metronidazole 🐶 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 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

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 445.04 10.27 307 75730 24069 63388916
Abortion spontaneous 371.10 10.27 364 75673 46831 63366154
Clostridium difficile infection 369.50 10.27 298 75739 29624 63383361
Toxic encephalopathy 305.88 10.27 152 75885 6427 63406558
Abortion incomplete 299.73 10.27 120 75917 3011 63409974
Clostridium difficile colitis 260.60 10.27 208 75829 20361 63392624
Contraindicated product administered 209.09 10.27 13 76024 217635 63195350
Drug reaction with eosinophilia and systemic symptoms 201.45 10.27 225 75812 33611 63379374
Neurotoxicity 192.50 10.27 161 75876 16829 63396156
Acute generalised exanthematous pustulosis 189.01 10.27 134 75903 10965 63402020
International normalised ratio fluctuation 179.98 10.27 78 75959 2400 63410585
Systemic lupus erythematosus 172.65 10.27 23 76014 208895 63204090
Abdominal pain 169.48 10.27 748 75289 292708 63120277
Arthropathy 157.82 10.27 43 75994 234749 63178236
Colitis 157.27 10.27 239 75798 48289 63364696
Pseudomembranous colitis 156.91 10.27 76 75961 3036 63409949
Glossodynia 149.45 10.27 19 76018 178857 63234128
Drug hypersensitivity 148.03 10.27 749 75288 309938 63103047
Alopecia 141.49 10.27 118 75919 337418 63075567
Therapeutic product effect decreased 138.32 10.27 31 76006 193156 63219829
Septic shock 130.69 10.27 263 75774 66366 63346619
Joint swelling 128.37 10.27 122 75915 327544 63085441
Synovitis 127.92 10.27 33 76004 186885 63226100
Bloody discharge 123.14 10.27 52 75985 1499 63411486
Crohn's disease 116.74 10.27 73 75964 4840 63408145
Anaphylactic reaction 114.55 10.27 248 75789 65852 63347133
Wound 111.37 10.27 29 76008 163234 63249751
Colitis ulcerative 110.42 10.27 146 75891 25945 63387040
Pericarditis 109.83 10.27 14 76023 131565 63281420
Haematochezia 109.38 10.27 215 75822 53329 63359656
Female genital tract fistula 105.59 10.27 81 75956 7478 63405507
Rheumatoid arthritis 104.74 10.27 90 75947 253729 63159256
Toxic epidermal necrolysis 104.50 10.27 140 75897 25194 63387791
Paraesthesia oral 104.36 10.27 122 75915 19134 63393851
Multiple organ dysfunction syndrome 103.02 10.27 217 75820 56535 63356450
Vaginal flatulence 101.88 10.27 58 75979 3235 63409750
Fatigue 98.66 10.27 642 75395 887386 62525599
Cerebellar syndrome 98 10.27 58 75979 3481 63409504
Vaginal discharge 97.70 10.27 84 75953 9114 63403871
Encephalopathy 95.04 10.27 168 75869 38452 63374533
Haemorrhage 92.38 10.27 217 75820 60805 63352180
Completed suicide 91.79 10.27 30 76007 145643 63267342
Hepatitis 91.44 10.27 168 75869 39620 63373365
Fall 91.20 10.27 210 75827 392124 63020861
Oral candidiasis 91.01 10.27 124 75913 22674 63390311
Lyme disease 88.96 10.27 54 75983 3395 63409590
Exposure during pregnancy 88.45 10.27 395 75642 155152 63257833
Cholecystitis chronic 87.18 10.27 83 75954 10278 63402707
Rash maculo-papular 86.69 10.27 145 75892 31751 63381234
Pancreatitis haemorrhagic 86.15 10.27 30 76007 503 63412482
Product use issue 85.25 10.27 83 75954 220437 63192548
Chronic sinusitis 84.42 10.27 90 75947 12753 63400232
Proctitis 84.21 10.27 62 75975 5379 63407606
Ataxia 78.58 10.27 94 75943 15101 63397884
Abdominal discomfort 78.43 10.27 167 75870 320718 63092267
Diverticulitis 76.18 10.27 155 75882 39402 63373583
Arthralgia 75.30 10.27 389 75648 569321 62843664
Dysbiosis 74.01 10.27 31 76006 875 63412110
Sinusitis 71.78 10.27 100 75937 226553 63186432
Faecal volume decreased 71.15 10.27 20 76017 157 63412828
Swelling 70.95 10.27 139 75898 275239 63137746
Helicobacter infection 70.29 10.27 13 76024 92772 63320213
Nasopharyngitis 69.32 10.27 124 75913 254133 63158852
Fistula 68.61 10.27 73 75964 10320 63402665
Procedural pain 68.12 10.27 105 75932 21464 63391521
Swelling face 67.66 10.27 198 75839 63277 63349708
Drug abuse 67.62 10.27 5 76032 72513 63340472
Psoriatic arthropathy 66.86 10.27 14 76023 91506 63321479
Hepatic enzyme increased 66.36 10.27 87 75950 202241 63210744
Cholestasis 66.01 10.27 123 75914 29311 63383674
Enterocolitis haemorrhagic 65.57 10.27 33 76004 1433 63411552
Muscle injury 65.51 10.27 3 76034 65342 63347643
Fixed eruption 63.47 10.27 30 76007 1134 63411851
Clostridial infection 63.40 10.27 48 75989 4344 63408641
Radiculopathy 63.16 10.27 64 75973 8547 63404438
Death 63.16 10.27 233 75804 374148 63038837
Pyrexia 61.82 10.27 846 75191 469632 62943353
Frequent bowel movements 60.36 10.27 103 75934 22919 63390066
Acinetobacter infection 54.75 10.27 30 76007 1553 63411432
Drug ineffective for unapproved indication 54.69 10.27 124 75913 33939 63379046
Angioedema 54.39 10.27 153 75884 47812 63365173
Folliculitis 52.94 10.27 10 76027 70307 63342678
Discomfort 52.82 10.27 74 75963 167300 63245685
Vomiting 52.15 10.27 950 75087 558667 62854318
Rectal haemorrhage 51.34 10.27 152 75885 48878 63364107
Lip swelling 49.79 10.27 113 75924 30950 63382035
Weight increased 49.60 10.27 154 75883 260638 63152347
Systemic mastocytosis 48.77 10.27 15 76022 166 63412819
Swollen tongue 48.62 10.27 120 75917 34680 63378305
Anal fistula 47.30 10.27 37 76000 3514 63409471
Loss of personal independence in daily activities 47.24 10.27 29 76008 97261 63315724
Stevens-Johnson syndrome 47.13 10.27 97 75940 24853 63388132
Musculoskeletal stiffness 45.96 10.27 95 75942 184523 63228462
Hepatic failure 44.68 10.27 118 75919 35538 63377447
Emotional distress 44.17 10.27 111 75926 32438 63380547
Necrosis ischaemic 43.35 10.27 21 76016 839 63412146
Pelvic inflammatory disease 42.81 10.27 26 76011 1636 63411349
Chromaturia 42.78 10.27 74 75963 16643 63396342
Cerebellar ataxia 42.40 10.27 21 76016 881 63412104
Knee arthroplasty 42.35 10.27 7 76030 54199 63358786
Pathogen resistance 42.34 10.27 45 75992 6353 63406632
Stomatitis 42.12 10.27 63 75974 138662 63274323
Mobility decreased 41.89 10.27 50 75987 121109 63291876
Clostridium colitis 41.89 10.27 27 76010 1887 63411098
Megacolon 41.87 10.27 27 76010 1888 63411097
Type IV hypersensitivity reaction 40.35 10.27 31 76006 2867 63410118
Abdominal pain lower 39.59 10.27 92 75945 25586 63387399
Peripheral swelling 39.44 10.27 174 75863 265768 63147217
Dysmetria 39.31 10.27 17 76020 520 63412465
Asthma 38.66 10.27 58 75979 127503 63285482
Beta haemolytic streptococcal infection 38.11 10.27 26 76011 1999 63410986
Oedematous pancreatitis 38.03 10.27 17 76020 564 63412421
Acute hepatic failure 37.90 10.27 74 75963 18253 63394732
Sepsis 37.83 10.27 313 75724 152810 63260175
Toxic shock syndrome 37.80 10.27 19 76018 823 63412162
Staphylococcal infection 37.72 10.27 122 75915 41134 63371851
Pelvic pain 37.45 10.27 62 75975 13457 63399528
Vanishing bile duct syndrome 37.27 10.27 18 76019 714 63412271
Endometritis 37.17 10.27 20 76017 998 63411987
Pouchitis 36.95 10.27 16 76021 491 63412494
Alcohol intolerance 36.77 10.27 11 76026 110 63412875
Drug intolerance 36.69 10.27 218 75819 308443 63104542
Fibromyalgia 36.30 10.27 26 76011 80394 63332591
Product dose omission issue 36.15 10.27 151 75886 234162 63178823
Dermatitis allergic 36.11 10.27 65 75972 15083 63397902
Pneumonia streptococcal 35.86 10.27 24 76013 1787 63411198
Stenotrophomonas infection 35.73 10.27 25 76012 2002 63410983
Hip arthroplasty 35.39 10.27 7 76030 47639 63365346
Dysarthria 35.23 10.27 122 75915 42589 63370396
International normalised ratio increased 35.21 10.27 129 75908 46296 63366689
Cough 35.19 10.27 206 75831 292537 63120448
Anal abscess 35.02 10.27 35 76002 4597 63408388
Disseminated intravascular coagulation 34.73 10.27 73 75964 18978 63394007
Axonal neuropathy 34.33 10.27 19 76018 1003 63411982
Rash macular 34.17 10.27 82 75955 23282 63389703
Lemierre syndrome 33.43 10.27 10 76027 100 63412885
Biliary dyskinesia 33.28 10.27 27 76010 2702 63410283
Rosacea 32.88 10.27 34 76003 4650 63408335
Erythema 32.68 10.27 338 75699 175413 63237572
Endocrine ophthalmopathy 32.67 10.27 16 76021 655 63412330
Uterine perforation 32.64 10.27 41 75996 6922 63406063
Anal fissure 32.55 10.27 33 76004 4410 63408575
Type 2 diabetes mellitus 32.47 10.27 18 76019 63850 63349135
Arthritis 32.03 10.27 56 75981 115865 63297120
Bursitis infective 32.02 10.27 20 76017 1323 63411662
Rash papular 31.99 10.27 63 75974 15639 63397346
Low birth weight baby 31.88 10.27 41 75996 7088 63405897
Abscess 31.71 10.27 65 75972 16603 63396382
Injury 31.58 10.27 172 75865 73075 63339910
Dysgeusia 31.47 10.27 125 75912 46585 63366400
Injection site pain 31.28 10.27 68 75969 129732 63283253
Drug interaction 31.20 10.27 415 75622 228716 63184269
Posterior reversible encephalopathy syndrome 31.08 10.27 66 75971 17279 63395706
Infusion related reaction 31.00 10.27 170 75867 245351 63167634
Thrombotic thrombocytopenic purpura 30.89 10.27 30 76007 3806 63409179
Impaired healing 30.70 10.27 47 75990 102495 63310490
Leukocytosis 30.65 10.27 84 75953 25851 63387134
Biliary sepsis 30.43 10.27 17 76020 914 63412071
Adenoviral hepatitis 30.36 10.27 13 76024 388 63412597
Adverse event 30.28 10.27 22 76015 67537 63345448
Mucous stools 30.12 10.27 31 76006 4217 63408768
Meningitis candida 29.91 10.27 8 76029 51 63412934
Idiosyncratic drug reaction 29.49 10.27 16 76021 812 63412173
Vulvovaginal swelling 29.43 10.27 14 76023 537 63412448
Vitamin K deficiency 29.20 10.27 13 76024 427 63412558
Enterovesical fistula 29.14 10.27 14 76023 549 63412436
Dermatitis bullous 29.11 10.27 43 75994 8465 63404520
Paraesthesia 28.76 10.27 301 75736 156665 63256320
Hepatitis infectious mononucleosis 28.60 10.27 9 76028 108 63412877
Diarrhoea haemorrhagic 28.52 10.27 44 75993 8998 63403987
Oedematous kidney 28.38 10.27 9 76028 111 63412874
Nystagmus 28.17 10.27 36 76001 6184 63406801
Treatment failure 27.85 10.27 133 75904 198910 63214075
Rectal tube insertion 27.80 10.27 6 76031 12 63412973
Large intestine perforation 27.78 10.27 42 75995 8440 63404545
Clostridium test positive 27.61 10.27 26 76011 3175 63409810
Gallbladder disorder 27.41 10.27 66 75971 18776 63394209
Premature baby 27.39 10.27 70 75967 20665 63392320
Intentional overdose 27.38 10.27 29 76008 74123 63338862
Stillbirth 27.37 10.27 37 76000 6713 63406272
Nausea 27.34 10.27 1267 74770 853204 62559781
Purple glove syndrome 26.94 10.27 10 76027 203 63412782
Coagulopathy 26.77 10.27 69 75968 20475 63392510
Acute psychosis 26.69 10.27 23 76014 2502 63410483
Distributive shock 26.60 10.27 18 76019 1365 63411620
Blood cholesterol increased 26.37 10.27 45 75992 93987 63318998
Ureteric obstruction 26.03 10.27 20 76017 1850 63411135
Enterococcal infection 25.90 10.27 39 75998 7809 63405176
Shock 25.77 10.27 74 75963 23389 63389596
Vaginal infection 25.73 10.27 38 75999 7480 63405505
Gingival swelling 25.63 10.27 29 76008 4389 63408596
Pancreatitis acute 25.43 10.27 81 75956 27085 63385900
Rectal abscess 25.40 10.27 17 76020 1266 63411719
Adverse drug reaction 25.37 10.27 35 76002 79679 63333306
Lower respiratory tract infection 25.22 10.27 78 75959 132229 63280756
Upper respiratory tract infection 25.15 10.27 37 76000 82010 63330975
Abdominal abscess 25.06 10.27 29 76008 4497 63408488
Hepatocellular injury 25.05 10.27 81 75956 27300 63385685
Injection site erythema 25.02 10.27 38 75999 83136 63329849
Generalised tonic-clonic seizure 24.91 10.27 84 75953 28932 63384053
Magnetic resonance imaging head abnormal 24.73 10.27 20 76017 1993 63410992
Incubator therapy 24.68 10.27 7 76030 57 63412928
Leukaemoid reaction 24.66 10.27 9 76028 174 63412811
Metabolic acidosis 24.49 10.27 113 75924 44956 63368029
Anxiety 24.43 10.27 381 75656 217160 63195825
Malignant neoplasm progression 24.24 10.27 38 75999 82083 63330902
Osmotic demyelination syndrome 24.14 10.27 13 76024 650 63412335
Proctalgia 24.03 10.27 33 76004 6077 63406908
Morganella infection 23.99 10.27 13 76024 658 63412327
Toxic shock syndrome streptococcal 23.85 10.27 8 76029 119 63412866
Influenza 23.75 10.27 60 75977 108662 63304323
Hyperleukocytosis 23.72 10.27 13 76024 673 63412312
Dyspepsia 23.69 10.27 206 75831 101990 63310995
Retained products of conception 23.55 10.27 8 76029 124 63412861
Skin ulcer 23.44 10.27 108 75929 42937 63370048
Intrauterine infection 23.43 10.27 8 76029 126 63412859
Intentional product misuse 23.42 10.27 23 76014 60894 63352091
Eosinophilia 23.30 10.27 70 75967 22686 63390299
Neuropathy peripheral 23.24 10.27 223 75814 113444 63299541
Intestinal perforation 23.17 10.27 47 75990 11916 63401069
Electrocardiogram QT prolonged 23.16 10.27 136 75901 59394 63353591
Cholecystitis acute 23.04 10.27 38 75999 8222 63404763
Ill-defined disorder 23.04 10.27 39 75998 81716 63331269
Foetal non-stress test abnormal 23.03 10.27 6 76031 34 63412951
Diarrhoea 22.89 10.27 1061 74976 714305 62698680
Fistula discharge 22.89 10.27 15 76022 1078 63411907
Procedural hypertension 22.88 10.27 10 76027 314 63412671
Feeling guilty 22.85 10.27 12 76025 570 63412415
Prescribed underdose 22.82 10.27 4 76033 29685 63383300
Hepatic necrosis 22.79 10.27 31 76006 5656 63407329
Irritable bowel syndrome 22.59 10.27 40 75997 82372 63330613
Candida infection 22.53 10.27 80 75957 28271 63384714
Leukoencephalopathy 22.32 10.27 27 76010 4386 63408599
Henoch-Schonlein purpura 22.04 10.27 15 76022 1148 63411837
Foetal monitoring abnormal 21.96 10.27 9 76028 240 63412745
Eyelid disorder 21.93 10.27 18 76019 1831 63411154
Haemostasis 21.93 10.27 9 76028 241 63412744
Blister 21.69 10.27 81 75956 129733 63283252
Therapeutic response decreased 21.68 10.27 25 76012 61500 63351485
Bronchitis 21.51 10.27 77 75960 124858 63288127
Pain 21.50 10.27 700 75337 739928 62673057
Foetal arrhythmia 21.17 10.27 8 76029 171 63412814
Klebsiella infection 20.73 10.27 37 76000 8529 63404456
Pneumonia 20.72 10.27 404 75633 456363 62956622
Colitis ischaemic 20.66 10.27 42 75995 10666 63402319
Postural orthostatic tachycardia syndrome 20.65 10.27 15 76022 1274 63411711
Pulmonary trichosporonosis 20.43 10.27 6 76031 56 63412929
Accidental exposure to product 20.41 10.27 4 76033 27401 63385584
Hypoglossal nerve paresis 20.40 10.27 7 76030 112 63412873
Weber tuning fork test abnormal 20.40 10.27 7 76030 112 63412873
Cholelithiasis 20.19 10.27 105 75932 43820 63369165
Retroperitoneal haematoma 20.19 10.27 21 76016 2892 63410093
Dyspnoea 20.15 10.27 621 75416 660692 62752293
Anterior interosseous syndrome 20.15 10.27 4 76033 4 63412981
Erythema multiforme 19.75 10.27 40 75997 10129 63402856
Abscess intestinal 19.75 10.27 16 76021 1598 63411387
Bacterial vulvovaginitis 19.35 10.27 12 76025 784 63412201
Injection site reaction 19.33 10.27 25 76012 58499 63354486
Wheezing 19.19 10.27 55 75982 95540 63317445
Vulval ulceration 19.14 10.27 9 76028 336 63412649
Drug-induced liver injury 19.08 10.27 97 75940 40125 63372860
Burning sensation 19.07 10.27 121 75916 54286 63358699
Vaginitis gardnerella 18.95 10.27 5 76032 30 63412955
Jaundice 18.68 10.27 77 75960 29174 63383811
Toxic skin eruption 18.60 10.27 45 75992 12840 63400145
Musculoskeletal pain 18.59 10.27 53 75984 92224 63320761
Injection site pruritus 18.57 10.27 16 76021 45100 63367885
Heparin-induced thrombocytopenia 18.40 10.27 25 76012 4557 63408428
Cholecystitis 18.36 10.27 50 75987 15327 63397658
Infusion site streaking 18.30 10.27 10 76027 515 63412470
Abortion infected 18.29 10.27 5 76032 35 63412950
Puerperal pyrexia 18.05 10.27 5 76032 37 63412948
Psychotic disorder due to a general medical condition 17.82 10.27 8 76029 268 63412717
White blood cell count decreased 17.71 10.27 96 75941 139008 63273977
Bone erosion 17.67 10.27 54 75983 17663 63395322
Depersonalisation/derealisation disorder 17.64 10.27 14 76023 1358 63411627
Tongue coated 17.61 10.27 14 76023 1361 63411624
Nervous system disorder 17.61 10.27 56 75981 18710 63394275
Electrocardiogram T wave alternans 17.60 10.27 5 76032 41 63412944
Candida sepsis 17.57 10.27 14 76023 1366 63411619
Device expulsion 17.52 10.27 10 76027 34912 63378073
Herpes simplex hepatitis 17.50 10.27 9 76028 409 63412576
Gastrointestinal injury 17.49 10.27 10 76027 562 63412423
Red cell fragmentation syndrome 17.49 10.27 5 76032 42 63412943
Foetal anaemia 17.49 10.27 6 76031 96 63412889
Thrombocytopenia 17.44 10.27 266 75771 150891 63262094
Enterocutaneous fistula 17.42 10.27 14 76023 1383 63411602
Hallucinations, mixed 17.38 10.27 25 76012 4804 63408181
Tachycardia 17.32 10.27 217 75820 117939 63295046
Wrong technique in product usage process 17.32 10.27 30 76007 62310 63350675
Airway peak pressure increased 17.31 10.27 8 76029 287 63412698
Venous haemorrhage 17.26 10.27 8 76029 289 63412696
Skin odour abnormal 17.26 10.27 15 76022 1651 63411334
White blood cells stool 17.19 10.27 3 76034 0 63412985
Medical device site pain 17.18 10.27 7 76030 184 63412801
Respiratory disorder 17.16 10.27 13 76024 39069 63373916
Sopor 17.01 10.27 3 76034 22161 63390824
Urticaria 16.97 10.27 286 75751 165516 63247469
Nodular rash 16.70 10.27 7 76030 198 63412787
Nasal ulcer 16.67 10.27 17 76020 2287 63410698
Hypertension 16.60 10.27 235 75802 279068 63133917
Mean cell haemoglobin increased 16.54 10.27 19 76018 2924 63410061
Torsade de pointes 16.53 10.27 44 75993 13307 63399678
Therapeutic product effect incomplete 16.38 10.27 225 75812 124831 63288154
Fusarium infection 16.37 10.27 10 76027 636 63412349
Fear of death 16.36 10.27 12 76025 1035 63411950
Herpes simplex colitis 16.12 10.27 4 76033 18 63412967
Vulval disorder 15.95 10.27 11 76026 861 63412124
Dysdiadochokinesis 15.93 10.27 6 76031 127 63412858
Aspergillus infection 15.92 10.27 32 76005 8061 63404924
Toxicity to various agents 15.78 10.27 205 75832 247045 63165940
Diarrhoea infectious 15.72 10.27 12 76025 1099 63411886
Large intestinal ulcer 15.70 10.27 20 76017 3424 63409561
Mastitis bacterial 15.67 10.27 5 76032 63 63412922
Retroperitoneal haemorrhage 15.62 10.27 18 76019 2779 63410206
Anal skin tags 15.61 10.27 9 76028 514 63412471
Reticulocytosis 15.47 10.27 6 76031 138 63412847
Swelling of eyelid 15.46 10.27 19 76018 3137 63409848
Prescribed overdose 15.46 10.27 11 76026 34142 63378843
Ballismus 15.43 10.27 6 76031 139 63412846
Perirectal abscess 15.38 10.27 11 76026 912 63412073
Cataract 15.36 10.27 28 76009 57025 63355960
Peripheral sensory neuropathy 15.30 10.27 30 76007 7421 63405564
Tendonitis 15.29 10.27 55 75982 19560 63393425
Skin test positive 15.22 10.27 10 76027 722 63412263
Rheumatoid factor positive 15.21 10.27 51 75986 84355 63328630
Gynaecological examination abnormal 15.11 10.27 3 76034 3 63412982
Systemic candida 15.04 10.27 19 76018 3226 63409759
Myocardial infarction 15.00 10.27 65 75972 99828 63313157
Abnormal faeces 15.00 10.27 25 76012 5455 63407530
Toxic leukoencephalopathy 14.99 10.27 10 76027 741 63412244
Bacterial vaginosis 14.97 10.27 13 76024 1429 63411556
Superinfection 14.93 10.27 17 76020 2590 63410395
Hospitalisation 14.93 10.27 52 75985 85029 63327956
Cholestatic liver injury 14.92 10.27 17 76020 2593 63410392
Type I hypersensitivity 14.88 10.27 18 76019 2924 63410061
Infective aneurysm 14.84 10.27 8 76029 401 63412584
Multiple sclerosis relapse 14.72 10.27 22 76015 48456 63364529
Optic neuropathy 14.72 10.27 15 76022 2017 63410968
Scar 14.68 10.27 43 75994 13739 63399246
Developmental delay 14.65 10.27 13 76024 1470 63411515
Venoocclusive liver disease 14.52 10.27 23 76014 4812 63408173
Interstitial lung disease 14.44 10.27 33 76004 61875 63351110
Memory impairment 14.37 10.27 70 75967 104188 63308797
Chemical burns of eye 14.29 10.27 5 76032 85 63412900
Enterocolitis 14.19 10.27 30 76007 7828 63405157
Trichoglossia 14.17 10.27 7 76030 292 63412693
Anaphylactic shock 14.15 10.27 61 75976 23572 63389413
Peritonitis 14.14 10.27 49 75988 17105 63395880
Tongue dry 14.12 10.27 11 76026 1038 63411947
Epidermal necrosis 14.11 10.27 11 76026 1039 63411946
Vaginal abscess 14.04 10.27 8 76029 447 63412538
Joint range of motion decreased 13.97 10.27 11 76026 32417 63380568
Orbital oedema 13.95 10.27 7 76030 302 63412683
Pseudomonas infection 13.93 10.27 37 76000 11176 63401809
Abdominal sepsis 13.91 10.27 12 76025 1307 63411678
COVID-19 13.88 10.27 79 75958 113024 63299961
Hyporeflexia 13.74 10.27 14 76023 1881 63411104
Geotrichum infection 13.73 10.27 8 76029 466 63412519
Consciousness fluctuating 13.69 10.27 10 76027 857 63412128
Delayed delivery 13.65 10.27 4 76033 37 63412948
Lower limb fracture 13.56 10.27 6 76031 24215 63388770
Large intestine infection 13.53 10.27 14 76023 1916 63411069
Blood glucose increased 13.51 10.27 53 75984 83703 63329282
Musculoskeletal disorder 13.44 10.27 4 76033 20640 63392345
Mental status changes 13.22 10.27 87 75950 39512 63373473
Haemodynamic instability 13.16 10.27 32 76005 9158 63403827
Pustule 13.15 10.27 13 76024 1686 63411299
Choriocarcinoma 13.11 10.27 4 76033 43 63412942
Calcification of muscle 13.11 10.27 4 76033 43 63412942
Lung disorder 13.11 10.27 35 76002 62226 63350759
Liver function test increased 13.07 10.27 12 76025 32799 63380186
Eye infection 13.04 10.27 38 75999 12107 63400878
Erythema nodosum 13.03 10.27 22 76015 4853 63408132
Intestinal dilatation 13.00 10.27 13 76024 1709 63411276
Premature delivery 12.97 10.27 71 75966 30210 63382775
Linear IgA disease 12.93 10.27 12 76025 1439 63411546
Pharyngeal oedema 12.92 10.27 41 75996 13680 63399305
Prothrombin time ratio decreased 12.80 10.27 8 76029 530 63412455
Congenital cardiovascular anomaly 12.65 10.27 5 76032 121 63412864
Femur fracture 12.63 10.27 19 76018 41737 63371248
Strongyloidiasis 12.45 10.27 11 76026 1237 63411748
Tongue discolouration 12.40 10.27 17 76020 3126 63409859
Procedural anxiety 12.36 10.27 9 76028 767 63412218
Neonatal respiratory distress 12.33 10.27 7 76030 388 63412597
Lymphomatoid papulosis 12.32 10.27 5 76032 130 63412855
Agranulocytosis 12.19 10.27 61 75976 25073 63387912
Gastrointestinal stoma complication 12.19 10.27 13 76024 1842 63411143
Leuconostoc infection 12.18 10.27 3 76034 13 63412972
Mouth swelling 12.15 10.27 21 76016 4719 63408266
Bacteraemia 12.15 10.27 47 75990 17301 63395684
Impaired work ability 12.10 10.27 3 76034 17472 63395513
Dry mouth 12.10 10.27 50 75987 77813 63335172
Wound haemorrhage 12.09 10.27 15 76022 2501 63410484
Laryngeal inflammation 12.04 10.27 5 76032 138 63412847
Sciatica 12.03 10.27 14 76023 34310 63378675
Skin burning sensation 11.95 10.27 38 75999 12696 63400289
Breast cancer 11.94 10.27 25 76012 48358 63364627
Oxygen saturation decreased 11.91 10.27 60 75977 88525 63324460
Obesity 11.87 10.27 11 76026 29941 63383044
Periorbital oedema 11.81 10.27 23 76014 5661 63407324
Liver disorder 11.81 10.27 107 75930 53580 63359405
Hypoalbuminaemia 11.79 10.27 36 76001 11769 63401216
Laboratory test abnormal 11.75 10.27 9 76028 26903 63386082
Drug level below therapeutic 11.75 10.27 21 76016 4845 63408140
Merycism 11.62 10.27 6 76031 275 63412710
Rhinorrhoea 11.56 10.27 40 75997 65537 63347448
Vulvovaginitis trichomonal 11.52 10.27 3 76034 17 63412968
Vulval haemorrhage 11.52 10.27 3 76034 17 63412968
Balance disorder 11.45 10.27 57 75980 84365 63328620
Diverticulum 11.45 10.27 36 76001 11955 63401030
Abscess fungal 11.43 10.27 4 76033 68 63412917
Pelvic fluid collection 11.39 10.27 9 76028 867 63412118
Haematoma infection 11.31 10.27 8 76029 652 63412333
Amoebiasis 11.28 10.27 4 76033 71 63412914
Fear 11.27 10.27 43 75994 15723 63397262
Wound secretion 11.25 10.27 20 76017 4594 63408391
Uterine hypertonus 11.25 10.27 6 76031 294 63412691
Macule 11.24 10.27 13 76024 2015 63410970
Chronic obstructive pulmonary disease 11.21 10.27 38 75999 62648 63350337
Haemophagocytic lymphohistiocytosis 11.17 10.27 33 76004 10594 63402391
Cytomegalovirus colitis 11.17 10.27 14 76023 2358 63410627
Cyanosis 11.15 10.27 45 75992 16890 63396095
Foetal exposure during pregnancy 11.15 10.27 71 75966 31891 63381094
Phantom limb syndrome 11.13 10.27 5 76032 168 63412817
Cholecystectomy 11.08 10.27 33 76004 10644 63402341
Pharyngeal inflammation 11.07 10.27 8 76029 674 63412311
Stenosis 11.02 10.27 11 76026 1443 63411542
Full blood count decreased 10.99 10.27 9 76028 26015 63386970
Peri-implantitis 10.97 10.27 4 76033 77 63412908
Blood osmolarity decreased 10.94 10.27 9 76028 919 63412066
Pain in extremity 10.87 10.27 308 75729 331178 63081807
Bartter's syndrome 10.85 10.27 3 76034 22 63412963
Suicide attempt 10.85 10.27 37 76000 60881 63352104
Hyperbilirubinaemia 10.83 10.27 34 76003 11280 63401705
Fluid retention 10.80 10.27 36 76001 59650 63353335
Refusal of treatment by relative 10.77 10.27 6 76031 321 63412664
Vitamin D increased 10.76 10.27 8 76029 704 63412281
Catheter site related reaction 10.71 10.27 9 76028 946 63412039
Serum sickness-like reaction 10.68 10.27 7 76030 503 63412482
Deep vein thrombosis 10.66 10.27 150 75887 83650 63329335
Hidradenitis 10.64 10.27 15 76022 2831 63410154
Intermittent positive pressure breathing 10.62 10.27 3 76034 24 63412961
Cytotoxic oedema 10.60 10.27 5 76032 188 63412797
Injection site swelling 10.58 10.27 26 76011 47546 63365439
Vitamin B1 deficiency 10.55 10.27 6 76031 334 63412651
Cardiac failure 10.54 10.27 63 75974 89079 63323906
Osteoarthritis 10.44 10.27 69 75968 95274 63317711
Agonal rhythm 10.41 10.27 3 76034 26 63412959
Malnutrition 10.35 10.27 41 75996 15257 63397728
Hypovolaemic shock 10.33 10.27 23 76014 6218 63406767
Hyperintensity in brain deep nuclei 10.31 10.27 3 76034 27 63412958
Staphylococcal sepsis 10.28 10.27 27 76010 8101 63404884
Gingival discomfort 10.28 10.27 6 76031 351 63412634

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 499.44 10.86 212 50949 5037 34900733
Appendicolith 236.94 10.86 151 51010 8450 34897320
Neurotoxicity 233.99 10.86 201 50960 17809 34887961
Appendicitis 233.65 10.86 185 50976 14622 34891148
Multiple organ dysfunction syndrome 209.20 10.86 390 50771 76176 34829594
Drug reaction with eosinophilia and systemic symptoms 179.08 10.86 231 50930 32781 34872989
Clostridium difficile colitis 156.19 10.86 151 51010 15579 34890191
Cerebellar syndrome 155.45 10.86 74 51087 2314 34903456
Abdominal distension 147.41 10.86 288 50873 58204 34847566
Ascites 143.39 10.86 250 50911 46321 34859449
Ataxia 143.25 10.86 136 51025 13717 34892053
Colitis 142.29 10.86 222 50939 37528 34868242
Pseudomembranous colitis 141.61 10.86 73 51088 2718 34903052
Abdominal pain 141.11 10.86 542 50619 163076 34742694
Drug abuse 130.59 10.86 3 51158 99093 34806677
Pathogen resistance 127.57 10.86 108 51053 9374 34896396
Death 121.31 10.86 251 50910 397798 34507972
Cardiogenic shock 121.07 10.86 171 50990 26447 34879323
Megacolon 120.60 10.86 57 51104 1753 34904017
Fistula 117.73 10.86 90 51071 6750 34899020
Night sweats 111.07 10.86 132 51029 17220 34888550
Ventricular fibrillation 108.17 10.86 150 51011 22804 34882966
Encephalopathy 107.91 10.86 189 50972 35130 34870640
Septic shock 96.78 10.86 277 50884 71557 34834213
Stress 96.10 10.86 165 50996 30182 34875588
Sepsis 93.68 10.86 486 50675 166075 34739695
Kounis syndrome 92.01 10.86 53 51108 2465 34903305
Abdominal abscess 90.13 10.86 63 51098 4112 34901658
Crohn's disease 89.01 10.86 56 51105 3061 34902709
Completed suicide 86.39 10.86 19 51142 98149 34807621
Blood phosphorus increased 85.97 10.86 79 51082 7642 34898128
Acute generalised exanthematous pustulosis 84.68 10.86 74 51087 6702 34899068
Clostridium difficile infection 79.48 10.86 117 51044 18781 34886989
Clostridial infection 76.60 10.86 54 51107 3573 34902197
Pyrexia 75.98 10.86 782 50379 332231 34573539
Cerebellar ataxia 75.07 10.86 35 51126 1043 34904727
Fall 72.22 10.86 116 51045 202769 34703001
Dysarthria 71.97 10.86 158 51003 34624 34871146
Product dose omission issue 66.52 10.86 47 51114 119664 34786106
Fixed eruption 65.38 10.86 37 51124 1663 34904107
Herpes simplex oesophagitis 60.68 10.86 19 51142 180 34905590
Anal abscess 56.59 10.86 58 51103 6415 34899355
Clostridium test positive 55.38 10.86 43 51118 3299 34902471
Fistula discharge 53.68 10.86 26 51135 845 34904925
Rash maculo-papular 51.93 10.86 123 51038 28328 34877442
Eosinophilia 51.86 10.86 117 51044 26105 34879665
Enterococcal infection 51.80 10.86 66 51095 9240 34896530
Cardiac failure congestive 48.51 10.86 31 51130 83239 34822531
Cholestasis 47.56 10.86 115 51046 26833 34878937
Anal fistula 46.52 10.86 48 51113 5351 34900419
Condition aggravated 45.40 10.86 455 50706 191741 34714029
Interstitial lung disease 44.32 10.86 20 51141 65262 34840508
Rheumatoid arthritis 44.21 10.86 3 51158 38235 34867535
Foetal cardiac arrest 44.00 10.86 10 51151 21 34905749
Hyphaema 43.82 10.86 20 51141 567 34905203
Dyspnoea 43.19 10.86 349 50812 376433 34529337
Cardiac failure 43.04 10.86 42 51119 91206 34814564
Anaphylactic reaction 42.91 10.86 124 51037 32177 34873593
Abscess 42.42 10.86 68 51093 11749 34894021
Linear IgA disease 40.97 10.86 27 51134 1599 34904171
Cough 40.37 10.86 101 51060 150039 34755731
Epileptic encephalopathy 39.90 10.86 14 51147 194 34905576
Hepatic cytolysis 39.69 10.86 74 51087 14422 34891348
Vomiting 39.29 10.86 543 50618 247078 34658692
Klebsiella infection 39.06 10.86 55 51106 8476 34897294
Abscess intestinal 38.27 10.86 26 51135 1620 34904150
Cytotoxic oedema 37.88 10.86 13 51148 168 34905602
Drug resistance 37.84 10.86 103 51058 25824 34879946
Intentional overdose 37.31 10.86 9 51152 43665 34862105
Nystagmus 37.20 10.86 40 51121 4675 34901095
Agranulocytosis 37.16 10.86 97 51064 23724 34882046
Rash morbilliform 37.15 10.86 33 51128 3054 34902716
Nervous system disorder 37.06 10.86 72 51089 14471 34891299
Cerebrovascular accident 35.61 10.86 43 51118 84768 34821002
Toxic epidermal necrolysis 34.65 10.86 89 51072 21557 34884213
Meningitis candida 34.47 10.86 10 51151 71 34905699
Prostate cancer 34.20 10.86 8 51153 39641 34866129
Diverticular perforation 34.14 10.86 33 51128 3401 34902369
Pneumonia 34.09 10.86 353 50808 362274 34543496
Malignant mesenteric neoplasm 34.03 10.86 9 51152 43 34905727
Undersensing 33.86 10.86 7 51154 7 34905763
Stoma site discomfort 33.69 10.86 8 51153 22 34905748
Chronic gastrointestinal bleeding 33.46 10.86 14 51147 320 34905450
Hospitalisation 30.72 10.86 23 51138 56879 34848891
Drug ineffective 30.30 10.86 878 50283 455873 34449897
Hyponatraemia 30.24 10.86 216 50945 82475 34823295
Gut fermentation syndrome 30.11 10.86 6 51155 4 34905766
Blood uric acid increased 30.02 10.86 52 51109 9572 34896198
Enterococcus test positive 30.01 10.86 19 51142 1050 34904720
Sensitisation 29.85 10.86 11 51150 177 34905593
Suicide attempt 29.82 10.86 10 51151 39106 34866664
Intestinal stenosis 29.60 10.86 25 51136 2161 34903609
Myasthenia gravis 29.22 10.86 43 51118 6897 34898873
Pouchitis 29.20 10.86 16 51145 675 34905095
Metabolic acidosis 29.15 10.86 134 51027 43546 34862224
Lack of spontaneous speech 28.87 10.86 8 51153 47 34905723
Malignant neoplasm progression 28.83 10.86 53 51108 87993 34817777
Jejunal ulcer perforation 28.77 10.86 9 51152 85 34905685
Colitis ulcerative 28.61 10.86 70 51091 16450 34889320
Aminoaciduria 28.53 10.86 12 51149 278 34905492
Candida infection 28.52 10.86 73 51088 17642 34888128
Dysmetria 28.17 10.86 15 51146 597 34905173
Magnetic resonance imaging head abnormal 28.13 10.86 20 51141 1341 34904429
Enterocutaneous fistula 28.07 10.86 18 51143 1017 34904753
Escherichia infection 27.63 10.86 46 51115 8199 34897571
Fungal peritonitis 27.33 10.86 16 51145 767 34905003
Therapeutic product effect decreased 27.33 10.86 112 51049 34631 34871139
Hypertension 27.28 10.86 105 51056 136338 34769432
Aphthous ulcer 27.13 10.86 35 51126 4960 34900810
Infusion site induration 27.06 10.86 11 51150 233 34905537
Leukocytosis 26.92 10.86 87 51074 23978 34881792
Influenza 26.91 10.86 20 51141 49646 34856124
Paraesthesia 26.66 10.86 173 50988 63999 34841771
Haemodynamic instability 26.56 10.86 49 51112 9474 34896296
Enterocolitis haemorrhagic 26.42 10.86 17 51144 966 34904804
Injection site pain 26.39 10.86 12 51149 38993 34866777
Perirectal abscess 26.31 10.86 21 51140 1677 34904093
Long QT syndrome 26.12 10.86 26 51135 2777 34902993
Rash erythematous 25.89 10.86 88 51073 24889 34880881
Antineutrophil cytoplasmic antibody 25.68 10.86 6 51155 15 34905755
Urethral valves 25.38 10.86 11 51150 275 34905495
Ileal perforation 25.03 10.86 15 51146 751 34905019
Transient ischaemic attack 24.98 10.86 5 51156 27608 34878162
Dysdiadochokinesis 24.95 10.86 10 51151 204 34905566
Hepatitis acute 24.93 10.86 42 51119 7559 34898211
Acute hepatic failure 24.76 10.86 60 51101 14014 34891756
Metastases to stomach 24.64 10.86 8 51153 86 34905684
Gastrointestinal inflammation 24.62 10.86 28 51133 3483 34902287
Dry mouth 24.32 10.86 98 51063 30067 34875703
Colitis ischaemic 24.26 10.86 38 51123 6437 34899333
Back pain 24.17 10.86 94 51067 121695 34784075
Drug therapy 24.12 10.86 17 51144 1124 34904646
General physical health deterioration 23.95 10.86 290 50871 127979 34777791
Haematotoxicity 23.91 10.86 43 51118 8151 34897619
Analgesic therapy 23.76 10.86 16 51145 982 34904788
Brain abscess 23.76 10.86 26 51135 3099 34902671
Fatigue 23.67 10.86 391 50770 370262 34535508
Botulism 23.49 10.86 9 51152 162 34905608
Cross sensitivity reaction 23.20 10.86 18 51143 1379 34904391
Tongue discolouration 23.16 10.86 17 51144 1198 34904572
Drug dependence 22.73 10.86 4 51157 24213 34881557
Dyspnoea exertional 22.71 10.86 18 51143 43261 34862509
Clostridium bacteraemia 22.71 10.86 9 51152 178 34905592
COVID-19 22.55 10.86 50 51111 77500 34828270
Mononucleosis syndrome 22.48 10.86 7 51154 65 34905705
Omental necrosis 22.46 10.86 6 51155 30 34905740
Peripheral swelling 21.73 10.86 50 51111 76491 34829279
Anal fissure 21.66 10.86 29 51132 4261 34901509
Bradycardia 21.62 10.86 49 51112 75369 34830401
Joint swelling 21.48 10.86 34 51127 59856 34845914
Functional gastrointestinal disorder 21.35 10.86 21 51140 2210 34903560
Swollen tongue 21.29 10.86 58 51103 14547 34891223
Nasopharyngitis 21.27 10.86 44 51117 69924 34835846
Cataract 21.21 10.86 6 51155 26180 34879590
Eastern Cooperative Oncology Group performance status 21.14 10.86 6 51155 39 34905731
Tissue infiltration 21.10 10.86 7 51154 81 34905689
Blood glucose increased 21.10 10.86 41 51120 66677 34839093
Cerebral cyst 21.08 10.86 10 51151 310 34905460
Hepatocellular injury 21.07 10.86 76 51085 22135 34883635
Alcohol intolerance 20.72 10.86 11 51150 435 34905335
Urinary retention 20.46 10.86 14 51147 36274 34869496
Oedema peripheral 20.39 10.86 98 51063 119714 34786056
Dizziness 20.35 10.86 213 50948 218308 34687462
Liver transplant failure 20.29 10.86 7 51154 92 34905678
Plasma cell myeloma 20.22 10.86 19 51142 42018 34863752
Idiosyncratic drug reaction 20.05 10.86 11 51150 465 34905305
Muscle abscess 19.89 10.86 12 51149 608 34905162
Blood bilirubin increased 19.58 10.86 109 51052 38187 34867583
Blood pressure increased 19.46 10.86 65 51096 88037 34817733
Liver abscess 19.16 10.86 26 51135 3869 34901901
Large intestine perforation 19.16 10.86 40 51121 8463 34897307
Ureteral disorder 19.15 10.86 8 51153 182 34905588
Epistaxis 19.12 10.86 35 51126 58216 34847554
Infection in an immunocompromised host 19.05 10.86 12 51149 657 34905113
Intestinal fistula 19.02 10.86 14 51147 991 34904779
Sleep disorder therapy 18.80 10.86 14 51147 1009 34904761
Incorrect route of product administration 18.76 10.86 56 51105 14789 34890981
White blood cell count decreased 18.72 10.86 74 51087 95371 34810399
Stoma site erythema 18.71 10.86 13 51148 840 34904930
Stenotrophomonas test positive 18.71 10.86 9 51152 288 34905482
International normalised ratio increased 18.69 10.86 126 51035 47201 34858569
Jaundice 18.52 10.86 94 51067 31788 34873982
Neutrophil count decreased 18.34 10.86 29 51132 51075 34854695
Dermatitis exfoliative 18.31 10.86 34 51127 6605 34899165
Vitamin A deficiency 18.10 10.86 5 51156 29 34905741
Clostridium colitis 18.09 10.86 15 51146 1264 34904506
Enteritis 17.99 10.86 38 51123 8104 34897666
Hyperphosphataemia 17.97 10.86 27 51134 4410 34901360
Deafness bilateral 17.74 10.86 14 51147 1100 34904670
Coronary artery disease 17.73 10.86 27 51134 48278 34857492
Wound dehiscence 17.67 10.86 23 51138 3288 34902482
Vitamin B1 deficiency 17.58 10.86 9 51152 330 34905440
Torsade de pointes 17.53 10.86 35 51126 7174 34898596
Hepatitis cholestatic 17.46 10.86 37 51124 7910 34897860
Arteriospasm coronary 17.29 10.86 23 51138 3359 34902411
Distal intestinal obstruction syndrome 17.16 10.86 9 51152 347 34905423
Serratia sepsis 17.11 10.86 6 51155 83 34905687
Oxygen saturation decreased 17.08 10.86 33 51128 53785 34851985
Chest pain 17.05 10.86 112 51049 126650 34779120
Platelet count decreased 17.01 10.86 104 51057 119613 34786157
Coagulation factor decreased 16.98 10.86 6 51155 85 34905685
Osteomyelitis fungal 16.95 10.86 8 51153 245 34905525
Stoma site discharge 16.69 10.86 14 51147 1199 34904571
Hepatic necrosis 16.69 10.86 24 51137 3770 34902000
Wrong technique in product usage process 16.46 10.86 17 51144 35969 34869801
Peritonitis 16.38 10.86 57 51104 16308 34889462
Prothrombin time shortened 16.33 10.86 15 51146 1449 34904321
Gastroenteritis Escherichia coli 16.24 10.86 9 51152 388 34905382
Leukoerythroblastosis 16.10 10.86 5 51156 46 34905724
Gastrointestinal wall thickening 16.04 10.86 15 51146 1483 34904287
Substance-induced psychotic disorder 15.97 10.86 16 51145 1722 34904048
Arterial angioplasty 15.73 10.86 5 51156 50 34905720
Carotid artery insufficiency 15.70 10.86 4 51157 16 34905754
Liver function test abnormal 15.59 10.86 88 51073 30986 34874784
Infusion site inflammation 15.55 10.86 5 51156 52 34905718
Anaphylactic shock 15.51 10.86 55 51106 15886 34889884
Abdominal tenderness 15.49 10.86 24 51137 4027 34901743
Peripheral sensory neuropathy 15.46 10.86 32 51129 6728 34899042
Insomnia 15.43 10.86 89 51072 103818 34801952
Colonic fistula 15.34 10.86 9 51152 433 34905337
Memory impairment 15.15 10.86 25 51136 43293 34862477
Small intestinal obstruction 15.07 10.86 52 51109 14814 34890956
Pollakiuria 15.05 10.86 5 51156 19669 34886101
Cardiac disorder 14.98 10.86 25 51136 43101 34862669
Dermatitis bullous 14.94 10.86 32 51129 6890 34898880
Full blood count decreased 14.92 10.86 4 51157 18084 34887686
Ileocaecal resection 14.83 10.86 5 51156 61 34905709
Enterococcal bacteraemia 14.80 10.86 16 51145 1881 34903889
Bladder cancer 14.61 10.86 3 51158 16275 34889495
Norovirus test positive 14.61 10.86 5 51156 64 34905706
Wound drainage 14.59 10.86 10 51151 632 34905138
Asthenia 14.55 10.86 262 50899 244989 34660781
Lymphocyte transformation test positive 14.51 10.86 3 51158 3 34905767
Optic neuropathy 14.34 10.86 16 51145 1949 34903821
Post embolisation syndrome 14.34 10.86 5 51156 68 34905702
Listeriosis 14.32 10.86 12 51149 1026 34904744
Stoma site inflammation 14.30 10.86 9 51152 492 34905278
Antibiotic level below therapeutic 14.27 10.86 5 51156 69 34905701
Necrosis 14.17 10.86 28 51133 5695 34900075
Reaction to excipient 14.07 10.86 9 51152 506 34905264
Bacteroides infection 14.07 10.86 6 51155 144 34905626
Dry skin 14.06 10.86 15 51146 31272 34874498
Necrotising enterocolitis neonatal 14.05 10.86 7 51154 242 34905528
Productive cough 14.00 10.86 21 51140 37792 34867978
Psoriasis 13.95 10.86 22 51139 38790 34866980
Anal inflammation 13.89 10.86 13 51148 1287 34904483
Metastases to heart 13.88 10.86 6 51155 149 34905621
Coagulation time prolonged 13.87 10.86 13 51148 1289 34904481
Disseminated intravascular coagulation 13.87 10.86 66 51095 21750 34884020
Herpes zoster 13.84 10.86 18 51143 34381 34871389
Diverticulitis 13.81 10.86 62 51099 19942 34885828
Stoma site haemorrhage 13.77 10.86 11 51150 879 34904891
Loss of personal independence in daily activities 13.73 10.86 17 51144 33162 34872608
Feeling abnormal 13.72 10.86 47 51114 63188 34842582
Fusobacterium infection 13.65 10.86 5 51156 79 34905691
Vestibular disorder 13.65 10.86 12 51149 1095 34904675
Pain in extremity 13.59 10.86 119 51042 126394 34779376
Drug withdrawal syndrome 13.57 10.86 6 51155 19828 34885942
Pseudomonal sepsis 13.54 10.86 21 51140 3526 34902244
Flavobacterium infection 13.54 10.86 5 51156 81 34905689
Alanine aminotransferase 13.48 10.86 4 51157 31 34905739
Hyperkalaemia 13.47 10.86 54 51107 69335 34836435
Toxic leukoencephalopathy 13.40 10.86 8 51153 398 34905372
Sedation 13.39 10.86 7 51154 20999 34884771
Ischaemic stroke 13.34 10.86 5 51156 18245 34887525
Lipase increased 13.33 10.86 37 51124 9379 34896391
Orthostatic hypotension 13.32 10.86 11 51150 25908 34879862
Hypothyroidism 13.27 10.86 7 51154 20895 34884875
Cortical visual impairment 13.26 10.86 4 51157 33 34905737
Nausea 13.26 10.86 616 50545 339292 34566478
Syncope 13.22 10.86 79 51082 91372 34814398
Drug ineffective for unapproved indication 13.13 10.86 69 51092 23646 34882124
Extravasation 13.13 10.86 15 51146 1875 34903895
Oedema 13.12 10.86 113 51048 45628 34860142
CNS ventriculitis 13.09 10.86 7 51154 281 34905489
Myocardial infarction 12.96 10.86 114 51047 120971 34784799
Muscle spasms 12.95 10.86 61 51100 74940 34830830
Pancreatitis necrotising 12.95 10.86 18 51143 2740 34903030
Stoma site odour 12.86 10.86 4 51157 37 34905733
Candida osteomyelitis 12.86 10.86 4 51157 37 34905733
Nasal congestion 12.86 10.86 9 51152 23048 34882722
Tachypnoea 12.76 10.86 57 51104 18295 34887475
Liver injury 12.53 10.86 49 51112 14829 34890941
Factor V inhibition 12.50 10.86 6 51155 191 34905579
Overdose 12.47 10.86 80 51081 90979 34814791
Post procedural bile leak 12.46 10.86 7 51154 310 34905460
Atrophic glossitis 12.44 10.86 3 51158 9 34905761
Prothrombin time prolonged 12.38 10.86 36 51125 9370 34896400
Procalcitonin increased 12.34 10.86 14 51147 1737 34904033
Hyperreflexia 12.27 10.86 19 51142 3187 34902583
Aggression 12.27 10.86 24 51137 38940 34866830
Dysuria 12.22 10.86 13 51148 27139 34878631
Inflammatory bowel disease 12.16 10.86 18 51143 2902 34902868
Neonatal cholestasis 12.16 10.86 4 51157 45 34905725
Intra-abdominal fluid collection 12.07 10.86 12 51149 1279 34904491
Pharyngeal inflammation 12.06 10.86 7 51154 330 34905440
Arthropathy 11.98 10.86 13 51148 26894 34878876
Peritoneal abscess 11.96 10.86 5 51156 114 34905656
Iron deficiency 11.76 10.86 25 51136 5356 34900414
Metastases to peritoneum 11.75 10.86 14 51147 1830 34903940
Ileostomy 11.69 10.86 9 51152 682 34905088
Rash pustular 11.67 10.86 25 51136 5383 34900387
Renal cortical necrosis 11.67 10.86 6 51155 222 34905548
Head injury 11.65 10.86 6 51155 18154 34887616
Graft versus host disease 11.63 10.86 38 51123 10531 34895239
Terminal ileitis 11.55 10.86 6 51155 227 34905543
Atrial fibrillation 11.50 10.86 119 51042 122274 34783496
Bronchitis 11.43 10.86 28 51133 41935 34863835
Romberg test positive 11.43 10.86 4 51157 55 34905715
Penile necrosis 11.43 10.86 4 51157 55 34905715
Intestinal ulcer 11.42 10.86 10 51151 908 34904862
Abdominal wall abscess 11.40 10.86 8 51153 525 34905245
Vipoma 11.40 10.86 3 51158 14 34905756
Tracheal oedema 11.40 10.86 3 51158 14 34905756
Rash macular 11.39 10.86 43 51118 12799 34892971
Sudden death 11.39 10.86 4 51157 15197 34890573
Disseminated cryptococcosis 11.36 10.86 12 51149 1374 34904396
Subdural haematoma 11.35 10.86 8 51153 20413 34885357
Rectal abscess 11.35 10.86 12 51149 1376 34904394
Hypoprothrombinaemia 11.25 10.86 7 51154 375 34905395
Psychogenic visual disorder 11.23 10.86 3 51158 15 34905755
Inhibitory drug interaction 11.06 10.86 13 51148 1675 34904095
Diarrhoea haemorrhagic 11.02 10.86 28 51133 6736 34899034
Blister 10.98 10.86 64 51097 22794 34882976
Staphylococcus test positive 10.98 10.86 18 51143 3168 34902602
Fungaemia 10.94 10.86 16 51145 2552 34903218
Hepatitis 10.89 10.86 66 51095 23838 34881932

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 799.94 9.77 365 108978 11075 79623970
Clostridium difficile infection 455.04 9.77 414 108929 42271 79592774
Neurotoxicity 436.96 9.77 360 108983 32158 79602887
Drug reaction with eosinophilia and systemic symptoms 367.70 9.77 447 108896 63797 79571248
Clostridium difficile colitis 353.66 9.77 318 109025 31965 79603080
Abortion incomplete 286.52 9.77 120 109223 2944 79632101
Multiple organ dysfunction syndrome 279.36 9.77 551 108792 119695 79515350
Pseudomembranous colitis 273.79 9.77 138 109205 5236 79629809
Cerebellar syndrome 245.33 9.77 129 109214 5351 79629694
Appendicolith 244.15 9.77 150 109193 8401 79626644
Abdominal pain 243.48 9.77 1118 108225 388451 79246594
Ataxia 240.06 9.77 229 109114 24810 79610235
Acute generalised exanthematous pustulosis 213.11 9.77 182 109161 17072 79617973
Colitis 207.83 9.77 366 108977 72941 79562104
Appendicitis 202.81 9.77 192 109151 20602 79614443
Encephalopathy 202.17 9.77 345 108998 67052 79567993
Completed suicide 193.89 9.77 49 109294 245718 79389327
Drug abuse 185.39 9.77 9 109334 162682 79472363
Septic shock 179.20 9.77 468 108875 122333 79512712
Fall 171.52 9.77 252 109091 487377 79147668
Megacolon 158.52 9.77 83 109260 3412 79631633
International normalised ratio fluctuation 156.59 9.77 82 109261 3372 79631673
Pathogen resistance 152.56 9.77 139 109204 14203 79620842
Rheumatoid arthritis 142.10 9.77 54 109289 208416 79426629
Synovitis 140.13 9.77 20 109323 150714 79484331
Fistula 131.01 9.77 122 109221 12818 79622227
Hand deformity 128.00 9.77 3 109340 103916 79531129
Anaphylactic reaction 127.12 9.77 324 109019 83419 79551626
Arthropathy 123.87 9.77 44 109299 177067 79457978
Fixed eruption 122.26 9.77 66 109277 2888 79632157
Rash maculo-papular 121.79 9.77 250 109093 55828 79579217
Contraindicated product administered 121.16 9.77 33 109310 157505 79477540
Bloody discharge 116.95 9.77 56 109287 1897 79633148
Cerebellar ataxia 114.78 9.77 55 109288 1866 79633179
Joint swelling 113.75 9.77 137 109206 288509 79346536
Ascites 112.25 9.77 290 109053 75272 79559773
Dysarthria 111.45 9.77 270 109073 67352 79567693
Abdominal distension 109.41 9.77 387 108956 119263 79515782
Death 103.50 9.77 413 108930 566101 79068944
Pyrexia 102.95 9.77 1399 107944 677310 78957735
Clostridial infection 100.02 9.77 74 109269 5640 79629405
Systemic lupus erythematosus 99.74 9.77 22 109321 121127 79513918
Cholestasis 98.97 9.77 220 109123 51889 79583156
Toxic epidermal necrolysis 98.29 9.77 200 109143 44381 79590664
Sepsis 96.92 9.77 667 108676 268761 79366284
Cardiogenic shock 94.74 9.77 190 109153 41724 79593321
Ventricular fibrillation 92.51 9.77 161 109182 31765 79603280
Alopecia 90.92 9.77 110 109233 231245 79403800
Paraesthesia oral 88.33 9.77 124 109219 20347 79614698
Enterocolitis haemorrhagic 87.97 9.77 48 109295 2146 79632899
Hepatitis 87.05 9.77 218 109125 55509 79579536
Clostridium test positive 85.71 9.77 71 109272 6383 79628662
Fatigue 83.19 9.77 845 108498 928882 78706163
Drug hypersensitivity 82.26 9.77 695 108648 298221 79336824
Lyme disease 81.23 9.77 53 109290 3297 79631748
Vomiting 80.40 9.77 1320 108023 664508 78970537
Pericarditis 79.82 9.77 22 109321 104214 79530831
Duodenal ulcer perforation 77.59 9.77 3 109340 66208 79568837
Product dose omission issue 77.41 9.77 138 109205 247399 79387646
Nasopharyngitis 77.19 9.77 144 109199 253737 79381308
Intentional overdose 76.36 9.77 25 109318 105935 79529110
Magnetic resonance imaging head abnormal 75.73 9.77 47 109296 2679 79632366
Blood phosphorus increased 74.32 9.77 81 109262 10266 79624779
Procedural pain 74.29 9.77 122 109221 22962 79612083
Enterococcal infection 73.81 9.77 99 109244 15561 79619484
Glossodynia 73.39 9.77 25 109318 103312 79531733
Wound 72.86 9.77 34 109309 116145 79518900
Pancreatitis haemorrhagic 72.59 9.77 31 109312 799 79634246
Cough 72.33 9.77 259 109084 366530 79268515
Macular degeneration 71.84 9.77 83 109260 11213 79623832
Abdominal abscess 71.77 9.77 67 109276 7060 79627985
Arthralgia 69.93 9.77 478 108865 571325 79063720
Sinusitis 69.59 9.77 100 109243 195401 79439644
Eosinophilia 68.33 9.77 175 109168 45170 79589875
Dysmetria 68.08 9.77 32 109311 1039 79634006
Swollen tongue 68.03 9.77 168 109175 42402 79592643
Kounis syndrome 67.30 9.77 52 109291 4230 79630815
Haemorrhage 66.22 9.77 274 109069 90844 79544201
Swelling face 65.64 9.77 231 109112 70981 79564064
Colitis ulcerative 65.20 9.77 146 109197 34596 79600449
Cholecystitis chronic 65.05 9.77 74 109269 9832 79625213
Chronic sinusitis 62.39 9.77 83 109260 12943 79622102
Nervous system disorder 61.00 9.77 122 109221 26734 79608311
Acute hepatic failure 60.43 9.77 130 109213 29983 79605062
Klebsiella infection 60.21 9.77 90 109253 15630 79619415
Nystagmus 60.04 9.77 71 109272 9833 79625212
Meningitis candida 58.94 9.77 17 109326 127 79634918
Diverticulitis 56.93 9.77 165 109178 45771 79589274
Helicobacter infection 54.71 9.77 14 109329 69690 79565355
Asthma 53.29 9.77 64 109279 135031 79500014
Haematochezia 52.65 9.77 249 109094 87396 79547649
Leukocytosis 51.86 9.77 154 109189 43301 79591744
Interstitial lung disease 51.55 9.77 47 109296 112553 79522492
Anal fissure 51.36 9.77 58 109285 7645 79627400
Anal fistula 50.99 9.77 55 109288 6889 79628156
Drug ineffective for unapproved indication 50.52 9.77 170 109173 51068 79583977
Female genital tract fistula 50.46 9.77 51 109292 5924 79629121
Dyspnoea 50.30 9.77 850 108493 856175 78778870
Pneumonia 50.22 9.77 622 108721 659624 78975421
Herpes simplex oesophagitis 50 9.77 19 109324 358 79634687
Vaginal discharge 49.43 9.77 56 109287 7407 79627638
Loss of personal independence in daily activities 49.16 9.77 41 109302 102539 79532506
Linear IgA disease 49.15 9.77 38 109305 3094 79631951
Abscess intestinal 48.99 9.77 36 109307 2715 79632330
Paraesthesia 48.98 9.77 411 108932 175912 79459133
Acinetobacter infection 48.69 9.77 36 109307 2741 79632304
Psoriatic arthropathy 48.63 9.77 23 109320 77976 79557069
Cardiac failure congestive 48.56 9.77 75 109268 142327 79492718
Rash macular 48.25 9.77 116 109227 28783 79606262
Stomatitis 47.50 9.77 80 109263 146677 79488368
Candida infection 47.10 9.77 137 109206 38077 79596968
Idiosyncratic drug reaction 47.09 9.77 27 109316 1330 79633715
Injection site pain 46.60 9.77 66 109277 129772 79505273
Influenza 46.40 9.77 66 109277 129540 79505505
International normalised ratio increased 46.10 9.77 234 109109 84487 79550558
Lip swelling 45.09 9.77 141 109202 40770 79594275
Peripheral swelling 44.53 9.77 204 109139 269413 79365632
Vaginal flatulence 44.29 9.77 33 109310 2542 79632503
Cardiac failure 44.29 9.77 91 109252 154751 79480294
Abdominal discomfort 44.27 9.77 185 109158 250542 79384503
Product use issue 44.13 9.77 144 109199 209678 79425367
Stevens-Johnson syndrome 44.10 9.77 136 109207 39030 79596015
Anal abscess 43.87 9.77 59 109284 9296 79625749
Folliculitis 43.70 9.77 11 109332 55369 79579676
Agranulocytosis 43.16 9.77 148 109195 44882 79590163
Exposure during pregnancy 42.80 9.77 261 109082 100871 79534174
Dermatitis bullous 42.79 9.77 73 109270 14172 79620873
Arthritis 42.63 9.77 57 109286 114823 79520222
Cytotoxic oedema 42.05 9.77 17 109326 380 79634665
Alcohol intolerance 42.04 9.77 18 109325 467 79634578
Weight increased 41.69 9.77 217 109126 277169 79357876
Axonal neuropathy 41.44 9.77 29 109314 2025 79633020
Angioedema 41.36 9.77 210 109133 75825 79559220
Systemic mastocytosis 41.18 9.77 16 109327 321 79634724
Mobility decreased 41.03 9.77 65 109278 122110 79512935
Dysdiadochokinesis 40.72 9.77 16 109327 331 79634714
Pouchitis 40.66 9.77 22 109321 967 79634078
Bronchitis 40.66 9.77 73 109270 130571 79504474
Abscess 40.35 9.77 94 109249 22857 79612188
Metabolic acidosis 40.14 9.77 221 109122 82308 79552737
Stress 39.94 9.77 215 109128 79397 79555648
Suicide attempt 39.92 9.77 33 109310 82899 79552146
Crohn's disease 39.06 9.77 28 109315 2032 79633013
Endometritis 38.98 9.77 20 109323 788 79634257
Malignant neoplasm progression 38.82 9.77 80 109263 135910 79499135
Rash morbilliform 38.79 9.77 45 109298 6105 79628940
Pelvic inflammatory disease 38.67 9.77 24 109319 1368 79633677
Necrosis ischaemic 38.66 9.77 22 109321 1068 79633977
Type 2 diabetes mellitus 38.55 9.77 15 109328 57107 79577938
Frequent bowel movements 38.45 9.77 108 109235 29431 79605614
Jaundice 37.63 9.77 159 109184 53190 79581855
Colitis ischaemic 37.58 9.77 72 109271 15287 79619758
Knee arthroplasty 37.36 9.77 7 109336 43241 79591804
Hypertension 37.32 9.77 283 109060 330709 79304336
Hyphaema 36.86 9.77 20 109323 884 79634161
Hepatocellular injury 36.86 9.77 146 109197 47447 79587598
Hepatic failure 36.82 9.77 174 109169 61038 79574007
Hepatic enzyme increased 36.57 9.77 128 109215 182482 79452563
Dysbiosis 36.38 9.77 22 109321 1197 79633848
Beta haemolytic streptococcal infection 36.35 9.77 27 109316 2070 79632975
Hepatic necrosis 36.14 9.77 53 109290 9047 79625998
Lemierre syndrome 36.10 9.77 12 109331 150 79634895
Injection site erythema 35.36 9.77 33 109310 78164 79556881
Staphylococcal infection 35.28 9.77 166 109177 58129 79576916
Oxygen saturation decreased 35.10 9.77 78 109265 128969 79506076
Undersensing 34.31 9.77 7 109336 7 79635038
Sopor 34.13 9.77 3 109340 33007 79602038
Large intestine perforation 34.07 9.77 67 109276 14500 79620545
Hospitalisation 33.71 9.77 48 109295 94188 79540857
Infusion related reaction 33.54 9.77 182 109161 230055 79404990
Oral candidiasis 33.47 9.77 103 109240 29525 79605520
Enterocutaneous fistula 33.44 9.77 25 109318 1936 79633109
Cataract 33.41 9.77 22 109321 62098 79572947
Toxic shock syndrome 33.35 9.77 21 109322 1228 79633817
Clostridium colitis 33.13 9.77 29 109314 2810 79632235
Pancreatitis acute 32.81 9.77 145 109198 49459 79585586
Abdominal pain lower 32.71 9.77 107 109236 31675 79603370
Proctitis 32.38 9.77 42 109301 6390 79628655
Hepatic cytolysis 32.18 9.77 96 109247 27055 79607990
Fibromyalgia 31.72 9.77 25 109318 64315 79570730
Dyspnoea exertional 31.50 9.77 44 109299 87029 79548016
Uterine perforation 31.48 9.77 41 109302 6262 79628783
Haemodynamic instability 31.45 9.77 72 109271 17310 79617735
Nausea 31.43 9.77 1608 107735 955588 78679457
Therapeutic product effect decreased 31.39 9.77 117 109226 163746 79471299
White blood cell count decreased 31.35 9.77 142 109201 188146 79446899
Disseminated intravascular coagulation 31.09 9.77 114 109229 35728 79599317
Neuropathy peripheral 30.94 9.77 313 109030 140992 79494053
Biliary sepsis 30.71 9.77 22 109321 1595 79633450
Drug resistance 30.70 9.77 127 109216 42086 79592959
Bradycardia 30.64 9.77 90 109253 135467 79499578
Neutrophil count decreased 30.60 9.77 51 109292 93908 79541137
Dermatitis allergic 30.51 9.77 73 109270 18057 79616988
Optic neuropathy 29.90 9.77 30 109313 3454 79631591
Oedematous pancreatitis 29.60 9.77 19 109324 1149 79633896
Torsade de pointes 29.57 9.77 75 109268 19237 79615808
Endocrine ophthalmopathy 29.39 9.77 16 109327 712 79634333
Fistula discharge 29.21 9.77 20 109323 1348 79633697
Coagulopathy 29.13 9.77 112 109231 35894 79599151
Epileptic encephalopathy 29.03 9.77 14 109329 482 79634563
Gut fermentation syndrome 28.93 9.77 6 109337 7 79635038
Diverticular perforation 28.91 9.77 38 109305 5855 79629190
Malignant mesenteric neoplasm 28.57 9.77 8 109335 53 79634992
Pelvic pain 28.27 9.77 59 109284 13322 79621723
Drug-induced liver injury 28.20 9.77 171 109172 65946 79569099
Peripheral sensory neuropathy 28.16 9.77 58 109285 12975 79622070
Pneumonia streptococcal 28.02 9.77 26 109317 2719 79632326
Musculoskeletal stiffness 27.36 9.77 135 109208 174873 79460172
Discomfort 27.25 9.77 85 109258 125532 79509513
Vitamin B1 deficiency 27.24 9.77 15 109328 683 79634362
Drug ineffective 27.24 9.77 1773 107570 1079140 78555905
Accidental exposure to product 27.20 9.77 5 109338 31317 79603728
Proctalgia 27.12 9.77 49 109294 9952 79625093
COVID-19 26.79 9.77 118 109225 157556 79477489
Drug therapy 26.70 9.77 18 109325 1183 79633862
Haematotoxicity 26.67 9.77 63 109280 15456 79619589
Vitamin K deficiency 26.65 9.77 15 109328 713 79634332
Emotional distress 26.56 9.77 117 109226 39852 79595193
Upper respiratory tract infection 26.55 9.77 53 109290 91115 79543930
Jejunal ulcer perforation 26.41 9.77 9 109334 122 79634923
Chronic gastrointestinal bleeding 26.36 9.77 13 109330 470 79634575
Type IV hypersensitivity reaction 25.97 9.77 30 109313 4051 79630994
Chromaturia 25.89 9.77 86 109257 25660 79609385
Biliary dyskinesia 25.77 9.77 24 109319 2521 79632524
Aminoaciduria 25.75 9.77 12 109331 382 79634663
Hallucinations, mixed 25.71 9.77 39 109304 6860 79628185
Stoma site discomfort 25.70 9.77 9 109334 133 79634912
Fungal peritonitis 25.69 9.77 17 109326 1083 79633962
Postural orthostatic tachycardia syndrome 25.59 9.77 16 109327 924 79634121
Joint range of motion decreased 25.52 9.77 7 109336 33275 79601770
Prostate cancer 25.50 9.77 7 109336 33261 79601784
Prescribed overdose 25.48 9.77 10 109333 37873 79597172
Adverse event 25.40 9.77 27 109316 60187 79574858
Wheezing 25.26 9.77 79 109264 116585 79518460
Pain in extremity 25.22 9.77 350 108993 364188 79270857
Osteoarthritis 25.22 9.77 51 109292 87258 79547787
Liver abscess 25.12 9.77 36 109307 6018 79629027
Systemic candida 25.12 9.77 38 109305 6668 79628377
Wrong technique in product usage process 25.09 9.77 39 109304 73836 79561209
Rhinorrhoea 25.04 9.77 41 109302 76033 79559012
Prescribed underdose 25.02 9.77 5 109338 29509 79605536
Peritonitis 25.01 9.77 90 109253 27946 79607099
Overdose 24.99 9.77 149 109194 184057 79450988
Blood uric acid increased 24.90 9.77 56 109287 13304 79621741
Hip arthroplasty 24.78 9.77 9 109334 35747 79599298
Hepatitis infectious mononucleosis 24.76 9.77 9 109334 149 79634896
Intentional product misuse 24.68 9.77 59 109284 95106 79539939
Tongue discolouration 24.64 9.77 28 109315 3715 79631330
Analgesic therapy 24.55 9.77 16 109327 993 79634052
Liver function test abnormal 24.55 9.77 162 109181 64313 79570732
Vanishing bile duct syndrome 24.53 9.77 20 109323 1758 79633287
Procedural hypertension 24.46 9.77 11 109332 322 79634723
Anaphylactic shock 24.39 9.77 106 109237 35890 79599155
Dermatitis exfoliative 24.36 9.77 49 109294 10780 79624265
Leukoencephalopathy 24.30 9.77 41 109302 7888 79627157
Diarrhoea haemorrhagic 24.14 9.77 55 109288 13179 79621866
Diarrhoea 24.12 9.77 1455 107888 879034 78756011
Injection site pruritus 24.09 9.77 14 109329 42269 79592776
Hypothyroidism 23.82 9.77 22 109321 52370 79582675
Adverse drug reaction 23.56 9.77 34 109309 66358 79568687
Cholecystitis acute 23.54 9.77 55 109288 13396 79621649
Substance-induced psychotic disorder 23.42 9.77 26 109317 3363 79631682
Purple glove syndrome 23.26 9.77 10 109333 262 79634783
Pseudomonas infection 22.99 9.77 72 109271 20831 79614214
Osmotic demyelination syndrome 22.97 9.77 18 109325 1495 79633550
Retained products of conception 22.86 9.77 8 109335 118 79634927
Shock 22.79 9.77 119 109224 43429 79591616
Long QT syndrome 22.67 9.77 34 109309 5921 79629124
Intrauterine infection 22.65 9.77 7 109336 68 79634977
Injection site reaction 22.63 9.77 25 109318 54760 79580285
Psychotic disorder due to a general medical condition 22.61 9.77 10 109333 281 79634764
Toxic leukoencephalopathy 22.60 9.77 16 109327 1138 79633907
Thrombocytopenia 22.60 9.77 499 108844 264760 79370285
Rectal tube insertion 22.49 9.77 5 109338 10 79635035
Cerebrovascular accident 22.47 9.77 123 109220 155169 79479876
Antineutrophil cytoplasmic antibody 22.38 9.77 6 109337 33 79635012
Hyperkalaemia 22.35 9.77 81 109262 114317 79520728
Aphthous ulcer 22.22 9.77 62 109281 16827 79618218
Small intestinal obstruction 22.20 9.77 85 109258 27187 79607858
Cholecystitis 22.16 9.77 74 109269 22138 79612907
Vulvovaginal swelling 22.15 9.77 11 109332 404 79634641
Urinary retention 22.14 9.77 27 109316 56603 79578442
Blood glucose increased 22.08 9.77 82 109261 114893 79520152
Oedematous kidney 21.98 9.77 9 109334 208 79634837
Intestinal perforation 21.98 9.77 63 109280 17363 79617682
Memory impairment 21.91 9.77 79 109264 111655 79523390
Multiple sclerosis relapse 21.80 9.77 19 109324 46514 79588531
Gastrointestinal inflammation 21.79 9.77 38 109305 7506 79627539
Fluid retention 21.72 9.77 39 109304 69770 79565275
Insomnia 21.70 9.77 223 109120 244947 79390098
Herpes simplex colitis 21.53 9.77 6 109337 39 79635006
Gingival swelling 21.51 9.77 29 109314 4580 79630465
Cross sensitivity reaction 21.49 9.77 26 109317 3686 79631359
Nodule 21.48 9.77 3 109340 22991 79612054
Drug intolerance 21.47 9.77 245 109098 263874 79371171
Dysgeusia 21.37 9.77 143 109200 57034 79578011
Rectal abscess 21.28 9.77 20 109323 2125 79632920
Stoma site haemorrhage 21.22 9.77 19 109324 1897 79633148
Platelet count decreased 21.18 9.77 168 109175 194496 79440549
Toxic skin eruption 21.12 9.77 73 109270 22220 79612825
Night sweats 21.12 9.77 133 109210 51962 79583083
Therapeutic response decreased 21.11 9.77 37 109306 66816 79568229
Deafness bilateral 20.97 9.77 20 109323 2165 79632880
Obesity 20.93 9.77 11 109332 35114 79599931
Oedema peripheral 20.91 9.77 233 109110 252055 79382990
Herpes zoster 20.89 9.77 62 109281 93021 79542024
Omental necrosis 20.78 9.77 6 109337 45 79635000
Anal skin tags 20.70 9.77 11 109332 466 79634579
Pharyngeal oedema 20.69 9.77 59 109284 16213 79618832
Leukaemoid reaction 20.69 9.77 10 109333 346 79634699
Lower respiratory tract infection 20.59 9.77 99 109244 129121 79505924
Acute psychosis 20.58 9.77 27 109316 4153 79630892
Strongyloidiasis 20.48 9.77 26 109317 3872 79631173
Blood bilirubin increased 20.33 9.77 158 109185 66074 79568971
Musculoskeletal pain 20.31 9.77 72 109271 102282 79532763
Iron deficiency 20.24 9.77 45 109298 10609 79624436
Eastern Cooperative Oncology Group performance status 20.23 9.77 6 109337 50 79634995
Vaginal infection 20.18 9.77 32 109311 5848 79629197
Geotrichum infection 20.14 9.77 14 109329 967 79634078
Incubator therapy 20.12 9.77 6 109337 51 79634994
Factor V inhibition 20.04 9.77 10 109333 371 79634674
Stenotrophomonas test positive 20.04 9.77 10 109333 371 79634674
Toxicity to various agents 20.03 9.77 433 108910 421107 79213938
Myocardial infarction 19.99 9.77 159 109184 183970 79451075
Red blood cell count decreased 19.88 9.77 30 109313 57483 79577562
Myasthenia gravis 19.84 9.77 44 109299 10355 79624690
Dyspepsia 19.74 9.77 232 109111 108455 79526590
Clostridium bacteraemia 19.63 9.77 10 109333 388 79634657
Sleep disorder therapy 19.60 9.77 14 109329 1010 79634035
Device malfunction 19.56 9.77 3 109340 21445 79613600
Stenotrophomonas infection 19.56 9.77 25 109318 3748 79631297
Pharyngeal inflammation 19.53 9.77 14 109329 1016 79634029
Neutropenic colitis 19.50 9.77 31 109312 5676 79629369
Foetal monitoring abnormal 19.50 9.77 8 109335 186 79634859
Weber tuning fork test abnormal 19.48 9.77 7 109336 112 79634933
Drug level below therapeutic 19.39 9.77 42 109301 9728 79625317
Venoocclusive liver disease 19.38 9.77 47 109296 11724 79623321
Herpes simplex hepatitis 19.33 9.77 11 109332 534 79634511
Stenosis 19.23 9.77 20 109323 2402 79632643
Plasma cell myeloma 19.17 9.77 27 109316 53232 79581813
Foetal arrhythmia 19.17 9.77 6 109337 61 79634984
Hypoglossal nerve paresis 19.14 9.77 7 109336 118 79634927
Chronic obstructive pulmonary disease 19.09 9.77 57 109286 85362 79549683
Liver transplant failure 19.03 9.77 7 109336 120 79634925
Pulmonary trichosporonosis 18.99 9.77 6 109337 63 79634982
Rash erythematous 18.96 9.77 140 109203 57629 79577416
Cerebral cyst 18.92 9.77 10 109333 419 79634626
Periorbital oedema 18.88 9.77 38 109305 8364 79626681
Escherichia infection 18.85 9.77 61 109282 17956 79617089
Ureteral disorder 18.82 9.77 11 109332 562 79634483
Swelling 18.81 9.77 198 109145 216513 79418532
Radiculopathy 18.75 9.77 39 109304 8785 79626260
Vaginitis gardnerella 18.72 9.77 5 109338 27 79635018
Transient ischaemic attack 18.69 9.77 27 109316 52668 79582377
Polyneuropathy 18.62 9.77 74 109269 24077 79610968
Mononucleosis syndrome 18.61 9.77 7 109336 128 79634917
Brain abscess 18.53 9.77 28 109315 4908 79630137
Prothrombin time ratio decreased 18.52 9.77 13 109330 912 79634133
Impaired healing 18.52 9.77 60 109283 87595 79547450
Adenoviral hepatitis 18.50 9.77 13 109330 914 79634131
Abortion infected 18.42 9.77 5 109338 29 79635016
Posterior reversible encephalopathy syndrome 18.28 9.77 78 109265 26203 79608842
Lack of spontaneous speech 18.05 9.77 8 109335 226 79634819
Gallbladder disorder 18.04 9.77 63 109280 19277 79615768
Blood pressure increased 17.99 9.77 194 109149 211166 79423879
Injection site swelling 17.87 9.77 23 109320 47109 79587936
Enterocolitis 17.86 9.77 52 109291 14460 79620585
Enterococcus test positive 17.84 9.77 18 109325 2086 79632959
Puerperal pyrexia 17.74 9.77 5 109338 34 79635011
Gastrointestinal wall thickening 17.70 9.77 20 109323 2637 79632408
Antibiotic level below therapeutic 17.63 9.77 6 109337 81 79634964
Jaundice neonatal 17.59 9.77 7 109336 150 79634895
Nasal ulcer 17.59 9.77 18 109325 2122 79632923
Distributive shock 17.52 9.77 20 109323 2667 79632378
Central nervous system lesion 17.52 9.77 49 109294 13319 79621726
Underdose 17.48 9.77 12 109331 33139 79601906
Irritable bowel syndrome 17.43 9.77 37 109306 62204 79572841
Malnutrition 17.40 9.77 69 109274 22433 79612612
Rash pustular 17.39 9.77 44 109299 11267 79623778
Dry eye 17.39 9.77 15 109328 36916 79598129
Henoch-Schonlein purpura 17.38 9.77 20 109323 2690 79632355
Myelodysplastic syndrome 17.31 9.77 10 109333 30291 79604754
Pain 17.27 9.77 789 108554 703013 78932032
Urticaria 17.25 9.77 353 108990 184848 79450197
Lung disorder 17.12 9.77 55 109288 80502 79554543
Stoma site discharge 17.11 9.77 18 109325 2191 79632854
Drug interaction 17.10 9.77 714 108629 414469 79220576
Retroperitoneal haematoma 17.05 9.77 28 109315 5269 79629776
Thrombotic thrombocytopenic purpura 16.98 9.77 31 109312 6345 79628700
Infusion site streaking 16.98 9.77 10 109333 518 79634527
Cholelithiasis 16.93 9.77 127 109216 52537 79582508
Botulism 16.92 9.77 9 109334 382 79634663
Feeling guilty 16.92 9.77 12 109331 856 79634189
Nephropathy toxic 16.92 9.77 64 109279 20355 79614690
White blood cells stool 16.78 9.77 3 109340 0 79635045
Hypotonic-hyporesponsive episode 16.78 9.77 3 109340 0 79635045
Haemostasis 16.69 9.77 9 109334 393 79634652
Aspergillus infection 16.66 9.77 61 109282 19100 79615945
Flatulence 16.66 9.77 108 109235 42616 79592429
Full blood count decreased 16.57 9.77 8 109335 26811 79608234
Perirectal abscess 16.47 9.77 17 109326 2024 79633021
Poisoning 16.46 9.77 7 109336 25265 79609780
Metastases to stomach 16.36 9.77 8 109335 284 79634761
Abdominal sepsis 16.32 9.77 17 109326 2045 79633000
Metastases to heart 16.28 9.77 8 109335 287 79634758
Osteomyelitis fungal 16.20 9.77 8 109335 290 79634755
Faecal volume decreased 16.09 9.77 7 109336 189 79634856
Arterial angioplasty 16.05 9.77 5 109338 50 79634995
Bacteraemia 16.02 9.77 88 109255 32736 79602309
Electrocardiogram QT prolonged 16.00 9.77 192 109151 90194 79544851
Rash papular 15.98 9.77 66 109277 21850 79613195
Carotid artery insufficiency 15.96 9.77 4 109339 16 79635029
Depersonalisation/derealisation disorder 15.92 9.77 16 109327 1846 79633199
Skin lesion 15.84 9.77 105 109238 41739 79593306
Tongue coated 15.83 9.77 14 109329 1375 79633670
Enteritis 15.83 9.77 50 109293 14533 79620512
Lower limb fracture 15.82 9.77 6 109337 23209 79611836
Injury 15.70 9.77 169 109174 77327 79557718
Enterovesical fistula 15.69 9.77 13 109330 1169 79633876
Amoebiasis 15.51 9.77 6 109337 119 79634926
Drug dependence 15.35 9.77 20 109323 40749 79594296
Infective aneurysm 15.32 9.77 12 109331 996 79634049
Organ failure 15.31 9.77 23 109320 4010 79631035
Osteoporosis 15.29 9.77 32 109311 54080 79580965
Pulmonary fibrosis 15.25 9.77 23 109320 44089 79590956
Epistaxis 15.22 9.77 90 109253 111425 79523620
Bladder cancer 15.17 9.77 4 109339 19522 79615523
Eyelid disorder 15.11 9.77 16 109327 1962 79633083
Intestinal stenosis 15.11 9.77 22 109321 3732 79631313
Airway peak pressure increased 15.08 9.77 8 109335 338 79634707
Coagulation factor decreased 15.07 9.77 7 109336 221 79634824
Mastitis bacterial 15.00 9.77 5 109338 63 79634982
Venous haemorrhage 14.90 9.77 8 109335 346 79634699
Burning sensation 14.87 9.77 134 109209 58498 79576547
Prothrombin time prolonged 14.86 9.77 54 109289 16845 79618200
Electrocardiogram T wave alternans 14.79 9.77 5 109338 66 79634979
Renal cortical necrosis 14.78 9.77 8 109335 352 79634693
Delayed delivery 14.77 9.77 4 109339 23 79635022
Red cell fragmentation syndrome 14.72 9.77 5 109338 67 79634978
Gynaecological examination abnormal 14.71 9.77 3 109340 3 79635042
Ill-defined disorder 14.69 9.77 44 109299 65831 79569214
Vulval ulceration 14.68 9.77 7 109336 235 79634810
Anterior interosseous syndrome 14.62 9.77 4 109339 24 79635021
Cardiac disorder 14.61 9.77 44 109299 65713 79569332
Back pain 14.57 9.77 312 109031 303868 79331177
Tissue infiltration 14.51 9.77 10 109333 681 79634364
Muscle abscess 14.51 9.77 12 109331 1076 79633969
Medication error 14.49 9.77 47 109296 68595 79566450
Stoma site inflammation 14.45 9.77 10 109333 686 79634359
Nasal congestion 14.43 9.77 55 109288 76497 79558548
Coronary artery disease 14.41 9.77 44 109299 65430 79569615
Sedation 14.41 9.77 31 109312 51864 79583181
Macule 14.40 9.77 19 109324 2938 79632107
Poisoning deliberate 14.36 9.77 4 109339 18824 79616221
Cortical visual impairment 14.35 9.77 4 109339 26 79635019
Bacteroides test positive 14.35 9.77 4 109339 26 79635019
C-reactive protein decreased 14.34 9.77 18 109325 2650 79632395
Fusarium infection 14.32 9.77 15 109328 1817 79633228
Erythema 14.23 9.77 404 108939 222886 79412159
Decreased appetite 14.22 9.77 359 108984 342059 79292986
Heparin-induced thrombocytopenia 14.20 9.77 37 109306 9645 79625400
Morganella infection 14.14 9.77 12 109331 1115 79633930
Device expulsion 14.12 9.77 9 109334 25852 79609193
Ureteric obstruction 14.09 9.77 18 109325 2698 79632347
Protein C decreased 13.97 9.77 5 109338 79 79634966
Vestibular disorder 13.90 9.77 17 109326 2438 79632607
Sciatica 13.90 9.77 15 109328 33207 79601838
Hypoalbuminaemia 13.89 9.77 62 109281 21235 79613810
Enterococcal bacteraemia 13.86 9.77 19 109324 3049 79631996
Tongue dry 13.82 9.77 12 109331 1150 79633895
Culture wound positive 13.81 9.77 8 109335 402 79634643
Vaginal abscess 13.77 9.77 8 109335 404 79634641
Post embolisation syndrome 13.69 9.77 5 109338 84 79634961
Hepatitis cholestatic 13.69 9.77 46 109297 13806 79621239
Pancreatitis 13.64 9.77 149 109194 68426 79566619
Depression 13.63 9.77 212 109131 216578 79418467
Haemolytic uraemic syndrome 13.63 9.77 23 109320 4426 79630619
Injection site bruising 13.59 9.77 22 109321 40980 79594065
Candida sepsis 13.58 9.77 17 109326 2496 79632549
Stoma site odour 13.58 9.77 5 109338 86 79634959
Anal inflammation 13.55 9.77 13 109330 1417 79633628
Candida osteomyelitis 13.52 9.77 4 109339 33 79635012
Intestinal fistula 13.49 9.77 13 109330 1425 79633620
Asthenia 13.49 9.77 569 108774 511120 79123925
Pruritus 13.48 9.77 666 108677 393982 79241063
Amnesia 13.44 9.77 43 109300 63014 79572031
Bacterial vaginosis 13.42 9.77 12 109331 1196 79633849
Post procedural bile leak 13.38 9.77 8 109335 426 79634619
Large intestine infection 13.38 9.77 19 109324 3150 79631895
Intra-abdominal fluid collection 13.36 9.77 19 109324 3153 79631892
Subdural haematoma 13.36 9.77 14 109329 31420 79603625
CNS ventriculitis 13.32 9.77 8 109335 430 79634615
Plantar fascial fibromatosis 13.31 9.77 4 109339 35 79635010
Catheter site related reaction 13.30 9.77 12 109331 1210 79633835
Ileostomy 13.29 9.77 14 109329 1706 79633339
Bacterial vulvovaginitis 13.29 9.77 9 109334 596 79634449
Joint injury 13.27 9.77 14 109329 31321 79603724
Pancytopenia 13.23 9.77 309 109034 165436 79469609
Bone erosion 13.22 9.77 54 109289 17793 79617252
Cholestatic liver injury 13.13 9.77 24 109319 4917 79630128
Vulval disorder 13.11 9.77 9 109334 609 79634436
Prothrombin time shortened 13.11 9.77 19 109324 3209 79631836
Mental status changes 13.09 9.77 145 109198 66814 79568231
Bursitis 13.07 9.77 18 109325 35826 79599219
Hyporeflexia 13.06 9.77 20 109323 3548 79631497
Ileal perforation 13.04 9.77 11 109332 1014 79634031
Blood pressure diastolic abnormal 13.03 9.77 5 109338 19197 79615848
Flavobacterium infection 12.98 9.77 5 109338 98 79634947
Epidermal necrosis 12.90 9.77 13 109330 1504 79633541
Premature delivery 12.89 9.77 65 109278 23402 79611643
Tachycardia 12.86 9.77 327 109016 177441 79457604
Nodular rash 12.81 9.77 7 109336 314 79634731
Medical device site pain 12.77 9.77 7 109336 316 79634729
Productive cough 12.75 9.77 70 109273 88261 79546784
Erythema multiforme 12.75 9.77 53 109290 17598 79617447
Gastroenteritis Escherichia coli 12.64 9.77 9 109334 646 79634399
Peripheral sensorimotor neuropathy 12.64 9.77 18 109325 2992 79632053
Intestinal dilatation 12.62 9.77 17 109326 2683 79632362
Hepatic amoebiasis 12.61 9.77 5 109338 106 79634939
Trichoglossia 12.59 9.77 9 109334 650 79634395
Sedation complication 12.58 9.77 3 109340 15666 79619379
Fungal sepsis 12.58 9.77 14 109329 1816 79633229
Oscillopsia 12.56 9.77 6 109337 202 79634843
Femur fracture 12.56 9.77 21 109322 38631 79596414
Mania 12.55 9.77 54 109289 18206 79616839
Generalised tonic-clonic seizure 12.52 9.77 103 109240 43807 79591238
Haematoma infection 12.51 9.77 13 109330 1560 79633485
Laboratory test abnormal 12.49 9.77 12 109331 28036 79607009
Colonic fistula 12.43 9.77 9 109334 663 79634382
Skin odour abnormal 12.40 9.77 15 109328 2126 79632919
Antibiotic associated colitis 12.40 9.77 3 109340 10 79635035
Tendonitis 12.39 9.77 65 109278 23765 79611280
Musculoskeletal disorder 12.36 9.77 7 109336 21441 79613604
Injection site haemorrhage 12.32 9.77 12 109331 27858 79607187
Bacteroides infection 12.30 9.77 7 109336 340 79634705
Serratia sepsis 12.30 9.77 6 109337 212 79634833
Lip dry 12.28 9.77 3 109340 15415 79619630
Breast cancer 12.28 9.77 17 109326 33764 79601281
Protein S decreased 12.28 9.77 5 109338 114 79634931
Fusobacterium infection 12.28 9.77 5 109338 114 79634931
Hyperphosphataemia 12.19 9.77 27 109316 6349 79628696
Rectal haemorrhage 12.19 9.77 159 109184 76141 79558904
Eye infection 12.15 9.77 40 109303 11880 79623165
Syncope 12.14 9.77 173 109170 179276 79455769
Abdominal tenderness 12.12 9.77 37 109306 10557 79624488
Chemical burns of eye 12.12 9.77 5 109338 118 79634927
Infusion site induration 12.07 9.77 11 109332 1124 79633921
Neuroleptic malignant syndrome 12.03 9.77 12 109331 27547 79607498
Ileocaecal resection 12.00 9.77 5 109338 121 79634924
Neoplasm progression 11.90 9.77 34 109309 51648 79583397
Diarrhoea infectious 11.84 9.77 13 109330 1661 79633384
Renal failure 11.82 9.77 360 108983 200608 79434437
Koebner phenomenon 11.82 9.77 4 109339 53 79634992
Aeromonas infection 11.78 9.77 7 109336 369 79634676
Skin test positive 11.75 9.77 11 109332 1163 79633882
Empyema 11.66 9.77 21 109322 4255 79630790
Delivery 11.64 9.77 9 109334 733 79634312
Hepatomegaly 11.60 9.77 54 109289 18820 79616225
Diabetic ketoacidosis 11.60 9.77 18 109325 34104 79600941
Vipoma 11.60 9.77 3 109340 14 79635031
Marchiafava-Bignami disease 11.60 9.77 3 109340 14 79635031
Wound dehiscence 11.58 9.77 27 109316 6568 79628477
Respiratory alkalosis 11.53 9.77 21 109322 4290 79630755
Head injury 11.51 9.77 21 109322 37348 79597697
Stoma site pain 11.51 9.77 12 109331 1446 79633599
Anorectal discomfort 11.50 9.77 19 109324 3592 79631453
Emphysema 11.47 9.77 4 109339 16296 79618749
Lactose intolerance 11.39 9.77 15 109328 2315 79632730
Procedural anxiety 11.38 9.77 9 109334 757 79634288
Rubber sensitivity 11.37 9.77 13 109330 1736 79633309
Hyperhidrosis 11.35 9.77 143 109200 151349 79483696
Stoma site erythema 11.35 9.77 13 109330 1740 79633305
Cardiovascular insufficiency 11.32 9.77 17 109326 2964 79632081
Diabetes mellitus inadequate control 11.25 9.77 10 109333 24254 79610791
Choriocarcinoma 11.25 9.77 4 109339 62 79634983
Areflexia 11.23 9.77 24 109319 5510 79629535
Distal intestinal obstruction syndrome 11.17 9.77 9 109334 778 79634267
Large intestinal ulcer 11.14 9.77 22 109321 4775 79630270
Fear of death 11.12 9.77 12 109331 1504 79633541
Vulvovaginitis trichomonal 11.11 9.77 3 109340 17 79635028
Vulval haemorrhage 11.11 9.77 3 109340 17 79635028
Uterine hypertonus 11.06 9.77 6 109337 265 79634780
Second primary malignancy 11.04 9.77 3 109340 14347 79620698
Coordination abnormal 10.99 9.77 50 109293 17262 79617783
Intestinal gangrene 10.97 9.77 3 109340 18 79635027
Restless legs syndrome 10.96 9.77 7 109336 20085 79614960
Orbital oedema 10.95 9.77 7 109336 420 79634625
Arrhythmia 10.93 9.77 45 109298 61227 79573818
Skin ulcer 10.92 9.77 118 109225 54032 79581013
Rash pruritic 10.91 9.77 148 109195 71481 79563564
Spinal stenosis 10.90 9.77 4 109339 15787 79619258
Arthritis reactive 10.85 9.77 8 109335 606 79634439
Myoclonus 10.83 9.77 70 109273 27590 79607455
Vitamin D increased 10.82 9.77 8 109335 609 79634436
Urinary tract infection 10.81 9.77 290 109053 274222 79360823
Culture stool positive 10.77 9.77 8 109335 613 79634432
Bacterial toxaemia 10.76 9.77 5 109338 158 79634887
Sinus congestion 10.76 9.77 7 109336 19889 79615156
Swelling of eyelid 10.75 9.77 19 109324 3792 79631253
Blood alkaline phosphatase increased 10.73 9.77 134 109209 63530 79571515
Necrosis 10.72 9.77 33 109310 9460 79625585
Disseminated tuberculosis 10.72 9.77 20 109323 4163 79630882
Postoperative ileus 10.70 9.77 10 109333 1055 79633990
Venoocclusive disease 10.65 9.77 21 109322 4552 79630493
Glaucoma 10.62 9.77 7 109336 19754 79615291
Serum sickness-like reaction 10.61 9.77 8 109335 627 79634418
Abdominal compartment syndrome 10.60 9.77 12 109331 1585 79633460
Road traffic accident 10.60 9.77 28 109315 43636 79591409
Fungaemia 10.60 9.77 21 109322 4570 79630475
Pulmonary arterial hypertension 10.59 9.77 14 109329 28352 79606693
Blood osmolarity decreased 10.59 9.77 11 109332 1320 79633725
Impaired work ability 10.54 9.77 7 109336 19674 79615371
Functional gastrointestinal disorder 10.54 9.77 22 109321 4968 79630077
Activated partial thromboplastin time prolonged 10.50 9.77 43 109300 14185 79620860
Scar 10.49 9.77 45 109298 15151 79619894
Leuconostoc infection 10.45 9.77 3 109340 22 79635023
Drug withdrawal syndrome neonatal 10.44 9.77 6 109337 297 79634748
Ballismus 10.38 9.77 6 109337 300 79634745
Mean cell haemoglobin increased 10.38 9.77 20 109323 4265 79630780
Bartter's syndrome 10.33 9.77 3 109340 23 79635022
Infection in an immunocompromised host 10.33 9.77 11 109332 1357 79633688
Electrocardiogram abnormal 10.33 9.77 5 109338 16732 79618313
Withdrawal syndrome 10.29 9.77 13 109330 26841 79608204
Influenza like illness 10.25 9.77 57 109286 71650 79563395
Metastases to bone 10.25 9.77 11 109332 24416 79610629
Lymphocyte count decreased 10.25 9.77 32 109311 47257 79587788
Arteriospasm coronary 10.20 9.77 26 109317 6690 79628355
Hyperbilirubinaemia 10.19 9.77 63 109280 24455 79610590
Abnormal faeces 10.17 9.77 28 109315 7543 79627502
Pain in jaw 10.16 9.77 31 109312 46120 79588925
Upper limb fracture 10.16 9.77 6 109337 17961 79617084
Electrocardiogram T wave biphasic 10.16 9.77 5 109338 180 79634865
Anti factor V antibody positive 10.11 9.77 3 109340 25 79635020
Paranoia 10.10 9.77 53 109290 19379 79615666
Pulmonary hypertension 10.09 9.77 33 109310 48047 79586998
Lung neoplasm malignant 10.09 9.77 14 109329 27778 79607267
Fracture 10.09 9.77 9 109334 21792 79613253
Lipase increased 10.04 9.77 47 109296 16419 79618626
Tubulointerstitial nephritis 10.01 9.77 88 109255 38147 79596898
Sensitisation 9.99 9.77 17 109326 3294 79631751
Hyperintensity in brain deep nuclei 9.98 9.77 5 109338 187 79634858
Hepatitis acute 9.95 9.77 45 109298 15497 79619548
Wound drainage 9.93 9.77 10 109333 1156 79633889
Chest pain 9.91 9.77 303 109040 282001 79353044
Feeling abnormal 9.90 9.77 156 109187 159043 79476002
Bone density decreased 9.88 9.77 3 109340 13344 79621701
Ischaemic stroke 9.87 9.77 19 109324 33112 79601933
Vitamin A deficiency 9.87 9.77 4 109339 90 79634955
Procalcitonin increased 9.82 9.77 16 109327 2990 79632055
Inappropriate antidiuretic hormone secretion 9.81 9.77 13 109330 26300 79608745
Bacterial infection 9.81 9.77 75 109268 31205 79603840
Akathisia 9.78 9.77 3 109340 13256 79621789

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




🐶 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 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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
140MG;125MG;125MG BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE RICONPHARMA LLC A217511 July 3, 2023 RX CAPSULE ORAL Dec. 29, 2023 COMPETITIVE GENERIC THERAPY

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
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
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 0338-1055 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 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 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 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 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