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

Stem definitionDrug idCAS RN
systemic antifungal agents, miconazole derivatives 2846 137234-62-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • voriconazole
  • voriconazol
  • vfend
  • UK109496
  • UK-109496
  • UK 109496
A triazole antifungal agent that specifically inhibits STEROL 14-ALPHA-DEMETHYLASE and CYTOCHROME P-450 CYP3A.
  • Molecular weight: 349.32
  • Formula: C16H14F3N5O
  • CLOGP: 0.79
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 1
  • TPSA: 76.72
  • ALOGS: -3.55
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.40 g O
0.40 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.70 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 1.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 34.35 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 96 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 2.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 8.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.42 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5.60 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
May 24, 2002 FDA PF PRISM CV
March 19, 2002 EMA
April 11, 2005 PMDA

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
Drug interaction 497.51 17.14 531 24854 228600 63235037
Bronchopulmonary aspergillosis 408.30 17.14 147 25238 8488 63455149
Mucormycosis 407.00 17.14 113 25272 2758 63460879
Periostitis 394.44 17.14 75 25310 285 63463352
Multiple organ dysfunction syndrome 354.45 17.14 242 25143 56510 63407127
Aspergillus infection 349.98 17.14 129 25256 7964 63455673
Drug level increased 235.94 17.14 134 25251 22602 63441035
Photosensitivity reaction 225.04 17.14 113 25272 14881 63448756
Drug resistance 218.88 17.14 128 25257 22805 63440832
Septic shock 202.60 17.14 186 25199 66443 63397194
Pneumonia fungal 196.16 17.14 76 25309 5379 63458258
Febrile neutropenia 195.95 17.14 239 25146 118210 63345427
Respiratory failure 189.07 17.14 218 25167 101640 63361997
Drug level below therapeutic 186.44 17.14 71 25314 4795 63458842
Cholestasis 170.65 17.14 120 25265 29314 63434323
Hallucination, visual 164.07 17.14 100 25285 19198 63444439
Drug ineffective 158.22 17.14 826 24559 1043939 62419698
Drug level decreased 156.20 17.14 72 25313 7847 63455790
Fatigue 147.14 17.14 87 25298 887941 62575696
Acute myeloid leukaemia 141.03 17.14 87 25298 17060 63446577
Squamous cell carcinoma of skin 140.80 17.14 62 25323 6070 63457567
Pain 135.16 17.14 64 25321 740564 62723073
Graft versus host disease 131.85 17.14 61 25324 6702 63456935
Systemic mycosis 128.74 17.14 38 25347 1159 63462478
Actinic keratosis 121.81 17.14 44 25341 2560 63461077
Cerebral aspergillosis 120.44 17.14 29 25356 393 63463244
Hepatotoxicity 119.57 17.14 107 25278 36934 63426703
Dilatation intrahepatic duct acquired 115.85 17.14 31 25354 655 63462982
Pathogen resistance 113.29 17.14 54 25331 6344 63457293
Fungal infection 110.18 17.14 102 25283 36772 63426865
Hallucination 106.13 17.14 120 25265 54697 63408940
Pancytopenia 103.07 17.14 158 25227 96775 63366862
Fluoride increased 102.07 17.14 16 25369 9 63463628
Venoocclusive liver disease 98.61 17.14 45 25340 4790 63458847
Sepsis 92.48 17.14 195 25190 152928 63310709
Joint swelling 88.25 17.14 13 25372 327653 63135984
Rheumatoid arthritis 88.11 17.14 3 25382 253816 63209821
Visual impairment 86.06 17.14 135 25250 84311 63379326
Skin candida 85.10 17.14 30 25355 1625 63462012
Arthropathy 80.71 17.14 3 25382 234789 63228848
Pulmonary mucormycosis 80.38 17.14 20 25365 313 63463324
Photodermatosis 79.85 17.14 21 25364 414 63463223
Blood bilirubin increased 74.77 17.14 83 25302 37057 63426580
Neurotoxicity 71.09 17.14 57 25328 16933 63446704
Fungaemia 70.79 17.14 29 25356 2374 63461263
Acute graft versus host disease 68.27 17.14 34 25351 4394 63459243
Acute respiratory distress syndrome 68.17 17.14 64 25321 23470 63440167
Abdominal discomfort 67.73 17.14 22 25363 320863 63142774
Pyrexia 67.02 17.14 367 25018 470111 62993526
Arthralgia 66.64 17.14 78 25307 569632 62894005
Hepatic function abnormal 66.31 17.14 78 25307 37064 63426573
Fluorosis 66.14 17.14 13 25372 61 63463576
Swelling 65.38 17.14 15 25370 275363 63188274
Acute graft versus host disease in intestine 65.12 17.14 25 25360 1724 63461913
Torsade de pointes 65.01 17.14 49 25336 13302 63450335
Cytomegalovirus infection 64.60 17.14 59 25326 20893 63442744
Gamma-glutamyltransferase increased 61.63 17.14 72 25313 33959 63429678
Therapeutic product effect decreased 61.51 17.14 4 25381 193183 63270454
Musculoskeletal stiffness 61.31 17.14 3 25382 184615 63279022
Hypertrophic osteoarthropathy 60.89 17.14 11 25374 29 63463608
Fusarium infection 58.66 17.14 18 25367 628 63463009
Pruritus 57.34 17.14 37 25348 361416 63102221
Blood alkaline phosphatase increased 57.27 17.14 78 25307 42889 63420748
Fall 57.19 17.14 44 25341 392290 63071347
Scedosporium infection 56.75 17.14 17 25368 546 63463091
Squamous cell carcinoma 56.63 17.14 38 25347 8594 63455043
Graft versus host disease in gastrointestinal tract 56.30 17.14 27 25358 3214 63460423
Immunosuppressant drug level increased 56.28 17.14 28 25357 3610 63460027
Mucosal inflammation 54.85 17.14 80 25305 46848 63416789
Acute graft versus host disease in skin 54.68 17.14 27 25358 3425 63460212
Neutrophil count decreased 54.45 17.14 88 25297 56318 63407319
Product use in unapproved indication 54.11 17.14 176 25209 178904 63284733
Toxoplasmosis 53.97 17.14 21 25364 1502 63462135
Acute graft versus host disease in liver 53.81 17.14 17 25368 654 63462983
Neutropenia 53.78 17.14 173 25212 174832 63288805
Electrocardiogram QT prolonged 53.59 17.14 90 25295 59440 63404197
Pneumonia 53.18 17.14 338 25047 456429 63007208
Alopecia 52.92 17.14 35 25350 337501 63126136
Encephalopathy 52.82 17.14 71 25314 38549 63425088
Nasopharyngitis 52.64 17.14 18 25367 254239 63209398
Drug hypersensitivity 51.77 17.14 30 25355 310657 63152980
Peripheral swelling 51.41 17.14 21 25364 265921 63197716
Candida infection 51.37 17.14 60 25325 28291 63435346
Product dose omission issue 51.33 17.14 15 25370 234298 63229339
Death 51.20 17.14 289 25096 374092 63089545
Hepatic cytolysis 50.68 17.14 45 25340 15362 63448275
Nervous system disorder 50.49 17.14 49 25336 18717 63444920
Lentigo 50.39 17.14 14 25371 342 63463295
Maternal exposure during pregnancy 50.24 17.14 13 25372 220049 63243588
Infusion related reaction 49.76 17.14 18 25367 245503 63218134
Thrombotic microangiopathy 49.74 17.14 38 25347 10523 63453114
Acute myeloid leukaemia recurrent 49.22 17.14 20 25365 1603 63462034
Synovitis 48.95 17.14 8 25377 186910 63276727
Fungal test positive 48.24 17.14 15 25370 547 63463090
Pseudomonas infection 47.72 17.14 38 25347 11175 63452462
Wound 47.50 17.14 5 25380 163258 63300379
Cytomegalovirus viraemia 47.30 17.14 29 25356 5620 63458017
Geotrichum infection 46.43 17.14 14 25371 460 63463177
Hypersensitivity 44.99 17.14 31 25354 292654 63170983
Dizziness 44.90 17.14 64 25321 429861 63033776
Renal impairment 44.80 17.14 105 25280 88250 63375387
Hepatocellular injury 44.77 17.14 55 25330 27326 63436311
Corneal perforation 44.42 17.14 14 25371 534 63463103
Bone marrow failure 43.38 17.14 56 25329 29234 63434403
Drug-induced liver injury 43.32 17.14 66 25319 40156 63423481
Hypokalaemia 42.79 17.14 114 25271 103690 63359947
Chronic graft versus host disease 42.51 17.14 22 25363 3080 63460557
Endophthalmitis 42.24 17.14 23 25362 3569 63460068
Platelet count decreased 41.44 17.14 121 25264 116001 63347636
Drug ineffective for unapproved indication 41.16 17.14 59 25326 34004 63429633
Acute kidney injury 41.15 17.14 211 25174 263204 63200433
Hypomagnesaemia 41.09 17.14 54 25331 28683 63434954
Graft versus host disease in skin 40.96 17.14 21 25364 2884 63460753
Posterior reversible encephalopathy syndrome 40.60 17.14 42 25343 17303 63446334
Aspergilloma 40.47 17.14 11 25374 247 63463390
Aspartate aminotransferase increased 40.14 17.14 102 25283 90175 63373462
Pneumonia bacterial 40.12 17.14 32 25353 9433 63454204
Strongyloidiasis 39.99 17.14 16 25369 1232 63462405
Alanine aminotransferase increased 39.82 17.14 111 25274 103659 63359978
Acute lymphocytic leukaemia recurrent 39.71 17.14 19 25366 2250 63461387
Liver function test abnormal 39.63 17.14 70 25315 48111 63415526
Rash 39.10 17.14 106 25279 560765 62902872
Pain in extremity 39.08 17.14 45 25340 331441 63132196
Headache 38.88 17.14 127 25258 633114 62830523
Mixed liver injury 38.86 17.14 24 25361 4711 63458926
Enterococcal infection 38.64 17.14 29 25356 7819 63455818
Altered state of consciousness 38.56 17.14 49 25336 25181 63438456
Chromatopsia 38.56 17.14 12 25373 439 63463198
Hypertransaminasaemia 38.41 17.14 27 25358 6582 63457055
Brain abscess 37.87 17.14 18 25367 2100 63461537
Exposure during pregnancy 37.84 17.14 8 25377 155539 63308098
Haemophagocytic lymphohistiocytosis 36.87 17.14 32 25353 10595 63453042
Fungal endocarditis 36.44 17.14 10 25375 233 63463404
Toxic encephalopathy 36.21 17.14 26 25359 6553 63457084
Sinusitis 36.18 17.14 23 25362 226630 63237007
Cytokine release syndrome 35.95 17.14 36 25349 14278 63449359
Halo vision 35.36 17.14 11 25374 402 63463235
Trichosporon infection 34.62 17.14 10 25375 282 63463355
Dyschromatopsia 34.36 17.14 11 25374 442 63463195
Malaise 34.21 17.14 72 25313 415882 63047755
Disseminated aspergillosis 34.12 17.14 8 25377 96 63463541
Disseminated intravascular coagulation 33.98 17.14 40 25345 19011 63444626
Lung transplant rejection 33.62 17.14 13 25372 914 63462723
Tracheobronchitis 33.32 17.14 14 25371 1221 63462416
Systemic candida 33.30 17.14 19 25366 3226 63460411
Immunosuppressant drug level decreased 33.14 17.14 13 25372 950 63462687
Drug intolerance 33.14 17.14 45 25340 308616 63155021
Myoclonus 32.86 17.14 36 25349 15832 63447805
Aspergillus test positive 32.78 17.14 10 25375 342 63463295
Staphylococcal infection 32.72 17.14 59 25326 41197 63422440
Delirium 32.37 17.14 66 25319 50475 63413162
Weight increased 32.27 17.14 34 25351 260758 63202879
Leukaemia recurrent 32.24 17.14 14 25371 1324 63462313
Granulomatous liver disease 32.15 17.14 12 25373 766 63462871
Pulmonary alveolar haemorrhage 31.70 17.14 21 25364 4647 63458990
Adenovirus infection 31.61 17.14 19 25366 3552 63460085
Solar lentigo 31.57 17.14 12 25373 805 63462832
Infective aneurysm 31.30 17.14 10 25375 399 63463238
Aspergillus test 31.19 17.14 5 25380 4 63463633
Off label use 30.57 17.14 407 24978 674055 62789582
Thrombocytopenia 30.10 17.14 130 25255 151027 63312610
Pulmonary haemorrhage 29.84 17.14 24 25361 7157 63456480
Photophobia 29.76 17.14 36 25349 17599 63446038
Pericarditis 29.58 17.14 8 25377 131571 63332066
Haemoptysis 29.34 17.14 46 25339 28680 63434957
Acute lymphocytic leukaemia 29.28 17.14 16 25369 2500 63461137
Cerebral fungal infection 28.73 17.14 7 25378 100 63463537
Necrosis 28.64 17.14 21 25364 5466 63458171
Dermatitis bullous 28.28 17.14 25 25360 8483 63455154
Renal failure 28.05 17.14 107 25278 117545 63346092
Impaired healing 27.72 17.14 4 25381 102538 63361099
Osteoarthritis 27.52 17.14 3 25382 95340 63368297
Infective pulmonary exacerbation of cystic fibrosis 27.51 17.14 25 25360 8792 63454845
Infection reactivation 27.12 17.14 12 25373 1187 63462450
Bacteraemia 27.00 17.14 34 25351 17314 63446323
Urinary tract infection 27.00 17.14 40 25345 264644 63198993
Acinetobacter infection 26.93 17.14 13 25372 1570 63462067
Graft versus host disease in liver 26.66 17.14 10 25375 647 63462990
Abdominal pain upper 26.57 17.14 26 25359 206418 63257219
Disorganised speech 26.51 17.14 12 25373 1253 63462384
Venoocclusive disease 26.50 17.14 14 25371 2044 63461593
Toxic epidermal necrolysis 26.47 17.14 41 25344 25293 63438344
Mobility decreased 26.07 17.14 8 25377 121151 63342486
Nephropathy toxic 25.96 17.14 25 25360 9454 63454183
Migraine 25.79 17.14 5 25380 103341 63360296
Pneumothorax 25.51 17.14 32 25353 16229 63447408
Mycotic endophthalmitis 25.44 17.14 6 25379 74 63463563
Dyspepsia 25.38 17.14 5 25380 102191 63361446
Bacterial infection 25.37 17.14 35 25350 19464 63444173
Primary myelofibrosis 25.36 17.14 6 25379 75 63463562
Colour blindness 25.19 17.14 8 25377 313 63463324
Respirovirus test positive 25.18 17.14 5 25380 25 63463612
Anxiety 25.11 17.14 30 25355 217511 63246126
Palpitations 25.08 17.14 7 25378 112763 63350874
Fungal skin infection 24.83 17.14 18 25367 4604 63459033
Lower respiratory tract infection fungal 24.76 17.14 8 25377 331 63463306
Disease progression 24.76 17.14 106 25279 122652 63340985
Bronchial anastomosis complication 24.55 17.14 5 25380 29 63463608
Rash maculo-papular 24.51 17.14 45 25340 31851 63431786
Arthritis 24.32 17.14 8 25377 115913 63347724
Human herpesvirus 6 infection 24.30 17.14 15 25370 2942 63460695
Xanthopsia 24.15 17.14 7 25378 200 63463437
Pleural effusion 24.07 17.14 87 25298 93123 63370514
Leukaemia 24.01 17.14 17 25368 4191 63459446
Graft versus host disease in lung 23.82 17.14 8 25377 374 63463263
Feeling abnormal 23.74 17.14 15 25370 148377 63315260
Urticaria 23.59 17.14 19 25366 165783 63297854
Obliterative bronchiolitis 23.49 17.14 13 25372 2082 63461555
Polyserositis 23.33 17.14 8 25377 399 63463238
Leukoencephalopathy 23.28 17.14 17 25368 4396 63459241
Back pain 23.16 17.14 44 25341 264101 63199536
Coccidioidomycosis 22.95 17.14 10 25375 954 63462683
Chest pain 22.64 17.14 32 25353 215927 63247710
Bacterial sepsis 22.60 17.14 16 25369 3942 63459695
Central nervous system fungal infection 22.55 17.14 6 25379 124 63463513
Blood cholesterol increased 22.53 17.14 5 25380 94027 63369610
Blood pressure increased 22.53 17.14 19 25366 162043 63301594
Tonsillitis bacterial 22.37 17.14 6 25379 128 63463509
Hyperlactacidaemia 22.27 17.14 14 25371 2835 63460802
Infection in an immunocompromised host 22.18 17.14 9 25376 719 63462918
Chronic graft versus host disease in skin 21.88 17.14 9 25376 744 63462893
Cytopenia 21.76 17.14 25 25360 11576 63452061
Contusion 21.59 17.14 17 25368 150027 63313610
Scintillating scotoma 21.46 17.14 6 25379 150 63463487
Agranulocytosis 21.29 17.14 37 25348 25097 63438540
Chronic papillomatous dermatitis 21.25 17.14 5 25380 61 63463576
Stenotrophomonas infection 21.15 17.14 12 25373 2015 63461622
Keratitis fungal 21.06 17.14 6 25379 161 63463476
Septal panniculitis 21.03 17.14 5 25380 64 63463573
Hepatic candidiasis 20.87 17.14 4 25381 16 63463621
Myocardial infarction 20.77 17.14 7 25378 99886 63363751
Cerebral haemorrhage 20.71 17.14 41 25344 30688 63432949
Pseudoaldosteronism 20.61 17.14 5 25380 70 63463567
Ocular surface squamous neoplasia 20.48 17.14 3 25382 0 63463637
Erythropsia 20.48 17.14 3 25382 0 63463637
Cross sensitivity reaction 20.43 17.14 12 25373 2150 63461487
Aplastic anaemia 20.32 17.14 22 25363 9547 63454090
Tuberculosis gastrointestinal 20.09 17.14 7 25378 366 63463271
Dermatitis exfoliative 20.08 17.14 17 25368 5442 63458195
Mental status changes 19.99 17.14 47 25338 39552 63424085
Drug level above therapeutic 19.84 17.14 16 25369 4789 63458848
Stem cell transplant 19.59 17.14 11 25374 1811 63461826
Adverse drug reaction 19.59 17.14 4 25381 79710 63383927
Gastrooesophageal reflux disease 19.37 17.14 7 25378 95632 63368005
Functional residual capacity increased 19.34 17.14 5 25380 92 63463545
Diarrhoea 19.33 17.14 188 25197 715178 62748459
Cytomegalovirus enterocolitis 19.32 17.14 8 25377 673 63462964
Post transplant lymphoproliferative disorder 19.19 17.14 16 25369 5015 63458622
Babesiosis 19.19 17.14 6 25379 223 63463414
Shock 19.17 17.14 34 25351 23429 63440208
Disseminated cryptococcosis 19.04 17.14 7 25378 428 63463209
Inappropriate schedule of product administration 18.82 17.14 9 25376 103956 63359681
Photopsia 18.59 17.14 15 25370 4494 63459143
Blood lactate dehydrogenase increased 18.25 17.14 33 25352 23083 63440554
Liver disorder 18.24 17.14 55 25330 53632 63410005
Hypoxia 18.23 17.14 59 25326 59733 63403904
Hepatosplenic candidiasis 18.19 17.14 6 25379 265 63463372
Hallucination, auditory 18.18 17.14 24 25361 12800 63450837
Procalcitonin increased 18.16 17.14 9 25376 1150 63462487
Hypercapnia 18.13 17.14 16 25369 5415 63458222
Neck pain 18.06 17.14 3 25382 69315 63394322
Brain oedema 17.75 17.14 25 25360 14170 63449467
Cystitis haemorrhagic 17.60 17.14 14 25371 4109 63459528
Cholecystitis acute 17.55 17.14 19 25366 8241 63455396
Phaeohyphomycosis 17.46 17.14 6 25379 301 63463336
Laryngeal inflammation 17.41 17.14 5 25380 138 63463499
Fungal sepsis 17.38 17.14 9 25376 1261 63462376

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
Photosensitivity reaction 707.00 14.38 308 38974 10286 34907363
Drug interaction 586.58 14.38 967 38315 224979 34692670
Bronchopulmonary aspergillosis 519.29 14.38 276 39006 14383 34903266
Drug ineffective 483.85 14.38 1356 37926 455395 34462254
Aspergillus infection 471.87 14.38 244 39038 12010 34905639
Drug level increased 431.33 14.38 283 38999 21813 34895836
Periostitis 383.25 14.38 85 39197 223 34917426
Actinic keratosis 365.05 14.38 151 39131 4416 34913233
Mucormycosis 361.59 14.38 162 39120 5780 34911869
Squamous cell carcinoma of skin 303.26 14.38 175 39107 10706 34906943
Cerebral aspergillosis 273.88 14.38 90 39192 1342 34916307
Drug resistance 258.43 14.38 222 39060 25705 34891944
Hallucination, visual 253.68 14.38 188 39094 17603 34900046
Multiple organ dysfunction syndrome 207.21 14.38 335 38947 76231 34841418
Hallucination 199.69 14.38 267 39015 51231 34866418
Fungal infection 174.30 14.38 144 39138 15791 34901858
Graft versus host disease 174.22 14.38 122 39160 10447 34907202
Photodermatosis 173.54 14.38 51 39231 512 34917137
Hepatotoxicity 170.77 14.38 162 39120 21323 34896326
Septic shock 163.44 14.38 291 38991 71543 34846106
Fatigue 159.93 14.38 111 39171 370542 34547107
Respiratory failure 157.74 14.38 365 38917 108207 34809442
Choroiditis 157.11 14.38 57 39225 1158 34916491
Scedosporium infection 154.95 14.38 52 39230 830 34916819
Pathogen resistance 146 14.38 105 39177 9377 34908272
Squamous cell carcinoma 145.30 14.38 113 39169 11362 34906287
Systemic mycosis 135.88 14.38 55 39227 1518 34916131
Pneumonia fungal 126.53 14.38 86 39196 7014 34910635
Hepatic function abnormal 122.46 14.38 196 39086 44167 34873482
Drug level below therapeutic 112.10 14.38 73 39209 5542 34912107
Solar lentigo 106.97 14.38 35 39247 514 34917135
Cholestasis 106.33 14.38 141 39141 26807 34890842
Condition aggravated 105.29 14.38 461 38821 191735 34725914
Febrile neutropenia 103.98 14.38 364 38918 136485 34781164
Visual impairment 102.69 14.38 161 39121 35641 34882008
Dysplastic naevus 98.18 14.38 32 39250 464 34917185
Completed suicide 96.65 14.38 3 39279 98165 34819484
Drug ineffective for unapproved indication 96.52 14.38 126 39156 23589 34894060
Drug abuse 94.20 14.38 4 39278 99092 34818557
Fluoride increased 92.64 14.38 20 39262 44 34917605
Drug level decreased 92.30 14.38 74 39208 7772 34909877
Disseminated mucormycosis 87.64 14.38 30 39252 510 34917139
Cheilitis 87.36 14.38 46 39236 2345 34915304
Product dose omission issue 84.64 14.38 16 39266 119695 34797954
Acute myeloid leukaemia 83.74 14.38 103 39179 18167 34899482
Fall 81.76 14.38 65 39217 202820 34714829
Fusarium infection 78.20 14.38 34 39248 1126 34916523
Pain 77.06 14.38 70 39212 204605 34713044
Fluorosis 76.26 14.38 17 39265 46 34917603
Myocardial infarction 75.99 14.38 21 39261 121064 34796585
Intraocular pressure increased 74.71 14.38 56 39226 5327 34912322
Fungaemia 73.38 14.38 42 39240 2526 34915123
Immunosuppressant drug level increased 73.13 14.38 58 39224 5997 34911652
Visual acuity reduced 72.33 14.38 90 39192 16059 34901590
Dyschromatopsia 71.28 14.38 24 39258 387 34917262
Dyspnoea 70.32 14.38 205 39077 376577 34541072
Candida infection 68.80 14.38 92 39190 17623 34900026
Asthenia 66.78 14.38 108 39174 245143 34672506
Drug level above therapeutic 65.16 14.38 47 39235 4214 34913435
Fungal endocarditis 65.16 14.38 22 39260 358 34917291
Uveitis 62.10 14.38 58 39224 7477 34910172
Graft versus host disease in gastrointestinal tract 61.81 14.38 43 39239 3640 34914009
Nephropathy toxic 60.99 14.38 73 39209 12515 34905134
Brain abscess 60.84 14.38 40 39242 3085 34914564
Treatment failure 60.14 14.38 150 39132 46547 34871102
Lip squamous cell carcinoma 59.05 14.38 16 39266 116 34917533
Drug-induced liver injury 58.16 14.38 111 39171 28721 34888928
Acute myeloid leukaemia recurrent 58.04 14.38 34 39248 2136 34915513
Toxic optic neuropathy 57.58 14.38 25 39257 825 34916824
Depression 57.00 14.38 19 39263 97079 34820570
Hepatocellular injury 57.00 14.38 95 39187 22116 34895533
Neurotoxicity 55.84 14.38 84 39198 17926 34899723
Aspergillus test positive 55.81 14.38 21 39261 474 34917175
Aspergilloma 55.78 14.38 19 39263 318 34917331
Diarrhoea 55.42 14.38 238 39044 389674 34527975
Pruritus 55.27 14.38 47 39235 141934 34775715
Anxiety 54.08 14.38 22 39260 99406 34818243
Arthralgia 54.06 14.38 67 39215 169974 34747675
Nausea 52.99 14.38 200 39082 339708 34577941
Dizziness 52.46 14.38 104 39178 218417 34699232
Inappropriate antidiuretic hormone secretion 52.25 14.38 68 39214 12685 34904964
Disseminated intravascular coagulation 51.62 14.38 90 39192 21726 34895923
Eye pain 50.88 14.38 69 39213 13393 34904256
Pseudomonas infection 50.70 14.38 66 39216 12316 34905333
Off label use 50.44 14.38 704 38578 418820 34498829
Blood pressure increased 50.40 14.38 18 39264 88084 34829565
Neurological symptom 50.35 14.38 40 39242 4145 34913504
Hepatitis cholestatic 50.34 14.38 53 39229 7894 34909755
Stenotrophomonas infection 48.52 14.38 30 39252 2080 34915569
Constipation 47.84 14.38 50 39232 136932 34780717
Pain in extremity 46.69 14.38 44 39238 126469 34791180
Disorganised speech 46.66 14.38 22 39260 883 34916766
Mediastinitis 45.62 14.38 20 39262 676 34916973
Alternaria infection 45.09 14.38 17 39265 386 34917263
Leukaemia recurrent 45.04 14.38 26 39256 1589 34916060
Acute graft versus host disease in skin 44.73 14.38 41 39241 5160 34912489
Dehydration 43.66 14.38 49 39233 129920 34787729
Liver disorder 43.54 14.38 107 39175 32890 34884759
Peripheral swelling 43.16 14.38 16 39266 76525 34841124
Renal ischaemia 42.72 14.38 18 39264 551 34917098
Product compounding quality issue 41.62 14.38 9 39273 20 34917629
Cardiac failure congestive 41.26 14.38 21 39261 83249 34834400
Inappropriate schedule of product administration 40.59 14.38 10 39272 62286 34855363
Back pain 39.73 14.38 47 39235 121742 34795907
Septic embolus 39.69 14.38 22 39260 1243 34916406
Chest pain 39.17 14.38 51 39231 126711 34790938
Xanthopsia 38.97 14.38 12 39270 143 34917506
Nasopharyngitis 38.83 14.38 15 39267 69953 34847696
Enterococcal infection 38.71 14.38 50 39232 9256 34908393
Weight decreased 38.05 14.38 89 39193 176212 34741437
Blood alkaline phosphatase increased 37.90 14.38 98 39184 31077 34886572
Acute graft versus host disease in liver 37.88 14.38 23 39259 1543 34916106
Hyperhidrosis 37.63 14.38 19 39263 75673 34841976
Malaise 37.60 14.38 97 39185 185728 34731921
Gallbladder oedema 37.55 14.38 13 39269 229 34917420
Product use in unapproved indication 37.42 14.38 243 39039 117256 34800393
Acute graft versus host disease 37.03 14.38 41 39241 6462 34911187
Cytomegalovirus viraemia 35.84 14.38 43 39239 7387 34910262
Phaeohyphomycosis 35.53 14.38 18 39264 846 34916803
Intentional overdose 35.08 14.38 4 39278 43670 34873979
Venoocclusive liver disease 35.03 14.38 44 39238 7922 34909727
Photophobia 34.74 14.38 41 39241 6923 34910726
Cystitis haemorrhagic 34.42 14.38 37 39245 5642 34912007
Hypertension 34.40 14.38 63 39219 136380 34781269
Enterococcal sepsis 34.01 14.38 22 39260 1650 34915999
Product contamination microbial 33.89 14.38 16 39266 644 34917005
Nocardiosis 33.69 14.38 31 39251 3920 34913729
Cytomegalovirus infection 33.68 14.38 84 39198 26051 34891598
Prostate cancer 33.48 14.38 3 39279 39646 34878003
Headache 33.20 14.38 115 39167 200520 34717129
Photopsia 33.08 14.38 23 39259 1945 34915704
Injection site pain 32.81 14.38 3 39279 39002 34878647
Pyrexia 32.61 14.38 540 38742 332473 34585176
Gamma-glutamyltransferase increased 32.60 14.38 89 39193 29142 34888507
Dyspnoea exertional 32.28 14.38 5 39277 43274 34874375
Acute respiratory distress syndrome 31.94 14.38 82 39200 25887 34891762
Pneumonia 31.91 14.38 578 38704 362049 34555600
Neutropenia 31.89 14.38 292 38990 156486 34761163
Renal abscess 31.80 14.38 12 39270 273 34917376
Pseudoporphyria 31.77 14.38 13 39269 369 34917280
Delirium 31.58 14.38 115 39167 43876 34873773
Transaminases increased 30.24 14.38 82 39200 26741 34890908
Graft versus host disease in skin 30.03 14.38 29 39253 3896 34913753
Vomiting 29.90 14.38 160 39122 247461 34670188
Scopulariopsis infection 29.80 14.38 9 39273 100 34917549
Liver injury 29.65 14.38 57 39225 14821 34902828
Sinusitis fungal 29.64 14.38 14 39268 564 34917085
Cerebrovascular accident 29.54 14.38 31 39251 84780 34832869
Asthma 29.49 14.38 6 39276 42650 34874999
Musculoskeletal stiffness 29.44 14.38 8 39274 46672 34870977
Rectal haemorrhage 29.24 14.38 5 39277 40244 34877405
Chronic graft versus host disease 29.20 14.38 30 39252 4343 34913306
Gastrooesophageal reflux disease 29.17 14.38 4 39278 37920 34879729
Halo vision 29.05 14.38 10 39272 173 34917476
Urticaria 29.05 14.38 17 39265 62360 34855289
Macular opacity 28.96 14.38 5 39277 0 34917649
Muscle spasms 28.94 14.38 25 39257 74976 34842673
Hepatic failure 28.90 14.38 95 39187 34436 34883213
Torsade de pointes 28.85 14.38 38 39244 7171 34910478
Lower respiratory tract infection fungal 28.75 14.38 14 39268 604 34917045
Ectropion 28.58 14.38 9 39273 116 34917533
Dyspepsia 27.96 14.38 4 39278 36728 34880921
Hypertrophic osteoarthropathy 27.52 14.38 8 39274 77 34917572
Foetal exposure during pregnancy 27.10 14.38 5 39277 38096 34879553
Post transplant lymphoproliferative disorder 27.04 14.38 35 39247 6493 34911156
Hepatic cytolysis 27.03 14.38 54 39228 14442 34903207
Joint swelling 26.94 14.38 17 39265 59873 34857776
Intentional product misuse 26.62 14.38 9 39273 45602 34872047
Blood bilirubin increased 26.55 14.38 99 39183 38197 34879452
Trichosporon infection 26.47 14.38 14 39268 720 34916929
Neuropsychiatric symptoms 26.43 14.38 15 39267 887 34916762
Pulmonary haemorrhage 26.33 14.38 44 39238 10260 34907389
Arthritis fungal 26.16 14.38 8 39274 93 34917556
Central nervous system fungal infection 26.04 14.38 11 39271 339 34917310
Pulmonary cavitation 26.01 14.38 15 39267 915 34916734
Osteomyelitis fungal 25.89 14.38 10 39272 243 34917406
Central nervous system lesion 25.76 14.38 34 39248 6429 34911220
Abscess fungal 25.62 14.38 10 39272 250 34917399
Pulmonary mucormycosis 25.62 14.38 14 39268 769 34916880
Gait disturbance 25.53 14.38 35 39247 85105 34832544
Product use issue 25.40 14.38 139 39143 63077 34854572
Lentigo 25.21 14.38 12 39270 492 34917157
Rheumatoid arthritis 25.17 14.38 6 39276 38232 34879417
Eye infection fungal 25.17 14.38 11 39271 369 34917280
Tongue necrosis 25.12 14.38 6 39276 24 34917625
Pancytopenia 25.10 14.38 188 39094 94969 34822680
Transmission of an infectious agent via product 24.98 14.38 9 39273 179 34917470
Gallbladder empyema 24.91 14.38 7 39275 59 34917590
Cytokine release syndrome 24.86 14.38 69 39213 22808 34894841
Altered state of consciousness 24.83 14.38 69 39213 22824 34894825
Chloropsia 24.59 14.38 5 39277 7 34917642
Loss of personal independence in daily activities 24.37 14.38 4 39278 33175 34884474
Acute lymphocytic leukaemia 24.35 14.38 23 39259 3006 34914643
BK virus infection 24.13 14.38 31 39251 5707 34911942
Mycobacterium avium complex infection 23.98 14.38 21 39261 2490 34915159
Lung infiltration 23.97 14.38 48 39234 12857 34904792
Psoriasis 23.83 14.38 7 39275 38805 34878844
Haemophagocytic lymphohistiocytosis 23.79 14.38 48 39234 12925 34904724
Splenic candidiasis 23.58 14.38 7 39275 73 34917576
Chromatopsia 23.38 14.38 10 39272 318 34917331
Drug hypersensitivity 23.25 14.38 34 39248 80495 34837154
Syncope 23.23 14.38 42 39240 91409 34826240
Sunburn 23.17 14.38 18 39264 1805 34915844
Pneumonia necrotising 23.03 14.38 13 39269 761 34916888
Pulmonary mass 23.02 14.38 47 39235 12765 34904884
Acute graft versus host disease in intestine 22.61 14.38 21 39261 2687 34914962
Angina pectoris 22.55 14.38 4 39278 31359 34886290
Staphylococcal sepsis 22.49 14.38 40 39242 9804 34907845
Skin mass 22.48 14.38 25 39257 3960 34913689
Urinary bladder rupture 22.46 14.38 7 39275 87 34917562
Acute lymphocytic leukaemia recurrent 22.37 14.38 22 39260 3022 34914627
Infectious pleural effusion 22.28 14.38 20 39262 2450 34915199
Abdominal pain 21.85 14.38 102 39180 163516 34754133
Retinal ischaemia 21.79 14.38 10 39272 377 34917272
Dry mouth 21.36 14.38 4 39278 30161 34887488
Pulmonary embolism 21.24 14.38 43 39239 89703 34827946
Aplasia 21.23 14.38 26 39256 4562 34913087
Klebsiella infection 21.23 14.38 36 39246 8495 34909154
Nervous system disorder 21.16 14.38 49 39233 14494 34903155
Cerebral fungal infection 21.13 14.38 9 39273 283 34917366
Malignant neoplasm progression 20.99 14.38 42 39240 88004 34829645
Burns second degree 20.89 14.38 14 39268 1115 34916534
Weight increased 20.82 14.38 46 39236 92987 34824662
Ocular surface squamous neoplasia 20.74 14.38 5 39277 21 34917628
Toxic skin eruption 20.73 14.38 42 39240 11343 34906306
Hospitalisation 20.72 14.38 20 39262 56882 34860767
Chronic obstructive pulmonary disease 20.51 14.38 15 39267 48903 34868746
Arthritis 20.47 14.38 5 39277 31341 34886308
Disseminated aspergillosis 20.28 14.38 12 39270 768 34916881
Urinary tract infection 20.14 14.38 40 39242 84041 34833608
Cytomegalovirus enterocolitis 20.03 14.38 13 39269 981 34916668
Antibiotic level below therapeutic 19.76 14.38 6 39276 68 34917581
Nephrolithiasis 19.50 14.38 5 39277 30328 34887321
Gastrointestinal wall thickening 19.50 14.38 15 39267 1483 34916166
Hypokalaemia 19.49 14.38 122 39160 58092 34859557
Wrong technique in product usage process 19.49 14.38 8 39274 35978 34881671
Necrotising retinitis 19.43 14.38 12 39270 830 34916819
Acute myocardial infarction 19.42 14.38 19 39263 53700 34863949
Scintillating scotoma 19.41 14.38 5 39277 29 34917620
Escherichia sepsis 19.14 14.38 25 39257 4679 34912970
Burns first degree 19.13 14.38 4 39278 7 34917642
Citrobacter infection 19.11 14.38 10 39272 503 34917146
Pulmonary alveolar haemorrhage 19.09 14.38 32 39250 7480 34910169
Oropharyngeal pain 19.04 14.38 8 39274 35477 34882172
Hallucinations, mixed 18.96 14.38 19 39263 2670 34914979
Colour blindness acquired 18.94 14.38 6 39276 79 34917570
Cerebral artery embolism 18.84 14.38 12 39270 876 34916773
Mental disorder 18.67 14.38 48 39234 15161 34902488
Mycobacterium abscessus infection 18.56 14.38 10 39272 534 34917115
Eye abscess 18.48 14.38 7 39275 161 34917488
Bacterial sepsis 18.47 14.38 26 39256 5224 34912425
Therapeutic product effect decreased 18.37 14.38 8 39274 34735 34882914
Peptic ulcer haemorrhage 18.27 14.38 10 39272 551 34917098
Urinary tract inflammation 18.16 14.38 7 39275 169 34917480
Sepsis 18.08 14.38 275 39007 166286 34751363
Endophthalmitis 18.08 14.38 21 39261 3487 34914162
Inhibitory drug interaction 17.92 14.38 15 39267 1673 34915976
Disease recurrence 17.87 14.38 59 39223 21431 34896218
Swelling 17.75 14.38 13 39269 42353 34875296
Retinal toxicity 17.61 14.38 9 39273 431 34917218
Mucosal ulceration 17.60 14.38 12 39270 983 34916666
Infective aneurysm 17.57 14.38 10 39272 595 34917054
Neuroendocrine carcinoma of the skin 17.56 14.38 11 39271 780 34916869
Transplant rejection 17.55 14.38 37 39245 10274 34907375
Somnolence 17.48 14.38 65 39217 111051 34806598
Deep vein thrombosis 17.45 14.38 29 39253 65219 34852430
Neurological decompensation 17.41 14.38 19 39263 2947 34914702
Bronchial artery embolisation 17.38 14.38 3 39279 0 34917649
Organising pneumonia 17.28 14.38 27 39255 5952 34911697
Pneumonia bacterial 17.27 14.38 40 39242 11832 34905817
Memory impairment 17.25 14.38 14 39268 43304 34874345
Aspartate aminotransferase 17.16 14.38 6 39276 109 34917540
Decreased appetite 17.14 14.38 113 39169 166279 34751370
Wheezing 16.96 14.38 13 39269 41389 34876260
Oral papilloma 16.95 14.38 4 39278 15 34917634
Fibrinous bronchitis 16.95 14.38 4 39278 15 34917634
Periostosis 16.95 14.38 4 39278 15 34917634
Pneumonia cytomegaloviral 16.95 14.38 19 39263 3035 34914614
Hypoxia 16.94 14.38 113 39169 54982 34862667
Transient ischaemic attack 16.91 14.38 5 39277 27608 34890041
Thrombotic microangiopathy 16.79 14.38 37 39245 10593 34907056
Pallor 16.77 14.38 4 39278 25476 34892173
Gastrointestinal wall thinning 16.75 14.38 4 39278 16 34917633
Neck pain 16.64 14.38 4 39278 25345 34892304
Photoonycholysis 16.37 14.38 4 39278 18 34917631
Inflammatory marker increased 16.37 14.38 24 39258 5004 34912645
Complications of transplant surgery 16.36 14.38 9 39273 501 34917148
Hypoproteinaemia 16.33 14.38 16 39266 2188 34915461
Abdominal pain upper 16.28 14.38 35 39247 71455 34846194
Incorrect dose administered 16.25 14.38 13 39269 40502 34877147
Insomnia 16.20 14.38 61 39221 103846 34813803
Retinal haemorrhage 16.15 14.38 24 39258 5065 34912584
Ureaplasma infection 16.05 14.38 8 39274 363 34917286
CARD9 deficiency 16.03 14.38 4 39278 20 34917629
Hyperammonaemia 16.02 14.38 27 39255 6340 34911309
Aspiration bone marrow abnormal 16.01 14.38 6 39276 134 34917515
Atrial fibrillation 15.92 14.38 77 39205 122316 34795333
Brain herniation 15.84 14.38 21 39261 3987 34913662
Mobility decreased 15.83 14.38 7 39275 30121 34887528
Hepatitis toxic 15.83 14.38 16 39266 2271 34915378
Hypersensitivity 15.52 14.38 28 39254 61007 34856642
Necrotising ulcerative gingivostomatitis 15.50 14.38 5 39277 70 34917579
Systemic candida 15.47 14.38 20 39262 3706 34913943
Mental disorder due to a general medical condition 15.45 14.38 6 39276 148 34917501
Candida test positive 15.45 14.38 8 39274 394 34917255
Solar dermatitis 15.44 14.38 5 39277 71 34917578
Donor leukocyte infusion 15.41 14.38 4 39278 24 34917625
Lung abscess 15.41 14.38 17 39265 2668 34914981
Lip ulceration 15.35 14.38 10 39272 759 34916890
Chronic pulmonary histoplasmosis 15.30 14.38 3 39279 3 34917646
Granulomatous dermatitis 15.30 14.38 7 39275 262 34917387
Renal impairment 15.30 14.38 168 39114 94345 34823304
Chronic granulomatous disease 15.27 14.38 4 39278 25 34917624
Bacterial infection 15.23 14.38 48 39234 17015 34900634
Graft versus host disease in lung 15.22 14.38 9 39273 575 34917074
Organ failure 15.16 14.38 15 39267 2076 34915573
Haematochezia 15.11 14.38 18 39264 46516 34871133
Chills 15.09 14.38 44 39238 80999 34836650
Leukaemia 15.03 14.38 22 39260 4581 34913068
Unevaluable event 15.00 14.38 9 39273 32581 34885068
Blood beta-D-glucan increased 14.96 14.38 8 39274 421 34917228
Stenotrophomonas bacteraemia 14.89 14.38 5 39277 80 34917569
Chondritis 14.87 14.38 6 39276 164 34917485
Flushing 14.86 14.38 9 39273 32411 34885238
Chest discomfort 14.80 14.38 24 39258 54506 34863143
Haemoptysis 14.75 14.38 78 39204 34928 34882721
International normalised ratio increased 14.64 14.38 19 39263 47308 34870341
Loss of consciousness 14.59 14.38 46 39236 82621 34835028
Arthropathy 14.54 14.38 6 39276 26901 34890748
Musculoskeletal pain 14.47 14.38 9 39273 31954 34885695
Coagulopathy 14.42 14.38 52 39230 19737 34897912
Ephelides 14.39 14.38 5 39277 89 34917560

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
Drug interaction 1102.61 13.69 1446 58053 413737 79271152
Photosensitivity reaction 868.61 13.69 387 59112 20740 79664149
Bronchopulmonary aspergillosis 839.22 13.69 384 59115 21910 79662979
Aspergillus infection 743.12 13.69 337 59162 18824 79666065
Periostitis 737.22 13.69 155 59344 505 79684384
Mucormycosis 728.23 13.69 264 59235 8205 79676684
Drug ineffective 727.61 13.69 2097 57402 1078816 78606073
Drug level increased 714.51 13.69 416 59083 39235 79645654
Actinic keratosis 574.73 13.69 203 59296 5839 79679050
Multiple organ dysfunction syndrome 517.07 13.69 538 58961 119708 79565181
Squamous cell carcinoma of skin 463.81 13.69 221 59278 13812 79671077
Hallucination, visual 410.98 13.69 273 59226 32456 79652433
Drug resistance 381.42 13.69 288 59211 41925 79642964
Cerebral aspergillosis 367.50 13.69 108 59391 1688 79683201
Septic shock 355.71 13.69 448 59051 122353 79562536
Respiratory failure 338.10 13.69 535 58964 180376 79504513
Drug level below therapeutic 317.16 13.69 152 59347 9618 79675271
Hallucination 312.88 13.69 352 59147 85393 79599496
Fatigue 305.86 13.69 157 59342 929570 78755319
Pathogen resistance 272.89 13.69 156 59343 14186 79670703
Pneumonia fungal 268.64 13.69 142 59357 11068 79673821
Photodermatosis 260.41 13.69 72 59427 892 79683997
Graft versus host disease 258.25 13.69 153 59346 14873 79670016
Fungal infection 255.33 13.69 227 59272 41521 79643368
Systemic mycosis 255.14 13.69 90 59409 2576 79682313
Squamous cell carcinoma 247.60 13.69 151 59348 15471 79669418
Drug level decreased 245.83 13.69 146 59353 14256 79670633
Hepatotoxicity 240.85 13.69 241 59258 51111 79633778
Febrile neutropenia 233.18 13.69 525 58974 230474 79454415
Pain 230.86 13.69 119 59380 703683 78981206
Cholestasis 219.82 13.69 231 59268 51878 79633011
Scedosporium infection 213.42 13.69 68 59431 1410 79683479
Toxic optic neuropathy 187.12 13.69 58 59441 1095 79683794
Hepatic function abnormal 183.95 13.69 249 59250 72858 79612031
Fluoride increased 183.28 13.69 35 59464 57 79684832
Acute myeloid leukaemia 179.09 13.69 163 59336 30722 79654167
Visual impairment 167.09 13.69 269 59230 91862 79593027
Choroiditis 160.84 13.69 54 59445 1327 79683562
Drug ineffective for unapproved indication 143.53 13.69 184 59315 51054 79633835
Solar lentigo 142.72 13.69 47 59452 1086 79683803
Fall 139.20 13.69 97 59402 487532 79197357
Neurotoxicity 136.83 13.69 144 59355 32374 79652515
Arthralgia 135.86 13.69 136 59363 571667 79113222
Joint swelling 134.70 13.69 26 59473 288620 79396269
Fluorosis 133.66 13.69 29 59470 114 79684775
Fungaemia 132.71 13.69 66 59433 4525 79680364
Immunosuppressant drug level increased 124.75 13.69 80 59419 8947 79675942
Candida infection 121.09 13.69 146 59353 38068 79646821
Rheumatoid arthritis 121.08 13.69 9 59490 208461 79476428
Fusarium infection 120.65 13.69 47 59452 1785 79683104
Product dose omission issue 118.26 13.69 21 59478 247516 79437373
Pruritus 115.92 13.69 76 59423 394572 79290317
Brain abscess 111.15 13.69 60 59439 4876 79680013
Venoocclusive liver disease 110.01 13.69 82 59417 11689 79673200
Dysplastic naevus 109.64 13.69 33 59466 562 79684327
Dizziness 108.90 13.69 140 59359 526301 79158588
Nasopharyngitis 108.12 13.69 28 59471 253853 79431036
Pseudomonas infection 105.21 13.69 102 59397 20801 79664088
Peripheral swelling 105.19 13.69 35 59464 269582 79415307
Graft versus host disease in gastrointestinal tract 104.73 13.69 63 59436 6293 79678596
Arthropathy 104.71 13.69 7 59492 177104 79507785
Product use in unapproved indication 104.32 13.69 416 59083 249943 79434946
Drug hypersensitivity 103.10 13.69 47 59452 298869 79386020
Pulmonary mucormycosis 102.67 13.69 37 59462 1128 79683761
Dyschromatopsia 101.75 13.69 34 59465 823 79684066
Fungal endocarditis 100.12 13.69 31 59468 583 79684306
Musculoskeletal stiffness 97.63 13.69 9 59490 174999 79509890
Drug abuse 97.46 13.69 6 59493 162685 79522204
Hepatocellular injury 97.45 13.69 147 59352 47446 79637443
Off label use 94.48 13.69 1062 58437 906153 78778736
Pain in extremity 94.40 13.69 80 59419 364458 79320431
Nausea 94.10 13.69 382 59117 956814 78728075
Headache 93.22 13.69 220 59279 653552 79031337
Pancytopenia 92.47 13.69 303 59196 165442 79519447
Drug level above therapeutic 91.12 13.69 65 59434 8658 79676231
Nephropathy toxic 90.52 13.69 93 59406 20326 79664563
Swelling 90.18 13.69 25 59474 216686 79468203
Disseminated mucormycosis 90.10 13.69 30 59469 718 79684171
Cytomegalovirus infection 87.71 13.69 132 59367 42512 79642377
Pneumonia 87.29 13.69 812 58687 659434 79025455
Hypersensitivity 84.72 13.69 45 59454 262194 79422695
Visual acuity reduced 84.36 13.69 107 59392 29362 79655527
Pyrexia 83.43 13.69 822 58677 677887 79007002
Synovitis 83.41 13.69 8 59491 150726 79534163
Malaise 83.20 13.69 149 59350 489720 79195169
Cheilitis 83.02 13.69 51 59448 5290 79679599
Anxiety 82.73 13.69 41 59458 248471 79436418
Dilatation intrahepatic duct acquired 82.57 13.69 28 59471 710 79684179
Therapeutic product effect decreased 82.51 13.69 12 59487 163851 79521038
Hypertrophic osteoarthropathy 81.67 13.69 19 59480 109 79684780
Aspergillus test positive 81.12 13.69 28 59471 750 79684139
Neutropenia 81.00 13.69 426 59073 287284 79397605
Acute respiratory distress syndrome 80.30 13.69 129 59370 43938 79640951
Injection site pain 80.20 13.69 4 59495 129834 79555055
Abdominal discomfort 79.56 13.69 44 59455 250683 79434206
Aspergilloma 78.90 13.69 26 59473 602 79684287
Blood pressure increased 78.05 13.69 30 59469 211330 79473559
Diarrhoea 76.39 13.69 368 59131 880121 78804768
Condition aggravated 76.33 13.69 636 58863 500488 79184401
Lentigo 76.27 13.69 24 59475 477 79684412
Enterococcal infection 76.16 13.69 75 59424 15585 79669304
Drug-induced liver injury 75.35 13.69 158 59341 65959 79618930
Dyspnoea 74.45 13.69 358 59141 856667 78828222
Blood bilirubin increased 74.00 13.69 157 59342 66075 79618814
Systemic lupus erythematosus 73.98 13.69 4 59495 121145 79563744
Infusion related reaction 72.19 13.69 41 59458 230196 79454693
Leukaemia recurrent 71.77 13.69 37 59462 2737 79682152
Cytomegalovirus viraemia 71.07 13.69 66 59433 12755 79672134
Torsade de pointes 69.87 13.69 79 59420 19233 79665656
Delirium 69.73 13.69 178 59321 84449 79600440
Contraindicated product administered 69.72 13.69 16 59483 157522 79527367
Hepatic cytolysis 69.04 13.69 93 59406 27058 79657831
Blood alkaline phosphatase increased 68.92 13.69 149 59350 63515 79621374
Disorganised speech 68.89 13.69 33 59466 2084 79682805
Nervous system disorder 68.31 13.69 92 59407 26764 79658125
Acute graft versus host disease 67.59 13.69 58 59441 10109 79674780
Alopecia 67.26 13.69 45 59454 231310 79453579
Sepsis 67.14 13.69 386 59113 269042 79415847
Hepatitis cholestatic 66.73 13.69 66 59433 13786 79671103
Myocardial infarction 66.56 13.69 27 59472 184102 79500787
Discomfort 66.10 13.69 8 59491 125609 79559280
Acute graft versus host disease in liver 65.52 13.69 31 59468 1904 79682985
Graft versus host disease in skin 65.16 13.69 46 59453 6027 79678862
Endophthalmitis 65.08 13.69 47 59452 6381 79678508
Weight increased 64.56 13.69 67 59432 277319 79407570
Maternal exposure during pregnancy 64.28 13.69 12 59487 136526 79548363
Intraocular pressure increased 64.24 13.69 54 59445 9151 79675738
Back pain 62.68 13.69 81 59418 304099 79380790
Xanthopsia 62.45 13.69 19 59480 336 79684553
Stenotrophomonas infection 61.13 13.69 37 59462 3736 79681153
Urticaria 60.95 13.69 31 59468 185170 79499719
Acute graft versus host disease in skin 59.89 13.69 48 59451 7610 79677279
Halo vision 59.69 13.69 21 59478 596 79684293
Wound 59.67 13.69 8 59491 116171 79568718
Dyspepsia 59.52 13.69 6 59493 108681 79576208
Urinary tract infection 58.75 13.69 71 59428 274441 79410448
Disseminated intravascular coagulation 58.68 13.69 100 59399 35742 79649147
Septic embolus 57.85 13.69 29 59470 2022 79682867
Skin candida 57.37 13.69 29 59470 2058 79682831
Gamma-glutamyltransferase increased 56.94 13.69 126 59373 54554 79630335
Chest pain 56.30 13.69 77 59422 282227 79402662
Chronic graft versus host disease 56.24 13.69 44 59455 6737 79678152
Lip squamous cell carcinoma 56.18 13.69 17 59482 295 79684594
Phaeohyphomycosis 55.88 13.69 24 59475 1173 79683716
Haemophagocytic lymphohistiocytosis 55.83 13.69 75 59424 21762 79663127
Asthenia 54.73 13.69 197 59302 511492 79173397
Exposure during pregnancy 54.31 13.69 6 59493 101126 79583763
Arthritis 54.28 13.69 10 59489 114870 79570019
Geotrichum infection 53.60 13.69 22 59477 959 79683930
Pneumonia bacterial 53.45 13.69 69 59430 19262 79665627
Osteoarthritis 52.94 13.69 3 59496 87306 79597583
Inappropriate schedule of product administration 52.69 13.69 17 59482 133611 79551278
Neutrophil count decreased 52.56 13.69 172 59327 93787 79591102
Product compounding quality issue 52.27 13.69 11 59488 36 79684853
Electrocardiogram QT prolonged 51.95 13.69 167 59332 90219 79594670
Acute myeloid leukaemia recurrent 51.81 13.69 32 59467 3351 79681538
Photophobia 51.71 13.69 70 59429 20458 79664431
Renal impairment 51.69 13.69 244 59255 157539 79527350
Gastrooesophageal reflux disease 51.63 13.69 8 59491 104238 79580651
Acute graft versus host disease in intestine 51.40 13.69 34 59465 4007 79680882
Liver disorder 51.25 13.69 144 59355 72273 79612616
Abdominal pain upper 51.02 13.69 55 59444 223764 79461125
Altered state of consciousness 50.24 13.69 105 59394 43717 79641172
Central nervous system fungal infection 49.69 13.69 17 59482 443 79684446
Chloropsia 49.61 13.69 8 59491 0 79684889
Mediastinitis 49.34 13.69 20 59479 844 79684045
Mobility decreased 49.14 13.69 15 59484 122160 79562729
Acute lymphocytic leukaemia recurrent 48.88 13.69 35 59464 4689 79680200
Lower respiratory tract infection fungal 48.81 13.69 20 59479 868 79684021
Rash 48.70 13.69 244 59255 578114 79106775
Platelet count decreased 48.53 13.69 279 59220 194385 79490504
Staphylococcal infection 48.41 13.69 123 59376 58172 79626717
Klebsiella infection 48.06 13.69 59 59440 15661 79669228
Fungal test positive 47.98 13.69 21 59478 1075 79683814
Treatment failure 47.61 13.69 252 59247 170234 79514655
Impaired healing 47.58 13.69 5 59494 87650 79597239
Nocardiosis 47.43 13.69 37 59462 5642 79679247
Contusion 47.33 13.69 26 59473 148750 79536139
Acute lymphocytic leukaemia 47.29 13.69 35 59464 4934 79679955
Transaminases increased 47.01 13.69 113 59386 51630 79633259
Bone marrow failure 46.85 13.69 112 59387 50995 79633894
Chromatopsia 46.67 13.69 18 59481 665 79684224
Cystitis haemorrhagic 46.61 13.69 45 59454 9127 79675762
Intentional overdose 46.40 13.69 11 59488 105949 79578940
Infective aneurysm 46.37 13.69 20 59479 988 79683901
Trichosporon infection 46.37 13.69 20 59479 988 79683901
Cerebral fungal infection 46.27 13.69 16 59483 431 79684458
Loss of personal independence in daily activities 46.22 13.69 10 59489 102570 79582319
Hypokalaemia 45.19 13.69 220 59279 143820 79541069
Inappropriate antidiuretic hormone secretion 45.18 13.69 75 59424 26238 79658651
Uveitis 44.86 13.69 59 59440 16771 79668118
Pulmonary haemorrhage 44.61 13.69 55 59444 14662 79670227
Sinusitis 44.60 13.69 48 59451 195453 79489436
Disseminated aspergillosis 44.38 13.69 20 59479 1098 79683791
Immunosuppressant drug level decreased 44.12 13.69 24 59475 1980 79682909
Systemic candida 44.06 13.69 38 59461 6668 79678221
Weight decreased 44.02 13.69 128 59371 355070 79329819
Injection site erythema 43.65 13.69 4 59495 78193 79606696
Hypertension 43.45 13.69 116 59383 330876 79354013
Pulmonary alveolar haemorrhage 43.38 13.69 48 59451 11409 79673480
Alternaria infection 43.16 13.69 17 59482 665 79684224
Photopsia 42.91 13.69 34 59465 5302 79679587
Migraine 42.68 13.69 7 59492 87486 79597403
Thrombotic microangiopathy 42.28 13.69 63 59436 20106 79664783
Cytokine release syndrome 42.14 13.69 87 59412 35911 79648978
Stress 42.05 13.69 5 59494 79607 79605282
Encephalopathy 41.93 13.69 128 59371 67269 79617620
Post transplant lymphoproliferative disorder 41.65 13.69 47 59452 11417 79673472
Abscess fungal 41.62 13.69 14 59485 346 79684543
Product contamination microbial 41.01 13.69 18 59481 928 79683961
Asthma 40.99 13.69 25 59474 135070 79549819
Pseudoporphyria 40.96 13.69 16 59483 612 79684277
Vomiting 40.89 13.69 310 59189 665518 79019371
Neurological symptom 40.74 13.69 41 59458 8742 79676147
Abdominal pain 40.29 13.69 152 59347 389417 79295472
Blood cholesterol increased 40.17 13.69 7 59492 83713 79601176
Pneumothorax 39.90 13.69 74 59425 28249 79656640
Psoriasis 39.83 13.69 9 59490 89578 79595311
Pericarditis 39.80 13.69 14 59485 104222 79580667
Ocular surface squamous neoplasia 39.60 13.69 8 59491 20 79684869
Lung infiltration 38.93 13.69 65 59434 22847 79662042
Renal failure 38.87 13.69 270 59229 200698 79484191
BK virus infection 38.84 13.69 40 59459 8764 79676125
Palpitations 37.62 13.69 24 59475 126586 79558303
Muscle spasms 37.56 13.69 45 59454 174685 79510204
Renal ischaemia 37.47 13.69 18 59481 1144 79683745
Enterococcal sepsis 37.27 13.69 24 59475 2702 79682187
Macular opacity 37.21 13.69 6 59493 0 79684889
Dry mouth 36.88 13.69 10 59489 88009 79596880
Acinetobacter infection 36.87 13.69 24 59475 2753 79682136
Scopulariopsis infection 36.69 13.69 10 59489 117 79684772
Depression 36.67 13.69 66 59433 216724 79468165
Sunburn 36.48 13.69 27 59472 3806 79681083
Transmission of an infectious agent via product 36.40 13.69 11 59488 190 79684699
Osteomyelitis fungal 36.09 13.69 12 59487 286 79684603
Bacterial infection 35.91 13.69 75 59424 31205 79653684
Scintillating scotoma 35.57 13.69 11 59488 206 79684683
Rectal haemorrhage 35.28 13.69 7 59492 76293 79608596
Flushing 35.20 13.69 11 59488 88257 79596632
Toxoplasmosis 35.05 13.69 23 59476 2674 79682215
Oropharyngeal pain 34.94 13.69 19 59480 109334 79575555
Infectious pleural effusion 34.80 13.69 26 59473 3718 79681171
Neck pain 34.70 13.69 7 59492 75410 79609479
Corneal perforation 34.64 13.69 15 59484 748 79684141
Eye abscess 34.47 13.69 12 59487 330 79684559
Skin mass 34.43 13.69 36 59463 8027 79676862
Intentional product misuse 34.30 13.69 14 59485 95151 79589738
Liver function test abnormal 34.25 13.69 116 59383 64359 79620530
Leukaemia 33.81 13.69 31 59468 5894 79678995
Hyperhidrosis 33.66 13.69 38 59461 151454 79533435
Cardiac failure congestive 33.55 13.69 34 59465 142368 79542521
Aplasia 33.55 13.69 35 59464 7785 79677104
Disease progression 33.50 13.69 244 59255 184118 79500771
Necrosis 32.93 13.69 38 59461 9455 79675434
Haemoptysis 32.66 13.69 104 59395 55895 79628994
Myoclonus 32.55 13.69 67 59432 27593 79657296
Posterior reversible encephalopathy syndrome 32.52 13.69 65 59434 26216 79658673
Renal abscess 32.44 13.69 16 59483 1077 79683812
Bacterial sepsis 32.18 13.69 35 59464 8163 79676726
Mycotic endophthalmitis 32.10 13.69 10 59489 192 79684697
Graft versus host disease in lung 32.08 13.69 15 59484 897 79683992
Infection in an immunocompromised host 31.84 13.69 17 59482 1351 79683538
Acute kidney injury 31.75 13.69 554 58945 518850 79166039
Fibromyalgia 31.71 13.69 5 59494 64335 79620554
Constipation 31.53 13.69 107 59392 282943 79401946
Transplant rejection 31.51 13.69 54 59445 19383 79665506
Blood pressure fluctuation 31.38 13.69 6 59493 67139 79617750
Mental disorder 31.32 13.69 71 59428 31231 79653658
Arthritis fungal 31.15 13.69 9 59490 132 79684757
Pneumonia necrotising 30.69 13.69 16 59483 1211 79683678
Tracheobronchitis 30.44 13.69 19 59480 2027 79682862
Basal cell carcinoma 30.14 13.69 78 59421 37297 79647592
Insomnia 29.88 13.69 89 59410 245081 79439808
Hepatic failure 29.80 13.69 107 59392 61105 79623784
Fungal skin infection 29.52 13.69 29 59470 6007 79678882
Eye infection fungal 29.37 13.69 12 59487 517 79684372
Mucosal inflammation 29.35 13.69 123 59376 75457 79609432
Blood pressure systolic increased 29.24 13.69 7 59492 66979 79617910
Chest discomfort 29.19 13.69 36 59463 138008 79546881
Syncope 29.13 13.69 56 59443 179393 79505496
Mixed liver injury 29.13 13.69 32 59467 7546 79677343
Cytomegalovirus enterocolitis 28.82 13.69 17 59482 1638 79683251
Feeling hot 28.64 13.69 5 59494 59729 79625160
Blood beta-D-glucan increased 28.53 13.69 12 59487 557 79684332
Wheezing 28.47 13.69 27 59472 116637 79568252
Central nervous system lesion 28.37 13.69 42 59457 13326 79671563
Cerebrovascular accident 28.35 13.69 45 59454 155247 79529642
Hyperammonaemia 28.20 13.69 38 59461 11055 79673834
Pneumonia pseudomonal 28.17 13.69 28 59471 5883 79679006
Lower respiratory tract infection 28.07 13.69 33 59466 129187 79555702
Respiratory tract infection fungal 28.02 13.69 15 59484 1198 79683691
Mycobacterium abscessus infection 27.92 13.69 15 59484 1207 79683682
Gastrointestinal mucormycosis 27.91 13.69 11 59488 431 79684458
Sinusitis fungal 27.86 13.69 19 59480 2355 79682534
Eye pain 27.84 13.69 76 59423 37502 79647387
Brain herniation 27.80 13.69 31 59468 7432 79677457
Escherichia sepsis 27.75 13.69 33 59466 8475 79676414
Hypoxia 27.71 13.69 151 59348 103092 79581797
Pulmonary embolism 27.49 13.69 54 59445 171600 79513289
Toxic skin eruption 27.42 13.69 55 59444 22238 79662651
Lung transplant rejection 27.38 13.69 16 59483 1515 79683374
Colour blindness acquired 27.34 13.69 8 59491 123 79684766
Drug intolerance 27.31 13.69 103 59396 264016 79420873
Aspartate aminotransferase increased 27.22 13.69 187 59312 138454 79546435
Adverse event 26.86 13.69 6 59493 60208 79624681
Aspergillus test 26.82 13.69 6 59493 28 79684861
Pleural effusion 26.81 13.69 193 59306 145069 79539820
Potentiating drug interaction 26.80 13.69 33 59466 8786 79676103
Organ failure 26.79 13.69 23 59476 4010 79680879
Hallucinations, mixed 26.29 13.69 29 59470 6870 79678019
Splenic candidiasis 26.24 13.69 7 59492 75 79684814
Mycobacterium avium complex infection 26.11 13.69 24 59475 4576 79680313
Bacteraemia 25.95 13.69 68 59431 32756 79652133
Pulmonary mass 25.93 13.69 63 59436 28971 79655918
Neuropsychiatric symptoms 25.86 13.69 15 59484 1400 79683489
Depressed mood 25.71 13.69 3 59496 48477 79636412
C-reactive protein abnormal 25.64 13.69 3 59496 48364 79636525
Organising pneumonia 25.59 13.69 36 59463 10903 79673986
Feeling abnormal 25.56 13.69 50 59449 159149 79525740
Retinal haemorrhage 25.38 13.69 31 59468 8186 79676703
Graft versus host disease in liver 25.37 13.69 16 59483 1738 79683151
Dyspnoea exertional 25.20 13.69 17 59482 87056 79597833
Cerebral haemorrhage 24.90 13.69 97 59402 57576 79627313
Coagulopathy 24.88 13.69 71 59428 35935 79648954
Type 2 diabetes mellitus 24.87 13.69 6 59493 57116 79627773
Wrong technique in product usage process 24.84 13.69 12 59487 73863 79611026
Agranulocytosis 24.78 13.69 82 59417 44948 79639941
Fungal sepsis 24.75 13.69 16 59483 1814 79683075
Colour blindness 24.72 13.69 10 59489 420 79684469
Dehiscence 24.70 13.69 8 59491 175 79684714
Gallbladder empyema 24.59 13.69 7 59492 97 79684792
Pneumonia cytomegaloviral 24.54 13.69 24 59475 4945 79679944
Differentiation syndrome 24.52 13.69 18 59481 2506 79682383
Lung abscess 24.41 13.69 22 59477 4090 79680799
Venoocclusive disease 24.30 13.69 23 59476 4550 79680339
Tongue necrosis 24.29 13.69 6 59493 46 79684843
Mental status changes 23.72 13.69 106 59393 66853 79618036
Urinary bladder rupture 23.72 13.69 7 59492 111 79684778
Infection reactivation 23.69 13.69 18 59481 2639 79682250
Dermatitis bullous 23.65 13.69 40 59459 14205 79670684
Upper respiratory tract infection 23.56 13.69 20 59479 91148 79593741
Nasal congestion 23.45 13.69 14 59485 76538 79608351
Alanine aminotransferase increased 23.41 13.69 204 59295 162366 79522523
Anaphylactic reaction 23.37 13.69 17 59482 83726 79601163
Hypertransaminasaemia 23.23 13.69 36 59463 11888 79673001
Rash maculo-papular 23.14 13.69 93 59406 55985 79628904
Citrobacter infection 22.42 13.69 12 59487 958 79683931
Musculoskeletal pain 22.38 13.69 26 59473 102328 79582561
Stem cell transplant 22.35 13.69 20 59479 3684 79681205
Osteonecrosis of jaw 22.13 13.69 3 59496 43223 79641666
Transient ischaemic attack 22.05 13.69 6 59493 52689 79632200
Mucosal ulceration 22 13.69 15 59484 1858 79683031
Epstein-Barr virus infection 22.00 13.69 39 59460 14377 79670512
Chronic graft versus host disease in skin 21.87 13.69 14 59485 1560 79683329
Retinal ischaemia 21.81 13.69 11 59488 777 79684112
Flatulence 21.79 13.69 3 59496 42721 79642168
Lung consolidation 21.76 13.69 30 59469 8917 79675972
Memory impairment 21.72 13.69 31 59468 111703 79573186
Brain oedema 21.70 13.69 54 59445 25209 79659680
Primary myelofibrosis 21.62 13.69 7 59492 153 79684736
Neuroendocrine carcinoma of the skin 21.60 13.69 13 59486 1299 79683590
Ureaplasma infection 21.53 13.69 12 59487 1038 79683851
Strongyloidiasis 21.47 13.69 20 59479 3878 79681011
Granulomatous liver disease 21.41 13.69 13 59486 1320 79683569
Ectropion 21.37 13.69 9 59490 419 79684470
Capillary leak syndrome 21.36 13.69 20 59479 3905 79680984
Muscle injury 21.34 13.69 5 59494 48556 79636333
Penicillium infection 21.23 13.69 8 59491 277 79684612
Pulmonary cavitation 21.22 13.69 14 59485 1642 79683247
Staphylococcal bacteraemia 21.21 13.69 35 59464 12183 79672706
Oxygen saturation decreased 21.17 13.69 40 59459 129007 79555882
Aspiration bone marrow abnormal 21.08 13.69 7 59492 166 79684723
Escherichia bacteraemia 20.66 13.69 25 59474 6537 79678352
Chronic obstructive pulmonary disease 20.57 13.69 20 59479 85399 79599490
Hospitalisation 20.53 13.69 24 59475 94212 79590677
Haemodynamic instability 20.33 13.69 42 59457 17340 79667549
Toxic encephalopathy 20.17 13.69 33 59466 11407 79673482
Ileus paralytic 20.09 13.69 30 59469 9590 79675299
Adenovirus infection 20.06 13.69 28 59471 8419 79676470
Disseminated cryptococcosis 19.93 13.69 14 59485 1820 79683069
Infective pulmonary exacerbation of cystic fibrosis 19.91 13.69 35 59464 12816 79672073
Blastomycosis 19.79 13.69 10 59489 709 79684180
Procalcitonin increased 19.68 13.69 17 59482 2989 79681900
Red blood cell sedimentation rate increased 19.66 13.69 5 59494 45937 79638952
Necrotising retinitis 19.63 13.69 12 59487 1233 79683656
Chronic granulomatous disease 19.63 13.69 5 59494 44 79684845
Hyperbilirubinaemia 19.59 13.69 51 59448 24467 79660422
Antithrombin III deficiency 19.13 13.69 6 59493 118 79684771
Coccidioidomycosis 19.06 13.69 12 59487 1300 79683589
Hepatosplenomegaly 18.91 13.69 23 59476 6046 79678843
Solar dermatitis 18.70 13.69 7 59492 238 79684651
Folliculitis 18.61 13.69 9 59490 55371 79629518
Visual field defect 18.59 13.69 28 59471 9017 79675872
Periostosis 18.58 13.69 4 59495 15 79684874
Oral papilloma 18.58 13.69 4 59495 15 79684874
Klebsiella sepsis 18.52 13.69 17 59482 3235 79681654
Sleep disorder 18.47 13.69 22 59477 85655 79599234
Bronchial anastomosis complication 18.46 13.69 5 59494 57 79684832
Throat irritation 18.42 13.69 4 59495 40942 79643947
Fungal abscess central nervous system 18.37 13.69 6 59493 135 79684754
Joint stiffness 18.35 13.69 4 59495 40826 79644063
Renal disorder 18.32 13.69 71 59428 42034 79642855
Candida test positive 18.32 13.69 11 59488 1095 79683794
Drug clearance decreased 18.19 13.69 17 59482 3310 79681579
Rhinorrhoea 18.10 13.69 18 59481 76056 79608833
Angioedema 18.08 13.69 18 59481 76017 79608872
Pain in jaw 17.96 13.69 6 59493 46145 79638744
Cytomegalovirus infection reactivation 17.94 13.69 27 59472 8689 79676200
Adverse drug reaction 17.86 13.69 14 59485 66378 79618511
Human herpesvirus 6 infection 17.80 13.69 21 59478 5349 79679540
Cytomegalovirus test positive 17.66 13.69 22 59477 5925 79678964
Gastrointestinal wall thinning 17.65 13.69 4 59495 20 79684869
CARD9 deficiency 17.65 13.69 4 59495 20 79684869
Mental disorder due to a general medical condition 17.62 13.69 7 59492 280 79684609
Erythropsia 17.59 13.69 5 59494 69 79684820
Obliterative bronchiolitis 17.58 13.69 16 59483 3012 79681877
Swollen tongue 17.52 13.69 5 59494 42565 79642324
Heart rate decreased 17.48 13.69 16 59483 70300 79614589
Oliguria 17.45 13.69 38 59461 16271 79668618
Haematochezia 17.35 13.69 24 59475 87621 79597268
Pseudallescheria infection 17.34 13.69 4 59495 22 79684867
Hemiparesis 17.30 13.69 60 59439 33673 79651216
Bursitis 17.19 13.69 3 59496 35841 79649048
Tonsillitis bacterial 17.13 13.69 6 59493 168 79684721
Clostridium difficile colitis 17.07 13.69 58 59441 32225 79652664
Pallor 17.03 13.69 8 59491 50054 79634835
Cytopenia 16.91 13.69 43 59456 20340 79664549
Dehydration 16.91 13.69 112 59387 248075 79436814
Peptic ulcer haemorrhage 16.88 13.69 10 59489 971 79683918
Hepatic candidiasis 16.84 13.69 5 59494 81 79684808
Acanthamoeba infection 16.82 13.69 8 59491 497 79684392
Cystitis viral 16.81 13.69 9 59490 719 79684170
Keratitis fungal 16.80 13.69 7 59492 317 79684572
Respiratory distress 16.79 13.69 87 59412 58252 79626637
Pneumomediastinum 16.79 13.69 17 59482 3650 79681239
Chronic pulmonary histoplasmosis 16.53 13.69 3 59496 3 79684886
Exserohilum infection 16.53 13.69 3 59496 3 79684886
Neurological decompensation 16.52 13.69 20 59479 5233 79679656
Angina pectoris 16.50 13.69 9 59490 51723 79633166
Hallucination, auditory 16.49 13.69 43 59456 20650 79664239
Complications of transplant surgery 16.48 13.69 9 59490 748 79684141
Drug withdrawal syndrome 16.44 13.69 3 59496 34715 79650174
Road traffic accident 16.43 13.69 6 59493 43658 79641231
Photoonycholysis 16.39 13.69 4 59495 29 79684860
Meningitis fungal 16.37 13.69 6 59493 192 79684697
Chills 16.22 13.69 63 59436 160171 79524718
Rhabdomyolysis 16.21 13.69 132 59367 102999 79581890
Incorrect dose administered 16.18 13.69 20 59479 76610 79608279
Diverticulitis 16.16 13.69 7 59492 45929 79638960
Pseudomembranous colitis 16.15 13.69 20 59479 5354 79679535
Cognitive disorder 16.12 13.69 17 59482 69909 79614980
Pneumonia legionella 16.11 13.69 15 59484 2907 79681982
Functional residual capacity increased 16.05 13.69 5 59494 96 79684793
Diabetic ketoacidosis 16.05 13.69 3 59496 34119 79650770
Corneal bleeding 16.04 13.69 4 59495 32 79684857
Gait disturbance 16.04 13.69 90 59409 207416 79477473
Osteitis deformans 16.03 13.69 6 59493 204 79684685
Myelosuppression 15.97 13.69 66 59433 40230 79644659
Influenza like illness 15.90 13.69 18 59481 71689 79613200
Engraftment syndrome 15.88 13.69 11 59488 1398 79683491
Tuberculosis gastrointestinal 15.85 13.69 8 59491 566 79684323
Burns first degree 15.83 13.69 4 59495 34 79684855
Cytarabine syndrome 15.81 13.69 5 59494 101 79684788
Disease recurrence 15.75 13.69 70 59429 44039 79640850
Somnolence 15.70 13.69 109 59390 238872 79446017
Bone marrow transplant 15.61 13.69 11 59488 1437 79683452
Idiopathic pneumonia syndrome 15.56 13.69 8 59491 588 79684301
Hot flush 15.50 13.69 11 59488 54866 79630023
Burns second degree 15.48 13.69 14 59485 2614 79682275
Rhinovirus infection 15.47 13.69 24 59475 7929 79676960
Shock 15.47 13.69 69 59430 43479 79641410
Sciatica 15.46 13.69 3 59496 33219 79651670
Dysgeusia 15.45 13.69 12 59487 57165 79627724
Enterobacter infection 15.38 13.69 18 59481 4544 79680345
Pythium insidiosum infection 15.31 13.69 3 59496 6 79684883
Hepatic infection fungal 15.30 13.69 6 59493 232 79684657
Limb discomfort 15.21 13.69 3 59496 32847 79652042
Ill-defined disorder 15.20 13.69 16 59483 65859 79619030
Stupor 15.17 13.69 22 59477 6850 79678039
Loss of consciousness 15.16 13.69 69 59430 167874 79517015
Conductive deafness 15.13 13.69 6 59493 239 79684650
Cerebral artery embolism 15.10 13.69 12 59487 1879 79683010
Granulomatous dermatitis 15.04 13.69 7 59492 414 79684475
Suicidal ideation 15.02 13.69 21 59478 76319 79608570
Fibrinous bronchitis 14.98 13.69 4 59495 43 79684846
Ephelides 14.96 13.69 5 59494 121 79684768
Orthostatic hypotension 14.91 13.69 12 59487 56152 79628737
Hepatomegaly 14.82 13.69 39 59460 18835 79666054
Rash pruritic 14.80 13.69 19 59480 71610 79613279
Urinary tract inflammation 14.78 13.69 6 59493 254 79684635
Granuloma 14.71 13.69 24 59475 8273 79676616
Septal panniculitis 14.52 13.69 5 59494 133 79684756
Abdominal pain lower 14.52 13.69 3 59496 31779 79653110
Apraxia 14.44 13.69 14 59485 2853 79682036
Cataract 14.44 13.69 15 59484 62105 79622784
Acute myocardial infarction 14.36 13.69 22 59477 77014 79607875
Respirovirus test positive 14.34 13.69 5 59494 138 79684751
Staphylococcal sepsis 14.28 13.69 33 59466 14693 79670196
Viral haemorrhagic cystitis 14.19 13.69 12 59487 2049 79682840
Leukopenia 14.15 13.69 141 59358 116372 79568517
Endocarditis 14.07 13.69 27 59472 10570 79674319
Arteritis coronary 14.02 13.69 4 59495 56 79684833
Blood creatinine increased 13.99 13.69 177 59322 154880 79530009
Cardiovascular insufficiency 13.98 13.69 14 59485 2967 79681922
Gait inability 13.95 13.69 14 59485 58903 79625986
Sedation 13.88 13.69 11 59488 51884 79633005
Ecthyma 13.78 13.69 8 59491 748 79684141
Gastric perforation 13.73 13.69 16 59483 4021 79680868
Hypoproteinaemia 13.70 13.69 16 59483 4030 79680859

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J02AC03 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
CHEBI has role CHEBI:50183 P450 inhibitors
FDA MoA N0000182140 Cytochrome P450 2C19 Inhibitors
FDA MoA N0000182141 Cytochrome P450 3A4 Inhibitors
FDA MoA N0000185504 Cytochrome P450 2C9 Inhibitors
MeSH PA D058888 14-alpha Demethylase Inhibitors
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000935 Antifungal Agents
MeSH PA D065692 Cytochrome P-450 CYP3A 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
Invasive pulmonary aspergillosis indication 3214003
Candidiasis of the esophagus indication 20639004 DOID:13146
Fusarium infection indication 64250002
Disseminated candidiasis indication 70572005
Candidemia indication 432261003
Fungal Infection due to Scedosporium Apiospermum indication
Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients indication
Fungal Infection due to Fusarium Solani indication
Oropharyngeal Candidiasis off-label use
Hypocalcemia contraindication 5291005
Torsades de pointes contraindication 31722008
Hypokalemia contraindication 43339004
Cardiomyopathy contraindication 85898001 DOID:0050700
Prolonged QT interval contraindication 111975006
Hypomagnesemia contraindication 190855004
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Pregnancy, function contraindication 289908002
Visual impairment contraindication 397540003
Breastfeeding (mother) contraindication 413712001
Poor metabolizer due to cytochrome p450 CYP2C19 variant contraindication 424500005
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 13.93 acidic
pKa2 2.85 Basic
pKa3 1.42 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 4.85 CHEMBL
Cytochrome P450 2C19 Enzyme IC50 4.82 CHEMBL
Cholesterol 24-hydroxylase Enzyme Ki 7.96 CHEMBL
Cytochrome P450 3A4 Enzyme IC50 4.89 CHEMBL
Lanosterol 14-alpha demethylase Enzyme INHIBITOR MIC 8.73 WOMBAT-PK CHEMBL
Lanosterol 14-alpha demethylase Enzyme MIC 5.84 WOMBAT-PK
14-alpha sterol demethylase Cyp51A Enzyme Kd 5.44 CHEMBL
14-alpha sterol demethylase Enzyme Kd 6.37 CHEMBL
Cytochrome P450 11A1 Enzyme Kd 5.32 CHEMBL
Sterol 14-alpha-demethylase Enzyme Kd 7.25 CHEMBL
14-alpha sterol demethylase Enzyme Kd 7.25 CHEMBL
14-alpha sterol demethylase Enzyme Kd 7.25 CHEMBL

External reference:

IDSource
4021347 VUID
N0000148767 NUI
D00578 KEGG_DRUG
4021347 VANDF
C0393080 UMLSCUI
CHEBI:10023 CHEBI
VOR PDB_CHEM_ID
CHEMBL638 ChEMBL_ID
DB00582 DRUGBANK_ID
D065819 MESH_DESCRIPTOR_UI
71616 PUBCHEM_CID
7269 INN_ID
JFU09I87TR UNII
121243 RXNORM
16711 MMSL
179944 MMSL
43734 MMSL
d04803 MMSL
009650 NDDF
385469007 SNOMEDCT_US
386116008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3160 POWDER, FOR SUSPENSION 40 mg ORAL NDA 35 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3160 POWDER, FOR SUSPENSION 40 mg ORAL NDA 35 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3160 POWDER, FOR SUSPENSION 40 mg ORAL NDA 35 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3170 TABLET, FILM COATED 50 mg ORAL NDA 35 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3170 TABLET, FILM COATED 50 mg ORAL NDA 35 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3170 TABLET, FILM COATED 50 mg ORAL NDA 35 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3180 TABLET, FILM COATED 200 mg ORAL NDA 35 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3180 TABLET, FILM COATED 200 mg ORAL NDA 35 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3180 TABLET, FILM COATED 200 mg ORAL NDA 35 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3190 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 10 mg INTRAVENOUS NDA 33 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3190 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 10 mg INTRAVENOUS NDA 33 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3190 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 10 mg INTRAVENOUS NDA 33 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3190 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 10 mg INTRAVENOUS NDA 33 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3190 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 10 mg INTRAVENOUS NDA 33 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3190 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 10 mg INTRAVENOUS NDA 33 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3190 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 10 mg INTRAVENOUS NDA 33 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3190 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 10 mg INTRAVENOUS NDA 33 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3190 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 10 mg INTRAVENOUS NDA 33 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3190 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 10 mg INTRAVENOUS NDA 33 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3190 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 10 mg INTRAVENOUS NDA 33 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-4190 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 10 mg INTRAVENOUS NDA 33 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-4190 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 10 mg INTRAVENOUS NDA 33 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-4190 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 10 mg INTRAVENOUS NDA 33 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-4190 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 10 mg INTRAVENOUS NDA 33 sections
Voriconazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-1626 TABLET, FILM COATED 50 mg ORAL ANDA 31 sections
Voriconazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-1626 TABLET, FILM COATED 50 mg ORAL ANDA 31 sections
Voriconazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-1626 TABLET, FILM COATED 50 mg ORAL ANDA 31 sections
Voriconazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-1640 TABLET, FILM COATED 200 mg ORAL ANDA 31 sections
Voriconazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-1640 TABLET, FILM COATED 200 mg ORAL ANDA 31 sections
Voriconazole HUMAN PRESCRIPTION DRUG LABEL 1 0378-1640 TABLET, FILM COATED 200 mg ORAL ANDA 31 sections