88878 33696 46563368
Respiratory disorder neonatal 18.83 10.21 15 88983 913 46596151
Skin exfoliation 18.80 10.21 21 88977 32917 46564147
Intentional product use issue 18.63 10.21 46 88952 52734 46544330
Sensorimotor disorder 18.58 10.21 11 88987 411 46596653
Cellulitis orbital 18.55 10.21 11 88987 412 46596652
Spina bifida 18.55 10.21 13 88985 651 46596413
Decreased appetite 18.45 10.21 492 88506 193344 46403720
Activation syndrome 18.41 10.21 9 88989 227 46596837
Osteoarthritis 18.24 10.21 59 88939 61966 46535098
Cytomegalovirus infection 18.08 10.21 6 88992 18138 46578926
Cellulitis 17.92 10.21 71 88927 70217 46526847
Syncope 17.90 10.21 290 88708 104513 46492551
Chest pain 17.80 10.21 233 88765 176091 46420973
Aspiration 17.79 10.21 49 88949 9482 46587582
Drop attacks 17.75 10.21 13 88985 698 46596366
Acute abdomen 17.66 10.21 18 88980 1514 46595550
Cerebellar syndrome 17.62 10.21 27 88971 3438 46593626
Bradykinesia 17.55 10.21 29 88969 3937 46593127
Hypokalaemia 17.51 10.21 250 88748 87774 46509290
Bursitis 17.40 10.21 8 88990 19834 46577230
Phagophobia 17.25 10.21 5 88993 26 46597038
Empty sella syndrome 17.25 10.21 5 88993 26 46597038
Dementia 17.15 10.21 65 88933 14865 46582199
Agonal rhythm 17.09 10.21 5 88993 27 46597037
Poisoning deliberate 17.09 10.21 43 88955 7883 46589181
Retinal detachment 17.05 10.21 33 88965 5067 46591997
Binge eating 16.98 10.21 10 88988 370 46596694
Mental disorder 16.87 10.21 86 88912 22339 46574725
Inflammation 16.84 10.21 43 88955 48738 46548326
Radial nerve palsy 16.71 10.21 10 88988 381 46596683
Pulmonary renal syndrome 16.69 10.21 10 88988 382 46596682
Gastrooesophageal reflux disease 16.58 10.21 79 88919 74265 46522799
Dyspraxia 16.54 10.21 8 88990 197 46596867
Febrile neutropenia 16.51 10.21 109 88889 94518 46502546
Blood pressure increased 16.49 10.21 158 88840 126508 46470556
Rhinorrhoea 16.47 10.21 42 88956 47623 46549441
Tachyphrenia 16.38 10.21 16 88982 1278 46595786
Abnormal weight gain 16.37 10.21 17 88981 1461 46595603
No adverse event 16.28 10.21 25 88973 34206 46562858
Chorea 16.15 10.21 15 88983 1125 46595939
Vitamin B12 decreased 16.09 10.21 23 88975 2752 46594312
Negative thoughts 16.03 10.21 13 88985 812 46596252
Sudden death 15.93 10.21 47 88951 9457 46587607
Drug withdrawal syndrome neonatal 15.89 10.21 19 88979 1909 46595155
Loss of libido 15.82 10.21 16 88982 1333 46595731
Productive cough 15.79 10.21 47 88951 50668 46546396
Brief psychotic disorder with marked stressors 15.76 10.21 6 88992 80 46596984
Medulloblastoma 15.75 10.21 5 88993 37 46597027
Aspergillus test positive 15.65 10.21 9 88989 318 46596746
Intrusive thoughts 15.54 10.21 7 88991 146 46596918
Drowning 15.44 10.21 10 88988 439 46596625
Interstitial lung disease 15.40 10.21 52 88946 53897 46543167
Palmar-plantar erythrodysaesthesia syndrome 15.38 10.21 10 88988 20441 46576623
Enterococcus test positive 15.34 10.21 14 88984 1027 46596037
Anaphylactic reaction 15.29 10.21 51 88947 53061 46544003
Retrograde amnesia 15.25 10.21 9 88989 334 46596730
Homicidal ideation 15.25 10.21 18 88980 1784 46595280
Substance abuse 15.22 10.21 28 88970 4139 46592925
Cardiac hypertrophy 15.15 10.21 14 88984 1043 46596021
Gamma-glutamyltransferase increased 15.09 10.21 108 88890 31632 46565432
Joint range of motion decreased 15.07 10.21 5 88993 15119 46581945
Snoring 15.01 10.21 25 88973 3417 46593647
Influenza 14.99 10.21 104 88894 89166 46507898
Mental impairment 14.95 10.21 55 88943 12401 46584663
Nephrolithiasis 14.91 10.21 25 88973 33026 46564038
Pyroglutamic acidosis 14.83 10.21 8 88990 249 46596815
Cardio-respiratory arrest 14.82 10.21 177 88821 59692 46537372
Feeling of body temperature change 14.82 10.21 28 88970 4224 46592840
Pneumonia aspiration 14.72 10.21 107 88891 31498 46565566
Compulsive sexual behaviour 14.70 10.21 5 88993 47 46597017
Disseminated intravascular coagulation 14.70 10.21 9 88989 18996 46578068
Bundle branch block right 14.69 10.21 30 88968 4789 46592275
Neck pain 14.66 10.21 55 88943 55251 46541813
Developmental hip dysplasia 14.65 10.21 15 88983 1268 46595796
Granulocytopenia neonatal 14.65 10.21 4 88994 16 46597048
Status epilepticus 14.55 10.21 59 88939 13920 46583144
Injection site rash 14.46 10.21 6 88992 15807 46581257
Viral infection 14.46 10.21 22 88976 30213 46566851
Dyspnoea 14.45 10.21 820 88178 514728 46082336
Psychiatric decompensation 14.43 10.21 14 88984 1109 46595955
Therapy non-responder 14.42 10.21 36 88962 41116 46555948
Basophil count decreased 14.39 10.21 6 88992 103 46596961
Logorrhoea 14.35 10.21 20 88978 2339 46594725
Bronchitis 14.31 10.21 131 88867 105848 46491216
Antidepressant drug level increased 14.22 10.21 8 88990 271 46596793
Vasodilatation 14.18 10.21 20 88978 2365 46594699
Motor dysfunction 14.15 10.21 38 88960 7244 46589820
Nausea 14.15 10.21 1124 87874 686330 45910734
Tearfulness 14.13 10.21 27 88971 4108 46592956
Shared psychotic disorder 14.10 10.21 4 88994 19 46597045
Indifference 14.08 10.21 6 88992 109 46596955
Selective eating disorder 14.06 10.21 17 88981 1728 46595336
Vagus nerve disorder 14.03 10.21 6 88992 110 46596954
Tongue movement disturbance 14.02 10.21 7 88991 185 46596879
Neglect of personal appearance 13.98 10.21 6 88992 111 46596953
Hypothermia 13.96 10.21 53 88945 12130 46584934
Coronary artery disease 13.90 10.21 27 88971 33725 46563339
Acute psychosis 13.81 10.21 18 88980 1974 46595090
Chemical burns of eye 13.77 10.21 5 88993 58 46597006
Congenital hand malformation 13.75 10.21 8 88990 289 46596775
Intestinal mucosal atrophy 13.72 10.21 3 88995 3 46597061
Pyrexia 13.71 10.21 535 88463 348267 46248797
Bulimia nervosa 13.68 10.21 10 88988 535 46596529
Flushing 13.63 10.21 70 88928 64544 46532520
Akinesia 13.63 10.21 17 88981 1784 46595280
Polydipsia psychogenic 13.54 10.21 5 88993 61 46597003
Hip arthroplasty 13.43 10.21 9 88989 18103 46578961
Refusal of treatment by patient 13.41 10.21 31 88967 5384 46591680
Fluid retention 13.37 10.21 51 88947 50995 46546069
Helicobacter infection 13.35 10.21 3 88995 11733 46585331
Poor feeding infant 13.34 10.21 7 88991 206 46596858
Post-traumatic stress disorder 13.30 10.21 26 88972 4022 46593042
Stupor 13.30 10.21 24 88974 3496 46593568
Cyanosis 13.27 10.21 63 88935 15908 46581156
Mixed anxiety and depressive disorder 13.20 10.21 6 88992 128 46596936
Rabbit syndrome 13.13 10.21 8 88990 315 46596749
B-lymphocyte count increased 13.11 10.21 6 88992 130 46596934
Postmortem blood drug level increased 13.10 10.21 9 88989 436 46596628
Decubitus ulcer 12.99 10.21 45 88953 9853 46587211
Dyspnoea at rest 12.97 10.21 24 88974 3564 46593500
White blood cell count decreased 12.96 10.21 144 88854 112087 46484977
Optic nerve disorder 12.95 10.21 11 88987 733 46596331
Psychotic symptom 12.94 10.21 12 88986 898 46596166
Staphylococcal infection 12.76 10.21 31 88967 35740 46561324
Phaeochromocytoma 12.70 10.21 9 88989 459 46596605
Premature delivery 12.67 10.21 14 88984 22055 46575009
Somatic delusion 12.64 10.21 10 88988 603 46596461
Resuscitation 12.63 10.21 13 88985 1106 46595958
Postural tremor 12.63 10.21 6 88992 142 46596922
Red blood cell sedimentation rate increased 12.62 10.21 15 88983 22874 46574190
Haemoptysis 12.57 10.21 19 88979 26170 46570894
Infantile apnoea 12.55 10.21 11 88987 765 46596299
Skin ulcer 12.49 10.21 27 88971 32431 46564633
Peripheral paralysis 12.48 10.21 5 88993 77 46596987
Parkinson's disease 12.41 10.21 15 88983 1524 46595540
Hypotension 12.40 10.21 552 88446 232037 46365027
Medication error 12.36 10.21 101 88897 30810 46566254
Orthostatic intolerance 12.30 10.21 13 88985 1141 46595923
Agoraphobia 12.25 10.21 8 88990 356 46596708
Breast cancer 12.23 10.21 45 88953 45473 46551591
Catatonia 12.16 10.21 24 88974 3738 46593326
Transfusion 12.13 10.21 5 88993 13226 46583838
Respiratory depression 12.10 10.21 49 88949 11551 46585513
Cerebellar haematoma 12.06 10.21 8 88990 366 46596698
Blood pressure diastolic decreased 12.05 10.21 6 88992 14205 46582859
Therapeutic response decreased 12.03 10.21 42 88956 43103 46553961
Maternal drugs affecting foetus 11.96 10.21 30 88968 5488 46591576
Antiphospholipid antibodies 11.94 10.21 6 88992 161 46596903
Hyperreflexia 11.85 10.21 29 88969 5225 46591839
Hallucinations, mixed 11.78 10.21 24 88974 3825 46593239
Neurological decompensation 11.74 10.21 16 88982 1832 46595232
Dreamy state 11.73 10.21 4 88994 38 46597026
Anaemia 11.70 10.21 385 88613 255394 46341670
Inappropriate affect 11.69 10.21 11 88987 839 46596225
Sinus tachycardia 11.68 10.21 76 88922 21573 46575491
Fibula agenesis 11.65 10.21 3 88995 9 46597055
Sepsis 11.53 10.21 186 88812 135828 46461236
Foetal exposure during pregnancy 11.51 10.21 99 88899 30648 46566416
Generalised anxiety disorder 11.51 10.21 15 88983 1645 46595419
Gamma-glutamyltransferase abnormal 11.50 10.21 7 88991 275 46596789
Anaphylactic shock 11.49 10.21 13 88985 20261 46576803
Haematemesis 11.45 10.21 94 88904 28712 46568352
Injection site warmth 11.40 10.21 6 88992 13766 46583298
Increased appetite 11.39 10.21 39 88959 8488 46588576
Hypoaesthesia oral 11.34 10.21 45 88953 10514 46586550
Respiration abnormal 11.33 10.21 26 88972 4495 46592569
Skin lesion 11.33 10.21 21 88977 26692 46570372
Formication 11.33 10.21 24 88974 3932 46593132
Sinus disorder 11.28 10.21 9 88989 16554 46580510
Gastrointestinal disorder 11.23 10.21 67 88931 59509 46537555
Antipsychotic drug level below therapeutic 11.15 10.21 7 88991 291 46596773
Muscle disorder 11.13 10.21 25 88973 4261 46592803
Catastrophic reaction 10.99 10.21 3 88995 12 46597052
Product complaint 10.99 10.21 49 88949 12052 46585012
Vaginal haemorrhage 10.97 10.21 20 88978 25584 46571480
Nail avulsion 10.97 10.21 4 88994 47 46597017
Lower respiratory tract infection 10.89 10.21 61 88937 55028 46542036
Alcoholism 10.88 10.21 17 88981 2201 46594863
Lower limb fracture 10.87 10.21 5 88993 12393 46584671
Faecaloma 10.84 10.21 36 88962 7716 46589348
Mucosal inflammation 10.83 10.21 38 88960 38938 46558126
Product availability issue 10.81 10.21 12 88986 1113 46595951
Appetite disorder 10.80 10.21 28 88970 5226 46591838
Suspected suicide 10.80 10.21 26 88972 4635 46592429
Pulse absent 10.80 10.21 27 88971 4929 46592135
Weight increased 10.76 10.21 399 88599 164074 46432990
Compulsions 10.75 10.21 6 88992 200 46596864
Tendonitis 10.71 10.21 7 88991 14270 46582794
Haemoglobin decreased 10.71 10.21 177 88821 128772 46468292
Adrenal cyst 10.69 10.21 5 88993 114 46596950
Lipohypertrophy 10.63 10.21 10 88988 762 46596302
Pharyngeal erythema 10.63 10.21 14 88984 1551 46595513
Migraine 10.60 10.21 84 88914 69942 46527122
Anticholinergic syndrome 10.52 10.21 15 88983 1791 46595273
Sleep terror 10.50 10.21 10 88988 774 46596290
Bifascicular block 10.50 10.21 5 88993 119 46596945
Paresis 10.49 10.21 16 88982 2030 46595034
C-reactive protein increased 10.46 10.21 67 88931 58523 46538541
Polyneuropathy 10.46 10.21 47 88951 11597 46585467
Poverty of thought content 10.45 10.21 3 88995 15 46597049
Sinus congestion 10.43 10.21 6 88992 13103 46583961
Nose deformity 10.42 10.21 5 88993 121 46596943
Atrial fibrillation 10.40 10.21 137 88861 103453 46493611
Swollen tongue 10.37 10.21 93 88905 29139 46567925
Multiple organ dysfunction syndrome 10.36 10.21 57 88941 51653 46545411
Hyperphagia 10.33 10.21 14 88984 1594 46595470
Potentiating drug interaction 10.32 10.21 23 88975 3900 46593164
Snake bite 10.29 10.21 3 88995 16 46597048
Failure to thrive 10.27 10.21 32 88966 6632 46590432
Injection site urticaria 10.23 10.21 5 88993 11962 46585102
Acute myeloid leukaemia 10.22 10.21 9 88989 15769 46581295

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 443.33 10.73 1074 61577 176109 29713718
Intentional overdose 415.42 10.73 472 62179 41009 29848818
Intentional self-injury 345.33 10.73 260 62391 13272 29876555
Completed suicide 299.98 10.73 650 62001 98842 29790985
Suicide attempt 297.32 10.73 375 62276 36322 29853505
Agitation 230.54 10.73 409 62242 53664 29836163
Serotonin syndrome 210.95 10.73 222 62429 17669 29872158
Overdose 200.25 10.73 502 62149 83835 29805992
Suicidal ideation 198.04 10.73 306 62345 35808 29854019
Somnolence 184.43 10.73 531 62120 96232 29793595
Confusional state 179.22 10.73 654 61997 134180 29755647
Sopor 154.46 10.73 150 62501 10841 29878986
Drug abuse 153.05 10.73 447 62204 81625 29808202
Anxiety 153.02 10.73 474 62177 89397 29800430
Depression 145.73 10.73 468 62183 89969 29799858
Restlessness 133.07 10.73 198 62453 22401 29867426
Coma 128.19 10.73 270 62381 40179 29849648
Restless legs syndrome 102.63 10.73 97 62554 6775 29883052
Extrapyramidal disorder 100.69 10.73 118 62533 10575 29879252
Fall 92.04 10.73 673 61978 181199 29708628
Aggression 90.93 10.73 223 62428 36684 29853143
Drug interaction 89.02 10.73 717 61934 198851 29690976
Delirium 88.17 10.73 234 62417 40397 29849430
Tremor 82.36 10.73 344 62307 75019 29814808
Drug withdrawal syndrome 81.95 10.73 148 62503 19661 29870166
Akathisia 81.86 10.73 80 62571 5824 29884003
Electrocardiogram QT prolonged 81.45 10.73 210 62441 35625 29854202
Nightmare 80.12 10.73 112 62539 11964 29877863
Neuroleptic malignant syndrome 79.53 10.73 131 62520 16164 29873663
Sedation 79.07 10.73 131 62520 16242 29873585
Mania 77.97 10.73 96 62555 9058 29880769
Accidental overdose 73.64 10.73 135 62516 18140 29871687
Febrile neutropenia 67.66 10.73 74 62577 106619 29783208
Hallucination, visual 66.15 10.73 120 62531 15993 29873834
Wrong patient received product 65.13 10.73 43 62608 1774 29888053
Logorrhoea 64.46 10.73 45 62606 2037 29887790
Myoclonus 63.60 10.73 106 62545 13206 29876621
Parkinsonism 63.15 10.73 77 62574 7192 29882635
Depressed mood 61.43 10.73 120 62531 16909 29872918
Muscle twitching 60.72 10.73 80 62571 8075 29881752
Depressed level of consciousness 60.72 10.73 197 62454 38025 29851802
Disorientation 60.26 10.73 173 62478 31245 29858582
Interstitial lung disease 58.98 10.73 26 62625 60171 29829656
Insomnia 58.22 10.73 364 62287 92972 29796855
Pneumonia aspiration 57.57 10.73 192 62459 37588 29852239
Bradyphrenia 57.46 10.73 55 62596 3902 29885925
Abnormal behaviour 54.98 10.73 147 62504 25476 29864351
Withdrawal syndrome 54.30 10.73 90 62561 11160 29878667
Dyskinesia 49.64 10.73 128 62523 21706 29868121
Panic attack 49.56 10.73 75 62576 8606 29881221
Hallucination 48.23 10.73 217 62434 48842 29840985
Apathy 47.74 10.73 62 62589 6170 29883657
Delusion 47.58 10.73 88 62563 11901 29877926
Myocardial infarction 47.32 10.73 122 62529 125503 29764324
Psychomotor hyperactivity 46.88 10.73 71 62580 8153 29881674
Antidepressant drug level above therapeutic 45.64 10.73 16 62635 150 29889677
Inappropriate antidiuretic hormone secretion 45.53 10.73 84 62567 11338 29878489
Progressive multifocal leukoencephalopathy 44.71 10.73 73 62578 8940 29880887
Hallucination, auditory 44.18 10.73 76 62575 9713 29880114
Sleep disorder 43.32 10.73 131 62520 24348 29865479
Disturbance in attention 42.57 10.73 122 62529 22007 29867820
Illusion 42.51 10.73 24 62627 744 29889083
Poisoning 42.01 10.73 81 62570 11301 29878526
Psychotic disorder 41.76 10.73 119 62532 21396 29868431
Rheumatoid arthritis 41.62 10.73 17 62634 41180 29848647
Cough 41.44 10.73 130 62521 125512 29764315
Illness anxiety disorder 41.32 10.73 15 62636 157 29889670
Priapism 40.80 10.73 50 62601 4693 29885134
Antipsychotic drug level above therapeutic 40.01 10.73 26 62625 1044 29888783
Loss of consciousness 39.59 10.73 293 62358 79082 29810745
Platelet count decreased 39.24 10.73 104 62547 106025 29783802
Pruritus 39.20 10.73 122 62529 118082 29771745
Muscle rigidity 39.08 10.73 74 62577 10187 29879640
Atrial fibrillation 38.45 10.73 108 62543 108016 29781811
Tachycardia 37.23 10.73 273 62378 73466 29816361
Paranoia 36.99 10.73 72 62579 10116 29879711
Hyponatraemia 36.36 10.73 253 62398 66949 29822878
Pneumonia 35.72 10.73 489 62162 333817 29556010
Renal failure 35.49 10.73 144 62507 128822 29761005
Persecutory delusion 35.43 10.73 32 62619 2108 29887719
Mental disorder 34.96 10.73 83 62568 13366 29876461
Nasopharyngitis 34.92 10.73 43 62608 58806 29831021
Rhabdomyolysis 34.77 10.73 240 62411 63340 29826487
Pyrexia 34.30 10.73 423 62228 294066 29595761
Accidental death 34.24 10.73 31 62620 2048 29887779
Major depression 33.95 10.73 42 62609 3980 29885847
Disease progression 33.70 10.73 73 62578 79801 29810026
Blood creatine phosphokinase increased 33.15 10.73 180 62471 43668 29846159
Cardiac failure congestive 32.51 10.73 81 62570 84326 29805501
Tardive dyskinesia 32.20 10.73 46 62605 5011 29884816
Hypomania 32.08 10.73 31 62620 2225 29887602
Hyponatraemic coma 31.94 10.73 9 62642 37 29889790
Selective eating disorder 31.52 10.73 27 62624 1657 29888170
Drug dependence 31.35 10.73 107 62544 21188 29868639
On and off phenomenon 30.76 10.73 34 62617 2857 29886970
Analgesic drug level above therapeutic 29.55 10.73 13 62638 232 29889595
Poisoning deliberate 29.52 10.73 48 62603 5856 29883971
Rash 29.52 10.73 258 62393 191631 29698196
Prescription drug used without a prescription 29.43 10.73 23 62628 1239 29888588
Neuropathy peripheral 29.24 10.73 65 62586 70410 29819417
Respiratory arrest 29.18 10.73 130 62521 29128 29860699
Anaemia 28.84 10.73 287 62364 207705 29682122
Hyperhidrosis 28.67 10.73 239 62412 66851 29822976
Platypnoea 28.57 10.73 8 62643 32 29889795
Oesophageal obstruction 28.31 10.73 15 62636 409 29889418
Miosis 28.29 10.73 55 62596 7721 29882106
Urinary retention 28.25 10.73 140 62511 32777 29857050
Asthma 27.77 10.73 21 62630 36153 29853674
Dystonia 27.44 10.73 62 62589 9665 29880162
Product prescribing error 27.24 10.73 87 62564 16646 29873181
Infusion related reaction 26.96 10.73 27 62624 40537 29849290
Macrophages increased 26.86 10.73 11 62640 163 29889664
Catatonia 26.66 10.73 39 62612 4341 29885486
Altered state of consciousness 26.66 10.73 97 62554 19822 29870005
Diarrhoea 26.60 10.73 516 62135 333587 29556240
Pleural effusion 26.30 10.73 74 62577 73992 29815835
Hyperreflexia 26.17 10.73 31 62620 2808 29887019
Hallucinations, mixed 26.07 10.73 29 62622 2454 29887373
Depressive symptom 26.06 10.73 24 62627 1621 29888206
Product prescribing issue 25.78 10.73 18 62633 815 29889012
Dysgraphia 25.55 10.73 23 62628 1508 29888319
Benign gastrointestinal neoplasm 25.33 10.73 10 62641 134 29889693
Cytomegalovirus infection 25.19 10.73 9 62642 23665 29866162
Alcohol use 25.16 10.73 35 62616 3720 29886107
Sarcopenia 25.07 10.73 12 62639 262 29889565
Bipolar disorder 25.01 10.73 35 62616 3741 29886086
Thrombocytopenia 24.90 10.73 176 62475 136868 29752959
Urticaria 24.64 10.73 48 62603 54558 29835269
Stomatitis 24.56 10.73 25 62626 37254 29852573
Congenital cerebrovascular anomaly 24.47 10.73 6 62645 12 29889815
Respiratory disorder neonatal 24.20 10.73 20 62631 1168 29888659
Feeling guilty 23.89 10.73 12 62639 292 29889535
Renal impairment 23.77 10.73 93 62558 84091 29805736
Aptyalism 23.59 10.73 11 62640 226 29889601
Herpes zoster 23.48 10.73 17 62634 29926 29859901
Feeling jittery 23.04 10.73 34 62617 3814 29886013
Bradykinesia 22.99 10.73 31 62620 3199 29886628
Pulmonary congestion 22.91 10.73 67 62584 12220 29877607
Cogwheel rigidity 22.88 10.73 19 62632 1117 29888710
Slow speech 22.87 10.73 18 62633 980 29888847
IVth nerve disorder 22.75 10.73 6 62645 18 29889809
Mood altered 22.63 10.73 52 62599 8198 29881629
Drug hypersensitivity 22.49 10.73 71 62580 68448 29821379
Arthralgia 22.48 10.73 179 62472 135612 29754215
Pressure of speech 22.29 10.73 13 62638 429 29889398
Ataxia 21.85 10.73 63 62588 11399 29878428
Acute psychosis 21.60 10.73 23 62628 1853 29887974
Erythema 21.59 10.73 86 62565 77365 29812462
Vestibular disorder 21.57 10.73 16 62635 797 29889030
Parkinsonian gait 21.53 10.73 13 62638 458 29889369
Injection site pain 21.52 10.73 19 62632 30291 29859536
Acute kidney injury 21.44 10.73 424 62227 273418 29616409
Perforated ulcer 21.41 10.73 9 62642 143 29889684
Irritability 21.19 10.73 100 62551 22950 29866877
Decreased gait velocity 21.06 10.73 8 62643 96 29889731
Acute myocardial infarction 21.01 10.73 50 62601 52889 29836938
Helplessness 20.94 10.73 7 62644 56 29889771
Sepsis 20.69 10.73 201 62450 146194 29743633
Psychomotor skills impaired 20.59 10.73 23 62628 1956 29887871
Activation syndrome 20.55 10.73 8 62643 103 29889724
Temperature regulation disorder 20.53 10.73 13 62638 499 29889328
Dysarthria 20.29 10.73 121 62530 30369 29859458
Depersonalisation/derealisation disorder 20.18 10.73 13 62638 514 29889313
Sinusitis 20.16 10.73 24 62627 33321 29856506
Substance abuse 20.00 10.73 45 62606 6995 29882832
Hanging 19.88 10.73 8 62643 113 29889714
Bezoar 19.83 10.73 16 62635 903 29888924
Hypertonia 19.72 10.73 34 62617 4351 29885476
Dyspnoea 19.67 10.73 539 62112 332756 29557071
Rebound effect 19.52 10.73 20 62631 1541 29888286
Loss of proprioception 19.48 10.73 10 62641 255 29889572
Mucosal inflammation 19.47 10.73 21 62630 30473 29859354
Verbal abuse 19.34 10.73 9 62642 184 29889643
Dementia with Lewy bodies 19.05 10.73 13 62638 567 29889260
Suspected suicide 19.03 10.73 28 62623 3133 29886694
Blood ethanol increased 19.00 10.73 11 62640 358 29889469
Arachnoid cyst 18.14 10.73 9 62642 213 29889614
Metabolic syndrome 18.13 10.73 19 62632 1503 29888324
Homicide 18.02 10.73 16 62635 1030 29888797
Hypervigilance 17.87 10.73 8 62643 149 29889678
Cardiac failure 17.77 10.73 102 62549 83316 29806511
Blood creatinine increased 17.75 10.73 115 62536 91260 29798567
Seizure 17.74 10.73 297 62354 98178 29791649
Renal disorder 17.71 10.73 14 62637 23570 29866257
Arthritis 17.68 10.73 15 62636 24386 29865441
Hangover 17.61 10.73 16 62635 1062 29888765
Antipsychotic drug level increased 17.57 10.73 27 62624 3139 29886688
Ejaculation failure 17.45 10.73 14 62637 784 29889043
Circulatory collapse 17.36 10.73 86 62565 20128 29869699
Drug ineffective 17.22 10.73 562 62089 339825 29550002
Loose associations 17.14 10.73 6 62645 56 29889771
Eosinophilic myocarditis 17.05 10.73 11 62640 436 29889391
Amnestic disorder 17.04 10.73 8 62643 167 29889660
Respiratory rate decreased 17.03 10.73 20 62631 1795 29888032
Myelodysplastic syndrome 17.02 10.73 9 62642 18769 29871058
Implant site extravasation 17.01 10.73 11 62640 438 29889389
Peritonitis 16.94 10.73 12 62639 21363 29868464
Peripheral swelling 16.90 10.73 68 62583 61006 29828821
Septic shock 16.87 10.73 72 62579 63535 29826292
Chest pain 16.82 10.73 161 62490 117466 29772361
Osteonecrosis of jaw 16.77 10.73 9 62642 18609 29871218
Psychiatric decompensation 16.72 10.73 17 62634 1298 29888529
Balance disorder 16.66 10.73 132 62519 36361 29853466
Sexual dysfunction 16.65 10.73 38 62613 5963 29883864
Ejaculation disorder 16.64 10.73 15 62636 985 29888842
Neonatal respiratory distress syndrome 16.61 10.73 30 62621 3982 29885845
Hepatic steatosis 16.50 10.73 68 62583 14725 29875102
Urine sodium decreased 16.34 10.73 8 62643 184 29889643
Respiratory tract infection 16.32 10.73 6 62645 15500 29874327
Oesophageal haemorrhage 16.28 10.73 16 62635 1172 29888655
Postoperative respiratory failure 16.10 10.73 6 62645 68 29889759
Alcoholism 16.05 10.73 27 62624 3387 29886440
Feelings of worthlessness 15.84 10.73 8 62643 197 29889630
Soft tissue mass 15.74 10.73 9 62642 286 29889541
Psychomotor retardation 15.68 10.73 22 62629 2357 29887470
Tubulointerstitial nephritis 15.60 10.73 9 62642 17882 29871945
Haemoglobin decreased 15.55 10.73 158 62493 113940 29775887
Hyperbilirubinaemia 15.54 10.73 8 62643 16934 29872893
Erectile dysfunction 15.53 10.73 77 62574 18025 29871802
Rapid eye movements sleep abnormal 15.48 10.73 8 62643 207 29889620
Nervousness 15.43 10.73 57 62594 11731 29878096
Off label use 15.24 10.73 401 62250 248889 29640938
Intentional product misuse 15.06 10.73 124 62527 34543 29855284
Self esteem decreased 15.06 10.73 11 62640 535 29889292
Sleep deficit 15.05 10.73 10 62641 417 29889410
Eosinophilic pleural effusion 15.04 10.73 8 62643 220 29889607
Posture abnormal 14.99 10.73 19 62632 1845 29887982
Cellulitis 14.98 10.73 49 62602 46735 29843092
Tricuspid valve sclerosis 14.96 10.73 5 62646 40 29889787
Speech disorder 14.88 10.73 95 62556 24417 29865410
Urinary hesitation 14.87 10.73 21 62630 2263 29887564
Drug withdrawal syndrome neonatal 14.78 10.73 25 62626 3150 29886677
Fear of disease 14.78 10.73 8 62643 228 29889599
Insulin resistance 14.77 10.73 11 62640 551 29889276
Gait disturbance 14.76 10.73 229 62422 74548 29815279
Stupor 14.75 10.73 24 62627 2929 29886898
Anger 14.75 10.73 54 62597 11066 29878761
Drug reaction with eosinophilia and systemic symptoms 14.70 10.73 23 62628 28465 29861362
Gout 14.69 10.73 9 62642 17306 29872521
Asphyxia 14.66 10.73 34 62617 5391 29884436
Neonatal hyponatraemia 14.65 10.73 6 62645 89 29889738
Mood swings 14.62 10.73 42 62609 7584 29882243
Pancytopenia 14.58 10.73 111 62540 84941 29804886
Fear of weight gain 14.49 10.73 4 62647 15 29889812
Xanthoma 14.47 10.73 6 62645 92 29889735
Acute myeloid leukaemia 14.41 10.73 10 62641 17996 29871831
Upper respiratory tract infection 14.36 10.73 22 62629 27454 29862373
Bronchopulmonary aspergillosis 14.26 10.73 4 62647 12280 29877547
Sudden cardiac death 14.21 10.73 27 62624 3725 29886102
Body temperature abnormal 14.18 10.73 10 62641 460 29889367
Failure to thrive 14.15 10.73 43 62608 8011 29881816
Pyroglutamic acidosis 14.07 10.73 6 62645 99 29889728
Sinus bradycardia 14.03 10.73 55 62596 11640 29878187
JC virus infection 14.01 10.73 18 62633 1772 29888055
Sepsis neonatal 14.00 10.73 8 62643 254 29889573
Psoriasis 13.97 10.73 44 62607 42462 29847365
Pelvic fracture 13.93 10.73 20 62631 2188 29887639
Non-alcoholic steatohepatitis 13.89 10.73 12 62639 745 29889082
Pulmonary fibrosis 13.85 10.73 8 62643 15882 29873945
Locked-in syndrome 13.83 10.73 8 62643 260 29889567
Dry skin 13.75 10.73 16 62635 22438 29867389
White blood cell count decreased 13.72 10.73 111 62540 83836 29805991
Mumps 13.69 10.73 6 62645 106 29889721
Palmar-plantar erythrodysaesthesia syndrome 13.67 10.73 7 62644 14863 29874964
Wrong product administered 13.66 10.73 30 62621 4588 29885239
Neutropenia 13.66 10.73 188 62463 128352 29761475
Tumour lysis syndrome 13.53 10.73 5 62646 12880 29876947
Malignant neoplasm progression 13.52 10.73 92 62559 72195 29817632
Obsessive-compulsive disorder 13.52 10.73 28 62623 4113 29885714
Polypectomy 13.34 10.73 10 62641 506 29889321
Cryptorchism 13.34 10.73 17 62634 1660 29888167
Hyporesponsive to stimuli 13.27 10.73 13 62638 949 29888878
Spinal cord injury thoracic 13.20 10.73 6 62645 116 29889711
Back pain 13.19 10.73 144 62507 102452 29787375
Mastication disorder 13.15 10.73 14 62637 1128 29888699
Sensory disturbance 13.13 10.73 34 62617 5777 29884050
Housebound 13.11 10.73 7 62644 194 29889633
Acute pulmonary oedema 13.08 10.73 40 62611 7475 29882352
Hypotonia 13.06 10.73 38 62613 6910 29882917
Pneumocystis jirovecii pneumonia 13.06 10.73 10 62641 17110 29872717
Consciousness fluctuating 12.98 10.73 13 62638 975 29888852
Alcohol poisoning 12.94 10.73 26 62625 3738 29886089
Dementia 12.90 10.73 56 62595 12405 29877422
Electrocardiogram QRS complex prolonged 12.90 10.73 28 62623 4249 29885578
Nephrolithiasis 12.83 10.73 20 62631 24790 29865037
Basal cell carcinoma 12.76 10.73 9 62642 16059 29873768
Social avoidant behaviour 12.62 10.73 22 62629 2841 29886986
Hypersomnia 12.60 10.73 52 62599 11264 29878563
Mitral valve sclerosis 12.58 10.73 6 62645 130 29889697
Dysaesthesia 12.54 10.73 19 62632 2182 29887645
Limited symptom panic attack 12.53 10.73 5 62646 69 29889758
Nasal discomfort 12.47 10.73 14 62637 1197 29888630
Incoherent 12.46 10.73 27 62624 4091 29885736
Abdominal discomfort 12.46 10.73 56 62595 48735 29841092
Diabetes insipidus 12.29 10.73 19 62632 2220 29887607
Homicidal ideation 12.28 10.73 20 62631 2443 29887384
Blood pressure increased 12.26 10.73 94 62557 71834 29817993
Epilepsy 12.14 10.73 78 62573 20091 29869736
Mutism 12.07 10.73 11 62640 733 29889094
Small for dates baby 12.05 10.73 23 62628 3185 29886642
Cold sweat 11.96 10.73 44 62607 9038 29880789
Impaired driving ability 11.96 10.73 20 62631 2498 29887329
Sinus tachycardia 11.95 10.73 64 62587 15440 29874387
Agitated depression 11.92 10.73 7 62644 234 29889593
Electric shock 11.87 10.73 6 62645 148 29889679
Implant site infection 11.79 10.73 12 62639 917 29888910
Intentional product use issue 11.78 10.73 38 62613 36402 29853425
Inappropriate schedule of product administration 11.78 10.73 43 62608 39685 29850142
Kidney congestion 11.76 10.73 7 62644 240 29889587
Rash erythematous 11.71 10.73 18 62633 22434 29867393
Contraindication to medical treatment 11.66 10.73 9 62642 476 29889351
Inferior vena caval occlusion 11.65 10.73 4 62647 35 29889792
Nasal congestion 11.61 10.73 13 62638 18553 29871274
Suprapubic pain 11.60 10.73 8 62643 355 29889472
Intentional device misuse 11.58 10.73 7 62644 247 29889580
Plasma cell myeloma 11.58 10.73 65 62586 53397 29836430
Bladder dilatation 11.56 10.73 14 62637 1298 29888529
Toxic encephalopathy 11.50 10.73 28 62623 4581 29885246
Formication 11.50 10.73 16 62635 1701 29888126
Lung disorder 11.49 10.73 31 62620 31438 29858389
Dysphoria 11.48 10.73 18 62633 2130 29887697
Splenomegaly 11.45 10.73 7 62644 13473 29876354
Blood urea increased 11.39 10.73 31 62620 31350 29858477
Respiratory depression 11.38 10.73 51 62600 11452 29878375
Fluid retention 11.25 10.73 22 62629 24976 29864851
Cerebellar ataxia 11.22 10.73 12 62639 972 29888855
Head discomfort 11.20 10.73 21 62630 2869 29886958
Cerebrovascular accident 11.20 10.73 116 62535 83361 29806466
Pseudomonas infection 11.12 10.73 4 62647 10478 29879349
Jealous delusion 11.12 10.73 7 62644 266 29889561
Panic disorder 11.11 10.73 13 62638 1162 29888665
Suspiciousness 11.10 10.73 8 62643 381 29889446
Pharyngitis bacterial 11.09 10.73 4 62647 41 29889786
Flatulence 11.01 10.73 13 62638 18116 29871711
Respiratory acidosis 10.99 10.73 26 62625 4176 29885651
Thrombotic stroke 10.93 10.73 7 62644 274 29889553
Hyperthermia 10.93 10.73 46 62605 10053 29879774
Hypertrophic scar 10.92 10.73 3 62648 11 29889816
Thinking abnormal 10.92 10.73 30 62621 5281 29884546
Staphylococcal infection 10.87 10.73 30 62621 30194 29859633
Prostate cancer 10.85 10.73 21 62630 23936 29865891
JC virus CSF test positive 10.85 10.73 5 62646 100 29889727
Pneumonitis 10.83 10.73 26 62625 27428 29862399
Agitation neonatal 10.81 10.73 12 62639 1013 29888814
Hepatic function abnormal 10.80 10.73 48 62603 41897 29847930
Joint swelling 10.76 10.73 56 62595 46890 29842937
Porphyria acute 10.76 10.73 5 62646 102 29889725

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
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
CHEBI has role CHEBI:35474 minor tranquilisers
CHEBI has role CHEBI:37890 alpha-adrenoceptor antagonists
CHEBI has role CHEBI:37955 h1-receptor blockers
CHEBI has role CHEBI:37956 histamine receptor blocker
CHEBI has role CHEBI:48279 serotonin antagonists
CHEBI has role CHEBI:146270 oneirogens

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Major depressive disorder indication 370143000
Excessive vomiting in pregnancy off-label use 14094001
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 2A GPCR ANTAGONIST Ki 7.16 CHEMBL CHEMBL
5-hydroxytryptamine receptor 2C GPCR ANTAGONIST Ki 7.41 CHEMBL CHEMBL
D(3) dopamine receptor GPCR Ki 5.24 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-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
Alpha-2A adrenergic receptor GPCR ANTAGONIST Ki 7.70 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
4020978 VUID
N0000148449 NUI
D00563 KEGG_DRUG
4020978 VANDF
C0049506 UMLSCUI
CHEBI:6950 CHEBI
CHEMBL654 ChEMBL_ID
D000078785 MESH_DESCRIPTOR_UI
DB00370 DRUGBANK_ID
7241 IUPHAR_LIGAND_ID
6481 INN_ID
A051Q2099Q UNII
4205 PUBCHEM_CID
15996 RXNORM
46110 MMSL
5120 MMSL
d04025 MMSL
006054 NDDF
108430001 SNOMEDCT_US
386847004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-0105 TABLET, FILM COATED 15 mg ORAL NDA 31 sections
REMERONSOLTAB HUMAN PRESCRIPTION DRUG LABEL 1 0052-0106 TABLET, ORALLY DISINTEGRATING 15 mg ORAL NDA 31 sections
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-0107 TABLET, FILM COATED 30 mg ORAL NDA 31 sections
REMERONSOLTAB HUMAN PRESCRIPTION DRUG LABEL 1 0052-0108 TABLET, ORALLY DISINTEGRATING 30 mg ORAL NDA 31 sections
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-0109 TABLET, FILM COATED 45 mg ORAL NDA 31 sections
REMERONSOLTAB HUMAN PRESCRIPTION DRUG LABEL 1 0052-0110 TABLET, ORALLY DISINTEGRATING 45 mg ORAL NDA 31 sections
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-4364 TABLET, FILM COATED 15 mg ORAL NDA 31 sections
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-4365 TABLET, FILM COATED 30 mg ORAL NDA 31 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3515 TABLET, FILM COATED 15 mg ORAL ANDA 28 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3530 TABLET, FILM COATED 30 mg ORAL ANDA 28 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3545 TABLET, FILM COATED 45 mg ORAL ANDA 28 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8078 TABLET 7.50 mg ORAL ANDA 25 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8268 TABLET, FILM COATED 15 mg ORAL ANDA 25 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8269 TABLET, FILM COATED 30 mg ORAL ANDA 25 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0904-6519 TABLET, FILM COATED 15 mg ORAL ANDA 24 sections
Mirtazapine Human Prescription Drug Label 1 13107-001 TABLET, FILM COATED 7.50 mg ORAL ANDA 25 sections
Mirtazapine Human Prescription Drug Label 1 13107-003 TABLET, FILM COATED 30 mg ORAL ANDA 25 sections
Mirtazapine Human Prescription Drug Label 1 13107-031 TABLET, FILM COATED 15 mg ORAL ANDA 25 sections
Mirtazapine Human Prescription Drug Label 1 13107-032 TABLET, FILM COATED 45 mg ORAL ANDA 25 sections
MIRTAZAPINE HUMAN PRESCRIPTION DRUG LABEL 1 16590-153 TABLET, FILM COATED 15 mg ORAL ANDA 26 sections
MIRTAZAPINE HUMAN PRESCRIPTION DRUG LABEL 1 16590-154 TABLET, FILM COATED 30 mg ORAL ANDA 26 sections
MIRTAZAPINE HUMAN PRESCRIPTION DRUG LABEL 1 16590-155 TABLET, FILM COATED 45 mg ORAL ANDA 26 sections
Mirtazapine Human Prescription Drug Label 1 17856-0101 TABLET, FILM COATED 7.50 mg ORAL ANDA 25 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 21695-081 TABLET, FILM COATED 15 mg ORAL ANDA 29 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 21695-082 TABLET, FILM COATED 30 mg ORAL ANDA 29 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 21695-083 TABLET, FILM COATED 45 mg ORAL ANDA 29 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 33261-073 TABLET, FILM COATED 15 mg ORAL ANDA 25 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 33261-074 TABLET, FILM COATED 30 mg ORAL ANDA 26 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 42254-086 TABLET, FILM COATED 15 mg ORAL ANDA 26 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 42254-087 TABLET, FILM COATED 30 mg ORAL ANDA 26 sections