zopiclone ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
hypnotic tranquillizers 2873 43200-80-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • zopiclone
  • zimovane
  • imovane
S(+)-enantiomer of racemic zopiclone; azabicyclo(4.3.0)nonane; a nonbenzodiazepine; one of the so-called of Z drugs (zopiclone, eszopiclone, zolpidem, and zaleplon) for which there is some correlation with tumors; was term of zopiclone 2004-2007
  • Molecular weight: 388.81
  • Formula: C17H17ClN6O3
  • CLOGP: 1.25
  • LIPINSKI: 0
  • HAC: 9
  • HDO: 0
  • TPSA: 91.76
  • ALOGS: -2.64
  • ROTB: 3

Drug dosage:

DoseUnitRoute
7.50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.12 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 4.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.28 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 1.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.20 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5.20 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 15, 2004 FDA SUNOVION PHARMS 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
Lower respiratory tract infection 722.44 11.49 1035 113842 131272 63242873
Intentional overdose 697.36 11.49 762 114115 73390 63300755
Coma 595.70 11.49 656 114221 63708 63310437
Intentional self-injury 593.93 11.49 439 114438 25248 63348897
Folliculitis 457.21 11.49 599 114278 69718 63304427
Muscle injury 450.45 11.49 573 114304 64772 63309373
Muscle spasticity 445.29 11.49 346 114531 21448 63352697
Ill-defined disorder 431.81 11.49 630 114247 81125 63293020
Poisoning deliberate 410.88 11.49 255 114622 10963 63363182
Ear pain 403.28 11.49 407 114470 35711 63338434
Body temperature increased 378.94 11.49 399 114478 36793 63337352
Irritable bowel syndrome 378.37 11.49 595 114282 81817 63292328
Respiratory disorder 347.08 11.49 390 114487 38692 63335453
Gastrointestinal disorder 302.78 11.49 707 114170 130532 63243613
Sinusitis 302.07 11.49 999 113878 225654 63148491
Night sweats 288.40 11.49 397 114480 48417 63325728
Impaired healing 286.96 11.49 597 114280 101945 63272200
Blister 269.05 11.49 671 114206 129143 63245002
Confusional state 268.28 11.49 988 113889 235392 63138753
Pneumonia aspiration 244.42 11.49 307 114570 34233 63339912
Schizoaffective disorder 243.27 11.49 122 114755 3440 63370705
Peripheral swelling 225.76 11.49 1016 113861 264926 63109219
Stomatitis 223.04 11.49 653 114224 138072 63236073
Sleep disorder due to general medical condition, insomnia type 219.05 11.49 362 114515 51855 63322290
Product dose omission issue 204.49 11.49 84 114793 234229 63139916
Somnolence 201.83 11.49 746 114131 177939 63196206
Sleep disorder 172.44 11.49 425 114452 81141 63293004
Insomnia 166.78 11.49 801 114076 214451 63159694
Pruritus 165.10 11.49 1169 113708 360284 63013861
Nasopharyngitis 161.49 11.49 895 113982 253362 63120783
Death 156.11 11.49 274 114603 374107 63000038
Electrocardiogram QT prolonged 139.63 11.49 323 114554 59207 63314938
Electric shock 135.83 11.49 60 114817 1260 63372885
Toxicity to various agents 134.73 11.49 836 114041 246414 63127731
Weight increased 131.75 11.49 865 114012 259927 63114218
Urticaria 131.26 11.49 621 114256 165181 63208964
Joint swelling 126.01 11.49 1018 113859 326648 63047497
Cardiac failure congestive 111.48 11.49 17 114860 92416 63281729
Drug level increased 104.00 11.49 164 114713 22572 63351573
Infection 99.68 11.49 733 114144 228440 63145705
Akathisia 96.47 11.49 100 114777 9046 63365099
Therapeutic product effect decreased 89.83 11.49 628 114249 192559 63181586
Miosis 87.83 11.49 86 114791 7267 63366878
Intervertebral discitis 85.62 11.49 60 114817 3168 63370977
Post-traumatic stress disorder 83.34 11.49 72 114805 5179 63368966
Depressed level of consciousness 81.88 11.49 273 114604 61805 63312340
Suicide attempt 80.44 11.49 268 114609 60650 63313495
Prescription form tampering 75.11 11.49 31 114846 547 63373598
Injection site pain 74.36 11.49 75 114802 129725 63244420
Contusion 73.42 11.49 494 114383 149550 63224595
Drug ineffective 71.94 11.49 1397 113480 1043368 62330777
Neovascularisation 71.73 11.49 37 114840 1108 63373037
Sepsis 65.57 11.49 110 114767 153013 63221132
White blood cell count decreased 64.24 11.49 95 114782 139009 63235136
Obstructive airways disorder 61.94 11.49 124 114753 20575 63353570
Abdominal pain upper 60.99 11.49 606 114271 205838 63168307
Antipsychotic drug level increased 60.47 11.49 50 114827 3385 63370760
Medication error 59.50 11.49 219 114658 52065 63322080
Granulocyte count increased 59.42 11.49 30 114847 858 63373287
Respiratory failure 59.32 11.49 58 114819 101800 63272345
Lupus vasculitis 58.99 11.49 26 114851 543 63373602
Vaginal flatulence 58.11 11.49 48 114829 3245 63370900
Drug dependence 57.55 11.49 133 114744 24350 63349795
Proctitis 56.50 11.49 59 114818 5382 63368763
Sputum discoloured 56.37 11.49 104 114773 16243 63357902
Vocal cord dysfunction 56.29 11.49 25 114852 532 63373613
Duodenal ulcer perforation 55.88 11.49 308 114569 86901 63287244
Pneumonia 55.73 11.49 543 114334 456224 62917921
Back pain 54.89 11.49 724 114153 263421 63110724
Skin candida 54.05 11.49 35 114842 1620 63372525
Pain in extremity 53.74 11.49 365 114512 331121 63043024
Cerebrovascular accident 53.65 11.49 70 114807 107954 63266191
Platelet count decreased 52.94 11.49 80 114797 116042 63258103
Pyrexia 52.85 11.49 1167 113710 469311 62904834
Broncholithiasis 52.25 11.49 19 114858 234 63373911
Demyelination 51.32 11.49 63 114814 6857 63367288
Hepatocellular injury 49.90 11.49 135 114742 27246 63346899
Newborn persistent pulmonary hypertension 49.85 11.49 18 114859 217 63373928
COVID-19 49.58 11.49 80 114797 113023 63261122
Urine leukocyte esterase positive 48.72 11.49 45 114832 3534 63370611
Wrong technique in product usage process 48.68 11.49 26 114851 62314 63311831
Myocardial infarction 48.31 11.49 66 114811 99827 63274318
Abortion spontaneous 47.95 11.49 13 114864 47182 63326963
Bronchial wall thickening 47.24 11.49 31 114846 1468 63372677
Lymph node calcification 47.23 11.49 19 114858 313 63373832
Foetal death 47.20 11.49 77 114800 10903 63363242
Unevaluable event 47.12 11.49 17 114860 51369 63322776
Helicobacter infection 46.87 11.49 308 114569 92477 63281668
Therapy interrupted 46.82 11.49 3 114874 32452 63341693
Incorrect route of product administration 46.71 11.49 132 114745 27320 63346825
Altered state of consciousness 46.59 11.49 125 114752 25105 63349040
Disease progression 46.50 11.49 95 114782 122663 63251482
Nausea 46.20 11.49 1186 113691 853285 62520860
Injection site reaction 44.83 11.49 25 114852 58499 63315646
Sinus rhythm 43.32 11.49 24 114853 832 63373313
Injection site erythema 43.28 11.49 52 114825 83122 63291023
Premature delivery 43.09 11.49 3 114874 30278 63343867
Temperature intolerance 42.86 11.49 66 114811 8898 63365247
Neutropenia 42.26 11.49 168 114709 174837 63199308
Post cholecystectomy syndrome 42.12 11.49 19 114858 420 63373725
Colitis ulcerative 42.02 11.49 123 114754 25968 63348177
Somnambulism 41.98 11.49 51 114826 5492 63368653
Osmolar gap increased 41.19 11.49 13 114864 100 63374045
No adverse event 40.96 11.49 12 114865 41393 63332752
Female genital tract fistula 40.93 11.49 59 114818 7500 63366645
Blood glucose increased 40.84 11.49 55 114822 83701 63290444
Laryngeal stenosis 40.72 11.49 25 114852 1053 63373092
Frequent bowel movements 40.45 11.49 112 114765 22910 63351235
Urinary tract infection 40.16 11.49 297 114580 264387 63109758
Pulmonary hypertension 40.10 11.49 9 114868 37114 63337031
Mydriasis 39.89 11.49 75 114802 11881 63362264
Decompression sickness 39.76 11.49 12 114865 78 63374067
Drug hypersensitivity 39.69 11.49 365 114512 310322 63063823
Hospitalisation 39.37 11.49 58 114819 85023 63289122
Cryopyrin associated periodic syndrome 39.10 11.49 17 114860 343 63373802
Thrombosis 38.71 11.49 36 114841 64719 63309426
Hypersensitivity 38.71 11.49 744 114133 291941 63082204
Gastrooesophageal reflux disease 38.18 11.49 300 114577 95339 63278806
Product quality issue 38.13 11.49 9 114868 35856 63338289
Therapy cessation 38.12 11.49 5 114872 30452 63343693
Injection site pruritus 37.98 11.49 17 114860 45099 63329046
Completed suicide 37.66 11.49 136 114741 145537 63228608
Excessive eye blinking 36.79 11.49 25 114852 1255 63372890
Renal impairment 36.41 11.49 65 114812 88290 63285855
Condition aggravated 35.92 11.49 512 114365 401705 62972440
Chronic kidney disease 35.34 11.49 19 114858 45379 63328766
Contraindicated product administered 35.09 11.49 571 114306 217077 63157068
Atrial fibrillation 34.93 11.49 102 114775 116534 63257611
Total lung capacity decreased 34.78 11.49 30 114847 2153 63371992
Blood immunoglobulin A increased 34.49 11.49 20 114857 758 63373387
Progressive multifocal leukoencephalopathy 34.46 11.49 74 114803 12897 63361248
Bronchopulmonary aspergillosis allergic 33.90 11.49 30 114847 2228 63371917
Vaginal discharge 33.59 11.49 60 114817 9138 63365007
Overdose 33.55 11.49 337 114540 114741 63259404
Liver function test abnormal 33.55 11.49 23 114854 48158 63325987
Extrapyramidal disorder 33.26 11.49 74 114803 13210 63360935
Swelling 33.06 11.49 690 114187 274688 63099457
Aspartate aminotransferase 32.91 11.49 16 114861 421 63373724
Paradoxical drug reaction 32.75 11.49 39 114838 4113 63370032
Coronary artery disease 32.74 11.49 9 114868 32368 63341777
Hypervolaemia 32.53 11.49 6 114871 28407 63345738
Renal failure 32.32 11.49 107 114770 117545 63256600
Diabetes mellitus 32.23 11.49 32 114845 55778 63318367
Glomerular filtration rate increased 31.83 11.49 20 114857 878 63373267
Deep vein thrombosis postoperative 30.36 11.49 65 114812 11304 63362841
Asphyxia 30.24 11.49 46 114831 6135 63368010
Calcium deficiency 30.23 11.49 21 114856 1093 63373052
Middle insomnia 30.06 11.49 69 114808 12574 63361571
Post-traumatic neck syndrome 30.04 11.49 27 114850 2047 63372098
Dyspnoea exertional 30.01 11.49 39 114838 60263 63313882
Alopecia 30.00 11.49 430 114447 337106 63037039
Postmortem blood drug level abnormal 29.68 11.49 14 114863 344 63373801
Hyponatraemia 29.46 11.49 321 114556 111579 63262566
Depressed mood 29.20 11.49 147 114730 40044 63334101
Injection site bruising 29.19 11.49 20 114857 41890 63332255
Red blood cells urine 29.03 11.49 16 114861 549 63373596
Eye irritation 29.01 11.49 3 114874 21968 63352177
Libido increased 28.87 11.49 22 114855 1323 63372822
Maternal exposure during pregnancy 28.75 11.49 257 114620 219805 63154340
Full blood count decreased 28.73 11.49 6 114871 26018 63348127
Carcinoid tumour pulmonary 28.66 11.49 15 114862 463 63373682
Gallbladder adenocarcinoma 28.60 11.49 10 114867 109 63374036
Adrenal insufficiency 28.41 11.49 84 114793 17831 63356314
Concussion 28.40 11.49 56 114821 9188 63364957
Mobility decreased 28.18 11.49 118 114759 121041 63253104
Cellulitis 28.09 11.49 67 114810 81891 63292254
Postmortem blood drug level increased 28.03 11.49 16 114861 588 63373557
Exposure during pregnancy 27.34 11.49 167 114710 155380 63218765
Feeling abnormal 27.31 11.49 157 114720 148235 63225910
Coordination abnormal 27.23 11.49 70 114807 13703 63360442
Neoplasm malignant 27.17 11.49 10 114867 29851 63344294
Soft tissue injury 26.92 11.49 23 114854 1629 63372516
Sopor 26.89 11.49 4 114873 22160 63351985
Behaviour disorder 26.81 11.49 31 114846 3168 63370977
Injection site swelling 26.65 11.49 28 114849 47544 63326601
Hostility 26.38 11.49 24 114853 1848 63372297
Vasoplegia syndrome 26.36 11.49 23 114854 1676 63372469
Haemoglobin urine 26.34 11.49 10 114867 140 63374005
Lupus nephritis 26.33 11.49 29 114848 2810 63371335
Deep vein thrombosis 26.03 11.49 72 114805 83728 63290417
Seizure 25.67 11.49 138 114739 132496 63241649
Aspartate aminotransferase increased 25.56 11.49 81 114796 90196 63283949
Lung opacity 25.39 11.49 30 114847 3138 63371007
Surgery 25.20 11.49 17 114860 35895 63338250
Radiculopathy 25.06 11.49 51 114826 8560 63365585
Electrocardiogram repolarisation abnormality 24.93 11.49 20 114857 1297 63372848
Cytomegalovirus infection 24.92 11.49 4 114873 20948 63353197
Neutrophil count increased 24.80 11.49 76 114801 16451 63357694
Throat clearing 24.70 11.49 26 114851 2393 63371752
Staphylococcal infection 24.58 11.49 23 114854 41233 63332912
Arthritis 24.49 11.49 117 114760 115804 63258341
Antipsychotic drug level above therapeutic 24.48 11.49 18 114859 1025 63373120
Agitation neonatal 24.32 11.49 14 114863 523 63373622
Diaphragmatic rupture 24.06 11.49 11 114866 251 63373894
Multiple organ dysfunction syndrome 24.06 11.49 41 114836 56711 63317434
Psychotic symptom 23.96 11.49 21 114856 1540 63372605
Hypotonia neonatal 23.75 11.49 19 114858 1227 63372918
Accidental exposure to product 23.58 11.49 10 114867 27395 63346750
X-ray abnormal 23.56 11.49 48 114829 8062 63366083
Cardiac arrest 23.51 11.49 87 114790 92458 63281687
White blood cells urine positive 23.30 11.49 37 114840 5121 63369024
Vitamin B12 increased 23.23 11.49 18 114859 1110 63373035
Rash 23.13 11.49 1238 113639 559633 62814512
Neonatal respiratory failure 22.89 11.49 11 114866 282 63373863
Presyncope 22.57 11.49 11 114866 27774 63346371
Cholestasis 22.34 11.49 109 114768 29325 63344820
Neutropenic sepsis 22.30 11.49 73 114804 16365 63357780
Pulmonary embolism 22.25 11.49 122 114755 116562 63257583
Neonatal asphyxia 22.07 11.49 11 114866 306 63373839
Distal intestinal obstruction syndrome 21.93 11.49 12 114865 406 63373739
Hypothermia 21.84 11.49 64 114813 13517 63360628
Atelectasis 21.67 11.49 6 114871 21477 63352668
Abdominal discomfort 21.58 11.49 430 114447 320455 63053690
Antidepressant drug level above therapeutic 21.43 11.49 12 114865 425 63373720
Suicidal ideation 21.28 11.49 189 114688 62232 63311913
Device dislocation 21.15 11.49 10 114867 25695 63348450
Drug abuse 20.95 11.49 212 114665 72306 63301839
Septic shock 20.88 11.49 57 114820 66572 63307573
Malignant polyp 20.68 11.49 9 114868 182 63373963
Rales 20.58 11.49 60 114817 12637 63361508
Bursitis 20.58 11.49 126 114751 36915 63337230
Blood pressure systolic decreased 20.58 11.49 43 114834 7354 63366791
Bronchiolitis 20.36 11.49 25 114852 2722 63371423
Drug resistance 20.33 11.49 8 114869 22925 63351220
Balance disorder 20.33 11.49 238 114639 84184 63289961
Adjustment disorder with depressed mood 20.31 11.49 52 114825 10152 63363993
Myocarditis septic 20.29 11.49 6 114871 36 63374109
Fluid retention 20.29 11.49 49 114828 59637 63314508
Plasma cell myeloma 20.26 11.49 21 114856 35884 63338261
Therapeutic product effect incomplete 20.07 11.49 138 114739 124918 63249227
Oral candidiasis 19.94 11.49 88 114789 22710 63351435
Therapeutic reaction time decreased 19.92 11.49 23 114854 2347 63371798
Lactic acidosis 19.87 11.49 128 114749 38159 63335986
Nightmare 19.85 11.49 78 114799 19116 63355029
Urine abnormality 19.75 11.49 41 114836 6978 63367167
Drug level above therapeutic 19.71 11.49 33 114844 4772 63369373
Burnout syndrome 19.70 11.49 9 114868 205 63373940
Negative thoughts 19.54 11.49 15 114862 912 63373233
Hypertension 19.47 11.49 372 114505 278931 63095214
Fungal infection 19.23 11.49 23 114854 36851 63337294
Nodule 19.20 11.49 7 114870 21019 63353126
Sternal fracture 19.16 11.49 22 114855 2232 63371913
Rheumatoid factor increased 19.11 11.49 20 114857 1829 63372316
Dyspnoea 19.03 11.49 1415 113462 659898 62714247
Loss of personal independence in daily activities 18.95 11.49 101 114776 97189 63276956
Right ventricular failure 18.90 11.49 4 114873 17184 63356961
Disturbance in attention 18.81 11.49 126 114751 38063 63336082
Monocyte percentage increased 18.74 11.49 16 114861 1132 63373013
Post procedural complication 18.72 11.49 4 114873 17070 63357075
Osteomyelitis 18.68 11.49 12 114865 26008 63348137
Fear of disease 18.60 11.49 17 114860 1317 63372828
Blindness 18.54 11.49 8 114869 21691 63352454
Rheumatoid factor positive 18.53 11.49 84 114793 84322 63289823
Blood creatine increased 18.52 11.49 35 114842 5566 63368579
Hepatotoxicity 18.38 11.49 24 114853 37017 63337128
Cholelithiasis 18.38 11.49 32 114845 43893 63330252
Skin ulcer 18.34 11.49 31 114846 43014 63331131
Blood test abnormal 18.22 11.49 66 114811 15563 63358582
Joint injury 18.20 11.49 16 114861 29556 63344589
Toxicologic test abnormal 18.19 11.49 13 114864 708 63373437
Transient ischaemic attack 18.19 11.49 25 114852 37728 63336417
Infusion related reaction 18.19 11.49 577 114300 244944 63129201
Wrong rate 18.08 11.49 6 114871 55 63374090
Hypocoagulable state 18.05 11.49 16 114861 1191 63372954
Hallucination, synaesthetic 17.99 11.49 6 114871 56 63374089
Visual impairment 17.97 11.49 85 114792 84361 63289784
Bulimia nervosa 17.92 11.49 11 114866 463 63373682
Hypersensitivity vasculitis 17.89 11.49 29 114848 4083 63370062
Bone pain 17.68 11.49 46 114831 54595 63319550
Neoplasm progression 17.67 11.49 24 114853 36404 63337741
Gallbladder disorder 17.67 11.49 6 114871 18836 63355309
Gait deviation 17.36 11.49 6 114871 63 63374082
Tooth hypoplasia 17.19 11.49 6 114871 65 63374080
Intentional product use issue 17.17 11.49 326 114551 127566 63246579
Drug eruption 17.09 11.49 16 114861 28678 63345467
Lymphadenopathy 17.03 11.49 27 114850 38431 63335714
Haematocrit increased 16.97 11.49 21 114856 2305 63371840
Neonatal seizure 16.95 11.49 11 114866 511 63373634
Rheumatoid nodule 16.91 11.49 5 114872 17150 63356995
Coagulopathy 16.89 11.49 8 114869 20536 63353609
Dry skin 16.84 11.49 50 114827 56837 63317308
Ascites 16.74 11.49 30 114847 40698 63333447
Myalgia 16.64 11.49 177 114700 146352 63227793
Anaemia 16.62 11.49 404 114473 293026 63081119
Myelocyte percentage increased 16.61 11.49 8 114869 206 63373939
Angina pectoris 16.51 11.49 18 114859 30060 63344085
Ligament pain 16.44 11.49 8 114869 211 63373934
Antibody test abnormal 16.32 11.49 11 114866 545 63373600
Hypocalcaemia 16.31 11.49 20 114857 31693 63342452
Temperature regulation disorder 16.31 11.49 35 114842 6097 63368048
Asthenia 16.23 11.49 849 114028 382755 62991390
Housebound 15.94 11.49 8 114869 226 63373919
Creatinine renal clearance decreased 15.63 11.49 5 114872 16303 63357842
Tenosynovitis 15.61 11.49 3 114874 13792 63360353
Cardiac failure 15.50 11.49 96 114781 89046 63285099
Band neutrophil percentage increased 15.50 11.49 8 114869 240 63373905
Acute respiratory failure 15.47 11.49 24 114853 34461 63339684
Posterior reversible encephalopathy syndrome 15.46 11.49 6 114871 17339 63356806
Tenderness 15.42 11.49 11 114866 22567 63351578
Choking 15.36 11.49 46 114831 9833 63364312
Gait disturbance 15.33 11.49 236 114641 182942 63191203
Blood immunoglobulin E increased 15.22 11.49 26 114851 3823 63370322
Psoriatic arthropathy 15.18 11.49 100 114777 91420 63282725
Procedural anxiety 15.15 11.49 12 114865 764 63373381
Granulomatous liver disease 15.12 11.49 12 114865 766 63373379
Urine oxalate increased 15.08 11.49 8 114869 254 63373891
Poor feeding infant 15.06 11.49 9 114868 361 63373784
Diabetic hyperosmolar coma 15.06 11.49 9 114868 361 63373784
Malignant neoplasm progression 15.04 11.49 87 114790 82034 63292111
Postnatal growth restriction 14.86 11.49 4 114873 16 63374129
Accommodation disorder 14.81 11.49 9 114868 372 63373773
Breast cancer 14.71 11.49 42 114835 48341 63325804
Diverticulitis 14.64 11.49 31 114846 39526 63334619
Urinary tract obstruction 14.62 11.49 19 114858 2189 63371956
Ankle fracture 14.60 11.49 7 114870 17848 63356297
Pharyngeal paraesthesia 14.43 11.49 18 114859 1991 63372154
Dry mouth 14.33 11.49 209 114668 77654 63296491
Complement factor C4 decreased 14.32 11.49 8 114869 282 63373863
Cardiomegaly 14.26 11.49 7 114870 17607 63356538
Eye pruritus 14.26 11.49 8 114869 18663 63355482
Retinal depigmentation 14.24 11.49 8 114869 285 63373860
Multiple sclerosis 14.23 11.49 84 114793 24288 63349857
Respiratory tract infection 14.14 11.49 34 114843 41449 63332696
Alanine aminotransferase increased 14.06 11.49 120 114757 103650 63270495
Hepatitis 14.05 11.49 32 114845 39756 63334389
Autoimmune disorder 14.04 11.49 65 114812 17112 63357033
Basal cell carcinoma 14.03 11.49 18 114859 27973 63346172
Treatment noncompliance 14.03 11.49 29 114848 37296 63336849
Chronic obstructive pulmonary disease 13.99 11.49 62 114815 62624 63311521
Pulmonary congestion 13.99 11.49 7 114870 17411 63356734
Mass 13.95 11.49 4 114873 13996 63360149
Drug use disorder 13.89 11.49 29 114848 4955 63369190
Ocular hyperaemia 13.86 11.49 15 114862 25129 63349016
Hepatic function abnormal 13.84 11.49 29 114848 37113 63337032
Crystal urine present 13.82 11.49 16 114861 1638 63372507
Acute hepatic failure 13.79 11.49 8 114869 18319 63355826
Hypoaesthesia 13.74 11.49 218 114659 168175 63205970
Leukocytosis 13.72 11.49 16 114861 25919 63348226
Hypoventilation 13.65 11.49 28 114849 4726 63369419
Pericarditis 13.64 11.49 323 114554 131256 63242889
Treatment failure 13.58 11.49 266 114611 198777 63175368
Glucocorticoids increased 13.58 11.49 6 114871 126 63374019
Spinal stenosis 13.57 11.49 5 114872 14920 63359225
Leukopenia 13.56 11.49 83 114794 77207 63296938
Abdominal pain 13.54 11.49 655 114222 292801 63081344
Dizziness 13.50 11.49 638 114239 429287 62944858
Tri-iodothyronine free decreased 13.49 11.49 8 114869 316 63373829
Eosinophil count abnormal 13.47 11.49 10 114867 578 63373567
Caesarean section 13.45 11.49 7 114870 17025 63357120
Chest pain 13.44 11.49 293 114584 215666 63158479
Pericardial effusion 13.41 11.49 21 114856 30037 63344108
Disseminated intravascular coagulation 13.39 11.49 9 114868 19042 63355103
Rhinorrhoea 13.37 11.49 67 114810 65510 63308635
Occult blood 13.32 11.49 14 114863 1287 63372858
Device issue 13.31 11.49 14 114863 23767 63350378
Ear infection 13.28 11.49 31 114846 38182 63335963
Anti-cyclic citrullinated peptide antibody positive 13.21 11.49 289 114588 115923 63258222
Hyperhidrosis 13.17 11.49 271 114606 107565 63266580
Drug diversion 13.06 11.49 12 114865 936 63373209
Premature baby 13.03 11.49 11 114866 20724 63353421
Gastrointestinal haemorrhage 12.81 11.49 90 114787 81086 63293059
Chest wall mass 12.80 11.49 5 114872 76 63374069
Cardiac disorder 12.76 11.49 48 114829 50768 63323377
Failed induction of labour 12.72 11.49 8 114869 352 63373793
Sensory level abnormal 12.70 11.49 6 114871 148 63373997
Hypoacusis 12.66 11.49 15 114862 24136 63350009
Swollen joint count 12.56 11.49 13 114864 1173 63372972
Myocardial depression 12.52 11.49 9 114868 495 63373650
Myelocyte count increased 12.52 11.49 8 114869 362 63373783
Pain 12.49 11.49 1526 113351 739102 62635043
Eye paraesthesia 12.48 11.49 6 114871 154 63373991
Hypoalbuminaemia 12.47 11.49 3 114874 11802 63362343
Hypercalcaemia 12.43 11.49 20 114857 28302 63345843
Blood pressure abnormal 12.37 11.49 6 114871 15192 63358953
Injection site warmth 12.36 11.49 6 114871 15189 63358956
Cerebral infarction 12.36 11.49 15 114862 23878 63350267
Oedema 12.30 11.49 115 114762 97507 63276638
Inappropriate antidiuretic hormone secretion 12.27 11.49 58 114819 15404 63358741
Liver injury 12.25 11.49 62 114815 60458 63313687
Anuria 12.17 11.49 50 114827 12501 63361644
Blood creatinine increased 12.16 11.49 101 114776 87743 63286402
Dactylitis 12.16 11.49 19 114858 2593 63371552
Adverse event 12.14 11.49 72 114805 67487 63306658
Seasonal allergy 12.11 11.49 12 114865 20938 63353207
Anticonvulsant drug level above therapeutic 12.08 11.49 9 114868 523 63373622
Osteonecrosis 12.06 11.49 16 114861 24514 63349631
Band neutrophil count increased 12.04 11.49 8 114869 387 63373758
Decreased appetite 12.02 11.49 354 114523 250698 63123447
Eye disorder 11.99 11.49 14 114863 22671 63351474
Complication associated with device 11.96 11.49 8 114869 16970 63357175
Pancreatic carcinoma recurrent 11.92 11.49 5 114872 92 63374053
Throat irritation 11.82 11.49 112 114765 37535 63336610
Incorrect dose administered 11.82 11.49 62 114815 59906 63314239
Epistaxis 11.79 11.49 80 114797 72645 63301500
Eosinophilia 11.76 11.49 76 114801 22680 63351465
Rectal haemorrhage 11.70 11.49 138 114739 48892 63325253
Labelled drug-food interaction medication error 11.68 11.49 6 114871 178 63373967
Blood triglycerides increased 11.67 11.49 4 114873 12484 63361661
Pleural effusion 11.66 11.49 110 114767 93100 63281045
Urinary sediment present 11.64 11.49 17 114860 2186 63371959
Tobacco interaction 11.57 11.49 4 114873 42 63374103
Viral infection 11.56 11.49 30 114847 35633 63338512
Chronic sinusitis 11.55 11.49 50 114827 12793 63361352

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
Depression 944.72 11.96 852 42323 96246 34817510
Drug interaction 661.28 11.96 1075 42100 224871 34688885
Poisoning deliberate 427.76 11.96 204 42971 7640 34906116
Coma 412.06 11.96 385 42790 45293 34868463
Loss of personal independence in daily activities 208.15 11.96 230 42945 32949 34880807
Intentional overdose 189.32 11.96 251 42924 43423 34870333
Psychiatric decompensation 186.80 11.96 85 43090 2852 34910904
Depression suicidal 154.61 11.96 71 43104 2434 34911322
Psychomotor skills impaired 149.56 11.96 80 43095 3826 34909930
Suicidal ideation 149.31 11.96 215 42960 40173 34873583
Somnolence 146.99 11.96 382 42793 110734 34803022
Depressive symptom 142.66 11.96 70 43105 2789 34910967
Toxicity to various agents 142.66 11.96 556 42619 199806 34713950
Tearfulness 141.21 11.96 68 43107 2599 34911157
Suicide attempt 137.00 11.96 203 42972 38913 34874843
Miosis 136.60 11.96 105 43070 9430 34904326
Hypothermia 107.29 11.96 96 43079 10652 34903104
Intentional self-injury 106.89 11.96 107 43068 13664 34900092
Psychotic disorder 88.62 11.96 129 43046 24323 34889433
Paranoia 88.61 11.96 91 43084 11977 34901779
Prescription form tampering 85.26 11.96 29 43146 437 34913319
Drug dependence 83.78 11.96 125 43050 24092 34889664
Electrocardiogram QT prolonged 80.83 11.96 165 43010 40787 34872969
Neuroleptic malignant syndrome 75.99 11.96 102 43073 17832 34895924
Hepatocellular injury 75.91 11.96 114 43061 22097 34891659
Disease progression 73.79 11.96 21 43154 108056 34805700
Blood mercury abnormal 69.30 11.96 21 43154 213 34913543
Product dose omission issue 68.58 11.96 31 43144 119680 34794076
5-hydroxyindolacetic acid in urine increased 67.36 11.96 21 43154 236 34913520
Drug abuse 65.47 11.96 269 42906 98827 34814929
Overdose 62.39 11.96 250 42925 90809 34822947
Low density lipoprotein decreased 60.07 11.96 29 43146 1114 34912642
Device dislocation 54.94 11.96 52 43123 6197 34907559
Confusional state 52.56 11.96 331 42844 143829 34769927
Housebound 52.28 11.96 17 43158 221 34913535
Cardiac failure congestive 51.84 11.96 19 43156 83251 34830505
Asphyxia 51.00 11.96 52 43123 6783 34906973
Cerebral artery thrombosis 50.94 11.96 23 43152 757 34912999
Dystonic tremor 49.56 11.96 16 43159 203 34913553
Altered state of consciousness 46.05 11.96 93 43082 22800 34890956
Myocardial infarction 45.99 11.96 49 43126 121036 34792720
Brain scan abnormal 45.26 11.96 22 43153 858 34912898
Agitation 43.70 11.96 163 43012 57236 34856520
Fall 43.25 11.96 411 42764 202474 34711282
Thrombosis 42.31 11.96 6 43169 50452 34863304
Cholestasis 40.09 11.96 97 43078 26851 34886905
Restless legs syndrome 39.24 11.96 50 43125 8304 34905452
Arteriovenous fistula 37.67 11.96 21 43154 1090 34912666
Withdrawal syndrome 37.07 11.96 60 43115 12395 34901361
Hepatic cytolysis 36.74 11.96 65 43110 14431 34899325
Serum ferritin abnormal 36.35 11.96 13 43162 229 34913527
Death 36.32 11.96 316 42859 397733 34516023
Macrophages increased 36.09 11.96 12 43163 168 34913588
Anxiety 36.01 11.96 228 42947 99200 34814556
Mental status changes 35.80 11.96 3 43172 38080 34875676
Bladder dilatation 34.40 11.96 22 43153 1470 34912286
Pneumonia aspiration 33.57 11.96 121 43054 41782 34871974
Logorrhoea 33.18 11.96 26 43149 2400 34911356
Alcohol poisoning 31.78 11.96 30 43145 3563 34910193
Bradypnoea 31.71 11.96 27 43148 2802 34910954
Hyperthermia 31.54 11.96 51 43124 10526 34903230
Agranulocytosis 31.50 11.96 82 43093 23739 34890017
Hepatic neoplasm 31.03 11.96 23 43152 1954 34911802
Tardive dyskinesia 30.98 11.96 37 43138 5753 34908003
Dysarthria 30.95 11.96 104 43071 34678 34879078
Toxic skin eruption 30.08 11.96 52 43123 11333 34902423
Respiratory tract haemorrhage 29.96 11.96 19 43156 1251 34912505
Implant site extravasation 29.79 11.96 13 43162 394 34913362
Puncture site haematoma 29.63 11.96 10 43165 147 34913609
Psychomotor retardation 29.50 11.96 29 43146 3621 34910135
Respiratory failure 29.27 11.96 56 43119 108516 34805240
Gastrointestinal haemorrhage 29.13 11.96 40 43135 88437 34825319
Prescribed overdose 28.62 11.96 49 43126 10598 34903158
Tooth injury 28.36 11.96 18 43157 1187 34912569
Overlap syndrome 28.33 11.96 9 43166 108 34913648
Hypoglycaemia 28.26 11.96 138 43037 54502 34859254
Sedation 27.46 11.96 72 43103 20934 34892822
Behaviour disorder 27.30 11.96 32 43143 4878 34908878
Coronary artery disease 26.88 11.96 13 43162 48292 34865464
Post concussion syndrome 26.68 11.96 9 43166 132 34913624
Muscle rigidity 26.44 11.96 47 43128 10471 34903285
Feelings of worthlessness 26.02 11.96 11 43164 308 34913448
Renal failure 25.96 11.96 79 43096 130478 34783278
Accessory spleen 25.96 11.96 9 43166 144 34913612
Burnout syndrome 25.73 11.96 9 43166 148 34913608
Diarrhoea 25.61 11.96 334 42841 389578 34524178
Dystonia 25.41 11.96 47 43128 10798 34902958
Drug monitoring procedure incorrectly performed 25.20 11.96 10 43165 237 34913519
Depressed mood 25.04 11.96 66 43109 19251 34894505
Rheumatoid arthritis 24.58 11.96 103 43072 38135 34875621
Obesity 24.34 11.96 51 43124 12827 34900929
Blood ethanol increased 24.15 11.96 12 43163 491 34913265
Injection site pain 24.09 11.96 9 43166 38996 34874760
Dyspnoea 23.92 11.96 325 42850 376457 34537299
Tremor 23.74 11.96 179 42996 82408 34831348
Contraindicated product administered 23.50 11.96 69 43106 21412 34892344
Behavioural addiction 23.46 11.96 7 43168 67 34913689
Pneumonia 22.94 11.96 313 42862 362314 34551442
Antiphospholipid antibodies positive 22.71 11.96 10 43165 310 34913446
Areflexia 22.50 11.96 23 43152 3008 34910748
Red blood cell elliptocytes present 22.36 11.96 8 43167 141 34913615
Coma scale abnormal 22.08 11.96 26 43149 3982 34909774
Faecaloma 21.89 11.96 30 43145 5347 34908409
Paraneoplastic rash 21.81 11.96 7 43168 87 34913669
Rash maculo-papular 21.81 11.96 81 43094 28370 34885386
Optic nerve operation 21.51 11.96 11 43164 479 34913277
Perineal infection 21.45 11.96 12 43163 627 34913129
Hyperreflexia 21.43 11.96 23 43152 3183 34910573
Scrotal infection 21.21 11.96 12 43163 641 34913115
Femoral artery aneurysm 21.20 11.96 8 43167 165 34913591
Therapy non-responder 21.08 11.96 11 43164 39135 34874621
Deep vein thrombosis 20.97 11.96 30 43145 65218 34848538
VACTERL syndrome 20.85 11.96 6 43169 50 34913706
Drug ineffective 20.76 11.96 419 42756 456332 34457424
Substance abuse 20.32 11.96 35 43140 7606 34906150
Bradycardia 20.30 11.96 161 43014 75257 34838499
Eosinophil percentage increased 20.20 11.96 11 43164 545 34913211
Drug intolerance 19.96 11.96 134 43041 59436 34854320
Restlessness 19.91 11.96 73 43102 25409 34888347
General physical health deterioration 19.89 11.96 244 42931 128025 34785731
Opiates positive 19.75 11.96 11 43164 570 34913186
Neutrophil percentage increased 19.54 11.96 17 43158 1816 34911940
Antipsychotic drug level increased 19.54 11.96 24 43151 3841 34909915
Disorientation 19.49 11.96 87 43088 33101 34880655
Abulia 19.42 11.96 11 43164 589 34913167
Lymphocyte percentage decreased 19.24 11.96 18 43157 2114 34911642
Spinal cord haemorrhage 19.18 11.96 9 43166 324 34913432
Expired product administered 18.95 11.96 22 43153 3319 34910437
Toxic epidermal necrolysis 18.62 11.96 64 43111 21582 34892174
Delirium febrile 18.52 11.96 5 43170 32 34913724
Sepsis 18.52 11.96 125 43050 166436 34747320
Pemphigoid 18.38 11.96 36 43139 8630 34905126
Disturbance in attention 18.35 11.96 72 43103 25873 34887883
Blood pressure diastolic abnormal 18.30 11.96 26 43149 4792 34908964
Hypersexuality 18.29 11.96 15 43160 1478 34912278
Device malfunction 18.24 11.96 40 43135 10381 34903375
Acute kidney injury 18.18 11.96 499 42676 304489 34609267
Depressed level of consciousness 17.89 11.96 102 43073 42739 34871017
Reduced facial expression 17.82 11.96 13 43162 1078 34912678
Drug resistance 17.75 11.96 5 43170 25922 34887834
Infected dermal cyst 17.74 11.96 12 43163 882 34912874
Acute respiratory failure 17.70 11.96 8 43167 30920 34882836
Respiratory depression 17.60 11.96 52 43123 16193 34897563
Normochromic normocytic anaemia 17.57 11.96 24 43151 4263 34909493
Ischaemic stroke 17.52 11.96 56 43119 18194 34895562
Phlebotomy 17.48 11.96 6 43169 93 34913663
Hemiplegia 17.33 11.96 31 43144 6941 34906815
Blepharospasm 17.33 11.96 13 43162 1125 34912631
Blood pressure systolic increased 17.30 11.96 65 43110 22887 34890869
Cardiac arrest 17.16 11.96 61 43114 96098 34817658
Pyrexia 17.10 11.96 299 42876 332714 34581042
Phonophobia 17.08 11.96 7 43168 181 34913575
Band neutrophil percentage increased 16.81 11.96 6 43169 105 34913651
Capillary fragility 16.75 11.96 5 43170 48 34913708
Intentional device misuse 16.52 11.96 7 43168 197 34913559
Chronic kidney disease 16.40 11.96 16 43159 41194 34872562
Anal haemorrhage 16.37 11.96 18 43157 2560 34911196
Loss of consciousness 16.34 11.96 165 43010 82502 34831254
Urine leukocyte esterase positive 16.23 11.96 9 43166 462 34913294
Therapeutic response decreased 16.14 11.96 8 43167 29305 34884451
COVID-19 16.07 11.96 46 43129 77504 34836252
Blood pressure diastolic decreased 16.02 11.96 35 43140 9059 34904697
Hypersensitivity 15.99 11.96 32 43143 61003 34852753
Blood cholesterol decreased 15.86 11.96 12 43163 1052 34912704
Pain 15.82 11.96 169 43006 204506 34709250
Conjunctival hyperaemia 15.65 11.96 17 43158 2385 34911371
Implant site infection 15.60 11.96 12 43163 1078 34912678
General symptom 15.50 11.96 11 43164 873 34912883
Bacillus bacteraemia 15.31 11.96 5 43170 66 34913690
Double inlet left ventricle 15.04 11.96 4 43171 24 34913732
Blood glucose increased 15.01 11.96 38 43137 66680 34847076
Respiratory arrest 14.92 11.96 8 43167 28035 34885721
Disease prodromal stage 14.90 11.96 4 43171 25 34913731
Urogenital haemorrhage 14.78 11.96 10 43165 735 34913021
Hallucination, auditory 14.72 11.96 40 43135 11877 34901879
Hemivertebra 14.71 11.96 6 43169 153 34913603
Mean cell haemoglobin concentration increased 14.68 11.96 8 43167 397 34913359
Obsessive thoughts 14.66 11.96 10 43165 745 34913011
Bone marrow failure 14.63 11.96 9 43166 29244 34884512
Cough 14.61 11.96 117 43058 150023 34763733
pH urine increased 14.48 11.96 5 43170 79 34913677
Pancreatitis 14.46 11.96 16 43159 38875 34874881
Clumsiness 14.44 11.96 14 43161 1718 34912038
Wrong technique in product usage process 14.28 11.96 14 43161 35972 34877784
Congenital hand malformation 14.28 11.96 9 43166 586 34913170
Dermatitis psoriasiform 14.21 11.96 13 43162 1483 34912273
Obsessive-compulsive disorder 14.16 11.96 25 43150 5539 34908217
Product prescribing error 14.14 11.96 61 43114 22866 34890890
Sensorimotor disorder 14.02 11.96 8 43167 434 34913322
Gamma-glutamyltransferase increased 13.82 11.96 72 43103 29159 34884597
Intra-abdominal fluid collection 13.82 11.96 12 43163 1279 34912477
Perineal pain 13.77 11.96 10 43165 823 34912933
Univentricular heart 13.63 11.96 4 43171 36 34913720
Spleen congestion 13.62 11.96 7 43168 308 34913448
Dermal cyst 13.56 11.96 14 43161 1853 34911903
Heart rate decreased 13.53 11.96 76 43099 31669 34882087
Electrocardiogram abnormal 13.44 11.96 33 43142 9214 34904542
Body temperature decreased 13.44 11.96 41 43134 12993 34900763
Psychiatric symptom 13.40 11.96 19 43156 3494 34910262
Blood creatinine increased 13.38 11.96 66 43109 94910 34818846
Speech disorder 13.36 11.96 65 43110 25621 34888135
Peripheral swelling 13.36 11.96 49 43126 76492 34837264
Neutrophil count increased 13.29 11.96 49 43126 17097 34896659
Oxygen saturation decreased 12.93 11.96 112 43063 53706 34860050
Candida infection 12.92 11.96 3 43172 17712 34896044
Dysuria 12.92 11.96 67 43108 27085 34886671
Diabetic coma 12.91 11.96 10 43165 907 34912849
Exhibitionism 12.91 11.96 4 43171 44 34913712
Mania 12.84 11.96 33 43142 9478 34904278
Joint swelling 12.80 11.96 35 43140 59855 34853901
Bradyphrenia 12.79 11.96 22 43153 4776 34908980
Incoherent 12.64 11.96 21 43154 4431 34909325
Tendon pain 12.63 11.96 17 43158 2978 34910778
Snoring 12.62 11.96 18 43157 3328 34910428
Erythrosis 12.58 11.96 5 43170 119 34913637
Abdominal compartment syndrome 12.57 11.96 10 43165 943 34912813
Differential white blood cell count abnormal 12.56 11.96 12 43163 1447 34912309
Red blood cell burr cells present 12.52 11.96 4 43171 49 34913707
Rash pruritic 12.51 11.96 9 43166 26932 34886824
Reading disorder 12.46 11.96 8 43167 538 34913218
Microvascular coronary artery disease 12.30 11.96 4 43171 52 34913704
Onychomycosis 12.29 11.96 15 43160 2385 34911371
Mean cell haemoglobin concentration decreased 12.24 11.96 11 43164 1226 34912530
Neuropathy peripheral 12.23 11.96 57 43118 83206 34830550
Brain stem syndrome 12.21 11.96 8 43167 557 34913199
Tachycardia 12.17 11.96 159 43016 84613 34829143
Hypercapnia 11.99 11.96 20 43155 4235 34909521

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
Coma 934.82 10.45 1007 137295 99642 79506444
Poisoning deliberate 798.09 10.45 463 137839 18365 79587721
Intentional overdose 575.22 10.45 809 137493 105151 79500935
Intentional self-injury 363.13 10.45 359 137943 32060 79574026
Somnolence 361.79 10.45 1071 137231 237910 79368176
Lower respiratory tract infection 339.49 10.45 715 137587 128505 79477581
Depression 339.05 10.45 983 137319 215807 79390279
Ear pain 235.71 10.45 288 138014 32581 79573505
Muscle spasticity 226.11 10.45 230 138072 21245 79584841
Suicide attempt 208.59 10.45 451 137851 82481 79523605
Pneumonia aspiration 204.93 10.45 395 137907 66572 79539514
Miosis 195.90 10.45 185 138117 15604 79590482
Toxicity to various agents 182.86 10.45 1304 136998 420236 79185850
Product dose omission issue 175.42 10.45 106 138196 247431 79358655
Muscle injury 169.32 10.45 303 137999 48258 79557828
Folliculitis 167.41 10.45 325 137977 55055 79551031
Body temperature increased 166.34 10.45 286 138016 44134 79561952
Respiratory disorder 160.41 10.45 283 138019 44573 79561513
Ill-defined disorder 159.67 10.45 353 137949 65522 79540564
Confusional state 157.66 10.45 1017 137285 316980 79289106
Cardiac failure congestive 151.81 10.45 31 138271 142371 79463715
Psychiatric decompensation 148.40 10.45 90 138212 3873 79602213
Suicidal ideation 144.91 10.45 372 137930 75968 79530118
Drug interaction 144.24 10.45 1220 137082 413963 79192123
Night sweats 137.53 10.45 289 138013 51806 79554280
Irritable bowel syndrome 131.52 10.45 316 137986 61925 79544161
Electric shock 128.73 10.45 58 138244 1336 79604750
Sleep disorder due to general medical condition, insomnia type 128.46 10.45 253 138049 43303 79562783
Death 126.12 10.45 530 137772 565984 79040102
Sinusitis 114.39 10.45 653 137649 194848 79411238
Psychomotor skills impaired 109.74 10.45 83 138219 5154 79600932
Depression suicidal 108.43 10.45 73 138229 3769 79602317
Hypothermia 103.53 10.45 160 138142 22586 79583500
Hepatocellular injury 103.10 10.45 244 138058 47349 79558737
Depressive symptom 98.89 10.45 85 138217 6338 79599748
Mental status changes 95.45 10.45 5 138297 66954 79539132
Insomnia 93.92 10.45 737 137565 244433 79361653
Electrocardiogram QT prolonged 92.90 10.45 356 137946 90030 79516056
Disease progression 90.41 10.45 112 138190 184250 79421836
Respiratory failure 89.67 10.45 109 138193 180802 79425284
Myocardial infarction 89.10 10.45 113 138189 184016 79422070
Gastrointestinal disorder 87.75 10.45 432 137870 121773 79484313
Akathisia 86.76 10.45 111 138191 13148 79592938
Duodenal ulcer perforation 84.50 10.45 280 138022 65931 79540155
Impaired healing 84.22 10.45 338 137964 87317 79518769
Altered state of consciousness 82.58 10.45 213 138089 43609 79562477
Sepsis 81.77 10.45 220 138082 269208 79336878
Drug dependence 80.82 10.45 202 138100 40567 79565519
Post-traumatic stress disorder 80.08 10.45 67 138235 4814 79601272
Tearfulness 79.16 10.45 73 138229 5972 79600114
Overdose 77.98 10.45 567 137735 183639 79422447
Blister 76.47 10.45 409 137893 119067 79487019
Helicobacter infection 74.48 10.45 278 138024 69426 79536660
Asphyxia 73.38 10.45 96 138206 11624 79594462
Antipsychotic drug level increased 72.37 10.45 69 138233 5888 79600198
Neovascularisation 70.29 10.45 37 138265 1208 79604878
Sleep disorder 69.62 10.45 314 137988 85363 79520723
Contusion 69.44 10.45 469 137833 148307 79457779
Depressed level of consciousness 68.90 10.45 341 137961 96311 79509775
Urine leukocyte esterase positive 68.87 10.45 57 138245 4034 79602052
Intervertebral discitis 66.54 10.45 60 138242 4768 79601318
Drug ineffective 65.28 10.45 1405 136897 1079508 78526578
Injection site pain 64.56 10.45 78 138224 129760 79476326
Blood mercury abnormal 62.28 10.45 21 138281 213 79605873
Pneumonia 61.55 10.45 792 137510 659454 78946632
Housebound 61.09 10.45 25 138277 451 79605635
5-hydroxyindolacetic acid in urine increased 60.19 10.45 21 138281 238 79605848
Urticaria 59.84 10.45 536 137766 184665 79421421
Lupus vasculitis 59.83 10.45 26 138276 548 79605538
Paranoia 58.65 10.45 114 138188 19318 79586768
Neuroleptic malignant syndrome 58.29 10.45 140 138162 27419 79578667
Nasopharyngitis 58.26 10.45 685 137617 253196 79352890
COVID-19 57.22 10.45 117 138185 157557 79448529
Coronary artery disease 57.14 10.45 21 138281 65453 79540633
Somnambulism 56.12 10.45 59 138243 5662 79600424
Depressed mood 55.71 10.45 198 138104 48282 79557804
Renal failure 55.18 10.45 172 138130 200796 79405290
Vocal cord dysfunction 54.93 10.45 25 138277 590 79605496
Drug resistance 54.81 10.45 5 138297 42208 79563878
Behaviour disorder 54.73 10.45 61 138241 6252 79599834
Incorrect route of product administration 54.08 10.45 158 138144 34771 79571315
Thrombosis 51.61 10.45 42 138260 84058 79522028
Cardiac arrest 51.07 10.45 142 138160 171954 79434132
Wrong technique in product usage process 50.39 10.45 33 138269 73842 79532244
Skin candida 50.32 10.45 36 138266 2051 79604035
Broncholithiasis 50.08 10.45 18 138284 224 79605862
Renal impairment 50.01 10.45 126 138176 157657 79448429
Completed suicide 49.68 10.45 238 138064 245529 79360557
Cholestasis 49.29 10.45 200 138102 51909 79554177
Psychotic disorder 49.22 10.45 171 138131 41231 79564855
Low density lipoprotein decreased 49.01 10.45 29 138273 1192 79604894
Prescription form tampering 48.31 10.45 20 138282 372 79605714
Rheumatoid arthritis 48.04 10.45 563 137739 207907 79398179
Myelosuppression 46.79 10.45 7 138295 40289 79565797
Peripheral swelling 45.47 10.45 688 137614 268929 79337157
Contraindicated product administered 44.91 10.45 444 137858 157094 79448992
Dystonic tremor 44.23 10.45 16 138286 203 79605883
Temperature intolerance 43.79 10.45 68 138234 9637 79596449
Demyelination 43.08 10.45 61 138241 7962 79598124
Foetal death 42.95 10.45 61 138241 7983 79598103
Obstructive airways disorder 42.80 10.45 136 138166 31323 79574763
Granulocyte count increased 42.58 10.45 27 138275 1258 79604828
Deep vein thrombosis 41.96 10.45 92 138210 120827 79485259
White blood cell count decreased 41.85 10.45 176 138126 188112 79417974
Laryngeal stenosis 41.49 10.45 25 138277 1063 79605023
Extrapyramidal disorder 41.45 10.45 109 138193 22570 79583516
Infusion related reaction 40.96 10.45 593 137709 229644 79376442
Lymph node calcification 40.67 10.45 18 138284 397 79605689
Osmolar gap increased 40.64 10.45 13 138289 110 79605976
Chronic kidney disease 40.64 10.45 33 138269 66121 79539965
Blood glucose increased 40.29 10.45 87 138215 114888 79491198
Sputum discoloured 40.25 10.45 105 138197 21638 79584448
Gastrointestinal haemorrhage 40.13 10.45 127 138175 147592 79458494
Decompression sickness 39.75 10.45 12 138290 82 79606004
Multiple organ dysfunction syndrome 39.69 10.45 94 138208 120152 79485934
Bladder dilatation 38.78 10.45 31 138271 2088 79603998
Post cholecystectomy syndrome 38.41 10.45 17 138285 375 79605711
White blood cells urine positive 38.40 10.45 50 138252 6025 79600061
Cytomegalovirus infection 38.37 10.45 13 138289 42631 79563455
Cryopyrin associated periodic syndrome 38.12 10.45 17 138285 382 79605704
Platelet count decreased 37.89 10.45 191 138111 194473 79411613
Burnout syndrome 37.59 10.45 16 138286 320 79605766
Atrial fibrillation 37.48 10.45 196 138106 197690 79408396
Stomatitis 37.26 10.45 404 137898 146353 79459733
Bronchial wall thickening 36.75 10.45 33 138269 2608 79603478
Injection site reaction 36.65 10.45 25 138277 54760 79551326
Monocyte percentage increased 36.40 10.45 30 138272 2111 79603975
Acute respiratory failure 36.20 10.45 30 138272 59511 79546575
Disturbance in attention 36.02 10.45 179 138123 50622 79555464
Loss of personal independence in daily activities 35.77 10.45 302 138000 102278 79503808
Hypervolaemia 35.10 10.45 15 138287 42675 79563411
Product quality issue 34.91 10.45 8 138294 33932 79572154
Pulmonary hypertension 34.85 10.45 20 138282 48060 79558026
Pain in extremity 34.35 10.45 436 137866 364102 79241984
Drug abuse 34.25 10.45 432 137870 162259 79443827
Pruritus 34.12 10.45 911 137391 393737 79212349
Hepatic cytolysis 33.90 10.45 114 138188 27037 79579049
Injection site erythema 33.80 10.45 52 138250 78145 79527941
Neutrophil count increased 33.72 10.45 120 138182 29276 79576810
Cerebral artery thrombosis 33.50 10.45 22 138280 1089 79604997
Neutropenia 33.47 10.45 328 137974 287382 79318704
Balance disorder 33.40 10.45 289 138013 98568 79507518
Postmortem blood drug level abnormal 32.90 10.45 18 138284 636 79605450
Pericarditis 32.78 10.45 300 138002 103936 79502150
Calcium deficiency 32.59 10.45 20 138282 879 79605207
Carcinoid tumour pulmonary 32.39 10.45 15 138287 369 79605717
Anti-cyclic citrullinated peptide antibody positive 32.36 10.45 251 138051 82892 79523194
Coagulopathy 32.36 10.45 11 138291 35995 79570091
Ascites 31.94 10.45 51 138251 75511 79530575
Neutrophil percentage increased 31.86 10.45 40 138262 4649 79601437
Psychomotor retardation 31.71 10.45 46 138256 6138 79599948
Weight increased 31.50 10.45 665 137637 276721 79329365
Red blood cells urine 31.44 10.45 18 138284 695 79605391
Alcohol poisoning 30.98 10.45 40 138262 4781 79601305
X-ray abnormal 30.92 10.45 44 138258 5769 79600317
Post-traumatic neck syndrome 30.80 10.45 27 138275 2067 79604019
Choking 30.61 10.45 66 138236 12035 79594051
Injection site pruritus 30.06 10.45 18 138284 42265 79563821
Lymphocyte percentage decreased 29.98 10.45 40 138262 4936 79601150
Deep vein thrombosis postoperative 29.95 10.45 61 138241 10691 79595395
Gastrooesophageal reflux disease 29.79 10.45 294 138008 103952 79502134
Therapy cessation 29.63 10.45 14 138288 37548 79568538
Mydriasis 29.44 10.45 82 138220 17561 79588525
Medication error 29.42 10.45 212 138090 68430 79537656
Brain scan abnormal 29.27 10.45 21 138281 1202 79604884
Hyponatraemia 29.25 10.45 452 137850 177396 79428690
Respiratory arrest 29.21 10.45 34 138268 57516 79548570
Therapy interrupted 29.18 10.45 9 138293 31332 79574754
Neurotoxicity 29.11 10.45 10 138292 32508 79573578
Total lung capacity decreased 28.57 10.45 30 138272 2875 79603211
Blood immunoglobulin A increased 28.51 10.45 19 138283 964 79605122
Bradypnoea 28.14 10.45 43 138259 6009 79600077
Blood calcium decreased 28.11 10.45 10 138292 31809 79574277
Gallbladder adenocarcinoma 27.93 10.45 10 138292 123 79605963
Band neutrophil percentage increased 27.83 10.45 14 138288 415 79605671
Joint swelling 27.77 10.45 676 137626 287970 79318116
Arteriovenous fistula 27.36 10.45 21 138281 1333 79604753
Bronchopulmonary aspergillosis allergic 27.27 10.45 30 138272 3031 79603055
Colitis ulcerative 27.22 10.45 126 138176 34616 79571470
Excessive eye blinking 27.19 10.45 23 138279 1678 79604408
Injection site swelling 27.14 10.45 25 138277 47107 79558979
Macrophages increased 26.93 10.45 12 138290 269 79605817
Postmortem blood drug level increased 26.81 10.45 17 138285 792 79605294
Sopor 26.51 10.45 12 138290 32998 79573088
Aspartate aminotransferase 26.47 10.45 15 138287 568 79605518
Dyspnoea exertional 26.45 10.45 71 138231 87002 79519084
Blood test abnormal 26.36 10.45 79 138223 17631 79588455
Soft tissue injury 26.27 10.45 23 138279 1758 79604328
Agitation 26.00 10.45 276 138026 99439 79506647
Lupus nephritis 25.97 10.45 29 138273 2979 79603107
Unevaluable event 25.95 10.45 35 138267 55550 79550536
Haemoglobin urine 25.94 10.45 10 138292 153 79605933
Diaphragmatic rupture 25.84 10.45 11 138291 220 79605866
Angina pectoris 25.79 10.45 31 138271 51701 79554385
General physical health deterioration 25.70 10.45 642 137660 274596 79331490
Anxiety 25.42 10.45 587 137715 247925 79358161
Glomerular filtration rate increased 24.95 10.45 19 138283 1192 79604894
Blood creatinine increased 24.86 10.45 162 138140 154895 79451191
No adverse event 24.84 10.45 17 138285 37175 79568911
Anaemia 24.82 10.45 585 137717 444430 79161656
Cellulitis 24.81 10.45 101 138201 108959 79497127
Multiple sclerosis 24.74 10.45 90 138212 22192 79583894
Puncture site haematoma 24.72 10.45 10 138292 175 79605911
Feelings of worthlessness 24.52 10.45 14 138288 538 79605548
Injection site bruising 24.51 10.45 21 138281 40981 79565105
Hepatotoxicity 24.32 10.45 32 138270 51320 79554766
Cerebral infarction 24.26 10.45 26 138276 45650 79560436
Abdominal pain upper 24.25 10.45 533 137769 223286 79382800
Aspartate aminotransferase increased 24.23 10.45 141 138161 138500 79467586
Hospitalisation 24.22 10.45 83 138219 94153 79511933
Liver function test abnormal 24.10 10.45 47 138255 64428 79541658
Libido increased 23.97 10.45 23 138279 1978 79604108
Prescribed overdose 23.75 10.45 129 138173 37754 79568332
Drug hypersensitivity 23.70 10.45 370 137932 298546 79307540
Posterior reversible encephalopathy syndrome 23.67 10.45 8 138294 26273 79579813
Pemphigus 23.38 10.45 270 138032 99312 79506774
Middle insomnia 23.27 10.45 71 138231 15998 79590088
Abortion spontaneous 23.27 10.45 11 138291 29496 79576590
Staphylococcal infection 23.11 10.45 41 138261 58254 79547832
Concussion 23.10 10.45 51 138251 9452 79596634
Toxic skin eruption 23.05 10.45 88 138214 22205 79583881
Frequent bowel movements 23.05 10.45 107 138195 29432 79576654
Aspergillus infection 23.02 10.45 3 138299 19158 79586928
Hostility 22.97 10.45 24 138278 2286 79603800
Drug detoxification 22.82 10.45 12 138290 391 79605695
Accidental exposure to product 22.74 10.45 13 138289 31309 79574777
Coma scale abnormal 22.73 10.45 48 138254 8630 79597456
Atelectasis 22.56 10.45 14 138288 32243 79573843
Pemphigoid 22.49 10.45 68 138234 15247 79590839
Serum ferritin abnormal 22.27 10.45 12 138290 411 79605675
Glossodynia 22.00 10.45 275 138027 103062 79503024
Osteomyelitis 21.98 10.45 15 138287 32850 79573236
Obsessive-compulsive disorder 21.97 10.45 38 138264 5889 79600197
Throat clearing 21.91 10.45 25 138277 2629 79603457
Disseminated intravascular coagulation 21.86 10.45 18 138284 35824 79570262
Surgery 21.85 10.45 15 138287 32751 79573335
Band neutrophil count increased 21.63 10.45 14 138288 676 79605410
Ligament pain 21.52 10.45 10 138292 248 79605838
Haemodialysis 21.46 10.45 3 138299 18165 79587921
Hepatic neoplasm 21.35 10.45 28 138274 3398 79602688
Dry mouth 21.27 10.45 240 138062 87779 79518307
Specific gravity urine increased 21.18 10.45 12 138290 454 79605632
Blood pressure systolic increased 21.16 10.45 193 138109 66793 79539293
Infection 21.15 10.45 559 137743 241153 79364933
Full blood count decreased 21.15 10.45 10 138292 26809 79579277
Presyncope 21.11 10.45 24 138278 41030 79565056
Bursitis 21.10 10.45 120 138182 35724 79570362
Urine abnormality 20.99 10.45 45 138257 8174 79597912
Proctitis 20.97 10.45 39 138263 6393 79599693
Heart rate decreased 20.91 10.45 200 138102 70116 79535970
Psychiatric symptom 20.90 10.45 41 138261 6994 79599092
Septic shock 20.87 10.45 126 138176 122675 79483411
Malignant neoplasm progression 20.83 10.45 144 138158 135846 79470240
Vaginal flatulence 20.83 10.45 24 138278 2551 79603535
Alanine aminotransferase increased 20.76 10.45 181 138121 162389 79443697
Myocarditis septic 20.54 10.45 6 138296 36 79606050
Cardiac failure 20.40 10.45 171 138131 154671 79451415
Rheumatoid nodule 20.31 10.45 3 138299 17435 79588651
Haematuria 20.26 10.45 57 138245 68779 79537307
Therapy partial responder 20.25 10.45 3 138299 17394 79588692
Cerebrovascular accident 20.23 10.45 172 138130 155120 79450966
Condition aggravated 20.22 10.45 689 137613 500435 79105651
Bone marrow failure 20.21 10.45 36 138266 51071 79555015
Chills 20.20 10.45 179 138123 160055 79446031
Post procedural complication 20.19 10.45 8 138294 23821 79582265
Plasma cell myeloma 19.75 10.45 39 138263 53220 79552866
Hepatic function abnormal 19.74 10.45 63 138239 73044 79533042
Fear of disease 19.69 10.45 17 138285 1275 79604811
Nightmare 19.68 10.45 93 138209 25768 79580318
Accessory spleen 19.67 10.45 9 138293 215 79605871
International normalised ratio increased 19.56 10.45 78 138224 84643 79521443
Paraneoplastic rash 19.48 10.45 7 138295 87 79605999
Implant site extravasation 19.46 10.45 14 138288 805 79605281
Hyperthermia 19.31 10.45 72 138230 17965 79588121
Coordination abnormal 19.28 10.45 70 138232 17242 79588844
Nausea 19.27 10.45 1415 136887 955781 78650305
Transient ischaemic attack 19.19 10.45 39 138263 52656 79553430
Adjustment disorder with depressed mood 19.04 10.45 46 138256 9040 79597046
Toxicologic test abnormal 18.94 10.45 17 138285 1343 79604743
Lactic acidosis 18.93 10.45 196 138106 70163 79535923
Fungal infection 18.78 10.45 27 138275 41721 79564365
Epistaxis 18.64 10.45 115 138187 111400 79494686
Myelocyte percentage increased 18.59 10.45 9 138293 245 79605841
Creatinine renal clearance decreased 18.53 10.45 5 138297 18997 79587089
Bilirubin urine present 18.44 10.45 10 138292 347 79605739
Product storage error 18.43 10.45 3 138299 16223 79589863
Blood immunoglobulin E increased 18.35 10.45 35 138267 5847 79600239
Malignant polyp 18.35 10.45 8 138294 170 79605916
Discomfort 18.31 10.45 313 137989 125304 79480782
Respiratory tract haemorrhage 18.24 10.45 19 138283 1804 79604282
Hallucination 18.17 10.45 228 138074 85517 79520569
Scrotal infection 18.15 10.45 12 138290 601 79605485
Inappropriate antidiuretic hormone secretion 18.15 10.45 92 138210 26221 79579865
Oedema 18.13 10.45 127 138175 119453 79486633
Agranulocytosis 18.11 10.45 137 138165 44893 79561193
Optic nerve operation 18.02 10.45 11 138291 479 79605607
Paradoxical drug reaction 17.96 10.45 39 138263 7146 79598940
Respiratory depression 17.94 10.45 95 138207 27535 79578551
Sternal fracture 17.86 10.45 22 138280 2508 79603578
Mean cell haemoglobin concentration decreased 17.82 10.45 30 138272 4549 79601537
Gait deviation 17.69 10.45 6 138296 62 79606024
Distal intestinal obstruction syndrome 17.67 10.45 13 138289 774 79605312
Fluid retention 17.59 10.45 62 138240 69747 79536339
Ataxia 17.59 10.45 88 138214 24951 79581135
Cardio-respiratory arrest 17.57 10.45 113 138189 108397 79497689
Dysarthria 17.54 10.45 187 138115 67435 79538651
Myalgia 17.47 10.45 222 138080 185419 79420667
Pulmonary embolism 17.40 10.45 202 138100 171452 79434634
Tenosynovitis 17.39 10.45 3 138299 15551 79590535
Haemorrhage 17.38 10.45 90 138212 91028 79515058
Hallucination, synaesthetic 17.36 10.45 6 138296 66 79606020
Transplant rejection 17.36 10.45 6 138296 19431 79586655
Metastases to lung 17.30 10.45 5 138297 18158 79587928
Wrong rate 17.20 10.45 6 138296 68 79606018
Vasoplegia syndrome 17.17 10.45 26 138276 3604 79602482
Femoral artery aneurysm 17.15 10.45 8 138294 200 79605886
Acute myocardial infarction 17.11 10.45 72 138230 76964 79529122
Antidepressant drug level above therapeutic 17.08 10.45 12 138290 664 79605422
Ventricular tachycardia 17.07 10.45 29 138273 41906 79564180
Back pain 17.07 10.45 667 137635 303513 79302573
Red blood cell elliptocytes present 17.01 10.45 8 138294 204 79605882
Opiates positive 16.92 10.45 14 138288 990 79605096
Neutropenic sepsis 16.86 10.45 92 138210 26972 79579114
Tuberculosis 16.84 10.45 3 138299 15195 79590891
Blood pressure diastolic abnormal 16.82 10.45 72 138230 19130 79586956
Blood ethanol increased 16.82 10.45 12 138290 681 79605405
Diverticulitis 16.72 10.45 34 138268 45902 79560184
Hypoventilation 16.69 10.45 38 138264 7186 79598900
Vitamin B12 increased 16.57 10.45 15 138287 1198 79604888
Skin ulcer 16.56 10.45 44 138258 54106 79551980
Rheumatoid factor increased 16.49 10.45 18 138284 1803 79604283
Toxic epidermal necrolysis 16.47 10.45 133 138169 44448 79561638
Electrocardiogram repolarisation abnormality 16.47 10.45 20 138282 2247 79603839
Rash maculo-papular 16.43 10.45 159 138143 55919 79550167
Mania 16.41 10.45 69 138233 18191 79587895
Lung opacity 16.41 10.45 31 138271 5143 79600943
Diabetes mellitus 16.36 10.45 75 138227 78315 79527771
Urinary retention 16.31 10.45 160 138142 56470 79549616
Seizure 16.25 10.45 230 138072 188604 79417482
Antipsychotic drug level above therapeutic 16.18 10.45 19 138283 2061 79604025
Acute hepatic failure 16.15 10.45 17 138285 30096 79575990
Scratch 16.11 10.45 41 138261 8322 79597764
Respiratory tract infection 16.11 10.45 38 138264 48651 79557435
Ventricular fibrillation 16.05 10.45 19 138283 31907 79574179
Nodule 16.05 10.45 10 138292 22984 79583102
Pleural effusion 15.88 10.45 168 138134 145094 79460992
Mean cell haemoglobin decreased 15.81 10.45 34 138268 6190 79599896
Urine oxalate increased 15.79 10.45 8 138294 241 79605845
Blood pressure diastolic decreased 15.76 10.45 98 138204 30118 79575968
Procedural anxiety 15.74 10.45 12 138290 754 79605332
Bronchiolitis 15.72 10.45 27 138275 4161 79601925
Erythrosis 15.71 10.45 7 138295 157 79605929
Epstein-Barr virus infection 15.64 10.45 3 138299 14413 79591673
Drug monitoring procedure incorrectly performed 15.64 10.45 10 138292 473 79605613
Red cell distribution width increased 15.62 10.45 60 138242 15182 79590904
Drug eruption 15.59 10.45 33 138269 43902 79562184
Oxygen saturation decreased 15.49 10.45 312 137990 128735 79477351
Prostate cancer 15.48 10.45 21 138281 33247 79572839
Hypersensitivity vasculitis 15.47 10.45 36 138266 6907 79599179
Haematotoxicity 15.29 10.45 4 138298 15515 79590571
Perineal infection 15.19 10.45 12 138290 795 79605291
Bronchopulmonary aspergillosis 15.14 10.45 10 138292 22284 79583802
Product prescribing error 15.12 10.45 131 138171 44682 79561404
Restless legs syndrome 15.10 10.45 72 138230 20020 79586066
Phlebotomy 15.10 10.45 6 138296 100 79605986
Therapeutic reaction time decreased 15.06 10.45 24 138278 3477 79602609
Persecutory delusion 15.06 10.45 29 138273 4880 79601206
Drug level above therapeutic 15.01 10.45 41 138261 8682 79597404
Urinary tract infection 14.96 10.45 362 137940 274150 79331936
Tooth injury 14.91 10.45 18 138284 2010 79604076
Logorrhoea 14.91 10.45 27 138275 4338 79601748
Progressive multifocal leukoencephalopathy 14.89 10.45 73 138229 20527 79585559
Communication disorder 14.87 10.45 26 138276 4064 79602022
Urine analysis abnormal 14.74 10.45 34 138268 6486 79599600
Oliguria 14.62 10.45 5 138297 16304 79589782
Adrenal insufficiency 14.61 10.45 92 138210 28395 79577691
Systemic lupus erythematosus 14.57 10.45 293 138009 120856 79485230
Ventricular extrasystoles 14.56 10.45 8 138294 19696 79586390
Abdominal distension 14.49 10.45 135 138167 119515 79486571
Eye irritation 14.43 10.45 9 138293 20672 79585414
Menopause 14.39 10.45 18 138284 2084 79604002
Anhedonia 14.38 10.45 4 138298 14894 79591192
Neoplasm progression 14.33 10.45 44 138258 51638 79554448
Lymphadenopathy 14.30 10.45 46 138256 53201 79552885
Serotonin syndrome 14.22 10.45 36 138266 44991 79561095
Mucosal inflammation 14.22 10.45 75 138227 75505 79530581
Nephropathy toxic 14.09 10.45 9 138293 20410 79585676
Right ventricular failure 14.08 10.45 12 138290 23485 79582601
Hypertension 14.06 10.45 452 137850 330540 79275546
Electrocardiogram QRS complex shortened 14.05 10.45 11 138291 719 79605367
Therapeutic product effect decreased 14.05 10.45 378 137924 163485 79442601
Hallucination, auditory 14.02 10.45 72 138230 20621 79585465
Polymicrogyria 14.00 10.45 3 138299 3 79606083
Crystal urine present 14.00 10.45 18 138284 2142 79603944
Analgesic drug level increased 13.97 10.45 22 138280 3156 79602930
Substance abuse 13.86 10.45 45 138257 10481 79595605
Distributive shock 13.80 10.45 20 138282 2667 79603419
Prothrombin time prolonged 13.79 10.45 6 138296 16893 79589193
Bezoar 13.79 10.45 20 138282 2668 79603418
Retinal depigmentation 13.79 10.45 8 138294 317 79605769
Eosinophil count abnormal 13.77 10.45 11 138291 740 79605346
Glucocorticoids increased 13.74 10.45 6 138296 128 79605958
Post concussion syndrome 13.70 10.45 10 138292 588 79605498
Accommodation disorder 13.70 10.45 10 138292 588 79605498
Uveitis 13.70 10.45 6 138296 16824 79589262
Hepatic enzyme increased 13.65 10.45 414 137888 182196 79423890
Leukocytosis 13.53 10.45 35 138267 43420 79562666
Rash pruritic 13.52 10.45 71 138231 71558 79534528
Bradycardia 13.48 10.45 319 137983 135238 79470848
Headache 13.43 10.45 1312 136990 652460 78953626
Visual impairment 13.41 10.45 99 138203 92032 79514054
Activated partial thromboplastin time prolonged 13.40 10.45 4 138298 14224 79591862
Amyotrophy 13.38 10.45 10 138292 610 79605476
Tubulointerstitial nephritis 13.33 10.45 29 138273 38206 79567880
Poor quality sleep 13.33 10.45 76 138226 22646 79583440
Bacterial infection 13.32 10.45 21 138281 31259 79574827
Paternal exposure timing unspecified 13.31 10.45 5 138297 71 79606015
Appendicitis 13.24 10.45 10 138292 20784 79585302
Complement factor C4 decreased 13.24 10.45 8 138294 342 79605744
Coronary artery occlusion 13.21 10.45 5 138297 15310 79590776
Splenomegaly 13.19 10.45 10 138292 20744 79585342
Cardiac disorder 13.08 10.45 64 138238 65693 79540393
Hand deformity 13.06 10.45 253 138049 103666 79502420
Tongue disorder 13.03 10.45 4 138298 13971 79592115
Delirium febrile 13.00 10.45 5 138297 76 79606010
Infusion site scar 12.97 10.45 8 138294 355 79605731
Feeling abnormal 12.97 10.45 196 138106 159003 79447083
Dialysis 12.93 10.45 8 138294 18454 79587632
Pancreatitis 12.93 10.45 68 138234 68507 79537579
Reading disorder 12.93 10.45 12 138290 990 79605096
Arthritis 12.91 10.45 132 138170 114748 79491338
Poor venous access 12.90 10.45 64 138238 18085 79588001
Maternal exposure timing unspecified 12.87 10.45 30 138272 5762 79600324
Autoimmune disorder 12.83 10.45 60 138242 16552 79589534
Urine bilirubin decreased 12.79 10.45 6 138296 152 79605934
Swollen joint count 12.76 10.45 13 138289 1202 79604884
Ileus 12.75 10.45 16 138286 26195 79579891
Nystagmus 12.73 10.45 42 138260 9862 79596224
Disorganised speech 12.73 10.45 17 138285 2100 79603986
Device issue 12.72 10.45 17 138285 27091 79578995
Phonophobia 12.67 10.45 9 138293 507 79605579
Temperature regulation disorder 12.66 10.45 30 138272 5823 79600263
Tri-iodothyronine free decreased 12.63 10.45 8 138294 372 79605714
Antibody test abnormal 12.61 10.45 10 138292 666 79605420
Eye paraesthesia 12.58 10.45 6 138296 158 79605928
Panniculitis 12.55 10.45 3 138299 12368 79593718
Injection site warmth 12.50 10.45 5 138297 14802 79591284
Hypersexuality 12.49 10.45 15 138287 1665 79604421
Injection site mass 12.48 10.45 10 138292 20174 79585912
Myocardial depression 12.47 10.45 9 138293 520 79605566
Thrombotic microangiopathy 12.46 10.45 10 138292 20159 79585927
Diabetic coma 12.45 10.45 13 138289 1238 79604848
Encephalitis 12.44 10.45 5 138297 14755 79591331
Infected dermal cyst 12.39 10.45 13 138289 1245 79604841
Viral infection 12.38 10.45 36 138266 42980 79563106
Staphylococcal bacteraemia 12.33 10.45 3 138299 12215 79593871
Drug use disorder 12.32 10.45 38 138264 8613 79597473
Psychotic symptom 12.31 10.45 19 138283 2678 79603408
Labelled drug-food interaction medication error 12.31 10.45 6 138296 166 79605920
Female genital tract fistula 12.25 10.45 30 138272 5945 79600141
Therapeutic response decreased 12.21 10.45 67 138235 66786 79539300
Pharyngeal paraesthesia 12.18 10.45 19 138283 2702 79603384
Red blood cell sedimentation rate increased 12.12 10.45 40 138262 45902 79560184
Urine ketone body present 12.11 10.45 22 138280 3543 79602543
Enterococcal infection 12.10 10.45 6 138296 15654 79590432
Flank pain 12.06 10.45 10 138292 19834 79586252
Failed induction of labour 12.05 10.45 7 138295 278 79605808
Eosinophil percentage increased 12.03 10.45 14 138288 1504 79604582
Drug reaction with eosinophilia and systemic symptoms 12.01 10.45 167 138135 64077 79542009
Tenderness 11.96 10.45 14 138288 23628 79582458
Cardiac valve disease 11.96 10.45 29 138273 5712 79600374
Hyperbilirubinaemia 11.90 10.45 15 138287 24503 79581583
Social anxiety disorder 11.85 10.45 9 138293 562 79605524
Cholelithiasis 11.83 10.45 49 138253 52615 79553471
Spinal cord haemorrhage 11.81 10.45 9 138293 565 79605521
Angina unstable 11.80 10.45 7 138295 16520 79589566
Ischaemic stroke 11.79 10.45 98 138204 33033 79573053
Failure to thrive 11.77 10.45 3 138299 11841 79594245
Eye pruritus 11.74 10.45 11 138291 20559 79585527
Venoocclusive liver disease 11.66 10.45 3 138299 11768 79594318
Hyperlipidaemia 11.61 10.45 17 138285 26076 79580010
Fall 11.58 10.45 989 137313 486640 79119446
Chronic sinusitis 11.53 10.45 49 138253 12977 79593109
Hepatic encephalopathy 11.50 10.45 15 138287 24151 79581935
Tachycardia 11.46 10.45 396 137906 177372 79428714
Thirst decreased 11.44 10.45 7 138295 306 79605780
Myelodysplastic syndrome 11.40 10.45 22 138280 30279 79575807
Wound infection 11.40 10.45 76 138226 23915 79582171
pH urine increased 11.37 10.45 8 138294 444 79605642
Red blood cells urine positive 11.35 10.45 26 138276 4937 79601149
Hypercholesterolaemia 11.34 10.45 14 138288 23081 79583005
Exhibitionism 11.34 10.45 4 138298 47 79606039
Negative thoughts 11.25 10.45 13 138289 1386 79604700
Hallucination, visual 11.21 10.45 96 138206 32633 79573453
Hyperhidrosis 11.20 10.45 343 137959 151149 79454937
Diabetic hyperosmolar coma 11.17 10.45 10 138292 787 79605299
Incoherent 11.15 10.45 34 138268 7658 79598428
Rales 11.15 10.45 66 138236 19935 79586151
Platelet disorder 11.15 10.45 19 138283 2910 79603176
Spinal fracture 11.09 10.45 9 138293 18045 79588041
Alcohol abuse 11.08 10.45 27 138275 5336 79600750
Glycosylated haemoglobin increased 11.02 10.45 64 138238 19196 79586890
Myocardial ischaemia 11.00 10.45 17 138285 25502 79580584
Tooth hypoplasia 10.99 10.45 6 138296 211 79605875
Sinus tachycardia 10.98 10.45 105 138197 36803 79569283
Hypocoagulable state 10.98 10.45 16 138286 2143 79603943
Bacterial test 10.92 10.45 12 138290 1211 79604875
Treatment noncompliance 10.91 10.45 50 138252 52218 79553868
Coronary artery stenosis 10.90 10.45 4 138298 12480 79593606
Abulia 10.87 10.45 11 138291 1009 79605077
Disorientation 10.87 10.45 161 138141 62615 79543471
Spinal stenosis 10.84 10.45 7 138295 15784 79590302
Pneumonia fungal 10.84 10.45 3 138299 11207 79594879
Subarachnoid haemorrhage 10.83 10.45 16 138286 24449 79581637
Cutaneous lupus erythematosus 10.80 10.45 19 138283 2984 79603102
Malaise 10.78 10.45 988 137314 488881 79117205
Joint injury 10.73 10.45 24 138278 31311 79574775
Viral disease carrier 10.73 10.45 3 138299 15 79606071
Drug diversion 10.70 10.45 12 138290 1238 79604848
Red blood cell burr cells present 10.70 10.45 4 138298 56 79606030
Behavioural addiction 10.70 10.45 4 138298 56 79606030
Oesophageal carcinoma 10.65 10.45 3 138299 11081 79595005
Menopausal symptoms 10.65 10.45 15 138287 1948 79604138
Lacrimation increased 10.65 10.45 14 138288 22463 79583623
Occult blood 10.61 10.45 14 138288 1709 79604377
Intentional product use issue 10.61 10.45 342 137960 151770 79454316
Meningitis herpes 10.59 10.45 6 138296 227 79605859
Sinus rhythm 10.54 10.45 10 138292 848 79605238
Peripheral venous disease 10.54 10.45 55 138247 15854 79590232
End stage renal disease 10.53 10.45 4 138298 12216 79593870
Mixed liver injury 10.53 10.45 33 138269 7545 79598541
Optic nerve cupping 10.51 10.45 4 138298 59 79606027
Throat irritation 10.51 10.45 113 138189 40833 79565253
Osteonecrosis 10.50 10.45 24 138278 31071 79575015
Regurgitation 10.50 10.45 18 138284 2769 79603317
Bladder cancer 10.50 10.45 11 138291 19515 79586571
Dermatitis psoriasiform 10.47 10.45 18 138284 2776 79603310
Hypercalcaemia 10.46 10.45 33 138269 38397 79567689
Pulmonary thrombosis 10.46 10.45 4 138298 12167 79593919

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N05CF01 NERVOUS SYSTEM
PSYCHOLEPTICS
HYPNOTICS AND SEDATIVES
Benzodiazepine related drugs
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D006993 Hypnotics and Sedatives
CHEBI has role CHEBI:35488 central nervous system depressants
CHEBI has role CHEBI:35717 hypnotics

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Insomnia indication 193462001
Suicidal thoughts contraindication 6471006
Asthenia contraindication 13791008
Alcohol intoxication contraindication 25702006
Depressive disorder contraindication 35489007
Hepatic failure contraindication 59927004
Sleep automatism contraindication 247962006
Severe chronic obstructive pulmonary disease contraindication 313299006




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.95 Basic
pKa2 2.26 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
GABA A receptor alpha-5/beta-2/gamma-3 Ion channel POSITIVE MODULATOR Ki 6.75 WOMBAT-PK DRUG LABEL
GABA-A receptor alpha-1/beta-2/gamma-2 Ion channel POSITIVE MODULATOR Ki 7.18 WOMBAT-PK DRUG LABEL
GABA-A receptor alpha-5/beta-3/gamma-2 Ion channel POSITIVE MODULATOR Ki 7.28 WOMBAT-PK DRUG LABEL
GABA-A receptor alpha-1/beta-2/gamma-3 Ion channel POSITIVE MODULATOR Ki 7.16 WOMBAT-PK DRUG LABEL
GABA A receptor alpha-3/beta-2/gamma-2 Ion channel POSITIVE MODULATOR Ki 6.58 WOMBAT-PK DRUG LABEL
GABA A receptor alpha-3/beta-2/gamma-3 Ion channel POSITIVE MODULATOR Ki 6.49 WOMBAT-PK DRUG LABEL
GABA A receptor alpha-5/beta-3/gamma-3 Ion channel POSITIVE MODULATOR Ki 6.75 WOMBAT-PK DRUG LABEL
GABA A receptor alpha-5/beta-2/gamma-2 Ion channel POSITIVE MODULATOR Ki 7.28 WOMBAT-PK DRUG LABEL
GABA-A receptor; anion channel Ion channel IC50 7.54 CHEMBL

External reference:

IDSource
D01372 KEGG_DRUG
C1436328 UMLSCUI
CHEBI:53762 CHEBI
ZPC PDB_CHEM_ID
CHEMBL135400 ChEMBL_ID
DB01198 DRUGBANK_ID
C515050 MESH_SUPPLEMENTAL_RECORD_UI
5735 PUBCHEM_CID
7430 IUPHAR_LIGAND_ID
4462 INN_ID
03A5ORL08Q UNII
152527 RXNORM
003775 NDDF
321174005 SNOMEDCT_US
395929002 SNOMEDCT_US

Pharmaceutical products:

None