fluconazole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
systemic antifungal agents, miconazole derivatives 1187 86386-73-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fluconazole
  • difluconazole
  • flunazol
  • diflucan
Triazole antifungal agent that is used to treat oropharyngeal CANDIDIASIS and cryptococcal MENINGITIS in AIDS.
  • Molecular weight: 306.28
  • Formula: C13H12F2N6O
  • CLOGP: 0.10
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 1
  • TPSA: 81.65
  • ALOGS: -2.34
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.20 g O
0.20 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 75 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 9.33 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 90 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.75 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.31 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.89 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 30 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 29, 1990 FDA PFIZER

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 596.51 9.83 766 84460 104779 56102062
Candida infection 465.34 9.83 353 84873 25314 56181527
Drug interaction 384.74 9.83 926 84300 208829 55998012
Rheumatoid arthritis 362.86 9.83 70 85156 382534 55824307
Fungal infection 284.55 9.83 298 84928 32695 56174146
Mucosal inflammation 262.60 9.83 324 84902 42486 56164355
Synovitis 224.11 9.83 4 85222 161301 56045540
Contraindicated product administered 223.45 9.83 15 85211 186271 56020570
Sepsis 214.00 9.83 577 84649 139263 56067578
Oral candidiasis 211.14 9.83 196 85030 18567 56188274
Pemphigus 203.19 9.83 8 85218 157204 56049637
Cytokine release syndrome 193.57 9.83 148 85078 10727 56196114
Joint swelling 193.04 9.83 99 85127 289701 55917140
Multiple organ dysfunction syndrome 189.17 9.83 309 84917 52461 56154380
Hand deformity 180.32 9.83 5 85221 134487 56072354
Systemic lupus erythematosus 179.00 9.83 29 85197 180049 56026792
Glossodynia 177.86 9.83 14 85212 152444 56054397
Pancytopenia 167.97 9.83 397 84829 88318 56118523
Stevens-Johnson syndrome 166.23 9.83 188 85038 22475 56184366
Thrombocytopenia 164.93 9.83 517 84709 135707 56071134
Arthropathy 156.41 9.83 54 85172 200221 56006620
Septic shock 154.98 9.83 307 84919 60528 56146313
Drug intolerance 150.47 9.83 109 85117 264709 55942132
Neutropenia 147.37 9.83 550 84676 157617 56049224
Arthralgia 144.88 9.83 343 84883 501326 55705515
Therapeutic product effect decreased 144.36 9.83 39 85187 169413 56037428
Abdominal discomfort 136.73 9.83 131 85095 277143 55929698
Pyrexia 131.52 9.83 1082 84144 417691 55789150
Cytomegalovirus infection 129.64 9.83 153 85073 19143 56187698
Platelet count decreased 123.45 9.83 398 84828 105985 56100856
Infusion related reaction 122.59 9.83 83 85143 208848 55997993
Wound 114.40 9.83 34 85192 138770 56068071
Maternal exposure during pregnancy 114.32 9.83 73 85153 189480 56017361
Pathogen resistance 114.19 9.83 85 85141 5915 56200926
Graft versus host disease 113.52 9.83 89 85137 6692 56200149
Alopecia 109.50 9.83 172 85054 293286 55913555
Female genital tract fistula 107.09 9.83 73 85153 4419 56202422
Mucormycosis 106.44 9.83 61 85165 2713 56204128
Systemic candida 106.44 9.83 63 85163 2978 56203863
Aspergillus infection 103.94 9.83 88 85138 7377 56199464
Cryptococcosis 103.87 9.83 44 85182 1002 56205839
Neutrophil count decreased 103.11 9.83 231 84995 49591 56157250
Toxic epidermal necrolysis 97.07 9.83 142 85084 21900 56184941
Abortion spontaneous 96.36 9.83 208 85018 43545 56163296
Discomfort 93.41 9.83 49 85177 141712 56065129
Drug ineffective 93.37 9.83 917 84309 918072 55288769
Oesophageal candidiasis 92.50 9.83 71 85155 5174 56201667
Swelling 91.84 9.83 138 85088 239633 55967208
Deep vein thrombosis 91.09 9.83 290 84936 76687 56130154
Pericarditis 89.16 9.83 27 85199 108896 56097945
Treatment failure 86.86 9.83 78 85148 170314 56036527
Bronchopulmonary aspergillosis 84.71 9.83 82 85144 8182 56198659
Sinusitis fungal 84.41 9.83 43 85183 1507 56205334
Vaginal discharge 82.44 9.83 71 85155 6092 56200749
Immune reconstitution inflammatory syndrome 79.23 9.83 67 85159 5607 56201234
Hepatic enzyme increased 78.68 9.83 86 85140 171298 56035543
Fixed eruption 78.41 9.83 35 85191 908 56205933
Hypersensitivity 77.28 9.83 171 85055 256237 55950604
Drug resistance 77.27 9.83 123 85103 20419 56186422
Fungaemia 76.96 9.83 45 85181 2079 56204762
Helicobacter infection 76.92 9.83 10 85216 73258 56133583
Peripheral swelling 76.24 9.83 150 85076 234576 55972265
Nasopharyngitis 73.68 9.83 139 85087 220820 55986021
Fall 73.21 9.83 286 84940 357224 55849617
Salpingo-oophorectomy unilateral 71.69 9.83 30 85196 662 56206179
Neutropenic sepsis 70.04 9.83 100 85126 15085 56191756
Musculoskeletal stiffness 69.73 9.83 80 85146 155927 56050914
Mouth ulceration 68.83 9.83 144 85082 29496 56177345
Cytomegalovirus viraemia 68.52 9.83 59 85167 5061 56201780
Vulvovaginal candidiasis 65.25 9.83 46 85180 2940 56203901
Fatigue 65.16 9.83 824 84402 787728 55419113
Enterococcal infection 63.90 9.83 66 85160 7118 56199723
Disseminated mucormycosis 63.89 9.83 19 85207 143 56206698
Sputum increased 61.55 9.83 39 85187 2085 56204756
Laryngitis fungal 61.30 9.83 18 85208 129 56206712
Infective aneurysm 60.98 9.83 23 85203 382 56206459
Skin candida 59.81 9.83 33 85193 1363 56205478
Therapeutic product effect incomplete 59.66 9.83 44 85182 105987 56100854
Pain 58.50 9.83 683 84543 662501 55544340
Respiratory failure 57.93 9.83 291 84935 94771 56112070
Acute graft versus host disease in skin 57.91 9.83 44 85182 3158 56203683
Meningitis cryptococcal 57.65 9.83 31 85195 1216 56205625
Torsade de pointes 57.48 9.83 82 85144 12358 56194483
Intentional overdose 57.36 9.83 16 85210 68101 56138740
Blood lactate dehydrogenase increased 57.09 9.83 108 85118 20567 56186274
Irritable bowel syndrome 55.96 9.83 17 85209 68441 56138400
Bacterial sepsis 55.94 9.83 46 85180 3703 56203138
Immune effector cell-associated neurotoxicity syndrome 55.46 9.83 33 85193 1575 56205266
Vaginal flatulence 55.32 9.83 25 85201 668 56206173
Respiratory symptom 54.16 9.83 40 85186 2750 56204091
Bone marrow failure 53.92 9.83 127 85099 28159 56178682
Pulmonary embolism 53.79 9.83 311 84915 106813 56100028
Acute myeloid leukaemia 53.64 9.83 94 85132 16878 56189963
Impaired healing 52.92 9.83 33 85193 86808 56120033
White blood cell count decreased 52.73 9.83 349 84877 125641 56081200
Psoriatic arthropathy 52.68 9.83 23 85203 73985 56132856
Pseudomonas infection 51.95 9.83 70 85156 10001 56196840
Renal failure 51.76 9.83 315 84911 110185 56096656
Anaemia 51.45 9.83 625 84601 266886 55939955
Product use issue 51.29 9.83 130 85096 185911 56020930
Blood bilirubin increased 51.28 9.83 138 85088 33216 56173625
Embolism venous 51.20 9.83 39 85187 2809 56204032
Uterine perforation 51.19 9.83 56 85170 6449 56200392
Fungal sepsis 50.60 9.83 28 85198 1163 56205678
Acute generalised exanthematous pustulosis 50.00 9.83 68 85158 9801 56197040
Hypomagnesaemia 49.53 9.83 114 85112 24901 56181940
Cytomegalovirus test positive 49.28 9.83 38 85188 2788 56204053
Suicide attempt 47.93 9.83 14 85212 57822 56149019
Dermatitis bullous 47.50 9.83 58 85168 7515 56199326
Aplastic anaemia 47.50 9.83 63 85163 8865 56197976
Pneumonia fungal 47.25 9.83 47 85179 4846 56201995
Aspartate aminotransferase increased 46.26 9.83 247 84979 82355 56124486
Cystitis haemorrhagic 45.97 9.83 42 85184 3895 56202946
Proctitis 45.90 9.83 35 85191 2525 56204316
Coccidioidomycosis 45.69 9.83 24 85202 897 56205944
Neurotoxicity 45.47 9.83 84 85142 15711 56191130
International normalised ratio increased 45.04 9.83 158 85068 43883 56162958
Cutaneous coccidioidomycosis 44.68 9.83 10 85216 18 56206823
Folliculitis 44.31 9.83 14 85212 54965 56151876
Injection site pain 44.21 9.83 68 85158 117050 56089791
Dysphagia 43.83 9.83 242 84984 81705 56125136
Bacteraemia 43.59 9.83 82 85144 15549 56191292
Acute kidney injury 43.48 9.83 556 84670 240207 55966634
Mobility decreased 42.88 9.83 52 85174 98939 56107902
Drug level increased 41.64 9.83 95 85131 20630 56186211
Hepatic function abnormal 41.59 9.83 131 85095 34427 56172414
C-reactive protein abnormal 41.21 9.83 4 85222 36805 56170036
Staphylococcal infection 41.13 9.83 138 85088 37480 56169361
Oral fungal infection 40.66 9.83 33 85193 2607 56204234
Jarisch-Herxheimer reaction 40.44 9.83 16 85210 304 56206537
Nasal polyps 40.43 9.83 36 85190 3229 56203612
Drug reaction with eosinophilia and systemic symptoms 39.38 9.83 118 85108 30186 56176655
Colitis 39.35 9.83 146 85080 41665 56165176
Cholecystitis chronic 38.92 9.83 60 85166 9688 56197153
Immunosuppressant drug level increased 38.57 9.83 35 85191 3218 56203623
Diastolic dysfunction 38.31 9.83 45 85181 5600 56201241
Acute graft versus host disease 38.30 9.83 39 85187 4136 56202705
Loss of personal independence in daily activities 38.24 9.83 40 85186 81329 56125512
Knee arthroplasty 38.01 9.83 10 85216 44249 56162592
Agranulocytosis 37.12 9.83 96 85130 22563 56184278
Pneumonia 37.01 9.83 841 84385 406257 55800584
Enterobacter infection 36.67 9.83 28 85198 2024 56204817
Geotrichum infection 36.62 9.83 17 85209 484 56206357
Tonsillar haemorrhage 36.34 9.83 14 85212 247 56206594
Hypokalaemia 36.17 9.83 256 84970 94181 56112660
Blood alkaline phosphatase increased 35.83 9.83 135 85091 38810 56168031
Shock haemorrhagic 35.23 9.83 55 85171 8978 56197863
Candida sepsis 35.16 9.83 23 85203 1299 56205542
Device related infection 35.12 9.83 92 85134 21788 56185053
Tumour lysis syndrome 34.82 9.83 51 85175 7872 56198969
Injection site erythema 34.27 9.83 40 85186 77408 56129433
Epstein-Barr virus infection 34.20 9.83 49 85177 7414 56199427
Fungal oesophagitis 33.76 9.83 17 85209 581 56206260
Hypertension 33.65 9.83 224 85002 244054 55962787
Injury 33.52 9.83 179 85047 59672 56147169
Breast cancer 33.46 9.83 16 85210 48817 56158024
Hepatic failure 33.26 9.83 119 85107 33367 56173474
Neuropathy peripheral 33.26 9.83 268 84958 102625 56104216
Alanine aminotransferase increased 33.06 9.83 249 84977 93413 56113428
Ill-defined disorder 33.00 9.83 33 85193 68510 56138331
BK virus infection 32.53 9.83 31 85195 3033 56203808
Vaginal infection 31.79 9.83 45 85181 6732 56200109
Disseminated intravascular coagulation 31.62 9.83 78 85148 17807 56189034
Arthritis 31.36 9.83 65 85161 99787 56107054
Klebsiella infection 31.33 9.83 48 85178 7708 56199133
Clostridium difficile colitis 31.32 9.83 80 85146 18658 56188183
Toxic neuropathy 31.19 9.83 14 85212 368 56206473
Symmetrical drug-related intertriginous and flexural exanthema 31.16 9.83 14 85212 369 56206472
Inappropriate schedule of product administration 30.91 9.83 49 85177 83338 56123503
Oral disorder 30.81 9.83 49 85177 8126 56198715
Congenital absence of cranial vault 30.79 9.83 7 85219 14 56206827
Rash maculo-papular 30.68 9.83 105 85121 28802 56178039
Intentional product use issue 30.42 9.83 66 85160 99667 56107174
Electrocardiogram QT prolonged 30.39 9.83 163 85063 54425 56152416
Contusion 30.04 9.83 97 85129 128333 56078508
Condition aggravated 29.96 9.83 356 84870 344542 55862299
Acute myeloid leukaemia recurrent 29.87 9.83 22 85204 1506 56205335
Blood pressure increased 29.72 9.83 116 85110 145060 56061781
Cholestasis 29.65 9.83 99 85127 26814 56180027
Engraftment syndrome 29.39 9.83 14 85212 423 56206418
Gastrointestinal fungal infection 29.05 9.83 12 85214 256 56206585
Erythema multiforme 29.01 9.83 52 85174 9502 56197339
Haemophagocytic lymphohistiocytosis 28.94 9.83 52 85174 9520 56197321
Eosinophilia 28.80 9.83 81 85145 19996 56186845
Toxoplasmosis 28.47 9.83 21 85205 1441 56205400
Fibromyalgia 28.34 9.83 29 85197 59574 56147267
Red blood cell sedimentation rate increased 28.33 9.83 10 85216 36613 56170228
Wrong technique in product usage process 28.00 9.83 28 85198 58140 56148701
Plasma cell myeloma 27.84 9.83 142 85084 46504 56160337
Drug abuse 27.74 9.83 37 85189 67573 56139268
Leukopenia 27.56 9.83 193 85033 70747 56136094
Adverse event 27.42 9.83 26 85200 55350 56151491
Injection site swelling 27.32 9.83 16 85210 43562 56163279
Abscess neck 27.09 9.83 15 85211 624 56206217
Respiratory tract infection fungal 26.66 9.83 13 85213 414 56206427
Gastrointestinal disorder 26.44 9.83 85 85141 112617 56094224
Staphylococcal sepsis 26.26 9.83 43 85183 7306 56199535
Adrenal insufficiency 26.22 9.83 67 85159 15630 56191211
Keratitis fungal 26.03 9.83 10 85216 175 56206666
Puerperal pyrexia 25.97 9.83 7 85219 35 56206806
Tricuspid valve incompetence 25.80 9.83 60 85166 13193 56193648
Soft tissue neoplasm 25.74 9.83 8 85218 71 56206770
Sepsis syndrome 25.67 9.83 16 85210 831 56206010
Chronic graft versus host disease 25.57 9.83 28 85198 3228 56203613
Septic embolus 25.56 9.83 16 85210 837 56206004
Hyperbilirubinaemia 25.26 9.83 51 85175 10184 56196657
Pleural effusion 25.14 9.83 218 85008 85262 56121579
Encephalopathy 25.03 9.83 113 85113 35212 56171629
Drug ineffective for unapproved indication 24.41 9.83 90 85136 25603 56181238
Accidental exposure to product 24.39 9.83 4 85222 24643 56182198
Drug eruption 24.27 9.83 90 85136 25673 56181168
Failure to thrive 24.24 9.83 39 85187 6531 56200310
Liver abscess 24.16 9.83 25 85201 2701 56204140
Nasal abscess 24.06 9.83 9 85217 146 56206695
Blast cell count increased 24.00 9.83 12 85214 404 56206437
Acute graft versus host disease in intestine 23.48 9.83 20 85206 1690 56205151
Oesophagitis 23.48 9.83 60 85166 13997 56192844
Antithrombin III decreased 23.47 9.83 10 85216 231 56206610
Enterococcal sepsis 23.44 9.83 18 85208 1312 56205529
Systemic mycosis 23.39 9.83 17 85209 1140 56205701
Sinus polyp 23.38 9.83 11 85215 323 56206518
Gamma-glutamyltransferase increased 23.35 9.83 101 85125 30904 56175937
Focal myositis 23.35 9.83 6 85220 24 56206817
Enterococcal bacteraemia 23.31 9.83 18 85208 1323 56205518
Pain in extremity 23.21 9.83 314 84912 297117 55909724
Stem cell transplant 23.14 9.83 20 85206 1724 56205117
Hip arthroplasty 23.08 9.83 15 85211 38608 56168233
Basal cell carcinoma 23.03 9.83 5 85221 25216 56181625
Blood pressure systolic increased 22.89 9.83 17 85209 40819 56166022
Encephalitis fungal 22.78 9.83 6 85220 27 56206814
Weight increased 22.76 9.83 230 84996 229473 55977368
Oropharyngeal candidiasis 22.59 9.83 16 85210 1030 56205811
Joint neoplasm 22.44 9.83 7 85219 63 56206778
Tongue coated 22.25 9.83 17 85209 1230 56205611
Resorption bone increased 22.21 9.83 17 85209 1233 56205608
Chronic sinusitis 22.19 9.83 43 85183 8335 56198506
Thrombotic microangiopathy 22.17 9.83 46 85180 9365 56197476
Dizziness 21.73 9.83 420 84806 375720 55831121
Diabetic macroangiopathy 21.72 9.83 8 85218 124 56206717
Venoocclusive liver disease 21.70 9.83 30 85196 4391 56202450
Fat necrosis 21.69 9.83 13 85213 629 56206212
Oral pain 21.63 9.83 88 85138 26205 56180636
Nail infection 21.62 9.83 22 85204 2331 56204510
Viral haemorrhagic cystitis 21.56 9.83 14 85212 781 56206060
Emphysema 21.47 9.83 47 85179 9929 56196912
Overdose 21.38 9.83 85 85141 105745 56101096
Sleep disorder 21.28 9.83 44 85182 67619 56139222
Lung infiltration 21.27 9.83 57 85169 13681 56193160
Delayed graft function 21.20 9.83 15 85211 964 56205877
Emotional distress 20.93 9.83 95 85131 29668 56177173
Prothrombin time shortened 20.87 9.83 19 85207 1754 56205087
Disseminated cryptococcosis 20.85 9.83 11 85215 415 56206426
Renal impairment 20.77 9.83 200 85026 80513 56126328
Congestive cardiomyopathy 20.73 9.83 34 85192 5785 56201056
Staphylococcal bacteraemia 20.71 9.83 32 85194 5177 56201664
Odynophagia 20.56 9.83 37 85189 6781 56200060
Poor peripheral circulation 20.56 9.83 26 85200 3491 56203350
Blood cholesterol increased 20.54 9.83 50 85176 72529 56134312
Acute lymphocytic leukaemia 20.52 9.83 23 85203 2721 56204120
Gastrointestinal mucormycosis 20.51 9.83 9 85217 224 56206617
Transplant rejection 20.47 9.83 46 85180 9888 56196953
Cystic fibrosis related diabetes 20.43 9.83 6 85220 43 56206798
Candida test positive 20.42 9.83 14 85212 855 56205986
Incorrect dose administered 20.31 9.83 30 85196 52517 56154324
Overgrowth fungal 20.20 9.83 7 85219 90 56206751
Tongue blistering 20.13 9.83 17 85209 1420 56205421
Radiculopathy 20.05 9.83 33 85193 5632 56201209
Long QT syndrome 20.01 9.83 24 85202 3052 56203789
Cytopenia 19.91 9.83 45 85181 9710 56197131
Urinary tract infection fungal 19.88 9.83 12 85214 588 56206253
Product dose omission issue 19.87 9.83 206 85020 204547 56002294
Leukocytosis 19.87 9.83 80 85146 23711 56183130
Engraft failure 19.77 9.83 10 85216 345 56206496
Disease recurrence 19.74 9.83 80 85146 23780 56183061
Gastritis fungal 19.72 9.83 7 85219 97 56206744
Malaise 19.68 9.83 416 84810 367444 55839397
Graft versus host disease in lung 19.61 9.83 10 85216 351 56206490
Anhedonia 19.42 9.83 45 85181 9869 56196972
Acinetobacter infection 19.40 9.83 17 85209 1493 56205348
Generalised oedema 19.34 9.83 57 85169 14444 56192397
Diverticulum 19.28 9.83 48 85178 11018 56195823
Herpes simplex 19.20 9.83 38 85188 7480 56199361
Graft versus host disease in skin 19.07 9.83 22 85204 2685 56204156
Vulvovaginal pruritus 18.93 9.83 22 85204 2706 56204135
Livedo reticularis 18.92 9.83 20 85206 2215 56204626
Stenotrophomonas infection 18.87 9.83 18 85208 1763 56205078
Blastomycosis 18.86 9.83 9 85217 273 56206568
Mucosal disorder 18.72 9.83 19 85207 2007 56204834
Cerebral toxoplasmosis 18.69 9.83 13 85213 813 56206028
Plasma cell leukaemia 18.67 9.83 15 85211 1168 56205673
Feeling abnormal 18.63 9.83 122 85104 133480 56073361
Therapeutic response decreased 18.62 9.83 32 85194 52726 56154115
Necrotising enterocolitis neonatal 18.61 9.83 8 85218 189 56206652
Headache 18.61 9.83 676 84550 558368 55648473
Respiratory moniliasis 18.57 9.83 8 85218 190 56206651
Toxic skin eruption 18.47 9.83 49 85177 11690 56195151
Coagulation factor V level decreased 18.33 9.83 9 85217 291 56206550
Toxicity to various agents 18.26 9.83 235 84991 224329 55982512
Pulmonary haemorrhage 18.19 9.83 35 85191 6748 56200093
Ureaplasma infection 18.17 9.83 11 85215 542 56206299
Inhibitory drug interaction 18.13 9.83 20 85206 2324 56204517
Type 2 diabetes mellitus 17.88 9.83 27 85199 46835 56160006
Blood culture positive 17.70 9.83 27 85199 4319 56202522
Blood pressure fluctuation 17.69 9.83 21 85205 40339 56166502
Hepatitis acute 17.56 9.83 39 85187 8318 56198523
Pseudomonal sepsis 17.52 9.83 19 85207 2167 56204674
Pneumonia cryptococcal 17.50 9.83 12 85214 733 56206108
Growth failure 17.47 9.83 9 85217 323 56206518
HIV infection 17.46 9.83 10 85216 444 56206397
Fungal endocarditis 17.36 9.83 8 85218 224 56206617
Shock 17.30 9.83 72 85154 21656 56185185
Fibrin degradation products increased 17.27 9.83 7 85219 142 56206699
Hiatus hernia 17.15 9.83 67 85159 19585 56187256
Aeromonas infection 17.11 9.83 6 85220 80 56206761
Pulmonary infarction 17.00 9.83 20 85206 2492 56204349
Hepatic artery aneurysm 16.98 9.83 4 85222 10 56206831
Pharyngeal stenosis 16.98 9.83 4 85222 10 56206831
Status epilepticus 16.95 9.83 56 85170 15085 56191756
Nervous system disorder 16.75 9.83 60 85166 16829 56190012
Renal tubular acidosis 16.67 9.83 16 85210 1579 56205262
Acid base balance abnormal 16.61 9.83 8 85218 248 56206593
Candida osteomyelitis 16.48 9.83 3 85223 0 56206841
Secondary amyloidosis 16.47 9.83 6 85220 90 56206751
Constipation 16.40 9.83 411 84815 201532 56005309
Metabolic acidosis 16.26 9.83 111 85115 40343 56166498
Septic pulmonary embolism 16.23 9.83 5 85221 43 56206798
Stoma site candida 16.21 9.83 4 85222 13 56206828
Arteritis infective 16.13 9.83 5 85221 44 56206797
Rash erythematous 16.09 9.83 104 85122 37117 56169724
Posterior reversible encephalopathy syndrome 16.09 9.83 57 85169 15903 56190938
Purpura senile 16.05 9.83 10 85216 519 56206322
Vulvovaginal discomfort 16.01 9.83 18 85208 2137 56204704
Skin exfoliation 15.89 9.83 103 85123 36797 56170044
Injection site bruising 15.88 9.83 21 85205 38500 56168341
Live birth 15.78 9.83 5 85221 19600 56187241
Renal abscess 15.77 9.83 11 85215 691 56206150
Foetal death 15.76 9.83 38 85188 8549 56198292
Respiratory syncytial virus infection 15.66 9.83 29 85197 5432 56201409
Oral mucosal blistering 15.66 9.83 28 85198 5106 56201735
Blood creatinine increased 15.64 9.83 188 85038 80003 56126838
Capillary leak syndrome 15.60 9.83 17 85209 1949 56204892
PRIDE syndrome 15.57 9.83 4 85222 16 56206825
Infective chondritis 15.57 9.83 4 85222 16 56206825
Hiccups 15.44 9.83 17 85209 1971 56204870
Post procedural bile leak 15.31 9.83 6 85220 111 56206730
Mediastinal effusion 15.30 9.83 5 85221 53 56206788
Neural tube defect 15.29 9.83 7 85219 193 56206648
Hypoglossal nerve paresis 15.21 9.83 6 85220 113 56206728
Injection site pruritus 15.20 9.83 25 85201 41906 56164935
Vulvovaginal mycotic infection 15.19 9.83 27 85199 4901 56201940
Poikiloderma 15.19 9.83 7 85219 196 56206645
Gallbladder disorder 15.05 9.83 59 85167 17275 56189566
Diffuse large B-cell lymphoma 15.03 9.83 33 85193 6983 56199858
Epstein-Barr virus associated lymphoproliferative disorder 15.03 9.83 16 85210 1787 56205054
Respiratory tract haemorrhage 14.99 9.83 9 85217 437 56206404
Pulmonary arterial hypertension 14.90 9.83 11 85215 26492 56180349
Vulvovaginitis 14.85 9.83 8 85218 315 56206526
Fungal skin infection 14.85 9.83 24 85202 4034 56202807
Myelosuppression 14.82 9.83 59 85167 17396 56189445
Splenic vein thrombosis 14.80 9.83 8 85218 317 56206524
Enterocolitis 14.76 9.83 33 85193 7071 56199770
Vulvovaginal swelling 14.75 9.83 9 85217 450 56206391
Leukoencephalopathy 14.74 9.83 24 85202 4058 56202783
Leukaemia 14.74 9.83 23 85203 3752 56203089
Haemodialysis 14.69 9.83 37 85189 8554 56198287
Hysterectomy 14.69 9.83 37 85189 8554 56198287
Atelectasis 14.61 9.83 63 85163 19245 56187596
Graft versus host disease in gastrointestinal tract 14.51 9.83 20 85206 2919 56203922
Primary adrenal insufficiency 14.44 9.83 6 85220 130 56206711
Petechiae 14.39 9.83 48 85178 12991 56193850
Cushing's syndrome 14.20 9.83 10 85216 638 56206203
Angina bullosa haemorrhagica 14.11 9.83 6 85220 138 56206703
Staphylococcus test positive 14.09 9.83 22 85204 3591 56203250
Nightmare 14.07 9.83 4 85222 16822 56190019
Acinetobacter test positive 14.04 9.83 5 85221 70 56206771
Abdominal pain 14.04 9.83 501 84725 258304 55948537
Encephalitis 14 9.83 35 85191 8055 56198786
Duodenal stenosis 13.92 9.83 9 85217 498 56206343
Philadelphia positive acute lymphocytic leukaemia 13.91 9.83 5 85221 72 56206769
Cachexia 13.87 9.83 26 85200 4916 56201925
Systemic inflammatory response syndrome 13.87 9.83 27 85199 5251 56201590
Multiple sclerosis 13.82 9.83 13 85213 27789 56179052
Proteus infection 13.82 9.83 11 85215 845 56205996
Angioimmunoblastic T-cell lymphoma 13.80 9.83 6 85220 146 56206695
Restlessness 13.73 9.83 12 85214 26574 56180267
Insomnia 13.73 9.83 206 85020 191654 56015187
Angiodermatitis 13.66 9.83 5 85221 76 56206765
Post transplant lymphoproliferative disorder 13.64 9.83 25 85201 4647 56202194
Fungal test positive 13.64 9.83 9 85217 516 56206325
Off label use 13.60 9.83 696 84530 555484 55651357
Streptococcal sepsis 13.59 9.83 15 85211 1745 56205096
Right ventricular failure 13.50 9.83 4 85222 16375 56190466
Tarsal tunnel syndrome 13.42 9.83 9 85217 530 56206311
Mucosal erosion 13.42 9.83 13 85213 1298 56205543
Dehydration 13.42 9.83 325 84901 158500 56048341
Central nervous system lymphoma 13.33 9.83 14 85212 1539 56205302
Immunosuppressant drug level decreased 13.27 9.83 11 85215 895 56205946
Acute respiratory distress syndrome 13.25 9.83 67 85159 21859 56184982
Pneumothorax 13.23 9.83 51 85175 14816 56192025
Exposure via breast milk 13.23 9.83 15 85211 1797 56205044
Xanthopsia 13.19 9.83 6 85220 163 56206678
Eczema 13.16 9.83 76 85150 26077 56180764
Acquired macroglossia 12.95 9.83 6 85220 170 56206671
Ileus paralytic 12.95 9.83 23 85203 4172 56202669
Herpes simplex oesophagitis 12.92 9.83 6 85220 171 56206670
Medication error 12.91 9.83 28 85198 42307 56164534
CD4 lymphocytes decreased 12.90 9.83 13 85213 1362 56205479
Chronic hepatitis C 12.89 9.83 6 85220 172 56206669
Vulvovaginal disorder 12.88 9.83 3 85223 7 56206834
Prescribed overdose 12.86 9.83 9 85217 22287 56184554
Escherichia infection 12.86 9.83 43 85183 11656 56195185
Cushingoid 12.84 9.83 32 85194 7352 56199489
Dysbiosis 12.81 9.83 10 85216 747 56206094
Disease progression 12.75 9.83 227 84999 104946 56101895
Acute sinusitis 12.72 9.83 21 85205 3592 56203249
Rhinorrhoea 12.70 9.83 44 85182 56993 56149848
Refractory anaemia with an excess of blasts 12.65 9.83 8 85218 426 56206415
Acute febrile neutrophilic dermatosis 12.64 9.83 18 85208 2707 56204134
Lymphadenopathy 12.64 9.83 94 85132 35114 56171727
Product deposit 12.64 9.83 6 85220 180 56206661
Sleep apnoea syndrome 12.64 9.83 75 85151 25986 56180855
Hypoalbuminaemia 12.59 9.83 40 85186 10559 56196282
Neutropenic colitis 12.55 9.83 18 85208 2725 56204116
Multiple-drug resistance 12.54 9.83 22 85204 3952 56202889
Dermatitis diaper 12.37 9.83 6 85220 189 56206652
Rhinocerebral mucormycosis 12.34 9.83 7 85219 305 56206536
Gallbladder fibrosis 12.34 9.83 3 85223 9 56206832
Metapneumovirus pneumonia 12.34 9.83 3 85223 9 56206832
Jaundice 12.25 9.83 77 85149 27217 56179624
Fracture 12.20 9.83 6 85220 18012 56188829
Gait disturbance 12.15 9.83 174 85052 163147 56043694
Enterocolitis bacterial 12.14 9.83 6 85220 197 56206644
Skin maceration 12.11 9.83 4 85222 44 56206797
Hyperhidrosis 12.08 9.83 88 85138 94000 56112841
Joint stiffness 12.03 9.83 22 85204 35403 56171438
Biliary dyskinesia 12.00 9.83 17 85209 2546 56204295
Thrombophlebitis 11.94 9.83 22 85204 4105 56202736
Vomiting projectile 11.94 9.83 12 85214 1253 56205588
Injection site reaction 11.90 9.83 41 85185 53206 56153635
Varicella zoster virus infection 11.89 9.83 17 85209 2567 56204274
Extremity necrosis 11.83 9.83 13 85213 1505 56205336
Haemorrhage 11.79 9.83 134 85092 56263 56150578
Cholelithiasis 11.78 9.83 101 85125 39363 56167478
Psoriasis 11.76 9.83 87 85139 92605 56114236
Road traffic accident 11.74 9.83 15 85211 27912 56178929
Palatal oedema 11.74 9.83 8 85218 484 56206357
Bone erosion 11.73 9.83 4 85222 14970 56191871
Out of specification test results 11.72 9.83 5 85221 116 56206725
Gastrointestinal necrosis 11.68 9.83 17 85209 2609 56204232
CSF culture positive 11.67 9.83 3 85223 12 56206829
Anal candidiasis 11.67 9.83 3 85223 12 56206829
Malnutrition 11.61 9.83 47 85179 13961 56192880
Subdiaphragmatic abscess 11.57 9.83 4 85222 51 56206790
Adverse drug reaction 11.51 9.83 55 85171 65077 56141764
Central nervous system leukaemia 11.45 9.83 5 85221 123 56206718
Bursitis 11.41 9.83 15 85211 27567 56179274
Pulmonary oedema 11.37 9.83 123 85103 51020 56155821
Flushing 11.36 9.83 61 85165 70039 56136802
Musculoskeletal pain 11.36 9.83 74 85152 81078 56125763
Cardiomyopathy acute 11.36 9.83 6 85220 227 56206614
Labelled drug-drug interaction medication error 11.35 9.83 41 85185 11545 56195296
Cytomegalovirus oesophagitis 11.33 9.83 6 85220 228 56206613
Mucosal toxicity 11.33 9.83 7 85219 358 56206483
Citrobacter test positive 11.30 9.83 3 85223 14 56206827
Intentional product misuse 11.28 9.83 40 85186 51464 56155377
Diabetic hyperosmolar coma 11.26 9.83 7 85219 362 56206479
Splenic infarction 11.25 9.83 13 85213 1589 56205252
Thrombocytosis 11.24 9.83 25 85201 5337 56201504
Night sweats 11.18 9.83 29 85197 41184 56165657
Genital haemorrhage 11.16 9.83 29 85197 6833 56200008
Encephalitis protozoal 11.13 9.83 3 85223 15 56206826
Enterobacter test positive 11.10 9.83 6 85220 238 56206603
Oliguria 11.09 9.83 33 85193 8407 56198434
Hepatotoxicity 11.08 9.83 83 85143 31070 56175771
Pain in jaw 11.00 9.83 28 85198 40008 56166833
Vaginal mucosal blistering 10.97 9.83 3 85223 16 56206825
Abdominal pain upper 10.92 9.83 197 85029 178116 56028725
Swollen tongue 10.91 9.83 81 85145 30243 56176598
Feeling hot 10.89 9.83 30 85196 41757 56165084
Foot deformity 10.87 9.83 12 85214 23813 56183028
Hallucinations, mixed 10.86 9.83 22 85204 4402 56202439
Stress 10.85 9.83 49 85177 58861 56147980
Lymphocyte count decreased 10.84 9.83 76 85150 27863 56178978
SJS-TEN overlap 10.83 9.83 6 85220 250 56206591
Vulvovaginal burning sensation 10.79 9.83 13 85213 1661 56205180
Encephalitis cytomegalovirus 10.78 9.83 8 85218 554 56206287
Adenovirus reactivation 10.75 9.83 5 85221 143 56206698
Coagulation time prolonged 10.74 9.83 11 85215 1174 56205667
Inflammation 10.71 9.83 61 85165 69010 56137831
Clostridial infection 10.68 9.83 21 85205 4114 56202727
Perihepatic abscess 10.67 9.83 3 85223 18 56206823
Lymphopenia 10.67 9.83 52 85174 16722 56190119
Dyspareunia 10.59 9.83 15 85211 2245 56204596
Idiopathic intracranial hypertension 10.59 9.83 16 85210 2538 56204303
Brain oedema 10.59 9.83 44 85182 13227 56193614
Hallucination, tactile 10.53 9.83 6 85220 264 56206577
Apraxia 10.51 9.83 13 85213 1706 56205135
Skin atrophy 10.50 9.83 22 85204 4508 56202333
Myocardial infarction 10.47 9.83 90 85136 92780 56114061
Heparin-induced thrombocytopenia 10.40 9.83 21 85205 4193 56202648
Mastitis fungal 10.36 9.83 4 85222 71 56206770
Tenosynovitis 10.35 9.83 3 85223 12458 56194383
Heliotrope rash 10.35 9.83 5 85221 156 56206685
Vulvovaginal erythema 10.34 9.83 6 85220 273 56206568
Urinary tract infection enterococcal 10.33 9.83 16 85210 2593 56204248
Muscle spasticity 10.32 9.83 9 85217 19951 56186890
Opsoclonus myoclonus 10.32 9.83 5 85221 157 56206684
Lichenification 10.29 9.83 7 85219 422 56206419
Pneumonia influenzal 10.22 9.83 12 85214 1492 56205349
Dyspnoea 10.19 9.83 766 84460 591811 55615030
Herpes simplex test positive 10.18 9.83 5 85221 162 56206679
Leukaemic infiltration extramedullary 10.16 9.83 4 85222 75 56206766
Herpes dermatitis 10.16 9.83 3 85223 22 56206819
Ataxia 10.15 9.83 46 85180 14357 56192484
Marrow hyperplasia 10.04 9.83 8 85218 616 56206225
Skin hyperpigmentation 10.03 9.83 24 85202 5373 56201468
Joint effusion 10.03 9.83 5 85221 14893 56191948
Sepsis neonatal 10.00 9.83 7 85219 442 56206399
Hepatorenal failure 10.00 9.83 8 85218 619 56206222
Low cardiac output syndrome 10.00 9.83 6 85220 291 56206550
Clostridium difficile infection 9.98 9.83 73 85153 27125 56179716
Aplasia 9.97 9.83 20 85206 3976 56202865
Rash morbilliform 9.95 9.83 17 85209 2990 56203851
Withdrawal syndrome 9.95 9.83 8 85218 18454 56188387
Herpes simplex viraemia 9.93 9.83 5 85221 171 56206670
Obstructive airways disorder 9.88 9.83 52 85174 17230 56189611
Exposure during pregnancy 9.88 9.83 146 85080 136196 56070645

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 488.99 10.80 921 68588 120928 31506907
Candida infection 353.98 10.80 290 69219 15968 31611867
Immune reconstitution inflammatory syndrome 271.90 10.80 188 69321 7990 31619845
Pyrexia 236.10 10.80 1297 68212 302543 31325292
Meningitis cryptococcal 227.01 10.80 108 69401 2215 31625620
Pancytopenia 191.77 10.80 520 68989 86796 31541039
Drug interaction 180.54 10.80 918 68591 207625 31420210
Mucormycosis 180.35 10.80 126 69383 5444 31622391
Cytokine release syndrome 161.79 10.80 191 69318 16451 31611384
Neutropenia 159.11 10.80 669 68840 139695 31488140
Multiple organ dysfunction syndrome 155.54 10.80 412 69097 67791 31560044
Sepsis 151.61 10.80 697 68812 151232 31476603
Septic shock 149.19 10.80 398 69111 65760 31562075
Graft versus host disease 147.42 10.80 146 69363 10301 31617534
Completed suicide 141.96 10.80 17 69492 91497 31536338
Cryptococcosis 139.50 10.80 78 69431 2260 31625575
Drug abuse 139.40 10.80 15 69494 87743 31540092
Aspergillus infection 131.91 10.80 144 69365 11384 31616451
Toxic epidermal necrolysis 128.71 10.80 185 69324 19339 31608496
Platelet count decreased 125.53 10.80 527 68982 109908 31517927
Pathogen resistance 121.66 10.80 121 69388 8580 31619255
Fungal infection 120.42 10.80 154 69355 14397 31613438
Enterococcal infection 112.19 10.80 116 69393 8615 31619220
Mucosal inflammation 110.96 10.80 238 69271 34189 31593646
Thrombocytopenia 108.63 10.80 607 68902 142140 31485695
Systemic candida 107.66 10.80 74 69435 3112 31624723
Neutrophil count decreased 104.42 10.80 279 69230 46115 31581720
Oral candidiasis 102.51 10.80 124 69385 10953 31616882
Aplastic anaemia 101.90 10.80 113 69396 9090 31618745
Cytomegalovirus infection 96.49 10.80 185 69324 24522 31603313
Fall 95.01 10.80 164 69345 185925 31441910
Bronchopulmonary aspergillosis 91.04 10.80 130 69379 13504 31614331
Drug resistance 84.78 10.80 170 69339 23283 31604552
Arthralgia 83.30 10.80 127 69382 151297 31476538
Disseminated intravascular coagulation 81.70 10.80 155 69354 20382 31607453
Dyspnoea 81.25 10.80 433 69076 343046 31284789
Oesophageal candidiasis 78.93 10.80 68 69441 4009 31623826
Product dose omission issue 74.46 10.80 73 69436 105513 31522322
Rheumatoid arthritis 73.81 10.80 9 69500 47800 31580035
Myocardial infarction 72.70 10.80 85 69424 113369 31514466
Hepatotoxicity 70.76 10.80 140 69369 18986 31608849
Pseudomonas infection 70.73 10.80 105 69404 11296 31616539
White blood cell count decreased 70.64 10.80 378 69131 87020 31540815
Intentional overdose 68.52 10.80 6 69503 41383 31586452
Blood bilirubin increased 66.98 10.80 199 69310 34937 31592898
Peripheral swelling 66.21 10.80 33 69476 67832 31560003
Torsade de pointes 65.53 10.80 78 69431 6772 31621063
Candida sepsis 63.76 10.80 37 69472 1152 31626683
Dizziness 62.16 10.80 226 69283 198921 31428914
Pain 61.60 10.80 207 69302 186552 31441283
Encephalitis 60.96 10.80 75 69434 6740 31621095
Cytomegalovirus viraemia 60.14 10.80 74 69435 6651 31621184
Joint swelling 60.13 10.80 21 69488 53410 31574425
Tumour lysis syndrome 59.81 10.80 115 69394 15270 31612565
Fungaemia 59.53 10.80 46 69463 2323 31625512
Immunosuppressant drug level increased 58.69 10.80 65 69444 5220 31622615
Respiratory failure 57.96 10.80 401 69108 101048 31526787
Fatigue 57.20 10.80 466 69043 334740 31293095
Acute myeloid leukaemia 56.63 10.80 126 69383 18546 31609289
Acinetobacter infection 56.08 10.80 33 69476 1055 31626780
Overdose 55.77 10.80 62 69447 84602 31543233
Pneumonia 55.49 10.80 1037 68472 334275 31293560
Acute graft versus host disease in skin 54.65 10.80 60 69449 4772 31623063
Stevens-Johnson syndrome 51.31 10.80 116 69393 17256 31610579
Bone marrow failure 50.90 10.80 156 69353 27852 31599983
Bacteraemia 50.14 10.80 116 69393 17518 31610317
Alanine aminotransferase increased 49.88 10.80 307 69202 74349 31553486
Wrong technique in product usage process 49.73 10.80 7 69502 33336 31594499
Staphylococcal infection 49.63 10.80 164 69345 30468 31597367
Cytomegalovirus chorioretinitis 48.52 10.80 48 69461 3380 31624455
Neurotoxicity 47.53 10.80 108 69401 16118 31611717
Prostate cancer 47.36 10.80 12 69497 37589 31590246
Toxicity to various agents 47.21 10.80 221 69288 181266 31446569
Insomnia 46.13 10.80 86 69423 94750 31533085
Cardiac failure congestive 46.13 10.80 64 69445 79323 31548512
Death 45.61 10.80 539 68970 360030 31267805
Coccidioidomycosis 45.54 10.80 25 69484 698 31627137
Nasopharyngitis 45.40 10.80 43 69466 63202 31564633
Drug level increased 44.98 10.80 121 69388 20065 31607770
Acute graft versus host disease 44.54 10.80 61 69448 6092 31621743
Electrocardiogram QT prolonged 44.40 10.80 183 69326 37804 31590031
Intentional product misuse 44.30 10.80 14 69495 37937 31589898
Venoocclusive liver disease 44.17 10.80 67 69442 7345 31620490
Trichosporon infection 43.62 10.80 24 69485 673 31627162
Blood lactate dehydrogenase increased 43.41 10.80 120 69389 20219 31607616
Lymphocyte count decreased 43.25 10.80 121 69388 20528 31607307
Pain in extremity 43.09 10.80 122 69387 116081 31511754
Therapeutic product effect incomplete 42.98 10.80 21 69488 43675 31584160
Systemic mycosis 42.61 10.80 31 69478 1428 31626407
Inappropriate schedule of product administration 42.13 10.80 30 69479 50793 31577042
HIV infection 41.90 10.80 32 69477 1588 31626247
Drug reaction with eosinophilia and systemic symptoms 41.08 10.80 152 69357 29866 31597969
Fusarium infection 40.95 10.80 27 69482 1059 31626776
Psoriasis 40.84 10.80 26 69483 46693 31581142
Cystitis haemorrhagic 40.67 10.80 54 69455 5235 31622600
Anxiety 40.46 10.80 87 69422 90946 31536889
Aspartate aminotransferase increased 40.07 10.80 255 69254 62464 31565371
Gait disturbance 39.73 10.80 68 69441 77427 31550408
Pruritus genital 39.68 10.80 21 69488 544 31627291
Leukopenia 39.37 10.80 239 69270 57589 31570246
Pseudomembranous colitis 38.63 10.80 38 69471 2657 31625178
Agranulocytosis 38.28 10.80 118 69391 21129 31606706
Depression 37.75 10.80 90 69419 90725 31537110
Pneumonia fungal 37.42 10.80 57 69452 6272 31621563
Feeling abnormal 37.24 10.80 42 69467 56960 31570875
Cerebrovascular accident 36.98 10.80 74 69435 79410 31548425
Suicidal ideation 36.57 10.80 17 69492 36389 31591446
Stomatitis 36.31 10.80 177 69332 39261 31588574
Chest pain 36.25 10.80 133 69376 116824 31511011
Aplasia 35.58 10.80 45 69464 4158 31623677
Clostridium difficile colitis 35.17 10.80 88 69421 13968 31613867
Hyperferritinaemia 35.10 10.80 17 69492 363 31627472
Injection site pain 35.06 10.80 16 69493 34618 31593217
Clostridium test positive 34.42 10.80 34 69475 2390 31625445
Graft versus host disease in gastrointestinal tract 33.91 10.80 40 69469 3439 31624396
Fungal skin infection 33.73 10.80 34 69475 2449 31625386
Acute myocardial infarction 33.69 10.80 37 69472 50786 31577049
Fungal peritonitis 33.55 10.80 21 69488 752 31627083
Bacterial infection 33.31 10.80 85 69424 13654 31614181
Asthma 32.95 10.80 27 69482 42584 31585251
Psoriatic arthropathy 32.58 10.80 3 69506 19880 31607955
Acute myeloid leukaemia recurrent 32.41 10.80 30 69479 1944 31625891
Hyperhidrosis 31.98 10.80 62 69447 67331 31560504
Hyperbilirubinaemia 31.72 10.80 91 69418 15659 31612176
Hepatic function abnormal 31.72 10.80 176 69333 41046 31586789
Penis injury 31.33 10.80 14 69495 247 31627588
Stress 31.33 10.80 8 69501 24933 31602902
Drug intolerance 31.18 10.80 41 69468 51992 31575843
Chronic graft versus host disease 30.98 10.80 43 69466 4349 31623486
Memory impairment 30.96 10.80 23 69486 38107 31589728
Phalangeal hypoplasia 30.61 10.80 10 69499 70 31627765
Acquired immunodeficiency syndrome 30.60 10.80 17 69492 486 31627349
Toxic neuropathy 30.35 10.80 17 69492 494 31627341
Epidermolysis bullosa 30.24 10.80 11 69498 110 31627725
Encephalitis viral 30.19 10.80 23 69486 1137 31626698
Immune effector cell-associated neurotoxicity syndrome 30.17 10.80 32 69477 2447 31625388
Liver disorder 30.02 10.80 137 69372 29570 31598265
Meningitis coccidioides 29.96 10.80 8 69501 24 31627811
Blood pressure increased 29.95 10.80 83 69426 79550 31548285
Arthropathy 29.67 10.80 8 69501 24043 31603792
Abdominal discomfort 29.52 10.80 42 69467 51525 31576310
Penile haemorrhage 29.46 10.80 18 69491 617 31627218
Pneumonia cryptococcal 29.46 10.80 20 69489 824 31627011
Blood alkaline phosphatase increased 29.15 10.80 135 69374 29318 31598517
Differentiation syndrome 28.91 10.80 23 69486 1212 31626623
Device related infection 28.88 10.80 90 69419 16209 31611626
Musculoskeletal stiffness 28.61 10.80 29 69480 41296 31586539
Hypoalbuminaemia 28.60 10.80 70 69439 10958 31616877
Portal fibrosis 28.57 10.80 14 69495 307 31627528
Cachexia 28.54 10.80 52 69457 6627 31621208
Disseminated coccidioidomycosis 28.39 10.80 8 69501 31 31627804
Aggression 28.38 10.80 24 69485 37267 31590568
Long QT syndrome 27.94 10.80 30 69479 2326 31625509
Porphyria acute 27.80 10.80 14 69495 326 31627509
Stem cell transplant 27.74 10.80 28 69481 2020 31625815
Chronic obstructive pulmonary disease 27.67 10.80 35 69474 45131 31582704
Klebsiella infection 27.52 10.80 56 69453 7747 31620088
Weight increased 27.24 10.80 92 69417 82855 31544980
Fungal test positive 27.01 10.80 16 69493 518 31627317
Acute respiratory distress syndrome 26.94 10.80 116 69393 24424 31603411
Aortoenteric fistula 26.72 10.80 10 69499 109 31627726
Angina pectoris 26.59 10.80 16 69493 29625 31598210
Chest discomfort 26.52 10.80 42 69467 49327 31578508
Bacterial sepsis 26.47 10.80 42 69467 4786 31623049
Coagulopathy 26.38 10.80 95 69414 18420 31609415
Cholestasis 26.36 10.80 117 69392 24958 31602877
Headache 26.12 10.80 267 69242 183385 31444450
Oropharyngeal candidiasis 25.77 10.80 17 69492 667 31627168
Loss of personal independence in daily activities 25.75 10.80 15 69494 28273 31599562
Blood corticosterone increased 25.62 10.80 5 69504 0 31627835
Musculoskeletal pain 25.52 10.80 17 69492 29811 31598024
Blood pressure fluctuation 25.46 10.80 9 69500 22727 31605108
Hepatic failure 25.40 10.80 140 69369 32562 31595273
Infection 25.32 10.80 283 69226 81648 31546187
Drug dependence 25.18 10.80 9 69500 22570 31605265
Hypertension 25.12 10.80 171 69338 127929 31499906
Haemodynamic instability 25.03 10.80 57 69452 8518 31619317
Systemic inflammatory response syndrome 24.77 10.80 47 69462 6178 31621657
CD4 lymphocytes decreased 24.70 10.80 24 69485 1653 31626182
Enterococcal sepsis 24.60 10.80 23 69486 1510 31626325
Enterococcal bacteraemia 24.57 10.80 24 69485 1664 31626171
Cough 24.47 10.80 184 69325 134630 31493205
Malaise 24.37 10.80 244 69265 168267 31459568
Hepatic cytolysis 24.23 10.80 65 69444 10758 31617077
Adenovirus infection 24.22 10.80 40 69469 4714 31623121
Wound dehiscence 24.07 10.80 32 69477 3106 31624729
Cerebral toxoplasmosis 24.04 10.80 23 69486 1554 31626281
Toxoplasmosis 23.83 10.80 21 69488 1276 31626559
Foetal exposure during pregnancy 23.68 10.80 33 69476 40843 31586992
Wound infection fungal 23.57 10.80 7 69502 34 31627801
Intracranial pressure increased 23.44 10.80 34 69475 3581 31624254
Aspartate aminotransferase 23.43 10.80 9 69500 106 31627729
Cardiac disorder 23.39 10.80 31 69478 39183 31588652
Therapeutic product effect decreased 23.28 10.80 21 69488 31601 31596234
Haemophagocytic lymphohistiocytosis 23.06 10.80 67 69442 11611 31616224
COVID-19 23.03 10.80 54 69455 54767 31573068
Heart rate decreased 23.01 10.80 17 69492 28249 31599586
Pulmonary haemorrhage 22.81 10.80 59 69450 9556 31618279
Blood culture positive 22.51 10.80 38 69471 4560 31623275
Osteoarthritis 22.31 10.80 7 69502 19060 31608775
Acute kidney injury 22.25 10.80 785 68724 278929 31348906
Encephalitis fungal 22.20 10.80 10 69499 180 31627655
Sedation 22.12 10.80 7 69502 18958 31608877
Endocarditis candida 21.99 10.80 8 69501 80 31627755
Kaposi's sarcoma 21.89 10.80 17 69492 865 31626970
Hospitalisation 21.78 10.80 48 69461 49759 31578076
Staphylococcal sepsis 21.60 10.80 56 69453 9081 31618754
Gallstone ileus 21.55 10.80 6 69503 22 31627813
Engraftment syndrome 21.43 10.80 17 69492 892 31626943
Adrenal suppression 21.42 10.80 14 69495 541 31627294
Syncope 21.36 10.80 105 69404 85077 31542758
Coronary artery disease 21.34 10.80 43 69466 46044 31581791
Heart rate irregular 21.30 10.80 3 69506 14286 31613549
Stenotrophomonas test positive 21.25 10.80 11 69498 272 31627563
Ocular icterus 21.24 10.80 28 69481 2695 31625140
Arthritis fungal 21.07 10.80 8 69501 91 31627744
Road traffic accident 21.07 10.80 5 69504 16376 31611459
Disseminated cryptococcosis 21.05 10.80 20 69489 1340 31626495
Pulmonary mucormycosis 20.96 10.80 15 69494 673 31627162
C-reactive protein increased 20.88 10.80 180 69329 48470 31579365
Graft versus host disease in skin 20.71 10.80 32 69477 3565 31624270
Cytomegalovirus test positive 20.65 10.80 32 69477 3573 31624262
Cytopenia 20.63 10.80 62 69447 10948 31616887
Fluorosis 20.62 10.80 7 69502 56 31627779
Incorrect dose administered 20.58 10.80 29 69480 35723 31592112
Atelectasis 20.51 10.80 80 69429 16109 31611726
Anterior displaced anus 20.50 10.80 4 69505 0 31627835
Central venous pressure increased 20.50 10.80 5 69504 9 31627826
Jaundice 20.49 10.80 125 69384 30162 31597673
Stiff person syndrome 20.40 10.80 8 69501 100 31627735
Dysbiosis 20.13 10.80 12 69497 393 31627442
Sleep apnoea syndrome 19.81 10.80 8 69501 18617 31609218
Acute generalised exanthematous pustulosis 19.72 10.80 42 69467 5998 31621837
Drug-induced liver injury 19.39 10.80 105 69404 24258 31603577
Hypokalaemia 19.35 10.80 191 69318 53383 31574452
Haematotoxicity 19.25 10.80 46 69463 7091 31620744
Pseudomonal sepsis 19.20 10.80 29 69480 3167 31624668
Mycobacterium avium complex infection 19.01 10.80 25 69484 2401 31625434
Gastrooesophageal reflux disease 18.98 10.80 28 69481 33843 31593992
Engraft failure 18.94 10.80 12 69497 439 31627396
Neutropenic sepsis 18.91 10.80 65 69444 12314 31615521
Secondary adrenocortical insufficiency 18.59 10.80 18 69491 1234 31626601
Therapy cessation 18.58 10.80 5 69504 15050 31612785
Muscle spasms 18.43 10.80 82 69427 68236 31559599
Irritability 18.33 10.80 14 69495 22875 31604960
Central nervous system vasculitis 18.30 10.80 12 69497 466 31627369
Gamma-glutamyltransferase increased 18.29 10.80 114 69395 27711 31600124
Respiratory tract infection fungal 18.20 10.80 14 69495 702 31627133
Mobility decreased 18.20 10.80 20 69489 27449 31600386
Adrenal insufficiency 18.07 10.80 65 69444 12594 31615241
Drug ineffective for unapproved indication 17.94 10.80 82 69427 17708 31610127
Vision blurred 17.84 10.80 41 69468 41874 31585961
Elbow synostosis 17.82 10.80 5 69504 19 31627816
Mycetoma mycotic 17.81 10.80 7 69502 88 31627747
Odynophagia 17.80 10.80 36 69473 4957 31622878
Flushing 17.78 10.80 24 69485 30104 31597731
Hypertransaminasaemia 17.75 10.80 33 69476 4271 31623564
Hepatic enzyme increased 17.64 10.80 137 69372 35771 31592064
Blast cell count increased 17.63 10.80 16 69493 1011 31626824
Hepatic necrosis 17.57 10.80 30 69479 3633 31624202
Choreoathetosis 17.55 10.80 16 69493 1017 31626818
Congenital foot malformation 17.47 10.80 11 69498 398 31627437
Epstein-Barr viraemia 17.41 10.80 16 69493 1027 31626808
Eschar 17.34 10.80 13 69496 627 31627208
Opportunistic infection 17.31 10.80 19 69490 1510 31626325
Rash maculo-papular 17.30 10.80 106 69403 25613 31602222
Skin necrosis 17.22 10.80 38 69471 5560 31622275
Oral mucosal erythema 17.04 10.80 11 69498 416 31627419
Idiosyncratic drug reaction 16.97 10.80 11 69498 419 31627416
Enterococcus test positive 16.89 10.80 14 69495 782 31627053
Back pain 16.83 10.80 156 69353 109257 31518578
Synostosis 16.82 10.80 7 69502 103 31627732
Diabetic ketoacidosis 16.81 10.80 8 69501 16897 31610938
Myalgia 16.73 10.80 100 69409 77158 31550677
Mediastinitis 16.69 10.80 13 69496 664 31627171
Blood glucose increased 16.67 10.80 73 69436 61010 31566825
Acanthamoeba infection 16.65 10.80 11 69498 433 31627402
Brachycephaly 16.58 10.80 6 69503 59 31627776
Staphylococcal bacteraemia 16.57 10.80 45 69464 7503 31620332
Pulmonary alveolar haemorrhage 16.55 10.80 42 69467 6724 31621111
Dyspnoea exertional 16.52 10.80 38 69471 38799 31589036
Bradycardia 16.50 10.80 87 69422 69240 31558595
IVth nerve paralysis 16.40 10.80 7 69502 110 31627725
Swollen tongue 16.40 10.80 4 69505 12858 31614977
Streptococcal infection 16.37 10.80 33 69476 4534 31623301
Bladder cancer 16.20 10.80 6 69503 14719 31613116
Escherichia sepsis 16.01 10.80 31 69478 4136 31623699
Swelling face 15.99 10.80 14 69495 21376 31606459
Arthritis 15.97 10.80 22 69487 27363 31600472
Nephropathy toxic 15.96 10.80 58 69451 11295 31616540
Hyperadrenocorticism 15.96 10.80 7 69502 118 31627717
Contraindicated product administered 15.95 10.80 12 69497 19760 31608075
Renal impairment 15.92 10.80 272 69237 86077 31541758
Prostatic specific antigen increased 15.79 10.80 5 69504 13533 31614302
Pneumonia pseudomonal 15.75 10.80 28 69481 3501 31624334
Brain abscess 15.75 10.80 25 69484 2850 31624985
Product prescribing error 15.74 10.80 12 69497 19630 31608205
SARS-CoV-2 sepsis 15.69 10.80 7 69502 123 31627712
Enterobacter test positive 15.63 10.80 8 69501 193 31627642
Unevaluable event 15.50 10.80 27 69482 30548 31597287
Anticonvulsant drug level abnormal 15.43 10.80 5 69504 34 31627801
Hepatomegaly 15.34 10.80 51 69458 9499 31618336
Geotrichum infection 15.23 10.80 11 69498 501 31627334
Anger 15.17 10.80 3 69506 11150 31616685
Culture stool positive 15.05 10.80 8 69501 209 31627626
Dermatitis 14.93 10.80 47 69462 8509 31619326
Respiratory distress 14.84 10.80 125 69384 33428 31594407
Generalised oedema 14.71 10.80 57 69452 11444 31616391
Type 2 diabetes mellitus 14.69 10.80 7 69502 14777 31613058
Mucosal infection 14.62 10.80 8 69501 222 31627613
Faeces pale 14.58 10.80 16 69493 1271 31626564
HIV associated nephropathy 14.54 10.80 9 69500 316 31627519
Oedema 14.53 10.80 150 69359 42411 31585424
Candida pneumonia 14.51 10.80 9 69500 317 31627518
Familial periodic paralysis 14.49 10.80 6 69503 87 31627748
Nosocomial infection 14.47 10.80 15 69494 1117 31626718
Gastrointestinal mucormycosis 14.43 10.80 7 69502 150 31627685
Cytomegalovirus test 14.41 10.80 5 69504 43 31627792
Sputum purulent 14.37 10.80 10 69499 429 31627406
Klebsiella sepsis 14.36 10.80 19 69490 1836 31625999
Venoocclusive disease 14.31 10.80 23 69486 2649 31625186
Acute hepatic failure 14.27 10.80 61 69448 12798 31615037
Osteonecrosis of jaw 14.24 10.80 10 69499 17061 31610774
Lung neoplasm malignant 14.22 10.80 9 69500 16221 31611614
Angioedema 14.21 10.80 33 69476 33585 31594250
Rectal perforation 14.11 10.80 10 69499 442 31627393
Gastrointestinal wall thinning 14.10 10.80 4 69505 16 31627819
Stenotrophomonas infection 14.00 10.80 19 69490 1881 31625954
Hepatocellular injury 13.99 10.80 88 69421 21456 31606379
Transplant rejection 13.99 10.80 50 69459 9658 31618177
Application site haematoma 13.83 10.80 5 69504 49 31627786
Renal failure 13.76 10.80 361 69148 122969 31504866
Pseudomonas test positive 13.62 10.80 14 69495 1032 31626803
Sleep disorder 13.60 10.80 23 69486 26325 31601510
Gram stain positive 13.58 10.80 6 69503 103 31627732
Cytomegalovirus enterocolitis 13.53 10.80 13 69496 883 31626952
Pleural effusion 13.44 10.80 235 69274 74685 31553150
Neurological symptom 13.42 10.80 27 69482 3704 31624131
Organ failure 13.42 10.80 19 69490 1957 31625878
Peritoneal candidiasis 13.38 10.80 4 69505 20 31627815
Rhinovirus infection 13.37 10.80 26 69483 3479 31624356
Acute lymphocytic leukaemia 13.37 10.80 26 69483 3480 31624355
Balance disorder 13.33 10.80 40 69469 37382 31590453
Nasal congestion 13.32 10.80 15 69494 20366 31607469
Liver transplant rejection 13.13 10.80 19 69490 1997 31625838
Obesity 13.12 10.80 4 69505 11096 31616739
Multiple sclerosis relapse 13.10 10.80 5 69504 12042 31615793
Plasma cell myeloma 13.06 10.80 185 69324 56346 31571489
Bone marrow disorder 13.04 10.80 17 69492 1619 31626216
Hypoperfusion 12.95 10.80 14 69495 1094 31626741
Meningism 12.86 10.80 7 69502 192 31627643
Respiratory paralysis 12.78 10.80 5 69504 62 31627773
Candida endophthalmitis 12.75 10.80 6 69503 120 31627715
Viral test positive 12.70 10.80 7 69502 197 31627638
Viraemia 12.66 10.80 14 69495 1122 31626713
Obstructive airways disorder 12.58 10.80 6 69503 12658 31615177
Haematochezia 12.53 10.80 46 69463 40418 31587417
Blood creatinine increased 12.45 10.80 269 69240 88809 31539026
Platelet transfusion 12.37 10.80 15 69494 1328 31626507
Prothrombin time prolonged 12.34 10.80 46 69463 9066 31618769
Basal cell carcinoma 12.30 10.80 13 69496 18166 31609669
Hyperthyroidism 12.27 10.80 3 69506 9628 31618207
Intentional product use issue 12.26 10.80 61 69448 49286 31578549
Hepatitis cholestatic 12.23 10.80 39 69470 7107 31620728
Haemodialysis 12.21 10.80 49 69460 9996 31617839
Hepatitis fulminant 12.17 10.80 26 69483 3720 31624115
Blood creatine phosphokinase increased 12.17 10.80 49 69460 41925 31585910
Streptococcal bacteraemia 12.07 10.80 17 69492 1743 31626092
Contusion 11.98 10.80 35 69474 32993 31594842
Rhinorrhoea 11.96 10.80 20 69489 22992 31604843
Ventricular tachycardia 11.96 10.80 91 69418 23610 31604225
Vascular device infection 11.94 10.80 24 69485 3291 31624544
Skin cancer 11.81 10.80 3 69506 9382 31618453
Wheezing 11.75 10.80 40 69469 35946 31591889
Ischaemic hepatitis 11.73 10.80 16 69493 1591 31626244
Colitis ulcerative 11.72 10.80 14 69495 18515 31609320
Erectile dysfunction 11.68 10.80 15 69494 19220 31608615
Periorbital cellulitis 11.67 10.80 7 69502 232 31627603
Polyomavirus viraemia 11.65 10.80 11 69498 731 31627104
Dermatitis exfoliative 11.64 10.80 36 69473 6456 31621379
Monocytopenia 11.63 10.80 5 69504 80 31627755
Central nervous system lesion 11.62 10.80 34 69475 5914 31621921
Oesophagitis 11.62 10.80 56 69453 12360 31615475
Cholangitis infective 11.61 10.80 7 69502 234 31627601
Angina unstable 11.60 10.80 5 69504 11190 31616645
Device malfunction 11.58 10.80 3 69506 9263 31618572
End stage AIDS 11.57 10.80 4 69505 34 31627801
Dysarthria 11.57 10.80 34 69475 31983 31595852
Fungal oesophagitis 11.56 10.80 8 69501 340 31627495
Dystonia 11.53 10.80 4 69505 10221 31617614
Product quality issue 11.50 10.80 11 69498 16100 31611735
Accidental overdose 11.46 10.80 14 69495 18336 31609499
Oral fungal infection 11.45 10.80 14 69495 1250 31626585
Delusion 11.44 10.80 6 69503 11991 31615844
Nephrolithiasis 11.42 10.80 27 69482 27312 31600523
Depressed mood 11.42 10.80 13 69496 17562 31610273
Paraesthesia 11.40 10.80 74 69435 55997 31571838
Product administration error 11.37 10.80 10 69499 15237 31612598
T-cell lymphoma recurrent 11.37 10.80 4 69505 36 31627799
Heart rate increased 11.29 10.80 49 69460 41061 31586774
Klebsiella bacteraemia 11.29 10.80 14 69495 1268 31626567
Citrobacter infection 11.28 10.80 9 69500 476 31627359
Injection site swelling 11.28 10.80 4 69505 10083 31617752
Spinal cord disorder 11.24 10.80 11 69498 764 31627071
Somnolence 11.24 10.80 152 69357 99293 31528542
Superinfection fungal 11.24 10.80 3 69506 9 31627826
Weight decreased 11.23 10.80 266 69243 159686 31468149
Gout 11.21 10.80 14 69495 18160 31609675
HIV wasting syndrome 11.20 10.80 5 69504 88 31627747
Asthenia 11.18 10.80 392 69117 224363 31403472
Macule 11.13 10.80 13 69496 1106 31626729
Nervous system disorder 11.12 10.80 58 69451 13205 31614630
Epstein-Barr virus infection 11.05 10.80 37 69472 6916 31620919
Gastroduodenal ulcer 11.04 10.80 8 69501 366 31627469
Psychotic disorder 11.02 10.80 20 69489 22273 31605562
Anaemia 11.01 10.80 573 68936 212949 31414886
Eyelid ptosis congenital 11.00 10.80 5 69504 92 31627743
Blood pressure systolic increased 11.00 10.80 16 69493 19454 31608381
Drug withdrawal syndrome 11.00 10.80 15 69494 18735 31609100
Laryngitis fungal 11.00 10.80 4 69505 40 31627795
Metastases to bone 10.99 10.80 5 69504 10843 31616992
Migraine 10.94 10.80 9 69500 14171 31613664
Myelodysplastic syndrome 10.91 10.80 76 69433 19175 31608660
Trichoglossia 10.88 10.80 7 69502 263 31627572
Haemorrhagic necrotic pancreatitis 10.85 10.80 6 69503 170 31627665
Hepatic cirrhosis 10.84 10.80 11 69498 15663 31612172
Candida test positive 10.83 10.80 8 69501 377 31627458
Hyperleukocytosis 10.83 10.80 16 69493 1713 31626122
Pleocytosis 10.81 10.80 9 69500 506 31627329

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 899.49 9.69 1458 128943 202860 70595183
Candida infection 744.18 9.69 569 129832 33904 70764139
Drug interaction 493.59 9.69 1681 128720 379760 70418283
Rheumatoid arthritis 361.70 9.69 53 130348 291752 70506291
Pancytopenia 342.15 9.69 816 129585 150291 70647752
Mucosal inflammation 341.98 9.69 516 129885 67334 70730709
Completed suicide 340.48 9.69 19 130382 227116 70570927
Immune reconstitution inflammatory syndrome 333.26 9.69 238 130163 12752 70785291
Cytokine release syndrome 320.40 9.69 314 130087 26153 70771890
Fungal infection 317.88 9.69 368 130033 37099 70760944
Multiple organ dysfunction syndrome 309.77 9.69 643 129758 107872 70690171
Sepsis 306.23 9.69 1067 129334 243478 70554565
Pyrexia 303.26 9.69 2029 128372 604923 70193120
Meningitis cryptococcal 295.07 9.69 137 130264 3191 70794852
Mucormycosis 272.90 9.69 175 130226 7839 70790204
Septic shock 267.93 9.69 619 129782 111639 70686404
Neutropenia 257.88 9.69 1045 129356 256111 70541932
Pathogen resistance 255.75 9.69 205 130196 13074 70784969
Thrombocytopenia 243.97 9.69 977 129424 238133 70559910
Cryptococcosis 243.93 9.69 120 130281 3190 70794853
Joint swelling 234.84 9.69 86 130315 253125 70544918
Arthralgia 232.54 9.69 354 130047 503036 70295007
Platelet count decreased 228.45 9.69 784 129617 177438 70620605
Graft versus host disease 227.66 9.69 202 130199 14821 70783222
Oral candidiasis 209.82 9.69 244 130157 24708 70773335
Synovitis 209.72 9.69 6 130395 129222 70668821
Aspergillus infection 199.68 9.69 203 130198 17665 70780378
Cytomegalovirus infection 195.49 9.69 299 130102 39459 70758584
Systemic candida 190.79 9.69 125 130276 5809 70792234
Toxic epidermal necrolysis 179.89 9.69 287 130114 39270 70758773
Neutrophil count decreased 173.80 9.69 437 129964 83119 70714924
Stevens-Johnson syndrome 172.27 9.69 267 130134 35640 70762403
Enterococcal infection 163.54 9.69 166 130235 14416 70783627
Fall 163.30 9.69 359 130042 443737 70354306
Bronchopulmonary aspergillosis 161.12 9.69 196 130205 20806 70777237
Contraindicated product administered 160.85 9.69 27 130374 134585 70663458
Arthropathy 156.93 9.69 41 130360 150016 70648027
Drug intolerance 151.42 9.69 116 130285 225571 70572472
Drug abuse 146.98 9.69 44 130357 147212 70650831
Hand deformity 144.18 9.69 3 130398 86479 70711564
Aplastic anaemia 143.11 9.69 165 130236 16551 70781492
Therapeutic product effect decreased 142.26 9.69 43 130358 142975 70655068
Peripheral swelling 136.56 9.69 140 130261 236423 70561620
Drug resistance 134.03 9.69 247 130154 37943 70760100
Oesophageal candidiasis 132.12 9.69 116 130285 8391 70789652
Abdominal discomfort 128.54 9.69 123 130278 214535 70583508
Pemphigus 124.17 9.69 7 130394 83029 70715014
Nasopharyngitis 119.95 9.69 139 130262 222067 70575976
Systemic lupus erythematosus 118.33 9.69 22 130379 101880 70696163
Intentional overdose 117.02 9.69 20 130381 98415 70699628
Torsade de pointes 112.12 9.69 152 130249 17964 70780079
Pain 111.33 9.69 689 129712 628127 70169916
Suicide attempt 109.43 9.69 10 130391 79500 70718543
Fatigue 109.38 9.69 980 129421 823339 69974704
Pseudomonas infection 108.01 9.69 153 130248 18841 70779202
Glossodynia 104.08 9.69 17 130384 86470 70711573
Infusion related reaction 104 9.69 126 130275 197408 70600635
White blood cell count decreased 103.94 9.69 600 129801 169541 70628502
Respiratory failure 103.05 9.69 595 129806 168140 70629903
Fungaemia 102.87 9.69 74 130327 4008 70794035
Cytomegalovirus viraemia 102.82 9.69 117 130284 11568 70786475
Acute graft versus host disease 102.06 9.69 106 130295 9456 70788587
Immunosuppressant drug level increased 101.67 9.69 97 130304 7810 70790233
Blood bilirubin increased 101.04 9.69 290 130111 59611 70738432
Neurotoxicity 98.54 9.69 188 130213 29638 70768405
Musculoskeletal stiffness 96.47 9.69 78 130323 147682 70650361
Acute graft versus host disease in skin 96.45 9.69 90 130311 7047 70790996
Acute myeloid leukaemia 94.89 9.69 189 130212 30751 70767292
Drug level increased 94.61 9.69 208 130193 36261 70761782
Tumour lysis syndrome 94.40 9.69 153 130248 21207 70776836
Staphylococcal infection 91.49 9.69 260 130141 53144 70744899
Disseminated intravascular coagulation 91.01 9.69 195 130206 33403 70764640
Wound 87.36 9.69 36 130365 98696 70699347
Bone marrow failure 86.30 9.69 241 130160 48769 70749274
Blood lactate dehydrogenase increased 85.14 9.69 195 130206 34932 70763111
Maternal exposure during pregnancy 84.29 9.69 54 130347 115291 70682752
Candida sepsis 84.09 9.69 53 130348 2302 70795741
Discomfort 83.21 9.69 45 130356 105391 70692652
Cystitis haemorrhagic 80.68 9.69 89 130312 8504 70789539
Swelling 79.87 9.69 140 130261 188399 70609644
Injection site pain 79.41 9.69 60 130341 117559 70680484
Pneumonia 78.77 9.69 1535 128866 594697 70203346
Therapeutic product effect incomplete 78.60 9.69 63 130338 119819 70678224
Bacteraemia 76.97 9.69 168 130233 29141 70768902
Drug reaction with eosinophilia and systemic symptoms 76.65 9.69 258 130143 57755 70740288
Dizziness 76.19 9.69 520 129881 463621 70334422
Hepatotoxicity 72.29 9.69 211 130190 43775 70754268
Coccidioidomycosis 71.84 9.69 38 130363 1180 70796863
Alopecia 71.52 9.69 162 130239 198328 70599715
Immune effector cell-associated neurotoxicity syndrome 71.51 9.69 59 130342 3919 70794124
Helicobacter infection 71.48 9.69 9 130392 55647 70742396
Leukopenia 70.47 9.69 384 130017 106176 70691867
Blood pressure increased 70.27 9.69 151 130250 188366 70609677
Neutropenic sepsis 69.43 9.69 146 130255 24684 70773359
Fixed eruption 69.28 9.69 48 130353 2448 70795595
Duodenal ulcer perforation 68.82 9.69 7 130394 51105 70746938
Pneumonia fungal 68.52 9.69 88 130313 9865 70788178
Dyspnoea 68.41 9.69 1001 129400 769059 70028984
Aspartate aminotransferase increased 68.10 9.69 433 129968 126545 70671498
Bacterial sepsis 68.02 9.69 77 130324 7570 70790473
Hypersensitivity 67.99 9.69 207 130194 229605 70568438
Laryngitis fungal 67.32 9.69 20 130381 120 70797923
Sinusitis fungal 67.22 9.69 44 130357 2041 70796002
Alanine aminotransferase increased 67.19 9.69 483 129918 146997 70651046
Overdose 66.62 9.69 132 130269 169613 70628430
Product dose omission issue 66.41 9.69 193 130208 217275 70580768
Clostridium difficile colitis 65.93 9.69 157 130244 28839 70769204
Psoriatic arthropathy 65.25 9.69 19 130382 64752 70733291
Venoocclusive liver disease 65.17 9.69 89 130312 10589 70787454
Agranulocytosis 64.97 9.69 192 130209 40106 70757937
Acute generalised exanthematous pustulosis 64.95 9.69 108 130293 15289 70782754
Mobility decreased 62.80 9.69 58 130343 102941 70695102
Pericarditis 62.78 9.69 39 130362 84666 70713377
Hepatic function abnormal 62.23 9.69 269 130132 67727 70730316
Electrocardiogram QT prolonged 62.14 9.69 311 130090 83206 70714837
Salpingo-oophorectomy unilateral 61.72 9.69 28 130373 617 70797426
Deep vein thrombosis 61.62 9.69 382 130019 110660 70687383
Encephalitis 60.97 9.69 98 130303 13487 70784556
Acinetobacter infection 60.62 9.69 45 130356 2559 70795484
Inappropriate schedule of product administration 60.49 9.69 65 130336 107490 70690553
Myocardial infarction 58.70 9.69 144 130257 171501 70626542
Toxicity to various agents 58.37 9.69 437 129964 381735 70416308
Skin candida 58.36 9.69 38 130363 1747 70796296
Loss of personal independence in daily activities 57.71 9.69 43 130358 84867 70713176
Mouth ulceration 57.63 9.69 166 130235 34183 70763860
Systemic mycosis 57.41 9.69 43 130358 2479 70795564
Device related infection 57.38 9.69 159 130242 32026 70766017
Klebsiella infection 57.30 9.69 98 130303 14194 70783849
Hypertension 57.20 9.69 315 130086 295718 70502325
Pain in extremity 57.09 9.69 361 130040 327721 70470322
Chronic graft versus host disease 56.56 9.69 66 130335 6704 70791339
Acute kidney injury 55.98 9.69 1202 129199 473422 70324621
Irritable bowel syndrome 54.87 9.69 13 130388 50837 70747206
Toxic neuropathy 53.51 9.69 28 130373 850 70797193
Wrong technique in product usage process 53.21 9.69 30 130371 68668 70729375
Cholestasis 53.05 9.69 201 130200 47671 70750372
Headache 53.01 9.69 750 129651 579655 70218388
Hepatic failure 52.75 9.69 228 130173 57397 70740646
Hyperbilirubinaemia 52.18 9.69 123 130278 22445 70775598
Cytomegalovirus test positive 51.63 9.69 57 130344 5451 70792592
Impaired healing 51.41 9.69 37 130364 74337 70723706
Renal failure 51.06 9.69 552 129849 188518 70609525
Geotrichum infection 49.70 9.69 28 130373 987 70797056
Infective aneurysm 49.66 9.69 27 130374 887 70797156
Female genital tract fistula 49.57 9.69 43 130358 3060 70794983
Malaise 49.47 9.69 533 129868 432399 70365644
Arthritis 48.93 9.69 65 130336 97915 70700128
Blood alkaline phosphatase increased 48.64 9.69 225 130176 58296 70739747
Acute myeloid leukaemia recurrent 48.14 9.69 42 130359 3012 70795031
Oropharyngeal candidiasis 47.97 9.69 32 130369 1533 70796510
Weight increased 47.82 9.69 256 130145 242075 70555968
Pruritus genital 47.80 9.69 28 130373 1064 70796979
C-reactive protein abnormal 47.73 9.69 7 130394 38572 70759471
Uterine perforation 46.85 9.69 56 130345 5835 70792208
Vulvovaginal candidiasis 46.56 9.69 37 130364 2329 70795714
Engraftment syndrome 46.53 9.69 29 130372 1235 70796808
Plasma cell myeloma 46.52 9.69 261 130140 72940 70725103
Long QT syndrome 46.30 9.69 53 130348 5274 70792769
Pneumonia cryptococcal 46.06 9.69 30 130371 1380 70796663
Hypomagnesaemia 45.87 9.69 172 130229 40592 70757451
Intentional product misuse 44.87 9.69 48 130353 79547 70718496
Graft versus host disease in gastrointestinal tract 44.82 9.69 55 130346 5889 70792154
Injection site erythema 44.53 9.69 41 130360 72883 70725160
Feeling abnormal 44.39 9.69 125 130276 142194 70655849
Haemophagocytic lymphohistiocytosis 44.38 9.69 106 130295 19506 70778537
Contusion 44.09 9.69 107 130294 127929 70670114
Renal impairment 43.00 9.69 429 129972 143508 70654535
Injection site swelling 42.85 9.69 13 130388 43144 70754899
Cutaneous coccidioidomycosis 42.74 9.69 10 130391 18 70798025
Blood pressure fluctuation 42.59 9.69 28 130373 58984 70739059
Rash maculo-papular 42.50 9.69 195 130206 50350 70747693
Stem cell transplant 42.38 9.69 42 130359 3543 70794500
Penis injury 42.30 9.69 14 130387 125 70797918
Aplasia 42.10 9.69 59 130342 7192 70790851
Enterococcal bacteraemia 41.98 9.69 37 130364 2689 70795354
Insomnia 41.92 9.69 232 130169 217574 70580469
Dermatitis bullous 41.63 9.69 80 130321 12677 70785366
Dysphagia 40.60 9.69 350 130051 112484 70685559
Fungal peritonitis 40.48 9.69 25 130376 1047 70796996
Trichosporon infection 40.38 9.69 24 130377 937 70797106
Disseminated mucormycosis 40.30 9.69 21 130380 632 70797411
Enterobacter infection 39.77 9.69 43 130358 4017 70794026
Systemic inflammatory response syndrome 39.75 9.69 71 130330 10641 70787402
Disseminated cryptococcosis 39.64 9.69 30 130371 1757 70796286
Breast cancer 39.46 9.69 7 130394 33542 70764501
Intentional product use issue 39.36 9.69 103 130298 120039 70678004
Hyperhidrosis 39.26 9.69 118 130283 131468 70666575
Musculoskeletal pain 39.20 9.69 66 130335 90261 70707782
Product use issue 38.96 9.69 184 130217 179753 70618290
Respiratory tract infection fungal 38.81 9.69 25 130376 1128 70796915
Epstein-Barr virus infection 38.53 9.69 79 130322 13119 70784924
Cachexia 38.53 9.69 67 130334 9833 70788210
Oral fungal infection 38.52 9.69 38 130363 3188 70794855
Hypokalaemia 38.22 9.69 389 130012 130799 70667244
Drug ineffective for unapproved indication 38.01 9.69 156 130245 38382 70759661
Enterococcal sepsis 37.98 9.69 34 130367 2523 70795520
Gait disturbance 37.93 9.69 193 130208 184913 70613130
Fungal oesophagitis 37.87 9.69 22 130379 823 70797220
Pulmonary haemorrhage 37.76 9.69 80 130321 13593 70784450
Cerebral toxoplasmosis 37.70 9.69 31 130370 2049 70795994
Blood pressure systolic increased 37.63 9.69 30 130371 57229 70740814
Toxoplasmosis 37.38 9.69 34 130367 2576 70795467
Eosinophilia 37.26 9.69 160 130241 40159 70757884
Fibromyalgia 36.94 9.69 21 130380 47853 70750190
Blood culture positive 36.70 9.69 58 130343 7868 70790175
Knee arthroplasty 36.55 9.69 9 130392 34292 70763751
HIV infection 36.42 9.69 26 130375 1391 70796652
Cytopenia 36.40 9.69 91 130310 17232 70780811
Embolism venous 36.40 9.69 40 130361 3805 70794238
Fungal test positive 36.35 9.69 23 130378 1006 70797037
Ileus paralytic 36.34 9.69 61 130340 8700 70789343
Fusarium infection 36.06 9.69 28 130373 1704 70796339
Graft versus host disease in skin 36.00 9.69 48 130353 5582 70792461
Odynophagia 35.93 9.69 66 130335 10109 70787934
Adrenal insufficiency 35.91 9.69 115 130286 25080 70772963
Psoriasis 35.70 9.69 80 130321 98353 70699690
Blast cell count increased 35.45 9.69 25 130376 1312 70796731
Penile haemorrhage 35.41 9.69 18 130383 514 70797529
International normalised ratio increased 35.37 9.69 262 130139 80464 70717579
Rhinorrhoea 35.25 9.69 42 130359 66329 70731714
Sleep disorder 35.24 9.69 46 130355 69826 70728217
Transplant rejection 34.62 9.69 92 130309 18079 70779964
Gastrointestinal fungal infection 34.48 9.69 16 130385 372 70797671
Staphylococcal bacteraemia 34.34 9.69 68 130333 11014 70787029
Gastrointestinal mucormycosis 34.21 9.69 16 130385 379 70797664
Vaginal discharge 34.19 9.69 42 130359 4501 70793542
Pleural effusion 34.06 9.69 384 130017 132480 70665563
Stress 34.02 9.69 45 130356 67921 70730122
Meningitis coccidioides 33.94 9.69 10 130391 58 70797985
Acute respiratory distress syndrome 33.83 9.69 158 130243 41096 70756947
Shock haemorrhagic 33.82 9.69 91 130310 18015 70780028
Adenovirus infection 33.45 9.69 55 130346 7713 70790330
Pseudomembranous colitis 33.33 9.69 44 130357 5067 70792976
Staphylococcal sepsis 33.04 9.69 75 130326 13352 70784691
Memory impairment 33.03 9.69 76 130325 92565 70705478
Anaemia 33.02 9.69 973 129428 402450 70395593
Flushing 33.00 9.69 63 130338 82109 70715934
Red blood cell sedimentation rate increased 32.73 9.69 15 130386 38627 70759416
Nervous system disorder 32.43 9.69 108 130293 24038 70774005
Clostridium test positive 32.11 9.69 42 130359 4794 70793249
Incorrect dose administered 31.57 9.69 46 130355 66673 70731370
Mucosal disorder 31.55 9.69 34 130367 3164 70794879
Jaundice 31.39 9.69 178 130223 49930 70748113
Sputum increased 31.22 9.69 38 130363 4034 70794009
Liver disorder 31.18 9.69 207 130194 61361 70736682
Coagulopathy 30.77 9.69 132 130269 33117 70764926
Hypoalbuminaemia 30.72 9.69 91 130310 19031 70779012
Keratitis fungal 30.47 9.69 14 130387 318 70797725
Gamma-glutamyltransferase increased 30.42 9.69 178 130223 50507 70747536
Hyperferritinaemia 30.31 9.69 17 130384 594 70797449
Respiratory symptom 30.16 9.69 36 130365 3745 70794298
Suicidal ideation 30.06 9.69 51 130350 69545 70728498
Prostate cancer 29.85 9.69 10 130391 31153 70766890
Differentiation syndrome 29.72 9.69 28 130373 2219 70795824
Erythema multiforme 29.69 9.69 82 130319 16482 70781561
Fungal skin infection 29.53 9.69 43 130358 5429 70792614
Haemodialysis 29.20 9.69 84 130317 17282 70780761
Blood cholesterol increased 29.16 9.69 46 130355 64558 70733485
Cytomegalovirus chorioretinitis 29.12 9.69 42 130359 5256 70792787
Cardiac failure congestive 29.03 9.69 139 130262 135318 70662725
Engraft failure 29.00 9.69 17 130384 647 70797396
Intracranial pressure increased 28.91 9.69 50 130351 7306 70790737
Osteonecrosis of jaw 28.86 9.69 20 130381 40982 70757061
Lymphocyte count decreased 28.83 9.69 157 130244 43382 70754661
Cough 28.73 9.69 423 129978 324954 70473089
Basal cell carcinoma 28.66 9.69 13 130388 33685 70764358
Stenotrophomonas infection 28.56 9.69 33 130368 3316 70794727
Dysbiosis 28.21 9.69 19 130382 925 70797118
Encephalopathy 28.08 9.69 202 130199 61459 70736584
Fungal sepsis 28.01 9.69 24 130377 1679 70796364
Toxic skin eruption 27.81 9.69 91 130310 20071 70777972
Endocarditis candida 27.73 9.69 10 130391 118 70797925
Adverse event 27.68 9.69 30 130371 49431 70748612
Acute lymphocytic leukaemia 27.66 9.69 42 130359 5503 70792540
Ill-defined disorder 27.65 9.69 36 130365 54705 70743338
Nightmare 27.46 9.69 4 130397 22152 70775891
Heart rate decreased 27.20 9.69 45 130356 61970 70736073
Accidental exposure to product 26.87 9.69 9 130392 28042 70770001
Atelectasis 26.81 9.69 115 130286 28847 70769196
Enterobacter test positive 26.79 9.69 14 130387 424 70797619
Blood creatinine increased 26.77 9.69 390 130011 142611 70655432
Aortoenteric fistula 26.65 9.69 10 130391 133 70797910
Bradycardia 26.63 9.69 128 130273 124487 70673556
Haemodynamic instability 26.58 9.69 76 130325 15582 70782461
Blood corticosterone increased 26.50 9.69 5 130396 0 70798043
Pseudomonal sepsis 26.30 9.69 41 130360 5496 70792547
Jarisch-Herxheimer reaction 26.27 9.69 17 130384 773 70797270
Respiratory moniliasis 26.26 9.69 12 130389 269 70797774
Poisoning 26.00 9.69 5 130396 22617 70775426
Neutrophilic dermatosis 25.99 9.69 15 130386 554 70797489
Candida test positive 25.93 9.69 19 130382 1059 70796984
Asthma 25.85 9.69 124 130277 120669 70677374
Diastolic dysfunction 25.83 9.69 55 130346 9378 70788665
Gastrointestinal disorder 25.74 9.69 103 130298 105324 70692719
Type 2 diabetes mellitus 25.49 9.69 26 130375 44054 70753989
Symmetrical drug-related intertriginous and flexural exanthema 25.45 9.69 16 130385 692 70797351
Injection site pruritus 25.20 9.69 21 130380 39189 70758854
Post procedural bile leak 25.17 9.69 13 130388 384 70797659
Pneumonia pseudomonal 25.14 9.69 39 130362 5207 70792836
Myelodysplastic syndrome 25.10 9.69 115 130286 29670 70768373
Acute myocardial infarction 25.02 9.69 61 130340 72826 70725217
Oesophagitis 25.00 9.69 95 130306 22557 70775486
Joint stiffness 24.97 9.69 17 130384 35159 70762884
Vaginal infection 24.96 9.69 39 130362 5239 70792804
Epidermolysis bullosa 24.95 9.69 11 130390 226 70797817
Cholecystitis chronic 24.91 9.69 54 130347 9322 70788721
Pain in jaw 24.87 9.69 25 130376 42644 70755399
Haematotoxicity 24.81 9.69 68 130333 13606 70784437
Folliculitis 24.75 9.69 25 130376 42545 70755498
Muscle spasms 24.50 9.69 174 130227 153872 70644171
Coronary artery disease 24.41 9.69 49 130352 62687 70735356
Sedation 24.36 9.69 30 130371 46701 70751342
Oral disorder 24.34 9.69 53 130348 9176 70788867
Road traffic accident 24.30 9.69 17 130384 34665 70763378
Septic embolus 24.26 9.69 23 130378 1837 70796206
Nephropathy toxic 24.15 9.69 82 130319 18432 70779611
Sepsis syndrome 24.13 9.69 20 130381 1337 70796706
Neuropathy peripheral 24.11 9.69 347 130054 126549 70671494
Multiple-drug resistance 23.85 9.69 46 130355 7309 70790734
Injection site bruising 23.67 9.69 21 130380 38011 70760032
Acute graft versus host disease in intestine 23.58 9.69 32 130369 3784 70794259
Mycobacterium avium complex infection 23.47 9.69 34 130367 4272 70793771
Graft versus host disease in lung 23.30 9.69 16 130385 804 70797239
Thrombotic microangiopathy 23.23 9.69 79 130322 17769 70780274
Stenotrophomonas test positive 23.19 9.69 12 130389 356 70797687
Disseminated coccidioidomycosis 23.02 9.69 8 130393 84 70797959
Abscess neck 23.00 9.69 18 130383 1108 70796935
Hypertensive crisis 22.69 9.69 4 130397 19258 70778785
Tonsillar haemorrhage 22.58 9.69 11 130390 286 70797757
Chronic hepatitis C 22.57 9.69 14 130387 591 70797452
Medication error 22.53 9.69 44 130357 56868 70741175
Extravasation blood 22.53 9.69 12 130389 378 70797665
Disease recurrence 22.52 9.69 132 130269 37471 70760572
Nasal congestion 22.51 9.69 55 130346 65617 70732426
Encephalitis viral 22.42 9.69 25 130376 2417 70795626
Generalised oedema 22.30 9.69 89 130312 21619 70776424
Proteus infection 22.29 9.69 21 130380 1664 70796379
Nasal polyps 22.24 9.69 34 130367 4482 70793561
Myelosuppression 22.23 9.69 112 130289 30033 70768010
Focal myositis 22.19 9.69 6 130395 24 70798019
Bacterial infection 22.11 9.69 102 130299 26390 70771653
Musculoskeletal disorder 21.75 9.69 5 130396 19966 70778077
Fracture 21.71 9.69 5 130396 19939 70778104
Death 21.70 9.69 744 129657 509317 70288726
Drug dependence 21.60 9.69 22 130379 37299 70760744
Cerebrovascular accident 21.40 9.69 165 130236 143305 70654738
Growth failure 21.38 9.69 10 130391 237 70797806
Ventricular tachycardia 21.26 9.69 127 130274 36296 70761747
Joint neoplasm 21.10 9.69 7 130394 63 70797980
Nail infection 21.10 9.69 23 130378 2168 70795875
Vascular device infection 21.05 9.69 46 130355 7984 70790059
Metabolic acidosis 20.95 9.69 219 130182 74127 70723916
Nosocomial infection 20.89 9.69 25 130376 2608 70795435
Schizophrenia 20.84 9.69 3 130398 16765 70781278
Therapeutic response decreased 20.79 9.69 48 130353 58405 70739638
Pulmonary mucormycosis 20.76 9.69 16 130385 963 70797080
Mycetoma mycotic 20.57 9.69 8 130393 118 70797925
Streptococcal infection 20.53 9.69 45 130356 7826 70790217
Mediastinitis 20.52 9.69 15 130386 833 70797210
Irritability 20.50 9.69 24 130377 38201 70759842
Sinus polyp 20.34 9.69 12 130389 462 70797581
Arthritis fungal 20.33 9.69 8 130393 122 70797921
Portal fibrosis 20.29 9.69 13 130388 581 70797462
Primary adrenal insufficiency 20.28 9.69 9 130392 188 70797855
Intentional self-injury 20.28 9.69 17 130384 31633 70766410
Abdominal pain upper 20.23 9.69 243 130158 193359 70604684
Injection site reaction 20.21 9.69 38 130363 49814 70748229
Balance disorder 20.18 9.69 91 130310 90037 70708006
Bursitis 20.15 9.69 12 130389 26661 70771382
Pseudomonas test positive 20.09 9.69 20 130381 1696 70796347
BK virus infection 20.08 9.69 45 130356 7944 70790099
Epstein-Barr viraemia 19.95 9.69 21 130380 1902 70796141
Right ventricular failure 19.89 9.69 8 130393 22266 70775777
CD4 lymphocytes decreased 19.87 9.69 24 130377 2527 70795516
Wound infection fungal 19.85 9.69 9 130392 198 70797845
Hepatocellular injury 19.85 9.69 149 130252 45942 70752101
Somnolence 19.82 9.69 278 130123 215328 70582715
Myalgia 19.81 9.69 205 130196 167687 70630356
Acquired immunodeficiency syndrome 19.66 9.69 10 130391 286 70797757
Exposure via breast milk 19.62 9.69 15 130386 892 70797151
Enterococcus test positive 19.45 9.69 20 130381 1763 70796280
Klebsiella sepsis 19.44 9.69 25 130376 2806 70795237
Diabetic macroangiopathy 19.37 9.69 8 130393 139 70797904
Liver abscess 19.37 9.69 36 130365 5563 70792480
Hip arthroplasty 19.31 9.69 14 130387 28026 70770017
Fluorosis 19.31 9.69 7 130394 84 70797959
Skin lesion 19.28 9.69 129 130272 38331 70759712
Soft tissue neoplasm 19.23 9.69 7 130394 85 70797958
Urinary tract infection fungal 19.16 9.69 15 130386 924 70797119
Wound dehiscence 19.12 9.69 38 130363 6170 70791873
Limb discomfort 18.98 9.69 16 130385 29689 70768354
Acanthamoeba infection 18.92 9.69 12 130389 527 70797516
Adverse drug reaction 18.82 9.69 44 130357 53300 70744743
Nasal abscess 18.82 9.69 8 130393 150 70797893
Fat necrosis 18.79 9.69 14 130387 801 70797242
Oral pain 18.70 9.69 104 130297 28962 70769081
Neurological symptom 18.67 9.69 42 130359 7431 70790612
Angina pectoris 18.64 9.69 38 130363 48345 70749698
Philadelphia positive acute lymphocytic leukaemia 18.62 9.69 8 130393 154 70797889
Drug-induced liver injury 18.60 9.69 171 130230 55942 70742101
Overgrowth fungal 18.53 9.69 7 130394 95 70797948
Influenza like illness 18.48 9.69 60 130341 65271 70732772
Disease progression 18.46 9.69 397 130004 156275 70641768
Venoocclusive disease 18.44 9.69 30 130371 4170 70793873
Lymphadenopathy 18.41 9.69 153 130248 48638 70749405
Hepatic enzyme increased 18.40 9.69 192 130209 156798 70641245
Osteoarthritis 18.38 9.69 72 130329 74075 70723968
Choreoathetosis 18.36 9.69 18 130383 1498 70796545
Pulmonary arterial hypertension 18.30 9.69 20 130381 32835 70765208
Bone erosion 18.21 9.69 3 130398 15170 70782873
Depression 18.13 9.69 257 130144 198717 70599326
Restlessness 18.07 9.69 31 130370 42097 70755946
Antithrombin III decreased 18.07 9.69 11 130390 449 70797594
Pulmonary embolism 18.06 9.69 394 130007 155473 70642570
Colitis 17.99 9.69 188 130213 63626 70734417
Encephalitis fungal 17.99 9.69 8 130393 168 70797875
Peripheral sensory neuropathy 17.92 9.69 56 130345 12054 70785989
Hepatic cirrhosis 17.92 9.69 18 130383 30713 70767330
Brain abscess 17.90 9.69 31 130370 4535 70793508
Tongue blistering 17.89 9.69 17 130384 1362 70796681
Pneumonia influenzal 17.85 9.69 23 130378 2587 70795456
Resorption bone increased 17.82 9.69 17 130384 1368 70796675
Oxygen saturation decreased 17.79 9.69 133 130268 116296 70681747
Nocardiosis 17.77 9.69 33 130368 5096 70792947
Dystonia 17.73 9.69 7 130394 19699 70778344
Weight decreased 17.69 9.69 435 129966 310053 70487990
Dry eye 17.60 9.69 20 130381 32262 70765781
Abscess 17.59 9.69 80 130321 20574 70777469
Hepatitis fulminant 17.59 9.69 38 130363 6543 70791500
Tongue coated 17.59 9.69 16 130385 1212 70796831
Cushingoid 17.56 9.69 44 130357 8344 70789699
COVID-19 17.53 9.69 118 130283 105639 70692404
Lung neoplasm malignant 17.50 9.69 12 130389 24730 70773313
Bladder cancer 17.47 9.69 5 130396 17237 70780806
Paraesthesia 17.46 9.69 177 130224 145360 70652683
Rhinocerebral mucormycosis 17.46 9.69 13 130388 743 70797300
Diffuse large B-cell lymphoma 17.42 9.69 59 130342 13243 70784800
Aspartate aminotransferase 17.39 9.69 9 130392 267 70797776
Injection site mass 17.37 9.69 6 130395 18337 70779706
Feeling hot 17.28 9.69 40 130361 48630 70749413
Multiple sclerosis relapse 17.25 9.69 33 130368 42984 70755059
T-cell lymphoma recurrent 16.94 9.69 6 130395 67 70797976
Multiple sclerosis 16.93 9.69 13 130388 25272 70772771
Respiratory distress 16.85 9.69 164 130237 54486 70743557
Rash erythematous 16.83 9.69 157 130244 51561 70746482
SARS-CoV-2 sepsis 16.73 9.69 7 130394 126 70797917
Acute febrile neutrophilic dermatosis 16.64 9.69 26 130375 3493 70794550
Platelet transfusion 16.62 9.69 20 130381 2098 70795945
Neutropenic colitis 16.60 9.69 32 130369 5082 70792961
Angioimmunoblastic T-cell lymphoma 16.58 9.69 11 130390 522 70797521
Cognitive disorder 16.54 9.69 57 130344 60899 70737144
Hepatitis cholestatic 16.47 9.69 56 130345 12594 70785449
Shock 16.47 9.69 129 130272 40296 70757747
Inhibitory drug interaction 16.45 9.69 27 130374 3780 70794263
Dysarthria 16.42 9.69 59 130342 62254 70735789
Puerperal pyrexia 16.30 9.69 5 130396 34 70798009
Back pain 16.24 9.69 377 130024 270775 70527268
Virologic failure 16.23 9.69 27 130374 3823 70794220
Muscle spasticity 16.13 9.69 8 130393 19681 70778362
Skin oedema 16.07 9.69 17 130384 1549 70796494
Throat irritation 16.06 9.69 25 130376 35279 70762764
Cytomegalovirus gastroenteritis 16.04 9.69 10 130391 426 70797617
Genital haemorrhage 16.03 9.69 34 130367 5781 70792262
Injection site warmth 16.01 9.69 3 130398 13822 70784221
Culture stool positive 15.95 9.69 11 130390 557 70797486
HIV associated nephropathy 15.93 9.69 9 130392 319 70797724
Candida osteomyelitis 15.93 9.69 5 130396 37 70798006
Arteritis infective 15.91 9.69 6 130395 81 70797962
Vulvovaginal disorder 15.90 9.69 3 130398 0 70798043
Rhinovirus infection 15.89 9.69 37 130364 6696 70791347
Hyperadrenocorticism 15.88 9.69 9 130392 321 70797722
Respiratory syncytial virus infection 15.86 9.69 40 130361 7615 70790428
Hot flush 15.86 9.69 43 130358 49541 70748502
Pulmonary infarction 15.78 9.69 25 130376 3398 70794645
Prescribed overdose 15.75 9.69 16 130385 27165 70770878
Prothrombin time shortened 15.70 9.69 23 130378 2919 70795124
Acid base balance abnormal 15.68 9.69 9 130392 329 70797714
Clostridial infection 15.68 9.69 32 130369 5297 70792746
Heart rate irregular 15.60 9.69 19 130382 29724 70768319
Drug eruption 15.52 9.69 125 130276 39371 70758672
Product prescribing error 15.52 9.69 30 130371 38922 70759121
Mucosal infection 15.49 9.69 10 130391 453 70797590
Staphylococcus test positive 15.48 9.69 34 130367 5920 70792123
Fluid retention 15.42 9.69 62 130339 63323 70734720
Coagulation factor V level decreased 15.37 9.69 11 130390 591 70797452
Leukaemia recurrent 15.26 9.69 22 130379 2753 70795290
Obesity 15.24 9.69 16 130385 26755 70771288
Meningitis 15.24 9.69 43 130358 8750 70789293
Vulvovaginal pruritus 15.17 9.69 19 130382 2077 70795966
Acanthosis 15.16 9.69 10 130391 470 70797573
Limb injury 15.11 9.69 15 130386 25737 70772306
Cerebral fungal infection 15.11 9.69 9 130392 353 70797690
IVth nerve paralysis 15.08 9.69 7 130394 163 70797880
Lung infiltration 15.01 9.69 79 130322 21545 70776498
Anal candidiasis 15.00 9.69 4 130397 15 70798028
Metapneumovirus pneumonia 15.00 9.69 4 130397 15 70798028
Liver transplant rejection 14.95 9.69 23 130378 3049 70794994
Cardio-respiratory arrest 14.91 9.69 116 130285 100561 70697482
Candida pneumonia 14.88 9.69 10 130391 485 70797558
Emphysema 14.88 9.69 61 130340 14999 70783044
Chest pain 14.86 9.69 350 130051 250910 70547133
Macule 14.84 9.69 21 130380 2582 70795461
PRIDE syndrome 14.79 9.69 4 130397 16 70798027
Presyncope 14.77 9.69 29 130372 37409 70760634
Petechiae 14.68 9.69 72 130329 19100 70778943
Epidermolysis 14.68 9.69 10 130391 496 70797547
Cytomegalovirus infection reactivation 14.65 9.69 36 130365 6745 70791298
Foot deformity 14.63 9.69 10 130391 20645 70777398
Cytomegalovirus test 14.61 9.69 5 130396 50 70797993
Mastitis fungal 14.60 9.69 4 130397 17 70798026
Influenza 14.60 9.69 136 130265 113564 70684479
Splenomegaly 14.55 9.69 71 130330 18799 70779244
Hysterectomy 14.54 9.69 32 130369 5580 70792463
Escherichia infection 14.47 9.69 64 130337 16267 70781776
Adrenal suppression 14.45 9.69 15 130386 1337 70796706
Hyperleukocytosis 14.43 9.69 19 130382 2182 70795861
Pharyngeal stenosis 14.42 9.69 4 130397 18 70798025
Asthenia 14.41 9.69 691 129710 456975 70341068
Osteomyelitis fungal 14.41 9.69 8 130393 274 70797769
Pneumonia klebsiella 14.39 9.69 28 130373 4476 70793567
Encephalitis protozoal 14.35 9.69 5 130396 53 70797990
Joint injury 14.34 9.69 17 130384 26915 70771128
Dementia 14.34 9.69 12 130389 22353 70775690
Hepatomegaly 14.34 9.69 67 130334 17425 70780618
Central nervous system leukaemia 14.30 9.69 9 130392 390 70797653
Gastritis fungal 14.23 9.69 7 130394 186 70797857
Hypoxia 14.22 9.69 246 130155 93098 70704945
Dermatitis 14.22 9.69 72 130329 19345 70778698
Posterior reversible encephalopathy syndrome 14.19 9.69 85 130316 24317 70773726
Mediastinal effusion 14.18 9.69 5 130396 55 70797988
Vulvovaginitis 14.15 9.69 8 130393 284 70797759
Fungal endocarditis 14.09 9.69 10 130391 530 70797513
Blood beta-D-glucan increased 14.08 9.69 10 130391 531 70797512
Peritoneal candidiasis 14.07 9.69 4 130397 20 70798023
Gastrointestinal wall thinning 14.07 9.69 4 130397 20 70798023
Withdrawal syndrome 14.05 9.69 15 130386 24889 70773154
Bone marrow disorder 14.04 9.69 22 130379 2963 70795080
Treatment failure 13.90 9.69 184 130217 143958 70654085
Brain oedema 13.89 9.69 82 130319 23336 70774707
Device malfunction 13.84 9.69 9 130392 19075 70778968
Vaginal mucosal blistering 13.83 9.69 3 130398 3 70798040
Hypoglossal nerve paresis 13.80 9.69 6 130395 119 70797924
Epstein-Barr virus associated lymphoproliferative disorder 13.78 9.69 23 130378 3266 70794777
Gallstone ileus 13.76 9.69 4 130397 22 70798021
Cytomegalovirus oesophagitis 13.72 9.69 11 130390 701 70797342
Immunosuppressant drug level decreased 13.68 9.69 17 130384 1843 70796200
Respiratory paralysis 13.64 9.69 5 130396 62 70797981
Plasma cell leukaemia 13.60 9.69 17 130384 1854 70796189
Vulvovaginal discomfort 13.60 9.69 16 130385 1639 70796404
Pulmonary alveolar haemorrhage 13.59 9.69 46 130355 10323 70787720
Ischaemic hepatitis 13.57 9.69 23 130378 3306 70794737
Ocular icterus 13.57 9.69 30 130371 5247 70792796
Central nervous system lesion 13.56 9.69 52 130349 12401 70785642
Fibrin degradation products increased 13.51 9.69 8 130393 310 70797733
Bronchitis 13.48 9.69 144 130257 117099 70680944
Blood albumin decreased 13.46 9.69 78 130323 22049 70775994
Eye irritation 13.44 9.69 8 130393 17780 70780263
Anticonvulsant drug level abnormal 13.43 9.69 5 130396 65 70797978
Chest discomfort 13.42 9.69 155 130246 124226 70673817
Sedation complication 13.38 9.69 4 130397 13406 70784637
Psychotic disorder 13.38 9.69 31 130370 37670 70760373
Aggression 13.35 9.69 45 130356 48401 70749642
Porphyria acute 13.33 9.69 14 130387 1265 70796778
Pulmonary cavitation 13.33 9.69 15 130386 1465 70796578
Prothrombin time prolonged 13.27 9.69 62 130339 16128 70781915
Hepatic cytolysis 13.24 9.69 70 130331 19122 70778921
Blood sodium decreased 13.23 9.69 100 130301 30898 70767145
Leukaemia 13.20 9.69 30 130371 5345 70792698
Underdose 13.18 9.69 21 130380 29362 70768681
Chronic obstructive pulmonary disease 13.18 9.69 86 130315 77555 70720488
Streptococcal bacteraemia 13.14 9.69 22 130379 3131 70794912
Skin exfoliation 13.12 9.69 142 130259 48484 70749559
Product substitution issue 13.07 9.69 9 130392 18504 70779539
Gastrointestinal necrosis 13.05 9.69 29 130372 5089 70792954
Hypophosphataemia 13.00 9.69 62 130339 16264 70781779
HIV-associated neurocognitive disorder 12.96 9.69 8 130393 335 70797708
Faeces pale 12.95 9.69 20 130381 2660 70795383
Ureaplasma infection 12.95 9.69 11 130390 761 70797282
Application site haematoma 12.90 9.69 5 130396 73 70797970
Renal abscess 12.89 9.69 12 130389 937 70797106
Gram stain positive 12.87 9.69 6 130395 141 70797902
Cushing's syndrome 12.86 9.69 12 130389 939 70797104
Cerebral aspergillosis 12.84 9.69 16 130385 1740 70796303
Angiodermatitis 12.84 9.69 5 130396 74 70797969
Organ failure 12.81 9.69 24 130377 3732 70794311
Oedema genital 12.78 9.69 9 130392 471 70797572
Injection site haemorrhage 12.67 9.69 17 130384 25510 70772533
Stiff person syndrome 12.66 9.69 8 130393 349 70797694
Delusion 12.64 9.69 10 130391 19155 70778888
Middle insomnia 12.63 9.69 5 130396 14048 70783995
Unevaluable event 12.62 9.69 51 130350 52012 70746031
Infective chondritis 12.58 9.69 4 130397 31 70798012
Anger 12.55 9.69 7 130394 16125 70781918
Cardiovascular insufficiency 12.54 9.69 20 130381 2733 70795310
Blood glucose increased 12.45 9.69 125 130276 102857 70695186
Inflammation 12.43 9.69 89 130312 78576 70719467
Tarsal tunnel syndrome 12.37 9.69 9 130392 496 70797547
Drug withdrawal syndrome 12.35 9.69 26 130375 32689 70765354
Pulmonary fibrosis 12.34 9.69 28 130373 34282 70763761
Lupus-like syndrome 12.31 9.69 3 130398 11512 70786531
Herpes simplex 12.31 9.69 47 130354 11185 70786858
Purpura senile 12.28 9.69 9 130392 502 70797541
Migraine 12.27 9.69 80 130321 72158 70725885
Dermatitis exfoliative 12.27 9.69 45 130356 10506 70787537
Graft versus host disease in liver 12.24 9.69 15 130386 1603 70796440
Rectal perforation 12.24 9.69 11 130390 820 70797223
Live birth 12.22 9.69 5 130396 13774 70784269
Graft loss 12.20 9.69 12 130389 1003 70797040
Hepatosplenomegaly 12.14 9.69 30 130371 5640 70792403
Klebsiella test positive 12.13 9.69 14 130387 1405 70796638
Kidney transplant rejection 12.02 9.69 43 130358 9918 70788125
Hallucination, tactile 12.00 9.69 9 130392 520 70797523
Dry mouth 11.98 9.69 78 130323 70379 70727664
Heart rate increased 11.95 9.69 131 130270 106017 70692026
Gastrooesophageal reflux disease 11.94 9.69 108 130293 90731 70707312
Anxiety 11.92 9.69 311 130090 220019 70578024
Vertigo 11.88 9.69 67 130334 62576 70735467
Blood fibrinogen increased 11.87 9.69 15 130386 1654 70796389
Condition aggravated 11.86 9.69 654 129747 426981 70371062
Nausea 11.84 9.69 1379 129022 850709 69947334
Citrobacter infection 11.79 9.69 11 130390 861 70797182
Hepatic artery aneurysm 11.78 9.69 4 130397 39 70798004
Product storage error 11.77 9.69 6 130395 14535 70783508
Poor quality sleep 11.77 9.69 12 130389 20337 70777706
Gallbladder fibrosis 11.76 9.69 3 130398 9 70798034
Aplasia pure red cell 11.75 9.69 35 130366 7339 70790704
Secondary adrenocortical insufficiency 11.75 9.69 19 130382 2628 70795415
Tendonitis 11.74 9.69 14 130387 22108 70775935
Haemorrhage 11.74 9.69 218 130183 83597 70714446
Blastomycosis 11.72 9.69 9 130392 539 70797504
Klebsiella bacteraemia 11.71 9.69 19 130382 2635 70795408
Superinfection bacterial 11.71 9.69 13 130388 1251 70796792
Chronic lymphocytic leukaemia 11.70 9.69 30 130371 5768 70792275
Candida endophthalmitis 11.69 9.69 6 130395 175 70797868
Urinary tract candidiasis 11.68 9.69 10 130391 699 70797344
Exposure during pregnancy 11.66 9.69 104 130297 87613 70710430
Leukaemic infiltration extramedullary 11.65 9.69 6 130395 176 70797867
Viral test positive 11.65 9.69 8 130393 402 70797641
Transaminases increased 11.63 9.69 135 130266 46883 70751160
Cytomegalovirus enterocolitis 11.63 9.69 14 130387 1469 70796574
Duodenal stenosis 11.63 9.69 10 130391 703 70797340
Autoimmune haemolytic anaemia 11.63 9.69 36 130365 7710 70790333
Cardiac disorder 11.57 9.69 63 130338 59352 70738691
Cryptococcal cutaneous infection 11.56 9.69 6 130395 179 70797864
Lichenification 11.55 9.69 10 130391 710 70797333
Product administration error 11.53 9.69 23 130378 29500 70768543
Lymphopenia 11.53 9.69 88 130313 27271 70770772
Chronic sinusitis 11.53 9.69 38 130363 8413 70789630
Stoma site candida 11.52 9.69 3 130398 10 70798033
Periostitis 11.51 9.69 9 130392 553 70797490
Exostosis 11.49 9.69 6 130395 14339 70783704
Ankle fracture 11.46 9.69 7 130394 15337 70782706
Injury 11.44 9.69 176 130225 65069 70732974
Secondary amyloidosis 11.44 9.69 6 130395 183 70797860
Enterocolitis 11.42 9.69 51 130350 13015 70785028
Hospitalisation 11.37 9.69 97 130304 82471 70715572
Red blood cell schistocytes present 11.35 9.69 9 130392 565 70797478
Thrombophlebitis 11.32 9.69 30 130371 5886 70792157
Erythroblast count increased 11.30 9.69 3 130398 11 70798032
Hyperuricaemia 11.30 9.69 45 130356 10921 70787122
Neuroleptic malignant syndrome 11.28 9.69 19 130382 25988 70772055
Escherichia sepsis 11.27 9.69 35 130366 7508 70790535
Chronic myeloid leukaemia recurrent 11.25 9.69 7 130394 297 70797746
Rash pustular 11.19 9.69 43 130358 10265 70787778
Syncope 11.19 9.69 226 130175 165483 70632560
Skin maceration 11.18 9.69 4 130397 46 70797997
Visual impairment 11.18 9.69 94 130307 80156 70717887
Gallbladder disorder 11.14 9.69 63 130338 17649 70780394
Metastases to liver 11.14 9.69 19 130382 25859 70772184
Splenic vein thrombosis 11.14 9.69 10 130391 745 70797298
Full blood count abnormal 11.12 9.69 29 130372 33849 70764194
Night sweats 11.09 9.69 42 130359 43642 70754401
Sinusitis 11.05 9.69 232 130169 168963 70629080
Blood pressure diastolic decreased 11.03 9.69 19 130382 25761 70772282
Hepatic necrosis 11.02 9.69 38 130363 8608 70789435
Metastases to bone 11.01 9.69 15 130386 22361 70775682
Panniculitis 10.99 9.69 3 130398 10673 70787370
Xanthopsia 10.98 9.69 7 130394 310 70797733
Disability 10.96 9.69 7 130394 14976 70783067
Pancreatic carcinoma 10.94 9.69 5 130396 12899 70785144
Hallucinations, mixed 10.91 9.69 31 130370 6331 70791712
Product use in unapproved indication 10.89 9.69 476 129925 207002 70591041
Failure to thrive 10.80 9.69 44 130357 10785 70787258
Viral haemorrhagic cystitis 10.78 9.69 15 130386 1816 70796227
Acquired macroglossia 10.77 9.69 6 130395 207 70797836
Lower limb fracture 10.75 9.69 9 130392 16763 70781280
Wheezing 10.69 9.69 116 130285 94054 70703989
Scopulariopsis infection 10.67 9.69 5 130396 119 70797924
Osteopenia 10.66 9.69 9 130392 16688 70781355
Angina bullosa haemorrhagica 10.64 9.69 6 130395 212 70797831
Eschar 10.60 9.69 12 130389 1179 70796864
Vulvovaginal mycotic infection 10.60 9.69 23 130378 3972 70794071
Cystic fibrosis related diabetes 10.59 9.69 6 130395 214 70797829
Gastric disorder 10.58 9.69 29 130372 33293 70764750
Transmission of an infectious agent via transplant 10.55 9.69 3 130398 15 70798028
Retroviral infection 10.55 9.69 3 130398 15 70798028
Anaphylactic shock 10.52 9.69 28 130373 32462 70765581
Spinal cord injury thoracic 10.52 9.69 5 130396 123 70797920
Bacillus infection 10.51 9.69 11 130390 990 70797053
Thrombotic thrombocytopenic purpura 10.50 9.69 30 130371 6147 70791896
Infection 10.50 9.69 481 129920 210304 70587739
Idiosyncratic drug reaction 10.48 9.69 12 130389 1194 70796849
Escherichia bacteraemia 10.46 9.69 29 130372 5840 70792203
Necrotising retinitis 10.44 9.69 12 130389 1199 70796844
Vulvovaginal swelling 10.42 9.69 7 130394 339 70797704
Blood test abnormal 10.42 9.69 7 130394 14583 70783460
Colitis ulcerative 10.42 9.69 30 130371 33893 70764150
Haemoglobin decreased 10.40 9.69 469 129932 204690 70593353
Blood chloride increased 10.39 9.69 26 130375 4927 70793116
Skin cancer 10.35 9.69 6 130395 13530 70784513
Poor peripheral circulation 10.34 9.69 21 130380 3464 70794579
Immune reconstitution inflammatory syndrome associated tuberculosis 10.33 9.69 10 130391 820 70797223
Interstitial lung disease 10.33 9.69 133 130268 104552 70693491
Hypofibrinogenaemia 10.31 9.69 15 130386 1892 70796151
Joint effusion 10.31 9.69 8 130393 15469 70782574
Hypertransaminasaemia 10.28 9.69 38 130363 8905 70789138
Impaired work ability 10.20 9.69 9 130392 16331 70781712
Herpes simplex oesophagitis 10.12 9.69 7 130394 356 70797687
Chronic graft versus host disease in skin 10.12 9.69 13 130388 1458 70796585
Allergic transfusion reaction 10.10 9.69 4 130397 62 70797981
Haemolytic anaemia 10.09 9.69 59 130342 16735 70781308
Poikiloderma 10.09 9.69 7 130394 358 70797685
Sopor 10.08 9.69 27 130374 31240 70766803
Mania 10.08 9.69 10 130391 17164 70780879
Streptococcal sepsis 10.06 9.69 17 130384 2437 70795606
Respiratory arrest 10.06 9.69 58 130343 53875 70744168
Hypogammaglobulinaemia 10.06 9.69 45 130356 11493 70786550
Peripheral sensorimotor neuropathy 10.05 9.69 18 130383 2704 70795339
Loss of consciousness 10.03 9.69 214 130187 155502 70642541
Encephalitis cytomegalovirus 10.02 9.69 11 130390 1045 70796998
Aeromonas infection 10.00 9.69 7 130394 363 70797680
Blood iron decreased 9.97 9.69 6 130395 13255 70784788
Carpal tunnel syndrome 9.93 9.69 10 130391 17047 70780996
Myocarditis toxoplasmal 9.93 9.69 4 130397 65 70797978
Emotional disorder 9.92 9.69 6 130395 13220 70784823
Autonomic neuropathy 9.90 9.69 14 130387 1721 70796322
Trichoglossia 9.87 9.69 8 130393 518 70797525
Sputum abnormal 9.87 9.69 11 130390 1063 70796980
Pneumonitis 9.85 9.69 148 130253 54449 70743594
Lung disorder 9.85 9.69 81 130320 69403 70728640
Clostridium difficile infection 9.85 9.69 112 130289 38704 70759339
Drug level above therapeutic 9.84 9.69 34 130367 7708 70790335
Iatrogenic infection 9.82 9.69 4 130397 67 70797976
Mycobacterium abscessus infection 9.81 9.69 12 130389 1280 70796763
Pulmonary hilum mass 9.81 9.69 6 130395 247 70797796
Central nervous system vasculitis 9.81 9.69 12 130389 1281 70796762
Premature delivery 9.77 9.69 15 130386 21289 70776754
Rash morbilliform 9.77 9.69 27 130374 5428 70792615
Neutropenic infection 9.72 9.69 15 130386 1994 70796049
Oral mucosa erosion 9.71 9.69 14 130387 1751 70796292

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective 55.15 29.94 34 210 1018 88530

Pharmacologic Action:

SourceCodeDescription
ATC D01AC15 DERMATOLOGICALS
ANTIFUNGALS FOR DERMATOLOGICAL USE
ANTIFUNGALS FOR TOPICAL USE
Imidazole and triazole derivatives
ATC J01RA07 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC J02AC01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIMYCOTICS FOR SYSTEMIC USE
ANTIMYCOTICS FOR SYSTEMIC USE
Triazole and tetrazole derivatives
FDA CS M0002083 Azoles
FDA EPC N0000175487 Azole Antifungal
FDA MoA N0000182140 Cytochrome P450 2C19 Inhibitors
FDA MoA N0000182141 Cytochrome P450 3A4 Inhibitors
FDA MoA N0000185504 Cytochrome P450 2C9 Inhibitors
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:50183 P450 inhibitors
CHEBI has role CHEBI:78298 environmental contaminants
MeSH PA D058888 14-alpha Demethylase Inhibitors
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000935 Antifungal Agents
MeSH PA D065689 Cytochrome P-450 CYP2C19 Inhibitors
MeSH PA D065688 Cytochrome P-450 CYP2C9 Inhibitors
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006727 Hormone Antagonists
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D065088 Steroid Synthesis Inhibitors

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

DiseaseRelationSNOMED_IDDOID
Cryptococcal meningitis indication 14232007
Candidiasis of the esophagus indication 20639004 DOID:13146
Mucocutaneous candidiasis indication 29147005
Disseminated candidiasis indication 70572005
Candidal vulvovaginitis indication 72605008 DOID:2272
Candidiasis of mouth indication 79740000 DOID:14262
Candidal septicemia indication 187022007
Candidemia indication 432261003
Prevention of Disseminated Candidiasis indication
Candidal Urinary Tract Infection indication
Oropharyngeal Candidiasis indication
Tinea capitis off-label use 5441008
Tinea pedis off-label use 6020002 DOID:12403
Histoplasmosis off-label use 12962009 DOID:1731
Tinea manus off-label use 48971001 DOID:13369
Pityriasis versicolor off-label use 56454009 DOID:9060
Blastomycosis off-label use 69996000 DOID:12663
Tinea corporis off-label use 84849002
Disseminated coccidioidomycosis off-label use 85055004
Cutaneous leishmaniasis off-label use 240637006 DOID:9111
Tinea cruris off-label use 399029005
Onychomycosis due to dermatophyte off-label use 402134005
Pulmonary coccidioidomycosis off-label use 417018008
Onychomycosis due to Candida off-label use
Prevention of Vulvovaginal Candidiasis off-label use
Kidney disease contraindication 90708001 DOID:557
Prolonged QT interval contraindication 111975006
Disease of liver contraindication 235856003 DOID:409
Pregnancy, function contraindication 289908002
Congenital long QT syndrome contraindication 442917000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.55 acidic
pKa2 1.84 Basic
pKa3 1.24 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Cytochrome P450 2C9 Enzyme IC50 4.54 CHEMBL
Cytochrome P450 2C19 Enzyme IC50 5.09 CHEMBL
Lanosterol 14-alpha demethylase Enzyme Kd 4.40 CHEMBL
Cytochrome P450 3A4 Enzyme IC50 5.10 CHEMBL
Lanosterol 14-alpha demethylase Enzyme INHIBITOR IC50 6.70 WOMBAT-PK CHEMBL
Lanosterol 14-alpha demethylase Enzyme Kd 6.70 CHEMBL
14-alpha sterol demethylase Cyp51A Enzyme Kd 4.92 CHEMBL
14-alpha sterol demethylase Enzyme Kd 5.39 CHEMBL
Mycocyclosin synthase Enzyme Kd 5.22 CHEMBL
Sterol 14-alpha demethylase Enzyme IC50 6.06 CHEMBL

External reference:

IDSource
4019493 VUID
N0000147613 NUI
D00322 KEGG_DRUG
4019493 VANDF
C0016277 UMLSCUI
CHEBI:46081 CHEBI
TPF PDB_CHEM_ID
CHEMBL106 ChEMBL_ID
DB00196 DRUGBANK_ID
D015725 MESH_DESCRIPTOR_UI
3365 PUBCHEM_CID
5851 INN_ID
8VZV102JFY UNII
202813 RXNORM
3884 MMSL
4732 MMSL
59176 MMSL
d00071 MMSL
003534 NDDF
31865003 SNOMEDCT_US
387174006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3410 TABLET 50 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3410 TABLET 50 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3410 TABLET 50 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3420 TABLET 100 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3420 TABLET 100 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3420 TABLET 100 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3430 TABLET 200 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3430 TABLET 200 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3430 TABLET 200 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3440 POWDER, FOR SUSPENSION 350 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3440 POWDER, FOR SUSPENSION 350 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3440 POWDER, FOR SUSPENSION 350 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3450 POWDER, FOR SUSPENSION 1400 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3450 POWDER, FOR SUSPENSION 1400 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3450 POWDER, FOR SUSPENSION 1400 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3500 TABLET 150 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3500 TABLET 150 mg ORAL NDA 27 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3500 TABLET 150 mg ORAL NDA 27 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0143-9666 INJECTION 2 mg INTRAVENOUS ANDA 21 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0143-9667 INJECTION 2 mg INTRAVENOUS ANDA 21 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0143-9668 INJECTION 2 mg INTRAVENOUS ANDA 21 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0143-9669 INJECTION 2 mg INTRAVENOUS ANDA 21 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0143-9899 INJECTION 2 mg INTRAVENOUS ANDA 21 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0172-5410 TABLET 50 mg ORAL ANDA 13 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0172-5410 TABLET 50 mg ORAL ANDA 13 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0172-5411 TABLET 100 mg ORAL ANDA 13 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0172-5411 TABLET 100 mg ORAL ANDA 13 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0172-5412 TABLET 150 mg ORAL ANDA 13 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0172-5412 TABLET 150 mg ORAL ANDA 13 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0172-5413 TABLET 200 mg ORAL ANDA 13 sections