voriconazole Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| systemic antifungal agents, miconazole derivatives | 2846 | 137234-62-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A triazole antifungal agent that specifically inhibits STEROL 14-ALPHA-DEMETHYLASE and CYTOCHROME P-450 CYP3A.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.40 | g | O |
| 0.40 | g | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 24, 2002 | FDA | PF PRISM CV |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Bronchopulmonary aspergillosis | 659.94 | 16.44 | 212 | 21604 | 8453 | 53318797 |
| Aspergillus infection | 581.47 | 16.44 | 186 | 21630 | 7310 | 53319940 |
| Drug interaction | 399.86 | 16.44 | 469 | 21347 | 218860 | 53108390 |
| Mucormycosis | 333.06 | 16.44 | 95 | 21721 | 2505 | 53324745 |
| Periostitis | 298.82 | 16.44 | 58 | 21758 | 245 | 53327005 |
| Multiple organ dysfunction syndrome | 242.94 | 16.44 | 193 | 21623 | 55484 | 53271766 |
| Drug level increased | 205.79 | 16.44 | 119 | 21697 | 20302 | 53306948 |
| Drug resistance | 205.63 | 16.44 | 118 | 21698 | 19844 | 53307406 |
| Photosensitivity reaction | 201.80 | 16.44 | 103 | 21713 | 13725 | 53313525 |
| Pneumonia fungal | 180.73 | 16.44 | 69 | 21747 | 4587 | 53322663 |
| Febrile neutropenia | 179.95 | 16.44 | 218 | 21598 | 104718 | 53222532 |
| Septic shock | 176.89 | 16.44 | 169 | 21647 | 62060 | 53265190 |
| Drug level below therapeutic | 161.89 | 16.44 | 60 | 21756 | 3673 | 53323577 |
| Fungal infection | 143.16 | 16.44 | 113 | 21703 | 32133 | 53295117 |
| Cerebral aspergillosis | 141.03 | 16.44 | 33 | 21783 | 383 | 53326867 |
| Cholestasis | 134.85 | 16.44 | 104 | 21712 | 28591 | 53298659 |
| Drug level decreased | 133.56 | 16.44 | 62 | 21754 | 6712 | 53320538 |
| Respiratory failure | 130.37 | 16.44 | 182 | 21634 | 100330 | 53226920 |
| Acute myeloid leukaemia | 130.22 | 16.44 | 83 | 21733 | 16849 | 53310401 |
| Graft versus host disease | 124.51 | 16.44 | 60 | 21756 | 7062 | 53320188 |
| Fatigue | 124.04 | 16.44 | 73 | 21743 | 730433 | 52596817 |
| Actinic keratosis | 108.39 | 16.44 | 40 | 21776 | 2418 | 53324832 |
| Dilatation intrahepatic duct acquired | 107.35 | 16.44 | 30 | 21786 | 732 | 53326518 |
| Scedosporium infection | 103.71 | 16.44 | 27 | 21789 | 499 | 53326751 |
| Pain | 102.30 | 16.44 | 57 | 21759 | 588341 | 52738909 |
| Pathogen resistance | 99.00 | 16.44 | 50 | 21766 | 6510 | 53320740 |
| Hallucination, visual | 98.98 | 16.44 | 73 | 21743 | 18759 | 53308491 |
| Systemic mycosis | 92.50 | 16.44 | 29 | 21787 | 1063 | 53326187 |
| Fusarium infection | 90.09 | 16.44 | 25 | 21791 | 594 | 53326656 |
| Drug ineffective | 89.37 | 16.44 | 604 | 21212 | 816641 | 52510609 |
| Hallucination | 87.54 | 16.44 | 109 | 21707 | 53729 | 53273521 |
| Pancytopenia | 85.71 | 16.44 | 142 | 21674 | 90786 | 53236464 |
| Visual impairment | 81.32 | 16.44 | 123 | 21693 | 72789 | 53254461 |
| Squamous cell carcinoma of skin | 80.97 | 16.44 | 41 | 21775 | 5366 | 53321884 |
| Photodermatosis | 80.26 | 16.44 | 21 | 21795 | 396 | 53326854 |
| Venoocclusive liver disease | 78.35 | 16.44 | 38 | 21778 | 4534 | 53322716 |
| Hepatotoxicity | 75.90 | 16.44 | 74 | 21742 | 27806 | 53299444 |
| Fluoride increased | 71.91 | 16.44 | 12 | 21804 | 15 | 53327235 |
| Sepsis | 71.79 | 16.44 | 174 | 21642 | 146255 | 53180995 |
| Fungaemia | 69.46 | 16.44 | 28 | 21788 | 2149 | 53325101 |
| Blood bilirubin increased | 69.03 | 16.44 | 79 | 21737 | 35651 | 53291599 |
| Geotrichum infection | 68.40 | 16.44 | 19 | 21797 | 453 | 53326797 |
| Keratitis fungal | 63.05 | 16.44 | 14 | 21802 | 126 | 53327124 |
| Pyrexia | 61.71 | 16.44 | 326 | 21490 | 402867 | 52924383 |
| Acute graft versus host disease in intestine | 60.95 | 16.44 | 24 | 21792 | 1732 | 53325518 |
| Torsade de pointes | 60.77 | 16.44 | 47 | 21769 | 12958 | 53314292 |
| Hypertrophic osteoarthropathy | 60.64 | 16.44 | 11 | 21805 | 29 | 53327221 |
| Joint swelling | 59.17 | 16.44 | 12 | 21804 | 234626 | 53092624 |
| Pneumonia | 58.77 | 16.44 | 324 | 21492 | 406845 | 52920405 |
| Graft versus host disease in gastrointestinal tract | 57.94 | 16.44 | 27 | 21789 | 2947 | 53324303 |
| Fall | 54.89 | 16.44 | 40 | 21776 | 358400 | 52968850 |
| Product use in unapproved indication | 52.42 | 16.44 | 131 | 21685 | 112158 | 53215092 |
| Blood alkaline phosphatase increased | 52.21 | 16.44 | 74 | 21742 | 41288 | 53285962 |
| Neurotoxicity | 51.94 | 16.44 | 46 | 21770 | 15303 | 53311947 |
| Acute graft versus host disease | 51.17 | 16.44 | 28 | 21788 | 4289 | 53322961 |
| Immunosuppressant drug level increased | 51.15 | 16.44 | 26 | 21790 | 3429 | 53323821 |
| Gamma-glutamyltransferase increased | 49.88 | 16.44 | 65 | 21751 | 33490 | 53293760 |
| Cytomegalovirus infection | 49.72 | 16.44 | 50 | 21766 | 19489 | 53307761 |
| Acute graft versus host disease in skin | 49.44 | 16.44 | 25 | 21791 | 3261 | 53323989 |
| Acute respiratory distress syndrome | 49.19 | 16.44 | 54 | 21762 | 23278 | 53303972 |
| Acute graft versus host disease in liver | 49.08 | 16.44 | 16 | 21800 | 666 | 53326584 |
| Thrombotic microangiopathy | 48.62 | 16.44 | 36 | 21780 | 9301 | 53317949 |
| Squamous cell carcinoma | 48.39 | 16.44 | 34 | 21782 | 8098 | 53319152 |
| Fungal test positive | 48.12 | 16.44 | 15 | 21801 | 539 | 53326711 |
| Hepatic function abnormal | 48.03 | 16.44 | 67 | 21749 | 36832 | 53290418 |
| Cytomegalovirus viraemia | 47.38 | 16.44 | 28 | 21788 | 4963 | 53322287 |
| Arthralgia | 46.98 | 16.44 | 67 | 21749 | 439716 | 52887534 |
| Acute myeloid leukaemia recurrent | 46.69 | 16.44 | 19 | 21797 | 1494 | 53325756 |
| Encephalopathy | 46.67 | 16.44 | 66 | 21750 | 36742 | 53290508 |
| Electrocardiogram QT prolonged | 46.43 | 16.44 | 83 | 21733 | 56320 | 53270930 |
| Arthropathy | 46.04 | 16.44 | 3 | 21813 | 141450 | 53185800 |
| Fluorosis | 45.64 | 16.44 | 8 | 21808 | 16 | 53327234 |
| Headache | 44.47 | 16.44 | 96 | 21720 | 536725 | 52790525 |
| Drug hypersensitivity | 42.70 | 16.44 | 28 | 21788 | 265214 | 53062036 |
| Graft versus host disease in skin | 42.32 | 16.44 | 21 | 21795 | 2632 | 53324618 |
| Pruritus | 42.15 | 16.44 | 35 | 21781 | 293797 | 53033453 |
| Swelling | 41.93 | 16.44 | 13 | 21803 | 191092 | 53136158 |
| Abdominal discomfort | 40.34 | 16.44 | 20 | 21796 | 221042 | 53106208 |
| Phaeohyphomycosis | 39.89 | 16.44 | 11 | 21805 | 255 | 53326995 |
| Strongyloidiasis | 39.52 | 16.44 | 15 | 21801 | 980 | 53326270 |
| Lentigo | 39.18 | 16.44 | 11 | 21805 | 273 | 53326977 |
| Maternal exposure during pregnancy | 39.13 | 16.44 | 8 | 21808 | 155631 | 53171619 |
| Musculoskeletal stiffness | 39.03 | 16.44 | 3 | 21813 | 123365 | 53203885 |
| Product dose omission issue | 38.65 | 16.44 | 15 | 21801 | 191605 | 53135645 |
| Chronic graft versus host disease | 38.43 | 16.44 | 21 | 21795 | 3207 | 53324043 |
| Nasopharyngitis | 37.25 | 16.44 | 16 | 21800 | 192279 | 53134971 |
| Therapeutic product effect decreased | 37.22 | 16.44 | 4 | 21812 | 125651 | 53201599 |
| Neutropenia | 37.18 | 16.44 | 146 | 21670 | 159039 | 53168211 |
| Mixed liver injury | 37.17 | 16.44 | 22 | 21794 | 3911 | 53323339 |
| Peripheral swelling | 37.08 | 16.44 | 19 | 21797 | 206089 | 53121161 |
| Corneal perforation | 36.75 | 16.44 | 12 | 21804 | 502 | 53326748 |
| Systemic candida | 36.71 | 16.44 | 20 | 21796 | 3037 | 53324213 |
| Liver function test abnormal | 36.10 | 16.44 | 68 | 21748 | 48003 | 53279247 |
| Aspergillus test positive | 36.07 | 16.44 | 11 | 21805 | 367 | 53326883 |
| Brain abscess | 35.89 | 16.44 | 17 | 21799 | 1924 | 53325326 |
| Hepatic cytolysis | 35.76 | 16.44 | 28 | 21788 | 7857 | 53319393 |
| Pneumonia bacterial | 35.59 | 16.44 | 28 | 21788 | 7912 | 53319338 |
| Halo vision | 35.41 | 16.44 | 11 | 21805 | 391 | 53326859 |
| Posterior reversible encephalopathy syndrome | 35.10 | 16.44 | 38 | 21778 | 16122 | 53311128 |
| Lung transplant rejection | 35.03 | 16.44 | 13 | 21803 | 798 | 53326452 |
| Dizziness | 34.72 | 16.44 | 62 | 21754 | 372197 | 52955053 |
| Trichosporon infection | 34.64 | 16.44 | 10 | 21806 | 275 | 53326975 |
| Exposure during pregnancy | 34.49 | 16.44 | 5 | 21811 | 124855 | 53202395 |
| Hypertransaminasaemia | 34.17 | 16.44 | 21 | 21795 | 3995 | 53323255 |
| Endophthalmitis | 33.73 | 16.44 | 20 | 21796 | 3567 | 53323683 |
| Solar lentigo | 33.72 | 16.44 | 12 | 21804 | 653 | 53326597 |
| Renal impairment | 33.54 | 16.44 | 92 | 21724 | 83226 | 53244024 |
| Rash | 33.52 | 16.44 | 84 | 21732 | 446107 | 52881143 |
| Hypersensitivity | 32.87 | 16.44 | 23 | 21793 | 210642 | 53116608 |
| Pain in extremity | 32.86 | 16.44 | 41 | 21775 | 285009 | 53042241 |
| Adenovirus infection | 32.81 | 16.44 | 19 | 21797 | 3243 | 53324007 |
| Pseudomonas infection | 32.81 | 16.44 | 30 | 21786 | 10398 | 53316852 |
| Platelet count decreased | 32.77 | 16.44 | 108 | 21708 | 107991 | 53219259 |
| Hepatocellular injury | 32.57 | 16.44 | 50 | 21766 | 29936 | 53297314 |
| Alopecia | 32.34 | 16.44 | 29 | 21787 | 234554 | 53092696 |
| Pulmonary alveolar haemorrhage | 32.19 | 16.44 | 21 | 21795 | 4429 | 53322821 |
| Immunosuppressant drug level decreased | 32.17 | 16.44 | 13 | 21803 | 1004 | 53326246 |
| Candida infection | 31.56 | 16.44 | 45 | 21771 | 25228 | 53302022 |
| Dyschromatopsia | 31.30 | 16.44 | 10 | 21806 | 390 | 53326860 |
| Toxic encephalopathy | 31.19 | 16.44 | 23 | 21793 | 5904 | 53321346 |
| Granulomatous liver disease | 31.13 | 16.44 | 12 | 21804 | 818 | 53326432 |
| Leukaemia recurrent | 31.08 | 16.44 | 14 | 21802 | 1413 | 53325837 |
| Aspergillus test | 31.08 | 16.44 | 5 | 21811 | 4 | 53327246 |
| Altered state of consciousness | 30.69 | 16.44 | 44 | 21772 | 24792 | 53302458 |
| Fungal endocarditis | 30.40 | 16.44 | 9 | 21807 | 271 | 53326979 |
| Urticaria | 30.23 | 16.44 | 9 | 21807 | 135876 | 53191374 |
| Infective aneurysm | 30.16 | 16.44 | 10 | 21806 | 439 | 53326811 |
| Bone marrow failure | 29.64 | 16.44 | 48 | 21768 | 30067 | 53297183 |
| Drug-induced liver injury | 29.33 | 16.44 | 47 | 21769 | 29186 | 53298064 |
| Aspartate aminotransferase increased | 29.18 | 16.44 | 88 | 21728 | 83941 | 53243309 |
| Lower respiratory tract infection fungal | 29.10 | 16.44 | 9 | 21807 | 315 | 53326935 |
| Chromatopsia | 29.09 | 16.44 | 10 | 21806 | 491 | 53326759 |
| Aspergilloma | 28.83 | 16.44 | 8 | 21808 | 190 | 53327060 |
| Acute kidney injury | 28.83 | 16.44 | 190 | 21626 | 253678 | 53073572 |
| Alanine aminotransferase increased | 28.82 | 16.44 | 95 | 21721 | 95000 | 53232250 |
| Graft versus host disease in liver | 28.72 | 16.44 | 10 | 21806 | 510 | 53326740 |
| Enterococcal infection | 28.18 | 16.44 | 24 | 21792 | 7574 | 53319676 |
| Photophobia | 28.15 | 16.44 | 34 | 21782 | 16224 | 53311026 |
| Delirium | 27.93 | 16.44 | 56 | 21760 | 41373 | 53285877 |
| Acute lymphocytic leukaemia recurrent | 27.81 | 16.44 | 15 | 21801 | 2233 | 53325017 |
| Myoclonus | 27.35 | 16.44 | 33 | 21783 | 15731 | 53311519 |
| Cerebral fungal infection | 27.12 | 16.44 | 6 | 21810 | 53 | 53327197 |
| Fungal skin infection | 26.93 | 16.44 | 18 | 21798 | 3954 | 53323296 |
| Cytokine release syndrome | 26.78 | 16.44 | 24 | 21792 | 8105 | 53319145 |
| Dermatitis bullous | 26.69 | 16.44 | 24 | 21792 | 8139 | 53319111 |
| Toxic epidermal necrolysis | 26.61 | 16.44 | 40 | 21776 | 23510 | 53303740 |
| Coccidioidomycosis | 26.57 | 16.44 | 11 | 21805 | 904 | 53326346 |
| Venoocclusive disease | 26.23 | 16.44 | 14 | 21802 | 2041 | 53325209 |
| Primary myelofibrosis | 26.02 | 16.44 | 6 | 21810 | 65 | 53327185 |
| Diarrhoea | 26.00 | 16.44 | 150 | 21666 | 625396 | 52701854 |
| Leukaemia | 25.62 | 16.44 | 17 | 21799 | 3689 | 53323561 |
| Colour blindness | 25.39 | 16.44 | 8 | 21808 | 298 | 53326952 |
| Haemoptysis | 25.33 | 16.44 | 43 | 21773 | 27996 | 53299254 |
| Urinary tract infection | 25.11 | 16.44 | 37 | 21779 | 239866 | 53087384 |
| Malaise | 24.80 | 16.44 | 70 | 21746 | 357547 | 52969703 |
| Staphylococcal infection | 24.67 | 16.44 | 51 | 21765 | 38497 | 53288753 |
| Pneumothorax | 24.55 | 16.44 | 31 | 21785 | 15476 | 53311774 |
| Wound | 24.52 | 16.44 | 4 | 21812 | 91553 | 53235697 |
| Disseminated intravascular coagulation | 24.46 | 16.44 | 35 | 21781 | 19684 | 53307566 |
| Death | 24.45 | 16.44 | 238 | 21578 | 356994 | 52970256 |
| Obliterative bronchiolitis | 24.09 | 16.44 | 13 | 21803 | 1937 | 53325313 |
| Anxiety | 24.03 | 16.44 | 27 | 21789 | 196677 | 53130573 |
| Weight increased | 24 | 16.44 | 29 | 21787 | 204538 | 53122712 |
| Infective pulmonary exacerbation of cystic fibrosis | 23.82 | 16.44 | 26 | 21790 | 11130 | 53316120 |
| Graft versus host disease in lung | 23.81 | 16.44 | 8 | 21808 | 366 | 53326884 |
| Nephropathy toxic | 23.78 | 16.44 | 23 | 21793 | 8549 | 53318701 |
| Nausea | 23.68 | 16.44 | 197 | 21619 | 755894 | 52571356 |
| Leukoencephalopathy | 23.61 | 16.44 | 17 | 21799 | 4207 | 53323043 |
| Respirovirus test positive | 23.51 | 16.44 | 5 | 21811 | 36 | 53327214 |
| Liver disorder | 23.25 | 16.44 | 51 | 21765 | 40104 | 53287146 |
| Bronchopulmonary aspergillosis allergic | 23.09 | 16.44 | 11 | 21805 | 1261 | 53325989 |
| Infusion related reaction | 23.05 | 16.44 | 18 | 21798 | 155939 | 53171311 |
| Sinusitis | 23.02 | 16.44 | 21 | 21795 | 168543 | 53158707 |
| Stenotrophomonas infection | 22.64 | 16.44 | 12 | 21804 | 1724 | 53325526 |
| Disease progression | 22.58 | 16.44 | 92 | 21724 | 101828 | 53225422 |
| Hyperlactacidaemia | 22.55 | 16.44 | 14 | 21802 | 2711 | 53324539 |
| Renal failure | 22.46 | 16.44 | 102 | 21714 | 118350 | 53208900 |
| Abdominal pain upper | 22.38 | 16.44 | 21 | 21795 | 166270 | 53160980 |
| Thrombocytopenia | 22.37 | 16.44 | 114 | 21702 | 138613 | 53188637 |
| Blood pressure increased | 22.35 | 16.44 | 15 | 21801 | 140464 | 53186786 |
| Bacterial sepsis | 22.27 | 16.44 | 16 | 21800 | 3946 | 53323304 |
| Chronic graft versus host disease in skin | 22.17 | 16.44 | 9 | 21807 | 703 | 53326547 |
| Infection reactivation | 22.15 | 16.44 | 10 | 21806 | 1014 | 53326236 |
| Pulmonary haemorrhage | 21.92 | 16.44 | 20 | 21796 | 6913 | 53320337 |
| Acute lymphocytic leukaemia | 21.91 | 16.44 | 14 | 21802 | 2851 | 53324399 |
| Skin candida | 21.76 | 16.44 | 10 | 21806 | 1057 | 53326193 |
| Pseudoaldosteronism | 21.61 | 16.44 | 5 | 21811 | 55 | 53327195 |
| Bacteraemia | 21.38 | 16.44 | 29 | 21787 | 15520 | 53311730 |
| Myocardial infarction | 21.35 | 16.44 | 7 | 21809 | 99347 | 53227903 |
| Pleural effusion | 21.27 | 16.44 | 82 | 21734 | 88497 | 53238753 |
| Tonsillitis bacterial | 21.22 | 16.44 | 6 | 21810 | 153 | 53327097 |
| Chronic papillomatous dermatitis | 21.21 | 16.44 | 5 | 21811 | 60 | 53327190 |
| Tracheobronchitis | 20.97 | 16.44 | 10 | 21806 | 1149 | 53326101 |
| Post transplant lymphoproliferative disorder | 20.86 | 16.44 | 16 | 21800 | 4355 | 53322895 |
| Scintillating scotoma | 20.82 | 16.44 | 6 | 21810 | 164 | 53327086 |
| Hepatic candidiasis | 20.78 | 16.44 | 4 | 21812 | 16 | 53327234 |
| Procalcitonin increased | 20.65 | 16.44 | 9 | 21807 | 840 | 53326410 |
| Palpitations | 20.64 | 16.44 | 8 | 21808 | 102340 | 53224910 |
| Aplastic anaemia | 20.63 | 16.44 | 21 | 21795 | 8300 | 53318950 |
| Asthenia | 20.48 | 16.44 | 72 | 21744 | 343518 | 52983732 |
| Drug ineffective for unapproved indication | 20.35 | 16.44 | 33 | 21783 | 20687 | 53306563 |
| Septal panniculitis | 20.12 | 16.44 | 5 | 21811 | 76 | 53327174 |
| Back pain | 20.07 | 16.44 | 41 | 21775 | 234206 | 53093044 |
| Off label use | 20.03 | 16.44 | 287 | 21529 | 471925 | 52855325 |
| Tuberculosis gastrointestinal | 20.01 | 16.44 | 7 | 21809 | 362 | 53326888 |
| Skin exfoliation | 19.95 | 16.44 | 45 | 21771 | 36038 | 53291212 |
| Encephalitis | 19.61 | 16.44 | 20 | 21796 | 7924 | 53319326 |
| Neutrophil count decreased | 19.53 | 16.44 | 54 | 21762 | 49044 | 53278206 |
| Cytomegalovirus enterocolitis | 19.42 | 16.44 | 8 | 21808 | 649 | 53326601 |
| Chest pain | 19.25 | 16.44 | 30 | 21786 | 190155 | 53137095 |
| Mucosal inflammation | 18.98 | 16.44 | 49 | 21767 | 42735 | 53284515 |
| Hypokalaemia | 18.96 | 16.44 | 84 | 21732 | 96433 | 53230817 |
| Disseminated cryptococcosis | 18.70 | 16.44 | 7 | 21809 | 440 | 53326810 |
| Dermatitis exfoliative | 18.52 | 16.44 | 17 | 21799 | 5919 | 53321331 |
| Migraine | 18.49 | 16.44 | 5 | 21811 | 80412 | 53246838 |
| Central nervous system fungal infection | 18.38 | 16.44 | 5 | 21811 | 110 | 53327140 |
| Necrosis | 18.34 | 16.44 | 16 | 21800 | 5215 | 53322035 |
| Agranulocytosis | 18.33 | 16.44 | 34 | 21782 | 23715 | 53303535 |
| Feeling abnormal | 18.30 | 16.44 | 17 | 21799 | 135284 | 53191966 |
| Cholecystitis acute | 18.02 | 16.44 | 19 | 21797 | 7824 | 53319426 |
| Disseminated trichosporonosis | 18.01 | 16.44 | 4 | 21812 | 36 | 53327214 |
| Hepatosplenic candidiasis | 17.98 | 16.44 | 6 | 21810 | 269 | 53326981 |
| Drug clearance decreased | 17.92 | 16.44 | 9 | 21807 | 1157 | 53326093 |
| Cystitis haemorrhagic | 17.87 | 16.44 | 14 | 21802 | 3930 | 53323320 |
| Osteomyelitis fungal | 17.87 | 16.44 | 3 | 21813 | 4 | 53327246 |
| Hallucination, auditory | 17.79 | 16.44 | 23 | 21793 | 11750 | 53315500 |
| Eye abscess | 17.77 | 16.44 | 5 | 21811 | 125 | 53327125 |
| Shock | 17.70 | 16.44 | 33 | 21783 | 23106 | 53304144 |
| Pulmonary mucormycosis | 17.66 | 16.44 | 5 | 21811 | 128 | 53327122 |
| Drug intolerance | 17.57 | 16.44 | 36 | 21780 | 205457 | 53121793 |
| Dyspepsia | 17.51 | 16.44 | 5 | 21811 | 77595 | 53249655 |
| Rash maculo-papular | 17.46 | 16.44 | 38 | 21778 | 29711 | 53297539 |
| Gastrooesophageal reflux disease | 17.45 | 16.44 | 6 | 21810 | 82657 | 53244593 |
| Laryngeal inflammation | 17.34 | 16.44 | 5 | 21811 | 137 | 53327113 |
| Arthritis | 17.31 | 16.44 | 7 | 21809 | 87291 | 53239959 |
| Bacterial infection | 17.31 | 16.44 | 28 | 21788 | 17519 | 53309731 |
| Cerebral haemorrhage | 17.25 | 16.44 | 38 | 21778 | 29958 | 53297292 |
| Flushing | 16.98 | 16.44 | 4 | 21812 | 70596 | 53256654 |
| Osteoarthritis | 16.94 | 16.44 | 4 | 21812 | 70482 | 53256768 |
| Disseminated aspergillosis | 16.89 | 16.44 | 4 | 21812 | 49 | 53327201 |
| Cytomegalovirus test positive | 16.83 | 16.44 | 12 | 21804 | 2923 | 53324327 |
| Impaired healing | 16.76 | 16.44 | 3 | 21813 | 64202 | 53263048 |
| Xanthopsia | 16.63 | 16.44 | 5 | 21811 | 159 | 53327091 |
| Stem cell transplant | 16.60 | 16.44 | 10 | 21806 | 1835 | 53325415 |
| Blood lactate dehydrogenase increased | 16.58 | 16.44 | 31 | 21785 | 21750 | 53305500 |
| Extraskeletal ossification | 16.54 | 16.44 | 4 | 21812 | 54 | 53327196 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Bronchopulmonary aspergillosis | 845.77 | 14.06 | 371 | 34304 | 13316 | 32465535 |
| Aspergillus infection | 797.95 | 14.06 | 339 | 34336 | 11235 | 32467616 |
| Photosensitivity reaction | 645.62 | 14.06 | 281 | 34394 | 9882 | 32468969 |
| Drug interaction | 475.08 | 14.06 | 839 | 33836 | 217346 | 32261505 |
| Drug level increased | 418.88 | 14.06 | 263 | 34412 | 19817 | 32459034 |
| Periostitis | 326.19 | 14.06 | 72 | 34603 | 197 | 32478654 |
| Mucormycosis | 319.23 | 14.06 | 144 | 34531 | 5510 | 32473341 |
| Actinic keratosis | 311.26 | 14.06 | 127 | 34548 | 3783 | 32475068 |
| Fungal infection | 303.57 | 14.06 | 194 | 34481 | 15061 | 32463790 |
| Cerebral aspergillosis | 303.45 | 14.06 | 96 | 34579 | 1332 | 32477519 |
| Drug ineffective | 300.05 | 14.06 | 991 | 33684 | 382486 | 32096365 |
| Drug resistance | 228.26 | 14.06 | 192 | 34483 | 22773 | 32456078 |
| Scedosporium infection | 218.71 | 14.06 | 67 | 34608 | 830 | 32478021 |
| Hallucination, visual | 209.87 | 14.06 | 162 | 34513 | 16997 | 32461854 |
| Squamous cell carcinoma of skin | 203.02 | 14.06 | 128 | 34547 | 9698 | 32469153 |
| Multiple organ dysfunction syndrome | 200.18 | 14.06 | 305 | 34370 | 69549 | 32409302 |
| Graft versus host disease | 170.52 | 14.06 | 119 | 34556 | 10687 | 32468164 |
| Hallucination | 155.27 | 14.06 | 233 | 34442 | 52386 | 32426465 |
| Photodermatosis | 154.80 | 14.06 | 45 | 34630 | 459 | 32478392 |
| Hepatotoxicity | 148.97 | 14.06 | 140 | 34535 | 19197 | 32459654 |
| Fatigue | 148.58 | 14.06 | 96 | 34579 | 350605 | 32128246 |
| Squamous cell carcinoma | 139.46 | 14.06 | 106 | 34569 | 10862 | 32467989 |
| Respiratory failure | 138.06 | 14.06 | 333 | 34342 | 106849 | 32372002 |
| Septic shock | 137.26 | 14.06 | 256 | 34419 | 68733 | 32410118 |
| Pneumonia fungal | 130.19 | 14.06 | 82 | 34593 | 6198 | 32472653 |
| Choroiditis | 127.99 | 14.06 | 47 | 34628 | 1045 | 32477806 |
| Condition aggravated | 127.56 | 14.06 | 410 | 34265 | 155251 | 32323600 |
| Endophthalmitis | 122.65 | 14.06 | 67 | 34608 | 3882 | 32474969 |
| Systemic mycosis | 118.86 | 14.06 | 48 | 34627 | 1390 | 32477461 |
| Pathogen resistance | 116.71 | 14.06 | 90 | 34585 | 9420 | 32469431 |
| Febrile neutropenia | 108.09 | 14.06 | 326 | 34349 | 119240 | 32359611 |
| Cholestasis | 96.29 | 14.06 | 131 | 34544 | 26902 | 32451949 |
| Visual impairment | 96.04 | 14.06 | 145 | 34530 | 32743 | 32446108 |
| Fluoride increased | 93.68 | 14.06 | 20 | 34655 | 44 | 32478807 |
| Solar lentigo | 91.01 | 14.06 | 29 | 34646 | 412 | 32478439 |
| Cheilitis | 90.55 | 14.06 | 46 | 34629 | 2295 | 32476556 |
| Drug level below therapeutic | 90.03 | 14.06 | 56 | 34619 | 4139 | 32474712 |
| Hepatic function abnormal | 88.61 | 14.06 | 166 | 34509 | 44674 | 32434177 |
| Completed suicide | 85.32 | 14.06 | 3 | 34672 | 92514 | 32386337 |
| Myocardial infarction | 82.13 | 14.06 | 17 | 34658 | 125659 | 32353192 |
| Dysplastic naevus | 80.48 | 14.06 | 26 | 34649 | 387 | 32478464 |
| Fall | 79.77 | 14.06 | 56 | 34619 | 196145 | 32282706 |
| Disseminated mucormycosis | 79.17 | 14.06 | 23 | 34652 | 234 | 32478617 |
| Fungaemia | 78.63 | 14.06 | 43 | 34632 | 2496 | 32476355 |
| Fusarium infection | 75.15 | 14.06 | 32 | 34643 | 1062 | 32477789 |
| Candida infection | 74.87 | 14.06 | 91 | 34584 | 16712 | 32462139 |
| Drug level decreased | 74.75 | 14.06 | 59 | 34616 | 6387 | 32472464 |
| Product dose omission issue | 73.27 | 14.06 | 11 | 34664 | 102564 | 32376287 |
| Acute myeloid leukaemia | 71.45 | 14.06 | 95 | 34580 | 19079 | 32459772 |
| Drug level above therapeutic | 70.95 | 14.06 | 44 | 34631 | 3234 | 32475617 |
| Drug abuse | 69.42 | 14.06 | 4 | 34671 | 80239 | 32398612 |
| Phaeohyphomycosis | 68.62 | 14.06 | 28 | 34647 | 833 | 32478018 |
| Immunosuppressant drug level increased | 68.22 | 14.06 | 51 | 34624 | 5094 | 32473757 |
| Pain | 65.68 | 14.06 | 62 | 34613 | 187494 | 32291357 |
| Mycotic endophthalmitis | 61.27 | 14.06 | 14 | 34661 | 47 | 32478804 |
| Aspergilloma | 60.17 | 14.06 | 20 | 34655 | 327 | 32478524 |
| Asthenia | 59.68 | 14.06 | 100 | 34575 | 235844 | 32243007 |
| Treatment failure | 59.49 | 14.06 | 130 | 34545 | 39033 | 32439818 |
| Dyspnoea | 59.13 | 14.06 | 194 | 34481 | 361851 | 32117000 |
| Dyschromatopsia | 58.70 | 14.06 | 20 | 34655 | 354 | 32478497 |
| Graft versus host disease in gastrointestinal tract | 56.86 | 14.06 | 39 | 34636 | 3402 | 32475449 |
| Fluorosis | 55.52 | 14.06 | 13 | 34662 | 50 | 32478801 |
| Visual acuity reduced | 54.51 | 14.06 | 77 | 34598 | 16368 | 32462483 |
| Depression | 54.13 | 14.06 | 18 | 34657 | 97042 | 32381809 |
| Trichosporon infection | 53.77 | 14.06 | 23 | 34652 | 772 | 32478079 |
| Nephropathy toxic | 53.71 | 14.06 | 65 | 34610 | 11881 | 32466970 |
| Intraocular pressure increased | 53.49 | 14.06 | 46 | 34629 | 5612 | 32473239 |
| Uveitis | 52.80 | 14.06 | 48 | 34627 | 6302 | 32472549 |
| Pseudomonas infection | 51.61 | 14.06 | 64 | 34611 | 11992 | 32466859 |
| Diarrhoea | 51.29 | 14.06 | 208 | 34467 | 364594 | 32114257 |
| Neurological symptom | 50.36 | 14.06 | 37 | 34638 | 3598 | 32475253 |
| Inappropriate antidiuretic hormone secretion | 49.99 | 14.06 | 63 | 34612 | 12000 | 32466851 |
| Acute myeloid leukaemia recurrent | 49.79 | 14.06 | 29 | 34646 | 1901 | 32476950 |
| Nausea | 49.57 | 14.06 | 176 | 34499 | 320673 | 32158178 |
| Brain abscess | 47.88 | 14.06 | 33 | 34642 | 2901 | 32475950 |
| Product use in unapproved indication | 47.08 | 14.06 | 201 | 34474 | 87003 | 32391848 |
| Pruritus | 46.85 | 14.06 | 41 | 34634 | 128661 | 32350190 |
| Anxiety | 46.65 | 14.06 | 22 | 34653 | 95983 | 32382868 |
| Dizziness | 46.64 | 14.06 | 96 | 34579 | 209522 | 32269329 |
| Hepatocellular injury | 46.62 | 14.06 | 91 | 34584 | 25227 | 32453624 |
| Constipation | 46.32 | 14.06 | 40 | 34635 | 126333 | 32352518 |
| Mediastinitis | 46.02 | 14.06 | 20 | 34655 | 698 | 32478153 |
| Disseminated intravascular coagulation | 46.00 | 14.06 | 86 | 34589 | 23090 | 32455761 |
| Geotrichum infection | 45.03 | 14.06 | 18 | 34657 | 507 | 32478344 |
| Liver disorder | 44.61 | 14.06 | 102 | 34573 | 31552 | 32447299 |
| Central nervous system fungal infection | 44.46 | 14.06 | 16 | 34659 | 335 | 32478516 |
| Chest pain | 43.45 | 14.06 | 41 | 34634 | 124096 | 32354755 |
| Neurotoxicity | 43.34 | 14.06 | 66 | 34609 | 15004 | 32463847 |
| Leukaemia recurrent | 43.27 | 14.06 | 25 | 34650 | 1614 | 32477237 |
| Drug ineffective for unapproved indication | 42.97 | 14.06 | 63 | 34612 | 13849 | 32465002 |
| Pain in extremity | 41.93 | 14.06 | 39 | 34636 | 118862 | 32359989 |
| Product compounding quality issue | 41.79 | 14.06 | 9 | 34666 | 21 | 32478830 |
| Blood pressure increased | 40.41 | 14.06 | 17 | 34658 | 79337 | 32399514 |
| Renal ischaemia | 39.73 | 14.06 | 17 | 34658 | 571 | 32478280 |
| Acute graft versus host disease | 39.51 | 14.06 | 41 | 34634 | 6329 | 32472522 |
| Eye pain | 39.08 | 14.06 | 58 | 34617 | 12890 | 32465961 |
| Photophobia | 39.01 | 14.06 | 41 | 34634 | 6423 | 32472428 |
| Cardiac failure congestive | 38.89 | 14.06 | 21 | 34654 | 84831 | 32394020 |
| Arthralgia | 38.33 | 14.06 | 62 | 34613 | 148386 | 32330465 |
| Xanthopsia | 38.22 | 14.06 | 12 | 34663 | 162 | 32478689 |
| Dehydration | 38.08 | 14.06 | 49 | 34626 | 128909 | 32349942 |
| Alternaria infection | 37.56 | 14.06 | 14 | 34661 | 325 | 32478526 |
| Peripheral swelling | 37.53 | 14.06 | 13 | 34662 | 68332 | 32410519 |
| Aspergillus test positive | 36.92 | 14.06 | 15 | 34660 | 441 | 32478410 |
| Pseudoporphyria | 36.68 | 14.06 | 13 | 34662 | 260 | 32478591 |
| Enterococcal infection | 36.68 | 14.06 | 47 | 34628 | 9100 | 32469751 |
| Acute graft versus host disease in liver | 36.41 | 14.06 | 21 | 34654 | 1351 | 32477500 |
| Rheumatoid arthritis | 36.25 | 14.06 | 3 | 34672 | 44541 | 32434310 |
| Burns second degree | 36.07 | 14.06 | 14 | 34661 | 364 | 32478487 |
| Cytomegalovirus viraemia | 35.93 | 14.06 | 40 | 34635 | 6687 | 32472164 |
| Cytokine release syndrome | 35.75 | 14.06 | 57 | 34618 | 13478 | 32465373 |
| Pneumonia | 35.06 | 14.06 | 552 | 34123 | 354700 | 32124151 |
| Enterococcal sepsis | 35.06 | 14.06 | 22 | 34653 | 1651 | 32477200 |
| Acute graft versus host disease in skin | 34.58 | 14.06 | 34 | 34641 | 4923 | 32473928 |
| Hepatitis cholestatic | 34.14 | 14.06 | 43 | 34632 | 8182 | 32470669 |
| Septic embolus | 33.83 | 14.06 | 19 | 34656 | 1162 | 32477689 |
| Weight decreased | 33.73 | 14.06 | 79 | 34596 | 164739 | 32314112 |
| Nasopharyngitis | 33.56 | 14.06 | 13 | 34662 | 63774 | 32415077 |
| Product contamination microbial | 33.51 | 14.06 | 16 | 34659 | 697 | 32478154 |
| Blood alkaline phosphatase increased | 33.17 | 14.06 | 92 | 34583 | 32040 | 32446811 |
| Scopulariopsis infection | 32.77 | 14.06 | 10 | 34665 | 122 | 32478729 |
| Nocardiosis | 32.59 | 14.06 | 29 | 34646 | 3702 | 32475149 |
| Vomiting | 32.57 | 14.06 | 135 | 34540 | 235422 | 32243429 |
| Eye infection fungal | 32.56 | 14.06 | 13 | 34662 | 365 | 32478486 |
| Lip squamous cell carcinoma | 32.47 | 14.06 | 9 | 34666 | 76 | 32478775 |
| Malaise | 32.32 | 14.06 | 90 | 34585 | 177048 | 32301803 |
| Hyperhidrosis | 32.05 | 14.06 | 18 | 34657 | 71150 | 32407701 |
| Back pain | 31.95 | 14.06 | 43 | 34632 | 111010 | 32367841 |
| Graft versus host disease in skin | 31.45 | 14.06 | 28 | 34647 | 3576 | 32475275 |
| Headache | 31.31 | 14.06 | 106 | 34569 | 196091 | 32282760 |
| Hypertension | 31.29 | 14.06 | 58 | 34617 | 131692 | 32347159 |
| Intentional overdose | 30.77 | 14.06 | 4 | 34671 | 41597 | 32437254 |
| Arthritis fungal | 30.34 | 14.06 | 9 | 34666 | 99 | 32478752 |
| Cystitis haemorrhagic | 30.09 | 14.06 | 32 | 34643 | 5082 | 32473769 |
| Post transplant lymphoproliferative disorder | 29.98 | 14.06 | 34 | 34641 | 5800 | 32473051 |
| Acute respiratory distress syndrome | 29.81 | 14.06 | 76 | 34599 | 25177 | 32453674 |
| Venoocclusive liver disease | 29.77 | 14.06 | 38 | 34637 | 7327 | 32471524 |
| Urinary tract infection | 29.74 | 14.06 | 25 | 34650 | 80046 | 32398805 |
| Disseminated aspergillosis | 29.72 | 14.06 | 11 | 34664 | 250 | 32478601 |
| Cerebrovascular accident | 29.62 | 14.06 | 29 | 34646 | 86291 | 32392560 |
| Toxic optic neuropathy | 29.49 | 14.06 | 15 | 34660 | 750 | 32478101 |
| Lentigo | 29.37 | 14.06 | 12 | 34663 | 358 | 32478493 |
| Macular opacity | 29.22 | 14.06 | 5 | 34670 | 0 | 32478851 |
| Asthma | 28.67 | 14.06 | 6 | 34669 | 44059 | 32434792 |
| Psoriasis | 28.57 | 14.06 | 7 | 34668 | 46116 | 32432735 |
| Pulmonary cavitation | 28.46 | 14.06 | 15 | 34660 | 808 | 32478043 |
| Inappropriate schedule of product administration | 28.29 | 14.06 | 7 | 34668 | 45818 | 32433033 |
| Torsade de pointes | 28.01 | 14.06 | 37 | 34638 | 7378 | 32471473 |
| Gallbladder oedema | 27.85 | 14.06 | 10 | 34665 | 208 | 32478643 |
| Hepatic failure | 27.32 | 14.06 | 92 | 34583 | 35588 | 32443263 |
| Drug-induced liver injury | 26.95 | 14.06 | 71 | 34604 | 23992 | 32454859 |
| Central nervous system lesion | 26.65 | 14.06 | 32 | 34643 | 5800 | 32473051 |
| Chronic graft versus host disease | 26.50 | 14.06 | 28 | 34647 | 4412 | 32474439 |
| Cytomegalovirus infection | 26.37 | 14.06 | 73 | 34602 | 25391 | 32453460 |
| Fungal endocarditis | 26.36 | 14.06 | 10 | 34665 | 244 | 32478607 |
| Pyrexia | 26.34 | 14.06 | 483 | 34192 | 319485 | 32159366 |
| Stenotrophomonas infection | 26.29 | 14.06 | 19 | 34656 | 1801 | 32477050 |
| Acanthamoeba keratitis | 26.04 | 14.06 | 8 | 34667 | 100 | 32478751 |
| Dyspnoea exertional | 25.98 | 14.06 | 5 | 34670 | 38956 | 32439895 |
| Lower respiratory tract infection fungal | 25.94 | 14.06 | 13 | 34662 | 630 | 32478221 |
| Gallbladder empyema | 25.59 | 14.06 | 7 | 34668 | 56 | 32478795 |
| Photopsia | 25.39 | 14.06 | 19 | 34656 | 1900 | 32476951 |
| Transmission of an infectious agent via product | 25.16 | 14.06 | 9 | 34666 | 185 | 32478666 |
| Muscle spasms | 24.92 | 14.06 | 23 | 34652 | 70395 | 32408456 |
| Injection site pain | 24.88 | 14.06 | 3 | 34672 | 33055 | 32445796 |
| Dyspepsia | 24.88 | 14.06 | 3 | 34672 | 33052 | 32445799 |
| Tongue necrosis | 24.87 | 14.06 | 6 | 34669 | 27 | 32478824 |
| Rectal haemorrhage | 24.54 | 14.06 | 5 | 34670 | 37418 | 32441433 |
| Fungal skin infection | 24.32 | 14.06 | 21 | 34654 | 2576 | 32476275 |
| Urticaria | 24.19 | 14.06 | 17 | 34658 | 59597 | 32419254 |
| Gastrooesophageal reflux disease | 24.16 | 14.06 | 4 | 34671 | 34734 | 32444117 |
| Nervous system disorder | 24.06 | 14.06 | 49 | 34626 | 14000 | 32464851 |
| Haemophagocytic lymphohistiocytosis | 23.67 | 14.06 | 43 | 34632 | 11292 | 32467559 |
| Chromatopsia | 23.59 | 14.06 | 9 | 34666 | 223 | 32478628 |
| Infectious pleural effusion | 23.39 | 14.06 | 19 | 34656 | 2142 | 32476709 |
| Gamma-glutamyltransferase increased | 23.23 | 14.06 | 79 | 34596 | 30703 | 32448148 |
| Osteomyelitis fungal | 23.15 | 14.06 | 9 | 34666 | 235 | 32478616 |
| Urinary bladder rupture | 23.05 | 14.06 | 7 | 34668 | 84 | 32478767 |
| Lung infiltration | 22.93 | 14.06 | 46 | 34629 | 13002 | 32465849 |
| Disease recurrence | 22.89 | 14.06 | 52 | 34623 | 16012 | 32462839 |
| Cerebral fungal infection | 22.87 | 14.06 | 9 | 34666 | 243 | 32478608 |
| Pulmonary haemorrhage | 22.65 | 14.06 | 39 | 34636 | 9818 | 32469033 |
| Acute graft versus host disease in intestine | 22.47 | 14.06 | 20 | 34655 | 2553 | 32476298 |
| Pulmonary embolism | 22.46 | 14.06 | 34 | 34641 | 83625 | 32395226 |
| Retinal ischaemia | 22.44 | 14.06 | 10 | 34665 | 371 | 32478480 |
| Abscess fungal | 22.39 | 14.06 | 8 | 34667 | 164 | 32478687 |
| Transaminases increased | 22.31 | 14.06 | 68 | 34607 | 24960 | 32453891 |
| Pancytopenia | 22.24 | 14.06 | 170 | 34505 | 91065 | 32387786 |
| Cytomegalovirus enterocolitis | 22.15 | 14.06 | 13 | 34662 | 864 | 32477987 |
| Hypertrophic osteoarthropathy | 22.13 | 14.06 | 7 | 34668 | 97 | 32478754 |
| Acute myocardial infarction | 22.01 | 14.06 | 16 | 34659 | 55133 | 32423718 |
| Off label use | 22.00 | 14.06 | 453 | 34222 | 305867 | 32172984 |
| Neutropenia | 21.95 | 14.06 | 240 | 34435 | 141935 | 32336916 |
| Halo vision | 21.73 | 14.06 | 8 | 34667 | 179 | 32478672 |
| Pulmonary alveolar haemorrhage | 21.60 | 14.06 | 32 | 34643 | 7097 | 32471754 |
| Ureaplasma infection | 21.33 | 14.06 | 8 | 34667 | 189 | 32478662 |
| BK virus infection | 21.03 | 14.06 | 26 | 34649 | 4855 | 32473996 |
| Angina pectoris | 21.03 | 14.06 | 4 | 34671 | 31422 | 32447429 |
| Sepsis | 20.91 | 14.06 | 260 | 34415 | 158574 | 32320277 |
| Altered state of consciousness | 20.77 | 14.06 | 61 | 34614 | 21936 | 32456915 |
| Musculoskeletal stiffness | 20.65 | 14.06 | 8 | 34667 | 39256 | 32439595 |
| Sunburn | 20.25 | 14.06 | 16 | 34659 | 1734 | 32477117 |
| Neuroendocrine carcinoma of the skin | 20.17 | 14.06 | 11 | 34664 | 635 | 32478216 |
| Klebsiella infection | 20.14 | 14.06 | 33 | 34642 | 7979 | 32470872 |
| Scintillating scotoma | 20.13 | 14.06 | 5 | 34670 | 26 | 32478825 |
| Meningitis coccidioides | 19.97 | 14.06 | 5 | 34670 | 27 | 32478824 |
| Peptic ulcer haemorrhage | 19.94 | 14.06 | 10 | 34665 | 485 | 32478366 |
| Pulmonary mass | 19.88 | 14.06 | 41 | 34634 | 11819 | 32467032 |
| Necrotising retinitis | 19.78 | 14.06 | 12 | 34663 | 848 | 32478003 |
| Systemic candida | 19.74 | 14.06 | 20 | 34655 | 3001 | 32475850 |
| Aplasia | 19.69 | 14.06 | 24 | 34651 | 4418 | 32474433 |
| Hallucinations, mixed | 19.57 | 14.06 | 19 | 34656 | 2708 | 32476143 |
| Drug hypersensitivity | 19.54 | 14.06 | 30 | 34645 | 73370 | 32405481 |
| Gait disturbance | 19.43 | 14.06 | 35 | 34640 | 80373 | 32398478 |
| Organising pneumonia | 19.41 | 14.06 | 27 | 34648 | 5654 | 32473197 |
| Prostate cancer | 19.41 | 14.06 | 3 | 34672 | 27403 | 32451448 |
| Syncope | 19.39 | 14.06 | 42 | 34633 | 90082 | 32388769 |
| Chloropsia | 19.34 | 14.06 | 4 | 34671 | 7 | 32478844 |
| Citrobacter infection | 19.14 | 14.06 | 10 | 34665 | 529 | 32478322 |
| Colour blindness acquired | 19.11 | 14.06 | 6 | 34669 | 81 | 32478770 |
| Splenic candidiasis | 19.11 | 14.06 | 6 | 34669 | 81 | 32478770 |
| Burns first degree | 18.99 | 14.06 | 4 | 34671 | 8 | 32478843 |
| Decreased appetite | 18.74 | 14.06 | 98 | 34577 | 160715 | 32318136 |
| Pulmonary mucormycosis | 18.71 | 14.06 | 10 | 34665 | 554 | 32478297 |
| Cerebral artery embolism | 18.64 | 14.06 | 12 | 34663 | 941 | 32477910 |
| Abdominal pain | 18.64 | 14.06 | 89 | 34586 | 149440 | 32329411 |
| Bacterial infection | 18.48 | 14.06 | 44 | 34631 | 13962 | 32464889 |
| Eye abscess | 18.48 | 14.06 | 7 | 34668 | 170 | 32478681 |
| Joint swelling | 18.18 | 14.06 | 17 | 34658 | 51718 | 32427133 |
| Toxic skin eruption | 18.13 | 14.06 | 39 | 34636 | 11575 | 32467276 |
| Retinal toxicity | 18.04 | 14.06 | 9 | 34666 | 432 | 32478419 |
| Intentional product misuse | 17.90 | 14.06 | 8 | 34667 | 36043 | 32442808 |
| Neurological decompensation | 17.88 | 14.06 | 18 | 34657 | 2680 | 32476171 |
| Oral papilloma | 17.85 | 14.06 | 4 | 34671 | 12 | 32478839 |
| Bacterial sepsis | 17.80 | 14.06 | 25 | 34650 | 5283 | 32473568 |
| Acute lymphocytic leukaemia recurrent | 17.68 | 14.06 | 19 | 34656 | 3053 | 32475798 |
| Mycobacterium abscessus infection | 17.68 | 14.06 | 10 | 34665 | 620 | 32478231 |
| Bronchial artery embolisation | 17.53 | 14.06 | 3 | 34672 | 0 | 32478851 |
| Staphylococcal sepsis | 17.48 | 14.06 | 35 | 34640 | 9878 | 32468973 |
| Abdominal pain upper | 17.47 | 14.06 | 28 | 34647 | 67310 | 32411541 |
| Retinal haemorrhage | 17.36 | 14.06 | 24 | 34651 | 4997 | 32473854 |
| Hospitalisation | 17.32 | 14.06 | 16 | 34659 | 48955 | 32429896 |
| Transplant rejection | 17.27 | 14.06 | 35 | 34640 | 9964 | 32468887 |
| Nephrolithiasis | 17.23 | 14.06 | 4 | 34671 | 27350 | 32451501 |
| Chronic obstructive pulmonary disease | 17.16 | 14.06 | 16 | 34659 | 48737 | 32430114 |
| Wrong technique in product usage process | 17.07 | 14.06 | 8 | 34667 | 35051 | 32443800 |
| Inhibitory drug interaction | 17.01 | 14.06 | 14 | 34661 | 1607 | 32477244 |
| Gastrointestinal wall thinning | 16.96 | 14.06 | 4 | 34671 | 16 | 32478835 |
| Hyperammonaemia | 16.96 | 14.06 | 26 | 34649 | 5943 | 32472908 |
| Flushing | 16.94 | 14.06 | 6 | 34669 | 31121 | 32447730 |
| Leukaemia | 16.80 | 14.06 | 21 | 34654 | 3965 | 32474886 |
| Loss of personal independence in daily activities | 16.76 | 14.06 | 4 | 34671 | 26829 | 32452022 |
| Aspartate aminotransferase | 16.66 | 14.06 | 6 | 34669 | 126 | 32478725 |
| Arthritis | 16.63 | 14.06 | 4 | 34671 | 26688 | 32452163 |
| International normalised ratio increased | 16.21 | 14.06 | 17 | 34658 | 49018 | 32429833 |
| Blood bilirubin increased | 16.19 | 14.06 | 83 | 34592 | 38701 | 32440150 |
| Product use issue | 16.17 | 14.06 | 104 | 34571 | 52673 | 32426178 |
| Antibiotic level below therapeutic | 16.17 | 14.06 | 5 | 34670 | 64 | 32478787 |
| Deep vein thrombosis | 16.05 | 14.06 | 27 | 34648 | 63686 | 32415165 |
| Hypersensitivity | 15.96 | 14.06 | 23 | 34652 | 57735 | 32421116 |
| Hypokalaemia | 15.93 | 14.06 | 107 | 34568 | 54987 | 32423864 |
| Graft versus host disease in lung | 15.86 | 14.06 | 9 | 34666 | 561 | 32478290 |
| Periostosis | 15.76 | 14.06 | 4 | 34671 | 23 | 32478828 |
| Solar dermatitis | 15.76 | 14.06 | 5 | 34670 | 70 | 32478781 |
| Chondritis | 15.75 | 14.06 | 6 | 34669 | 148 | 32478703 |
| Malignant neoplasm progression | 15.73 | 14.06 | 38 | 34637 | 78458 | 32400393 |
| Weight increased | 15.61 | 14.06 | 42 | 34633 | 83621 | 32395230 |
| Pneumonia bacterial | 15.61 | 14.06 | 35 | 34640 | 10681 | 32468170 |
| Ephelides | 15.56 | 14.06 | 5 | 34670 | 73 | 32478778 |
| Delirium | 15.52 | 14.06 | 90 | 34585 | 43956 | 32434895 |
| Abdominal discomfort | 15.51 | 14.06 | 20 | 34655 | 52604 | 32426247 |
| Chronic pulmonary histoplasmosis | 15.46 | 14.06 | 3 | 34672 | 3 | 32478848 |
| Insomnia | 15.45 | 14.06 | 55 | 34620 | 100293 | 32378558 |
| Apraxia | 15.44 | 14.06 | 12 | 34663 | 1269 | 32477582 |
| Granulomatous dermatitis | 15.41 | 14.06 | 7 | 34668 | 272 | 32478579 |
| Escherichia sepsis | 15.36 | 14.06 | 21 | 34654 | 4327 | 32474524 |
| Lip ulceration | 15.35 | 14.06 | 10 | 34665 | 800 | 32478051 |
| Fibrinous bronchitis | 15.35 | 14.06 | 4 | 34671 | 26 | 32478825 |
| Sinusitis fungal | 15.18 | 14.06 | 8 | 34667 | 431 | 32478420 |
| Candida test positive | 15.04 | 14.06 | 8 | 34667 | 439 | 32478412 |
| Hepatitis toxic | 15.02 | 14.06 | 15 | 34660 | 2213 | 32476638 |
| Thrombotic microangiopathy | 14.98 | 14.06 | 32 | 34643 | 9450 | 32469401 |
| Hypoxia | 14.92 | 14.06 | 101 | 34574 | 52031 | 32426820 |
| Skin mass | 14.86 | 14.06 | 19 | 34656 | 3670 | 32475181 |
| Chronic granulomatous disease | 14.85 | 14.06 | 4 | 34671 | 30 | 32478821 |
| Pneumonia cytomegaloviral | 14.73 | 14.06 | 17 | 34658 | 2955 | 32475896 |
| Mental disorder due to a general medical condition | 14.72 | 14.06 | 6 | 34669 | 178 | 32478673 |
| Necrotising ulcerative gingivostomatitis | 14.65 | 14.06 | 5 | 34670 | 89 | 32478762 |
| Donor leukocyte infusion | 14.62 | 14.06 | 4 | 34671 | 32 | 32478819 |
| Overdose | 14.58 | 14.06 | 46 | 34629 | 87031 | 32391820 |
| Injury | 14.53 | 14.06 | 3 | 34672 | 22242 | 32456609 |
| Blood beta-D-glucan increased | 14.49 | 14.06 | 8 | 34667 | 473 | 32478378 |
| Musculoskeletal pain | 14.45 | 14.06 | 8 | 34667 | 31889 | 32446962 |
| Unevaluable event | 14.40 | 14.06 | 9 | 34666 | 33577 | 32445274 |
| Penicillium infection | 14.39 | 14.06 | 5 | 34670 | 94 | 32478757 |
| Loss of consciousness | 14.34 | 14.06 | 43 | 34632 | 82664 | 32396187 |
| Wheezing | 14.32 | 14.06 | 11 | 34664 | 36863 | 32441988 |
| Dry mouth | 14.29 | 14.06 | 4 | 34671 | 24115 | 32454736 |
| Haemoptysis | 14.17 | 14.06 | 72 | 34603 | 33453 | 32445398 |
| Brain herniation | 14.14 | 14.06 | 19 | 34656 | 3852 | 32474999 |
| Swelling | 14.10 | 14.06 | 12 | 34663 | 38210 | 32440641 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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 | cytochrome P450 inhibitor |
| 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 (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 | 0049-3180 | 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 | 0049-4190 | 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 | 0378-1640 | 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 | 16714-199 | 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 |
| Voriconazole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 39822-1077 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 10 mg | INTRAVENOUS | NDA | 32 sections |
| voriconazole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 40032-038 | SUSPENSION | 40 mg | ORAL | ANDA | 29 sections |
| voriconazole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 40032-088 | TABLET, FILM COATED | 50 mg | ORAL | ANDA | 28 sections |
| voriconazole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 40032-089 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 28 sections |
| VORICONAZOLE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43386-038 | POWDER, FOR SUSPENSION | 40 mg | ORAL | ANDA | 29 sections |
| voriconazole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43386-088 | TABLET, FILM COATED | 50 mg | ORAL | ANDA | 29 sections |
| voriconazole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43386-089 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 29 sections |
| Voriconazole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43547-377 | TABLET, COATED | 50 mg | ORAL | ANDA | 18 sections |
| Voriconazole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43547-378 | TABLET, COATED | 200 mg | ORAL | ANDA | 18 sections |
| VORICONAZOLE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 47781-466 | INJECTION, POWDER, FOR SOLUTION | 10 mg | INTRAVENOUS | ANDA | 28 sections |
| Voriconazole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51079-164 | TABLET, FILM COATED | 50 mg | ORAL | ANDA | 31 sections |