mirtazapine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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: 3.07
  • 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 ยตM/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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 2.654 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.467 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 38.637 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 43.053 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 24.750 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 32.220 % High 1
herg hERG pIC50 4.986 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 5.212 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 26.853 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 17.250 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,NTRK2,PDK4,PRKDC,TGFBR1 14
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.590 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.468 High 1
mh-clint Mouse hepatocyte intrinsic clearance 154.882 High 1
mppb Mouse plasma protein binding (% unbound) 21.950 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.879 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
pppb Pig plasma protein binding (% unbound) 38.200 % High 1
rat-kpuu-brain Rat brain Kpuu 0.698 % High 1
rh-clint Rat hepatocyte intrinsic clearance 229.087 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 64.540 % High 1
rppb Rat plasma protein binding (% unbound) 25.700 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 877.001 uM High 1

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 1152.37 9.70 1034 137874 92800 90396739
Toxicity to various agents 1087.98 9.70 1735 137173 286111 90203428
Serotonin syndrome 962.39 9.70 643 138265 37244 90452295
Suicide attempt 925.80 9.70 831 138077 74568 90414971
Completed suicide 842.47 9.70 1074 137834 143984 90345555
Suicidal ideation 724.75 9.70 719 138189 73136 90416403
Drug abuse 687.54 9.70 735 138173 81612 90407927
Drug interaction 675.29 9.70 1379 137529 275074 90214465
Intentional self-injury 659.94 9.70 462 138446 28872 90460667
Sopor 610.73 9.70 412 138496 24232 90465307
Electrocardiogram QT prolonged 544.47 9.70 612 138296 71844 90417695
Hyponatraemia 517.15 9.70 815 138093 132723 90356816
Somnolence 510.17 9.70 1043 137865 208041 90281498
Agitation 460.71 9.70 541 138367 66557 90422982
Systemic lupus erythematosus 453.21 9.70 25 138883 361871 90127668
Pemphigus 452.72 9.70 10 138898 326854 90162685
Coma 439.03 9.70 549 138359 72083 90417456
Hand deformity 423.00 9.70 6 138902 296356 90193183
Glossodynia 379.98 9.70 30 138878 321749 90167790
Overdose 377.72 9.70 781 138127 156928 90332611
Infusion related reaction 377.46 9.70 88 138820 416692 90072847
Arthropathy 365.86 9.70 61 138847 366181 90123358
Depressed level of consciousness 362.14 9.70 500 138408 72284 90417255
Synovitis 357.23 9.70 43 138865 329709 90159830
Joint swelling 333.66 9.70 178 138730 503122 89986417
Pericarditis 322.26 9.70 24 138884 270127 90219412
Tremor 318.00 9.70 716 138192 152457 90337082
Helicobacter infection 313.78 9.70 7 138901 226843 90262696
Fall 313.59 9.70 1514 137394 480296 90009243
Duodenal ulcer perforation 313.49 9.70 5 138903 221283 90268256
Alopecia 306.88 9.70 190 138718 494881 89994658
Neuroleptic malignant syndrome 292.01 9.70 217 138691 14879 90474660
Folliculitis 287.87 9.70 5 138903 204348 90285191
Rheumatoid arthritis 285.01 9.70 100 138808 362514 90127025
Restlessness 284.20 9.70 311 138597 35409 90454130
Disorientation 278.64 9.70 341 138567 43773 90445766
Swelling 276.47 9.70 149 138759 418909 90070630
Muscle rigidity 266.34 9.70 201 138707 14108 90475431
Psoriatic arthropathy 256.76 9.70 26 138882 228309 90261230
Impaired healing 252.42 9.70 31 138877 234168 90255371
Sinusitis 250.73 9.70 106 138802 342982 90146557
Treatment failure 247.20 9.70 79 138829 303849 90185690
Inappropriate antidiuretic hormone secretion 247.13 9.70 219 138689 19286 90470253
Rheumatoid factor positive 242.59 9.70 4 138904 171646 90317893
Tachycardia 242.37 9.70 657 138251 157016 90332523
Therapeutic product effect decreased 231.39 9.70 69 138839 277502 90212037
Rash 228.78 9.70 556 138352 795544 89693995
Muscle injury 228.02 9.70 10 138898 176644 90312895
Akathisia 226.18 9.70 165 138743 10994 90478545
Abdominal discomfort 226.10 9.70 239 138669 477089 90012450
Wound 225.57 9.70 91 138817 302889 90186650
Dyskinesia 225.23 9.70 279 138629 36255 90453284
Rheumatic fever 218.81 9.70 3 138905 153118 90336421
Nasopharyngitis 213.54 9.70 186 138722 406918 90082621
Poisoning deliberate 210.65 9.70 186 138722 16300 90473239
Drug hypersensitivity 208.71 9.70 242 138666 463367 90026172
Irritable bowel syndrome 208.24 9.70 34 138874 207414 90282125
Disturbance in attention 203.97 9.70 303 138605 46806 90442733
Hypersensitivity 201.81 9.70 240 138668 454437 90035102
Drug intolerance 201.08 9.70 234 138674 447357 90042182
Dissociation 199.96 9.70 126 138782 6589 90482950
Contraindicated product administered 199.38 9.70 122 138786 320017 90169522
Seizure 192.98 9.70 593 138315 152036 90337503
Discomfort 189.06 9.70 92 138816 274243 90215296
Blister 187.49 9.70 78 138830 254920 90234619
Restless legs syndrome 184.60 9.70 199 138709 22271 90467268
Mydriasis 181.17 9.70 164 138744 14848 90474691
Urticaria 178.84 9.70 131 138777 312603 90176936
Depersonalisation/derealisation disorder 172.43 9.70 72 138836 1560 90487979
Urinary retention 169.51 9.70 247 138661 37497 90452042
Hepatic enzyme increased 168.06 9.70 183 138725 360553 90128986
Nightmare 167.35 9.70 186 138722 21539 90468000
Product use issue 165.48 9.70 157 138751 329762 90159777
Peripheral swelling 163.85 9.70 237 138671 412869 90076670
Hallucination 160.50 9.70 329 138579 65630 90423909
Aggression 160.12 9.70 201 138707 26467 90463072
Lower respiratory tract infection 159.57 9.70 93 138815 250566 90238973
C-reactive protein abnormal 158.74 9.70 9 138899 127420 90362119
Drug withdrawal syndrome 157.55 9.70 207 138701 28516 90461023
Stomatitis 152.00 9.70 119 138789 274579 90214960
Hallucination, visual 151.49 9.70 182 138726 22910 90466629
Joint range of motion decreased 151.00 9.70 16 138892 135627 90353912
Depressed mood 151.00 9.70 274 138634 49948 90439591
Poisoning 150.70 9.70 149 138759 15068 90474471
Pain 148.45 9.70 908 138000 995433 89494106
Gastric pH decreased 144.21 9.70 55 138853 931 90488608
Extrapyramidal disorder 143.88 9.70 150 138758 16153 90473386
Gastrointestinal disorder 142.26 9.70 111 138797 256576 90232963
Mania 141.18 9.70 139 138769 13985 90475554
Altered state of consciousness 141.08 9.70 206 138702 31326 90458213
Bursitis 140.41 9.70 18 138890 131636 90357903
Ill-defined disorder 140.05 9.70 54 138854 184837 90304702
Psychotic disorder 139.69 9.70 204 138704 31026 90458513
Wheezing 139.65 9.70 97 138811 237983 90251556
Confusional state 139.34 9.70 1041 137867 385164 90104375
Loss of consciousness 139.05 9.70 502 138406 139736 90349803
Intentional product use issue 137.29 9.70 81 138827 216811 90272728
Cogwheel rigidity 136.54 9.70 66 138842 2036 90487503
Liver injury 135.67 9.70 46 138862 170521 90319018
Anxiety 133.46 9.70 872 138036 308900 90180639
Sedation 132.54 9.70 253 138655 47918 90441621
Derealisation 132.09 9.70 58 138850 1427 90488112
Arthralgia 129.56 9.70 684 138224 777838 89711701
Dystonia 129.55 9.70 144 138764 16675 90472864
Feeling of despair 128.96 9.70 73 138835 3131 90486408
Blood cholesterol increased 128.42 9.70 80 138828 207932 90281607
Infection 128.15 9.70 224 138684 361870 90127669
Lip dry 126.14 9.70 7 138901 100948 90388591
Type 2 diabetes mellitus 124.32 9.70 79 138829 203165 90286374
Fibromyalgia 123.69 9.70 82 138826 206187 90283352
Dysarthria 120.06 9.70 261 138647 54221 90435318
Tardive dyskinesia 119.48 9.70 113 138795 10817 90478722
Hypotension 117.82 9.70 878 138030 324519 90165020
Hyperhidrosis 117.81 9.70 467 138441 135838 90353701
Withdrawal syndrome 113.86 9.70 156 138752 22368 90467171
Facet joint syndrome 113.74 9.70 10 138898 98379 90391160
Gestational diabetes 113.01 9.70 108 138800 10474 90479065
Suspected suicide 112.47 9.70 103 138805 9465 90480074
Osteoarthritis 111.81 9.70 82 138826 195648 90293891
Parkinsonism 109.33 9.70 121 138787 13944 90475595
Injury 108.49 9.70 86 138822 197263 90292276
Delusion 107.47 9.70 119 138789 13721 90475818
Labelled drug-drug interaction medication error 104.06 9.70 120 138788 14462 90475077
Autoimmune disorder 103.67 9.70 3 138905 76741 90412798
Speech disorder 102.29 9.70 220 138688 45365 90444174
Miosis 101.67 9.70 97 138811 9387 90480152
Drug dependence 99.82 9.70 169 138739 29158 90460381
Blood lactic acid decreased 99.82 9.70 34 138874 408 90489131
Cardio-respiratory arrest 98.82 9.70 265 138643 62875 90426664
Rhabdomyolysis 96.79 9.70 231 138677 51025 90438514
Hypophagia 96.71 9.70 187 138721 35750 90453789
H1N1 influenza 95.23 9.70 51 138857 1959 90487580
Inflammation 94.23 9.70 81 138827 178511 90311028
Hallucination, auditory 93.66 9.70 119 138789 15856 90473683
Peripheral venous disease 93.14 9.70 10 138898 83911 90405628
Knee arthroplasty 92.09 9.70 10 138898 83172 90406367
Abnormal behaviour 91.48 9.70 141 138767 22487 90467052
Vitamin B1 decreased 89.58 9.70 33 138875 505 90489034
Drooling 89.37 9.70 66 138842 4480 90485059
Depressive symptom 89.08 9.70 70 138838 5215 90484324
Myoclonus 88.33 9.70 127 138781 19041 90470498
Wound infection 87.59 9.70 27 138881 106375 90383164
Pruritus 87.58 9.70 480 138428 541045 89948494
Lower limb fracture 87.39 9.70 13 138895 85000 90404539
Mental disorder 86.76 9.70 168 138740 32150 90457389
Cardiac output increased 85.96 9.70 32 138876 505 90489034
Rheumatoid factor negative 85.49 9.70 33 138875 578 90488961
Pulmonary fibrosis 85.46 9.70 29 138879 107474 90382065
Grip strength decreased 84.75 9.70 19 138889 92557 90396982
Asthma 84.53 9.70 151 138757 242009 90247530
Asphyxia 84.53 9.70 77 138831 7026 90482513
Cardiac arrest 82.33 9.70 349 138559 104586 90384953
Delirium 81.81 9.70 347 138561 104012 90385527
Mood swings 80.90 9.70 127 138781 20575 90468964
Hypertonia 79.89 9.70 65 138843 5090 90484449
Hip arthroplasty 79.86 9.70 11 138897 76197 90413342
Hallucinations, mixed 78.36 9.70 68 138840 5821 90483718
Mobility decreased 75.00 9.70 171 138737 250563 90238976
Maternal exposure during pregnancy 74.24 9.70 292 138616 359771 90129768
Syncope 74.12 9.70 400 138508 132263 90357276
Intestinal pseudo-obstruction 73.98 9.70 36 138872 1127 90488412
Incontinence 72.40 9.70 96 138812 13339 90476200
Drug ineffective 71.74 9.70 1598 137310 1382700 89106839
Dysphagia 71.39 9.70 351 138557 111927 90377612
Hypercholesterolaemia 70.72 9.70 33 138875 100859 90388680
Psoriasis 69.78 9.70 74 138834 147680 90341859
Feeling jittery 69.60 9.70 101 138807 15270 90474269
Pleurothotonus 69.28 9.70 36 138872 1299 90488240
Prescribed overdose 66.80 9.70 33 138875 97592 90391947
On and off phenomenon 66.55 9.70 44 138864 2499 90487040
Therapeutic product ineffective 66.18 9.70 43 138865 2371 90487168
Oedema 65.40 9.70 130 138778 200165 90289374
Psychomotor hyperactivity 65.15 9.70 89 138819 12724 90476815
Hyperkinesia 64.75 9.70 39 138869 1880 90487659
Panic attack 64.69 9.70 132 138776 26233 90463306
Musculoskeletal stiffness 64.67 9.70 235 138673 296297 90193242
Red blood cell sedimentation rate increased 64.41 9.70 23 138885 82572 90406967
Parosmia 64.10 9.70 66 138842 7003 90482536
Major depression 64.04 9.70 78 138830 9957 90479582
Acute respiratory distress syndrome 63.84 9.70 138 138770 28548 90460991
Bradyphrenia 63.55 9.70 68 138840 7544 90481995
Anger 63.36 9.70 91 138817 13629 90475910
Product administration error 63.31 9.70 131 138777 26292 90463247
Impulsive behaviour 63.18 9.70 37 138871 1693 90487846
Hypokalaemia 63.16 9.70 380 138528 130736 90358803
Abnormal dreams 63.08 9.70 82 138826 11175 90478364
Circulatory collapse 62.67 9.70 126 138782 24778 90464761
Muscle disorder 62.49 9.70 58 138850 5421 90484118
Ventricular fibrillation 61.73 9.70 91 138817 13953 90475586
Headache 61.39 9.70 942 137966 861804 89627735
Irritability 61.25 9.70 155 138753 35507 90454032
Psychomotor retardation 61.11 9.70 54 138854 4735 90484804
Feeling of body temperature change 60.98 9.70 58 138850 5591 90483948
Depression 60.18 9.70 715 138193 299886 90189653
Unresponsive to stimuli 59.64 9.70 160 138748 37961 90451578
Respiratory arrest 59.54 9.70 147 138761 33164 90456375
Product monitoring error 59.51 9.70 52 138856 4492 90485047
Accidental overdose 59.51 9.70 133 138775 28140 90461399
Product prescribing error 59.23 9.70 138 138770 30007 90459532
Schizophrenia 58.98 9.70 92 138816 14822 90474717
Cyanosis 58.28 9.70 106 138802 19349 90470190
Acute kidney injury 58.08 9.70 748 138160 319639 90169900
Hypoaesthesia 57.86 9.70 266 138642 313944 90175595
Electrocardiogram abnormal 57.68 9.70 75 138833 10223 90479316
Exostosis 57.28 9.70 7 138901 53127 90436412
Paranoia 57.26 9.70 84 138824 12824 90476715
Pallor 57.13 9.70 147 138761 34018 90455521
Progressive multifocal leukoencephalopathy 57.01 9.70 93 138815 15562 90473977
Menstrual disorder 56.91 9.70 58 138850 6080 90483459
Injection site pain 55.62 9.70 114 138794 173585 90315954
Drug withdrawal syndrome neonatal 55.60 9.70 38 138870 2281 90487258
Balance disorder 54.41 9.70 293 138615 96787 90392752
Nail disorder 54.31 9.70 12 138896 59055 90430484
Product quality issue 53.99 9.70 27 138881 79298 90410241
Torsade de pointes 53.68 9.70 89 138819 15093 90474446
Adjustment disorder with depressed mood 53.26 9.70 11 138897 56742 90432797
Lactic acidosis 52.85 9.70 184 138724 50279 90439260
Sciatica 52.23 9.70 47 138861 101335 90388204
Hypothermia 52.01 9.70 89 138819 15486 90474053
Bradycardia 51.78 9.70 260 138648 83587 90405952
Status epilepticus 51.75 9.70 99 138809 18775 90470764
Pneumonia aspiration 51.61 9.70 159 138749 40781 90448758
Liver disorder 51.59 9.70 66 138842 121203 90368336
Arthritis 50.91 9.70 113 138795 167202 90322337
Death 50.80 9.70 982 137926 455569 90033970
Polydipsia 50.61 9.70 46 138862 4185 90485354
Migraine 50.56 9.70 138 138770 190254 90299285
Blood prolactin increased 50.43 9.70 43 138865 3594 90485945
Catatonia 50.38 9.70 54 138854 6002 90483537
Bradykinesia 50.36 9.70 57 138851 6731 90482808
Generalised tonic-clonic seizure 50.15 9.70 142 138766 34761 90454778
Bezoar 49.98 9.70 38 138870 2696 90486843
Gait inability 49.59 9.70 93 138815 146363 90343176
C-reactive protein increased 49.28 9.70 130 138778 181259 90308280
Haematemesis 49.23 9.70 138 138770 33588 90455951
Emotional disorder 49.16 9.70 85 138823 14912 90474627
Galactorrhoea 48.60 9.70 47 138861 4625 90484914
Gastrooesophageal reflux disease 48.46 9.70 115 138793 166222 90323317
Contusion 48.45 9.70 209 138699 251007 90238532
Osteoporosis 48.25 9.70 46 138862 96485 90393054
Neonatal seizure 48.18 9.70 22 138886 595 90488944
Anticholinergic syndrome 47.68 9.70 37 138871 2706 90486833
Injection site pruritus 47.39 9.70 12 138896 53822 90435717
Pain in extremity 47.19 9.70 452 138456 450077 90039462
Vertigo 47.07 9.70 222 138686 69589 90419950
Panic reaction 46.36 9.70 46 138862 4671 90484868
Upper gastrointestinal haemorrhage 46.04 9.70 106 138802 22870 90466669
Back injury 45.96 9.70 8 138900 46614 90442925
Abdominal pain upper 45.77 9.70 310 138598 332364 90157175
Hepatocellular injury 45.76 9.70 122 138786 28836 90460703
Hyperlactacidaemia 45.67 9.70 43 138865 4093 90485446
Vitamin B1 increased 45.21 9.70 15 138893 165 90489374
Myelosuppression 45.19 9.70 13 138895 53578 90435961
Coma scale abnormal 44.76 9.70 49 138859 5577 90483962
Persecutory delusion 44.63 9.70 38 138870 3170 90486369
Adverse event 43.91 9.70 70 138838 117348 90372191
Blood creatine phosphokinase increased 43.70 9.70 133 138775 33890 90455649
Cognitive disorder 43.41 9.70 216 138692 69191 90420348
Obesity 43.26 9.70 59 138849 105448 90384091
Tonic clonic movements 43.15 9.70 29 138879 1693 90487846
Aphasia 43.02 9.70 154 138754 42658 90446881
Paralysis 42.90 9.70 69 138839 11409 90478130
Onychomycosis 42.65 9.70 4 138904 37372 90452167
Device expulsion 42.60 9.70 6 138902 40880 90448659
Hypertonia neonatal 42.38 9.70 16 138892 263 90489276
Chorea 42.31 9.70 31 138877 2079 90487460
Therapeutic product effect incomplete 42.02 9.70 154 138754 193742 90295797
Respiratory failure 41.90 9.70 318 138590 118100 90371439
Freezing phenomenon 41.81 9.70 29 138879 1783 90487756
Hypoaesthesia oral 41.75 9.70 81 138827 15519 90474020
Laryngitis 41.55 9.70 13 138895 50740 90438799
Injection site erythema 41.49 9.70 54 138854 98448 90391091
Acute motor-sensory axonal neuropathy 41.16 9.70 17 138891 358 90489181
Euphoric mood 41.12 9.70 46 138862 5363 90484176
Sinus tachycardia 40.96 9.70 116 138792 28397 90461142
Intentional product misuse 40.81 9.70 256 138652 89348 90400191
Fatigue 40.76 9.70 1405 137503 1152618 89336921
Immune reconstitution inflammatory syndrome 40.69 9.70 52 138856 6967 90482572
Upper respiratory tract infection 40.41 9.70 85 138823 128233 90361306
Sleep paralysis 40.35 9.70 22 138886 876 90488663
Aspiration 40.21 9.70 80 138828 15613 90473926
Foetal exposure during pregnancy 40.17 9.70 151 138757 42824 90446715
Sudden death 39.98 9.70 65 138843 10844 90478695
Erythema 39.89 9.70 198 138710 229048 90260491
Drug reaction with eosinophilia and systemic symptoms 39.77 9.70 150 138758 42608 90446931
Parkinsonian gait 39.70 9.70 19 138889 573 90488966
Prescribed underdose 39.58 9.70 34 138874 74985 90414554
Hyperprolactinaemia 39.25 9.70 45 138863 5388 90484151
Excessive masturbation 39.16 9.70 9 138899 19 90489520
Lupus-like syndrome 39.12 9.70 13 138895 48833 90440706
Onychomadesis 39.08 9.70 11 138897 45987 90443552
Fracture 39.01 9.70 97 138811 21979 90467560
Scan abnormal 38.38 9.70 19 138889 618 90488921
Blood sodium decreased 38.37 9.70 111 138797 27502 90462037
Hyperreflexia 38.10 9.70 49 138859 6608 90482931
Bradypnoea 37.81 9.70 41 138867 4617 90484922
Gamma-glutamyltransferase increased 37.70 9.70 136 138772 37816 90451723
Increased appetite 37.68 9.70 66 138842 11699 90477840
Incoherent 37.28 9.70 42 138866 4935 90484604
Injection site reaction 37.24 9.70 52 138856 92028 90397511
Salivary hypersecretion 37.23 9.70 57 138851 9035 90480504
Phagophobia 36.82 9.70 10 138898 51 90489488
C-reactive protein 36.76 9.70 3 138905 31364 90458175
Vitamin B12 decreased 36.72 9.70 43 138865 5267 90484272
Accidental death 36.41 9.70 28 138880 2020 90487519
Bradycardia neonatal 36.33 9.70 22 138886 1071 90488468
Road traffic accident 35.85 9.70 69 138839 107557 90381982
Foot deformity 35.35 9.70 24 138884 59627 90429912
Systemic infection 35.26 9.70 40 138868 4735 90484804
Lung disorder 35.20 9.70 115 138793 149768 90339771
Musculoskeletal pain 35.17 9.70 139 138769 171112 90318427
Hypoxia 34.96 9.70 210 138698 72189 90417350
Stoma site discharge 34.94 9.70 27 138881 1962 90487577
Histrionic personality disorder 34.71 9.70 9 138899 37 90489502
Mental impairment 34.46 9.70 78 138830 16642 90472897
Night sweats 34.42 9.70 93 138815 128673 90360866
Macular degeneration 34.33 9.70 8 138900 37962 90451577
Communication disorder 34.24 9.70 33 138875 3233 90486306
Opisthotonus 34.05 9.70 15 138893 372 90489167
Psychotic symptom 34.02 9.70 28 138880 2228 90487311
Neck pain 33.82 9.70 78 138830 113885 90375654
Merycism 32.96 9.70 14 138894 317 90489222
Off label use 32.89 9.70 1369 137539 1100883 89388656
Autonomic nervous system imbalance 32.72 9.70 33 138875 3417 90486122
Pulmonary embolism 32.53 9.70 325 138583 130495 90359044
Joint dislocation 32.15 9.70 14 138894 44568 90444971
Affective disorder 32.12 9.70 49 138859 7744 90481795
Urinary hesitation 31.88 9.70 28 138880 2435 90487104
Cholestasis 31.84 9.70 125 138783 36174 90453365
Ear infection 31.77 9.70 36 138872 69739 90419800
Dyspepsia 31.75 9.70 176 138732 197984 90291555
Neonatal asphyxia 31.71 9.70 14 138894 349 90489190
Respiratory disorder neonatal 31.34 9.70 22 138886 1379 90488160
Liver function test increased 31.34 9.70 51 138857 84804 90404735
Taste disorder 31.14 9.70 29 138879 61517 90428022
Walking aid user 31.09 9.70 8 138900 35498 90454041
Musculoskeletal toxicity 30.98 9.70 16 138892 570 90488969
Abulia 30.84 9.70 17 138891 692 90488847
Stupor 30.82 9.70 40 138868 5442 90484097
Decreased appetite 30.74 9.70 775 138133 375765 90113774
Drug tolerance decreased 30.62 9.70 6 138902 32124 90457415
Helplessness 30.62 9.70 13 138895 294 90489245
Chemical burn of oral cavity 30.60 9.70 9 138899 64 90489475
Immunodeficiency 30.51 9.70 14 138894 43220 90446319
Radial nerve palsy 30.35 9.70 16 138892 595 90488944
Thinking abnormal 30.29 9.70 60 138848 11672 90477867
Chest wall mass 30.23 9.70 16 138892 600 90488939
Therapeutic drug monitoring analysis not performed 30.03 9.70 21 138887 1308 90488231
Pyelonephritis 29.92 9.70 86 138822 21230 90468309
Cyclothymic disorder 29.90 9.70 12 138896 234 90489305
Potentiating drug interaction 29.80 9.70 40 138868 5622 90483917
Substance abuse 29.70 9.70 39 138869 5367 90484172
Agranulocytosis 29.47 9.70 119 138789 34883 90454656
Sleep disorder due to a general medical condition 29.30 9.70 16 138892 44722 90444817
Respiratory acidosis 29.25 9.70 48 138860 8071 90481468
Self-injurious ideation 29.21 9.70 30 138878 3173 90486366
Rhonchi 29.19 9.70 29 138879 2949 90486590
Reduced facial expression 29.07 9.70 27 138881 2526 90487013
Orthostatic hypotension 28.92 9.70 134 138774 41693 90447846
Arrhythmia 28.81 9.70 135 138773 42197 90447342
Joint stiffness 28.73 9.70 47 138861 77995 90411544
Cough 28.52 9.70 396 138512 368566 90120973
Injection site bruising 28.46 9.70 23 138885 52284 90437255
Intracranial pressure increased 28.32 9.70 43 138865 6768 90482771
Product dose omission issue 28.28 9.70 298 138610 291389 90198150
Nephropathy toxic 28.19 9.70 61 138847 12627 90476912
Ballismus 28.15 9.70 10 138898 137 90489402
Hyperthermia 28.07 9.70 54 138854 10281 90479258
Postmortem blood drug level increased 27.99 9.70 16 138892 699 90488840
Medication overuse headache 27.74 9.70 21 138887 1480 90488059
Faecaloma 27.72 9.70 54 138854 10377 90479162
Hepatic cytolysis 27.55 9.70 107 138801 30809 90458730
Sensory loss 27.41 9.70 75 138833 18000 90471539
Ear pain 27.12 9.70 29 138879 57673 90431866
Ulcer haemorrhage 27.10 9.70 4 138904 26317 90463222
Tremor neonatal 26.97 9.70 10 138898 156 90489383
Therapeutic response decreased 26.96 9.70 61 138847 89668 90399871
Antipsychotic drug level decreased 26.92 9.70 13 138895 400 90489139
Tongue movement disturbance 26.86 9.70 13 138895 402 90489137
Mutism 26.77 9.70 22 138886 1747 90487792
Norepinephrine increased 26.71 9.70 8 138900 61 90489478
Hypotonia 26.61 9.70 56 138852 11370 90478169
Suicidal behaviour 26.60 9.70 27 138881 2817 90486722
Nasal congestion 26.48 9.70 55 138853 83359 90406180
Humerus fracture 26.42 9.70 51 138857 9734 90479805
Tachycardia paroxysmal 26.37 9.70 12 138896 322 90489217
Coeliac disease 26.36 9.70 18 138890 44592 90444947
Poor feeding infant 26.23 9.70 14 138894 534 90489005
Cerebellar syndrome 26.19 9.70 31 138877 3841 90485698
Live birth 26.10 9.70 51 138857 79056 90410483
Agitation neonatal 26.04 9.70 14 138894 542 90488997
Premature labour 26.02 9.70 61 138847 13315 90476224
Blood bilirubin decreased 25.99 9.70 17 138891 948 90488591
Social avoidant behaviour 25.90 9.70 29 138879 3384 90486155
Indifference 25.86 9.70 10 138898 176 90489363
Dementia 25.85 9.70 88 138820 23773 90465766
Rhinorrhoea 25.76 9.70 61 138847 88255 90401284
Agoraphobia 25.76 9.70 14 138894 554 90488985
Emotional distress 25.75 9.70 118 138790 36544 90452995
Tearfulness 25.52 9.70 34 138874 4746 90484793
Pneumonia 25.50 9.70 764 138144 637295 89852244
Frequent bowel movements 25.25 9.70 30 138878 56905 90432634
Akinesia 25.05 9.70 21 138887 1715 90487824
Hypertension 24.98 9.70 523 138385 457009 90032530
Facial nerve disorder 24.93 9.70 14 138894 591 90488948
Postural tremor 24.92 9.70 13 138895 473 90489066
Acute psychosis 24.82 9.70 27 138881 3051 90486488
CYP3A4 polymorphism 24.80 9.70 8 138900 80 90489459
Cerebral ventricle dilatation 24.74 9.70 17 138891 1029 90488510
Disability 24.67 9.70 16 138892 40729 90448810
Visceral congestion 24.59 9.70 12 138896 378 90489161
Language disorder 24.48 9.70 25 138883 2627 90486912
Newborn persistent pulmonary hypertension 24.45 9.70 11 138897 287 90489252
Apathy 24.44 9.70 53 138855 10987 90478552
Alcoholism 24.38 9.70 21 138887 1779 90487760
Hepatic cirrhosis 24.32 9.70 37 138871 63216 90426323
Purple glove syndrome 24.15 9.70 10 138898 212 90489327
Myoclonic epilepsy 24.13 9.70 20 138888 1607 90487932
Retinal detachment 24.13 9.70 40 138868 6782 90482757
Post-traumatic stress disorder 24.10 9.70 40 138868 6788 90482751
Constipation 24.03 9.70 581 138327 279814 90209725
Posture abnormal 24.02 9.70 25 138883 2686 90486853
Mental status changes 23.78 9.70 133 138775 44546 90444993
Acute abdomen 23.75 9.70 20 138888 1643 90487896
Loose tooth 23.73 9.70 29 138879 3714 90485825
Neonatal respiratory failure 23.70 9.70 11 138897 309 90489230
Disorganised speech 23.55 9.70 21 138887 1864 90487675
Eosinophilic cellulitis 23.52 9.70 10 138898 227 90489312
Febrile nonhaemolytic transfusion reaction 23.48 9.70 5 138903 6 90489533
Hypercapnia 23.41 9.70 39 138869 6638 90482901
Orgasm abnormal 23.41 9.70 8 138900 97 90489442
Pyrexia 23.24 9.70 804 138104 659681 89829858
Drug use disorder 23.16 9.70 44 138864 8299 90481240
Activation syndrome 23.16 9.70 10 138898 236 90489303
Tinnitus 22.74 9.70 128 138780 42974 90446565
Fluid retention 22.52 9.70 65 138843 88026 90401513
Cataract 22.49 9.70 48 138860 72044 90417495
Neonatal hypoxia 22.48 9.70 14 138894 717 90488822
Cerebral mass effect 22.14 9.70 16 138892 1050 90488489
Refusal of treatment by patient 22.14 9.70 35 138873 5703 90483836
Clonus 22.08 9.70 35 138873 5715 90483824
Anaphylactic reaction 22.07 9.70 65 138843 87459 90402080
Sensorimotor disorder 22.06 9.70 14 138894 741 90488798
Bipolar disorder 22.06 9.70 45 138863 8940 90480599
Transferrin saturation decreased 22.01 9.70 15 138893 896 90488643
Antidepressant drug level above therapeutic 22.01 9.70 12 138896 478 90489061
Swollen tongue 21.99 9.70 133 138775 45823 90443716
Glomerular filtration rate increased 21.95 9.70 21 138887 2039 90487500
Amniotic fluid volume increased 21.90 9.70 9 138899 187 90489352
Behaviour disorder 21.78 9.70 31 138877 4604 90484935
Bipolar I disorder 21.76 9.70 21 138887 2061 90487478
Muscular weakness 21.74 9.70 207 138701 206459 90283080
Failure to thrive 21.69 9.70 43 138865 8368 90481171
Vagus nerve disorder 21.68 9.70 8 138900 123 90489416
Hip fracture 21.43 9.70 104 138804 32973 90456566
Breast discomfort 21.35 9.70 13 138895 639 90488900
Thirst 21.20 9.70 64 138844 16231 90473308
Noninfective gingivitis 21.16 9.70 21 138887 2132 90487407
Dehydration 21.15 9.70 417 138491 194030 90295509
Blood albumin abnormal 21.07 9.70 16 138892 1133 90488406
Therapy non-responder 21.04 9.70 123 138785 136581 90352958
Vasodilatation 21.03 9.70 24 138884 2860 90486679
Regressive behaviour 20.98 9.70 9 138899 209 90489330
Crush syndrome 20.97 9.70 10 138898 299 90489240
Chest pain 20.96 9.70 354 138554 319291 90170248
Food craving 20.86 9.70 20 138888 1947 90487592
Ataxia 20.84 9.70 68 138840 17974 90471565
Serum serotonin increased 20.82 9.70 9 138899 213 90489326
Snoring 20.80 9.70 32 138876 5094 90484445
Blood calcium abnormal 20.77 9.70 20 138888 1957 90487582
Intrusive thoughts 20.77 9.70 11 138897 413 90489126
Wrong product administered 20.76 9.70 40 138868 7625 90481914
Pulse absent 20.74 9.70 35 138873 6020 90483519
Cardiac hypertrophy 20.71 9.70 16 138892 1162 90488377
Bundle branch block right 20.68 9.70 33 138875 5420 90484119
Blood alkaline phosphatase abnormal 20.68 9.70 17 138891 1351 90488188
Anaemia macrocytic 20.64 9.70 30 138878 4542 90484997
Drop attacks 20.61 9.70 13 138895 681 90488858
Homicidal ideation 20.60 9.70 19 138889 1761 90487778
Chronic fatigue syndrome 20.54 9.70 18 138890 1561 90487978
Adverse reaction 20.39 9.70 10 138898 29702 90459837
Thymus disorder 20.35 9.70 10 138898 320 90489219
Neuropathy peripheral 20.15 9.70 125 138783 136845 90352694
Hypotonia neonatal 20.02 9.70 17 138891 1413 90488126
Alkalosis hypochloraemic 20.00 9.70 9 138899 235 90489304
Transaminases increased 19.99 9.70 111 138797 37081 90452458
Pelvic haematoma 19.97 9.70 13 138895 719 90488820
Decubitus ulcer 19.93 9.70 51 138857 11762 90477777
Hypnagogic hallucination 19.90 9.70 9 138899 238 90489301
Ageusia 19.86 9.70 62 138846 16014 90473525
Blepharospasm 19.84 9.70 34 138874 55411 90434128
Infantile vomiting 19.79 9.70 8 138900 159 90489380
Nail avulsion 19.74 9.70 10 138898 342 90489197
Pyuria 19.60 9.70 20 138888 2099 90487440
Parkinson's disease 19.59 9.70 15 138893 1075 90488464
Talipes 19.58 9.70 18 138890 1662 90487877
Negative thoughts 19.51 9.70 15 138893 1082 90488457
Fungal infection 19.43 9.70 22 138886 42639 90446900
Compulsive shopping 19.39 9.70 13 138895 756 90488783
Muscle twitching 19.36 9.70 81 138827 24121 90465418
Blood alkaline phosphatase increased 19.24 9.70 133 138775 47946 90441593
Secondary hypogonadism 19.17 9.70 8 138900 173 90489366
Cleft palate 19.15 9.70 16 138892 1300 90488239
Sialoadenitis 19.11 9.70 20 138888 2162 90487377
Sporotrichosis 19.06 9.70 6 138902 55 90489484
Paranasal sinus inflammation 19.05 9.70 12 138896 627 90488912
Shock 19.02 9.70 91 138817 28687 90460852
Long QT syndrome 18.97 9.70 27 138881 4010 90485529
Hallucination, synaesthetic 18.97 9.70 6 138902 56 90489483
Obsessive-compulsive symptom 18.95 9.70 7 138901 108 90489431
Vision blurred 18.90 9.70 255 138653 110038 90379501
Self-medication 18.90 9.70 24 138884 3196 90486343
Bulimia nervosa 18.79 9.70 11 138897 503 90489036
JC virus infection 18.77 9.70 22 138886 2697 90486842
Rheumatoid nodule 18.73 9.70 4 138904 20162 90469377
Logorrhoea 18.72 9.70 22 138886 2705 90486834
Drowning 18.69 9.70 11 138897 508 90489031
Agonal rhythm 18.66 9.70 5 138903 24 90489515
Antidepressant drug level increased 18.58 9.70 10 138898 388 90489151
Giant cell arteritis 18.45 9.70 23 138885 3006 90486533
Blood pressure diastolic decreased 18.45 9.70 9 138899 26817 90462722
Brief psychotic disorder with marked stressors 18.42 9.70 6 138902 62 90489477
B-lymphocyte count increased 18.27 9.70 7 138901 120 90489419
Thyroxine free decreased 18.24 9.70 13 138895 835 90488704
Stoma site hypergranulation 18.23 9.70 10 138898 403 90489136
Aptyalism 18.19 9.70 12 138896 679 90488860
Cytomegalovirus infection 18.18 9.70 9 138899 26593 90462946
Formication 18.18 9.70 29 138879 4762 90484777
Essential tremor 18.17 9.70 16 138892 1396 90488143
Neglect of personal appearance 18.17 9.70 7 138901 122 90489417
Incorrect route of product administration 18.16 9.70 31 138877 50595 90438944
Hyperphagia 18.14 9.70 22 138886 2796 90486743
Heart rate increased 18.12 9.70 258 138650 112644 90376895
Non-cardiogenic pulmonary oedema 18.06 9.70 15 138893 1209 90488330
Maternal exposure timing unspecified 17.98 9.70 6 138902 22477 90467062
Palpitations 17.94 9.70 302 138606 136426 90353113
Maternal drugs affecting foetus 17.93 9.70 30 138878 5125 90484414
Spina bifida 17.80 9.70 13 138895 867 90488672
Lethargy 17.74 9.70 161 138747 62978 90426561
Congenital hypogonadotropic hypogonadism 17.73 9.70 5 138903 30 90489509
Hypopituitarism foetal 17.73 9.70 5 138903 30 90489509
Sinus congestion 17.68 9.70 10 138898 27414 90462125
Illusion 17.64 9.70 15 138893 1249 90488290
Polyuria 17.62 9.70 44 138864 9996 90479543
Tic 17.61 9.70 18 138890 1893 90487646
Crying 17.61 9.70 82 138826 25563 90463976
Product complaint 17.55 9.70 53 138855 13447 90476092
Dysaesthesia 17.51 9.70 30 138878 5225 90484314
Somnambulism 17.48 9.70 33 138875 6195 90483344
Abnormal weight gain 17.47 9.70 21 138887 2644 90486895
Wrong patient received product 17.45 9.70 24 138884 3453 90486086
Tachyphrenia 17.44 9.70 17 138891 1689 90487850
Skin exfoliation 17.44 9.70 50 138858 67863 90421676
Stoma site erythema 17.38 9.70 16 138892 1480 90488059
Respiratory depression 17.37 9.70 58 138850 15517 90474022
Psychiatric decompensation 17.36 9.70 18 138890 1925 90487614
Echolalia 17.34 9.70 9 138899 324 90489215
Resuscitation 17.31 9.70 15 138893 1281 90488258
Skull fracture 17.22 9.70 15 138893 1290 90488249
Blood bilirubin abnormal 17.20 9.70 18 138890 1946 90487593
Pregnancy 17.20 9.70 44 138864 62003 90427536
Respiratory disorder 17.18 9.70 47 138861 64769 90424770
Back pain 17.17 9.70 363 138545 316812 90172727
Hypokinesia 17.10 9.70 58 138850 15639 90473900
Obsessive-compulsive disorder 16.73 9.70 27 138881 4477 90485062
Electric shock sensation 16.72 9.70 16 138892 1554 90487985
False positive investigation result 16.69 9.70 12 138896 781 90488758
Avoidant personality disorder 16.65 9.70 6 138902 86 90489453
General physical health deterioration 16.64 9.70 684 138224 354431 90135108
Loss of libido 16.62 9.70 15 138893 1352 90488187
Lung consolidation 16.61 9.70 28 138880 4812 90484727
Developmental hip dysplasia 16.59 9.70 16 138892 1569 90487970
Hyperacusis 16.57 9.70 21 138887 2790 90486749
Sinus disorder 16.54 9.70 17 138891 34430 90455109
Blood pressure diastolic abnormal 16.44 9.70 5 138903 19876 90469663
Cellulitis orbital 16.42 9.70 11 138897 639 90488900
Aspartate aminotransferase decreased 16.41 9.70 13 138895 980 90488559
Pulmonary vein occlusion 16.40 9.70 6 138902 90 90489449
Female sexual arousal disorder 16.38 9.70 5 138903 41 90489498
Pelvic fracture 16.37 9.70 56 138852 15163 90474376
Malnutrition 16.35 9.70 64 138844 18494 90471045
Nystagmus 16.35 9.70 35 138873 7192 90482347
Internal fixation of fracture 16.28 9.70 12 138896 812 90488727
Dependence 16.24 9.70 18 138890 2077 90487462
Dyspraxia 16.22 9.70 8 138900 258 90489281
Eye infection viral 15.95 9.70 7 138901 172 90489367
Porphyria acute 15.83 9.70 4 138904 17971 90471568
Female genital tract fistula 15.69 9.70 4 138904 17864 90471675
Neutrophil count abnormal 15.68 9.70 25 138883 4103 90485436
Metabolic acidosis 15.66 9.70 142 138766 55534 90434005
Postictal paralysis 15.59 9.70 8 138900 281 90489258
Aspergillus test positive 15.59 9.70 9 138899 401 90489138
Granulocytopenia neonatal 15.52 9.70 4 138904 16 90489523
Cranial nerve paralysis 15.52 9.70 8 138900 284 90489255
Dyspnoea at rest 15.50 9.70 27 138881 4764 90484775
Labyrinthitis 15.48 9.70 20 138888 2709 90486830
White blood cell count abnormal 15.45 9.70 35 138873 7469 90482070
Natural killer cell count decreased 15.44 9.70 6 138902 107 90489432
Glomerular filtration rate decreased 15.41 9.70 59 138849 16873 90472666
Pharyngeal disorder 15.36 9.70 19 138889 2464 90487075
Hepatitis acute 15.35 9.70 44 138864 10843 90478696
Alcohol interaction 15.23 9.70 16 138892 1738 90487801
Educational problem 15.20 9.70 10 138898 563 90488976
Cachexia 15.20 9.70 33 138875 6845 90482694
Eyelid myoclonus 15.19 9.70 6 138902 112 90489427
Dizziness 15.15 9.70 1073 137835 588211 89901328
Autoscopy 15.14 9.70 6 138902 113 90489426
Enterococcus test positive 15.02 9.70 14 138894 1315 90488224
Pulmonary renal syndrome 15.01 9.70 10 138898 575 90488964
Drug level increased 15.01 9.70 83 138825 27679 90461860
Hyperkalaemia 15.00 9.70 159 138749 64805 90424734
Vasoplegia syndrome 15.00 9.70 20 138888 2794 90486745
Liver function test abnormal 14.98 9.70 131 138777 50714 90438825
Bronchitis 14.90 9.70 156 138752 152771 90336768
Jaundice 14.86 9.70 93 138815 32424 90457115
Selective eating disorder 14.82 9.70 17 138891 2036 90487503
Compulsive sexual behaviour 14.76 9.70 5 138903 59 90489480
Anaphylactic shock 14.73 9.70 16 138892 31601 90457938
Swelling face 14.73 9.70 190 138718 81162 90408377
Drug dose titration not performed 14.71 9.70 11 138897 761 90488778
Binge eating 14.71 9.70 10 138898 595 90488944
Radiculopathy 14.69 9.70 5 138903 18500 90471039
Shared psychotic disorder 14.63 9.70 4 138904 21 90489518
Antipsychotic drug level below therapeutic 14.59 9.70 8 138900 322 90489217
Junctional ectopic tachycardia 14.54 9.70 7 138901 214 90489325
Osteitis 14.54 9.70 23 138885 3750 90485789
Convulsive threshold lowered 14.52 9.70 9 138899 457 90489082
Skin necrosis 14.49 9.70 4 138904 16937 90472602
Congenital hand malformation 14.48 9.70 8 138900 327 90489212
Paroxysmal perceptual alteration 14.46 9.70 5 138903 63 90489476
Empty sella syndrome 14.46 9.70 5 138903 63 90489476
Psychiatric symptom 14.44 9.70 33 138875 7085 90482454
Clostridium test positive 14.40 9.70 28 138880 5373 90484166
Rabbit syndrome 14.37 9.70 8 138900 332 90489207
Blood glucose fluctuation 14.35 9.70 27 138881 5056 90484483
Reversible cerebral vasoconstriction syndrome 14.32 9.70 24 138884 4106 90485433
Dissociative disorder 14.26 9.70 10 138898 626 90488913
Blood creatinine abnormal 14.20 9.70 24 138884 4133 90485406
Extensor plantar response 14.18 9.70 14 138894 1413 90488126
No adverse event 14.06 9.70 55 138853 67927 90421612
Medulloblastoma 13.98 9.70 5 138903 70 90489469
Injection site rash 13.96 9.70 10 138898 24163 90465376
Blood lactic acid increased 13.89 9.70 37 138871 8741 90480798
Generalised anxiety disorder 13.84 9.70 19 138889 2728 90486811
Tooth injury 13.74 9.70 14 138894 1467 90488072
Alcohol use 13.74 9.70 15 138893 1702 90487837
Hypokinetic dysarthria 13.65 9.70 4 138904 28 90489511
Retroperitoneal haematoma 13.63 9.70 21 138887 3347 90486192
Retroperitoneal haemorrhage 13.60 9.70 20 138888 3060 90486479
Lacunar infarction 13.59 9.70 21 138887 3356 90486183
White matter lesion 13.56 9.70 18 138890 2503 90487036
Dreamy state 13.53 9.70 4 138904 29 90489510
Cerebral atrophy 13.53 9.70 28 138880 5618 90483921
Creatinine renal clearance decreased 13.52 9.70 6 138902 18893 90470646
Dysdiadochokinesis 13.50 9.70 6 138902 152 90489387
Nephrolithiasis 13.46 9.70 35 138873 49050 90440489
Hyperventilation 13.43 9.70 31 138877 6697 90482842
Small for dates baby 13.40 9.70 26 138882 4981 90484558
Vasoconstriction 13.38 9.70 11 138897 874 90488665
Subdural haemorrhage 13.37 9.70 21 138887 3402 90486137
Rectal spasm 13.36 9.70 6 138902 156 90489383
Optic disc haemorrhage 13.36 9.70 6 138902 156 90489383
Basal cell carcinoma 13.35 9.70 19 138889 33370 90456169
Chemical burns of eye 13.31 9.70 5 138903 81 90489458
Gambling 13.31 9.70 7 138901 259 90489280
Tenosynovitis 13.31 9.70 3 138905 14564 90474975
Somatic symptom disorder 13.29 9.70 21 138887 3420 90486119
Palmar-plantar erythrodysaesthesia syndrome 13.26 9.70 14 138894 28009 90461530
Decreased interest 13.18 9.70 24 138884 4383 90485156
Rash pruritic 13.17 9.70 73 138835 82141 90407398
Cerebellar haematoma 13.16 9.70 8 138900 392 90489147
Snake bite 13.16 9.70 3 138905 6 90489533
Antipsychotic drug level increased 13.15 9.70 22 138886 3757 90485782
Femoral neck fracture 13.14 9.70 40 138868 10193 90479346
Electrocardiogram QRS complex shortened 13.13 9.70 9 138899 543 90488996
Retrograde amnesia 13.10 9.70 9 138899 545 90488994
Dermatitis allergic 13.09 9.70 57 138851 17270 90472269
Treatment noncompliance 13.09 9.70 129 138779 51598 90437941
Congenital pharyngeal anomaly 13.08 9.70 4 138904 33 90489506
Gastritis 13.05 9.70 109 138799 41644 90447895
Respiration abnormal 13.04 9.70 34 138874 7929 90481610
Chronic spontaneous urticaria 13.02 9.70 15 138893 1805 90487734
Eyelid haematoma 12.98 9.70 5 138903 87 90489452
Colitis ulcerative 12.96 9.70 48 138860 60218 90429321
Gait disturbance 12.95 9.70 505 138403 259991 90229548
Orthostatic intolerance 12.93 9.70 13 138895 1341 90488198
Lipohypertrophy 12.91 9.70 10 138898 729 90488810
Patient elopement 12.88 9.70 6 138902 170 90489369
Blood alcohol increased 12.88 9.70 9 138899 560 90488979
Laryngeal granuloma 12.85 9.70 3 138905 7 90489532
Repetitive speech 12.80 9.70 8 138900 412 90489127
Kussmaul respiration 12.76 9.70 7 138901 282 90489257
Ventricular extrasystoles 12.75 9.70 47 138861 13203 90476336
Hyporesponsive to stimuli 12.72 9.70 14 138894 1603 90487936
Acute coronary syndrome 12.71 9.70 41 138867 10772 90478767
Polyneuropathy 12.67 9.70 61 138847 19280 90470259
Hyperdynamic left ventricle 12.65 9.70 7 138901 287 90489252
Groin infection 12.64 9.70 9 138899 577 90488962
Rash erythematous 12.64 9.70 54 138854 65050 90424489
Respiratory tract congestion 12.63 9.70 14 138894 27396 90462143
Anal infection 12.63 9.70 5 138903 94 90489445
Blood osmolarity decreased 12.61 9.70 11 138897 948 90488591
Mixed anxiety and depressive disorder 12.58 9.70 8 138900 425 90489114
Viral infection 12.56 9.70 28 138880 41386 90448153
Glassy eyes 12.53 9.70 5 138903 96 90489443
Stoma site inflammation 12.50 9.70 10 138898 764 90488775
Acquired epidermolysis bullosa 12.49 9.70 4 138904 39 90489500
Foramen magnum stenosis 12.47 9.70 6 138902 183 90489356
Rectal haemorrhage 12.44 9.70 75 138833 82669 90406870
Tachypnoea 12.40 9.70 65 138843 21244 90468295
Hypernatraemia 12.34 9.70 37 138871 9350 90480189
Haemorrhage intracranial 12.33 9.70 51 138857 15111 90474428
Coordination abnormal 12.33 9.70 65 138843 21291 90468248
Dystrophic calcification 12.33 9.70 6 138902 188 90489351
Somatic delusion 12.26 9.70 9 138899 605 90488934
Electrocardiogram T wave inversion 12.24 9.70 21 138887 3662 90485877
Phaeochromocytoma 12.22 9.70 9 138899 608 90488931
Submaxillary gland enlargement 12.22 9.70 4 138904 42 90489497
Tendonitis 12.13 9.70 9 138899 21363 90468176
Central nervous system inflammation 12.12 9.70 6 138902 195 90489344
Ototoxicity 12.10 9.70 15 138893 1949 90487590
Abdominal rigidity 12.10 9.70 17 138891 2495 90487044
Hypersomnia 12.07 9.70 65 138843 21466 90468073
Neonatal pneumonia 12.06 9.70 4 138904 44 90489495
Fear 12.05 9.70 54 138854 16568 90472971
Eye irritation 12.01 9.70 21 138887 33957 90455582
Metamyelocyte count increased 11.98 9.70 6 138902 200 90489339
Inappropriate affect 11.98 9.70 11 138897 1014 90488525
Impaired gastric emptying 11.96 9.70 45 138863 12764 90476775
Skin discolouration 11.94 9.70 112 138796 44203 90445336
Back disorder 11.91 9.70 13 138895 25618 90463921
Optic nerve disorder 11.87 9.70 12 138896 1246 90488293
Adrenal cyst 11.86 9.70 5 138903 111 90489428
Febrile neutropenia 11.84 9.70 171 138737 158178 90331361
Compulsions 11.79 9.70 6 138902 207 90489332
Drug ineffective for unapproved indication 11.79 9.70 155 138753 66489 90423050
Pancytopenia 11.78 9.70 254 138654 120009 90369530
Substance use disorder 11.77 9.70 15 138893 2005 90487534
Euglycaemic diabetic ketoacidosis 11.76 9.70 28 138880 6173 90483366
Impaired self-care 11.74 9.70 14 138894 1748 90487791
Personality change 11.73 9.70 31 138877 7290 90482249
Atrioventricular block first degree 11.62 9.70 34 138874 8477 90481062
Intestinal infarction 11.60 9.70 11 138897 1056 90488483
Aplastic anaemia 11.60 9.70 3 138905 13266 90476273
Hemianopia homonymous 11.53 9.70 10 138898 855 90488684
Short-bowel syndrome 11.47 9.70 9 138899 669 90488870
Polydipsia psychogenic 11.46 9.70 5 138903 121 90489418
Myoglobin blood increased 11.46 9.70 13 138895 1539 90488000
Congenital melanocytic naevus 11.45 9.70 3 138905 13 90489526
Visual acuity reduced transiently 11.43 9.70 6 138902 221 90489318
Eye haematoma 11.43 9.70 5 138903 122 90489417
Polyarthritis 11.39 9.70 7 138901 18343 90471196
Nose deformity 11.38 9.70 6 138902 223 90489316
Drug withdrawal headache 11.32 9.70 4 138904 54 90489485
Haemoglobin abnormal 11.31 9.70 30 138878 7070 90482469
Pancreatitis necrotising 11.30 9.70 16 138892 2365 90487174
Bifascicular block 11.28 9.70 5 138903 126 90489413
Large for dates baby 11.26 9.70 8 138900 511 90489028
Peripheral paralysis 11.24 9.70 5 138903 127 90489412
Immature respiratory system 11.18 9.70 4 138904 56 90489483
Herpes zoster 11.18 9.70 92 138816 94552 90394987
Urinary incontinence 11.18 9.70 97 138811 37469 90452070
Mood altered 11.18 9.70 54 138854 17090 90472449
Facial paresis 11.13 9.70 21 138887 3942 90485597
Pharyngeal erythema 11.12 9.70 14 138894 1848 90487691
Chemical submission 11.11 9.70 8 138900 522 90489017
Osteoporosis postmenopausal 11.11 9.70 7 138901 366 90489173
Gangrene 11.09 9.70 3 138905 12873 90476666
Granulocyte percentage 11.06 9.70 4 138904 58 90489481
Tenderness 11.04 9.70 15 138893 26853 90462686
Neutropenic sepsis 11.03 9.70 56 138852 18074 90471465
HIV-associated neurocognitive disorder 11.03 9.70 5 138903 133 90489406
Sneezing 10.98 9.70 18 138890 29851 90459688
Electrocardiogram repolarisation abnormality 10.97 9.70 12 138896 1364 90488175
Spondylitis 10.96 9.70 4 138904 14174 90475365
Tension 10.95 9.70 20 138888 3662 90485877
Breast pain 10.92 9.70 38 138870 10380 90479159
Defaecation disorder 10.92 9.70 10 138898 919 90488620
Stoma site infection 10.83 9.70 10 138898 928 90488611
Alcohol poisoning 10.83 9.70 14 138894 1898 90487641
Joint injury 10.82 9.70 21 138887 32643 90456896
Intestinal mucosal atrophy 10.78 9.70 3 138905 17 90489522
Renal impairment 10.76 9.70 224 138684 105197 90384342
Drug-disease interaction 10.73 9.70 10 138898 940 90488599
Organ failure 10.71 9.70 18 138890 3087 90486452
Eye movement disorder 10.70 9.70 27 138881 6171 90483368
Angiopathy 10.67 9.70 25 138883 5455 90484084
Drug screen positive 10.66 9.70 20 138888 3737 90485802
Paraneoplastic dermatomyositis 10.66 9.70 5 138903 144 90489395
Quadriplegia 10.60 9.70 15 138893 2216 90487323
Feeding disorder 10.59 9.70 54 138854 17458 90472081
Blood bilirubin unconjugated decreased 10.58 9.70 4 138904 66 90489473
Electrocardiogram T wave amplitude decreased 10.53 9.70 7 138901 401 90489138
Rubber sensitivity 10.53 9.70 17 138891 2820 90486719
Cholestatic liver injury 10.51 9.70 20 138888 3777 90485762
Encephalopathy neonatal 10.50 9.70 3 138905 19 90489520
Anal incontinence 10.49 9.70 51 138857 16179 90473360
Affect lability 10.44 9.70 55 138853 18008 90471531
Torticollis 10.42 9.70 16 138892 2542 90486997
Myelocyte count increased 10.41 9.70 7 138901 409 90489130
Wernicke-Korsakoff syndrome 10.37 9.70 4 138904 70 90489469
Streptococcal endocarditis 10.32 9.70 5 138903 155 90489384
Spinal fusion surgery 10.32 9.70 3 138905 12280 90477259
Claudication of jaw muscles 10.31 9.70 4 138904 71 90489468
Dementia Alzheimer's type 10.28 9.70 10 138898 991 90488548
Poverty of thought content 10.24 9.70 3 138905 21 90489518
Inadequate analgesia 10.21 9.70 18 138890 3206 90486333
Anxiety disorder 10.18 9.70 23 138885 4899 90484640
Alcohol abuse 10.15 9.70 14 138894 2019 90487520
Labelled drug-disease interaction issue 10.11 9.70 4 138904 75 90489464
Congenital hydronephrosis 10.11 9.70 7 138901 429 90489110
Feeling hot 10.07 9.70 74 138834 77934 90411605
Blood pressure systolic abnormal 10.06 9.70 9 138899 19469 90470070
Head injury 10.06 9.70 82 138826 31106 90458433
Heart rate decreased 10.01 9.70 45 138863 53460 90436079
Hyperammonaemia 9.95 9.70 27 138881 6448 90483091
Pyroglutamic acidosis 9.93 9.70 11 138897 1269 90488270
Drug diversion 9.90 9.70 10 138898 1037 90488502
Mucosal inflammation 9.88 9.70 50 138858 57575 90431964
Infantile apnoea 9.88 9.70 11 138897 1276 90488263
Subdural haematoma 9.84 9.70 51 138857 16594 90472945
Blood phosphorus decreased 9.84 9.70 23 138885 5011 90484528
Eyelid injury 9.79 9.70 5 138903 174 90489365
Multimorbidity 9.75 9.70 8 138900 634 90488905
Urinary tract infection 9.74 9.70 567 138341 305065 90184474
Pulseless electrical activity 9.73 9.70 33 138875 8899 90480640
Basophil count decreased 9.73 9.70 6 138902 302 90489237
Duodenitis 9.72 9.70 21 138887 4342 90485197
Paresis 9.71 9.70 16 138892 2698 90486841

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 739.17 10.86 1574 91268 227562 42300931
Intentional overdose 611.45 10.86 653 92189 50803 42477690
Completed suicide 496.37 10.86 811 92031 95654 42432839
Intentional self-injury 473.85 10.86 335 92507 14867 42513626
Suicide attempt 418.47 10.86 509 92333 45591 42482902
Drug abuse 417.14 10.86 787 92055 103984 42424509
Suicidal ideation 388.08 10.86 501 92341 47660 42480833
Overdose 387.57 10.86 765 92077 104499 42423994
Serotonin syndrome 383.48 10.86 370 92472 25475 42503018
Agitation 325.50 10.86 537 92305 63777 42464716
Coma 281.56 10.86 455 92387 53099 42475394
Somnolence 278.76 10.86 805 92037 140300 42388193
Confusional state 253.70 10.86 872 91970 166725 42361768
Extrapyramidal disorder 217.51 10.86 221 92621 16191 42512302
Sopor 212.92 10.86 198 92644 13004 42515489
Restlessness 189.65 10.86 274 92568 28975 42499518
Aggression 181.99 10.86 337 92505 43826 42484667
Anxiety 163.83 10.86 599 92243 117961 42410532
Sedation 162.92 10.86 261 92581 30214 42498279
Drug interaction 151.31 10.86 1047 91795 265952 42262541
Depressed level of consciousness 148.54 10.86 325 92517 47645 42480848
Neuroleptic malignant syndrome 141.89 10.86 203 92639 21269 42507224
Hallucination, auditory 134.54 10.86 164 92678 14700 42513793
Febrile neutropenia 129.65 10.86 128 92714 185575 42342918
Psychotic disorder 128.06 10.86 229 92613 28979 42499514
Poisoning deliberate 128.00 10.86 133 92709 10001 42518492
Fall 127.12 10.86 910 91932 233610 42294883
Delirium 118.67 10.86 315 92527 52204 42476289
Withdrawal syndrome 117.78 10.86 153 92689 14622 42513871
Hallucination, visual 116.43 10.86 183 92659 20837 42507656
Drug withdrawal syndrome 115.77 10.86 185 92657 21364 42507129
Akathisia 112.41 10.86 126 92716 10325 42518168
Electrocardiogram QT prolonged 111.82 10.86 291 92551 47654 42480839
Inappropriate antidiuretic hormone secretion 108.72 10.86 156 92686 16385 42512108
Depressed mood 108.54 10.86 188 92654 23196 42505297
Dyskinesia 107.40 10.86 196 92646 25194 42503299
Insomnia 97.66 10.86 512 92330 117741 42410752
Disorientation 94.40 10.86 230 92612 36159 42492334
Restless legs syndrome 93.44 10.86 110 92732 9504 42518989
Pruritus 93.14 10.86 168 92674 188603 42339890
Abnormal behaviour 92.04 10.86 188 92654 26263 42502230
Mania 91.63 10.86 114 92728 10433 42518060
Bradyphrenia 90.84 10.86 82 92760 5180 42523313
Tremor 90.12 10.86 434 92408 96495 42431998
Accidental overdose 86.60 10.86 191 92651 28139 42500354
Intrusive thoughts 86.41 10.86 34 92808 432 42528061
Off label use 84.75 10.86 937 91905 637398 41891095
Parkinsonism 80.02 10.86 107 92735 10516 42517977
Delusion of grandeur 78.93 10.86 51 92791 1945 42526548
Panic attack 75.29 10.86 106 92736 10939 42517554
Depression 73.37 10.86 454 92388 110909 42417584
Poisoning 73.26 10.86 122 92720 14577 42513916
Bradykinesia 71.64 10.86 73 92769 5363 42523130
Pneumonia aspiration 69.88 10.86 254 92588 49824 42478669
Hallucination 69.81 10.86 279 92563 57228 42471265
Dementia 68.15 10.86 126 92716 16354 42512139
Tachycardia 67.78 10.86 414 92428 100673 42427820
Drug ineffective 67.49 10.86 968 91874 629229 41899264
Psychomotor hyperactivity 67.16 10.86 100 92742 10858 42517635
Systemic infection 66.97 10.86 69 92773 5136 42523357
Antidepressant drug level above therapeutic 65.26 10.86 24 92818 250 42528243
Myoclonus 65.02 10.86 126 92716 16939 42511554
Affective disorder 64.34 10.86 72 92770 5888 42522605
Wrong patient received product 64.15 10.86 57 92785 3526 42524967
Logorrhoea 63.31 10.86 51 92791 2756 42525737
Pyrexia 63.17 10.86 552 92290 393490 42135003
Rhinalgia 62.97 10.86 43 92799 1801 42526692
Asphyxia 62.92 10.86 84 92758 8242 42520251
Interstitial lung disease 62.04 10.86 48 92794 78414 42450079
Hypomania 61.79 10.86 48 92794 2460 42526033
Homicidal ideation 61.40 10.86 50 92792 2744 42525749
Muscle rigidity 61.32 10.86 101 92741 11958 42516535
Miosis 60.95 10.86 107 92735 13339 42515154
Paranoia 60.22 10.86 109 92733 13917 42514576
Substance abuse 60.01 10.86 85 92757 8820 42519673
Respiratory depression 59.69 10.86 129 92713 18739 42509754
Loss of consciousness 59.25 10.86 374 92468 91980 42436513
Delusion 58.86 10.86 111 92731 14623 42513870
Pulmonary congestion 58.54 10.86 115 92727 15615 42512878
Nasopharyngitis 58.42 10.86 58 92784 83938 42444555
Illusion 58.00 10.86 33 92809 996 42527497
On and off phenomenon 57.83 10.86 53 92789 3414 42525079
Drug dependence 57.28 10.86 166 92676 28928 42499565
Schizophrenia 57.24 10.86 91 92751 10459 42518034
Dystonia 56.97 10.86 101 92741 12689 42515804
Disturbance in attention 56.50 10.86 168 92674 29698 42498795
Muscle twitching 56.35 10.86 96 92746 11684 42516809
Tachyphrenia 55.02 10.86 36 92806 1403 42527090
Apathy 54.83 10.86 79 92763 8327 42520166
Lymphocyte count abnormal 54.19 10.86 42 92800 2145 42526348
Altered state of consciousness 53.85 10.86 163 92679 29096 42499397
Nightmare 53.43 10.86 147 92695 24865 42503628
Rhabdomyolysis 53.21 10.86 321 92521 77698 42450795
Arthralgia 53.14 10.86 248 92594 204990 42323503
Neurodegenerative disorder 51.82 10.86 23 92819 402 42528091
Tardive dyskinesia 51.02 10.86 69 92773 6855 42521638
Rash 50.75 10.86 374 92468 276580 42251913
Analgesic drug level above therapeutic 50.53 10.86 21 92821 310 42528183
Priapism 50.52 10.86 66 92776 6341 42522152
Myelosuppression 50.29 10.86 13 92829 40448 42488045
Seizure 48.83 10.86 438 92404 120123 42408370
Mental disorder 47.86 10.86 115 92727 17914 42510579
Cough 47.41 10.86 213 92629 177890 42350603
Illness anxiety disorder 46.93 10.86 17 92825 169 42528324
Drug hypersensitivity 46.71 10.86 91 92751 99298 42429195
Urinary retention 45.88 10.86 198 92644 42016 42486477
Inappropriate schedule of product administration 45.78 10.86 87 92755 95815 42432678
Brain oedema 45.35 10.86 106 92736 16221 42512272
Infusion related reaction 44.61 10.86 40 92802 60766 42467727
Suspected suicide 44.50 10.86 61 92781 6138 42522355
Disease progression 44.39 10.86 162 92680 143494 42384999
Loss of libido 43.72 10.86 43 92799 3027 42525466
Mood swings 43.64 10.86 73 92769 8753 42519740
General physical health deterioration 42.92 10.86 511 92331 150735 42377758
Injection site pain 42.42 10.86 38 92804 57760 42470733
Drug withdrawal syndrome neonatal 41.63 10.86 50 92792 4411 42524082
Dry skin 41.58 10.86 27 92815 48311 42480182
Vestibular disorder 41.51 10.86 28 92814 1149 42527344
Dysarthria 41.20 10.86 184 92658 39623 42488870
Anger 41.17 10.86 89 92753 12929 42515564
Feelings of worthlessness 41.01 10.86 18 92824 306 42528187
Neutrophil count increased 40.93 10.86 115 92727 19689 42508804
Erythema 40.38 10.86 113 92729 108680 42419813
Renal failure 39.99 10.86 169 92673 143557 42384936
Paroxysmal perceptual alteration 39.92 10.86 16 92826 214 42528279
Hyponatraemia 39.74 10.86 366 92476 101096 42427397
Arthritis 39.72 10.86 21 92821 42044 42486449
Antipsychotic drug level above therapeutic 39.30 10.86 28 92814 1256 42527237
Blood creatine phosphokinase increased 38.27 10.86 207 92635 48131 42480362
Stomatitis 38.26 10.86 32 92810 50297 42478196
Multiple organ dysfunction syndrome 38.11 10.86 98 92744 96937 42431556
Pneumonia 38.09 10.86 669 92173 421480 42107013
Oscillopsia 37.85 10.86 16 92826 247 42528246
Thinking abnormal 37.79 10.86 61 92781 7100 42521393
Hyperkinesia 36.82 10.86 33 92809 2065 42526428
Sudden cardiac death 36.65 10.86 44 92798 3880 42524613
Accidental death 36.33 10.86 39 92803 3044 42525449
Hyperreflexia 36.27 10.86 42 92800 3565 42524928
Respiratory arrest 36.17 10.86 140 92702 28284 42500209
Rheumatoid arthritis 36.11 10.86 24 92818 42416 42486077
Dysphoria 36.03 10.86 37 92805 2743 42525750
Cytokine release syndrome 35.49 10.86 27 92815 44500 42483993
Slow speech 35.12 10.86 30 92812 1760 42526733
Irritability 34.54 10.86 137 92705 27991 42500502
Mental impairment 34.25 10.86 80 92762 12237 42516256
Eczema 33.71 10.86 16 92826 34070 42494423
Bipolar disorder 33.44 10.86 42 92800 3880 42524613
Septic shock 33.44 10.86 96 92746 91576 42436917
Gout 33.03 10.86 10 92832 28045 42500448
Electrocardiogram abnormal 32.82 10.86 70 92772 10075 42518418
Mood altered 32.45 10.86 72 92770 10646 42517847
Hyponatraemic coma 32.39 10.86 9 92833 33 42528460
Decreased gait velocity 32.16 10.86 13 92829 178 42528315
Progressive multifocal leukoencephalopathy 32.15 10.86 75 92767 11461 42517032
Alcohol use 31.77 10.86 35 92807 2813 42525680
Pleurothotonus 31.63 10.86 24 92818 1187 42527306
Myocardial infarction 31.38 10.86 151 92691 123858 42404635
Respiratory disorder neonatal 30.71 10.86 29 92813 1941 42526552
Upper respiratory tract infection 30.62 10.86 28 92814 42145 42486348
Temperature regulation disorder 30.34 10.86 23 92819 1136 42527357
Cardiac failure congestive 30.23 10.86 91 92751 85511 42442982
Asthma 30.19 10.86 56 92786 62258 42466235
Tumour lysis syndrome 29.91 10.86 6 92836 22225 42506268
Prostate cancer 29.70 10.86 32 92810 44611 42483882
Photopsia 29.50 10.86 31 92811 2361 42526132
Selective eating disorder 29.49 10.86 27 92815 1737 42526756
Product prescribing error 28.77 10.86 123 92719 25989 42502504
Pressure of speech 28.76 10.86 17 92825 552 42527941
Dissociative disorder 28.63 10.86 18 92824 654 42527839
Dementia with Lewy bodies 28.55 10.86 20 92822 873 42527620
Urinary hesitation 28.29 10.86 34 92808 3001 42525492
Sexual dysfunction 28.26 10.86 52 92790 6723 42521770
Platypnoea 28.25 10.86 8 92834 32 42528461
Aptyalism 28.21 10.86 15 92827 395 42528098
Dissociation 28.21 10.86 38 92804 3760 42524733
Urticaria 28.13 10.86 76 92766 73960 42454533
Back pain 28.10 10.86 187 92655 141589 42386904
Herpes zoster 28.00 10.86 26 92816 38851 42489642
Cytomegalovirus infection 27.85 10.86 18 92824 32288 42496205
Joint swelling 27.24 10.86 68 92774 67954 42460539
Urogenital haemorrhage 27.18 10.86 18 92824 716 42527777
Pleural effusion 27.17 10.86 114 92728 97052 42431441
Macrophages increased 26.87 10.86 11 92831 156 42528337
Sepsis 26.86 10.86 291 92551 199043 42329450
Platelet count decreased 26.85 10.86 184 92658 138397 42390096
Appendicitis 26.83 10.86 6 92836 20607 42507886
Cognitive disorder 26.82 10.86 146 92696 34026 42494467
White blood cell count decreased 26.45 10.86 137 92705 110259 42418234
Substance dependence 26.39 10.86 17 92825 645 42527848
Intentional product use issue 26.36 10.86 75 92767 71758 42456735
Malignant neoplasm progression 26.27 10.86 134 92708 108266 42420227
Depersonalisation/derealisation disorder 26.15 10.86 17 92825 655 42527838
Atrial fibrillation 25.75 10.86 188 92654 139405 42389088
Ejaculation disorder 25.69 10.86 20 92822 1028 42527465
Erectile dysfunction 25.65 10.86 115 92727 24798 42503695
Hyperarousal 25.59 10.86 8 92834 48 42528445
COVID-19 25.53 10.86 148 92694 115800 42412693
Benign gastrointestinal neoplasm 25.49 10.86 10 92832 126 42528367
Hyperventilation 25.43 10.86 33 92809 3149 42525344
Sinusitis 25.20 10.86 40 92802 47252 42481241
Product dose omission issue 25.18 10.86 215 92627 154150 42374343
Product monitoring error 25.17 10.86 39 92803 4384 42524109
Acute psychosis 25.00 10.86 27 92815 2122 42526371
Antipsychotic drug level increased 24.97 10.86 40 92802 4626 42523867
Alcoholism 24.38 10.86 31 92811 2899 42525594
Diarrhoea 24.37 10.86 792 92050 460057 42068436
Swelling 24.29 10.86 52 92790 54833 42473660
Hangover 24.24 10.86 20 92822 1118 42527375
Congenital cerebrovascular anomaly 24.22 10.86 6 92836 12 42528481
Agitation neonatal 24.15 10.86 22 92820 1406 42527087
Persecutory delusion 23.98 10.86 34 92808 3530 42524963
Thrombocytopenia 23.97 10.86 282 92560 189997 42338496
Loose associations 23.83 10.86 8 92834 62 42528431
Neonatal epileptic seizure 23.72 10.86 8 92834 63 42528430
Catatonia 23.68 10.86 46 92796 6193 42522300
Circulatory collapse 23.51 10.86 108 92734 23528 42504965
Electrocardiogram QRS complex prolonged 23.42 10.86 44 92798 5779 42522714
Alcohol interaction 23.40 10.86 26 92816 2109 42526384
Drug use disorder 23.34 10.86 62 92780 10271 42518222
Feeling jittery 23.31 10.86 38 92804 4460 42524033
Ascites 23.21 10.86 56 92786 56622 42471871
Oesophageal obstruction 22.87 10.86 15 92827 587 42527906
Bronchopulmonary aspergillosis 22.73 10.86 7 92835 19422 42509071
Stupor 22.59 10.86 31 92811 3122 42525371
IVth nerve disorder 22.51 10.86 6 92836 18 42528475
Abdominal discomfort 22.48 10.86 86 92756 75169 42453324
Pulmonary oedema 22.29 10.86 195 92647 53077 42475416
Nasal discomfort 22.23 10.86 22 92820 1560 42526933
Autoscopy 22.04 10.86 11 92831 253 42528240
Major depression 21.97 10.86 41 92801 5357 42523136
Hypersomnia 21.97 10.86 76 92766 14542 42513951
Speech disorder 21.90 10.86 123 92719 28998 42499495
Postoperative respiratory failure 21.89 10.86 9 92833 129 42528364
Nervousness 21.79 10.86 72 92770 13460 42515033
Sinus tachycardia 21.77 10.86 96 92746 20557 42507936
Lung disorder 21.54 10.86 45 92797 47878 42480615
Homicide 21.43 10.86 17 92825 898 42527595
Wrong product administered 21.35 10.86 44 92798 6182 42522311
Frequent bowel movements 21.24 10.86 10 92832 21397 42507096
Psychomotor retardation 21.24 10.86 36 92806 4363 42524130
Neonatal tachypnoea 21.12 10.86 12 92830 361 42528132
Arthropathy 21.07 10.86 20 92822 29577 42498916
Fear 21.03 10.86 62 92780 10903 42517590
Abulia 21.01 10.86 15 92827 675 42527818
Product use issue 20.87 10.86 91 92751 76660 42451833
Incoherent 20.87 10.86 37 92805 4648 42523845
Stoma site infection 20.83 10.86 17 92825 936 42527557
No adverse event 20.79 10.86 33 92809 38988 42489505
Floppy infant 20.77 10.86 9 92833 148 42528345
Gait disturbance 20.70 10.86 314 92528 97686 42430807
Epilepsy 20.66 10.86 112 92730 26059 42502434
Hallucinations, mixed 20.55 10.86 31 92811 3404 42525089
Congenital hyperinsulinaemic hypoglycaemia 20.53 10.86 4 92838 0 42528493
Ejaculation failure 20.51 10.86 16 92826 825 42527668
Blood creatinine increased 20.35 10.86 148 92694 109855 42418638
Bronchiectasis 20.19 10.86 7 92835 18012 42510481
Infection 20.15 10.86 152 92690 111916 42416577
SARS-CoV-2 test positive 20.13 10.86 51 92791 8209 42520284
Sleep disorder 20.10 10.86 176 92666 47919 42480574
Cardiogenic shock 20.09 10.86 29 92813 35611 42492882
Hyperbilirubinaemia 19.93 10.86 10 92832 20625 42507868
Pulmonary alveolar haemorrhage 19.93 10.86 4 92838 14812 42513681
Soliloquy 19.91 10.86 14 92828 615 42527878
Sarcopenia 19.90 10.86 16 92826 862 42527631
Hyperhidrosis 19.89 10.86 292 92550 90220 42438273
Sedation complication 19.87 10.86 28 92814 2891 42525602
Dysgraphia 19.86 10.86 26 92816 2502 42525991
Cogwheel rigidity 19.86 10.86 22 92820 1779 42526714
Postictal state 19.82 10.86 17 92825 1003 42527490
Cold sweat 19.80 10.86 62 92780 11268 42517225
Substance use disorder 19.79 10.86 39 92803 5306 42523187
Suspiciousness 19.57 10.86 12 92830 417 42528076
Antisocial behaviour 19.31 10.86 12 92830 427 42528066
Psychomotor skills impaired 19.31 10.86 38 92804 5166 42523327
JC virus infection 19.25 10.86 28 92814 2976 42525517
Sleep paralysis 19.24 10.86 11 92831 335 42528158
Haemoglobin decreased 19.22 10.86 190 92652 132281 42396212
Pneumocystis jirovecii pneumonia 19.15 10.86 16 92826 25165 42503328
Reduced facial expression 19.14 10.86 20 92822 1513 42526980
Bacteraemia 18.93 10.86 16 92826 25024 42503469
Sinus bradycardia 18.76 10.86 73 92769 14780 42513713
Tracheal pain 18.65 10.86 6 92836 40 42528453
Oesophageal haemorrhage 18.65 10.86 19 92823 1395 42527098
Agitated depression 18.65 10.86 10 92832 268 42528225
Hyperphosphataemia 18.59 10.86 3 92839 13001 42515492
Respiratory tract infection 18.49 10.86 18 92824 26304 42502189
Feeling guilty 18.45 10.86 11 92831 363 42528130
Palmar-plantar erythrodysaesthesia syndrome 18.38 10.86 11 92831 20571 42507922
Prescription drug used without a prescription 18.31 10.86 26 92816 2704 42525789
Neutropenia 18.24 10.86 315 92527 199116 42329377
Accidental poisoning 18.17 10.86 18 92824 1278 42527215
Derealisation 18.16 10.86 15 92827 840 42527653
Helplessness 18.15 10.86 7 92835 84 42528409
Nephropathy toxic 18.09 10.86 7 92835 16831 42511662
Potentiating drug interaction 17.97 10.86 42 92800 6426 42522067
Hypertonia 17.93 10.86 36 92806 4965 42523528
Ataxia 17.79 10.86 76 92766 16049 42512444
Fear of weight gain 17.76 10.86 4 92838 4 42528489
Acute myocardial infarction 17.68 10.86 66 92776 58099 42470394
Sensory level abnormal 17.60 10.86 6 92836 49 42528444
Sleep disorder due to a general medical condition 17.55 10.86 8 92834 17445 42511048
Hypervigilance 17.47 10.86 8 92834 151 42528342
Lymphocyte count decreased 17.43 10.86 112 92730 27697 42500796
Self esteem decreased 17.42 10.86 12 92830 510 42527983
Acute myeloid leukaemia 17.10 10.86 14 92828 22242 42506251
Encephalocele 17.09 10.86 5 92837 23 42528470
Urine sodium decreased 17.09 10.86 8 92834 159 42528334
Abnormal dreams 17.06 10.86 48 92794 8223 42520270
Intentional product misuse 17.03 10.86 208 92634 61692 42466801
Body temperature abnormal 17.00 10.86 15 92827 919 42527574
Patient elopement 17.00 10.86 8 92834 161 42528332
Fungal infection 16.98 10.86 11 92831 19711 42508782
Verbal abuse 16.96 10.86 9 92833 236 42528257
Activation syndrome 16.95 10.86 8 92834 162 42528331
Pain 16.95 10.86 405 92437 244443 42284050
Hepatic failure 16.94 10.86 36 92806 38064 42490429
Dysphagia 16.93 10.86 237 92605 72482 42456011
Posture abnormal 16.89 10.86 24 92818 2497 42525996
Failure to thrive 16.87 10.86 52 92790 9370 42519123
Accidental exposure to product 16.72 10.86 12 92830 20381 42508112
Faecaloma 16.64 10.86 40 92802 6230 42522263
Basal cell carcinoma 16.61 10.86 15 92827 22718 42505775
Bezoar 16.57 10.86 17 92825 1259 42527234
Rapid eye movements sleep abnormal 16.52 10.86 8 92834 172 42528321
Tubulointerstitial nephritis 16.51 10.86 27 92815 31521 42496972
Cardiac failure 16.46 10.86 151 92691 106705 42421788
Implant site extravasation 16.29 10.86 11 92831 452 42528041
Visceral oedema 16.27 10.86 6 92836 63 42528430
Parkinsonian gait 16.24 10.86 12 92830 570 42527923
Blood ethanol increased 16.14 10.86 11 92831 459 42528034
Perforated ulcer 16.14 10.86 9 92833 261 42528232
Hypersensitivity 16.12 10.86 92 92750 72278 42456215
COVID-19 pneumonia 16.11 10.86 14 92828 21599 42506894
Pneumonia bacterial 16.09 10.86 7 92835 15685 42512808
Hanging 16.07 10.86 8 92834 183 42528310
Intentional device misuse 16.02 10.86 9 92833 265 42528228
Tricuspid valve sclerosis 15.99 10.86 5 92837 30 42528463
Peripheral swelling 15.96 10.86 123 92719 90147 42438346
Infant irritability 15.94 10.86 6 92836 67 42528426
Arachnoid cyst 15.93 10.86 9 92833 268 42528225
Osteonecrosis of jaw 15.90 10.86 11 92831 19038 42509455
Bladder dilatation 15.87 10.86 19 92823 1671 42526822
Blood uric acid increased 15.83 10.86 7 92835 15540 42512953
Product prescribing issue 15.66 10.86 41 92801 6732 42521761
Torticollis 15.56 10.86 17 92825 1353 42527140
Blood pressure systolic increased 15.53 10.86 23 92819 27945 42500548
Depressive symptom 15.35 10.86 29 92813 3824 42524669
Coma scale abnormal 15.35 10.86 32 92810 4533 42523960
Mydriasis 15.33 10.86 48 92794 8722 42519771
Thrombosis 15.31 10.86 87 92755 68424 42460069
Spinal cord injury thoracic 15.29 10.86 7 92835 132 42528361
Screaming 15.26 10.86 20 92822 1927 42526566
Glabellar reflex abnormal 15.22 10.86 5 92837 36 42528457
Drug dispensed to wrong patient 15.20 10.86 11 92831 506 42527987
Haematemesis 15.03 10.86 115 92727 30084 42498409
Inflammation 15.03 10.86 32 92810 33815 42494678
Pneumonitis 14.97 10.86 44 92798 41674 42486819
Amnestic disorder 14.90 10.86 9 92833 304 42528189
Rapid eye movement sleep behaviour disorder 14.85 10.86 9 92833 306 42528187
Panic disorder 14.78 10.86 16 92826 1261 42527232
Nasal congestion 14.74 10.86 26 92816 29475 42499018
JC virus CSF test positive 14.73 10.86 7 92835 144 42528349
Productive cough 14.72 10.86 60 92782 51507 42476986
Drug tolerance 14.67 10.86 26 92816 3264 42525229
Mutism 14.66 10.86 17 92825 1445 42527048
Multiple drug therapy 14.58 10.86 15 92827 1114 42527379
Frenulum breve 14.54 10.86 4 92838 14 42528479
Full blood count decreased 14.51 10.86 14 92828 20546 42507947
Bacterial infection 14.46 10.86 24 92818 27855 42500638
Tension 14.40 10.86 22 92820 2442 42526051
Housebound 14.38 10.86 8 92834 231 42528262
Myelodysplastic syndrome 14.37 10.86 17 92825 22728 42505765
Foetal exposure during pregnancy 14.35 10.86 162 92680 47149 42481344
Neonatal hyponatraemia 14.35 10.86 6 92836 90 42528403
Hypoxia 14.34 10.86 91 92751 69695 42458798
Social avoidant behaviour 14.26 10.86 26 92816 3338 42525155
Eosinophilic pleural effusion 14.24 10.86 9 92833 330 42528163
Loss of proprioception 14.17 10.86 10 92832 442 42528051
Respiratory rate decreased 14.08 10.86 24 92818 2921 42525572
Libido decreased 14.05 10.86 33 92809 5065 42523428
Staphylococcal infection 14.03 10.86 39 92803 37604 42490889
Bladder cancer 14.02 10.86 10 92832 17037 42511456
Cerebellar ataxia 13.90 10.86 15 92827 1178 42527315
Mumps 13.89 10.86 6 92836 98 42528395
Rash maculo-papular 13.87 10.86 39 92803 37464 42491029
Limited symptom panic attack 13.87 10.86 5 92837 49 42528444
Pancytopenia 13.86 10.86 177 92665 117566 42410927
Pulmonary fibrosis 13.81 10.86 23 92819 26658 42501835
Ventricular fibrillation 13.78 10.86 28 92814 30095 42498398
Obsessive-compulsive disorder 13.78 10.86 39 92803 6704 42521789
Sensory disturbance 13.75 10.86 40 92802 6983 42521510
Psychotic symptom 13.50 10.86 21 92821 2369 42526124
Emotional distress 13.47 10.86 70 92772 16023 42512470
Aspergillus infection 13.41 10.86 9 92833 15828 42512665
Drug abuser 13.36 10.86 26 92816 3505 42524988
Small for dates baby 13.36 10.86 33 92809 5230 42523263
Anaphylactic reaction 13.32 10.86 48 92794 42695 42485798
Anaemia 13.29 10.86 488 92354 279790 42248703
Dyspepsia 13.18 10.86 143 92699 41209 42487284
Alcohol abuse 13.17 10.86 28 92814 4021 42524472
Cytomegalovirus infection reactivation 13.13 10.86 4 92838 11174 42517319
Xanthoma 13.11 10.86 6 92836 113 42528380
Coordination abnormal 13.11 10.86 43 92799 8007 42520486
Nephrolithiasis 13.11 10.86 39 92803 36791 42491702
Balance disorder 13.06 10.86 160 92682 47485 42481008
Polypectomy 13.03 10.86 11 92831 635 42527858
Convulsive threshold lowered 13.00 10.86 10 92832 505 42527988
Rash erythematous 12.91 10.86 32 92810 32059 42496434
Hypertension 12.85 10.86 272 92570 166932 42361561
Blood test abnormal 12.85 10.86 6 92836 12900 42515593
Sepsis neonatal 12.84 10.86 8 92834 286 42528207
Paresis 12.82 10.86 21 92821 2475 42526018
Influenza 12.81 10.86 81 92761 62094 42466399
False positive investigation result 12.78 10.86 11 92831 652 42527841
Pain in extremity 12.78 10.86 241 92601 150363 42378130
Splenomegaly 12.75 10.86 11 92831 17036 42511457
Abnormal weight gain 12.75 10.86 15 92827 1295 42527198
Anorgasmia 12.73 10.86 14 92828 1123 42527370
Freezing phenomenon 12.68 10.86 18 92824 1871 42526622
Anticipatory anxiety 12.66 10.86 4 92838 25 42528468
Myasthenia gravis 12.58 10.86 10 92832 16127 42512366
Rhinorrhoea 12.56 10.86 32 92810 31762 42496731
Transplant rejection 12.51 10.86 7 92835 13581 42514912
Blood pressure increased 12.46 10.86 152 92690 101776 42426717
Vasculitis 12.44 10.86 13 92829 18381 42510112
Psoriasis 12.39 10.86 59 92783 48545 42479948
Rash pruritic 12.38 10.86 35 92807 33568 42494925
Panic reaction 12.38 10.86 17 92825 1713 42526780
Fluid retention 12.35 10.86 32 92810 31587 42496906
Paradoxical drug reaction 12.33 10.86 30 92812 4708 42523785
Aspartate aminotransferase increased 12.33 10.86 108 92734 77055 42451438
Retinal vascular disorder 12.31 10.86 7 92835 211 42528282
Suicidal behaviour 12.30 10.86 16 92826 1530 42526963
Dysstasia 12.30 10.86 62 92780 14024 42514469
Stoma site erythema 12.30 10.86 13 92829 997 42527496
Osmotic demyelination syndrome 12.27 10.86 13 92829 999 42527494
Feeling abnormal 12.27 10.86 217 92625 69569 42458924
Gastrointestinal disorder 12.26 10.86 56 92786 46597 42481896
Oropharyngeal spasm 12.25 10.86 7 92835 213 42528280
Activated partial thromboplastin time prolonged 12.22 10.86 10 92832 15893 42512600
Obstructive airways disorder 12.21 10.86 22 92820 24737 42503756
Neonatal respiratory distress syndrome 12.21 10.86 29 92813 4484 42524009
Haemophagocytic lymphohistiocytosis 12.19 10.86 13 92829 18209 42510284
Medication error 12.17 10.86 118 92724 33036 42495457
Dyspnoea 12.14 10.86 816 92026 441805 42086688
Mitral valve sclerosis 12.08 10.86 7 92835 219 42528274
Injection site bruising 12.04 10.86 5 92837 11520 42516973
Mastication disorder 12.04 10.86 17 92825 1759 42526734
Feeling of despair 12.03 10.86 14 92828 1194 42527299
Metabolic syndrome 12.01 10.86 18 92824 1965 42526528
Chills 11.99 10.86 139 92703 93927 42434566
Anticholinergic syndrome 11.96 10.86 16 92826 1573 42526920
Oropharyngeal pain 11.80 10.86 50 92792 42460 42486033
Renal impairment 11.79 10.86 169 92673 110059 42418434
Behaviour disorder 11.78 10.86 38 92804 7016 42521477
Radial nerve injury 11.70 10.86 4 92838 33 42528460
Tongue movement disturbance 11.68 10.86 6 92836 147 42528346
Neuropathy peripheral 11.66 10.86 154 92688 101699 42426794
Alcohol problem 11.61 10.86 5 92837 81 42528412
Pelvic fracture 11.60 10.86 21 92821 2680 42525813
Poor quality sleep 11.60 10.86 46 92796 9394 42519099
Hypothermia 11.58 10.86 56 92786 12459 42516034
Syncope 11.58 10.86 291 92551 99115 42429378
Systemic lupus erythematosus 11.58 10.86 3 92839 9321 42519172
Binge eating 11.57 10.86 6 92836 150 42528343
Coagulopathy 11.56 10.86 19 92823 22143 42506350
Neonatal asphyxia 11.49 10.86 9 92833 467 42528026
Blood pressure fluctuation 11.49 10.86 26 92816 26882 42501611
Drug monitoring procedure not performed 11.45 10.86 9 92833 469 42528024
Lymphadenopathy 11.40 10.86 36 92806 33329 42495164
Respiratory acidosis 11.39 10.86 35 92807 6296 42522197
Generalised anxiety disorder 11.33 10.86 12 92830 922 42527571
Stoma site discharge 11.32 10.86 15 92827 1461 42527032
Leukopenia 11.28 10.86 227 92615 74519 42453974
Light chain disease 11.25 10.86 6 92836 159 42528334
Posterior reversible encephalopathy syndrome 11.24 10.86 7 92835 12814 42515679
Pyroglutamic acidosis 11.19 10.86 11 92831 774 42527719
Cardiac murmur 11.17 10.86 7 92835 12768 42515725
Unresponsive to stimuli 11.15 10.86 111 92731 31292 42497201
Varicella zoster pneumonia 11.12 10.86 7 92835 255 42528238
Osteomyelitis 11.11 10.86 14 92828 18209 42510284
Full blood count abnormal 11.10 10.86 31 92811 29845 42498648
Squamous cell carcinoma of skin 11.09 10.86 7 92835 12719 42515774
Consciousness fluctuating 11.08 10.86 14 92828 1301 42527192
Sleep deficit 11.07 10.86 12 92830 947 42527546
Pseudomonas infection 11.06 10.86 11 92831 15912 42512581
Oxygen saturation decreased 11.03 10.86 89 92753 64598 42463895
Initial insomnia 11.01 10.86 26 92816 4004 42524489
Treatment noncompliance 10.98 10.86 128 92714 37544 42490949
Device kink 10.94 10.86 9 92833 501 42527992

FDA Adverse Event Reporting System (Geriatric)

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 1807.96 10.11 3175 197958 477380 109910786
Intentional overdose 1321.77 10.11 1408 199725 131093 110257073
Serotonin syndrome 1263.69 10.11 966 200167 58187 110329979
Completed suicide 1263.66 10.11 1860 199273 240521 110147645
Suicide attempt 1120.99 10.11 1149 199984 102245 110285921
Drug abuse 1048.73 10.11 1446 199687 175965 110212201
Suicidal ideation 1045.76 10.11 1059 200074 92878 110295288
Intentional self-injury 836.24 10.11 628 200505 36801 110351365
Overdose 746.77 10.11 1442 199691 232352 110155814
Sopor 724.14 10.11 571 200562 35975 110352191
Drug interaction 722.83 10.11 2273 198860 497910 109890256
Somnolence 708.43 10.11 1627 199506 295822 110092344
Coma 705.55 10.11 967 200166 116902 110271264
Agitation 663.90 10.11 919 200214 112132 110276034
Electrocardiogram QT prolonged 589.85 10.11 852 200281 108108 110280058
Hyponatraemia 445.14 10.11 1123 200010 216530 110171636
Depressed level of consciousness 431.97 10.11 751 200382 111527 110276639
Synovitis 411.56 10.11 21 201112 274071 110114095
Neuroleptic malignant syndrome 408.32 10.11 400 200733 33659 110354507
Fall 406.15 10.11 2165 198968 601317 109786849
Restlessness 397.55 10.11 501 200632 55758 110332408
Infusion related reaction 385.29 10.11 108 201025 381054 110007112
Systemic lupus erythematosus 368.04 10.11 24 201109 254314 110133852
Hand deformity 366.63 10.11 6 201127 218500 110169666
Confusional state 358.16 10.11 1743 199390 466937 109921229
Disorientation 346.95 10.11 528 200605 70143 110318023
Tremor 346.19 10.11 977 200156 201255 110186911
Pemphigus 343.97 10.11 10 201123 214560 110173606
Inappropriate antidiuretic hormone secretion 341.09 10.11 362 200771 33489 110354677
Extrapyramidal disorder 331.16 10.11 331 200802 28536 110359630
Arthropathy 329.25 10.11 62 201071 287460 110100706
Aggression 323.21 10.11 465 200668 58745 110329421
Poisoning deliberate 322.66 10.11 313 200820 26018 110362148
Joint swelling 303.38 10.11 218 200915 442627 109945539
Akathisia 302.11 10.11 250 200883 16863 110371303
Helicobacter infection 300.99 10.11 6 201127 181871 110206295
Glossodynia 298.74 10.11 29 201104 221975 110166191
Rheumatoid arthritis 284.48 10.11 95 201038 299518 110088648
Restless legs syndrome 281.80 10.11 282 200851 24344 110363822
Pericarditis 276.29 10.11 36 201097 219078 110169088
Muscle rigidity 274.64 10.11 275 200858 23756 110364410
Nasopharyngitis 271.57 10.11 193 200940 394168 109993998
Drug hypersensitivity 269.67 10.11 257 200876 453833 109934333
Duodenal ulcer perforation 268.66 10.11 13 201120 177687 110210479
Folliculitis 268.01 10.11 8 201125 167645 110220521
Tachycardia 263.70 10.11 959 200174 225686 110162480
Dyskinesia 261.93 10.11 391 200742 51055 110337111
Hallucination, visual 252.11 10.11 335 200798 39270 110348896
Psoriatic arthropathy 251.29 10.11 31 201102 196730 110191436
Drug withdrawal syndrome 250.15 10.11 327 200806 37727 110350439
Sedation 249.75 10.11 452 200681 69231 110318935
Swelling 249.40 10.11 166 200967 350875 110037291
Sinusitis 238.14 10.11 121 201012 296567 110091599
Psychotic disorder 237.98 10.11 372 200761 50565 110337601
Impaired healing 234.82 10.11 38 201095 196679 110191487
Depressed mood 230.21 10.11 404 200729 60405 110327761
Disturbance in attention 227.12 10.11 406 200727 61589 110326577
Rash 226.71 10.11 752 200381 820212 109567954
Delirium 221.88 10.11 643 200490 134382 110253784
Rheumatoid factor positive 219.19 10.11 4 201129 131636 110256530
Irritable bowel syndrome 216.89 10.11 23 201110 164192 110223974
Mania 215.92 10.11 226 200907 20570 110367596
Alopecia 213.50 10.11 209 200924 364544 110023622
Therapeutic product effect decreased 212.55 10.11 89 201044 244227 110143939
Poisoning 211.66 10.11 263 200870 28842 110359324
Anxiety 211.46 10.11 1208 199925 343870 110044296
Seizure 209.34 10.11 877 200256 220308 110167858
Muscle injury 207.51 10.11 12 201121 140795 110247371
C-reactive protein abnormal 204.39 10.11 7 201126 129688 110258478
Abdominal discomfort 203.70 10.11 250 200883 393608 109994558
Withdrawal syndrome 203.69 10.11 268 200865 31112 110357054
Hallucination, auditory 202.42 10.11 245 200888 26152 110362014
Urticaria 201.73 10.11 170 200963 318687 110069479
Urinary retention 197.12 10.11 409 200724 69274 110318892
Altered state of consciousness 195.42 10.11 365 200768 57261 110330905
Dissociation 193.23 10.11 153 200980 9689 110378477
Nightmare 193.03 10.11 292 200841 38571 110349595
Loss of consciousness 190.96 10.11 785 200348 195521 110192645
Arthralgia 190.75 10.11 751 200382 778881 109609285
Hallucination 189.29 10.11 506 200627 100926 110287240
Bursitis 182.85 10.11 14 201119 129904 110258262
Treatment failure 180.08 10.11 144 200989 277090 110111076
Stomatitis 179.80 10.11 137 200996 270105 110118061
Hypersensitivity 179.41 10.11 286 200847 403712 109984454
Sleep disorder due to general medical condition, insomnia type 176.75 10.11 3 201130 105640 110282526
Dystonia 176.24 10.11 226 200907 25579 110362587
Drug intolerance 175.64 10.11 293 200840 406219 109981947
Parkinsonism 175.16 10.11 209 200924 21978 110366188
Depersonalisation/derealisation disorder 167.32 10.11 81 201052 2100 110386066
Wound 164.90 10.11 112 201021 234325 110153841
Peripheral swelling 163.87 10.11 303 200830 403731 109984435
Rhabdomyolysis 163.04 10.11 536 200597 119865 110268301
Drug dependence 162.38 10.11 311 200822 49709 110338457
Blister 162.12 10.11 107 201026 227269 110160897
Facet joint syndrome 160.96 10.11 3 201130 96825 110291341
Mydriasis 157.57 10.11 198 200935 21959 110366207
Osteoarthritis 156.47 10.11 68 201065 182555 110205611
Abnormal behaviour 156.43 10.11 266 200867 38773 110349393
Accidental overdose 155.80 10.11 312 200821 51522 110336644
Miosis 155.62 10.11 196 200937 21787 110366379
Joint range of motion decreased 153.58 10.11 20 201113 121812 110266354
Hepatic enzyme increased 152.26 10.11 217 200916 320675 110067491
Fibromyalgia 149.04 10.11 62 201071 170847 110217319
Suspected suicide 146.86 10.11 159 200974 15040 110373126
Intentional product use issue 146.21 10.11 141 200992 247765 110140401
Lip dry 146.04 10.11 9 201124 100074 110288092
Product use issue 145.70 10.11 213 200920 311482 110076684
Cogwheel rigidity 145.03 10.11 88 201045 3610 110384556
Ill-defined disorder 144.90 10.11 52 201081 156801 110231365
Pain 144.80 10.11 1080 200053 953875 109434291
Gastrointestinal disorder 144.58 10.11 136 200997 241816 110146350
Discomfort 143.88 10.11 108 201025 214599 110173567
Myoclonus 141.79 10.11 232 200901 32766 110355400
Dysarthria 141.44 10.11 404 200729 83717 110304449
Asphyxia 141.38 10.11 151 200982 14064 110374102
Lower respiratory tract infection 141.37 10.11 140 200993 242966 110145200
Psychomotor hyperactivity 140.71 10.11 179 200954 20098 110368068
Tardive dyskinesia 136.39 10.11 145 200988 13434 110374732
Wheezing 135.08 10.11 159 200974 255071 110133095
Pruritus 134.68 10.11 572 200561 580988 109807178
Bradyphrenia 133.62 10.11 134 200999 11594 110376572
Derealisation 132.74 10.11 69 201064 2089 110386077
Mental disorder 131.88 10.11 246 200887 38545 110349621
Delusion 131.71 10.11 188 200945 23567 110364599
Inflammation 131.03 10.11 96 201037 193142 110195024
Contraindicated product administered 131.02 10.11 155 200978 248112 110140054
Pneumonia aspiration 128.76 10.11 382 200751 80851 110307315
Feeling of despair 122.87 10.11 80 201053 3718 110384448
Gastric pH decreased 122.70 10.11 52 201081 978 110387188
Hyperhidrosis 121.43 10.11 666 200467 186632 110201534
Asthma 118.96 10.11 169 200964 250122 110138044
Infection 115.38 10.11 310 200823 361890 110026276
Blood cholesterol increased 115.00 10.11 100 201033 184685 110203481
Panic attack 113.06 10.11 195 200938 28745 110359421
Mood swings 112.71 10.11 171 200962 22641 110365525
Intrusive thoughts 111.90 10.11 44 201089 677 110387489
Respiratory arrest 109.92 10.11 292 200841 58007 110330159
Speech disorder 108.70 10.11 301 200832 61268 110326898
Schizophrenia 108.39 10.11 164 200969 21662 110366504
Peripheral venous disease 107.99 10.11 13 201120 84104 110304062
Type 2 diabetes mellitus 107.78 10.11 98 201035 177134 110211032
Systemic infection 104.24 10.11 108 201025 9711 110378455
Liver injury 104.22 10.11 73 201060 150340 110237826
Arthritis 103.91 10.11 91 201042 167495 110220671
On and off phenomenon 102.72 10.11 76 201057 4348 110383818
Substance abuse 102.68 10.11 120 201013 12343 110375823
Myelosuppression 102.42 10.11 23 201110 94317 110293849
Autoimmune disorder 101.56 10.11 4 201129 65479 110322687
Bradykinesia 101.00 10.11 111 201022 10677 110377489
Febrile neutropenia 99.46 10.11 273 200860 316494 110071672
Anger 98.94 10.11 146 200987 18861 110369305
Injury 98.61 10.11 106 201027 177159 110211007
Product prescribing error 96.67 10.11 257 200876 51074 110337092
Hallucinations, mixed 96.61 10.11 98 201035 8595 110379571
Hypertonia 95.68 10.11 96 201037 8310 110379856
Off label use 95.56 10.11 2043 199090 1498142 108890024
Respiratory depression 95.41 10.11 192 200941 31809 110356357
Feeling jittery 94.40 10.11 125 201008 14597 110373569
Paranoia 94.36 10.11 156 200977 22218 110365948
Pleurothotonus 94.27 10.11 58 201075 2440 110385726
Irritability 93.75 10.11 243 200890 47566 110340600
Lung disorder 93.28 10.11 114 201019 179933 110208233
Major depression 87.06 10.11 102 201031 10519 110377647
Delusion of grandeur 86.63 10.11 53 201080 2207 110385959
Labelled drug-drug interaction medication error 85.22 10.11 174 200959 29128 110359038
Blood lactic acid decreased 84.69 10.11 34 201099 554 110387612
Lower limb fracture 84.59 10.11 17 201116 75331 110312835
Cardio-respiratory arrest 83.34 10.11 424 200709 115412 110272754
Cardiac arrest 83.24 10.11 628 200505 196125 110192041
Wrong patient received product 83.00 10.11 80 201053 6594 110381572
Antidepressant drug level above therapeutic 82.88 10.11 36 201097 721 110387445
Logorrhoea 82.49 10.11 70 201063 4887 110383279
Electrocardiogram abnormal 82.36 10.11 133 201000 18576 110369590
Grip strength decreased 82.25 10.11 22 201111 80152 110308014
Product monitoring error 80.38 10.11 90 201043 8837 110379329
Pulmonary fibrosis 79.76 10.11 43 201090 101999 110286167
Psychomotor retardation 79.67 10.11 84 201049 7708 110380458
Wound infection 79.36 10.11 38 201095 96427 110291739
Homicidal ideation 79.07 10.11 60 201073 3567 110384599
Blood creatine phosphokinase increased 78.85 10.11 302 200831 72775 110315391
Injection site pain 78.85 10.11 126 201007 177796 110210370
Sciatica 78.18 10.11 35 201098 92364 110295802
Syncope 77.17 10.11 631 200502 201905 110186261
Hypotension 76.82 10.11 1359 199774 522490 109865676
Cardiac output increased 76.64 10.11 32 201101 579 110387587
Knee arthroplasty 76.46 10.11 13 201120 64935 110323231
Erythema 76.09 10.11 273 200860 291174 110096992
Abnormal dreams 75.09 10.11 104 201029 12676 110375490
Progressive multifocal leukoencephalopathy 74.72 10.11 150 200983 24806 110363360
Hyperkinesia 74.61 10.11 55 201078 3129 110385037
Affective disorder 74.49 10.11 97 201036 11144 110377022
Depressive symptom 74.35 10.11 84 201049 8330 110379836
Depression 74.18 10.11 893 200240 316442 110071724
Cough 74.14 10.11 513 200620 461128 109927038
Accidental death 73.82 10.11 66 201067 4943 110383223
Loss of libido 73.14 10.11 54 201079 3079 110385087
Incontinence 72.88 10.11 118 201015 16517 110371649
Migraine 72.87 10.11 125 201008 171527 110216639
Dementia 72.69 10.11 171 200962 31502 110356664
Illusion 71.69 10.11 45 201088 1962 110386204
Maternal exposure during pregnancy 70.42 10.11 233 200900 254650 110133516
Dysphagia 69.95 10.11 499 200634 153101 110235065
Drooling 69.53 10.11 75 201058 7064 110381102
H1N1 influenza 68.18 10.11 51 201082 2967 110385199
Hyperreflexia 67.82 10.11 85 201048 9400 110378766
Product administration error 67.73 10.11 184 200949 37033 110351133
Nail disorder 67.32 10.11 12 201121 57923 110330243
Circulatory collapse 67 10.11 201 200932 42792 110345374
Onychomadesis 66.93 10.11 4 201129 45659 110342507
Vitamin B1 decreased 66.43 10.11 33 201100 906 110387260
Hip arthroplasty 66.09 10.11 11 201122 55802 110332364
Hypercholesterolaemia 65.73 10.11 42 201091 90795 110297371
Gestational diabetes 65.69 10.11 74 201059 7315 110380851
Feeling of body temperature change 65.58 10.11 68 201065 6120 110382046
Apathy 65.51 10.11 111 201022 16128 110372038
Obesity 65.03 10.11 66 201067 113285 110274881
Cognitive disorder 64.83 10.11 323 200810 87188 110300978
Oedema 64.37 10.11 183 200950 209793 110178373
Pain in extremity 63.49 10.11 573 200560 486545 109901621
Intentional product misuse 63.00 10.11 436 200697 132468 110255698
Bezoar 62.90 10.11 55 201078 3999 110384167
Gastrooesophageal reflux disease 62.73 10.11 147 200986 179829 110208337
Urinary hesitation 62.05 10.11 58 201075 4600 110383566
Catatonia 62.01 10.11 89 201044 11211 110376955
Mental impairment 61.81 10.11 131 201002 22508 110365658
Osteoporosis 60.76 10.11 42 201091 87110 110301056
Hypophagia 60.53 10.11 222 200911 52404 110335762
Tachyphrenia 60.45 10.11 43 201090 2313 110385853
Unresponsive to stimuli 60.32 10.11 253 200880 63537 110324629
Mobility decreased 60.24 10.11 225 200908 237197 110150969
Drug ineffective 60.05 10.11 2213 198920 1518327 108869839
Pyrexia 59.38 10.11 1215 199918 897050 109491116
Upper respiratory tract infection 59.13 10.11 92 201041 131236 110256930
Thinking abnormal 59.12 10.11 102 201031 15038 110373128
Therapeutic product ineffective 58.82 10.11 44 201089 2560 110385606
Pneumonia 58.79 10.11 1183 199950 875531 109512635
Haematemesis 58.70 10.11 238 200895 58870 110329296
Coeliac disease 57.13 10.11 6 201127 43181 110344985
Lymphocyte count abnormal 57.05 10.11 42 201091 2384 110385782
Paroxysmal perceptual alteration 56.90 10.11 21 201112 269 110387897
Incoherent 56.75 10.11 73 201060 8285 110379881
Injection site pruritus 56.64 10.11 12 201121 51246 110336920
General physical health deterioration 56.60 10.11 1087 200046 424208 109963958
Anticholinergic syndrome 56.45 10.11 53 201080 4227 110383939
Priapism 56.08 10.11 61 201072 5800 110382366
Sleep disorder due to a general medical condition 55.97 10.11 13 201120 52099 110336067
Galactorrhoea 55.86 10.11 52 201081 4103 110384063
Psoriasis 55.78 10.11 106 201027 139887 110248279
Menstrual disorder 55.12 10.11 55 201078 4729 110383437
Hypoaesthesia 55.06 10.11 340 200793 313883 110074283
Intestinal pseudo-obstruction 55.05 10.11 47 201086 3309 110384857
Liver disorder 54.69 10.11 110 201023 142133 110246033
Persecutory delusion 54.22 10.11 62 201071 6229 110381937
Headache 54.09 10.11 1208 199925 881169 109506997
Neurodegenerative disorder 53.74 10.11 27 201106 760 110387406
Red blood cell sedimentation rate increased 52.93 10.11 39 201094 78263 110309903
Product quality issue 52.90 10.11 38 201095 77261 110310905
Coma scale abnormal 52.49 10.11 76 201057 9650 110378516
C-reactive protein increased 52.41 10.11 211 200922 217708 110170458
Sinus tachycardia 52.27 10.11 189 200944 44304 110343862
Insomnia 51.56 10.11 932 200201 359658 110028508
Impulsive behaviour 51.49 10.11 45 201088 3270 110384896
Acute psychosis 51.41 10.11 54 201079 4933 110383233
Helplessness 51.28 10.11 21 201112 361 110387805
Drug use disorder 50.99 10.11 106 201027 17968 110370198
Bipolar disorder 50.99 10.11 72 201061 8935 110379231
Balance disorder 50.95 10.11 375 200758 116185 110271981
Abulia 50.86 10.11 31 201102 1282 110386884
Erectile dysfunction 50.23 10.11 107 201026 18449 110369717
Sleep paralysis 49.82 10.11 27 201106 891 110387275
Injection site erythema 49.43 10.11 59 201074 94117 110294049
Adjustment disorder with depressed mood 49.05 10.11 10 201123 43873 110344293
Frequent bowel movements 48.98 10.11 35 201098 71355 110316811
Hypothermia 48.82 10.11 131 201002 26171 110361995
Analgesic drug level above therapeutic 48.63 10.11 22 201111 487 110387679
Status epilepticus 48.63 10.11 147 200986 31424 110356742
Parkinsonian gait 48.56 10.11 28 201105 1044 110387122
Antipsychotic drug level above therapeutic 48.04 10.11 38 201095 2402 110385764
Aptyalism 47.86 10.11 26 201107 862 110387304
Anaphylactic shock 47.74 10.11 17 201116 51529 110336637
Interstitial lung disease 47.60 10.11 115 201018 139219 110248947
Hyperprolactinaemia 47.14 10.11 59 201074 6516 110381650
Rhinorrhoea 47.10 10.11 71 201062 102595 110285571
Dissociative disorder 47.09 10.11 29 201104 1222 110386944
Gait inability 47.03 10.11 112 201021 136264 110251902
Nasal congestion 47.02 10.11 66 201067 98216 110289950
Sudden death 46.80 10.11 123 201010 24272 110363894
Muscle disorder 46.45 10.11 59 201074 6613 110381553
Taste disorder 46.26 10.11 31 201102 65356 110322810
Back pain 45.90 10.11 442 200691 370554 110017612
Polydipsia 45.82 10.11 63 201070 7625 110380541
Blood prolactin increased 45.62 10.11 49 201084 4593 110383573
Feelings of worthlessness 45.53 10.11 22 201111 568 110387598
Injection site reaction 45.49 10.11 57 201076 89013 110299153
Panic reaction 45.11 10.11 52 201081 5270 110382896
Abdominal pain upper 44.44 10.11 413 200720 348698 110039468
Bradycardia 44.23 10.11 455 200678 155062 110233104
Neck pain 44.17 10.11 99 201034 123031 110265135
Lupus-like syndrome 44.16 10.11 10 201123 40782 110347384
Cytomegalovirus infection 43.94 10.11 22 201111 54422 110333744
Pulmonary congestion 43.82 10.11 140 200993 30826 110357340
Stupor 43.76 10.11 64 201069 8201 110379965
Increased appetite 43.62 10.11 89 201044 14888 110373278
Generalised tonic-clonic seizure 43.49 10.11 206 200927 54474 110333692
C-reactive protein 43.44 10.11 3 201130 30328 110357838
Neutrophil count increased 43.11 10.11 150 200983 34502 110353664
Road traffic accident 43.06 10.11 81 201052 107317 110280849
Wrong product administered 43.00 10.11 74 201059 10886 110377280
Vitamin B1 increased 42.70 10.11 15 201118 165 110388001
Sudden cardiac death 42.69 10.11 52 201081 5585 110382581
Cataract 42.57 10.11 49 201084 79436 110308730
Potentiating drug interaction 42.30 10.11 76 201057 11567 110376599
Death 42.16 10.11 1611 199522 697258 109690908
Reduced facial expression 42.11 10.11 42 201091 3609 110384557
Therapeutic product effect incomplete 41.93 10.11 237 200896 223568 110164598
Liver function test increased 41.83 10.11 60 201073 88488 110299678
Device expulsion 41.62 10.11 4 201129 30887 110357279
Mood altered 41.24 10.11 108 201025 21267 110366899
Contusion 40.61 10.11 253 200880 233108 110155058
Posture abnormal 40.40 10.11 45 201088 4393 110383773
Faecaloma 40.39 10.11 86 201047 14822 110373344
Fungal infection 40.30 10.11 21 201112 50785 110337381
Muscle twitching 40.25 10.11 133 201000 29802 110358364
Illness anxiety disorder 40.23 10.11 16 201117 254 110387912
Musculoskeletal stiffness 40.08 10.11 321 200812 279501 110108665
Back injury 40.02 10.11 18 201115 47381 110340785
Brain oedema 39.90 10.11 136 200997 30962 110357204
Rhinalgia 39.54 10.11 42 201091 3887 110384279
Exostosis 39.52 10.11 17 201116 45939 110342227
Night sweats 39.43 10.11 119 201014 133864 110254302
Pallor 39.42 10.11 205 200928 56262 110331904
Communication disorder 39.00 10.11 47 201086 4992 110383174
Fracture 38.73 10.11 116 201017 24672 110363494
Electrocardiogram QRS complex prolonged 38.67 10.11 78 201055 12943 110375223
Hypertension 38.54 10.11 674 200459 509410 109878756
Substance dependence 38.45 10.11 21 201112 704 110387462
Torsade de pointes 38.42 10.11 109 201024 22491 110365675
Fatigue 38.28 10.11 1815 199318 1214143 109174023
Social avoidant behaviour 38.20 10.11 48 201085 5321 110382845
Mutism 38.12 10.11 37 201096 3076 110385090
Musculoskeletal pain 38.09 10.11 187 200946 182836 110205330
Ataxia 38.04 10.11 131 201002 29977 110358189
Pulmonary oedema 37.98 10.11 313 200820 100346 110287820
Tonic clonic movements 37.88 10.11 36 201097 2916 110385250
Product dose omission issue 37.86 10.11 388 200745 321394 110066772
Ear infection 37.75 10.11 35 201098 62697 110325469
Stoma site discharge 37.61 10.11 35 201098 2760 110385406
Bronchitis 37.15 10.11 153 200980 156879 110231287
Emotional disorder 36.81 10.11 87 201046 16073 110372093
Antipsychotic drug level increased 36.67 10.11 54 201079 6961 110381205
Euphoric mood 36.49 10.11 61 201072 8766 110379400
Cyanosis 36.36 10.11 128 201005 29613 110358553
Alcohol interaction 36.31 10.11 39 201094 3655 110384511
Oscillopsia 36.05 10.11 17 201116 415 110387751
Merycism 36.01 10.11 16 201117 339 110387827
Laryngitis 35.98 10.11 16 201117 42395 110345771
Photopsia 35.66 10.11 50 201083 6164 110382002
Agranulocytosis 35.65 10.11 213 200920 61547 110326619
Foot deformity 35.64 10.11 22 201111 48458 110339708
JC virus infection 35.60 10.11 46 201087 5244 110382922
Septic shock 35.11 10.11 157 200976 157371 110230795
Hypomania 35.01 10.11 65 201068 10145 110378021
Activation syndrome 34.96 10.11 16 201117 364 110387802
Phagophobia 34.96 10.11 10 201123 52 110388114
Ejaculation failure 34.65 10.11 16 201117 372 110387794
Hyperthermia 34.62 10.11 101 201032 21171 110366995
Respiratory acidosis 34.32 10.11 77 201056 13749 110374417
Prescribed overdose 34.29 10.11 67 201066 87514 110300652
Ejaculation disorder 34.00 10.11 18 201115 566 110387600
Substance use disorder 33.70 10.11 53 201080 7237 110380929
Pressure of speech 33.46 10.11 24 201109 1308 110386858
Failure to thrive 33.03 10.11 75 201058 13499 110374667
Hypotonia 32.91 10.11 82 201051 15663 110372503
Live birth 32.90 10.11 47 201086 69437 110318729
Hypoaesthesia oral 32.90 10.11 86 201047 16916 110371250
Chest pain 32.85 10.11 484 200649 375891 110012275
Decreased gait velocity 32.83 10.11 13 201120 204 110387962
Hypersomnia 32.79 10.11 119 201014 27942 110360224
Injection site bruising 32.78 10.11 27 201106 51236 110336930
Food craving 32.75 10.11 28 201105 1975 110386191
Incorrect route of product administration 32.70 10.11 41 201092 64020 110324146
Blepharospasm 32.54 10.11 31 201102 54820 110333346
Acute motor-sensory axonal neuropathy 32.51 10.11 17 201116 521 110387645
Paralysis 32.35 10.11 81 201052 15519 110372647
Immune reconstitution inflammatory syndrome 32.35 10.11 83 201050 16143 110372023
Premature labour 32.22 10.11 59 201074 9113 110379053
Psychomotor skills impaired 32.20 10.11 51 201082 7007 110381159
Abnormal weight gain 31.98 10.11 36 201097 3555 110384611
Hyperarousal 31.93 10.11 9 201124 44 110388122
Anaphylactic reaction 31.88 10.11 104 201029 114196 110273970
Vestibular disorder 31.70 10.11 31 201102 2601 110385565
Blood sodium decreased 31.68 10.11 146 200987 38173 110349993
Drug tolerance decreased 31.36 10.11 6 201127 27534 110360632
Fluid retention 31.30 10.11 79 201054 94228 110293938
Alcohol use 31.18 10.11 38 201095 4084 110384082
Self-injurious ideation 31.16 10.11 39 201094 4307 110383859
Alcoholism 31.05 10.11 36 201097 3671 110384495
Suicidal behaviour 31.05 10.11 35 201098 3462 110384704
Lactic acidosis 31.04 10.11 281 200852 92530 110295636
Myocardial infarction 31.01 10.11 213 200920 191870 110196296
Cytokine release syndrome 30.93 10.11 50 201083 70256 110317910
Feeling guilty 30.78 10.11 20 201113 926 110387240
Dry skin 30.69 10.11 97 201036 107556 110280610
Exposure during pregnancy 30.44 10.11 179 200954 167245 110220921
Herpes zoster 29.96 10.11 99 201034 108280 110279886
Thrombotic microangiopathy 29.89 10.11 8 201125 29141 110359025
Hypercapnia 29.80 10.11 64 201069 11095 110377071
Akinesia 29.70 10.11 35 201098 3632 110384534
Platypnoea 29.67 10.11 8 201125 32 110388134
Hyponatraemic coma 29.33 10.11 9 201124 62 110388104
Histrionic personality disorder 29.29 10.11 8 201125 34 110388132
Clonus 29.28 10.11 55 201078 8661 110379505
Stoma site infection 29.16 10.11 25 201108 1770 110386396
Pregnancy 28.99 10.11 30 201103 51037 110337129
Sexual dysfunction 28.87 10.11 54 201079 8476 110379690
Basal cell carcinoma 28.76 10.11 24 201109 45246 110342920
Serum serotonin increased 28.74 10.11 14 201119 368 110387798
Treatment noncompliance 28.64 10.11 229 200904 72761 110315405
Salivary hypersecretion 28.62 10.11 83 201050 17338 110370828
Obsessive-compulsive disorder 28.56 10.11 49 201084 7192 110380974
Bradypnoea 28.34 10.11 54 201079 8595 110379571
Ear pain 28.30 10.11 33 201100 53193 110334973
Thrombocytopenia 28.28 10.11 455 200678 348430 110039736
Freezing phenomenon 28.24 10.11 29 201104 2580 110385586
Blood pressure diastolic decreased 28.22 10.11 15 201118 35870 110352296
No adverse event 27.61 10.11 58 201075 73781 110314385
Stoma site erythema 27.51 10.11 26 201107 2091 110386075
Formication 27.42 10.11 42 201091 5606 110382560
Arrhythmia 27.14 10.11 218 200915 69357 110318809
Tongue movement disturbance 27.06 10.11 15 201118 518 110387648
Palmar-plantar erythrodysaesthesia syndrome 27.00 10.11 21 201112 41004 110347162
Benign gastrointestinal neoplasm 26.96 10.11 10 201123 130 110388036
Parosmia 26.88 10.11 68 201065 13112 110375054
Fear 26.80 10.11 98 201035 23095 110365071
Patient elopement 26.78 10.11 13 201120 339 110387827
Pelvic fracture 26.78 10.11 71 201062 14083 110374083
Mental status changes 26.76 10.11 233 200900 75889 110312277
Tracheal pain 26.74 10.11 8 201125 50 110388116
Immunodeficiency 26.69 10.11 19 201114 38819 110349347
Adverse event 26.37 10.11 105 201028 108704 110279462
Inappropriate schedule of product administration 26.28 10.11 240 200893 203397 110184769
Somnambulism 26.13 10.11 44 201089 6361 110381805
Vertigo 26.05 10.11 257 200876 86613 110301553
Disease progression 25.99 10.11 301 200832 243733 110144433
Hypokinesia 25.88 10.11 93 201040 21733 110366433
Multiple organ dysfunction syndrome 25.60 10.11 166 200967 151544 110236622
Emotional distress 25.45 10.11 154 200979 44693 110343473
Behaviour disorder 25.39 10.11 55 201078 9592 110378574
Language disorder 25.25 10.11 33 201100 3805 110384361
Muscular weakness 25.11 10.11 310 200823 248158 110140008
Psychotic symptom 25.05 10.11 33 201100 3834 110384332
Chemical burn of oral cavity 25.03 10.11 8 201125 64 110388102
Therapeutic response decreased 24.75 10.11 91 201042 96408 110291758
Gait disturbance 24.73 10.11 672 200461 277536 110110630
Cleft palate 24.73 10.11 13 201120 403 110387763
Transplant rejection 24.71 10.11 7 201126 24560 110363606
Hyperventilation 24.69 10.11 52 201081 8895 110379271
Hepatocellular injury 24.50 10.11 167 200966 50475 110337691
Bladder dilatation 24.42 10.11 26 201107 2413 110385753
Rash pruritic 24.17 10.11 94 201039 97975 110290191
Tumour lysis syndrome 24.03 10.11 13 201120 30788 110357378
Medication overuse headache 23.84 10.11 21 201112 1542 110386624
Macrophages increased 23.81 10.11 11 201122 256 110387910
Onychomycosis 23.78 10.11 21 201112 38510 110349656
Resuscitation 23.76 10.11 28 201105 2905 110385261
False positive investigation result 23.60 10.11 20 201113 1394 110386772
IVth nerve disorder 23.58 10.11 6 201127 18 110388148
Sinus congestion 23.56 10.11 13 201120 30446 110357720
Urogenital haemorrhage 23.37 10.11 17 201116 947 110387219
Rapid eye movements sleep abnormal 23.31 10.11 11 201122 269 110387897
Colitis ulcerative 23.27 10.11 68 201065 77295 110310871
Acute myeloid leukaemia 23.24 10.11 21 201112 38089 110350077
Disability 23.23 10.11 13 201120 30210 110357956
COVID-19 23.19 10.11 310 200823 244750 110143416
Indifference 23.15 10.11 12 201121 361 110387805
Rash erythematous 23.14 10.11 74 201059 81758 110306408
Cardiac failure congestive 23.12 10.11 170 200963 150830 110237336
Norepinephrine increased 23.11 10.11 8 201125 84 110388082
Bacterial infection 22.94 10.11 30 201103 46006 110342160
Loose associations 22.94 10.11 8 201125 86 110388080
Skin exfoliation 22.92 10.11 82 201051 87569 110300597
Blood pressure systolic increased 22.81 10.11 76 201057 82915 110305251
Hypokalaemia 22.77 10.11 462 200671 181986 110206180
Psychiatric decompensation 22.72 10.11 39 201094 5726 110382440
Respiratory tract congestion 22.69 10.11 14 201119 30843 110357323
Hyporesponsive to stimuli 22.67 10.11 27 201106 2833 110385333
Disorganised speech 22.66 10.11 29 201104 3274 110384892
Lethargy 22.56 10.11 265 200868 93311 110294855
Rhonchi 22.50 10.11 34 201099 4484 110383682
Bronchiectasis 22.39 10.11 20 201113 36473 110351693
Regressive behaviour 22.37 10.11 10 201123 215 110387951
Eosinophilic cellulitis 22.28 10.11 11 201122 298 110387868
Dyspnoea 22.20 10.11 1723 199410 1105149 109283017
Binge eating 22.19 10.11 14 201119 616 110387550
Pulmonary toxicity 22.15 10.11 3 201130 17743 110370423
Convulsive threshold lowered 22.14 10.11 17 201116 1029 110387137
Prescribed underdose 22.09 10.11 54 201079 65120 110323046
Suspiciousness 22.02 10.11 15 201118 752 110387414
Bulimia nervosa 21.91 10.11 11 201122 309 110387857
Libido decreased 21.89 10.11 39 201094 5896 110382270
Drug abuser 21.85 10.11 37 201096 5372 110382794
Drowning 21.85 10.11 16 201117 901 110387265
Electric shock sensation 21.76 10.11 22 201111 1922 110386244
Decreased interest 21.75 10.11 35 201098 4873 110383293
Opisthotonus 21.69 10.11 15 201118 771 110387395
Oesophageal obstruction 21.61 10.11 18 201115 1225 110386941
Hallucination, synaesthetic 21.58 10.11 7 201126 59 110388107
Tachypnoea 21.55 10.11 134 200999 39261 110348905
Sneezing 21.52 10.11 16 201117 31968 110356198
Oesophageal ulcer haemorrhage 21.31 10.11 16 201117 936 110387230
Heart rate decreased 21.25 10.11 78 201055 82678 110305488
Sinus disorder 21.22 10.11 17 201116 32711 110355455
Malignant neoplasm progression 21.13 10.11 209 200924 174358 110213808
Congenital cerebrovascular anomaly 21.08 10.11 5 201128 10 110388156
Anorgasmia 20.98 10.11 20 201113 1626 110386540
Therapy non-responder 20.91 10.11 184 200949 157123 110231043
Dysphoria 20.90 10.11 40 201093 6388 110381778
Feeling hot 20.78 10.11 90 201043 91016 110297150
Pyroglutamic acidosis 20.62 10.11 22 201111 2046 110386120
Snoring 20.58 10.11 41 201092 6743 110381423
Agoraphobia 20.55 10.11 14 201119 702 110387464
CYP3A4 polymorphism 20.52 10.11 7 201126 70 110388096
Cachexia 20.45 10.11 61 201072 12944 110375222
Sensory disturbance 20.44 10.11 74 201059 17355 110370811
Tendonitis 20.37 10.11 11 201122 26072 110362094
Hypernatraemia 20.31 10.11 75 201058 17758 110370408
Alcohol abuse 20.29 10.11 34 201099 4895 110383271
Sensory loss 20.20 10.11 85 201048 21372 110366794
Dehydration 20.19 10.11 658 200475 278853 110109313
Gout 20.17 10.11 22 201111 36544 110351622
Torticollis 20.12 10.11 27 201106 3194 110384972
Sputum discoloured 20.10 10.11 13 201120 27932 110360234
Therapeutic drug monitoring analysis not performed 20.07 10.11 21 201112 1910 110386256
Chorea 20.02 10.11 27 201106 3208 110384958
Eczema 20.00 10.11 66 201067 72227 110315939
Obsessive-compulsive personality disorder 20.00 10.11 8 201125 129 110388037
Blood pressure diastolic abnormal 19.99 10.11 11 201122 25804 110362362
Antidepressant drug level increased 19.99 10.11 13 201120 603 110387563
Vitamin B12 decreased 19.98 10.11 35 201098 5222 110382944
Drug screen positive 19.76 10.11 39 201094 6371 110381795
Crush syndrome 19.73 10.11 11 201122 384 110387782
Purple glove syndrome 19.73 10.11 10 201123 287 110387879
Glassy eyes 19.62 10.11 9 201124 206 110387960
Joint stiffness 19.58 10.11 60 201073 67183 110320983
Agonal rhythm 19.54 10.11 9 201124 208 110387958
Epstein-Barr virus infection 19.49 10.11 5 201128 18733 110369433
Paresis 19.39 10.11 33 201100 4811 110383355
Foetal death 19.36 10.11 3 201130 16042 110372124
Product prescribing issue 19.23 10.11 59 201074 12713 110375453
Postoperative respiratory failure 19.23 10.11 9 201124 216 110387950
Screaming 19.21 10.11 33 201100 4848 110383318
Homicide 19.19 10.11 16 201117 1090 110387076
Internal fixation of fracture 19.16 10.11 12 201121 521 110387645
Neuropathy peripheral 19.14 10.11 221 200912 179056 110209110
Negative thoughts 19.11 10.11 19 201114 1627 110386539
Breast discomfort 19.02 10.11 12 201121 528 110387638
Cold sweat 19.00 10.11 85 201048 21946 110366220
Normal newborn 18.99 10.11 8 201125 21888 110366278
Vision blurred 18.94 10.11 335 200798 128687 110259479
Blood osmolarity decreased 18.92 10.11 18 201115 1460 110386706
Educational problem 18.86 10.11 12 201121 536 110387630
Autonomic nervous system imbalance 18.83 10.11 36 201097 5744 110382422
Hangover 18.82 10.11 23 201110 2479 110385687
Injection site swelling 18.81 10.11 54 201079 61736 110326430
Macular degeneration 18.64 10.11 8 201125 21651 110366515
Nephrolithiasis 18.63 10.11 60 201073 66152 110322014
White blood cell count decreased 18.63 10.11 299 200834 229091 110159075
Radiculopathy 18.56 10.11 6 201127 19330 110368836
Skin necrosis 18.43 10.11 8 201125 21504 110366662
Visceral congestion 18.40 10.11 17 201116 1328 110386838
Ulcer haemorrhage 18.40 10.11 9 201124 22562 110365604
Sensorimotor disorder 18.38 10.11 16 201117 1156 110387010
Productive cough 18.32 10.11 127 201006 114178 110273988
Bladder cancer 18.27 10.11 7 201126 20285 110367881
Chemical submission 18.23 10.11 12 201121 568 110387598
Pleural effusion 18.22 10.11 221 200912 177488 110210678
Tenderness 18.22 10.11 16 201117 29421 110358745
Hyperphagia 18.20 10.11 27 201106 3504 110384662
Respiratory rate decreased 18.00 10.11 37 201096 6221 110381945
Cytomegalovirus viraemia 17.98 10.11 5 201128 17759 110370407
Female genital tract fistula 17.98 10.11 4 201129 16515 110371651
Emotional poverty 17.95 10.11 15 201118 1025 110387141
Nystagmus 17.92 10.11 54 201079 11523 110376643
Postmortem blood drug level increased 17.86 10.11 16 201117 1201 110386965
Sinus bradycardia 17.86 10.11 103 201030 29380 110358786
Autoscopy 17.73 10.11 7 201126 109 110388057
Drug dispensed to wrong patient 17.69 10.11 13 201120 736 110387430
Acute kidney injury 17.68 10.11 1363 199770 634067 109754099
Diarrhoea 17.68 10.11 1809 199324 1137696 109250470
Pyuria 17.68 10.11 23 201110 2640 110385526
Amnestic disorder 17.67 10.11 13 201120 737 110387429
Dementia with Lewy bodies 17.63 10.11 15 201118 1051 110387115
Postictal state 17.62 10.11 22 201111 2424 110385742
Antidepressant drug level decreased 17.59 10.11 4 201129 6 110388160
Platelet count decreased 17.53 10.11 304 200829 230139 110158027
Self esteem decreased 17.50 10.11 15 201118 1062 110387104
Blood bilirubin decreased 17.45 10.11 17 201116 1420 110386746
Thirst 17.42 10.11 82 201051 21625 110366541
Accidental poisoning 17.32 10.11 22 201111 2465 110385701
Dependence 17.23 10.11 23 201110 2706 110385460
Hepatic cirrhosis 17.19 10.11 64 201069 67562 110320604
Bipolar I disorder 17.19 10.11 21 201112 2262 110385904
Facial nerve disorder 17.19 10.11 13 201120 769 110387397
Panic disorder 17.17 10.11 26 201107 3435 110384731
Hyperlactacidaemia 17.16 10.11 43 201090 8243 110379923
Osteomyelitis 17.09 10.11 25 201108 36575 110351591
Decreased appetite 16.98 10.11 1042 200091 474804 109913362
Self-medication 16.94 10.11 36 201097 6196 110381970
Tachycardia paroxysmal 16.91 10.11 10 201123 391 110387775
Generalised anxiety disorder 16.91 10.11 23 201110 2756 110385410
Drop attacks 16.89 10.11 15 201118 1113 110387053
Tricuspid valve sclerosis 16.88 10.11 5 201128 30 110388136
Hypervigilance 16.88 10.11 12 201121 645 110387521
Dysaesthesia 16.85 10.11 38 201095 6809 110381357
Oesophageal haemorrhage 16.82 10.11 19 201114 1884 110386282
Aspiration 16.79 10.11 104 201029 30429 110357737
Dizziness 16.77 10.11 1481 199652 696712 109691454
Gamma-glutamyltransferase increased 16.77 10.11 178 200955 61131 110327035
Skin fissures 16.76 10.11 12 201121 24446 110363720
Second primary malignancy 16.66 10.11 6 201127 18062 110370104
Swelling face 16.65 10.11 248 200885 92073 110296093
Respiratory disorder 16.60 10.11 70 201063 71312 110316854
Hanging 16.54 10.11 8 201125 207 110387959
Dyspraxia 16.50 10.11 9 201124 301 110387865
Visceral oedema 16.39 10.11 6 201127 75 110388091
Ageusia 16.35 10.11 75 201058 19570 110368596
Medication error 16.34 10.11 276 200857 105090 110283076
Orgasm abnormal 16.33 10.11 8 201125 213 110387953
Walking aid user 16.29 10.11 13 201120 25062 110363104
Disinhibition 16.20 10.11 24 201109 3110 110385056
Drug diversion 16.15 10.11 16 201117 1364 110386802
Adverse reaction 16.11 10.11 18 201115 29576 110358590
Infusion site reaction 16.09 10.11 6 201127 17676 110370490
Soliloquy 16.07 10.11 14 201119 1013 110387153
Somatic symptom disorder 16.06 10.11 24 201109 3135 110385031
Glabellar reflex abnormal 15.98 10.11 5 201128 37 110388129
Repetitive speech 15.95 10.11 10 201123 435 110387731
Sarcopenia 15.95 10.11 15 201118 1199 110386967
Medical observation abnormal 15.93 10.11 3 201130 0 110388166
Postural tremor 15.89 10.11 14 201119 1028 110387138
Somatic delusion 15.88 10.11 12 201121 709 110387457
Long QT syndrome 15.87 10.11 38 201095 7080 110381086
Aspergillus infection 15.76 10.11 14 201119 25602 110362564
Agitated depression 15.73 10.11 11 201122 576 110387590
Drug dose titration not performed 15.63 10.11 14 201119 1051 110387115
Loss of personal independence in daily activities 15.60 10.11 186 200947 149834 110238332
Post-traumatic stress disorder 15.56 10.11 36 201097 6560 110381606
Impaired self-care 15.27 10.11 21 201112 2543 110385623
Myelodysplastic syndrome 15.26 10.11 28 201105 37456 110350710
Hypertriglyceridaemia 15.21 10.11 64 201069 16090 110372076
Drug level increased 15.21 10.11 143 200990 47576 110340590
Pancreatitis acute 15.11 10.11 172 200961 60102 110328064
Spinal cord injury thoracic 15.11 10.11 7 201126 164 110388002
Pseudomonas infection 15.10 10.11 17 201116 27836 110360330
Obstructive airways disorder 15.05 10.11 39 201094 46110 110342056
Pulmonary alveolar haemorrhage 15.01 10.11 9 201124 20141 110368025
Avoidant personality disorder 14.99 10.11 6 201127 97 110388069
Disseminated intravascular coagulation 14.96 10.11 33 201100 41253 110346913
Dysgraphia 14.95 10.11 29 201104 4676 110383490
Upper gastrointestinal haemorrhage 14.92 10.11 148 200985 49948 110338218
Hepatic steatosis 14.90 10.11 145 200988 48686 110339480
Blood ethanol increased 14.86 10.11 11 201122 630 110387536
Leukopenia 14.85 10.11 365 200768 148426 110239740
Cardiac hypertrophy 14.81 10.11 18 201115 1929 110386237
Polyarthritis 14.80 10.11 8 201125 18955 110369211
Blood pressure systolic abnormal 14.79 10.11 14 201119 24836 110363330
Haemolysis 14.75 10.11 5 201128 15634 110372532
Limited symptom panic attack 14.75 10.11 5 201128 49 110388117
Urinary incontinence 14.69 10.11 144 200989 48443 110339723
Cerebral mass effect 14.69 10.11 20 201113 2399 110385767
Transferrin saturation decreased 14.67 10.11 15 201118 1328 110386838
Aphasia 14.63 10.11 168 200965 58829 110329337
BK virus infection 14.62 10.11 3 201130 13103 110375063
Humerus fracture 14.60 10.11 48 201085 10728 110377438
Creatinine renal clearance decreased 14.57 10.11 11 201122 21804 110366362
Blood pressure increased 14.56 10.11 358 200775 258015 110130151
Prostate cancer 14.55 10.11 29 201104 37612 110350554
Porphyria acute 14.55 10.11 8 201125 18772 110369394
Slow speech 14.48 10.11 24 201109 3424 110384742
Sensory level abnormal 14.48 10.11 7 201126 181 110387985
Talipes 14.44 10.11 7 201126 182 110387984
Hepatitis acute 14.42 10.11 70 201063 18696 110369470
Joint dislocation 14.41 10.11 25 201108 34165 110354001
Ulcer 14.40 10.11 36 201097 43080 110345086
Eosinophilic pleural effusion 14.39 10.11 10 201123 518 110387648
Blood lactic acid increased 14.37 10.11 62 201071 15759 110372407
Bronchopulmonary aspergillosis 14.34 10.11 20 201113 29843 110358323
Vasodilatation 14.33 10.11 25 201108 3719 110384447
Full blood count abnormal 14.28 10.11 53 201080 55999 110332167
Blood uric acid increased 14.19 10.11 11 201122 21518 110366648
Myasthenia gravis 14.17 10.11 11 201122 21500 110366666
Injection site rash 14.17 10.11 13 201120 23406 110364760
Gangrene 14.12 10.11 6 201127 16335 110371831
Blood alcohol increased 14.10 10.11 13 201120 1013 110387153
Neglect of personal appearance 14.08 10.11 9 201124 405 110387761
Feeling drunk 14.07 10.11 31 201102 5469 110382697
Thrombosis 14.04 10.11 128 201005 108534 110279632
Stoma site inflammation 14.00 10.11 13 201120 1022 110387144
Diet refusal 13.97 10.11 12 201121 852 110387314
Prostatism 13.96 10.11 6 201127 117 110388049
Cytomegalovirus infection reactivation 13.93 10.11 8 201125 18325 110369841
Compulsive shopping 13.92 10.11 12 201121 856 110387310
Meningioma surgery 13.86 10.11 3 201130 3 110388163
Pelvic haematoma 13.86 10.11 13 201120 1036 110387130
JC virus CSF test positive 13.71 10.11 7 201126 204 110387962
Bone density decreased 13.69 10.11 6 201127 16036 110372130
Circadian rhythm sleep disorder 13.62 10.11 13 201120 1059 110387107
Accidental exposure to product 13.60 10.11 46 201087 49962 110338204
Vasculitis 13.56 10.11 28 201105 35845 110352321
Rectal haemorrhage 13.47 10.11 146 200987 119687 110268479
Thymus disorder 13.46 10.11 10 201123 576 110387590
Inadequate analgesia 13.42 10.11 29 201104 5048 110383118
Acute respiratory distress syndrome 13.42 10.11 152 200981 53046 110335120
Ocular discomfort 13.39 10.11 40 201093 8493 110379673
Hunger 13.39 10.11 34 201099 6570 110381596
Loss of proprioception 13.38 10.11 12 201121 902 110387264
Pulmonary vein occlusion 13.38 10.11 6 201127 130 110388036
Joint effusion 13.38 10.11 11 201122 20894 110367272
Abdominal rigidity 13.34 10.11 24 201109 3656 110384510
Pulse absent 13.29 10.11 48 201085 11244 110376922
Lack of application site rotation 13.28 10.11 5 201128 68 110388098
Influenza 13.21 10.11 222 200911 168879 110219287
Toxicologic test abnormal 13.20 10.11 14 201119 1293 110386873
Stoma site hypergranulation 13.19 10.11 10 201123 594 110387572
Hypnagogic hallucination 13.17 10.11 7 201126 222 110387944
Kussmaul respiration 13.15 10.11 9 201124 455 110387711
Natural killer cell count decreased 13.09 10.11 6 201127 137 110388029
Eyelid myoclonus 13.05 10.11 6 201127 138 110388028
Prescription drug used without a prescription 12.97 10.11 30 201103 5466 110382700
Oral herpes 12.94 10.11 29 201104 36051 110352115
Bacteraemia 12.94 10.11 37 201096 42353 110345813
Conduction disorder 12.90 10.11 25 201108 4030 110384136
Violence-related symptom 12.89 10.11 12 201121 947 110387219
Eye movement disorder 12.88 10.11 43 201090 9685 110378481
Chronic sinusitis 12.86 10.11 16 201117 25068 110363098
B-lymphocyte count increased 12.86 10.11 6 201127 143 110388023
Seronegative arthritis 12.81 10.11 4 201129 13173 110374993
Forced expiratory volume decreased 12.80 10.11 4 201129 13172 110374994
Electroencephalogram abnormal 12.75 10.11 32 201101 6141 110382025
Eye irritation 12.74 10.11 26 201107 33426 110354740
Liver function test abnormal 12.74 10.11 186 200947 68764 110319402
Febrile bone marrow aplasia 12.73 10.11 8 201125 17457 110370709
Enuresis 12.72 10.11 25 201108 4071 110384095
Nasal discomfort 12.72 10.11 32 201101 6149 110382017
White matter lesion 12.70 10.11 20 201113 2734 110385432
Poverty of thought content 12.65 10.11 5 201128 78 110388088
Rash maculo-papular 12.63 10.11 81 201052 74141 110314025
Malnutrition 12.63 10.11 89 201044 27190 110360976
Refusal of treatment by patient 12.60 10.11 42 201091 9452 110378714
Mean cell haemoglobin decreased 12.59 10.11 35 201098 7139 110381027
Pneumocystis jirovecii pneumonia 12.54 10.11 38 201095 42697 110345469
Psychiatric symptom 12.45 10.11 41 201092 9172 110378994
Hepatitis cholestatic 12.42 10.11 64 201069 17502 110370664
Hypoalbuminaemia 12.38 10.11 21 201112 28953 110359213
Laryngeal granuloma 12.34 10.11 3 201130 7 110388159
Antipsychotic drug level decreased 12.31 10.11 14 201119 1398 110386768
Personality change 12.30 10.11 46 201087 10956 110377210
Hypokinetic dysarthria 12.30 10.11 4 201129 34 110388132
Tension 12.29 10.11 28 201105 5050 110383116
Tinnitus 12.26 10.11 166 200967 60374 110327792
Respiratory tract infection 12.26 10.11 78 201055 71539 110316627
Essential tremor 12.26 10.11 16 201117 1842 110386324
Blood osmolarity increased 12.23 10.11 11 201122 830 110387336
Ocular hyperaemia 12.20 10.11 34 201099 39252 110348914
Thyroxine free decreased 12.20 10.11 13 201120 1207 110386959
Anal incontinence 12.20 10.11 75 201058 21889 110366277
Metabolic encephalopathy 12.17 10.11 46 201087 11014 110377152
Dysstasia 12.13 10.11 102 201031 32884 110355282
Rabbit syndrome 12.11 10.11 8 201125 381 110387785
Impaired gastric emptying 12.04 10.11 52 201081 13223 110374943
Radial nerve injury 12.00 10.11 4 201129 37 110388129
Antisocial behaviour 11.93 10.11 11 201122 857 110387309
Facial paresis 11.91 10.11 31 201102 6082 110382084
Affect lability 11.88 10.11 66 201067 18571 110369595
Bundle branch block right 11.81 10.11 49 201084 12242 110375924
Giant cell arteritis 11.78 10.11 23 201110 3726 110384440
Skin lesion 11.78 10.11 51 201082 51580 110336586
Urinary tract disorder 11.76 10.11 30 201103 5814 110382352
Echolalia 11.76 10.11 9 201124 542 110387624
Enthesopathy 11.75 10.11 4 201129 12474 110375692
Dystrophic calcification 11.68 10.11 6 201127 177 110387989
Hyperacusis 11.67 10.11 20 201113 2932 110385234
Light chain disease 11.65 10.11 7 201126 282 110387884
Drug reaction with eosinophilia and systemic symptoms 11.64 10.11 212 200921 81883 110306283
Resting tremor 11.62 10.11 15 201118 1708 110386458
Haemophagocytic lymphohistiocytosis 11.62 10.11 25 201108 31534 110356632
Extensor plantar response 11.62 10.11 16 201117 1939 110386227
Drug dose omission by device 11.51 10.11 6 201127 14510 110373656
Impaired work ability 11.42 10.11 19 201114 26400 110361766
Colitis 11.36 10.11 125 201008 102198 110285968
Parkinson's disease 11.34 10.11 14 201119 1525 110386641
Implant site extravasation 11.31 10.11 11 201122 917 110387249
Shared psychotic disorder 11.31 10.11 4 201129 45 110388121
Dementia Alzheimer's type 11.30 10.11 11 201122 918 110387248
Decubitus ulcer 11.24 10.11 64 201069 18172 110369994
Flushing 11.22 10.11 129 201004 104607 110283559
Drug withdrawal headache 11.21 10.11 5 201128 107 110388059
Dyspepsia 11.20 10.11 263 200870 190702 110197464
Orthostatic hypotension 11.19 10.11 176 200957 66073 110322093
Arterial occlusive disease 11.18 10.11 7 201126 15301 110372865
Cholestasis 11.12 10.11 172 200961 64346 110323820
Perforated ulcer 11.10 10.11 10 201123 756 110387410
Ballismus 11.09 10.11 7 201126 308 110387858
Injection site urticaria 11.09 10.11 9 201124 17206 110370960
Haemoptysis 11.08 10.11 80 201053 71274 110316892
Fatty liver alcoholic 11.07 10.11 4 201129 48 110388118
Alkalosis hypochloraemic 11.07 10.11 9 201124 592 110387574
Skin ulcer 11.06 10.11 69 201064 63576 110324590
Arachnoid cyst 11.06 10.11 8 201125 442 110387724
Bronchial aspiration procedure 11.05 10.11 7 201126 310 110387856
Product dose omission in error 11.04 10.11 16 201117 23496 110364670
Partner stress 11.03 10.11 7 201126 311 110387855
Acute abdomen 11.03 10.11 21 201112 3340 110384826
Cerebral atrophy 11.02 10.11 39 201094 9046 110379120
Living alone 11.00 10.11 4 201129 49 110388117
Mitral valve incompetence 10.99 10.11 28 201105 33301 110354865
Aplastic anaemia 10.96 10.11 17 201116 24291 110363875
Submaxillary gland enlargement 10.93 10.11 4 201129 50 110388116
COVID-19 pneumonia 10.92 10.11 33 201100 37110 110351056
Chemical burns of eye 10.88 10.11 5 201128 115 110388051
Retrograde amnesia 10.87 10.11 10 201123 777 110387389
Intestinal operation 10.86 10.11 9 201124 608 110387558
Skull fracture 10.86 10.11 16 201117 2064 110386102
Housebound 10.85 10.11 8 201125 455 110387711
Stoma site reaction 10.84 10.11 8 201125 456 110387710
Coronary artery disease 10.83 10.11 81 201052 71609 110316557
Marital problem 10.83 10.11 6 201127 207 110387959
Obsessive-compulsive symptom 10.82 10.11 7 201126 322 110387844
Lymphocyte count decreased 10.80 10.11 155 200978 57088 110331078
Anhedonia 10.76 10.11 56 201077 15372 110372794
Allergic reaction to excipient 10.74 10.11 10 201123 789 110387377
Joint injury 10.73 10.11 37 201096 39957 110348209
Device difficult to use 10.73 10.11 11 201122 18794 110369372
Proctitis 10.72 10.11 9 201124 16918 110371248
Eyelid haematoma 10.72 10.11 5 201128 119 110388047
Verbal abuse 10.72 10.11 7 201126 327 110387839
Cerebellar haematoma 10.65 10.11 9 201124 625 110387541
Osteonecrosis of jaw 10.61 10.11 48 201085 47969 110340197
Upper-airway cough syndrome 10.58 10.11 8 201125 15849 110372317
Polydipsia psychogenic 10.57 10.11 7 201126 335 110387831
Flight of ideas 10.56 10.11 10 201123 806 110387360
Rectal spasm 10.55 10.11 6 201127 218 110387948
Breast pain 10.52 10.11 41 201092 9959 110378207
Peripheral T-cell lymphoma unspecified recurrent 10.52 10.11 4 201129 56 110388110
Radial nerve palsy 10.51 10.11 8 201125 478 110387688
Drug eruption 10.49 10.11 56 201077 53603 110334563
Weight fluctuation 10.46 10.11 15 201118 22130 110366036
Tic 10.46 10.11 21 201112 3472 110384694
Sialoadenitis 10.42 10.11 18 201115 2655 110385511
Acne 10.42 10.11 29 201104 33491 110354675
Laboratory test abnormal 10.39 10.11 43 201090 44036 110344130
Medulloblastoma 10.39 10.11 5 201128 128 110388038
Rubber sensitivity 10.38 10.11 17 201116 2401 110385765
Vertebroplasty 10.38 10.11 7 201126 345 110387821
Crying 10.38 10.11 81 201052 25547 110362619
Hepatic cytolysis 10.36 10.11 149 200984 54904 110333262
Pulmonary mass 10.36 10.11 34 201099 37267 110350899
Cellulitis orbital 10.35 10.11 11 201122 1019 110387147
Carbon monoxide poisoning 10.33 10.11 7 201126 348 110387818
Alcohol poisoning 10.33 10.11 38 201095 8982 110379184
Dreamy state 10.33 10.11 4 201129 59 110388107
Breath sounds abnormal 10.32 10.11 19 201114 25385 110362781
Anaemia macrocytic 10.32 10.11 33 201100 7270 110380896
Pulmonary renal syndrome 10.31 10.11 10 201123 831 110387335
Secretion discharge 10.29 10.11 13 201120 20231 110367935
Congenital central nervous system anomaly 10.28 10.11 5 201128 131 110388035
Alcohol problem 10.27 10.11 4 201129 60 110388106
Unemployment 10.27 10.11 4 201129 60 110388106
Mental disability 10.26 10.11 6 201127 230 110387936
Hypersexuality 10.24 10.11 15 201118 1925 110386241
Blood test abnormal 10.20 10.11 23 201110 28531 110359635
Suspected suicide attempt 10.17 10.11 7 201126 357 110387809
Blood pressure fluctuation 10.17 10.11 87 201046 74737 110313429
Reversible cerebral vasoconstriction syndrome 10.17 10.11 25 201108 4736 110383430
Fluid intake restriction 10.15 10.11 4 201129 62 110388104
Hyperuricaemia 10.13 10.11 7 201126 14524 110373642
Breast cancer female 10.12 10.11 5 201128 12463 110375703

FDA Adverse Event Reporting System (Pediatric)

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
Neonatal asphyxia 37.12 33.83 22 744 221 112966
Neonatal seizure 35.98 33.83 28 738 455 112732

Pharmacologic Action:

SourceCodeDescription
ATC N06AX11 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Other antidepressants
MeSH PA D000317 Adrenergic alpha-Antagonists
MeSH PA D000928 Antidepressive Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D011619 Psychotropic Drugs
MeSH PA D012702 Serotonin Antagonists
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018490 Serotonin Agents
MeSH PA D018663 Adrenergic Agents
MeSH PA D018674 Adrenergic Antagonists
MeSH PA D058669 Adrenergic alpha-2 Receptor Antagonists
MeSH PA D058830 Serotonin 5-HT2 Receptor Antagonists
MeSH PA D058831 Serotonin 5-HT3 Receptor Antagonists
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:37890 ฮฑ-adrenergic antagonist
CHEBI has role CHEBI:37955 H<small><sub>1</sub></small>-receptor antagonist
CHEBI has role CHEBI:37956 histamine antagonist
CHEBI has role CHEBI:48279 serotonergic antagonist
CHEBI has role CHEBI:50779 appetite enhancer
CHEBI has role CHEBI:50919 antiemetic
CHEBI has role CHEBI:74518 anti-obesity agent
CHEBI has role CHEBI:146270 oneirogen

Related Drugs by ATC class:

N06AX Other antidepressants 28 drugs

Drug Use | Suggest Off label Use Form| |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




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Cats Management of weight loss in cats Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Mirataz Dechra, Ltd. 1

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

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3515 TABLET, FILM COATED 15 mg ORAL ANDA 29 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3530 TABLET, FILM COATED 30 mg ORAL ANDA 29 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3545 TABLET, FILM COATED 45 mg ORAL ANDA 29 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 0615-8489 TABLET, FILM COATED 7.50 mg ORAL ANDA 28 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0904-6519 TABLET, FILM COATED 15 mg ORAL ANDA 25 sections
Mirtazapine Human Prescription Drug Label 1 13107-001 TABLET, FILM COATED 7.50 mg ORAL ANDA 27 sections
Mirtazapine Human Prescription Drug Label 1 13107-003 TABLET, FILM COATED 30 mg ORAL ANDA 27 sections
Mirtazapine Human Prescription Drug Label 1 13107-031 TABLET, FILM COATED 15 mg ORAL ANDA 27 sections
Mirtazapine Human Prescription Drug Label 1 13107-032 TABLET, FILM COATED 45 mg ORAL ANDA 27 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 31722-407 TABLET, FILM COATED 7.50 mg ORAL ANDA 27 sections
mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 31722-408 TABLET, FILM COATED 15 mg ORAL ANDA 27 sections
mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 31722-409 TABLET, FILM COATED 30 mg ORAL ANDA 27 sections
mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 31722-410 TABLET, FILM COATED 45 mg ORAL ANDA 27 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
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 42254-269 TABLET, FILM COATED 45 mg ORAL ANDA 26 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 42291-494 TABLET 7.50 mg ORAL ANDA 24 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 42291-952 TABLET, FILM COATED 30 mg ORAL ANDA 25 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 43353-378 TABLET, FILM COATED 30 mg ORAL ANDA 24 sections