zopiclone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 µM/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
BA (Bioavailability) 80 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.701 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 2.249 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 20.464 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 2.382 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 76.760 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 78.290 % High 1
herg hERG pIC50 4.653 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.205 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 6.237 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 66.720 % High 1
kinase-safety-class EIF2AK3,GRK2,PDK1,PDK2,PDK4 5
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 5.702 High 1
mh-clint Mouse hepatocyte intrinsic clearance 5.070 High 1
mppb Mouse plasma protein binding (% unbound) 66.100 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 23.014 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 79.020 % High 1
rh-clint Rat hepatocyte intrinsic clearance 3.334 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 89.790 % High 1
rppb Rat plasma protein binding (% unbound) 64.690 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 926.830 uM High 1

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 684.48 11.25 1628 198548 249031 90179240
Coma 677.69 11.25 819 199357 71813 90356458
Intentional overdose 668.70 11.25 926 199250 92908 90335363
Intentional self-injury 532.49 11.25 473 199703 28861 90399410
Poisoning deliberate 485.51 11.25 353 199823 16133 90412138
Ill-defined disorder 432.84 11.25 1133 199043 183758 90244513
Muscle injury 399.74 11.25 1069 199107 175585 90252686
Ear pain 374.81 11.25 545 199631 57157 90371114
Schizoaffective disorder 365.00 11.25 193 199983 4954 90423317
Folliculitis 360.44 11.25 1131 199045 203222 90225049
Body temperature increased 359.23 11.25 468 199708 44242 90384029
Sleep disorder due to general medical condition, insomnia type 340.11 11.25 826 199350 127868 90300403
Muscle spasticity 327.19 11.25 397 199779 34925 90393346
Sinusitis 326.50 11.25 1561 198615 341527 90086744
Irritable bowel syndrome 320.81 11.25 1098 199078 206350 90221921
Product dose omission issue 318.27 11.25 123 200053 291564 90136707
Blister 281.86 11.25 1213 198963 253785 90174486
Gastrointestinal disorder 280.63 11.25 1217 198959 255470 90172801
Respiratory disorder 278.88 11.25 508 199668 64308 90363963
Impaired healing 266.49 11.25 1124 199052 233075 90195196
Confusional state 260.77 11.25 1600 198576 384605 90043666
Infection 248.15 11.25 1506 198670 360588 90067683
Death 240.40 11.25 399 199777 456152 89972119
Peripheral swelling 225.98 11.25 1624 198552 411482 90016789
Pneumonia aspiration 214.28 11.25 350 199826 40590 90387681
Stomatitis 201.88 11.25 1164 199012 273534 90154737
Food allergy 198.90 11.25 263 199913 25215 90403056
Sleep disorder 194.62 11.25 910 199266 197120 90231151
Joint swelling 192.64 11.25 1825 198351 501475 89926796
Contusion 190.16 11.25 1073 199103 250143 90178128
Temperature regulation disorder 186.66 11.25 194 199982 14385 90413886
Foetal death 182.34 11.25 227 199949 20496 90407775
Somnolence 180.58 11.25 926 199250 208158 90220113
Electrocardiogram QT prolonged 166.25 11.25 441 199735 72015 90356256
Hypersensitivity 164.69 11.25 1630 198546 453047 89975224
Nasopharyngitis 159.53 11.25 1484 198692 405620 90022651
Drug level increased 155.77 11.25 245 199931 27517 90400754
Cardiac failure congestive 150.31 11.25 20 200156 98674 90329597
Insomnia 148.89 11.25 1251 198925 332223 90096048
Night sweats 145.52 11.25 617 199559 128149 90300122
Toxicity to various agents 143.79 11.25 1108 199068 286738 90141533
Electric shock 140.62 11.25 71 200105 1651 90426620
Rheumatoid arthritis 138.10 11.25 1314 198862 361300 90066971
Weight increased 136.88 11.25 1468 198708 416459 90011812
Immunodeficiency 135.59 11.25 297 199879 42937 90385334
Suicide attempt 131.53 11.25 416 199760 74983 90353288
Injection site pain 130.29 11.25 115 200061 173584 90254687
Drug ineffective 129.02 11.25 2219 197957 1382079 89046192
Drug use disorder 127.06 11.25 122 200054 8221 90420050
Prescribed overdose 126.39 11.25 488 199688 97137 90331134
Pyrexia 123.43 11.25 2096 198080 658389 89769882
Miosis 122.85 11.25 127 200049 9357 90418914
White blood cell count decreased 122.51 11.25 113 200063 166996 90261275
Pruritus 120.62 11.25 1770 198406 539755 89888516
Neutropenia 117.78 11.25 197 199979 224707 90203564
Disease progression 117.08 11.25 104 200072 156511 90271760
Infusion related reaction 114.05 11.25 1414 198762 415366 90012905
Nausea 113.11 11.25 1750 198426 1108566 89319705
Subcutaneous drug absorption impaired 107.54 11.25 141 200035 13404 90414867
Intentional product misuse 106.41 11.25 436 199740 89168 90339103
Injection site reaction 105.12 11.25 36 200140 92044 90336227
X-ray abnormal 103.70 11.25 276 199900 45148 90383123
Overdose 102.16 11.25 647 199529 157062 90271209
Frequent bowel movements 101.01 11.25 316 199860 56619 90371652
Myelosuppression 100.85 11.25 4 200172 53587 90374684
Breast cancer stage II 98.86 11.25 232 199944 35102 90393169
Adjustment disorder with depressed mood 96.12 11.25 310 199866 56443 90371828
Rash erythematous 95.62 11.25 339 199837 64765 90363506
Sepsis 94.60 11.25 157 200019 179657 90248614
Medication error 93.58 11.25 403 199773 84249 90344022
Duodenal ulcer perforation 90.74 11.25 815 199361 220473 90207798
Cerebrovascular accident 88.81 11.25 85 200091 123448 90304823
Hyperhidrosis 88.15 11.25 559 199617 135746 90292525
Neovascularisation 87.80 11.25 51 200125 1579 90426692
Platelet count decreased 87.58 11.25 104 200072 136865 90291406
Sinus rhythm 87.18 11.25 48 200128 1338 90426933
Pustular psoriasis 85.63 11.25 150 200026 18406 90409865
Akathisia 83.73 11.25 113 200063 11046 90417225
Pneumonia 83.59 11.25 954 199222 637105 89791166
Respiratory failure 83.37 11.25 83 200093 118335 90309936
Sputum discoloured 81.63 11.25 155 200021 20236 90408035
Bezoar 81.53 11.25 59 200117 2675 90425596
Contraindicated product administered 79.42 11.25 1067 199109 319072 90109199
General symptom 78.91 11.25 127 200049 14541 90413730
Rash vesicular 78.71 11.25 143 200033 18054 90410217
Intervertebral discitis 78.28 11.25 71 200105 4449 90423822
Urinary tract infection 78.08 11.25 378 199798 305254 90123017
No adverse event 76.87 11.25 27 200149 67955 90360316
Post-traumatic stress disorder 75.35 11.25 84 200092 6744 90421527
Hepatic enzyme increased 74.32 11.25 1164 199012 359572 90068699
Helicobacter infection 74.19 11.25 797 199379 226053 90202218
Drug dependence 72.91 11.25 184 199992 29143 90399128
Premature delivery 72.58 11.25 3 200173 38759 90389512
Dry skin 71.37 11.25 54 200122 88019 90340252
Proctitis 71.26 11.25 124 200052 15135 90413136
Osmolar gap increased 70.48 11.25 23 200153 159 90428112
Depressed level of consciousness 70.33 11.25 333 199843 72451 90355820
Swollen tongue 69.81 11.25 242 199934 45714 90382557
Injection site erythema 69.38 11.25 69 200107 98433 90329838
Obstructive airways disorder 69.28 11.25 167 200009 25702 90402569
Unevaluable event 68.85 11.25 18 200158 54830 90373441
Prescription form tampering 68.36 11.25 33 200143 694 90427577
Anti-cyclic citrullinated peptide antibody positive 67.53 11.25 809 199367 235624 90192647
Vaginal flatulence 67.41 11.25 109 200067 12529 90415742
Glomerular filtration rate increased 67.30 11.25 47 200129 2013 90426258
COVID-19 67.15 11.25 173 200003 168670 90259601
Colitis ulcerative 66.67 11.25 287 199889 59979 90368292
Pulmonary fibrosis 66.50 11.25 436 199740 107067 90321204
Myositis 65.95 11.25 157 200019 23971 90404300
Abortion spontaneous 65.50 11.25 19 200157 54037 90374234
Injection site pruritus 65.09 11.25 19 200157 53815 90374456
Myocardial infarction 65.07 11.25 83 200093 105889 90322382
Bronchopulmonary aspergillosis allergic 64.91 11.25 59 200117 3707 90424564
Total lung capacity decreased 64.52 11.25 59 200117 3736 90424535
Blood glucose increased 63.40 11.25 70 200106 95176 90333095
Wrong technique in product usage process 63.15 11.25 40 200136 71531 90356740
Renal failure 62.94 11.25 121 200055 130886 90297385
Granulocyte count increased 62.13 11.25 40 200136 1494 90426777
Urticaria 62.09 11.25 1003 199173 311731 90116540
Accidental exposure to product 61.23 11.25 10 200166 42356 90385915
Therapeutic product effect decreased 60.73 11.25 905 199271 276666 90151605
Dislocation of vertebra 59.98 11.25 264 199912 55704 90372567
Bursitis 59.75 11.25 496 199680 131158 90297113
Pulmonary hypertension 59.35 11.25 11 200165 42512 90385759
Eye irritation 59.33 11.25 4 200172 33974 90394297
Thrombosis 59.24 11.25 45 200131 73206 90355065
Antipsychotic drug level increased 58.95 11.25 56 200120 3723 90424548
Therapy interrupted 58.22 11.25 19 200157 50089 90378182
Back disorder 57.75 11.25 155 200021 25476 90402795
Renal impairment 57.35 11.25 90 200086 105331 90322940
Bronchial wall thickening 56.83 11.25 43 200133 2088 90426183
Chronic kidney disease 56.63 11.25 20 200156 50171 90378100
Diabetes mellitus 56.22 11.25 37 200139 64838 90363433
Atrial fibrillation 55.38 11.25 134 200042 133477 90294794
Female genital tract fistula 55.17 11.25 122 200054 17746 90410525
Seizure 55.02 11.25 164 200012 152465 90275806
Pericarditis 54.57 11.25 869 199307 269282 90158989
Extrapyramidal disorder 54.56 11.25 115 200061 16188 90412083
Product quality issue 54.24 11.25 57 200119 79268 90349003
Post cholecystectomy syndrome 54.01 11.25 30 200146 851 90427420
Deep vein thrombosis 53.96 11.25 74 200102 91546 90336725
Abdominal pain upper 53.21 11.25 1031 199145 331643 90096628
Lupus vasculitis 52.39 11.25 26 200150 582 90427689
Septic shock 51.58 11.25 66 200110 84094 90344177
Onychomycosis 51.46 11.25 10 200166 37366 90390905
Blood calcium decreased 51.42 11.25 4 200172 30178 90398093
Cryopyrin associated periodic syndrome 51.06 11.25 25 200151 543 90427728
Surgery 50.45 11.25 18 200158 44869 90383402
Vaginal discharge 50.36 11.25 124 200052 19340 90408931
Skin exfoliation 49.66 11.25 46 200130 67867 90360404
Decompression sickness 49.61 11.25 16 200160 106 90428165
Discomfort 49.36 11.25 866 199310 273469 90154802
Hepatitis 49.30 11.25 50 200126 70689 90357582
Back pain 49.04 11.25 978 199198 316197 90112074
Fluid retention 48.96 11.25 348 199828 87743 90340528
Altered state of consciousness 48.72 11.25 167 200009 31365 90396906
Aspartate aminotransferase increased 48.64 11.25 96 200080 102841 90325430
Suicidal ideation 48.42 11.25 304 199872 73551 90354720
Adverse reaction 47.76 11.25 5 200171 29707 90398564
Upper respiratory tract infection 47.74 11.25 463 199713 127855 90300416
Therapy cessation 47.46 11.25 11 200165 36350 90391921
Demyelination 47.28 11.25 73 200103 8067 90420204
Incorrect route of product administration 47.01 11.25 229 199947 50397 90377874
Pain in extremity 46.99 11.25 706 199470 449823 89978448
Hypervolaemia 46.75 11.25 8 200168 32749 90395522
Temperature intolerance 46.38 11.25 90 200086 11940 90416331
Coronary artery disease 46.28 11.25 9 200167 33614 90394657
Neck pain 45.90 11.25 116 200060 113847 90314424
Chronic sinusitis 45.85 11.25 136 200040 23666 90404605
Full blood count decreased 45.24 11.25 6 200170 29683 90398588
Broncholithiasis 45.00 11.25 19 200157 288 90427983
Hypothermia 44.37 11.25 103 200073 15472 90412799
Skin candida 43.95 11.25 34 200142 1707 90426564
Hospitalisation 43.79 11.25 141 200035 127959 90300312
Blood immunoglobulin A increased 43.62 11.25 30 200146 1253 90427018
Lung opacity 43.08 11.25 60 200116 6042 90422229
White blood cells urine positive 43.08 11.25 62 200114 6436 90421835
Dyspnoea exertional 42.96 11.25 58 200118 72230 90356041
Radiculopathy 42.80 11.25 113 200063 18392 90409879
Swelling 42.46 11.25 1219 198957 417839 90010432
Newborn persistent pulmonary hypertension 42.21 11.25 18 200158 280 90427991
Dysphonia 42.18 11.25 261 199915 62823 90365448
Malignant neoplasm progression 42.10 11.25 110 200066 106760 90321511
Throat clearing 41.89 11.25 47 200129 3800 90424471
Red blood cell sedimentation rate abnormal 41.83 11.25 3 200173 24201 90404070
Postmortem blood drug level abnormal 41.68 11.25 17 200159 235 90428036
Onychomadesis 41.56 11.25 25 200151 45973 90382298
Dizziness 40.66 11.25 991 199185 588293 89839978
Pulmonary embolism 40.66 11.25 150 200026 130670 90297601
Lymph node calcification 40.64 11.25 19 200157 371 90427900
Rales 40.07 11.25 100 200076 15727 90412544
Sopor 40.00 11.25 4 200172 24640 90403631
Vocal cord dysfunction 39.93 11.25 25 200151 889 90427382
Substance use disorder 39.51 11.25 34 200142 1986 90426285
Cytomegalovirus infection 39.07 11.25 6 200170 26596 90401675
Asphyxia 38.89 11.25 62 200114 7041 90421230
Cellulitis 38.32 11.25 91 200085 91246 90337025
Device dislocation 38.26 11.25 11 200165 31471 90396800
Chest wall mass 37.83 11.25 21 200155 595 90427676
Myalgia 37.83 11.25 229 199947 174896 90253375
Liver function test abnormal 37.70 11.25 34 200142 50811 90377460
Libido increased 37.50 11.25 31 200145 1713 90426558
Loss of personal independence in daily activities 37.29 11.25 164 200012 135941 90292330
Hepatotoxicity 37.28 11.25 28 200148 45814 90382457
Delirium 37.08 11.25 373 199803 103986 90324285
Antipsychotic drug level above therapeutic 37.07 11.25 28 200148 1356 90426915
Feeling abnormal 37.01 11.25 217 199959 167018 90261253
Post-traumatic neck syndrome 36.85 11.25 36 200140 2478 90425793
Paradoxical drug reaction 36.75 11.25 54 200122 5712 90422559
Bone pain 36.56 11.25 50 200126 61933 90366338
Skin ulcer 36.51 11.25 34 200142 50041 90378230
Soft tissue injury 36.50 11.25 33 200143 2059 90426212
Hyperlipidaemia 36.47 11.25 4 200172 22912 90405359
Drug resistance 36.35 11.25 11 200165 30438 90397833
Amnesia 36.27 11.25 383 199793 108122 90320149
Hepatocellular injury 35.23 11.25 142 200034 28816 90399455
Staphylococcal infection 35.19 11.25 33 200143 48406 90379865
Anaemia 35.02 11.25 558 199618 352244 90076027
Abdominal distension 34.80 11.25 159 200017 130442 90297829
Atelectasis 34.75 11.25 6 200170 24403 90403868
Nail disorder 34.49 11.25 48 200128 59019 90369252
Vitamin B12 increased 34.23 11.25 30 200146 1796 90426475
Hostility 34.16 11.25 33 200143 2240 90426031
Aspartate aminotransferase 34.12 11.25 21 200155 724 90427547
Eye pruritus 33.73 11.25 11 200165 29016 90399255
Fungal infection 33.49 11.25 27 200149 42634 90385637
Laryngeal stenosis 33.48 11.25 26 200150 1313 90426958
Cholelithiasis 33.41 11.25 40 200136 52466 90375805
Alanine aminotransferase increased 33.39 11.25 141 200035 118197 90310074
Completed suicide 33.29 11.25 186 199990 144872 90283399
Hepatic function abnormal 33.08 11.25 32 200144 46256 90382015
Maternal exposure timing unspecified 32.94 11.25 117 200059 22366 90405905
Dermatitis atopic 32.91 11.25 6 200170 23466 90404805
Cardiac arrest 32.81 11.25 120 200056 104815 90323456
Neoplasm progression 32.68 11.25 30 200146 44456 90383815
Oral candidiasis 32.65 11.25 160 200016 35295 90392976
Injection site swelling 32.62 11.25 51 200125 59788 90368483
Epistaxis 32.48 11.25 89 200087 85036 90343235
Somnambulism 32.25 11.25 53 200123 6175 90422096
Porphyria acute 32.09 11.25 100 200076 17875 90410396
Arthritis 31.98 11.25 227 199949 167088 90261183
Rectal haemorrhage 31.97 11.25 301 199875 82443 90345828
Scan abnormal 31.87 11.25 19 200157 618 90427653
Epidermal necrosis 31.27 11.25 32 200144 2329 90425942
Nodule 31.21 11.25 10 200166 26676 90401595
Neoplasm malignant 31.19 11.25 18 200158 33862 90394409
Walking aid user 31.11 11.25 158 200018 35348 90392923
Excessive eye blinking 30.79 11.25 25 200151 1347 90426924
Coeliac disease 30.73 11.25 186 199990 44424 90383847
Plasma cell myeloma 30.63 11.25 27 200149 40801 90387470
Asthma 30.47 11.25 725 199451 241435 90186836
Maternal exposure during pregnancy 30.44 11.25 586 199590 359477 90068794
Behaviour disorder 30.40 11.25 44 200132 4591 90423680
Impaired quality of life 30.21 11.25 7 200169 23137 90405134
Therapy partial responder 30.13 11.25 6 200170 22037 90406234
Transient ischaemic attack 29.54 11.25 31 200145 43145 90385126
Blood osmolarity increased 29.47 11.25 15 200161 355 90427916
Pleural effusion 29.44 11.25 137 200039 111854 90316417
Acute respiratory failure 29.16 11.25 31 200145 42887 90385384
Therapeutic response decreased 29.13 11.25 101 200075 89628 90338643
Mydriasis 29.13 11.25 86 200090 14926 90413345
Gastrointestinal haemorrhage 29.02 11.25 102 200074 90146 90338125
Skin haemorrhage 28.85 11.25 6 200170 21374 90406897
Multiple organ dysfunction syndrome 28.73 11.25 68 200108 68268 90360003
Posterior reversible encephalopathy syndrome 28.68 11.25 7 200169 22332 90405939
Neutrophil count decreased 28.65 11.25 73 200103 71459 90356812
Neuropathy peripheral 28.59 11.25 181 199995 136789 90291482
Osteomyelitis 28.31 11.25 13 200163 27833 90400438
Finger deformity 28.18 11.25 19 200157 32878 90395393
Lupus vulgaris 28.00 11.25 183 199993 44876 90383395
Vertebral artery occlusion 27.61 11.25 12 200164 196 90428075
Urine leukocyte esterase positive 27.36 11.25 35 200141 3247 90425024
Analgesic drug level increased 27.33 11.25 33 200143 2886 90425385
Vision blurred 27.21 11.25 138 200038 110155 90318116
Drug abuse 27.20 11.25 290 199886 82057 90346214
Rheumatoid factor increased 27.19 11.25 30 200146 2381 90425890
Drug detoxification 27.17 11.25 14 200162 340 90427931
Gallbladder adenocarcinoma 27.07 11.25 10 200166 104 90428167
Drug eruption 27.07 11.25 23 200153 35384 90392887
Cataract 27.04 11.25 76 200100 72016 90356255
Progressive multifocal leukoencephalopathy 26.94 11.25 86 200090 15569 90412702
Colorectal cancer metastatic 26.87 11.25 19 200157 830 90427441
Coagulopathy 26.76 11.25 9 200167 23280 90404991
Right ventricular failure 26.73 11.25 5 200171 19200 90409071
Red blood cells urine 26.68 11.25 16 200160 526 90427745
Hypoaesthesia 26.67 11.25 511 199665 313699 90114572
Vasoplegia syndrome 26.66 11.25 32 200144 2782 90425489
Premature baby 26.61 11.25 11 200165 25066 90403205
C-reactive protein increased 26.57 11.25 264 199912 181125 90247146
Rheumatoid nodule 26.52 11.25 6 200170 20160 90408111
Blood test abnormal 26.50 11.25 104 200072 20848 90407423
Breast cancer 26.38 11.25 49 200127 53712 90374559
Rash pruritic 26.38 11.25 93 200083 82121 90346150
Disability 26.26 11.25 167 200009 40578 90387693
Wrong rate 26.22 11.25 11 200165 164 90428107
Creatinine renal clearance decreased 26.14 11.25 5 200171 18894 90409377
Influenza 26.10 11.25 190 199986 139074 90289197
Cardiac failure 25.89 11.25 139 200037 109357 90318914
Skin fissures 25.79 11.25 7 200169 20802 90407469
Angioedema 25.57 11.25 237 199939 64639 90363632
Musculoskeletal toxicity 25.53 11.25 16 200160 570 90427701
Blood pressure abnormal 25.52 11.25 6 200170 19639 90408632
Pain 25.49 11.25 2542 197634 993799 89434472
Fear of disease 25.20 11.25 23 200153 1453 90426818
Calcium deficiency 25.19 11.25 22 200154 1311 90426960
Condition aggravated 25.04 11.25 1068 199108 594477 89833794
Postmortem blood drug level increased 24.98 11.25 17 200159 698 90427573
Concussion 24.91 11.25 67 200109 11024 90417247
Viral infection 24.84 11.25 33 200143 41381 90386890
Haemoglobin urine 24.80 11.25 10 200166 134 90428137
Hypoalbuminaemia 24.74 11.25 3 200173 15894 90412377
Carcinoid tumour pulmonary 24.69 11.25 15 200161 505 90427766
Respiratory tract infection 24.67 11.25 59 200117 59019 90369252
Blindness 24.62 11.25 14 200162 26554 90401717
Respiratory tract congestion 24.62 11.25 15 200161 27395 90400876
Respiratory acidosis 24.58 11.25 55 200121 8064 90420207
Palpitations 24.45 11.25 189 199987 136539 90291732
Sternal fracture 24.40 11.25 31 200145 2856 90425415
Incorrect dose administered 24.19 11.25 91 200085 78839 90349432
Joint injury 24.03 11.25 22 200154 32642 90395629
Hypotonia neonatal 23.86 11.25 22 200154 1408 90426863
Haemophagocytic lymphohistiocytosis 23.85 11.25 3 200173 15456 90412815
Rectal spasm 23.66 11.25 10 200166 152 90428119
Rash 23.63 11.25 2053 198123 794047 89634224
Osteonecrosis of jaw 23.61 11.25 31 200145 39072 90389199
Disseminated intravascular coagulation 23.59 11.25 9 200167 21529 90406742
Pericardial effusion 23.50 11.25 28 200148 36805 90391466
Vaccination site pain 23.11 11.25 13 200163 378 90427893
Drug ineffective for unapproved indication 23.10 11.25 237 199939 66407 90361864
Taste disorder 22.99 11.25 65 200111 61481 90366790
Poisoning 22.99 11.25 80 200096 15137 90413134
Metastases to liver 22.91 11.25 18 200158 28789 90399482
Blood pressure systolic decreased 22.87 11.25 58 200118 9212 90419059
Injection site bruising 22.84 11.25 51 200125 52256 90376015
Paraesthesia 22.83 11.25 402 199774 249924 90178347
Vomiting 22.83 11.25 1468 198708 786825 89641446
Product use issue 22.79 11.25 918 199258 329001 90099270
Hypoacusis 22.66 11.25 17 200159 27833 90400438
Rhinorrhoea 22.65 11.25 109 200067 88207 90340064
Fall 22.61 11.25 853 199323 480957 89947314
Hepatic steatosis 22.61 11.25 29 200147 36916 90391355
Diaphragmatic rupture 22.55 11.25 11 200165 237 90428034
Herpes zoster 22.46 11.25 120 200056 94524 90333747
Burnout syndrome 22.38 11.25 11 200165 241 90428030
Tenderness 22.38 11.25 16 200160 26852 90401419
Victim of chemical submission 22.16 11.25 16 200160 723 90427548
Injection site rash 22.03 11.25 13 200163 24160 90404111
Neutrophil count increased 21.95 11.25 93 200083 19297 90408974
Paraesthesia oral 21.80 11.25 132 200044 31527 90396744
Basal cell carcinoma 21.71 11.25 25 200151 33364 90394907
Caesarean section 21.66 11.25 7 200169 18570 90409701
Injury 21.61 11.25 580 199596 196769 90231502
Device issue 21.60 11.25 20 200156 29517 90398754
Disease recurrence 21.58 11.25 31 200145 37622 90390649
Ankle fracture 21.51 11.25 9 200167 20361 90407910
Drug hypersensitivity 21.48 11.25 822 199354 462787 89965484
Agitation neonatal 21.30 11.25 14 200162 542 90427729
Multiple sclerosis relapse 21.24 11.25 53 200123 52252 90376019
Ocular hyperaemia 21.23 11.25 26 200150 33772 90394499
Skin discolouration 21.21 11.25 41 200135 44274 90383997
Oropharyngeal pain 21.17 11.25 158 200018 115029 90313242
Osteoarthritis 20.96 11.25 305 199871 195425 90232846
Bacterial infection 20.82 11.25 13 200163 23431 90404840
International normalised ratio increased 20.77 11.25 46 200130 47270 90381001
Respiratory rate decreased 20.76 11.25 34 200142 3949 90424322
Acute hepatic failure 20.75 11.25 12 200164 22549 90405722
Electrocardiogram repolarisation abnormality 20.72 11.25 20 200156 1356 90426915
Blood immunoglobulin E increased 20.71 11.25 36 200140 4389 90423882
Gallbladder disorder 20.51 11.25 9 200167 19794 90408477
Ascites 20.48 11.25 47 200129 47693 90380578
Middle insomnia 20.26 11.25 82 200094 16669 90411602
Anaphylactic reaction 20.20 11.25 112 200064 87412 90340859
Chronic obstructive pulmonary disease 20.19 11.25 89 200087 73740 90354531
Anion gap increased 20.18 11.25 25 200151 2245 90426026
Therapeutic reaction time decreased 20.13 11.25 32 200144 3626 90424645
Osteonecrosis 20.11 11.25 17 200159 26224 90402047
Psoriasis 20.01 11.25 447 199729 147307 90280964
Hypothyroidism 19.93 11.25 56 200120 53071 90375200
Neonatal respiratory failure 19.90 11.25 11 200165 309 90427962
Angina pectoris 19.84 11.25 35 200141 39125 90389146
Accommodation disorder 19.81 11.25 12 200164 402 90427869
Decreased immune responsiveness 19.80 11.25 53 200123 8695 90419576
Influenza like illness 19.80 11.25 101 200075 80510 90347761
Mass 19.76 11.25 5 200171 15572 90412699
Oral pain 19.64 11.25 26 200150 32657 90395614
Blood calcium increased 19.63 11.25 65 200111 11993 90416278
Distal intestinal obstruction syndrome 19.63 11.25 13 200163 510 90427761
Cerebral infarction 19.46 11.25 18 200158 26578 90401693
Fluid replacement 19.42 11.25 14 200162 631 90427640
Deafness 19.29 11.25 13 200163 22501 90405770
Aspiration 19.13 11.25 77 200099 15616 90412655
Myocarditis septic 19.11 11.25 6 200170 36 90428235
Drug-induced liver injury 19.03 11.25 119 200057 90199 90338072
Cardiomegaly 18.98 11.25 9 200167 18916 90409355
Bacterial disease carrier 18.97 11.25 22 200154 1844 90426427
Blood alkaline phosphatase abnormal 18.96 11.25 19 200157 1349 90426922
Acne 18.91 11.25 21 200155 28486 90399785
Malignant polyp 18.83 11.25 9 200167 185 90428086
Skin necrosis 18.69 11.25 7 200169 16934 90411337
Neonatal asphyxia 18.61 11.25 11 200165 352 90427919
Intentional dose omission 18.55 11.25 8 200168 17775 90410496
Product label confusion 18.52 11.25 14 200162 22836 90405435
Swelling face 18.45 11.25 267 199909 81085 90347186
Rhinitis allergic 18.41 11.25 7 200169 16778 90411493
Leukocytosis 18.27 11.25 25 200151 30965 90397306
Blepharospasm 18.27 11.25 62 200114 55383 90372888
Vasculitis 18.27 11.25 14 200162 22679 90405592
Thrombotic microangiopathy 18.23 11.25 6 200170 15737 90412534
Diverticulitis 18.18 11.25 46 200130 45141 90383130
Chills 18.13 11.25 195 199981 131786 90296485
Myelodysplastic syndrome 18.00 11.25 12 200164 20891 90407380
Antidepressant drug level above therapeutic 17.95 11.25 12 200164 478 90427793
Flushing 17.92 11.25 118 200058 88373 90339898
Nightmare 17.87 11.25 95 200081 21630 90406641
Tenosynovitis 17.87 11.25 5 200171 14562 90413709
Post procedural complication 17.70 11.25 10 200166 19032 90409239
Bone disorder 17.69 11.25 15 200161 23105 90405166
Gastric disorder 17.68 11.25 29 200147 33355 90394916
Osteopenia 17.51 11.25 15 200161 22987 90405284
Hyperglycaemia 17.48 11.25 56 200120 50914 90377357
Seasonal allergy 17.48 11.25 15 200161 22968 90405303
Syncope 17.43 11.25 198 199978 132465 90295806
PO2 increased 17.42 11.25 15 200161 877 90427394
Joint effusion 17.41 11.25 11 200165 19699 90408572
Lymphadenopathy 17.35 11.25 48 200128 45727 90382544
Product dose omission in error 17.35 11.25 12 200164 20491 90407780
Aplastic anaemia 17.34 11.25 4 200172 13265 90415006
Drug diversion 17.26 11.25 16 200160 1031 90427240
Drug level above therapeutic 17.19 11.25 39 200137 5770 90422501
Hypercalcaemia 16.99 11.25 31 200145 34209 90394062
Weight decreased 16.96 11.25 1013 199163 378897 90049374
Chest discomfort 16.84 11.25 210 199966 138155 90290116
General physical health deterioration 16.83 11.25 952 199224 354163 90074108
Hallucination, synaesthetic 16.82 11.25 6 200170 56 90428215
Housebound 16.81 11.25 9 200167 237 90428034
Illness 16.75 11.25 109 200067 81860 90346411
Respiratory arrest 16.67 11.25 30 200146 33281 90394990
Urine abnormality 16.64 11.25 46 200130 7691 90420580
Negative thoughts 16.63 11.25 16 200160 1081 90427190
Pulmonary arterial hypertension 16.61 11.25 20 200156 26167 90402104
Therapeutic product effect incomplete 16.54 11.25 315 199861 193581 90234690
Hyponatraemia 16.54 11.25 399 199777 133139 90295132
Hypocalcaemia 16.38 11.25 44 200132 42324 90385947
Blood triglycerides increased 16.37 11.25 5 200171 13756 90414515
Feeling cold 16.35 11.25 22 200154 27443 90400828
Cholinergic syndrome 16.29 11.25 13 200163 683 90427588
Pulmonary oedema 16.28 11.25 76 200100 62004 90366267
Eye pain 16.24 11.25 47 200129 44121 90384150
Nephropathy toxic 16.24 11.25 4 200172 12684 90415587
Dactylitis 16.20 11.25 30 200146 3843 90424428
Gait deviation 16.19 11.25 6 200170 63 90428208
Blood bilirubin increased 16.17 11.25 46 200130 43424 90384847
Clostridium difficile infection 16.10 11.25 35 200141 36210 90392061
Renal tubular necrosis 16.08 11.25 6 200170 14549 90413722
Blood albumin abnormal 16.00 11.25 16 200160 1133 90427138
Hand deformity 15.94 11.25 804 199372 295558 90132713
Feeling jittery 15.90 11.25 7 200169 15364 90412907
Burning sensation 15.87 11.25 79 200097 63373 90364898
Product administration interrupted 15.87 11.25 4 200172 12488 90415783
Leukopenia 15.84 11.25 144 200032 100566 90327705
Headache 15.81 11.25 2155 198021 860591 89567680
Myelocyte percentage increased 15.81 11.25 8 200168 187 90428084
Vaginal haemorrhage 15.79 11.25 28 200148 31243 90397028
Arterial occlusive disease 15.78 11.25 4 200172 12442 90415829
Intensive care 15.74 11.25 17 200159 1317 90426954
Medical observation 15.73 11.25 8 200168 189 90428082
Labelled drug-food interaction medication error 15.72 11.25 9 200167 271 90428000
Toxicologic test abnormal 15.72 11.25 13 200163 719 90427552
Renal disorder 15.66 11.25 38 200138 37821 90390450
Jaundice 15.64 11.25 30 200146 32487 90395784
Muscle spasms 15.62 11.25 430 199746 251453 90176818
Basilar artery occlusion 15.61 11.25 8 200168 192 90428079
Presyncope 15.60 11.25 29 200147 31776 90396495
Aphasia 15.42 11.25 46 200130 42766 90385505
Wound infection 15.39 11.25 325 199851 106077 90322194
Feeling hot 15.37 11.25 250 199926 77758 90350513
Groin pain 15.34 11.25 4 200172 12209 90416062
Monocyte percentage increased 15.33 11.25 16 200160 1192 90427079
Depressed mood 15.27 11.25 174 200002 50048 90378223
Bulimia nervosa 15.12 11.25 11 200165 503 90427768
Epilepsy 14.99 11.25 113 200063 82093 90346178
Pneumococcal infection 14.93 11.25 16 200160 1229 90427042
Sinus tachycardia 14.89 11.25 111 200065 28402 90399869
Febrile neutropenia 14.85 11.25 253 199923 158096 90270175
Blood calcium abnormal 14.80 11.25 20 200156 1957 90426314
Back injury 14.78 11.25 53 200123 46569 90381702
Ligament pain 14.66 11.25 8 200168 219 90428052
Band neutrophil percentage increased 14.66 11.25 8 200168 219 90428052
Hip fracture 14.65 11.25 32 200144 33045 90395226
Injection site haemorrhage 14.63 11.25 25 200151 28293 90399978
Clumsiness 14.61 11.25 23 200153 2584 90425687
Lactic acidosis 14.53 11.25 173 200003 50290 90377981
Increased appetite 14.50 11.25 4 200172 11761 90416510
Haematuria 14.50 11.25 35 200141 34902 90393369
Tooth hypoplasia 14.45 11.25 6 200170 87 90428184
Retinitis 14.41 11.25 139 200037 38319 90389952
Urine output decreased 14.25 11.25 5 200171 12598 90415673
Malnutrition 14.25 11.25 12 200164 18546 90409725
Eye swelling 14.23 11.25 27 200149 29359 90398912
Psychotic symptom 14.19 11.25 21 200155 2235 90426036
Urine oxalate increased 14.18 11.25 8 200168 234 90428037
Haematotoxicity 14.13 11.25 5 200171 12530 90415741
Joint range of motion decreased 14.09 11.25 396 199780 135247 90293024
Diarrhoea 14.04 11.25 1839 198337 937351 89490920
Neurotoxicity 14.04 11.25 16 200160 21451 90406820
Device related infection 14.03 11.25 22 200154 25764 90402507
Gastroenteritis 14.03 11.25 27 200149 29202 90399069
Spinal disorder 13.99 11.25 57 200119 11622 90416649
Product administration error 13.95 11.25 23 200153 26400 90401871
Bladder dilatation 13.89 11.25 14 200162 1001 90427270
Lacrimation increased 13.88 11.25 24 200152 27038 90401233
Eosinophil count abnormal 13.83 11.25 13 200163 853 90427418
Disturbance in attention 13.78 11.25 162 200014 46947 90381324
Oral disorder 13.76 11.25 3 200173 10342 90417929
Bronchiolitis 13.74 11.25 26 200150 3386 90424885
Breast cancer female 13.57 11.25 8 200168 14878 90413393
Femur fracture 13.56 11.25 54 200122 46028 90382243
Cardiac disorder 13.55 11.25 72 200104 56800 90371471
Livedo reticularis 13.48 11.25 26 200150 3433 90424838
Hyperbilirubinaemia 13.42 11.25 7 200169 13929 90414342
Neonatal seizure 13.34 11.25 11 200165 606 90427665
Dementia 13.33 11.25 20 200156 23841 90404430
Cardiomyopathy 13.28 11.25 15 200161 20191 90408080
Complication associated with device 13.26 11.25 14 200162 19435 90408836
Pneumocystis jirovecii pneumonia 13.19 11.25 17 200159 21599 90406672
Adrenal insufficiency 13.17 11.25 112 200064 29809 90398462
Pre-eclampsia 13.17 11.25 4 200172 11044 90417227
Treatment noncompliance 13.17 11.25 64 200112 51663 90376608
Enterococcal infection 13.08 11.25 3 200173 9988 90418283
Scar 13.04 11.25 9 200167 15386 90412885
Breath sounds abnormal 13.03 11.25 9 200167 15377 90412894
Sleep apnoea syndrome 13.02 11.25 32 200144 31715 90396556
Glaucoma 13.00 11.25 16 200160 20739 90407532
Blood potassium increased 12.99 11.25 16 200160 20733 90407538
Abortion induced 12.97 11.25 5 200171 11883 90416388
Flank pain 12.93 11.25 14 200162 19208 90409063
Gastroenteritis viral 12.92 11.25 30 200146 30325 90397946
Anaphylactic shock 12.87 11.25 32 200144 31585 90396686
Diabetic hyperosmolar coma 12.86 11.25 9 200167 387 90427884
Urinary tract obstruction 12.82 11.25 20 200156 2229 90426042
Tongue disorder 12.82 11.25 4 200172 10856 90417415
Dehydration 12.82 11.25 329 199847 194118 90234153
Aspergillus infection 12.76 11.25 4 200172 10819 90417452
Cholecystectomy 12.73 11.25 5 200171 11750 90416521
Lupus nephritis 12.73 11.25 31 200145 4801 90423470
Glucocorticoids increased 12.70 11.25 6 200170 120 90428151
Coma scale abnormal 12.65 11.25 34 200142 5592 90422679
Normal newborn 12.65 11.25 20 200156 23342 90404929
Crystal urine present 12.59 11.25 16 200160 1474 90426797
Uveitis 12.56 11.25 10 200166 15893 90412378
Complement factor C4 decreased 12.52 11.25 8 200168 295 90427976
Spinal stenosis 12.50 11.25 12 200164 17412 90410859
Medication overuse headache 12.50 11.25 16 200160 1485 90426786
Pleuritic pain 12.49 11.25 51 200125 10410 90417861
Carpal tunnel syndrome 12.47 11.25 21 200155 23907 90404364
Vascular stent stenosis 12.46 11.25 11 200165 665 90427606
Anticholinergic syndrome 12.43 11.25 22 200154 2721 90425550
Retinal depigmentation 12.37 11.25 8 200168 301 90427970
Persecutory delusion 12.37 11.25 24 200152 3184 90425087
Hemiparesis 12.34 11.25 33 200143 31786 90396485
Anuria 12.33 11.25 65 200111 14753 90413518
Blood magnesium decreased 12.23 11.25 10 200166 15683 90412588
Device breakage 12.18 11.25 8 200168 14036 90414235
Mobility decreased 12.17 11.25 442 199734 250292 90177979
Respiratory syncytial virus infection 12.13 11.25 4 200172 10476 90417795
Neutropenic sepsis 12.11 11.25 75 200101 18055 90410216
Procedural anxiety 12.07 11.25 12 200164 844 90427427
Communication disorder 12.06 11.25 24 200152 3242 90425029
Lung neoplasm malignant 12.02 11.25 22 200154 24251 90404020
Haematoma 11.98 11.25 45 200131 39003 90389268
Blood bilirubin abnormal 11.95 11.25 18 200158 1946 90426325
Frostbite 11.93 11.25 7 200169 221 90428050
Pregnancy 11.91 11.25 198 199978 61849 90366422
Injection site mass 11.87 11.25 19 200157 22071 90406200
Visual acuity reduced 11.79 11.25 21 200155 23389 90404882
Pharyngeal oedema 11.73 11.25 8 200168 13763 90414508
Hypocoagulable state 11.71 11.25 16 200160 1583 90426688
Aspartate aminotransferase abnormal 11.69 11.25 21 200155 2628 90425643
Water intoxication 11.67 11.25 10 200166 581 90427690
Antinuclear antibody positive 11.66 11.25 3 200173 9238 90419033
Polyarthritis 11.65 11.25 14 200162 18336 90409935
Spinal operation 11.61 11.25 4 200172 10192 90418079
Colitis 11.57 11.25 218 199958 69724 90358547
Strabismus 11.45 11.25 20 200156 2448 90425823
Haemorrhage 11.43 11.25 98 200078 69271 90359000
Cytopenia 11.41 11.25 13 200163 17436 90410835
Liver function test increased 11.40 11.25 126 200050 84729 90343542
Dyspepsia 11.36 11.25 541 199635 197619 90230652
Hypersensitivity vasculitis 11.30 11.25 27 200149 4132 90424139
Pulmonary granuloma 11.29 11.25 16 200160 1637 90426634

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 917.70 11.90 917 55079 110446 42454893
Drug interaction 655.74 11.90 1218 54778 265781 42299558
Coma 578.27 11.90 513 55483 53041 42512298
Poisoning deliberate 541.47 11.90 265 55731 9869 42555470
Psychiatric decompensation 292.07 11.90 132 55864 4090 42561249
Psychomotor skills impaired 256.90 11.90 129 55867 5075 42560264
Suicidal ideation 251.23 11.90 313 55683 47848 42517491
Depression suicidal 248.66 11.90 109 55887 3136 42562203
Tearfulness 237.59 11.90 108 55888 3392 42561947
Depressive symptom 230.74 11.90 109 55887 3744 42561595
Intentional overdose 227.19 11.90 308 55688 51148 42514191
Toxicity to various agents 222.02 11.90 733 55263 228403 42336936
Miosis 206.02 11.90 158 55838 13288 42552051
Somnolence 197.55 11.90 515 55481 140590 42424749
Inspiratory capacity decreased 196.50 11.90 90 55906 2877 42562462
Loss of personal independence in daily activities 174.21 11.90 267 55729 49549 42515790
Suicide attempt 169.60 11.90 253 55743 45847 42519492
Psychotic disorder 167.15 11.90 199 55797 29009 42536330
Paranoia 162.45 11.90 140 55856 13886 42551453
Substance use disorder 139.04 11.90 87 55909 5258 42560081
Intentional self-injury 135.47 11.90 131 55865 15071 42550268
Drug abuse 132.01 11.90 368 55628 104403 42460936
Drug use disorder 131.71 11.90 109 55887 10224 42555115
Asphyxia 119.19 11.90 94 55902 8232 42557107
Overdose 116.50 11.90 353 55643 104911 42460428
Drug dependence 113.22 11.90 164 55832 28930 42536409
Hypothermia 109.92 11.90 107 55889 12408 42552931
Electrocardiogram QT prolonged 96.55 11.90 202 55794 47743 42517596
Neuroleptic malignant syndrome 95.40 11.90 129 55867 21343 42543996
Disease progression 93.30 11.90 36 55960 143620 42421719
Altered state of consciousness 87.38 11.90 146 55850 29113 42536226
Product dose omission issue 84.42 11.90 49 55947 154316 42411023
Dystonic tremor 82.46 11.90 27 55969 336 42565003
Blood mercury abnormal 80.67 11.90 25 55971 257 42565082
Prescription form tampering 75.79 11.90 29 55967 583 42564756
Cerebral artery thrombosis 73.75 11.90 35 55961 1214 42564125
Brain scan abnormal 70.97 11.90 34 55962 1205 42564134
Device dislocation 70.74 11.90 68 55928 7763 42557576
IVth nerve paralysis 69.60 11.90 27 55969 564 42564775
Poisoning 69.42 11.90 91 55905 14608 42550731
Agitation 67.66 11.90 212 55784 64102 42501237
Low density lipoprotein decreased 66.34 11.90 33 55963 1271 42564068
Hepatocellular injury 65.22 11.90 114 55882 23564 42541775
Hepatic cytolysis 62.28 11.90 120 55876 26724 42538615
Bradypnoea 61.59 11.90 49 55947 4344 42560995
Confusional state 56.89 11.90 396 55600 167201 42398138
Anxiety 56.59 11.90 306 55690 118254 42447085
Neurodegenerative disorder 55.74 11.90 21 55975 404 42564935
Dystonia 55.53 11.90 76 55920 12714 42552625
Substance dependence 53.20 11.90 23 55973 639 42564700
Cardiac failure congestive 51.46 11.90 24 55972 85578 42479761
Tardive dyskinesia 51.29 11.90 54 55942 6870 42558469
Housebound 51.17 11.90 17 55979 222 42565117
5-hydroxyindolacetic acid in urine increased 50.17 11.90 16 55980 182 42565157
Substance abuse 49.81 11.90 60 55936 8845 42556494
Pneumonia aspiration 48.06 11.90 160 55836 49918 42515421
Dementia 46.24 11.90 80 55916 16400 42548939
IgA nephropathy 45.63 11.90 32 55964 2342 42562997
Acute kidney injury 45.24 11.90 705 55291 366632 42198707
Logorrhoea 45.22 11.90 34 55962 2773 42562566
Hypoglycaemia 44.52 11.90 176 55820 59678 42505661
Cholestasis 43.83 11.90 118 55878 32761 42532578
Hyperthermia 43.35 11.90 67 55929 12507 42552832
Prescribed overdose 43.34 11.90 68 55928 12859 42552480
Fall 41.17 11.90 480 55516 234040 42331299
Mental status changes 40.85 11.90 4 55992 42111 42523228
Areflexia 40.59 11.90 36 55960 3707 42561632
Thrombosis 39.97 11.90 20 55976 68491 42496848
Dyspnoea 39.78 11.90 381 55615 442240 42123099
Hallucination, auditory 38.92 11.90 70 55926 14794 42550545
Death 38.06 11.90 416 55580 470769 42094570
Jaw clicking 37.13 11.90 10 55986 59 42565280
Psychiatric symptom 36.75 11.90 36 55960 4205 42561134
Hepatic neoplasm 36.33 11.90 27 55969 2164 42563175
Gastrointestinal haemorrhage 36.28 11.90 45 55951 97681 42467658
Macrophages increased 36.24 11.90 12 55984 155 42565184
Phonophobia 36.02 11.90 14 55982 294 42565045
Arteriovenous fistula 35.75 11.90 21 55975 1131 42564208
Diarrhoea 35.58 11.90 411 55585 460438 42104901
Post concussion syndrome 35.49 11.90 12 55984 166 42565173
Bladder dilatation 35.35 11.90 24 55972 1666 42563673
Dissociation 34.34 11.90 33 55963 3765 42561574
Restless legs syndrome 34.23 11.90 52 55944 9562 42555777
Serum ferritin abnormal 33.90 11.90 13 55983 263 42565076
Injection site pain 33.52 11.90 17 55979 57781 42507558
Accidental poisoning 33.47 11.90 21 55975 1275 42564064
Myocardial infarction 32.20 11.90 72 55924 123937 42441402
Antipsychotic drug level increased 32.11 11.90 35 55961 4631 42560708
Opiates positive 31.30 11.90 15 55981 532 42564807
Pyrexia 30.94 11.90 350 55646 393692 42171647
Hemiplegia 30.03 11.90 44 55952 7835 42557504
Agranulocytosis 29.53 11.90 98 55898 30514 42534825
Withdrawal syndrome 29.43 11.90 62 55934 14713 42550626
Extrapyramidal disorder 29.42 11.90 66 55930 16346 42548993
Tremor 29.37 11.90 223 55773 96706 42468633
Tooth injury 29.15 11.90 19 55977 1232 42564107
Toxic skin eruption 28.97 11.90 59 55937 13671 42551668
Muscle rigidity 28.07 11.90 54 55942 12005 42553334
Depressed level of consciousness 27.92 11.90 131 55865 47839 42517500
Pneumonia 27.89 11.90 389 55607 421760 42143579
5-hydroxyindolacetic acid increased 27.78 11.90 9 55987 108 42565231
Overlap syndrome 27.77 11.90 12 55984 333 42565006
Puncture site haematoma 27.63 11.90 10 55986 171 42565168
Implant site extravasation 27.42 11.90 13 55983 450 42564889
Sepsis 27.30 11.90 152 55844 199182 42366157
Respiratory tract haemorrhage 27.10 11.90 19 55977 1390 42563949
Cough 27.10 11.90 131 55865 177972 42387367
Disorientation 27.04 11.90 107 55889 36282 42529057
Pain 26.77 11.90 200 55796 244648 42320691
No adverse event 26.62 11.90 9 55987 39012 42526327
Dysarthria 26.39 11.90 113 55883 39694 42525645
Myocarditis 26.28 11.90 69 55927 18869 42546470
Accessory spleen 26.20 11.90 9 55987 131 42565208
Tachycardia 25.98 11.90 224 55772 100863 42464476
Deep vein thrombosis 25.96 11.90 38 55958 76919 42488420
Drug ineffective 25.35 11.90 633 55363 629564 41935775
Renal failure 25.33 11.90 100 55896 143626 42421713
Delirium 25.32 11.90 136 55860 52383 42512956
Respiratory failure 25.32 11.90 85 55911 128047 42437292
Psychomotor retardation 25.19 11.90 30 55966 4369 42560970
Mydriasis 25.16 11.90 43 55953 8727 42556612
Hypersensitivity 25.13 11.90 35 55961 72335 42493004
Burnout syndrome 24.81 11.90 9 55987 155 42565184
Acute respiratory failure 24.76 11.90 10 55986 38848 42526491
Coma scale abnormal 24.30 11.90 30 55966 4535 42560804
Blood ethanol increased 24.22 11.90 12 55984 458 42564881
Rhabdomyolysis 23.91 11.90 180 55816 77839 42487500
Behaviour disorder 23.50 11.90 37 55959 7017 42558322
Restlessness 23.36 11.90 88 55908 29161 42536178
Expired product administered 23.20 11.90 28 55968 4135 42561204
Electrocardiogram abnormal 23.09 11.90 45 55951 10100 42555239
Lymphocyte percentage decreased 23.06 11.90 21 55975 2238 42563101
Spasmodic dysphonia 23.05 11.90 12 55984 509 42564830
General physical health deterioration 22.80 11.90 301 55695 150945 42414394
Ischaemic stroke 22.18 11.90 72 55924 22161 42543178
Blood follicle stimulating hormone increased 22.08 11.90 9 55987 215 42565124
Feelings of worthlessness 21.99 11.90 10 55986 314 42565025
Behavioural addiction 21.92 11.90 7 55989 80 42565259
Rheumatoid arthritis 21.90 11.90 112 55884 42328 42523011
Rash 21.69 11.90 246 55750 276708 42288631
Eosinophil percentage increased 21.52 11.90 12 55984 585 42564754
Neutrophil percentage increased 21.51 11.90 19 55977 1946 42563393
Respiratory depression 21.51 11.90 64 55932 18804 42546535
Paraneoplastic rash 21.39 11.90 7 55989 87 42565252
Social anxiety disorder 21.35 11.90 12 55984 594 42564745
Hyperreflexia 21.32 11.90 25 55971 3582 42561757
Reduced facial expression 21.28 11.90 17 55979 1516 42563823
Hypoxia 21.14 11.90 37 55959 69749 42495590
Faecaloma 21.04 11.90 33 55963 6237 42559102
Drug monitoring procedure incorrectly performed 20.88 11.90 10 55986 354 42564985
Obesity 20.86 11.90 58 55938 16401 42548938
Victim of chemical submission 20.85 11.90 8 55988 162 42565177
Optic nerve operation 20.82 11.90 11 55985 481 42564858
Alcohol abuse 20.58 11.90 26 55970 4023 42561316
Perineal infection 20.53 11.90 12 55984 640 42564699
Panic attack 20.45 11.90 45 55951 11000 42554339
VACTERL syndrome 20.17 11.90 6 55990 53 42565286
Contraindicated product administered 20.16 11.90 76 55920 25196 42540143
Hyponatraemic seizure 20.15 11.90 8 55988 178 42565161
Craniofacial fracture 20.06 11.90 10 55986 387 42564952
Heart rate decreased 19.98 11.90 98 55898 36434 42528905
Persecutory delusion 19.91 11.90 24 55972 3540 42561799
Antiphospholipid antibodies positive 19.89 11.90 10 55986 394 42564945
Hypersexuality 19.72 11.90 17 55979 1685 42563654
Red blood cell elliptocytes present 19.49 11.90 7 55989 117 42565222
Delirium febrile 19.42 11.90 5 55991 24 42565315
Depressed mood 19.21 11.90 71 55925 23313 42542026
Disturbance in attention 19.19 11.90 84 55912 29782 42535557
Loss of consciousness 18.90 11.90 195 55801 92159 42473180
Spinal cord haemorrhage 18.76 11.90 9 55987 320 42565019
Wrong technique in product usage process 18.76 11.90 17 55979 42618 42522721
Rash maculo-papular 18.68 11.90 98 55898 37405 42527934
Cardiac arrest 18.66 11.90 77 55919 109243 42456096
Candida infection 18.66 11.90 3 55993 21607 42543732
Coronary artery disease 18.63 11.90 26 55970 53694 42511645
Wheezing 18.52 11.90 27 55969 54754 42510585
Neuropathy peripheral 18.49 11.90 70 55926 101783 42463556
Therapeutic response decreased 18.49 11.90 13 55983 36999 42528340
Hypovitaminosis 18.47 11.90 12 55984 774 42564565
Fatigue 18.43 11.90 434 55562 435207 42130132
Disease prodromal stage 18.35 11.90 5 55991 31 42565308
Therapy non-responder 18.33 11.90 26 55970 53333 42512006
Phlebotomy 18.30 11.90 6 55990 75 42565264
Treatment failure 18.25 11.90 34 55962 62590 42502749
Device malfunction 18.22 11.90 46 55950 12281 42553058
Bradycardia 18.21 11.90 182 55814 85302 42480037
Fibrous histiocytoma 18.08 11.90 9 55987 347 42564992
Back pain 17.86 11.90 111 55885 141665 42423674
Blood pressure diastolic decreased 17.79 11.90 41 55955 10334 42555005
Delusion 17.77 11.90 51 55945 14683 42550656
Glabellar reflex abnormal 17.71 11.90 5 55991 36 42565303
Scrotal infection 17.70 11.90 12 55984 831 42564508
Hypercapnia 17.69 11.90 28 55968 5333 42560006
Dissociative disorder 17.63 11.90 11 55985 661 42564678
Sedation 17.56 11.90 83 55913 30392 42534947
Haemorrhage 17.54 11.90 33 55963 60530 42504809
Pruritus 17.52 11.90 161 55835 188610 42376729
Malignant neoplasm progression 17.49 11.90 78 55918 108322 42457017
Orthostatic hypotension 17.43 11.90 83 55913 30487 42534852
Hallucination, visual 17.42 11.90 64 55932 20956 42544383
Arthralgia 17.38 11.90 179 55817 205059 42360280
Blood glucose increased 17.37 11.90 45 55951 73654 42491685
Bone marrow failure 17.37 11.90 11 55985 33082 42532257
Accidental exposure to product 17.23 11.90 3 55993 20390 42544949
Product prescribing error 17.21 11.90 74 55922 26038 42539301
Drug resistance 17.15 11.90 12 55984 34236 42531103
Pancreatitis 17.04 11.90 19 55977 43249 42522090
Conversion disorder 16.83 11.90 10 55986 550 42564789
Enterobacter pneumonia 16.82 11.90 10 55986 551 42564788
Bradyphrenia 16.70 11.90 27 55969 5235 42560104
Band neutrophil percentage increased 16.66 11.90 6 55990 101 42565238
Vein disorder 16.66 11.90 17 55979 2085 42563254
Infected dermal cyst 16.60 11.90 12 55984 921 42564418
Femoral artery aneurysm 16.55 11.90 7 55989 184 42565155
Hallucination, tactile 16.38 11.90 10 55986 578 42564761
Epilepsy 16.36 11.90 73 55923 26098 42539241
Drug hypersensitivity 16.35 11.90 71 55925 99318 42466021
Capillary fragility 16.35 11.90 5 55991 49 42565290
Chronic kidney disease 16.25 11.90 23 55973 47218 42518121
Bruxism 16.21 11.90 17 55979 2152 42563187
Abdominal discomfort 16.21 11.90 48 55948 75207 42490132
Laboratory test abnormal 16.20 11.90 5 55991 22973 42542366
Yawning 16.11 11.90 11 55985 771 42564568
Pain in extremity 15.97 11.90 124 55872 150480 42414859
Muscle contracture 15.96 11.90 14 55982 1421 42563918
Oxygen saturation decreased 15.91 11.90 142 55854 64545 42500794
Choking 15.65 11.90 29 55967 6269 42559070
Nausea 15.49 11.90 400 55596 396399 42168940
Anal haemorrhage 15.48 11.90 19 55977 2854 42562485
Differential white blood cell count abnormal 15.48 11.90 15 55981 1729 42563610
Cytomegalovirus infection 15.29 11.90 12 55984 32294 42533045
Speech disorder 15.13 11.90 77 55919 29044 42536295
Type 2 diabetes mellitus 15 11.90 3 55993 18468 42546871
Abulia 14.91 11.90 10 55986 680 42564659
Respiratory tract infection 14.88 11.90 8 55988 26314 42539025
Incoherent 14.82 11.90 24 55972 4661 42560678
Hemivertebra 14.81 11.90 6 55990 141 42565198
Double inlet left ventricle 14.79 11.90 4 55992 24 42565315
Therapy partial responder 14.77 11.90 4 55992 20017 42545322
Aggression 14.73 11.90 104 55892 44059 42521280
pH urine increased 14.54 11.90 5 55991 73 42565266
Blepharospasm 14.52 11.90 13 55983 1355 42563984
Dyskinesia 14.52 11.90 69 55927 25321 42540018
Pancreas infection 14.50 11.90 8 55988 382 42564957
Urogenital haemorrhage 14.35 11.90 10 55986 724 42564615
Arthritis infective 14.32 11.90 22 55974 4084 42561255
Implant site infection 14.28 11.90 12 55984 1149 42564190
Intentional device misuse 14.13 11.90 7 55989 267 42565072
Jaundice cholestatic 14.08 11.90 25 55971 5228 42560111
Blood pressure systolic increased 13.87 11.90 73 55923 27895 42537444
Sleep disorder due to a general medical condition 13.83 11.90 3 55993 17450 42547889
Intentional product misuse 13.77 11.90 133 55863 61767 42503572
Sluggishness 13.77 11.90 21 55975 3875 42561464
Blood pressure diastolic abnormal 13.73 11.90 27 55969 6101 42559238
Perineal pain 13.68 11.90 11 55985 990 42564349
Specific gravity urine increased 13.61 11.90 6 55990 175 42565164
Full blood count decreased 13.58 11.90 5 55991 20555 42544784
Illusion 13.41 11.90 11 55985 1018 42564321
Toxic epidermal necrolysis 13.39 11.90 70 55926 26680 42538659
Univentricular heart 13.38 11.90 4 55992 36 42565303
Urine leukocyte esterase positive 13.37 11.90 8 55988 446 42564893
Peripheral swelling 13.36 11.90 67 55929 90203 42475136
Bradyarrhythmia 13.31 11.90 17 55979 2658 42562681
Sensorimotor disorder 13.24 11.90 8 55988 454 42564885
Monocyte percentage increased 13.17 11.90 11 55985 1044 42564295
Pemphigoid 13.17 11.90 39 55957 11428 42553911
Neck pain 13.16 11.90 12 55984 30002 42535337
Foreign body aspiration 13.07 11.90 7 55989 315 42565024
Alcohol poisoning 13.06 11.90 30 55966 7544 42557795
Ascites 13.05 11.90 35 55961 56643 42508696
General symptom 13.03 11.90 11 55985 1060 42564279
Congenital hand malformation 13 11.90 9 55987 645 42564694
Electrocardiogram T wave amplitude increased 13.00 11.90 5 55991 102 42565237
Obsessive thoughts 12.96 11.90 10 55986 848 42564491
Hypoparathyroidism secondary 12.92 11.90 6 55990 198 42565141
Psoriasis 12.78 11.90 28 55968 48576 42516763
Abdominal compartment syndrome 12.73 11.90 11 55985 1094 42564245
Oral dysaesthesia 12.69 11.90 5 55991 109 42565230
Fungal infection 12.69 11.90 5 55991 19717 42545622
Persistent depressive disorder 12.67 11.90 8 55988 491 42564848
Blood cholesterol decreased 12.66 11.90 11 55985 1102 42564237
Clumsiness 12.64 11.90 14 55982 1886 42563453
Asthenia 12.62 11.90 277 55719 280516 42284823
Hypomania 12.58 11.90 16 55980 2492 42562847
Polyuria 12.41 11.90 35 55961 9976 42555363
Spleen congestion 12.39 11.90 7 55989 350 42564989
Erythrosis 12.32 11.90 5 55991 118 42565221
Gamma-glutamyltransferase increased 12.32 11.90 79 55917 32418 42532921
Acquired haemophilia 12.29 11.90 13 55983 1662 42563677
Pleural effusion 12.27 11.90 76 55920 97090 42468249
Eosinophil count decreased 12.25 11.90 19 55977 3557 42561782
Hand fracture 12.21 11.90 17 55979 2889 42562450
Psoriatic arthropathy 12.17 11.90 9 55987 24958 42540381
Anterior chamber cleavage syndrome 12.10 11.90 3 55993 12 42565327
Snoring 12.09 11.90 20 55976 3953 42561386
Parkinsonism 12.07 11.90 36 55960 10587 42554752
Dermal cyst 12.03 11.90 14 55982 1989 42563350
Hallucination 12.03 11.90 122 55874 57385 42507954
Plasma cell myeloma 12.03 11.90 28 55968 47550 42517789
Drug tolerance 12.00 11.90 18 55978 3272 42562067
Reading disorder 11.97 11.90 8 55988 541 42564798

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 1175.81 10.42 1300 216213 116569 110255217
Poisoning deliberate 976.68 10.42 622 216891 25709 110346077
Intentional overdose 643.36 10.42 1027 216486 131474 110240312
Somnolence 390.76 10.42 1380 216133 296069 110075717
Intentional self-injury 380.05 10.42 417 217096 37012 110334774
Lower respiratory tract infection 334.02 10.42 1145 216368 241961 110129825
Suicide attempt 301.00 10.42 643 216870 102751 110269035
Miosis 286.43 10.42 280 217233 21703 110350083
Suicidal ideation 269.77 10.42 581 216932 93356 110278430
Ear pain 267.02 10.42 419 217094 52807 110318979
Toxicity to various agents 251.54 10.42 1712 215801 478843 109892943
Product dose omission issue 250.65 10.42 162 217351 321620 110050166
Psychiatric decompensation 243.59 10.42 148 217365 5617 110366169
Depression 237.63 10.42 1242 216271 316093 110055693
Drug use disorder 205.77 10.42 214 217299 17860 110353926
Pneumonia aspiration 202.54 10.42 475 217038 80758 110291028
Psychomotor skills impaired 202.10 10.42 142 217371 6916 110364870
Death 183.55 10.42 730 216783 698139 109673647
Cardiac failure congestive 178.97 10.42 39 217474 150961 110220825
Disease progression 174.01 10.42 135 217378 243899 110127887
Foetal death 173.79 10.42 185 217328 15860 110355926
Depression suicidal 171.52 10.42 111 217402 4713 110367073
Body temperature increased 169.36 10.42 349 217164 54364 110317422
Sleep disorder due to general medical condition, insomnia type 165.02 10.42 520 216993 105123 110266663
Depressive symptom 160.76 10.42 133 217380 8281 110363505
Temperature regulation disorder 158.99 10.42 159 217354 12667 110359119
Muscle spasticity 158.75 10.42 267 217246 35648 110336138
Muscle injury 156.87 10.42 620 216893 140187 110231599
Overdose 154.68 10.42 885 216628 232909 110138877
Ill-defined disorder 153.01 10.42 663 216850 156190 110215596
Substance use disorder 151.44 10.42 121 217392 7169 110364617
Prescribed overdose 149.77 10.42 445 217068 87136 110284650
Myelosuppression 149.39 10.42 9 217504 94331 110277455
Rheumatoid arthritis 148.03 10.42 1053 216460 298560 110073226
Confusional state 146.59 10.42 1487 216026 467193 109904593
Electric shock 144.40 10.42 71 217442 1757 110370029
Respiratory disorder 143.91 10.42 385 217128 70997 110300789
Asphyxia 136.75 10.42 154 217359 14061 110357725
Hypothermia 136.01 10.42 210 217303 26092 110345694
Tearfulness 133.23 10.42 113 217400 7282 110364504
Inspiratory capacity decreased 131.68 10.42 75 217438 2520 110369266
Sinusitis 130.25 10.42 1014 216499 295674 110076112
Contusion 125.79 10.42 838 216675 232523 110139263
Mental status changes 124.47 10.42 6 217507 76116 110295670
Sepsis 123.64 10.42 289 217224 327057 110044729
Irritable bowel syndrome 120.20 10.42 639 216874 163576 110208210
Folliculitis 117.05 10.42 644 216869 167009 110204777
Altered state of consciousness 113.33 10.42 308 217205 57318 110314468
Respiratory failure 106.96 10.42 161 217352 215171 110156615
Food allergy 105.58 10.42 161 217352 19787 110351999
Electrocardiogram QT prolonged 104.28 10.42 458 217055 108502 110263284
Drug dependence 104.08 10.42 273 217240 49747 110322039
Paranoia 98.43 10.42 166 217347 22208 110349578
Infusion related reaction 97.32 10.42 1162 216351 380000 109991786
Neutropenia 95.20 10.42 396 217117 374224 109997562
Insomnia 94.57 10.42 1105 216408 359485 110012301
Injection site pain 94.34 10.42 127 217386 177795 110193991
Pneumonia 92.90 10.42 1192 216321 875522 109496264
Adjustment disorder with depressed mood 91.81 10.42 240 217273 43643 110328143
Blister 91.52 10.42 762 216751 226614 110145172
Drug interaction 91.37 10.42 1436 216077 498747 109873039
Myocardial infarction 91.22 10.42 148 217365 191935 110179851
Neovascularisation 90.29 10.42 51 217462 1686 110370100
Frequent bowel movements 89.93 10.42 327 217186 71063 110300723
Night sweats 87.12 10.42 505 217008 133478 110238308
White blood cell count decreased 86.99 10.42 202 217311 229188 110142598
Injection site reaction 85.49 10.42 34 217479 89036 110282750
Psychotic disorder 83.47 10.42 255 217258 50682 110321104
Antipsychotic drug level increased 83.35 10.42 85 217428 6930 110364856
Impaired healing 83.34 10.42 667 216846 196050 110175736
Platelet count decreased 82.60 10.42 209 217304 230234 110141552
Bezoar 81.47 10.42 66 217447 3988 110367798
Extrapyramidal disorder 81.06 10.42 177 217336 28690 110343096
Renal failure 80.81 10.42 206 217307 226368 110145418
Hepatocellular injury 80.64 10.42 251 217262 50391 110321395
Thrombosis 80.13 10.42 58 217455 108604 110263182
Post-traumatic stress disorder 78.51 10.42 80 217433 6516 110365270
Depressed level of consciousness 76.81 10.42 429 217084 111849 110259937
Bursitis 76.38 10.42 477 217036 129441 110242345
X-ray abnormal 76.22 10.42 205 217308 37912 110333874
Infection 75.51 10.42 1064 216449 361136 110010650
Drug resistance 74.49 10.42 11 217502 56363 110315423
Dystonic tremor 74.42 10.42 28 217485 349 110371437
Contraindicated product administered 73.35 10.42 779 216734 247488 110124298
Blood mercury abnormal 70.76 10.42 25 217488 257 110371529
Gastrointestinal disorder 70.46 10.42 757 216756 241195 110130591
Akathisia 70.07 10.42 123 217390 16990 110354796
Deep vein thrombosis 70.03 10.42 104 217409 139783 110232003
Drug abuse 70.01 10.42 592 216921 176819 110194967
Osmolar gap increased 69.87 10.42 23 217490 187 110371599
Poisoning 69.07 10.42 167 217346 28938 110342848
Breast cancer stage II 68.13 10.42 160 217353 27215 110344571
Drug ineffective 67.49 10.42 2382 215131 1518158 108853628
Immunodeficiency 67.00 10.42 198 217315 38640 110333146
Sputum discoloured 65.95 10.42 160 217353 27785 110344001
Gastrointestinal haemorrhage 64.99 10.42 143 217370 165375 110206411
Duodenal ulcer perforation 64.93 10.42 583 216930 177117 110194669
White blood cells urine positive 64.80 10.42 77 217436 7447 110364339
Lupus vulgaris 64.53 10.42 179 217334 33704 110338082
Incorrect route of product administration 64.13 10.42 273 217240 63788 110307998
Neuroleptic malignant syndrome 63.95 10.42 179 217334 33880 110337906
Anti-cyclic citrullinated peptide antibody positive 63.93 10.42 592 216921 181392 110190394
No adverse event 63.36 10.42 33 217480 73806 110297980
COVID-19 62.87 10.42 258 217255 244802 110126984
Joint swelling 62.71 10.42 1221 216292 441624 109930162
Swollen tongue 62.58 10.42 260 217253 60102 110311684
Housebound 62.06 10.42 26 217487 437 110371349
Intentional product misuse 61.47 10.42 460 217053 132444 110239342
Cardiac arrest 61.21 10.42 191 217322 196562 110175224
Intervertebral discitis 60.97 10.42 72 217441 6918 110364868
Discomfort 60.77 10.42 668 216845 214039 110157747
Wrong technique in product usage process 60.12 10.42 50 217463 87298 110284488
Coronary artery disease 60.11 10.42 33 217480 71657 110300129
Atrial fibrillation 60.02 10.42 240 217273 229402 110142384
Helicobacter infection 59.59 10.42 583 216930 181294 110190492
Accidental exposure to product 59.07 10.42 13 217500 49995 110321791
Cytomegalovirus infection 58.82 10.42 17 217496 54427 110317359
Sleep disorder 58.52 10.42 623 216890 198021 110173765
Vaginal flatulence 57.31 10.42 93 217420 12051 110359735
Colitis ulcerative 57.23 10.42 302 217211 77061 110294725
Proctitis 57.18 10.42 112 217401 16815 110354971
Acute respiratory failure 57.03 10.42 39 217474 75221 110296565
Nasopharyngitis 56.73 10.42 1090 216423 393271 109978515
IVth nerve paralysis 56.28 10.42 27 217486 632 110371154
Chronic kidney disease 55.89 10.42 41 217472 76250 110295536
Blood glucose increased 55.78 10.42 110 217403 132386 110239400
Hepatic enzyme increased 55.41 10.42 913 216600 319979 110051807
Post cholecystectomy syndrome 55.36 10.42 29 217484 823 110370963
Lupus vasculitis 54.85 10.42 26 217487 592 110371194
Dysphonia 53.85 10.42 293 217220 75636 110296150
Bronchopulmonary aspergillosis allergic 53.31 10.42 74 217439 8352 110363434
Peripheral swelling 53.19 10.42 1102 216411 402932 109968854
Malignant neoplasm progression 52.52 10.42 172 217341 174395 110197391
Granulocyte count increased 52.41 10.42 38 217475 1945 110369841
Bradypnoea 51.81 10.42 74 217439 8575 110363211
Renal impairment 51.77 10.42 193 217320 188252 110183534
Pulmonary fibrosis 51.69 10.42 361 217152 101681 110270105
Cryopyrin associated periodic syndrome 51.54 10.42 25 217488 600 110371186
Behaviour disorder 51.25 10.42 78 217435 9569 110362217
Low density lipoprotein decreased 51.24 10.42 33 217480 1389 110370397
Dry skin 51.05 10.42 83 217430 107570 110264216
Somnambulism 51.01 10.42 63 217450 6342 110365444
Chronic sinusitis 50.25 10.42 135 217378 24949 110346837
Pulmonary hypertension 49.92 10.42 23 217490 55197 110316589
Dislocation of vertebra 49.86 10.42 194 217319 43527 110328259
Bronchial wall thickening 49.73 10.42 45 217468 3162 110368624
Multiple organ dysfunction syndrome 49.53 10.42 144 217369 151566 110220220
Hyperhidrosis 49.05 10.42 574 216939 186724 110185062
Medication error 48.90 10.42 365 217148 105001 110266785
Cerebral artery thrombosis 48.79 10.42 34 217479 1634 110370152
Hypersensitivity 48.71 10.42 1088 216425 402910 109968876
Brain scan abnormal 48.25 10.42 33 217480 1538 110370248
Temperature intolerance 47.97 10.42 93 217420 13857 110357929
Nausea 47.79 10.42 1967 215546 1233723 109138063
Injection site erythema 47.14 10.42 70 217443 94106 110277680
Hepatic cytolysis 47.14 10.42 224 217289 54829 110316957
Urine leukocyte esterase positive 47.04 10.42 47 217466 3739 110368047
Decompression sickness 47.03 10.42 15 217498 109 110371677
Female genital tract fistula 46.05 10.42 101 217412 16418 110355368
Total lung capacity decreased 45.79 10.42 63 217450 7051 110364735
Coagulopathy 45.64 10.42 12 217501 40899 110330887
Injection site pruritus 45.34 10.42 22 217491 51236 110320550
Substance dependence 45.18 10.42 24 217489 701 110371085
Therapy partial responder 45.08 10.42 9 217504 37052 110334734
Anxiety 45.01 10.42 940 216573 344138 110027648
Blood test abnormal 44.97 10.42 141 217372 28413 110343373
Broncholithiasis 44.58 10.42 18 217495 274 110371512
Demyelination 44.22 10.42 72 217441 9357 110362429
Hypervolaemia 44.10 10.42 21 217492 49439 110322347
Maternal exposure timing unspecified 44.03 10.42 115 217398 20898 110350888
5-hydroxyindolacetic acid in urine increased 43.68 10.42 16 217497 184 110371602
Ascites 43.59 10.42 72 217441 92736 110279050
Prescription form tampering 43.45 10.42 21 217492 500 110371286
Bladder dilatation 43.39 10.42 37 217476 2402 110369384
Obstructive airways disorder 42.64 10.42 192 217321 45957 110325829
Pericarditis 42.58 10.42 636 216877 218478 110153308
Aspartate aminotransferase increased 42.51 10.42 166 217347 159770 110212016
Condition aggravated 42.04 10.42 1112 216401 733724 109638062
Throat clearing 41.78 10.42 47 217466 4286 110367500
Vocal cord dysfunction 41.71 10.42 25 217488 925 110370861
Vaginal discharge 41.69 10.42 102 217411 17806 110353980
Therapy cessation 41.63 10.42 18 217495 44839 110326947
Blood immunoglobulin A increased 41.34 10.42 30 217483 1538 110370248
Hepatic function abnormal 41.26 10.42 70 217443 89225 110282561
Mydriasis 41.16 10.42 116 217397 22041 110349745
Skin candida 40.77 10.42 35 217478 2293 110369493
Depressed mood 40.69 10.42 231 217282 60578 110311208
Neurodegenerative disorder 40.62 10.42 23 217490 764 110371022
Substance abuse 40.34 10.42 81 217432 12382 110359404
Coeliac disease 40.14 10.42 180 217333 43007 110328779
Product quality issue 40.13 10.42 56 217457 77243 110294543
Anaemia 39.97 10.42 797 216716 546289 109825497
Porphyria acute 39.57 10.42 103 217410 18677 110353109
Post-traumatic neck syndrome 39.43 10.42 36 217477 2559 110369227
General symptom 39.40 10.42 66 217447 8780 110363006
Subcutaneous drug absorption impaired 39.38 10.42 61 217452 7598 110364188
Postmortem blood drug level abnormal 39.36 10.42 21 217492 619 110371167
Burnout syndrome 39.31 10.42 18 217495 378 110371408
Hepatotoxicity 39.23 10.42 40 217473 63360 110308426
Surgery 39.22 10.42 16 217497 41267 110330519
Blood calcium decreased 39.08 10.42 11 217502 35834 110335952
Delirium 39.06 10.42 422 217091 134603 110237183
Rash erythematous 38.83 10.42 285 217228 81547 110290239
Seizure 38.74 10.42 265 217248 220920 110150866
Pemphigus 38.69 10.42 615 216898 213955 110157831
Agitation 38.30 10.42 365 217148 112686 110259100
Alanine aminotransferase increased 38.02 10.42 209 217304 183564 110188222
Abdominal distension 37.97 10.42 196 217317 174907 110196879
Neck pain 37.95 10.42 120 217393 123010 110248776
Septic shock 37.84 10.42 170 217343 157358 110214428
Glomerular filtration rate increased 37.69 10.42 31 217482 1914 110369872
Posterior reversible encephalopathy syndrome 37.65 10.42 10 217503 33851 110337935
Neurotoxicity 37.51 10.42 18 217495 42189 110329597
Therapy interrupted 37.51 10.42 26 217487 49796 110321990
Soft tissue injury 37.40 10.42 33 217480 2243 110369543
Cholestasis 37.35 10.42 236 217277 64282 110307504
Cardiac murmur 37.10 10.42 3 217510 24625 110347161
Epistaxis 36.81 10.42 132 217381 130240 110241546
Dyspnoea exertional 36.78 10.42 95 217418 103965 110267821
Angina pectoris 36.66 10.42 41 217472 62254 110309532
Lymph node calcification 36.40 10.42 18 217495 451 110371335
Swelling face 36.36 10.42 308 217205 92013 110279773
Unevaluable event 35.94 10.42 38 217475 59189 110312597
Urinary tract infection 35.78 10.42 440 217073 325842 110045944
Retinitis 35.69 10.42 142 217371 32185 110339601
Drug intolerance 35.54 10.42 1049 216464 405463 109966323
Drug detoxification 35.34 10.42 19 217494 569 110371217
Myalgia 35.30 10.42 274 217239 222107 110149679
Laryngeal stenosis 35.16 10.42 26 217487 1372 110370414
Eye irritation 35.13 10.42 11 217502 33441 110338345
Monocyte percentage increased 35.09 10.42 32 217481 2271 110369515
Haematuria 34.85 10.42 69 217444 82936 110288850
Disturbance in attention 34.80 10.42 225 217288 61770 110310016
Full blood count decreased 34.71 10.42 10 217503 32089 110339697
Libido increased 34.31 10.42 33 217480 2506 110369280
Weight increased 34.31 10.42 1074 216439 418570 109953216
Red blood cell sedimentation rate abnormal 34.25 10.42 4 217509 24505 110347281
Skin exfoliation 34.17 10.42 76 217437 87575 110284211
Amnesia 34.08 10.42 337 217176 105071 110266715
Cerebral infarction 34.06 10.42 31 217482 51807 110319979
Radiculopathy 33.76 10.42 99 217414 19237 110352549
Aspartate aminotransferase 33.72 10.42 22 217491 947 110370839
Dermatitis atopic 33.70 10.42 5 217508 25536 110346250
Paraesthesia oral 33.32 10.42 143 217370 33528 110338258
Upper respiratory tract infection 33.28 10.42 400 217113 130928 110240858
Victim of chemical submission 33.17 10.42 21 217492 858 110370928
Skin ulcer 33.14 10.42 46 217467 63599 110308187
Cerebrovascular accident 32.85 10.42 215 217298 181069 110190717
Hostility 32.64 10.42 33 217480 2663 110369123
Pleural effusion 32.58 10.42 210 217303 177499 110194287
Respiratory arrest 32.55 10.42 40 217473 58259 110313527
Pulmonary embolism 32.32 10.42 268 217245 214206 110157580
Headache 32.22 10.42 2079 215434 880298 109491488
Atelectasis 32.10 10.42 16 217497 36696 110335090
Choking 31.97 10.42 83 217430 15027 110356759
Osteomyelitis 31.93 10.42 16 217497 36584 110335202
Analgesic drug level increased 31.73 10.42 39 217474 3907 110367879
Fungal infection 31.50 10.42 32 217481 50774 110321012
Abortion spontaneous 31.43 10.42 14 217499 34268 110337518
Impaired quality of life 31.29 10.42 10 217503 30007 110341779
Urticaria 31.27 10.42 835 216678 318022 110053764
Completed suicide 31.26 10.42 315 217198 242066 110129720
Coma scale abnormal 31.22 10.42 63 217450 9663 110362123
Hospitalisation 31.17 10.42 159 217354 142334 110229452
Glossodynia 31.00 10.42 611 216902 221393 110150393
Pain in extremity 30.83 10.42 726 216787 486392 109885394
Nodule 30.43 10.42 13 217500 32618 110339168
Red blood cells urine 30.43 10.42 18 217495 650 110371136
Sopor 30.38 10.42 17 217496 36529 110335257
Onychomadesis 30.37 10.42 27 217486 45636 110326150
Vitamin B12 increased 30.24 10.42 28 217485 2027 110369759
Lung opacity 29.97 10.42 69 217444 11583 110360203
Transplant rejection 29.81 10.42 6 217507 24561 110347225
Neutrophil count increased 29.67 10.42 141 217372 34511 110337275
Skin fissures 29.62 10.42 6 217507 24452 110347334
Cardiac failure 29.39 10.42 232 217281 187394 110184392
Neutrophil percentage increased 29.38 10.42 42 217471 4871 110366915
Metastases to lung 29.34 10.42 5 217508 23058 110348728
Chills 29.24 10.42 237 217276 190343 110181443
Rales 29.21 10.42 111 217402 24628 110347158
Carcinoid tumour pulmonary 29.18 10.42 15 217498 409 110371377
Pregnancy 29.07 10.42 186 217327 50881 110320905
Vision blurred 28.78 10.42 143 217370 128879 110242907
Fear of disease 28.65 10.42 23 217490 1372 110370414
Stomatitis 28.62 10.42 715 216798 269527 110102259
Lymphocyte percentage decreased 28.30 10.42 43 217470 5267 110366519
Injection site swelling 28.04 10.42 49 217464 61741 110310045
Antipsychotic drug level above therapeutic 27.97 10.42 29 217484 2411 110369375
Macular degeneration 27.94 10.42 100 217413 21559 110350227
Neoplasm progression 27.73 10.42 53 217460 64542 110307244
Eye pruritus 27.60 10.42 15 217498 32760 110339026
Plasma cell myeloma 27.58 10.42 51 217462 62885 110308901
Epidermal necrosis 27.57 10.42 32 217481 3018 110368768
Walking aid user 27.57 10.42 110 217403 24965 110346821
Calcium deficiency 27.54 10.42 21 217492 1161 110370625
Cellulitis 27.35 10.42 141 217372 125875 110245911
Rheumatoid factor increased 27.33 10.42 29 217484 2476 110369310
Creatinine renal clearance decreased 27.16 10.42 5 217508 21810 110349976
Hand deformity 27.10 10.42 591 216922 217915 110153871
Band neutrophil percentage increased 26.96 10.42 14 217499 390 110371396
Lymphadenopathy 26.86 10.42 53 217460 63782 110308004
Gallbladder adenocarcinoma 26.85 10.42 10 217503 121 110371665
Persecutory delusion 26.78 10.42 46 217467 6245 110365541
Rheumatoid nodule 26.72 10.42 4 217509 20292 110351494
Social anxiety disorder 26.65 10.42 19 217494 947 110370839
IgA nephropathy 26.55 10.42 32 217481 3141 110368645
Respiratory tract infection 26.39 10.42 64 217449 71553 110300233
Oral candidiasis 26.08 10.42 164 217349 44596 110327190
Macrophages increased 26.07 10.42 12 217501 255 110371531
International normalised ratio increased 25.74 10.42 86 217427 86686 110285100
Adverse reaction 25.72 10.42 13 217500 29581 110342205
Anti-cyclic citrullinated peptide antibody 25.60 10.42 92 217421 19872 110351914
Sternal fracture 25.42 10.42 32 217481 3284 110368502
Nail disorder 25.34 10.42 47 217466 57888 110313898
Hallucination, auditory 25.27 10.42 111 217402 26286 110345500
Diabetes mellitus 25.24 10.42 105 217408 99276 110272510
Respiratory depression 25.10 10.42 127 217386 31874 110339912
Thrombotic microangiopathy 25.05 10.42 13 217500 29136 110342650
Pustular psoriasis 25.05 10.42 71 217442 13534 110358252
Haemoglobin urine 24.96 10.42 10 217503 149 110371637
Diaphragmatic rupture 24.88 10.42 11 217502 212 110371574
Opiates positive 24.83 10.42 18 217495 921 110370865
Cataract 24.82 10.42 77 217436 79408 110292378
Phonophobia 24.77 10.42 16 217497 677 110371109
Neutrophil count decreased 24.76 10.42 138 217375 120803 110250983
Bronchopulmonary aspergillosis 24.67 10.42 14 217499 29849 110341937
Staphylococcal infection 24.61 10.42 64 217449 69880 110301906
Tuberculosis 24.60 10.42 3 217510 17771 110354015
Haemodialysis 24.50 10.42 3 217510 17716 110354070
Psychomotor retardation 24.45 10.42 50 217463 7742 110364044
Fluid replacement 24.26 10.42 18 217495 955 110370831
Viral infection 24.24 10.42 42 217471 53097 110318689
Prostate cancer 24.15 10.42 23 217490 37618 110334168
Rash pruritic 24.05 10.42 105 217408 97964 110273822
Epstein-Barr virus infection 23.98 10.42 4 217509 18734 110353052
Neuropathy peripheral 23.94 10.42 231 217282 179046 110192740
Drug eruption 23.94 10.42 43 217470 53616 110318170
Renal injury 23.93 10.42 4 217509 18709 110353077
Hallucination, visual 23.63 10.42 146 217367 39459 110332327
Wrong rate 23.60 10.42 10 217503 173 110371613
Bone marrow failure 23.51 10.42 49 217464 57799 110313987
Blood bilirubin increased 23.44 10.42 74 217439 75898 110295888
Ventricular fibrillation 23.43 10.42 28 217485 41285 110330501
Specific gravity urine increased 23.41 10.42 14 217499 516 110371270
Arteriovenous fistula 23.35 10.42 21 217492 1464 110370322
Abdominal pain upper 23.35 10.42 873 216640 348238 110023548
Hypoalbuminaemia 23.34 10.42 14 217499 28960 110342826
Therapeutic response decreased 23.25 10.42 104 217409 96395 110275391
Haemophagocytic lymphohistiocytosis 23.06 10.42 17 217496 31542 110340244
Multiple sclerosis 23.05 10.42 106 217407 25592 110346194
Concussion 23.01 10.42 62 217451 11476 110360310
Febrile neutropenia 22.94 10.42 462 217051 316305 110055481
5-hydroxyindolacetic acid increased 22.91 10.42 9 217504 127 110371659
Interstitial lung disease 22.90 10.42 170 217343 139164 110232622
Excessive eye blinking 22.84 10.42 23 217490 1847 110369939
Haemorrhage 22.80 10.42 120 217393 106572 110265214
Postmortem blood drug level increased 22.76 10.42 19 217494 1198 110370588
Decreased immune responsiveness 22.67 10.42 55 217458 9551 110362235
Aspergillus infection 22.65 10.42 11 217502 25605 110346181
Bone pain 22.61 10.42 60 217453 65073 110306713
Appendicitis 22.58 10.42 14 217499 28450 110343336
Exostosis 22.34 10.42 161 217352 45795 110325991
Pulmonary alveolar haemorrhage 22.31 10.42 6 217507 20144 110351642
Transient ischaemic attack 22.16 10.42 59 217454 63923 110307863
Haematotoxicity 22.02 10.42 7 217506 21075 110350711
Onychomycosis 21.98 10.42 26 217487 38505 110333281
Back pain 21.84 10.42 915 216598 370081 110001705
Myelodysplastic syndrome 21.69 10.42 25 217488 37459 110334327
Rectal spasm 21.66 10.42 10 217503 214 110371572
Communication disorder 21.65 10.42 37 217476 5002 110366784
Hepatic neoplasm 21.59 10.42 32 217481 3835 110367951
Cholelithiasis 21.58 10.42 59 217454 63363 110308423
Finger deformity 21.49 10.42 20 217493 33072 110338714
Balance disorder 21.34 10.42 335 217178 116225 110255561
Product storage error 21.33 10.42 8 217505 21720 110350066
Hyponatraemia 21.33 10.42 570 216943 217083 110154703
Mucosal inflammation 21.18 10.42 107 217406 96034 110275752
Blood immunoglobulin E increased 21.15 10.42 46 217467 7436 110364350
Asthma 21.07 10.42 643 216870 249648 110122138
Diarrhoea 20.99 10.42 1943 215570 1137562 109234224
Alcohol abuse 20.93 10.42 36 217477 4893 110366893
Enterococcal infection 20.85 10.42 7 217506 20359 110351427
Paradoxical drug reaction 20.85 10.42 54 217459 9763 110362023
Vaccination site pain 20.65 10.42 13 217500 526 110371260
Respiratory acidosis 20.61 10.42 67 217446 13759 110358027
Bilirubin urine present 20.53 10.42 11 217502 327 110371459
Anticholinergic syndrome 20.50 10.42 33 217480 4247 110367539
Ligament pain 20.47 10.42 10 217503 244 110371542
Aspiration 20.43 10.42 116 217397 30417 110341369
Right ventricular failure 20.27 10.42 13 217500 25941 110345845
Colorectal cancer metastatic 20.25 10.42 20 217493 1569 110370217
Presyncope 20.21 10.42 41 217472 48846 110322940
Wound 20.20 10.42 604 216909 233833 110137953
Device issue 20.02 10.42 23 217490 34512 110337274
Venoocclusive liver disease 20.01 10.42 3 217510 15204 110356582
Sinus tachycardia 20.00 10.42 153 217360 44340 110327446
Lupus-like syndrome 19.88 10.42 143 217370 40649 110331137
Gangrene 19.81 10.42 4 217509 16337 110355449
Myocarditis septic 19.80 10.42 6 217507 36 110371750
Puncture site haematoma 19.75 10.42 10 217503 264 110371522
Blood osmolarity increased 19.73 10.42 15 217498 826 110370960
Blood calcium increased 19.72 10.42 79 217434 17961 110353825
Serum ferritin abnormal 19.71 10.42 12 217501 457 110371329
Hyperlipidaemia 19.59 10.42 25 217488 35823 110335963
Band neutrophil count increased 19.58 10.42 14 217499 701 110371085
Feelings of worthlessness 19.57 10.42 13 217500 577 110371209
Rectal haemorrhage 19.57 10.42 338 217175 119495 110252291
Bacterial infection 19.56 10.42 38 217475 45998 110325788
Splenomegaly 19.51 10.42 12 217501 24486 110347300
Logorrhoea 19.49 10.42 35 217478 4922 110366864
Urine abnormality 19.28 10.42 50 217463 9046 110362740
Product administration error 19.28 10.42 27 217486 37190 110334596
Hyperthermia 19.27 10.42 88 217425 21184 110350602
Pneumonia fungal 19.21 10.42 3 217510 14751 110357035
COVID-19 pneumonia 19.19 10.42 27 217486 37116 110334670
Laryngitis 19.15 10.42 146 217367 42265 110329521
Toxic epidermal necrolysis 19.13 10.42 183 217330 56544 110315242
Accessory spleen 19.02 10.42 9 217504 204 110371582
Vertebral artery occlusion 18.96 10.42 12 217501 490 110371296
Sinus rhythm 18.92 10.42 16 217497 1027 110370759
Psychiatric symptom 18.87 10.42 50 217463 9163 110362623
Tenderness 18.87 10.42 18 217495 29419 110342367
Intentional dose omission 18.72 10.42 8 217505 20072 110351714
Liver function test abnormal 18.68 10.42 71 217442 68879 110302907
Vasculitis 18.61 10.42 26 217487 35847 110335939
Paraneoplastic rash 18.55 10.42 7 217506 88 110371698
Panniculitis 18.50 10.42 4 217509 15578 110356208
Hepatic encephalopathy 18.44 10.42 17 217496 28239 110343547
Areflexia 18.43 10.42 41 217472 6728 110365058
Bone erosion 18.41 10.42 155 217358 46216 110325570
Vasoplegia syndrome 18.39 10.42 36 217477 5403 110366383
Accommodation disorder 18.38 10.42 13 217500 640 110371146
Appendicolith 18.33 10.42 3 217510 14252 110357534
Medical observation 18.26 10.42 9 217504 224 110371562
Anhedonia 18.24 10.42 4 217509 15424 110356362
Disorientation 18.23 10.42 216 217297 70455 110301331
Myelocyte percentage increased 18.11 10.42 9 217504 228 110371558
General physical health deterioration 18.09 10.42 1016 216497 424279 109947507
Arterial occlusive disease 18.04 10.42 4 217509 15304 110356482
Middle insomnia 17.97 10.42 84 217429 20418 110351368
Therapeutic reaction time decreased 17.92 10.42 35 217478 5244 110366542
Pseudomonas infection 17.89 10.42 17 217496 27836 110343950
Aplastic anaemia 17.88 10.42 13 217500 24295 110347491
Drug ineffective for unapproved indication 17.87 10.42 293 217220 102545 110269241
Feeling abnormal 17.84 10.42 249 217264 180462 110191324
Therapeutic product effect decreased 17.81 10.42 617 216896 243699 110128087
Hepatitis 17.76 10.42 104 217409 89950 110281836
Tenosynovitis 17.74 10.42 5 217508 16278 110355508
Toxicologic test abnormal 17.69 10.42 17 217496 1290 110370496
Disseminated intravascular coagulation 17.61 10.42 34 217479 41252 110330534
Heart rate decreased 17.56 10.42 244 217269 82512 110289274
Bacterial disease carrier 17.56 10.42 22 217491 2247 110369539
Prothrombin time prolonged 17.55 10.42 6 217507 17255 110354531
Spasmodic dysphonia 17.47 10.42 12 217501 563 110371223
Malignant polyp 17.38 10.42 8 217505 170 110371616
Blood creatinine increased 17.36 10.42 254 217259 182635 110189151
Post concussion syndrome 17.35 10.42 13 217500 700 110371086
Respiratory rate decreased 17.15 10.42 38 217475 6220 110365566
Failure to thrive 17.14 10.42 3 217510 13571 110358215
Hallucination, synaesthetic 17.13 10.42 6 217507 60 110371726
Deep vein thrombosis postoperative 17.00 10.42 185 217328 59106 110312680
Systemic lupus erythematosus 16.99 10.42 636 216877 253702 110118084
Blood pressure systolic increased 16.93 10.42 243 217270 82748 110289038
Leukocytosis 16.91 10.42 52 217461 53776 110318010
Fluid retention 16.87 10.42 270 217243 94037 110277749
Feeling hot 16.74 10.42 262 217251 90844 110280942
Hypoventilation 16.70 10.42 44 217469 8037 110363749
Inappropriate antidiuretic hormone secretion 16.69 10.42 119 217394 33732 110338054
Optic nerve operation 16.67 10.42 11 217502 483 110371303
Ventricular tachycardia 16.66 10.42 47 217466 49962 110321824
Tubulointerstitial nephritis 16.66 10.42 53 217460 54231 110317555
Injection site rash 16.62 10.42 13 217500 23406 110348380
Oliguria 16.51 10.42 8 217505 18649 110353137
Pulmonary arterial hypertension 16.50 10.42 24 217489 32544 110339242
Wound infection 16.45 10.42 274 217239 96191 110275595
Back disorder 16.39 10.42 83 217430 20839 110350947
Blindness 16.34 10.42 29 217484 36330 110335456
Blood ethanol increased 16.30 10.42 12 217501 629 110371157
Post procedural complication 16.29 10.42 17 217496 26641 110345145
Nephropathy toxic 16.26 10.42 18 217495 27460 110344326
Cardiac disorder 16.18 10.42 86 217427 76194 110295592
Angioedema 16.15 10.42 278 217235 98222 110273564
Labelled drug-food interaction medication error 16.12 10.42 8 217505 202 110371584
Pericardial effusion 16.10 10.42 58 217455 57159 110314627
Dactylitis 16.01 10.42 29 217484 4104 110367682
Vomiting 16.01 10.42 1558 215955 909117 109462669
Osteonecrosis 16.00 10.42 26 217487 33715 110338071
Disability 15.94 10.42 108 217405 30115 110341671
Blood pressure diastolic decreased 15.91 10.42 123 217390 35762 110336024
Pneumocystis jirovecii pneumonia 15.89 10.42 38 217475 42697 110329089
Metastases to lymph nodes 15.68 10.42 5 217508 15027 110356759
Glabellar reflex abnormal 15.60 10.42 5 217508 37 110371749
Urine bilirubin decreased 15.60 10.42 7 217506 140 110371646
Obsessive-compulsive disorder 15.55 10.42 40 217473 7201 110364585
Urine oxalate increased 15.50 10.42 8 217505 220 110371566
Uveitis 15.47 10.42 12 217501 21698 110350088
Dehydration 15.40 10.42 425 217088 279086 110092700
Rhinitis allergic 15.39 10.42 8 217505 17914 110353872
Dyspepsia 15.38 10.42 488 217025 190477 110181309
Ocular hyperaemia 15.36 10.42 34 217479 39252 110332534
Graft versus host disease 15.27 10.42 9 217504 18797 110352989
Flushing 15.26 10.42 132 217381 104604 110267182
Diverticulitis 15.23 10.42 54 217459 53468 110318318
Blood pressure abnormal 15.23 10.42 13 217500 22411 110349375
Ileus 15.22 10.42 23 217490 30706 110341080
Intensive care 15.21 10.42 21 217492 2358 110369428
Poor quality sleep 15.21 10.42 101 217412 27976 110343810
Tachycardia 15.20 10.42 567 216946 226078 110145708
Skin necrosis 15.19 10.42 12 217501 21500 110350286
Phlebotomy 15.19 10.42 6 217507 86 110371700
Distal intestinal obstruction syndrome 15.15 10.42 14 217499 1011 110370775
Rash vesicular 15.10 10.42 63 217450 14589 110357197
Loss of personal independence in daily activities 15.01 10.42 394 217119 149626 110222160
Staphylococcal bacteraemia 15.01 10.42 7 217506 16681 110355105
Poor venous access 15.01 10.42 91 217422 24431 110347355
Spinal disorder 15 10.42 54 217459 11674 110360112
Dyspnoea 14.97 10.42 1928 215585 1104944 109266842
Respiratory syncytial virus infection 14.79 10.42 5 217508 14479 110357307
Schizoaffective disorder 14.78 10.42 24 217489 3112 110368674
Respiratory tract haemorrhage 14.75 10.42 19 217494 1995 110369791
Bacteraemia 14.75 10.42 39 217474 42351 110329435
Acute hepatic failure 14.73 10.42 31 217482 36437 110335349
Hypercalcaemia 14.71 10.42 45 217468 46612 110325174
Rhinorrhoea 14.69 10.42 130 217383 102536 110269250
Breath sounds abnormal 14.64 10.42 17 217496 25387 110346399
Eosinophil count abnormal 14.59 10.42 14 217499 1060 110370726
Antidepressant drug level above therapeutic 14.53 10.42 12 217501 745 110371041
Oxygen saturation decreased 14.49 10.42 408 217105 156574 110215212
Cytopenia 14.48 10.42 23 217490 30093 110341693
Hypogammaglobulinaemia 14.43 10.42 11 217502 20065 110351721
Respiratory tract congestion 14.43 10.42 24 217489 30833 110340953
Injection site bruising 14.40 10.42 52 217461 51211 110320575
Embolism 14.39 10.42 7 217506 16282 110355504
Product label confusion 14.38 10.42 14 217499 22663 110349123
Metastases to liver 14.36 10.42 30 217483 35356 110336430
Acute myocardial infarction 14.35 10.42 101 217412 83676 110288110
Implant site extravasation 14.35 10.42 13 217500 915 110370871
BK virus infection 14.33 10.42 4 217509 13102 110358684
Taste disorder 14.27 10.42 73 217440 65314 110306472
Injection site haemorrhage 14.26 10.42 27 217486 33001 110338785
Scrotal infection 14.22 10.42 12 217501 768 110371018
Red blood cell elliptocytes present 14.03 10.42 7 217506 179 110371607
Electrocardiogram repolarisation abnormality 14.02 10.42 20 217493 2315 110369471
Anaphylactic shock 14.01 10.42 53 217460 51493 110320293
Cerebral haemorrhage 13.92 10.42 73 217440 64895 110306891
Red cell distribution width increased 13.91 10.42 70 217443 17532 110354254
Disorganised speech 13.86 10.42 24 217489 3279 110368507
Delusion 13.81 10.42 87 217426 23668 110348118
Pulmonary thrombosis 13.79 10.42 5 217508 13858 110357928
Electrocardiogram QRS complex shortened 13.70 10.42 12 217501 808 110370978
Urine analysis abnormal 13.69 10.42 37 217476 6860 110364926
Granulocytopenia 13.68 10.42 4 217509 12711 110359075
Stress cardiomyopathy 13.65 10.42 7 217506 15799 110355987
Lupus nephritis 13.63 10.42 29 217484 4616 110367170
Pulseless electrical activity 13.63 10.42 8 217505 16749 110355037
Polymicrogyria 13.63 10.42 3 217510 3 110371783
Dizziness 13.62 10.42 1185 216328 697008 109674778
Oesophageal carcinoma 13.60 10.42 3 217510 11521 110360265
Acquired haemophilia 13.59 10.42 21 217492 2610 110369176
Hypophosphataemia 13.57 10.42 28 217485 33154 110338632
Cardio-respiratory arrest 13.53 10.42 154 217359 115682 110256104
Feeling jittery 13.51 10.42 6 217507 14716 110357070
Blood follicle stimulating hormone increased 13.50 10.42 9 217504 402 110371384
Diplopia 13.50 10.42 40 217473 41854 110329932
Crystal urine present 13.49 10.42 18 217495 1956 110369830
Drug-induced liver injury 13.49 10.42 161 217352 119906 110251880
Lactic acidosis 13.47 10.42 257 217256 92554 110279232
Medication overuse headache 13.47 10.42 16 217497 1547 110370239
Basilar artery occlusion 13.45 10.42 8 217505 292 110371494
Multiple sclerosis relapse 13.44 10.42 52 217461 50188 110321598
Gait deviation 13.42 10.42 6 217507 119 110371667
Oral pain 13.37 10.42 34 217479 37410 110334376
Influenza 13.35 10.42 243 217270 168858 110202928
Prostatic specific antigen increased 13.34 10.42 4 217509 12507 110359279
Disease prodromal stage 13.31 10.42 5 217508 62 110371724
Enthesopathy 13.29 10.42 4 217509 12474 110359312
Glucocorticoids increased 13.28 10.42 6 217507 122 110371664
Device related infection 13.27 10.42 37 217476 39482 110332304
Product dose omission in error 13.27 10.42 16 217497 23496 110348290
Mania 13.26 10.42 78 217435 20718 110351068
Deafness 13.22 10.42 20 217493 26689 110345097
Product administration interrupted 13.21 10.42 3 217510 11289 110360497
Chronic obstructive pulmonary disease 13.19 10.42 144 217369 109014 110262772
Procedural anxiety 13.19 10.42 12 217501 849 110370937
Myocardial ischaemia 13.19 10.42 20 217493 26664 110345122
Pregnancy of partner 13.16 10.42 8 217505 304 110371482
Nephropathy 13.15 10.42 5 217508 13462 110358324
Angina unstable 13.15 10.42 8 217505 16424 110355362
Toxic skin eruption 13.15 10.42 96 217417 27419 110344367
Tooth injury 13.14 10.42 19 217494 2227 110369559
Pruritus 13.13 10.42 1321 216192 580239 109791547
Perineal infection 13.12 10.42 12 217501 855 110370931
Pneumococcal infection 13.07 10.42 17 217496 1802 110369984
Delirium febrile 13.03 10.42 5 217508 66 110371720
Pneumonia viral 12.98 10.42 3 217510 11154 110360632
Skin discolouration 12.97 10.42 51 217462 48995 110322791
Shock haemorrhagic 12.92 10.42 21 217492 27226 110344560
Incoherent 12.91 10.42 41 217472 8317 110363469
Differential white blood cell count abnormal 12.89 10.42 19 217494 2265 110369521
Drug level above therapeutic 12.87 10.42 51 217462 11537 110360249
Activated partial thromboplastin time prolonged 12.86 10.42 15 217498 22353 110349433
Tongue disorder 12.85 10.42 6 217507 14292 110357494
Enterocolitis 12.85 10.42 11 217502 18938 110352848
Paternal exposure timing unspecified 12.83 10.42 5 217508 69 110371717
Oropharyngeal pain 12.79 10.42 188 217325 135088 110236698
Joint range of motion decreased 12.78 10.42 322 217191 121510 110250276
Flank pain 12.78 10.42 16 217497 23114 110348672
Femoral artery aneurysm 12.77 10.42 7 217506 218 110371568
Erythrosis 12.77 10.42 7 217506 218 110371568
Joint noise 12.73 10.42 30 217483 5113 110366673
Hypovitaminosis 12.67 10.42 15 217498 1445 110370341
Spinal operation 12.66 10.42 3 217510 10969 110360817
Lung neoplasm malignant 12.66 10.42 30 217483 33812 110337974
Osteopenia 12.65 10.42 15 217498 22194 110349592
Pleuritic pain 12.62 10.42 64 217449 16076 110355710
Pemphigoid 12.62 10.42 74 217439 19633 110352153
Device leakage 12.59 10.42 8 217505 16040 110355746
Dialysis 12.57 10.42 12 217501 19607 110352179
Pathological fracture 12.56 10.42 4 217509 12028 110359758
Arthritis 12.55 10.42 243 217270 167343 110204443
Oral disorder 12.51 10.42 4 217509 11999 110359787
Hyperglycaemia 12.51 10.42 107 217406 84983 110286803
Kidney transplant rejection 12.48 10.42 4 217509 11983 110359803
Systemic inflammatory response syndrome 12.48 10.42 5 217508 13038 110358748
Syncope 12.47 10.42 303 217210 202233 110169553
Tendonitis 12.46 10.42 20 217493 26063 110345723
Ischaemic stroke 12.41 10.42 130 217383 41133 110330653
Hypercapnia 12.30 10.42 49 217464 11110 110360676
Joint injury 12.30 10.42 39 217474 39955 110331831
Hepatic cirrhosis 12.24 10.42 194 217319 67432 110304354
Hypersexuality 12.22 10.42 17 217496 1923 110369863
Coronary artery occlusion 12.18 10.42 8 217505 15764 110356022
Spinal fracture 12.15 10.42 16 217497 22617 110349169
Caesarean section 12.11 10.42 6 217507 13811 110357975
Water intoxication 12.09 10.42 12 217501 947 110370839
Eye pain 12.06 10.42 54 217459 50045 110321741
Myopathy 12.06 10.42 19 217494 24941 110346845
Complement factor C4 decreased 12.05 10.42 8 217505 355 110371431
Weight decreased 12.03 10.42 1073 216440 466984 109904802
Retinal depigmentation 11.99 10.42 8 217505 358 110371428
Body height decreased 11.97 10.42 3 217510 10560 110361226
Bronchospasm 11.96 10.42 26 217487 30213 110341573
Impaired work ability 11.94 10.42 21 217492 26398 110345388
Electrocardiogram T wave amplitude increased 11.94 10.42 5 217508 84 110371702
Lacrimation increased 11.93 10.42 27 217486 30923 110340863
Progressive multifocal leukoencephalopathy 11.88 10.42 87 217426 24869 110346917
PO2 increased 11.88 10.42 15 217498 1544 110370242
Acute myeloid leukaemia 11.84 10.42 37 217476 38073 110333713
Gout 11.72 10.42 35 217478 36531 110335255
Eosinophil percentage increased 11.71 10.42 15 217498 1567 110370219
Drug diversion 11.68 10.42 14 217499 1366 110370420
Accidental poisoning 11.67 10.42 19 217494 2468 110369318
Lung infiltration 11.66 10.42 19 217494 24609 110347177
Strabismus 11.63 10.42 23 217490 3476 110368310
Clumsiness 11.56 10.42 24 217489 3756 110368030
Immune reconstitution inflammatory syndrome 11.52 10.42 9 217504 16217 110355569
Hallucination, tactile 11.52 10.42 12 217501 1003 110370783
Hallucination 11.52 10.42 271 217242 101161 110270625
Red blood cells urine positive 11.51 10.42 29 217484 5156 110366630
Hypoaesthesia 11.47 10.42 503 217010 313720 110058066
Electrolyte imbalance 11.47 10.42 36 217477 36992 110334794
Diabetes mellitus inadequate control 11.45 10.42 26 217487 29749 110342037
Hemiparesis 11.39 10.42 46 217467 43857 110327929
Drug screen positive 11.36 10.42 33 217480 6377 110365409
Urine ketone body present 11.28 10.42 24 217489 3822 110367964
Negative thoughts 11.24 10.42 15 217498 1631 110370155
Amyotrophy 11.23 10.42 10 217503 688 110371098
Aspartate aminotransferase abnormal 11.23 10.42 22 217491 3303 110368483
Cytomegalovirus viraemia 11.23 10.42 11 217502 17753 110354033
Peripheral venous disease 11.23 10.42 230 217283 83887 110287899
Eye paraesthesia 11.21 10.42 6 217507 178 110371608
Drug effective for unapproved indication 11.20 10.42 7 217506 14160 110357626
Dystonia 11.19 10.42 88 217425 25717 110346069
Psychotic symptom 11.19 10.42 24 217489 3843 110367943
Blood pressure diastolic abnormal 11.17 10.42 88 217425 25727 110346059
Gallbladder disorder 11.15 10.42 15 217498 21014 110350772
Hypoparathyroidism secondary 11.14 10.42 7 217506 282 110371504
Oesophagitis 11.11 10.42 25 217488 28690 110343096
Antibody test abnormal 11.11 10.42 12 217501 1046 110370740
Glycosylated haemoglobin increased 11.05 10.42 82 217431 23537 110348249
Eye swelling 11.05 10.42 31 217482 33017 110338769
Disease recurrence 11.05 10.42 72 217441 60712 110311074
Therapy change 11.02 10.42 3 217510 9994 110361792
Hypothyroidism 11.02 10.42 91 217422 72808 110298978
Glaucoma 11.01 10.42 17 217496 22500 110349286
Blood pressure systolic decreased 11.01 10.42 54 217459 13387 110358399
Cardiac failure acute 11.01 10.42 19 217494 24059 110347727
Clostridium difficile infection 10.93 10.42 59 217454 52070 110319716
Gastric cancer 10.90 10.42 4 217509 11004 110360782
Tumour marker abnormal 10.88 10.42 7 217506 294 110371492
Incorrect dose administered 10.88 10.42 141 217372 103500 110268286
Adenovirus infection 10.87 10.42 4 217509 10990 110360796
Herpes zoster 10.82 10.42 149 217364 108230 110263556
Mean cell haemoglobin concentration decreased 10.80 10.42 30 217483 5652 110366134
Anaphylactic reaction 10.75 10.42 159 217354 114141 110257645
Product prescribing error 10.75 10.42 151 217362 51180 110320606
Hyponatraemic seizure 10.74 10.42 10 217503 729 110371057
Injection site mass 10.73 10.42 20 217493 24593 110347193
Infusion site scar 10.72 10.42 8 217505 428 110371358
End stage renal disease 10.71 10.42 16 217497 21457 110350329
Hypersensitivity vasculitis 10.69 10.42 34 217479 6903 110364883
Eosinophil count decreased 10.68 10.42 31 217482 5987 110365799
Gastric disorder 10.64 10.42 32 217481 33325 110338461
Failed induction of labour 10.63 10.42 7 217506 306 110371480
Renal tubular necrosis 10.63 10.42 28 217485 30447 110341339
Hypoxia 10.57 10.42 185 217328 129330 110242456
Post procedural haemorrhage 10.52 10.42 9 217504 15503 110356283
Cutaneous lupus erythematosus 10.50 10.42 22 217491 3466 110368320
Blood phosphorus increased 10.47 10.42 10 217503 16330 110355456
pH urine increased 10.45 10.42 8 217505 445 110371341

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
Trismus 55.72 50.78 21 347 157 113428

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:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35488 central nervous system depressant
CHEBI has role CHEBI:35717 sedative

Related Drugs by ATC class:

N05CF Benzodiazepine related drugs 3 drugs
eszopiclonezaleplonzolpidem

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




🐶 Veterinary Drug Use

None

🐶 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:32315 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