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

Stem definitionDrug idCAS RN
antiprotozoals and radiosensitizers, metronidazole derivatives 1790 443-48-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • metronidazole
  • anagiardil
  • metronidazol
  • metropol
  • metrotab
  • mexibol
  • nidazole
  • trichazol
  • trichobrol
  • metronidazole hydrochloride
  • metronidazole phosphate
  • metronidazole benzoate
  • metronidazole HCl
  • rozex
A nitroimidazole used to treat AMEBIASIS; VAGINITIS; TRICHOMONAS INFECTIONS; GIARDIASIS; ANAEROBIC BACTERIA; and TREPONEMAL INFECTIONS.
  • Molecular weight: 171.16
  • Formula: C6H9N3O3
  • CLOGP: -0.46
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 1
  • TPSA: 81.19
  • ALOGS: -1.46
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.50 g V
1.50 g P
2 g O
2 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 10 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 10 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 194.56 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.40 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.85 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.96 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 7.10 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -0.047 Moderate 0.66
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.502 Moderate 0.66
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 57.677 10^-6 cm/s Moderate 0.66
dh-clint Dog hepatocyte intrinsic clearance 2.642 uL/min/10^6 cells Moderate 0.66
dppb Dog plasma protein binding (% unbound) 88.490 % Moderate 0.66
fcs-ppb Fetal calf serum protein binding (% unbound) 94.040 % Moderate 0.66
herg hERG pIC50 3.842 pIC50 Moderate 0.66
hh-clint Human hepatocyte intrinsic clearance 1.026 uL/min/10^6 cells Moderate 0.66
hlm-clint Human liver microsomal intrinsic clearance 3.069 uL/min/mg protein Moderate 0.66
hppb Human plasma protein binding (% unbound) 91.450 % Moderate 0.66
kinase-safety-class ACVR2A,ACVR2B,AKT2,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,IGF1R,ITK,JAK2,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK8,MAPK9,MAPKAPK2,MARK4,MET,MTOR,NTRK2,PAK4,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1,ZAP70 53
kinase-selectivity-class AXL,BRAF,CDK9,DYRK1B,GRK2,GSK3B,MAP2K6,MAPK1,MAPK7,PRKDC,STK33,TEK,TTK 13
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 1.112 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.963 Moderate 0.66
mh-clint Mouse hepatocyte intrinsic clearance 2.512 Moderate 0.66
mppb Mouse plasma protein binding (% unbound) 93.870 Moderate 0.66
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 2.213 Moderate 0.66
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 93.130 % Moderate 0.66
rat-kpuu-brain Rat brain Kpuu 0.253 % High 1
rh-clint Rat hepatocyte intrinsic clearance 1.671 uL/min/10^6 cells Moderate 0.66
rh-fuinc Rat hepatocyte fraction unbound in incubation 96.730 % Moderate 0.66
rppb Rat plasma protein binding (% unbound) 88.380 % Moderate 0.66
solubility-dd Solubility at pH 7.4 in DMSO 922.571 uM Moderate 0.66

Approvals:

DateAgencyCompanyOrphan
July 18, 1963 FDA GD SEARLE LLC
July 4, 2014 PMDA Pfizer Japan Inc.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Macular degeneration 690.78 9.51 451 93119 37519 90497358
Clostridium difficile infection 441.57 9.51 337 93233 35908 90498969
Toxic encephalopathy 426.71 9.51 199 93371 8500 90526377
Abortion spontaneous 391.91 9.51 373 93197 53683 90481194
Colitis 374.81 9.51 410 93160 69532 90465345
Drug reaction with eosinophilia and systemic symptoms 336.79 9.51 309 93261 42449 90492428
Abortion incomplete 316.67 9.51 120 93450 3020 90531857
Female genital tract fistula 314.54 9.51 208 93362 17660 90517217
Clostridium difficile colitis 304.96 9.51 239 93331 26467 90508410
Chronic sinusitis 295.81 9.51 224 93346 23578 90511299
Vaginal flatulence 295.11 9.51 176 93394 12462 90522415
Proctitis 294.03 9.51 188 93382 15071 90519806
Paraesthesia oral 285.47 9.51 247 93323 31412 90503465
Haematochezia 285.44 9.51 359 93211 70554 90464323
Vaginal discharge 284.44 9.51 202 93368 19262 90515615
Pemphigus 273.24 9.51 16 93554 326848 90208029
Neurotoxicity 268.93 9.51 203 93367 21264 90513613
Abdominal pain 266.02 9.51 955 92615 394766 90140111
Hand deformity 265.72 9.51 9 93561 296353 90238524
Radiculopathy 261.11 9.51 188 93382 18317 90516560
Contraindicated product administered 254.95 9.51 20 93550 320119 90214758
Oral candidiasis 253.80 9.51 243 93327 35212 90499665
Systemic lupus erythematosus 247.11 9.51 39 93531 361857 90173020
International normalised ratio fluctuation 240.78 9.51 98 93472 2995 90531882
Glossodynia 235.46 9.51 28 93542 321751 90213126
Angioedema 230.73 9.51 309 93261 64567 90470310
Arthropathy 229.58 9.51 49 93521 366193 90168684
Swollen tongue 223.18 9.51 256 93314 45700 90489177
Acute generalised exanthematous pustulosis 223.15 9.51 152 93418 13551 90521326
Swelling face 216.94 9.51 338 93232 81014 90453863
Synovitis 211.04 9.51 42 93528 329710 90205167
Colitis ulcerative 209.67 9.51 284 93286 59982 90474895
Procedural pain 206.06 9.51 211 93359 33149 90501728
Anti-cyclic citrullinated peptide antibody positive 202.45 9.51 10 93560 236423 90298454
Joint swelling 190.31 9.51 145 93425 503155 90031722
Pseudomembranous colitis 188.19 9.51 88 93482 3780 90531097
Duodenal ulcer perforation 184.36 9.51 11 93559 221277 90313600
Pericarditis 182.36 9.51 30 93540 270121 90264756
Alopecia 181.66 9.51 147 93423 494924 90039953
Drug ineffective for unapproved indication 179.22 9.51 278 93292 66366 90468511
Septic shock 176.57 9.51 314 93256 83846 90451031
Bloody discharge 173.76 9.51 71 93499 2192 90532685
Wound 173.35 9.51 49 93521 302931 90231946
Therapeutic product effect decreased 172.14 9.51 38 93532 277533 90257344
Psoriatic arthropathy 159.46 9.51 23 93547 228312 90306565
Rectal haemorrhage 156.25 9.51 295 93275 82449 90452428
Encephalopathy 155.70 9.51 215 93355 46229 90488648
Multiple organ dysfunction syndrome 153.80 9.51 263 93307 68073 90466804
Folliculitis 151.37 9.51 17 93553 204336 90330541
Hepatic enzyme increased 145.35 9.51 97 93473 360639 90174238
Anaphylactic reaction 141.07 9.51 292 93278 87232 90447645
Toxic epidermal necrolysis 141.01 9.51 171 93399 32357 90502520
Muscle injury 140.65 9.51 11 93559 176643 90358234
Cerebellar syndrome 137.29 9.51 71 93499 3801 90531076
Lyme disease 136.47 9.51 73 93497 4189 90530688
Helicobacter infection 134.81 9.51 34 93536 226816 90308061
Frequent bowel movements 130.60 9.51 221 93349 56714 90478163
Rash maculo-papular 130.52 9.51 185 93385 40748 90494129
Fibromyalgia 130.39 9.51 27 93543 206242 90328635
Crohn's disease 127.62 9.51 73 93497 4778 90530099
Rheumatoid arthritis 126.39 9.51 113 93457 362501 90172376
Rheumatic fever 120.60 9.51 10 93560 153111 90381766
Nasopharyngitis 116.15 9.51 150 93420 406954 90127923
Type 2 diabetes mellitus 115.96 9.51 33 93537 203211 90331666
Product use issue 115.94 9.51 102 93468 329817 90205060
Stomatitis 115.92 9.51 70 93500 274628 90260249
Sleep disorder due to general medical condition, insomnia type 114.95 9.51 4 93566 128690 90406187
Haemorrhage 113.62 9.51 233 93337 69136 90465741
Drug hypersensitivity 112.93 9.51 842 92728 462767 90072110
Sinusitis 111.29 9.51 114 93456 342974 90191903
Abdominal discomfort 109.34 9.51 204 93366 477124 90057753
Impaired healing 108.55 9.51 53 93517 234146 90300731
Mobility decreased 105.64 9.51 64 93506 250670 90284207
Erythema 103.59 9.51 490 93080 228756 90306121
Ataxia 100.48 9.51 108 93462 17934 90516943
Dysbiosis 99.47 9.51 44 93526 1658 90533219
Staphylococcal infection 99.35 9.51 179 93391 48260 90486617
Swelling 97.81 9.51 177 93393 418881 90115996
Fatigue 95.84 9.51 749 92821 1153274 89381603
Cholecystitis chronic 95.38 9.51 80 93490 9746 90525131
Therapeutic product effect incomplete 93.16 9.51 422 93148 193474 90341403
Cholestasis 92.82 9.51 148 93422 36151 90498726
Fall 92.75 9.51 227 93343 481583 90053294
Diverticulitis 92.70 9.51 167 93403 45020 90489857
Pancreatitis haemorrhagic 92.39 9.51 32 93538 617 90534260
Asthma 92.36 9.51 69 93501 242091 90292786
Weight increased 90.14 9.51 185 93385 417742 90117135
Dysphonia 89.61 9.51 200 93370 62884 90471993
Vanishing bile duct syndrome 88.42 9.51 38 93532 1334 90533543
Arthralgia 86.58 9.51 462 93108 778060 89756817
Swollen joint count increased 85.57 9.51 8 93562 111198 90423679
Pyrexia 83.27 9.51 1044 92526 659441 89875436
Joint range of motion decreased 83.17 9.51 19 93551 135624 90399253
Discomfort 82.48 9.51 97 93473 274238 90260639
Blood cholesterol increased 82.29 9.51 57 93513 207955 90326922
Fistula 81.13 9.51 80 93490 12009 90522868
Irritable bowel syndrome 80.54 9.51 58 93512 207390 90327487
Fixed eruption 79.98 9.51 38 93532 1692 90533185
Sepsis 79.49 9.51 382 93188 179432 90355445
Posterior reversible encephalopathy syndrome 75.74 9.51 104 93466 22235 90512642
Ill-defined disorder 75.37 9.51 49 93521 184842 90350035
Wheezing 75.04 9.51 81 93489 237999 90296878
Peripheral swelling 74.57 9.51 201 93369 412905 90121972
Breast cancer stage III 74.12 9.51 3 93567 84444 90450433
Lip dry 68.54 9.51 11 93559 100944 90433933
Anal fistula 68.34 9.51 47 93523 4254 90530623
Enterocolitis haemorrhagic 67.93 9.51 34 93536 1698 90533179
Nausea 66.98 9.51 1557 92013 1108759 89426118
Musculoskeletal stiffness 65.83 9.51 129 93441 296403 90238474
Hepatic failure 65.70 9.51 134 93436 39594 90495283
Bursitis 65.35 9.51 27 93543 131627 90403250
Faecal volume decreased 65.31 9.51 20 93550 256 90534621
Knee arthroplasty 63.95 9.51 6 93564 83176 90451701
Lower respiratory tract infection 62.90 9.51 101 93469 250558 90284319
Clostridial infection 62.89 9.51 46 93524 4590 90530287
Linear IgA disease 61.92 9.51 35 93535 2239 90532638
Chromaturia 61.57 9.51 87 93483 19100 90515777
Dysmetria 60.96 9.51 24 93546 671 90534206
Drug abuse 60.57 9.51 7 93563 82340 90452537
Blister 60.07 9.51 107 93463 254891 90279986
Drug ineffective 59.97 9.51 1859 91711 1382439 89152438
Completed suicide 59.72 9.51 38 93532 145020 90389857
Stevens-Johnson syndrome 59.52 9.51 108 93462 29268 90505609
Dry mouth 58.68 9.51 62 93508 183997 90350880
Wound infection 57.56 9.51 19 93551 106383 90428494
Hip arthroplasty 57.27 9.51 6 93564 76202 90458675
Prescribed overdose 57.26 9.51 15 93555 97610 90437267
Sleep disorder 56.37 9.51 73 93497 197957 90336920
Hepatitis 56.37 9.51 181 93389 70558 90464319
Anaemia 56.19 9.51 584 92986 352218 90182659
Exposure during pregnancy 55.65 9.51 429 93141 237981 90296896
Adverse event 55.25 9.51 26 93544 117392 90417485
Memory impairment 54.82 9.51 74 93496 197170 90337707
Death 54.56 9.51 264 93306 456287 90078590
Rheumatoid factor positive 54.51 9.51 58 93512 171592 90363285
Musculoskeletal pain 54.24 9.51 58 93512 171193 90363684
Prescribed underdose 53.65 9.51 7 93563 75012 90459865
Sciatica 53.29 9.51 19 93551 101363 90433514
Pelvic pain 52.82 9.51 72 93498 15285 90519592
Acinetobacter infection 52.24 9.51 30 93540 1978 90532899
Emotional distress 51.79 9.51 116 93454 36546 90498331
Clostridium colitis 51.73 9.51 30 93540 2015 90532862
Rosacea 51.44 9.51 45 93525 5802 90529075
Cerebellar ataxia 51.20 9.51 23 93547 899 90533978
Abscess 51.03 9.51 79 93491 18812 90516065
Lung disorder 50.62 9.51 48 93522 149835 90385042
Anal fissure 50.53 9.51 43 93527 5342 90529535
Loss of personal independence in daily activities 50.32 9.51 40 93530 136065 90398812
Lip swelling 49.95 9.51 118 93452 38492 90496385
Henoch-Schonlein purpura 49.67 9.51 27 93543 1600 90533277
Acute hepatic failure 49.65 9.51 86 93484 22475 90512402
Pathogen resistance 49.50 9.51 51 93519 8064 90526813
Pancreatitis acute 49.22 9.51 105 93465 32010 90502867
Systemic mastocytosis 49.20 9.51 15 93555 189 90534688
Pulmonary fibrosis 48.77 9.51 25 93545 107478 90427399
Iron deficiency 47.41 9.51 54 93516 9558 90525319
Obesity 47.17 9.51 25 93545 105482 90429395
Peripheral venous disease 47.15 9.51 14 93556 83907 90450970
Megacolon 46.97 9.51 29 93541 2185 90532692
Type IV hypersensitivity reaction 46.68 9.51 36 93534 3890 90530987
Vomiting 46.62 9.51 1103 92467 787190 89747687
Autoimmune disorder 46.54 9.51 11 93559 76733 90458144
Necrosis ischaemic 46.44 9.51 22 93548 973 90533904
Hypertension 46.14 9.51 280 93290 457252 90077625
International normalised ratio increased 46.12 9.51 130 93440 47186 90487691
Dislocation of vertebra 45.93 9.51 3 93567 55965 90478912
Drug interaction 45.60 9.51 461 93109 275992 90258885
Nystagmus 45.14 9.51 46 93524 7181 90527696
Large intestine infection 44.51 9.51 30 93540 2627 90532250
Diarrhoea haemorrhagic 44.49 9.51 55 93515 10608 90524269
Anal abscess 44.43 9.51 41 93529 5667 90529210
Arthritis 44.28 9.51 65 93505 167250 90367627
Pelvic inflammatory disease 44.06 9.51 26 93544 1804 90533073
Adjustment disorder with depressed mood 43.87 9.51 4 93566 56749 90478128
Large intestine perforation 43.63 9.51 52 93518 9660 90525217
Liver injury 43.46 9.51 68 93502 170499 90364378
Dermatitis allergic 43.40 9.51 70 93500 17257 90517620
Disseminated intravascular coagulation 43.40 9.51 79 93491 21459 90513418
Lemierre syndrome 43.30 9.51 12 93558 105 90534772
Pneumonia 43.09 9.51 436 93134 637623 89897254
Lower limb fracture 42.89 9.51 17 93553 84996 90449881
Night sweats 42.59 9.51 42 93528 128724 90406153
Toxic shock syndrome 42.44 9.51 21 93549 1023 90533854
Dysarthria 42.13 9.51 138 93432 54344 90480533
Abdominal pain lower 42.09 9.51 95 93475 30082 90504795
General physical health deterioration 42.02 9.51 206 93364 354909 90179968
Dysgeusia 41.43 9.51 134 93436 52426 90482451
Osteoarthritis 41.00 9.51 88 93482 195642 90339235
Metabolic acidosis 40.37 9.51 138 93432 55538 90479339
Premature baby 39.60 9.51 83 93487 24994 90509883
Leukocytosis 38.25 9.51 93 93477 30897 90503980
Low birth weight baby 38.17 9.51 48 93522 9419 90525458
Hypercholesterolaemia 38.12 9.51 29 93541 100863 90434014
Leukoencephalopathy 37.93 9.51 35 93535 4838 90530039
Idiosyncratic drug reaction 37.90 9.51 19 93551 952 90533925
Coagulopathy 37.85 9.51 78 93492 23211 90511666
Alcohol intolerance 37.77 9.51 11 93559 117 90534760
Adenoviral hepatitis 37.52 9.51 15 93555 437 90534440
Road traffic accident 36.89 9.51 34 93536 107592 90427285
Endometritis 36.87 9.51 20 93550 1180 90533697
Foetal anaemia 36.64 9.51 11 93559 131 90534746
Beta haemolytic streptococcal infection 36.46 9.51 26 93544 2493 90532384
Haemolytic uraemic syndrome 36.13 9.51 27 93543 2784 90532093
Vitamin K deficiency 35.91 9.51 15 93555 490 90534387
Candida infection 35.60 9.51 96 93474 33961 90500916
Oedematous pancreatitis 35.55 9.51 17 93553 768 90534109
Pneumonia streptococcal 35.45 9.51 24 93546 2117 90532760
Rash papular 35.25 9.51 70 93500 20285 90514592
Gingival swelling 35.18 9.51 34 93536 4979 90529898
Abdominal abscess 34.95 9.51 35 93535 5352 90529525
Dermatitis bullous 34.93 9.51 48 93522 10268 90524609
Pouchitis 34.79 9.51 16 93554 661 90534216
Thrombotic thrombocytopenic purpura 34.71 9.51 31 93539 4107 90530770
Constipation 34.24 9.51 441 93129 279954 90254923
Injection site reaction 34.11 9.51 27 93543 92053 90442824
Axonal neuropathy 33.98 9.51 19 93551 1190 90533687
Upper respiratory tract infection 33.80 9.51 50 93520 128268 90406609
Proctalgia 33.75 9.51 42 93528 8156 90526721
Cough 33.51 9.51 233 93337 368729 90166148
Tubulointerstitial nephritis 33.38 9.51 78 93492 25265 90509612
Endocrine ophthalmopathy 33.28 9.51 18 93552 1056 90533821
Uterine perforation 33.20 9.51 40 93530 7514 90527363
Generalised tonic-clonic seizure 33.14 9.51 95 93475 34808 90500069
X-ray abnormal 33.06 9.51 4 93566 45420 90489457
Clostridium test positive 33.05 9.51 34 93536 5367 90529510
Hepatocellular injury 32.69 9.51 84 93486 28874 90506003
Hepatitis infectious mononucleosis 32.65 9.51 10 93560 128 90534749
Bursitis infective 32.59 9.51 20 93550 1490 90533387
Shock 31.99 9.51 83 93487 28695 90506182
Intestinal perforation 31.97 9.51 54 93516 13827 90521050
Mucous stools 31.92 9.51 33 93537 5238 90529639
Biliary sepsis 31.88 9.51 17 93553 969 90533908
Stenotrophomonas infection 31.85 9.51 24 93546 2505 90532372
Purple glove syndrome 31.81 9.51 11 93559 211 90534666
Blepharospasm 31.61 9.51 9 93561 55436 90479441
Biliary dyskinesia 31.27 9.51 24 93546 2575 90532302
Herpes simplex colitis 30.97 9.51 9 93561 95 90534782
Intentional overdose 30.58 9.51 31 93539 93803 90441074
C-reactive protein abnormal 30.41 9.51 53 93517 127376 90407501
Amnesia 29.84 9.51 41 93529 108464 90426413
Dyspepsia 29.62 9.51 324 93246 197836 90337041
Insomnia 29.59 9.51 212 93358 333262 90201615
Gallbladder disorder 29.49 9.51 64 93506 19739 90515138
Toxic skin eruption 29.46 9.51 56 93514 15718 90519159
Eosinophilia 29.40 9.51 80 93490 28453 90506424
Vulvovaginal swelling 29.39 9.51 15 93555 781 90534096
Meningitis candida 28.97 9.51 8 93562 69 90534808
Pericoronitis 28.92 9.51 9 93561 122 90534755
Premature delivery 28.91 9.51 97 93473 38665 90496212
Stillbirth 28.84 9.51 37 93533 7406 90527471
Type I hypersensitivity 28.82 9.51 28 93542 4127 90530750
Abnormal faeces 28.74 9.51 35 93535 6647 90528230
Mania 28.70 9.51 52 93518 14072 90520805
Ureteric obstruction 28.69 9.51 21 93549 2097 90532780
Rectal tube insertion 28.68 9.51 6 93564 12 90534865
Enterovesical fistula 28.47 9.51 14 93556 673 90534204
Neuropathy peripheral 28.41 9.51 240 93330 136730 90398147
Rash macular 28.35 9.51 82 93488 30198 90504679
Hepatic necrosis 28.15 9.51 34 93536 6404 90528473
Abscess intestinal 28.14 9.51 20 93550 1908 90532969
Osmotic demyelination syndrome 28.10 9.51 16 93554 1038 90533839
Endoscopic retrograde cholangiopancreatography 28.03 9.51 10 93560 211 90534666
Exostosis 27.85 9.51 10 93560 53124 90481753
Large intestine erosion 27.84 9.51 9 93561 139 90534738
Malignant neoplasm progression 27.80 9.51 42 93528 106828 90428049
Jaundice 27.55 9.51 85 93485 32432 90502445
Joint stiffness 27.53 9.51 24 93546 78018 90456859
Adverse drug reaction 27.43 9.51 49 93521 116652 90418225
Oedematous kidney 27.37 9.51 9 93561 147 90534730
Gait inability 27.33 9.51 70 93500 146386 90388491
Herpes simplex hepatitis 27.23 9.51 13 93557 585 90534292
Onychomadesis 27.10 9.51 7 93563 45991 90488886
Vitamin B1 deficiency 26.76 9.51 12 93558 467 90534410
Inflammation 26.43 9.51 95 93475 178497 90356380
Sleep disorder due to a general medical condition 25.99 9.51 7 93563 44731 90490146
Infusion related reaction 25.97 9.51 290 93280 416490 90118387
Injection site pain 25.97 9.51 92 93478 173607 90361270
Enterococcal infection 25.90 9.51 41 93529 9950 90524927
Coeliac disease 25.88 9.51 7 93563 44603 90490274
Eyelid disorder 25.76 9.51 20 93550 2183 90532694
Incubator therapy 25.71 9.51 7 93563 57 90534820
Acute psychosis 25.70 9.51 23 93547 3055 90531822
Hepatic cirrhosis 25.44 9.51 17 93553 63236 90471641
Gastrointestinal disorder 25.36 9.51 158 93412 256529 90278348
Intermittent positive pressure breathing 25.29 9.51 7 93563 61 90534816
Rectal abscess 25.28 9.51 17 93553 1483 90533394
Fistula discharge 25.17 9.51 15 93555 1060 90533817
Heparin-induced thrombocytopenia 24.78 9.51 29 93541 5283 90529594
Erythema multiforme 24.78 9.51 45 93525 12201 90522676
Skin ulcer 24.77 9.51 110 93460 49965 90484912
Large intestinal ulcer 24.59 9.51 25 93545 3892 90530985
Therapeutic response decreased 24.58 9.51 34 93536 89695 90445182
Lupus vulgaris 24.45 9.51 8 93562 45051 90489826
Liver function test increased 24.42 9.51 31 93539 84824 90450053
Dyspnoea 24.41 9.51 708 92862 880247 89654630
Intentional product use issue 24.39 9.51 128 93442 216764 90318113
Depression 24.34 9.51 196 93374 300405 90234472
Intrauterine infection 24.25 9.51 8 93562 132 90534745
Bronchitis 24.22 9.51 79 93491 152848 90382029
Taste disorder 24.14 9.51 17 93553 61529 90473348
Joint dislocation 24.04 9.51 8 93562 44574 90490303
Renal tubular necrosis 23.95 9.51 49 93521 14506 90520371
Burning sensation 23.94 9.51 129 93441 63323 90471554
Migraine 23.93 9.51 108 93462 190284 90344593
Foetal non-stress test abnormal 23.91 9.51 6 93564 34 90534843
Procedural hypertension 23.90 9.51 10 93560 328 90534549
Leukaemoid reaction 23.84 9.51 9 93561 224 90534653
Cytomegalovirus colitis 23.83 9.51 23 93547 3363 90531514
Retained products of conception 23.82 9.51 8 93562 140 90534737
Walking aid user 23.80 9.51 4 93566 35502 90499375
Weight decreased 23.72 9.51 536 93034 379374 90155503
Product dose omission issue 23.71 9.51 190 93380 291497 90243380
Contusion 23.61 9.51 157 93413 251059 90283818
Haemodynamic instability 23.58 9.51 43 93527 11696 90523181
Cholecystitis acute 23.57 9.51 38 93532 9366 90525511
Anaphylactic shock 23.48 9.51 79 93491 31538 90503339
Injection site erythema 23.47 9.51 41 93529 98461 90436416
Morganella infection 23.42 9.51 13 93557 803 90534074
Magnetic resonance imaging head abnormal 23.15 9.51 20 93550 2536 90532341
Platelet count increased 23.02 9.51 60 93510 20799 90514078
Pustule 23.01 9.51 21 93549 2862 90532015
Feeling guilty 22.97 9.51 12 93558 656 90534221
Tachycardia 22.73 9.51 256 93314 157417 90377460
Foetal monitoring abnormal 22.62 9.51 9 93561 259 90534618
Underdose 22.43 9.51 14 93556 54003 90480874
Hyperleukocytosis 22.41 9.51 13 93557 874 90534003
Vaginal infection 22.38 9.51 35 93535 8405 90526472
Klebsiella infection 22.33 9.51 39 93531 10258 90524619
Nail disorder 22.28 9.51 17 93553 59050 90475827
Aspergillus infection 22.19 9.51 40 93530 10783 90524094
Secretion discharge 22.12 9.51 50 93520 15846 90519031
Vulval disorder 22.10 9.51 15 93555 1329 90533548
Venoocclusive liver disease 21.99 9.51 29 93541 5964 90528913
Electrocardiogram QT prolonged 21.95 9.51 139 93431 72317 90462560
Neutropenic colitis 21.67 9.51 24 93546 4119 90530758
Intentional product misuse 21.62 9.51 37 93533 89567 90445310
Onychomycosis 21.43 9.51 6 93564 37370 90497507
Hypoglossal nerve paresis 21.42 9.51 7 93563 112 90534765
Weber tuning fork test abnormal 21.42 9.51 7 93563 112 90534765
Osteoporosis 21.39 9.51 42 93528 96489 90438388
Liver abscess 21.38 9.51 22 93548 3474 90531403
Pulmonary trichosporonosis 21.31 9.51 6 93564 56 90534821
Laryngitis 21.29 9.51 13 93557 50740 90484137
Immunodeficiency 21.23 9.51 9 93561 43225 90491652
Treatment failure 21.16 9.51 206 93364 303722 90231155
Hyporeflexia 21.07 9.51 18 93552 2248 90532629
Peritonitis 21.05 9.51 56 93514 19649 90515228
Postural orthostatic tachycardia syndrome 21.03 9.51 18 93552 2254 90532623
Liver function test abnormal 21.00 9.51 106 93464 50739 90484138
Foetal exposure during pregnancy 20.95 9.51 94 93476 42881 90491996
Hallucination 20.89 9.51 128 93442 65831 90469046
Renal failure 20.87 9.51 217 93353 130790 90404087
Foetal arrhythmia 20.83 9.51 8 93562 209 90534668
Haemophagocytic lymphohistiocytosis 20.82 9.51 48 93522 15411 90519466
Anterior interosseous syndrome 20.74 9.51 4 93566 4 90534873
Nervous system disorder 20.72 9.51 59 93511 21534 90513343
Wound complication 20.57 9.51 25 93545 4738 90530139
Agranulocytosis 20.52 9.51 81 93489 34921 90499956
Gastrooesophageal reflux disease 20.52 9.51 95 93475 166242 90368635
Retroperitoneal haematoma 20.24 9.51 21 93549 3347 90531530
Skin odour abnormal 20.03 9.51 16 93554 1819 90533058
Diarrhoea 20.00 9.51 1172 92398 938018 89596859
Enterocutaneous fistula 19.96 9.51 15 93555 1559 90533318
Cholestatic liver injury 19.87 9.51 22 93548 3775 90531102
Live birth 19.70 9.51 32 93538 79075 90455802
Colitis ischaemic 19.65 9.51 41 93529 12305 90522572
Haemostasis 19.50 9.51 9 93561 375 90534502
Psychotic disorder due to a general medical condition 19.49 9.51 8 93562 250 90534627
Dysdiadochokinesis 19.48 9.51 7 93563 151 90534726
Decreased appetite 19.33 9.51 273 93297 376267 90158610
Candida sepsis 19.31 9.51 15 93555 1638 90533239
Enterocolitis 19.29 9.51 37 93533 10453 90524424
Bacterial vaginosis 19.23 9.51 15 93555 1648 90533229
Torsade de pointes 19.20 9.51 46 93524 15136 90519741
Abortion infected 19.02 9.51 5 93565 35 90534842
Product quality issue 18.92 9.51 33 93537 79292 90455585
Ecthyma 18.85 9.51 9 93561 405 90534472
Tongue coated 18.84 9.51 15 93555 1698 90533179
Cholecystitis 18.79 9.51 49 93521 16991 90517886
Electrocardiogram T wave alternans 18.78 9.51 5 93565 37 90534840
Puerperal pyrexia 18.78 9.51 5 93565 37 90534840
Airway peak pressure increased 18.77 9.51 9 93561 409 90534468
Pseudomonas infection 18.76 9.51 45 93525 14820 90520057
Acute kidney injury 18.75 9.51 448 93122 319939 90214938
Infusion site streaking 18.64 9.51 10 93560 577 90534300
Injection site pruritus 18.45 9.51 17 93553 53817 90481060
Vulval ulceration 18.39 9.51 9 93561 428 90534449
Respiratory disorder 18.32 9.51 24 93546 64792 90470085
Red cell fragmentation syndrome 18.22 9.51 5 93565 42 90534835
Distributive shock 18.20 9.51 20 93550 3404 90531473
Toxic shock syndrome streptococcal 18.17 9.51 8 93562 298 90534579
Back injury 18.12 9.51 13 93557 46609 90488268
Venous haemorrhage 18.05 9.51 8 93562 303 90534574
Hallucinations, mixed 17.86 9.51 26 93544 5863 90529014
Toxic leukoencephalopathy 17.66 9.51 11 93559 842 90534035
Nodular rash 17.60 9.51 7 93563 201 90534676
Accidental exposure to product 17.56 9.51 11 93559 42355 90492522
Chills 17.56 9.51 211 93359 131770 90403107
Peripheral sensory neuropathy 17.47 9.51 33 93537 9217 90525660
Idiopathic intracranial hypertension 17.46 9.51 20 93550 3561 90531316
Respiratory failure 17.40 9.51 193 93377 118225 90416652
Cholelithiasis 17.33 9.51 103 93467 52403 90482474
Depersonalisation/derealisation disorder 17.33 9.51 14 93556 1618 90533259
Tendonitis 17.30 9.51 55 93515 21317 90513560
Hospitalisation 17.11 9.51 71 93499 128029 90406848
Paralysis 16.98 9.51 37 93533 11441 90523436
Mental status changes 16.97 9.51 91 93479 44588 90490289
Medication error 16.94 9.51 39 93531 84613 90450264
Influenza 16.90 9.51 80 93490 139184 90395693
Periventricular leukomalacia 16.89 9.51 7 93563 224 90534653
Vulvovaginitis trichomonal 16.89 9.51 4 93566 17 90534860
Wrong technique in product usage process 16.86 9.51 30 93540 71541 90463336
Polyneuropathy 16.79 9.51 51 93519 19290 90515587
Medical device site pain 16.78 9.51 7 93563 228 90534649
Nasal ulcer 16.71 9.51 17 93553 2649 90532228
Ear infection 16.66 9.51 29 93541 69746 90465131
Fear of death 16.61 9.51 12 93558 1175 90533702
Optic neuropathy 16.54 9.51 17 93553 2681 90532196
Perirectal abscess 16.44 9.51 11 93559 952 90533925
Mastitis bacterial 16.40 9.51 5 93565 63 90534814
Retroperitoneal haemorrhage 16.38 9.51 18 93552 3062 90531815
Cataract 16.29 9.51 31 93539 72061 90462816
Stenosis 16.28 9.51 15 93555 2069 90532808
Ballismus 16.22 9.51 6 93564 141 90534736
Vomiting projectile 16.07 9.51 14 93556 1795 90533082
Diarrhoea infectious 16.06 9.51 12 93558 1237 90533640
Sopor 16.03 9.51 3 93567 24641 90510236
Staphylococcal sepsis 15.93 9.51 32 93538 9351 90525526
Vaginitis gardnerella 15.92 9.51 5 93565 70 90534807
Wound abscess 15.87 9.51 6 93564 150 90534727
Tongue necrosis 15.85 9.51 5 93565 71 90534806
Pyroglutamic acidosis 15.80 9.51 12 93558 1268 90533609
Fluid balance positive 15.75 9.51 4 93566 24 90534853
Streptococcal endocarditis 15.72 9.51 6 93564 154 90534723
Pharyngeal oedema 15.60 9.51 40 93530 13731 90521146
Rash morbilliform 15.57 9.51 20 93550 4009 90530868
Gynaecological examination abnormal 15.55 9.51 3 93567 3 90534874
Hypovolaemic shock 15.55 9.51 27 93543 7067 90527810
Gastrointestinal injury 15.49 9.51 10 93560 814 90534063
Pancytopenia 15.45 9.51 191 93379 120072 90414805
Infective aneurysm 15.44 9.51 8 93562 430 90534447
Pain in extremity 15.39 9.51 351 93219 450178 90084699
Disseminated tuberculosis 15.37 9.51 18 93552 3281 90531596
Paraparesis 15.34 9.51 17 93553 2921 90531956
Drug level below therapeutic 15.27 9.51 24 93546 5790 90529087
Chemical burns of eye 15.24 9.51 5 93565 81 90534796
Wound secretion 15.09 9.51 22 93548 4968 90529909
Incorrect route of product administration 15.09 9.51 18 93552 50608 90484269
Telangiectasia 14.97 9.51 12 93558 1371 90533506
Bacterial vulvovaginitis 14.97 9.51 10 93560 863 90534014
White blood cell count decreased 14.92 9.51 106 93464 167003 90367874
Bacterial colitis 14.91 9.51 6 93564 178 90534699
Pulmonary embolism 14.80 9.51 203 93367 130617 90404260
Cyanosis 14.79 9.51 49 93521 19406 90515471
Thrombocytopenia 14.79 9.51 300 93270 208425 90326452
Crying 14.76 9.51 59 93511 25586 90509291
Scar 14.71 9.51 42 93528 15353 90519524
Anal skin tags 14.66 9.51 9 93561 671 90534206
Tongue discolouration 14.55 9.51 18 93552 3475 90531402
Superinfection 14.54 9.51 17 93553 3095 90531782
Mean cell haemoglobin increased 14.49 9.51 19 93551 3886 90530991
Abdominal sepsis 14.41 9.51 12 93558 1447 90533430
Gastrointestinal stoma complication 14.39 9.51 15 93555 2404 90532473
Cytomegalovirus infection 14.36 9.51 60 93510 26542 90508335
Rash pustular 14.32 9.51 28 93542 8021 90526856
Consciousness fluctuating 14.24 9.51 10 93560 936 90533941
Delayed delivery 14.24 9.51 4 93566 37 90534840
Tongue dry 14.22 9.51 11 93559 1194 90533683
Delivery 14.19 9.51 13 93557 1780 90533097
Rubber sensitivity 14.10 9.51 16 93554 2821 90532056
Gastrointestinal wall thickening 14.08 9.51 14 93556 2123 90532754
Orbital oedema 14.03 9.51 7 93563 347 90534530
White matter lesion 13.88 9.51 15 93555 2506 90532371
Vaginal abscess 13.84 9.51 8 93562 534 90534343
Periorbital oedema 13.78 9.51 25 93545 6774 90528103
Systemic candida 13.76 9.51 21 93549 4938 90529939
Hallucination, auditory 13.76 9.51 42 93528 15933 90518944
Eye infection 13.73 9.51 39 93531 14215 90520662
Face oedema 13.70 9.51 54 93516 23264 90511613
Choriocarcinoma 13.70 9.51 4 93566 43 90534834
Tongue oedema 13.61 9.51 22 93548 5432 90529445
Flatulence 13.56 9.51 81 93489 41286 90493591
Muscle spasticity 13.53 9.51 10 93560 35312 90499565
Eczema 13.53 9.51 21 93549 52849 90482028
Procedural hypotension 13.45 9.51 12 93558 1588 90533289
Strongyloidiasis 13.44 9.51 12 93558 1590 90533287
Ileostomy 13.24 9.51 13 93557 1941 90532936
Intestinal dilatation 13.16 9.51 14 93556 2296 90532581
Interstitial lung disease 13.14 9.51 38 93532 76367 90458510
Reticulocytosis 13.07 9.51 6 93564 247 90534630
Catheter site related reaction 13.04 9.51 10 93560 1071 90533806
Fusarium infection 13.04 9.51 10 93560 1072 90533805
Waterhouse-Friderichsen syndrome 13.02 9.51 3 93567 11 90534866
Mouth swelling 13.00 9.51 22 93548 5640 90529237
Fluid retention 12.93 9.51 47 93523 88044 90446833
Vulvovaginal inflammation 12.91 9.51 10 93560 1088 90533789
Hidradenitis 12.91 9.51 19 93551 4328 90530549
Geotrichum infection 12.89 9.51 8 93562 608 90534269
Erythema nodosum 12.83 9.51 22 93548 5702 90529175
Laryngeal inflammation 12.83 9.51 5 93565 136 90534741
Developmental delay 12.82 9.51 12 93558 1688 90533189
Psychotic disorder 12.82 9.51 65 93505 31165 90503712
Procedural anxiety 12.77 9.51 9 93561 847 90534030
Device expulsion 12.77 9.51 14 93556 40872 90494005
Fear 12.76 9.51 42 93528 16580 90518297
Oscillopsia 12.69 9.51 5 93565 140 90534737
Fibula agenesis 12.67 9.51 4 93566 57 90534820
Pleural calcification 12.67 9.51 4 93566 57 90534820
Seborrhoeic keratosis 12.62 9.51 16 93554 3164 90531713
Spina bifida occulta 12.60 9.51 4 93566 58 90534819
Bacteraemia 12.59 9.51 51 93519 22249 90512628
Tubo-ovarian abscess 12.54 9.51 7 93563 437 90534440
Diverticulum 12.51 9.51 34 93536 12079 90522798
Pneumoperitoneum 12.51 9.51 12 93558 1741 90533136
Mucosal ulceration 12.47 9.51 10 93560 1143 90533734
Dystonia 12.46 9.51 42 93528 16777 90518100
Lymphomatoid papulosis 12.43 9.51 5 93565 148 90534729
Deep vein thrombosis 12.41 9.51 147 93423 91473 90443404
Seizure 12.39 9.51 224 93346 152405 90382472
Skin test positive 12.37 9.51 9 93561 891 90533986
Laboratory test abnormal 12.35 9.51 15 93555 41839 90493038
Wound haemorrhage 12.30 9.51 15 93555 2852 90532025
Trichoglossia 12.27 9.51 7 93563 456 90534421
Multiple sclerosis relapse 12.25 9.51 22 93548 52283 90482594
Drug resistance 12.24 9.51 63 93507 30386 90504491
Lymphadenitis 12.17 9.51 18 93552 4119 90530758
Skin lesion 12.14 9.51 73 93497 37292 90497585
Dermatitis exfoliative 12.04 9.51 21 93549 5515 90529362
Blood culture positive 12.04 9.51 20 93550 5052 90529825
Muscle haemorrhage 11.98 9.51 16 93554 3330 90531547
Vitamin D increased 11.96 9.51 9 93561 937 90533940
Adverse reaction 11.93 9.51 8 93562 29704 90505173
COVID-19 11.93 9.51 114 93456 168729 90366148
Diverticulum intestinal 11.89 9.51 28 93542 9114 90525763
Blood osmolarity decreased 11.86 9.51 9 93561 950 90533927
Malaise 11.81 9.51 728 92842 585258 89949619
Overdose 11.78 9.51 105 93465 157604 90377273
Abscess fungal 11.75 9.51 4 93566 73 90534804
Melanocytic naevus 11.71 9.51 20 93550 5166 90529711
Uterine hypertonus 11.71 9.51 6 93564 315 90534562
Amoebiasis 11.70 9.51 4 93566 74 90534803
Leuconostoc infection 11.67 9.51 3 93567 19 90534858
Bartter's syndrome 11.67 9.51 3 93567 19 90534858
Staphylococcus test 11.67 9.51 3 93567 19 90534858
Myocardial infarction 11.65 9.51 63 93507 105909 90428968
Refusal of treatment by relative 11.60 9.51 6 93564 321 90534556
Small intestinal obstruction 11.54 9.51 48 93522 21186 90513691
Merycism 11.54 9.51 6 93564 325 90534552
Macule 11.51 9.51 14 93556 2655 90532222
Congenital umbilical hernia 11.45 9.51 6 93564 330 90534547
Hyperbilirubinaemia 11.41 9.51 36 93534 13900 90520977
Vulvovaginal discomfort 11.40 9.51 14 93556 2683 90532194
Acute on chronic liver failure 11.38 9.51 6 93564 334 90534543
Epilepsy 11.33 9.51 45 93525 82161 90452716
Activated partial thromboplastin time prolonged 11.32 9.51 25 93545 7800 90527077
Peri-implantitis 11.32 9.51 4 93566 82 90534795
Impaired work ability 11.27 9.51 3 93567 19323 90515554
Haemolytic anaemia 11.26 9.51 32 93538 11665 90523212
Encephalitis 11.25 9.51 31 93539 11103 90523774
Hypoproteinaemia 11.21 9.51 15 93555 3127 90531750
Epidermal necrosis 11.20 9.51 13 93557 2348 90532529
Escherichia infection 11.17 9.51 39 93531 15856 90519021
Femur fracture 11.14 9.51 19 93551 46063 90488814
Ileus 11.12 9.51 40 93530 16506 90518371
Pre-existing disease 11.09 9.51 5 93565 197 90534680
Hepatic pain 11.09 9.51 16 93554 3579 90531298
Oedema mouth 11.09 9.51 13 93557 2373 90532504
Placental insufficiency 11.08 9.51 11 93559 1664 90533213
Pelvic fluid collection 11.07 9.51 9 93561 1050 90533827
Pharyngeal inflammation 11.06 9.51 9 93561 1051 90533826
Headache 11.06 9.51 1034 92536 861712 89673165
Stoma closure 11.05 9.51 5 93565 199 90534678
Cytotoxic oedema 11.02 9.51 5 93565 200 90534677
Hypothyroidism 11.02 9.51 24 93546 53103 90481774
Generalised bullous fixed drug eruption 11.01 9.51 6 93564 357 90534520
Ileal ulcer 11.01 9.51 9 93561 1057 90533820
Peripheral vascular disorder 11.00 9.51 22 93548 6409 90528468
Swelling of eyelid 10.98 9.51 20 93550 5434 90529443
Anxiety 10.97 9.51 407 93163 309365 90225512
Peritoneal tuberculosis 10.97 9.51 7 93563 559 90534318
Helicobacter gastritis 10.94 9.51 11 93559 1689 90533188
Calcification of muscle 10.93 9.51 5 93565 204 90534673
Agonal rhythm 10.85 9.51 3 93567 26 90534851
Phantom limb syndrome 10.75 9.51 5 93565 212 90534665
Hyperintensity in brain deep nuclei 10.75 9.51 3 93567 27 90534850
Respiratory distress 10.75 9.51 73 93497 38873 90496004
Serum sickness-like reaction 10.72 9.51 7 93563 581 90534296
Vulval haemorrhage 10.65 9.51 3 93567 28 90534849
Paraesthesia 10.65 9.51 336 93234 249990 90284887
C-reactive protein increased 10.58 9.51 128 93442 181261 90353616
Breast cancer 10.57 9.51 25 93545 53736 90481141
Culture wound positive 10.56 9.51 5 93565 221 90534656
Injection site bruising 10.55 9.51 24 93546 52283 90482594
Substance-induced psychotic disorder 10.54 9.51 14 93556 2898 90531979
Product dose omission in error 10.51 9.51 4 93566 20499 90514378
Diverticular perforation 10.50 9.51 16 93554 3756 90531121
Corneal perforation 10.46 9.51 7 93563 606 90534271
Crystal nephropathy 10.41 9.51 9 93561 1142 90533735
Gastrointestinal inflammation 10.38 9.51 22 93548 6674 90528203
Dermatitis 10.38 9.51 48 93522 22172 90512705
Blood alkaline phosphatase increased 10.37 9.51 85 93485 47994 90486883
Hypoalbuminaemia 10.32 9.51 38 93532 15859 90519018
Dysphagia 10.27 9.51 168 93402 112110 90422767
Granulomatosis with polyangiitis 10.25 9.51 13 93557 2572 90532305
Synovial cyst 10.21 9.51 31 93539 11721 90523156
Cholecystectomy 10.21 9.51 31 93539 11724 90523153
Product contamination 10.19 9.51 9 93561 1175 90533702
Lupus-like syndrome 10.19 9.51 22 93548 48824 90486053
Necrotising enterocolitis neonatal 10.15 9.51 5 93565 241 90534636
Pericardial disease 10.15 9.51 5 93565 241 90534636
Subdural abscess 10.13 9.51 3 93567 34 90534843
Crystal deposit intestine 10.12 9.51 4 93566 113 90534764
Pharyngeal erythema 10.11 9.51 11 93559 1851 90533026
Anorectal discomfort 10.09 9.51 14 93556 3020 90531857
Brain stem ischaemia 10.09 9.51 4 93566 114 90534763
Gastroenteritis 10.08 9.51 58 93512 29171 90505706
Congenital skin dimples 10.06 9.51 4 93566 115 90534762
Cardiac failure 9.99 9.51 69 93501 109427 90425450
Oedema 9.99 9.51 146 93424 200149 90334728
Gingival discomfort 9.97 9.51 6 93564 432 90534445
Haematocrit increased 9.94 9.51 14 93556 3064 90531813
Suicide attempt 9.94 9.51 42 93528 75357 90459520
Medical device pain 9.91 9.51 10 93560 1542 90533335
Abdominal mass 9.90 9.51 15 93555 3506 90531371
Organ failure 9.84 9.51 14 93556 3091 90531786
Paresis 9.75 9.51 13 93557 2701 90532176
Tracheal obstruction 9.74 9.51 4 93566 125 90534752
Neonatal respiratory distress 9.72 9.51 7 93563 682 90534195
Injection site warmth 9.70 9.51 3 93567 17512 90517365
Dyspnoea exertional 9.69 9.51 40 93530 72248 90462629
Wound infection bacterial 9.69 9.51 7 93563 685 90534192
Vascular access site occlusion 9.68 9.51 3 93567 40 90534837
Naevus flammeus 9.68 9.51 4 93566 127 90534750
Nephropathy toxic 9.68 9.51 32 93538 12656 90522221
Hepatomegaly 9.63 9.51 33 93537 13293 90521584
Haematoma infection 9.59 9.51 7 93563 696 90534181
HER2 positive breast cancer 9.57 9.51 6 93564 464 90534413
Eastern Cooperative Oncology Group performance status 9.54 9.51 4 93566 132 90534745

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
Toxic encephalopathy 715.45 11.24 302 65883 6651 42548499
Neurotoxicity 313.79 11.24 274 65911 23377 42531773
Appendicolith 307.37 11.24 215 65970 13241 42541909
Appendicitis 302.42 11.24 253 65932 20360 42534790
Multiple organ dysfunction syndrome 273.33 11.24 518 65667 96517 42458633
Drug reaction with eosinophilia and systemic symptoms 238.47 11.24 310 65875 41765 42513385
Clostridium difficile colitis 211.86 11.24 210 65975 21042 42534108
Ascites 201.25 11.24 335 65850 56343 42498807
Abdominal distension 198.24 11.24 380 65805 71355 42483795
Ventricular fibrillation 194.62 11.24 237 65948 29886 42525264
Cerebellar syndrome 188.46 11.24 91 66094 2764 42552386
Ataxia 176.98 11.24 168 66017 15957 42539193
Colitis 164.94 11.24 275 65910 46297 42508853
Abdominal pain 157.73 11.24 649 65536 189822 42365328
Cardiogenic shock 154.64 11.24 231 65954 35409 42519741
Megacolon 151.34 11.24 73 66112 2212 42552938
Pseudomembranous colitis 148.90 11.24 80 66105 3053 42552097
Blood phosphorus increased 144.17 11.24 134 66051 12391 42542759
Drug abuse 140.47 11.24 5 66180 104766 42450384
Death 134.61 11.24 337 65848 470848 42084302
Myasthenia gravis 129.48 11.24 142 66043 15995 42539155
Pathogen resistance 128.90 11.24 121 66064 11329 42543821
Stress 128.00 11.24 239 65946 43973 42511177
Sleep disorder therapy 125.35 11.24 96 66089 6798 42548352
Hyperphosphataemia 124.98 11.24 126 66059 12878 42542272
Sepsis 124.46 11.24 625 65560 198709 42356441
Encephalopathy 122.87 11.24 226 65959 41107 42514043
Fistula 119.92 11.24 99 66086 7813 42547337
Analgesic therapy 116.76 11.24 90 66095 6434 42548716
Incorrect route of product administration 114.79 11.24 164 66021 24141 42531009
Kounis syndrome 111.69 11.24 68 66117 3300 42551850
Fall 107.02 11.24 124 66061 234396 42320754
Acute generalised exanthematous pustulosis 104.84 11.24 95 66090 8500 42546650
Cerebellar ataxia 103.62 11.24 46 66139 1147 42554003
Septic shock 99.54 11.24 341 65844 91331 42463819
Drug therapy 97.05 11.24 80 66105 6300 42548850
Dysarthria 95.62 11.24 199 65986 39608 42515542
Night sweats 94.68 11.24 135 66050 19834 42535316
Abdominal abscess 90.58 11.24 70 66115 5023 42550127
Drug ineffective 89.12 11.24 1421 64764 628776 41926374
Hypophosphataemia 88.33 11.24 134 66051 20811 42534339
Completed suicide 87.66 11.24 21 66164 96444 42458706
Activated partial thromboplastin time prolonged 86.66 11.24 115 66070 15788 42539362
Crohn's disease 85.72 11.24 55 66130 2929 42552221
Antacid therapy 84.25 11.24 65 66120 4652 42550498
Blood uric acid increased 84.07 11.24 112 66073 15435 42539715
Clostridium difficile infection 81.79 11.24 135 66050 22524 42532626
Anticoagulant therapy 79.93 11.24 62 66123 4473 42550677
Neuralgia 79.71 11.24 143 66042 25504 42529646
Clostridial infection 74.97 11.24 56 66129 3818 42551332
Iron deficiency 74.63 11.24 89 66096 10972 42544178
Condition aggravated 70.34 11.24 665 65520 260089 42295061
End stage renal disease 67.09 11.24 104 66081 16454 42538696
Pyrexia 64.14 11.24 911 65274 393131 42162019
Fistula discharge 63.27 11.24 32 66153 1076 42554074
Ulcer 62.10 11.24 100 66085 16341 42538809
Cardiac failure 59.75 11.24 47 66138 106809 42448341
Agranulocytosis 58.82 11.24 140 66045 30472 42524678
Herpes simplex oesophagitis 58.16 11.24 20 66165 244 42554906
Fixed eruption 57.86 11.24 40 66145 2414 42552736
Dysmetria 57.60 11.24 27 66158 766 42554384
Bronchopulmonary aspergillosis allergic 56.43 11.24 51 66134 4547 42550603
Hyponatraemia 56.19 11.24 308 65877 101154 42453996
Anal abscess 56.01 11.24 65 66120 7785 42547365
Interstitial lung disease 54.22 11.24 27 66158 78435 42476715
Cardiac failure congestive 54.03 11.24 33 66152 85569 42469581
Linear IgA disease 53.68 11.24 36 66149 2067 42553083
Enterococcal infection 53.58 11.24 79 66106 11960 42543190
Swelling 53.38 11.24 197 65988 54688 42500462
Cholestasis 53.35 11.24 141 66044 32738 42522412
Rash maculo-papular 53.09 11.24 153 66032 37350 42517800
Malignant neoplasm progression 53.03 11.24 54 66131 108346 42446804
Clostridium test positive 52.26 11.24 53 66132 5452 42549698
Abscess 51.56 11.24 85 66100 14163 42540987
Eosinophilia 51.28 11.24 139 66046 32760 42522390
Dry mouth 51.05 11.24 157 66028 39722 42515428
Rheumatoid arthritis 50.73 11.24 4 66181 42436 42512714
Back pain 50.68 11.24 89 66096 141687 42413463
Total lung capacity decreased 50.64 11.24 43 66142 3527 42551623
Blood calcium increased 50.53 11.24 64 66121 8390 42546760
Toxic epidermal necrolysis 49.96 11.24 121 66064 26629 42528521
Cough 49.35 11.24 129 66056 177974 42377176
Hospitalisation 49.26 11.24 27 66158 74303 42480847
Blood cholesterol increased 48.92 11.24 120 66065 26621 42528529
General physical health deterioration 48.59 11.24 401 65784 150845 42404305
Pneumonia 48.53 11.24 421 65764 421728 42133422
Fatigue 47.65 11.24 440 65745 435201 42119949
Anal fistula 46.95 11.24 53 66132 6160 42548990
Cerebrovascular accident 46.85 11.24 49 66136 97111 42458039
Product dose omission issue 46.54 11.24 107 66078 154258 42400892
COVID-19 45.93 11.24 68 66117 115880 42439270
Congenital hiatus hernia 45.52 11.24 52 66133 6122 42549028
Injection site pain 44.51 11.24 17 66168 57781 42497369
Foetal cardiac arrest 43.41 11.24 10 66175 21 42555129
Vomiting 42.77 11.24 659 65526 289064 42266086
Aortic stenosis 42.74 11.24 60 66125 8685 42546465
Hepatic cytolysis 42.42 11.24 114 66071 26730 42528420
Drug resistance 42.14 11.24 133 66052 34115 42521035
Dyspnoea 41.00 11.24 465 65720 442156 42112994
Nystagmus 40.72 11.24 46 66139 5350 42549800
Bacteroides infection 40.52 11.24 33 66152 2554 42552596
Prostate cancer 39.99 11.24 10 66175 44633 42510517
Nervous system disorder 39.00 11.24 84 66101 17111 42538039
Dysdiadochokinesis 38.92 11.24 15 66170 258 42554892
Epileptic encephalopathy 37.69 11.24 15 66170 282 42554868
Influenza 36.48 11.24 26 66159 62149 42493001
Blood test abnormal 36.37 11.24 69 66116 12837 42542313
Dizziness 35.98 11.24 233 65952 249021 42306129
Hyphaema 35.95 11.24 19 66166 701 42554449
Vitamin B1 deficiency 35.93 11.24 16 66169 402 42554748
Thrombosis 35.93 11.24 205 65980 68306 42486844
Anaphylactic reaction 35.51 11.24 146 66039 42597 42512553
Serratia sepsis 34.78 11.24 12 66173 148 42555002
Cytotoxic oedema 34.77 11.24 13 66172 205 42554945
Hyperlipidaemia 34.62 11.24 92 66093 21424 42533726
Nasopharyngitis 34.50 11.24 48 66137 83948 42471202
Rash morbilliform 34.10 11.24 37 66148 4116 42551034
Stoma site discomfort 33.21 11.24 8 66177 22 42555128
Suicide attempt 33.17 11.24 15 66170 46085 42509065
Dry skin 32.84 11.24 17 66168 48321 42506829
Haemodynamic instability 32.78 11.24 65 66120 12492 42542658
Pain in extremity 32.57 11.24 122 66063 150482 42404668
Abscess intestinal 32.50 11.24 25 66160 1781 42553369
Chronic gastrointestinal bleeding 32.46 11.24 14 66171 325 42554825
Intentional overdose 32.23 11.24 20 66165 51436 42503714
Frontal lobe epilepsy 32.22 11.24 8 66177 26 42555124
Loss of personal independence in daily activities 31.71 11.24 19 66166 49797 42505353
Drug hypersensitivity 31.61 11.24 263 65922 99126 42456024
Drug dependence 31.49 11.24 4 66181 29090 42526060
Undersensing 31.31 11.24 7 66178 12 42555138
Alcohol intolerance 31.21 11.24 14 66171 358 42554792
Klebsiella infection 31.21 11.24 60 66125 11272 42543878
Joint swelling 30.92 11.24 36 66149 67986 42487164
Pleuritic pain 30.86 11.24 46 66139 7031 42548119
Diverticular perforation 30.32 11.24 33 66152 3683 42551467
Peripheral swelling 30.17 11.24 59 66126 90211 42464939
Arteriospasm coronary 30.13 11.24 37 66148 4701 42550449
Lung opacity 29.95 11.24 41 66144 5796 42549354
Epistaxis 29.69 11.24 36 66149 66790 42488360
Acute hepatic failure 29.52 11.24 75 66110 16998 42538152
Malignant mesenteric neoplasm 29.16 11.24 8 66177 42 42555108
Bradycardia 28.46 11.24 56 66129 85428 42469722
Gut fermentation syndrome 28.19 11.24 6 66179 7 42555143
Blood pressure increased 28.07 11.24 74 66111 101854 42453296
Plasma cell myeloma 27.77 11.24 20 66165 47558 42507592
Lack of spontaneous speech 27.72 11.24 8 66177 52 42555098
Hypothyroidism 27.20 11.24 8 66177 32076 42523074
Productive cough 27.18 11.24 24 66161 51543 42503607
Meningitis candida 27.14 11.24 10 66175 151 42554999
Cataract 27.13 11.24 7 66178 30597 42524553
Urinary retention 27.01 11.24 16 66169 42198 42512952
Large intestine perforation 26.89 11.24 51 66134 9485 42545665
Dyspnoea exertional 26.85 11.24 23 66162 50125 42505025
Leukocytosis 26.70 11.24 104 66081 29604 42525546
Enterocutaneous fistula 26.14 11.24 19 66166 1242 42553908
Insomnia 26.08 11.24 95 66090 118158 42436992
Pouchitis 26.05 11.24 17 66168 932 42554218
Substance-induced psychotic disorder 25.95 11.24 27 66158 2862 42552288
Urethral valves 25.72 11.24 11 66174 250 42554900
Nasal congestion 25.67 11.24 7 66178 29494 42525656
Long QT syndrome 25.62 11.24 28 66157 3139 42552011
Aminoaciduria 25.60 11.24 11 66174 253 42554897
Oxygen saturation decreased 25.54 11.24 38 66147 64649 42490501
Troponin increased 25.28 11.24 76 66109 18986 42536164
Sleep disorder 25.26 11.24 144 66041 47951 42507199
Hyperkalaemia 24.85 11.24 55 66130 80403 42474747
Sensitisation 24.75 11.24 11 66174 275 42554875
Jejunal ulcer perforation 24.61 11.24 8 66177 81 42555069
Magnetic resonance imaging head abnormal 24.57 11.24 20 66165 1547 42553603
Peritonitis 24.44 11.24 74 66111 18559 42536591
Listeriosis 24.23 11.24 19 66166 1392 42553758
Botulism 24.02 11.24 10 66175 212 42554938
Enterocolitis haemorrhagic 23.90 11.24 17 66168 1074 42554076
Serratia infection 23.79 11.24 18 66167 1251 42553899
Perirectal abscess 23.77 11.24 21 66164 1817 42553333
Fungal peritonitis 23.69 11.24 16 66169 929 42554221
Wrong technique in product usage process 23.51 11.24 19 66166 42616 42512534
Memory impairment 23.45 11.24 26 66159 50196 42504954
Gout 23.43 11.24 96 66089 27959 42527191
Colitis ischaemic 23.36 11.24 41 66144 7185 42547965
Drug-induced liver injury 23.08 11.24 119 66066 38154 42516996
Large intestine infection 23.08 11.24 22 66163 2099 42553051
Intestinal stenosis 23.05 11.24 25 66160 2779 42552371
Colitis ulcerative 23.01 11.24 91 66094 26084 42529066
White blood cell count decreased 22.85 11.24 91 66094 110305 42444845
Aphthous ulcer 22.43 11.24 36 66149 5865 42549285
Myelosuppression 22.34 11.24 18 66167 40443 42514707
Candida infection 22.21 11.24 79 66106 21531 42533619
Cardiac disorder 22.12 11.24 26 66159 48906 42506244
Metabolic acidosis 22.03 11.24 147 66038 51711 42503439
Tongue discolouration 21.76 11.24 17 66168 1239 42553911
Escherichia infection 21.76 11.24 52 66133 11344 42543806
Neonatal cholestasis 21.61 11.24 7 66178 70 42555080
Aspiration 21.58 11.24 69 66116 17817 42537333
Paraesthesia 21.57 11.24 191 65994 73268 42481882
Chest pain 21.36 11.24 128 66057 139402 42415748
Injection site erythema 21.33 11.24 3 66182 20192 42534958
Feeling abnormal 21.31 11.24 48 66137 69738 42485412
Enterococcus test positive 21.29 11.24 19 66166 1666 42553484
Platelet count decreased 21.28 11.24 127 66058 138454 42416696
Liver abscess 21.23 11.24 32 66153 4938 42550212
Antineutrophil cytoplasmic antibody 21.20 11.24 6 66179 36 42555114
Cerebral cyst 20.97 11.24 10 66175 295 42554855
Infusion site induration 20.81 11.24 11 66174 406 42554744
Blood glucose increased 20.67 11.24 53 66132 73646 42481504
Dermatitis exfoliative 20.64 11.24 38 66147 6909 42548241
Treatment failure 20.59 11.24 167 66018 62457 42492693
Hepatitis acute 20.53 11.24 44 66141 8931 42546219
Therapeutic product effect decreased 20.42 11.24 117 66068 39033 42516117
Orthostatic hypotension 20.40 11.24 11 66174 30559 42524591
Metastases to stomach 20.24 11.24 7 66178 87 42555063
Functional gastrointestinal disorder 20.13 11.24 22 66163 2466 42552684
Arthralgia 19.96 11.24 213 65972 205025 42350125
Depression 19.89 11.24 97 66088 111266 42443884
Ischaemic stroke 19.87 11.24 5 66180 22228 42532922
Nightmare 19.85 11.24 7 66178 25005 42530145
Hyperreflexia 19.52 11.24 26 66159 3581 42551569
Rash erythematous 19.50 11.24 100 66085 31991 42523159
Cross sensitivity reaction 19.42 11.24 18 66167 1657 42553493
Herpes zoster 19.42 11.24 19 66166 38858 42516292
Accidental exposure to product 19.40 11.24 4 66181 20389 42534761
Disease progression 19.34 11.24 137 66048 143519 42411631
Colonic fistula 19.17 11.24 11 66174 478 42554672
Jaundice 19.12 11.24 105 66080 34484 42520666
Neutrophil count decreased 19.05 11.24 44 66141 63371 42491779
Lipase increased 18.88 11.24 47 66138 10519 42544631
Gastrointestinal inflammation 18.82 11.24 29 66156 4563 42550587
Psoriasis 18.75 11.24 29 66156 48575 42506575
Liver transplant failure 18.74 11.24 7 66178 110 42555040
Anal fissure 18.61 11.24 31 66154 5208 42549942
Omental necrosis 18.43 11.24 5 66180 25 42555125
Idiosyncratic drug reaction 18.42 11.24 11 66174 515 42554635
Muscle spasms 18.39 11.24 70 66115 85974 42469176
Aggression 18.37 11.24 25 66160 44138 42511012
Intestinal fistula 18.35 11.24 15 66170 1167 42553983
Hepatocellular injury 18.20 11.24 79 66106 23599 42531551
Weight increased 18.18 11.24 96 66089 107887 42447263
Chronic coronary syndrome 18.09 11.24 9 66176 292 42554858
Malaise 17.98 11.24 227 65958 211929 42343221
Hepatic necrosis 17.88 11.24 26 66159 3887 42551263
Arthropathy 17.85 11.24 12 66173 29585 42525565
Procedural pain 17.66 11.24 32 66153 5747 42549403
Infection in an immunocompromised host 17.65 11.24 14 66171 1043 42554107
Antibiotic level below therapeutic 17.54 11.24 6 66179 72 42555078
Sedation 17.54 11.24 13 66172 30462 42524688
Eastern Cooperative Oncology Group performance status 17.52 11.24 5 66180 31 42555119
Diabetes mellitus 17.52 11.24 156 66029 59931 42495219
Brain abscess 17.48 11.24 27 66158 4257 42550893
Mononucleosis syndrome 17.38 11.24 7 66178 136 42555014
Post embolisation syndrome 17.32 11.24 6 66179 75 42555075
Torsade de pointes 17.26 11.24 40 66145 8554 42546596
Stenotrophomonas test positive 17.10 11.24 9 66176 329 42554821
Clostridium bacteraemia 17.10 11.24 8 66177 226 42554924
Pseudomonas infection 17.05 11.24 59 66126 15864 42539286
Ileostomy 16.96 11.24 14 66171 1104 42554046
Syncope 16.94 11.24 88 66097 99318 42455832
Bladder cancer 16.94 11.24 3 66182 17044 42538106
Injection site swelling 16.84 11.24 3 66182 16970 42538180
Hepatitis cholestatic 16.82 11.24 43 66142 9781 42545369
Coagulation factor decreased 16.76 11.24 6 66179 83 42555067
Pollakiuria 16.70 11.24 7 66178 22498 42532652
Atrial fibrillation 16.50 11.24 138 66047 139455 42415695
Ureteral disorder 16.49 11.24 7 66178 156 42554994
Parasitic gastroenteritis 16.49 11.24 7 66178 156 42554994
Anxiety 16.48 11.24 112 66073 118448 42436702
Jarisch-Herxheimer reaction 16.42 11.24 12 66173 791 42554359
Therapy interrupted 16.38 11.24 7 66178 22243 42532907
Subperiosteal abscess 16.32 11.24 6 66179 90 42555060
Blood bilirubin increased 16.31 11.24 117 66068 42135 42513015
Disseminated intravascular coagulation 16.30 11.24 79 66106 24715 42530435
Contusion 16.25 11.24 25 66160 41960 42513190
Enteritis 16.15 11.24 45 66140 10771 42544379
Stoma site erythema 16.06 11.24 13 66172 997 42554153
Rash pustular 16.01 11.24 32 66153 6183 42548967
Full blood count decreased 15.90 11.24 6 66179 20554 42534596
Neoplasm progression 15.89 11.24 13 66172 28987 42526163
Haematuria 15.88 11.24 42 66143 57757 42497393
Dysuria 15.76 11.24 15 66170 31081 42524069
Bronchitis 15.63 11.24 31 66154 47170 42507980
Vitamin A deficiency 15.62 11.24 5 66180 48 42555102
International normalised ratio increased 15.59 11.24 128 66057 48040 42507110
Eczema 15.53 11.24 18 66167 34068 42521082
Carotid artery insufficiency 15.46 11.24 4 66181 16 42555134
Sleep disorder due to a general medical condition 15.45 11.24 4 66181 17449 42537701
Arterial angioplasty 15.43 11.24 5 66180 50 42555100
Ileal perforation 15.40 11.24 13 66172 1058 42554092
Rhinorrhoea 15.35 11.24 16 66169 31778 42523372
Leukoerythroblastosis 15.35 11.24 5 66180 51 42555099
Intestinal ulcer 15.33 11.24 13 66172 1064 42554086
Antibiotic level above therapeutic 15.26 11.24 9 66176 412 42554738
Accidental overdose 15.15 11.24 13 66172 28317 42526833
Alopecia 14.98 11.24 14 66171 29262 42525888
Renal cortical necrosis 14.95 11.24 7 66178 198 42554952
Romberg test positive 14.85 11.24 5 66180 57 42555093
Coagulopathy 14.84 11.24 71 66114 22091 42533059
Osteosarcoma 14.78 11.24 8 66177 310 42554840
Adverse drug reaction 14.76 11.24 22 66163 37412 42517738
Urinary tract infection 14.70 11.24 92 66093 99192 42455958
Muscle abscess 14.70 11.24 12 66173 932 42554218
Clostridium colitis 14.61 11.24 15 66170 1566 42553584
Venoocclusive liver disease 14.54 11.24 42 66143 10260 42544890
Prothrombin time shortened 14.54 11.24 15 66170 1574 42553576
Sudden death 14.37 11.24 4 66181 16625 42538525
Abdominal discomfort 14.35 11.24 64 66121 75191 42479959
Head injury 14.34 11.24 7 66178 20575 42534575
Vestibular disorder 14.33 11.24 13 66172 1164 42553986
Lymphocyte transformation test positive 14.33 11.24 3 66182 3 42555147
Electrocardiogram T wave biphasic 14.33 11.24 7 66178 218 42554932
Norovirus test positive 14.32 11.24 5 66180 64 42555086
Gallbladder fistula 14.28 11.24 4 66181 23 42555127
Deafness bilateral 14.28 11.24 14 66171 1383 42553767
Hepatic amoebiasis 14.25 11.24 5 66180 65 42555085
Pancreatitis acute 14.17 11.24 95 66090 33469 42521681
Infusion site inflammation 14.11 11.24 5 66180 67 42555083
Myelodysplastic syndrome 14.02 11.24 9 66176 22736 42532414
Osteomyelitis fungal 13.99 11.24 8 66177 345 42554805
Haematotoxicity 13.82 11.24 43 66142 10942 42544208
Poisoning 13.74 11.24 3 66182 14696 42540454
Distal intestinal obstruction syndrome 13.72 11.24 9 66176 498 42554652
Intention tremor 13.67 11.24 9 66176 501 42554649
Stoma site discharge 13.63 11.24 14 66171 1462 42553688
Peripheral sensory neuropathy 13.63 11.24 37 66148 8725 42546425
Arthritis 13.61 11.24 28 66157 42037 42513113
Micturition urgency 13.54 11.24 45 66140 11853 42543297
Gastrointestinal disorder 13.53 11.24 121 66064 46532 42508618
Drug ineffective for unapproved indication 13.53 11.24 120 66065 46043 42509107
Abdominal wall abscess 13.46 11.24 10 66175 676 42554474
Overdose 13.39 11.24 102 66083 105162 42449988
Osteoarthritis 13.30 11.24 11 66174 24394 42530756
Stoma site inflammation 13.29 11.24 9 66176 525 42554625
Cytokine release syndrome 13.29 11.24 31 66154 44496 42510654
Systemic candida 13.24 11.24 27 66158 5292 42549858
Transaminases increased 13.24 11.24 92 66093 32793 42522357
CNS ventriculitis 13.22 11.24 8 66177 384 42554766
Penile abscess 13.18 11.24 6 66179 159 42554991
Small intestinal obstruction 13.17 11.24 57 66128 17004 42538146
Diverticulitis 13.17 11.24 70 66115 22703 42532447
Subdural haematoma 13.15 11.24 10 66175 23128 42532022
Toxic skin eruption 13.10 11.24 49 66136 13681 42541469
Muscular weakness 13.08 11.24 76 66109 83422 42471728
Asthenia 13.08 11.24 334 65851 280459 42274691
Hypomagnesaemia 13.02 11.24 15 66170 28473 42526677
Cardiovascular disorder 13.01 11.24 48 66137 13317 42541833
Prostatic specific antigen increased 12.99 11.24 5 66180 16920 42538230
Amnesia 12.97 11.24 15 66170 28422 42526728
Stoma site haemorrhage 12.93 11.24 12 66173 1107 42554043
Cortical visual impairment 12.93 11.24 4 66181 34 42555116
Arrhythmia 12.91 11.24 27 66158 40290 42514860
Wound dehiscence 12.85 11.24 22 66163 3778 42551372
Hyperhidrosis 12.83 11.24 85 66100 90427 42464723
Ileocaecal resection 12.81 11.24 8 66177 406 42554744
Tachypnoea 12.81 11.24 67 66118 21595 42533555
Gastrointestinal wall thickening 12.74 11.24 15 66170 1824 42553326
Liver function test abnormal 12.68 11.24 90 66095 32301 42522849
Geotrichum infection 12.66 11.24 9 66176 568 42554582
Soft tissue necrosis 12.66 11.24 8 66177 415 42554735
Drug withdrawal syndrome 12.65 11.24 9 66176 21540 42533610
Erectile dysfunction 12.65 11.24 12 66173 24901 42530249
Diarrhoea haemorrhagic 12.44 11.24 33 66152 7674 42547476
Candida osteomyelitis 12.35 11.24 4 66181 40 42555110
Cholangitis sclerosing 12.33 11.24 15 66170 1887 42553263
Flavobacterium infection 12.33 11.24 5 66180 99 42555051
Hypertension 12.32 11.24 184 66001 167020 42388130
Diabetic ketoacidosis 12.29 11.24 10 66175 22357 42532793
Influenza like illness 12.28 11.24 19 66166 31821 42523329
Atrophic glossitis 12.26 11.24 3 66182 9 42555141
Stoma site odour 12.26 11.24 4 66181 41 42555109
Therapy partial responder 12.23 11.24 8 66177 20013 42535137
Terminal ileitis 12.21 11.24 9 66176 601 42554549
Pancreatitis necrotising 12.18 11.24 21 66164 3628 42551522
Deep vein thrombosis 12.08 11.24 70 66115 76887 42478263
Fluid retention 12.07 11.24 19 66166 31600 42523550
Pain 12.00 11.24 289 65896 244559 42310591
Anal inflammation 11.96 11.24 16 66169 2213 42552937
Myocardial infarction 11.92 11.24 129 66056 123880 42431270
Necrotising enterocolitis neonatal 11.79 11.24 7 66178 324 42554826
Hypoprothrombinaemia 11.79 11.24 8 66177 468 42554682
Ocular hyperaemia 11.79 11.24 5 66180 15958 42539192
Leukopenia 11.74 11.24 172 66013 74574 42480576
Inappropriate schedule of product administration 11.69 11.24 94 66091 95808 42459342
Intra-abdominal fluid collection 11.66 11.24 13 66172 1490 42553660
Cerebral infarction 11.64 11.24 19 66166 31150 42524000
Parechovirus infection 11.60 11.24 3 66182 12 42555138
Abdominal tenderness 11.56 11.24 24 66161 4765 42550385
Reaction to excipient 11.56 11.24 9 66176 653 42554497
Pasteurella infection 11.56 11.24 5 66180 117 42555033
Post procedural discharge 11.55 11.24 7 66178 337 42554813
Immune thrombocytopenia 11.52 11.24 41 66144 11175 42543975
Renal disorder 11.46 11.24 17 66168 28963 42526187
Peritoneal abscess 11.44 11.24 5 66180 120 42555030
Breath sounds abnormal 11.41 11.24 43 66142 12050 42543100
Hyperthyroidism 11.40 11.24 4 66181 14337 42540813
Gastrointestinal stoma output decreased 11.36 11.24 5 66180 122 42555028
Hepatitis 11.36 11.24 77 66108 27223 42527927
Factor V inhibition 11.29 11.24 6 66179 224 42554926
Extensor plantar response 11.28 11.24 9 66176 676 42554474
Necrosis 11.27 11.24 29 66156 6622 42548528
Aeromonas infection 11.25 11.24 7 66178 353 42554797

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
Toxic encephalopathy 1134.23 9.60 497 140787 14717 110433298
Neurotoxicity 615.23 9.60 476 140808 41731 110406284
Drug reaction with eosinophilia and systemic symptoms 564.49 9.60 607 140677 81488 110366527
Clostridium difficile infection 521.46 9.60 473 140811 51656 110396359
Clostridium difficile colitis 461.13 9.60 409 140875 43369 110404646
Colitis 433.65 9.60 592 140692 101731 110346284
Multiple organ dysfunction syndrome 423.63 9.60 723 140561 150987 110297028
Abdominal pain 351.92 9.60 1441 139843 511548 109936467
Appendicolith 349.00 9.60 221 141063 14034 110433981
Cerebellar syndrome 323.44 9.60 159 141125 6143 110441872
Pseudomembranous colitis 315.40 9.60 157 141127 6234 110441781
Appendicitis 307.86 9.60 270 141014 28194 110419821
Ataxia 306.57 9.60 276 141008 29832 110418183
Abortion incomplete 294.40 9.60 120 141164 2952 110445063
Encephalopathy 281.86 9.60 427 140857 80628 110367387
Acute generalised exanthematous pustulosis 259.73 9.60 218 141066 21446 110426569
Synovitis 251.80 9.60 28 141256 274064 110173951
Female genital tract fistula 237.82 9.60 185 141099 16334 110431681
Hand deformity 236.12 9.60 10 141274 218496 110229519
Chronic sinusitis 232.14 9.60 218 141066 24866 110423149
Septic shock 231.45 9.60 576 140708 156952 110291063
Paraesthesia oral 231.38 9.60 249 141035 33422 110414593
Vaginal flatulence 224.28 9.60 158 141126 11986 110436029
Arthropathy 219.98 9.60 49 141235 287473 110160542
Macular degeneration 217.45 9.60 197 141087 21462 110426553
Vaginal discharge 214.26 9.60 180 141104 17728 110430287
Proctitis 210.53 9.60 174 141110 16753 110431262
Pemphigus 210.09 9.60 17 141267 214553 110233462
International normalised ratio fluctuation 209.57 9.60 103 141181 3977 110444038
Fall 208.23 9.60 280 141004 603202 109844813
Systemic lupus erythematosus 203.54 9.60 39 141245 254299 110193716
Procedural pain 201.69 9.60 238 141046 35327 110412688
Ventricular fibrillation 199.59 9.60 255 141029 41058 110406957
Megacolon 198.48 9.60 101 141183 4204 110443811
Joint swelling 198.01 9.60 165 141119 442680 110005335
Swollen tongue 195.82 9.60 308 140976 60054 110387961
Anti-cyclic citrullinated peptide antibody positive 194.41 9.60 9 141275 181975 110266040
Ascites 193.19 9.60 390 140894 92418 110355597
Contraindicated product administered 188.52 9.60 43 141241 248224 110199791
Sepsis 186.96 9.60 871 140413 326475 110121540
Rheumatoid arthritis 185.86 9.60 75 141209 299538 110148477
Radiculopathy 182.69 9.60 170 141114 19166 110428849
Glossodynia 179.86 9.60 33 141251 221971 110226044
Swelling face 178.10 9.60 376 140908 91945 110356070
Drug abuse 176.65 9.60 13 141271 177398 110270617
Duodenal ulcer perforation 174.18 9.60 14 141270 177686 110270329
Pathogen resistance 170.11 9.60 157 141127 17515 110430500
Drug ineffective 167.80 9.60 2797 138487 1517743 108930272
Bloody discharge 164.71 9.60 77 141207 2656 110445359
Rash maculo-papular 163.01 9.60 319 140965 73903 110374112
Pericarditis 162.31 9.60 40 141244 219074 110228941
Haematochezia 161.89 9.60 415 140869 115109 110332906
Alopecia 160.44 9.60 138 141146 364615 110083400
Fistula 159.20 9.60 142 141142 15157 110432858
Cerebellar ataxia 158.14 9.60 69 141215 2019 110445996
Folliculitis 154.25 9.60 17 141267 167636 110280379
Drug ineffective for unapproved indication 154.12 9.60 379 140905 102459 110345556
Psoriatic arthropathy 153.59 9.60 32 141252 196729 110251286
Blood phosphorus increased 153.10 9.60 143 141141 16197 110431818
Completed suicide 153.06 9.60 59 141225 242322 110205693
Angioedema 152.94 9.60 368 140916 98132 110349883
Sleep disorder therapy 151.59 9.60 103 141181 7368 110440647
Nasopharyngitis 150.61 9.60 169 141115 394192 110053823
Cardiogenic shock 149.12 9.60 265 141019 57073 110390942
Oral candidiasis 147.41 9.60 230 141054 44530 110403485
Wound 144.86 9.60 59 141225 234378 110213637
Muscle injury 144.04 9.60 9 141275 140798 110307217
Toxic epidermal necrolysis 143.47 9.60 259 141025 56468 110391547
Dysarthria 143.40 9.60 326 140958 83795 110364220
Colitis ulcerative 142.22 9.60 309 140975 77054 110370961
Analgesic therapy 139.71 9.60 97 141187 7187 110440828
Fibromyalgia 137.15 9.60 26 141258 170883 110277132
Iron deficiency 136.46 9.60 142 141142 18334 110429681
Myasthenia gravis 135.51 9.60 152 141132 21359 110426656
Anaphylactic reaction 135.45 9.60 386 140898 113914 110334101
Cholestasis 134.10 9.60 271 141013 64247 110383768
Hyperphosphataemia 133.93 9.60 133 141151 16248 110431767
Abdominal distension 133.45 9.60 509 140775 174594 110273421
Helicobacter infection 133.15 9.60 34 141250 181843 110266172
Type 2 diabetes mellitus 131.94 9.60 32 141252 177200 110270815
Pyrexia 130.56 9.60 1734 139550 896531 109551484
Fixed eruption 130.30 9.60 76 141208 4156 110443859
Stomatitis 126.60 9.60 96 141188 270146 110177869
Rheumatic fever 124.89 9.60 8 141276 122571 110325444
Lyme disease 123.69 9.60 74 141210 4242 110443773
Sinusitis 121.26 9.60 120 141164 296568 110151447
Drug therapy 118.96 9.60 88 141196 7203 110440812
Dysmetria 118.36 9.60 50 141234 1349 110446666
Arthralgia 115.98 9.60 557 140727 779075 109668940
Sleep disorder due to general medical condition, insomnia type 113.55 9.60 5 141279 105638 110342377
Hepatic enzyme increased 112.44 9.60 147 141137 320745 110127270
Linear IgA disease 112.33 9.60 70 141214 4319 110443696
Fatigue 110.98 9.60 1007 140277 1214951 109233064
Activated partial thromboplastin time prolonged 109.50 9.60 139 141145 22229 110425786
Mobility decreased 109.09 9.60 86 141198 237336 110210679
Clostridial infection 107.20 9.60 78 141206 6224 110441791
Bursitis 105.87 9.60 19 141265 129899 110318116
Joint range of motion decreased 105.62 9.60 15 141269 121817 110326198
Antacid therapy 100.45 9.60 71 141213 5413 110442602
Impaired healing 98.54 9.60 65 141219 196652 110251363
Anticoagulant therapy 97.25 9.60 69 141215 5292 110442723
Wheezing 93.48 9.60 113 141171 255117 110192898
Product use issue 93.44 9.60 159 141125 311536 110136479
Peripheral swelling 93.42 9.60 239 141045 403795 110044220
Abdominal discomfort 92.60 9.60 231 141053 393627 110054388
Clostridium test positive 91.94 9.60 90 141194 10803 110437212
Kounis syndrome 91.07 9.60 69 141215 5856 110442159
Blood uric acid increased 90.27 9.60 124 141160 21405 110426610
Staphylococcal infection 89.54 9.60 243 141041 69701 110378314
Death 89.01 9.60 526 140758 698343 109749672
Weight increased 88.23 9.60 260 141024 419384 110028631
Breast cancer stage III 87.56 9.60 3 141281 79114 110368901
Enterocolitis haemorrhagic 86.14 9.60 49 141235 2555 110445460
Grip strength decreased 85.49 9.60 4 141280 80170 110367845
Lip dry 85.19 9.60 13 141271 100070 110347945
Asthma 84.27 9.60 118 141166 250173 110197842
Cough 83.28 9.60 306 140978 461335 109986680
Hypophosphataemia 83.25 9.60 151 141133 33031 110414984
Abdominal abscess 82.27 9.60 77 141207 8742 110439273
Enterococcal infection 81.95 9.60 115 141169 20251 110427764
Swollen joint count increased 80.84 9.60 7 141277 83654 110364361
Nystagmus 80.20 9.60 86 141198 11491 110436524
Eosinophilia 79.96 9.60 207 141077 57729 110390286
Pneumonia 79.83 9.60 726 140558 875988 109572027
Acute hepatic failure 79.15 9.60 156 141128 36312 110411703
Dysphonia 79.08 9.60 245 141039 75684 110372331
Drug hypersensitivity 78.84 9.60 907 140377 453183 109994832
Pancreatitis haemorrhagic 78.33 9.60 34 141250 982 110447033
Stress 77.58 9.60 303 140981 105045 110342970
Irritable bowel syndrome 77.31 9.60 58 141226 164157 110283858
Frequent bowel movements 76.81 9.60 233 141051 71157 110376858
Osteoarthritis 75.58 9.60 73 141211 182550 110265465
Memory impairment 75.55 9.60 84 141200 196860 110251155
Agranulocytosis 75.52 9.60 211 141073 61549 110386466
Anal fistula 75.27 9.60 72 141212 8401 110439614
Ill-defined disorder 74.35 9.60 55 141229 156798 110291217
Intentional overdose 73.09 9.60 39 141245 132462 110315553
Abscess 72.76 9.60 128 141156 27341 110420674
Rectal haemorrhage 72.10 9.60 324 140960 119509 110328506
End stage renal disease 71.61 9.60 111 141173 21362 110426653
Diverticulitis 71.59 9.60 189 141095 53333 110394682
Loss of personal independence in daily activities 70.60 9.60 53 141231 149967 110298048
Therapeutic product effect decreased 69.26 9.60 129 141155 244187 110203828
Nervous system disorder 69.22 9.60 136 141148 31585 110416430
Haemorrhage 69.16 9.60 295 140989 106397 110341618
Musculoskeletal pain 68.10 9.60 80 141204 182943 110265072
Vomiting 67.92 9.60 1581 139703 909094 109538921
Magnetic resonance imaging head abnormal 67.62 9.60 47 141237 3488 110444527
Prescribed overdose 66.78 9.60 15 141269 87566 110360449
Anal fissure 66.00 9.60 72 141212 9809 110438206
Peripheral venous disease 64.96 9.60 14 141270 84103 110363912
Arthritis 64.81 9.60 71 141213 167515 110280500
Cholecystitis chronic 64.81 9.60 70 141214 9430 110438585
Sciatica 64.37 9.60 19 141265 92380 110355635
Large intestine infection 63.99 9.60 50 141234 4442 110443573
Discomfort 63.88 9.60 110 141174 214597 110233418
Leukocytosis 62.01 9.60 180 141104 53648 110394367
Pancreatitis acute 61.39 9.60 193 141091 60081 110387934
Vitamin B1 deficiency 60.54 9.60 28 141256 942 110447073
Adverse event 60.05 9.60 32 141252 108777 110339238
Stevens-Johnson syndrome 59.08 9.60 162 141122 46739 110401276
Knee arthroplasty 58.69 9.60 7 141277 64941 110383074
Wound infection 58.39 9.60 25 141259 96440 110351575
Dysdiadochokinesis 58.38 9.60 22 141262 436 110447579
Large intestine perforation 58.33 9.60 88 141196 16541 110431474
Anal abscess 58.04 9.60 73 141211 11565 110436450
Vanishing bile duct syndrome 57.99 9.60 41 141243 3127 110444888
Klebsiella infection 57.94 9.60 97 141187 19912 110428103
Erythema 57.37 9.60 597 140687 290850 110157165
Obesity 57.37 9.60 37 141247 113314 110334701
Injection site pain 56.82 9.60 87 141197 177835 110270180
Insomnia 56.81 9.60 252 141032 360338 110087677
Prescribed underdose 56.54 9.60 8 141276 65166 110382849
Alcohol intolerance 55.27 9.60 21 141263 426 110447589
Congenital hiatus hernia 55.24 9.60 53 141231 6206 110441809
Interstitial lung disease 55.02 9.60 58 141226 139276 110308739
Neuralgia 54.78 9.60 161 141123 48317 110399698
International normalised ratio increased 54.75 9.60 238 141046 86534 110361481
Road traffic accident 54.43 9.60 35 141249 107363 110340652
Malignant neoplasm progression 54.19 9.60 87 141197 174480 110273535
Idiosyncratic drug reaction 53.78 9.60 30 141254 1506 110446509
Nausea 53.64 9.60 2005 139279 1233685 109214330
C-reactive protein abnormal 53.48 9.60 52 141232 129643 110318372
Hepatitis 53.05 9.60 242 141042 89812 110358203
Candida infection 52.88 9.60 158 141126 47851 110400164
Haemodynamic instability 52.22 9.60 100 141184 22788 110425227
Abscess intestinal 51.94 9.60 39 141245 3265 110444750
Jaundice 51.68 9.60 180 141104 59056 110388959
Meningitis candida 51.23 9.60 17 141267 228 110447787
Herpes simplex oesophagitis 50.97 9.60 20 141264 444 110447571
Hypertension 50.50 9.60 413 140871 509671 109938344
Coagulopathy 50.24 9.60 140 141144 40771 110407244
Dyspnoea 50.20 9.60 1056 140228 1105816 109342199
Hepatic failure 50.02 9.60 197 141087 68542 110379473
Lower limb fracture 49.81 9.60 17 141267 75331 110372684
Cardiac failure 49.77 9.60 103 141181 187523 110260492
Rheumatoid factor positive 49.55 9.60 57 141227 131583 110316432
Fistula discharge 49.20 9.60 29 141255 1617 110446398
Metabolic acidosis 48.69 9.60 254 141030 99490 110348525
Bronchitis 48.05 9.60 79 141205 156953 110291062
Cardiac failure congestive 47.11 9.60 75 141209 150925 110297090
Acinetobacter infection 47.10 9.60 38 141246 3535 110444480
Lung disorder 46.78 9.60 100 141184 179947 110268068
Autoimmune disorder 46.47 9.60 13 141271 65470 110382545
Influenza 46.41 9.60 91 141193 169010 110279005
Hip arthroplasty 45.82 9.60 8 141276 55805 110392210
Depression 45.72 9.60 229 141055 317106 110130909
Pain in extremity 45.70 9.60 400 140884 486718 109961297
Bronchopulmonary aspergillosis allergic 45.48 9.60 55 141229 8371 110439644
Hospitalisation 45.19 9.60 70 141214 142423 110305592
Bacteroides infection 44.88 9.60 34 141250 2885 110445130
Product dose omission issue 44.78 9.60 235 141049 321547 110126468
Therapeutic product effect incomplete 44.76 9.60 460 140824 223345 110224670
Rash morbilliform 44.72 9.60 53 141231 7898 110440117
Lemierre syndrome 44.62 9.60 14 141270 155 110447860
Total lung capacity decreased 44.35 9.60 50 141234 7064 110440951
Diarrhoea haemorrhagic 44.20 9.60 75 141209 15564 110432451
Drug resistance 43.84 9.60 165 141119 56209 110391806
Hepatic necrosis 42.89 9.60 58 141226 9864 110438151
Aortic stenosis 42.84 9.60 67 141217 12992 110435023
Hepatic cytolysis 42.70 9.60 161 141123 54892 110393123
Hepatocellular injury 42.56 9.60 152 141132 50490 110397525
Injection site reaction 42.50 9.60 31 141253 89039 110358976
Peritonitis 42.44 9.60 114 141170 32493 110415522
Neuropathy peripheral 42.02 9.60 381 140903 178896 110269119
Disseminated intravascular coagulation 41.86 9.60 132 141152 41154 110406861
Dermatitis bullous 41.74 9.60 78 141206 17451 110430564
Posterior reversible encephalopathy syndrome 41.70 9.60 116 141168 33745 110414270
Systemic mastocytosis 41.56 9.60 16 141268 337 110447678
Cataract 41.53 9.60 25 141259 79460 110368555
Cytotoxic oedema 41.19 9.60 17 141267 432 110447583
Crohn's disease 41.11 9.60 28 141256 2010 110446005
Liver abscess 40.93 9.60 50 141234 7689 110440326
Suicide attempt 40.86 9.60 43 141241 103351 110344664
Migraine 40.82 9.60 100 141184 171552 110276463
Pulmonary fibrosis 40.82 9.60 42 141242 102000 110346015
Lip swelling 40.82 9.60 150 141134 50517 110397498
Infusion related reaction 40.80 9.60 302 140982 380860 110067155
Thrombosis 40.77 9.60 258 141026 108404 110339611
Nail disorder 40.20 9.60 12 141272 57923 110390092
Pouchitis 40.16 9.60 24 141260 1373 110446642
Axonal neuropathy 40.13 9.60 29 141255 2289 110445726
Incorrect route of product administration 39.87 9.60 175 141109 63886 110384129
Liver function test abnormal 39.66 9.60 184 141100 68766 110379249
Sleep disorder due to a general medical condition 39.58 9.60 9 141275 52103 110395912
COVID-19 38.73 9.60 171 141113 244889 110203126
Constipation 38.23 9.60 656 140628 357130 110090885
Amnesia 38.22 9.60 47 141237 105361 110342654
Necrosis ischaemic 38.17 9.60 23 141261 1336 110446679
Haemolytic uraemic syndrome 38.05 9.60 39 141245 4946 110443069
Hypothyroidism 37.98 9.60 23 141261 72876 110375139
Pseudomonas infection 37.90 9.60 99 141185 27754 110420261
Pelvic inflammatory disease 37.44 9.60 24 141260 1556 110446459
Adverse drug reaction 37.30 9.60 48 141236 105511 110342504
Osteoporosis 37.03 9.60 34 141250 87118 110360897
Exostosis 36.83 9.60 7 141277 45949 110402066
Endometritis 36.79 9.60 20 141264 954 110447061
Contusion 36.78 9.60 163 141121 233198 110214817
Adjustment disorder with depressed mood 36.66 9.60 6 141278 43877 110404138
Onychomadesis 36.50 9.60 7 141277 45656 110402359
Injection site erythema 36.29 9.60 40 141244 94136 110353879
Oxygen saturation decreased 36.13 9.60 93 141191 156889 110291126
Coeliac disease 35.87 9.60 6 141278 43181 110404834
Toxic shock syndrome 35.80 9.60 23 141261 1497 110446518
Herpes simplex colitis 35.72 9.60 11 141273 114 110447901
Sopor 35.46 9.60 3 141281 36543 110411472
Dysbiosis 35.38 9.60 26 141258 2106 110445909
Substance-induced psychotic disorder 35.32 9.60 39 141245 5385 110442630
Colitis ischaemic 35.03 9.60 73 141211 17677 110430338
Clostridium colitis 34.95 9.60 31 141253 3284 110444731
Undersensing 34.81 9.60 7 141277 7 110448008
X-ray abnormal 34.71 9.60 4 141280 38113 110409902
Toxic skin eruption 34.61 9.60 95 141189 27420 110420595
Torsade de pointes 34.59 9.60 84 141200 22516 110425499
Anaemia 34.47 9.60 929 140355 546157 109901858
Pelvic pain 34.36 9.60 68 141216 15874 110432141
Henoch-Schonlein purpura 34.25 9.60 32 141252 3625 110444390
Venoocclusive liver disease 34.15 9.60 66 141218 15141 110432874
Rash macular 34.13 9.60 118 141166 38568 110409447
Chromaturia 33.64 9.60 98 141186 29262 110418753
Accidental exposure to product 33.55 9.60 11 141273 49997 110398018
Enterocutaneous fistula 33.40 9.60 26 141258 2297 110445718
Ulcer 33.36 9.60 126 141158 42990 110405025
Underdose 33.19 9.60 20 141264 63534 110384481
Neutropenic colitis 33.13 9.60 46 141238 8019 110439996
Blood calcium increased 33.07 9.60 72 141212 17968 110430047
Therapeutic response decreased 32.95 9.60 45 141239 96454 110351561
Proctalgia 32.95 9.60 60 141224 13162 110434853
Leukoencephalopathy 32.73 9.60 49 141235 9146 110438869
Blister 32.22 9.60 165 141119 227211 110220804
Dyspnoea exertional 32.16 9.60 52 141232 104008 110344007
Hyphaema 31.77 9.60 19 141265 1088 110446927
Beta haemolytic streptococcal infection 31.75 9.60 28 141256 2943 110445072
Frontal lobe epilepsy 31.72 9.60 8 141276 36 110447979
Abdominal pain lower 31.41 9.60 112 141172 37171 110410844
Hyperlipidaemia 31.33 9.60 109 141175 35739 110412276
Decreased appetite 31.27 9.60 424 140860 475422 109972593
Peripheral sensory neuropathy 31.07 9.60 67 141217 16613 110431402
Taste disorder 30.88 9.60 23 141261 65364 110382651
Bradycardia 30.76 9.60 99 141185 155418 110292597
Wrong technique in product usage process 30.57 9.60 40 141244 87308 110360707
Serratia sepsis 30.56 9.60 12 141272 267 110447748
Rash pustular 30.44 9.60 57 141227 12772 110435243
Inflammation 30.43 9.60 135 141149 193103 110254912
Medication error 30.41 9.60 55 141229 105311 110342704
Type IV hypersensitivity reaction 30.34 9.60 38 141246 5995 110442020
Diverticular perforation 30.29 9.60 39 141245 6323 110441692
Dermatitis exfoliative 30.21 9.60 53 141231 11294 110436721
Gout 30.08 9.60 109 141175 36457 110411558
Long QT syndrome 29.84 9.60 41 141243 7077 110440938
Product quality issue 29.60 9.60 33 141251 77266 110370749
Uterine perforation 29.59 9.60 40 141244 6800 110441215
Vitamin K deficiency 29.58 9.60 17 141267 904 110447111
Biliary sepsis 29.52 9.60 22 141262 1821 110446194
White blood cell count decreased 29.46 9.60 172 141112 229218 110218797
Blepharospasm 29.01 9.60 17 141267 54834 110393181
Gastrointestinal wall thickening 28.85 9.60 29 141255 3594 110444421
Urinary retention 28.65 9.60 28 141256 69655 110378360
Pericoronitis 28.57 9.60 10 141274 159 110447856
Epileptic encephalopathy 28.50 9.60 15 141269 670 110447345
Systemic candida 28.41 9.60 48 141236 9926 110438089
Dermatitis allergic 28.32 9.60 76 141208 21648 110426367
Gait inability 28.25 9.60 85 141199 136291 110311724
Troponin increased 28.21 9.60 93 141191 29673 110418342
Drug-induced liver injury 28.04 9.60 255 141029 119812 110328203
Optic neuropathy 27.78 9.60 32 141252 4626 110443389
Anaphylactic shock 27.78 9.60 135 141149 51411 110396604
Gastrooesophageal reflux disease 27.58 9.60 127 141157 179849 110268166
Back injury 27.56 9.60 13 141271 47386 110400629
Emotional distress 27.52 9.60 122 141162 44725 110403290
Lower respiratory tract infection 27.26 9.60 190 141094 242916 110205099
Stenosis 27.01 9.60 27 141257 3324 110444691
Chronic gastrointestinal bleeding 26.91 9.60 13 141271 483 110447532
Polyneuropathy 26.82 9.60 96 141188 31916 110416099
Cerebrovascular accident 26.57 9.60 130 141154 181154 110266861
Herpes simplex hepatitis 26.51 9.60 15 141269 774 110447241
Ileostomy 26.48 9.60 23 141261 2369 110445646
Small intestinal obstruction 26.48 9.60 96 141188 32117 110415898
Purple glove syndrome 26.42 9.60 11 141273 286 110447729
Mania 26.36 9.60 72 141212 20724 110427291
Tubulointerstitial nephritis 26.32 9.60 138 141146 54146 110393869
Stoma site discomfort 26.26 9.60 9 141275 134 110447881
Fungal peritonitis 26.25 9.60 18 141266 1307 110446708
Live birth 26.24 9.60 30 141254 69454 110378561
Neutrophil count decreased 26.05 9.60 74 141210 120867 110327148
Lipase increased 26.05 9.60 67 141217 18605 110429410
Tongue discolouration 25.98 9.60 29 141255 4052 110443963
Off label use 25.93 9.60 2238 139046 1497947 108950068
Eastern Cooperative Oncology Group performance status 25.90 9.60 9 141275 140 110447875
Gingival swelling 25.89 9.60 33 141251 5297 110442718
Cholestatic liver injury 25.82 9.60 39 141245 7337 110440678
Hepatitis infectious mononucleosis 25.74 9.60 10 141274 216 110447799
Cytomegalovirus colitis 25.67 9.60 38 141246 7023 110440992
Endocrine ophthalmopathy 25.67 9.60 18 141266 1355 110446660
Fluid retention 25.66 9.60 51 141233 94256 110353759
Injection site pruritus 25.57 9.60 17 141267 51241 110396774
Eczema 25.41 9.60 33 141251 72260 110375755
Geotrichum infection 25.28 9.60 17 141267 1195 110446820
Osmotic demyelination syndrome 25.22 9.60 21 141263 2042 110445973
Shock 25.14 9.60 135 141149 53453 110394562
Oedematous pancreatitis 24.84 9.60 19 141265 1635 110446380
Procedural hypertension 24.71 9.60 11 141273 338 110447677
Aphthous ulcer 24.65 9.60 71 141213 21065 110426950
Overdose 24.63 9.60 186 141098 233608 110214407
Malignant mesenteric neoplasm 24.45 9.60 7 141277 55 110447960
Hyperkalaemia 24.45 9.60 90 141194 135706 110312309
Pneumonia streptococcal 24.31 9.60 26 141258 3463 110444552
Lung opacity 24.27 9.60 49 141235 11603 110436412
Laryngitis 24.10 9.60 12 141272 42399 110405616
Nodule 24.06 9.60 6 141278 32625 110415390
Prostate cancer 24.01 9.60 9 141275 37632 110410383
Hyponatraemia 23.93 9.60 401 140883 217252 110230763
Aminoaciduria 23.92 9.60 11 141273 365 110447650
Generalised tonic-clonic seizure 23.81 9.60 135 141149 54545 110393470
Hallucinations, mixed 23.66 9.60 41 141243 8652 110439363
Musculoskeletal stiffness 23.54 9.60 236 141048 279586 110168429
Jejunal ulcer perforation 23.41 9.60 8 141276 118 110447897
Aspergillus infection 23.36 9.60 79 141205 25537 110422478
Intestinal perforation 23.13 9.60 69 141215 20875 110427140
Chest pain 23.07 9.60 340 140944 376035 110071980
Adenoviral hepatitis 23.06 9.60 15 141269 997 110447018
Gut fermentation syndrome 22.95 9.60 6 141278 32 110447983
Blood bilirubin increased 22.92 9.60 171 141113 75801 110372214
Cholecystitis 22.88 9.60 79 141205 25803 110422212
Intrauterine infection 22.86 9.60 7 141277 71 110447944
Strongyloidiasis 22.86 9.60 30 141254 4956 110443059
Rectal tube insertion 22.84 9.60 5 141279 10 110448005
Psychotic disorder due to a general medical condition 22.81 9.60 10 141274 296 110447719
Tongue coated 22.56 9.60 19 141265 1877 110446138
Retained products of conception 22.53 9.60 8 141276 133 110447882
Device malfunction 22.49 9.60 3 141281 25555 110422460
Stoma site haemorrhage 22.49 9.60 21 141263 2377 110445638
Pulmonary embolism 22.44 9.60 392 140892 214082 110233933
Biliary dyskinesia 22.32 9.60 21 141263 2400 110445615
Myelodysplastic syndrome 22.23 9.60 10 141274 37474 110410541
Escherichia infection 22.20 9.60 74 141210 23742 110424273
Deafness bilateral 22.19 9.60 22 141262 2682 110445333
Herpes zoster 22.13 9.60 68 141216 108311 110339704
Multiple sclerosis relapse 22.06 9.60 19 141265 50221 110397794
Muscular weakness 21.97 9.60 207 141077 248261 110199754
Pharyngeal oedema 21.95 9.60 58 141226 16370 110431645
Endoscopic retrograde cholangiopancreatography 21.94 9.60 9 141275 225 110447790
Drug level below therapeutic 21.87 9.60 47 141237 11626 110436389
Abnormal faeces 21.87 9.60 41 141243 9195 110438820
Plasma cell myeloma 21.84 9.60 29 141255 62907 110385108
Stoma site discharge 21.57 9.60 22 141262 2773 110445242
Vulvovaginal swelling 21.54 9.60 12 141272 601 110447414
Weight decreased 21.52 9.60 765 140519 467292 109980723
Antibiotic level below therapeutic 21.43 9.60 7 141277 89 110447926
Amoebiasis 21.35 9.60 8 141276 156 110447859
Drug interaction 21.18 9.60 810 140474 499373 109948642
Gastrointestinal inflammation 21.15 9.60 41 141243 9428 110438587
Poisoning deliberate 21.13 9.60 4 141280 26327 110421688
Arteriospasm coronary 21.06 9.60 40 141244 9060 110438955
Aspiration 21.01 9.60 86 141198 30447 110417568
Toxic leukoencephalopathy 20.90 9.60 17 141267 1600 110446415
Back pain 20.75 9.60 341 140943 370655 110077360
Oedematous kidney 20.70 9.60 9 141275 261 110447754
Organ failure 20.58 9.60 28 141256 4789 110443226
Rhinorrhoea 20.54 9.60 65 141219 102601 110345414
Incubator therapy 20.54 9.60 6 141278 51 110447964
Blood alkaline phosphatase increased 20.47 9.60 158 141126 70777 110377238
Sedation 20.44 9.60 36 141248 69647 110378368
Thrombocytopenia 20.41 9.60 587 140697 348298 110099717
Rectal abscess 20.41 9.60 21 141263 2675 110445340
Distributive shock 20.36 9.60 31 141253 5873 110442142
Dyspepsia 20.32 9.60 350 140934 190615 110257400
Factor V inhibition 20.23 9.60 10 141274 391 110447624
Skin odour abnormal 20.20 9.60 20 141264 2434 110445581
Lupus vulgaris 20.16 9.60 9 141275 33874 110414141
Dry eye 20.09 9.60 25 141259 55768 110392247
Mean cell haemoglobin increased 20.09 9.60 30 141254 5587 110442428
Benign prostatic hyperplasia 20.07 9.60 60 141224 18174 110429841
Blood pressure increased 20.07 9.60 222 141062 258151 110189864
Weber tuning fork test abnormal 19.96 9.60 7 141277 112 110447903
Respiratory disorder 19.94 9.60 38 141246 71344 110376671
Chronic coronary syndrome 19.88 9.60 9 141275 288 110447727
Renal failure 19.87 9.60 403 140881 226171 110221844
Foetal arrhythmia 19.86 9.60 6 141278 58 110447957
Hypoglossal nerve paresis 19.79 9.60 7 141277 115 110447900
Stenotrophomonas test positive 19.77 9.60 10 141274 411 110447604
Foetal monitoring abnormal 19.73 9.60 8 141276 194 110447821
Walking aid user 19.72 9.60 4 141280 25071 110422944
Anal skin tags 19.69 9.60 11 141273 554 110447461
Enterocolitis 19.59 9.60 61 141223 18888 110429127
Drug dependence 19.54 9.60 21 141263 49999 110398016
Injection site bruising 19.50 9.60 22 141262 51241 110396774
Joint stiffness 19.49 9.60 35 141249 67208 110380807
Cholecystitis acute 19.37 9.60 54 141230 15728 110432287
Jaundice neonatal 19.25 9.60 8 141276 207 110447808
Liver injury 19.19 9.60 113 141171 150300 110297715
Pyroglutamic acidosis 19.18 9.60 18 141266 2050 110445965
Pulmonary trichosporonosis 19.16 9.60 6 141278 66 110447949
Dysgeusia 19.16 9.60 154 141130 69831 110378184
Leukaemoid reaction 19.05 9.60 10 141274 444 110447571
Periorbital oedema 19.05 9.60 41 141243 10151 110437864
Abdominal sepsis 19.03 9.60 19 141265 2336 110445679
Injection site swelling 18.97 9.60 31 141253 61759 110386256
Abortion infected 18.77 9.60 5 141279 29 110447986
Renal tubular necrosis 18.77 9.60 83 141201 30392 110417623
Myelosuppression 18.69 9.60 60 141224 94280 110353735
Postural orthostatic tachycardia syndrome 18.66 9.60 17 141267 1865 110446150
Thrombotic thrombocytopenic purpura 18.65 9.60 33 141251 7078 110440937
Hallucination 18.63 9.60 205 141079 101227 110346788
Hepatomegaly 18.61 9.60 65 141219 21349 110426666
Condition aggravated 18.59 9.60 1131 140153 733705 109714310
Cardiac disorder 18.48 9.60 44 141240 76236 110371779
Delivery 18.43 9.60 13 141271 988 110447027
Skin lesion 18.39 9.60 121 141163 51510 110396505
Acute psychosis 18.36 9.60 27 141257 4960 110443055
Cerebral cyst 18.26 9.60 10 141274 484 110447531
Swelling 18.23 9.60 327 140957 350714 110097301
Rash erythematous 18.20 9.60 172 141112 81660 110366355
Asthenia 18.18 9.60 708 140576 688291 109759724
Bacterial colitis 18.12 9.60 8 141276 241 110447774
Anal inflammation 18.10 9.60 19 141265 2477 110445538
Puerperal pyrexia 18.09 9.60 5 141279 34 110447981
Heparin-induced thrombocytopenia 18.06 9.60 43 141241 11381 110436634
Macule 18.06 9.60 23 141261 3690 110444325
Perirectal abscess 18.00 9.60 18 141266 2216 110445799
Platelet count increased 17.98 9.60 74 141210 26260 110421755
Liver transplant failure 17.94 9.60 7 141277 153 110447862
Listeriosis 17.92 9.60 20 141264 2794 110445221
Immunodeficiency 17.91 9.60 14 141270 38824 110409191
Serratia infection 17.84 9.60 18 141266 2241 110445774
Antineutrophil cytoplasmic antibody 17.78 9.60 6 141278 85 110447930
Blood test abnormal 17.76 9.60 78 141206 28476 110419539
Tachycardia 17.57 9.60 396 140888 226249 110221766
Intra-abdominal fluid collection 17.57 9.60 23 141261 3791 110444224
Trichoglossia 17.54 9.60 12 141272 868 110447147
Nasal ulcer 17.54 9.60 19 141265 2568 110445447
Joint dislocation 17.52 9.60 11 141273 34179 110413836
Neoplasm progression 17.51 9.60 35 141249 64560 110383455
Hyporeflexia 17.50 9.60 24 141260 4136 110443879
Botulism 17.48 9.60 10 141274 527 110447488
Haematotoxicity 17.47 9.60 63 141221 21019 110426996
Lack of spontaneous speech 17.47 9.60 8 141276 263 110447752
Enteritis 17.40 9.60 59 141225 19097 110428918
Omental necrosis 17.39 9.60 5 141279 40 110447975
C-reactive protein decreased 17.38 9.60 20 141264 2889 110445126
Gastroenteritis Escherichia coli 17.35 9.60 14 141270 1303 110446712
Malnutrition 17.34 9.60 75 141209 27204 110420811
Prothrombin time prolonged 17.32 9.60 55 141229 17206 110430809
Flatulence 17.25 9.60 120 141164 52029 110395986
Brain abscess 17.21 9.60 31 141253 6743 110441272
Secretion discharge 17.21 9.60 61 141223 20183 110427832
Blood glucose increased 17.19 9.60 99 141185 132397 110315618
Petechiae 17.10 9.60 67 141217 23250 110424765
Bacterial infection 17.07 9.60 109 141175 45927 110402088
Premature delivery 17.06 9.60 81 141203 30551 110417464
Ear infection 17.00 9.60 34 141250 62698 110385317
Post embolisation syndrome 16.99 9.60 6 141278 98 110447917
Eyelid disorder 16.90 9.60 18 141266 2387 110445628
Rash papular 16.81 9.60 75 141209 27564 110420451
Respiratory tract infection 16.80 9.60 42 141242 71575 110376440
Retroperitoneal haematoma 16.80 9.60 29 141255 6102 110441913
Feeling guilty 16.76 9.60 12 141272 934 110447081
Colonic fistula 16.75 9.60 11 141273 743 110447272
Pleuritic pain 16.72 9.60 52 141232 16088 110431927
Gallbladder disorder 16.72 9.60 62 141222 20967 110427048
Infusion site streaking 16.61 9.60 10 141274 580 110447435
Ileocaecal resection 16.59 9.60 10 141274 581 110447434
Ureteral disorder 16.56 9.60 10 141274 583 110447432
Hepatic amoebiasis 16.46 9.60 6 141278 108 110447907
Arterial angioplasty 16.40 9.60 5 141279 50 110447965
Hyperintensity in brain deep nuclei 16.40 9.60 7 141277 194 110447821
Carotid artery insufficiency 16.24 9.60 4 141280 16 110447999
Face oedema 16.17 9.60 85 141199 33384 110414631
Enterovesical fistula 16.14 9.60 14 141270 1439 110446576
Epistaxis 16.07 9.60 99 141185 130273 110317742
Pharyngeal inflammation 16.05 9.60 15 141269 1699 110446316
Central nervous system lesion 16.01 9.60 50 141234 15503 110432512
Rosacea 15.99 9.60 26 141258 5210 110442805
Paralysis 15.92 9.60 50 141234 15550 110432465
Nasal congestion 15.87 9.60 68 141216 98214 110349801
Hepatitis cholestatic 15.86 9.60 54 141230 17512 110430503
Vaginal infection 15.86 9.60 30 141254 6774 110441241
Emphysema 15.85 9.60 3 141281 19753 110428262
Hypercholesterolaemia 15.83 9.60 61 141223 90776 110357239
Laryngeal inflammation 15.81 9.60 8 141276 329 110447686
Muscle spasms 15.77 9.60 255 141029 277902 110170113
Ecthyma 15.75 9.60 12 141272 1027 110446988
Coagulation factor decreased 15.68 9.60 8 141276 335 110447680
Mononucleosis syndrome 15.67 9.60 7 141277 217 110447798
Diabetes mellitus 15.65 9.60 195 141089 99186 110348829
Platelet count decreased 15.60 9.60 204 141080 230239 110217776
Vestibular disorder 15.56 9.60 18 141266 2614 110445401
Paraesthesia 15.55 9.60 463 140821 276058 110171957
Clostridium bacteraemia 15.48 9.60 9 141275 489 110447526
Large intestinal ulcer 15.46 9.60 27 141257 5734 110442281
Gastrointestinal oedema 15.36 9.60 20 141264 3278 110444737
Mastitis bacterial 15.35 9.60 5 141279 63 110447952
Sinus congestion 15.33 9.60 10 141274 30449 110417566
Gamma-glutamyltransferase increased 15.23 9.60 132 141152 61177 110386838
Intestinal stenosis 15.20 9.60 24 141260 4691 110443324
Immune thrombocytopenia 15.19 9.60 63 141221 22431 110425584
Electrocardiogram T wave biphasic 15.18 9.60 7 141277 234 110447781
Blood pressure diastolic abnormal 15.13 9.60 7 141277 25808 110422207
Red cell fragmentation syndrome 15.07 9.60 5 141279 67 110447948
Vaginitis gardnerella 15.07 9.60 5 141279 67 110447948
Renal cortical necrosis 15.06 9.60 9 141275 515 110447500
Delayed delivery 15.05 9.60 4 141280 23 110447992
Penile abscess 15.01 9.60 6 141278 140 110447875
Parasitic gastroenteritis 15.01 9.60 7 141277 240 110447775
Influenza like illness 15.00 9.60 60 141224 88352 110359663
Diabetic ketoacidosis 14.98 9.60 19 141265 42039 110405976
Erythema multiforme 14.97 9.60 60 141224 21037 110426978
Venous haemorrhage 14.96 9.60 8 141276 369 110447646
Femur fracture 14.92 9.60 21 141263 44448 110403567
Gynaecological examination abnormal 14.92 9.60 3 141281 3 110448012
Anterior interosseous syndrome 14.90 9.60 4 141280 24 110447991
Nephropathy toxic 14.83 9.60 72 141212 27406 110420609
Cross sensitivity reaction 14.82 9.60 26 141258 5541 110442474
Depersonalisation/derealisation disorder 14.75 9.60 16 141268 2165 110445850
Areflexia 14.74 9.60 29 141255 6740 110441275
Wound abscess 14.71 9.60 8 141276 382 110447633
Diabetes mellitus inadequate control 14.68 9.60 10 141274 29765 110418250
Gallbladder fistula 14.63 9.60 4 141280 26 110447989
Micturition urgency 14.57 9.60 56 141228 19264 110428751
Haemostasis 14.56 9.60 9 141275 547 110447468
Bacterial vaginosis 14.56 9.60 13 141271 1389 110446626
Upper respiratory tract infection 14.54 9.60 103 141181 131225 110316790
Culture wound positive 14.50 9.60 8 141276 393 110447622
Miosis 14.46 9.60 5 141279 21978 110426037
Pain 14.43 9.60 1038 140246 953917 109494098
Extensor plantar response 14.39 9.60 15 141269 1940 110446075
Product dose omission in error 14.38 9.60 6 141278 23506 110424509
Ischaemic stroke 14.33 9.60 19 141265 41244 110406771
Ileus paralytic 14.24 9.60 40 141244 11697 110436318
Hyperreflexia 14.24 9.60 35 141249 9450 110438565
Impaired work ability 14.24 9.60 8 141276 26411 110421604
Burning sensation 14.18 9.60 143 141141 69069 110378946
Breast cancer 14.16 9.60 17 141267 38525 110409490
Catheter site related reaction 14.15 9.60 13 141271 1441 110446574
Protein C decreased 14.14 9.60 5 141279 82 110447933
Enterococcus test positive 14.14 9.60 18 141266 2886 110445129
Muscle spasticity 14.12 9.60 15 141269 35900 110412115
Jarisch-Herxheimer reaction 14.08 9.60 12 141272 1205 110446810
Peritoneal tuberculosis 14.07 9.60 9 141275 581 110447434
Osteomyelitis fungal 14.06 9.60 8 141276 417 110447598
Poisoning 14.05 9.60 10 141274 29095 110418920
Mental status changes 14.05 9.60 154 141130 75968 110372047
Febrile neutropenia 14.04 9.60 303 140981 316464 110131551
Intestinal fistula 14.03 9.60 14 141270 1719 110446296
Osteosarcoma 14.00 9.60 8 141276 421 110447594
Productive cough 13.99 9.60 87 141197 114218 110333797
Idiopathic intracranial hypertension 13.98 9.60 21 141263 3931 110444084
Sedation complication 13.98 9.60 4 141280 19851 110428164
Second primary malignancy 13.96 9.60 3 141281 18065 110429950
Restless legs syndrome 13.94 9.60 7 141277 24619 110423396
Intestinal dilatation 13.91 9.60 20 141264 3600 110444415
Candida sepsis 13.86 9.60 18 141266 2943 110445072
Head injury 13.76 9.60 21 141263 42996 110405019
Pancreatitis necrotising 13.75 9.60 25 141259 5476 110442539
Small intestinal perforation 13.73 9.60 22 141262 4354 110443661
Bacteraemia 13.70 9.60 97 141187 42293 110405722
Blood pressure systolic increased 13.66 9.60 57 141227 82934 110365081
Disseminated tuberculosis 13.65 9.60 24 141260 5122 110442893
Neuroleptic malignant syndrome 13.64 9.60 14 141270 34045 110413970
Hypoalbuminaemia 13.60 9.60 73 141211 28901 110419114
Aspartate aminotransferase increased 13.53 9.60 283 141001 159653 110288362
Candida osteomyelitis 13.49 9.60 4 141280 36 110447979
Ileus 13.47 9.60 76 141208 30653 110417362
Pancytopenia 13.47 9.60 357 140927 209256 110238759
Lung neoplasm malignant 13.45 9.60 14 141270 33828 110414187
Type I hypersensitivity 13.45 9.60 27 141257 6366 110441649
Neck pain 13.42 9.60 97 141187 123033 110324982
Metastases to stomach 13.42 9.60 7 141277 307 110447708
Rubber sensitivity 13.41 9.60 16 141268 2402 110445613
Osteonecrosis 13.37 9.60 14 141270 33727 110414288
Airway peak pressure increased 13.34 9.60 9 141275 636 110447379
Bacteroides test positive 13.30 9.60 4 141280 38 110447977
Vulval ulceration 13.29 9.60 7 141277 313 110447702
Pulmonary hypertension 13.26 9.60 32 141252 55188 110392827
CNS ventriculitis 13.22 9.60 9 141275 646 110447369
Plantar fascial fibromatosis 13.21 9.60 4 141280 39 110447976
Ureteric obstruction 13.15 9.60 18 141266 3096 110444919
Prothrombin time ratio decreased 13.15 9.60 13 141271 1579 110446436
Tongue dry 13.08 9.60 12 141272 1328 110446687
Psoriasis 13.08 9.60 115 141169 139878 110308137
Hepatitis acute 13.02 9.60 53 141231 18713 110429302
Nodular rash 12.97 9.60 7 141277 329 110447686
Lupus-like syndrome 12.96 9.60 20 141264 40772 110407243
Vaginal abscess 12.96 9.60 8 141276 485 110447530
Epilepsy 12.93 9.60 75 141209 100134 110347881
Hyperthyroidism 12.93 9.60 11 141273 29250 110418765
Akathisia 12.91 9.60 3 141281 17110 110430905
Brain stem ischaemia 12.89 9.60 7 141277 333 110447682
Haematoma infection 12.88 9.60 13 141271 1619 110446396
Electrocardiogram QT prolonged 12.80 9.60 203 141081 108757 110339258
Abdominal compartment syndrome 12.80 9.60 14 141270 1913 110446102
Morganella infection 12.79 9.60 12 141272 1367 110446648
Myoclonus 12.78 9.60 79 141205 32919 110415096
Cortical visual impairment 12.77 9.60 4 141280 44 110447971
Fungal sepsis 12.73 9.60 15 141269 2222 110445793
Skin haemorrhage 12.70 9.60 8 141276 24819 110423196
Myocardial infarction 12.65 9.60 171 141113 191912 110256103
Peripheral sensorimotor neuropathy 12.62 9.60 20 141264 3923 110444092
Antibiotic associated colitis 12.61 9.60 3 141281 10 110448005
Hyperhidrosis 12.60 9.60 166 141118 187132 110260883
Chemical burns of eye 12.58 9.60 5 141279 115 110447900
Cardiovascular disorder 12.54 9.60 60 141224 22700 110425315
Intentional product use issue 12.53 9.60 232 141052 247674 110200341
Leuconostoc infection 12.46 9.60 4 141280 48 110447967
Metastases to bone 12.45 9.60 13 141271 31359 110416656
Subdural haematoma 12.44 9.60 17 141267 36437 110411578
Prothrombin time shortened 12.37 9.60 19 141265 3627 110444388
Aeromonas infection 12.34 9.60 8 141276 529 110447486
Product use in unapproved indication 12.32 9.60 694 140590 446683 110001332
Empyema 12.29 9.60 24 141260 5546 110442469
Stoma site odour 12.19 9.60 5 141279 125 110447890
Disorientation 12.15 9.60 141 141143 70530 110377485
Muscle abscess 12.14 9.60 12 141272 1457 110446558
Vulvovaginal inflammation 12.13 9.60 9 141275 740 110447275
Extravasation 12.09 9.60 22 141262 4823 110443192
Tachypnoea 12.07 9.60 89 141195 39306 110408709
Device expulsion 12.03 9.60 13 141271 30878 110417137
Cholelithiasis 12.03 9.60 129 141155 63293 110384722
Tongue necrosis 12.01 9.60 5 141279 130 110447885
Waterhouse-Friderichsen syndrome 11.99 9.60 3 141281 13 110448002
Infective aneurysm 11.99 9.60 12 141272 1480 110446535
Fungaemia 11.98 9.60 25 141259 6061 110441954
Flavobacterium infection 11.97 9.60 5 141279 131 110447884
Anorectal discomfort 11.94 9.60 20 141264 4106 110443909
Medical device site pain 11.91 9.60 7 141277 388 110447627
Glaucoma 11.88 9.60 7 141277 22510 110425505
Ocular hyperaemia 11.79 9.60 20 141264 39266 110408749
Tendonitis 11.76 9.60 65 141219 26018 110421997
Intestinal ulcer 11.75 9.60 15 141269 2412 110445603
Urinary tract infection 11.75 9.60 322 140962 325960 110122055
Foot deformity 11.71 9.60 28 141256 48452 110399563
Dizziness 11.68 9.60 752 140532 697441 109750574
Fusarium infection 11.68 9.60 16 141268 2755 110445260
Tubo-ovarian abscess 11.61 9.60 7 141277 407 110447608
Gastrointestinal necrosis 11.61 9.60 26 141258 6614 110441401
Stoma site inflammation 11.56 9.60 10 141274 1025 110446990
Stoma closure 11.50 9.60 7 141277 414 110447601
Prostatic cyst 11.48 9.60 3 141281 16 110447999
Parechovirus infection 11.48 9.60 3 141281 16 110447999
Nightmare 11.47 9.60 20 141264 38843 110409172
Stenotrophomonas infection 11.45 9.60 24 141260 5834 110442181
Faecal volume decreased 11.44 9.60 7 141277 418 110447597
Electrocardiogram T wave alternans 11.41 9.60 5 141279 148 110447867
Arthritis reactive 11.40 9.60 9 141275 811 110447204
Withdrawal syndrome 11.36 9.60 14 141270 31366 110416649
Chest discomfort 11.36 9.60 155 141129 173693 110274322
Meningitis aseptic 11.36 9.60 33 141251 9837 110438178
Oscillopsia 11.33 9.60 7 141277 425 110447590
Metastases to heart 11.33 9.60 7 141277 425 110447590
Vulvovaginitis trichomonal 11.32 9.60 3 141281 17 110447998
Nosocomial infection 11.32 9.60 17 141267 3182 110444833
Pulmonary arterial hypertension 11.31 9.60 15 141269 32553 110415462
Post procedural bile leak 11.28 9.60 7 141277 429 110447586
Protein S decreased 11.22 9.60 5 141279 154 110447861
Cardiac murmur 11.20 9.60 9 141275 24619 110423396
Intestinal gangrene 11.18 9.60 3 141281 18 110447997
Dry skin 11.16 9.60 86 141198 107567 110340448
Squamous cell carcinoma of skin 11.16 9.60 4 141280 17199 110430816
Oedema peripheral 11.16 9.60 327 140957 328333 110119682
Necrosis 11.13 9.60 36 141248 11370 110436645
Streptococcal endocarditis 11.12 9.60 6 141278 282 110447733
Infection in an immunocompromised host 11.10 9.60 13 141271 1914 110446101
Vitamin D increased 11.09 9.60 9 141275 844 110447171
Uterine hypertonus 11.08 9.60 6 141278 284 110447731
Fluid balance positive 11.08 9.60 4 141280 70 110447945
Marchiafava-Bignami disease 11.04 9.60 3 141281 19 110447996
Red blood cell count decreased 11.02 9.60 45 141239 65878 110382137
Procedural anxiety 11.02 9.60 9 141275 852 110447163
Abdominal tenderness 10.99 9.60 38 141246 12419 110435596
Vitamin A deficiency 10.99 9.60 5 141279 162 110447853
Appendicitis perforated 10.97 9.60 18 141266 3634 110444381
Infusion site induration 10.93 9.60 11 141273 1365 110446650
Pasteurella infection 10.93 9.60 5 141279 164 110447851
Paranoia 10.93 9.60 57 141227 22317 110425698
Functional gastrointestinal disorder 10.93 9.60 24 141260 6025 110441990
Choriocarcinoma 10.92 9.60 4 141280 73 110447942
Romberg test positive 10.91 9.60 6 141278 293 110447722
Staphylococcus test 10.91 9.60 3 141281 20 110447995
Bartter's syndrome 10.91 9.60 3 141281 20 110447995
Stoma site pain 10.90 9.60 13 141271 1950 110446065
Fear of death 10.88 9.60 12 141272 1655 110446360
Suspected suicide 10.82 9.60 3 141281 15196 110432819
Foot fracture 10.81 9.60 10 141274 25536 110422479
Hepatic cirrhosis 10.79 9.60 47 141237 67579 110380436
Bacterial toxaemia 10.79 9.60 5 141279 169 110447846
Terminal ileitis 10.78 9.60 12 141272 1672 110446343
Documented hypersensitivity to administered product 10.77 9.60 10 141274 1124 110446891
Haemorrhagic infarction 10.77 9.60 9 141275 880 110447135
Injection site haemorrhage 10.68 9.60 16 141268 33012 110415003
Culture stool positive 10.65 9.60 8 141276 670 110447345
Ballismus 10.62 9.60 6 141278 309 110447706
Hypoaesthesia 10.58 9.60 313 140971 313910 110134105
Vulval disorder 10.56 9.60 9 141275 904 110447111
Hypotonic-hyporesponsive episode 10.54 9.60 3 141281 23 110447992
Subperiosteal abscess 10.53 9.60 4 141280 81 110447934
Koebner phenomenon 10.53 9.60 4 141280 81 110447934
Diarrhoea 10.49 9.60 1633 139651 1137872 109310143
Erythema nodosum 10.47 9.60 25 141259 6628 110441387
Exposure during pregnancy 10.42 9.60 284 141000 167140 110280875
Scar 10.41 9.60 46 141238 16835 110431180
Disability 10.41 9.60 14 141270 30209 110417806
Infective pulmonary exacerbation of cystic fibrosis 10.36 9.60 3 141281 14768 110433247
Cytopenia 10.32 9.60 14 141270 30102 110417913
Necrotising colitis 10.32 9.60 12 141272 1753 110446262
Leukopenia 10.31 9.60 256 141028 148535 110299480
Blood osmolarity decreased 10.27 9.60 11 141273 1467 110446548
Osteopenia 10.25 9.60 8 141276 22201 110425814
Decreased vibratory sense 10.22 9.60 8 141276 712 110447303
Pustule 10.16 9.60 17 141267 3487 110444528
Stoma site erythema 10.12 9.60 13 141271 2104 110445911
Orbital oedema 10.11 9.60 7 141277 516 110447499
Drug withdrawal syndrome neonatal 10.11 9.60 6 141278 339 110447676
Eye infection 10.07 9.60 41 141243 14477 110433538
Perforation 10.07 9.60 12 141272 1798 110446217
Amylase increased 10.03 9.60 37 141247 12482 110435533
Vulval haemorrhage 10.02 9.60 3 141281 28 110447987
Lymphocyte transformation test positive 10.02 9.60 3 141281 28 110447987
Postoperative ileus 10.01 9.60 10 141274 1230 110446785
Hypovolaemic shock 9.97 9.60 41 141243 14542 110433473
Proteus test positive 9.96 9.60 8 141276 740 110447275
Blood cholesterol increased 9.94 9.60 171 141113 184614 110263401
Acute motor-sensory axonal neuropathy 9.93 9.60 7 141277 531 110447484
Abdominal wall oedema 9.93 9.60 3 141281 29 110447986
Tongue oedema 9.89 9.60 28 141256 8228 110439787
Polyarthritis 9.85 9.60 6 141278 18957 110429058
Pain in jaw 9.82 9.60 33 141251 51144 110396871
Pancreatitis 9.79 9.60 171 141113 93362 110354653
Gastrointestinal disorder 9.71 9.60 235 141049 241717 110206298
Limb injury 9.69 9.60 21 141263 37615 110410400
Distal intestinal obstruction syndrome 9.66 9.60 9 141275 1016 110446999
Staphylococcal sepsis 9.61 9.60 46 141238 17408 110430607
Faecal calprotectin decreased 9.61 9.60 4 141280 104 110447911

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Generalised tonic-clonic seizure 32.65 24.01 10 104 139 113700

Pharmacologic Action:

SourceCodeDescription
ATC A01AB17 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Antiinfectives and antiseptics for local oral treatment
ATC A02BD01 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD02 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD03 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD08 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD11 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD13 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC A02BD15 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC D06BX01 DERMATOLOGICALS
ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
CHEMOTHERAPEUTICS FOR TOPICAL USE
Other chemotherapeutics
ATC G01AF01 GENITO URINARY SYSTEM AND SEX HORMONES
GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
Imidazole derivatives
ATC J01RA03 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC J01RA04 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC J01RA10 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC J01RA14 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC J01XD01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
OTHER ANTIBACTERIALS
Imidazole derivatives
ATC P01AB01 ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS
ANTIPROTOZOALS
AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
Nitroimidazole derivatives
ATC P01AB51 ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS
ANTIPROTOZOALS
AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
Nitroimidazole derivatives
ATC P01AB52 ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS
ANTIPROTOZOALS
AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
Nitroimidazole derivatives
FDA CS M0014907 Nitroimidazoles
FDA EPC N0000175435 Nitroimidazole Antimicrobial
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000977 Antiparasitic Agents
MeSH PA D000981 Antiprotozoal Agents
CHEBI has role CHEBI:33231 antitubercular 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:35442 antiparasitic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:35718 antifungal agent
CHEBI has role CHEBI:36047 antibacterial drug
CHEBI has role CHEBI:49201 anti-ulcer drug
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:50685 antitrichomonal drug
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:78298 environmental contaminant
CHEBI has role CHEBI:86327 antifungal drug
CHEBI has role CHEBI:132992 radiosensitizing agent
CHEBI has role CHEBI:171664 antiamoebic agent

Related Drugs by ATC class:

A01AB Antiinfectives and antiseptics for local oral treatment 22 drugs
amphotericin Bbenzoxonium chloridecetylpyridiniumchlorhexidinechlortetracyclineclotrimazoledomiphendoxycyclinehexetidinehydrogen peroxidemepartricinmiconazole show all 22 →
A02BD Combinations for eradication of Helicobacter pylori 13 drugs
amoxicillinbismuth subcitrateclarithromycinesomeprazolelansoprazolelevofloxacinomeprazolepantoprazolerabeprazolerifabutintetracyclinetinidazole show all 13 →
D06BX Other chemotherapeutics 2 drugs
ingenol mebutatetirbanibulin
G01AF Imidazole derivatives 16 drugs
azanidazolebutoconazoleclotrimazoleeconazolefenticonazoleflutrimazoleisoconazoleketoconazolemiconazoleomoconazoleornidazoleoxiconazole show all 16 →
J01RA Combinations of antibacterials 18 drugs
amikacinazithromycincefepimecefiximecefuroximeciprofloxacinfluconazolelevofloxacinnitazoxanidenorfloxacinnystatinofloxacin show all 18 →
J01XD Imidazole derivatives 2 drugs
ornidazoletinidazole
P01AB Nitroimidazole derivatives 7 drugs
azanidazolefurazolidonenimorazoleornidazolepropenidazolesecnidazoletinidazole

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

DiseaseRelationSNOMED_IDDOID
Bacterial septicemia indication 10001005 DOID:0040085
Infection of skin AND/OR subcutaneous tissue indication 19824006
Abscess of liver indication 27916005
Acute amebiasis indication 39224005
Peritonitis indication 48661000
Lower respiratory tract infection indication 50417007
Infectious inflammation of intestine indication 55184003
Infection by Trichomonas indication 56335008 DOID:1947
Giardiasis indication 58265007 DOID:10718
Tubo-ovarian abscess indication 58949002
Abscess of lung indication 73452002 DOID:0060317
Abdominal abscess indication 75100008
Amebic liver abscess indication 75119003
Endometritis indication 78623009 DOID:1002
Septicemia due to Bacteroides indication 79587009
Infection of bone indication 111253001
Female genital tract infection indication 125585007
Infectious disease of abdomen indication 128070006
Bacteroides infection of central nervous system indication 128119004
Bacterial endocarditis indication 301183007
Infectious disorder of joint indication 363162000
Amebic dysentery indication 387754006
Rosacea indication 398909004 DOID:8881
Bacterial vaginosis indication 419760006 DOID:3385
Infection due to anaerobic bacteria indication 423451008
Abscess of brain indication 441806004
Peptostreptococcus infection indication 135341000119101
Intra-Abdominal Clostridium Abscess indication
Skin and Skin Structure Fusobacterium Infection indication
Peptostreptococcus Liver Abscess indication
Skin and Skin Structure Clostridium Infection indication
Clostridium Septicemia indication
Bacteroides Empyema indication
Skin and Skin Structure Peptococcus Infection indication
Bacteroides Endomyometritis indication
Peptostreptococcus Tubo-Ovarian Abscess indication
Intra-Abdominal Anaerobic Abscess indication
Bacteroides Endocarditis indication
Eubacterium Liver Abscess indication
Clostridium Liver Abscess indication
Peptostreptococcus Peritonitis indication
Bacteroides Liver Abscess indication
Bacteroides Peritonitis indication
Bacteroides Tubo-Ovarian Abscess indication
Vaginal Cuff Surgery Post-Op Clostridium Infection indication
Peptococcus Endomyometritis indication
Clostridium Peritonitis indication
B. Fragilis Infections indication
Bacteroides Pneumonia indication
Bacteroides Osteomyelitis indication
Post-Operative Vaginal Cuff Peptostreptococcus Infection indication
Bacteroides Endometritis indication
Intra-Abdominal Bacteroides Abscess indication
Bacteroides Brain Abscess indication
Peptococcus Endometritis indication
Intra-Abdominal Peptostreptococcus Abscess indication
Vaginal Cuff Surgery Post-Op Infection indication
Peptostreptococcus Endomyometritis indication
Clostridium Tubo-Ovarian Abscess indication
Peptococcus Liver Abscess indication
Peptococcus Tubo-Ovarian Abscess indication
Vaginal Cuff Surgery Post-Op Bacteroides Infection indication
Intra-Abdominal Eubacterium Abscess indication
Prevention of Perioperative Infection indication
Skin and Skin Structure Bacteroides Fragilis Infection indication
Peptococcus Peritonitis indication
Clostridium Endomyometritis indication
Meningitis due to Bacteroides indication
Eubacterium Peritonitis indication
Bacteroides Joint Infection indication
Peptostreptococcus Endometritis indication
Vaginal Cuff Surgery Post-Op Peptococcus Infection indication
Intra-Abdominal Peptococcus Abscess indication
Clostridium Endometritis indication
Duodenal Ulcer due to H. Pylori indication
Colorectal Perioperative Infection indication
Pyrexia of unknown origin off-label use 7520000
Crohn's disease off-label use 34000006
Balantidiasis off-label use 57725006 DOID:12386
Gas gangrene caused by clostridium perfringens off-label use 266093005
Diverticulitis of gastrointestinal tract off-label use 271366000
Infection by Dracunculus medinensis off-label use 396334002 DOID:14418
Pseudomembranous enterocolitis off-label use 397683000
Helicobacter pylori-associated gastritis off-label use 708164002
Diabetic Foot Infection off-label use
Sexual Transmitted Disease Exposure from Sexual Assault off-label use
Recurrent Persistent Urethritis off-label use
Periodontal Infections off-label use
Alcoholism contraindication 7200002
Propylene glycol contraindication 13668001
Lowered convulsive threshold contraindication 19260006
Cockayne syndrome contraindication 21086008 DOID:2962
Alcohol intoxication contraindication 25702006
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Diabetes mellitus contraindication 73211009 DOID:9351
Disorder of optic nerve contraindication 77157004 DOID:1891
Disorder of brain contraindication 81308009 DOID:936
Epilepsy contraindication 84757009 DOID:1826
Leukopenia contraindication 84828003 DOID:615
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Seizure disorder contraindication 128613002
Disease of blood AND/OR blood-forming organ contraindication 191124002 DOID:74
Non-infective meningitis contraindication 230155003
Disease of liver contraindication 235856003 DOID:409
Edema contraindication 267038008
Pregnancy, function contraindication 289908002
Peripheral nerve disease contraindication 302226006
Neutropenic disorder contraindication 303011007 DOID:1227
Skin irritation contraindication 367466007
Disulfiram contraindication 387212009
Breastfeeding (mother) contraindication 413712001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.4 acidic
pKa2 2.68 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1.3% NUVESSA ALEMBIC THERAP N205223 March 24, 2014 RX GEL VAGINAL 8658678 June 27, 2028 TREATMENT OF BACTERIAL VAGINOSIS
1.3% NUVESSA ALEMBIC THERAP N205223 March 24, 2014 RX GEL VAGINAL 8946276 June 28, 2032 TREATMENT OF BACTERIAL VAGINOSIS WITH METRONIDAZOLE GEL
1.3% NUVESSA ALEMBIC THERAP N205223 March 24, 2014 RX GEL VAGINAL 9198858 June 28, 2032 TREATMENT OF BACTERIAL VAGINOSIS WITH METRONIDAZOLE GEL
500MG/5ML LIKMEZ SAPTALIS PHARMS N216755 Sept. 22, 2023 RX SUSPENSION ORAL 12257236 Jan. 16, 2039 TREATMENT OF AMEBIASIS IN ADULTS AND PEDIATRIC PATIENTS
500MG/5ML LIKMEZ SAPTALIS PHARMS N216755 Sept. 22, 2023 RX SUSPENSION ORAL 12257236 Jan. 16, 2039 TREATMENT OF ANAEROBIC BACTERIAL INFECTIONS IN ADULTS
500MG/5ML LIKMEZ SAPTALIS PHARMS N216755 Sept. 22, 2023 RX SUSPENSION ORAL 12257236 Jan. 16, 2039 TREATMENT OF TRICHOMONIASIS IN ADULTS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Thioredoxin reductase Enzyme Ki 5.48 CHEMBL

External reference:

IDSource
4017836 VUID
N0000146194 NUI
D00409 KEGG_DRUG
4017836 VANDF
4017837 VANDF
C0025872 UMLSCUI
CHEBI:6909 CHEBI
2MN PDB_CHEM_ID
CHEMBL137 ChEMBL_ID
DB00916 DRUGBANK_ID
CHEMBL1200869 ChEMBL_ID
D008795 MESH_DESCRIPTOR_UI
4173 PUBCHEM_CID
1032 INN_ID
10914 IUPHAR_LIGAND_ID
69198-10-3 SECONDARY_CAS_RN
73334-05-1 SECONDARY_CAS_RN
13182-89-3 SECONDARY_CAS_RN
140QMO216E UNII
DB15759 DRUGBANK_ID
103866 RXNORM
14032 MMSL
47797 MMSL
4863 MMSL
5105 MMSL
5106 MMSL
7877 MMSL
d00108 MMSL
002958 NDDF
002959 NDDF
005129 NDDF
1222004 SNOMEDCT_US
372602008 SNOMEDCT_US
3941003 SNOMEDCT_US
395793001 SNOMEDCT_US
CHEMBL2106886 ChEMBL_ID
CHEMBL1466172 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Flagyl HUMAN PRESCRIPTION DRUG LABEL 1 0025-1942 CAPSULE 375 mg ORAL NDA 25 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0143-9772 INJECTION, SOLUTION 500 mg INTRAVENOUS ANDA 24 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0168-0323 CREAM 7.50 mg TOPICAL ANDA 18 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0168-0383 LOTION 7.50 mg TOPICAL ANDA 19 sections
Noritate HUMAN PRESCRIPTION DRUG LABEL 1 0187-5202 CREAM 10 mg TOPICAL NDA 20 sections
Vandazole HUMAN PRESCRIPTION DRUG LABEL 1 0245-0860 GEL 7.50 mg VAGINAL NDA 27 sections
METRONIDAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 0264-5535 SOLUTION 500 mg INTRAVENOUS NDA 26 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0338-1055 INJECTION, SOLUTION 500 mg INTRAVENOUS NDA 24 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0338-9541 INJECTION, SOLUTION 500 mg INTRAVENOUS NDA 23 sections
METRONIDAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9991 INJECTION, SOLUTION 500 mg INTRAVENOUS ANDA 14 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0409-0152 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 27 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0440-1795 TABLET 250 mg ORAL ANDA 13 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0440-1796 TABLET 500 mg ORAL ANDA 13 sections
Nuvessa HUMAN PRESCRIPTION DRUG LABEL 1 0642-7466 GEL 65 mg TOPICAL NDA 29 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0713-0574 GEL 10 mg TOPICAL ANDA 25 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0713-0575 GEL 7.50 mg VAGINAL ANDA 12 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0713-0633 CREAM 7.50 mg TOPICAL ANDA 11 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0713-0637 GEL 7.50 mg TOPICAL ANDA 9 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0904-7126 TABLET 500 mg ORAL ANDA 24 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0904-7156 TABLET 250 mg ORAL ANDA 24 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 10544-265 TABLET 500 mg ORAL ANDA 12 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 10544-270 TABLET 500 mg ORAL ANDA 23 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 10544-562 TABLET 250 mg ORAL ANDA 23 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 10544-938 TABLET 500 mg ORAL ANDA 23 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 12634-172 TABLET, FILM COATED 500 mg ORAL ANDA 21 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 15338-150 TABLET 500 mg ORAL NDA 24 sections
Metronidazole Human Prescription Drug Label 1 15955-388 TABLET 250 mg ORAL ANDA 23 sections
Metronidazole Human Prescription Drug Label 1 15955-389 TABLET 500 mg ORAL ANDA 23 sections
Metronidazole Human Prescription Drug Label 1 16571-664 TABLET 500 mg ORAL ANDA 23 sections
Metronidazole Human Prescription Drug Label 1 16571-665 TABLET 250 mg ORAL ANDA 23 sections