metoclopramide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
sulpiride derivatives and analogues 1782 364-62-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • metoclopramide
  • metoclopramide hydrochloride
  • metochlopramide
  • methochlopramide
  • metoclopramide hydrochloride hydrate
  • metoclopramide monohydrochloride
  • metoclopramide HCl
  • AHR-3070-C
  • metaclopramide
A dopamine D2 antagonist that is used as an antiemetic.
  • Molecular weight: 299.80
  • Formula: C14H22ClN3O2
  • CLOGP: 2.34
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 67.59
  • ALOGS: -2.99
  • ROTB: 7
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
30 mg O
30 mg P
30 mg R

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 33.36 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Hosey CM, Chan R, Benet LZ
S (Water solubility) 67 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 20 % Hosey CM, Chan R, Benet LZ
BA (Bioavailability) 76 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 3.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.60 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 7.20 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.284 Moderate 0.65
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.667 Moderate 0.65
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 13.521 10^-6 cm/s Moderate 0.65
dh-clint Dog hepatocyte intrinsic clearance 3.311 uL/min/10^6 cells Moderate 0.65
dppb Dog plasma protein binding (% unbound) 89.830 % Moderate 0.65
fcs-ppb Fetal calf serum protein binding (% unbound) 87.170 % Moderate 0.65
herg hERG pIC50 4.614 pIC50 Moderate 0.65
hh-clint Human hepatocyte intrinsic clearance 1.191 uL/min/10^6 cells Moderate 0.65
hlm-clint Human liver microsomal intrinsic clearance 3.516 uL/min/mg protein Moderate 0.65
hppb Human plasma protein binding (% unbound) 82.950 % Moderate 0.65
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 2.649 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.811 Moderate 0.65
mh-clint Mouse hepatocyte intrinsic clearance 37.154 Moderate 0.65
mppb Mouse plasma protein binding (% unbound) 88.680 Moderate 0.65
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 10.257 Moderate 0.65
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
pppb Pig plasma protein binding (% unbound) 89.810 % Moderate 0.65
rat-kpuu-brain Rat brain Kpuu 0.076 % High 1
rh-clint Rat hepatocyte intrinsic clearance 15.488 uL/min/10^6 cells Moderate 0.65
rh-fuinc Rat hepatocyte fraction unbound in incubation 90.640 % Moderate 0.65
rppb Rat plasma protein binding (% unbound) 85.680 % Moderate 0.65
solubility-dd Solubility at pH 7.4 in DMSO 916.220 uM Moderate 0.65

Approvals:

DateAgencyCompanyOrphan
Feb. 7, 1979 FDA BAXTER HLTHCARE CORP

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 834.65 10.19 1105 134745 157244 90335353
Joint swelling 462.12 10.19 96 135754 503204 89989393
Vomiting 437.86 10.19 2329 133521 785964 89706633
Synovitis 427.71 10.19 15 135835 329737 90162860
Hand deformity 417.52 10.19 5 135845 296357 90196240
Arthropathy 399.98 10.19 42 135808 366200 90126397
Nausea 380.93 10.19 2901 132949 1107415 89385182
Systemic lupus erythematosus 378.98 10.19 48 135802 361848 90130749
Drug ineffective 378.14 10.19 962 134888 1383336 89109261
Glossodynia 375.40 10.19 28 135822 321751 90170846
Rheumatoid arthritis 356.64 10.19 58 135792 362556 90130041
Contraindicated product administered 343.71 10.19 39 135811 320100 90172497
Hypokalaemia 340.49 10.19 663 135187 130453 90362144
Therapeutic product effect decreased 321.34 10.19 25 135825 277546 90215051
Pericarditis 302.67 10.19 28 135822 270123 90222474
Wound 298.90 10.19 48 135802 302932 90189665
Swelling 283.42 10.19 137 135713 418921 90073676
Duodenal ulcer perforation 276.97 10.19 13 135837 221275 90271322
Helicobacter infection 272.50 10.19 17 135833 226833 90265764
Abdominal discomfort 265.41 10.19 197 135653 477131 90015466
Psoriatic arthropathy 263.04 10.19 21 135829 228314 90264283
Constipation 241.15 10.19 944 134906 279451 90213146
Serotonin syndrome 239.83 10.19 290 135560 37597 90455000
Folliculitis 234.80 10.19 19 135831 204334 90288263
Rheumatoid factor positive 232.83 10.19 5 135845 171645 90320952
Dehydration 227.81 10.19 725 135125 193722 90298875
Abdominal pain 226.72 10.19 1181 134669 394540 90098057
Dystonia 225.15 10.19 193 135657 16626 90475971
Weight increased 223.97 10.19 179 135671 417748 90074849
Anaemia 220.40 10.19 1079 134771 351723 90140874
Impaired healing 218.12 10.19 43 135807 234156 90258441
Neutropenic sepsis 214.59 10.19 194 135656 17936 90474661
Discomfort 210.73 10.19 74 135776 274261 90218336
Neutropenia 209.62 10.19 777 135073 224127 90268470
Irritable bowel syndrome 208.77 10.19 31 135819 207417 90285180
Nasopharyngitis 208.73 10.19 182 135668 406922 90085675
Sinusitis 204.67 10.19 131 135719 342957 90149640
Hepatic enzyme increased 204.15 10.19 146 135704 360590 90132007
Mucosal inflammation 201.60 10.19 332 135518 57293 90435304
Acute kidney injury 201.59 10.19 982 134868 319405 90173192
Hyponatraemia 201.49 10.19 545 135305 132993 90359604
Arthralgia 197.92 10.19 559 135291 777963 89714634
Pyrexia 190.15 10.19 1661 134189 658824 89833773
Treatment failure 186.87 10.19 112 135738 303816 90188781
Extrapyramidal disorder 186.20 10.19 171 135679 16132 90476465
Musculoskeletal stiffness 182.70 10.19 109 135741 296423 90196174
Diarrhoea 174.11 10.19 2159 133691 937031 89555566
Peripheral swelling 172.16 10.19 220 135630 412886 90079711
Blood cholesterol increased 168.72 10.19 51 135799 207961 90284636
Drug intolerance 167.95 10.19 257 135593 447334 90045263
Type 2 diabetes mellitus 166.36 10.19 49 135801 203195 90289402
Hypomagnesaemia 165.44 10.19 234 135616 35354 90457243
Fibromyalgia 164.74 10.19 52 135798 206217 90286380
Swollen tongue 158.36 10.19 263 135587 45693 90446904
Thrombocytopenia 155.83 10.19 673 135177 208052 90284545
C-reactive protein abnormal 151.64 10.19 10 135840 127419 90365178
Joint range of motion decreased 144.27 10.19 17 135833 135626 90356971
Sepsis 142.13 10.19 590 135260 179224 90313373
Colitis 140.98 10.19 319 135531 69623 90422974
Torsade de pointes 140.80 10.19 142 135708 15040 90477557
Atelectasis 140.27 10.19 178 135672 24231 90468366
Product use issue 137.08 10.19 176 135674 329743 90162854
Alopecia 136.53 10.19 341 135509 494730 89997867
Tardive dyskinesia 135.37 10.19 120 135730 10810 90481787
Neuropathy peripheral 129.84 10.19 476 135374 136494 90356103
Electrocardiogram QT prolonged 128.12 10.19 314 135536 72142 90420455
Pain 128 10.19 922 134928 995419 89497178
Osteoarthritis 126.17 10.19 68 135782 195662 90296935
Facet joint syndrome 125.64 10.19 5 135845 98384 90394213
Bursitis 125.02 10.19 23 135827 131631 90360966
Grip strength decreased 124.34 10.19 3 135847 92573 90400024
Malignant neoplasm progression 123.70 10.19 397 135453 106473 90386124
Lip dry 122.89 10.19 7 135843 100948 90391649
Ill-defined disorder 122.48 10.19 62 135788 184829 90307768
Urticaria 121.66 10.19 175 135675 312559 90180038
Toxic epidermal necrolysis 121.37 10.19 193 135657 32335 90460262
Liver injury 117.86 10.19 54 135796 170513 90322084
Computerised tomogram thorax abnormal 117.42 10.19 59 135791 2028 90490569
Pulmonary embolism 116.81 10.19 446 135404 130374 90362223
Wheezing 116.47 10.19 111 135739 237969 90254628
Impaired gastric emptying 115.50 10.19 118 135732 12691 90479906
Neutrophil count decreased 114.99 10.19 299 135551 71233 90421364
Pancytopenia 114.03 10.19 418 135432 119845 90372752
Cytokine release syndrome 112.77 10.19 172 135678 27801 90464796
Mobility decreased 112.37 10.19 126 135724 250608 90241989
Peripheral venous disease 111.64 10.19 3 135847 83918 90408679
Sleep disorder 110.82 10.19 81 135769 197949 90294648
Contusion 110.68 10.19 128 135722 251088 90241509
Parkinsonism 106.34 10.19 118 135732 13947 90478650
Psoriasis 104.88 10.19 45 135805 147709 90344888
Infusion related reaction 104.33 10.19 301 135549 416479 90076118
Hypoxia 103.69 10.19 290 135560 72109 90420488
Sciatica 102.30 10.19 15 135835 101367 90391230
Ileus 102.01 10.19 125 135725 16421 90476176
Decreased appetite 101.86 10.19 935 134915 375605 90116992
Blister 101.84 10.19 140 135710 254858 90237739
Neovascularisation 100.38 10.19 49 135801 1581 90491016
Aplastic anaemia 99.77 10.19 111 135739 13158 90479439
Hypercholesterolaemia 97.15 10.19 17 135833 100875 90391722
Cardiac arrest 95.52 10.19 360 135490 104575 90388022
Inflammation 94.89 10.19 77 135773 178515 90314082
Rash maculo-papular 93.06 10.19 196 135654 40737 90451860
Drug ineffective for unapproved indication 92.55 10.19 264 135586 66380 90426217
Gastritis 91.54 10.19 197 135653 41556 90451041
Computerised tomogram thorax 91.08 10.19 33 135817 492 90492105
Injection site pain 90.91 10.19 76 135774 173623 90318974
Product dose omission issue 90.79 10.19 188 135662 291499 90201098
Hip arthroplasty 90.60 10.19 6 135844 76202 90416395
Road traffic accident 87.94 10.19 26 135824 107600 90384997
Knee arthroplasty 87.03 10.19 11 135839 83171 90409426
Hypotension 86.95 10.19 806 135044 324591 90168006
Intentional product use issue 86.67 10.19 119 135731 216773 90275824
Phaeochromocytoma crisis 86.07 10.19 29 135821 344 90492253
Electrolyte imbalance 86.00 10.19 139 135711 23606 90468991
Drug interaction 84.86 10.19 706 135144 275747 90216850
Arthritis 84.18 10.19 76 135774 167239 90325358
Red blood cell sedimentation rate increased 83.85 10.19 12 135838 82583 90410014
Septic shock 82.71 10.19 296 135554 83864 90408733
Cholecystitis chronic 80.50 10.19 86 135764 9740 90482857
Hypoaesthesia 80 10.19 225 135625 313985 90178612
Ejection fraction decreased 79.62 10.19 142 135708 26111 90466486
Adverse event 78.31 10.19 39 135811 117379 90375218
Lower limb fracture 78.28 10.19 16 135834 84997 90407600
Restlessness 77.70 10.19 168 135682 35552 90457045
Dysphonia 77.24 10.19 239 135611 62845 90429752
Pleural effusion 76.63 10.19 352 135498 111639 90380958
Autoimmune disorder 75.95 10.19 12 135838 76732 90415865
Pulmonary fibrosis 75.87 10.19 33 135817 107470 90385127
Condition aggravated 75.79 10.19 552 135298 594993 89897604
Peripheral circulatory failure 74.87 10.19 40 135810 1564 90491033
Adverse drug reaction 74.51 10.19 41 135809 116660 90375937
Prescribed overdose 73.76 10.19 27 135823 97598 90394999
Oculogyric crisis 73.46 10.19 46 135804 2433 90490164
Swelling face 73.12 10.19 278 135572 81074 90411523
Subileus 72.91 10.19 53 135797 3591 90489006
Night sweats 72.89 10.19 52 135798 128714 90363883
Angioedema 72.33 10.19 238 135612 64638 90427959
Adjustment disorder with depressed mood 72.06 10.19 3 135847 56750 90435847
Stevens-Johnson syndrome 71.88 10.19 145 135705 29231 90463366
Prescribed underdose 71.44 10.19 13 135837 75006 90417591
Tachycardia 71.20 10.19 442 135408 157231 90335366
Asthma 70.44 10.19 162 135688 241998 90250599
Rash 70.03 10.19 810 135040 795290 89697307
Gait inability 69.61 10.19 70 135780 146386 90346211
Lower respiratory tract infection 69.49 10.19 172 135678 250487 90242110
Transfusion 68.33 10.19 106 135744 17382 90475215
Mouth ulceration 67.24 10.19 170 135680 39804 90452793
Bone erosion 66.67 10.19 3 135847 53018 90439579
Dysphagia 65.39 10.19 337 135513 111941 90380656
Left ventricular dysfunction 64.57 10.19 94 135756 14575 90478022
Infection 64.52 10.19 301 135549 361793 90130804
Wound infection 64.22 10.19 40 135810 106362 90386235
Leukopenia 61.97 10.19 307 135543 100403 90392194
Emotional distress 61.75 10.19 156 135694 36506 90456091
Memory impairment 61.45 10.19 127 135723 197117 90295480
Blepharospasm 61.36 10.19 6 135844 55439 90437158
Therapeutic response decreased 61.05 10.19 29 135821 89700 90402897
Anuria 60.98 10.19 92 135758 14726 90477871
Injury 60.70 10.19 128 135722 197221 90295376
Haematemesis 60.49 10.19 147 135703 33579 90459018
Urinary retention 59.85 10.19 157 135693 37587 90455010
Pneumonitis 58.45 10.19 172 135678 43998 90448599
Injection site reaction 57.85 10.19 33 135817 92047 90400550
Ascites 57.64 10.19 180 135670 47560 90445037
Akathisia 57.30 10.19 77 135773 11082 90481515
Therapeutic product effect incomplete 55.35 10.19 131 135719 193765 90298832
Dyskinesia 53.94 10.19 148 135702 36386 90456211
Renal ischaemia 53.31 10.19 24 135826 642 90491955
Hepatocellular injury 52.78 10.19 127 135723 28831 90463766
Blood creatinine increased 52.71 10.19 295 135555 101091 90391506
Pancreatitis acute 52.38 10.19 135 135715 31980 90460617
Phaeochromocytoma 51.84 10.19 23 135827 594 90492003
Cholestasis 51.57 10.19 145 135705 36154 90456443
Exostosis 51.04 10.19 9 135841 53125 90439472
Hepatic failure 50.95 10.19 153 135697 39575 90453022
Malnutrition 50.75 10.19 96 135754 18462 90474135
Blood cholesterol decreased 50.21 10.19 33 135817 1898 90490699
Cholecystitis 50.18 10.19 91 135759 16949 90475648
Paradoxical drug reaction 49.96 10.19 52 135798 5714 90486883
Encephalopathy 49.65 10.19 168 135682 46276 90446321
Sleep disorder due to a general medical condition 49.10 10.19 5 135845 44733 90447864
Product quality issue 49.02 10.19 29 135821 79296 90413301
Agitation 48.96 10.19 215 135635 66883 90425714
Coeliac disease 48.92 10.19 5 135845 44605 90447992
Enterocolitis 48.78 10.19 69 135781 10421 90482176
Respiratory failure 47.95 10.19 323 135527 118095 90374502
Peritonitis 47.89 10.19 97 135753 19608 90472989
Hypocalcaemia 47.73 10.19 156 135694 42212 90450385
Foot deformity 47.66 10.19 15 135835 59636 90432961
Lupus-like syndrome 47.52 10.19 8 135842 48838 90443759
Diabetes insipidus 47.40 10.19 39 135811 3173 90489424
Disease progression 46.96 10.19 398 135452 156217 90336380
Clonus 46.53 10.19 50 135800 5700 90486897
Lung disorder 46.26 10.19 97 135753 149786 90342811
Dysuria 46.13 10.19 147 135703 39254 90453343
Respiratory dyskinesia 46.04 10.19 12 135838 52 90492545
Seizure 45.83 10.19 388 135462 152241 90340356
PCO2 increased 45.68 10.19 27 135823 1286 90491311
Ventricular fibrillation 45.22 10.19 78 135772 13966 90478631
Small intestinal obstruction 45.18 10.19 99 135751 21135 90471462
Hyperglycaemia 44.83 10.19 173 135677 50797 90441800
Premature delivery 44.82 10.19 144 135706 38618 90453979
Hypophosphataemia 44.60 10.19 80 135770 14774 90477823
Neuroglycopenia 44.30 10.19 25 135825 1090 90491507
Musculoskeletal pain 44.01 10.19 122 135728 171129 90321468
Intestinal obstruction 43.90 10.19 139 135711 36992 90455605
Gamma-glutamyltransferase increased 43.90 10.19 141 135709 37811 90454786
Gastric polyps 43.87 10.19 44 135806 4628 90487969
Ear infection 43.84 10.19 25 135825 69750 90422847
Hyperprolactinaemia 43.54 10.19 47 135803 5386 90487211
Gastroenteritis 42.74 10.19 118 135732 29111 90463486
Blood magnesium decreased 42.69 10.19 81 135769 15612 90476985
Paraesthesia oral 42.58 10.19 124 135726 31535 90461062
Blood bicarbonate decreased 42.16 10.19 36 135814 3083 90489514
Duodenal stenosis 42.01 10.19 20 135830 610 90491987
Bacteraemia 41.93 10.19 99 135751 22201 90470396
Long QT syndrome 41.60 10.19 40 135810 3997 90488600
Obesity 41.01 10.19 59 135791 105448 90387149
PO2 increased 40.95 10.19 22 135828 870 90491727
Febrile bone marrow aplasia 40.84 10.19 61 135789 9677 90482920
Multiple organ dysfunction syndrome 40.40 10.19 206 135644 68130 90424467
Hypoglycaemia 40.21 10.19 209 135641 69639 90422958
Deep vein thrombosis 40.19 10.19 255 135595 91365 90401232
Alanine aminotransferase increased 39.95 10.19 309 135541 118029 90374568
Hyperkalaemia 39.93 10.19 198 135652 64766 90427831
Oesophagitis 39.67 10.19 83 135767 17166 90475431
Excessive eye blinking 39.50 10.19 25 135825 1347 90491250
Device expulsion 39.11 10.19 7 135843 40879 90451718
Muscle rigidity 39.10 10.19 74 135776 14235 90478362
Platelet count decreased 38.92 10.19 344 135506 136625 90355972
Aspartate aminotransferase increased 38.85 10.19 276 135574 102661 90389936
Skin candida 38.70 10.19 27 135823 1714 90490883
Injection site bruising 38.61 10.19 15 135835 52292 90440305
Leukocytosis 38.48 10.19 118 135732 30872 90461725
Polydipsia 38.18 10.19 39 135811 4192 90488405
Blood alkaline phosphatase increased 38.12 10.19 158 135692 47921 90444676
Hypoalbuminaemia 37.15 10.19 77 135773 15820 90476777
Alveolitis 37.07 10.19 33 135817 2988 90489609
Urinary tract infection 37.06 10.19 654 135196 304978 90187619
Mixed liver injury 36.72 10.19 51 135799 7572 90485025
Hypophagia 36.67 10.19 128 135722 35809 90456788
Oedema 36.53 10.19 165 135685 200130 90292467
Joint stiffness 36.28 10.19 38 135812 78004 90414593
Hydronephrosis 36.22 10.19 66 135784 12336 90480261
Hepatic cytolysis 35.88 10.19 115 135735 30801 90461796
Chronic sinusitis 35.71 10.19 97 135753 23705 90468892
Dyspnoea 35.58 10.19 1637 134213 879318 89613279
Nervous system disorder 35.45 10.19 91 135759 21502 90471095
Vascular encephalopathy 35.38 10.19 19 135831 751 90491846
Antinuclear antibody negative 35.23 10.19 14 135836 272 90492325
Syncope 35.06 10.19 328 135522 132335 90360262
Hypersensitivity 34.85 10.19 476 135374 454201 90038396
Completed suicide 34.61 10.19 107 135743 144951 90347646
General physical health deterioration 34.61 10.19 735 135115 354380 90138217
Aplasia 34.60 10.19 36 135814 3955 90488642
Dementia 34.56 10.19 96 135754 23765 90468832
Premature baby 34.47 10.19 99 135751 24978 90467619
Immunodeficiency 34.31 10.19 11 135839 43223 90449374
Injection site swelling 34.07 10.19 24 135826 59815 90432782
No adverse event 34.03 10.19 31 135819 67951 90424646
Bradykinesia 33.58 10.19 46 135804 6742 90485855
Blood pH decreased 33.51 10.19 29 135821 2529 90490068
Accidental exposure to product 33.23 10.19 11 135839 42355 90450242
Anaphylactic reaction 33.22 10.19 235 135615 87289 90405308
Sinus tachycardia 33.03 10.19 106 135744 28407 90464190
Blood bilirubin increased 33.02 10.19 141 135709 43329 90449268
Joint dislocation 32.56 10.19 13 135837 44569 90448028
Therapy non-responder 32.50 10.19 101 135749 136603 90355994
Onychomycosis 32.46 10.19 8 135842 37368 90455229
Intestinal perforation 32.16 10.19 67 135783 13814 90478783
Drug dependence 32.16 10.19 107 135743 29220 90463377
Maternal exposure during delivery 32.10 10.19 34 135816 3812 90488785
Apallic syndrome 32.04 10.19 18 135832 778 90491819
Diabetes mellitus inadequate control 31.98 10.19 80 135770 18604 90473993
Injection site erythema 31.88 10.19 62 135788 98440 90394157
Renal failure 31.71 10.19 318 135532 130689 90361908
Anxiety disorder 31.67 10.19 38 135812 4884 90487713
Blood urea increased 31.62 10.19 109 135741 30304 90462293
Pain in extremity 31.59 10.19 480 135370 450049 90042548
Cataract 31.43 10.19 37 135813 72055 90420542
Urosepsis 31.33 10.19 86 135764 21146 90471451
Coombs positive haemolytic anaemia 30.99 10.19 15 135835 475 90492122
Stomatitis 30.94 10.19 263 135587 274435 90218162
Procedural pain 30.79 10.19 115 135735 33245 90459352
Laryngitis 30.73 10.19 19 135831 50734 90441863
Eructation 30.63 10.19 57 135793 10825 90481772
Erysipelas 30.10 10.19 51 135799 9001 90483596
Escherichia bacteraemia 30.10 10.19 40 135810 5695 90486902
Proctitis 30.07 10.19 69 135781 15190 90477407
Dry mouth 29.88 10.19 158 135692 183901 90308696
Atrioventricular block first degree 29.70 10.19 49 135801 8462 90484135
Drug tolerance decreased 29.67 10.19 6 135844 32124 90460473
Liver function test increased 29.61 10.19 51 135799 84804 90407793
Nail infection 29.41 10.19 27 135823 2545 90490052
Neonatal respiratory depression 29.15 10.19 11 135839 185 90492412
Upper gastrointestinal haemorrhage 29.00 10.19 88 135762 22888 90469709
Neonatal gastrointestinal disorder 28.94 10.19 9 135841 81 90492516
Presyncope 28.83 10.19 109 135741 31696 90460901
Sinobronchitis 28.62 10.19 16 135834 685 90491912
Stupor 28.41 10.19 38 135812 5444 90487153
Circulatory collapse 28.32 10.19 92 135758 24812 90467785
Gait disturbance 28.19 10.19 252 135598 260244 90232353
Multiple drug therapy 28.11 10.19 43 135807 6966 90485631
Hemianopia 28.08 10.19 24 135826 2058 90490539
Calcium deficiency 28.07 10.19 20 135830 1313 90491284
Tumour pain 28.03 10.19 23 135827 1864 90490733
Pregnancy 27.96 10.19 31 135819 62016 90430581
Generalised tonic-clonic seizure 27.91 10.19 115 135735 34788 90457809
Palmar-plantar erythrodysaesthesia syndrome 27.89 10.19 99 135751 27924 90464673
Lethargy 27.85 10.19 176 135674 62963 90429634
Vitamin B12 decreased 27.82 10.19 37 135813 5273 90487324
Inappropriate antidiuretic hormone secretion 27.78 10.19 78 135772 19427 90473170
Hyperhidrosis 27.04 10.19 318 135532 135987 90356610
Premature labour 26.93 10.19 61 135789 13315 90479282
Gastritis haemorrhagic 26.87 10.19 22 135828 1778 90490819
Cholelithiasis 26.77 10.19 152 135698 52354 90440243
Disseminated intravascular coagulation 26.73 10.19 82 135768 21456 90471141
Adverse reaction 26.52 10.19 6 135844 29706 90462891
Injection site pruritus 26.41 10.19 25 135825 53809 90438788
Radiation pneumonitis 26.26 10.19 22 135828 1836 90490761
Faecaloma 26.13 10.19 52 135798 10379 90482218
Female genital tract fistula 25.99 10.19 72 135778 17796 90474801
Vaginal discharge 25.95 10.19 76 135774 19388 90473209
Infusion site streaking 25.62 10.19 14 135836 573 90492024
Pituitary tumour benign 25.59 10.19 23 135827 2109 90490488
Immune effector cell-associated neurotoxicity syndrome 25.44 10.19 37 135813 5731 90486866
Pneumonia 25.34 10.19 1184 134666 636875 89855722
Abdominal tenderness 25.20 10.19 48 135802 9276 90483321
Hypochloraemia 25.19 10.19 25 135825 2597 90490000
Neuroleptic malignant syndrome 25.17 10.19 64 135786 15032 90477565
Hypotonia 25.14 10.19 54 135796 11372 90481225
Hepatic cirrhosis 24.95 10.19 35 135815 63218 90429379
Loss of personal independence in daily activities 24.88 10.19 112 135738 135993 90356604
Autoimmune thyroiditis 24.83 10.19 37 135813 5856 90486741
Myocardial reperfusion injury 24.79 10.19 9 135841 135 90492462
Respiratory syncytial virus infection 24.77 10.19 51 135799 10429 90482168
Vaginal flatulence 24.74 10.19 57 135793 12581 90480016
Tremor 24.73 10.19 344 135506 152829 90339768
Genitourinary tract neoplasm 24.70 10.19 7 135843 44 90492553
Oral candidiasis 24.65 10.19 112 135738 35343 90457254
Electrocardiogram T wave inversion 24.63 10.19 29 135821 3654 90488943
Hyponatraemic seizure 24.60 10.19 13 135837 497 90492100
Oropharyngeal spasm 24.55 10.19 11 135839 291 90492306
Liver disorder 24.52 10.19 96 135754 121173 90371424
Duodenal perforation 24.34 10.19 17 135833 1081 90491516
Onychomadesis 24.21 10.19 20 135830 45978 90446619
Unresponsive to stimuli 24.00 10.19 117 135733 38004 90454593
Secondary adrenocortical insufficiency 23.95 10.19 23 135827 2295 90490302
Interstitial lung disease 23.86 10.19 196 135654 76209 90416388
Enterochromaffin cell hyperplasia 23.81 10.19 7 135843 51 90492546
Papillary cystadenoma lymphomatosum 23.70 10.19 9 135841 154 90492443
Onychalgia 23.58 10.19 17 135833 1137 90491460
Walking aid user 23.35 10.19 12 135838 35494 90457103
Carcinoid tumour of the stomach 23.34 10.19 9 135841 161 90492436
Gynaecomastia 23.33 10.19 10 135840 237 90492360
Disturbance in social behaviour 23.21 10.19 30 135820 4158 90488439
Atrial fibrillation 23.18 10.19 304 135546 133307 90359290
Immune-mediated enterocolitis 23.18 10.19 32 135818 4725 90487872
Herpes simplex reactivation 23.11 10.19 16 135834 1003 90491594
Blood creatine increased 22.83 10.19 39 135811 6928 90485669
Xeroderma 22.82 10.19 11 135839 345 90492252
Neoplasm progression 22.82 10.19 129 135721 44357 90448240
Blood pressure increased 22.57 10.19 188 135662 197029 90295568
Cancer pain 22.57 10.19 29 135821 3996 90488601
Inappropriate schedule of product administration 22.53 10.19 132 135718 149801 90342796
Gastrointestinal disorder 22.53 10.19 261 135589 256426 90236171
Non-cardiac chest pain 22.53 10.19 38 135812 6683 90485914
Aquagenic pruritus 22.32 10.19 6 135844 30 90492567
Gaze palsy 22.30 10.19 19 135831 1622 90490975
Dermatitis exfoliative 22.25 10.19 34 135816 5502 90487095
Malignant polyp 22.18 10.19 9 135841 185 90492412
Pruritus 22.18 10.19 630 135220 540895 89951702
Non-small cell lung cancer 22.14 10.19 30 135820 4351 90488246
Sinus disorder 22.13 10.19 12 135838 34435 90458162
Acute abdomen 22.08 10.19 19 135831 1644 90490953
Drug resistance 22.04 10.19 9 135841 30440 90462157
Nail disorder 22.01 10.19 34 135816 59033 90433564
Skin haemorrhage 21.95 10.19 3 135847 21377 90471220
Erythema 21.83 10.19 473 135377 228773 90263824
Paranoia 21.81 10.19 55 135795 12853 90479744
Abdominal distension 21.77 10.19 295 135555 130306 90362291
Acute respiratory distress syndrome 21.75 10.19 93 135757 28593 90464004
Pancreatitis 21.74 10.19 179 135671 69647 90422950
Gelastic seizure 21.72 10.19 5 135845 11 90492586
Tumour lysis syndrome 21.50 10.19 50 135800 11102 90481495
Hyperreflexia 21.47 10.19 37 135813 6620 90485977
Taste disorder 21.46 10.19 37 135813 61509 90431088
Insomnia 21.45 10.19 361 135489 333113 90159484
Brain oedema 21.40 10.19 66 135784 17319 90475278
Renal impairment 21.37 10.19 247 135603 105174 90387423
Haemorrhoids 21.36 10.19 88 135762 26614 90465983
Injection site rash 21.34 10.19 5 135845 24168 90468429
Hypergastrinaemia 21.28 10.19 8 135842 133 90492464
Arrhythmia 21.22 10.19 122 135728 42210 90450387
Plantar erythema 21.21 10.19 9 135841 208 90492389
Muscle contractions involuntary 21.17 10.19 24 135826 2904 90489693
Low birth weight baby 21.13 10.19 45 135805 9422 90483175
Oxygen saturation abnormal 21.12 10.19 29 135821 4259 90488338
Lacrimation increased 20.72 10.19 88 135762 26974 90465623
Heart rate decreased 20.71 10.19 30 135820 53475 90439122
Enteritis 20.70 10.19 47 135803 10274 90482323
Hepatitis cholestatic 20.63 10.19 42 135808 8519 90484078
Cachexia 20.59 10.19 37 135813 6841 90485756
Rectal haemorrhage 20.58 10.19 202 135648 82542 90410055
Thymus disorder 20.56 10.19 10 135840 320 90492277
Initial insomnia 20.49 10.19 44 135806 9266 90483331
Face oedema 20.38 10.19 79 135771 23239 90469358
Muscle twitching 20.35 10.19 81 135769 24121 90468476
Torticollis 20.27 10.19 22 135828 2536 90490061
Back injury 20.24 10.19 24 135826 46598 90445999
Thirst 20.18 10.19 62 135788 16233 90476364
Systemic infection 20.15 10.19 30 135820 4745 90487852
Amnesia 20.01 10.19 89 135761 108416 90384181
Biliary dyskinesia 19.98 10.19 22 135828 2577 90490020
Gastrointestinal sounds abnormal 19.83 10.19 29 135821 4514 90488083
Radiculopathy 19.83 10.19 67 135783 18438 90474159
Lung infiltration 19.73 10.19 59 135791 15223 90477374
Stomatitis haemorrhagic 19.72 10.19 7 135843 98 90492499
Aortic rupture 19.66 10.19 7 135843 99 90492498
Gallbladder injury 19.57 10.19 16 135834 1290 90491307
Peripheral sensory neuropathy 19.54 10.19 43 135807 9207 90483390
Back disorder 19.51 10.19 7 135843 25624 90466973
Proctalgia 19.50 10.19 40 135810 8158 90484439
Cardiac failure 19.36 10.19 250 135600 109246 90383351
Venoocclusive disease 19.26 10.19 21 135829 2434 90490163
Fluid replacement 19.19 10.19 12 135838 633 90491964
Hiatus hernia 19.06 10.19 82 135768 25279 90467318
Polyneuropathy 18.97 10.19 68 135782 19273 90473324
Acute interstitial pneumonitis 18.91 10.19 13 135837 806 90491791
Hiccups 18.88 10.19 23 135827 3003 90489594
Ileus paralytic 18.73 10.19 30 135820 5055 90487542
Amylase increased 18.62 10.19 36 135814 7036 90485561
Therapy interrupted 18.52 10.19 29 135821 50079 90442518
Jaundice 18.50 10.19 97 135753 32420 90460177
Weight decreased 18.43 10.19 720 135130 379190 90113407
Hypertonia 18.42 10.19 30 135820 5125 90487472
Wrong technique in product usage process 18.37 10.19 51 135799 71520 90421077
Chorea 18.23 10.19 19 135831 2091 90490506
Lip erosion 18.20 10.19 15 135835 1223 90491374
Posterior reversible encephalopathy syndrome 18.17 10.19 74 135776 22265 90470332
Hypoglycaemic seizure 18.14 10.19 11 135839 549 90492048
Staring 18.07 10.19 17 135833 1653 90490944
Respiratory alkalosis 18.02 10.19 24 135826 3424 90489173
Staphylococcal sepsis 18.02 10.19 42 135808 9341 90483256
Obstruction gastric 18.01 10.19 15 135835 1241 90491356
Dysaesthesia 18.00 10.19 30 135820 5225 90487372
Aspiration 17.87 10.19 58 135792 15635 90476962
Metastases to liver 17.84 10.19 88 135762 28719 90463878
Gastrointestinal stoma complication 17.78 10.19 20 135830 2399 90490198
Cholestatic liver injury 17.69 10.19 25 135825 3772 90488825
Food allergy 17.69 10.19 8 135842 25470 90467127
Hyperthyroidism 17.64 10.19 64 135786 18246 90474351
Fluid retention 17.64 10.19 70 135780 88021 90404576
Myoclonus 17.63 10.19 66 135784 19102 90473495
Delusional disorder, persecutory type 17.58 10.19 9 135841 322 90492275
Nasal congestion 17.53 10.19 65 135785 83349 90409248
Oromandibular dystonia 17.39 10.19 11 135839 592 90492005
Status epilepticus 17.37 10.19 65 135785 18809 90473788
Maternal exposure timing unspecified 17.35 10.19 6 135844 22477 90470120
Bronchial aspiration procedure 17.34 10.19 8 135842 227 90492370
Toxic cardiomyopathy 17.25 10.19 9 135841 335 90492262
Respiratory depression 17.23 10.19 57 135793 15518 90477079
Diabetic gastroparesis 17.23 10.19 9 135841 336 90492261
Ultrasound foetal abnormal 17.16 10.19 7 135843 146 90492451
Illness 17.14 10.19 64 135786 81905 90410692
Large intestine perforation 17.06 10.19 42 135808 9670 90482927
Cholangitis 17.03 10.19 35 135815 7147 90485450
Somnolence 17.00 10.19 422 135428 208662 90283935
Thoracic operation 16.98 10.19 7 135843 150 90492447
Blood pressure fluctuation 16.95 10.19 33 135817 52380 90440217
Leukoencephalopathy 16.93 10.19 28 135822 4845 90487752
Neutropenic infection 16.92 10.19 17 135833 1792 90490805
Visual impairment 16.62 10.19 123 135727 132242 90360355
Melaena 16.61 10.19 99 135751 34698 90457899
Loss of consciousness 16.59 10.19 299 135551 139939 90352658
Pelvic neoplasm 16.57 10.19 9 135841 364 90492233
Flail chest 16.47 10.19 6 135844 91 90492506
Influenza 16.27 10.19 132 135718 139132 90353465
Flatulence 16.24 10.19 112 135738 41255 90451342
Omentectomy 16.18 10.19 5 135845 44 90492553
Talipes 16.10 10.19 16 135834 1664 90490933
Paraesthesia 16.08 10.19 271 135579 250055 90242542
Lung perforation 16.06 10.19 6 135844 98 90492499
Disorientation 15.90 10.19 117 135733 43997 90448600
Altered state of consciousness 15.88 10.19 91 135759 31441 90461156
Micturition disorder 15.75 10.19 21 135829 2999 90489598
Ulcer haemorrhage 15.73 10.19 10 135840 26311 90466286
Metastases to spinal cord 15.71 10.19 8 135842 283 90492314
Peripheral motor neuropathy 15.69 10.19 17 135833 1956 90490641
Myocardial ischaemia 15.68 10.19 51 135799 13763 90478834
Pulmonary oedema 15.65 10.19 152 135698 61928 90430669
Cardio-respiratory arrest 15.63 10.19 154 135696 62986 90429611
Intentional product misuse 15.63 10.19 75 135775 89529 90403068
Granulocytopenia neonatal 15.60 10.19 4 135846 16 90492581
Persistent postural-perceptual dizziness 15.60 10.19 4 135846 16 90492581
Parkinson's disease 15.60 10.19 13 135837 1077 90491520
Neuroendocrine tumour 15.56 10.19 12 135838 889 90491708
Hallucination 15.42 10.19 159 135691 65800 90426797
Generalised oedema 15.41 10.19 63 135787 18990 90473607
Injection site haemorrhage 15.29 10.19 12 135838 28306 90464291
Myoglobin blood increased 15.28 10.19 15 135835 1537 90491060
Starvation 15.26 10.19 10 135840 572 90492025
Catheter site bruise 15.23 10.19 10 135840 574 90492023
Methaemoglobinaemia 15.22 10.19 24 135826 3991 90488606
Flushing 15.20 10.19 201 135649 88290 90404307
Intestinal ischaemia 15.17 10.19 38 135812 8845 90483752
Joint injury 15.07 10.19 16 135834 32648 90459949
Candida infection 15.06 10.19 95 135755 33962 90458635
Haemoglobin decreased 15.04 10.19 333 135517 161623 90330974
Azotaemia 15.04 10.19 28 135822 5320 90487277
Naevus haemorrhage 14.99 10.19 6 135844 119 90492478
Lactic acidosis 14.98 10.19 128 135722 50335 90442262
Blood pressure decreased 14.97 10.19 175 135675 74720 90417877
Blood pressure diastolic decreased 14.96 10.19 11 135839 26815 90465782
Cystitis noninfective 14.94 10.19 14 135836 1355 90491242
Vascular pain 14.87 10.19 12 135838 950 90491647
Clostridium difficile colitis 14.74 10.19 79 135771 26627 90465970
Vagus nerve disorder 14.71 10.19 6 135844 125 90492472
Decubitus ulcer 14.68 10.19 45 135805 11768 90480829
Abnormal behaviour 14.64 10.19 70 135780 22558 90470039
Stridor 14.63 10.19 26 135824 4767 90487830
Escherichia test positive 14.60 10.19 19 135831 2651 90489946
Bone density decreased 14.51 10.19 4 135846 17341 90475256
Blood lactate dehydrogenase increased 14.51 10.19 77 135773 25855 90466742
Meconium ileus 14.44 10.19 3 135847 3 90492594
Polyglandular disorder 14.31 10.19 7 135843 227 90492370
Drug tolerance increased 14.25 10.19 7 135843 229 90492368
Morning sickness 14.23 10.19 12 135838 1010 90491587
Underdose 14.23 10.19 38 135812 53979 90438618
Patent ductus arteriosus 14.22 10.19 25 135825 4544 90488053
Maternal exposure during pregnancy 14.19 10.19 421 135429 359642 90132955
Metastases to central nervous system 14.18 10.19 58 135792 17484 90475113
Performance status decreased 14.08 10.19 24 135826 4256 90488341
Device related infection 14.04 10.19 76 135774 25710 90466887
Joint effusion 13.98 10.19 6 135844 19704 90472893
Sudden death 13.97 10.19 42 135808 10867 90481730
Autoimmune haemolytic anaemia 13.97 10.19 28 135822 5617 90486980
Urinary tract obstruction 13.88 10.19 17 135833 2232 90490365
Bile duct stenosis 13.84 10.19 15 135835 1727 90490870
Disability 13.75 10.19 25 135825 40720 90451877
Antiphospholipid syndrome 13.73 10.19 17 135833 2257 90490340
Gastric ulcer 13.69 10.19 79 135771 27369 90465228
PCO2 decreased 13.62 10.19 13 135837 1287 90491310
Streptococcal endocarditis 13.56 10.19 6 135844 154 90492443
Hyperlipidaemia 13.48 10.19 69 135781 22847 90469750
Muscle spasticity 13.48 10.19 20 135830 35302 90457295
Blood sodium decreased 13.46 10.19 79 135771 27534 90465063
Oesophageal ulcer 13.40 10.19 26 135824 5093 90487504
Sneezing 13.37 10.19 15 135835 29854 90462743
Peptic ulcer 13.36 10.19 27 135823 5448 90487149
Muscle spasms 13.30 10.19 282 135568 251601 90240996
Blood potassium increased 13.29 10.19 64 135786 20685 90471912
Muscle contracture 13.29 10.19 15 135835 1806 90490791
Product prescribing error 13.27 10.19 84 135766 30061 90462536
Hypertension 13.21 10.19 556 135294 456976 90035621
Immune-mediated hepatitis 13.15 10.19 19 135831 2925 90489672
Respiratory tract congestion 13.13 10.19 13 135837 27397 90465200
Complex regional pain syndrome 13.12 10.19 18 135832 2641 90489956
Carpal tunnel syndrome 13.10 10.19 10 135840 23918 90468679
Allergic sinusitis 13.08 10.19 16 135834 2097 90490500
Bundle branch block 13.02 10.19 11 135839 928 90491669
Throat irritation 13.02 10.19 34 135816 48661 90443936
General symptom 13.01 10.19 3 135847 14665 90477932
Economic problem 12.98 10.19 20 135830 3261 90489336
Granulomatous liver disease 12.92 10.19 11 135839 938 90491659
Rhinovirus infection 12.91 10.19 28 135822 5935 90486662
Postictal state 12.86 10.19 13 135837 1380 90491217
Urinary tract infection enterococcal 12.80 10.19 19 135831 2997 90489600
Oliguria 12.77 10.19 40 135810 10584 90482013
Paraneoplastic pleural effusion 12.76 10.19 4 135846 37 90492560
Mechanical ileus 12.76 10.19 10 135840 759 90491838
Foetal exposure during pregnancy 12.75 10.19 109 135741 42866 90449731
Pulmonary air leakage 12.67 10.19 4 135846 38 90492559
Bronchiectasis 12.65 10.19 9 135841 22321 90470276
Galactorrhoea 12.57 10.19 24 135826 4648 90487949
Therapy cessation 12.55 10.19 22 135828 36339 90456258
Blood phosphorus decreased 12.49 10.19 25 135825 5009 90487588
Conjunctivitis viral 12.49 10.19 7 135843 301 90492296
Electrocardiogram change 12.48 10.19 10 135840 784 90491813
Hyperphosphataemia 12.46 10.19 21 135829 3690 90488907
Bronchitis 12.45 10.19 158 135692 152769 90339828
Sinus arrhythmia 12.43 10.19 13 135837 1436 90491161
Tachypnoea 12.42 10.19 64 135786 21245 90471352
Supraventricular tachycardia 12.41 10.19 53 135797 16283 90476314
Helicobacter gastritis 12.40 10.19 14 135836 1686 90490911
Bone marrow leukaemic cell infiltration 12.40 10.19 4 135846 41 90492556
Blood albumin decreased 12.37 10.19 54 135796 16749 90475848
Blood bilirubin abnormal 12.37 10.19 15 135835 1949 90490648
Abdominal sepsis 12.36 10.19 13 135837 1446 90491151
Metastases to spine 12.33 10.19 21 135829 3722 90488875
Prolactin-producing pituitary tumour 12.31 10.19 5 135845 103 90492494
Labelled drug-drug interaction issue 12.24 10.19 16 135834 2242 90490355
Oesophageal neoplasm 12.23 10.19 4 135846 43 90492554
Electroencephalogram abnormal 12.22 10.19 22 135828 4074 90488523
Back pain 12.22 10.19 587 135263 316588 90176009
Cough 12.21 10.19 673 135177 368289 90124308
Anaemia of malignant disease 12.18 10.19 9 135841 625 90491972
Nephrogenic systemic fibrosis 12.17 10.19 22 135828 4086 90488511
Porphyria 12.06 10.19 6 135844 202 90492395
Pneumoperitoneum 12.05 10.19 14 135836 1739 90490858
Bacterial test positive 11.98 10.19 26 135824 5513 90487084
Intestinal dilatation 11.95 10.19 16 135834 2294 90490303
Autoimmune lung disease 11.93 10.19 5 135845 112 90492485
Activated partial thromboplastin time prolonged 11.85 10.19 32 135818 7793 90484804
Device dislocation 11.85 10.19 18 135832 31464 90461133
Gastrointestinal necrosis 11.84 10.19 19 135831 3206 90489391
Leg amputation 11.81 10.19 16 135834 2321 90490276
Pelvic pain 11.81 10.19 50 135800 15307 90477290
Intentional self-injury 11.80 10.19 16 135834 29318 90463279
Haemangioma of skin 11.74 10.19 9 135841 661 90491936
Otospondylomegaepiphyseal dysplasia 11.73 10.19 5 135845 117 90492480
Acute myocardial infarction 11.71 10.19 91 135759 34799 90457798
Basal cell carcinoma 11.71 10.19 20 135830 33369 90459228
Urea urine increased 11.70 10.19 3 135847 12 90492585
Dyspnoea paroxysmal nocturnal 11.70 10.19 11 135839 1069 90491528
Ischaemia 11.62 10.19 25 135825 5270 90487327
Foetal malpresentation 11.61 10.19 5 135845 120 90492477
Hepatitis fulminant 11.53 10.19 21 135829 3924 90488673
Chills 11.51 10.19 269 135581 131712 90360885
Mucosal erosion 11.47 10.19 14 135836 1831 90490766
Acute pulmonary oedema 11.45 10.19 36 135814 9544 90483053
Abortion spontaneous 11.44 10.19 42 135808 54014 90438583
Device difficult to use 11.41 10.19 6 135844 17519 90475078
Dermatitis atopic 11.40 10.19 11 135839 23461 90469136
Peritoneal perforation 11.35 10.19 5 135845 127 90492470
Hepatitis acute 11.30 10.19 39 135811 10848 90481749
Staphylococcus test positive 11.29 10.19 22 135828 4323 90488274
Tracheitis 11.29 10.19 10 135840 900 90491697
Ultrasound abdomen abnormal 11.27 10.19 4 135846 56 90492541
Urine output decreased 11.26 10.19 43 135807 12560 90480037
AST/ALT ratio abnormal 11.24 10.19 5 135845 130 90492467
Sulphaemoglobinaemia 11.23 10.19 8 135842 525 90492072
Subacute combined cord degeneration 11.22 10.19 6 135844 235 90492362
Metastatic malignant melanoma 11.21 10.19 13 135837 1611 90490986
Abdominal wall mass 11.21 10.19 4 135846 57 90492540
Anal injury 11.17 10.19 5 135845 132 90492465
Drug clearance decreased 11.15 10.19 14 135836 1884 90490713
Depressed level of consciousness 11.15 10.19 162 135688 72622 90419975
Chronic hepatitis 11.15 10.19 11 135839 1134 90491463
Pneumonia klebsiella 11.14 10.19 18 135832 3054 90489543
C-reactive protein increased 11.12 10.19 198 135652 181191 90311406
Bronchopulmonary aspergillosis 11.11 10.19 40 135810 11358 90481239
Respiratory acidosis 11.11 10.19 32 135818 8087 90484510
Vocal cord paresis 11.10 10.19 5 135845 134 90492463
Toxic skin eruption 11.09 10.19 50 135800 15724 90476873
Gastrointestinal mucosal exfoliation 11.06 10.19 5 135845 135 90492462
Pneumonia parainfluenzae viral 11.06 10.19 7 135843 377 90492220
Anaemia folate deficiency 11.06 10.19 8 135842 538 90492059
Agranulocytosis 11.04 10.19 90 135760 34912 90457685
Gastrointestinal ulcer haemorrhage 11.02 10.19 10 135840 928 90491669
Prothrombin time prolonged 11.02 10.19 36 135814 9736 90482861
Opisthotonus 11.01 10.19 7 135843 380 90492217
Device issue 11.01 10.19 17 135833 29520 90463077
Gastrointestinal dilation procedure 11 10.19 3 135847 16 90492581
Reflux gastritis 11.00 10.19 12 135838 1392 90491205
Epilepsy 10.99 10.19 75 135775 82131 90410466
Foetal growth restriction 10.98 10.19 35 135815 9345 90483252
Electrocardiogram QT interval abnormal 10.97 10.19 6 135844 246 90492351
Blood disorder 10.95 10.19 31 135819 7759 90484838
Polyarthritis 10.93 10.19 7 135843 18343 90474254
Cholecystitis acute 10.93 10.19 35 135815 9369 90483228
Panniculitis 10.91 10.19 4 135846 14454 90478143
Abdominal rigidity 10.91 10.19 16 135834 2496 90490101
Renal tubular necrosis 10.89 10.19 47 135803 14508 90478089
Anaphylactoid reaction 10.86 10.19 22 135828 4446 90488151
Epilepsy congenital 10.85 10.19 3 135847 17 90492580
Blood calcium decreased 10.85 10.19 80 135770 30102 90462495
Oral pain 10.83 10.19 85 135765 32598 90459999
Endocrine disorder 10.83 10.19 10 135840 950 90491647
Foetal heart rate abnormal 10.81 10.19 10 135840 952 90491645
Neutropenic colitis 10.80 10.19 21 135829 4122 90488475
Encephalitis 10.79 10.19 39 135811 11095 90481502
Bone marrow failure 10.79 10.19 84 135766 32137 90460460
Therapeutic response shortened 10.79 10.19 11 135839 22868 90469729
COVID-19 10.77 10.19 183 135667 168660 90323937
Embolism 10.76 10.19 35 135815 9446 90483151
Protein total decreased 10.74 10.19 29 135821 7060 90485537
Neck pain 10.73 10.19 114 135736 113849 90378748
Vena cava thrombosis 10.72 10.19 16 135834 2536 90490061
Gastric haemorrhage 10.71 10.19 29 135821 7074 90485523
Pneumonia aspiration 10.70 10.19 101 135749 40839 90451758
Toxic encephalopathy 10.68 10.19 33 135817 8666 90483931
Anal inflammation 10.68 10.19 7 135843 401 90492196
Salpingectomy 10.63 10.19 7 135843 404 90492193
Abdominal mass 10.62 10.19 19 135831 3502 90489095
Leukostasis syndrome 10.61 10.19 4 135846 67 90492530
Affect lability 10.61 10.19 7 135843 18056 90474541
Hospitalisation 10.56 10.19 132 135718 127968 90364629
Restless arm syndrome 10.56 10.19 4 135846 68 90492529
Incorrect product administration duration 10.56 10.19 57 135793 19265 90473332
Nephrocalcinosis 10.48 10.19 11 135839 1221 90491376
Eye irritation 10.47 10.19 22 135828 33956 90458641
Device breakage 10.41 10.19 4 135846 14040 90478557
Incoherent 10.36 10.19 23 135827 4954 90487643
Status migrainosus 10.31 10.19 5 135845 159 90492438
CSF white blood cell count decreased 10.31 10.19 3 135847 21 90492576
Metastases to abdominal cavity 10.27 10.19 8 135842 602 90491995
Malignant pleural effusion 10.26 10.19 17 135833 2947 90489650
Lymphopenia 10.22 10.19 64 135786 22817 90469780
Foot fracture 10.22 10.19 15 135835 26591 90466006
Craniocerebral injury 10.21 10.19 18 135832 3280 90489317
Febrile infection 10.20 10.19 14 135836 2055 90490542
Hypoxic-ischaemic encephalopathy 10.20 10.19 22 135828 4646 90487951

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 665.27 10.52 1214 77780 184489 42357852
Drug ineffective 333.51 10.52 409 78585 629788 41912553
Vomiting 329.50 10.52 1230 77764 288493 42253848
Nausea 214.67 10.52 1361 77633 395438 42146903
General physical health deterioration 167.83 10.52 638 78356 150608 42391733
Cytokine release syndrome 131.60 10.52 269 78725 44258 42498083
Dehydration 130.14 10.52 564 78430 141203 42401138
Decreased appetite 125.48 10.52 696 78298 192441 42349900
Aplastic anaemia 123.70 10.52 133 78861 12251 42530090
Lymphoid tissue hypoplasia 116.09 10.52 48 78946 830 42541511
Thymus hypoplasia 113.55 10.52 47 78947 815 42541526
Pyrexia 112.95 10.52 1170 77824 392872 42149469
Dystonia 109.94 10.52 127 78867 12663 42529678
Product dose omission issue 108.31 10.52 77 78917 154288 42388053
Constipation 106.79 10.52 587 78407 161704 42380637
Neutropenic sepsis 92.19 10.52 130 78864 15816 42526525
Drug abuse 82.07 10.52 46 78948 104725 42437616
Serotonin syndrome 79.74 10.52 159 78835 25686 42516655
Drug intolerance 79.52 10.52 25 78969 80399 42461942
Therapeutic product effect incomplete 72.03 10.52 21 78973 70918 42471423
Disseminated aspergillosis 71.85 10.52 43 78951 1687 42540654
Mucosal inflammation 71.77 10.52 228 78766 49146 42493195
Thrombocytopenia 65.61 10.52 588 78406 189691 42352650
Impaired gastric emptying 64.34 10.52 58 78936 4308 42538033
Neutropenia 63.58 10.52 606 78388 198825 42343516
Off label use 63.34 10.52 820 78174 637515 41904826
Systemic infection 59.33 10.52 60 78934 5145 42537196
Pneumonitis 58.22 10.52 190 78804 41528 42500813
Abdominal pain 56.90 10.52 571 78423 189900 42352441
Premature baby 55.95 10.52 129 78865 23024 42519317
Rash maculo-papular 55.24 10.52 174 78820 37329 42505012
Hypokalaemia 53.67 10.52 269 78725 71452 42470889
Ileus 52.28 10.52 112 78882 19027 42523314
Toxic epidermal necrolysis 49.86 10.52 135 78859 26615 42515726
Anaemia 49.03 10.52 760 78234 279518 42262823
Treatment failure 46.90 10.52 29 78965 62595 42479746
Peripheral swelling 46.89 10.52 59 78935 90211 42452130
Malignant neoplasm progression 46.45 10.52 352 78642 108048 42434293
Therapeutic product effect decreased 44.80 10.52 9 78985 39141 42503200
Foetal exposure during pregnancy 43.90 10.52 189 78805 47122 42495219
Alveolar lung disease 43.88 10.52 20 78974 442 42541899
Diarrhoea 43.48 10.52 1139 77855 459710 42082631
Psoriasis 43.13 10.52 18 78976 48586 42493755
Arthralgia 42.89 10.52 215 78779 205023 42337318
Pneumonia 42.64 10.52 1053 77941 421096 42121245
Intentional product misuse 41.91 10.52 32 78962 61868 42480473
Meconium abnormal 41.02 10.52 12 78982 67 42542274
Completed suicide 40.47 10.52 73 78921 96392 42445949
Oesophagitis 39.11 10.52 87 78907 15160 42527181
Hepatic failure 37.52 10.52 155 78839 37945 42504396
Clostridium difficile colitis 37.37 10.52 105 78889 21147 42521194
Pulmonary interstitial emphysema syndrome 37.18 10.52 19 78975 544 42541797
Long QT syndrome 37.00 10.52 37 78957 3130 42539211
Sepsis 36.92 10.52 546 78448 198788 42343553
Delirium 35.14 10.52 191 78803 52328 42490013
Joint swelling 34.76 10.52 45 78949 67977 42474364
Loss of personal independence in daily activities 34.70 10.52 25 78969 49791 42492550
Intentional product use issue 34.21 10.52 50 78944 71783 42470558
Leukopenia 33.87 10.52 246 78748 74500 42467841
Hypophagia 33.41 10.52 118 78876 26838 42515503
Injection site pain 33.00 10.52 35 78959 57763 42484578
Electrocardiogram QT prolonged 31.83 10.52 174 78820 47771 42494570
Enteritis 31.52 10.52 65 78929 10751 42531590
Wheezing 31.47 10.52 33 78961 54748 42487593
Post concussion syndrome 31.46 10.52 12 78982 166 42542175
Asthma 31.04 10.52 42 78952 62272 42480069
Hiccups 30.72 10.52 69 78925 12102 42530239
Death 30.49 10.52 654 78340 470531 42071810
Cachexia 30.13 10.52 54 78940 8050 42534291
Rheumatoid arthritis 29.95 10.52 21 78973 42419 42499922
Condition aggravated 29.89 10.52 324 78670 260430 42281911
Drug resistance 29.88 10.52 13 78981 34235 42508106
Neutropenic infection 29.83 10.52 26 78968 1847 42540494
Hepatic cytolysis 29.48 10.52 113 78881 26731 42515610
Weight increased 29.45 10.52 102 78892 107881 42434460
Mesothelioma 29.34 10.52 15 78979 430 42541911
COVID-19 29.33 10.52 113 78881 115835 42426506
Device dislocation 28.88 10.52 52 78942 7779 42534562
Stress 28.49 10.52 24 78970 44188 42498153
Neuroleptic malignant syndrome 28.35 10.52 96 78898 21376 42520965
Laparotomy 27.09 10.52 13 78981 324 42542017
Aminoaciduria 26.89 10.52 12 78982 252 42542089
Eosinophil percentage decreased 26.33 10.52 12 78982 265 42542076
Blood creatine decreased 26.17 10.52 12 78982 269 42542072
Impetigo 25.96 10.52 21 78973 1345 42540996
Tardive dyskinesia 25.57 10.52 46 78948 6878 42535463
Gastrointestinal hypermotility 25.48 10.52 10 78984 150 42542191
Wrong technique in product usage process 25.27 10.52 25 78969 42610 42499731
Urticaria 25.21 10.52 63 78931 73973 42468368
Extrapyramidal disorder 24.95 10.52 77 78917 16335 42526006
Stevens-Johnson syndrome 24.88 10.52 94 78900 22084 42520257
Hospitalisation 24.73 10.52 64 78930 74266 42468075
Necrotising enterocolitis neonatal 24.30 10.52 12 78982 319 42542022
Subileus 23.84 10.52 31 78963 3490 42538851
Procalcitonin decreased 23.69 10.52 11 78983 254 42542087
Dysphagia 23.62 10.52 222 78772 72497 42469844
Swelling 23.49 10.52 41 78953 54844 42487497
Arthropathy 23.15 10.52 13 78981 29584 42512757
Headache 23 10.52 309 78685 239060 42303281
No adverse event 22.99 10.52 23 78971 38998 42503343
Thrombosis 22.79 10.52 59 78935 68452 42473889
Feeling abnormal 22.52 10.52 61 78933 69725 42472616
Pleural effusion 22.42 10.52 277 78717 96889 42445452
Product use in unapproved indication 22.42 10.52 226 78768 184230 42358111
Ileus paralytic 22.36 10.52 46 78948 7595 42534746
Genital erythema 22.22 10.52 11 78983 294 42542047
Failure to thrive 22.21 10.52 52 78942 9370 42532971
Acute kidney injury 22.19 10.52 861 78133 366476 42175865
Colitis 22.08 10.52 155 78839 46417 42495924
Conjunctival irritation 22.00 10.52 8 78986 96 42542245
Toxicity to various agents 21.94 10.52 296 78698 228840 42313501
Congenital pneumonia 21.93 10.52 8 78986 97 42542244
Disease recurrence 21.86 10.52 14 78980 29664 42512677
Vascular access site occlusion 21.77 10.52 7 78987 56 42542285
Blood alkaline phosphatase increased 21.68 10.52 121 78873 33476 42508865
Musculoskeletal stiffness 21.39 10.52 47 78947 57718 42484623
Pruritus 21.03 10.52 236 78758 188535 42353806
Malnutrition 20.98 10.52 67 78927 14475 42527866
Psoriatic arthropathy 20.96 10.52 10 78984 24957 42517384
Therapy non-responder 20.95 10.52 42 78952 53317 42489024
Erectile dysfunction 20.88 10.52 10 78984 24903 42517438
Vocal cord inflammation 20.67 10.52 7 78987 67 42542274
Jaundice 20.63 10.52 122 78872 34467 42507874
Product use issue 20.58 10.52 73 78921 76678 42465663
Platelet count decreased 20.54 10.52 366 78628 138215 42404126
Toxic encephalopathy 20.51 10.52 42 78952 6911 42535430
Hyponatraemia 20.37 10.52 282 78712 101180 42441161
Low birth weight baby 20.34 10.52 52 78942 9903 42532438
Suicide attempt 20.13 10.52 34 78960 46066 42496275
Diabetes mellitus 19.79 10.52 52 78942 60035 42482306
Septic shock 19.73 10.52 258 78736 91414 42450927
Inappropriate schedule of product administration 19.69 10.52 101 78893 95801 42446540
Hyperbilirubinaemia 19.57 10.52 83 78911 20552 42521789
Full blood count abnormal 19.52 10.52 16 78978 29860 42512481
Blood pressure increased 19.46 10.52 110 78884 101818 42440523
Cardiac failure congestive 19.42 10.52 87 78907 85515 42456826
Injection site swelling 19.21 10.52 4 78990 16969 42525372
Blood cholesterol increased 19.17 10.52 13 78981 26728 42515613
Synovitis 19.07 10.52 3 78991 15564 42526777
Pulmonary sepsis 19.06 10.52 27 78967 3297 42539044
Intentional overdose 18.94 10.52 42 78952 51414 42490927
Hyperthermia malignant 18.93 10.52 24 78970 2634 42539707
Trismus 18.92 10.52 25 78969 2859 42539482
Starvation 18.89 10.52 12 78982 524 42541817
Talipes 18.87 10.52 22 78972 2214 42540127
Acute generalised exanthematous pustulosis 18.72 10.52 46 78948 8549 42533792
Therapy interrupted 18.55 10.52 9 78985 22241 42520100
Viral rash 18.47 10.52 8 78986 156 42542185
Electrocardiogram QT shortened 18.42 10.52 8 78986 157 42542184
Disturbance in attention 18.29 10.52 17 78977 29849 42512492
Hypoalbuminaemia 18.21 10.52 67 78927 15543 42526798
Neutropenic colitis 18.20 10.52 31 78963 4439 42537902
Nightmare 18.15 10.52 12 78982 25000 42517341
Blood pressure fluctuation 18.09 10.52 14 78980 26894 42515447
Superior vena cava occlusion 18.02 10.52 7 78987 102 42542239
Pseudomonal sepsis 18.00 10.52 30 78964 4219 42538122
Abdominal neoplasm 17.99 10.52 11 78983 449 42541892
Klebsiella bacteraemia 17.88 10.52 22 78972 2342 42539999
Adverse drug reaction 17.87 10.52 26 78968 37408 42504933
Obstructive airways disorder 17.80 10.52 12 78982 24747 42517594
Haematopoietic stem cell mobilisation 17.69 10.52 10 78984 352 42541989
Laryngeal cancer metastatic 17.57 10.52 6 78988 59 42542282
Psychotic disorder 17.45 10.52 17 78977 29191 42513150
Accidental exposure to product 17.38 10.52 8 78986 20385 42521956
Frequent bowel movements 17.33 10.52 9 78985 21398 42520943
Heart sounds abnormal 17.32 10.52 14 78980 896 42541445
Hepatocellular injury 17.13 10.52 88 78906 23590 42518751
Chills 16.73 10.52 256 78738 93810 42448531
Epileptic encephalopathy 16.70 10.52 9 78985 288 42542053
Oral mucosal eruption 16.60 10.52 10 78984 397 42541944
Pain in extremity 16.48 10.52 189 78805 150415 42391926
Tumour lysis syndrome 16.34 10.52 83 78911 22148 42520193
Abdominal pain upper 16.34 10.52 229 78765 82380 42459961
Diffuse alveolar damage 16.28 10.52 22 78972 2570 42539771
Venous angioma of brain 16.26 10.52 5 78989 34 42542307
Maternal drugs affecting foetus 16.13 10.52 27 78967 3812 42538529
Cytomegalovirus viraemia 16.06 10.52 49 78945 10328 42532013
Proctitis bacterial 15.95 10.52 7 78987 141 42542200
Aortic valve calcification 15.92 10.52 11 78983 554 42541787
Fall 15.84 10.52 323 78671 234197 42308144
Non-small cell lung cancer 15.82 10.52 31 78963 4943 42537398
Haematemesis 15.81 10.52 103 78891 30096 42512245
Transfusion 15.68 10.52 49 78945 10465 42531876
Bladder cancer 15.63 10.52 6 78988 17041 42525300
Paresis 15.40 10.52 21 78973 2475 42539866
Memory impairment 15.39 10.52 45 78949 50177 42492164
Obstruction gastric 15.37 10.52 14 78980 1054 42541287
Therapy partial responder 15.36 10.52 9 78985 20012 42522329
Spleen congestion 15.15 10.52 9 78985 348 42541993
Rash 14.91 10.52 395 78599 276559 42265782
Cardiac disorder 14.88 10.52 44 78950 48888 42493453
Blood bilirubin increased 14.73 10.52 131 78863 42121 42500220
Bacteraemia 14.73 10.52 88 78906 24952 42517389
Ventricular septal defect 14.70 10.52 28 78966 4371 42537970
Hepatitis fulminant 14.68 10.52 30 78964 4929 42537412
Hypometabolism 14.68 10.52 7 78987 172 42542169
Tachypnoea 14.63 10.52 79 78915 21583 42520758
Gastritis 14.63 10.52 85 78909 23862 42518479
Asthenia 14.60 10.52 648 78346 280145 42262196
Incorrect dose administered 14.46 10.52 50 78944 52924 42489417
Prostate cancer 14.42 10.52 39 78955 44604 42497737
Crepitations 14.39 10.52 24 78970 3377 42538964
Gastrointestinal motility disorder 14.26 10.52 22 78972 2899 42539442
Gamma-glutamyltransferase increased 14.16 10.52 106 78888 32391 42509950
Suicidal ideation 14.15 10.52 44 78950 48117 42494224
Dyschezia 14.14 10.52 17 78977 1767 42540574
Heart rate decreased 14.13 10.52 29 78965 36503 42505838
Gait disturbance 14.10 10.52 115 78879 97885 42444456
Aggression 13.95 10.52 39 78955 44124 42498217
Postnatal growth restriction 13.94 10.52 7 78987 193 42542148
Diabetic gastroparesis 13.90 10.52 6 78988 116 42542225
Acute abdomen 13.89 10.52 18 78976 2019 42540322
Chemotherapeutic drug level increased 13.86 10.52 8 78986 293 42542048
Immune-mediated hepatitis 13.84 10.52 25 78969 3749 42538592
Spinal cord paralysis 13.76 10.52 6 78988 119 42542222
Symmetrical drug-related intertriginous and flexural exanthema 13.72 10.52 12 78982 856 42541485
Device issue 13.70 10.52 4 78990 13505 42528836
Colitis ulcerative 13.69 10.52 17 78977 26158 42516183
Ascites 13.68 10.52 163 78831 56515 42485826
Stress cardiomyopathy 13.63 10.52 21 78973 2764 42539577
Blood folate decreased 13.57 10.52 12 78982 869 42541472
Cancer pain 13.56 10.52 24 78970 3543 42538798
Underdose 13.50 10.52 7 78987 16659 42525682
Neutrophil count decreased 13.44 10.52 178 78816 63237 42479104
Impaired work ability 13.38 10.52 3 78991 12088 42530253
Therapy cessation 13.30 10.52 11 78983 20439 42521902
Depression 13.28 10.52 137 78857 111226 42431115
Cytokine storm 13.26 10.52 12 78982 896 42541445
Illness 13.24 10.52 16 78978 24914 42517427
Sopor 13.23 10.52 4 78990 13198 42529143
Platelet transfusion 13.20 10.52 16 78978 1678 42540663
Spinal cord injury thoracic 13.15 10.52 6 78988 133 42542208
Abdominal compartment syndrome 13.07 10.52 13 78981 1092 42541249
Myocardial infarction 13.03 10.52 157 78837 123852 42418489
Laboratory test abnormal 13.02 10.52 14 78980 22964 42519377
Tongue disorder 13.01 10.52 30 78964 5353 42536988
Tumour pain 12.98 10.52 14 78980 1293 42541048
Febrile bone marrow aplasia 12.98 10.52 45 78949 10136 42532205
Blood creatine phosphokinase increased 12.94 10.52 46 78948 48292 42494049
Lumbar vertebral fracture 12.88 10.52 22 78972 3157 42539184
Transient ischaemic attack 12.86 10.52 27 78967 33712 42508629
Road traffic accident 12.75 10.52 10 78984 19083 42523258
Small intestinal obstruction 12.75 10.52 64 78930 16997 42525344
Renal vasculitis 12.71 10.52 7 78987 234 42542107
Blood urea increased 12.66 10.52 104 78890 32689 42509652
Papillary renal cell carcinoma 12.62 10.52 8 78986 348 42541993
Blood aluminium increased 12.59 10.52 3 78991 6 42542335
Myelosuppression 12.58 10.52 36 78958 40425 42501916
Generalised oedema 12.52 10.52 59 78935 15277 42527064
Restlessness 12.52 10.52 95 78899 29154 42513187
Pericardial effusion 12.48 10.52 95 78899 29180 42513161
Oesophageal cancer metastatic 12.46 10.52 8 78986 356 42541985
Seborrhoeic dermatitis 12.39 10.52 17 78977 2015 42540326
Nasopharyngitis 12.34 10.52 98 78896 83898 42458443
Drug ineffective for unapproved indication 12.31 10.52 44 78950 46119 42496222
Peripheral sensory neuropathy 12.30 10.52 40 78954 8722 42533619
Chemotherapeutic drug level above therapeutic 12.13 10.52 4 78990 35 42542306
Hygroma colli 12.13 10.52 4 78990 35 42542306
Cholestasis 12.01 10.52 103 78891 32776 42509565
Foetal hypokinesia 11.96 10.52 8 78986 382 42541959
Injection site erythema 11.78 10.52 12 78982 20183 42522158
Vascular access complication 11.65 10.52 8 78986 399 42541942
Drug clearance decreased 11.48 10.52 17 78977 2161 42540180
Neck pain 11.46 10.52 24 78970 29990 42512351
Hypogonadism 11.42 10.52 18 78976 2416 42539925
Stomatitis 11.39 10.52 143 78851 50186 42492155
Post-traumatic neck syndrome 11.37 10.52 6 78988 184 42542157
Myasthenia gravis 11.36 10.52 8 78986 16129 42526212
Rhinitis 11.35 10.52 4 78990 11973 42530368
Herpes zoster reactivation 11.27 10.52 8 78986 421 42541920
Retching 11.25 10.52 36 78958 7785 42534556
Phaeochromocytoma crisis 11.25 10.52 5 78989 104 42542237
Micturition urgency 11.23 10.52 4 78990 11894 42530447
Rheumatoid nodule 11.19 10.52 20 78974 2975 42539366
Product quality issue 11.16 10.52 10 78984 17872 42524469
Restrictive cardiomyopathy 11.12 10.52 10 78984 740 42541601
Angle closure glaucoma 11.11 10.52 12 78982 1110 42541231
Sedation 11.11 10.52 25 78969 30450 42511891
Oesophageal hypomotility 11.07 10.52 3 78991 12 42542329
Lenticulostriatal vasculopathy 11.07 10.52 3 78991 12 42542329
Congenital nasal septum deviation 11.07 10.52 3 78991 12 42542329
Performance status decreased 11.07 10.52 26 78968 4694 42537647
Eastern Cooperative Oncology Group performance status worsened 11.03 10.52 13 78981 1323 42541018
Febrile infection 10.99 10.52 19 78975 2752 42539589
Cyanosis 10.96 10.52 56 78938 14975 42527366
Hepatic infection 10.90 10.52 10 78984 760 42541581
Eczema asteatotic 10.87 10.52 8 78986 445 42541896
Skeletal dysplasia 10.87 10.52 5 78989 113 42542228
Lung infiltration 10.83 10.52 53 78941 13936 42528405
Colorectal cancer metastatic 10.81 10.52 11 78983 950 42541391
Hepatitis 10.76 10.52 87 78907 27213 42515128
Therapeutic response decreased 10.74 10.52 34 78960 36978 42505363
Bone marrow failure 10.72 10.52 101 78893 32992 42509349
Joint injury 10.70 10.52 7 78987 14669 42527672
Escherichia bacteraemia 10.63 10.52 27 78967 5122 42537219
Nephrolithiasis 10.57 10.52 34 78960 36796 42505545
Benign soft tissue neoplasm 10.55 10.52 5 78989 121 42542220
Incorrect route of product administration 10.54 10.52 18 78976 24287 42518054
Peptic ulcer 10.53 10.52 21 78973 3391 42538950

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 1401.70 9.92 2171 185788 314596 110086744
Vomiting 650.93 9.92 3161 184798 907514 109493826
Nausea 524.47 9.92 3738 184221 1231952 109169388
Drug ineffective 472.02 9.92 1196 186763 1519344 108881996
Synovitis 417.99 9.92 10 187949 274082 110127258
Joint swelling 411.56 9.92 121 187838 442724 109958616
Hand deformity 345.19 9.92 5 187954 218501 110182839
Arthropathy 341.69 9.92 43 187916 287479 110113861
Hypokalaemia 335.34 9.92 867 187092 181581 110219759
Constipation 322.71 9.92 1333 186626 356453 110044887
Therapeutic product effect decreased 320.40 9.92 25 187934 244291 110157049
Rheumatoid arthritis 319.32 9.92 61 187898 299552 110101788
Pyrexia 308.68 9.92 2590 185369 895675 109505665
Systemic lupus erythematosus 307.22 9.92 36 187923 254302 110147038
Dystonia 301.80 9.92 290 187669 25515 110375825
Dehydration 296.32 9.92 1096 186863 278415 110122925
Serotonin syndrome 295.73 9.92 430 187529 58723 110342617
Glossodynia 279.44 9.92 27 187932 221977 110179363
Neutropenic sepsis 271.48 9.92 297 187662 30449 110370891
Swelling 257.16 9.92 138 187821 350903 110050437
Psoriatic arthropathy 255.55 9.92 21 187938 196740 110204600
Helicobacter infection 243.04 9.92 17 187942 181860 110219480
Mucosal inflammation 239.93 9.92 515 187444 95626 110305714
Duodenal ulcer perforation 236.32 9.92 17 187942 177683 110223657
Pericarditis 232.60 9.92 45 187914 219069 110182271
Neutropenia 228.92 9.92 1247 186712 373373 110027967
Wound 227.07 9.92 59 187900 234378 110166962
Contraindicated product administered 226.54 9.92 70 187889 248197 110153143
Cytokine release syndrome 225.16 9.92 418 187541 69888 110331452
Aplastic anaemia 223.68 9.92 240 187719 24068 110377272
Diarrhoea 223.68 9.92 2933 185026 1136572 109264768
Muscle injury 223.33 9.92 3 187956 140804 110260536
Weight increased 221.30 9.92 232 187727 419412 109981928
Abdominal pain 220.74 9.92 1560 186399 511429 109889911
Decreased appetite 213.50 9.92 1462 186497 474384 109926956
Arthralgia 213.33 9.92 650 187309 778982 109622358
Anaemia 212.17 9.92 1623 186336 545463 109855877
Thrombocytopenia 200.23 9.92 1142 186817 347743 110053597
Rheumatoid factor positive 199.86 9.92 5 187954 131635 110269705
Impaired healing 199.32 9.92 45 187914 196672 110204668
Abdominal discomfort 193.14 9.92 231 187728 393627 110007713
Peripheral swelling 186.63 9.92 248 187711 403786 109997554
Folliculitis 185.35 9.92 31 187928 167622 110233718
Drug intolerance 185.26 9.92 252 187707 406260 109995080
Nasopharyngitis 184.27 9.92 240 187719 394121 110007219
Treatment failure 180.64 9.92 125 187834 277109 110124231
Musculoskeletal stiffness 178.60 9.92 129 187830 279693 110121647
Irritable bowel syndrome 177.96 9.92 32 187927 164183 110237157
Sinusitis 177.63 9.92 146 187813 296542 110104798
Blood cholesterol increased 176.09 9.92 48 187911 184737 110216603
Fibromyalgia 173.34 9.92 39 187920 170870 110230470
Hepatic enzyme increased 167.32 9.92 179 187780 320713 110080627
C-reactive protein abnormal 165.23 9.92 15 187944 129680 110271660
Hyponatraemia 162.63 9.92 767 187192 216886 110184454
Sleep disorder due to general medical condition, insomnia type 160.42 9.92 4 187955 105639 110295701
Malignant neoplasm progression 157.59 9.92 651 187308 173916 110227424
Wheezing 156.02 9.92 123 187836 255107 110146233
Toxic epidermal necrolysis 155.66 9.92 316 187643 56411 110344929
Bursitis 155.31 9.92 19 187940 129899 110271441
Acute kidney injury 154.57 9.92 1705 186254 633725 109767615
General physical health deterioration 153.30 9.92 1241 186718 424054 109977286
Product dose omission issue 152.17 9.92 194 187765 321588 110079752
Type 2 diabetes mellitus 151.17 9.92 56 187903 177176 110224164
Discomfort 146.35 9.92 92 187867 214615 110186725
Sepsis 143.22 9.92 1000 186959 326346 110074994
Osteoarthritis 142.37 9.92 66 187893 182557 110218783
Lip dry 140.84 9.92 7 187952 100076 110301264
Rash maculo-papular 140.67 9.92 357 187602 73865 110327475
Colitis 138.82 9.92 436 187523 101887 110299453
Joint range of motion decreased 138.10 9.92 21 187938 121811 110279529
Extrapyramidal disorder 137.26 9.92 205 187754 28662 110372678
Ileus 135.90 9.92 211 187748 30518 110370822
Urticaria 133.14 9.92 210 187749 318647 110082693
Ill-defined disorder 128.09 9.92 53 187906 156800 110244540
Electrocardiogram QT prolonged 127.87 9.92 442 187517 108518 110292822
Neuropathy peripheral 122.57 9.92 616 187343 178661 110222679
Hypomagnesaemia 122.44 9.92 298 187661 60072 110341268
Impaired gastric emptying 122.01 9.92 131 187828 13144 110388196
Psoriasis 121.47 9.92 43 187916 139950 110261390
Peripheral venous disease 121.25 9.92 5 187954 84112 110317228
Intentional product use issue 119.75 9.92 147 187812 247759 110153581
Torsade de pointes 116.89 9.92 167 187792 22433 110378907
Pneumonitis 115.92 9.92 339 187620 76192 110325148
Contusion 115.24 9.92 136 187823 233225 110168115
Grip strength decreased 111.57 9.92 6 187953 80168 110321172
Asthma 109.13 9.92 160 187799 250131 110151209
Injection site pain 108.39 9.92 86 187873 177836 110223504
Lymphoid tissue hypoplasia 108.07 9.92 54 187905 1611 110399729
Product use issue 106.44 9.92 232 187727 311463 110089877
Thymus hypoplasia 104.47 9.92 53 187906 1634 110399706
Road traffic accident 102.11 9.92 28 187931 107370 110293970
Computerised tomogram thorax abnormal 102.03 9.92 62 187897 2733 110398607
Atelectasis 98.93 9.92 203 187756 36509 110364831
Phaeochromocytoma crisis 98.75 9.92 36 187923 478 110400862
Therapeutic product effect incomplete 98.61 9.92 142 187817 223663 110177677
Pulmonary embolism 95.97 9.92 659 187300 213815 110187525
Neutrophil count decreased 95.29 9.92 433 187526 120508 110280832
Inflammation 93.93 9.92 114 187845 193124 110208216
Leukopenia 91.84 9.92 497 187462 148294 110253046
Neovascularisation 91.61 9.92 49 187910 1688 110399652
Mobility decreased 91.12 9.92 165 187794 237257 110164083
Condition aggravated 90.90 9.92 805 187154 734031 109667309
Red blood cell sedimentation rate increased 89.88 9.92 13 187946 78289 110323051
Swollen tongue 89.14 9.92 265 187694 60097 110341243
Stevens-Johnson syndrome 88.24 9.92 225 187734 46676 110354664
Hypercholesterolaemia 87.64 9.92 23 187936 90814 110310526
Completed suicide 87.28 9.92 175 187784 242206 110159134
Computerised tomogram thorax 86.98 9.92 33 187926 493 110400847
Parkinsonism 86.69 9.92 144 187815 22043 110379297
Subileus 86.16 9.92 78 187881 6359 110394981
Sciatica 86.15 9.92 25 187934 92374 110308966
Arthritis 85.62 9.92 95 187864 167491 110233849
Hepatic failure 85.17 9.92 284 187675 68455 110332885
Blister 84.62 9.92 161 187798 227215 110174125
Pancytopenia 84.46 9.92 628 187331 208985 110192355
Tardive dyskinesia 83.31 9.92 109 187850 13470 110387870
Hypoaesthesia 81.46 9.92 268 187691 313955 110087385
Sleep disorder 80.83 9.92 133 187826 198511 110202829
Transfusion 79.72 9.92 150 187809 25322 110376018
Knee arthroplasty 78.85 9.92 9 187950 64939 110336401
Systemic infection 78.36 9.92 90 187869 9729 110391611
Liver injury 78.23 9.92 84 187875 150329 110251011
Hip arthroplasty 78.22 9.92 4 187955 55809 110345531
Pneumonia 77.94 9.92 1995 185964 874719 109526621
Memory impairment 77.25 9.92 135 187824 196809 110204531
Oesophagitis 76.45 9.92 158 187801 28557 110372783
Septic shock 75.85 9.92 493 187466 157035 110244305
Long QT syndrome 75.77 9.92 76 187883 7042 110394298
Disseminated aspergillosis 75.43 9.92 49 187910 2431 110398909
Oculogyric crisis 75.35 9.92 58 187901 3774 110397566
Pleural effusion 74.20 9.92 537 187422 177172 110224168
Night sweats 74.04 9.92 71 187888 133912 110267428
Blepharospasm 73.62 9.92 5 187954 54846 110346494
Adverse drug reaction 73.62 9.92 44 187915 105515 110295825
Alopecia 73.53 9.92 344 187615 364409 110036931
Injection site reaction 72.87 9.92 30 187929 89040 110312300
Lower limb fracture 72.84 9.92 19 187940 75329 110326011
Sleep disorder due to a general medical condition 72.20 9.92 4 187955 52108 110349232
Restlessness 71.09 9.92 234 187725 56025 110345315
Therapeutic response decreased 70.48 9.92 38 187921 96461 110304879
Gastritis 70.24 9.92 226 187733 53473 110347867
Peripheral circulatory failure 68.08 9.92 41 187918 1778 110399562
Hypoxia 67.11 9.92 413 187546 129102 110272238
Gait inability 66.75 9.92 80 187879 136296 110265044
Hepatocellular injury 66.12 9.92 213 187746 50429 110350911
Haematemesis 66.07 9.92 236 187723 58872 110342468
Hepatic cytolysis 64.28 9.92 223 187736 54830 110346510
Dysphagia 63.46 9.92 463 187496 153137 110248203
Pain 62.99 9.92 1194 186765 953761 109447579
Obesity 62.71 9.92 60 187899 113291 110288049
Product quality issue 61.69 9.92 27 187932 77272 110324068
Cholecystitis chronic 61.01 9.92 78 187881 9422 110391918
Musculoskeletal pain 60.99 9.92 138 187821 182885 110218455
Platelet count decreased 60.79 9.92 629 187330 229814 110171526
Autoimmune disorder 60.53 9.92 18 187941 65465 110335875
Electrolyte imbalance 59.92 9.92 168 187791 36860 110364480
Hypophagia 59.57 9.92 211 187748 52415 110348925
Tachycardia 57.60 9.92 614 187345 226031 110175309
Adverse event 57.44 9.92 60 187899 108749 110292591
Dysphonia 56.95 9.92 268 187691 75661 110325679
Pain in extremity 56.94 9.92 541 187418 486577 109914763
Wound infection 55.81 9.92 49 187910 96416 110304924
Infusion related reaction 55.61 9.92 399 187560 380763 110020577
Injury 55.60 9.92 138 187821 177127 110224213
Hypotension 55.57 9.92 1222 186737 522627 109878713
Cholestasis 55.36 9.92 237 187722 64281 110337059
Injection site swelling 55.29 9.92 18 187941 61772 110339568
Hiccups 55.00 9.92 87 187872 12782 110388558
Phaeochromocytoma 53.65 9.92 27 187932 818 110400522
Swelling face 53.36 9.92 303 187656 92018 110309322
Pulmonary fibrosis 53.04 9.92 57 187902 101985 110299355
Neuroleptic malignant syndrome 52.65 9.92 152 187807 33907 110367433
Coeliac disease 52.39 9.92 6 187953 43181 110358159
Malnutrition 51.45 9.92 131 187828 27148 110374192
Enterocolitis 51.31 9.92 105 187854 18844 110382496
Gamma-glutamyltransferase increased 50.15 9.92 222 187737 61087 110340253
Loss of personal independence in daily activities 50.07 9.92 113 187846 149907 110251433
Blood alkaline phosphatase increased 50.04 9.92 246 187713 70689 110330651
Injection site erythema 49.63 9.92 52 187907 94124 110307216
Injection site bruising 49.41 9.92 13 187946 51250 110350090
Clostridium difficile colitis 49.10 9.92 175 187784 43603 110357737
Febrile bone marrow aplasia 48.74 9.92 98 187861 17367 110383973
Cardiac arrest 48.13 9.92 529 187430 196224 110205116
Small intestinal obstruction 48.10 9.92 142 187817 32071 110369269
Lung disorder 47.71 9.92 152 187807 179895 110221445
Exostosis 47.57 9.92 10 187949 45946 110355394
Onychomadesis 47.13 9.92 10 187949 45653 110355687
Hypoalbuminaemia 46.43 9.92 131 187828 28843 110372497
Lupus-like syndrome 46.29 9.92 7 187952 40785 110360555
Ascites 46.22 9.92 293 187666 92515 110308825
Blood pressure increased 46.17 9.92 254 187705 258119 110143221
Blood pressure fluctuation 44.51 9.92 37 187922 74787 110326553
Drug resistance 44.50 9.92 20 187939 56354 110344986
Alanine aminotransferase increased 43.98 9.92 492 187467 183281 110218059
Urinary retention 43.82 9.92 234 187725 69449 110331891
Foot deformity 43.60 9.92 14 187945 48466 110352874
Akathisia 43.04 9.92 92 187867 17021 110384319
Blood bilirubin increased 43.02 9.92 248 187711 75724 110325616
Prescribed underdose 42.92 9.92 29 187930 65145 110336195
Intentional product misuse 42.83 9.92 102 187857 132802 110268538
Alveolar lung disease 42.82 9.92 22 187937 697 110400643
Neutropenic infection 42.80 9.92 39 187920 3206 110398134
Peritonitis 41.53 9.92 136 187823 32471 110368869
Hypocalcaemia 41.44 9.92 220 187739 65146 110336194
Bacteraemia 41.33 9.92 162 187797 42228 110359112
Respiratory dyskinesia 41.32 9.92 12 187947 72 110401268
Rash 41.29 9.92 1071 186888 819893 109581447
Cachexia 41.21 9.92 77 187882 12928 110388412
Neuroglycopenia 41.16 9.92 25 187934 1101 110400239
Escherichia bacteraemia 41.10 9.92 67 187892 10097 110391243
Therapy non-responder 40.85 9.92 134 187825 157173 110244167
Blood magnesium decreased 40.85 9.92 99 187860 19897 110381443
Injection site pruritus 40.75 9.92 18 187941 51240 110350100
Disease progression 40.56 9.92 611 187348 243423 110157917
Emotional distress 40.23 9.92 167 187792 44680 110356660
Prescribed overdose 40.12 9.92 54 187905 87527 110313813
Inappropriate schedule of product administration 39.86 9.92 194 187765 203443 110197897
Cholecystitis 39.52 9.92 115 187844 25767 110375573
Intestinal obstruction 39.28 9.92 187 187772 53040 110348300
Accidental exposure to product 39.07 9.92 18 187941 49990 110351350
Tumour lysis syndrome 38.81 9.92 128 187831 30673 110370667
Gait disturbance 38.75 9.92 295 187664 277913 110123427
Encephalopathy 38.59 9.92 253 187706 80802 110320538
Blood cholesterol decreased 38.51 9.92 34 187925 2682 110398658
Gastroenteritis 38.42 9.92 149 187810 38651 110362689
Pulmonary interstitial emphysema syndrome 38.36 9.92 19 187940 556 110400784
Urinary tract infection 38.07 9.92 772 187187 325510 110075830
Ileus paralytic 37.83 9.92 70 187889 11667 110389673
Fall 37.73 9.92 761 187198 602721 109798619
Mouth ulceration 37.64 9.92 172 187787 47966 110353374
No adverse event 37.54 9.92 42 187917 73797 110327543
Dyskinesia 37.43 9.92 180 187779 51266 110350074
Premature delivery 36.56 9.92 125 187834 30507 110370833
Drug ineffective for unapproved indication 36.36 9.92 299 187660 102539 110298801
Aminoaciduria 36.17 9.92 16 187943 360 110400980
Muscle rigidity 35.95 9.92 106 187853 23925 110377415
Heart rate decreased 35.95 9.92 53 187906 82703 110318637
Blood creatinine increased 35.23 9.92 470 187489 182419 110218921
Insomnia 35.01 9.92 418 187541 360172 110041168
Cancer pain 34.96 9.92 50 187909 6722 110394618
Onychomycosis 34.87 9.92 11 187948 38520 110362820
Blood urea increased 34.86 9.92 185 187774 54772 110346568
Intestinal perforation 34.85 9.92 96 187863 20848 110380492
Aplasia 34.72 9.92 54 187905 7819 110393521
Jaundice 34.61 9.92 195 187764 59041 110342299
Pregnancy 34.61 9.92 22 187937 51045 110350295
Vascular encephalopathy 34.58 9.92 20 187939 804 110400536
COVID-19 34.53 9.92 259 187700 244801 110156539
Oral candidiasis 34.31 9.92 159 187800 44601 110356739
Joint dislocation 34.25 9.92 8 187951 34182 110367158
Aspartate aminotransferase increased 34.19 9.92 419 187540 159517 110241823
Enteritis 34.08 9.92 90 187869 19066 110382274
Nail disorder 34.03 9.92 29 187930 57906 110343434
Ear infection 33.78 9.92 34 187925 62698 110338642
Neutropenic colitis 33.75 9.92 54 187905 8011 110393329
Left ventricular dysfunction 33.60 9.92 102 187857 23391 110377949
Drug abuse 33.58 9.92 171 187788 177240 110224100
Oedema 33.49 9.92 214 187745 209762 110191578
Joint injury 33.48 9.92 13 187946 39981 110361359
Gastric polyps 33.36 9.92 44 187915 5479 110395861
Clonus 33.29 9.92 56 187903 8660 110392680
Hyperglycaemia 33.15 9.92 253 187706 84837 110316503
Palmar-plantar erythrodysaesthesia syndrome 33.13 9.92 148 187811 40877 110360463
Mixed liver injury 32.79 9.92 67 187892 12012 110389328
Respiratory failure 32.68 9.92 531 187428 214801 110186539
Calcium deficiency 32.67 9.92 22 187937 1160 110400180
PCO2 increased 32.63 9.92 27 187932 1950 110399390
Sinobronchitis 32.37 9.92 16 187943 466 110400874
Anuria 32.33 9.92 103 187856 24238 110377102
Pruritus 32.11 9.92 748 187211 580812 109820528
Post concussion syndrome 31.78 9.92 18 187941 695 110400645
Hyperprolactinaemia 31.69 9.92 47 187912 6528 110394812
Non-small cell lung cancer 31.67 9.92 52 187907 7883 110393457
Cataract 31.59 9.92 54 187905 79431 110321909
PO2 increased 31.54 9.92 24 187935 1535 110399805
Lower respiratory tract infection 31.44 9.92 263 187696 242843 110158497
Duodenal stenosis 31.43 9.92 20 187939 957 110400383
Device expulsion 31.40 9.92 7 187952 30884 110370456
Drug interaction 31.20 9.92 1090 186869 499093 109902247
Syncope 30.94 9.92 500 187459 202036 110199304
Chills 30.82 9.92 475 187484 190105 110211235
Stress 30.75 9.92 85 187874 105263 110296077
Maternal exposure during delivery 30.70 9.92 34 187925 3531 110397809
Wrong technique in product usage process 30.63 9.92 64 187895 87284 110314056
Liver disorder 30.52 9.92 131 187828 142112 110259228
Angioedema 30.44 9.92 278 187681 98222 110303118
Tumour pain 30.34 9.92 31 187928 2936 110398404
Muscle spasms 30.34 9.92 314 187645 277843 110123497
Immunodeficiency 30.31 9.92 14 187945 38824 110362516
Eructation 30.23 9.92 71 187888 13986 110387354
Paraesthesia oral 29.90 9.92 125 187834 33546 110367794
Therapy interrupted 29.19 9.92 25 187934 49797 110351543
Apallic syndrome 29.17 9.92 20 187939 1086 110400254
Infection 28.60 9.92 438 187521 361762 110039578
Drug tolerance decreased 28.49 9.92 6 187953 27534 110373806
Joint stiffness 28.30 9.92 44 187915 67199 110334141
Hypophosphataemia 27.78 9.92 121 187838 33061 110368279
Laryngitis 27.76 9.92 19 187940 42392 110358948
Suicide attempt 27.59 9.92 87 187872 103307 110298033
Deep vein thrombosis 27.56 9.92 361 187598 139526 110261814
Back injury 27.51 9.92 24 187935 47375 110353965
Acute abdomen 27.15 9.92 31 187928 3330 110398010
Dry mouth 26.91 9.92 214 187745 199734 110201606
Pancreatitis acute 26.81 9.92 185 187774 60089 110341251
Circulatory collapse 26.77 9.92 144 187815 42849 110358491
Nasal congestion 26.72 9.92 82 187877 98200 110303140
Toxic encephalopathy 26.58 9.92 71 187888 15143 110386197
Hyperbilirubinaemia 26.56 9.92 113 187846 30558 110370782
Peripheral sensory neuropathy 26.32 9.92 75 187884 16605 110384735
Hepatitis fulminant 26.28 9.92 50 187909 8510 110392830
Starvation 25.81 9.92 18 187941 1005 110400335
Dysuria 25.69 9.92 183 187776 60048 110341292
Sinus tachycardia 25.68 9.92 146 187813 44347 110356993
Leukocytosis 25.61 9.92 168 187791 53660 110347680
Macular degeneration 25.51 9.92 88 187871 21571 110379769
Ejection fraction decreased 25.51 9.92 137 187822 40743 110360597
Intentional overdose 25.48 9.92 127 187832 132374 110268966
Immune-mediated hepatitis 25.47 9.92 43 187916 6668 110394672
Underdose 25.42 9.92 43 187916 63511 110337829
Maternal exposure timing unspecified 25.29 9.92 3 187956 21010 110380330
Peptic ulcer 25.26 9.92 46 187913 7573 110393767
Hydronephrosis 25.25 9.92 85 187874 20580 110380760
Skin candida 25.05 9.92 25 187934 2303 110399037
Illness 24.96 9.92 65 187894 82106 110319234
Blood pressure diastolic decreased 24.96 9.92 15 187944 35870 110365470
Upper gastrointestinal haemorrhage 24.84 9.92 158 187801 49938 110351402
Multiple drug therapy 24.84 9.92 47 187912 7967 110393373
Diabetes insipidus 24.81 9.92 42 187917 6528 110394812
Alveolitis 24.73 9.92 34 187925 4405 110396935
Non-cardiac chest pain 24.70 9.92 54 187905 10144 110391196
Genital erythema 24.65 9.92 12 187947 338 110401002
Carcinoid tumour of the stomach 24.55 9.92 10 187949 182 110401158
Vitamin B12 decreased 24.51 9.92 37 187922 5220 110396120
Faecaloma 24.47 9.92 68 187891 14840 110386500
Injection site rash 24.43 9.92 5 187954 23414 110377926
Failure to thrive 24.38 9.92 64 187895 13510 110387830
Respiratory tract congestion 24.27 9.92 11 187948 30846 110370494
Anxiety disorder 24.25 9.92 36 187923 5004 110396336
Adverse reaction 24.15 9.92 10 187949 29584 110371756
Autoimmune thyroiditis 24.12 9.92 41 187918 6393 110394947
Seizure 24.04 9.92 518 187441 220667 110180673
Fluid retention 24.02 9.92 81 187878 94226 110307114
Infusion site streaking 23.91 9.92 14 187945 576 110400764
Stupor 23.81 9.92 47 187912 8218 110393122
Paradoxical drug reaction 23.80 9.92 52 187907 9765 110391575
Proctitis 23.75 9.92 73 187886 16854 110384486
Excessive eye blinking 23.74 9.92 22 187937 1848 110399492
Polydipsia 23.72 9.92 45 187914 7643 110393697
Neck pain 23.69 9.92 118 187841 123012 110278328
Food allergy 23.63 9.92 3 187956 19945 110381395
Myocardial reperfusion injury 23.63 9.92 9 187950 136 110401204
Drug hypersensitivity 23.41 9.92 590 187369 453500 109947840
Secondary adrenocortical insufficiency 23.27 9.92 33 187926 4401 110396939
Renal ischaemia 23.26 9.92 24 187935 2299 110399041
Torticollis 23.18 9.92 28 187931 3193 110398147
Blood bicarbonate decreased 23.15 9.92 38 187921 5759 110395581
Vaginal discharge 23.08 9.92 75 187884 17833 110383507
Pulmonary sepsis 23.00 9.92 36 187923 5242 110396098
Back disorder 22.82 9.92 4 187955 20918 110380422
Urosepsis 22.80 9.92 108 187851 30567 110370773
Generalised tonic-clonic seizure 22.67 9.92 165 187794 54515 110346825
Drug clearance decreased 22.11 9.92 31 187928 4091 110397249
Procedural pain 22.06 9.92 119 187840 35446 110365894
Female genital tract fistula 22.03 9.92 70 187889 16449 110384891
Pseudomonal sepsis 22.02 9.92 48 187911 8998 110392342
Fluid replacement 21.97 9.92 16 187943 957 110400383
Agitation 21.96 9.92 291 187668 112760 110288580
Renal failure 21.93 9.92 522 187437 226052 110175288
Gaze palsy 21.92 9.92 28 187931 3379 110397961
Immune effector cell-associated neurotoxicity syndrome 21.92 9.92 65 187894 14717 110386623
Device issue 21.90 9.92 16 187943 34519 110366821
Venoocclusive disease 21.90 9.92 39 187920 6311 110395029
Metastases to spinal cord 21.82 9.92 10 187949 245 110401095
Gelastic seizure 21.76 9.92 5 187954 9 110401331
Dementia 21.74 9.92 109 187850 31564 110369776
Cholangitis 21.59 9.92 69 187890 16266 110385074
Vaginal flatulence 21.55 9.92 57 187902 12087 110389253
Genitourinary tract neoplasm 21.45 9.92 7 187952 65 110401275
Impaired work ability 21.44 9.92 9 187950 26410 110374930
Chronic sinusitis 21.40 9.92 92 187867 24992 110376348
Interstitial lung disease 21.28 9.92 344 187615 138990 110262350
Sudden death 21.22 9.92 90 187869 24305 110377035
Hyperhidrosis 21.12 9.92 441 187518 186857 110214483
Anaphylactic reaction 20.88 9.92 291 187668 114009 110287331
Respiratory alkalosis 20.85 9.92 36 187923 5685 110395655
Pancreatitis 20.84 9.92 247 187712 93286 110308054
Hemianopia 20.75 9.92 25 187934 2843 110398497
Lymphopenia 20.73 9.92 128 187831 40042 110361298
Gastrointestinal disorder 20.69 9.92 288 187671 241664 110159676
Tachypnoea 20.63 9.92 126 187833 39269 110362071
Oropharyngeal spasm 20.62 9.92 12 187947 488 110400852
Generalised oedema 20.61 9.92 105 187854 30599 110370741
Liver function test increased 20.60 9.92 79 187880 88469 110312871
Off label use 20.55 9.92 2235 185724 1497950 108903390
Obstruction gastric 20.54 9.92 21 187938 1990 110399350
Diabetic gastroparesis 20.28 9.92 11 187948 390 110400950
Intestinal ischaemia 20.17 9.92 67 187892 16112 110385228
Hepatic cirrhosis 20.16 9.92 54 187905 67572 110333768
Conjunctival irritation 20.14 9.92 8 187951 136 110401204
Disease recurrence 20.10 9.92 46 187913 60738 110340602
Flushing 20.09 9.92 269 187690 104467 110296873
Enterochromaffin cell hyperplasia 20.07 9.92 7 187952 81 110401259
Incorrect route of product administration 19.98 9.92 50 187909 64011 110337329
Hypoglycaemia 19.78 9.92 292 187667 115812 110285528
Sinus disorder 19.69 9.92 16 187943 32712 110368628
Abdominal tenderness 19.65 9.92 56 187903 12401 110388939
Klebsiella bacteraemia 19.56 9.92 32 187927 4837 110396503
Myoclonus 19.52 9.92 109 187850 32889 110368451
Venous angioma of brain 19.51 9.92 6 187953 45 110401295
Amylase increased 19.47 9.92 56 187903 12463 110388877
Visual impairment 19.44 9.92 141 187818 134287 110267053
Hyperreflexia 19.42 9.92 47 187912 9438 110391902
Ultrasound foetal abnormal 19.41 9.92 7 187952 90 110401250
Aortic rupture 19.40 9.92 9 187950 227 110401113
Peripheral motor neuropathy 19.40 9.92 29 187930 4057 110397283
Methaemoglobinaemia 19.38 9.92 46 187913 9122 110392218
Intentional self-injury 19.35 9.92 21 187938 37408 110363932
Feeling abnormal 19.29 9.92 205 187754 180506 110220834
Pituitary tumour benign 19.27 9.92 24 187935 2823 110398517
Lung infiltration 19.25 9.92 88 187871 24540 110376800
Therapy cessation 19.22 9.92 29 187930 44828 110356512
Large intestine perforation 19.10 9.92 67 187892 16562 110384778
Hypochloraemia 19.10 9.92 27 187932 3591 110397749
Product dose omission in error 19.10 9.92 8 187951 23504 110377836
Throat irritation 18.97 9.92 39 187920 53513 110347827
Hospitalisation 18.94 9.92 153 187806 142340 110259000
Flail chest 18.86 9.92 7 187952 98 110401242
Inappropriate antidiuretic hormone secretion 18.83 9.92 110 187849 33741 110367599
Weight decreased 18.76 9.92 974 186985 467083 109934257
Bone marrow failure 18.76 9.92 165 187794 57683 110343657
Muscle spasticity 18.73 9.92 20 187939 35895 110365445
Erysipelas 18.70 9.92 57 187902 13101 110388239
Blood pressure systolic increased 18.69 9.92 75 187884 82916 110318424
Dyspnoea 18.67 9.92 2151 185808 1104721 109296619
Lethargy 18.64 9.92 242 187717 93334 110308006
Hyponatraemic seizure 18.64 9.92 13 187946 726 110400614
Rhinovirus infection 18.59 9.92 53 187906 11736 110389604
Drug use disorder 18.57 9.92 4 187955 18070 110383270
Nail infection 18.51 9.92 22 187937 2466 110398874
Malignant polyp 18.50 9.92 8 187951 170 110401170
Radiation pneumonitis 18.47 9.92 30 187929 4506 110396834
Electrocardiogram T wave inversion 18.46 9.92 34 187925 5646 110395694
Polyneuropathy 18.45 9.92 105 187854 31907 110369433
Immune-mediated enterocolitis 18.27 9.92 48 187911 10137 110391203
Taste disorder 18.17 9.92 54 187905 65333 110336007
Eye irritation 18.16 9.92 18 187941 33434 110367906
Vascular access site occlusion 17.95 9.92 7 187952 113 110401227
Opisthotonus 17.92 9.92 13 187946 773 110400567
Blood sodium decreased 17.87 9.92 119 187840 38200 110363140
Onychalgia 17.67 9.92 15 187944 1122 110400218
Cystitis noninfective 17.66 9.92 18 187941 1700 110399640
Pancreatic carcinoma metastatic 17.59 9.92 28 187931 4136 110397204
Febrile infection 17.55 9.92 29 187930 4419 110396921
Cyanosis 17.43 9.92 98 187861 29643 110371697
Blood creatine increased 17.40 9.92 51 187908 11470 110389870
Biliary dyskinesia 17.34 9.92 21 187938 2400 110398940
Neoplasm progression 17.34 9.92 177 187782 64418 110336922
Bile duct stenosis 17.23 9.92 22 187937 2654 110398686
Liver function test abnormal 17.13 9.92 186 187773 68764 110332576
Epilepsy 17.08 9.92 100 187859 100109 110301231
Post transplant lymphoproliferative disorder 17.00 9.92 3 187956 15610 110385730
Papillary cystadenoma lymphomatosum 16.95 9.92 8 187951 210 110401130
Bronchial aspiration procedure 16.88 9.92 9 187950 308 110401032
Oesophageal ulcer 16.88 9.92 40 187919 7924 110393416
Obstructive airways disorder 16.87 9.92 33 187926 46116 110355224
Haematopoietic stem cell mobilisation 16.83 9.92 10 187949 423 110400917
Influenza 16.79 9.92 195 187764 168906 110232434
Radiculopathy 16.56 9.92 71 187888 19265 110382075
Proctitis bacterial 16.53 9.92 7 187952 141 110401199
Bradykinesia 16.53 9.92 48 187911 10740 110390600
Blood pH decreased 16.52 9.92 29 187930 4640 110396700
Atrial fibrillation 16.49 9.92 509 187450 229133 110172207
Embolism 16.49 9.92 63 187896 16226 110385114
Acanthosis 16.49 9.92 11 187948 571 110400769
Muscle twitching 16.48 9.92 97 187862 29838 110371502
Sneezing 16.47 9.92 18 187941 31966 110369374
Staphylococcal sepsis 16.45 9.92 66 187893 17388 110383952
Pericardial effusion 16.43 9.92 159 187800 57058 110344282
Thymus disorder 16.42 9.92 11 187948 575 110400765
Escherichia test positive 16.39 9.92 25 187934 3559 110397781
Incorrect dose administered 16.33 9.92 106 187853 103535 110297805
Dysaesthesia 16.29 9.92 36 187923 6811 110394529
Sopor 16.27 9.92 23 187936 36523 110364817
Disturbance in social behaviour 16.09 9.92 30 187929 5028 110396312
Acne 16.04 9.92 20 187939 33500 110367840
Product use in unapproved indication 16.02 9.92 610 187349 446767 109954573
Tenosynovitis 15.94 9.92 4 187955 16279 110385061
Device difficult to use 15.93 9.92 6 187953 18799 110382541
Stress cardiomyopathy 15.89 9.92 61 187898 15745 110385595
Xeroderma 15.81 9.92 11 187948 612 110400728
Full blood count abnormal 15.78 9.92 46 187913 56006 110345334
Pure white cell aplasia 15.76 9.92 7 187952 159 110401181
Toxic skin eruption 15.69 9.92 90 187869 27425 110373915
Eosinophilia 15.67 9.92 159 187800 57777 110343563
Presyncope 15.62 9.92 139 187820 48748 110352592
Disability 15.57 9.92 17 187942 30206 110371134
Spleen congestion 15.52 9.92 10 187949 489 110400851
Injection site haemorrhage 15.50 9.92 20 187939 33008 110368332
Mesothelioma 15.49 9.92 9 187950 365 110400975
Neonatal gastrointestinal disorder 15.46 9.92 5 187954 45 110401295
Hypogonadism 15.45 9.92 18 187941 1976 110399364
Hyperkalaemia 15.39 9.92 320 187639 135476 110265864
Adrenal insufficiency 15.38 9.92 124 187835 42266 110359074
Allergic sinusitis 15.36 9.92 17 187942 1764 110399576
Omentectomy 15.36 9.92 5 187954 46 110401294
Drug dose omission by device 15.35 9.92 3 187956 14513 110386827
Vascular pain 15.28 9.92 14 187945 1159 110400181
Extravasation blood 15.27 9.92 10 187949 503 110400837
Acute generalised exanthematous pustulosis 15.18 9.92 75 187884 21589 110379751
Colorectal cancer metastatic 15.17 9.92 16 187943 1573 110399767
Oxygen saturation abnormal 15.08 9.92 31 187928 5580 110395760
Foetal heart rate disorder 15.08 9.92 5 187954 49 110401291
Morning sickness 15.08 9.92 12 187947 820 110400520
Amnesia 15.03 9.92 111 187848 105297 110296043
Laryngeal cancer metastatic 14.99 9.92 5 187954 50 110401290
Trismus 14.94 9.92 34 187925 6562 110394778
Therapy partial responder 14.89 9.92 25 187934 37036 110364304
Performance status decreased 14.87 9.92 36 187923 7230 110394110
Paraesthesia 14.86 9.92 357 187602 276164 110125176
Hypometabolism 14.82 9.92 7 187952 184 110401156
Impetigo 14.81 9.92 20 187939 2548 110398792
Mucosal erosion 14.80 9.92 21 187938 2803 110398537
Gastrointestinal sounds abnormal 14.73 9.92 32 187927 5986 110395354
Hepatitis acute 14.63 9.92 67 187892 18699 110382641
Agranulocytosis 14.61 9.92 165 187794 61595 110339745
Metastases to central nervous system 14.60 9.92 77 187882 22740 110378600
Abdominal sepsis 14.60 9.92 19 187940 2336 110399004
Acute interstitial pneumonitis 14.59 9.92 15 187944 1431 110399909
Metastatic malignant melanoma 14.50 9.92 23 187936 3386 110397954
Pelvic neoplasm 14.46 9.92 8 187951 295 110401045
Suicidal ideation 14.33 9.92 97 187862 93840 110307500
Erythema 14.33 9.92 619 187340 290828 110110512
Enterocolitis infectious 14.33 9.92 23 187936 3421 110397919
Bronchiectasis 14.31 9.92 25 187934 36468 110364872
Naevus haemorrhage 14.26 9.92 6 187953 119 110401221
Leukoencephalopathy 14.18 9.92 41 187918 9154 110392186
Joint effusion 14.17 9.92 9 187950 20896 110380444
Gallbladder injury 14.17 9.92 14 187945 1274 110400066
Dry eye 14.15 9.92 48 187911 55745 110345595
Renal impairment 14.15 9.92 420 187539 188025 110213315
Lung perforation 14.08 9.92 6 187953 123 110401217
Laboratory test abnormal 14.06 9.92 34 187925 44045 110357295
Immune reconstitution inflammatory syndrome 14.04 9.92 5 187954 16221 110385119
Nightmare 14.03 9.92 28 187931 38835 110362505
Hypersensitivity 13.99 9.92 553 187406 403445 109997895
Sulphaemoglobinaemia 13.93 9.92 10 187949 585 110400755
Lacrimation increased 13.76 9.92 95 187864 30855 110370485
COVID-19 treatment 13.72 9.92 9 187950 454 110400886
Tooth disorder 13.71 9.92 18 187941 29491 110371849
Carpal tunnel syndrome 13.67 9.92 11 187948 22599 110378741
Galactorrhoea 13.67 9.92 25 187934 4130 110397210
Hiatus hernia 13.64 9.92 87 187872 27519 110373821
Duodenal perforation 13.64 9.92 20 187939 2750 110398590
Multiple sclerosis relapse 13.59 9.92 42 187917 50198 110351142
Transplant rejection 13.59 9.92 13 187946 24554 110376786
Superior vena cava occlusion 13.53 9.92 7 187952 225 110401115
Burning sensation 13.50 9.92 66 187893 69146 110332194
Device related infection 13.48 9.92 114 187845 39405 110361935
Blood disorder 13.48 9.92 42 187917 9768 110391572
Neutrophilic dermatosis 13.45 9.92 11 187948 781 110400559
Multiple-drug resistance 13.45 9.92 3 187956 13232 110388108
Paresis 13.30 9.92 27 187932 4817 110396523
Proctalgia 13.27 9.92 51 187908 13171 110388169
Hypergastrinaemia 13.26 9.92 8 187951 348 110400992
Platelet transfusion 13.23 9.92 20 187939 2826 110398514
Herpes zoster 13.22 9.92 119 187840 108260 110293080
Tumour perforation 13.20 9.92 10 187949 635 110400705
Polyglandular disorder 13.14 9.92 7 187952 239 110401101
Intentional dose omission 13.13 9.92 9 187950 20071 110381269
Procedural nausea 13.13 9.92 13 187946 1186 110400154
Live birth 13.13 9.92 67 187892 69417 110331923
Metastases to liver 13.11 9.92 104 187855 35282 110366058
Antinuclear antibody negative 13.09 9.92 6 187953 147 110401193
Cholelithiasis 13.05 9.92 165 187794 63257 110338083
Papillary renal cell carcinoma 13.00 9.92 8 187951 361 110400979
Initial insomnia 12.93 9.92 43 187916 10346 110390994
Infusion site reaction 12.86 9.92 7 187952 17675 110383665
Therapeutic response shortened 12.79 9.92 19 187940 29564 110371776
Stomatitis haemorrhagic 12.73 9.92 7 187952 255 110401085
Vocal cord inflammation 12.71 9.92 7 187952 256 110401084
Mood swings 12.70 9.92 12 187947 22800 110378540
Decubitus ulcer 12.69 9.92 63 187896 18173 110383167
C-reactive protein increased 12.64 9.92 278 187681 217641 110183699
Blood phosphorus decreased 12.62 9.92 35 187924 7630 110393710
Hypercalcaemia 12.59 9.92 128 187831 46529 110354811
Eastern Cooperative Oncology Group performance status worsened 12.59 9.92 20 187939 2949 110398391
Erectile dysfunction 12.57 9.92 8 187951 18548 110382792
Heart sounds abnormal 12.53 9.92 14 187945 1468 110399872
Thrombosis 12.53 9.92 121 187838 108541 110292799
Neonatal respiratory depression 12.48 9.92 5 187954 87 110401253
Metastases to abdominal cavity 12.47 9.92 11 187948 867 110400473
Multiple organ dysfunction syndrome 12.46 9.92 342 187617 151368 110249972
Spinal cord injury thoracic 12.46 9.92 6 187953 165 110401175
Mechanical ileus 12.44 9.92 13 187946 1264 110400076
Dermatitis exfoliative 12.42 9.92 45 187914 11302 110390038
Muscle atrophy 12.40 9.92 50 187909 13204 110388136
Device breakage 12.34 9.92 4 187955 13765 110387575
Thoracic operation 12.32 9.92 7 187952 272 110401068
Impaired quality of life 12.29 9.92 20 187939 29997 110371343
Cytomegalovirus infection reactivation 12.28 9.92 8 187951 18325 110383015
Paraneoplastic pleural effusion 12.27 9.92 4 187955 37 110401303
Hyperthermia malignant 12.24 9.92 23 187936 3877 110397463
Irritability 12.22 9.92 41 187918 47768 110353572
Hypertension 12.19 9.92 726 187233 509358 109891982
Abdominal wall mass 12.13 9.92 5 187954 94 110401246
Nephrogenic systemic fibrosis 12.12 9.92 28 187931 5455 110395885
Streptococcal endocarditis 12.11 9.92 7 187952 281 110401059
Aortitis 12.09 9.92 16 187943 1999 110399341
Foetal malpresentation 12.03 9.92 5 187954 96 110401244
Atrioventricular block first degree 12.00 9.92 52 187907 14173 110387167
Lipase increased 11.94 9.92 63 187896 18609 110382731
Aphasia 11.93 9.92 153 187806 58844 110342496
Pyloric stenosis 11.86 9.92 9 187950 573 110400767
Sinus congestion 11.82 9.92 21 187938 30438 110370902
Skin infection 11.79 9.92 72 187887 22437 110378903
Blood aluminium increased 11.76 9.92 3 187956 10 110401330
Haemorrhoids 11.69 9.92 102 187857 35570 110365770
Immune-mediated hypothyroidism 11.69 9.92 19 187940 2856 110398484
Plantar erythema 11.63 9.92 7 187952 303 110401037
Schizophrenia 11.55 9.92 12 187947 21814 110379526
Retching 11.53 9.92 72 187887 22610 110378730
Electrocardiogram change 11.52 9.92 13 187946 1378 110399962
Spinal cord paralysis 11.51 9.92 6 187953 196 110401144
Hypoglycaemic seizure 11.51 9.92 11 187948 961 110400379
Mania 11.51 9.92 11 187948 20785 110380555
Respiratory syncytial virus infection 11.51 9.92 52 187907 14432 110386908
Lip erosion 11.48 9.92 15 187944 1851 110399489
Exposure via skin contact 11.47 9.92 4 187955 13143 110388197
Eye pain 11.46 9.92 45 187914 50054 110351286
Basal cell carcinoma 11.45 9.92 39 187920 45231 110356109
Dermatitis atopic 11.44 9.92 16 187943 25525 110375815
Toxic cardiomyopathy 11.43 9.92 10 187949 779 110400561
Stomatitis 11.39 9.92 361 187598 269881 110131459
Blood parathyroid hormone decreased 11.38 9.92 4 187955 13085 110388255
Affect lability 11.35 9.92 9 187950 18628 110382712
Chorea 11.33 9.92 20 187939 3215 110398125
Ulcer haemorrhage 11.30 9.92 13 187946 22558 110378782
Increased tendency to bruise 11.30 9.92 3 187956 11755 110389585
Symmetrical drug-related intertriginous and flexural exanthema 11.29 9.92 15 187944 1882 110399458
Anaemia of malignant disease 11.28 9.92 11 187948 985 110400355
Ocular hyperaemia 11.24 9.92 32 187927 39254 110362086
Candida infection 11.23 9.92 128 187831 47881 110353459
Delusional disorder, persecutory type 11.18 9.92 9 187950 625 110400715
Myalgia 11.16 9.92 290 187669 222091 110179249
Seborrhoeic dermatitis 11.16 9.92 18 187941 2689 110398651
Face oedema 11.13 9.92 96 187863 33373 110367967
Injection site warmth 11.12 9.92 8 187951 17397 110383943
Poor peripheral circulation 11.06 9.92 23 187936 4174 110397166
Disseminated intravascular coagulation 11.02 9.92 113 187846 41173 110360167
Disorientation 10.98 9.92 175 187784 70496 110330844
Electroencephalogram abnormal 10.98 9.92 29 187930 6144 110395196
Tremor 10.96 9.92 434 187525 201798 110199542
Walking aid user 10.95 9.92 16 187943 25059 110376281
Protein total decreased 10.93 9.92 42 187917 10848 110390492
Bladder cancer 10.92 9.92 11 187948 20281 110381059
Foetal death 10.86 9.92 55 187904 15990 110385350
Autoimmune lung disease 10.85 9.92 6 187953 221 110401119
Autoimmune haemolytic anaemia 10.80 9.92 41 187918 10526 110390814
Musculoskeletal chest pain 10.80 9.92 85 187874 28762 110372578
Acute respiratory distress syndrome 10.77 9.92 138 187821 53060 110348280
Brain oedema 10.76 9.92 90 187869 31008 110370332
Respiratory depression 10.75 9.92 92 187867 31909 110369431
Bone density decreased 10.75 9.92 7 187952 16035 110385305
Pneumoperitoneum 10.70 9.92 22 187937 3962 110397378
Foetal heart rate abnormal 10.69 9.92 9 187950 666 110400674
Hyperuricaemia 10.68 9.92 51 187908 14480 110386860
Peritoneal neoplasm 10.67 9.92 5 187954 129 110401211
Muscle contracture 10.67 9.92 18 187941 2790 110398550
Prostate cancer metastatic 10.66 9.92 25 187934 4918 110396422
Haemoglobin decreased 10.65 9.92 521 187438 248206 110153134
Hypertonia 10.65 9.92 35 187924 8371 110392969
Blood albumin decreased 10.64 9.92 82 187877 27570 110373770
Depression 10.63 9.92 436 187523 316899 110084441
Urea urine increased 10.63 9.92 3 187956 16 110401324
Epileptic encephalopathy 10.57 9.92 9 187950 676 110400664
Benign soft tissue neoplasm 10.57 9.92 5 187954 132 110401208
Cholestatic liver injury 10.53 9.92 32 187927 7344 110393996
Limb injury 10.51 9.92 31 187928 37605 110363735
Heart rate irregular 10.49 9.92 27 187932 34247 110367093
Chemotherapeutic drug level increased 10.48 9.92 8 187951 514 110400826
Gastrointestinal dilation procedure 10.48 9.92 3 187956 17 110401323
Cardiac murmur 10.47 9.92 16 187943 24612 110376728
Skin burning sensation 10.47 9.92 13 187946 21812 110379528
Diffuse alveolar damage 10.46 9.92 22 187937 4025 110397315
Porphyria 10.45 9.92 6 187953 238 110401102
Sedation complication 10.42 9.92 11 187948 19844 110381496
Radiation oesophagitis 10.36 9.92 10 187949 884 110400456
Blood potassium increased 10.35 9.92 94 187865 33155 110368185
Blood pressure diastolic increased 10.35 9.92 10 187949 18797 110382543
Cardio-respiratory arrest 10.34 9.92 264 187695 115572 110285768
Oesophageal neoplasm 10.33 9.92 5 187954 139 110401201
Skin cancer 10.32 9.92 9 187950 17775 110383565
Gastritis haemorrhagic 10.32 9.92 19 187940 3154 110398186
Gout 10.30 9.92 30 187929 36536 110364804
Ear pain 10.24 9.92 51 187908 53175 110348165
Vena cava thrombosis 10.23 9.92 20 187939 3474 110397866
Dyschezia 10.19 9.92 21 187938 3786 110397554
Pathogen resistance 10.19 9.92 9 187950 17663 110383677
Panniculitis 10.17 9.92 7 187952 15575 110385765
Posterior reversible encephalopathy syndrome 10.17 9.92 95 187864 33766 110367574
Muscle contractions involuntary 10.17 9.92 23 187936 4421 110396919
Adjustment disorder with anxiety 10.14 9.92 5 187954 145 110401195
Pneumovirus test positive 10.13 9.92 4 187955 67 110401273
Biliary sepsis 10.09 9.92 14 187945 1829 110399511
Restless arm syndrome 10.07 9.92 4 187955 68 110401272
AST/ALT ratio abnormal 10.04 9.92 5 187954 148 110401192
Nervous system disorder 10.04 9.92 90 187869 31631 110369709
Congenital anomaly in offspring 10.02 9.92 4 187955 69 110401271
Presbyopia 9.98 9.92 9 187950 730 110400610
Blood potassium decreased 9.97 9.92 138 187821 53976 110347364
Acute pulmonary oedema 9.96 9.92 56 187903 16940 110384400
Oesophageal stenosis 9.94 9.92 25 187934 5140 110396200
Headache 9.94 9.92 1331 186628 881046 109520294
Cholecystitis acute 9.92 9.92 53 187906 15729 110385611

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A03FA01 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
PROPULSIVES
Propulsives
MeSH PA D000932 Antiemetics
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D015259 Dopamine Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018492 Dopamine Antagonists
MeSH PA D065127 Dopamine D2 Receptor Antagonists
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:48561 dopaminergic antagonist
CHEBI has role CHEBI:50919 antiemetic
CHEBI has role CHEBI:55324 gastrointestinal drug
FDA MoA N0000175799 Dopamine D2 Antagonists
FDA EPC N0000175800 Dopamine-2 Receptor Antagonist
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:50514 vasoconstrictor agent
CHEBI has role CHEBI:55323 antidiarrhoeal drug
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:73336 vulnerary
CHEBI has role CHEBI:76916 hyperglycemic agent
CHEBI has role CHEBI:78298 environmental contaminant

Related Drugs by ATC class:

A03FA Propulsives 9 drugs
acotiamidealizapridebromopridecinitapridecisaprideclebopridedomperidoneitopridemosapride

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

DiseaseRelationSNOMED_IDDOID
Diabetic gastroparesis indication 34140002
Intubation of gastrointestinal tract indication 235419001
Gastroesophageal reflux disease indication 235595009 DOID:8534
Chemotherapy-induced nausea and vomiting indication 236084000
Prevention of Post-Operative Nausea and Vomiting indication
Gastrointestinal Radiography Adjunct indication
Suicidal thoughts contraindication 6471006
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Cirrhosis of liver contraindication 19943007 DOID:5082
Parkinsonism contraindication 32798002
Depressive disorder contraindication 35489007
Hypertensive disorder contraindication 38341003 DOID:10763
Body fluid retention contraindication 43498006
Mechanical ileus contraindication 46420000
Chronic heart failure contraindication 48447003
Gastrointestinal perforation contraindication 51875005
Gastrointestinal hemorrhage contraindication 74474003
Tardive dyskinesia contraindication 102449007
Deficiency of cytochrome-b>5< reductase contraindication 124184009
Seizure disorder contraindication 128613002
Impaired renal function disorder contraindication 197663003
Anastomosis of intestine contraindication 235407009
Pheochromocytoma contraindication 302835009
Porphyria contraindication 418470004
Acquired torsion dystonia contraindication 433493000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.17 acidic
pKa2 8.94 Basic
pKa3 1.08 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 15MG BASE/SPRAY GIMOTI QOL MEDCL N209388 June 19, 2020 RX SPRAY, METERED NASAL 11020361 Dec. 22, 2029 NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS
EQ 15MG BASE/SPRAY GIMOTI QOL MEDCL N209388 June 19, 2020 RX SPRAY, METERED NASAL 11628150 Dec. 22, 2029 NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS
EQ 15MG BASE/SPRAY GIMOTI QOL MEDCL N209388 June 19, 2020 RX SPRAY, METERED NASAL 11813231 Dec. 22, 2029 NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS
EQ 15MG BASE/SPRAY GIMOTI QOL MEDCL N209388 June 19, 2020 RX SPRAY, METERED NASAL 12194008 Dec. 22, 2029 NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS
EQ 15MG BASE/SPRAY GIMOTI QOL MEDCL N209388 June 19, 2020 RX SPRAY, METERED NASAL 12194009 Dec. 22, 2029 NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS
EQ 15MG BASE/SPRAY GIMOTI QOL MEDCL N209388 June 19, 2020 RX SPRAY, METERED NASAL 8334281 May 16, 2030 NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS
EQ 15MG BASE/SPRAY GIMOTI QOL MEDCL N209388 June 19, 2020 RX SPRAY, METERED NASAL 12377064 Nov. 17, 2038 NASAL ADMINISTRATION OF METOCLOPRAMIDE FOR TREATMENT OF DIABETIC GASTROPARESIS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
D(2) dopamine receptor GPCR ANTAGONIST Ki 7.19 WOMBAT-PK CHEMBL
5-hydroxytryptamine receptor 3A Ion channel ANTAGONIST Ki 6.70 WOMBAT-PK CHEMBL
5-hydroxytryptamine receptor 4 GPCR AGONIST EC50 6 WOMBAT-PK CHEMBL
5-hydroxytryptamine receptor 2B GPCR Ki 6.40 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 5.90 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 7.66 WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR WOMBAT-PK
Aldehyde oxidase Enzyme IC50 4.51 WOMBAT-PK
Cytochrome P450 2D6 Enzyme IC50 6.10 DRUG MATRIX
Myeloperoxidase Enzyme IC50 6.46 CHEMBL
Solute carrier family 22 member 1 Transporter IC50 4.02 CHEMBL
Serotonin 3 (5-HT3) receptor Ion channel Kd 7.30 CHEMBL
Alpha-2A adrenergic receptor GPCR Ki 5.99 DRUG MATRIX
5-hydroxytryptamine receptor 2A GPCR Ki 5.98 DRUG MATRIX
D(2) dopamine receptor GPCR Ki 6.98 CHEMBL
D(2) dopamine receptor GPCR Ki 7.10 CHEMBL
D(2) dopamine receptor GPCR ANTAGONIST Ki 7.54 IUPHAR
5-hydroxytryptamine receptor 4 GPCR Ki 6.05 CHEMBL
D(3) dopamine receptor GPCR IC50 7.21 CHEMBL
Serotonin 3 (5-HT3) receptor Ion channel Ki 6.68 CHEMBL
Serotonin 1 (5-HT1) receptor GPCR IC50 5.11 CHEMBL
Adrenergic receptor alpha-2 GPCR IC50 5.11 CHEMBL
Adrenergic receptor alpha-1 GPCR IC50 4.48 CHEMBL
Serotonin 2 (5-HT2) receptor GPCR IC50 4.88 CHEMBL
Serotonin 3 receptor (5HT3) Ion channel Ki 6.70 CHEMBL
5-hydroxytryptamine receptor 4 GPCR Ki 6.26 CHEMBL
5-hydroxytryptamine receptor 4 GPCR AGONIST Ki 6 IUPHAR

External reference:

IDSource
4019835 VUID
N0000147923 NUI
D00726 KEGG_DRUG
54143-57-6 SECONDARY_CAS_RN
4017905 VANDF
4019835 VANDF
C0025853 UMLSCUI
CHEBI:107736 CHEBI
CHEMBL86 ChEMBL_ID
CHEMBL1200940 ChEMBL_ID
DB01233 DRUGBANK_ID
D008787 MESH_DESCRIPTOR_UI
4168 PUBCHEM_CID
241 IUPHAR_LIGAND_ID
1740 INN_ID
L4YEB44I46 UNII
267036 RXNORM
1062 MMSL
34842 MMSL
5099 MMSL
d00298 MMSL
001877 NDDF
004778 NDDF
31147000 SNOMEDCT_US
372776000 SNOMEDCT_US
56549003 SNOMEDCT_US
L4YEB44I46 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0093-2203 TABLET 10 mg ORAL ANDA 27 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0093-2204 TABLET 5 mg ORAL ANDA 27 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0121-0576 SOLUTION 5 mg ORAL ANDA 28 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0121-1576 SOLUTION 5 mg ORAL ANDA 28 sections
METOCLOPRAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9771 INJECTION 5 mg INTRAMUSCULAR ANDA 13 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0409-3414 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 15 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0409-5255 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 23 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0440-1771 TABLET 10 mg ORAL ANDA 22 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0615-7698 TABLET 5 mg ORAL ANDA 26 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0615-8285 TABLET 10 mg ORAL ANDA 26 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0703-4502 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 23 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 0703-4502 INJECTION, SOLUTION 5 mg INTRAMUSCULAR ANDA 23 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 12634-112 TABLET 10 mg ORAL ANDA 22 sections
METOCLOPRAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-150 TABLET 5 mg ORAL ANDA 25 sections
METOCLOPRAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-151 TABLET 10 mg ORAL ANDA 25 sections
REGLAN HUMAN PRESCRIPTION DRUG LABEL 1 16590-906 TABLET 10 mg ORAL NDA 24 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 17856-0576 SOLUTION 5 mg ORAL ANDA 24 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 17856-1190 SOLUTION 5 mg ORAL ANDA 16 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 21695-346 TABLET 10 mg ORAL ANDA 19 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 21695-485 TABLET 5 mg ORAL ANDA 19 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 23155-240 INJECTION 5 mg INTRAMUSCULAR ANDA 21 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 33261-166 TABLET 10 mg ORAL ANDA 22 sections
METOCLOPRAMIDE hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 40032-580 TABLET, ORALLY DISINTEGRATING 10 mg ORAL ANDA 25 sections
METOCLOPRAMIDE hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 40032-581 TABLET, ORALLY DISINTEGRATING 5 mg ORAL ANDA 25 sections
Metoclopramide Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42254-196 TABLET 5 mg ORAL ANDA 22 sections
Metoclopramide Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42254-266 TABLET 10 mg ORAL ANDA 22 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 42291-595 TABLET 5 mg ORAL ANDA 27 sections
Metoclopramide HUMAN PRESCRIPTION DRUG LABEL 1 42291-596 TABLET 10 mg ORAL ANDA 27 sections
Metoclopramide Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43353-808 TABLET 10 mg ORAL ANDA 22 sections
METOCLOPRAMIDE hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43386-580 TABLET, ORALLY DISINTEGRATING 10 mg ORAL ANDA 24 sections