metronidazole ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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 ยตM/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

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
Clostridium difficile infection 563.10 10.13 375 69369 26823 56195500
Abortion spontaneous 374.56 10.13 359 69385 43394 56178929
Clostridium difficile colitis 372.51 10.13 252 69492 18486 56203837
Macular degeneration 342.19 10.13 240 69504 18668 56203655
Toxic encephalopathy 300.73 10.13 147 69597 5791 56216532
Abortion incomplete 295.95 10.13 120 69624 3007 56219316
Rheumatoid arthritis 252.81 10.13 80 69664 382524 55839799
Pseudomembranous colitis 190.64 10.13 86 69658 2817 56219506
Contraindicated product administered 183.67 10.13 12 69732 186274 56036049
Acute generalised exanthematous pustulosis 173.26 10.13 123 69621 9746 56212577
Neurotoxicity 171.13 10.13 148 69596 15647 56206676
International normalised ratio fluctuation 169.67 10.13 75 69669 2339 56219984
Drug hypersensitivity 166.24 10.13 728 69016 274477 55947846
Drug reaction with eosinophilia and systemic symptoms 163.98 10.13 195 69549 30109 56192214
Systemic lupus erythematosus 162.65 10.13 17 69727 180061 56042262
Abdominal pain 148.25 10.13 674 69070 258131 55964192
Arthropathy 142.96 10.13 36 69708 200239 56022084
Alopecia 137.61 10.13 98 69646 293360 55928963
Colitis 128.96 10.13 205 69539 41606 56180717
Glossodynia 128.79 10.13 18 69726 152440 56069883
Joint swelling 126.66 10.13 104 69640 289696 55932627
Synovitis 123.10 10.13 25 69719 161280 56061043
Septic shock 122.95 10.13 248 69496 60587 56161736
Therapeutic product effect decreased 121.81 10.13 30 69714 169422 56052901
Anaphylactic reaction 118.63 10.13 240 69504 58755 56163568
Crohn's disease 114.89 10.13 81 69663 6346 56215977
Bloody discharge 111.03 10.13 48 69696 1417 56220906
Diverticulitis 101.35 10.13 169 69575 35683 56186640
Encephalopathy 97.84 10.13 165 69579 35160 56187163
Hepatitis 97.44 10.13 165 69579 35276 56187047
Exposure during pregnancy 95.70 10.13 378 69366 135964 56086359
Haemorrhage 93.32 10.13 212 69532 56185 56166138
Wound 93.30 10.13 28 69716 138776 56083547
Multiple organ dysfunction syndrome 92.51 10.13 203 69541 52567 56169756
Cerebellar syndrome 92.11 10.13 56 69688 3411 56218912
Completed suicide 91.78 10.13 26 69718 133807 56088516
Pericarditis 91.64 10.13 13 69731 108910 56113413
Fall 90.90 10.13 192 69552 357318 55865005
Cholecystitis chronic 89.10 10.13 83 69661 9665 56212658
Fatigue 88.48 10.13 594 69150 787958 55434365
Lyme disease 84.34 10.13 50 69694 2908 56219415
Toxic epidermal necrolysis 79.14 10.13 116 69628 21926 56200397
Arthralgia 78.23 10.13 338 69406 501331 55720992
Ataxia 75.14 10.13 91 69653 14312 56208011
Rash maculo-papular 74.77 10.13 131 69613 28776 56193547
Sinusitis 73.30 10.13 82 69662 197499 56024824
Nasopharyngitis 73.27 10.13 100 69644 220859 56001464
Pouchitis 73.25 10.13 26 69718 446 56221877
Faecal volume decreased 71.99 10.13 20 69724 144 56222179
Clostridial infection 71.34 10.13 51 69693 4084 56218239
Pancreatitis haemorrhagic 70.48 10.13 25 69719 428 56221895
Product use issue 70.35 10.13 76 69668 185965 56036358
Haematochezia 68.64 10.13 161 69583 43557 56178766
Cholestasis 68.36 10.13 121 69623 26792 56195531
Enterocolitis haemorrhagic 65.93 10.13 33 69711 1368 56220955
Abdominal discomfort 65.43 10.13 155 69589 277119 55945204
Drug abuse 64.72 10.13 5 69739 67605 56154718
Dysbiosis 64.66 10.13 27 69717 730 56221593
Colitis ulcerative 63.68 10.13 111 69633 24280 56198043
Fistula 61.64 10.13 65 69679 8790 56213533
Swelling 60.67 10.13 129 69615 239642 55982681
Vaginal flatulence 60.15 10.13 25 69719 668 56221655
Female genital tract fistula 58.86 10.13 47 69697 4445 56217878
Weight increased 58.60 10.13 123 69621 229580 55992743
Death 56.89 10.13 224 69520 341202 55881121
Vomiting 55.70 10.13 896 68848 497332 55724991
Pyrexia 55.70 10.13 776 68968 417997 55804326
Lip swelling 54.12 10.13 108 69636 26164 56196159
Oral candidiasis 53.76 10.13 89 69655 18674 56203649
Vaginal discharge 53.50 10.13 51 69693 6112 56216211
Hepatic enzyme increased 53.40 10.13 81 69663 171303 56051020
Muscle injury 52.84 10.13 3 69741 52497 56169826
Fixed eruption 52.76 10.13 25 69719 918 56221405
Acinetobacter infection 52.36 10.13 29 69715 1481 56220842
Psoriatic arthropathy 51.43 10.13 14 69730 73994 56148329
Swelling face 49.90 10.13 168 69576 55901 56166422
Paraesthesia oral 48.94 10.13 74 69670 14375 56207948
Infusion related reaction 48.30 10.13 118 69626 208813 56013510
Emotional distress 48.24 10.13 111 69633 29652 56192671
Folliculitis 47.57 10.13 6 69738 54973 56167350
Systemic mastocytosis 46.36 10.13 15 69729 191 56222132
Pelvic inflammatory disease 46.12 10.13 27 69717 1534 56220789
Discomfort 45.13 10.13 66 69678 141695 56080628
Hepatic failure 44.80 10.13 116 69628 33370 56188953
Necrosis ischaemic 43.65 10.13 21 69723 798 56221525
Injury 43.61 10.13 168 69576 59683 56162640
Anal fistula 43.04 10.13 33 69711 2941 56219382
Chromaturia 41.65 10.13 71 69673 15254 56207069
Acute hepatic failure 41.41 10.13 74 69670 16504 56205819
Abdominal pain lower 40.64 10.13 89 69655 23003 56199320
Clostridium colitis 40.37 10.13 26 69718 1753 56220570
Pathogen resistance 39.92 10.13 43 69701 5957 56216366
Rosacea 39.49 10.13 36 69708 4077 56218246
Asthma 39.44 10.13 49 69695 112721 56109602
Cerebellar ataxia 39.13 10.13 20 69724 867 56221456
Paraesthesia 38.90 10.13 286 69458 130228 56092095
Beta haemolytic streptococcal infection 38.88 10.13 26 69718 1868 56220455
Sepsis 38.63 10.13 301 69443 139539 56082784
Proctitis 38.35 10.13 29 69715 2531 56219792
Megacolon 38.28 10.13 25 69719 1726 56220597
Vanishing bile duct syndrome 37.83 10.13 18 69726 667 56221656
Peripheral swelling 37.79 10.13 156 69588 234570 55987753
Dysgeusia 37.65 10.13 124 69620 40791 56181532
Helicobacter infection 37.63 10.13 22 69722 73246 56149077
Loss of personal independence in daily activities 36.98 10.13 28 69716 81341 56140982
Stomatitis 36.75 10.13 58 69686 120752 56101571
Angioedema 36.70 10.13 124 69620 41329 56180994
Alcohol intolerance 36.49 10.13 10 69734 68 56222255
Cough 36.34 10.13 182 69562 259779 55962544
Musculoskeletal stiffness 36.13 10.13 88 69656 155919 56066404
Type IV hypersensitivity reaction 36.00 10.13 28 69716 2548 56219775
Knee arthroplasty 35.58 10.13 6 69738 44253 56178070
Drug intolerance 35.55 10.13 188 69556 264630 55957693
Axonal neuropathy 34.93 10.13 19 69725 936 56221387
International normalised ratio increased 34.89 10.13 127 69617 43914 56178409
Dermatitis allergic 34.41 10.13 62 69682 13916 56208407
Treatment failure 34.28 10.13 103 69641 170289 56052034
Injection site pain 33.97 10.13 58 69686 117060 56105263
Biliary dyskinesia 33.97 10.13 27 69717 2536 56219787
Uterine perforation 33.76 10.13 41 69703 6464 56215859
Product dose omission issue 33.62 10.13 135 69609 204618 56017705
Rash macular 33.56 10.13 77 69667 20527 56201796
Anal abscess 33.19 10.13 33 69711 4164 56218159
Stenotrophomonas infection 33.12 10.13 23 69721 1758 56220565
Dysarthria 33.00 10.13 116 69628 39434 56182889
Drug interaction 32.95 10.13 401 69343 209354 56012969
Vaginal infection 32.42 10.13 41 69703 6736 56215587
Abscess 32.27 10.13 63 69681 15018 56207305
Adenoviral hepatitis 31.61 10.13 13 69731 338 56221985
Mobility decreased 31.58 10.13 46 69698 98945 56123378
Bursitis infective 31.55 10.13 20 69724 1312 56221011
Vulvovaginal swelling 31.42 10.13 14 69730 445 56221878
Leukocytosis 31.39 10.13 82 69662 23709 56198614
Pelvic pain 30.97 10.13 54 69690 11813 56210510
Thrombotic thrombocytopenic purpura 30.83 10.13 30 69714 3687 56218636
Colitis ischaemic 30.70 10.13 49 69695 9971 56212352
Biliary sepsis 30.54 10.13 17 69727 877 56221446
Disseminated intravascular coagulation 30.42 10.13 68 69676 17817 56204506
Rash papular 29.98 10.13 57 69687 13326 56208997
Diarrhoea haemorrhagic 29.84 10.13 43 69701 8000 56214323
Stevens-Johnson syndrome 29.79 10.13 78 69666 22585 56199738
Meningitis candida 29.64 10.13 8 69736 51 56222272
Pneumonia streptococcal 29.54 10.13 21 69723 1667 56220656
Hip arthroplasty 29.41 10.13 6 69738 38617 56183706
Enterovesical fistula 29.24 10.13 14 69730 526 56221797
Endometritis 28.87 10.13 17 69727 976 56221347
Vitamin K deficiency 28.78 10.13 13 69731 427 56221896
Influenza 28.72 10.13 46 69698 95215 56127108
Diarrhoea 28.67 10.13 1012 68732 637495 55584828
Low birth weight baby 28.58 10.13 37 69707 6221 56216102
Chronic sinusitis 28.50 10.13 43 69701 8335 56213988
Gallbladder disorder 28.47 10.13 65 69679 17269 56205054
Coagulopathy 28.36 10.13 68 69676 18648 56203675
Diarrhoea infectious 28.00 10.13 17 69727 1033 56221290
Abdominal abscess 27.99 10.13 30 69714 4132 56218191
Dysmetria 27.80 10.13 13 69731 463 56221860
Rectal tube insertion 27.59 10.13 6 69738 12 56222311
Enterococcal infection 27.53 10.13 39 69705 7145 56215178
Stillbirth 27.23 10.13 36 69708 6178 56216145
Swollen tongue 27.09 10.13 91 69653 30233 56192090
Rectal abscess 27.07 10.13 17 69727 1097 56221226
Ureteric obstruction 27.00 10.13 20 69724 1692 56220631
Bacterial vaginosis 26.82 10.13 17 69727 1115 56221208
Pain 26.79 10.13 622 69122 662562 55559761
Shock 26.76 10.13 73 69671 21655 56200668
Injection site erythema 26.71 10.13 34 69710 77414 56144909
Arthritis 26.68 10.13 52 69692 99800 56122523
Purple glove syndrome 26.61 10.13 10 69734 203 56222120
Adverse event 26.54 10.13 18 69726 55358 56166965
Hyperleukocytosis 26.54 10.13 13 69731 514 56221809
Staphylococcal infection 26.11 10.13 104 69640 37514 56184809
Electrocardiogram QT prolonged 25.98 10.13 135 69609 54453 56167870
Magnetic resonance imaging head abnormal 25.85 10.13 20 69724 1806 56220517
Metabolic acidosis 25.83 10.13 109 69635 40345 56181978
Acute psychosis 25.72 10.13 22 69722 2290 56220033
Abscess intestinal 25.45 10.13 18 69726 1417 56220906
Gingival swelling 25.41 10.13 28 69716 3978 56218345
Posterior reversible encephalopathy syndrome 25.28 10.13 59 69685 15901 56206422
Cholecystitis acute 25.14 10.13 38 69706 7378 56214945
Premature baby 25.14 10.13 66 69678 19139 56203184
Oedematous pancreatitis 24.82 10.13 12 69732 461 56221862
Abdominal sepsis 24.77 10.13 17 69727 1275 56221048
Osmotic demyelination syndrome 24.76 10.13 13 69731 596 56221727
Anal fissure 24.69 10.13 27 69717 3804 56218519
Toxic shock syndrome 24.43 10.13 13 69731 613 56221710
Leukaemoid reaction 24.36 10.13 9 69735 174 56222149
Clostridium test positive 24.19 10.13 22 69722 2483 56219840
Frequent bowel movements 24.17 10.13 59 69685 16365 56205958
Toxic shock syndrome streptococcal 24.17 10.13 8 69736 110 56222213
Lemierre syndrome 24.03 10.13 8 69736 112 56222211
Generalised tonic-clonic seizure 23.99 10.13 82 69662 27484 56194839
Morganella infection 23.93 10.13 13 69731 639 56221684
Candida infection 23.80 10.13 78 69666 25589 56196734
Fistula discharge 23.77 10.13 15 69729 976 56221347
Procedural hypertension 23.76 10.13 10 69734 276 56222047
Intestinal perforation 23.72 10.13 46 69698 10913 56211410
Intrauterine infection 23.71 10.13 8 69736 117 56222206
Off label use 23.47 10.13 518 69226 555662 55666661
Procedural pain 23.46 10.13 58 69686 16213 56206110
Impaired healing 23.40 10.13 45 69699 86796 56135527
Eosinophilia 23.29 10.13 66 69678 20011 56202312
Leukoencephalopathy 23.29 10.13 27 69717 4055 56218268
Hepatocellular injury 23.19 10.13 79 69665 26435 56195888
Fibromyalgia 22.89 10.13 24 69720 59579 56162744
Anxiety 22.83 10.13 351 69393 192821 56029502
Foetal non-stress test abnormal 22.83 10.13 6 69738 34 56222289
Type 2 diabetes mellitus 22.77 10.13 15 69729 46847 56175476
Feeling guilty 22.76 10.13 12 69732 555 56221768
Proctalgia 22.74 10.13 31 69713 5478 56216845
Klebsiella infection 22.50 10.13 37 69707 7719 56214604
Rectal haemorrhage 22.17 10.13 106 69638 41361 56180962
Large intestine perforation 22.16 10.13 37 69707 7814 56214509
Mucous stools 22.07 10.13 24 69720 3360 56218963
Urticaria 22.01 10.13 275 69469 144401 56077922
Hepatitis infectious mononucleosis 21.94 10.13 7 69737 85 56222238
Dermatitis bullous 21.80 10.13 36 69708 7537 56214786
Bronchitis 21.79 10.13 69 69675 112242 56110081
Malignant neoplasm progression 21.74 10.13 36 69708 73551 56148772
Infected fistula 21.73 10.13 8 69736 153 56222170
Ill-defined disorder 21.71 10.13 32 69712 68511 56153812
Haemostasis 21.63 10.13 9 69735 241 56222082
Intentional overdose 21.38 10.13 32 69712 68085 56154238
Bone erosion 21.20 10.13 53 69691 14921 56207402
Cholelithiasis 21.19 10.13 101 69643 39363 56182960
Incubator therapy 21.16 10.13 6 69738 47 56222276
Drug ineffective for unapproved indication 21.12 10.13 75 69669 25618 56196705
Retroperitoneal haematoma 20.71 10.13 21 69723 2712 56219611
Radiculopathy 20.60 10.13 30 69714 5635 56216688
Hepatic necrosis 20.58 10.13 29 69715 5287 56217036
Nausea 20.50 10.13 1149 68595 763029 55459294
Henoch-Schonlein purpura 20.48 10.13 14 69730 1043 56221280
Pancreatitis acute 20.36 10.13 73 69671 25051 56197272
Hypoglossal nerve paresis 20.17 10.13 7 69737 112 56222211
Blood cholesterol increased 20.09 10.13 37 69707 72542 56149781
Distributive shock 20.08 10.13 14 69730 1077 56221246
Bacterial vulvovaginitis 20.07 10.13 12 69732 709 56221614
Anterior interosseous syndrome 20.01 10.13 4 69740 4 56222319
Injection site pruritus 19.60 10.13 14 69730 41917 56180406
Hidradenitis 19.59 10.13 20 69724 2604 56219719
Vaginitis gardnerella 19.38 10.13 5 69739 26 56222297
Heparin-induced thrombocytopenia 19.38 10.13 25 69719 4189 56218134
Lower respiratory tract infection 19.26 10.13 75 69669 114719 56107604
Upper respiratory tract infection 19.15 10.13 37 69707 71251 56151072
Neuropathy peripheral 18.97 10.13 203 69541 102690 56119633
Foetal monitoring abnormal 18.96 10.13 8 69736 222 56222101
Postural orthostatic tachycardia syndrome 18.95 10.13 13 69731 974 56221349
Burning sensation 18.89 10.13 114 69630 48582 56173741
Thrombocytopenia 18.65 10.13 254 69490 135970 56086353
Hallucinations, mixed 18.42 10.13 25 69719 4399 56217924
Accidental exposure to product 18.41 10.13 4 69740 24643 56197680
Endocrine ophthalmopathy 18.29 10.13 10 69734 498 56221825
Cholecystitis 18.28 10.13 49 69695 14386 56207937
Adverse drug reaction 18.21 10.13 33 69711 65099 56157224
Vulval ulceration 18.14 10.13 8 69736 248 56222075
Nervous system disorder 18.13 10.13 54 69690 16835 56205488
Depersonalisation/derealisation disorder 18.09 10.13 14 69730 1265 56221058
Gastrointestinal injury 18.05 10.13 10 69734 511 56221812
Foetal arrhythmia 18.02 10.13 7 69737 156 56222167
Red cell fragmentation syndrome 18.00 10.13 5 69739 36 56222287
Puerperal pyrexia 17.88 10.13 5 69739 37 56222286
Injection site reaction 17.72 10.13 24 69720 53223 56169100
Candida sepsis 17.68 10.13 14 69730 1308 56221015
Drug-induced liver injury 17.64 10.13 87 69657 34375 56187948
Wrong technique in product usage process 17.61 10.13 28 69716 58140 56164183
Erythema 17.53 10.13 281 69463 155658 56066665
Electrocardiogram T wave alternans 17.43 10.13 5 69739 41 56222282
Vulval disorder 17.39 10.13 11 69733 719 56221604
Intentional product misuse 17.35 10.13 23 69721 51481 56170842
Therapeutic response decreased 17.33 10.13 24 69720 52734 56169589
Device expulsion 17.33 10.13 8 69736 30441 56191882
Medical device site pain 17.20 10.13 7 69737 177 56222146
Nystagmus 17.18 10.13 28 69716 5797 56216526
Venous haemorrhage 17.13 10.13 8 69736 284 56222039
White blood cells stool 17.08 10.13 3 69741 0 56222323
Airway peak pressure increased 17.05 10.13 8 69736 287 56222036
Superinfection 16.92 10.13 17 69727 2171 56220152
Fear of death 16.91 10.13 12 69732 950 56221373
White blood cell count decreased 16.57 10.13 90 69654 125900 56096423
Nodular rash 16.47 10.13 7 69737 198 56222125
Sopor 16.46 10.13 3 69741 20919 56201404
Tachycardia 16.42 10.13 202 69542 105674 56116649
Enterocutaneous fistula 16.35 10.13 13 69731 1222 56221101
Foetal exposure during pregnancy 16.33 10.13 84 69660 33739 56188584
Respiratory disorder 16.32 10.13 11 69733 33946 56188377
Jaundice 16.24 10.13 72 69672 27222 56195101
Tongue coated 16.24 10.13 13 69731 1234 56221089
Injection site swelling 16.23 10.13 18 69726 43560 56178763
Vulvovaginitis trichomonal 16.17 10.13 4 69740 17 56222306
Infusion site streaking 16.15 10.13 9 69735 465 56221858
Orbital oedema 16.15 10.13 7 69737 208 56222115
Retroperitoneal haemorrhage 15.91 10.13 18 69726 2632 56219691
Anaphylactic shock 15.81 10.13 61 69683 21679 56200644
Skin odour abnormal 15.69 10.13 14 69730 1541 56220782
Trichoglossia 15.69 10.13 7 69737 223 56222100
Abnormal faeces 15.55 10.13 24 69720 4744 56217579
Pain in extremity 15.55 10.13 267 69477 297164 55925159
Irritable bowel syndrome 15.53 10.13 39 69705 68419 56153904
Torsade de pointes 15.52 10.13 42 69702 12398 56209925
Systemic candida 15.51 10.13 19 69725 3022 56219301
Venoocclusive liver disease 15.48 10.13 23 69721 4398 56217925
Toxic leukoencephalopathy 15.44 10.13 10 69734 681 56221642
Myocardial infarction 15.37 10.13 61 69683 92809 56129514
Perirectal abscess 15.35 10.13 11 69733 884 56221439
Psychotic disorder due to a general medical condition 15.33 10.13 7 69737 236 56222087
Reticulocytosis 15.27 10.13 6 69738 138 56222185
Cataract 15.20 10.13 25 69719 51222 56171101
Type I hypersensitivity 15.17 10.13 17 69727 2461 56219862
Oedematous kidney 15.15 10.13 5 69739 68 56222255
Hepatic amoebiasis 15.03 10.13 4 69740 24 56222299
Toxic skin eruption 15.02 10.13 40 69704 11699 56210624
Gynaecological examination abnormal 15.01 10.13 3 69741 3 56222320
Amoebiasis 14.96 10.13 5 69739 71 56222252
Dyspnoea 14.90 10.13 592 69152 591985 55630338
Calcification of muscle 14.89 10.13 4 69740 25 56222298
Peripheral sensory neuropathy 14.81 10.13 29 69715 6927 56215396
Blister 14.75 10.13 77 69667 108810 56113513
Skin ulcer 14.73 10.13 90 69654 38518 56183805
Large intestinal ulcer 14.71 10.13 19 69725 3187 56219136
Infective aneurysm 14.65 10.13 8 69736 397 56221926
Foetal anaemia 14.64 10.13 5 69739 76 56222247
COVID-19 14.63 10.13 46 69698 75012 56147311
Large intestine infection 14.63 10.13 14 69730 1686 56220637
Scar 14.55 10.13 41 69703 12392 56209931
Strongyloidiasis 14.45 10.13 12 69732 1199 56221124
Musculoskeletal pain 14.28 10.13 52 69692 81100 56141223
Intestinal dilatation 14.27 10.13 13 69731 1470 56220853
Prothrombin time ratio decreased 14.22 10.13 8 69736 421 56221902
Prescribed underdose 14.13 10.13 4 69740 20613 56201710
Chemical burns of eye 14.13 10.13 5 69739 85 56222238
Tongue dry 14.05 10.13 11 69733 1011 56221312
Blood glucose increased 13.99 10.13 47 69697 75104 56147219
Peritonitis 13.93 10.13 48 69696 16154 56206169
Pneumonia 13.92 10.13 391 69353 406707 55815616
Ballismus 13.92 10.13 5 69739 89 56222234
Linear IgA disease 13.77 10.13 12 69732 1281 56221042
Erythema multiforme 13.72 10.13 34 69710 9520 56212803
Gastrointestinal stoma complication 13.61 10.13 13 69731 1562 56220761
Pseudomonas infection 13.58 10.13 35 69709 10036 56212287
Delayed delivery 13.52 10.13 4 69740 37 56222286
Hypertension 13.51 10.13 217 69527 244061 55978262
Amoebic brain abscess 13.48 10.13 3 69741 7 56222316
Hypoalbuminaemia 13.44 10.13 36 69708 10563 56211760
Mental status changes 13.42 10.13 86 69658 37415 56184908
Anal skin tags 13.42 10.13 8 69736 470 56221853
Breast cancer 13.42 10.13 25 69719 48808 56173515
Skin test positive 13.23 10.13 9 69735 665 56221658
Multiple sclerosis relapse 13.23 10.13 22 69722 44881 56177442
Pruritus 13.19 10.13 498 69246 316125 55906198
Pustule 13.18 10.13 12 69732 1357 56220966
Developmental delay 13.15 10.13 12 69732 1360 56220963
Geotrichum infection 13.07 10.13 8 69736 493 56221830
Neonatal respiratory distress 13.00 10.13 7 69737 338 56221985
Optic neuropathy 12.96 10.13 14 69730 1946 56220377
Merycism 12.93 10.13 6 69738 210 56222113
Pharyngeal oedema 12.88 10.13 41 69703 13244 56209079
Balance disorder 12.83 10.13 50 69694 76470 56145853
Femur fracture 12.78 10.13 18 69726 39277 56183046
Haemophagocytic lymphohistiocytosis 12.63 10.13 33 69711 9539 56212784
Musculoskeletal disorder 12.61 10.13 4 69740 19143 56203180
Hospitalisation 12.58 10.13 49 69695 74951 56147372
Wound haemorrhage 12.53 10.13 15 69729 2330 56219993
Retained products of conception 12.53 10.13 5 69739 120 56222203
Liver disorder 12.51 10.13 96 69648 44274 56178049
Congenital cardiovascular anomaly 12.49 10.13 5 69739 121 56222202
Consciousness fluctuating 12.47 10.13 9 69735 731 56221592
Cholecystectomy 12.39 10.13 33 69711 9651 56212672
Lymphomatoid papulosis 12.38 10.13 5 69739 124 56222199
Hyporeflexia 12.32 10.13 13 69731 1758 56220565
Epidermal necrosis 12.30 10.13 10 69734 970 56221353
Toxicity to various agents 12.25 10.13 200 69544 224364 55997959
Hyperbilirubinaemia 12.22 10.13 34 69710 10201 56212122
Neutropenic colitis 12.19 10.13 16 69728 2727 56219596
Laryngeal inflammation 12.09 10.13 5 69739 132 56222191
Enterocolitis 12.07 10.13 27 69717 7077 56215246
Cyanosis 12.02 10.13 45 69699 15765 56206558
Erythema nodosum 11.91 10.13 20 69724 4245 56218078
Vaginal abscess 11.90 10.13 7 69737 401 56221922
Leuconostoc infection 11.90 10.13 3 69741 14 56222309
Oxygen saturation decreased 11.81 10.13 54 69690 79013 56143310
Fear 11.81 10.13 43 69701 14865 56207458
Helicobacter gastritis 11.78 10.13 12 69732 1558 56220765
Tendonitis 11.74 10.13 49 69695 18048 56204275
Hyperintensity in brain deep nuclei 11.73 10.13 3 69741 15 56222308
Abscess fungal 11.58 10.13 4 69740 63 56222260
Fusarium infection 11.53 10.13 8 69736 611 56221712
Diverticulum 11.52 10.13 35 69709 11031 56211292
Stenosis 11.50 10.13 11 69733 1323 56221000
Bacteraemia 11.48 10.13 44 69700 15587 56206736
Staphylococcal sepsis 11.46 10.13 27 69717 7322 56215001
Agranulocytosis 11.45 10.13 57 69687 22602 56199721
Pelvic fluid collection 11.45 10.13 9 69735 832 56221491
Vulval haemorrhage 11.41 10.13 3 69741 17 56222306
Ileostomy closure 11.37 10.13 5 69739 154 56222169
Pharyngeal inflammation 11.34 10.13 8 69736 627 56221696
Drug resistance 11.33 10.13 53 69691 20489 56201834
Tongue discolouration 11.33 10.13 16 69728 2923 56219400
Periorbital oedema 11.30 10.13 22 69722 5232 56217091
Pulmonary embolism 11.27 10.13 191 69553 106933 56115390
Mouth swelling 11.16 10.13 19 69725 4078 56218245
Deep vein thrombosis 11.14 10.13 145 69599 76832 56145491
Interstitial lung disease 11.10 10.13 35 69709 57028 56165295
Rhinorrhoea 11.08 10.13 35 69709 57002 56165321
Vitamin B1 deficiency 11.06 10.13 6 69738 294 56222029
Rash morbilliform 11.05 10.13 16 69728 2991 56219332
Wound secretion 11.03 10.13 19 69725 4115 56218208
Dyspnoea exertional 11.03 10.13 33 69711 54656 56167667
Serum sickness-like reaction 10.96 10.13 7 69737 465 56221858
Hypovolaemic shock 10.96 10.13 22 69722 5351 56216972
Blood osmolarity decreased 10.95 10.13 9 69735 887 56221436
Phantom limb syndrome 10.94 10.13 5 69739 169 56222154
Refusal of treatment by relative 10.86 10.13 6 69738 305 56222018
Cytotoxic oedema 10.83 10.13 5 69739 173 56222150
Joint stiffness 10.77 10.13 17 69727 35408 56186915
Wheezing 10.76 10.13 52 69692 74974 56147349
Bartter's syndrome 10.75 10.13 3 69741 22 56222301
Memory impairment 10.74 10.13 63 69681 86494 56135829
Uterine hypertonus 10.70 10.13 6 69738 314 56222009
Vulvovaginal pain 10.66 10.13 14 69730 2388 56219935
Polyneuropathy 10.64 10.13 38 69706 13012 56209311
Fluid retention 10.64 10.13 33 69711 54045 56168278
Procedural anxiety 10.60 10.13 8 69736 696 56221627
Laboratory test abnormal 10.59 10.13 9 69735 24686 56197637
Intervertebral disc protrusion 10.46 10.13 7 69737 21687 56200636
Chills 10.46 10.13 182 69562 102422 56119901
Nodule 10.43 10.13 5 69739 18614 56203709
Haemolytic anaemia 10.43 10.13 31 69713 9654 56212669
Organ failure 10.43 10.13 14 69730 2439 56219884
Amniotic cavity infection 10.42 10.13 10 69734 1208 56221115
Acute on chronic liver failure 10.42 10.13 5 69739 189 56222134
Blood culture positive 10.34 10.13 19 69725 4327 56217996
Agonal rhythm 10.31 10.13 3 69741 26 56222297
Documented hypersensitivity to administered product 10.30 10.13 7 69737 517 56221806
Eyelid disorder 10.29 10.13 11 69733 1510 56220813
Plasma cell myeloma 10.25 10.13 27 69717 46619 56175704
Vulvovaginal discomfort 10.25 10.13 13 69731 2142 56220181
Corneal perforation 10.22 10.13 7 69737 523 56221800
Tumour necrosis 10.22 10.13 8 69736 735 56221588
Tongue oedema 10.20 10.13 18 69726 3974 56218349

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 491.70 10.97 206 47040 4644 31645454
Neurotoxicity 230.26 10.97 192 47054 16034 31634064
Clostridium difficile colitis 213.42 10.97 173 47073 13883 31636215
Clostridium difficile infection 205.79 10.97 185 47061 17094 31633004
Appendicitis 197.47 10.97 152 47094 11313 31638785
Appendicolith 190.05 10.97 114 47132 5617 31644481
Multiple organ dysfunction syndrome 163.15 10.97 332 46914 67871 31582227
Pseudomembranous colitis 160.41 10.97 79 47167 2616 31647482
Drug reaction with eosinophilia and systemic symptoms 149 10.97 203 47043 29815 31620283
Ataxia 136.22 10.97 129 47117 12734 31637364
Colitis 130.14 10.97 203 47043 33684 31616414
Cerebellar syndrome 130.01 10.97 64 47182 2117 31647981
Death 128.43 10.97 213 47033 360356 31289742
Pathogen resistance 125.57 10.97 104 47142 8597 31641501
Abdominal pain 121.34 10.97 484 46762 145468 31504630
Megacolon 115.55 10.97 54 47192 1588 31648510
Drug abuse 113.03 10.97 4 47242 87754 31562344
Abdominal distension 112.09 10.97 239 47007 50445 31599653
Encephalopathy 110.31 10.97 184 47062 32290 31617808
Ascites 104.40 10.97 205 47041 40808 31609290
Septic shock 103.93 10.97 273 46973 65885 31584213
Fistula 96.64 10.97 75 47171 5646 31644452
Crohn's disease 92.17 10.97 64 47182 4057 31646041
Abdominal abscess 89.43 10.97 62 47184 3920 31646178
Clostridial infection 85.82 10.97 57 47189 3358 31646740
Sepsis 85.31 10.97 449 46797 151480 31498618
Acute generalised exanthematous pustulosis 84.67 10.97 71 47175 5969 31644129
Cardiogenic shock 81.53 10.97 131 47115 22277 31627821
Completed suicide 80.10 10.97 19 47227 91495 31558603
Night sweats 78.95 10.97 107 47139 15625 31634473
Cerebellar ataxia 76.84 10.97 35 47211 969 31649129
Pyrexia 73.67 10.97 733 46513 303107 31346991
Dysarthria 73.09 10.97 153 47093 31864 31618234
Fixed eruption 70.19 10.97 37 47209 1416 31648682
Product dose omission issue 69.92 10.97 35 47211 105551 31544547
Stress 65.06 10.97 126 47120 24815 31625283
Ventricular fibrillation 64.25 10.97 107 47139 18741 31631357
Fall 64.09 10.97 112 47134 185977 31464121
Clostridium test positive 62.22 10.97 41 47205 2383 31647715
Herpes simplex oesophagitis 60.81 10.97 19 47227 175 31649923
Rheumatoid arthritis 58.81 10.97 3 47243 47806 31602292
Kounis syndrome 57.79 10.97 37 47209 2047 31648051
Brain abscess 55.89 10.97 41 47205 2834 31647264
Enterococcal infection 55.84 10.97 67 47179 8664 31641434
Anal abscess 55.44 10.97 55 47191 5745 31644353
Eosinophilia 54.09 10.97 112 47134 23141 31626957
Rash maculo-papular 53.07 10.97 118 47128 25601 31624497
Cholestasis 51.69 10.97 115 47131 24960 31625138
Cardiac failure congestive 45.89 10.97 31 47215 79356 31570742
Hyphaema 45.06 10.97 20 47226 520 31649578
Dyspnoea 44.39 10.97 315 46931 343164 31306934
Foetal cardiac arrest 43.82 10.97 10 47236 21 31650077
Hepatic cytolysis 43.14 10.97 66 47180 10757 31639341
Linear IgA disease 41.50 10.97 27 47219 1535 31648563
Drug resistance 41.16 10.97 101 47145 23352 31626746
Interstitial lung disease 41.16 10.97 20 47226 61383 31588715
Cardiac failure 40.48 10.97 41 47205 85912 31564186
Anaphylactic reaction 40.42 10.97 116 47130 29437 31620661
Abscess intestinal 39.61 10.97 26 47220 1501 31648597
Nervous system disorder 39.58 10.97 71 47175 13192 31636906
Klebsiella infection 39.03 10.97 53 47193 7750 31642348
Toxic epidermal necrolysis 38.52 10.97 88 47158 19436 31630662
Rash morbilliform 38.06 10.97 32 47214 2699 31647399
Cytotoxic oedema 38.00 10.97 13 47233 163 31649935
Cough 37.99 10.97 91 47155 134723 31515375
Intentional overdose 37.38 10.97 8 47238 41381 31608717
Plasma cell myeloma 37.01 10.97 19 47227 56512 31593586
Prostate cancer 36.67 10.97 6 47240 37595 31612503
Anal fistula 36.13 10.97 40 47206 4743 31645355
Paraesthesia 35.80 10.97 172 47074 55899 31594199
Pouchitis 35.59 10.97 18 47228 631 31649467
Clostridium colitis 35.31 10.97 22 47224 1160 31648938
Stoma site discomfort 34.99 10.97 8 47238 17 31650081
Enterococcus test positive 34.89 10.97 19 47227 777 31649321
Nystagmus 34.83 10.97 38 47208 4432 31645666
Meningitis candida 34.29 10.97 10 47236 71 31650027
Diverticular perforation 33.95 10.97 32 47214 3137 31646961
Malignant mesenteric neoplasm 33.87 10.97 9 47237 43 31650055
Undersensing 33.73 10.97 7 47239 7 31650091
Enterocutaneous fistula 33.51 10.97 19 47227 841 31649257
Cerebrovascular accident 32.98 10.97 42 47204 79442 31570656
Fistula discharge 32.84 10.97 16 47230 517 31649581
Vomiting 31.75 10.97 489 46757 223484 31426614
Hospitalisation 30.77 10.97 18 47228 49789 31600309
Sensitisation 30.48 10.97 11 47235 163 31649935
Jejunal ulcer perforation 30.26 10.97 9 47237 69 31650029
Perirectal abscess 30.23 10.97 22 47224 1502 31648596
Gut fermentation syndrome 30.00 10.97 6 47240 4 31650094
Escherichia infection 29.76 10.97 45 47201 7259 31642839
Blood phosphorus increased 29.65 10.97 35 47211 4447 31645651
Lack of spontaneous speech 29.48 10.97 8 47238 42 31650056
Intestinal stenosis 29.44 10.97 24 47222 1939 31648159
Liver abscess 29.10 10.97 31 47215 3520 31646578
Magnetic resonance imaging head abnormal 28.72 10.97 20 47226 1273 31648825
Candida infection 28.51 10.97 70 47176 16188 31633910
Chronic obstructive pulmonary disease 28.36 10.97 16 47230 45150 31604948
Aphthous ulcer 28.06 10.97 34 47212 4440 31645658
Pneumonia 27.93 10.97 343 46903 334969 31315129
Haematotoxicity 27.71 10.97 43 47203 7094 31643004
Chronic gastrointestinal bleeding 27.70 10.97 12 47234 294 31649804
Acute hepatic failure 27.65 10.97 60 47186 12799 31637299
Enterocolitis haemorrhagic 27.62 10.97 17 47229 877 31649221
Condition aggravated 27.56 10.97 369 46877 163640 31486458
Diverticulitis 27.27 10.97 75 47171 18570 31631528
Fungal peritonitis 27.25 10.97 16 47230 757 31649341
Infusion site induration 26.87 10.97 11 47235 233 31649865
Hepatitis acute 26.86 10.97 41 47205 6668 31643430
Suicide attempt 26.73 10.97 11 47235 37237 31612861
Ileal perforation 25.75 10.97 15 47231 699 31649399
Hypertension 25.70 10.97 101 47145 127999 31522099
Haemodynamic instability 25.70 10.97 46 47200 8529 31641569
Long QT syndrome 25.64 10.97 24 47222 2332 31647766
Antineutrophil cytoplasmic antibody 25.57 10.97 6 47240 15 31650083
Dysdiadochokinesis 25.48 10.97 10 47236 189 31649909
Swollen tongue 25.40 10.97 58 47188 12804 31637294
Metastases to stomach 25.38 10.97 8 47238 76 31650022
Urethral valves 25.30 10.97 11 47235 272 31649826
Dysmetria 25.21 10.97 13 47233 475 31649623
Abscess 24.96 10.97 51 47195 10436 31639662
Fatigue 24.94 10.97 351 46895 334855 31315243
Leukocytosis 24.81 10.97 81 47165 22033 31628065
Colitis ulcerative 24.63 10.97 72 47174 18457 31631641
Rash erythematous 24.60 10.97 82 47164 22545 31627553
Gastrointestinal inflammation 24.41 10.97 27 47219 3198 31646900
Metabolic acidosis 24.24 10.97 120 47126 39457 31610641
Tongue discolouration 24.17 10.97 17 47229 1100 31648998
Dyspnoea exertional 24.04 10.97 14 47232 38823 31611275
Clostridium bacteraemia 23.86 10.97 8 47238 94 31650004
Cross sensitivity reaction 23.78 10.97 18 47228 1305 31648793
Influenza 23.41 10.97 19 47227 44306 31605792
Botulism 23.39 10.97 9 47237 161 31649937
Blood bilirubin increased 23.30 10.97 109 47137 35027 31615071
Malignant neoplasm progression 23.30 10.97 52 47194 78946 31571152
Myocardial infarction 23.05 10.97 89 47157 113365 31536733
Colitis ischaemic 22.85 10.97 36 47210 6016 31644082
Cerebral cyst 22.60 10.97 10 47236 258 31649840
Omental necrosis 22.36 10.97 6 47240 30 31650068
Psoriasis 22.31 10.97 22 47224 46697 31603401
Injection site pain 22.13 10.97 12 47234 34622 31615476
Eastern Cooperative Oncology Group performance status 21.88 10.97 6 47240 33 31650065
Tissue infiltration 21.71 10.97 7 47239 72 31650026
Functional gastrointestinal disorder 21.70 10.97 21 47225 2127 31647971
Intentional product misuse 21.68 10.97 15 47231 37936 31612162
Muscle abscess 21.59 10.97 12 47234 511 31649587
Back pain 21.48 10.97 87 47159 109326 31540772
Peripheral swelling 21.41 10.97 43 47203 67822 31582276
Stoma site erythema 21.29 10.97 13 47233 661 31649437
Oedema peripheral 21.15 10.97 88 47158 109751 31540347
Drug dependence 21.15 10.97 4 47242 22575 31627523
Transient ischaemic attack 21.02 10.97 5 47241 24051 31626047
Idiosyncratic drug reaction 20.91 10.97 11 47235 419 31649679
Hepatocellular injury 20.75 10.97 75 47171 21469 31628629
Cataract 20.70 10.97 5 47241 23802 31626296
Asthma 20.42 10.97 20 47226 42591 31607507
Large intestine perforation 20.42 10.97 39 47207 7597 31642501
Liver transplant failure 20.16 10.97 7 47239 92 31650006
Jaundice 20.11 10.97 94 47152 30193 31619905
Nasopharyngitis 20.01 10.97 40 47206 63205 31586893
Enteritis 19.91 10.97 37 47209 7062 31643036
Peritonitis 19.84 10.97 59 47187 15268 31634830
COVID-19 19.74 10.97 32 47214 54789 31595309
Hepatitis cholestatic 19.73 10.97 37 47209 7109 31642989
Intestinal fistula 19.52 10.97 14 47232 934 31649164
Stoma site discharge 19.40 10.97 14 47232 943 31649155
Ureteral disorder 19.39 10.97 8 47238 173 31649925
Blood pressure increased 19.20 10.97 58 47188 79575 31570523
Blood glucose increased 19.01 10.97 39 47207 61044 31589054
Stenotrophomonas test positive 18.97 10.97 9 47237 274 31649824
Mononucleosis syndrome 18.76 10.97 6 47240 60 31650038
Inflammatory bowel disease 18.75 10.97 21 47225 2522 31647576
Epistaxis 18.73 10.97 32 47214 53675 31596423
Deafness bilateral 18.45 10.97 14 47232 1019 31649079
Dermatitis exfoliative 18.41 10.97 34 47212 6458 31643640
Urinary retention 18.39 10.97 14 47232 33711 31616387
Torsade de pointes 18.34 10.97 35 47211 6815 31643283
Wound dehiscence 18.32 10.97 23 47223 3115 31646983
Rosacea 18.04 10.97 14 47232 1053 31649045
Vitamin B1 deficiency 18.02 10.97 9 47237 307 31649791
Vitamin A deficiency 18.01 10.97 5 47241 29 31650069
Amoebiasis 17.86 10.97 6 47240 71 31650027
Bradycardia 17.80 10.97 49 47197 69278 31580820
Coronary artery disease 17.45 10.97 26 47220 46061 31604037
Coagulation factor decreased 17.41 10.97 6 47240 77 31650021
Hyponatraemia 17.24 10.97 177 47069 73622 31576476
Dizziness 17.18 10.97 202 47044 198945 31451153
Gastroenteritis Escherichia coli 17.09 10.97 8 47238 236 31649862
Osteomyelitis fungal 17.03 10.97 8 47238 238 31649860
Hepatic necrosis 17.00 10.97 24 47222 3639 31646459
Weight increased 16.88 10.97 65 47181 82882 31567216
Neutrophil count decreased 16.78 10.97 27 47219 46367 31603731
Liver function test abnormal 16.76 10.97 88 47158 29604 31620494
Joint swelling 16.72 10.97 34 47212 53397 31596701
Abdominal tenderness 16.67 10.97 24 47222 3704 31646394
International normalised ratio increased 16.65 10.97 120 47126 45103 31604995
Prothrombin time shortened 16.64 10.97 15 47231 1389 31648709
Peripheral sensory neuropathy 16.58 10.97 32 47214 6283 31643815
Helicobacter gastritis 16.50 10.97 14 47232 1196 31648902
Agranulocytosis 16.42 10.97 69 47177 21178 31628920
Bacteroides infection 16.26 10.97 6 47240 95 31650003
Infusion site inflammation 16.20 10.97 5 47241 44 31650054
Distal intestinal obstruction syndrome 16.10 10.97 8 47238 270 31649828
Syncope 15.93 10.97 69 47177 85113 31564985
Alcohol intolerance 15.80 10.97 9 47237 402 31649696
Wound drainage 15.75 10.97 10 47236 545 31649553
Necrosis 15.66 10.97 28 47218 5188 31644910
Chest pain 15.64 10.97 106 47140 116851 31533247
Arterial angioplasty 15.64 10.97 5 47241 50 31650048
Carotid artery insufficiency 15.63 10.97 4 47242 16 31650082
Dermatitis bullous 15.61 10.97 31 47215 6214 31643884
Wrong technique in product usage process 15.58 10.97 16 47230 33327 31616771
Drug ineffective 15.52 10.97 729 46517 394844 31255254
Substance-induced psychotic disorder 15.45 10.97 15 47231 1525 31648573
Acute myocardial infarction 15.35 10.97 33 47213 50790 31599308
Optic neuropathy 15.31 10.97 16 47230 1777 31648321
Toxic leukoencephalopathy 15.25 10.97 8 47238 303 31649795
Listeriosis 15.17 10.97 12 47234 928 31649170
Pollakiuria 15.10 10.97 4 47242 17898 31632200
Norovirus test positive 15.05 10.97 5 47241 57 31650041
General physical health deterioration 15.01 10.97 245 47001 113190 31536908
Stoma site haemorrhage 14.99 10.97 11 47235 761 31649337
Reaction to excipient 14.97 10.97 9 47237 445 31649653
Infection in an immunocompromised host 14.86 10.97 10 47236 602 31649496
Oxygen saturation decreased 14.74 10.97 32 47214 49083 31601015
Gastrointestinal wall thickening 14.72 10.97 14 47232 1388 31648710
Tachypnoea 14.72 10.97 56 47190 16427 31633671
Stoma site inflammation 14.66 10.97 9 47237 462 31649636
Epileptic encephalopathy 14.62 10.97 6 47240 128 31649970
Hepatic amoebiasis 14.52 10.97 5 47241 64 31650034
Lymphocyte transformation test positive 14.46 10.97 3 47243 3 31650095
Atrophic glossitis 14.46 10.97 3 47243 3 31650095
White blood cell count decreased 14.45 10.97 74 47172 87324 31562774
Lipase increased 14.38 10.97 37 47209 8806 31641292
Enterococcal bacteraemia 14.30 10.97 15 47231 1673 31648425
Post embolisation syndrome 14.25 10.97 5 47241 68 31650030
Pancreatitis necrotising 14.24 10.97 18 47228 2453 31647645
Necrotising enterocolitis neonatal 14.20 10.97 7 47239 232 31649866
Antibiotic level below therapeutic 14.18 10.97 5 47241 69 31650029
Metastases to heart 14.16 10.97 6 47240 139 31649959
Alanine aminotransferase 14.15 10.97 4 47242 25 31650073
Stoma site odour 14.15 10.97 4 47242 25 31650073
Coagulation time prolonged 14.14 10.97 13 47233 1235 31648863
Extravasation 13.91 10.97 15 47231 1727 31648371
CNS ventriculitis 13.88 10.97 7 47239 244 31649854
Loss of personal independence in daily activities 13.88 10.97 13 47233 28275 31621823
Anal fissure 13.79 10.97 21 47225 3408 31646690
Cortical visual impairment 13.64 10.97 4 47242 29 31650069
Productive cough 13.62 10.97 18 47228 33522 31616576
Thrombocytopenia 13.59 10.97 293 46953 142454 31507644
Pulmonary fibrosis 13.53 10.97 4 47242 16656 31633442
Diarrhoea 13.50 10.97 648 46598 351761 31298337
Anal inflammation 13.48 10.97 8 47238 386 31649712
Therapeutic product effect decreased 13.48 10.97 87 47159 31535 31618563
Pseudomonal sepsis 13.46 10.97 20 47226 3176 31646922
Flavobacterium infection 13.45 10.97 5 47241 81 31650017
Fusobacterium infection 13.45 10.97 5 47241 81 31650017
Anaphylactic shock 13.42 10.97 49 47197 14096 31636002
Diabetes mellitus 13.38 10.97 27 47219 42529 31607569
Full blood count decreased 13.38 10.97 4 47242 16536 31633562
Platelet count decreased 13.36 10.97 103 47143 110332 31539766
Hyperreflexia 13.21 10.97 19 47227 2930 31647168
Insomnia 13.16 10.97 85 47161 94751 31555347
Polyneuropathy 13.11 10.97 46 47200 12976 31637122
Disseminated intravascular coagulation 13.09 10.97 63 47183 20474 31629624
Aeromonas infection 13.09 10.97 7 47239 276 31649822
Factor V inhibition 13.04 10.97 6 47240 170 31649928
Bladder cancer 12.98 10.97 3 47243 14722 31635376
Hepatitis 12.87 10.97 66 47180 22000 31628098
Peritoneal abscess 12.76 10.97 5 47241 94 31650004
Metastases to peritoneum 12.74 10.97 14 47232 1646 31648452
Drug withdrawal syndrome 12.72 10.97 6 47240 18744 31631354
Prothrombin time prolonged 12.68 10.97 36 47210 9076 31641022
Procalcitonin increased 12.65 10.97 14 47232 1659 31648439
Fluid retention 12.64 10.97 11 47235 24791 31625307
Sudden death 12.64 10.97 3 47243 14454 31635644
Acanthamoeba infection 12.60 10.97 8 47238 436 31649662
Rectal abscess 12.55 10.97 11 47235 981 31649117
Alanine aminotransferase increased 12.52 10.97 168 47078 74488 31575610
Candida osteomyelitis 12.51 10.97 4 47242 40 31650058
Amoebic colitis 12.43 10.97 5 47241 101 31649997
Pain in extremity 12.42 10.97 112 47134 116091 31534007
Oedema 12.39 10.97 107 47139 42454 31607644
Cardiac disorder 12.23 10.97 25 47221 39189 31610909
Intestinal ulcer 12.22 10.97 10 47236 812 31649286
Small intestinal obstruction 12.22 10.97 46 47200 13426 31636672
Herpes zoster 12.16 10.97 18 47228 31975 31618123
Neonatal cholestasis 12.09 10.97 4 47242 45 31650053
Pharyngeal inflammation 12.06 10.97 7 47239 324 31649774
Wheezing 12.04 10.97 22 47224 35964 31614134
Orthostatic hypotension 11.93 10.97 11 47235 24108 31625990
Vestibular disorder 11.88 10.97 11 47235 1054 31649044
Osteomyelitis bacterial 11.83 10.97 7 47239 336 31649762
Inhibitory drug interaction 11.83 10.97 13 47233 1529 31648569
Leukopenia 11.79 10.97 135 47111 57693 31592405
Blister 11.78 10.97 62 47184 20874 31629224
Nasal congestion 11.71 10.97 8 47238 20373 31629725
Fungaemia 11.71 10.97 16 47230 2353 31647745
Rash pustular 11.69 10.97 24 47222 4925 31645173
Overdose 11.68 10.97 76 47170 84588 31565510
Drug ineffective for unapproved indication 11.65 10.97 55 47191 17735 31632363
Romberg test positive 11.63 10.97 4 47242 51 31650047
Infusion site swelling 11.52 10.97 15 47231 2106 31647992
Sedation 11.50 10.97 7 47239 18958 31631140
Hyperkalaemia 11.50 10.97 53 47193 64298 31585800
Abdominal wall abscess 11.46 10.97 8 47238 511 31649587
Aggression 11.44 10.97 24 47222 37267 31612831
Disseminated cryptococcosis 11.37 10.97 12 47234 1348 31648750
Liver injury 11.36 10.97 45 47201 13447 31636651
Penile necrosis 11.36 10.97 4 47242 55 31650043
Vipoma 11.35 10.97 3 47243 14 31650084
Tracheal oedema 11.35 10.97 3 47243 14 31650084
Memory impairment 11.31 10.97 25 47221 38105 31611993
Nausea 11.30 10.97 564 46682 307383 31342715
Rash macular 11.25 10.97 40 47206 11355 31638743
Pseudomonas infection 11.24 10.97 40 47206 11361 31638737
Hypoprothrombinaemia 11.24 10.97 7 47239 369 31649729
Psychogenic visual disorder 11.18 10.97 3 47243 15 31650083
Neurological symptom 11.16 10.97 20 47226 3711 31646387
Toxic skin eruption 11.16 10.97 37 47209 10143 31639955
Vasculitis 11.15 10.97 33 47213 8517 31641581
Staphylococcal infection 11.11 10.97 81 47165 30551 31619547
Tension headache 11.00 10.97 12 47234 1399 31648699
Tetanus 10.98 10.97 4 47242 61 31650037

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 791.05 10.04 355 99738 10051 70818300
Clostridium difficile infection 758.53 10.04 543 99550 38273 70790078
Clostridium difficile colitis 512.83 10.04 382 99711 28614 70799737
Neurotoxicity 408.66 10.04 338 99755 29488 70798863
Pseudomembranous colitis 318.62 10.04 152 99941 4959 70823392
Drug reaction with eosinophilia and systemic symptoms 299.59 10.04 389 99704 57624 70770727
Abortion incomplete 283.27 10.04 120 99973 2942 70825409
Rheumatoid arthritis 257.02 10.04 50 100043 291755 70536596
Ataxia 229.98 10.04 219 99874 22998 70805353
Multiple organ dysfunction syndrome 222.06 10.04 480 99613 108035 70720316
Cerebellar syndrome 219.28 10.04 119 99974 5112 70823239
Abdominal pain 209.37 10.04 996 99097 341131 70487220
Encephalopathy 206.63 10.04 337 99756 61324 70767027
Acute generalised exanthematous pustulosis 197.46 10.04 168 99925 15229 70813122
Appendicolith 194.07 10.04 113 99980 5567 70822784
Completed suicide 187.56 10.04 45 100048 227090 70601261
Septic shock 180.75 10.04 452 99641 111806 70716545
Colitis 169.74 10.04 315 99778 63499 70764852
Drug abuse 167.66 10.04 10 100083 147246 70681105
Fall 164.94 10.04 232 99861 443864 70384487
Appendicitis 164.13 10.04 157 99936 16576 70811775
International normalised ratio fluctuation 151.19 10.04 79 100014 3140 70825211
Megacolon 149.79 10.04 78 100015 3078 70825273
Pathogen resistance 146.45 10.04 133 99960 13146 70815205
Synovitis 132.57 10.04 14 100079 129214 70699137
Anaphylactic reaction 132.51 10.04 313 99780 74661 70753690
Clostridial infection 116.70 10.04 80 100013 5249 70823102
Fixed eruption 116.50 10.04 61 100032 2435 70825916
Rash maculo-papular 115.46 10.04 234 99859 50311 70778040
Cerebellar ataxia 112.38 10.04 54 100039 1790 70826561
Arthropathy 112.12 10.04 36 100057 150021 70678330
Bloody discharge 109.42 10.04 52 100041 1681 70826670
Dysarthria 108.86 10.04 259 99834 62054 70766297
Contraindicated product administered 108.48 10.04 28 100065 134584 70693767
Hand deformity 108.00 10.04 3 100090 86479 70741872
Joint swelling 106.67 10.04 120 99973 253091 70575260
Death 106.21 10.04 367 99726 509694 70318657
Cholestasis 105.06 10.04 218 99875 47654 70780697
Fistula 104.64 10.04 101 99992 10780 70817571
Pyrexia 95.34 10.04 1289 98804 605663 70222688
Hepatitis 95.27 10.04 215 99878 49765 70778586
Systemic lupus erythematosus 92.75 10.04 16 100077 101886 70726465
Diverticulitis 92.70 10.04 191 99902 41543 70786808
Enterocolitis haemorrhagic 89.34 10.04 48 100045 2020 70826331
Sepsis 88.73 10.04 620 99473 243925 70584426
Clostridium test positive 88.34 10.04 65 100028 4771 70823580
Toxic epidermal necrolysis 87.82 10.04 181 99912 39376 70788975
Drug hypersensitivity 85.80 10.04 649 99444 261810 70566541
Alopecia 84.74 10.04 93 100000 198397 70629954
Abdominal distension 83.96 10.04 331 99762 104338 70724013
Nasopharyngitis 80.44 10.04 118 99975 222088 70606263
Ascites 79.83 10.04 243 99850 67304 70761047
Enterococcal infection 78.71 10.04 100 99993 14482 70813869
Magnetic resonance imaging head abnormal 78.38 10.04 47 100046 2445 70825906
Vomiting 77.04 10.04 1219 98874 591892 70236459
Lyme disease 76.93 10.04 49 100044 2840 70825511
Fatigue 75.93 10.04 771 99322 823548 70004803
Abdominal abscess 74.73 10.04 67 100026 6511 70821840
Product dose omission issue 73.45 10.04 121 99972 217347 70611004
Pouchitis 72.98 10.04 32 100061 855 70827496
Haemorrhage 71.25 10.04 270 99823 83545 70744806
Cough 71.12 10.04 229 99864 325148 70503203
Paraesthesia 69.56 10.04 396 99697 145141 70683210
Eosinophilia 68.70 10.04 166 99927 40153 70788198
Intentional overdose 67.75 10.04 27 100066 98408 70729943
Cholecystitis chronic 66.64 10.04 74 100019 9302 70819049
Acute hepatic failure 65.44 10.04 130 99963 27542 70800809
Asthma 64.29 10.04 46 100047 120747 70707604
Sinusitis 64.05 10.04 87 100006 169108 70659243
Nervous system disorder 63.93 10.04 119 99974 24027 70804324
Pericarditis 63.83 10.04 20 100073 84685 70743666
Arthralgia 63.40 10.04 433 99660 502957 70325394
Klebsiella infection 61.83 10.04 88 100005 14204 70814147
Wound 60.31 10.04 32 100061 98700 70729651
Duodenal ulcer perforation 59.61 10.04 3 100090 51109 70777242
Cardiogenic shock 59.22 10.04 147 99946 36160 70792191
Glossodynia 59.06 10.04 24 100069 86463 70741888
Pancreatitis haemorrhagic 58.97 10.04 26 100067 704 70827647
Meningitis candida 58.46 10.04 17 100076 127 70828224
Weight increased 56.88 10.04 165 99928 242166 70586185
Abscess intestinal 55.88 10.04 38 100055 2460 70825891
Swelling face 53.28 10.04 203 99890 62961 70765390
Ventricular fibrillation 53.20 10.04 118 99975 26993 70801358
Dysmetria 52.96 10.04 26 100067 904 70827447
Lip swelling 51.51 10.04 134 99959 33920 70794431
Swollen tongue 51.21 10.04 141 99952 36905 70791446
Linear IgA disease 50.50 10.04 38 100055 2886 70825465
Herpes simplex oesophagitis 50.17 10.04 19 100074 344 70828007
Leukocytosis 49.98 10.04 146 99947 39522 70788829
Influenza 49.92 10.04 52 100041 113648 70714703
Infusion related reaction 49.70 10.04 130 99963 197404 70630947
Injection site pain 49.20 10.04 56 100037 117563 70710788
Cardiac failure congestive 48.92 10.04 72 100021 135385 70692966
Anal fistula 48.70 10.04 51 100042 5999 70822352
Candida infection 48.44 10.04 132 99961 34341 70794010
Clostridium colitis 48.03 10.04 35 100058 2531 70825820
Acinetobacter infection 47.57 10.04 35 100058 2569 70825782
Colitis ischaemic 46.96 10.04 77 100016 14060 70814291
Exposure during pregnancy 46.81 10.04 246 99847 87471 70740880
Rash macular 46.58 10.04 108 99985 25436 70802915
Interstitial lung disease 45.82 10.04 48 100045 104637 70723714
Nystagmus 45.58 10.04 61 100032 9294 70819057
Brain abscess 45.07 10.04 43 100050 4523 70823828
Dyspnoea 44.92 10.04 791 99302 769269 70059082
International normalised ratio increased 42.80 10.04 226 99867 80500 70747851
Peripheral swelling 42.77 10.04 180 99913 236383 70591968
Cytotoxic oedema 42.60 10.04 17 100076 356 70827995
Pelvic inflammatory disease 42.21 10.04 25 100068 1271 70827080
Axonal neuropathy 42.13 10.04 29 100064 1915 70826436
Cardiac failure 41.26 10.04 88 100005 143453 70684898
Kounis syndrome 41.25 10.04 36 100057 3375 70824976
Paraesthesia oral 40.83 10.04 76 100017 15341 70813010
Systemic mastocytosis 40.59 10.04 16 100077 324 70828027
Loss of personal independence in daily activities 40.57 10.04 36 100057 84874 70743477
Rash morbilliform 40.41 10.04 44 100049 5411 70822940
Plasma cell myeloma 40.10 10.04 27 100066 73174 70755177
Anal abscess 39.96 10.04 54 100039 8304 70820047
Necrosis ischaemic 39.76 10.04 22 100071 982 70827369
Crohn's disease 39.00 10.04 31 100062 2553 70825798
Bronchitis 38.85 10.04 66 100027 117177 70711174
Stomatitis 38.45 10.04 77 100016 128434 70699917
Chronic obstructive pulmonary disease 38.21 10.04 32 100061 77609 70750742
Psoriatic arthropathy 38.09 10.04 22 100071 64749 70763602
Hyphaema 38.09 10.04 20 100073 803 70827548
Folliculitis 38.04 10.04 7 100086 42563 70785788
Diarrhoea 37.32 10.04 1403 98690 781938 70046413
Injection site erythema 37.21 10.04 29 100064 72895 70755456
Beta haemolytic streptococcal infection 37.20 10.04 27 100066 1940 70826411
Pneumonia 37.13 10.04 605 99488 595627 70232724
Therapeutic product effect decreased 36.83 10.04 93 100000 142925 70685426
Metabolic acidosis 36.62 10.04 204 99889 74142 70754209
Jaundice 36.61 10.04 154 99939 49954 70778397
Dyspnoea exertional 36.58 10.04 34 100059 78396 70749955
Intentional product misuse 36.54 10.04 35 100058 79560 70748791
Dermatitis bullous 36.47 10.04 65 100028 12692 70815659
Enterocutaneous fistula 36.02 10.04 25 100068 1673 70826678
Hepatic failure 35.98 10.04 169 99924 57456 70770895
Anal fissure 35.64 10.04 44 100049 6189 70822162
Hepatocellular injury 35.52 10.04 144 99949 45947 70782404
Suicide attempt 35.31 10.04 36 100057 79474 70748877
Drug resistance 34.93 10.04 126 99967 38064 70790287
Amoebiasis 34.90 10.04 11 100082 111 70828240
Liver abscess 34.42 10.04 41 100052 5558 70822793
Alcohol intolerance 34.23 10.04 15 100078 400 70827951
Hepatic necrosis 34.15 10.04 51 100042 8595 70819756
Undersensing 34.11 10.04 7 100086 7 70828344
Abdominal pain lower 33.78 10.04 102 99991 28114 70800237
Oxygen saturation decreased 33.78 10.04 71 100022 116358 70711993
Large intestine perforation 33.65 10.04 64 100029 13131 70815220
Hypertension 33.64 10.04 262 99831 295771 70532580
Arthritis 33.53 10.04 54 100039 97926 70730425
Product use issue 33.08 10.04 136 99957 179801 70648550
Sopor 33.07 10.04 3 100090 31264 70797087
Dysbiosis 32.83 10.04 19 100074 925 70827426
Uterine perforation 32.74 10.04 41 100052 5850 70822501
Malignant neoplasm progression 32.25 10.04 78 100015 121661 70706690
Knee arthroplasty 32.06 10.04 5 100088 34296 70794055
Colitis ulcerative 31.95 10.04 113 99980 33810 70794541
Haematochezia 31.75 10.04 194 99899 72887 70755464
Angioedema 31.63 10.04 181 99912 66429 70761922
Mobility decreased 31.42 10.04 61 100032 102938 70725413
Rosacea 31.23 10.04 32 100061 3669 70824682
Cataract 31.19 10.04 20 100073 55625 70772726
Dysdiadochokinesis 31.17 10.04 13 100080 306 70828045
Haematotoxicity 30.85 10.04 63 100030 13611 70814740
Stevens-Johnson syndrome 30.77 10.04 116 99977 35791 70792560
Myocardial infarction 30.76 10.04 131 99962 171514 70656837
Pancreatitis acute 30.74 10.04 136 99957 45088 70783263
Dermatitis allergic 30.54 10.04 70 100023 16361 70811990
Endometritis 30.53 10.04 17 100076 768 70827583
Abdominal discomfort 30.36 10.04 178 99915 214480 70613871
Torsade de pointes 30.23 10.04 74 100019 18042 70810309
Abscess 29.94 10.04 80 100013 20574 70807777
Neuropathy peripheral 29.91 10.04 292 99801 126604 70701747
Coagulopathy 29.82 10.04 109 99984 33140 70795211
Pain in extremity 29.57 10.04 308 99785 327774 70500577
Hepatic cytolysis 29.51 10.04 76 100017 19116 70809235
Procedural pain 29.45 10.04 73 100020 17936 70810415
Biliary sepsis 29.33 10.04 21 100072 1477 70826874
Emotional distress 29.31 10.04 117 99976 37071 70791280
Optic neuropathy 29.20 10.04 29 100064 3204 70825147
Cholecystitis acute 29.14 10.04 57 100036 11937 70816414
Diarrhoea infectious 28.92 10.04 21 100072 1510 70826841
Type 2 diabetes mellitus 28.87 10.04 13 100080 44067 70784284
Vanishing bile duct syndrome 28.81 10.04 20 100073 1339 70827012
Peripheral sensory neuropathy 28.76 10.04 57 100036 12053 70816298
Gut fermentation syndrome 28.76 10.04 6 100087 7 70828344
Neutrophil count decreased 28.64 10.04 46 100047 83510 70744841
Idiosyncratic drug reaction 28.55 10.04 19 100074 1187 70827164
Malignant mesenteric neoplasm 28.34 10.04 8 100085 53 70828298
Lemierre syndrome 28.32 10.04 10 100083 147 70828204
Proctalgia 28.30 10.04 46 100047 8337 70820014
Vitamin B1 deficiency 28.14 10.04 15 100078 621 70827730
Prostate cancer 28.11 10.04 5 100088 31158 70797193
Hepatic amoebiasis 28.11 10.04 9 100084 96 70828255
Staphylococcal infection 27.95 10.04 149 99944 53255 70775096
Dysgeusia 27.91 10.04 141 99952 49361 70778990
Drug intolerance 27.90 10.04 195 99898 225492 70602859
Hospitalisation 27.79 10.04 46 100047 82522 70745829
Disseminated intravascular coagulation 27.52 10.04 107 99986 33491 70794860
Hallucinations, mixed 27.27 10.04 39 100054 6323 70822028
Peritonitis 27.14 10.04 90 100003 26069 70802282
Fistula discharge 27.14 10.04 18 100075 1118 70827233
Jejunal ulcer perforation 27.08 10.04 9 100084 109 70828242
Diverticular perforation 26.98 10.04 36 100057 5468 70822883
Biliary dyskinesia 26.39 10.04 24 100069 2375 70825976
Postural orthostatic tachycardia syndrome 26.37 10.04 14 100079 575 70827776
Thrombocytopenia 26.35 10.04 479 99614 238631 70589720
Hepatic enzyme increased 26.21 10.04 123 99970 156867 70671484
Stoma site discomfort 26.09 10.04 9 100084 123 70828228
Leukoencephalopathy 25.96 10.04 41 100052 7253 70821098
Fungal peritonitis 25.64 10.04 17 100076 1055 70827296
Fluid retention 25.62 10.04 31 100062 63354 70764997
Bradycardia 25.61 10.04 90 100003 124525 70703826
Chromaturia 25.35 10.04 82 100011 23446 70804905
Procedural hypertension 25.29 10.04 11 100082 288 70828063
White blood cell count decreased 25.18 10.04 139 99954 170002 70658349
Liver function test abnormal 25.11 10.04 160 99933 60986 70767365
Drug-induced liver injury 25.04 10.04 150 99943 55963 70772388
Injection site pruritus 25 10.04 12 100081 39198 70789153
Osmotic demyelination syndrome 24.98 10.04 18 100075 1279 70827072
Injection site swelling 24.90 10.04 15 100078 43142 70785209
Systemic candida 24.88 10.04 36 100057 5898 70822453
Bacterial vaginosis 24.86 10.04 16 100077 944 70827407
Nausea 24.78 10.04 1453 98640 850635 69977716
Blood bilirubin increased 24.76 10.04 157 99936 59744 70768607
Infected fistula 24.74 10.04 11 100082 304 70828047
Pelvic pain 24.60 10.04 52 100041 11508 70816843
Injury 24.54 10.04 167 99926 65078 70763273
Wrong technique in product usage process 24.32 10.04 37 100056 68661 70759690
Agranulocytosis 24.30 10.04 117 99976 40181 70788170
Toxic leukoencephalopathy 24.26 10.04 16 100077 984 70827367
Accidental exposure to product 24.25 10.04 5 100088 28046 70800305
Intestinal perforation 24.12 10.04 63 100030 15981 70812370
Diarrhoea haemorrhagic 24.08 10.04 52 100041 11678 70816673
COVID-19 24.07 10.04 73 100020 105684 70722667
Pseudomonas infection 24.01 10.04 70 100023 18924 70809427
Tongue discolouration 23.97 10.04 27 100066 3447 70824904
Vitamin K deficiency 23.89 10.04 14 100079 698 70827653
Anaphylactic shock 23.85 10.04 100 99993 32390 70795961
Pneumonia streptococcal 23.78 10.04 23 100070 2460 70825891
Vulvovaginal swelling 23.75 10.04 11 100082 335 70828016
Swelling 23.74 10.04 162 99931 188377 70639974
Vaginal infection 23.57 10.04 33 100060 5245 70823106
Drug ineffective for unapproved indication 23.31 10.04 112 99981 38426 70789925
Upper respiratory tract infection 23.28 10.04 48 100045 79226 70749125
Rhinorrhoea 23.26 10.04 36 100057 66335 70762016
Hyperkalaemia 23.25 10.04 75 100018 106516 70721835
Dermatitis exfoliative 23.08 10.04 48 100045 10503 70817848
Purple glove syndrome 23.06 10.04 10 100083 260 70828091
Haemodynamic instability 23.05 10.04 61 100032 15597 70812754
Rectal abscess 23.01 10.04 19 100074 1652 70826699
Neutropenic colitis 22.88 10.04 32 100061 5082 70823269
Overdose 22.82 10.04 143 99950 169602 70658749
Blood phosphorus increased 22.66 10.04 37 100056 6733 70821618
Stoma site haemorrhage 22.63 10.04 19 100074 1690 70826661
Urticaria 22.52 10.04 339 99754 162710 70665641
Polyneuropathy 22.50 10.04 74 100019 21341 70807010
Strongyloidiasis 22.45 10.04 27 100066 3696 70824655
Intrauterine infection 22.45 10.04 7 100086 68 70828283
Rectal tube insertion 22.35 10.04 5 100088 10 70828341
Herpes zoster 22.27 10.04 55 100038 85180 70743171
Cross sensitivity reaction 22.26 10.04 26 100067 3452 70824899
Antineutrophil cytoplasmic antibody 22.20 10.04 6 100087 33 70828318
Cholecystitis 22.17 10.04 72 100021 20629 70807722
Stress 22.11 10.04 168 99925 67798 70760553
Deafness bilateral 22.02 10.04 20 100073 1976 70826375
Gingival swelling 21.78 10.04 28 100065 4101 70824250
Clostridium bacteraemia 21.76 10.04 10 100083 299 70828052
Discomfort 21.76 10.04 76 100017 105360 70722991
Substance-induced psychotic disorder 21.73 10.04 24 100069 2999 70825352
Osteoarthritis 21.68 10.04 45 100048 74102 70754249
Helicobacter infection 21.67 10.04 28 100065 55628 70772723
Toxic shock syndrome 21.62 10.04 15 100078 1003 70827348
Adverse event 21.28 10.04 23 100070 49438 70778913
Chronic gastrointestinal bleeding 21.19 10.04 11 100082 431 70827920
Leukaemoid reaction 21.05 10.04 10 100083 323 70828028
Pharyngeal oedema 20.96 10.04 59 100034 15637 70812714
Helicobacter gastritis 20.92 10.04 21 100072 2350 70826001
Urinary retention 20.89 10.04 26 100067 52494 70775857
Eastern Cooperative Oncology Group performance status 20.85 10.04 6 100087 43 70828308
Omental necrosis 20.61 10.04 6 100087 45 70828306
Injection site reaction 20.55 10.04 24 100069 49828 70778523
Aphthous ulcer 20.47 10.04 56 100037 14600 70813751
Escherichia infection 20.46 10.04 60 100033 16271 70812080
Long QT syndrome 20.44 10.04 31 100062 5296 70823055
Rash erythematous 20.42 10.04 134 99959 51584 70776767
Cerebral cyst 20.41 10.04 10 100083 346 70828005
Pain 20.34 10.04 705 99388 628111 70200240
Factor V inhibition 20.31 10.04 10 100083 350 70828001
Type IV hypersensitivity reaction 20.28 10.04 25 100068 3510 70824841
Gastrointestinal inflammation 20.18 10.04 35 100058 6688 70821663
Oedema peripheral 20.18 10.04 215 99878 227876 70600475
Pruritus 20.15 10.04 634 99459 344926 70483425
Stenotrophomonas test positive 20.10 10.04 10 100083 358 70827993
Prothrombin time ratio decreased 20.03 10.04 13 100080 778 70827573
Wheezing 20.03 10.04 67 100026 94103 70734248
Hypothyroidism 19.99 10.04 21 100072 45734 70782617
Enterococcus test positive 19.94 10.04 18 100075 1765 70826586
Pharyngeal inflammation 19.90 10.04 14 100079 958 70827393
Acute psychosis 19.79 10.04 26 100067 3890 70824461
Fibromyalgia 19.79 10.04 23 100070 47851 70780500
Small intestinal obstruction 19.77 10.04 78 100015 24577 70803774
Cerebrovascular accident 19.73 10.04 120 99973 143350 70685001
Multiple sclerosis relapse 19.64 10.04 19 100074 42998 70785353
Musculoskeletal stiffness 19.59 10.04 125 99968 147635 70680716
Cholelithiasis 19.52 10.04 124 99969 47216 70781135
Ureteral disorder 19.50 10.04 11 100082 510 70827841
Enterocolitis 19.33 10.04 51 100042 13015 70815336
Gallbladder disorder 19.33 10.04 62 100031 17650 70810701
Adenoviral hepatitis 19.25 10.04 13 100080 832 70827519
Vaginitis gardnerella 19.24 10.04 5 100088 23 70828328
Drug interaction 19.23 10.04 688 99405 380753 70447598
Psychotic disorder due to a general medical condition 19.23 10.04 9 100084 281 70828070
Hypoglossal nerve paresis 18.94 10.04 7 100086 118 70828233
Toxic skin eruption 18.84 10.04 67 100026 20095 70808256
Liver transplant failure 18.84 10.04 7 100086 120 70828231
Blood glucose increased 18.81 10.04 78 100015 102904 70725447
Hip arthroplasty 18.79 10.04 8 100085 28032 70800319
Anal skin tags 18.67 10.04 10 100083 418 70827933
Shock 18.64 10.04 109 99984 40316 70788035
Electrocardiogram QT prolonged 18.62 10.04 190 99903 83327 70745024
Haemostasis 18.52 10.04 9 100084 306 70828045
Nodule 18.46 10.04 3 100090 19966 70808385
Hepatitis infectious mononucleosis 18.42 10.04 7 100086 128 70828223
Abdominal sepsis 18.37 10.04 18 100075 1957 70826394
Lack of spontaneous speech 18.20 10.04 8 100085 215 70828136
Rash pustular 18.16 10.04 43 100050 10265 70818086
Pulmonary arterial hypertension 18.15 10.04 12 100081 32843 70795508
Joint range of motion decreased 18.13 10.04 7 100086 26019 70802332
Stenotrophomonas infection 18.12 10.04 23 100070 3326 70825025
Enteritis 17.89 10.04 49 100044 12782 70815569
Central nervous system lesion 17.81 10.04 48 100045 12405 70815946
Periorbital oedema 17.75 10.04 36 100057 7739 70820612
Retroperitoneal haematoma 17.72 10.04 28 100065 4957 70823394
Myelodysplastic syndrome 17.68 10.04 10 100083 29775 70798576
Antibiotic level below therapeutic 17.66 10.04 6 100087 78 70828273
Red blood cell count decreased 17.61 10.04 29 100064 52132 70776219
Puerperal pyrexia 17.60 10.04 5 100088 34 70828317
Therapeutic response decreased 17.49 10.04 35 100058 58418 70769933
Platelet count decreased 17.42 10.04 164 99929 178058 70650293
Insomnia 17.42 10.04 210 99883 217596 70610755
Blood pressure increased 17.36 10.04 176 99917 188341 70640010
Macular degeneration 17.36 10.04 35 100058 7493 70820858
Device malfunction 17.35 10.04 3 100090 19081 70809270
Gastrointestinal wall thickening 17.31 10.04 19 100074 2357 70825994
Coagulation factor decreased 17.14 10.04 7 100086 156 70828195
Oedematous pancreatitis 17.13 10.04 13 100080 1000 70827351
Metastases to stomach 17.08 10.04 8 100085 250 70828101
Foetal monitoring abnormal 17.06 10.04 7 100086 158 70828193
Thrombotic thrombocytopenic purpura 17.05 10.04 31 100062 6146 70822205
Botulism 16.99 10.04 9 100084 368 70827983
Chronic sinusitis 16.82 10.04 37 100056 8414 70819937
Incubator therapy 16.79 10.04 5 100088 41 70828310
Hidradenitis 16.74 10.04 21 100072 3001 70825350
Feeling guilty 16.70 10.04 12 100081 849 70827502
White blood cells stool 16.69 10.04 3 100090 0 70828351
Hypotonic-hyporesponsive episode 16.69 10.04 3 100090 0 70828351
Metastases to heart 16.68 10.04 8 100085 264 70828087
Rash papular 16.58 10.04 60 100033 18150 70810201
Hypoalbuminaemia 16.57 10.04 62 100031 19060 70809291
Faecal volume decreased 16.54 10.04 7 100086 171 70828180
Bone erosion 16.45 10.04 53 100040 15120 70813231
Osteomyelitis fungal 16.41 10.04 8 100085 274 70828077
Enterovesical fistula 16.36 10.04 13 100080 1070 70827281
Lower respiratory tract infection 16.24 10.04 92 100001 111821 70716530
Back pain 16.21 10.04 277 99816 270875 70557476
Prescribed underdose 16.19 10.04 5 100088 21380 70806971
Endocrine ophthalmopathy 16.19 10.04 10 100083 549 70827802
Bacteraemia 16.18 10.04 83 100010 29226 70799125
Stoma site discharge 16.15 10.04 16 100077 1763 70826588
Organ failure 16.06 10.04 23 100070 3733 70824618
Infective aneurysm 16.06 10.04 12 100081 902 70827449
Transient ischaemic attack 16.02 10.04 25 100068 45919 70782432
Arterial angioplasty 15.91 10.04 5 100088 50 70828301
Pulmonary fibrosis 15.85 10.04 15 100078 34295 70794056
Carotid artery insufficiency 15.84 10.04 4 100089 16 70828335
Foetal arrhythmia 15.82 10.04 5 100088 51 70828300
Red cell fragmentation syndrome 15.73 10.04 5 100088 52 70828299
Vulvovaginitis trichomonal 15.65 10.04 4 100089 17 70828334
Pancreatitis 15.65 10.04 146 99947 62522 70765829
Tachycardia 15.53 10.04 312 99781 158234 70670117
Muscle abscess 15.47 10.04 12 100081 954 70827397
Vaginal discharge 15.43 10.04 25 100068 4518 70823833
Hepatitis cholestatic 15.40 10.04 46 100047 12604 70815747
Electrocardiogram T wave alternans 15.40 10.04 5 100088 56 70828295
Toxicity to various agents 15.39 10.04 416 99677 381756 70446595
Mononucleosis syndrome 15.38 10.04 6 100087 118 70828233
Drug dependence 15.35 10.04 18 100075 37303 70791048
Perirectal abscess 15.33 10.04 16 100077 1874 70826477
Stoma site inflammation 15.31 10.04 10 100083 605 70827746
Prothrombin time prolonged 15.30 10.04 54 100039 16136 70812215
Coronary artery disease 15.22 10.04 42 100051 62694 70765657
Nephropathy toxic 15.19 10.04 59 100034 18455 70809896
Burning sensation 15.18 10.04 127 99966 52743 70775608
Venoocclusive liver disease 15.11 10.04 41 100052 10637 70817714
Bladder cancer 15.05 10.04 3 100090 17239 70811112
Dry eye 15.04 10.04 14 100079 32268 70796083
Granulomatous rosacea 15.03 10.04 7 100086 216 70828135
Infusion site streaking 15.01 10.04 9 100084 468 70827883
Tetanus 15.01 10.04 5 100088 61 70828290
Intestinal stenosis 14.96 10.04 21 100072 3346 70825005
Geotrichum infection 14.94 10.04 12 100081 1003 70827348
Tongue coated 14.93 10.04 13 100080 1215 70827136
Prescribed overdose 14.92 10.04 10 100083 27171 70801180
Venous haemorrhage 14.90 10.04 8 100085 336 70828015
Henoch-Schonlein purpura 14.89 10.04 18 100075 2477 70825874
Airway peak pressure increased 14.86 10.04 8 100085 338 70828013
Posterior reversible encephalopathy syndrome 14.82 10.04 71 100022 24331 70804020
Frequent bowel movements 14.67 10.04 64 100029 21089 70807262
Delayed delivery 14.65 10.04 4 100089 23 70828328
Ureteric obstruction 14.64 10.04 18 100075 2521 70825830
Memory impairment 14.64 10.04 74 100019 92567 70735784
Gynaecological examination abnormal 14.62 10.04 3 100090 3 70828348
Vulval disorder 14.62 10.04 9 100084 491 70827860
Tissue infiltration 14.61 10.04 10 100083 654 70827697
Underdose 14.59 10.04 12 100081 29371 70798980
Depersonalisation/derealisation disorder 14.55 10.04 15 100078 1733 70826618
Anterior interosseous syndrome 14.51 10.04 4 100089 24 70828327
Malnutrition 14.49 10.04 62 100031 20255 70808096
Jaundice neonatal 14.44 10.04 6 100087 140 70828211
Haemolytic uraemic syndrome 14.40 10.04 23 100070 4107 70824244
Intestinal dilatation 14.40 10.04 17 100076 2283 70826068
Rash pruritic 14.37 10.04 144 99949 62847 70765504
Musculoskeletal pain 14.36 10.04 72 100021 90255 70738096
Aeromonas infection 14.36 10.04 8 100085 362 70827989
Multiple sclerosis 14.29 10.04 9 100084 25276 70803075
Mental status changes 14.28 10.04 144 99949 62957 70765394
Adverse drug reaction 14.26 10.04 34 100059 53310 70775041
Full blood count decreased 14.24 10.04 8 100085 23910 70804441
Cortical visual impairment 14.24 10.04 4 100089 26 70828325
Psoriasis 14.24 10.04 81 100012 98352 70729999
Bacteroides test positive 14.24 10.04 4 100089 26 70828325
Night sweats 14.22 10.04 108 99985 43576 70784775
Trichoglossia 14.20 10.04 9 100084 517 70827834
Skin lesion 14.19 10.04 98 99995 38362 70789989
Infusion site induration 14.18 10.04 11 100082 874 70827477
Heparin-induced thrombocytopenia 14.12 10.04 36 100057 9001 70819350
Morganella infection 14.08 10.04 12 100081 1090 70827261
Candida sepsis 14.07 10.04 17 100076 2338 70826013
Prothrombin time shortened 14.05 10.04 19 100074 2923 70825428
Tongue dry 14.05 10.04 12 100081 1093 70827258
Intestinal fistula 14.05 10.04 13 100080 1316 70827035
Osteoporosis 14.03 10.04 30 100063 48877 70779474
Pancytopenia 14.02 10.04 295 99798 150812 70677539
Diabetes mellitus 14.01 10.04 53 100040 71771 70756580
Acanthamoeba infection 14.00 10.04 9 100084 530 70827821
Herpes simplex colitis 13.98 10.04 4 100089 28 70828323
Bacterial vulvovaginitis 13.95 10.04 9 100084 533 70827818
Injection site bruising 13.93 10.04 20 100073 38012 70790339
Productive cough 13.89 10.04 60 100033 78277 70750074
Ileal perforation 13.74 10.04 11 100082 915 70827436
Blood cholesterol increased 13.71 10.04 46 100047 64558 70763793
Post embolisation syndrome 13.66 10.04 5 100088 82 70828269
Peripheral sensorimotor neuropathy 13.65 10.04 18 100075 2704 70825647
Amoebic dysentery 13.63 10.04 4 100089 31 70828320
Enterococcal bacteraemia 13.62 10.04 18 100075 2708 70825643
Stoma site erythema 13.56 10.04 13 100080 1375 70826976
Inflammatory bowel disease 13.52 10.04 25 100068 5021 70823330
Gastrointestinal bacterial infection 13.46 10.04 10 100083 745 70827606
Vulval ulceration 13.46 10.04 6 100087 167 70828184
Sensitisation 13.41 10.04 17 100076 2456 70825895
Oral candidiasis 13.32 10.04 70 100023 24882 70803469
Female genital tract fistula 13.27 10.04 19 100074 3084 70825267
Abdominal tenderness 13.24 10.04 37 100056 9763 70818588
Tubulointerstitial nephritis 13.24 10.04 86 100007 32990 70795361
Obesity 13.21 10.04 11 100082 26760 70801591
Plantar fascial fibromatosis 13.20 10.04 4 100089 35 70828316
Syncope 13.16 10.04 160 99933 165549 70662802
Distributive shock 13.13 10.04 16 100077 2221 70826130
Nasal congestion 13.11 10.04 48 100045 65624 70762727
Amoebic brain abscess 13.09 10.04 3 100090 7 70828344
Bacteroides infection 13.06 10.04 7 100086 293 70828058
Large intestine infection 13.06 10.04 18 100075 2820 70825531
Ill-defined disorder 13.02 10.04 37 100056 54704 70773647
Epistaxis 13.00 10.04 88 100005 102539 70725812
Hepatomegaly 12.96 10.04 54 100039 17438 70810913
Stoma site pain 12.94 10.04 12 100081 1218 70827133
Breast cancer 12.94 10.04 17 100076 33532 70794819
Candida osteomyelitis 12.91 10.04 4 100089 38 70828313
Poisoning deliberate 12.90 10.04 4 100089 17056 70811295
Influenza like illness 12.87 10.04 48 100045 65283 70763068
Poisoning 12.86 10.04 8 100085 22614 70805737
Gastroenteritis Escherichia coli 12.84 10.04 8 100085 446 70827905
Flavobacterium infection 12.84 10.04 5 100088 98 70828253
Amoebic colitis 12.70 10.04 5 100088 101 70828250
Orbital oedema 12.68 10.04 7 100086 311 70828040
Vestibular disorder 12.66 10.04 16 100077 2304 70826047
Nodular rash 12.64 10.04 7 100086 313 70828038
Paranoia 12.52 10.04 53 100040 17235 70811116
Device expulsion 12.46 10.04 8 100085 22238 70806113
Lung disorder 12.46 10.04 53 100040 69431 70758920
Stenosis 12.40 10.04 15 100078 2066 70826285
Pain in jaw 12.39 10.04 26 100067 42643 70785708
Aspergillus infection 12.34 10.04 54 100039 17814 70810537
Sedation 12.32 10.04 30 100063 46701 70781650
Antibiotic associated colitis 12.31 10.04 3 100090 10 70828341
Herpes simplex hepatitis 12.29 10.04 8 100085 481 70827870
Femur fracture 12.28 10.04 20 100073 36112 70792239
Necrosis 12.20 10.04 33 100060 8548 70819803
Subdural haematoma 12.19 10.04 14 100079 29284 70799067
Hyporeflexia 12.17 10.04 19 100074 3328 70825023
Cardiac disorder 12.14 10.04 43 100050 59372 70768979
Retained products of conception 12.14 10.04 5 100088 114 70828237
Renal failure 12.11 10.04 351 99742 188719 70639632
C-reactive protein decreased 12.11 10.04 16 100077 2408 70825943
Areflexia 12.03 10.04 24 100069 5098 70823253
Impaired healing 11.98 10.04 59 100034 74315 70754036
Injection site haemorrhage 11.98 10.04 11 100082 25516 70802835
Chemical burns of eye 11.98 10.04 5 100088 118 70828233
Fusobacterium infection 11.94 10.04 5 100088 119 70828232
Mania 11.94 10.04 52 100041 17122 70811229
Fungaemia 11.93 10.04 21 100072 4061 70824290
Generalised tonic-clonic seizure 11.92 10.04 100 99993 41561 70786790
Culture wound positive 11.87 10.04 7 100086 353 70827998
Drug level below therapeutic 11.85 10.04 33 100060 8690 70819661
Vaginal abscess 11.78 10.04 7 100086 358 70827993
Koebner phenomenon 11.71 10.04 4 100089 53 70828298
Acute myocardial infarction 11.64 10.04 58 100035 72829 70755522
CNS ventriculitis 11.59 10.04 7 100086 369 70827982
Functional gastrointestinal disorder 11.58 10.04 22 100071 4509 70823842
Marchiafava-Bignami disease 11.51 10.04 3 100090 14 70828337
Skin odour abnormal 11.48 10.04 14 100079 1945 70826406
Fear of death 11.48 10.04 12 100081 1409 70826942
Epidermal necrosis 11.45 10.04 12 100081 1413 70826938
Musculoskeletal disorder 11.44 10.04 7 100086 19964 70808387
Intra-abdominal fluid collection 11.41 10.04 17 100076 2858 70825493
Empyema 11.36 10.04 20 100073 3867 70824484
Fungal sepsis 11.35 10.04 13 100080 1690 70826661
Intestinal gangrene 11.34 10.04 3 100090 15 70828336
Neuroleptic malignant syndrome 11.29 10.04 12 100081 25995 70802356
Anal inflammation 11.27 10.04 8 100085 555 70827796
Lipase increased 11.24 10.04 47 100046 15199 70813152
Post procedural bile leak 11.24 10.04 7 100086 390 70827961
Trichomoniasis 11.22 10.04 5 100088 139 70828212
Culture stool positive 11.21 10.04 8 100085 560 70827791
Fusarium infection 11.17 10.04 13 100080 1719 70826632
Procalcitonin increased 11.16 10.04 16 100077 2600 70825751
Serum sickness-like reaction 11.16 10.04 8 100085 564 70827787
Hyperbilirubinaemia 11.16 10.04 62 100031 22506 70805845
Abnormal faeces 11.13 10.04 27 100066 6546 70821805
Laboratory test abnormal 11.12 10.04 12 100081 25811 70802540
Flatulence 11.11 10.04 92 100001 38089 70790262
Blood pressure diastolic abnormal 11.08 10.04 4 100089 15500 70812851
Medical device site pain 11.07 10.04 6 100087 257 70828094
Joint injury 11.06 10.04 13 100080 26919 70801432
Hepatitis acute 11.06 10.04 44 100049 13918 70814433
Vulval haemorrhage 11.03 10.04 3 100090 17 70828334
Vipoma 11.03 10.04 3 100090 17 70828334
Scar 11.02 10.04 44 100049 13937 70814414
Rubber sensitivity 10.97 10.04 12 100081 1483 70826868
Hyperintensity in brain deep nuclei 10.96 10.04 4 100089 65 70828286
Irritable bowel syndrome 10.93 10.04 36 100057 50814 70777537
Lower limb fracture 10.90 10.04 5 100088 16767 70811584
Glaucoma 10.84 10.04 6 100087 18086 70810265
Myoclonus 10.84 10.04 69 100024 26286 70802065
Large intestinal ulcer 10.76 10.04 21 100072 4391 70823960
Blood osmolarity decreased 10.74 10.04 11 100082 1260 70827091
Respiratory alkalosis 10.73 10.04 20 100073 4041 70824310
Postoperative ileus 10.72 10.04 10 100083 1022 70827329
Wound drainage 10.70 10.04 10 100083 1025 70827326
Amniotic cavity infection 10.69 10.04 9 100084 804 70827547
Blood alkaline phosphatase increased 10.69 10.04 128 99965 58393 70769958
Bacterial infection 10.68 10.04 69 100024 26423 70801928
Bacterial toxaemia 10.63 10.04 5 100088 158 70828193
Head injury 10.60 10.04 20 100073 34121 70794230
Uterine hypertonus 10.60 10.04 6 100087 280 70828071
Tachypnoea 10.58 10.04 73 100020 28565 70799786
Arrhythmia 10.58 10.04 42 100051 56101 70772250
Angina pectoris 10.58 10.04 34 100059 48349 70780002
Emphysema 10.57 10.04 4 100089 15056 70813295
Oedematous kidney 10.57 10.04 5 100088 160 70828191
Cardiovascular insufficiency 10.53 10.04 16 100077 2737 70825614
Stoma site odour 10.53 10.04 4 100089 73 70828278
Injection site rash 10.50 10.04 5 100088 16405 70811946
Meningitis aseptic 10.47 10.04 26 100067 6393 70821958
Cholecystectomy 10.44 10.04 31 100062 8466 70819885
Tendonitis 10.42 10.04 60 100033 22062 70806289
Leuconostoc infection 10.37 10.04 3 100090 22 70828329
Diabetes mellitus inadequate control 10.34 10.04 10 100083 22635 70805716
Arthritis reactive 10.31 10.04 7 100086 452 70827899
Anorectal discomfort 10.29 10.04 17 100076 3124 70825227
Venoocclusive disease 10.25 10.04 20 100073 4180 70824171
Withdrawal syndrome 10.25 10.04 12 100081 24892 70803459
Bartter's syndrome 10.25 10.04 3 100090 23 70828328
Diabetic ketoacidosis 10.19 10.04 18 100075 31494 70796857
Upper limb fracture 10.17 10.04 5 100088 16114 70812237
Coagulation time prolonged 10.17 10.04 14 100079 2190 70826161
Fear 10.17 10.04 57 100036 20754 70807597
Skin test positive 10.15 10.04 10 100083 1094 70827257
Dysaesthesia 10.12 10.04 23 100070 5345 70823006
Spinal stenosis 10.11 10.04 4 100089 14649 70813702
Depression 10.10 10.04 209 99884 198765 70629586
Documented hypersensitivity to administered product 10.08 10.04 9 100084 870 70827481
Sinus congestion 10.07 10.04 6 100087 17367 70810984

FDA Adverse Event Reporting System (Pediatric)

None

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 D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000977 Antiparasitic Agents
MeSH PA D000981 Antiprotozoal Agents
CHEBI has role CHEBI:33281 antibiotics
CHEBI has role CHEBI:35442 antiparasitic drugs
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:36047 antibacterial drugs
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:50685 antitrichomonal agent
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:132992 radiosensitizing agents
CHEBI has role CHEBI:171664 antiamoebic drugs

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
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
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 Bacteroides 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 Peptococcus 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 Clostridium 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
Sexual Transmitted Disease Exposure from Sexual Assault off-label use
Periodontal Infections off-label use
Diabetic Foot Infection off-label use
Recurrent Persistent Urethritis off-label use
Alcoholism contraindication 7200002
Lowered convulsive threshold contraindication 19260006
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
Breastfeeding (mother) contraindication 413712001




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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% METROGEL GALDERMA LABS LP N021789 June 30, 2005 RX GEL TOPICAL 6881726 Feb. 21, 2022 ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA
1% METROGEL GALDERMA LABS LP N021789 June 30, 2005 RX GEL TOPICAL 7348317 Feb. 21, 2022 ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA
1.3% NUVESSA CHEMO RESEARCH SL N205223 March 24, 2014 RX GEL VAGINAL 8658678 June 27, 2028 TREATMENT OF BACTERIAL VAGINOSIS
1.3% NUVESSA CHEMO RESEARCH SL N205223 March 24, 2014 RX GEL VAGINAL 8946276 June 28, 2032 TREATMENT OF BACTERIAL VAGINOSIS WITH METRONIDAZOLE GEL
1.3% NUVESSA CHEMO RESEARCH SL N205223 March 24, 2014 RX GEL VAGINAL 9198858 June 28, 2032 TREATMENT OF BACTERIAL VAGINOSIS WITH METRONIDAZOLE GEL

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
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
CHEMBL1200869 ChEMBL_ID
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 0115-1474 GEL 7.50 mg TOPICAL ANDA 16 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0143-9772 INJECTION, SOLUTION 500 mg INTRAVENOUS ANDA 24 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0168-0275 GEL 7.50 mg TOPICAL ANDA 17 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0168-0323 CREAM 7.50 mg TOPICAL ANDA 18 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
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
METROGEL HUMAN PRESCRIPTION DRUG LABEL 1 0299-3820 GEL 10 mg TOPICAL NDA 27 sections
METROGEL HUMAN PRESCRIPTION DRUG LABEL 1 0299-3820 GEL 10 mg TOPICAL NDA 27 sections
MetroCream HUMAN PRESCRIPTION DRUG LABEL 1 0299-3836 CREAM 7.50 mg TOPICAL NDA 9 sections
MetroLotion HUMAN PRESCRIPTION DRUG LABEL 1 0299-3838 LOTION 7.50 mg TOPICAL NDA 10 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0338-1055 INJECTION, SOLUTION 500 mg INTRAVENOUS NDA 25 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0338-9541 INJECTION, SOLUTION 500 mg INTRAVENOUS NDA 24 sections
METRONIDAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 0404-9911 INJECTION, SOLUTION 500 mg INTRAVENOUS NDA 14 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0409-0152 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 27 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0409-7811 INJECTION, SOLUTION 500 mg INTRAVENOUS NDA 13 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 0713-0633 CREAM 7.50 mg TOPICAL ANDA 11 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 0713-0757 CREAM 7.50 mg TOPICAL ANDA 10 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0713-0757 CREAM 7.50 mg TOPICAL ANDA 10 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-7077 GEL 7.50 mg VAGINAL ANDA 21 sections
Metronidazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-7080 GEL 10 mg TOPICAL ANDA 23 sections