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) 0.39 mg/mL Benet LZ, Broccatelli F, Oprea TI
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

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 417.89 15.72 477 21988 199144 50383515
Bronchopulmonary aspergillosis 378.07 15.72 138 22327 7454 50575205
Mucormycosis 370.23 15.72 104 22361 2379 50580280
Periostitis 333.81 15.72 64 22401 225 50582434
Aspergillus infection 317.53 15.72 118 22347 6703 50575956
Multiple organ dysfunction syndrome 292.66 15.72 214 22251 50123 50532536
Drug level increased 211.08 15.72 122 22343 19146 50563513
Drug resistance 210.06 15.72 121 22344 18868 50563791
Photosensitivity reaction 203.38 15.72 104 22361 12807 50569852
Septic shock 192.65 15.72 177 22288 56998 50525661
Febrile neutropenia 181.37 15.72 220 22245 97447 50485212
Drug level below therapeutic 160.58 15.72 61 22404 3679 50578980
Pneumonia fungal 155.51 15.72 62 22403 4258 50578401
Respiratory failure 151.02 15.72 194 22271 90987 50491672
Drug level decreased 143.23 15.72 66 22399 6467 50576192
Cholestasis 138.52 15.72 104 22361 25297 50557362
Fatigue 132.99 15.72 75 22390 707526 49875133
Acute myeloid leukaemia 132.81 15.72 83 22382 14991 50567668
Graft versus host disease 124.97 15.72 59 22406 6107 50576552
Actinic keratosis 124.04 15.72 44 22421 2183 50580476
Systemic mycosis 123.74 15.72 37 22428 1060 50581599
Pain 113.54 15.72 58 22407 578845 50003814
Dilatation intrahepatic duct acquired 109.86 15.72 30 22435 615 50582044
Pathogen resistance 107.87 15.72 52 22413 5637 50577022
Hallucination, visual 106.56 15.72 75 22390 16507 50566152
Cerebral aspergillosis 106.07 15.72 26 22439 341 50582318
Fungal infection 103.25 15.72 94 22371 29871 50552788
Squamous cell carcinoma of skin 100.21 15.72 48 22417 5130 50577529
Hallucination 96.24 15.72 111 22354 46546 50536113
Fluoride increased 93.76 15.72 15 22450 9 50582650
Venoocclusive liver disease 87.05 15.72 41 22424 4220 50578439
Drug ineffective 86.53 15.72 639 21826 818694 49763965
Visual impairment 84.04 15.72 126 22339 68149 50514510
Pancytopenia 84.03 15.72 141 22324 83889 50498770
Hepatotoxicity 81.50 15.72 79 22386 27147 50555512
Photodermatosis 79.52 15.72 21 22444 377 50582282
Sepsis 78.97 15.72 179 22286 132746 50449913
Rheumatoid arthritis 76.89 15.72 3 22462 202547 50380112
Blood bilirubin increased 70.77 15.72 79 22386 31959 50550700
Joint swelling 70.63 15.72 12 22453 245274 50337385
Skin candida 65.59 15.72 24 22441 1302 50581357
Pulmonary mucormycosis 65.26 15.72 16 22449 210 50582449
Acute graft versus host disease 62.64 15.72 32 22433 3926 50578733
Fungaemia 62.56 15.72 26 22439 1986 50580673
Torsade de pointes 61.28 15.72 47 22418 11788 50570871
Acute graft versus host disease in intestine 60.65 15.72 24 22441 1615 50581044
Product use in unapproved indication 60.10 15.72 148 22317 115671 50466988
Hypertrophic osteoarthropathy 59.74 15.72 11 22454 29 50582630
Pyrexia 58.61 15.72 327 22138 379876 50202783
Fall 57.76 15.72 39 22426 334893 50247766
Arthropathy 57.75 15.72 3 22462 157903 50424756
Blood alkaline phosphatase increased 57.62 15.72 77 22388 37449 50545210
Graft versus host disease in gastrointestinal tract 57.55 15.72 27 22438 2754 50579905
Hepatic function abnormal 56.33 15.72 71 22394 32610 50550049
Arthralgia 55.56 15.72 68 22397 438634 50144025
Pneumonia 55.38 15.72 321 22144 378080 50204579
Gamma-glutamyltransferase increased 53.68 15.72 66 22399 29557 50553102
Neurotoxicity 52.25 15.72 47 22418 14693 50567966
Immunosuppressant drug level increased 51.94 15.72 26 22439 3056 50579603
Acute respiratory distress syndrome 51.77 15.72 55 22410 21044 50561615
Swelling 51.27 15.72 13 22452 200859 50381800
Scedosporium infection 50.59 15.72 15 22450 417 50582242
Abdominal discomfort 50.24 15.72 20 22445 231621 50351038
Thrombotic microangiopathy 50.15 15.72 37 22428 8754 50573905
Cytomegalovirus infection 49.81 15.72 50 22415 17912 50564747
Acute graft versus host disease in liver 49.54 15.72 16 22449 594 50582065
Acute graft versus host disease in skin 49.51 15.72 25 22440 2993 50579666
Encephalopathy 48.46 15.72 67 22398 33644 50549015
Fungal test positive 48.25 15.72 15 22450 491 50582168
Squamous cell carcinoma 47.39 15.72 34 22431 7705 50574954
Cytomegalovirus viraemia 46.76 15.72 28 22437 4681 50577978
Acute myeloid leukaemia recurrent 46.74 15.72 19 22446 1371 50581288
Electrocardiogram QT prolonged 46.51 15.72 83 22382 51803 50530856
Toxoplasmosis 46.39 15.72 19 22446 1398 50581261
Therapeutic product effect decreased 45.61 15.72 4 22461 136046 50446613
Musculoskeletal stiffness 45.27 15.72 3 22462 128478 50454181
Geotrichum infection 45.10 15.72 14 22451 456 50582203
Pruritus 45.00 15.72 36 22429 283532 50299127
Fluorosis 44.98 15.72 8 22457 16 50582643
Drug hypersensitivity 43.55 15.72 29 22436 250981 50331678
Maternal exposure during pregnancy 43.44 15.72 9 22456 159769 50422890
Nasopharyngitis 42.91 15.72 16 22449 192911 50389748
Renal impairment 42.79 15.72 100 22365 75561 50507098
Peripheral swelling 42.69 15.72 19 22446 205917 50376742
Neutropenia 42.23 15.72 153 22312 147812 50434847
Candida infection 41.96 15.72 52 22413 23471 50559188
Graft versus host disease in skin 41.43 15.72 21 22444 2535 50580124
Pseudomonas infection 41.42 15.72 34 22431 9396 50573263
Product dose omission issue 41.30 15.72 15 22450 183823 50398836
Hepatocellular injury 40.99 15.72 54 22411 25893 50556766
Mixed liver injury 40.85 15.72 23 22442 3428 50579231
Strongyloidiasis 40.47 15.72 15 22450 844 50581815
Lentigo 39.29 15.72 11 22454 248 50582411
Enterococcal infection 39.27 15.72 29 22436 6869 50575790
Neutrophil count decreased 39.18 15.72 72 22393 45954 50536705
Chronic graft versus host disease 39.15 15.72 21 22444 2846 50579813
Alopecia 39.00 15.72 31 22434 245016 50337643
Fusarium infection 38.92 15.72 13 22452 537 50582122
Rash 38.42 15.72 86 22379 437385 50145274
Nervous system disorder 37.54 15.72 41 22424 16182 50566477
Dizziness 37.50 15.72 60 22405 346309 50236350
Hepatic cytolysis 37.24 15.72 30 22435 8073 50574586
Pain in extremity 36.96 15.72 40 22425 272825 50309834
Posterior reversible encephalopathy syndrome 36.78 15.72 39 22426 14889 50567770
Corneal perforation 36.54 15.72 12 22453 470 50582189
Hypomagnesaemia 36.28 15.72 48 22417 23108 50559551
Fungal endocarditis 36.12 15.72 10 22455 216 50582443
Endophthalmitis 36.06 15.72 20 22445 2896 50579763
Liver function test abnormal 36.04 15.72 68 22397 44271 50538388
Synovitis 35.75 15.72 6 22459 123859 50458800
Pneumonia bacterial 35.60 15.72 28 22437 7281 50575378
Toxic encephalopathy 35.55 15.72 25 22440 5490 50577169
Headache 35.09 15.72 112 22353 506423 50076236
Lung transplant rejection 34.66 15.72 13 22452 756 50581903
Hypertransaminasaemia 34.64 15.72 21 22444 3590 50579069
Exposure during pregnancy 34.62 15.72 6 22459 121009 50461650
Hypersensitivity 34.51 15.72 27 22438 215134 50367525
Halo vision 34.46 15.72 11 22454 393 50582266
Mucosal inflammation 34.42 15.72 63 22402 40079 50542580
Hypokalaemia 34.10 15.72 101 22364 87891 50494768
Solar lentigo 34.02 15.72 12 22453 585 50582074
Altered state of consciousness 33.69 15.72 45 22420 21865 50560794
Acute kidney injury 33.60 15.72 194 22271 227864 50354795
Death 33.51 15.72 253 22212 325126 50257533
Wound 33.15 15.72 4 22461 105790 50476869
Immunosuppressant drug level decreased 33.03 15.72 13 22452 862 50581797
Brain abscess 32.83 15.72 16 22449 1775 50580884
Pulmonary alveolar haemorrhage 32.53 15.72 21 22444 4006 50578653
Aspergillus test positive 32.35 15.72 10 22455 321 50582338
Platelet count decreased 32.04 15.72 108 22357 100618 50482041
Adenovirus infection 31.88 15.72 19 22446 3149 50579510
Leukaemia recurrent 31.71 15.72 14 22451 1240 50581419
Infusion related reaction 31.59 15.72 18 22447 169539 50413120
Granulomatous liver disease 31.46 15.72 12 22453 731 50581928
Myoclonus 30.78 15.72 35 22430 14435 50568224
Aspergillus test 30.67 15.72 5 22460 4 50582655
Aspartate aminotransferase increased 30.66 15.72 90 22375 77908 50504751
Dyschromatopsia 30.54 15.72 10 22455 388 50582271
Infective aneurysm 30.51 15.72 10 22455 389 50582270
Delirium 30.33 15.72 58 22407 38134 50544525
Bone marrow failure 29.79 15.72 48 22417 27576 50555083
Chromatopsia 29.67 15.72 10 22455 425 50582234
Staphylococcal infection 29.41 15.72 55 22410 35561 50547098
Alanine aminotransferase increased 29.22 15.72 96 22369 88263 50494396
Systemic candida 28.77 15.72 17 22448 2773 50579886
Acute lymphocytic leukaemia recurrent 28.48 15.72 15 22450 1960 50580699
Graft versus host disease in liver 28.42 15.72 10 22455 484 50582175
Haemoptysis 28.35 15.72 45 22420 25528 50557131
Photophobia 28.32 15.72 34 22431 14853 50567806
Primary myelofibrosis 27.99 15.72 6 22459 41 50582618
Sinusitis 27.85 15.72 21 22444 170537 50412122
Drug-induced liver injury 27.85 15.72 47 22418 28048 50554611
Dermatitis bullous 27.67 15.72 24 22441 7149 50575510
Toxic epidermal necrolysis 27.61 15.72 40 22425 20952 50561707
Disseminated intravascular coagulation 27.59 15.72 36 22429 17099 50565560
Malaise 27.00 15.72 69 22396 335463 50247196
Weight increased 26.87 15.72 30 22435 201861 50380798
Cerebral fungal infection 26.63 15.72 6 22459 53 50582606
Fungal skin infection 26.48 15.72 18 22447 3741 50578918
Venoocclusive disease 26.21 15.72 14 22451 1882 50580777
Thrombocytopenia 26.03 15.72 119 22346 127554 50455105
Respirovirus test positive 25.98 15.72 5 22460 18 50582641
Urinary tract infection 25.95 15.72 37 22428 223983 50358676
Haemophagocytic lymphohistiocytosis 25.73 15.72 25 22440 8608 50574051
Cytokine release syndrome 25.72 15.72 25 22440 8609 50574050
Liver disorder 25.32 15.72 53 22412 37169 50545490
Colour blindness 25.25 15.72 8 22457 279 50582380
Leukaemia 25.24 15.72 17 22448 3482 50579177
Lower respiratory tract infection fungal 25.03 15.72 8 22457 287 50582372
Pneumothorax 24.99 15.72 31 22434 14003 50568656
Human herpesvirus 6 infection 24.60 15.72 15 22450 2591 50580068
Renal failure 24.48 15.72 103 22362 106530 50476129
Tracheobronchitis 24.30 15.72 11 22454 1033 50581626
Acute lymphocytic leukaemia 24.02 15.72 14 22451 2227 50580432
Infective pulmonary exacerbation of cystic fibrosis 23.75 15.72 23 22442 7886 50574773
Obliterative bronchiolitis 23.71 15.72 13 22452 1840 50580819
Leukoencephalopathy 23.64 15.72 17 22448 3866 50578793
Drug intolerance 23.63 15.72 38 22427 219066 50363593
Keratitis fungal 23.54 15.72 6 22459 93 50582566
Graft versus host disease in lung 23.51 15.72 8 22457 350 50582309
Off label use 23.48 15.72 317 22148 474109 50108550
Nephropathy toxic 23.46 15.72 23 22442 8006 50574653
Arthritis 23.32 15.72 5 22460 86716 50495943
Coccidioidomycosis 23.02 15.72 10 22455 852 50581807
Anxiety 22.97 15.72 27 22438 177579 50405080
Hyperlactacidaemia 22.95 15.72 14 22451 2419 50580240
Bacteraemia 22.73 15.72 30 22435 14403 50568256
Palpitations 22.45 15.72 7 22458 94499 50488160
Bacterial sepsis 22.42 15.72 16 22449 3596 50579063
Blood pressure increased 22.24 15.72 16 22449 133116 50449543
Myocardial infarction 22.24 15.72 6 22459 89021 50493638
Stenotrophomonas infection 22.16 15.72 12 22453 1657 50581002
Tonsillitis bacterial 22.16 15.72 6 22459 119 50582540
Chronic graft versus host disease in skin 21.81 15.72 9 22456 675 50581984
Infection reactivation 21.72 15.72 10 22455 977 50581682
Pulmonary haemorrhage 21.63 15.72 20 22445 6472 50576187
Chronic papillomatous dermatitis 21.37 15.72 5 22460 53 50582606
Pleural effusion 21.35 15.72 82 22383 81372 50501287
Pseudoaldosteronism 21.29 15.72 5 22460 54 50582605
Back pain 21.16 15.72 41 22424 219989 50362670
Feeling abnormal 21.07 15.72 15 22450 125477 50457182
Scintillating scotoma 21.03 15.72 6 22459 145 50582514
Impaired healing 20.99 15.72 3 22462 69783 50512876
Abdominal pain upper 20.83 15.72 24 22441 159285 50423374
Procalcitonin increased 20.78 15.72 9 22456 761 50581898
Disease progression 20.77 15.72 91 22374 95775 50486884
Septal panniculitis 20.73 15.72 5 22460 61 50582598
Necrosis 20.64 15.72 17 22448 4719 50577940
Aplastic anaemia 20.54 15.72 21 22444 7682 50574977
Osteoarthritis 20.52 15.72 3 22462 68603 50514056
Hepatic candidiasis 20.45 15.72 4 22461 16 50582643
Cross sensitivity reaction 20.31 15.72 12 22453 1957 50580702
Post transplant lymphoproliferative disorder 20.25 15.72 16 22449 4188 50578471
Tuberculosis gastrointestinal 19.93 15.72 7 22458 337 50582322
Cytomegalovirus enterocolitis 19.90 15.72 8 22457 561 50582098
Diarrhoea 19.72 15.72 167 22298 588309 49994350
Skin exfoliation 19.62 15.72 45 22420 33567 50549092
Dermatitis exfoliative 19.42 15.72 17 22448 5125 50577534
Disseminated cryptococcosis 19.07 15.72 7 22458 383 50582276
Drug ineffective for unapproved indication 19.00 15.72 34 22431 21247 50561412
Migraine 18.94 15.72 5 22460 75275 50507384
Agranulocytosis 18.84 15.72 34 22431 21387 50561272
Central nervous system fungal infection 18.77 15.72 5 22460 93 50582566
Chest pain 18.76 15.72 31 22434 176851 50405808
Urticaria 18.64 15.72 18 22447 129543 50453116
Babesiosis 18.57 15.72 6 22459 223 50582436
Dyspepsia 18.49 15.72 5 22460 74092 50508567
Shock 18.45 15.72 33 22432 20617 50562042
Blood lactate dehydrogenase increased 18.43 15.72 32 22433 19530 50563129
Cholecystitis acute 18.28 15.72 19 22446 7087 50575572
Rash maculo-papular 18.20 15.72 38 22427 26603 50556056
Contusion 18.06 15.72 14 22451 112169 50470490
Trichosporon infection 18.05 15.72 6 22459 244 50582415
Hallucination, auditory 17.99 15.72 23 22442 10705 50571954
Cerebral haemorrhage 17.80 15.72 38 22427 27014 50555645
Hepatosplenic candidiasis 17.78 15.72 6 22459 256 50582403
Flushing 17.74 15.72 4 22461 67011 50515648
Encephalitis 17.68 15.72 19 22446 7361 50575298
Cystitis haemorrhagic 17.64 15.72 14 22451 3688 50578971
Gastrooesophageal reflux disease 17.55 15.72 6 22459 76422 50506237
Nausea 17.52 15.72 215 22250 705183 49877476
Muscle spasms 17.42 15.72 18 22447 125535 50457124
Drug clearance decreased 17.35 15.72 9 22456 1140 50581519
Cytomegalovirus test positive 17.29 15.72 12 22453 2580 50580079
Eye abscess 17.25 15.72 5 22460 128 50582531
Bacterial infection 17.16 15.72 28 22437 16253 50566406
Laryngeal inflammation 17.11 15.72 5 22460 132 50582527
Stem cell transplant 16.77 15.72 10 22455 1658 50581001
Pericarditis 16.70 15.72 7 22458 78682 50503977
Sphingomonas paucimobilis infection 16.64 15.72 4 22461 48 50582611
Cytopenia 16.62 15.72 20 22445 8755 50573904
Xanthopsia 16.22 15.72 5 22460 159 50582500
Disseminated aspergillosis 16.21 15.72 4 22461 54 50582605
Melanoderma 16.13 15.72 5 22460 162 50582497
Anal infection 16.01 15.72 4 22461 57 50582602
Neck pain 15.94 15.72 3 22462 57064 50525595
Inappropriate schedule of product administration 15.88 15.72 6 22459 71825 50510834
Respiratory distress 15.82 15.72 39 22426 30450 50552209
Apallic syndrome 15.79 15.72 7 22458 626 50582033
Shock haemorrhagic 15.77 15.72 19 22446 8325 50574334
Mycobacterial peritonitis 15.76 15.72 4 22461 61 50582598
Sunburn 15.74 15.72 11 22454 2392 50580267
Sputum increased 15.73 15.72 10 22455 1857 50580802

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 659.06 13.92 286 34706 8972 29530563
Drug interaction 502.94 13.92 862 34130 196523 29343012
Bronchopulmonary aspergillosis 466.90 13.92 247 34745 12097 29527438
Aspergillus infection 441.05 13.92 226 34766 10355 29529180
Drug level increased 432.33 13.92 272 34720 18515 29521020
Periostitis 349.53 13.92 77 34915 180 29539355
Actinic keratosis 343.20 13.92 139 34853 3647 29535888
Drug ineffective 334.45 13.92 1062 33930 362108 29177427
Mucormycosis 330.28 13.92 148 34844 5010 29534525
Cerebral aspergillosis 266.12 13.92 88 34904 1268 29538267
Squamous cell carcinoma of skin 245.21 13.92 148 34844 9338 29530197
Drug resistance 225.66 13.92 194 34798 21346 29518189
Hallucination, visual 216.36 13.92 163 34829 14852 29524683
Multiple organ dysfunction syndrome 206.72 13.92 310 34682 62806 29476729
Hallucination 176.33 13.92 240 34752 44472 29495063
Fungal infection 174.10 13.92 138 34854 13547 29525988
Graft versus host disease 169.42 13.92 118 34874 9510 29530025
Photodermatosis 163.22 13.92 47 34945 412 29539123
Hepatotoxicity 151.72 13.92 143 34849 17724 29521811
Fatigue 146.49 13.92 98 34894 316723 29222812
Squamous cell carcinoma 142.60 13.92 109 34883 10142 29529393
Choroiditis 139.00 13.92 50 34942 938 29538597
Septic shock 138.65 13.92 258 34734 62302 29477233
Scedosporium infection 138.39 13.92 47 34945 738 29538797
Respiratory failure 136.88 13.92 333 34659 96798 29442737
Pathogen resistance 127.86 13.92 93 34899 8023 29531512
Condition aggravated 127.16 13.92 421 34571 145874 29393661
Systemic mycosis 121.41 13.92 49 34943 1272 29538263
Pneumonia fungal 111.56 13.92 75 34917 5702 29533833
Cholestasis 108.04 13.92 136 34856 23326 29516209
Febrile neutropenia 104.66 13.92 331 34661 111909 29427626
Visual impairment 102.99 13.92 150 34842 29558 29509977
Solar lentigo 97.86 13.92 31 34961 386 29539149
Hepatic function abnormal 97.23 13.92 170 34822 39089 29500446
Completed suicide 93.22 13.92 3 34989 90243 29449292
Fluoride increased 91.61 13.92 20 34972 44 29539491
Cheilitis 91.26 13.92 46 34946 2030 29537505
Drug level below therapeutic 91.09 13.92 59 34933 4212 29535323
Disseminated mucormycosis 90.73 13.92 28 34964 318 29539217
Dysplastic naevus 84.81 13.92 28 34964 401 29539134
Fall 78.74 13.92 57 34935 177121 29362414
Drug abuse 77.98 13.92 4 34988 79879 29459656
Myocardial infarction 77.02 13.92 18 34974 110278 29429257
Fluorosis 75.38 13.92 17 34975 46 29539489
Drug level decreased 75.18 13.92 61 34931 6186 29533349
Product dose omission issue 72.95 13.92 13 34979 96370 29443165
Immunosuppressant drug level increased 69.20 13.92 52 34940 4713 29534822
Acute myeloid leukaemia 67.08 13.92 90 34902 16423 29523112
Fungaemia 66.80 13.92 38 34954 2143 29537392
Drug level above therapeutic 66.38 13.92 44 34948 3266 29536269
Fusarium infection 65.05 13.92 29 34963 968 29538567
Candida infection 64.96 13.92 85 34907 15140 29524395
Dyschromatopsia 63.27 13.92 21 34971 306 29539229
Intraocular pressure increased 62.40 13.92 49 34943 4740 29534795
Treatment failure 62.21 13.92 136 34856 36803 29502732
Pain 61.88 13.92 67 34925 171365 29368170
Asthenia 60.61 13.92 101 34891 215149 29324386
Visual acuity reduced 60.30 13.92 81 34911 14795 29524740
Dyspnoea 59.36 13.92 194 34798 326538 29212997
Uveitis 57.08 13.92 51 34941 5896 29533639
Nephropathy toxic 53.76 13.92 65 34927 10691 29528844
Graft versus host disease in gastrointestinal tract 52.83 13.92 38 34954 3220 29536315
Hepatocellular injury 52.57 13.92 92 34900 21151 29518384
Depression 51.84 13.92 18 34974 85129 29454406
Acute myeloid leukaemia recurrent 51.81 13.92 30 34962 1750 29537785
Neurological symptom 51.67 13.92 38 34954 3332 29536203
Diarrhoea 51.55 13.92 211 34781 332487 29207048
Inappropriate antidiuretic hormone secretion 51.31 13.92 64 34928 10868 29528667
Drug ineffective for unapproved indication 51.03 13.92 73 34919 14141 29525394
Disseminated intravascular coagulation 50.06 13.92 87 34905 19893 29519642
Nausea 48.93 13.92 177 34815 289078 29250457
Aspergilloma 48.86 13.92 17 34975 288 29539247
Liver disorder 47.67 13.92 103 34889 27646 29511889
Pruritus 47.55 13.92 41 34951 116808 29422727
Dizziness 46.30 13.92 97 34895 189587 29349948
Mediastinitis 46.21 13.92 20 34972 621 29538914
Anxiety 45.56 13.92 22 34970 85343 29454192
Pseudomonas infection 45.38 13.92 60 34932 10792 29528743
Constipation 45.32 13.92 41 34951 114119 29425416
Eye pain 45.27 13.92 62 34930 11533 29528002
Pain in extremity 43.43 13.92 40 34952 110393 29429142
Toxic optic neuropathy 43.43 13.92 20 34972 721 29538814
Leukaemia recurrent 43.27 13.92 25 34967 1452 29538083
Brain abscess 43.12 13.92 31 34961 2624 29536911
Aspergillus test positive 43.01 13.92 17 34975 417 29539118
Renal ischaemia 42.83 13.92 18 34974 519 29539016
Blood pressure increased 42.57 13.92 17 34975 73786 29465749
Chest pain 42.35 13.92 42 34950 111931 29427604
Arthralgia 41.61 13.92 63 34929 139554 29399981
Product compounding quality issue 41.16 13.92 9 34983 20 29539515
Neurotoxicity 41.08 13.92 67 34925 14546 29524989
Acute graft versus host disease in skin 40.86 13.92 38 34954 4626 29534909
Product use in unapproved indication 39.46 13.92 205 34787 86670 29452865
Acute graft versus host disease 39.03 13.92 41 34951 5783 29533752
Cardiac failure congestive 38.98 13.92 21 34971 76560 29462975
Xanthopsia 38.59 13.92 12 34980 140 29539395
Photophobia 38.04 13.92 41 34951 5954 29533581
Dehydration 37.97 13.92 48 34944 114700 29424835
Acute graft versus host disease in liver 37.49 13.92 22 34970 1316 29538219
Blood alkaline phosphatase increased 37.38 13.92 95 34897 28311 29511224
Hepatitis cholestatic 36.66 13.92 43 34949 6850 29532685
Enterococcal infection 36.57 13.92 47 34945 8221 29531314
Peripheral swelling 36.24 13.92 15 34977 63724 29475811
Phaeohyphomycosis 35.97 13.92 18 34974 782 29538753
Nasopharyngitis 35.65 13.92 13 34979 59652 29479883
Burns second degree 35.32 13.92 14 34978 346 29539189
Enterococcal sepsis 35.14 13.92 22 34970 1480 29538055
Cytomegalovirus viraemia 34.57 13.92 40 34952 6280 29533255
Weight decreased 34.46 13.92 80 34912 150825 29388710
Product contamination microbial 34.28 13.92 16 34976 595 29538940
Septic embolus 34.07 13.92 19 34973 1031 29538504
Cytokine release syndrome 34.00 13.92 58 34934 13061 29526474
Back pain 33.61 13.92 43 34949 102241 29437294
Nocardiosis 33.37 13.92 29 34963 3231 29536304
Pseudoporphyria 33.23 13.92 13 34979 310 29539225
Alternaria infection 33.08 13.92 13 34979 314 29539221
Lip squamous cell carcinoma 32.90 13.92 9 34983 64 29539471
Acute respiratory distress syndrome 32.59 13.92 79 34913 22856 29516679
Stenotrophomonas infection 32.45 13.92 22 34970 1695 29537840
Hyperhidrosis 32.40 13.92 18 34974 64522 29475013
Drug-induced liver injury 32.29 13.92 76 34916 21579 29517956
Intentional overdose 31.88 13.92 4 34988 38524 29501011
Malaise 31.54 13.92 91 34901 159511 29380024
Fungal endocarditis 31.04 13.92 12 34980 277 29539258
Graft versus host disease in skin 30.51 13.92 28 34964 3351 29536184
Venoocclusive liver disease 30.09 13.92 39 34953 6878 29532657
Transaminases increased 30.03 13.92 76 34916 22586 29516949
Urinary tract infection 29.89 13.92 25 34967 72329 29467206
Inappropriate schedule of product administration 29.58 13.92 8 34984 44464 29495071
Scopulariopsis infection 29.34 13.92 9 34983 100 29539435
Pyrexia 29.26 13.92 490 34502 287132 29252403
Pneumonia 29.21 13.92 536 34456 319636 29219899
Headache 28.99 13.92 107 34885 173900 29365635
Hypertension 28.94 13.92 59 34933 116555 29422980
Lower respiratory tract infection fungal 28.93 13.92 14 34978 565 29538970
Cerebrovascular accident 28.89 13.92 29 34963 76882 29462653
Cystitis haemorrhagic 28.79 13.92 32 34960 4810 29534725
Post transplant lymphoproliferative disorder 28.77 13.92 34 34958 5459 29534076
Macular opacity 28.70 13.92 5 34987 0 29539535
Off label use 28.64 13.92 507 34485 300293 29239242
Hepatic failure 28.42 13.92 92 34900 31420 29508115
Chronic graft versus host disease 28.14 13.92 29 34963 4000 29535535
Torsade de pointes 28.11 13.92 37 34955 6624 29532911
Lentigo 27.83 13.92 12 34980 369 29539166
Injection site pain 27.76 13.92 3 34989 32443 29507092
Pulmonary cavitation 27.70 13.92 15 34977 768 29538767
Trichosporon infection 27.60 13.92 14 34978 626 29538909
Gallbladder oedema 27.53 13.92 10 34982 193 29539342
Rheumatoid arthritis 27.44 13.92 3 34989 32149 29507386
Dyspnoea exertional 27.42 13.92 5 34987 36485 29503050
Vomiting 27.21 13.92 144 34848 212116 29327419
Neutropenia 27.05 13.92 256 34736 131455 29408080
Gamma-glutamyltransferase increased 26.83 13.92 81 34911 26656 29512879
Central nervous system lesion 26.39 13.92 33 34959 5615 29533920
Eye infection fungal 26.28 13.92 11 34981 314 29539221
Arthritis fungal 25.99 13.92 8 34984 90 29539445
Osteomyelitis fungal 25.86 13.92 10 34982 231 29539304
Central nervous system fungal infection 25.77 13.92 11 34981 330 29539205
Rectal haemorrhage 25.39 13.92 5 34987 34544 29504991
Dyspepsia 25.23 13.92 3 34989 30122 29509413
Halo vision 25.21 13.92 9 34983 165 29539370
Muscle spasms 25.07 13.92 24 34968 65058 29474477
Urticaria 24.99 13.92 17 34975 54643 29484892
Photopsia 24.97 13.92 19 34973 1754 29537781
Transmission of an infectious agent via product 24.96 13.92 9 34983 170 29539365
Cytomegalovirus infection 24.88 13.92 72 34920 23143 29516392
Gallbladder empyema 24.87 13.92 7 34985 56 29539479
Tongue necrosis 24.82 13.92 6 34986 24 29539511
Gastrooesophageal reflux disease 24.35 13.92 4 34988 31492 29508043
Chloropsia 24.34 13.92 5 34987 7 29539528
Lung infiltration 24.09 13.92 47 34945 11732 29527803
Chromatopsia 23.60 13.92 9 34983 200 29539335
Pulmonary mass 23.35 13.92 44 34948 10704 29528831
Infectious pleural effusion 23.32 13.92 19 34973 1937 29537598
Pulmonary embolism 23.29 13.92 34 34958 76500 29463035
Splenic candidiasis 23.22 13.92 7 34985 73 29539462
Hypertrophic osteoarthropathy 22.88 13.92 7 34985 77 29539458
Nervous system disorder 22.86 13.92 48 34944 12626 29526909
Haemophagocytic lymphohistiocytosis 22.82 13.92 43 34949 10461 29529074
Asthma 22.68 13.92 6 34986 33843 29505692
Retinal ischaemia 22.65 13.92 10 34982 326 29539209
Musculoskeletal stiffness 22.64 13.92 8 34984 37450 29502085
Altered state of consciousness 22.60 13.92 63 34929 19826 29519709
Pancytopenia 22.53 13.92 172 34820 82996 29456539
Toxic skin eruption 22.52 13.92 41 34951 9716 29529819
Urinary bladder rupture 22.41 13.92 7 34985 83 29539452
Acute graft versus host disease in intestine 22.31 13.92 20 34972 2321 29537214
Acute lymphocytic leukaemia 22.21 13.92 21 34971 2610 29536925
Abscess fungal 22.14 13.92 8 34984 152 29539383
Pulmonary alveolar haemorrhage 21.78 13.92 32 34960 6348 29533187
Disease recurrence 21.74 13.92 54 34938 15860 29523675
Pulmonary haemorrhage 21.45 13.92 39 34953 9231 29530304
Sepsis 21.22 13.92 260 34732 142422 29397113
Drug hypersensitivity 21.20 13.92 30 34962 68376 29471159
Aplasia 21.03 13.92 25 34967 4038 29535497
Acute myocardial infarction 20.92 13.92 16 34976 48422 29491113
Joint swelling 20.67 13.92 17 34975 49613 29489922
Angina pectoris 20.53 13.92 4 34988 27846 29511689
Disseminated aspergillosis 20.49 13.92 10 34982 411 29539124
Ureaplasma infection 20.36 13.92 8 34984 193 29539342
Prostate cancer 20.29 13.92 3 34989 25524 29514011
Gait disturbance 20.04 13.92 35 34957 73314 29466221
Citrobacter infection 20.03 13.92 10 34982 432 29539103
Intentional product misuse 19.95 13.92 8 34984 34653 29504882
Necrotising retinitis 19.88 13.92 12 34980 756 29538779
Sunburn 19.87 13.92 16 34976 1604 29537931
Antibiotic level below therapeutic 19.87 13.92 6 34986 63 29539472
Mycobacterium abscessus infection 19.78 13.92 10 34982 444 29539091
Hallucinations, mixed 19.74 13.92 19 34973 2414 29537121
Klebsiella infection 19.72 13.92 33 34959 7316 29532219
BK virus infection 19.64 13.92 26 34966 4681 29534854
Scintillating scotoma 19.61 13.92 5 34987 26 29539509
Neuroendocrine carcinoma of the skin 19.52 13.92 11 34981 609 29538926
Peptic ulcer haemorrhage 19.49 13.92 10 34982 458 29539077
Syncope 19.48 13.92 42 34950 81329 29458206
Delirium 19.29 13.92 95 34897 39302 29500233
Psoriasis 19.28 13.92 7 34985 32220 29507315
Cytomegalovirus enterocolitis 19.25 13.92 12 34980 801 29538734
Acute lymphocytic leukaemia recurrent 19.20 13.92 19 34973 2497 29537038
Inhibitory drug interaction 19.06 13.92 15 34977 1455 29538080
Cerebral artery embolism 19.02 13.92 12 34980 818 29538717
Cerebral fungal infection 18.99 13.92 8 34984 232 29539303
Burns first degree 18.93 13.92 4 34988 7 29539528
Staphylococcal sepsis 18.90 13.92 36 34956 8826 29530709
Hospitalisation 18.85 13.92 16 34976 45972 29493563
Bacterial infection 18.82 13.92 45 34947 12903 29526632
Colour blindness acquired 18.77 13.92 6 34986 77 29539458
Eye abscess 18.72 13.92 7 34985 147 29539388
Abdominal pain upper 18.65 13.92 27 34965 60966 29478569
Abdominal pain 18.35 13.92 90 34902 135267 29404268
Aspartate aminotransferase 18.30 13.92 6 34986 84 29539451
Mucosal ulceration 18.28 13.92 12 34980 876 29538659
Organising pneumonia 18.22 13.92 26 34966 5022 29534513
Bacterial sepsis 18.13 13.92 25 34967 4678 29534857
Loss of personal independence in daily activities 18.04 13.92 4 34988 25436 29514099
Nephrolithiasis 17.93 13.92 4 34988 25330 29514205
Retinal toxicity 17.90 13.92 9 34983 395 29539140
Flushing 17.85 13.92 6 34986 28986 29510549
Decreased appetite 17.83 13.92 100 34892 145242 29394293
Malignant neoplasm progression 17.78 13.92 38 34954 73821 29465714
Neurological decompensation 17.70 13.92 18 34974 2444 29537091
Fibrinous bronchitis 17.69 13.92 4 34988 11 29539524
Mycotic endophthalmitis 17.66 13.92 5 34987 41 29539494
Arthritis 17.61 13.92 4 34988 25015 29514520
Blood bilirubin increased 17.50 13.92 83 34909 33810 29505725
Retinal haemorrhage 17.45 13.92 24 34968 4480 29535055
Oral papilloma 17.43 13.92 4 34988 12 29539523
Hyperammonaemia 17.34 13.92 27 34965 5636 29533899
Bronchial artery embolisation 17.22 13.92 3 34989 0 29539535
Chronic obstructive pulmonary disease 17.09 13.92 14 34978 40941 29498594
Gastrointestinal mucormycosis 16.91 13.92 6 34986 108 29539427
Wrong technique in product usage process 16.91 13.92 8 34984 31420 29508115
Escherichia sepsis 16.76 13.92 22 34970 3927 29535608
Periostosis 16.75 13.92 4 34988 15 29539520
Transplant rejection 16.74 13.92 35 34957 9177 29530358
Hypokalaemia 16.61 13.92 109 34883 50094 29489441
Hypersensitivity 16.59 13.92 23 34969 52880 29486655
Gastrointestinal wall thinning 16.54 13.92 4 34988 16 29539519
Pneumonia bacterial 16.40 13.92 35 34957 9308 29530227
Complications of transplant surgery 16.37 13.92 9 34983 475 29539060
Graft versus host disease in lung 16.08 13.92 9 34983 492 29539043
Granulomatous dermatitis 15.95 13.92 7 34985 225 29539310
Weight increased 15.65 13.92 43 34949 76624 29462911
Hepatitis toxic 15.61 13.92 15 34977 1901 29537634
Candida test positive 15.54 13.92 8 34984 369 29539166
Lip ulceration 15.48 13.92 10 34982 710 29538825
Solar dermatitis 15.45 13.92 5 34987 67 29539468
Malabsorption 15.40 13.92 15 34977 1933 29537602
Overdose 15.39 13.92 46 34946 79773 29459762
Gastrointestinal wall thickening 15.32 13.92 12 34980 1156 29538379
Chondritis 15.30 13.92 6 34986 144 29539391
International normalised ratio increased 15.25 13.92 18 34974 44354 29495181
Necrotising ulcerative gingivostomatitis 15.25 13.92 5 34987 70 29539465
Chronic granulomatous disease 15.21 13.92 4 34988 24 29539511
Donor leukocyte infusion 15.21 13.92 4 34988 24 29539511
Haemoptysis 15.19 13.92 74 34918 30476 29509059
Mental disorder due to a general medical condition 15.19 13.92 6 34986 147 29539388
Chronic pulmonary histoplasmosis 15.15 13.92 3 34989 3 29539532
Deep vein thrombosis 15.13 13.92 28 34964 57371 29482164
Therapeutic product effect decreased 15.08 13.92 8 34984 29443 29510092
Renal failure 15.06 13.92 210 34782 118389 29421146
Apraxia 15.05 13.92 12 34980 1186 29538349
Brain herniation 15.05 13.92 20 34972 3613 29535922
Sinusitis fungal 15.02 13.92 8 34984 396 29539139
Oropharyngeal pain 14.93 13.92 8 34984 29277 29510258
Ephelides 14.93 13.92 5 34987 75 29539460
Swelling 14.80 13.92 12 34980 35271 29504264
Pneumonia cytomegaloviral 14.71 13.92 17 34975 2665 29536870
Thrombotic microangiopathy 14.64 13.92 32 34960 8649 29530886
Hypoxia 14.55 13.92 101 34891 47278 29492257
Fungal skin infection 14.52 13.92 16 34976 2382 29537153
Insomnia 14.48 13.92 55 34937 88706 29450829
Urinary retention 14.47 13.92 10 34982 31888 29507647
Hepatic cytolysis 14.34 13.92 31 34961 8316 29531219
Skin mass 14.34 13.92 19 34973 3424 29536111
Dry mouth 14.33 13.92 4 34988 21780 29517755
Wheezing 14.33 13.92 11 34981 33229 29506306
Atypical mycobacterial lower respiratory tract infection 14.32 13.92 4 34988 31 29539504
Leukaemia 14.31 13.92 20 34972 3790 29535745
Product use issue 14.26 13.92 107 34885 51337 29488198
Systemic candida 14.22 13.92 17 34975 2763 29536772
Hepatomegaly 14.21 13.92 33 34959 9284 29530251
Somnolence 14.20 13.92 60 34932 93895 29445640
Coagulopathy 14.13 13.92 50 34942 17857 29521678
Steatohepatitis 14.10 13.92 7 34985 299 29539236
Loss of consciousness 14.04 13.92 43 34949 74013 29465522
Antithrombin III deficiency 14.04 13.92 5 34987 91 29539444
Unevaluable event 14.02 13.92 9 34983 29842 29509693
Transient ischaemic attack 14.01 13.92 5 34987 23265 29516270
Neck pain 13.99 13.92 4 34988 21443 29518092

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 909.18 13.96 1284 51249 360799 64085400
Photosensitivity reaction 804.83 13.96 360 52173 17813 64428386
Bronchopulmonary aspergillosis 731.72 13.96 342 52191 18743 64427456
Drug level increased 676.36 13.96 393 52140 33803 64412396
Aspergillus infection 676.22 13.96 309 52224 16070 64430129
Mucormycosis 667.49 13.96 244 52289 7097 64439102
Periostitis 645.20 13.96 136 52397 401 64445798
Actinic keratosis 542.31 13.96 191 52342 4974 64441225
Drug ineffective 483.85 13.96 1637 50896 838610 63607589
Multiple organ dysfunction syndrome 463.01 13.96 488 52045 100925 64345274
Cerebral aspergillosis 360.10 13.96 107 52426 1586 64444613
Squamous cell carcinoma of skin 356.21 13.96 180 52353 11696 64434503
Drug resistance 340.87 13.96 259 52274 34843 64411356
Septic shock 311.55 13.96 406 52127 105031 64341168
Hallucination, visual 309.86 13.96 223 52310 27611 64418588
Fatigue 278.01 13.96 132 52401 748598 63697601
Hallucination 274.39 13.96 317 52216 72471 64373728
Respiratory failure 273.44 13.96 479 52054 160704 64285495
Drug level below therapeutic 263.47 13.96 126 52407 7258 64438941
Fungal infection 248.21 13.96 213 52320 34038 64412161
Pathogen resistance 244.75 13.96 143 52390 12400 64433799
Graft versus host disease 242.22 13.96 147 52386 13666 64432533
Photodermatosis 241.50 13.96 68 52465 823 64445376
Squamous cell carcinoma 234.00 13.96 144 52389 13725 64432474
Systemic mycosis 232.79 13.96 83 52450 2240 64443959
Febrile neutropenia 222.02 13.96 479 52054 187178 64259021
Hepatotoxicity 218.11 13.96 212 52321 39750 64406449
Pneumonia fungal 216.06 13.96 117 52416 8760 64437439
Cholestasis 195.77 13.96 211 52322 44661 64401538
Drug level decreased 192.95 13.96 119 52414 11384 64434815
Scedosporium infection 189.53 13.96 61 52472 1193 64445006
Pain 186.77 13.96 110 52423 553401 63892798
Fluoride increased 174.45 13.96 34 52499 57 64446142
Visual impairment 150.64 13.96 239 52294 73838 64372361
Acute myeloid leukaemia 148.53 13.96 145 52388 27318 64418881
Hepatic function abnormal 142.65 13.96 216 52317 64097 64382102
Choroiditis 140.59 13.96 47 52486 1040 64445159
Fall 138.80 13.96 84 52449 416742 64029457
Solar lentigo 133.12 13.96 43 52490 851 64445348
Fungaemia 121.22 13.96 60 52473 3725 64442474
Fluorosis 114.80 13.96 24 52509 67 64446132
Immunosuppressant drug level increased 113.93 13.96 72 52461 7187 64439012
Rheumatoid arthritis 109.34 13.96 6 52527 164288 64281911
Product use in unapproved indication 109.06 13.96 354 52179 176264 64269935
Candida infection 108.62 13.96 131 52402 31288 64414911
Arthralgia 106.67 13.96 122 52411 442138 64004061
Joint swelling 101.93 13.96 25 52508 215357 64230842
Neurotoxicity 99.24 13.96 117 52416 27287 64418912
Product dose omission issue 97.39 13.96 20 52513 194727 64251472
Graft versus host disease in gastrointestinal tract 96.51 13.96 59 52474 5553 64440646
Pruritus 95.73 13.96 69 52464 312331 64133868
Venoocclusive liver disease 95.18 13.96 73 52460 9942 64436257
Dizziness 93.95 13.96 128 52405 430035 64016164
Nausea 93.02 13.96 329 52204 785471 63660728
Fusarium infection 92.20 13.96 38 52495 1531 64444668
Pseudomonas infection 92.19 13.96 92 52441 17791 64428408
Condition aggravated 91.67 13.96 567 51966 371859 64074340
Dysplastic naevus 90.38 13.96 28 52505 481 64445718
Dyschromatopsia 89.22 13.96 30 52503 676 64445523
Nasopharyngitis 88.51 13.96 25 52508 196048 64250151
Hepatocellular injury 87.88 13.96 143 52390 45092 64401107
Pain in extremity 87.68 13.96 71 52462 303014 64143185
Disseminated mucormycosis 86.24 13.96 27 52506 481 64445718
Drug hypersensitivity 86.19 13.96 43 52490 237772 64208427
Drug level above therapeutic 85.36 13.96 59 52474 6842 64439357
Cheilitis 85.36 13.96 51 52482 4605 64441594
Peripheral swelling 85.03 13.96 32 52501 209121 64237078
Drug abuse 84.58 13.96 6 52527 132368 64313831
Pneumonia 82.20 13.96 754 51779 558822 63887377
Headache 80.42 13.96 197 52336 529270 63916929
Dilatation intrahepatic duct acquired 77.96 13.96 27 52506 667 64445532
Nephropathy toxic 77.48 13.96 83 52450 17431 64428768
Pancytopenia 75.07 13.96 272 52261 143037 64303162
Hypertrophic osteoarthropathy 74.97 13.96 18 52515 109 64446090
Brain abscess 74.58 13.96 45 52488 4136 64442063
Injection site pain 74.33 13.96 4 52529 111404 64334795
Drug ineffective for unapproved indication 73.92 13.96 108 52425 31025 64415174
Pulmonary mucormycosis 73.82 13.96 27 52506 785 64445414
Arthropathy 73.09 13.96 7 52526 120960 64325239
Diarrhoea 73.07 13.96 322 52211 722382 63723817
Enterococcal infection 72.70 13.96 72 52461 13794 64432405
Pyrexia 72.27 13.96 733 51800 557911 63888288
Myocardial infarction 71.46 13.96 23 52510 165798 64280401
Blood pressure increased 70.79 13.96 26 52507 172526 64273673
Hypersensitivity 70.45 13.96 36 52497 196416 64249783
Anxiety 69.94 13.96 39 52494 202610 64243589
Aspergillus test positive 69.82 13.96 25 52508 683 64445516
Musculoskeletal stiffness 69.73 13.96 9 52524 123197 64323002
Torsade de pointes 69.37 13.96 78 52455 17285 64428914
Acute respiratory distress syndrome 68.83 13.96 118 52415 38817 64407382
Leukaemia recurrent 68.20 13.96 36 52497 2558 64443641
Blood alkaline phosphatase increased 67.92 13.96 145 52388 56134 64390065
Cytomegalovirus viraemia 67.76 13.96 62 52471 10766 64435433
Swelling 67.68 13.96 23 52510 160195 64286004
Cytomegalovirus infection 67.43 13.96 114 52419 37085 64409114
Urinary tract infection 67.26 13.96 54 52479 231542 64214657
Visual acuity reduced 67.13 13.96 96 52437 27045 64419154
Treatment failure 66.57 13.96 228 52305 116588 64329611
Dyspnoea 65.13 13.96 333 52200 718341 63727858
Liver disorder 65.01 13.96 138 52395 53213 64392986
Acute graft versus host disease 64.77 13.96 56 52477 9028 64437171
Malaise 64.47 13.96 142 52391 396105 64050094
Graft versus host disease in skin 64.46 13.96 45 52488 5302 64440897
Lentigo 64.29 13.96 21 52512 431 64445768
Acute graft versus host disease in liver 63.89 13.96 30 52503 1657 64444542
Off label use 63.52 13.96 790 51743 632016 63814183
Neutropenia 62.13 13.96 370 52163 239254 64206945
Fungal endocarditis 62.05 13.96 21 52512 483 64445716
Sepsis 61.87 13.96 359 52174 229982 64216217
Asthenia 60.52 13.96 165 52368 427879 64018320
Synovitis 59.17 13.96 6 52527 99084 64347115
Nervous system disorder 59.11 13.96 83 52450 22995 64423204
Abdominal discomfort 57.47 13.96 39 52494 182283 64263916
Therapeutic product effect decreased 57.32 13.96 12 52521 115339 64330860
Blood bilirubin increased 56.88 13.96 137 52396 57416 64388783
Contraindicated product administered 56.16 13.96 10 52523 107819 64338380
Back pain 54.97 13.96 74 52459 250097 64196102
Halo vision 54.89 13.96 20 52513 575 64445624
Chest pain 54.74 13.96 67 52466 235913 64210286
Xanthopsia 54.66 13.96 17 52516 296 64445903
Acute graft versus host disease in skin 54.51 13.96 45 52488 6810 64439389
Drug-induced liver injury 53.22 13.96 119 52414 47524 64398675
Photophobia 53.17 13.96 68 52465 17225 64428974
Phaeohyphomycosis 53.07 13.96 23 52510 1051 64445148
Endophthalmitis 52.95 13.96 40 52493 5325 64440874
Delirium 52.30 13.96 149 52384 69045 64377154
Infusion related reaction 52.07 13.96 35 52498 164432 64281767
Maternal exposure during pregnancy 51.92 13.96 8 52525 95876 64350323
Chronic graft versus host disease 51.58 13.96 42 52491 6234 64439965
Product compounding quality issue 51.31 13.96 11 52522 36 64446163
Hepatitis cholestatic 50.96 13.96 56 52477 12099 64434100
Intraocular pressure increased 50.90 13.96 47 52486 8255 64437944
Septic embolus 50.76 13.96 26 52507 1736 64444463
Weight increased 50.09 13.96 60 52473 213288 64232911
Geotrichum infection 49.79 13.96 21 52512 897 64445302
Acute graft versus host disease in intestine 49.75 13.96 33 52500 3576 64442623
Disseminated intravascular coagulation 49.43 13.96 92 52441 32256 64413943
Mediastinitis 48.92 13.96 20 52513 789 64445410
Gamma-glutamyltransferase increased 48.50 13.96 116 52417 48394 64397805
Urticaria 48.48 13.96 30 52503 147287 64298912
Exposure during pregnancy 48.25 13.96 4 52529 77671 64368528
Systemic lupus erythematosus 48.21 13.96 4 52529 77608 64368591
Discomfort 48.02 13.96 5 52528 80873 64365326
Lower respiratory tract infection fungal 47.85 13.96 20 52513 835 64445364
Arthritis 47.71 13.96 6 52527 83808 64362391
Pneumonia bacterial 47.62 13.96 60 52473 14975 64431224
Dyspepsia 47.59 13.96 5 52528 80307 64365892
Staphylococcal infection 47.28 13.96 118 52415 50560 64395639
Aspergilloma 47.11 13.96 17 52516 475 64445724
Stenotrophomonas infection 46.96 13.96 30 52503 3050 64443149
Pulmonary alveolar haemorrhage 46.36 13.96 48 52485 9690 64436509
Central nervous system fungal infection 45.80 13.96 16 52517 406 64445793
Abdominal pain upper 45.76 13.96 45 52488 174985 64271214
Fungal test positive 45.40 13.96 20 52513 951 64445248
Transaminases increased 44.98 13.96 107 52426 44487 64401712
Gastrooesophageal reflux disease 44.87 13.96 7 52526 83136 64363063
Cytokine release syndrome 44.80 13.96 69 52464 20760 64425439
Immunosuppressant drug level decreased 44.38 13.96 24 52509 1791 64444408
Neurological symptom 44.31 13.96 40 52493 6824 64439375
Trichosporon infection 43.74 13.96 19 52514 873 64445326
Nocardiosis 43.67 13.96 34 52499 4733 64441466
Post transplant lymphoproliferative disorder 43.57 13.96 46 52487 9498 64436701
Haemophagocytic lymphohistiocytosis 43.13 13.96 62 52471 17547 64428652
Injection site erythema 43.02 13.96 4 52529 70796 64375403
Skin candida 42.98 13.96 23 52510 1680 64444519
Vomiting 42.97 13.96 268 52265 550849 63895350
Alopecia 42.85 13.96 43 52490 165647 64280552
Rash 42.83 13.96 210 52323 458339 63987860
Hepatic cytolysis 42.81 13.96 55 52478 13994 64432205
Altered state of consciousness 42.70 13.96 95 52438 37807 64408392
Inappropriate antidiuretic hormone secretion 42.65 13.96 70 52463 22219 64423980
Toxic optic neuropathy 42.65 13.96 19 52514 928 64445271
Electrocardiogram QT prolonged 42.59 13.96 152 52381 79296 64366903
Uveitis 42.31 13.96 52 52481 12656 64433543
Acute myeloid leukaemia recurrent 42.16 13.96 27 52506 2757 64443442
Klebsiella infection 42.06 13.96 53 52480 13228 64432971
Pseudoporphyria 41.89 13.96 16 52517 526 64445673
Intentional overdose 41.44 13.96 11 52522 89933 64356266
Cerebral fungal infection 41.24 13.96 14 52519 325 64445874
Infective aneurysm 40.78 13.96 18 52515 860 64445339
Product contamination microbial 40.68 13.96 18 52515 865 64445334
Osteoarthritis 40.08 13.96 3 52530 63333 64382866
Wound 40.02 13.96 7 52526 76470 64369729
Encephalopathy 40 13.96 122 52411 58697 64387502
Acute lymphocytic leukaemia 39.66 13.96 31 52502 4340 64441859
Pneumothorax 39.52 13.96 71 52462 24227 64421972
Depression 39.45 13.96 55 52478 183236 64262963
Inappropriate schedule of product administration 39.39 13.96 13 52520 92273 64353926
Cystitis haemorrhagic 39.30 13.96 40 52493 7916 64438283
Renal impairment 39.22 13.96 215 52318 134802 64311397
Contusion 39.20 13.96 22 52511 113943 64332256
Thrombotic microangiopathy 38.41 13.96 57 52476 16598 64429601
Systemic candida 38.29 13.96 33 52500 5296 64440903
Impaired healing 37.88 13.96 3 52530 60470 64385729
Lung infiltration 37.83 13.96 64 52469 20825 64425374
Flushing 37.42 13.96 9 52524 78639 64367560
Enterococcal sepsis 37.30 13.96 24 52509 2470 64443729
Renal ischaemia 37.17 13.96 18 52515 1065 64445134
Chromatopsia 37.12 13.96 15 52518 574 64445625
Abscess fungal 36.89 13.96 12 52521 243 64445956
Chloropsia 36.68 13.96 6 52527 0 64446199
Macular opacity 36.68 13.96 6 52527 0 64446199
Infectious pleural effusion 36.65 13.96 25 52508 2837 64443362
Platelet count decreased 36.62 13.96 248 52285 167463 64278736
Scopulariopsis infection 36.46 13.96 10 52523 109 64446090
Renal failure 36.35 13.96 263 52270 181425 64264774
Transmission of an infectious agent via product 36.17 13.96 11 52522 177 64446022
Weight decreased 36.09 13.96 116 52417 285623 64160576
Osteomyelitis fungal 36.00 13.96 12 52521 263 64445936
Acute lymphocytic leukaemia recurrent 35.34 13.96 28 52505 3998 64442201
Hypokalaemia 35.32 13.96 194 52339 121709 64324490
Neutrophil count decreased 35.00 13.96 140 52393 77056 64369143
Scintillating scotoma 34.97 13.96 11 52522 199 64446000
Constipation 34.97 13.96 85 52448 229252 64216947
Eye abscess 34.74 13.96 12 52521 294 64445905
Abdominal pain 34.01 13.96 135 52398 312240 64133959
Rectal haemorrhage 33.82 13.96 5 52528 61812 64384387
Muscle spasms 33.79 13.96 39 52494 140984 64305215
Cardiac failure congestive 33.63 13.96 34 52499 130546 64315653
Palpitations 33.38 13.96 22 52511 104466 64341733
Pulmonary haemorrhage 33.35 13.96 47 52486 13062 64433137
Basal cell carcinoma 33.29 13.96 76 52457 30762 64415437
Sunburn 33.23 13.96 25 52508 3307 64442892
Sinusitis 33.22 13.96 42 52491 145886 64300313
Loss of personal independence in daily activities 33.11 13.96 9 52524 72445 64373754
Stress 32.88 13.96 5 52528 60529 64385670
Graft versus host disease in lung 32.63 13.96 15 52518 789 64445410
Psoriasis 32.59 13.96 9 52524 71694 64374505
BK virus infection 32.56 13.96 35 52498 7377 64438822
Disease progression 32.43 13.96 212 52321 141468 64304731
Oropharyngeal pain 32.26 13.96 16 52517 88851 64357348
Migraine 32.22 13.96 6 52527 62671 64383528
Disseminated aspergillosis 32.01 13.96 14 52519 654 64445545
Cerebrovascular accident 31.95 13.96 39 52494 137544 64308655
Mobility decreased 31.86 13.96 15 52518 85825 64360374
Myoclonus 31.78 13.96 66 52467 25052 64421147
Leukaemia 31.57 13.96 29 52504 5059 64441140
Hypertension 31.53 13.96 107 52426 259154 64187045
Photopsia 31.48 13.96 28 52505 4686 64441513
Fungal skin infection 31.39 13.96 29 52504 5096 64441103
Liver function test abnormal 31.28 13.96 113 52420 59288 64386911
Bone marrow failure 31.25 13.96 98 52435 47854 64398345
Arthritis fungal 31.16 13.96 9 52524 120 64446079
Posterior reversible encephalopathy syndrome 31.06 13.96 62 52471 22884 64423315
Bacterial infection 30.92 13.96 65 52468 24885 64421314
Aplasia 30.83 13.96 33 52500 6920 64439279
Haemoptysis 30.83 13.96 99 52434 48949 64397250
Bacterial sepsis 30.64 13.96 34 52499 7423 64438776
Toxoplasmosis 30.47 13.96 21 52512 2423 64443776
Pulmonary embolism 30.42 13.96 45 52488 146311 64299888
Alternaria infection 30.40 13.96 13 52520 575 64445624
Eye infection fungal 30.21 13.96 12 52521 439 64445760
Lip squamous cell carcinoma 29.75 13.96 10 52523 225 64445974
Syncope 29.45 13.96 52 52481 157583 64288616
Gastrointestinal mucormycosis 29.41 13.96 11 52522 341 64445858
Neck pain 29.36 13.96 7 52526 61526 64384673
Mycobacterium abscessus infection 29.32 13.96 15 52518 999 64445200
Blood pressure fluctuation 28.83 13.96 4 52529 51867 64394332
Corneal perforation 28.51 13.96 13 52520 671 64445528
Toxic skin eruption 28.41 13.96 54 52479 19230 64426969
Hyperhidrosis 28.38 13.96 36 52497 124884 64321315
Lung transplant rejection 28.15 13.96 16 52517 1316 64444883
Cytomegalovirus enterocolitis 27.89 13.96 16 52517 1339 64444860
Aspergillus test 27.68 13.96 6 52527 21 64446178
Colour blindness acquired 27.54 13.96 8 52525 109 64446090
Burns second degree 27.45 13.96 14 52519 926 64445273
Hyperammonaemia 27.43 13.96 37 52496 9867 64436332
Hallucinations, mixed 27.33 13.96 29 52504 6023 64440176
Chest discomfort 26.86 13.96 33 52500 116073 64330126
Dry mouth 26.69 13.96 8 52525 60410 64385789
Asthma 26.63 13.96 23 52510 95202 64350997
Hepatic failure 26.35 13.96 102 52431 55292 64390907
Intentional product misuse 26.27 13.96 13 52520 72282 64373917
Graft versus host disease in liver 25.98 13.96 16 52517 1525 64444674
Pulmonary mass 25.71 13.96 59 52474 23957 64422242
Splenic candidiasis 25.63 13.96 7 52526 75 64446124
Respiratory tract infection fungal 25.48 13.96 14 52519 1078 64445121
Venoocclusive disease 25.29 13.96 23 52510 3962 64442237
Skin mass 25.16 13.96 30 52503 7076 64439123
Colour blindness 24.79 13.96 10 52523 381 64445818
Transplant rejection 24.74 13.96 48 52485 17353 64428846
Wrong technique in product usage process 24.66 13.96 11 52522 64963 64381236
Dermatitis bullous 24.62 13.96 39 52494 12015 64434184
Insomnia 24.48 13.96 81 52452 197755 64248444
Ocular surface squamous neoplasia 24.46 13.96 4 52529 0 64446199
Urinary bladder rupture 24.40 13.96 7 52526 91 64446108
Potentiating drug interaction 24.33 13.96 31 52502 7821 64438378
Gallbladder empyema 24.33 13.96 7 52526 92 64446107
Feeling hot 24.28 13.96 4 52529 45659 64400540
Mixed liver injury 24.28 13.96 26 52507 5455 64440744
Retinal haemorrhage 24.19 13.96 30 52503 7368 64438831
Differentiation syndrome 24.09 13.96 17 52516 2037 64444162
Mycotic endophthalmitis 23.92 13.96 7 52526 98 64446101
Citrobacter infection 23.77 13.96 12 52521 777 64445422
Tongue necrosis 23.76 13.96 6 52527 46 64446153
Central nervous system lesion 23.74 13.96 38 52495 11811 64434388
Neuroendocrine carcinoma of the skin 23.73 13.96 13 52520 995 64445204
Acinetobacter infection 23.73 13.96 18 52515 2411 64443788
Acute kidney injury 23.47 13.96 504 52029 448736 63997463
Bacteraemia 23.37 13.96 61 52472 26850 64419349
Necrosis 23.36 13.96 31 52502 8140 64438059
Escherichia sepsis 23.34 13.96 29 52504 7136 64439063
Depressed mood 23.18 13.96 3 52530 41009 64405190
Pneumonia pseudomonal 23.04 13.96 24 52509 4879 64441320
Pain in jaw 22.99 13.96 3 52530 40752 64405447
Primary myelofibrosis 22.94 13.96 7 52526 114 64446085
Blood pressure systolic increased 22.87 13.96 6 52527 49447 64396752
Lower respiratory tract infection 22.84 13.96 26 52507 94588 64351611
Escherichia bacteraemia 22.83 13.96 25 52508 5378 64440821
Eye pain 22.82 13.96 67 52466 31558 64414641
Pulmonary cavitation 22.58 13.96 14 52519 1351 64444848
Feeling abnormal 22.40 13.96 47 52486 133555 64312644
Chronic graft versus host disease in skin 22.33 13.96 14 52519 1377 64444822
Infection reactivation 21.97 13.96 16 52517 2014 64444185
Strongyloidiasis 21.93 13.96 19 52514 3071 64443128
Mucosal ulceration 21.91 13.96 15 52518 1712 64444487
Stem cell transplant 21.91 13.96 20 52513 3461 64442738
Blood beta-D-glucan increased 21.90 13.96 10 52523 518 64445681
Retinal ischaemia 21.84 13.96 11 52522 709 64445490
Dyspnoea exertional 21.62 13.96 17 52516 73713 64372486
Coagulopathy 21.50 13.96 66 52467 31854 64414345
Aspartate aminotransferase increased 21.46 13.96 169 52364 119619 64326580
Blood cholesterol increased 21.45 13.96 7 52526 50059 64396140
Granulomatous liver disease 21.40 13.96 13 52520 1209 64444990
Anaphylactic reaction 21.20 13.96 15 52518 68649 64377550
Procalcitonin increased 21.17 13.96 17 52516 2474 64443725
Ileus paralytic 21.15 13.96 30 52503 8385 64437814
Upper respiratory tract infection 21.06 13.96 17 52516 72768 64373431
Epstein-Barr virus infection 20.96 13.96 37 52496 12451 64433748
Organising pneumonia 20.89 13.96 31 52502 9024 64437175
Disseminated cryptococcosis 20.81 13.96 14 52519 1553 64444646
Pleural effusion 20.75 13.96 175 52358 126384 64319815
Drug clearance decreased 20.42 13.96 17 52516 2602 64443597
Necrotising retinitis 20.42 13.96 12 52521 1051 64445148
Toxic encephalopathy 20.39 13.96 32 52501 9783 64436416
Agranulocytosis 20.36 13.96 73 52460 38156 64408043
Oxygen saturation decreased 20.33 13.96 35 52498 107141 64339058
Hypoxia 20.22 13.96 132 52401 88017 64358182
Pericarditis 20.18 13.96 13 52520 62503 64383696
Hypertransaminasaemia 20.12 13.96 27 52506 7164 64439035
Fungal sepsis 20.09 13.96 14 52519 1644 64444555
Keratitis fungal 20.02 13.96 7 52526 178 64446021
Lung consolidation 20.01 13.96 28 52505 7730 64438469
Adenovirus infection 19.94 13.96 27 52506 7228 64438971
Coccidioidomycosis 19.89 13.96 12 52521 1102 64445097
Mental status changes 19.52 13.96 100 52433 61062 64385137
Tracheobronchitis 19.47 13.96 14 52519 1728 64444471
Organ failure 19.29 13.96 19 52514 3614 64442585
Transient ischaemic attack 19.25 13.96 6 52527 44176 64402023
Flatulence 19.25 13.96 3 52530 35663 64410536
Renal disorder 19.23 13.96 68 52465 35297 64410902
Antithrombin III deficiency 19.05 13.96 6 52527 109 64446090
Human herpesvirus 6 infection 18.75 13.96 21 52512 4633 64441566
Rhinovirus infection 18.60 13.96 24 52509 6132 64440067
Infective pulmonary exacerbation of cystic fibrosis 18.58 13.96 34 52499 11762 64434437
Nasal congestion 18.46 13.96 13 52520 59645 64386554
Solar dermatitis 18.39 13.96 7 52526 228 64445971
Disease recurrence 18.36 13.96 62 52471 31448 64414751
Periostosis 18.24 13.96 4 52529 15 64446184
Oral papilloma 18.24 13.96 4 52529 15 64446184
Pneumonia cytomegaloviral 18.20 13.96 20 52513 4319 64441880
Obliterative bronchiolitis 18.13 13.96 16 52517 2649 64443550
Candida test positive 17.76 13.96 11 52522 1059 64445140
Lung abscess 17.74 13.96 18 52515 3548 64442651
Chronic obstructive pulmonary disease 17.72 13.96 19 52514 71029 64375170
Mucosal inflammation 17.71 13.96 99 52434 62485 64383714
Dehydration 17.56 13.96 104 52429 216659 64229540
Haemodynamic instability 17.50 13.96 38 52495 14874 64431325
Brain herniation 17.48 13.96 24 52509 6509 64439690
Gastrointestinal wall thinning 17.47 13.96 4 52529 19 64446180
Sinusitis fungal 17.46 13.96 13 52520 1693 64444506
Tonsillitis bacterial 17.45 13.96 6 52527 145 64446054
Cerebral haemorrhage 17.34 13.96 85 52448 51005 64395194
Peptic ulcer haemorrhage 17.28 13.96 10 52523 851 64445348
Diverticulitis 17.27 13.96 5 52528 38613 64407586
Mental disorder due to a general medical condition 17.25 13.96 7 52526 271 64445928
Septal panniculitis 17.22 13.96 5 52528 68 64446131
Cystitis viral 17.19 13.96 9 52524 629 64445570
Fibromyalgia 17.17 13.96 4 52529 35727 64410472
Memory impairment 17.17 13.96 27 52506 85655 64360544
Pseudallescheria infection 17.14 13.96 4 52529 21 64446178
Brain oedema 17.12 13.96 48 52485 22027 64424172
Acute myocardial infarction 17.00 13.96 19 52514 69699 64376500
Musculoskeletal pain 16.88 13.96 25 52508 81269 64364930
Hospitalisation 16.74 13.96 22 52511 75185 64371014
Angina pectoris 16.54 13.96 8 52525 45073 64401126
Rash maculo-papular 16.51 13.96 79 52454 46947 64399252
Gait disturbance 16.51 13.96 78 52455 172077 64274122
Staphylococcal bacteraemia 16.51 13.96 30 52503 10325 64435874
Acanthamoeba infection 16.45 13.96 8 52525 478 64445721
Hepatic candidiasis 16.41 13.96 5 52528 81 64446118
Hallucination, auditory 16.38 13.96 40 52493 16899 64429300
Suicidal ideation 16.37 13.96 18 52515 66524 64379675
Chronic pulmonary histoplasmosis 16.26 13.96 3 52530 3 64446196
Exserohilum infection 16.26 13.96 3 52530 3 64446196
Tuberculosis gastrointestinal 16.17 13.96 8 52525 496 64445703
Osteitis deformans 16.13 13.96 6 52527 183 64446016
Adverse event 16.10 13.96 6 52527 39483 64406716
Corneal bleeding 16.04 13.96 4 52529 29 64446170
Type 2 diabetes mellitus 15.97 13.96 4 52529 34016 64412183
Complications of transplant surgery 15.95 13.96 9 52524 730 64445469
Bone marrow transplant 15.91 13.96 11 52522 1276 64444923
Dysphonia 15.88 13.96 9 52524 46373 64399826
Cerebral artery embolism 15.85 13.96 12 52521 1602 64444597
Burns first degree 15.80 13.96 4 52529 31 64446168
Granulomatous dermatitis 15.77 13.96 7 52526 339 64445860
Heart rate decreased 15.76 13.96 13 52520 55054 64391145
Pallor 15.63 13.96 6 52527 38775 64407424
Wheezing 15.57 13.96 26 52507 80553 64365646
Loss of consciousness 15.57 13.96 65 52468 148300 64297899
Aspartate aminotransferase 15.46 13.96 6 52527 206 64445993
Cytomegalovirus test positive 15.45 13.96 20 52513 5124 64441075
Alanine aminotransferase increased 15.34 13.96 177 52356 138854 64307345
Drug intolerance 15.33 13.96 90 52443 187902 64258297
Chronic granulomatous disease 15.27 13.96 4 52529 36 64446163
Chills 15.12 13.96 59 52474 137205 64308994
Fibrinous bronchitis 15.08 13.96 4 52529 38 64446161
Throat irritation 15.06 13.96 4 52529 32707 64413492
Apraxia 15.05 13.96 14 52519 2481 64443718
Pythium insidiosum infection 15.05 13.96 3 52530 6 64446193
Penicillium infection 15.04 13.96 6 52527 222 64445977
Diabetic ketoacidosis 15.04 13.96 3 52530 29842 64416357
Respiratory distress 14.95 13.96 83 52450 52248 64393951
Ephelides 14.94 13.96 5 52528 111 64446088
Sleep disorder 14.86 13.96 16 52517 59693 64386506
Swollen tongue 14.78 13.96 5 52528 34949 64411250
Oliguria 14.72 13.96 35 52498 14541 64431658
Encephalitis 14.71 13.96 32 52501 12539 64433660
Fungal abscess central nervous system 14.69 13.96 5 52528 117 64446082
Neurological decompensation 14.52 13.96 18 52515 4418 64441781
C-reactive protein abnormal 14.47 13.96 3 52530 29044 64417155
Hepatomegaly 14.38 13.96 38 52495 16844 64429355
Gastric perforation 14.37 13.96 16 52517 3507 64442692
Incorrect dose administered 14.34 13.96 17 52516 60748 64385451
Somnolence 14.31 13.96 102 52431 203543 64242656
Respirovirus test positive 14.27 13.96 5 52528 128 64446071
Pseudoaldosteronism 14.16 13.96 5 52528 131 64446068

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
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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
200MG VFEND PF PRISM CV N021266 May 24, 2002 RX TABLET ORAL Jan. 29, 2022 NEW PATIENT POPULATION
50MG VFEND PF PRISM CV N021266 May 24, 2002 RX TABLET ORAL Jan. 29, 2022 NEW PATIENT POPULATION
200MG/VIAL VFEND PF PRISM CV N021267 May 24, 2002 RX INJECTABLE INTRAVENOUS Jan. 29, 2022 NEW PATIENT POPULATION
200MG/5ML VFEND PF PRISM CV N021630 Dec. 19, 2003 RX FOR SUSPENSION ORAL Jan. 29, 2022 NEW PATIENT POPULATION

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 34 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3160 POWDER, FOR SUSPENSION 40 mg ORAL NDA 34 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3170 TABLET, FILM COATED 50 mg ORAL NDA 34 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3170 TABLET, FILM COATED 50 mg ORAL NDA 34 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3180 TABLET, FILM COATED 200 mg ORAL NDA 34 sections
VFEND HUMAN PRESCRIPTION DRUG LABEL 1 0049-3180 TABLET, FILM COATED 200 mg ORAL NDA 34 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
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 0781-3416 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 10 mg INTRAVENOUS ANDA 30 sections
voriconazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-5667 TABLET, FILM COATED 50 mg ORAL ANDA 30 sections
voriconazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-5668 TABLET, FILM COATED 200 mg ORAL ANDA 30 sections
voriconazole HUMAN PRESCRIPTION DRUG LABEL 1 0904-6471 TABLET, FILM COATED 200 mg ORAL ANDA 30 sections
voriconazole HUMAN PRESCRIPTION DRUG LABEL 1 0904-6596 TABLET 50 mg ORAL ANDA 28 sections
Voriconazole HUMAN PRESCRIPTION DRUG LABEL 1 0904-7024 TABLET 200 mg ORAL ANDA 27 sections
Voriconazole Human Prescription Drug Label 1 16714-198 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Voriconazole Human Prescription Drug Label 1 16714-198 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Voriconazole Human Prescription Drug Label 1 16714-199 TABLET, FILM COATED 200 mg ORAL ANDA 28 sections
Voriconazole Human Prescription Drug Label 1 16714-199 TABLET, FILM COATED 200 mg ORAL ANDA 28 sections
Voriconazole Human Prescription Drug Label 1 27241-062 TABLET 50 mg ORAL ANDA 27 sections
Voriconazole Human Prescription Drug Label 1 27241-063 TABLET 200 mg ORAL ANDA 27 sections