ondansetron 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
serotonin receptor antagonists (5-HT3) 1992 99614-02-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • GR-38032F
  • GR38032F
  • ondansetron
  • ondansetron hydrochloride
  • ondansetron hydrochloride dihydrate
  • ondansetron HCl
A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.
  • Molecular weight: 293.37
  • Formula: C18H19N3O
  • CLOGP: 2.72
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 0
  • TPSA: 39.82
  • ALOGS: -3.07
  • ROTB: 2
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
16 mg O
16 mg P
16 mg R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 32 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 5 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.17 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 62 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.80 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.27 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 3.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 4, 1991 FDA NOVARTIS PHARMS CORP
Feb. 25, 2022 PMDA Maruishi Pharmaceutical Co., Ltd

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
Febrile neutropenia 1194.84 10.17 1782 227116 116667 63143457
Drug ineffective 976.58 10.17 1417 227481 1043348 62216776
Nausea 707.48 10.17 5372 223526 849099 62411025
Vomiting 612.53 10.17 3772 225126 555845 62704279
Synovitis 602.77 10.17 15 228883 186903 63073221
Systemic lupus erythematosus 550.14 10.17 57 228841 208861 63051263
Hand deformity 529.18 10.17 9 228889 159448 63100676
Constipation 522.63 10.17 1890 227008 223053 63037071
Arthropathy 509.15 10.17 112 228786 234680 63025444
Contraindicated product administered 494.40 10.17 93 228805 217555 63042569
Joint swelling 480.16 10.17 294 228604 327372 62932752
Therapeutic product effect decreased 446.38 10.17 79 228819 193108 63067016
Diarrhoea 426.11 10.17 4186 224712 711180 62548944
Glossodynia 424.66 10.17 68 228830 178808 63081316
Drug intolerance 399.14 10.17 317 228581 308344 62951780
Pericarditis 379.21 10.17 24 228874 131555 63128569
Rheumatoid arthritis 374.08 10.17 226 228672 253593 63006531
Treatment failure 371.45 10.17 127 228771 198916 63061208
Wound 351.53 10.17 79 228819 163184 63096940
Neutropenia 310.47 10.17 1352 227546 173653 63086471
Dehydration 304.29 10.17 1335 227563 172019 63088105
Duodenal ulcer perforation 288.92 10.17 5 228893 87204 63172920
Swelling 280.91 10.17 348 228550 275030 62985094
Disease progression 275.78 10.17 1021 227877 121737 63138387
Helicobacter infection 261.24 10.17 19 228879 92766 63167358
Arthralgia 260.36 10.17 1114 227784 568596 62691528
Death 254.40 10.17 2256 226642 372125 62887999
Torsade de pointes 252.51 10.17 275 228623 13076 63247048
Abdominal pain 242.04 10.17 1848 227050 291608 62968516
Thrombocytopenia 239.77 10.17 1130 227768 150027 63110097
Mucosal inflammation 225.50 10.17 513 228385 46415 63213709
Musculoskeletal stiffness 222.01 10.17 203 228695 184415 63075709
Neuropathy peripheral 220.74 10.17 903 227995 112764 63147360
Impaired healing 215.92 10.17 52 228846 102490 63157634
Hepatic enzyme increased 209.05 10.17 253 228645 202075 63058049
Muscle injury 204.09 10.17 7 228891 65338 63194786
White blood cell count decreased 203.39 10.17 1016 227882 138088 63122036
Serotonin syndrome 196.38 10.17 363 228535 28319 63231805
Hypoxia 186.63 10.17 556 228342 59236 63200888
Mobility decreased 183.81 10.17 104 228794 121055 63139069
Emotional distress 182.83 10.17 379 228519 32170 63227954
Decreased appetite 182.34 10.17 1536 227362 249516 63010608
Abdominal discomfort 179.24 10.17 577 228321 320308 62939816
Folliculitis 177.86 10.17 22 228876 70295 63189829
Electrocardiogram QT prolonged 177.75 10.17 545 228353 58985 63201139
Drug abuse 175.56 10.17 26 228872 72492 63187632
Discomfort 174.24 10.17 208 228690 167166 63092958
Sleep disorder due to general medical condition, insomnia type 168.93 10.17 4 228894 52213 63207911
Plasma cell myeloma 168.61 10.17 389 228509 35516 63224608
Neutropenic sepsis 163.48 10.17 246 228652 16192 63243932
Blood cholesterol increased 158.75 10.17 70 228828 93962 63166162
Toxicity to various agents 151.34 10.17 426 228472 246824 63013300
Therapeutic product effect incomplete 146.18 10.17 141 228757 124915 63135209
Neutrophil count decreased 145.34 10.17 491 228407 55915 63204209
Drug hypersensitivity 143.67 10.17 604 228294 310083 62950041
Febrile bone marrow aplasia 140.47 10.17 152 228746 7173 63252951
Pyrexia 140.24 10.17 2428 226470 468050 62792074
Cytokine release syndrome 137.79 10.17 211 228687 14103 63246021
Type 2 diabetes mellitus 137.19 10.17 31 228867 63837 63196287
Irritable bowel syndrome 134.98 10.17 64 228834 82348 63177776
Psoriatic arthropathy 133.93 10.17 82 228816 91438 63168686
Condition aggravated 133.31 10.17 876 228022 401341 62858783
Erythema 125.72 10.17 1072 227826 174679 63085445
Sepsis 121.91 10.17 957 227941 152166 63107958
Colitis 120.27 10.17 417 228481 48111 63212013
Encephalopathy 119.42 10.17 358 228540 38262 63221862
Left-to-right cardiac shunt 119.16 10.17 36 228862 100 63260024
Hospice care 117.40 10.17 144 228754 7788 63252336
C-reactive protein abnormal 115.16 10.17 15 228883 46081 63214043
Fatigue 112.24 10.17 4079 224819 883949 62376175
Completed suicide 112.24 10.17 222 228676 145451 63114673
Small intestinal obstruction 111.87 10.17 221 228677 18116 63242008
Flushing 109.34 10.17 548 228350 74539 63185585
Knee arthroplasty 109.27 10.17 30 228868 54176 63205948
Lower respiratory tract infection 107.75 10.17 195 228703 132112 63128012
Aplastic anaemia 106.46 10.17 151 228747 9418 63250706
Hip arthroplasty 104.61 10.17 22 228876 47624 63212500
Anaemia 103.19 10.17 1557 227341 291873 62968251
Osteoarthritis 102.94 10.17 115 228783 95228 63164896
Heart disease congenital 102.85 10.17 62 228836 1237 63258887
Blister 99.85 10.17 198 228700 129616 63130508
Intentional overdose 99.67 10.17 73 228825 74079 63186045
Red blood cell sedimentation rate increased 99.30 10.17 19 228879 43963 63216161
Platelet count decreased 97.55 10.17 735 228163 115387 63144737
Hereditary angioedema 97.24 10.17 128 228770 7434 63252690
Weight increased 96.73 10.17 548 228350 260244 62999880
Alopecia 95.40 10.17 769 228129 336767 62923357
Liver injury 93.12 10.17 51 228847 60469 63199655
Ventricular tachycardia 92.19 10.17 215 228683 19764 63240360
Inflammation 91.29 10.17 97 228801 82176 63177948
Loss of personal independence in daily activities 90.84 10.17 131 228767 97159 63162965
Full blood count decreased 88.89 10.17 250 228648 25774 63234350
Tachycardia 88.85 10.17 729 228169 117427 63142697
Malignant neoplasm progression 88.71 10.17 553 228345 81568 63178556
Laryngospasm 88.28 10.17 79 228819 2949 63257175
Injection site pain 87.46 10.17 213 228685 129587 63130537
Asthenia 87.34 10.17 1901 226997 381703 62878421
Fibromyalgia 86.81 10.17 97 228801 80323 63179801
Long QT syndrome 84.80 10.17 80 228818 3199 63256925
Ventricular fibrillation 84.77 10.17 153 228745 11714 63248410
Hypokalaemia 84.36 10.17 652 228246 103152 63156972
Oculogyric crisis 82.35 10.17 60 228838 1661 63258463
Pancytopenia 79.41 10.17 610 228288 96323 63163801
Chills 78.62 10.17 687 228211 112691 63147433
Intentional self-injury 76.06 10.17 4 228894 25683 63234441
Therapeutic response decreased 75.87 10.17 66 228832 61459 63198665
Neoplasm progression 75.12 10.17 295 228603 36133 63223991
Hypomagnesaemia 72.99 10.17 249 228649 28488 63231636
Ill-defined disorder 72.53 10.17 114 228784 81641 63178483
Pain 71.42 10.17 2080 226818 738548 62521576
Cardiac arrest 70.11 10.17 572 228326 91973 63168151
Pulmonary fibrosis 69.79 10.17 28 228870 39781 63220343
Anhedonia 69.05 10.17 134 228764 10840 63249284
Back pain 68.92 10.17 1336 227562 262809 62997315
Intestinal obstruction 67.62 10.17 255 228643 30644 63229480
Desmoplastic small round cell tumour 65.56 10.17 21 228877 75 63260049
Atelectasis 65.33 10.17 198 228700 21285 63238839
Product use issue 64.27 10.17 498 228400 220022 63040102
Device expulsion 63.83 10.17 23 228875 34899 63225225
Injection site erythema 63.82 10.17 127 228771 83047 63177077
Computerised tomogram thorax abnormal 63.66 10.17 52 228846 1711 63258413
Myocardial infarction 63.36 10.17 169 228729 99724 63160400
Nasopharyngitis 63.03 10.17 599 228299 253658 63006466
Carbohydrate antigen 125 increased 62.16 10.17 63 228835 2753 63257371
Pleural effusion 61.63 10.17 559 228339 92651 63167473
Anxiety 61.46 10.17 1114 227784 216427 63043697
Overdose 60.64 10.17 212 228686 114866 63145258
Retching 60.49 10.17 151 228747 14494 63245630
Osteoporosis 59.89 10.17 71 228827 57267 63202857
Joint range of motion decreased 59.88 10.17 21 228877 32407 63227717
Clostridium difficile infection 59.03 10.17 239 228659 29683 63230441
Arthritis 58.14 10.17 218 228680 115703 63144421
Dystonia 57.62 10.17 143 228755 13676 63246448
Dysgeusia 57.13 10.17 325 228573 46385 63213739
Anaphylactic reaction 56.96 10.17 421 228477 65679 63194445
Computerised tomogram thorax 56.30 10.17 29 228869 420 63259704
Palmar-plantar erythrodysaesthesia syndrome 55.48 10.17 196 228702 22819 63237305
Hypotension 55.12 10.17 1329 227569 271275 62988849
Blood pressure systolic increased 54.70 10.17 54 228844 47343 63212781
Macular degeneration 54.04 10.17 11 228887 24365 63235759
Calcium ionised decreased 53.89 10.17 25 228873 284 63259840
Transfusion 53.76 10.17 148 228750 15069 63245055
Injection site reaction 53.45 10.17 80 228818 58444 63201680
Hair colour changes 53.27 10.17 61 228837 3066 63257058
Congenital anomaly 53.10 10.17 47 228851 1729 63258395
Clonus 52.82 10.17 74 228824 4562 63255562
Suicide attempt 52.10 10.17 87 228811 60831 63199293
Anaphylactic shock 51.68 10.17 195 228703 23438 63236686
Ascites 50.88 10.17 285 228613 40443 63219681
Infection 50.16 10.17 556 228342 228617 63031507
Weight fluctuation 50.13 10.17 110 228788 9709 63250415
Segmental diverticular colitis 49.87 10.17 20 228878 154 63259970
Sedation 49.85 10.17 40 228858 38769 63221355
Leukopenia 49.81 10.17 461 228437 76829 63183295
Injection site swelling 49.58 10.17 59 228839 47513 63212611
Medication error 49.19 10.17 70 228828 52214 63207910
Abortion spontaneous 47.64 10.17 60 228838 47135 63212989
Opisthotonus 47.57 10.17 24 228874 332 63259792
C-reactive protein increased 46.91 10.17 179 228719 94528 63165596
Rheumatoid nodule 46.90 10.17 4 228894 17151 63242973
Hypercholesterolaemia 46.52 10.17 10 228888 21324 63238800
Impaired gastric emptying 46.37 10.17 110 228788 10222 63249902
Type I hypersensitivity 46.13 10.17 55 228843 2887 63257237
Osteonecrosis of jaw 45.37 10.17 36 228862 35087 63225037
Dilatation intrahepatic duct acquired 44.87 10.17 29 228869 657 63259467
Respiratory syncytial virus infection 44.53 10.17 86 228812 6932 63253192
Femur fracture 44.36 10.17 51 228847 41705 63218419
Peripheral swelling 43.96 10.17 684 228214 265258 62994866
Failure to thrive 43.00 10.17 86 228812 7112 63253012
Red blood cell count decreased 42.81 10.17 272 228626 40373 63219751
Basal cell carcinoma 42.46 10.17 24 228874 27967 63232157
Pedal pulse abnormal 42.27 10.17 18 228880 164 63259960
Lupus vasculitis 42.08 10.17 26 228872 543 63259581
Pneumonia 41.81 10.17 2030 226868 454737 62805387
Sinus tachycardia 41.04 10.17 185 228713 24083 63236041
Accidental exposure to product 40.85 10.17 24 228874 27381 63232743
Pulmonary embolism 40.84 10.17 619 228279 116065 63144059
Chest discomfort 40.69 10.17 589 228309 109380 63150744
Foot deformity 40.67 10.17 25 228873 27828 63232296
Oxygen saturation decreased 40.47 10.17 493 228405 88092 63172032
Blood potassium decreased 40.47 10.17 275 228623 41751 63218373
Dyspnoea 40.25 10.17 2833 226065 658480 62601644
Sopor 39.83 10.17 15 228883 22149 63237975
Dermatitis diaper 39.63 10.17 18 228880 194 63259930
Coronary artery disease 39.59 10.17 35 228863 32342 63227782
Otitis media chronic 39.16 10.17 16 228882 130 63259994
Hypersensitivity 39.06 10.17 782 228116 291903 62968221
Therapy interrupted 38.50 10.17 224 228674 32231 63227893
Sedation complication 38.41 10.17 3 228895 13819 63246305
Oral pain 38.37 10.17 203 228695 28191 63231933
Bone pain 38.32 10.17 332 228566 54309 63205815
Lactic acidosis 38.31 10.17 49 228849 38238 63221886
Intentional product use issue 38.09 10.17 287 228611 127605 63132519
Unresponsive to stimuli 37.93 10.17 230 228668 33586 63226538
Epistaxis 37.81 10.17 415 228483 72310 63187814
Vascular device infection 37.42 10.17 82 228816 7230 63252894
Electrocardiogram QRS complex 37.03 10.17 8 228890 0 63260124
Atrial septal defect 36.87 10.17 79 228819 6859 63253265
Joint stiffness 36.54 10.17 59 228839 41810 63218314
Bacteraemia 36.17 10.17 141 228757 17207 63242917
Blood pressure fluctuation 36.15 10.17 70 228828 46247 63213877
Hospitalisation 36.09 10.17 467 228431 84614 63175510
Bone density decreased 35.91 10.17 5 228893 14607 63245517
Cyclic vomiting syndrome 35.68 10.17 15 228883 132 63259992
Grip strength decreased 35.43 10.17 18 228880 22269 63237855
Feeling hot 35.34 10.17 306 228592 50048 63210076
Therapy non-responder 35.34 10.17 147 228751 75754 63184370
Hydronephrosis 35.02 10.17 101 228797 10561 63249563
Vasculitis 35.01 10.17 11 228887 18198 63241926
Bronchospasm 34.86 10.17 139 228759 17141 63242983
Contusion 34.83 10.17 359 228539 149685 63110439
Enterocolitis 34.55 10.17 83 228815 7775 63252349
Osteonecrosis 34.47 10.17 23 228875 24507 63235617
Aplasia 34.44 10.17 58 228840 4201 63255923
Drug resistance 34.30 10.17 20 228878 22913 63237211
Urinary tract infection 34.13 10.17 1220 227678 263464 62996660
Ventilation perfusion mismatch 34.13 10.17 22 228876 496 63259628
Sinusitis 33.81 10.17 594 228304 226059 63034065
Injection site pruritus 33.66 10.17 70 228828 45046 63215078
Gangrene 32.86 10.17 70 228828 6053 63254071
Device related infection 32.82 10.17 169 228729 23223 63236901
Renal impairment 32.51 10.17 186 228712 88169 63171955
Musculoskeletal pain 32.50 10.17 197 228701 92080 63168044
Right ventricular hypertrophy 32.49 10.17 24 228874 679 63259445
Product complaint 32.40 10.17 4 228894 12805 63247319
Ageusia 32.31 10.17 116 228782 13612 63246512
Illness 32.30 10.17 294 228604 48765 63211359
Acute respiratory failure 32.22 10.17 224 228674 34261 63225863
Incorrect route of product administration 32.00 10.17 31 228867 27421 63232703
Clostridium difficile colitis 31.98 10.17 153 228745 20416 63239708
Dysphagia 31.40 10.17 471 228427 88114 63172010
Wrong technique in product usage process 31.40 10.17 117 228781 62223 63197901
Diabetes mellitus 31.32 10.17 100 228798 55710 63204414
Infusion related reaction 31.25 10.17 661 228237 244860 63015264
Skin candida 31.13 10.17 34 228864 1621 63258503
Fall 30.70 10.17 1131 227767 391203 62868921
Blood magnesium decreased 30.62 10.17 111 228787 13087 63247037
Left atrial hypertrophy 30.34 10.17 10 228888 40 63260084
Apnoea 30.32 10.17 80 228818 7942 63252182
Neutropenic colitis 30.32 10.17 46 228852 3049 63257075
Facet joint syndrome 30.20 10.17 4 228894 12134 63247990
Product dose omission issue 29.95 10.17 1079 227819 233234 63026890
Sleep disorder 29.86 10.17 172 228726 81394 63178730
Long QT syndrome congenital 29.85 10.17 12 228886 93 63260031
Right ventricular enlargement 29.45 10.17 17 228881 312 63259812
Creatinine renal clearance decreased 29.36 10.17 11 228887 16297 63243827
Toxic erythema of chemotherapy 29.30 10.17 13 228885 132 63259992
Eating disorder 29.24 10.17 141 228757 18875 63241249
Myocardial reperfusion injury 28.90 10.17 12 228886 102 63260022
Asthma 28.87 10.17 307 228591 127254 63132870
Injection site bruising 28.82 10.17 68 228830 41842 63218282
Sense of oppression 28.62 10.17 26 228872 990 63259134
Peripheral venous disease 28.61 10.17 10 228888 15467 63244657
Injury 28.56 10.17 396 228502 72851 63187273
Feeding intolerance 28.31 10.17 23 228875 751 63259373
Gait inability 28.26 10.17 97 228801 52862 63207262
Sleep disorder due to a general medical condition 28.08 10.17 5 228893 12183 63247941
Lupus-like syndrome 28.07 10.17 10 228888 15285 63244839
Disease recurrence 27.91 10.17 36 228862 27994 63232130
Laevocardia 27.77 10.17 6 228892 0 63260124
Adverse event 27.76 10.17 137 228761 67422 63192702
Ejection fraction decreased 27.71 10.17 156 228742 22176 63237948
Dry skin 27.48 10.17 320 228578 56567 63203557
Mental status changes 27.45 10.17 240 228658 39359 63220765
Hypophagia 27.44 10.17 200 228698 31059 63229065
Weight decreased 27.36 10.17 1240 227658 275558 62984566
Pneumonitis 27.36 10.17 219 228679 35003 63225121
Breast cancer stage III 26.88 10.17 3 228895 10383 63249741
Respiratory distress 26.86 10.17 212 228686 33739 63226385
Troponin increased 26.85 10.17 89 228809 10032 63250092
Laboratory test abnormal 26.45 10.17 177 228721 26735 63233389
Cestode infection 26.14 10.17 15 228883 272 63259852
Exostosis 26.12 10.17 16 228882 17846 63242278
Pancreatitis 25.99 10.17 281 228617 48774 63211350
Joint dislocation 25.92 10.17 18 228880 18782 63241342
Muscle spasms 25.65 10.17 741 228157 155409 63104715
Panniculitis 25.52 10.17 5 228893 11380 63248744
Eustachian tube dysfunction 25.48 10.17 17 228881 407 63259717
Neurotoxicity 25.42 10.17 125 228773 16865 63243259
Pain in extremity 25.38 10.17 958 227940 330528 62929596
Taste disorder 25.27 10.17 107 228791 13555 63246569
Pulmonary artery stenosis congenital 25.15 10.17 14 228884 239 63259885
Poor feeding infant 25.09 10.17 16 228882 354 63259770
Sciatica 24.98 10.17 54 228844 34270 63225854
Otitis media acute 24.90 10.17 24 228874 986 63259138
Delirium 24.71 10.17 96 228802 50445 63209679
Ileus 24.71 10.17 112 228786 14613 63245511
Obstructive airways disorder 24.56 10.17 23 228875 20676 63239448
Drug eruption 24.51 10.17 41 228857 28653 63231471
Premature delivery 24.47 10.17 190 228708 30091 63230033
Hepatic function abnormal 24.18 10.17 62 228836 37080 63223044
Skin necrosis 24.15 10.17 10 228888 13940 63246184
Metastases to peritoneum 24.10 10.17 44 228854 3398 63256726
Electrolyte imbalance 24.09 10.17 139 228759 19937 63240187
Left ventricular dysfunction 23.84 10.17 96 228802 11892 63248232
Wheezing 23.74 10.17 225 228673 95370 63164754
Vascular access site thrombosis 23.70 10.17 8 228890 35 63260089
Tenosynovitis 23.70 10.17 10 228888 13785 63246339
Glaucoma 23.64 10.17 20 228878 18885 63241239
Gait disturbance 23.64 10.17 492 228406 182686 63077438
Abdominal distension 23.53 10.17 441 228457 86174 63173950
Interstitial lung disease 23.49 10.17 129 228769 61779 63198345
International normalised ratio increased 23.46 10.17 87 228811 46338 63213786
Postural orthostatic tachycardia syndrome 23.42 10.17 26 228872 1263 63258861
General physical health deterioration 23.40 10.17 550 228348 200852 63059272
Aphasia 23.39 10.17 201 228697 32799 63227325
Depressed level of consciousness 23.21 10.17 130 228768 61948 63198176
Metastases to meninges 23.16 10.17 37 228861 2565 63257559
Schizophrenia 23.11 10.17 4 228894 9948 63250176
Cerebral microhaemorrhage 23.11 10.17 11 228887 133 63259991
Drug dependence 22.81 10.17 33 228865 24450 63235674
Ventricular extrasystoles 22.77 10.17 93 228805 11594 63248530
Chest pain 22.33 10.17 972 227926 214987 63045137
Product use in unapproved indication 22.22 10.17 822 228076 178258 63081866
Obesity 21.90 10.17 47 228851 29905 63230219
Foetal death 21.89 10.17 88 228810 10892 63249232
Drug level increased 21.82 10.17 30 228868 22706 63237418
Hypervolaemia 21.71 10.17 176 228722 28237 63231887
Bone disorder 21.64 10.17 27 228871 21299 63238825
Congenital anomaly in offspring 21.62 10.17 11 228887 155 63259969
Neutrophil count abnormal 21.57 10.17 38 228860 2854 63257270
Cervix neoplasm 21.55 10.17 12 228886 205 63259919
Stress cardiomyopathy 21.52 10.17 79 228819 9371 63250753
Intentional product misuse 21.47 10.17 130 228768 60787 63199337
Coma 21.33 10.17 140 228758 64224 63195900
Thrombosis 21.30 10.17 340 228558 64415 63195709
Lower limb fracture 21.26 10.17 34 228864 24187 63235937
Administration site oedema 21.24 10.17 7 228891 28 63260096
Adenoidal hypertrophy 21.23 10.17 8 228890 51 63260073
Rhabdomyolysis 21.16 10.17 84 228814 43867 63216257
Neuralgia 21.13 10.17 163 228735 25763 63234361
Plantar erythema 21.09 10.17 12 228886 214 63259910
Lip dry 21.08 10.17 15 228883 15455 63244669
Disability 21.06 10.17 21 228877 18326 63241798
Hyperhidrosis 20.92 10.17 523 228375 107313 63152811
Alopecia areata 20.86 10.17 28 228870 1657 63258467
Amputation stump pain 20.86 10.17 7 228891 30 63260094
Vascular access site infection 20.85 10.17 8 228890 54 63260070
Intestinal perforation 20.83 10.17 92 228806 11871 63248253
Blood pressure diastolic decreased 20.77 10.17 31 228867 22675 63237449
Fracture 20.71 10.17 24 228874 19560 63240564
Oral candidiasis 20.66 10.17 147 228751 22651 63237473
Drug clearance decreased 20.46 10.17 26 228872 1458 63258666
Hyperemesis gravidarum 20.41 10.17 17 228881 575 63259549
Myoglobinuria 20.41 10.17 13 228885 287 63259837
Infective pulmonary exacerbation of cystic fibrosis 20.32 10.17 74 228824 8743 63251381
Joint effusion 20.19 10.17 19 228879 17041 63243083
Venoocclusive liver disease 20.12 10.17 50 228848 4785 63255339
Nail pigmentation 20.12 10.17 11 228887 181 63259943
Arterial occlusive disease 20.11 10.17 57 228841 5901 63254223
Throat tightness 20.02 10.17 156 228742 24731 63235393
Hypophosphataemia 19.99 10.17 88 228810 11338 63248786
Fluid replacement 19.98 10.17 13 228885 298 63259826
Adjustment disorder with depressed mood 19.91 10.17 6 228892 10198 63249926
Product substitution issue 19.91 10.17 17 228881 15979 63244145
Lung disorder 19.84 10.17 137 228761 62124 63198000
Liver disorder 19.76 10.17 113 228785 53574 63206550
Bursitis 19.66 10.17 68 228830 36973 63223151
Neonatal tachypnoea 19.59 10.17 10 228888 142 63259982
Anaesthetic complication neurological 19.36 10.17 12 228886 252 63259872
Paraesthesia 19.35 10.17 720 228178 156246 63103878
Gastroenteritis radiation 19.35 10.17 15 228883 457 63259667
Bulimia nervosa 19.29 10.17 15 228883 459 63259665
Paranoia 19.22 10.17 9 228889 11670 63248454
Capillary leak syndrome 19.19 10.17 31 228867 2169 63257955
Respiratory failure 19.17 10.17 492 228406 101366 63158758
Jaundice neonatal 19.16 10.17 20 228878 905 63259219
Poor peripheral circulation 19.14 10.17 42 228856 3707 63256417
Burkholderia cepacia complex infection 19.11 10.17 10 228888 150 63259974
Congenital pulmonary valve atresia 19.07 10.17 8 228890 70 63260054
Poisoning 19.04 10.17 13 228885 13687 63246437
Ventricular septal defect 18.99 10.17 46 228852 4332 63255792
Tracheal deviation 18.99 10.17 10 228888 152 63259972
Right ventricular dilatation 18.80 10.17 24 228874 1352 63258772
Lip pruritus 18.77 10.17 20 228878 927 63259197
Pregnancy 18.64 10.17 69 228829 36767 63223357
Univentricular heart 18.52 10.17 4 228894 0 63260124
Immune effector cell-associated neurotoxicity syndrome 18.40 10.17 31 228867 2246 63257878
Subchorionic haemorrhage 18.37 10.17 10 228888 163 63259961
Magnesium deficiency 18.37 10.17 16 228882 576 63259548
Pulmonary valve stenosis 18.32 10.17 13 228885 345 63259779
Non-cardiac chest pain 18.31 10.17 57 228841 6215 63253909
Finger deformity 18.23 10.17 3 228895 7742 63252382
Psoriasis 18.20 10.17 213 228685 86744 63173380
Cerebellar stroke 18.18 10.17 12 228886 282 63259842
Injection site haemorrhage 17.90 10.17 38 228860 24276 63235848
Pityriasis rosea 17.88 10.17 8 228890 83 63260041
Cerebral infarction 17.88 10.17 37 228861 23856 63236268
Transposition of the great vessels 17.79 10.17 11 228887 230 63259894
Feeding disorder 17.69 10.17 95 228803 13267 63246857
Cancer pain 17.62 10.17 37 228861 3168 63256956
Stridor 17.55 10.17 39 228859 3471 63256653
Arteriospasm coronary 17.54 10.17 42 228856 3926 63256198
Blood bilirubin increased 17.52 10.17 208 228690 36932 63223192
Hepatocellular injury 17.47 10.17 163 228735 27218 63232906
Madarosis 17.44 10.17 36 228862 3045 63257079
Haemoglobin decreased 17.37 10.17 665 228233 144820 63115304
Hot flush 17.35 10.17 270 228628 50889 63209235
Skin ulcer 17.28 10.17 88 228810 42957 63217167
Phrenic nerve paralysis 17.21 10.17 10 228888 186 63259938
Food aversion 17.18 10.17 18 228880 818 63259306
Generalised tonic-clonic seizure 17.16 10.17 170 228728 28846 63231278
Otospondylomegaepiphyseal dysplasia 17.16 10.17 8 228890 92 63260032
Pharyngeal paraesthesia 17.10 10.17 28 228870 1981 63258143
Laryngeal discomfort 17.09 10.17 12 228886 313 63259811
Dysentery 16.80 10.17 19 228879 942 63259182
Seizure 16.73 10.17 610 228288 132024 63128100
Peripheral sensory neuropathy 16.72 10.17 62 228836 7389 63252735
Large intestinal obstruction 16.69 10.17 30 228868 2289 63257835
Poisoning deliberate 16.47 10.17 10 228888 11208 63248916
Cyanosis 16.41 10.17 111 228787 16824 63243300
Treatment noncompliance 16.32 10.17 74 228824 37251 63222873
Pericardial effusion 16.30 10.17 173 228725 29885 63230239
Congenital tongue anomaly 16.29 10.17 4 228894 3 63260121
Haemorrhoids 16.27 10.17 136 228762 22014 63238110
Hypergeusia 16.27 10.17 5 228893 15 63260109
Cough 16.17 10.17 1245 227653 291498 62968626
Nail infection 16.11 10.17 31 228867 2492 63257632
Migraine 16.03 10.17 487 228411 102859 63157265
Dysphemia 16.03 10.17 32 228866 2643 63257481
Cleft palate 16.00 10.17 19 228879 993 63259131
Glioblastoma multiforme 15.99 10.17 17 228881 786 63259338
Tremor 15.92 10.17 605 228293 131634 63128490
Infusion site streaking 15.91 10.17 14 228884 511 63259613
Tendonitis 15.87 10.17 29 228869 19586 63240538
Rash erythematous 15.84 10.17 228 228670 42282 63217842
Carpal tunnel syndrome 15.78 10.17 32 228866 20785 63239339
Right ventricle outflow tract obstruction 15.76 10.17 4 228894 4 63260120
Malaise 15.70 10.17 1721 227177 414233 62845891
Monocyte count decreased 15.69 10.17 28 228870 2125 63257999
Injection site warmth 15.67 10.17 19 228879 15176 63244948
Rash maculo-papular 15.66 10.17 180 228718 31716 63228408
Heart rate decreased 15.65 10.17 98 228800 45462 63214662
Tongue oedema 15.60 10.17 44 228854 4542 63255582
Food intolerance 15.58 10.17 36 228862 3289 63256835
Electrocardiogram T wave inversion 15.56 10.17 37 228861 3444 63256680
Thrombocytopenic purpura 15.55 10.17 22 228876 1369 63258755
Deep vein thrombosis 15.54 10.17 404 228494 83396 63176728
Procedural vomiting 15.50 10.17 14 228884 529 63259595
Streptococcal bacteraemia 15.45 10.17 25 228873 1752 63258372
Enteritis 15.41 10.17 65 228833 8221 63251903
Septic shock 15.35 10.17 331 228567 66298 63193826
Tryptase increased 15.33 10.17 12 228886 371 63259753
Alveolitis 15.27 10.17 33 228865 2882 63257242
Vein discolouration 15.26 10.17 10 228888 232 63259892
Multiple fractures 15.21 10.17 6 228892 8612 63251512
Muscle twitching 15.12 10.17 122 228776 19546 63240578
High density lipoprotein abnormal 15.05 10.17 8 228890 124 63260000
Seizure like phenomena 15.03 10.17 19 228879 1060 63259064
Dementia 15.02 10.17 28 228870 18766 63241358
Tumour pain 15.00 10.17 22 228876 1415 63258709
Toxic encephalopathy 14.98 10.17 55 228843 6524 63253600
Onychalgia 14.97 10.17 18 228880 953 63259171
Hiccups 14.97 10.17 28 228870 2203 63257921
Anaphylactoid reaction 14.97 10.17 38 228860 3685 63256439
Lipase decreased 14.88 10.17 8 228890 127 63259997
Tumour lysis syndrome 14.80 10.17 68 228830 8922 63251202
Hair texture abnormal 14.72 10.17 41 228857 4202 63255922
Gastroenteritis viral 14.58 10.17 140 228758 23560 63236564
Therapy cessation 14.56 10.17 171 228727 30286 63229838
Wound infection 14.51 10.17 35 228863 21375 63238749
Orthostatic hypotension 14.47 10.17 74 228824 36086 63224038
Iritis 14.46 10.17 34 228864 3141 63256983
Tracheal injury 14.45 10.17 6 228892 51 63260073
Cognitive disorder 14.44 10.17 130 228768 55685 63204439
Plasmacytoma 14.44 10.17 30 228868 2549 63257575
IIIrd nerve paresis 14.25 10.17 8 228890 139 63259985
Colitis microscopic 14.17 10.17 8 228890 9331 63250793
Hyperkalaemia 14.13 10.17 126 228772 54077 63206047
Transmission of an infectious agent via product 14.05 10.17 8 228890 143 63259981
Uterine perforation 14.04 10.17 56 228842 6907 63253217
Transplant rejection 13.98 10.17 11 228887 10769 63249355
Herpes zoster 13.97 10.17 211 228687 82251 63177873
Premenstrual syndrome 13.93 10.17 15 228883 704 63259420
Pulmonary oedema neonatal 13.89 10.17 3 228895 0 63260124
Oedema neonatal 13.89 10.17 3 228895 0 63260124
Foetal damage 13.89 10.17 3 228895 0 63260124
Wolff-Parkinson-White syndrome congenital 13.89 10.17 3 228895 0 63260124
Right ventricular hypertension 13.89 10.17 3 228895 0 63260124
Medical device battery replacement 13.89 10.17 3 228895 0 63260124
Hypertension 13.85 10.17 845 228053 278458 62981666
Electrocardiogram PR shortened 13.85 10.17 10 228888 273 63259851
Drug withdrawal syndrome neonatal 13.82 10.17 26 228872 2055 63258069
Hypofibrinogenaemia 13.81 10.17 19 228879 1151 63258973
Ulcer 13.81 10.17 48 228850 26059 63234065
Product distribution issue 13.81 10.17 21 228877 1395 63258729
Rotator cuff syndrome 13.80 10.17 17 228881 13485 63246639
Cytopenia 13.71 10.17 80 228818 11521 63248603
Anomalous pulmonary venous connection 13.69 10.17 6 228892 59 63260065
Systemic inflammatory response syndrome 13.66 10.17 48 228850 5573 63254551
Lymphocyte count decreased 13.64 10.17 168 228730 30089 63230035
Neuroleptic malignant syndrome 13.61 10.17 14 228884 12042 63248082
Abdominal infection 13.58 10.17 25 228873 1943 63258181
Electrolyte depletion 13.54 10.17 9 228889 214 63259910
Gastroenteropancreatic neuroendocrine tumour disease 13.52 10.17 5 228893 30 63260094
Haematoma 13.52 10.17 72 228826 34748 63225376
Supraventricular tachycardia 13.51 10.17 93 228805 14178 63245946
Prescribed underdose 13.50 10.17 58 228840 29631 63230493
Hypoxic-ischaemic encephalopathy 13.49 10.17 40 228858 4247 63255877
Malnutrition 13.49 10.17 98 228800 15200 63244924
Acute coronary syndrome 13.41 10.17 72 228826 10054 63250070
Full blood count abnormal 13.40 10.17 174 228724 31543 63228581
Hepatic cirrhosis 13.40 10.17 45 228853 24689 63235435
Melaena 13.40 10.17 60 228838 30305 63229819
Upper respiratory tract infection 13.36 10.17 389 228509 81658 63178466
Alopecia totalis 13.36 10.17 11 228887 366 63259758
Uterine hypotonus 13.26 10.17 7 228891 107 63260017
Aggression 13.25 10.17 42 228856 23456 63236668
Uterine contractions during pregnancy 13.23 10.17 13 228885 547 63259577
Grunting 13.11 10.17 9 228889 226 63259898
COVID-19 pneumonia 13.10 10.17 92 228806 14117 63246007
Injection site urticaria 13.08 10.17 19 228879 14054 63246070
Developmental delay 13.08 10.17 21 228877 1462 63258662
Transferrin saturation decreased 13.05 10.17 15 228883 757 63259367
Biliary obstruction 13.00 10.17 31 228867 2890 63257234
Osteomyelitis 12.99 10.17 49 228849 25971 63234153
Acute myeloid leukaemia 12.98 10.17 106 228792 17041 63243083
Insurance issue 12.96 10.17 50 228848 6071 63254053
Sensitivity to weather change 12.83 10.17 5 228893 7232 63252892
Nasal polyps 12.83 10.17 3 228895 6036 63254088
Hyperbilirubinaemia neonatal 12.82 10.17 11 228887 388 63259736
Vocal cord paralysis 12.79 10.17 26 228872 2175 63257949
Joint injury 12.71 10.17 59 228839 29513 63230611
Pulmonary valve stenosis congenital 12.66 10.17 8 228890 174 63259950
Drug interaction 12.66 10.17 686 228212 228445 63031679
Blood pressure abnormal 12.63 10.17 96 228802 15102 63245022
Acute kidney injury 12.57 10.17 1108 227790 262307 62997817
Injection site phlebitis 12.55 10.17 7 228891 120 63260004
Breast cancer stage II 12.53 10.17 8 228890 8728 63251396
Haematochezia 12.46 10.17 128 228770 53416 63206708
Right-to-left cardiac shunt 12.39 10.17 9 228889 248 63259876
Dacryostenosis congenital 12.34 10.17 4 228894 15 63260109
Live birth 12.33 10.17 49 228849 25581 63234543
Pneumonia respiratory syncytial viral 12.32 10.17 17 228881 1033 63259091
Pulmonary thrombosis 12.30 10.17 63 228835 8639 63251485
Glycosylated haemoglobin increased 12.26 10.17 16 228882 12382 63247742
Carbon dioxide decreased 12.26 10.17 25 228873 2096 63258028
Electrocardiogram QT shortened 12.25 10.17 7 228891 126 63259998
Mast cell activation syndrome 12.25 10.17 15 228883 810 63259314
Radiculopathy 12.20 10.17 8 228890 8603 63251521
Procedural dizziness 12.20 10.17 7 228891 127 63259997
Bronchiectasis 12.08 10.17 25 228873 16117 63244007
Pathogen resistance 12.06 10.17 4 228894 6394 63253730
Oedema 12.06 10.17 264 228634 97358 63162766
Escherichia bacteraemia 12.00 10.17 36 228862 3847 63256277
Hallucination, visual 11.96 10.17 33 228865 19265 63240859
Moaning 11.94 10.17 15 228883 831 63259293
Intentional underdose 11.86 10.17 23 228875 1859 63258265
Blindness transient 11.85 10.17 35 228863 3709 63256415
Procedural nausea 11.85 10.17 15 228883 838 63259286
Gastrointestinal motility disorder 11.83 10.17 43 228855 5076 63255048
Wheelchair user 11.82 10.17 4 228894 6315 63253809
Pregnancy with advanced maternal age 11.82 10.17 3 228895 3 63260121
Headache 11.82 10.17 2518 226380 630723 62629401
Chronic hepatitis B 11.79 10.17 10 228888 347 63259777
Neutrophil percentage abnormal 11.76 10.17 4 228894 18 63260106
Abdominal pain lower 11.76 10.17 143 228755 25535 63234589
Polymenorrhoea 11.75 10.17 18 228880 1203 63258921
Atypical pneumonia 11.74 10.17 39 228859 4401 63255723
Right atrial enlargement 11.73 10.17 7 228891 137 63259987
Onychoclasis 11.72 10.17 49 228849 6173 63253951
Embolism 11.71 10.17 58 228840 7848 63252276
Injection site haematoma 11.66 10.17 5 228893 6827 63253297
Palmar erythema 11.64 10.17 22 228876 1745 63258379
Catheter site inflammation 11.62 10.17 15 228883 854 63259270
Fever neonatal 11.59 10.17 4 228894 19 63260105
Teething 11.59 10.17 4 228894 19 63260105
Pemphigoid 11.57 10.17 6 228892 7338 63252786
Tremor neonatal 11.55 10.17 7 228891 141 63259983
Lipase increased 11.53 10.17 68 228830 9832 63250292
Drug reaction with eosinophilia and systemic symptoms 11.51 10.17 73 228825 33763 63226361
Pulse absent 11.47 10.17 44 228854 5330 63254794
Chronic obstructive pulmonary disease 11.46 10.17 158 228740 62528 63197596
Exposure to toxic agent 11.43 10.17 3 228895 5584 63254540
Epiglottic oedema 11.40 10.17 6 228892 91 63260033
Protein urine 11.40 10.17 14 228884 758 63259366
Hyperreflexia 11.39 10.17 47 228851 5887 63254237
Food refusal 11.36 10.17 10 228888 365 63259759
Congenital anaemia 11.36 10.17 3 228895 4 63260120
Infusion site bruising 11.35 10.17 35 228863 3797 63256327
Ventricular hypoplasia 11.30 10.17 7 228891 147 63259977
Vaginal cellulitis 11.29 10.17 6 228892 93 63260031
Rhinovirus infection 11.29 10.17 39 228859 4490 63255634
Haemophagocytic lymphohistiocytosis 11.26 10.17 13 228885 10614 63249510
Psychotic disorder 11.23 10.17 51 228847 25661 63234463
Unintentional medical device removal 11.22 10.17 4 228894 6111 63254013
Eye irritation 11.22 10.17 41 228857 21930 63238194
Breast cancer metastatic 11.19 10.17 78 228820 11940 63248184
Right atrial dilatation 11.19 10.17 13 228885 664 63259460
Meningitis streptococcal 11.17 10.17 7 228891 150 63259974
Aspartate aminotransferase decreased 11.17 10.17 14 228884 774 63259350
Antidepressant discontinuation syndrome 11.16 10.17 5 228893 52 63260072
Tumour marker increased 11.12 10.17 41 228857 4874 63255250
Velopharyngeal incompetence 11.11 10.17 4 228894 22 63260102
Coronary artery occlusion 11.08 10.17 8 228890 8183 63251941
Migraine with aura 11.05 10.17 28 228870 2712 63257412
Dysuria 11.04 10.17 177 228721 33561 63226563
Hyperlipidaemia 11.02 10.17 35 228863 19536 63240588
Inappropriate antidiuretic hormone secretion 10.86 10.17 94 228804 15368 63244756
Otorrhoea 10.85 10.17 19 228879 1420 63258704
Pharyngeal hypoaesthesia 10.84 10.17 9 228889 303 63259821
Complication of device insertion 10.75 10.17 7 228891 7557 63252567
Metapneumovirus infection 10.73 10.17 16 228882 1044 63259080
Carbon dioxide abnormal 10.70 10.17 7 228891 162 63259962
Incorrect dose administered 10.66 10.17 152 228746 59816 63200308
Periorbital cellulitis 10.64 10.17 13 228885 700 63259424
Eosinophilia 10.63 10.17 44 228854 22712 63237412
Metastases to liver 10.55 10.17 131 228767 23508 63236616
Lymphorrhoea 10.54 10.17 5 228893 60 63260064
Blood creatine increased 10.46 10.17 44 228854 5557 63254567
Lupus nephritis 10.41 10.17 28 228870 2811 63257313
Musculoskeletal chest pain 10.36 10.17 119 228779 20964 63239160
Cerumen impaction 10.35 10.17 16 228882 1078 63259046
Eczema 10.31 10.17 71 228827 32220 63227904
Cephalhaematoma 10.30 10.17 3 228895 7 63260117
Arteriosclerosis coronary artery 10.30 10.17 9 228889 8364 63251760
Device difficult to use 10.28 10.17 19 228879 12777 63247347
COVID-19 immunisation 10.26 10.17 21 228877 1766 63258358
Neutropenic infection 10.25 10.17 18 228880 1349 63258775
Hypomania 10.23 10.17 5 228893 6325 63253799
Red cell distribution width increased 10.21 10.17 69 228829 10455 63249669
Lichen sclerosus 10.19 10.17 16 228882 1093 63259031
Dextrocardia 10.18 10.17 4 228894 29 63260095
Tricuspid valve disease 10.17 10.17 8 228890 249 63259875

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
Febrile neutropenia 932.41 10.64 1753 127999 135096 34692083
Vomiting 463.03 10.64 1980 127772 245641 34581538
Drug ineffective 368.54 10.64 713 129039 456038 34371141
Nausea 315.34 10.64 2247 127505 337661 34489518
Drug abuse 260.58 10.64 31 129721 99065 34728114
Completed suicide 252.55 10.64 33 129719 98135 34729044
Toxicity to various agents 218.83 10.64 253 129499 200109 34627070
Constipation 178.36 10.64 989 128763 135993 34691186
Cytokine release syndrome 173.95 10.64 308 129444 22569 34804610
Serotonin syndrome 173.51 10.64 285 129467 19648 34807531
Neutropenia 161.50 10.64 1065 128687 155713 34671466
Aplastic anaemia 153.64 10.64 185 129567 9531 34817648
Left-to-right cardiac shunt 148.58 10.64 35 129717 15 34827164
Pyrexia 142.24 10.64 1871 127881 331142 34496037
Diarrhoea 136.39 10.64 2115 127637 387797 34439382
Fatigue 132.07 10.64 2017 127735 368636 34458543
Plasma cell myeloma 128.14 10.64 395 129357 41642 34785537
Febrile bone marrow aplasia 122.81 10.64 152 129600 8057 34819122
Myocardial infarction 118.41 10.64 166 129586 120919 34706260
Abdominal pain 117.90 10.64 1022 128730 162596 34664583
Appendicolith 114.07 10.64 150 129602 8451 34818728
Thrombocytopenia 107.91 10.64 967 128785 155280 34671899
Overdose 102.48 10.64 112 129640 90947 34736232
Mucosal inflammation 101.50 10.64 345 129407 38277 34788902
Sepsis 98.72 10.64 998 128754 165563 34661616
Suicide attempt 96.21 10.64 15 129737 39101 34788078
Rhabdomyolysis 95.79 10.64 68 129684 68095 34759084
Electrocardiogram QT prolonged 95.74 10.64 352 129400 40600 34786579
Heart disease congenital 94.85 10.64 61 129691 1329 34825850
Dehydration 93.64 10.64 812 128940 129157 34698022
Appendicitis 92.15 10.64 183 129569 14624 34812555
Hospice care 91.98 10.64 121 129631 6819 34820360
Otitis media chronic 91.05 10.64 27 129725 66 34827113
Therapeutic product effect incomplete 90.62 10.64 37 129715 50504 34776675
Intentional overdose 88.60 10.64 26 129726 43648 34783531
Congenital anomaly 82.59 10.64 56 129696 1337 34825842
Coronary artery disease 80.88 10.64 39 129713 48266 34778913
Rheumatoid arthritis 80.86 10.64 21 129731 38217 34788962
Death 80.82 10.64 1989 127763 396060 34431119
Chills 74.07 10.64 535 129217 80508 34746671
Flushing 73.54 10.64 276 129476 32144 34795035
Failure to thrive 73.51 10.64 122 129630 8479 34818700
Ventricular fibrillation 73.02 10.64 219 129533 22735 34804444
Treatment failure 71.86 10.64 42 129710 46655 34780524
Blood creatine phosphokinase increased 70.96 10.64 39 129713 44818 34782361
Condition aggravated 70.69 10.64 421 129331 191775 34635404
Arthralgia 66.53 10.64 365 129387 169676 34657503
Drug resistance 65.94 10.64 9 129743 25918 34801261
Decreased appetite 65.40 10.64 922 128830 165470 34661709
White blood cell count decreased 62.88 10.64 585 129167 94860 34732319
Torsade de pointes 61.27 10.64 102 129650 7107 34820072
Interstitial lung disease 60.34 10.64 93 129659 65189 34761990
Musculoskeletal stiffness 58.74 10.64 52 129700 46628 34780551
Disease progression 58.01 10.64 635 129117 107442 34719737
Hepatic function abnormal 55.12 10.64 50 129702 44313 34782866
Neuropathy peripheral 54.67 10.64 510 129242 82753 34744426
Hypoxia 52.22 10.64 367 129385 54728 34772451
Ventricular tachyarrhythmia 51.57 10.64 26 129726 348 34826831
Erythema 50.60 10.64 528 129224 88252 34738927
Hyponatraemia 50.58 10.64 499 129253 82192 34744987
Suicidal ideation 49.61 10.64 46 129706 40342 34786837
Aggression 49.51 10.64 43 129709 38921 34788258
Blood phosphorus increased 48.73 10.64 96 129656 7625 34819554
Stomatitis 48.07 10.64 296 129456 42218 34784961
Neutrophil count decreased 47.61 10.64 339 129413 50765 34776414
Coma 46.23 10.64 61 129691 45617 34781562
Malignant neoplasm progression 46.17 10.64 515 129237 87531 34739648
Aplasia 45.99 10.64 70 129682 4518 34822661
Psoriasis 45.59 10.64 46 129706 38766 34788413
Wrong technique in product usage process 45.38 10.64 40 129712 35946 34791233
Therapeutic product effect decreased 43.35 10.64 39 129713 34704 34792475
Encephalopathy 43.18 10.64 251 129501 35068 34792111
Therapeutic response decreased 42.82 10.64 28 129724 29285 34797894
Renal impairment 42.58 10.64 193 129559 94320 34732859
Tachycardia 42.26 10.64 491 129261 84281 34742898
Prostate cancer 42.16 10.64 51 129701 39598 34787581
Inappropriate schedule of product administration 41.84 10.64 107 129645 62189 34764990
Depression 41.55 10.64 202 129550 96896 34730283
Platelet transfusion 40.00 10.64 38 129714 1488 34825691
Weight increased 38.97 10.64 195 129557 92838 34734341
Eustachian tube dysfunction 38.88 10.64 13 129739 53 34827126
Injection site pain 38.55 10.64 53 129699 38952 34788227
Anaphylactic reaction 38.48 10.64 228 129524 32073 34795106
Drug dependence 38.37 10.64 21 129731 24196 34802983
Clostridium difficile colitis 38.26 10.64 137 129615 15593 34811586
Loss of personal independence in daily activities 38.20 10.64 40 129712 33139 34794040
Platelet count decreased 38.00 10.64 640 129112 119077 34708102
Psoriatic arthropathy 37.98 10.64 13 129739 19785 34807394
Cardiogenic shock 37.79 10.64 197 129555 26421 34800758
Ascites 37.76 10.64 299 129453 46272 34780907
Myalgia 37.14 10.64 173 129579 83937 34743242
Otitis media acute 37.12 10.64 25 129727 590 34826589
Acute myocardial infarction 37.06 10.64 91 129661 53628 34773551
Cardiac failure congestive 36.93 10.64 171 129581 83099 34744080
Laevocardia 36.80 10.64 8 129744 0 34827179
Abdominal distension 36.25 10.64 354 129398 58138 34769041
Small intestinal obstruction 35.75 10.64 129 129623 14737 34812442
Lymphoid tissue hypoplasia 35.26 10.64 21 129731 397 34826782
Thymus hypoplasia 35.26 10.64 21 129731 397 34826782
Angina pectoris 34.79 10.64 39 129713 31324 34795855
Right ventricular hypertrophy 34.26 10.64 35 129717 1499 34825680
Labelled drug-drug interaction medication error 33.97 10.64 7 129745 14932 34812247
Full blood count decreased 33.81 10.64 145 129607 17943 34809236
Infusion related reaction 33.32 10.64 322 129430 52735 34774444
Synovitis 33.24 10.64 6 129746 14060 34813119
Colitis 33.19 10.64 247 129505 37503 34789676
Hallucination, auditory 33.17 10.64 3 129749 11914 34815265
Cerebral infarction 32.86 10.64 32 129720 27423 34799756
Poor feeding infant 32.82 10.64 22 129730 515 34826664
Atelectasis neonatal 32.20 10.64 7 129745 0 34827179
Asthma 32.05 10.64 69 129683 42587 34784592
Hypersensitivity 31.97 10.64 357 129395 60678 34766501
Blood pressure fluctuation 31.91 10.64 28 129724 25221 34801958
Negative pressure pulmonary oedema 31.55 10.64 16 129736 217 34826962
Asthenia 31.48 10.64 1159 128593 244092 34583087
Pneumonia 30.94 10.64 1643 128109 360984 34466195
Malignant catatonia 30.73 10.64 16 129736 230 34826949
Product used for unknown indication 30.69 10.64 27 129725 956 34826223
Pancytopenia 30.66 10.64 510 129242 94647 34732532
Intentional self-injury 30.21 10.64 7 129745 13764 34813415
Intentional product misuse 30.11 10.64 79 129673 45532 34781647
Fall 30.08 10.64 551 129201 202334 34624845
Adenoidal hypertrophy 29.95 10.64 14 129738 157 34827022
Immune-mediated hepatitis 29.94 10.64 39 129713 2176 34825003
Angina unstable 29.74 10.64 4 129748 11649 34815530
Impaired gastric emptying 29.53 10.64 49 129703 3404 34823775
Pulmonary artery stenosis congenital 29.37 10.64 20 129732 481 34826698
Blood pressure measurement 29.26 10.64 14 129738 166 34827013
Oxygen saturation immeasurable 29.02 10.64 9 129743 27 34827152
Neutropenic colitis 28.77 10.64 46 129706 3098 34824081
Drug interaction 28.60 10.64 630 129122 225316 34601863
Erectile dysfunction 28.44 10.64 21 129731 20616 34806563
Cardiac failure 28.38 10.64 210 129542 91038 34736141
Fear 28.20 10.64 3 129749 10473 34816706
Altered state of consciousness 28.20 10.64 26 129726 22867 34804312
Anal inflammation 27.84 10.64 29 129723 1271 34825908
Oral pain 27.80 10.64 96 129656 10731 34816448
Joint swelling 27.74 10.64 121 129631 59769 34767410
Disseminated aspergillosis 27.56 10.64 23 129729 757 34826422
Blood glucose increased 27.27 10.64 141 129611 66577 34760602
Cleft palate 27.00 10.64 21 129731 624 34826555
Neurotoxicity 26.75 10.64 135 129617 17875 34809304
Paranoia 26.74 10.64 6 129746 12062 34815117
Chemotherapeutic drug level increased 26.72 10.64 14 129738 204 34826975
Bacteraemia 26.67 10.64 144 129608 19573 34807606
Enterocolitis infectious 26.34 10.64 32 129720 1663 34825516
Tumour lysis syndrome 26.14 10.64 129 129623 16930 34810249
SARS-CoV-2 test negative 25.98 10.64 25 129727 995 34826184
Gastrointestinal haemorrhage 25.93 10.64 207 129545 88270 34738909
Disturbance in attention 25.89 10.64 35 129717 25910 34801269
Heart rate decreased 25.86 10.64 49 129703 31696 34795483
Hyperbilirubinaemia 25.54 10.64 127 129625 16716 34810463
Oropharyngeal discomfort 25.54 10.64 44 129708 3152 34824027
Hypoplastic left heart syndrome 25.51 10.64 14 129738 225 34826954
Dermatitis diaper 25.40 10.64 15 129737 279 34826900
Right ventricular enlargement 25.14 10.64 16 129736 342 34826837
Extravasation 25.12 10.64 33 129719 1857 34825322
Treatment noncompliance 25.03 10.64 41 129711 28059 34799120
Clostridium difficile infection 24.87 10.64 137 129615 18761 34808418
Dysentery 24.86 10.64 16 129736 349 34826830
Diabetes mellitus 24.69 10.64 90 129662 46783 34780396
Developmental delay 24.57 10.64 40 129712 2735 34824444
Therapy non-responder 24.20 10.64 70 129682 39076 34788103
Stress 24.14 10.64 194 129558 30153 34797026
Atrial septal defect 23.95 10.64 71 129681 7321 34819858
Diabetes mellitus inadequate control 23.89 10.64 10 129742 13454 34813725
Type 2 diabetes mellitus 23.84 10.64 15 129737 16017 34811162
Painful respiration 23.69 10.64 26 129726 1210 34825969
Hypotension 23.65 10.64 1027 128725 220622 34606557
Right aortic arch 23.64 10.64 7 129745 17 34827162
Electrocardiogram T wave biphasic 23.45 10.64 12 129740 166 34827013
Psychotic disorder 23.39 10.64 34 129718 24418 34802761
Coarctation of the aorta 23.29 10.64 17 129735 458 34826721
Coronary artery occlusion 23.21 10.64 6 129746 10956 34816223
Fixed eruption 23.08 10.64 30 129722 1670 34825509
Stridor 23.08 10.64 37 129715 2497 34824682
Right-to-left cardiac shunt 22.84 10.64 10 129742 95 34827084
Multiple congenital abnormalities 22.82 10.64 18 129734 546 34826633
Melaena 22.81 10.64 62 129690 35318 34791861
Hypoglycaemia 22.60 10.64 115 129637 54525 34772654
Post procedural hypotension 22.56 10.64 9 129743 66 34827113
Nephrolithiasis 22.56 10.64 191 129561 30142 34797037
Enteritis 22.50 10.64 74 129678 8068 34819111
Tubulointerstitial nephritis 22.39 10.64 27 129725 20997 34806182
Schizophrenia 22.05 10.64 3 129749 8663 34818516
Bladder cancer 21.87 10.64 17 129735 16261 34810918
Drug ineffective for unapproved indication 21.69 10.64 34 129718 23681 34803498
Croup infectious 21.56 10.64 15 129737 374 34826805
Embolism 21.49 10.64 71 129681 7758 34819421
Penile oedema 21.42 10.64 16 129736 447 34826732
Endocardial fibroelastosis 21.39 10.64 6 129746 11 34827168
Cleft lip 21.07 10.64 14 129738 323 34826856
Sepsis neonatal 21.06 10.64 13 129739 263 34826916
Pulse absent 21.00 10.64 58 129694 5745 34821434
Upper respiratory tract infection 20.93 10.64 201 129551 32858 34794321
Abnormal behaviour 20.81 10.64 38 129714 24931 34802248
Obesity 20.65 10.64 11 129741 12867 34814312
Back pain 20.62 10.64 595 129157 121194 34705985
Oxygen saturation decreased 20.59 10.64 297 129455 53521 34773658
Proctalgia 20.51 10.64 57 129695 5666 34821513
Cerebrovascular accident 20.24 10.64 209 129543 84602 34742577
Testicular germ cell cancer metastatic 20.13 10.64 8 129744 58 34827121
Change of bowel habit 20.10 10.64 22 129730 1021 34826158
Rash maculo-papular 20.04 10.64 177 129575 28274 34798905
Bacterial infection 20.04 10.64 120 129632 16943 34810236
Hypoplastic right heart syndrome 19.86 10.64 6 129746 16 34827163
Taste disorder 19.74 10.64 65 129687 7090 34820089
Depressed level of consciousness 19.57 10.64 87 129665 42754 34784425
Hypophosphataemia 19.55 10.64 87 129665 10939 34816240
Osteoarthritis 19.45 10.64 29 129723 20613 34806566
Osteonecrosis 19.44 10.64 16 129736 14874 34812305
Right ventricular dilatation 19.42 10.64 18 129734 683 34826496
Tendonitis 19.36 10.64 5 129747 9135 34818044
Glycosylated haemoglobin increased 19.27 10.64 9 129743 11351 34815828
Hyperhidrosis 19.23 10.64 391 129361 75301 34751878
Dry skin 19.20 10.64 189 129563 31098 34796081
Pain in extremity 18.91 10.64 343 129409 126170 34701009
Periorbital swelling 18.90 10.64 17 129735 620 34826559
Poisoning 18.80 10.64 11 129741 12215 34814964
International normalised ratio increased 18.79 10.64 101 129651 47226 34779953
Substance abuse 18.63 10.64 3 129749 7638 34819541
Meconium abnormal 18.46 10.64 8 129744 74 34827105
Necrotising retinitis 18.42 10.64 19 129733 823 34826356
Tachypnoea 18.41 10.64 124 129628 18228 34808951
Embryonal rhabdomyosarcoma 18.40 10.64 4 129748 0 34827179
Product dose omission issue 18.38 10.64 323 129429 119388 34707791
Hypokalaemia 18.37 10.64 311 129441 57903 34769276
Skin ulcer 18.35 10.64 34 129718 22182 34804997
Neutropenic sepsis 18.25 10.64 100 129652 13667 34813512
Hyperkalaemia 18.24 10.64 167 129585 69222 34757957
Cytomegalovirus infection 18.23 10.64 44 129708 26091 34801088
Arteriosclerosis coronary artery 18.13 10.64 12 129740 12473 34814706
Neonatal tachypnoea 18.10 10.64 10 129742 163 34827016
Hypomagnesaemia 18.09 10.64 141 129611 21710 34805469
Perihepatic abscess 18.08 10.64 9 129743 117 34827062
Atrioventricular block complete 18.08 10.64 6 129746 9313 34817866
Ageusia 18.02 10.64 81 129671 10227 34816952
Injection site haemorrhage 17.75 10.64 7 129745 9761 34817418
Parainfluenzae virus infection 17.63 10.64 35 129717 2795 34824384
Liver disorder 17.61 10.64 63 129689 32934 34794245
Joint range of motion decreased 17.54 10.64 3 129749 7309 34819870
Obstructive airways disorder 17.47 10.64 19 129733 15475 34811704
Hyperthermia malignant 17.44 10.64 30 129722 2147 34825032
Erythropenia 17.41 10.64 11 129741 232 34826947
Walking aid user 17.40 10.64 28 129724 1896 34825283
Depressed mood 17.38 10.64 28 129724 19289 34807890
Coronary artery stenosis 17.29 10.64 7 129745 9609 34817570
Congenital aortic stenosis 17.25 10.64 8 129744 88 34827091
Oedema peripheral 17.23 10.64 327 129425 119485 34707694
Hypophagia 17.20 10.64 150 129602 23872 34803307
Poisoning deliberate 17.18 10.64 4 129748 7840 34819339
Clonus 17.12 10.64 34 129718 2716 34824463
Haemorrhage 17.05 10.64 116 129636 51254 34775925
Feeding disorder 17.00 10.64 61 129691 6949 34820230
Road traffic accident 16.95 10.64 24 129728 17426 34809753
Neoplasm progression 16.95 10.64 146 129606 23154 34804025
Myopathy 16.92 10.64 11 129741 11543 34815636
Hyperaemia 16.90 10.64 22 129730 1227 34825952
Impetigo 16.72 10.64 20 129732 1023 34826156
Arthropathy 16.71 10.64 48 129704 26859 34800320
Right atrial enlargement 16.62 10.64 11 129741 252 34826927
Septic shock 16.61 10.64 366 129386 71468 34755711
Klebsiella bacteraemia 16.56 10.64 23 129729 1365 34825814
Immune effector cell-associated neurotoxicity syndrome 16.41 10.64 40 129712 3673 34823506
Electrocardiogram QT shortened 16.38 10.64 9 129743 145 34827034
Gait disturbance 16.38 10.64 220 129532 84920 34742259
Univentricular heart 16.34 10.64 6 129746 34 34827145
Laryngeal discomfort 16.25 10.64 10 129742 201 34826978
Dysgeusia 16.23 10.64 160 129592 26337 34800842
Pulmonary oedema neonatal 16.17 10.64 4 129748 3 34827176
Pemphigoid 16.09 10.64 6 129746 8660 34818519
Osteoporosis 16.06 10.64 14 129738 12654 34814525
Dyslipidaemia 16.04 10.64 4 129748 7484 34819695
Palmar-plantar erythrodysaesthesia syndrome 15.97 10.64 112 129640 16683 34810496
Oesophageal irritation 15.94 10.64 7 129745 67 34827112
Angioedema 15.83 10.64 78 129674 37296 34789883
Viral rash 15.81 10.64 8 129744 108 34827071
Incorrect dose administered 15.79 10.64 87 129665 40428 34786751
Urethral valves 15.78 10.64 11 129741 275 34826904
Mental status changes 15.71 10.64 213 129539 37870 34789309
Nasopharyngitis 15.65 10.64 175 129577 69793 34757386
Product substitution issue 15.64 10.64 9 129743 10086 34817093
Troponin T increased 15.59 10.64 30 129722 2341 34824838
Nephrotic syndrome 15.46 10.64 4 129748 7299 34819880
Velopharyngeal incompetence 15.44 10.64 5 129747 18 34827161
Incarcerated umbilical hernia 15.44 10.64 5 129747 18 34827161
Blood triglycerides increased 15.27 10.64 18 129734 14141 34813038
Deep vein thrombosis 15.26 10.64 333 129419 64915 34762264
Gastrointestinal malformation 15.25 10.64 7 129745 75 34827104
Anomalous pulmonary venous connection 15.25 10.64 7 129745 75 34827104
Neutropenic infection 15.22 10.64 23 129729 1475 34825704
Streptococcal bacteraemia 15.14 10.64 27 129725 1988 34825191
Blood pressure increased 15.07 10.64 233 129519 87869 34739310
Lactic acidosis 15.06 10.64 72 129680 34700 34792479
Ventricular hypoplasia 15.01 10.64 7 129745 78 34827101
Blood pressure systolic increased 14.96 10.64 40 129712 22912 34804267
Palmar erythema 14.95 10.64 11 129741 300 34826879
Laryngospasm 14.95 10.64 23 129729 1498 34825681
Feeling hot 14.95 10.64 123 129629 19249 34807930
Myasthenia gravis 14.84 10.64 58 129694 6882 34820297
Hyperthermia 14.81 10.64 78 129674 10499 34816680
Arthritis 14.71 10.64 63 129689 31283 34795896
Subileus 14.68 10.64 35 129717 3168 34824011
Respiratory arrest 14.66 10.64 54 129698 27989 34799190
Cataract 14.65 10.64 49 129703 26137 34801042
Mobility decreased 14.48 10.64 60 129692 30068 34797111
Cardiac arrest 14.44 10.64 463 129289 95696 34731483
Product administration error 14.42 10.64 24 129728 16320 34810859
Aorta hypoplasia 14.34 10.64 7 129745 87 34827092
Photosensitivity reaction 14.31 10.64 11 129741 10583 34816596
C-reactive protein increased 14.30 10.64 130 129622 53968 34773211
Knee arthroplasty 14.09 10.64 5 129747 7439 34819740
Malnutrition 14.05 10.64 88 129664 12621 34814558
Placental transfusion syndrome 14.04 10.64 4 129748 8 34827171
Visual acuity reduced 13.98 10.64 24 129728 16125 34811054
Thrombosis 13.94 10.64 264 129488 50194 34776985
Electrocardiogram ST segment elevation 13.93 10.64 47 129705 5191 34821988
Unresponsive to stimuli 13.86 10.64 160 129592 27409 34799770
Device malfunction 13.85 10.64 11 129741 10410 34816769
Adenoiditis 13.80 10.64 3 129749 0 34827179
Cardiac malposition 13.80 10.64 3 129749 0 34827179
Agonal respiration 13.80 10.64 3 129749 0 34827179
Cardiomyopathy neonatal 13.80 10.64 3 129749 0 34827179
Exposure during pregnancy 13.79 10.64 8 129744 8926 34818253
Right ventricle outflow tract obstruction 13.72 10.64 4 129748 9 34827170
Large intestine anastomosis 13.61 10.64 6 129746 58 34827121
Body temperature decreased 13.60 10.64 17 129735 13017 34814162
Feeding intolerance 13.49 10.64 8 129744 150 34827029
Glomerular filtration rate decreased 13.43 10.64 17 129735 12944 34814235
Pneumonia moraxella 13.38 10.64 5 129747 30 34827149
Immune reconstitution inflammatory syndrome 13.30 10.64 8 129744 8751 34818428
Dementia 13.26 10.64 19 129733 13729 34813450
Red blood cell sedimentation rate increased 13.05 10.64 9 129743 9153 34818026
Anger 12.93 10.64 15 129737 11869 34815310
Disease recurrence 12.87 10.64 39 129713 21451 34805728
Catheter site pain 12.83 10.64 20 129732 1318 34825861
Seminoma 12.81 10.64 9 129743 228 34826951
Anaphylactoid shock 12.81 10.64 11 129741 377 34826802
Shock haemorrhagic 12.72 10.64 14 129738 11340 34815839
Transient ischaemic attack 12.65 10.64 56 129696 27557 34799622
Cyanosis neonatal 12.63 10.64 10 129742 305 34826874
Injection site reaction 12.58 10.64 18 129734 13015 34814164
Vasculitis 12.58 10.64 14 129738 11282 34815897
Hypervolaemia 12.55 10.64 120 129632 19589 34807590
Respiratory rate increased 12.47 10.64 11 129741 9883 34817296
Accidental overdose 12.46 10.64 36 129716 20104 34807075
Stoma site pain 12.44 10.64 14 129738 670 34826509
Otorrhoea 12.42 10.64 13 129739 573 34826606
Tympanic membrane perforation 12.41 10.64 10 129742 313 34826866
Necrotising enterocolitis neonatal 12.41 10.64 9 129743 240 34826939
Underdose 12.37 10.64 20 129732 13760 34813419
Sexual dysfunction 12.33 10.64 4 129748 6299 34820880
Urine sodium decreased 12.33 10.64 8 129744 177 34827002
Fracture 12.29 10.64 5 129747 6844 34820335
Medical device site fistula 12.27 10.64 5 129747 39 34827140
Asphyxia 12.25 10.64 5 129747 6830 34820349
Myoclonus 12.18 10.64 95 129657 14630 34812549
Pulmonary valve incompetence 12.14 10.64 16 129736 903 34826276
Faeces discoloured 12.08 10.64 23 129729 14855 34812324
Therapeutic product effect prolonged 12.03 10.64 9 129743 252 34826927
Cardiac ventricular disorder 12.03 10.64 9 129743 252 34826927
Drug eruption 11.99 10.64 36 129716 19862 34807317
Anaesthetic complication neurological 11.99 10.64 10 129742 329 34826850
Rash 11.98 10.64 971 128781 221781 34605398
Hyperphosphataemia 11.97 10.64 40 129712 4397 34822782
Congenital hypothyroidism 11.83 10.64 4 129748 17 34827162
Neonatal tachycardia 11.83 10.64 4 129748 17 34827162
Lymphocytic oesophagitis 11.73 10.64 3 129749 3 34827176
Sinus tachycardia 11.71 10.64 107 129645 17253 34809926
Abdominal compartment syndrome 11.69 10.64 16 129736 937 34826242
Posterior reversible encephalopathy syndrome 11.68 10.64 70 129682 9884 34817295
Subarachnoid haemorrhage 11.66 10.64 18 129734 12617 34814562
Pseudomonal bacteraemia 11.65 10.64 20 129732 1429 34825750
Insomnia 11.64 10.64 295 129457 103612 34723567
Patent ductus arteriosus 11.62 10.64 33 129719 3321 34823858
Locked-in syndrome 11.61 10.64 9 129743 266 34826913
Basal cell carcinoma 11.54 10.64 36 129716 19622 34807557
Epilepsy 11.49 10.64 41 129711 21454 34805725
Diaphragmatic rupture 11.47 10.64 4 129748 19 34827160
Tuberculosis 11.47 10.64 9 129743 8568 34818611
Granulocytopenia 11.46 10.64 5 129747 6562 34820617
Inflammation 11.44 10.64 60 129692 28235 34798944
Pathogen resistance 11.40 10.64 11 129741 9471 34817708
Lymphoma 11.37 10.64 18 129734 12489 34814690
Injury 11.28 10.64 122 129630 20565 34806614
Hemiplegic migraine 11.27 10.64 3 129749 4 34827175
Benign prostatic hyperplasia 11.26 10.64 23 129729 14472 34812707
Transplant rejection 11.24 10.64 13 129739 10298 34816881
Biliary tract infection 11.23 10.64 13 129739 642 34826537
Hepatic steatosis 11.23 10.64 33 129719 18329 34808850
Gastritis erosive 11.20 10.64 4 129748 5928 34821251
Arterial angioplasty 11.20 10.64 5 129747 50 34827129
Seizure like phenomena 11.19 10.64 14 129738 750 34826429
Trismus 11.15 10.64 27 129725 2468 34824711
Transfusion 11.14 10.64 62 129690 8523 34818656
IIIrd nerve disorder 11.13 10.64 6 129746 93 34827086
Epistaxis 11.09 10.64 289 129463 57962 34769217
Upper airway obstruction 11.07 10.64 13 129739 652 34826527
Subacute cutaneous lupus erythematosus 11.07 10.64 16 129736 986 34826193
Cellulitis 11.06 10.64 266 129486 52685 34774494
Oesophageal carcinoma 10.95 10.64 11 129741 9293 34817886
Hyperbilirubinaemia neonatal 10.93 10.64 14 129738 768 34826411
Pharyngitis streptococcal 10.90 10.64 28 129724 2656 34824523
Cardiac failure chronic 10.88 10.64 8 129744 7871 34819308
Myocardial ischaemia 10.85 10.64 31 129721 17377 34809802
Speech sound disorder 10.82 10.64 7 129745 154 34827025
Infusion site urticaria 10.82 10.64 7 129745 154 34827025
Klebsiella test positive 10.82 10.64 13 129739 668 34826511
Spinal cord injury thoracic 10.79 10.64 6 129746 99 34827080
Movement disorder 10.79 10.64 18 129734 12230 34814949
Procedural vomiting 10.79 10.64 8 129744 221 34826958
Tardive dyskinesia 10.77 10.64 4 129748 5786 34821393
Hepatocellular injury 10.76 10.64 128 129624 22083 34805096
Wheezing 10.72 10.64 100 129652 41302 34785877
Haemodialysis 10.70 10.64 14 129738 10512 34816667
Anxiety 10.68 10.64 284 129468 99144 34728035
Pulmonary sepsis 10.65 10.64 25 129727 2240 34824939

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
Febrile neutropenia 2078.44 9.98 3326 289366 227673 79224023
Drug ineffective 919.51 9.98 1605 291087 1079308 78372388
Vomiting 901.86 9.98 4812 287880 661016 78790680
Nausea 776.53 9.98 6075 286617 951121 78500575
Constipation 494.13 9.98 2203 290489 280847 79170849
Synovitis 470.68 9.98 19 292673 150715 79300981
Neutropenia 452.49 9.98 2172 290520 285538 79166158
Drug abuse 444.18 9.98 42 292650 162649 79289047
Diarrhoea 413.07 9.98 4986 287706 875503 78576193
Serotonin syndrome 384.05 9.98 634 292058 44393 79407303
Joint swelling 365.76 9.98 313 292379 288333 79163363
Thrombocytopenia 355.57 9.98 1915 290777 263344 79188352
Arthropathy 354.15 9.98 105 292587 177006 79274690
Hand deformity 350.75 9.98 6 292686 103913 79347783
Dehydration 347.15 9.98 1813 290879 246374 79205322
Therapeutic product effect decreased 339.03 9.98 91 292601 163772 79287924
Toxicity to various agents 338.38 9.98 646 292046 420894 79030802
Completed suicide 329.42 9.98 252 292440 245515 79206181
Torsade de pointes 324.09 9.98 377 292315 18935 79432761
Abdominal pain 315.78 9.98 2477 290215 387092 79064604
Rheumatoid arthritis 302.77 9.98 196 292496 208274 79243422
Mucosal inflammation 299.05 9.98 775 291917 74805 79376891
Systemic lupus erythematosus 296.86 9.98 45 292647 121104 79330592
Cytokine release syndrome 292.47 9.98 496 292196 35502 79416194
Treatment failure 288.75 9.98 132 292560 170354 79281342
Aplastic anaemia 266.75 9.98 329 292363 17576 79434120
Electrocardiogram QT prolonged 265.16 9.98 832 291860 89554 79362142
Arthralgia 264.56 9.98 1140 291552 570663 78881033
Pyrexia 259.77 9.98 3706 288986 675003 78776693
Disease progression 253.65 9.98 1341 291351 183021 79268675
Contraindicated product administered 247.18 9.98 135 292557 157403 79294293
Sepsis 245.68 9.98 1762 290930 267666 79184030
Drug intolerance 244.62 9.98 369 292323 263750 79187946
Febrile bone marrow aplasia 236.80 9.98 265 292427 12755 79438941
Pericarditis 233.07 9.98 49 292643 104187 79347509
Musculoskeletal stiffness 222.48 9.98 189 292503 174819 79276877
Hypoxia 220.88 9.98 856 291836 102387 79349309
Flushing 217.46 9.98 766 291926 87502 79364194
Plasma cell myeloma 206.42 9.98 542 292150 52717 79398979
Duodenal ulcer perforation 204.45 9.98 9 292683 66202 79385494
White blood cell count decreased 203.71 9.98 1285 291407 187003 79264693
Death 202.11 9.98 3057 289635 563457 78888239
Helicobacter infection 201.26 9.98 14 292678 69690 79382006
Erythema 196.40 9.98 1448 291244 221842 79229854
Therapeutic product effect incomplete 195.15 9.98 141 292551 141504 79310192
Wound 195.06 9.98 91 292601 116088 79335608
Glossodynia 192.86 9.98 69 292623 103268 79348428
Fatigue 184.05 9.98 4585 288107 925142 78526554
Neuropathy peripheral 182.21 9.98 1010 291682 140295 79311401
Neutrophil count decreased 170.89 9.98 741 291951 93218 79358478
Ventricular fibrillation 168.13 9.98 366 292326 31560 79420136
Chills 167.39 9.98 1084 291608 159150 79292546
Hospice care 159.12 9.98 193 292499 10131 79441565
Neutropenic sepsis 156.11 9.98 322 292370 26742 79424954
Intentional overdose 155.98 9.98 98 292594 105862 79345834
Swelling 155.97 9.98 353 292339 216358 79235338
Encephalopathy 155.87 9.98 573 292119 66824 79384872
Impaired healing 149.71 9.98 67 292625 87588 79364108
Condition aggravated 149.58 9.98 1151 291541 499973 78951723
Decreased appetite 148.62 9.98 1914 290778 340504 79111192
Myocardial infarction 148.49 9.98 281 292411 183848 79267848
Small intestinal obstruction 147.45 9.98 316 292376 26956 79424740
Mobility decreased 146.79 9.98 139 292553 122036 79329660
Muscle injury 145.46 9.98 8 292684 48553 79403143
Overdose 143.44 9.98 287 292405 183919 79267777
Sleep disorder due to general medical condition, insomnia type 141.16 9.98 4 292688 43552 79408144
Hepatic enzyme increased 137.54 9.98 290 292402 182320 79269376
Colitis 137.03 9.98 583 292109 72724 79378972
Weight increased 134.17 9.98 543 292149 276843 79174853
Tachycardia 131.56 9.98 1108 291584 176660 79275036
C-reactive protein abnormal 123.07 9.98 16 292676 48351 79403345
Psoriatic arthropathy 119.19 9.98 69 292623 77930 79373766
Drug hypersensitivity 115.81 9.98 634 292058 298282 79153414
Type 2 diabetes mellitus 115.70 9.98 33 292659 57089 79394607
Appendicolith 114.49 9.98 149 292543 8402 79443294
Nasopharyngitis 111.75 9.98 515 292177 253366 79198330
Coronary artery disease 110.32 9.98 51 292641 65423 79386273
Pancytopenia 109.64 9.98 1008 291684 164737 79286959
Suicide attempt 106.03 9.98 89 292603 82843 79368853
Platelet count decreased 104.17 9.98 1133 291559 193531 79258165
Irritable bowel syndrome 104.07 9.98 49 292643 62192 79389504
Rhabdomyolysis 103.42 9.98 136 292556 102995 79348701
Blood cholesterol increased 103.21 9.98 93 292599 83627 79368069
Folliculitis 101.59 9.98 38 292654 55342 79396354
Anaemia 101.14 9.98 2239 290453 442776 79008920
Asthenia 100.28 9.98 2522 290170 509167 78942529
Loss of personal independence in daily activities 98.10 9.98 140 292552 102440 79349256
Hypokalaemia 97.80 9.98 881 291811 143159 79308537
Anaphylactic reaction 97.70 9.98 583 292109 83160 79368536
Malignant neoplasm progression 96.58 9.98 840 291852 135150 79316546
Fibromyalgia 95.38 9.98 59 292633 64281 79387415
Intentional self-injury 95.09 9.98 6 292686 32413 79419283
Osteoarthritis 95.07 9.98 108 292584 87201 79364495
Neoplasm progression 95.01 9.98 409 292283 51273 79400423
Red blood cell sedimentation rate increased 94.05 9.98 26 292666 45916 79405780
Drug resistance 94.02 9.98 20 292672 42193 79409503
Injection site pain 92.96 9.98 212 292480 129626 79322070
Inflammation 92.61 9.98 125 292567 93628 79358068
Therapeutic response decreased 88.89 9.98 69 292623 66784 79384912
Ventricular tachycardia 88.25 9.98 346 292346 41589 79410107
Ascites 87.48 9.98 525 292167 75037 79376659
Appendicitis 87.16 9.98 218 292474 20576 79431120
Cardiac arrest 86.74 9.98 990 291702 171106 79280590
Discomfort 86.02 9.98 210 292482 125407 79326289
Laryngospasm 84.33 9.98 88 292604 3909 79447787
Osteoporosis 83.91 9.98 47 292645 54065 79397631
Asthma 83.27 9.98 238 292454 134857 79316839
Knee arthroplasty 82.19 9.98 28 292664 43220 79408476
Aplasia 81.81 9.98 121 292571 7699 79443997
Abdominal discomfort 81.33 9.98 562 292130 250165 79201531
Failure to thrive 80.51 9.98 151 292541 11693 79440003
Leukopenia 79.26 9.98 713 291979 115800 79335896
Sopor 76.97 9.98 14 292678 32996 79418700
Hepatic function abnormal 76.84 9.98 93 292599 73014 79378682
Hypomagnesaemia 75.56 9.98 357 292335 46554 79405142
Back pain 73.69 9.98 1545 291147 302635 79149061
Pneumonia 73.42 9.98 3041 289651 657205 78794491
Hip arthroplasty 71.78 9.98 21 292671 35735 79415961
Full blood count decreased 71.48 9.98 239 292453 26580 79425116
Ventricular tachyarrhythmia 70.40 9.98 33 292659 377 79451319
Oxygen saturation decreased 70.34 9.98 754 291938 128293 79323403
Renal impairment 70.01 9.98 319 292373 157464 79294232
Long QT syndrome 69.42 9.98 97 292595 5858 79445838
Clonus 68.93 9.98 104 292588 6736 79444960
Blood pressure fluctuation 68.90 9.98 87 292605 67058 79384638
Dysgeusia 68.58 9.98 401 292291 56776 79394920
Blood pressure systolic increased 68.53 9.98 87 292605 66899 79384797
Hypotension 67.59 9.98 2104 290588 438213 79013483
Clostridium difficile infection 67.41 9.98 323 292369 42362 79409334
Clostridium difficile colitis 66.02 9.98 264 292428 32019 79419677
Joint range of motion decreased 65.98 9.98 20 292672 33262 79418434
Oculogyric crisis 65.91 9.98 67 292625 2885 79448811
Arthritis 64.65 9.98 211 292481 114669 79337027
Interstitial lung disease 64.63 9.98 205 292487 112395 79339301
Fall 63.18 9.98 1337 291355 486292 78965404
Palmar-plantar erythrodysaesthesia syndrome 63.05 9.98 265 292427 32869 79418827
Drug dependence 62.37 9.98 36 292656 40733 79410963
Desmoplastic small round cell tumour 62.20 9.98 21 292671 90 79451606
Coma 61.52 9.98 178 292514 100471 79351225
Pleural effusion 61.20 9.98 808 291884 144454 79307242
Bacteraemia 60.51 9.98 260 292432 32564 79419132
Neutropenic colitis 57.84 9.98 87 292605 5620 79446076
Transfusion 57.66 9.98 191 292501 21139 79430557
Feeling hot 57.42 9.98 396 292296 59338 79392358
Computerised tomogram thorax abnormal 56.02 9.98 56 292636 2363 79449333
Intentional product use issue 55.94 9.98 328 292364 151784 79299912
Computerised tomogram thorax 55.75 9.98 29 292663 421 79451275
Oral pain 55.67 9.98 248 292444 31550 79420146
Atelectasis 55.28 9.98 250 292442 32007 79419689
Injection site erythema 54.10 9.98 130 292562 78067 79373629
Impaired gastric emptying 53.72 9.98 118 292574 10235 79441461
Anaphylactic shock 53.70 9.98 268 292424 35728 79415968
Unresponsive to stimuli 53.13 9.98 369 292323 55419 79396277
Therapy non-responder 53.00 9.98 168 292524 92137 79359559
Wrong technique in product usage process 52.56 9.98 121 292571 73754 79377942
Liver injury 52.42 9.98 79 292613 56535 79395161
Hereditary angioedema 52.18 9.98 80 292612 5255 79446441
Neurotoxicity 52.02 9.98 247 292445 32271 79419425
Lactic acidosis 51.88 9.98 113 292579 70246 79381450
Injection site swelling 51.63 9.98 58 292634 47074 79404622
Retching 51.38 9.98 161 292531 17306 79434390
Hyponatraemia 50.32 9.98 925 291767 176923 79274773
Blood pressure diastolic abnormal 49.70 9.98 6 292686 19196 79432500
Obesity 49.62 9.98 34 292658 35091 79416605
Carbohydrate antigen 125 increased 49.55 9.98 50 292642 2134 79449562
Segmental diverticular colitis 49.52 9.98 20 292672 154 79451542
Pulmonary embolism 49.34 9.98 895 291797 170759 79280937
Lower respiratory tract infection 48.92 9.98 276 292416 128944 79322752
Blood creatine phosphokinase increased 48.85 9.98 106 292586 65984 79385712
Blood phosphorus increased 48.20 9.98 113 292579 10234 79441462
Blister 48.10 9.98 250 292442 119226 79332470
Heart rate decreased 47.77 9.98 118 292574 70198 79381498
Injection site reaction 47.37 9.98 80 292612 54705 79396991
Pain 47.26 9.98 2107 290585 701695 78750001
Dyspnoea 47.07 9.98 3702 288990 853323 78598373
Device expulsion 47.00 9.98 18 292674 25843 79425853
Mental status changes 46.67 9.98 412 292280 66547 79385149
Osteonecrosis of jaw 46.48 9.98 54 292638 43172 79408524
Wheezing 46.47 9.98 245 292447 116419 79335277
Sinusitis 46.29 9.98 476 292216 195025 79256671
Calcium ionised decreased 45.97 9.98 28 292664 559 79451137
Blood pressure systolic abnormal 45.62 9.98 5 292687 17242 79434454
Intentional product misuse 45.50 9.98 187 292505 94978 79356718
Dry skin 45.15 9.98 414 292278 67581 79384115
Hair colour changes 45.02 9.98 66 292626 4166 79447530
Platelet transfusion 44.88 9.98 49 292643 2293 79449403
Schizophrenia 44.86 9.98 3 292689 15437 79436259
Product use issue 44.07 9.98 525 292167 209297 79242399
Cerebral infarction 43.99 9.98 62 292630 45614 79406082
Pain in extremity 43.86 9.98 1011 291681 363527 79088169
Dystonia 43.76 9.98 175 292517 21224 79430472
Aggression 43.52 9.98 75 292617 50883 79400813
C-reactive protein increased 43.40 9.98 286 292406 128741 79322955
Diabetes mellitus 43.39 9.98 145 292547 78245 79373451
Basal cell carcinoma 43.16 9.98 44 292648 37331 79414365
Type I hypersensitivity 43.09 9.98 66 292626 4332 79447364
Peripheral swelling 43.00 9.98 713 291979 268904 79182792
Disability 42.75 9.98 6 292686 17114 79434582
Hypophagia 42.57 9.98 299 292393 45068 79406628
Hyperhidrosis 42.53 9.98 787 291905 150705 79300991
Bronchospasm 42.10 9.98 192 292500 24667 79427029
Medication error 41.50 9.98 122 292570 68520 79383176
Labelled drug-drug interaction medication error 41.47 9.98 25 292667 27625 79424071
Lupus vasculitis 41.44 9.98 26 292666 548 79451148
Obstructive airways disorder 41.15 9.98 33 292659 31426 79420270
Prostate cancer 40.94 9.98 37 292655 33231 79418465
Pedal pulse abnormal 40.85 9.98 18 292674 176 79451520
Pancreatitis 40.82 9.98 408 292284 68167 79383529
Bone erosion 40.69 9.98 8 292684 17839 79433857
Pulmonary fibrosis 40.41 9.98 62 292630 44050 79407646
Vasculitis 40.09 9.98 21 292671 25081 79426615
Liver disorder 40.05 9.98 134 292558 72283 79379413
Cyclic vomiting syndrome 39.50 9.98 15 292677 96 79451600
Poisoning 39.11 9.98 22 292670 25250 79426446
Osteonecrosis 38.97 9.98 34 292658 31061 79420635
Ageusia 38.93 9.98 142 292550 16490 79435206
Contusion 38.69 9.98 354 292338 148422 79303274
Depressed level of consciousness 38.47 9.98 203 292489 96449 79355247
Sedation complication 37.95 9.98 6 292686 15663 79436033
Taste disorder 37.81 9.98 136 292556 15687 79436009
Bone density decreased 37.61 9.98 3 292689 13344 79438352
Hypercholesterolaemia 37.36 9.98 19 292673 23076 79428620
Abdominal distension 37.29 9.98 632 292060 119018 79332678
Epistaxis 36.96 9.98 595 292097 110920 79340776
Hypoglycaemia 36.85 9.98 220 292472 101374 79350322
Disease recurrence 36.69 9.98 66 292626 44043 79407653
Rash maculo-papular 36.51 9.98 340 292352 55738 79395958
Ill-defined disorder 36.36 9.98 122 292570 65753 79385943
Enteritis 36.27 9.98 127 292565 14456 79437240
Tumour lysis syndrome 36.25 9.98 179 292513 23760 79427936
Pneumonitis 36.18 9.98 362 292330 60498 79391198
Foot deformity 35.78 9.98 22 292670 24052 79427644
Sleep disorder due to a general medical condition 35.66 9.98 5 292687 14272 79437424
Sinus tachycardia 35.66 9.98 245 292447 36663 79415033
Dilatation intrahepatic duct acquired 35.51 9.98 26 292666 712 79450984
Hypophosphataemia 35.38 9.98 156 292536 19757 79431939
Hypervolaemia 35.29 9.98 273 292419 42417 79409279
Treatment noncompliance 35.28 9.98 88 292604 52180 79399516
Premature delivery 35.20 9.98 175 292517 23292 79428404
Stridor 35.19 9.98 68 292624 5385 79446311
Hallucination, auditory 35.04 9.98 16 292676 20677 79431019
Intestinal obstruction 34.94 9.98 274 292418 42746 79408950
Paranoia 34.53 9.98 14 292678 19418 79432278
Long QT syndrome congenital 34.47 9.98 15 292677 142 79451554
Melaena 34.13 9.98 112 292580 60778 79390918
Musculoskeletal pain 33.86 9.98 228 292464 102126 79349570
Dysentery 33.85 9.98 31 292661 1171 79450525
Bone pain 33.83 9.98 333 292359 55409 79396287
Accidental exposure to product 33.81 9.98 39 292653 31283 79420413
Injection site bruising 33.53 9.98 62 292630 40940 79410756
Immune-mediated hepatitis 33.22 9.98 53 292639 3603 79448093
Blood magnesium decreased 32.94 9.98 134 292558 16378 79435318
Injection site pruritus 32.78 9.98 66 292626 42217 79409479
Poisoning deliberate 32.76 9.98 14 292678 18814 79432882
Hyperkalaemia 32.50 9.98 266 292426 114132 79337564
Psoriasis 32.49 9.98 194 292498 89393 79362303
Tendonitis 32.44 9.98 24 292668 23806 79427890
Glaucoma 32.35 9.98 16 292676 19745 79431951
Electrocardiogram QRS complex 32.28 9.98 7 292685 0 79451696
Lymphoid tissue hypoplasia 32.25 9.98 27 292665 903 79450793
Sense of oppression 32.19 9.98 34 292658 1532 79450164
Electrocardiogram QT shortened 32.12 9.98 16 292676 211 79451485
Drug eruption 32.03 9.98 71 292621 43864 79407832
Cardiac failure congestive 31.97 9.98 351 292341 142051 79309645
Immune effector cell-associated neurotoxicity syndrome 31.88 9.98 68 292624 5780 79445916
Disseminated aspergillosis 31.81 9.98 29 292663 1089 79450607
Septic shock 31.74 9.98 630 292062 122171 79329525
Embolism 31.58 9.98 118 292574 13864 79437832
International normalised ratio increased 31.50 9.98 182 292510 84539 79367157
Negative pressure pulmonary oedema 31.40 9.98 16 292676 222 79451474
Thymus hypoplasia 31.19 9.98 27 292665 946 79450750
Acute respiratory failure 31.09 9.98 345 292347 59196 79392500
Gait disturbance 31.05 9.98 555 292137 206951 79244745
Laryngeal discomfort 30.84 9.98 22 292670 578 79451118
Enterocolitis 30.74 9.98 120 292572 14392 79437304
Hepatocellular injury 30.70 9.98 288 292404 47305 79404391
Oral candidiasis 30.62 9.98 200 292492 29428 79422268
Neutrophil count abnormal 30.52 9.98 50 292642 3476 79448220
Chest discomfort 30.44 9.98 692 292000 137352 79314344
SARS-CoV-2 test negative 30.40 9.98 31 292661 1340 79450356
Altered state of consciousness 30.19 9.98 73 292619 43749 79407947
Deep vein thrombosis 30.14 9.98 617 292075 120302 79331394
Psychotic disorder 30.11 9.98 67 292625 41335 79410361
Dementia 29.66 9.98 28 292664 24631 79427065
Fracture 29.62 9.98 22 292670 21779 79429917
Ventilation perfusion mismatch 29.56 9.98 22 292670 618 79451078
Vascular device infection 29.56 9.98 94 292598 10182 79441514
Anaesthetic complication neurological 29.44 9.98 22 292670 622 79451074
Cytomegalovirus infection 29.41 9.98 71 292621 42573 79409123
Panniculitis 29.38 9.98 5 292687 12366 79439330
Blood potassium decreased 29.28 9.98 280 292412 46232 79405464
Apnoea 29.17 9.98 102 292590 11602 79440094
Hot flush 29.12 9.98 319 292373 54558 79397138
Product used for unknown indication 29.06 9.98 32 292660 1512 79450184
Cognitive disorder 28.88 9.98 145 292547 69781 79381915
Injection site haemorrhage 28.71 9.98 36 292656 27834 79423862
Myocardial reperfusion injury 28.69 9.98 12 292680 102 79451594
Pulse absent 28.68 9.98 92 292600 10011 79441685
Drug interaction 28.60 9.98 1239 291453 413944 79037752
Therapy interrupted 28.49 9.98 205 292487 31136 79420560
Weight fluctuation 28.45 9.98 101 292591 11574 79440122
Left atrial hypertrophy 28.38 9.98 10 292682 50 79451646
Streptococcal bacteraemia 28.38 9.98 49 292643 3557 79448139
Acute myocardial infarction 28.37 9.98 166 292526 76870 79374826
Arteriosclerosis coronary artery 28.31 9.98 15 292677 17801 79433895
Product substitution issue 28.09 9.98 20 292672 20236 79431460
Glycosylated haemoglobin increased 28.07 9.98 18 292674 19242 79432454
Lupus-like syndrome 28.07 9.98 8 292684 13849 79437847
Tenosynovitis 27.98 9.98 11 292681 15543 79436153
Substance abuse 27.97 9.98 3 292689 10523 79441173
Transmission of an infectious agent via product 27.94 9.98 14 292678 187 79451509
Opisthotonus 27.93 9.98 22 292670 674 79451022
Dysphagia 27.79 9.98 615 292077 121521 79330175
Respiratory distress 27.76 9.98 332 292360 58007 79393689
Cardiogenic shock 27.72 9.98 255 292437 41659 79410037
Anal inflammation 27.55 9.98 30 292662 1400 79450296
Cardiac failure 27.53 9.98 401 292291 154441 79297255
Large intestinal obstruction 27.51 9.98 46 292646 3253 79448443
Skin ulcer 27.41 9.98 104 292588 54046 79397650
Paraesthesia 27.09 9.98 843 291849 175480 79276216
Burkholderia cepacia complex infection 27.06 9.98 16 292676 302 79451394
Suicidal ideation 26.80 9.98 167 292525 76173 79375523
Oxygen saturation immeasurable 26.76 9.98 9 292683 38 79451658
Blood pressure measurement 26.54 9.98 18 292674 435 79451261
Ileus 26.52 9.98 176 292516 26035 79425661
Aphasia 26.36 9.98 275 292417 46457 79405239
Cestode infection 26.34 9.98 15 292677 263 79451433
Hyperthermia 26.00 9.98 133 292559 17904 79433792
Malnutrition 25.81 9.98 156 292536 22346 79429350
Myalgia 25.76 9.98 503 292189 185138 79266558
Pemphigoid 25.69 9.98 12 292680 15303 79436393
Coronary artery occlusion 25.69 9.98 12 292680 15303 79436393
Arteriospasm coronary 25.65 9.98 68 292624 6648 79445048
Sciatica 25.63 9.98 52 292640 33170 79418526
Breast cancer stage III 25.61 9.98 3 292689 9823 79441873
Erectile dysfunction 25.36 9.98 11 292681 14653 79437043
Joint stiffness 25.09 9.98 72 292620 40758 79410938
Dyslipidaemia 24.93 9.98 6 292686 11627 79440069
Toxic erythema of chemotherapy 24.81 9.98 14 292678 241 79451455
Abortion spontaneous 24.68 9.98 44 292648 29463 79422233
Venoocclusive liver disease 24.66 9.98 97 292595 11674 79440022
Red blood cell count decreased 24.66 9.98 321 292371 57192 79394504
Drug clearance decreased 24.61 9.98 44 292648 3283 79448413
Extravasation 24.49 9.98 47 292645 3703 79447993
Device related infection 24.41 9.98 212 292480 34082 79417614
Peripheral venous disease 24.40 9.98 14 292678 15895 79435801
Respiratory syncytial virus infection 24.36 9.98 83 292609 9319 79442377
Exostosis 24.24 9.98 16 292676 16842 79434854
Joint injury 24.21 9.98 49 292643 31286 79420410
Seizure like phenomena 24.17 9.98 32 292660 1835 79449861
Haematoma 24.06 9.98 104 292588 52091 79399605
Anaphylactoid reaction 23.95 9.98 58 292634 5364 79446332
Delirium 23.93 9.98 197 292495 84430 79367266
Hospitalisation 23.86 9.98 482 292210 93754 79357942
Grip strength decreased 23.86 9.98 27 292665 21842 79429854
Bladder cancer 23.69 9.98 22 292670 19504 79432192
Nasal congestion 23.61 9.98 174 292518 76378 79375318
Amputation stump pain 23.56 9.98 8 292684 35 79451661
Body temperature decreased 23.39 9.98 52 292640 32093 79419603
Vascular access site thrombosis 23.38 9.98 8 292684 36 79451660
Diabetes mellitus inadequate control 23.30 9.98 33 292659 24231 79427465
Electrocardiogram T wave biphasic 23.14 9.98 12 292680 173 79451523
Joint dislocation 23.13 9.98 17 292675 16922 79434774
Herpes zoster 23.11 9.98 224 292468 92859 79358837
Proctalgia 23.08 9.98 85 292607 9916 79441780
Sleep disorder 23.08 9.98 202 292490 85475 79366221
Capillary leak syndrome 22.99 9.98 47 292645 3878 79447818
Bursitis 22.92 9.98 62 292630 35782 79415914
Skin candida 22.86 9.98 33 292659 2054 79449642
Hyperaemia 22.84 9.98 41 292651 3069 79448627
Pharyngeal paraesthesia 22.77 9.98 38 292654 2683 79449013
Gastrointestinal haemorrhage 22.76 9.98 393 292299 147326 79304370
Cervix neoplasm 22.67 9.98 12 292680 181 79451515
Infection 22.57 9.98 695 291997 241017 79210679
Carpal tunnel syndrome 22.54 9.98 23 292669 19505 79432191
Oedema peripheral 22.21 9.98 731 291961 251557 79200139
Feeding intolerance 21.95 9.98 21 292671 839 79450857
Oropharyngeal discomfort 21.95 9.98 67 292625 7099 79444597
Blood pressure diastolic decreased 21.89 9.98 49 292643 30167 79421529
Blood bilirubin increased 21.79 9.98 353 292339 65879 79385817
Stress cardiomyopathy 21.79 9.98 90 292602 11076 79440620
Gait inability 21.67 9.98 127 292565 58790 79392906
Tubulointerstitial nephritis 21.66 9.98 70 292622 38165 79413531
Malignant catatonia 21.52 9.98 16 292676 449 79451247
Bone disorder 21.51 9.98 23 292669 19090 79432606
Administration site oedema 21.31 9.98 7 292685 27 79451669
Depression 21.31 9.98 619 292073 216171 79235525
Creatinine renal clearance decreased 21.23 9.98 23 292669 18979 79432717
Throat tightness 21.17 9.98 175 292517 27732 79423964
Post procedural hypotension 21.17 9.98 9 292683 80 79451616
Urinary tract infection 21.05 9.98 1220 291472 273292 79178404
Neuralgia 21.02 9.98 201 292491 33183 79418513
Injury 20.75 9.98 183 292509 77313 79374383
Escherichia bacteraemia 20.71 9.98 62 292630 6500 79445196
Tryptase increased 20.69 9.98 18 292674 635 79451061
Orthostatic hypotension 20.69 9.98 121 292571 56043 79395653
Toxic encephalopathy 20.61 9.98 90 292602 11350 79440346
Neutropenic infection 20.45 9.98 34 292658 2393 79449303
Testicular germ cell cancer metastatic 20.34 9.98 8 292684 57 79451639
Nephrolithiasis 20.22 9.98 291 292401 53000 79398696
Palmar erythema 20.19 9.98 30 292662 1917 79449779
Transplant rejection 20.13 9.98 25 292667 19412 79432284
Road traffic accident 20.12 9.98 87 292605 43577 79408119
Oedema 20.11 9.98 313 292379 119267 79332429
Infective pulmonary exacerbation of cystic fibrosis 20.11 9.98 97 292595 12754 79438942
Pathogen resistance 20.10 9.98 14 292678 14328 79437368
Incorrect dose administered 20.06 9.98 182 292510 76448 79375248
Alopecia areata 19.98 9.98 29 292663 1814 79449882
Foetal death 19.96 9.98 70 292622 7974 79443722
Joint effusion 19.91 9.98 22 292670 17992 79433704
Cerebral microhaemorrhage 19.86 9.98 12 292680 236 79451460
Supraventricular tachycardia 19.84 9.98 140 292552 21130 79430566
Procedural vomiting 19.60 9.98 19 292673 772 79450924
Adverse event 19.48 9.98 135 292557 60079 79391617
Fluid replacement 19.48 9.98 16 292676 521 79451175
Madarosis 19.39 9.98 36 292656 2766 79448930
Magnesium deficiency 19.37 9.98 17 292675 607 79451089
Hyperlipidaemia 19.16 9.98 42 292650 26051 79425645
Coronary artery stenosis 19.13 9.98 11 292681 12473 79439223
Lung disorder 19.11 9.98 196 292496 80361 79371335
Granulocytopenia 19.10 9.98 9 292683 11422 79440274
Exposure to toxic agent 19.09 9.98 5 292687 9153 79442543
Femur fracture 19.07 9.98 75 292617 38577 79413119
Bronchiectasis 19.07 9.98 33 292659 22353 79429343
Ulcer 19.05 9.98 52 292640 29920 79421776
Glioblastoma multiforme 18.99 9.98 23 292669 1205 79450491
Immune reconstitution inflammatory syndrome 18.76 9.98 14 292678 13827 79437869
Myopathy 18.74 9.98 29 292663 20534 79431162
Macular degeneration 18.72 9.98 9 292683 11287 79440409
Peripheral sensory neuropathy 18.71 9.98 96 292596 12937 79438759
Insomnia 18.70 9.98 723 291969 244447 79207249
Periorbital cellulitis 18.69 9.98 20 292672 915 79450781
Vein discolouration 18.21 9.98 13 292679 342 79451354
Hyperbilirubinaemia 18.20 9.98 153 292539 24365 79427331
Rotator cuff syndrome 18.17 9.98 15 292677 14080 79437616
Pseudomonal bacteraemia 18.16 9.98 37 292655 3045 79448651
Haemorrhoids 18.16 9.98 175 292517 28953 79422743
Chemotherapeutic drug level increased 18.14 9.98 13 292679 344 79451352
Uveitis 18.12 9.98 21 292671 16809 79434887
Cancer pain 17.94 9.98 51 292641 5194 79446502
Cardiac murmur 17.85 9.98 19 292673 15805 79435891
Vascular access site infection 17.85 9.98 9 292683 122 79451574
Tracheal deviation 17.78 9.98 10 292682 171 79451525
Cytopenia 17.77 9.98 132 292560 20251 79431445
Metastases to meninges 17.51 9.98 40 292652 3561 79448135
Drug ineffective for unapproved indication 17.51 9.98 113 292579 51125 79400571
Pregnancy 17.51 9.98 46 292646 26805 79424891
Chest pain 17.51 9.98 1232 291460 281072 79170624
Metastases to peritoneum 17.45 9.98 45 292647 4327 79447369
Abdominal pain lower 17.44 9.98 186 292506 31596 79420100
Tachypnoea 17.29 9.98 187 292505 31876 79419820
Haemorrhage 17.25 9.98 233 292459 90885 79360811
Thrombosis 17.13 9.98 417 292275 83683 79368013
Respiratory failure 17.08 9.98 820 291872 180091 79271605
Inappropriate schedule of product administration 17.06 9.98 367 292325 133261 79318435
Plantar erythema 17.06 9.98 12 292680 308 79451388
Blood triglycerides increased 17.04 9.98 32 292660 21008 79430688
Blood glucose increased 17.03 9.98 308 292384 114667 79337029
Sedation 16.96 9.98 116 292576 51779 79399917
IIIrd nerve paresis 16.95 9.98 10 292682 188 79451508
Deformity 16.94 9.98 7 292685 9598 79442098
Nephrotic syndrome 16.90 9.98 10 292682 11164 79440532
Procedural nausea 16.79 9.98 18 292674 825 79450871
Premenstrual syndrome 16.73 9.98 15 292677 551 79451145
Osteomyelitis 16.71 9.98 63 292629 32802 79418894
Nail pigmentation 16.67 9.98 12 292680 320 79451376
Sleep apnoea syndrome 16.62 9.98 73 292619 36405 79415291
Lower limb fracture 16.53 9.98 38 292654 23177 79428519
Device adhesion issue 16.49 9.98 3 292689 7072 79444624
Injection site warmth 16.46 9.98 18 292674 14789 79436907
Therapeutic product effect prolonged 16.44 9.98 15 292677 564 79451132
Enterocolitis infectious 16.38 9.98 34 292658 2835 79448861
Hydronephrosis 16.35 9.98 115 292577 17339 79434357
Tremor 16.28 9.98 772 291920 169311 79282385
Drug reaction with eosinophilia and systemic symptoms 16.20 9.98 154 292538 64090 79387606
Hypergeusia 16.18 9.98 5 292687 15 79451681
Myoglobinuria 16.04 9.98 20 292672 1080 79450616
Skin necrosis 16.02 9.98 26 292666 18061 79433635
Visual acuity reduced 15.97 9.98 55 292637 29414 79422282
Posterior reversible encephalopathy syndrome 15.94 9.98 157 292535 26124 79425572
Underdose 15.93 9.98 65 292627 33086 79418610
Atrial fibrillation 15.84 9.98 883 291809 197003 79254693
Colitis microscopic 15.78 9.98 10 292682 10758 79440938
Eosinophil count increased 15.71 9.98 24 292668 17081 79434615
Electrolyte imbalance 15.69 9.98 178 292514 30703 79420993
Sensitivity to weather change 15.66 9.98 5 292687 8042 79443654
Lip pruritus 15.63 9.98 18 292674 894 79450802
Infusion site streaking 15.62 9.98 14 292678 514 79451182
Seizure 15.59 9.98 845 291847 187989 79263707
Gastric cancer 15.55 9.98 9 292683 10170 79441526
Congenital anomaly in offspring 15.41 9.98 7 292685 74 79451622
Angina unstable 15.36 9.98 23 292669 16504 79435192
Gastroenteropancreatic neuroendocrine tumour disease 15.34 9.98 6 292686 42 79451654
Oesophageal carcinoma 15.30 9.98 11 292681 11073 79440623
Nasal polyps 15.27 9.98 4 292688 7323 79444373
Klebsiella bacteraemia 15.27 9.98 34 292658 2976 79448720
Perihepatic abscess 15.26 9.98 9 292683 169 79451527
Tumour pain 15.24 9.98 29 292663 2270 79449426
Myoclonus 15.23 9.98 162 292530 27498 79424198
Epilepsy 15.07 9.98 88 292604 40772 79410924
Muscle twitching 15.05 9.98 148 292544 24616 79427080
Uterine perforation 14.91 9.98 54 292638 6249 79445447
Skin cancer 14.90 9.98 20 292672 15020 79436676
Pulseless electrical activity 14.89 9.98 96 292596 14064 79437632
Lip dry 14.78 9.98 21 292671 15397 79436299
Uterine hypotonus 14.71 9.98 7 292685 83 79451613
Eye irritation 14.60 9.98 34 292658 20647 79431049
Fixed eruption 14.57 9.98 33 292659 2921 79448775
Eczema 14.47 9.98 89 292603 40729 79410967
Bacterial infection 14.44 9.98 177 292515 31103 79420593
Haemodialysis 14.39 9.98 28 292664 18140 79433556
Acute myeloid leukaemia 14.36 9.98 175 292517 30710 79420986
Hypothyroidism 14.34 9.98 123 292569 52269 79399427
Non-cardiac chest pain 14.27 9.98 71 292621 9453 79442243
Polymenorrhoea 14.26 9.98 18 292674 984 79450712
Wound infection 14.24 9.98 43 292649 23948 79427748
Chronic obstructive pulmonary disease 14.22 9.98 224 292468 85195 79366501
Subchorionic haemorrhage 14.21 9.98 8 292684 137 79451559
Troponin increased 14.21 9.98 120 292572 19135 79432561
Haematochezia 14.20 9.98 231 292461 87414 79364282
Abdominal infection 14.12 9.98 37 292655 3592 79448104
Blood alkaline phosphatase increased 13.98 9.98 319 292373 63345 79388351
Suspected suicide 13.95 9.98 11 292681 10565 79441131
Adjustment disorder with depressed mood 13.93 9.98 8 292684 9078 79442618
Angina pectoris 13.92 9.98 122 292570 51610 79400086
Multiple fractures 13.91 9.98 6 292686 8020 79443676
Seminoma 13.85 9.98 9 292683 202 79451494
Head and neck cancer metastatic 13.83 9.98 3 292689 0 79451696
Foetal damage 13.83 9.98 3 292689 0 79451696
Thrombocytopenic purpura 13.80 9.98 29 292663 2440 79449256
Hair texture abnormal 13.72 9.98 36 292656 3498 79448198
Autoimmune disorder 13.69 9.98 25 292667 16587 79435109
Muscle spasms 13.66 9.98 778 291914 173952 79277744
Cholecystitis 13.62 9.98 133 292559 22079 79429617
Acute kidney injury 13.62 9.98 2138 290554 517266 78934430
Cellulitis 13.60 9.98 509 292183 108551 79343145
Onychalgia 13.39 9.98 17 292675 935 79450761
Electrocardiogram QRS complex prolonged 13.39 9.98 12 292680 10821 79440875
Shock haemorrhagic 13.36 9.98 34 292658 20026 79431670
Arterial occlusive disease 13.36 9.98 64 292628 8392 79443304
Respiratory rate increased 13.34 9.98 38 292654 21562 79430134
Tuberculosis 13.32 9.98 22 292670 15176 79436520
Lymphopenia 13.29 9.98 171 292521 30386 79421310
Eating disorder 13.22 9.98 125 292567 20572 79431124
Pharyngeal hypoaesthesia 13.19 9.98 11 292681 366 79451330
Rhinovirus infection 13.15 9.98 61 292631 7892 79443804
Sexual dysfunction 13.15 9.98 6 292686 7757 79443939
Disturbance in attention 13.14 9.98 121 292571 50680 79401016
Migraine 13.08 9.98 417 292275 87076 79364620
Klebsiella test positive 13.02 9.98 23 292669 1700 79449996
Intestinal infarction 13.02 9.98 20 292672 1316 79450380
Catatonia 13.01 9.98 8 292684 8748 79442948
Hyperreflexia 12.91 9.98 63 292629 8322 79443374
Antipsychotic drug level increased 12.91 9.98 3 292689 5954 79445742
Drug-induced liver injury 12.90 9.98 168 292524 65949 79385747
Anorectal disorder 12.89 9.98 27 292665 2266 79449430
Vocal cord paralysis 12.87 9.98 29 292663 2558 79449138
Parainfluenzae virus infection 12.87 9.98 48 292644 5634 79446062
Alopecia totalis 12.84 9.98 11 292681 380 79451316
Miosis 12.80 9.98 24 292668 15765 79435931
Postictal state 12.74 9.98 24 292668 1865 79449831
Electrocardiogram PR shortened 12.73 9.98 10 292682 305 79451391
Cyanosis 12.73 9.98 145 292547 25037 79426659
Hyperthermia malignant 12.66 9.98 31 292661 2886 79448810
Breast cancer stage II 12.66 9.98 7 292685 8113 79443583
Low density lipoprotein increased 12.65 9.98 8 292684 8614 79443082
Abdominal mass 12.65 9.98 35 292657 3510 79448186
Tracheal injury 12.62 9.98 6 292686 71 79451625
Intestinal perforation 12.54 9.98 108 292584 17318 79434378
Onychoclasis 12.53 9.98 47 292645 5531 79446165
Large intestine polyp 12.49 9.98 17 292675 12691 79439005
Moaning 12.48 9.98 18 292674 1119 79450577
Depressive symptom 12.48 9.98 4 292688 6419 79445277
Tongue disorder 12.46 9.98 20 292672 13955 79437741
Blood phosphorus decreased 12.43 9.98 53 292639 6615 79445081
Left ventricular dysfunction 12.40 9.98 117 292575 19244 79432452
Product prescribing error 12.36 9.98 105 292587 44708 79406988
Ventricular hypertrophy 12.33 9.98 5 292687 6933 79444763
Medical device site fistula 12.33 9.98 5 292687 39 79451657
Drug level increased 12.29 9.98 90 292602 39561 79412135
Mucormycosis 12.23 9.98 8 292684 8461 79443235
Gangrene 12.16 9.98 65 292627 8899 79442797
Aortic arteriosclerosis 12.11 9.98 9 292683 8909 79442787
Muscle haemorrhage 12.11 9.98 4 292688 6296 79445400
Breast cancer metastatic 12.10 9.98 63 292629 8539 79443157
Nail infection 12.06 9.98 27 292665 2372 79449324
Phrenic nerve paralysis 12.03 9.98 10 292682 331 79451365
Lymphocyte count decreased 12.01 9.98 242 292450 47047 79404649
Postural orthostatic tachycardia syndrome 12.00 9.98 16 292676 924 79450772
Irritability 11.99 9.98 95 292597 41049 79410647
Cardiac pacemaker evaluation 11.94 9.98 7 292685 130 79451566
Metabolic acidosis 11.93 9.98 222 292470 82307 79369389
Generalised tonic-clonic seizure 11.92 9.98 227 292465 43683 79408013
Erythropenia 11.91 9.98 11 292681 420 79451276
Electrocardiogram T wave inversion 11.85 9.98 45 292647 5327 79446369
Gastroenteritis radiation 11.83 9.98 14 292678 716 79450980
Cerebrovascular accident 11.82 9.98 458 292234 154834 79296862
Food intolerance 11.81 9.98 36 292656 3812 79447884
Alveolitis 11.81 9.98 38 292654 4142 79447554
Carbon dioxide decreased 11.77 9.98 34 292658 3494 79448202
Sialoadenitis 11.76 9.98 24 292668 1977 79449719
Hyperemesis gravidarum 11.76 9.98 11 292681 427 79451269
Lipase decreased 11.70 9.98 8 292684 196 79451500
Gastroenteritis viral 11.67 9.98 141 292551 24690 79427006
Device malfunction 11.64 9.98 40 292652 21408 79430288
Coating in mouth 11.61 9.98 9 292683 269 79451427
Intraocular pressure increased 11.61 9.98 10 292682 9195 79442501
Tardive dyskinesia 11.59 9.98 13 292679 10558 79441138
Therapy cessation 11.55 9.98 198 292494 37364 79414332
Unintentional medical device removal 11.53 9.98 7 292685 7705 79443991
Small cell lung cancer extensive stage 11.52 9.98 4 292688 19 79451677
Anger 11.50 9.98 29 292663 17133 79434563
Sinus node dysfunction 11.50 9.98 7 292685 7694 79444002
Chronic hepatitis B 11.49 9.98 11 292681 440 79451256
Cerebral haemorrhage 11.45 9.98 146 292546 57527 79394169
Drug use disorder 11.41 9.98 9 292683 8642 79443054
Large intestine perforation 11.40 9.98 92 292600 14475 79437221
Stomatitis 11.38 9.98 653 292039 146104 79305592
Subileus 11.37 9.98 46 292646 5608 79446088
Lipase increased 11.31 9.98 101 292591 16365 79435331
Arteriosclerosis 11.30 9.98 32 292660 18195 79433501
Lichen sclerosus 11.30 9.98 16 292676 978 79450718
Poor quality sleep 11.27 9.98 44 292648 22678 79429018
Painful respiration 11.26 9.98 33 292659 3420 79448276
Arterial angioplasty 11.25 9.98 5 292687 50 79451646
Cerebellar stroke 11.25 9.98 12 292680 547 79451149
Necrotising retinitis 11.25 9.98 18 292674 1227 79450469
Drug abuser 11.24 9.98 4 292688 6009 79445687
Muscle rigidity 11.21 9.98 117 292575 19765 79431931
Vaginal cellulitis 11.19 9.98 6 292686 93 79451603
Device difficult to use 11.16 9.98 20 292672 13365 79438331
Catheter site infection 11.15 9.98 52 292640 6743 79444953
Shock 11.15 9.98 104 292588 43444 79408252
Monoclonal immunoglobulin increased 11.10 9.98 7 292685 149 79451547
Cardiotoxicity 11.09 9.98 80 292612 12159 79439537
Weight decreased 11.09 9.98 1477 291215 353721 79097975
Periorbital disorder 11.08 9.98 5 292687 52 79451644
Dysphemia 11.07 9.98 33 292659 3451 79448245
Anaphylactoid shock 11.07 9.98 14 292678 767 79450929
Hypomania 11.06 9.98 7 292685 7537 79444159
Influenza B virus test positive 11.05 9.98 10 292682 372 79451324
Formication 11.02 9.98 42 292650 4981 79446715
Systemic inflammatory response syndrome 11.01 9.98 76 292616 11389 79440307
Cataract 10.99 9.98 161 292531 61959 79389737
Laryngeal dyspnoea 10.98 9.98 9 292683 292 79451404
Benign prostatic hyperplasia 10.95 9.98 16 292676 11596 79440100
Enterocutaneous fistula 10.92 9.98 23 292669 1938 79449758
Incarcerated umbilical hernia 10.91 9.98 5 292687 54 79451642
Large intestine anastomosis 10.91 9.98 6 292686 98 79451598
Enterovirus test positive 10.88 9.98 9 292683 296 79451400
High density lipoprotein abnormal 10.82 9.98 7 292685 156 79451540
Progressive multifocal leukoencephalopathy 10.79 9.98 39 292653 20561 79431135
Red cell distribution width abnormal 10.74 9.98 8 292684 225 79451471
Alopecia 10.73 9.98 718 291974 230637 79221059
Cytotoxic oedema 10.72 9.98 10 292682 387 79451309
Wrist fracture 10.68 9.98 17 292675 11904 79439792
Medical device pain 10.68 9.98 19 292673 1412 79450284
Psychomotor skills impaired 10.65 9.98 3 292689 5234 79446462
Choking sensation 10.58 9.98 35 292657 3871 79447825
Catheter site swelling 10.57 9.98 22 292670 1838 79449858
Antithrombin III decreased 10.53 9.98 11 292681 489 79451207
Inability to afford medication 10.51 9.98 28 292664 2745 79448951
Food aversion 10.48 9.98 16 292676 1047 79450649
Neutrophil percentage abnormal 10.48 9.98 4 292688 26 79451670
Therapeutic response shortened 10.48 9.98 27 292665 15836 79435860
Dental caries 10.46 9.98 17 292675 11803 79439893
Central nervous system stimulation 10.45 9.98 5 292687 60 79451636
Injection site discomfort 10.43 9.98 3 292689 5163 79446533
Procedural dizziness 10.40 9.98 6 292686 108 79451588
Chronic graft versus host disease 10.35 9.98 6 292686 6775 79444921
Drug dose omission by device 10.32 9.98 5 292687 6245 79445451
Feeding disorder 10.30 9.98 98 292594 16156 79435540
Apathy 10.28 9.98 20 292672 12957 79438739
Nocardiosis 10.24 9.98 4 292688 5675 79446021
Asphyxia 10.24 9.98 17 292675 11703 79439993
Respiratory arrest 10.24 9.98 149 292543 57401 79394295
Euphoric mood 10.23 9.98 8 292684 7718 79443978
Chest injury 10.21 9.98 28 292664 2793 79448903
Abnormal behaviour 10.20 9.98 85 292607 36336 79415360
Colorectal cancer 10.19 9.98 10 292682 8637 79443059
IIIrd nerve disorder 10.16 9.98 6 292686 113 79451583
Psychomotor hyperactivity 10.14 9.98 30 292662 16819 79434877
Electrocardiogram ST segment elevation 10.13 9.98 59 292633 8338 79443358
Blood pressure inadequately controlled 10.11 9.98 5 292687 6172 79445524
Cardiac disorder 10.10 9.98 175 292517 65582 79386114
Adverse drug reaction 10.10 9.98 177 292515 66215 79385481
Transposition of the great vessels 10.10 9.98 5 292687 65 79451631

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
Human herpesvirus 6 infection 47.75 35.52 15 340 45 89392
Cardiac failure 45.06 35.52 15 340 57 89380
Congestive cardiomyopathy 41.28 35.52 14 341 57 89380
Multiple organ dysfunction syndrome 36.76 35.52 15 340 112 89325

Pharmacologic Action:

SourceCodeDescription
ATC A04AA01 ALIMENTARY TRACT AND METABOLISM
ANTIEMETICS AND ANTINAUSEANTS
ANTIEMETICS AND ANTINAUSEANTS
Serotonin (5HT3) antagonists
FDA MoA N0000175817 Serotonin 3 Receptor Antagonists
FDA EPC N0000175818 Serotonin-3 Receptor Antagonist
MeSH PA D000932 Antiemetics
MeSH PA D000982 Antipruritics
MeSH PA D002491 Central Nervous System Agents
MeSH PA D003879 Dermatologic Agents
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D058831 Serotonin 5-HT3 Receptor Antagonists
MeSH PA D018490 Serotonin Agents
MeSH PA D012702 Serotonin Antagonists

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

DiseaseRelationSNOMED_IDDOID
Chemotherapy-induced nausea and vomiting indication 236084000
Prevention of Radiation-Induced Nausea and Vomiting indication
Prevention of Post-Operative Nausea and Vomiting indication
Excessive vomiting in pregnancy off-label use 14094001
Torsades de pointes contraindication 31722008
Hepatic failure contraindication 59927004
Extrapyramidal disease contraindication 76349003
Prolonged QT interval contraindication 111975006
Seizure disorder contraindication 128613002
Congenital long QT syndrome contraindication 442917000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.13 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
5-hydroxytryptamine receptor 3A Ion channel ANTAGONIST Ki 7.80 WOMBAT-PK CHEMBL
5-hydroxytryptamine receptor 2B GPCR Ki 6.34 DRUG MATRIX
Aldehyde oxidase Enzyme IC50 5.68 WOMBAT-PK
Solute carrier family 22 member 1 Transporter IC50 4.69 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 5.77 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 7.52 CHEMBL
Multidrug and toxin extrusion protein 2 Transporter IC50 6.80 CHEMBL
Solute carrier family 22 member 3 Transporter IC50 4.76 CHEMBL
Neuronal acetylcholine receptor; alpha4/beta2 Ion channel Ki 4.34 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 6.09 WOMBAT-PK
5-hydroxytryptamine receptor 3B Ion channel Ki 8.30 CHEMBL
5-hydroxytryptamine receptor 1B GPCR Ki 5.43 CHEMBL
Mu-type opioid receptor GPCR Ki 5.54 CHEMBL
Muscarinic acetylcholine receptor M1 GPCR Ki 5 CHEMBL
Gastrin/cholecystokinin type B receptor GPCR Ki 6.17 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 6.17 CHEMBL
Neuronal acetylcholine receptor subunit alpha-7 Ion channel IC50 4.60 CHEMBL
5-hydroxytryptamine receptor 2C GPCR Ki 5.30 CHEMBL
5-hydroxytryptamine receptor 4 GPCR Ki 5.92 CHEMBL
5-hydroxytryptamine receptor 3A Ion channel Ki 9.11 CHEMBL
5-hydroxytryptamine receptor 1D GPCR Ki 4.70 CHEMBL
5-hydroxytryptamine receptor 3A Ion channel Kd 7.11 CHEMBL
Serotonin 3 (5-HT3) receptor Ion channel Ki 9.11 CHEMBL
Serotonin 2 (5-HT2) receptor GPCR Ki 5 CHEMBL
Serotonin 3 receptor (5HT3) Ion channel Ki 7.92 CHEMBL

External reference:

IDSource
4019865 VUID
N0000147951 NUI
D00456 KEGG_DRUG
103639-04-9 SECONDARY_CAS_RN
4019563 VANDF
4019865 VANDF
C0061851 UMLSCUI
CHEBI:7773 CHEBI
S87 PDB_CHEM_ID
CHEMBL46 ChEMBL_ID
CHEMBL399705 ChEMBL_ID
CHEMBL428411 ChEMBL_ID
CHEMBL3186492 ChEMBL_ID
CHEMBL1201111 ChEMBL_ID
DB00904 DRUGBANK_ID
D017294 MESH_DESCRIPTOR_UI
4595 PUBCHEM_CID
2290 IUPHAR_LIGAND_ID
5965 INN_ID
4AF302ESOS UNII
203148 RXNORM
27290 MMSL
39615 MMSL
5202 MMSL
90631 MMSL
d00867 MMSL
003568 NDDF
004807 NDDF
108418007 SNOMEDCT_US
108419004 SNOMEDCT_US
372487007 SNOMEDCT_US
830157000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ondansetron Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-0064 SOLUTION 4 mg ORAL ANDA 27 sections
ZOFRAN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0675 TABLET, FILM COATED 4 mg ORAL NDA 31 sections
ZOFRAN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0676 TABLET, FILM COATED 8 mg ORAL NDA 31 sections
Ondansetron Hydrochloride and Dextrose HUMAN PRESCRIPTION DRUG LABEL 1 0143-9771 INJECTION, SOLUTION 32 mg INTRAVENOUS ANDA 24 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0143-9890 INJECTION 2 mg INTRAMUSCULAR ANDA 26 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0143-9891 INJECTION 2 mg INTRAMUSCULAR ANDA 26 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0378-0315 TABLET, FILM COATED 4 mg ORAL ANDA 28 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0378-0344 TABLET, FILM COATED 8 mg ORAL ANDA 28 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0378-0374 TABLET, FILM COATED 24 mg ORAL ANDA 28 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0378-7732 TABLET, ORALLY DISINTEGRATING 4 mg ORAL ANDA 28 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0378-7734 TABLET, ORALLY DISINTEGRATING 8 mg ORAL ANDA 28 sections
ONDANSETRON HUMAN PRESCRIPTION DRUG LABEL 1 0404-9930 INJECTION 2 mg INTRAVENOUS ANDA 19 sections
ONDANSETRON HUMAN PRESCRIPTION DRUG LABEL 1 0404-9930 INJECTION 2 mg INTRAVENOUS ANDA 19 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0409-4755 INJECTION, SOLUTION 2 mg INTRAMUSCULAR ANDA 32 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0409-4759 INJECTION, SOLUTION 2 mg INTRAMUSCULAR ANDA 32 sections
Ondansetron Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1726 INJECTION 2 mg INTRAMUSCULAR ANDA 27 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8185 TABLET, FILM COATED 4 mg ORAL ANDA 26 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8185 TABLET, FILM COATED 4 mg ORAL ANDA 26 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6078 INJECTION 2 mg INTRAMUSCULAR ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6078 INJECTION 2 mg INTRAMUSCULAR ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6079 INJECTION 2 mg INTRAMUSCULAR ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6079 INJECTION 2 mg INTRAMUSCULAR ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6080 INJECTION 2 mg INTRAMUSCULAR ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6080 INJECTION 2 mg INTRAMUSCULAR ANDA 27 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6551 TABLET, FILM COATED 4 mg ORAL ANDA 27 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6551 TABLET, FILM COATED 4 mg ORAL ANDA 27 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6552 TABLET, FILM COATED 8 mg ORAL ANDA 27 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6552 TABLET, FILM COATED 8 mg ORAL ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0904-7073 SOLUTION 4 mg ORAL ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0904-7073 SOLUTION 4 mg ORAL ANDA 27 sections