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

Stem definitionDrug idCAS RN
597 55-56-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • chlorhexidine hydrochloride
  • chlorhexidine
  • chlorohex
  • chlorohexidine
  • chlorhexidine gluconate
  • chlorhexidine acetate
A disinfectant and topical anti-infective agent used also as mouthwash to prevent oral plaque.
  • Molecular weight: 505.45
  • Formula: C22H30Cl2N10
  • CLOGP: 4.81
  • LIPINSKI: 2
  • HAC: 10
  • HDO: 10
  • TPSA: 167.58
  • ALOGS: -4.29
  • ROTB: 9
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
30 mg O
30 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Bocci G, Oprea TI, Benet LZ
BA (Bioavailability) 1 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility) 0.03 mg/mL Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.973 Moderate 0.78
caco2-efflux Caco-2 efflux ratio (BA/AB) 14.791 Moderate 0.78
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.362 10^-6 cm/s Moderate 0.78
dh-clint Dog hepatocyte intrinsic clearance 8.630 uL/min/10^6 cells Moderate 0.78
dppb Dog plasma protein binding (% unbound) 0.150 % Moderate 0.78
fcs-ppb Fetal calf serum protein binding (% unbound) 6.670 % Moderate 0.78
herg hERG pIC50 5.170 pIC50 Moderate 0.78
hh-clint Human hepatocyte intrinsic clearance 15.453 uL/min/10^6 cells Moderate 0.78
hlm-clint Human liver microsomal intrinsic clearance 8.414 uL/min/mg protein Moderate 0.78
hppb Human plasma protein binding (% unbound) 0.450 % Moderate 0.78
kinase-safety-class ACVR2A,ACVR2B,AKT1,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK4,CDK5,CDK9,CHEK1,CSF1R,DDR1,DYRK1B,EIF2AK3,EPHA2,EPHB4,ERBB2,FLT3,GRK2,GSK3B,ITK,JAK1,JAK2,KIT,MAP2K1,MAP2K6,MAP3K1,MAP3K21,MAP3K7,MAP4K1,MAP4K3,MAPK1,MAPK12,MAPK7,MAPK9,MAPKAPK2,MARK4,MELK,MET,MTOR,NTRK2,PAK4,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1,ULK2 65
kinase-selectivity-class ACVR2A,ACVR2B,AXL,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,FLT3,GRK2,MAP3K21,MAPK12,MAPK7,PDK4,SIK2,STK33,TEK,TTK 18
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 8.670 Moderate 0.78
mh-clint Mouse hepatocyte intrinsic clearance 10.023 Moderate 0.78
mppb Mouse plasma protein binding (% unbound) 0.110 Moderate 0.78
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 38.107 Moderate 0.78
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 1.870 % Moderate 0.78
rh-clint Rat hepatocyte intrinsic clearance 9.226 uL/min/10^6 cells Moderate 0.78
rh-fuinc Rat hepatocyte fraction unbound in incubation 0.660 % Moderate 0.78
rppb Rat plasma protein binding (% unbound) 0.200 % Moderate 0.78
solubility-dd Solubility at pH 7.4 in DMSO 292.415 uM Moderate 0.78

Approvals:

DateAgencyCompanyOrphan
Sept. 17, 1976 FDA MOLNLYCKE HLTH

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
Folliculitis 2564.53 26.98 3081 263745 201272 90160349
Muscle injury 2262.68 26.98 2692 264134 173962 90187659
Irritable bowel syndrome 2211.55 26.98 2883 263943 204565 90157056
Impaired healing 2138.85 26.98 3019 263807 231180 90130441
Lower respiratory tract infection 2025.93 26.98 3050 263776 247609 90114012
Sleep disorder due to general medical condition, insomnia type 1877.13 26.98 2098 264728 126596 90235025
Ill-defined disorder 1759.46 26.98 2432 264394 182459 90179162
Blister 1729.76 26.98 2864 263962 252134 90109487
Stomatitis 1691.39 26.98 2955 263871 271743 90089878
Helicobacter infection 1530.11 26.98 2542 264284 224308 90137313
Duodenal ulcer perforation 1496.90 26.98 2483 264343 218805 90142816
Gastrointestinal disorder 1465.11 26.98 2672 264154 254015 90107606
Pericarditis 1115.92 26.98 2458 264368 267693 90093928
Anti-cyclic citrullinated peptide antibody positive 1083.26 26.98 2244 264582 234189 90127432
Sinusitis 1083.26 26.98 2812 264014 340276 90021345
Hand deformity 1079.87 26.98 2566 264260 293796 90067825
Confusional state 969.44 26.98 2912 263914 383293 89978328
Glossodynia 963.23 26.98 2586 264240 319193 90042428
Peripheral swelling 951.77 26.98 3023 263803 410083 89951538
Wound 906.75 26.98 2435 264391 300545 90061076
Joint swelling 875.11 26.98 3355 263471 499945 89861676
Weight increased 873.53 26.98 2959 263867 414968 89946653
Synovitis 867.71 26.98 2529 264297 327223 90034398
Infection 852.25 26.98 2670 264156 359424 90002197
Swelling 834.73 26.98 2920 263906 416138 89945483
Pemphigus 808.79 26.98 2453 264373 324411 90037210
Hypersensitivity 806.62 26.98 3051 263775 451626 89909995
Hepatic enzyme increased 804.22 26.98 2611 264215 358125 90003496
Contusion 802.29 26.98 2069 264757 249147 90112474
Nasopharyngitis 784.29 26.98 2806 264020 404298 89957323
Discomfort 777.87 26.98 2162 264664 272173 90089448
Cough 769.02 26.98 92 266734 368870 89992751
Systemic lupus erythematosus 744.93 26.98 2550 264276 359346 90002275
Therapeutic product effect decreased 723.25 26.98 2122 264704 275449 90086172
Injury 695.58 26.98 1688 265138 195661 90165960
Toxicity to various agents 686.56 26.98 40 266786 287806 90073815
Night sweats 686.40 26.98 1303 265523 127463 90234158
Drug interaction 682.77 26.98 31 266795 276422 90085199
Product dose omission issue 670.69 26.98 49 266777 291638 90069983
Anaemia 670.02 26.98 116 266710 352686 90008935
Lip dry 665.60 26.98 1121 265705 99834 90261787
Nausea 656.40 26.98 1438 265388 1108878 89252743
Arthropathy 632.71 26.98 2438 264388 363804 89997817
Acute kidney injury 622.45 26.98 99 266727 320288 90041333
Joint range of motion decreased 622.25 26.98 1289 265537 134354 90227267
Facet joint syndrome 615.02 26.98 1067 265759 97322 90264299
Sleep disorder 599.19 26.98 1599 265227 196431 90165190
Rheumatic fever 591.84 26.98 1358 265468 151763 90209858
Fall 582.28 26.98 349 266477 481461 89880160
Hypotension 577.72 26.98 126 266700 325271 90036350
Death 572.65 26.98 316 266510 456235 89905386
Infusion related reaction 544.13 26.98 2548 264278 414232 89947389
Rheumatoid arthritis 532.62 26.98 2296 264530 360318 90001303
Urinary tract infection 525.29 26.98 127 266699 305505 90056116
Type 2 diabetes mellitus 522.48 26.98 1547 265279 201697 90159924
Deep vein thrombosis postoperative 514.90 26.98 822 266004 69987 90291634
C-reactive protein abnormal 507.73 26.98 1144 265682 126285 90235336
Pruritus 500.28 26.98 3009 263817 538516 89823105
Constipation 494.78 26.98 110 266716 280285 90081336
Fibromyalgia 465.11 26.98 1500 265326 204769 90156852
Peripheral venous disease 461.65 26.98 861 265965 83060 90278561
Autoimmune disorder 454.58 26.98 813 266013 75931 90285690
Dehydration 443.03 26.98 34 266792 194413 90167208
Urticaria 436.02 26.98 1950 264876 310784 90050837
Somnolence 425.92 26.98 56 266770 209028 90152593
Road traffic accident 422.86 26.98 961 265865 106665 90254956
Psoriatic arthropathy 418.53 26.98 1550 265276 226785 90134836
Blood pressure increased 416.02 26.98 47 266779 197170 90164451
Swollen joint count increased 414.96 26.98 973 265853 110233 90251388
Injection site pain 411.39 26.98 25 266801 173674 90187947
Gait inability 407.32 26.98 1147 265679 145309 90216312
Grip strength decreased 404.87 26.98 863 265963 91713 90269908
Completed suicide 404.73 26.98 4 266822 145054 90216567
Neutropenia 389.19 26.98 92 266734 224812 90136809
Feeling abnormal 387.38 26.98 27 266799 167208 90194413
COVID-19 386.11 26.98 29 266797 168814 90192807
Adjustment disorder with depressed mood 384.30 26.98 638 266188 56115 90305506
Myalgia 381.56 26.98 37 266789 175088 90186533
Blood cholesterol increased 379.45 26.98 1410 265416 206602 90155019
Wound infection 375.42 26.98 911 265915 105491 90256130
Bursitis 372.88 26.98 1038 265788 130616 90231005
Lower limb fracture 372.33 26.98 793 266033 84220 90277401
Liver injury 369.65 26.98 1224 265602 169343 90192278
Ear pain 354.21 26.98 621 266205 57081 90304540
Abdominal discomfort 353.45 26.98 2510 264316 474818 89886803
Erythema 348.26 26.98 120 266706 229126 90132495
Dislocation of vertebra 347.02 26.98 605 266221 55363 90306258
Rheumatoid factor positive 342.29 26.98 1198 265628 170452 90191169
Hypercholesterolaemia 337.07 26.98 846 265980 100046 90261575
Haemoglobin decreased 335.59 26.98 41 266785 161915 90199706
Hyperhidrosis 330.84 26.98 17 266809 136288 90225333
Contraindicated product administered 327.54 26.98 1829 264997 318310 90043311
Breast cancer stage III 323.88 26.98 747 266079 83700 90277921
Alopecia 319.92 26.98 2521 264305 492550 89869071
Influenza 318.18 26.98 24 266802 139240 90222381
Obesity 315.81 26.98 849 265977 104658 90256963
Tremor 314.38 26.98 40 266786 153133 90208488
Respiratory disorder 312.43 26.98 629 266197 64187 90297434
Sciatica 310.72 26.98 823 266003 100559 90261062
X-ray abnormal 306.66 26.98 510 266316 44914 90316707
Dry mouth 301.51 26.98 1206 265620 182853 90178768
Seizure 301.12 26.98 45 266781 152584 90209037
Insomnia 297.69 26.98 1838 264988 331636 90029985
Syncope 297.12 26.98 25 266801 132638 90228983
Muscle spasticity 294.56 26.98 437 266389 34885 90326736
Hyponatraemia 294.10 26.98 27 266799 133511 90228110
Renal failure 292.55 26.98 25 266801 130982 90230639
White blood cell count decreased 289.77 26.98 68 266758 167041 90194580
Chills 287.17 26.98 28 266798 131953 90229668
Drug ineffective 283.98 26.98 2661 264165 1381637 88979984
Myocardial infarction 278.60 26.98 7 266819 105965 90255656
Atrial fibrillation 273.94 26.98 35 266791 133576 90228045
Inappropriate schedule of product administration 272.16 26.98 55 266771 149878 90211743
Platelet count decreased 271.08 26.98 40 266786 136929 90224692
Lung disorder 269.85 26.98 1012 265814 148871 90212750
Cerebrovascular accident 269.32 26.98 26 266800 123507 90238114
Chest discomfort 267.93 26.98 43 266783 138322 90223299
Heart rate increased 265.05 26.98 17 266809 112885 90248736
Palpitations 259.19 26.98 45 266781 136683 90224938
Off label use 249.37 26.98 2065 264761 1100187 89261434
Pulmonary embolism 248.10 26.98 43 266783 130777 90230844
Sepsis 243.77 26.98 112 266714 179702 90181919
Cardiac failure 241.48 26.98 22 266804 109474 90252147
Inflammation 241.34 26.98 1104 265722 177488 90184133
Loss of consciousness 241.28 26.98 58 266768 140180 90221441
Pancytopenia 240.60 26.98 34 266792 120229 90241392
Wheezing 236.56 26.98 1350 265476 236730 90124891
Mobility decreased 235.04 26.98 1400 265426 249334 90112287
Disease progression 234.33 26.98 84 266742 156531 90205090
Injection site erythema 230.72 26.98 15 266811 98487 90263134
Renal impairment 230.31 26.98 22 266804 105399 90256222
General physical health deterioration 226.12 26.98 1803 265023 353312 90008309
Pulmonary fibrosis 224.37 26.98 762 266064 106741 90254880
Balance disorder 223.83 26.98 16 266810 97064 90264557
Oxygen saturation decreased 223.15 26.98 27 266799 107456 90254165
Drug abuse 222.13 26.98 4 266822 82343 90279278
C-reactive protein 220.91 26.98 359 266467 31008 90330613
Cardiac failure congestive 219.89 26.98 19 266807 98675 90262946
Oropharyngeal pain 215.95 26.98 39 266787 115148 90246473
Blood glucose increased 215.90 26.98 17 266809 95229 90266392
Liver disorder 215.09 26.98 815 266011 120454 90241167
Body temperature increased 214.38 26.98 433 266393 44277 90317344
Vision blurred 214.16 26.98 34 266792 110259 90251362
Pleural effusion 209.78 26.98 38 266788 111953 90249668
Incorrect dose administered 208.29 26.98 5 266821 78925 90282696
Gastrointestinal haemorrhage 207.71 26.98 15 266811 90233 90271388
Malignant neoplasm progression 207.38 26.98 33 266793 106837 90254784
Rash 206.95 26.98 3390 263436 792710 89568911
Thrombocytopenia 205.39 26.98 187 266639 208538 90153083
Respiratory failure 203.66 26.98 49 266777 118369 90243252
Osteoarthritis 199.09 26.98 1117 265709 194613 90167008
Febrile neutropenia 199.04 26.98 109 266717 158240 90203381
Suicide attempt 190.88 26.98 7 266819 75392 90286229
Interstitial lung disease 187.07 26.98 9 266817 76396 90285225
Depressed level of consciousness 186.92 26.98 6 266820 72778 90288843
Diarrhoea 184.34 26.98 1823 265003 937367 89424254
Cardiac arrest 183.27 26.98 42 266784 104893 90256728
Coma 182.99 26.98 7 266819 72625 90288996
Productive cough 182.68 26.98 11 266815 77052 90284569
Dysphagia 182.53 26.98 52 266774 112226 90249395
Illness 179.33 26.98 17 266809 81952 90279669
Herpes zoster 177.51 26.98 32 266794 94612 90267009
Rhinorrhoea 176.57 26.98 25 266801 88291 90273330
Blood creatinine increased 176.23 26.98 41 266785 101345 90260276
Influenza like illness 175.61 26.98 17 266809 80594 90281027
Nasal congestion 175.52 26.98 20 266806 83394 90278227
Prescribed underdose 174.70 26.98 552 266274 74467 90287154
Onychomadesis 174.22 26.98 405 266421 45593 90316028
Breast cancer stage II 173.95 26.98 346 266480 34988 90326633
Prescribed overdose 173.01 26.98 656 266170 96969 90264652
Bradycardia 171.76 26.98 22 266804 83825 90277796
Cognitive disorder 170.50 26.98 8 266818 69399 90292222
Wrong technique in product usage process 170.31 26.98 10 266816 71561 90290060
Bone erosion 170.14 26.98 438 266388 52583 90309038
Stress 170.06 26.98 20 266806 81375 90280246
Chronic obstructive pulmonary disease 167.83 26.98 13 266813 73816 90287805
Hypoglycaemia 162.51 26.98 11 266815 69837 90291784
Nail disorder 162.49 26.98 461 266365 58606 90303015
Suicidal ideation 162.41 26.98 15 266811 73840 90287781
Blood pressure decreased 160.02 26.98 17 266809 74878 90286743
Haematochezia 159.76 26.98 13 266813 70900 90290721
Maternal exposure timing unspecified 159.24 26.98 258 266568 22225 90339396
Electrocardiogram QT prolonged 158.58 26.98 15 266811 72441 90289180
Retinitis 158.32 26.98 350 266476 38108 90323513
Musculoskeletal pain 158.30 26.98 953 265873 170298 90191323
Abdominal pain upper 158.08 26.98 1585 265241 331089 90030532
Lupus vulgaris 157.98 26.98 385 266441 44674 90316947
Diabetes mellitus 157.68 26.98 8 266818 64867 90296754
Pyrexia 156.97 26.98 2773 264053 657712 89703909
Anti-cyclic citrullinated peptide antibody 156.79 26.98 285 266541 26936 90334685
Alanine aminotransferase increased 155.31 26.98 77 266749 118261 90243360
Cataract 154.96 26.98 16 266810 72076 90289545
Agitation 154.85 26.98 11 266815 67087 90294534
Live birth 154.84 26.98 549 266277 78558 90283063
Drug intolerance 154.31 26.98 2003 264823 445588 89916033
Swelling face 153.66 26.98 27 266799 81325 90280296
Septic shock 152.43 26.98 31 266795 84129 90277492
Hallucination 151.68 26.98 11 266815 65948 90295673
Deep vein thrombosis 151.60 26.98 41 266785 91579 90270042
Cellulitis 150.90 26.98 41 266785 91296 90270325
Cardiac disorder 148.55 26.98 4 266822 56868 90304753
Exostosis 147.43 26.98 416 266410 52718 90308903
Maternal exposure during pregnancy 145.67 26.98 1661 265165 358402 90003219
Dry skin 144.63 26.98 40 266786 88033 90273588
Cardio-respiratory arrest 143.85 26.98 11 266815 63129 90298492
Delirium 143.77 26.98 649 266177 103710 90257911
Vertigo 143.77 26.98 18 266808 69793 90291828
Flushing 141.97 26.98 42 266784 88449 90273172
Onychomycosis 141.45 26.98 329 266497 37047 90324574
Intentional product use issue 140.48 26.98 1106 265720 215786 90145835
Neuropathy peripheral 140.41 26.98 118 266708 136852 90224769
Oedema 140.14 26.98 1040 265786 199255 90162366
Burning sensation 139.22 26.98 13 266813 63439 90298182
Thrombosis 139.04 26.98 24 266802 73227 90288394
Dyspnoea exertional 138.72 26.98 23 266803 72265 90289356
Injection site swelling 137.54 26.98 10 266816 59829 90301792
Multiple organ dysfunction syndrome 137.42 26.98 19 266807 68317 90293304
Pneumonia 136.70 26.98 1211 265615 636848 89724773
Skin exfoliation 136.29 26.98 19 266807 67894 90293727
Medication error 135.54 26.98 551 266275 84101 90277520
Hyperkalaemia 133.18 26.98 17 266809 64947 90296674
Dysphonia 133.04 26.98 15 266811 63069 90298552
Angioedema 132.94 26.98 17 266809 64859 90296762
Hypoaesthesia 131.83 26.98 1460 265366 312750 90048871
Drug ineffective for unapproved indication 130.60 26.98 20 266806 66624 90294997
Walking aid user 130.51 26.98 309 266517 35197 90326424
Lupus-like syndrome 129.28 26.98 376 266450 48470 90313151
Aspartate aminotransferase increased 129.13 26.98 71 266755 102866 90258755
Metabolic acidosis 128.85 26.98 9 266817 55667 90305954
Rash erythematous 128.82 26.98 19 266807 65085 90296536
Leukopenia 128.47 26.98 68 266758 100642 90260979
Dysarthria 128.46 26.98 8 266818 54474 90307147
Product label confusion 127.52 26.98 236 266590 22614 90339007
Laryngitis 126.08 26.98 382 266444 50371 90311250
Multiple sclerosis relapse 125.40 26.98 7 266819 52298 90309323
Finger deformity 124.96 26.98 290 266536 32607 90329014
Hypokalaemia 124.79 26.98 121 266705 130995 90230626
Haemorrhage 124.70 26.98 26 266800 69343 90292278
Adverse event 124.59 26.98 678 266148 116740 90244881
Lactic acidosis 123.35 26.98 6 266820 50457 90311164
Myelosuppression 123.05 26.98 9 266817 53582 90308039
Amnesia 122.27 26.98 637 266189 107868 90253753
Cystitis 122.03 26.98 24 266802 66694 90294927
Throat irritation 121.62 26.98 5 266821 48690 90312931
Hip arthroplasty 121.18 26.98 495 266331 75713 90285908
Hepatic cirrhosis 120.39 26.98 435 266391 62818 90298803
Neutrophil count decreased 120.27 26.98 31 266795 71501 90290120
Sedation 120.13 26.98 5 266821 48166 90313455
Back pain 119.97 26.98 503 266323 316672 90044949
Blood pressure fluctuation 119.78 26.98 9 266817 52404 90309217
Lethargy 119.15 26.98 21 266805 63118 90298503
Bone pain 118.32 26.98 20 266806 61963 90299658
Hepatic function abnormal 118.20 26.98 4 266822 46284 90315337
Injection site pruritus 118.19 26.98 11 266815 53823 90307798
Pregnancy 117.49 26.98 426 266400 61621 90300000
Chronic kidney disease 116.48 26.98 8 266818 50183 90311438
Unevaluable event 115.77 26.98 13 266813 54835 90306786
Blood pressure systolic increased 115.50 26.98 17 266809 58328 90303293
Liver function test abnormal 115.43 26.98 9 266817 50836 90310785
Blepharospasm 114.75 26.98 392 266434 55053 90306568
Overdose 112.02 26.98 182 266644 157527 90204094
Porphyria acute 110.97 26.98 194 266632 17781 90343840
Therapy interrupted 110.65 26.98 10 266816 50098 90311523
Dry eye 107.74 26.98 20 266806 57911 90303710
Colitis 107.19 26.98 36 266790 69906 90291715
Dyspepsia 106.84 26.98 970 265856 197190 90164431
Hypothyroidism 106.29 26.98 15 266811 53112 90308509
Bronchitis 106.27 26.98 179 266647 152748 90208873
Dizziness 105.80 26.98 1167 265659 588117 89773504
International normalised ratio increased 105.68 26.98 9 266817 47307 90314314
Disturbance in attention 105.11 26.98 9 266817 47100 90314521
Drug reaction with eosinophilia and systemic symptoms 104.79 26.98 5 266821 42753 90318868
Flatulence 104.15 26.98 4 266822 41363 90320258
Fungal infection 101.38 26.98 6 266820 42655 90318966
Hypoxia 101.37 26.98 43 266783 72356 90289265
Nephrolithiasis 100.24 26.98 13 266813 49072 90312549
Musculoskeletal stiffness 99.94 26.98 1322 265504 295210 90066411
Intentional product misuse 99.69 26.98 71 266755 89533 90272088
Disorientation 99.61 26.98 8 266818 44106 90317515
Aphasia 98.84 26.98 7 266819 42805 90318816
Femur fracture 97.07 26.98 11 266815 46071 90315550
Swollen tongue 96.73 26.98 11 266815 45945 90315676
Pneumonia aspiration 96.56 26.98 6 266820 40934 90320687
Orthostatic hypotension 96.10 26.98 7 266819 41820 90319801
Speech disorder 95.72 26.98 11 266815 45574 90316047
Blood potassium decreased 94.26 26.98 14 266812 47713 90313908
Dyskinesia 93.85 26.98 3 266823 36531 90325090
Surgery 93.84 26.98 11 266815 44876 90316745
Cholelithiasis 93.72 26.98 20 266806 52486 90309135
Taste disorder 93.32 26.98 394 266432 61152 90300469
Restlessness 91.52 26.98 3 266823 35717 90325904
Haematocrit decreased 90.64 26.98 9 266817 41823 90319798
Red blood cell count decreased 90.62 26.98 14 266812 46337 90315284
Disease recurrence 90.38 26.98 5 266821 37648 90323973
Heart rate decreased 90.31 26.98 23 266803 53482 90308139
Ascites 89.82 26.98 16 266810 47724 90313897
Transient ischaemic attack 89.22 26.98 11 266815 43165 90318456
Generalised tonic-clonic seizure 89.18 26.98 3 266823 34900 90326721
Acute myocardial infarction 89.14 26.98 3 266823 34887 90326734
Intestinal obstruction 88.92 26.98 5 266821 37126 90324495
Hot flush 88.79 26.98 32 266794 59456 90302165
Haematoma 88.40 26.98 7 266819 39041 90322580
Urinary retention 87.63 26.98 6 266820 37738 90323883
Headache 87.46 26.98 1906 264920 860840 89500781
Tinnitus 86.62 26.98 12 266814 43090 90318531
Back injury 86.49 26.98 318 266508 46304 90315317
Weight decreased 86.14 26.98 710 266116 379200 89982421
Agranulocytosis 86.08 26.98 4 266822 34998 90326623
Breast cancer 85.35 26.98 26 266800 53735 90307886
Hepatic failure 84.91 26.98 9 266817 39719 90321902
Subcutaneous drug absorption impaired 84.68 26.98 147 266679 13398 90348223
Arrhythmia 84.57 26.98 12 266814 42320 90319301
Full blood count abnormal 84.44 26.98 6 266820 36591 90325030
Arthralgia 84.03 26.98 2937 263889 775585 89586036
Therapy cessation 83.78 26.98 6 266820 36355 90325266
Pallor 83.71 26.98 4 266822 34161 90327460
C-reactive protein increased 83.52 26.98 859 265967 180530 90181091
Nervousness 83.40 26.98 4 266822 34052 90327569
Gastritis 83.03 26.98 12 266814 41741 90319880
Epistaxis 82.81 26.98 77 266749 85048 90276573
Eye pain 82.67 26.98 15 266811 44153 90317468
Jaundice 82.36 26.98 3 266823 32514 90329107
Abdominal pain 81.55 26.98 758 266068 394963 89966658
Eczema 81.39 26.98 27 266799 52843 90308778
Sinus disorder 81.39 26.98 5 266821 34442 90327179
Angina pectoris 80.87 26.98 10 266816 39150 90322471
Transaminases increased 80.59 26.98 8 266818 37184 90324437
Plasma cell myeloma 80.58 26.98 12 266814 40816 90320805
Hyperglycaemia 80.29 26.98 25 266801 50945 90310676
Viral infection 79.85 26.98 13 266813 41401 90320220
Liver function test increased 79.49 26.98 474 266352 84381 90277240
Melaena 79.44 26.98 6 266820 34791 90326830
Acute respiratory failure 79.42 26.98 15 266811 42903 90318718
Toxic epidermal necrolysis 79.08 26.98 4 266822 32524 90329097
Procedural pain 78.35 26.98 5 266821 33355 90328266
Limb discomfort 77.91 26.98 10 266816 38050 90323571
Mental status changes 77.77 26.98 18 266808 44661 90316960
Joint dislocation 77.65 26.98 298 266528 44284 90317337
Blood creatine phosphokinase increased 77.30 26.98 6 266820 34017 90327604
Respiratory tract infection 76.66 26.98 39 266787 59039 90302582
Lymphadenopathy 76.64 26.98 20 266806 45755 90315866
Pulmonary hypertension 76.30 26.98 16 266810 42507 90319114
Oral herpes 75.92 26.98 6 266820 33518 90328103
Oral candidiasis 75.85 26.98 8 266818 35447 90326174
Knee arthroplasty 75.59 26.98 461 266365 82721 90278900
Vaginal haemorrhage 75.54 26.98 4 266822 31267 90330354
Mental disorder 75.44 26.98 5 266821 32313 90329308
Neoplasm progression 75.32 26.98 19 266807 44467 90317154
Pancreatitis acute 74.87 26.98 5 266821 32110 90329511
Pulmonary oedema 74.74 26.98 45 266781 62035 90299586
Pericardial effusion 74.63 26.98 10 266816 36823 90324798
Encephalopathy 74.57 26.98 22 266804 46422 90315199
Hemiparesis 74.04 26.98 5 266821 31814 90329807
Disability 73.98 26.98 276 266550 40469 90321152
Dysgeusia 73.93 26.98 31 266795 52529 90309092
Throat tightness 73.72 26.98 3 266823 29481 90332140
Paraesthesia oral 73.60 26.98 5 266821 31654 90329967
Unresponsive to stimuli 73.43 26.98 12 266814 38109 90323512
Hepatotoxicity 73.08 26.98 22 266804 45820 90315801
Clostridium difficile infection 73.05 26.98 10 266816 36235 90325386
Malaise 72.89 26.98 1250 265576 584736 89776885
Hepatic steatosis 72.59 26.98 11 266815 36934 90324687
Lymphocyte count decreased 72.26 26.98 9 266817 35041 90326580
Rash maculo-papular 72.23 26.98 16 266810 40917 90320704
Grip strength 71.99 26.98 109 266717 8856 90352765
Drug withdrawal syndrome 71.56 26.98 3 266823 28720 90332901
Hepatic cytolysis 71.53 26.98 5 266821 30911 90330710
Haematemesis 71.16 26.98 8 266818 33718 90327903
Full blood count decreased 71.09 26.98 4 266822 29685 90331936
Coronary artery disease 70.88 26.98 8 266818 33615 90328006
Blood bilirubin increased 70.88 26.98 20 266806 43450 90318171
Drug resistance 70.23 26.98 5 266821 30444 90331177
Haemoptysis 70.06 26.98 8 266818 33312 90328309
Skin disorder 69.71 26.98 12 266814 36694 90324927
Seronegative arthritis 69.53 26.98 161 266665 18073 90343548
Immunodeficiency 68.47 26.98 21 266805 43213 90318408
Sleep apnoea syndrome 68.34 26.98 7 266819 31740 90329881
Incorrect route of product administration 68.32 26.98 313 266513 50313 90311308
Joint injury 68.29 26.98 8 266818 32656 90328965
Hypocalcaemia 68.15 26.98 20 266806 42348 90319273
Acne 67.77 26.98 4 266822 28503 90333118
Device issue 67.70 26.98 5 266821 29532 90332089
Limb injury 67.69 26.98 7 266819 31501 90330120
Stevens-Johnson syndrome 67.25 26.98 5 266821 29371 90332250
General symptom 66.69 26.98 139 266687 14529 90347092
Abdominal pain lower 66.69 26.98 6 266820 30171 90331450
Product prescribing error 66.60 26.98 6 266820 30139 90331482
Mucosal inflammation 66.31 26.98 44 266782 57581 90304040
Multiple sclerosis 65.90 26.98 4 266822 27836 90333785
Cerebral infarction 65.53 26.98 3 266823 26593 90335028
Pneumonitis 65.51 26.98 24 266802 44146 90317475
Blood urea increased 64.71 26.98 7 266819 30406 90331215
Tachycardia 64.67 26.98 242 266584 157431 90204190
Hip fracture 64.64 26.98 10 266816 33067 90328554
Memory impairment 64.18 26.98 874 265952 196370 90165251
Mouth ulceration 64.06 26.98 19 266807 39955 90321666
Cerebral haemorrhage 64.02 26.98 12 266814 34510 90327111
Depressed mood 63.91 26.98 34 266792 50188 90311433
Migraine 63.75 26.98 848 265978 189544 90172077
Urinary incontinence 63.68 26.98 16 266810 37550 90324071
Localised infection 63.68 26.98 11 266815 33551 90328070
Accidental exposure to product 62.87 26.98 23 266803 42343 90319278
Crying 62.84 26.98 3 266823 25642 90335979
Diplopia 62.68 26.98 6 266820 28708 90332913
Blood sodium decreased 62.37 26.98 5 266821 27608 90334013
Neoplasm malignant 62.35 26.98 12 266814 33868 90327753
Gastroenteritis viral 62.08 26.98 8 266818 30347 90331274
Sinus congestion 61.84 26.98 5 266821 27419 90334202
Eye disorder 61.75 26.98 5 266821 27385 90334236
Gastric disorder 61.07 26.98 12 266814 33372 90328249
Respiratory arrest 60.88 26.98 12 266814 33299 90328322
Swollen joint count 60.87 26.98 99 266727 8554 90353067
Metastases to liver 60.36 26.98 7 266819 28800 90332821
Drug-induced liver injury 60.30 26.98 464 266362 89854 90271767
Acute respiratory distress syndrome 60.04 26.98 7 266819 28679 90332942
Head injury 59.66 26.98 10 266816 31178 90330443
Rash macular 59.52 26.98 9 266817 30271 90331350
Blindness 59.48 26.98 5 266821 26563 90335058
Blood calcium decreased 59.26 26.98 9 266817 30173 90331448
Epilepsy 59.23 26.98 430 266396 81776 90279845
Gastric ulcer 59.22 26.98 6 266820 27442 90334179
Dysuria 59.13 26.98 21 266805 39380 90322241
Haematuria 59.00 26.98 15 266811 34922 90326699
Eye irritation 58.52 26.98 14 266812 33964 90327657
Device dislocation 58.26 26.98 11 266815 31471 90330150
Dysstasia 58.11 26.98 4 266822 25048 90336573
Bone marrow failure 58.07 26.98 12 266814 32209 90329412
Ocular hyperaemia 58.07 26.98 14 266812 33784 90327837
Pollakiuria 58.04 26.98 13 266813 32992 90328629
Rash vesicular 58.03 26.98 150 266676 18047 90343574
Carpal tunnel syndrome 57.99 26.98 3 266823 23925 90337696
Foetal exposure during pregnancy 57.84 26.98 27 266799 42948 90318673
Hypoacusis 57.78 26.98 7 266819 27843 90333778
No adverse event 57.70 26.98 69 266757 67913 90293708
Eosinophilia 57.21 26.98 8 266818 28525 90333096
Eye pruritus 56.21 26.98 9 266817 29018 90332603
Eating disorder 55.98 26.98 8 266818 28065 90333556
Coeliac disease 55.95 26.98 270 266556 44340 90317281
Lung neoplasm malignant 55.94 26.98 4 266822 24269 90337352
Lip swelling 55.56 26.98 22 266804 38588 90323033
Blood alkaline phosphatase increased 54.93 26.98 37 266789 48042 90313579
Poor quality sleep 54.33 26.98 5 266821 24688 90336933
Iron deficiency anaemia 54.24 26.98 4 266822 23658 90337963
Acute hepatic failure 54.14 26.98 3 266823 22558 90339063
Anaphylactic reaction 54.09 26.98 110 266716 87414 90274207
Withdrawal syndrome 54.04 26.98 3 266823 22521 90339100
Restless legs syndrome 53.88 26.98 3 266823 22467 90339154
Palmar-plantar erythrodysaesthesia syndrome 53.57 26.98 9 266817 28014 90333607
Posterior reversible encephalopathy syndrome 53.52 26.98 3 266823 22336 90339285
Face oedema 53.29 26.98 4 266822 23314 90338307
Proteinuria 53.21 26.98 4 266822 23287 90338334
Foot deformity 53.19 26.98 329 266497 59322 90302299
Leukocytosis 52.92 26.98 13 266813 30977 90330644
Fracture 52.78 26.98 3 266823 22073 90339548
Chronic sinusitis 51.88 26.98 5 266821 23797 90337824
Irritability 51.85 26.98 20 266806 35642 90325979
Ventricular tachycardia 51.78 26.98 6 266820 24702 90336919
Product administration error 51.61 26.98 8 266818 26415 90335206
Upper limb fracture 51.38 26.98 3 266823 21575 90340046
Shock 51.28 26.98 11 266815 28767 90332854
Hypersomnia 51.25 26.98 3 266823 21528 90340093
Pain in jaw 50.82 26.98 40 266786 47945 90313676
Injection site rash 50.34 26.98 6 266820 24167 90337454
Pustular psoriasis 50.21 26.98 144 266682 18412 90343209
Accidental overdose 49.99 26.98 11 266815 28262 90333359
Cytomegalovirus infection 49.86 26.98 9 266817 26593 90335028
Skin discolouration 49.44 26.98 35 266791 44280 90317341
Mood swings 48.92 26.98 3 266823 20699 90340922
Vasculitis 48.86 26.98 5 266821 22688 90338933
Pulmonary arterial hypertension 48.78 26.98 9 266817 26178 90335443
Bacterial infection 48.38 26.98 6 266820 23438 90338183
Blood pressure diastolic decreased 48.32 26.98 10 266816 26816 90334805
Premature baby 48.06 26.98 8 266818 25069 90336552
Haemorrhoids 48.00 26.98 10 266816 26692 90334929
Skin ulcer 47.87 26.98 46 266780 50029 90311592
Treatment noncompliance 47.75 26.98 49 266777 51678 90309943
Product storage error 47.63 26.98 3 266823 20238 90341383
Rib fracture 47.32 26.98 10 266816 26425 90335196
Pharyngitis 46.83 26.98 5 266821 21942 90339679
Candida infection 46.45 26.98 21 266805 34036 90327585
Adverse reaction 46.43 26.98 192 266634 29520 90332101
Gallbladder disorder 46.41 26.98 3 266823 19800 90341821
Glaucoma 46.21 26.98 4 266822 20751 90340870
Presyncope 45.97 26.98 18 266808 31787 90329834
Ankle fracture 45.15 26.98 4 266822 20366 90341255
Hypervolaemia 44.99 26.98 20 266806 32737 90328884
Ejection fraction decreased 44.86 26.98 11 266815 26242 90335379
Hypophagia 44.75 26.98 25 266801 35912 90325709
Hyperlipidaemia 44.62 26.98 7 266819 22909 90338712
Rash pruritic 44.55 26.98 111 266715 82103 90279518
Therapeutic response shortened 44.52 26.98 7 266819 22872 90338749
Respiratory distress 44.45 26.98 30 266796 38916 90322705
Skin laceration 44.31 26.98 11 266815 26024 90335597
Pain in extremity 44.14 26.98 1000 265826 449529 89912092
Myelodysplastic syndrome 44.00 26.98 5 266821 20898 90340723
Intervertebral disc protrusion 43.45 26.98 13 266813 27183 90334438
Impaired quality of life 43.01 26.98 8 266818 23136 90338485
Heavy menstrual bleeding 42.99 26.98 5 266821 20525 90341096
Ischaemic stroke 42.64 26.98 7 266819 22159 90339462
Neutrophil count increased 42.46 26.98 4 266822 19386 90342235
Gamma-glutamyltransferase increased 42.30 26.98 30 266796 37922 90323699
Cardiogenic shock 42.30 26.98 10 266816 24458 90337163
Spondylitis 42.29 26.98 114 266712 14064 90347557
Hyperthyroidism 42.25 26.98 3 266823 18307 90343314
Spinal fracture 42.25 26.98 7 266819 22009 90339612
Motor dysfunction 42.02 26.98 4 266822 19226 90342395
Foot fracture 41.99 26.98 13 266813 26593 90335028
Retching 41.83 26.98 4 266822 19155 90342466
Red blood cell sedimentation rate increased 41.80 26.98 399 266427 82196 90279425
Red blood cell sedimentation rate abnormal 41.63 26.98 10 266816 24194 90337427
Hepatic enzyme 41.54 26.98 64 266762 5280 90356341
Post procedural complication 41.51 26.98 4 266822 19038 90342583
Nightmare 41.48 26.98 7 266819 21718 90339903
Product substitution issue 41.41 26.98 3 266823 18005 90343616
Hypomagnesaemia 41.18 26.98 27 266799 35561 90326060
Subarachnoid haemorrhage 41.12 26.98 3 266823 17901 90343720
Disseminated intravascular coagulation 40.99 26.98 7 266819 21531 90340090
Infusion site pain 40.85 26.98 5 266821 19733 90341888
Coordination abnormal 40.52 26.98 7 266819 21349 90340272
Conjunctivitis 40.48 26.98 14 266812 26692 90334929
Basal cell carcinoma 40.47 26.98 24 266802 33365 90328256
Pyelonephritis 40.41 26.98 7 266819 21309 90340312
Underdose 40.32 26.98 285 266541 53732 90307889
Poor venous access 40.29 26.98 5 266821 19522 90342099
Ulcer haemorrhage 40.28 26.98 169 266657 26152 90335469
Rash papular 40.13 26.98 6 266820 20349 90341272
Injection site warmth 40.04 26.98 3 266823 17512 90344109
Skin lesion 39.76 26.98 31 266795 37334 90324287
Visual acuity reduced 39.63 26.98 10 266816 23400 90338221
Blood test abnormal 39.46 26.98 7 266819 20945 90340676
Drug eruption 39.45 26.98 28 266798 35379 90326242
Myositis 39.36 26.98 158 266668 23970 90337651
Oesophagitis 39.30 26.98 3 266823 17246 90344375
Oral pain 38.91 26.98 24 266802 32659 90328962
Ataxia 38.78 26.98 4 266822 18038 90343583
Tachypnoea 38.27 26.98 8 266818 21301 90340320
Photosensitivity reaction 38.14 26.98 4 266822 17803 90343818
Overlap syndrome 37.69 26.98 80 266746 8468 90353153
Radiculopathy 37.54 26.98 5 266821 18500 90343121
Vitamin D deficiency 37.46 26.98 4 266822 17552 90344069
Coagulopathy 37.44 26.98 11 266815 23278 90338343
Impaired work ability 37.41 26.98 6 266820 19320 90342301
Deafness 37.38 26.98 10 266816 22504 90339117
Hiatus hernia 37.24 26.98 14 266812 25347 90336274
Clostridium difficile colitis 37.16 26.98 16 266810 26690 90334931
Nodule 37.11 26.98 16 266810 26670 90334951
Adrenal insufficiency 36.99 26.98 21 266805 29900 90331721
Nervous system disorder 36.98 26.98 9 266817 21584 90340037
Bronchospasm 36.73 26.98 8 266818 20701 90340920
Extrapyramidal disorder 36.69 26.98 3 266823 16300 90345321
Cardiomegaly 36.35 26.98 6 266820 18919 90342702
Ear infection 36.27 26.98 339 266487 69436 90292185
Staphylococcal infection 36.19 26.98 54 266772 48385 90313236
Joint stiffness 36.08 26.98 370 266456 77672 90283949
Tenderness 35.97 26.98 17 266809 26851 90334770
Skin burning sensation 35.97 26.98 7 266819 19604 90342017
Therapy non-responder 35.94 26.98 584 266242 136120 90225501
Glomerular filtration rate decreased 35.76 26.98 4 266822 16928 90344693
Back disorder 35.72 26.98 160 266666 25471 90336150
Intentional dose omission 35.62 26.98 5 266821 17778 90343843
Uveitis 35.58 26.98 3 266823 15900 90345721
Rhinitis allergic 35.37 26.98 4 266822 16781 90344840
Polyneuropathy 35.28 26.98 7 266819 19334 90342287
Osteopenia 34.96 26.98 12 266814 22990 90338631
Lacrimation increased 34.91 26.98 18 266808 27044 90334577
Toothache 34.84 26.98 11 266815 22219 90339402
Cyst 34.76 26.98 4 266822 16557 90345064
Ileus 34.72 26.98 4 266822 16542 90345079
Glycosylated haemoglobin increased 34.64 26.98 3 266823 15559 90346062
Vomiting 34.49 26.98 1934 264892 786359 89575262
Dermatitis atopic 34.39 26.98 13 266813 23459 90338162
Small intestinal obstruction 34.19 26.98 10 266816 21224 90340397
Abscess 34.12 26.98 7 266819 18884 90342737
Thirst 34.04 26.98 4 266822 16291 90345330
Aggression 34.01 26.98 18 266808 26650 90334971
Anal incontinence 33.87 26.98 4 266822 16226 90345395
Sinus tachycardia 33.86 26.98 21 266805 28492 90333129
Mitral valve incompetence 33.81 26.98 12 266814 22512 90339109
Musculoskeletal disorder 33.71 26.98 11 266815 21758 90339863
Cholecystitis 33.64 26.98 5 266821 17035 90344586
Spinal compression fracture 33.59 26.98 3 266823 15175 90346446
Seasonal allergy 33.23 26.98 13 266813 22970 90338651
Secretion discharge 32.97 26.98 4 266822 15892 90345729
Ulcer 32.86 26.98 29 266797 32853 90328768
Metastases to central nervous system 32.74 26.98 6 266820 17536 90344085
Pseudomonas infection 32.73 26.98 3 266823 14862 90346759
Therapeutic product effect incomplete 32.72 26.98 389 266437 193507 90168114
Feeding disorder 32.66 26.98 6 266820 17506 90344115
Subdural haematoma 32.60 26.98 5 266821 16640 90344981
Photophobia 32.49 26.98 11 266815 21258 90340363
Spinal stenosis 32.43 26.98 6 266820 17418 90344203
Bone density decreased 32.22 26.98 6 266820 17339 90344282
Renal tubular necrosis 31.88 26.98 3 266823 14552 90347069
Feeling jittery 31.55 26.98 4 266822 15367 90346254
Pelvic pain 31.52 26.98 4 266822 15353 90346268
Skin fissures 31.38 26.98 11 266815 20798 90340823
Malnutrition 31.27 26.98 8 266818 18550 90343071
Pelvic fracture 31.15 26.98 4 266822 15215 90346406
Poisoning 31.14 26.98 4 266822 15213 90346408
Flank pain 31.05 26.98 9 266817 19213 90342408
Right ventricular failure 31.01 26.98 9 266817 19196 90342425
Hypercalcaemia 30.97 26.98 33 266793 34207 90327414
Escherichia infection 30.62 26.98 5 266821 15890 90345731
Mental impairment 30.60 26.98 6 266820 16714 90344907
Ventricular fibrillation 30.48 26.98 3 266823 14041 90347580
Normal newborn 30.46 26.98 143 266683 23219 90338402
Joint effusion 30.45 26.98 10 266816 19700 90341921
Cytopenia 30.42 26.98 7 266819 17442 90344179
Electrolyte imbalance 30.32 26.98 16 266810 23729 90337892
Blood pressure abnormal 30.29 26.98 10 266816 19635 90341986
Brain oedema 30.26 26.98 7 266819 17378 90344243
Needle issue 30.18 26.98 3 266823 13931 90347690
Circulatory collapse 30.05 26.98 18 266808 24886 90336735
Intestinal perforation 30.04 26.98 3 266823 13878 90347743
Neuralgia 30.04 26.98 29 266797 31471 90330150
Cardiomyopathy 29.93 26.98 11 266815 20195 90341426
Muscle twitching 29.90 26.98 17 266809 24185 90337436
Therapeutic response decreased 29.87 26.98 149 266677 89580 90272041
Complication associated with device 29.82 26.98 10 266816 19439 90342182
Facial paralysis 29.67 26.98 5 266821 15529 90346092
Ligament sprain 29.49 26.98 4 266822 14595 90347026
Infusion site erythema 29.46 26.98 3 266823 13667 90347954
Labelled drug-drug interaction medication error 29.44 26.98 4 266822 14578 90347043
Product quality issue 29.36 26.98 360 266466 78965 90282656
Lymphoma 29.25 26.98 3 266823 13588 90348033
Cardiovascular disorder 28.98 26.98 3 266823 13489 90348132
Upper respiratory tract infection 28.94 26.98 240 266586 128078 90233543
Osteonecrosis 28.91 26.98 21 266805 26220 90335401
Muscle tightness 28.83 26.98 3 266823 13436 90348185
Incontinence 28.82 26.98 3 266823 13432 90348189
Torsade de pointes 28.75 26.98 5 266821 15177 90346444
Hallucination, auditory 28.68 26.98 6 266820 15969 90345652
Premature labour 28.66 26.98 3 266823 13373 90348248
Upper-airway cough syndrome 28.63 26.98 5 266821 15130 90346491
Rotator cuff syndrome 28.54 26.98 6 266820 15913 90345708
Emotional distress 28.24 26.98 40 266786 36622 90324999
Mania 28.22 26.98 4 266822 14120 90347501
Spinal pain 28.15 26.98 6 266820 15761 90345860
Aphthous ulcer 28.10 26.98 8 266818 17279 90344342
Skin infection 27.71 26.98 9 266817 17855 90343766
Musculoskeletal chest pain 27.50 26.98 18 266808 23732 90337889
Splenomegaly 27.43 26.98 3 266823 12921 90348700
Escherichia urinary tract infection 27.40 26.98 4 266822 13811 90347810
Gangrene 27.30 26.98 3 266823 12873 90348748
Pharyngeal oedema 27.28 26.98 4 266822 13767 90347854
Generalised oedema 27.18 26.98 11 266815 19042 90342579

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
Anaphylactic reaction 247.22 14.66 150 11347 42593 42567245
Burkholderia test positive 193.63 14.66 47 11450 1003 42608835
Recalled product administered 131.36 14.66 32 11465 693 42609145
Product contamination microbial 130.28 14.66 32 11465 718 42609120
Burkholderia infection 122.46 14.66 22 11475 93 42609745
Osteonecrosis of jaw 92.73 14.66 60 11437 18989 42590849
Burkholderia cepacia complex infection 83.07 14.66 19 11478 310 42609528
Recalled product 79.47 14.66 19 11478 379 42609459
Mechanical ventilation complication 78.03 14.66 21 11476 683 42609155
Anaphylactic shock 76.81 14.66 58 11439 23459 42586379
Respiratory tract infection bacterial 68.74 14.66 24 11473 1885 42607953
Sputum culture positive 62.81 14.66 22 11475 1744 42608094
Respiratory tract infection viral 58.53 14.66 25 11472 3381 42606457
Inspiratory capacity decreased 48.43 14.66 21 11476 2946 42606892
Haemothorax 48.28 14.66 25 11472 5211 42604627
Cytokine release syndrome 45.43 14.66 58 11439 44469 42565369
Adverse reaction 42.47 14.66 21 11476 3972 42605866
Hypotension 42.44 14.66 159 11338 257472 42352366
Chemical burn of skin 41.62 14.66 7 11490 18 42609820
Angiopathy 39.29 14.66 22 11475 5355 42604483
Drug interaction 38.68 14.66 12 11485 266987 42342851
Culture positive 37.22 14.66 12 11485 737 42609101
Hypovolaemia 36.77 14.66 28 11469 11457 42598381
Suspected transmission of an infectious agent via product 34.37 14.66 12 11485 942 42608896
Epistaxis 33.95 14.66 63 11434 66763 42543075
Emphysema 33.86 14.66 27 11470 11808 42598030
Face oedema 32.48 14.66 28 11469 13638 42596200
Tachycardia 29.27 14.66 76 11421 101011 42508827
Sensitisation 29.21 14.66 8 11489 278 42609560
Pain in jaw 29.09 14.66 27 11470 14475 42595363
Shock haemorrhagic 26.50 14.66 27 11470 16215 42593623
Off label use 26.12 14.66 87 11410 638248 41971590
Drug ineffective 25.70 14.66 86 11411 630111 41979727
Capillary nail refill test abnormal 24.80 14.66 5 11492 43 42609795
Pneumothorax 24.53 14.66 31 11466 23512 42586326
Osteomyelitis 23.93 14.66 27 11470 18196 42591642
Dermatitis contact 23.93 14.66 15 11482 4488 42605350
Hypersensitivity 23.66 14.66 57 11440 72313 42537525
Osteonecrosis 23.42 14.66 25 11472 15840 42593998
Respiratory tract infection 23.31 14.66 32 11465 26290 42583548
Chemical burn 23.18 14.66 7 11490 346 42609492
Bone disorder 23.12 14.66 17 11480 6596 42603242
Jaw disorder 22.04 14.66 11 11486 2122 42607716
Corneal epithelium defect 21.95 14.66 7 11490 415 42609423
Steroid diabetes 21.74 14.66 12 11485 2840 42606998
Tooth disorder 21.55 14.66 21 11476 11958 42597880
Stomatitis 20.19 14.66 43 11454 50286 42559552
Exposed bone in jaw 18.83 14.66 9 11488 1580 42608258
Postoperative wound infection 18.60 14.66 14 11483 5628 42604210
Cardiac arrest 18.37 14.66 68 11429 109252 42500586
Oral disorder 18.26 14.66 13 11484 4799 42605039
Neutropenic sepsis 18.22 14.66 22 11475 15924 42593914
Anterior chamber inflammation 18.16 14.66 6 11491 398 42609440
Gingivitis 18.07 14.66 12 11485 3961 42605877
Serum procollagen type III N-terminal propeptide increased 18.06 14.66 4 11493 56 42609782
Application site reaction 17.99 14.66 6 11491 410 42609428
Transmission of an infectious agent via product 17.96 14.66 5 11492 185 42609653
Serratia infection 17.56 14.66 8 11489 1261 42608577
Catheter site discharge 17.36 14.66 7 11490 818 42609020
Toxicity to various agents 17.15 14.66 22 11475 229114 42380724
Respiratory distress 17.08 14.66 36 11461 41784 42568054
Catheter site rash 16.90 14.66 5 11492 230 42609608
Thrombocytopenia 16.80 14.66 98 11399 190181 42419657
Keratic precipitates 16.80 14.66 5 11492 235 42609603
Lip haemorrhage 16.63 14.66 7 11490 913 42608925
Product quality issue 16.22 14.66 22 11475 17860 42591978
Corneal oedema 16.04 14.66 8 11489 1540 42608298
Febrile neutropenia 15.98 14.66 95 11402 185608 42424230
Flatulence 15.73 14.66 26 11471 25126 42584712
Vascular device infection 15.50 14.66 13 11484 6097 42603741
Catheter site irritation 15.20 14.66 4 11493 119 42609719
Peri-implantitis 14.95 14.66 4 11493 127 42609711
Loose tooth 14.84 14.66 7 11490 1194 42608644
Somnolence 14.73 14.66 10 11487 141095 42468743

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
Folliculitis 2393.19 23.46 2273 222080 165380 110199566
Muscle injury 2043.19 23.46 1927 222426 138880 110226066
Irritable bowel syndrome 2007.34 23.46 2046 222307 162169 110202777
Sleep disorder due to general medical condition, insomnia type 1906.04 23.46 1635 222718 104008 110260938
Impaired healing 1903.80 23.46 2166 222187 194551 110170395
Helicobacter infection 1901.36 23.46 2085 222268 179792 110185154
Duodenal ulcer perforation 1831.31 23.46 2022 222331 175678 110189268
Hand deformity 1642.58 23.46 2117 222236 216389 110148557
Glossodynia 1636.26 23.46 2130 222223 219874 110145072
Lower respiratory tract infection 1616.54 23.46 2218 222135 240888 110124058
Ill-defined disorder 1579.97 23.46 1764 222589 155089 110209857
Blister 1500.24 23.46 2067 222286 225309 110139637
Stomatitis 1494.46 23.46 2259 222094 267983 110096963
Anti-cyclic citrullinated peptide antibody positive 1447.70 23.46 1814 222539 180170 110184776
Pemphigus 1444.79 23.46 1970 222383 212600 110152346
Systemic lupus erythematosus 1430.32 23.46 2143 222210 252195 110112751
Pericarditis 1429.14 23.46 1981 222372 217133 110147813
Wound 1396.96 23.46 2030 222323 232407 110132539
Synovitis 1308.46 23.46 2142 222211 271950 110092996
Gastrointestinal disorder 1210.68 23.46 1932 222421 240020 110124926
Hepatic enzyme increased 1095.17 23.46 2167 222186 318725 110046221
Discomfort 1092.58 23.46 1728 222625 212979 110151967
Arthropathy 1052.20 23.46 2000 222353 285522 110079424
Sinusitis 1004.30 23.46 1997 222356 294691 110070255
Lip dry 977.05 23.46 1108 223245 98975 110265971
Swelling 974.80 23.46 2179 222174 348862 110016084
Joint swelling 915.75 23.46 2454 221899 440391 109924555
Rheumatic fever 911.14 23.46 1182 223171 121397 110243549
Rheumatoid arthritis 910.48 23.46 1929 222424 297684 110067262
Facet joint syndrome 909.77 23.46 1051 223302 95777 110269169
Hypersensitivity 846.41 23.46 2250 222103 401748 109963198
Drug interaction 844.28 23.46 41 224312 500142 109864804
Alopecia 808.50 23.46 2075 222278 362678 110002268
Night sweats 808.48 23.46 1168 223185 132815 110232131
C-reactive protein abnormal 806.61 23.46 1147 223206 128548 110236398
Joint range of motion decreased 786.63 23.46 1097 223256 120735 110244211
Type 2 diabetes mellitus 777.97 23.46 1335 223018 175897 110189049
Toxicity to various agents 769.47 23.46 53 224300 480502 109884444
Injury 767.29 23.46 1327 223026 175938 110189008
Contusion 757.22 23.46 1544 222809 231817 110133129
Infusion related reaction 752.27 23.46 2077 222276 379085 109985861
Fibromyalgia 745.71 23.46 1284 223069 169625 110195321
Acute kidney injury 738.02 23.46 190 224163 635240 109729706
Weight increased 726.99 23.46 2182 222171 417462 109947484
Peripheral swelling 724.74 23.46 2127 222226 401907 109963039
Psoriatic arthropathy 719.50 23.46 1369 222984 195392 110169554
Therapeutic product effect decreased 708.51 23.46 1544 222809 242772 110122174
Abdominal discomfort 695.46 23.46 2062 222291 391796 109973150
Peripheral venous disease 673.63 23.46 842 223511 83275 110281671
Deep vein thrombosis postoperative 668.05 23.46 708 223645 58583 110306363
Nasopharyngitis 643.13 23.46 2008 222345 392353 109972593
Bursitis 626.52 23.46 1021 223332 128897 110236049
Anaemia 615.42 23.46 174 224179 546912 109818034
Autoimmune disorder 613.60 23.46 710 223643 64773 110300173
Swollen joint count increased 607.86 23.46 798 223555 82863 110282083
Rheumatoid factor positive 603.17 23.46 1011 223342 130629 110234317
Cough 592.47 23.46 110 224243 461531 109903415
Infection 591.14 23.46 1845 222508 360355 110004591
Death 580.73 23.46 350 224003 698519 109666427
Contraindicated product administered 579.39 23.46 1441 222912 246826 110118120
Confusional state 570.61 23.46 2165 222188 466515 109898431
Road traffic accident 570.12 23.46 882 223471 106516 110258430
Blood cholesterol increased 555.17 23.46 1185 223168 183600 110181346
Liver injury 536.68 23.46 1036 223317 149377 110215569
Lower limb fracture 529.33 23.46 707 223646 74641 110290305
Sleep disorder 510.53 23.46 1197 223156 197447 110167499
Maternal exposure during pregnancy 504.29 23.46 1391 222962 253492 110111454
Gait inability 502.12 23.46 952 223401 135424 110229522
Urticaria 500.62 23.46 1603 222750 317254 110047692
Dry mouth 493.44 23.46 1186 223167 198762 110166184
Obesity 493.37 23.46 851 223502 112500 110252446
Sciatica 482.25 23.46 753 223600 91646 110273300
Grip strength decreased 477.64 23.46 695 223658 79479 110285467
Product dose omission issue 475.15 23.46 50 224303 321732 110043214
Completed suicide 469.00 23.46 4 224349 242377 110122569
Breast cancer stage III 467.21 23.46 683 223670 78434 110286512
Hypotension 455.34 23.46 248 224105 523601 109841345
Wound infection 454.01 23.46 750 223603 95715 110269231
Inflammation 424.96 23.46 1097 223256 192141 110172805
Fall 411.98 23.46 371 223982 603111 109761835
Adjustment disorder with depressed mood 411.37 23.46 476 223877 43407 110321539
X-ray abnormal 409.64 23.46 444 223909 37673 110327273
Somnolence 405.60 23.46 60 224293 297389 110067557
Dehydration 403.61 23.46 47 224306 279464 110085482
Mobility decreased 392.06 23.46 1215 223138 236207 110128739
Osteoarthritis 384.42 23.46 1020 223333 181603 110183343
Drug intolerance 384.20 23.46 1738 222615 404774 109960172
Nausea 383.57 23.46 1260 223093 1234430 109130516
Lung disorder 382.43 23.46 1009 223344 179038 110185908
Constipation 367.93 23.46 133 224220 357653 110007293
Neutropenia 362.58 23.46 153 224200 374467 109990479
Dislocation of vertebra 353.65 23.46 440 223913 43281 110321665
Hypercholesterolaemia 346.55 23.46 644 223709 90193 110274753
Drug abuse 342.84 23.46 3 224350 177408 110187538
Renal failure 329.83 23.46 37 224316 226537 110138409
Pruritus 328.84 23.46 2161 222192 579399 109785547
C-reactive protein 327.13 23.46 354 223999 29977 110334969
Myalgia 322.00 23.46 37 224316 222344 110142602
Myocardial infarction 316.64 23.46 18 224335 192065 110172881
Urinary tract infection 316.12 23.46 133 224220 326149 110038797
Musculoskeletal pain 315.47 23.46 951 223402 182072 110182874
Wheezing 304.16 23.46 1172 223181 254058 110110888
Haemoglobin decreased 302.74 23.46 67 224286 248660 110116286
Blood pressure increased 299.92 23.46 77 224276 258296 110106650
Liver disorder 290.71 23.46 786 223567 141457 110223489
Nail disorder 282.74 23.46 458 223895 57477 110307469
Live birth 281.95 23.46 506 223847 68978 110295968
Seizure 280.73 23.46 54 224299 221131 110143815
Onychomadesis 279.42 23.46 401 223952 45262 110319684
Atrial fibrillation 277.19 23.46 63 224290 229579 110135367
COVID-19 276.94 23.46 77 224276 244983 110119963
Ear pain 275.17 23.46 432 223921 52794 110312152
Hyperhidrosis 274.08 23.46 30 224323 187268 110177678
Hyponatraemia 268.19 23.46 57 224296 217596 110147350
Syncope 266.66 23.46 45 224308 202491 110162455
Tremor 263.91 23.46 46 224307 202186 110162760
Renal impairment 263.89 23.46 35 224318 188410 110176536
Pregnancy 263.34 23.46 414 223939 50653 110314293
Cardiac failure 257.66 23.46 37 224316 187589 110177357
Insomnia 257.11 23.46 1424 222929 359166 110005780
Injection site pain 254.10 23.46 31 224322 177891 110187055
Respiratory disorder 247.51 23.46 486 223867 70896 110294050
Maternal exposure timing unspecified 247.44 23.46 257 224096 20756 110344190
Sepsis 245.73 23.46 183 224170 327163 110037783
Off label use 245.08 23.46 1913 222440 1498272 108866674
Feeling abnormal 245.00 23.46 37 224316 180674 110184272
Disease progression 243.60 23.46 95 224258 243939 110121007
Inappropriate schedule of product administration 243.50 23.46 57 224296 203580 110161366
Interstitial lung disease 242.81 23.46 9 224344 139325 110225621
Pulmonary fibrosis 241.60 23.46 596 223757 101446 110263500
Cerebrovascular accident 241.50 23.46 39 224314 181245 110183701
Chills 240.84 23.46 47 224306 190533 110174413
White blood cell count decreased 237.88 23.46 84 224269 229306 110135640
Erythema 233.22 23.46 152 224201 291295 110073651
Pancytopenia 231.05 23.46 69 224284 209544 110155402
Hypoaesthesia 226.68 23.46 1245 223108 312978 110051968
Onychomycosis 225.03 23.46 331 224022 38200 110326746
Gastrointestinal haemorrhage 224.13 23.46 34 224319 165484 110199462
Febrile neutropenia 224.01 23.46 188 224165 316579 110048367
Prescribed overdose 223.92 23.46 527 223826 87054 110277892
Influenza 219.46 23.46 39 224314 169062 110195884
Pulmonary embolism 214.87 23.46 83 224270 214391 110150555
Malignant neoplasm progression 214.47 23.46 46 224307 174521 110190425
Muscle spasticity 213.32 23.46 311 224042 35604 110329342
Rash 212.60 23.46 2571 221782 818393 109546553
Chest discomfort 211.17 23.46 47 224306 173801 110191145
Platelet count decreased 210.51 23.46 102 224251 230341 110134605
Lupus vulgaris 209.43 23.46 299 224054 33584 110331362
Abdominal pain upper 209.04 23.46 1317 223036 347794 110017152
Loss of consciousness 208.53 23.46 69 224284 196237 110168709
Retinitis 206.80 23.46 290 224063 32037 110332909
Finger deformity 205.98 23.46 293 224060 32799 110332147
Heart rate increased 205.53 23.46 25 224328 143809 110221137
Adverse event 204.24 23.46 583 223770 108226 110256720
Coma 204.06 23.46 8 224345 117861 110247085
Respiratory failure 203.36 23.46 91 224262 215241 110149705
Musculoskeletal stiffness 203.33 23.46 1111 223242 278711 110086235
Blepharospasm 203.07 23.46 384 223969 54467 110310479
Cardiac failure congestive 199.97 23.46 33 224320 150967 110213979
Rhabdomyolysis 199.28 23.46 11 224342 120390 110244556
Blood creatinine increased 198.31 23.46 62 224291 182827 110182119
Product label confusion 197.60 23.46 237 224116 22440 110342506
Bone erosion 196.23 23.46 344 224009 46027 110318919
Bradycardia 193.06 23.46 40 224313 155477 110209469
Palpitations 191.46 23.46 44 224309 159168 110205778
Blood glucose increased 189.39 23.46 23 224330 132473 110232473
Thrombocytopenia 188.86 23.46 259 224094 348626 110016320
Suicide attempt 186.17 23.46 5 224348 103389 110261557
Balance disorder 185.87 23.46 13 224340 116547 110248399
Haematochezia 183.88 23.46 13 224340 115511 110249435
Depressed level of consciousness 183.55 23.46 11 224342 112267 110252679
Drug ineffective 183.32 23.46 2090 222263 1518450 108846496
General physical health deterioration 179.58 23.46 1475 222878 423820 109941126
Incorrect dose administered 179.53 23.46 7 224346 103634 110261312
Hyperkalaemia 179.10 23.46 30 224323 135766 110229180
Productive cough 178.70 23.46 14 224339 114291 110250655
Oxygen saturation decreased 177.92 23.46 49 224304 156933 110208013
Prescribed underdose 177.40 23.46 402 223951 64772 110300174
Agitation 176.30 23.46 14 224339 113037 110251909
Multiple organ dysfunction syndrome 174.49 23.46 46 224307 151664 110213282
Vision blurred 173.54 23.46 27 224326 128995 110235951
Lupus-like syndrome 173.11 23.46 303 224050 40489 110324457
Exostosis 171.70 23.46 323 224030 45633 110319313
Hip arthroplasty 168.62 23.46 359 223994 55454 110309492
Breast cancer stage II 168.35 23.46 241 224112 27134 110337812
Porphyria acute 166.48 23.46 198 224155 18582 110346364
Anti-cyclic citrullinated peptide antibody 166.39 23.46 204 224149 19760 110345186
Cardiac arrest 165.14 23.46 97 224256 196656 110168290
Hypoglycaemia 163.88 23.46 21 224332 116083 110248863
Chronic obstructive pulmonary disease 163.50 23.46 16 224337 109142 110255804
Cardio-respiratory arrest 163.38 23.46 21 224332 115815 110249131
Taste disorder 162.31 23.46 389 223964 64998 110299948
Diabetes mellitus 161.66 23.46 10 224343 99371 110265575
Laryngitis 158.34 23.46 298 224055 42113 110322833
Deep vein thrombosis 157.90 23.46 44 224309 139843 110225103
Pleural effusion 157.26 23.46 82 224271 177627 110187319
Migraine 155.93 23.46 726 223627 170926 110194020
Electrocardiogram QT prolonged 155.51 23.46 19 224334 108941 110256005
Oedema 152.00 23.46 833 223520 209143 110155803
Oropharyngeal pain 151.85 23.46 43 224310 135233 110229713
Back injury 151.49 23.46 312 224041 47087 110317859
Cognitive disorder 151.28 23.46 6 224347 87505 110277441
Metabolic acidosis 151.04 23.46 14 224339 99730 110265216
Intentional product use issue 149.39 23.46 937 223416 246969 110117977
Dysphagia 146.44 23.46 64 224289 153536 110211410
Dyspepsia 145.97 23.46 769 223584 190196 110174750
Suicidal ideation 145.46 23.46 12 224341 93925 110271021
Septic shock 144.95 23.46 69 224284 157459 110207487
Rhinorrhoea 143.87 23.46 19 224334 102647 110262299
Myelosuppression 143.50 23.46 13 224340 94327 110270619
Injection site erythema 143.19 23.46 13 224340 94163 110270783
Pneumonia 142.51 23.46 1118 223235 875596 109489350
Stress 139.53 23.46 23 224330 105325 110259621
Alanine aminotransferase increased 138.78 23.46 102 224251 183671 110181275
Nasal congestion 138.17 23.46 18 224335 98264 110266682
Lactic acidosis 137.97 23.46 14 224339 92797 110272149
Diarrhoea 137.46 23.46 1565 222788 1137940 109227006
Thrombosis 136.83 23.46 27 224326 108635 110256311
Acute myocardial infarction 134.57 23.46 9 224344 83768 110281178
Herpes zoster 134.25 23.46 28 224325 108351 110256595
Influenza like illness 132.31 23.46 13 224340 88399 110276547
Hepatic function abnormal 131.37 23.46 14 224339 89281 110275665
Neuropathy peripheral 130.91 23.46 103 224250 179174 110185772
Wrong technique in product usage process 130.30 23.46 13 224340 87335 110277611
Blood pressure decreased 130.27 23.46 36 224317 115055 110249891
Leukopenia 126.78 23.46 72 224281 148719 110216227
Cardiac disorder 126.13 23.46 7 224346 76273 110288673
Dyspnoea exertional 124.61 23.46 29 224324 104031 110260915
Dysarthria 124.24 23.46 13 224340 84108 110280838
Coeliac disease 121.57 23.46 270 224083 42917 110322029
Blood pressure fluctuation 120.30 23.46 8 224345 74816 110290130
Adverse reaction 118.09 23.46 214 224139 29380 110335566
Cellulitis 117.78 23.46 54 224299 125962 110238984
International normalised ratio increased 117.05 23.46 18 224335 86754 110278192
Overdose 116.26 23.46 184 224169 233610 110131336
Vertigo 114.97 23.46 19 224334 86851 110278095
Angioedema 114.92 23.46 29 224324 98471 110266475
Amnesia 114.90 23.46 471 223882 104937 110260009
Swelling face 114.04 23.46 24 224329 92297 110272649
Cholestasis 112.97 23.46 4 224349 64514 110300432
Hallucination 112.44 23.46 33 224320 101399 110263547
Aspartate aminotransferase increased 111.67 23.46 96 224257 159840 110205106
Memory impairment 111.60 23.46 733 223620 196211 110168735
Dysphonia 111.46 23.46 12 224341 75917 110289029
Neutrophil count decreased 111.22 23.46 53 224300 120888 110244058
Haemoptysis 110.80 23.46 9 224344 71345 110293601
Sedation 110.43 23.46 8 224345 69675 110295271
C-reactive protein increased 110.39 23.46 789 223564 217130 110147816
Blood pressure systolic increased 110.17 23.46 18 224335 82973 110281973
Skin exfoliation 109.90 23.46 22 224331 87629 110277317
Knee arthroplasty 109.46 23.46 335 224018 64613 110300333
Treatment failure 109.18 23.46 947 223406 276287 110088659
Coronary artery disease 108.71 23.46 10 224343 71680 110293266
Illness 108.69 23.46 18 224335 82153 110282793
Blood creatine phosphokinase increased 108.68 23.46 11 224342 73066 110291880
Intentional product misuse 108.04 23.46 68 224285 132836 110232110
Haematuria 107.99 23.46 19 224334 82986 110281960
Grip strength 107.98 23.46 112 224241 9029 110355917
Ascites 106.98 23.46 28 224325 92780 110272166
Liver function test increased 106.45 23.46 408 223945 88140 110276806
Drug ineffective for unapproved indication 105.98 23.46 38 224315 102800 110262146
Back pain 103.92 23.46 394 223959 370602 109994344
Cataract 103.83 23.46 18 224335 79467 110285479
Walking aid user 103.47 23.46 184 224169 24891 110340055
Hepatic cirrhosis 103.14 23.46 337 224016 67289 110297657
Hypoxia 102.92 23.46 68 224285 129447 110235499
Lethargy 102.72 23.46 31 224322 93545 110271401
Chronic kidney disease 102.51 23.46 16 224337 76275 110288671
Disorientation 101.64 23.46 12 224341 70659 110294287
Hypothyroidism 100.93 23.46 14 224339 72885 110292061
Drug reaction with eosinophilia and systemic symptoms 100.06 23.46 22 224331 82073 110282873
Burkholderia test positive 99.39 23.46 40 224313 584 110364362
Disease recurrence 99.21 23.46 6 224347 60778 110304168
Paraesthesia 98.88 23.46 925 223428 275596 110089350
Pneumonia aspiration 98.54 23.46 22 224331 81211 110283735
Colitis 98.53 23.46 42 224311 102281 110262665
Orthostatic hypotension 98.45 23.46 10 224343 66239 110298707
Urinary retention 97.38 23.46 13 224340 69670 110295276
Weight decreased 96.31 23.46 556 223797 467501 109897445
Dry skin 96.23 23.46 49 224304 107604 110257342
Disturbance in attention 95.76 23.46 8 224345 61987 110302959
Muscle spasms 95.75 23.46 923 223430 277234 110087712
Melaena 95.67 23.46 13 224340 68744 110296202
Injection site swelling 95.37 23.46 8 224345 61782 110303164
Agranulocytosis 95.31 23.46 8 224345 61752 110303194
Transient ischaemic attack 94.20 23.46 10 224343 63972 110300974
Generalised tonic-clonic seizure 93.67 23.46 4 224349 54676 110310270
Product quality issue 93.60 23.46 357 223996 76942 110288004
Hyperglycaemia 91.94 23.46 29 224324 85061 110279885
Epilepsy 91.81 23.46 425 223928 99784 110265162
Hepatic cytolysis 91.18 23.46 5 224348 55048 110309898
Hepatic failure 91.04 23.46 15 224338 68724 110296222
Arthralgia 90.58 23.46 2144 222209 777488 109587458
Jaundice 90.53 23.46 8 224345 59228 110305718
Burkholderia infection 90.43 23.46 25 224328 98 110364848
Arrhythmia 90.35 23.46 16 224337 69559 110295387
Pancreatitis acute 89.83 23.46 9 224344 60265 110304681
Heart rate decreased 89.78 23.46 28 224325 82728 110282218
Swollen joint count 89.62 23.46 99 224254 8575 110356371
Angina pectoris 88.55 23.46 11 224342 62284 110302662
Bronchitis 87.51 23.46 114 224239 156918 110208028
Hypokalaemia 87.50 23.46 147 224206 182301 110182645
Body temperature increased 87.38 23.46 277 224076 54436 110310510
Renal disorder 86.87 23.46 3 224350 49476 110315470
Nephrolithiasis 86.47 23.46 15 224338 66197 110298749
Haematocrit decreased 86.30 23.46 15 224338 66102 110298844
Medication error 85.81 23.46 432 223921 104934 110260012
Burning sensation 85.47 23.46 18 224335 69194 110295752
Restlessness 84.90 23.46 8 224345 56251 110308695
Speech disorder 84.82 23.46 12 224341 61557 110303389
Intestinal obstruction 84.66 23.46 6 224347 53221 110311725
Pneumonitis 84.64 23.46 25 224328 76506 110288440
Flushing 84.56 23.46 54 224299 104682 110260264
Dyskinesia 84.20 23.46 5 224348 51441 110313505
Toxic epidermal necrolysis 83.17 23.46 9 224344 56718 110308228
Liver function test abnormal 82.98 23.46 19 224334 68931 110296015
Throat irritation 82.47 23.46 7 224346 53545 110311401
Haemorrhage 82.12 23.46 58 224295 106634 110258312
Haematoma 81.50 23.46 11 224342 58465 110306481
Rash erythematous 81.37 23.46 32 224321 81800 110283146
Respiratory arrest 81.17 23.46 11 224342 58288 110306658
Obstructive airways disorder 80.32 23.46 3 224350 46146 110318800
Unresponsive to stimuli 79.99 23.46 16 224337 63774 110301172
Blood urea increased 79.86 23.46 9 224344 54948 110309998
Foot deformity 79.77 23.46 248 224105 48232 110316714
Diverticulitis 79.74 23.46 8 224345 53514 110311432
Red blood cell count decreased 79.67 23.46 18 224335 65905 110299041
Full blood count abnormal 79.43 23.46 10 224343 56042 110308904
Tinnitus 78.44 23.46 14 224339 60526 110304420
Bone pain 78.28 23.46 18 224335 65115 110299831
Product contamination microbial 77.89 23.46 40 224313 1054 110363892
Aphasia 77.85 23.46 13 224340 58984 110305962
Drug resistance 77.63 23.46 11 224342 56363 110308583
Psychotic disorder 77.51 23.46 7 224346 50930 110314016
Hepatotoxicity 77.25 23.46 17 224336 63383 110301563
Mental status changes 76.96 23.46 29 224324 76093 110288853
Cerebral infarction 76.58 23.46 8 224345 51830 110313116
Delirium 76.13 23.46 502 223851 134523 110230423
Swollen tongue 75.99 23.46 15 224338 60347 110304599
Pallor 75.51 23.46 12 224341 56455 110308491
Transaminases increased 75.23 23.46 18 224335 63372 110301574
Blood bilirubin increased 75.06 23.46 30 224323 75942 110289004
Pericardial effusion 74.64 23.46 13 224340 57204 110307742
Viral infection 74.05 23.46 10 224343 53129 110311817
Eczema 74.00 23.46 27 224326 72266 110292680
Joint dislocation 73.90 23.46 193 224160 33997 110330949
Haematemesis 73.76 23.46 15 224338 59093 110305853
Multiple sclerosis relapse 73.58 23.46 8 224345 50232 110314714
Cholelithiasis 73.35 23.46 19 224334 63403 110301543
Product prescribing error 73.12 23.46 9 224344 51322 110313624
Rash maculo-papular 72.21 23.46 30 224323 74192 110290754
Pulmonary oedema 72 23.46 59 224294 100600 110264346
Mucosal inflammation 71.74 23.46 54 224299 96087 110268859
Neoplasm progression 71.62 23.46 21 224332 64574 110300372
Normal newborn 70.98 23.46 145 224208 21751 110343195
Injection site pruritus 70.59 23.46 10 224343 51248 110313698
Lymphocyte count decreased 70.45 23.46 15 224338 57228 110307718
Cerebral haemorrhage 70.44 23.46 22 224331 64946 110300000
Pneumocystis jirovecii pneumonia 70.41 23.46 4 224349 42731 110322215
Lymphadenopathy 70.33 23.46 21 224332 63814 110301132
Therapy interrupted 70.33 23.46 9 224344 49813 110315133
Dysgeusia 70.19 23.46 27 224326 69958 110294988
Tubulointerstitial nephritis 69.37 23.46 13 224340 54271 110310675
Encephalopathy 69.35 23.46 39 224314 81016 110283930
Incorrect route of product administration 68.81 23.46 285 224068 63776 110301170
Plasma cell myeloma 68.80 23.46 21 224332 62915 110302031
Ventricular tachycardia 68.30 23.46 10 224343 49999 110314947
Underdose 67.68 23.46 282 224071 63272 110301674
Hypocalcaemia 67.61 23.46 24 224329 65342 110299604
Hallucination, visual 67.50 23.46 3 224350 39602 110325344
Subcutaneous drug absorption impaired 66.65 23.46 80 224273 7579 110357367
Drug hypersensitivity 66.55 23.46 1292 223061 452798 109912148
Gastritis 66.24 23.46 14 224339 53685 110311261
Unevaluable event 66.14 23.46 19 224334 59208 110305738
Therapy non-responder 65.92 23.46 545 223808 156762 110208184
Red blood cell sedimentation rate increased 65.85 23.46 324 224029 77978 110286968
Diplopia 65.84 23.46 5 224348 41889 110323057
Bone marrow failure 65.63 23.46 18 224335 57830 110307116
Cystitis 65.37 23.46 26 224327 66010 110298936
Femur fracture 65.34 23.46 7 224346 44462 110320484
Proteinuria 65.16 23.46 4 224349 40014 110324932
Accidental overdose 65.00 23.46 13 224340 51821 110313125
Blood potassium decreased 64.95 23.46 15 224338 54099 110310847
Drug withdrawal syndrome 64.47 23.46 3 224350 38051 110326895
Aggression 64.29 23.46 20 224333 59190 110305756
Hemiparesis 64.28 23.46 7 224346 43896 110321050
Ear infection 64.20 23.46 275 224078 62457 110302489
Seronegative arthritis 64.03 23.46 104 224249 13073 110351873
Upper gastrointestinal haemorrhage 64.01 23.46 12 224341 50084 110314862
Dry eye 63.98 23.46 17 224336 55776 110309170
Recalled product administered 63.84 23.46 37 224316 1245 110363701
Therapy cessation 63.57 23.46 8 224345 44849 110320097
Oral candidiasis 63.39 23.46 8 224345 44752 110320194
Abnormal behaviour 63.27 23.46 4 224349 39035 110325911
Acute respiratory failure 63.27 23.46 37 224316 75223 110289723
Fungal infection 63.17 23.46 13 224340 50793 110314153
Cardiogenic shock 62.92 23.46 19 224334 57319 110307627
Gastroenteritis 62.81 23.46 4 224349 38796 110326150
Eosinophilia 62.14 23.46 20 224333 57916 110307030
Cytomegalovirus infection 61.66 23.46 17 224336 54427 110310519
Palmar-plantar erythrodysaesthesia syndrome 61.46 23.46 6 224347 41019 110323927
Acute hepatic failure 61.38 23.46 3 224350 36465 110328481
Tachycardia 61.30 23.46 244 224109 226401 110138545
Limb discomfort 61.14 23.46 6 224347 40848 110324098
Pulmonary hypertension 61.13 23.46 18 224335 55202 110309744
Metastases to liver 59.27 23.46 3 224350 35383 110329563
Overlap syndrome 59.02 23.46 82 224271 8977 110355969
Bacterial infection 58.88 23.46 11 224342 46025 110318921
Shock 58.36 23.46 18 224335 53570 110311376
Sleep apnoea syndrome 57.84 23.46 7 224346 40440 110324506
Hepatic steatosis 57.69 23.46 14 224339 48817 110316129
Urinary incontinence 57.26 23.46 14 224339 48573 110316373
Ventricular fibrillation 57.03 23.46 8 224345 41305 110323641
Joint injury 57.00 23.46 7 224346 39987 110324959
Ischaemic stroke 56.94 23.46 8 224345 41255 110323691
Neuroleptic malignant syndrome 56.70 23.46 3 224350 34056 110330890
Gastric ulcer 56.69 23.46 7 224346 39820 110325126
Nervousness 56.25 23.46 5 224348 36846 110328100
Hot flush 56.17 23.46 32 224321 66004 110298942
Acute respiratory distress syndrome 55.94 23.46 19 224334 53179 110311767
Subdural haematoma 55.50 23.46 5 224348 36449 110328497
Hepatic enzyme 55.21 23.46 60 224293 5103 110359843
Blood potassium increased 55.12 23.46 3 224350 33246 110331700
Dysstasia 54.61 23.46 3 224350 32983 110331963
Dysuria 54.45 23.46 27 224326 60204 110304742
Vasculitis 54.40 23.46 5 224348 35868 110329078
Procedural pain 53.81 23.46 5 224348 35560 110329386
Tachypnoea 53.52 23.46 8 224345 39387 110325559
Lung neoplasm malignant 53.29 23.46 4 224349 33838 110331108
Mental disorder 52.42 23.46 8 224345 38783 110326163
Myelodysplastic syndrome 52.36 23.46 7 224346 37477 110327469
Neutrophil count increased 52.09 23.46 5 224348 34647 110330299
Abdominal pain lower 51.99 23.46 7 224346 37276 110327670
Iron deficiency anaemia 51.85 23.46 3 224350 31556 110333390
Eye swelling 51.78 23.46 4 224349 33044 110331902
Blood sodium decreased 51.56 23.46 8 224345 38311 110326635
Head injury 51.47 23.46 12 224341 43005 110321941
Skin disorder 51.29 23.46 12 224341 42901 110322045
Stevens-Johnson syndrome 50.64 23.46 16 224337 46885 110318061
Posterior reversible encephalopathy syndrome 50.60 23.46 5 224348 33856 110331090
Exposure during pregnancy 50.58 23.46 541 223812 166883 110198063
Respiratory tract congestion 50.49 23.46 3 224350 30854 110334092
Nightmare 50.32 23.46 9 224344 38854 110326092
Limb injury 50.32 23.46 8 224345 37628 110327318
Blindness 50.29 23.46 7 224346 36352 110328594
Full blood count decreased 49.97 23.46 4 224349 32095 110332851
Throat tightness 49.90 23.46 5 224348 33484 110331462
Sinus congestion 49.73 23.46 3 224350 30456 110334490
Pollakiuria 49.67 23.46 14 224339 44181 110320765
Device issue 49.33 23.46 6 224347 34529 110330417
Status epilepticus 48.96 23.46 4 224349 31567 110333379
Myocarditis 48.95 23.46 3 224350 30052 110334894
Disseminated intravascular coagulation 48.45 23.46 12 224341 41274 110323672
Surgery 48.45 23.46 12 224341 41271 110323675
Gout 48.38 23.46 8 224345 36558 110328388
Cyanosis 48.34 23.46 3 224350 29738 110335208
Ejection fraction decreased 47.75 23.46 12 224341 40868 110324078
Paraesthesia oral 47.72 23.46 6 224347 33665 110331281
Localised infection 47.71 23.46 14 224339 43034 110321912
Eye pain 47.54 23.46 21 224332 50078 110314868
Oral herpes 47.50 23.46 8 224345 36072 110328874
Leukocytosis 47.36 23.46 25 224328 53803 110311143
Candida infection 47.36 23.46 19 224334 47990 110316956
Thrombotic microangiopathy 47.20 23.46 3 224350 29146 110335800
Sneezing 47.08 23.46 5 224348 31979 110332967
Hyperlipidaemia 47.08 23.46 8 224345 35840 110329106
Depressed mood 46.87 23.46 33 224320 60776 110304170
Extrapyramidal disorder 46.66 23.46 3 224350 28864 110336082
Injection site reaction 46.52 23.46 325 224028 88745 110276201
Ulcer haemorrhage 46.34 23.46 125 224228 22446 110342500
Eye pruritus 46.07 23.46 6 224347 32769 110332177
Rib fracture 45.55 23.46 7 224346 33763 110331183
Abdominal pain 45.54 23.46 749 223604 512240 109852706
Blood alkaline phosphatase increased 45.46 23.46 46 224307 70889 110294057
Product administration error 45.30 23.46 10 224343 37207 110327739
Neoplasm malignant 45.17 23.46 10 224343 37133 110327813
Acne 45.10 23.46 7 224346 33513 110331433
Ocular hyperaemia 44.99 23.46 12 224341 39274 110325672
Eating disorder 44.97 23.46 5 224348 30853 110334093
Hypomagnesaemia 44.92 23.46 34 224319 60336 110304610
Treatment noncompliance 44.91 23.46 49 224304 72941 110292005
Flatulence 44.74 23.46 25 224328 52124 110312822
Labelled drug-drug interaction medication error 44.66 23.46 4 224349 29298 110335648
Drug tolerance decreased 44.49 23.46 140 224213 27400 110337546
Mouth ulceration 44.40 23.46 21 224332 48117 110316829
Accidental exposure to product 44.33 23.46 23 224330 49985 110314961
Drug eruption 44.23 23.46 27 224326 53632 110311314
Hypophagia 44.05 23.46 26 224327 52600 110312346
Nephropathy toxic 43.98 23.46 3 224350 27475 110337471
Lip swelling 43.89 23.46 24 224329 50643 110314303
Irritability 43.87 23.46 21 224332 47788 110317158
Sinus disorder 43.66 23.46 7 224346 32721 110332225
Hypertension 43.45 23.46 1348 223005 508736 109856210
Adverse drug reaction 43.30 23.46 364 223989 105195 110259751
Clostridium difficile infection 43.29 23.46 26 224327 52103 110312843
Gastroenteritis viral 43.21 23.46 6 224347 31220 110333726
Appendicitis 43.07 23.46 4 224349 28460 110336486
Product use issue 42.98 23.46 879 223474 310816 110054130
Spondylitis 42.73 23.46 80 224273 11258 110353688
Therapeutic response shortened 42.60 23.46 5 224348 29578 110335368
Presyncope 42.58 23.46 23 224330 48864 110316082
Gamma-glutamyltransferase increased 42.54 23.46 37 224316 61272 110303674
Sinus bradycardia 42.41 23.46 5 224348 29478 110335468
Polyneuropathy 42.36 23.46 7 224346 32005 110332941
Epistaxis 42.19 23.46 130 224223 130242 110234704
Drug-induced liver injury 42.04 23.46 400 223953 119667 110245279
Disability 42 23.46 146 224207 30077 110334869
Dizziness 41.92 23.46 1087 223266 697106 109667840
Blood albumin decreased 41.54 23.46 4 224349 27648 110337298
Hepatitis 41.54 23.46 319 224034 89735 110275211
Eye disorder 41.34 23.46 5 224348 28901 110336045
Skin lesion 41.15 23.46 27 224326 51604 110313342
Blood pressure diastolic decreased 41.02 23.46 11 224342 35874 110329072
Blood calcium decreased 40.95 23.46 11 224342 35834 110329112
General symptom 40.54 23.46 68 224285 8778 110356168
Mitral valve incompetence 40.47 23.46 9 224344 33320 110331626
Pulmonary congestion 40.47 23.46 7 224346 30959 110333987
Crying 40.44 23.46 3 224350 25625 110339321
Aspergillus infection 40.42 23.46 3 224350 25613 110339333
Photosensitivity reaction 40.37 23.46 3 224350 25586 110339360
Rash macular 40.36 23.46 14 224339 38672 110326274
Hepatic encephalopathy 40.13 23.46 5 224348 28251 110336695
Hypoacusis 39.83 23.46 11 224342 35180 110329766
Hypersomnia 39.77 23.46 5 224348 28056 110336890
Hip fracture 39.76 23.46 11 224342 35140 110329806
Myocardial ischaemia 39.72 23.46 4 224349 26680 110338266
Pseudomonas infection 39.39 23.46 5 224348 27848 110337098
Asthma 39.31 23.46 720 223633 249571 110115375
Impaired work ability 39.22 23.46 4 224349 26415 110338531
Coagulopathy 39.05 23.46 17 224336 40894 110324052
Ataxia 38.92 23.46 7 224346 30101 110334845
Restless legs syndrome 38.53 23.46 3 224350 24623 110340323
Troponin increased 38.31 23.46 7 224346 29759 110335187
Subarachnoid haemorrhage 38.19 23.46 7 224346 29695 110335251
Tumour lysis syndrome 38.05 23.46 8 224345 30793 110334153
Ileus 37.92 23.46 8 224345 30721 110334225
Blood urine present 37.80 23.46 3 224350 24242 110340704
Mechanical ventilation complication 37.73 23.46 22 224331 749 110364197
Cardiac failure acute 37.48 23.46 3 224350 24075 110340871
Haemophagocytic lymphohistiocytosis 37.37 23.46 9 224344 31550 110333396
Pulmonary arterial hypertension 37.20 23.46 10 224343 32558 110332388
Blood triglycerides increased 37.19 23.46 3 224350 23923 110341023
Vaginal haemorrhage 36.70 23.46 4 224349 25070 110339876
Gastric disorder 36.69 23.46 11 224342 33346 110331600
Glycosylated haemoglobin increased 36.61 23.46 3 224350 23616 110341330
Pain 36.59 23.46 2324 222029 952631 109412315
Neuralgia 36.46 23.46 27 224326 48451 110316495
Toxic skin eruption 36.44 23.46 6 224347 27509 110337437
Circulatory collapse 36.33 23.46 21 224332 42972 110321974
Recalled product 36.26 23.46 24 224329 1026 110363920
Skin haemorrhage 36.24 23.46 4 224349 24823 110340123
Blood test abnormal 36.14 23.46 7 224346 28547 110336399
Arteriosclerosis 36.13 23.46 4 224349 24763 110340183
Transplant rejection 35.75 23.46 4 224349 24563 110340383
Device dislocation 35.71 23.46 10 224343 31694 110333252
Metastases to lung 35.55 23.46 3 224350 23060 110341886
Multiple sclerosis 35.42 23.46 5 224348 25693 110339253
Haemorrhoids 35.38 23.46 14 224339 35658 110329288
Poor quality sleep 35.29 23.46 7 224346 28070 110336876
Rash vesicular 35.10 23.46 86 224267 14566 110350380
Eye irritation 35.08 23.46 12 224341 33440 110331506
Cardiovascular disorder 34.98 23.46 3 224350 22757 110342189
Clostridium difficile colitis 34.75 23.46 23 224330 43755 110321191
Carpal tunnel syndrome 34.69 23.46 3 224350 22607 110342339
Brain oedema 34.68 23.46 10 224343 31088 110333858
Hallucination, auditory 34.42 23.46 6 224347 26391 110338555
Therapeutic response unexpected 34.40 23.46 4 224349 23839 110341107
Basal cell carcinoma 34.32 23.46 25 224328 45245 110319701
Joint stiffness 34.32 23.46 244 224109 66999 110297947
Chronic sinusitis 34.29 23.46 5 224348 25079 110339867
Skin ulcer 33.64 23.46 48 224305 63597 110301349
Renal tubular necrosis 33.61 23.46 10 224343 30465 110334481
Hyperthyroidism 33.39 23.46 9 224344 29252 110335694
Small intestinal obstruction 33.02 23.46 12 224341 32201 110332745
Cytopenia 33.00 23.46 10 224343 30106 110334840
Visual acuity reduced 32.95 23.46 12 224341 32161 110332785
Glomerular filtration rate decreased 32.87 23.46 9 224344 28947 110335999
Atrial flutter 32.79 23.46 5 224348 24257 110340689
Blood uric acid increased 32.65 23.46 3 224350 21526 110343420
Intervertebral disc protrusion 32.60 23.46 8 224345 27690 110337256
End stage renal disease 32.54 23.46 3 224350 21470 110343476
Metastases to central nervous system 32.50 23.46 4 224349 22813 110342133
Ulcer 32.44 23.46 24 224329 43092 110321854
Skin discolouration 32.36 23.46 31 224322 49015 110315931
Mood altered 32.35 23.46 3 224350 21372 110343574
Conjunctivitis 32.32 23.46 14 224339 33778 110331168
Skin laceration 32.26 23.46 14 224339 33739 110331207
Nervous system disorder 32.21 23.46 12 224341 31709 110333237
Ventricular extrasystoles 32.17 23.46 4 224349 22637 110342309
Eosinophil count increased 31.76 23.46 3 224350 21055 110343891
Pustular psoriasis 31.68 23.46 79 224274 13526 110351420
Paranoia 31.68 23.46 4 224349 22370 110342576
Injection site rash 31.26 23.46 5 224348 23414 110341532
Staphylococcal infection 31.14 23.46 59 224294 69885 110295061
Impaired quality of life 31.08 23.46 11 224342 30006 110334940
Poor venous access 31.06 23.46 6 224347 24516 110340430
Cold sweat 31.04 23.46 4 224349 22027 110342919
Splenomegaly 31.02 23.46 6 224347 24492 110340454
Foot fracture 30.82 23.46 7 224346 25539 110339407
Post procedural complication 30.80 23.46 8 224345 26650 110338296
Anuria 30.74 23.46 6 224347 24335 110340611
Flank pain 30.73 23.46 5 224348 23125 110341821
Middle insomnia 30.71 23.46 3 224350 20499 110344447
Rash papular 30.61 23.46 9 224344 27630 110337316
Product substitution issue 30.61 23.46 5 224348 23056 110341890
Generalised oedema 30.53 23.46 12 224341 30692 110334254
Uveitis 30.45 23.46 4 224349 21706 110343240
Thirst 30.45 23.46 4 224349 21703 110343243
Cardiomyopathy 30.34 23.46 15 224338 33510 110331436
Secretion discharge 30.22 23.46 3 224350 20241 110344705
COVID-19 pneumonia 30.18 23.46 19 224334 37124 110327822
Arteriosclerosis coronary artery 30.07 23.46 7 224346 25111 110339835
Pharyngitis 30.03 23.46 7 224346 25091 110339855
Electrolyte imbalance 30.01 23.46 19 224334 37009 110327937
Respiratory distress 29.87 23.46 59 224294 68815 110296131
Torsade de pointes 29.77 23.46 5 224348 22595 110342351
Hyperthermia 29.64 23.46 4 224349 21268 110343678
Glaucoma 29.62 23.46 5 224348 22512 110342434
Cardiomegaly 29.61 23.46 11 224342 29119 110335827
Breast cancer 29.59 23.46 21 224332 38521 110326425
Sinus tachycardia 29.50 23.46 28 224325 44465 110320481
Gallbladder disorder 29.20 23.46 4 224349 21025 110343921
Petechiae 28.92 23.46 6 224347 23311 110341635
Motor dysfunction 28.82 23.46 7 224346 24399 110340547
Mania 28.77 23.46 4 224349 20792 110344154
Hypervolaemia 28.49 23.46 35 224318 49425 110315521
Coordination abnormal 28.34 23.46 8 224345 25220 110339726
Urticaria thermal 28.25 23.46 16 224337 515 110364431
Product storage error 28.20 23.46 5 224348 21723 110343223
Atelectasis 28.19 23.46 20 224333 36692 110328254
Rash pruritic 28.17 23.46 103 224250 97966 110266980
Haemodynamic instability 28.16 23.46 6 224347 22882 110342064
Acute generalised exanthematous pustulosis 28.09 23.46 5 224348 21659 110343287
Sleep disorder due to general medical condition, hypersomnia type 28.02 23.46 27 224326 1992 110362954
Spinal stenosis 27.99 23.46 3 224350 19053 110345893
Tricuspid valve incompetence 27.90 23.46 7 224346 23866 110341080
Cholecystitis 27.64 23.46 9 224344 25873 110339073
Lymphoma 27.62 23.46 4 224349 20167 110344779
Deafness 27.29 23.46 10 224343 26699 110338247
Product dose omission in error 27.27 23.46 7 224346 23505 110341441
Oliguria 27.25 23.46 3 224350 18654 110346292
Activated partial thromboplastin time prolonged 27.24 23.46 6 224347 22362 110342584
Ankle fracture 26.98 23.46 4 224349 19815 110345131
Osteopenia 26.96 23.46 6 224347 22203 110342743
Lower gastrointestinal haemorrhage 26.93 23.46 3 224350 18483 110346463
Intestinal perforation 26.79 23.46 5 224348 20939 110344007
Joint effusion 26.72 23.46 5 224348 20900 110344046
Fear 26.72 23.46 7 224346 23186 110341760
Cytomegalovirus infection reactivation 26.64 23.46 3 224350 18330 110346616
Adrenal insufficiency 26.59 23.46 28 224325 42362 110322584
Pyelonephritis 26.58 23.46 9 224344 25241 110339705
Skin burning sensation 26.29 23.46 6 224347 21819 110343127
Haemorrhage intracranial 26.16 23.46 13 224340 28956 110335990
Radiculopathy 26.10 23.46 4 224349 19332 110345614
Micturition urgency 26.07 23.46 4 224349 19316 110345630
Escherichia infection 25.93 23.46 8 224345 23808 110341138
Upper respiratory tract infection 25.90 23.46 158 224195 131170 110233776
Retching 25.84 23.46 7 224346 22675 110342271
Mental impairment 25.76 23.46 7 224346 22632 110342314
Weight fluctuation 25.75 23.46 101 224252 22044 110342902
Photophobia 25.75 23.46 10 224343 25761 110339185
Needle issue 25.72 23.46 3 224350 17837 110347109
Intentional dose omission 25.25 23.46 5 224348 20075 110344871
Encephalitis 25.19 23.46 4 224349 18835 110346111
Renal injury 24.96 23.46 4 224349 18709 110346237
Respiratory tract infection 24.92 23.46 69 224284 71548 110293398
Injection site warmth 24.92 23.46 3 224350 17402 110347544
Peritonitis 24.73 23.46 18 224335 32589 110332357
Vitamin D deficiency 24.67 23.46 4 224349 18548 110346398
Upper limb fracture 24.65 23.46 6 224347 20882 110344064
Bronchopulmonary aspergillosis 24.65 23.46 15 224338 29848 110335098
Anal incontinence 24.61 23.46 7 224346 21957 110342989
Iron deficiency 24.54 23.46 4 224349 18472 110346474
Squamous cell carcinoma 24.51 23.46 4 224349 18459 110346487
Hyperbilirubinaemia 24.50 23.46 16 224337 30655 110334291
Premature delivery 24.44 23.46 16 224337 30616 110334330
Right ventricular failure 24.43 23.46 11 224342 25943 110339003
Aspiration 24.29 23.46 16 224337 30517 110334429
Duodenal ulcer 24.25 23.46 5 224348 19509 110345437
Pyrexia 24.21 23.46 2126 222227 896139 109468807
Benign prostatic hyperplasia 24.10 23.46 4 224349 18230 110346716
Hiatus hernia 24.02 23.46 13 224340 27593 110337353
Musculoskeletal disorder 23.99 23.46 8 224345 22656 110342290
Renal cyst 23.98 23.46 4 224349 18168 110346778
Malignant melanoma 23.96 23.46 3 224350 16888 110348058
Spinal fracture 23.94 23.46 8 224345 22625 110342321
Lung infiltration 23.88 23.46 10 224343 24618 110340328
Bronchospasm 23.85 23.46 16 224337 30223 110334723
Rhinitis 23.79 23.46 8 224345 22537 110342409
Acidosis 23.77 23.46 8 224345 22523 110342423
Red blood cell sedimentation rate abnormal 23.69 23.46 10 224343 24499 110340447
Enteritis 23.61 23.46 5 224348 19151 110345795
Lacrimation increased 23.58 23.46 17 224336 30933 110334013
Malnutrition 23.51 23.46 13 224340 27266 110337680
Incontinence 23.49 23.46 3 224350 16632 110348314
Nodule 23.49 23.46 19 224334 32612 110332334
Large intestine perforation 23.48 23.46 3 224350 16626 110348320

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A01AB03 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Antiinfectives and antiseptics for local oral treatment
ATC A01AB53 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Antiinfectives and antiseptics for local oral treatment
ATC B05CA02 BLOOD AND BLOOD FORMING ORGANS
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
IRRIGATING SOLUTIONS
Antiinfectives
ATC D08AC02 DERMATOLOGICALS
ANTISEPTICS AND DISINFECTANTS
ANTISEPTICS AND DISINFECTANTS
Biguanides and amidines
ATC D08AC52 DERMATOLOGICALS
ANTISEPTICS AND DISINFECTANTS
ANTISEPTICS AND DISINFECTANTS
Biguanides and amidines
ATC D09AA12 DERMATOLOGICALS
MEDICATED DRESSINGS
MEDICATED DRESSINGS
Medicated dressings with antiinfectives
ATC R02AA05 RESPIRATORY SYSTEM
THROAT PREPARATIONS
THROAT PREPARATIONS
Antiseptics
ATC S01AX09 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Other antiinfectives
ATC S02AA09 SENSORY ORGANS
OTOLOGICALS
ANTIINFECTIVES
Antiinfectives
ATC S03AA04 SENSORY ORGANS
OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
ANTIINFECTIVES
Antiinfectives
FDA PE N0000008478 Decreased Cell Wall Integrity
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:33281 antimicrobial agent
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:67079 anti-inflammatory agent
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000891 Anti-Infective Agents, Local
MeSH PA D003879 Dermatologic Agents
MeSH PA D003358 Cosmetics
MeSH PA D004202 Disinfectants
MeSH PA D009067 Mouthwashes
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:86327 antifungal drug
CHEBI has role CHEBI:35718 antifungal agent
CHEBI has role CHEBI:51076 antifouling biocide

Related Drugs by ATC class:

A01AB Antiinfectives and antiseptics for local oral treatment 22 drugs
amphotericin Bbenzoxonium chloridecetylpyridiniumchlortetracyclineclotrimazoledomiphendoxycyclinehexetidinehydrogen peroxidemepartricinmetronidazolemiconazole show all 22 →
B05CA Antiinfectives 8 drugs
cetylpyridiniumethacridinemandelic acidneomycinnitrofurazonenoxytiolinsulfamethizoletaurolidine
D08AC Biguanides and amidines 4 drugs
dibrompropamidinehexamidinepolihexanidepropamidine
D09AA Medicated dressings with antiinfectives 11 drugs
aluminium chlorohydratebenzalkoniumcetylpyridiniumclioquinolframycetinfusidic acidiodoformnitrofurazonephenylmercuric nitratepovidone-iodinetriclosan
R02AA Antiseptics 15 drugs
ambazonebenzalkoniumbenzethoniumcetrimoniumcetylpyridiniumchlorquinaldoldequaliniumdichlorobenzyl alcoholeuflavinehexamidinehexylresorcinoloctenidine show all 15 →
S01AX Other antiinfectives 13 drugs
bibrocatholcethexoniumdibrompropamidinehexamidinelotilanernitrofurazonepicloxydinepolihexanidepovidone-iodinepropamidineresorcinolsodium borate show all 13 →
S02AA Antiinfectives 17 drugs
acetic acidaluminium acetotartrateboric acidcefmenoximechloramphenicolciprofloxacinclioquinolfosfomycingentamicinhydrogen peroxidemiconazoleneomycin show all 17 →
S03AA Antiinfectives 7 drugs
chloramphenicolciprofloxacingentamicinhexamidineneomycinPolymyxin Btetracycline

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

DiseaseRelationSNOMED_IDDOID
Gingivitis indication 66383009 DOID:3087
Mouth Infection Prevention indication
Denture stomatitis off-label use 69254008 DOID:11875
Aphthous ulcer of mouth off-label use 426965005 DOID:9663
Dental Plaque Prevention off-label use
Periodontitis contraindication 41565005 DOID:824
Open wound contraindication 125643001
Front Tooth Fillings contraindication




🐶 Veterinary Drug Use

SpeciesUseRelation
Cats Topical antiseptic for surface wounds Indication
Cattle Metritis Indication
Cattle Vaginitis Indication
Dogs Topical antiseptic for surface wounds Indication
Horses Topical antiseptic for surface wounds Indication
Horses Metritis Indication
Horses Vaginitis Indication

🐶 Veterinary products

ProductApplicantIngredients
Nolvasan Antiseptic Ointment Zoetis Inc. 1
Nolvasan Cap-Tabs Zoetis Inc. 1
Nolvasan Suspension Zoetis Inc. 1
Privasan Antiseptic Ointment First Priority Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.17 Basic
pKa2 10.57 Basic
pKa3 3.32 Basic
pKa4 2.72 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
2%;70% (10.5ML) CHLORAPREP WITH TINT BECTON DICKINSON CO N020832 April 3, 2006 OTC SPONGE TOPICAL 7422388 April 25, 2027 USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENTS SKIN PRIOR TO SURGERY
2%;70% (26ML) CHLORAPREP WITH TINT BECTON DICKINSON CO N020832 May 3, 2005 OTC SPONGE TOPICAL 7422388 April 25, 2027 USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENTS SKIN PRIOR TO SURGERY
2%;70% (3ML) CHLORAPREP WITH TINT BECTON DICKINSON CO N020832 Oct. 10, 2006 OTC SPONGE TOPICAL 7422388 April 25, 2027 USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENTS SKIN PRIOR TO SURGERY
2% CHLORHEXIDINE GLUCONATE SAGE PRODS N021669 April 25, 2005 OTC CLOTH TOPICAL 7935093 Oct. 2, 2027 FOR THE PREPARATION OF SKIN PRIOR TO SURGERY; HELPS REDUCE BACTERIA THAT CAN POTENTIALLY CAUSE SKIN INFECTION

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
2%;70% SOLUPREP S SOLVENTUM N208288 Aug. 8, 2018 OTC SOLUTION TOPICAL Jan. 20, 2026 REVISIONS TO THE LABELING TO DESCRIBE MODIFIED FORMULATION BASED ON RESULTS OF STUDIES EM-05-014624 AND EM-05-014815

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
72 kDa type IV collagenase Enzyme IC50 5.12 CHEMBL
Matrix metalloproteinase-9 Enzyme IC50 5.12 CHEMBL
Dual specificity protein kinase CLK2 Kinase IC50 5.04 CHEMBL
Solute carrier family 22 member 1 Transporter IC50 6.68 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 6.40 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 6.15 CHEMBL
Multidrug and toxin extrusion protein 2 Transporter IC50 6.30 CHEMBL
Solute carrier family 22 member 3 Transporter IC50 6.39 CHEMBL
Synaptojanin-2 Enzyme IC50 5 CHEMBL
Trypanothione reductase Enzyme Ki 5.70 CHEMBL
CAAX prenyl protease 2 Enzyme AC50 5.24 CHEMBL

External reference:

IDSource
D00858 KEGG_DRUG
3697-42-5 SECONDARY_CAS_RN
18472-51-0 SECONDARY_CAS_RN
20791 RXNORM
C0008196 UMLSCUI
CHEBI:3614 CHEBI
XC9 PDB_CHEM_ID
CHEMBL790 ChEMBL_ID
CHEMBL1484251 ChEMBL_ID
CHEMBL4297088 ChEMBL_ID
D002710 MESH_DESCRIPTOR_UI
DB00878 DRUGBANK_ID
14052 IUPHAR_LIGAND_ID
C010882 MESH_SUPPLEMENTAL_RECORD_UI
500 INN_ID
R4KO0DY52L UNII
9552079 PUBCHEM_CID
4411 MMSL
6085 MMSL
003177 NDDF
003674 NDDF
003722 NDDF
003723 NDDF
108895000 SNOMEDCT_US
373568007 SNOMEDCT_US
96316004 SNOMEDCT_US
96317008 SNOMEDCT_US
96318003 SNOMEDCT_US
CHEMBL486819 ChEMBL_ID
56-95-1 SECONDARY_CAS_RN
4019393 VANDF
4019673 VANDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Chlorhexidine Gluconate 0.12% Oral Rinse HUMAN PRESCRIPTION DRUG LABEL 1 0116-0003 LIQUID 1.20 [iU] BUCCAL ANDA 18 sections
Bactoshield CHG HUMAN OTC DRUG LABEL 1 0116-0038 SOLUTION 2 mg TOPICAL NDA 14 sections
Bactoshield CHG HUMAN OTC DRUG LABEL 1 0116-0039 SOLUTION 2 mg TOPICAL NDA 14 sections
Bactoshield CHG HUMAN OTC DRUG LABEL 1 0116-0039 SOLUTION 2 mg TOPICAL NDA 14 sections
Cardinal Health HUMAN OTC DRUG LABEL 1 0116-0061 LIQUID 4 g TOPICAL NDA 13 sections
Chlorhexidine Gluconate HUMAN PRESCRIPTION DRUG LABEL 1 0116-0101 LIQUID 0.12 mg ORAL ANDA 17 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-0137 LIQUID 4 mg TOPICAL NDA 14 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-0161 LIQUID 4 mg TOPICAL NDA 15 sections
Chlorhexidine Gluconate HUMAN PRESCRIPTION DRUG LABEL 1 0116-0175 RINSE 1.20 mg ORAL ANDA 17 sections
BETASEPT HUMAN PRESCRIPTION DRUG LABEL 1 0116-0200 SOLUTION 0.04 mg TOPICAL NDA 14 sections
Chlorhexidine Gluconate HUMAN PRESCRIPTION DRUG LABEL 1 0116-0301 RINSE 1.20 mg ORAL ANDA 19 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-0401 LIQUID 4 mg TOPICAL NDA 14 sections
ANTISEPTIC SKIN CLEANSER HUMAN PRESCRIPTION DRUG LABEL 1 0116-0407 SOLUTION 4 g TOPICAL NDA 15 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-0767 LIQUID 4 g TOPICAL NDA 14 sections
NUPRO Chlorhexidine Gluconate HUMAN PRESCRIPTION DRUG LABEL 1 0116-0800 RINSE 1.20 mg ORAL ANDA 20 sections
CliniClean HUMAN OTC DRUG LABEL 1 0116-0901 SOLUTION 4 g TOPICAL NDA 14 sections
DYNA-HEX2 HUMAN OTC DRUG LABEL 1 0116-1021 LIQUID 2 g TOPICAL NDA 14 sections
DYNA-HEX2 HUMAN OTC DRUG LABEL 1 0116-1021 LIQUID 2 g TOPICAL NDA 14 sections
Dyna-Hex 2 HUMAN OTC DRUG LABEL 1 0116-1022 SOLUTION 20 mg TOPICAL NDA 14 sections
Dyna-Hex 2 HUMAN OTC DRUG LABEL 1 0116-1022 SOLUTION 20 mg TOPICAL NDA 14 sections
DYNA-HEX 4 HUMAN OTC DRUG LABEL 1 0116-1060 LIQUID 4 g TOPICAL NDA 15 sections
DYNA-HEX 4 HUMAN OTC DRUG LABEL 1 0116-1060 LIQUID 4 g TOPICAL NDA 15 sections
ANTISEPTIC SKIN CLEANSER HUMAN OTC DRUG LABEL 1 0116-1061 SOLUTION 4 g TOPICAL NDA 13 sections
ANTISEPTIC SKIN CLEANSER HUMAN OTC DRUG LABEL 1 0116-1061 SOLUTION 4 g TOPICAL NDA 13 sections
ANTISEPTIC SKIN CLEANSER HUMAN OTC DRUG LABEL 1 0116-1061 SOLUTION 4 g TOPICAL NDA 13 sections
Foster and Thrive HUMAN OTC DRUG LABEL 1 0116-1221 SOLUTION 4 g TOPICAL NDA 16 sections
Bactoshield CHG HUMAN OTC DRUG LABEL 1 0116-1344 SOLUTION 40 mg TOPICAL NDA 15 sections
Chlorhexidine Gluconate HUMAN PRESCRIPTION DRUG LABEL 1 0116-2001 RINSE 1.20 mg ORAL ANDA 17 sections
Scrub CareExidine -4 CHG HUMAN OTC DRUG LABEL 1 0116-2994 LIQUID 4 mg TOPICAL NDA 13 sections
Antiseptic Skin Cleanser HUMAN OTC DRUG LABEL 1 0116-3678 LIQUID 4 mg TOPICAL NDA 15 sections