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

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

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fluconazole
  • difluconazole
  • flunazol
  • diflucan
Triazole antifungal agent that is used to treat oropharyngeal CANDIDIASIS and cryptococcal MENINGITIS in AIDS.
  • Molecular weight: 306.28
  • Formula: C13H12F2N6O
  • CLOGP: -0.44
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 1
  • TPSA: 81.65
  • ALOGS: -2.34
  • ROTB: 5

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.20 g O
0.20 g P

ADMET properties:

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

Approvals:

DateAgencyCompanyOrphan
Jan. 29, 1990 FDA PFIZER

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 461.79 9.64 645 71270 93982 46520165
Candida infection 336.62 9.64 277 71638 21963 46592184
Drug interaction 276.11 9.64 811 71104 202283 46411864
Fungal infection 216.75 9.64 247 71668 29273 46584874
Rheumatoid arthritis 216.69 9.64 52 71863 240163 46373984
Mucosal inflammation 169.78 9.64 252 71663 38724 46575423
Multiple organ dysfunction syndrome 158.27 9.64 285 71630 51425 46562722
Sepsis 157.44 9.64 514 71401 135500 46478647
Oral candidiasis 144.71 9.64 156 71759 17376 46596771
Septic shock 130.94 9.64 281 71634 57612 46556535
Neutropenia 119.77 9.64 487 71428 142717 46471430
Stevens-Johnson syndrome 119.68 9.64 163 71752 23134 46591013
Pyrexia 118.61 9.64 930 70985 347872 46266275
Thrombocytopenia 114.32 9.64 441 71474 126140 46488007
Pancytopenia 112.69 9.64 337 71578 84721 46529426
Cytomegalovirus infection 108.81 9.64 137 71778 18007 46596140
Cytokine release syndrome 101.49 9.64 81 71834 6142 46608005
Mucormycosis 99.57 9.64 55 71860 2237 46611910
Graft versus host disease 99.52 9.64 82 71833 6506 46607641
Aspergillus infection 94.27 9.64 81 71834 6809 46607338
Fall 90.25 9.64 237 71678 328860 46285287
Arthralgia 90.12 9.64 276 71639 364327 46249820
Abortion spontaneous 89.80 9.64 204 71711 43442 46570705
Contraindicated product administered 85.67 9.64 11 71904 79936 46534211
Systemic candida 85.58 9.64 53 71862 2674 46611473
Platelet count decreased 84.22 9.64 341 71574 99683 46514464
Cryptococcosis 81.24 9.64 35 71880 817 46613330
Toxic epidermal necrolysis 78.86 9.64 131 71784 22147 46592000
Fixed eruption 77.48 9.64 34 71881 831 46613316
Joint swelling 75.18 9.64 87 71828 165986 46448161
Pathogen resistance 70.50 9.64 65 71850 5995 46608152
Immune reconstitution inflammatory syndrome 65.81 9.64 61 71854 5664 46608483
Bronchopulmonary aspergillosis 64.14 9.64 68 71847 7428 46606719
Fungaemia 63.25 9.64 39 71876 1952 46612195
Oesophageal candidiasis 62.88 9.64 57 71858 5143 46609004
Enterococcal infection 62.67 9.64 65 71850 6922 46607225
Drug resistance 62.64 9.64 103 71812 17265 46596882
Drug intolerance 62.36 9.64 81 71834 146968 46467179
Deep vein thrombosis 61.68 9.64 265 71650 79508 46534639
Laryngitis fungal 60.40 9.64 18 71897 134 46614013
Infective aneurysm 58.85 9.64 23 71892 415 46613732
Injury 58.79 9.64 175 71740 43852 46570295
Drug ineffective 58.01 9.64 718 71197 677120 45937027
Therapeutic product effect incomplete 56.15 9.64 25 71890 78128 46536019
Torsade de pointes 54.93 9.64 80 71835 12074 46602073
Disseminated mucormycosis 54.91 9.64 16 71899 109 46614038
Intentional overdose 54.76 9.64 16 71899 64928 46549219
Therapeutic product effect decreased 53.96 9.64 30 71885 82571 46531576
Sinusitis fungal 52.22 9.64 26 71889 852 46613295
Pneumonia fungal 49.13 9.64 45 71870 4115 46610032
Vulvovaginal candidiasis 49.01 9.64 37 71878 2584 46611563
Bacterial sepsis 48.93 9.64 42 71873 3525 46610622
Cytomegalovirus viraemia 48.19 9.64 46 71869 4432 46609715
Acute myeloid leukaemia 47.01 9.64 86 71829 15692 46598455
Pemphigus 46.68 9.64 7 71908 45267 46568880
Neutrophil count decreased 46.49 9.64 160 71755 43266 46570881
Suicide attempt 45.60 9.64 14 71901 55022 46559125
Injection site pain 45.44 9.64 59 71856 107093 46507054
Uterine perforation 45.37 9.64 56 71859 7211 46606936
Nasopharyngitis 45.15 9.64 107 71808 153891 46460256
Bone marrow failure 43.53 9.64 122 71793 29547 46584600
Arthropathy 43.24 9.64 40 71875 84660 46529487
Maternal exposure during pregnancy 42.94 9.64 57 71858 102492 46511655
Acute graft versus host disease in skin 42.72 9.64 36 71879 2946 46611201
Blood lactate dehydrogenase increased 42.35 9.64 96 71819 20404 46593743
Meningitis cryptococcal 42.06 9.64 25 71890 1170 46612977
Infusion related reaction 41.62 9.64 57 71858 101151 46512996
Fatigue 41.62 9.64 674 71241 608023 46006124
Abdominal discomfort 41.22 9.64 109 71806 151056 46463091
Mouth ulceration 41.02 9.64 112 71803 26720 46587427
Pseudomonas infection 40.90 9.64 62 71853 9696 46604451
Salpingo-oophorectomy unilateral 40.68 9.64 17 71898 367 46613780
Jarisch-Herxheimer reaction 40.57 9.64 16 71899 296 46613851
Dermatitis bullous 40.04 9.64 54 71861 7589 46606558
Acute generalised exanthematous pustulosis 39.77 9.64 60 71855 9345 46604802
Immune effector cell-associated neurotoxicity syndrome 39.65 9.64 20 71895 674 46613473
Systemic lupus erythematosus 39.31 9.64 26 71889 65154 46548993
Respiratory failure 39.03 9.64 265 71650 94551 46519596
Blood bilirubin increased 38.39 9.64 128 71787 34056 46580091
Fungal sepsis 37.80 9.64 23 71892 1124 46613023
Treatment failure 37.70 9.64 53 71862 93034 46521113
Headache 37.35 9.64 516 71399 477836 46136311
Geotrichum infection 37.31 9.64 17 71898 455 46613692
Injection site erythema 36.99 9.64 36 71879 74391 46539756
Breast cancer 36.96 9.64 12 71903 45506 46568641
Hand deformity 36.45 9.64 5 71910 34569 46579578
Cytomegalovirus test positive 36.25 9.64 32 71883 2788 46611359
International normalised ratio increased 35.64 9.64 155 71760 46728 46567419
White blood cell count decreased 35.63 9.64 295 71620 111936 46502211
Aspartate aminotransferase increased 35.45 9.64 225 71690 78475 46535672
Coccidioidomycosis 35.13 9.64 20 71895 863 46613284
Oral fungal infection 35.09 9.64 30 71885 2504 46611643
Cholecystitis chronic 34.85 9.64 60 71855 10439 46603708
Blood pressure increased 34.78 9.64 91 71824 126575 46487572
Pulmonary embolism 34.78 9.64 286 71629 108299 46505848
Female genital tract fistula 34.34 9.64 33 71882 3206 46610941
Fungal oesophagitis 34.31 9.64 17 71898 551 46613596
Toxicity to various agents 34.18 9.64 189 71726 211577 46402570
Glossodynia 33.80 9.64 13 71902 44360 46569787
Wrong technique in product usage process 33.79 9.64 21 71894 54401 46559746
Shock haemorrhagic 33.63 9.64 53 71862 8571 46605576
Acute graft versus host disease 33.49 9.64 36 71879 3994 46610153
Drug abuse 33.49 9.64 29 71886 63379 46550768
Staphylococcal infection 33.35 9.64 126 71789 35645 46578502
Hepatic function abnormal 32.72 9.64 122 71793 34299 46579848
Neurotoxicity 32.63 9.64 68 71847 13649 46600498
Bacteraemia 32.23 9.64 69 71846 14110 46600037
Tonsillar haemorrhage 32.20 9.64 12 71903 189 46613958
Peripheral swelling 32 9.64 130 71785 157941 46456206
Cystitis haemorrhagic 31.82 9.64 33 71882 3514 46610633
Enterobacter infection 31.71 9.64 25 71890 1862 46612285
Neutropenic sepsis 31.57 9.64 63 71852 12261 46601886
Sputum increased 31.10 9.64 24 71891 1732 46612415
Renal failure 31.08 9.64 289 71626 113305 46500842
Toxic neuropathy 30.82 9.64 14 71901 372 46613775
Keratitis fungal 29.69 9.64 10 71905 115 46614032
Respiratory symptom 29.67 9.64 25 71890 2045 46612102
Dizziness 29.55 9.64 359 71556 340055 46274092
Toxoplasmosis 29.04 9.64 21 71894 1373 46612774
Gastrointestinal fungal infection 28.76 9.64 12 71903 258 46613889
Drug eruption 28.67 9.64 85 71830 21244 46592903
Immunosuppressant drug level increased 28.48 9.64 30 71885 3252 46610895
Epstein-Barr virus infection 28.29 9.64 43 71872 6741 46607406
Overdose 28.19 9.64 73 71842 101906 46512241
Adrenal insufficiency 27.71 9.64 62 71853 13062 46601085
Agranulocytosis 27.56 9.64 86 71829 22099 46592048
Klebsiella infection 27.46 9.64 42 71873 6620 46607527
Inappropriate schedule of product administration 27.34 9.64 36 71879 64977 46549170
Injection site swelling 27.28 9.64 14 71901 40313 46573834
Musculoskeletal stiffness 27.20 9.64 70 71845 97923 46516224
Congenital absence of cranial vault 27.12 9.64 7 71908 28 46614119
Loss of personal independence in daily activities 26.89 9.64 29 71886 57154 46556993
Respiratory tract infection fungal 26.74 9.64 13 71902 404 46613743
Erythema multiforme 26.55 9.64 51 71864 9653 46604494
Pneumonia 26.02 9.64 761 71154 375559 46238588
Clostridium difficile colitis 25.96 9.64 75 71840 18478 46595669
Product dose omission issue 25.78 9.64 153 71762 168367 46445780
Blood alkaline phosphatase increased 25.69 9.64 125 71790 39484 46574663
Chronic graft versus host disease 25.61 9.64 26 71889 2699 46611448
Embolism venous 25.56 9.64 25 71890 2482 46611665
Abscess neck 25.53 9.64 14 71901 561 46613586
Puerperal pyrexia 25.37 9.64 7 71908 38 46614109
Drug level increased 25.27 9.64 74 71841 18367 46595780
Alanine aminotransferase increased 25.18 9.64 227 71688 88224 46525923
Oral disorder 25.05 9.64 44 71871 7778 46606369
Symmetrical drug-related intertriginous and flexural exanthema 24.98 9.64 11 71904 271 46613876
Acute myeloid leukaemia recurrent 24.55 9.64 19 71896 1377 46612770
Vaginal infection 24.53 9.64 38 71877 6055 46608092
Plasma cell myeloma 24.43 9.64 134 71781 44344 46569803
Eosinophilia 24.34 9.64 75 71840 19142 46595005
Drug reaction with eosinophilia and systemic symptoms 24.25 9.64 100 71815 29448 46584699
Systemic mycosis 24.06 9.64 16 71899 913 46613234
Hypomagnesaemia 23.91 9.64 82 71833 22128 46592019
Sinus polyp 23.72 9.64 11 71904 307 46613840
Septic embolus 23.70 9.64 15 71900 786 46613361
Alopecia 23.52 9.64 150 71765 162264 46451883
Acute kidney injury 23.44 9.64 501 71414 235354 46378793
Enterococcal sepsis 23.05 9.64 18 71897 1322 46612825
Gastrointestinal mucormycosis 23.05 9.64 9 71906 162 46613985
BK virus infection 22.89 9.64 25 71890 2824 46611323
Pain in extremity 22.72 9.64 272 71643 258408 46355739
Encephalitis fungal 22.68 9.64 6 71909 27 46614120
Stem cell transplant 22.62 9.64 20 71895 1746 46612401
Liver abscess 22.53 9.64 24 71891 2635 46611512
Encephalopathy 22.51 9.64 107 71808 33482 46580665
Nasal polyps 22.46 9.64 22 71893 2188 46611959
Sepsis syndrome 22.35 9.64 15 71900 869 46613278
Feeling abnormal 22.19 9.64 108 71807 124952 46489195
Hepatic failure 22.07 9.64 106 71809 33310 46580837
Failure to thrive 22.01 9.64 38 71877 6626 46607521
Acute lymphocytic leukaemia 21.70 9.64 24 71891 2749 46611398
Hyperbilirubinaemia 21.69 9.64 49 71866 10389 46603758
Focal myositis 21.24 9.64 6 71909 36 46614111
Oropharyngeal candidiasis 21.15 9.64 15 71900 951 46613196
Staphylococcal sepsis 21.12 9.64 40 71875 7492 46606655
Candida sepsis 20.92 9.64 17 71898 1322 46612825
Electrocardiogram QT prolonged 20.84 9.64 143 71772 51182 46562965
Congestive cardiomyopathy 20.76 9.64 34 71881 5679 46608468
Prothrombin time shortened 20.72 9.64 19 71896 1740 46612407
Gait disturbance 20.60 9.64 135 71780 145128 46469019
Gastritis fungal 20.52 9.64 7 71908 84 46614063
Device related infection 20.35 9.64 75 71840 20966 46593181
Cystic fibrosis related diabetes 20.33 9.64 6 71909 43 46614104
Rash maculo-papular 20.31 9.64 91 71824 27783 46586364
Nasal abscess 20.28 9.64 8 71907 148 46613999
Hypersensitivity 20.17 9.64 142 71773 150179 46463968
Accidental exposure to product 20.10 9.64 4 71911 21077 46593070
Psoriatic arthropathy 19.99 9.64 16 71899 36363 46577784
Tongue coated 19.83 9.64 16 71899 1232 46612915
Wound 19.80 9.64 22 71893 42780 46571367
Tumour lysis syndrome 19.76 9.64 38 71877 7198 46606949
Tongue blistering 19.66 9.64 17 71898 1441 46612706
Oral pain 19.63 9.64 83 71832 24714 46589433
Urinary tract infection fungal 19.62 9.64 12 71903 592 46613555
Disseminated intravascular coagulation 19.44 9.64 69 71846 18936 46595211
Mucosal disorder 19.44 9.64 19 71896 1885 46612262
Graft versus host disease in skin 19.42 9.64 21 71894 2346 46611801
Acute graft versus host disease in intestine 19.36 9.64 18 71897 1677 46612470
Blastomycosis 19.31 9.64 9 71906 254 46613893
Basal cell carcinoma 19.30 9.64 4 71911 20483 46593664
Engraft failure 19.22 9.64 10 71905 360 46613787
Pain 18.95 9.64 575 71340 476373 46137774
Delayed graft function 18.73 9.64 14 71901 963 46613184
Necrotising enterocolitis neonatal 18.72 9.64 8 71907 183 46613964
Inhibitory drug interaction 18.69 9.64 19 71896 1976 46612171
Arthritis 18.68 9.64 59 71856 77257 46536890
Engraftment syndrome 18.62 9.64 9 71906 276 46613871
Herpes simplex 18.59 9.64 37 71878 7186 46606961
Diastolic dysfunction 18.56 9.64 31 71884 5261 46608886
Thrombotic microangiopathy 18.39 9.64 40 71875 8266 46605881
Plasma cell leukaemia 18.33 9.64 15 71900 1178 46612969
Antithrombin III decreased 18.33 9.64 9 71906 286 46613861
Death 18.30 9.64 386 71529 335162 46278985
Hypertension 18.19 9.64 204 71711 196152 46417995
Blood pressure systolic increased 18.02 9.64 11 71904 28776 46585371
Injection site bruising 17.98 9.64 17 71898 35619 46578528
Knee arthroplasty 17.91 9.64 7 71908 23658 46590489
Venoocclusive liver disease 17.80 9.64 27 71888 4224 46609923
Leukopenia 17.74 9.64 172 71743 68171 46545976
Aplastic anaemia 17.65 9.64 36 71879 7117 46607030
Diabetic macroangiopathy 17.48 9.64 7 71908 135 46614012
Growth failure 17.48 9.64 9 71906 317 46613830
Pleural effusion 17.42 9.64 200 71715 82752 46531395
Incorrect dose administered 17.39 9.64 27 71888 45523 46568624
Graft versus host disease in lung 17.27 9.64 9 71906 325 46613822
Generalised oedema 17.14 9.64 55 71860 14344 46599803
Lung infiltration 17.04 9.64 54 71861 13989 46600158
Coagulation factor V level decreased 17.00 9.64 9 71906 336 46613811
Red blood cell sedimentation rate increased 16.95 9.64 7 71908 22882 46591265
Candida test positive 16.94 9.64 13 71902 930 46613217
Hepatic artery aneurysm 16.91 9.64 4 71911 10 46614137
Overgrowth fungal 16.88 9.64 6 71909 82 46614065
Post transplant lymphoproliferative disorder 16.87 9.64 25 71890 3831 46610316
Myocardial infarction 16.85 9.64 85 71830 97443 46516704
Injection site pruritus 16.72 9.64 22 71893 39721 46574426
Aeromonas infection 16.68 9.64 6 71909 85 46614062
Transplant rejection 16.65 9.64 42 71873 9554 46604593
Malaise 16.63 9.64 386 71529 330846 46283301
Blast cell count increased 16.61 9.64 9 71906 352 46613795
Purpura senile 16.60 9.64 11 71904 624 46613523
Stress 16.58 9.64 34 71881 51517 46562630
Renal tubular acidosis 16.54 9.64 16 71899 1567 46612580
Dysphagia 16.50 9.64 187 71728 77125 46537022
Graft versus host disease in gastrointestinal tract 16.48 9.64 20 71895 2530 46611617
Vulvovaginal disorder 16.43 9.64 3 71912 0 46614147
Neuropathy peripheral 16.42 9.64 213 71702 90680 46523467
Hypokalaemia 16.20 9.64 207 71708 87817 46526330
Central nervous system leukaemia 16.19 9.64 6 71909 93 46614054
Nightmare 16.14 9.64 3 71912 16595 46597552
Acquired macroglossia 16.13 9.64 6 71909 94 46614053
Cholestasis 16.12 9.64 83 71832 26810 46587337
Condition aggravated 16.09 9.64 273 71642 244779 46369368
Therapeutic response decreased 16.07 9.64 26 71889 43119 46571028
Haemophagocytic lymphohistiocytosis 16.06 9.64 38 71877 8304 46605843
Cushingoid 16.01 9.64 32 71883 6234 46607913
Blood pressure fluctuation 15.98 9.64 14 71901 30434 46583713
Arteritis infective 15.94 9.64 5 71910 45 46614102
Capillary leak syndrome 15.86 9.64 17 71898 1880 46612267
Suicidal ideation 15.85 9.64 40 71875 56342 46557805
Odynophagia 15.81 9.64 33 71882 6629 46607518
Pulmonary infarction 15.74 9.64 20 71895 2651 46611496
Disease recurrence 15.54 9.64 63 71852 18408 46595739
Mobility decreased 15.52 9.64 45 71870 60549 46553598
Infective chondritis 15.50 9.64 4 71911 16 46614131
Disseminated cryptococcosis 15.45 9.64 8 71907 285 46613862
Stomatitis 15.40 9.64 167 71748 68130 46546017
Hepatitis acute 15.36 9.64 37 71878 8177 46605970
Splenic vein thrombosis 15.32 9.64 8 71907 290 46613857
Respiratory syncytial virus infection 15.22 9.64 27 71888 4808 46609339
Emotional distress 15.21 9.64 90 71825 30617 46583530
Fat necrosis 15.17 9.64 10 71905 562 46613585
Neural tube defect 15.17 9.64 7 71908 193 46613954
Enterocolitis 15.16 9.64 31 71884 6137 46608010
Pseudomonal sepsis 15.11 9.64 17 71898 1985 46612162
Balance disorder 15.05 9.64 50 71865 64471 46549676
Long QT syndrome 14.99 9.64 21 71894 3059 46611088
HIV infection 14.85 9.64 10 71905 583 46613564
Pulmonary arterial hypertension 14.76 9.64 11 71904 25917 46588230
Thrombophlebitis superficial 14.56 9.64 27 71888 4976 46609171
Status epilepticus 14.51 9.64 51 71864 13928 46600219
Chronic sinusitis 14.45 9.64 27 71888 5006 46609141
Encephalitis 14.41 9.64 34 71881 7414 46606733
Stenotrophomonas infection 14.40 9.64 15 71900 1605 46612542
Intentional product misuse 14.39 9.64 32 71883 47096 46567051
Oesophagitis 14.34 9.64 50 71865 13601 46600546
Restlessness 14.31 9.64 11 71904 25513 46588634
Post procedural bile leak 14.25 9.64 6 71909 132 46614015
Swelling 14.19 9.64 123 71792 124388 46489759
Herpes simplex oesophagitis 14.05 9.64 6 71909 137 46614010
Feeling hot 13.99 9.64 23 71892 37905 46576242
Colitis 13.96 9.64 102 71813 37245 46576902
Tarsal tunnel syndrome 13.95 9.64 10 71905 645 46613502
Angina bullosa haemorrhagica 13.93 9.64 6 71909 140 46614007
Vulvovaginal pruritus 13.91 9.64 18 71897 2429 46611718
Leukaemia 13.90 9.64 21 71894 3274 46610873
Product use issue 13.90 9.64 87 71828 94557 46519590
Insomnia 13.86 9.64 175 71740 164749 46449398
Muscle spasms 13.86 9.64 122 71793 122991 46491156
Posterior reversible encephalopathy syndrome 13.83 9.64 53 71862 15088 46599059
Blood creatinine increased 13.78 9.64 179 71736 76224 46537923
Anhedonia 13.71 9.64 41 71874 10294 46603853
Hyperhidrosis 13.69 9.64 81 71834 89227 46524920
Respiratory tract haemorrhage 13.62 9.64 8 71907 366 46613781
Neutropenic colitis 13.61 9.64 17 71898 2215 46611932
Livedo reticularis 13.54 9.64 17 71898 2227 46611920
Multiple sclerosis 13.50 9.64 11 71904 24780 46589367
Dyspnoea 13.50 9.64 653 71262 514895 46099252
Right ventricular failure 13.50 9.64 4 71911 16089 46598058
Rhinocerebral mucormycosis 13.44 9.64 6 71909 153 46613994
Myalgia 13.41 9.64 123 71792 122965 46491182
Sleep disorder 13.31 9.64 33 71882 46762 46567385
Renal impairment 13.31 9.64 174 71741 74198 46539949
Stoma site candida 13.28 9.64 4 71911 31 46614116
Proteus infection 13.28 9.64 11 71904 879 46613268
Xanthopsia 13.26 9.64 6 71909 158 46613989
Gamma-glutamyltransferase increased 13.22 9.64 89 71826 31651 46582496
Acid base balance abnormal 13.18 9.64 7 71908 263 46613884
Acinetobacter test positive 13.18 9.64 5 71910 83 46614064
Product deposit 13.09 9.64 6 71909 163 46613984
Labelled drug-drug interaction medication error 13.03 9.64 37 71878 9024 46605123
Septic pulmonary embolism 12.96 9.64 4 71911 34 46614113
Varicella zoster virus infection 12.96 9.64 17 71898 2326 46611821
Pulmonary haemorrhage 12.92 9.64 30 71885 6475 46607672
Cachexia 12.86 9.64 25 71890 4774 46609373
Pharyngeal stenosis 12.83 9.64 3 71912 7 46614140
Shock 12.80 9.64 67 71848 21778 46592369
Anaemia 12.73 9.64 498 71417 255281 46358866
Chronic hepatitis C 12.73 9.64 6 71909 174 46613973
Withdrawal syndrome 12.71 9.64 6 71909 18128 46596019
Injection site reaction 12.65 9.64 35 71880 47814 46566333
Haemodialysis 12.64 9.64 37 71878 9180 46604967
Mucosal erosion 12.53 9.64 13 71902 1385 46612762
Duodenal stenosis 12.52 9.64 9 71906 583 46613564
Refractory anaemia with an excess of blasts 12.51 9.64 8 71907 427 46613720
Angiodermatitis 12.41 9.64 5 71910 98 46614049
Cushing's syndrome 12.38 9.64 10 71905 771 46613376
Vulvovaginitis 12.36 9.64 7 71908 299 46613848
Viral haemorrhagic cystitis 12.24 9.64 9 71906 604 46613543
Vulvovaginal discomfort 12.09 9.64 16 71899 2208 46611939
Skin maceration 11.96 9.64 4 71911 45 46614102
Epstein-Barr virus associated lymphoproliferative disorder 11.92 9.64 13 71902 1466 46612681
Gallbladder disorder 11.91 9.64 56 71859 17442 46596705
Mucosal toxicity 11.89 9.64 7 71908 322 46613825
Weight increased 11.86 9.64 180 71735 164293 46449854
Cardiomyopathy acute 11.63 9.64 6 71909 212 46613935
CSF culture positive 11.62 9.64 3 71912 12 46614135
Pneumothorax 11.60 9.64 49 71866 14580 46599567
Poikiloderma 11.58 9.64 4 71911 50 46614097
Oral mucosal blistering 11.45 9.64 24 71891 4836 46609311
Cytopenia 11.45 9.64 32 71883 7736 46606411
Flushing 11.34 9.64 56 71859 64558 46549589
Palatal oedema 11.34 9.64 8 71907 503 46613644
Nausea 11.32 9.64 909 71006 686545 45927602
Hallucination, tactile 11.31 9.64 6 71909 225 46613922
Aplasia 11.30 9.64 20 71895 3556 46610591
Subdiaphragmatic abscess 11.30 9.64 4 71911 54 46614093
Atelectasis 11.26 9.64 58 71857 18732 46595415
Hypoglossal nerve paresis 11.22 9.64 5 71910 127 46614020
Acute febrile neutrophilic dermatosis 11.17 9.64 17 71898 2668 46611479
Exposure via breast milk 11.10 9.64 12 71903 1340 46612807
Hepatic enzyme increased 11.09 9.64 77 71838 81710 46532437
Herpes dermatitis 11.08 9.64 3 71912 15 46614132
Encephalitis protozoal 11.08 9.64 3 71912 15 46614132
Gallbladder fibrosis 11.08 9.64 3 71912 15 46614132
Contusion 11.08 9.64 84 71831 87403 46526744
Product quality issue 11.05 9.64 24 71891 35624 46578523
Urinary tract infection enterococcal 11.05 9.64 16 71899 2402 46611745
Resorption bone increased 11.05 9.64 11 71904 1116 46613031
Vomiting projectile 11.00 9.64 12 71903 1353 46612794
Cytomegalovirus oesophagitis 10.98 9.64 6 71909 239 46613908
Pulmonary cavitation 10.95 9.64 9 71906 711 46613436
Systemic inflammatory response syndrome 10.92 9.64 25 71890 5346 46608801
Vaginal mucosal blistering 10.92 9.64 3 71912 16 46614131
Meningitis coccidioides 10.92 9.64 3 71912 16 46614131
Eye irritation 10.89 9.64 6 71909 16608 46597539
Infection 10.85 9.64 276 71639 133316 46480831
Marrow hyperplasia 10.78 9.64 8 71907 544 46613603
Citrobacter test positive 10.77 9.64 3 71912 17 46614130
Bradycardia 10.77 9.64 59 71856 66239 46547908
Biliary dyskinesia 10.75 9.64 17 71898 2756 46611391
Fracture 10.72 9.64 6 71909 16465 46597682
Somnolence 10.71 9.64 173 71742 156348 46457799
Fungal test positive 10.71 9.64 8 71907 550 46613597
Fungal endocarditis 10.66 9.64 6 71909 253 46613894
Psoriasis 10.66 9.64 74 71841 78530 46535617
Lichenification 10.64 9.64 7 71908 392 46613755
Perihepatic abscess 10.62 9.64 3 71912 18 46614129
Idiopathic intracranial hypertension 10.60 9.64 16 71899 2493 46611654
Premature delivery 10.59 9.64 11 71904 22058 46592089
Opsoclonus myoclonus 10.57 9.64 5 71910 146 46614001
Herpes virus infection 10.56 9.64 23 71892 4759 46609388
Gastrointestinal necrosis 10.55 9.64 17 71898 2801 46611346
Sepsis neonatal 10.49 9.64 7 71908 402 46613745
Palpitations 10.45 9.64 95 71820 95164 46518983
Rhinorrhoea 10.40 9.64 38 71877 47627 46566520
Cholelithiasis 10.36 9.64 98 71817 38583 46575564
Mastitis fungal 10.35 9.64 4 71911 70 46614077
Blood culture positive 10.30 9.64 22 71893 4490 46609657
Bone marrow myelogram abnormal 10.23 9.64 3 71912 21 46614126
Rash erythematous 10.20 9.64 89 71826 34261 46579886
Pain in jaw 10.19 9.64 28 71887 38344 46575803
Staphylococcal bacteraemia 10.16 9.64 23 71892 4881 46609266
Tricuspid valve incompetence 10.15 9.64 45 71870 13672 46600475
Fibromyalgia 10.15 9.64 26 71889 36437 46577710
Off label use 10.14 9.64 480 71435 379361 46234786
Heart rate decreased 10.14 9.64 21 71894 31702 46582445
Skin hyperpigmentation 10.10 9.64 24 71891 5258 46608889
Drug ineffective for unapproved indication 10.07 9.64 51 71864 16362 46597785
Herpes simplex viraemia 10.04 9.64 5 71910 164 46613983
Vertigo positional 10.03 9.64 16 71899 2614 46611533
Musculoskeletal pain 10.02 9.64 65 71850 70063 46544084
Oliguria 10.01 9.64 33 71882 8726 46605421
Injection site urticaria 9.99 9.64 3 71912 11964 46602183
Leukocytosis 9.98 9.64 66 71849 23332 46590815
Low cardiac output syndrome 9.94 9.64 6 71909 289 46613858
Fungal skin infection 9.94 9.64 19 71896 3583 46610564
Acute sinusitis 9.90 9.64 20 71895 3927 46610220
Hepatorenal failure 9.89 9.64 8 71907 618 46613529
Device expulsion 9.88 9.64 17 71898 27525 46586622
Diabetic hyperosmolar coma 9.88 9.64 7 71908 443 46613704
Anal candidiasis 9.88 9.64 3 71912 24 46614123
Depressed mood 9.87 9.64 23 71892 33296 46580851
Thrombocytosis 9.86 9.64 23 71892 4979 46609168
Exposure during pregnancy 9.78 9.64 113 71802 108099 46506048
Ileus paralytic 9.78 9.64 21 71894 4302 46609845
Jaundice 9.78 9.64 77 71838 28768 46585379
Balamuthia infection 9.77 9.64 3 71912 25 46614122
Product storage error 9.76 9.64 3 71912 11789 46602358
Drug withdrawal syndrome 9.74 9.64 17 71898 27367 46586780
Petechiae 9.71 9.64 42 71873 12628 46601519
Hypoalbuminaemia 9.71 9.64 36 71879 10091 46604056
Haemochromatosis 9.69 9.64 7 71908 457 46613690
Pruritus genital 9.66 9.64 8 71907 639 46613508
Clostridial infection 9.64 9.64 21 71894 4344 46609803

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 442.65 10.46 785 60279 105908 29785506
Candida infection 288.61 10.46 244 60820 15118 29876296
Immune reconstitution inflammatory syndrome 220.89 10.46 168 60896 8933 29882481
Pyrexia 215.05 10.46 1172 59892 293317 29598097
Pancytopenia 178.83 10.46 476 60588 84576 29806838
Mucormycosis 161.41 10.46 112 60952 5156 29886258
Drug interaction 151.11 10.46 803 60261 198765 29692649
Neutropenia 148.51 10.46 586 60478 127954 29763460
Completed suicide 143.97 10.46 17 61047 99475 29791939
Cytokine release syndrome 143.37 10.46 136 60928 9797 29881617
Multiple organ dysfunction syndrome 142.26 10.46 364 60700 63123 29828291
Meningitis cryptococcal 140.90 10.46 73 60991 1951 29889463
Graft versus host disease 138.99 10.46 135 60929 10015 29881399
Drug abuse 138.31 10.46 7 61057 82065 29809349
Sepsis 133.33 10.46 621 60443 145774 29745640
Septic shock 129.59 10.46 352 60712 63255 29828159
Enterococcal infection 115.65 10.46 111 60953 8113 29883301
Cryptococcosis 111.29 10.46 60 61004 1742 29889672
Aspergillus infection 111.07 10.46 120 60944 10094 29881320
Toxic epidermal necrolysis 108.43 10.46 157 60907 17783 29873631
Platelet count decreased 106.10 10.46 463 60601 105666 29785748
Fungal infection 103.36 10.46 133 60931 13467 29877947
Thrombocytopenia 95.79 10.46 540 60524 136504 29754910
Pathogen resistance 95.32 10.46 101 60963 8309 29883105
Bronchopulmonary aspergillosis 91.58 10.46 119 60945 12165 29879249
Oral candidiasis 90.04 10.46 112 60952 10959 29880455
Cytomegalovirus infection 88.68 10.46 167 60897 23507 29867907
Myocardial infarction 88.05 10.46 76 60988 125549 29765865
Systemic candida 87.58 10.46 60 61004 2704 29888710
Neutrophil count decreased 83.48 10.46 232 60832 42222 29849192
Fall 81.86 10.46 154 60910 181718 29709696
Drug resistance 75.37 10.46 142 60922 19991 29871423
Mucosal inflammation 74.71 10.46 181 60883 30313 29861101
Oesophageal candidiasis 67.23 10.46 61 61003 4149 29887265
Dyspnoea 67.12 10.46 402 60662 332893 29558521
Hepatotoxicity 66.71 10.46 127 60937 18018 29873396
Intentional overdose 65.48 10.46 5 61059 41476 29849938
Blood bilirubin increased 65.03 10.46 193 60871 36443 29854971
Disseminated intravascular coagulation 64.69 10.46 141 60923 22030 29869384
Dizziness 64.61 10.46 194 60870 194715 29696699
Overdose 64.11 10.46 47 61017 84290 29807124
Arthralgia 63.71 10.46 112 60952 135679 29755735
White blood cell count decreased 61.36 10.46 335 60729 83612 29807802
Torsade de pointes 60.50 10.46 74 60990 7116 29884298
Rheumatoid arthritis 59.64 10.46 7 61057 41190 29850224
Candida sepsis 58.01 10.46 33 61031 1066 29890348
Death 55.73 10.46 464 60600 356819 29534595
Product dose omission issue 55.46 10.46 63 61001 91568 29799846
Peripheral swelling 54.81 10.46 28 61036 61046 29830368
Cytomegalovirus viraemia 53.20 10.46 62 61002 5667 29885747
Alanine aminotransferase increased 51.99 10.46 293 60771 73983 29817431
Fungaemia 51.52 10.46 40 61024 2191 29889223
Cardiac failure congestive 51.11 10.46 58 61006 84349 29807065
Fatigue 51.09 10.46 414 60650 320259 29571155
Encephalitis 48.98 10.46 63 61001 6373 29885041
Toxicity to various agents 48.11 10.46 192 60872 176991 29714423
Stevens-Johnson syndrome 47.11 10.46 108 60956 17448 29873966
Pain 46.29 10.46 188 60876 172453 29718961
Acute graft versus host disease 45.57 10.46 58 61006 5806 29885608
Bone marrow failure 45.53 10.46 149 60915 29636 29861778
Immunosuppressant drug level increased 45.53 10.46 52 61012 4650 29886764
Pneumonia 44.65 10.46 941 60123 333365 29558049
Insomnia 44.64 10.46 76 60988 93260 29798154
Acinetobacter infection 44.55 10.46 27 61037 983 29890431
Porphyria acute 44.48 10.46 14 61050 93 29891321
Joint swelling 44.44 10.46 20 61044 46926 29844488
Nasopharyngitis 44.44 10.46 33 61031 58816 29832598
Acute myeloid leukaemia 44.22 10.46 107 60957 17899 29873515
Electrocardiogram QT prolonged 44.20 10.46 167 60897 35668 29855746
Cytomegalovirus chorioretinitis 43.86 10.46 43 61021 3225 29888189
Acute graft versus host disease in skin 43.83 10.46 50 61014 4466 29886948
Wrong technique in product usage process 43.39 10.46 6 61058 31149 29860265
Cerebrovascular accident 41.76 10.46 66 60998 83411 29808003
Cystitis haemorrhagic 41.46 10.46 50 61014 4737 29886677
Gait disturbance 41.45 10.46 55 61009 74722 29816692
Clostridium test positive 41.37 10.46 34 61030 2022 29889392
Trichosporon infection 41.04 10.46 22 61042 631 29890783
Aspartate aminotransferase increased 41.00 10.46 245 60819 63177 29828237
Respiratory failure 40.67 10.46 347 60717 100295 29791119
Pseudomonas infection 39.31 10.46 74 60990 10408 29881006
Intentional product misuse 39.24 10.46 11 61053 34656 29856758
Pruritus genital 38.79 10.46 19 61045 449 29890965
Pain in extremity 38.43 10.46 107 60957 110114 29781300
Lymphocyte count decreased 38.29 10.46 105 60959 18950 29872464
Acute myocardial infarction 37.07 10.46 32 61032 52907 29838507
Bacteraemia 36.65 10.46 91 60973 15469 29875945
Tumour lysis syndrome 36.51 10.46 81 60983 12804 29878610
Toxic neuropathy 36.24 10.46 17 61047 364 29891050
Fusarium infection 35.86 10.46 24 61040 1040 29890374
Pneumonia fungal 35.74 10.46 50 61014 5483 29885931
Injection site pain 35.48 10.46 9 61055 30301 29861113
Chest pain 35.47 10.46 122 60942 117505 29773909
Systemic mycosis 35.26 10.46 25 61039 1191 29890223
Leukopenia 35.05 10.46 215 60849 55944 29835470
Psoriasis 34.53 10.46 22 61042 42484 29848930
Blood lactate dehydrogenase increased 34.17 10.46 106 60958 20495 29870919
Acute myeloid leukaemia recurrent 34.06 10.46 27 61037 1525 29889889
Chronic graft versus host disease 34.02 10.46 42 61022 4077 29887337
Depression 33.64 10.46 85 60979 90352 29801062
Pseudomembranous colitis 33.48 10.46 35 61029 2833 29888581
Suicidal ideation 33.23 10.46 16 61048 36098 29855316
Venoocclusive liver disease 33.05 10.46 53 61011 6560 29884854
Therapeutic product effect incomplete 32.68 10.46 14 61050 33820 29857594
Staphylococcal infection 32.55 10.46 135 60929 30089 29861325
Anxiety 32.25 10.46 86 60978 89785 29801629
Feeling abnormal 32.22 10.46 41 61023 56715 29834699
Drug level increased 31.90 10.46 96 60968 18258 29873156
Aplasia 31.48 10.46 40 61024 3997 29887417
Fungal skin infection 30.79 10.46 31 61033 2401 29889013
Liver disorder 30.64 10.46 131 60933 29591 29861823
Coccidioidomycosis 30.60 10.46 18 61046 620 29890794
Meningitis coccidioides 30.54 10.46 8 61056 24 29891390
Acute respiratory distress syndrome 30.28 10.46 111 60953 23361 29868053
Hyperferritinaemia 30.26 10.46 15 61049 364 29891050
Graft versus host disease in gastrointestinal tract 29.82 10.46 34 61030 3035 29888379
Penis injury 29.77 10.46 13 61051 234 29891180
C-reactive protein increased 29.41 10.46 170 60894 43303 29848111
Agranulocytosis 29.35 10.46 105 60959 21837 29869577
Fungal test positive 28.81 10.46 16 61048 493 29890921
Encephalitis viral 28.77 10.46 22 61042 1178 29890236
Acquired immunodeficiency syndrome 28.66 10.46 16 61048 498 29890916
Stem cell transplant 28.52 10.46 28 61036 2103 29889311
Hypoalbuminaemia 28.40 10.46 67 60997 11025 29880389
Epidermolysis bullosa 28.20 10.46 10 61054 100 29891314
Long QT syndrome 28.19 10.46 29 61035 2304 29889110
Memory impairment 27.86 10.46 21 61043 37153 29854261
Hepatic function abnormal 27.71 10.46 163 60901 41782 29849632
Enterococcal bacteraemia 27.62 10.46 23 61041 1393 29890021
Headache 27.29 10.46 239 60825 182067 29709347
Differentiation syndrome 27.23 10.46 21 61043 1139 29890275
Cerebral toxoplasmosis 26.85 10.46 23 61041 1449 29889965
Malaise 26.74 10.46 215 60849 166747 29724667
Inappropriate schedule of product administration 26.63 10.46 25 61039 39703 29851711
Hyperhidrosis 26.57 10.46 61 61003 67029 29824385
Penile haemorrhage 26.05 10.46 16 61048 597 29890817
Blood corticosterone increased 25.99 10.46 5 61059 0 29891414
Immune effector cell-associated neurotoxicity syndrome 25.75 10.46 18 61046 838 29890576
Foetal exposure during pregnancy 24.95 10.46 23 61041 36848 29854566
Abdominal discomfort 24.94 10.46 38 61026 48753 29842661
Infection 24.90 10.46 256 60808 77818 29813596
Bacterial infection 24.85 10.46 69 60995 12541 29878873
Stomatitis 24.71 10.46 145 60919 37134 29854280
Blood alkaline phosphatase increased 24.56 10.46 128 60936 31359 29860055
Adrenal insufficiency 24.44 10.46 61 61003 10402 29881012
Weight increased 24.44 10.46 75 60989 74838 29816576
Aplastic anaemia 24.38 10.46 42 61022 5514 29885900
Hyperbilirubinaemia 24.33 10.46 83 60981 16859 29874555
Clostridium difficile colitis 24.31 10.46 69 60995 12699 29878715
Device related infection 24.12 10.46 83 60981 16932 29874482
Wound infection fungal 24.08 10.46 7 61057 34 29891380
Asthma 23.97 10.46 23 61041 36151 29855263
Bacterial sepsis 23.96 10.46 39 61025 4887 29886527
Aggression 23.84 10.46 24 61040 36883 29854531
Musculoskeletal pain 23.81 10.46 17 61047 30923 29860491
Haematotoxicity 23.68 10.46 44 61020 6126 29885288
Syncope 23.64 10.46 91 60973 84812 29806602
Portal fibrosis 23.60 10.46 13 61051 394 29891020
Pneumonia cryptococcal 23.57 10.46 16 61048 710 29890704
Chronic obstructive pulmonary disease 23.50 10.46 36 61028 46090 29845324
Cardiac disorder 23.50 10.46 28 61036 39865 29851549
Mycetoma mycotic 23.44 10.46 7 61057 38 29891376
Perivascular dermatitis 23.37 10.46 10 61054 171 29891243
Coronary artery disease 23.27 10.46 41 61023 49671 29841743
Oropharyngeal candidiasis 23.14 10.46 16 61048 732 29890682
Disseminated cryptococcosis 23.10 10.46 18 61046 991 29890423
Angina pectoris 23.00 10.46 16 61048 29502 29861912
Neurotoxicity 22.95 10.46 69 60995 13113 29878301
Hypertension 22.93 10.46 149 60915 121205 29770209
Staphylococcal sepsis 22.87 10.46 56 61008 9435 29881979
Aspartate aminotransferase 22.86 10.46 9 61055 123 29891291
Myalgia 22.77 10.46 80 60984 76587 29814827
Blood pressure increased 22.77 10.46 73 60991 71855 29819559
Cachexia 22.74 10.46 45 61019 6566 29884848
Arthropathy 22.68 10.46 7 61057 20720 29870694
Gallstone ileus 21.99 10.46 6 61058 22 29891392
Endocarditis candida 21.96 10.46 8 61056 87 29891327
CD4 lymphocytes decreased 21.94 10.46 24 61040 2046 29889368
Stress 21.85 10.46 7 61057 20228 29871186
Enterococcal sepsis 21.73 10.46 21 61043 1547 29889867
Blood culture positive 21.34 10.46 37 61027 4882 29886532
Hospitalisation 21.25 10.46 36 61028 44283 29847131
Pulmonary haemorrhage 21.15 10.46 54 61010 9338 29882076
Fluorosis 21.12 10.46 7 61057 56 29891358
Adenovirus infection 21.05 10.46 34 61030 4234 29887180
Chest discomfort 20.85 10.46 38 61026 45442 29845972
Secondary adrenocortical insufficiency 20.84 10.46 17 61047 1000 29890414
Anterior displaced anus 20.79 10.46 4 61060 0 29891414
Kaposi's sarcoma 20.68 10.46 17 61047 1011 29890403
Adrenal suppression 20.67 10.46 14 61050 619 29890795
Drug intolerance 20.62 10.46 38 61026 45253 29846161
Osteoarthritis 20.44 10.46 6 61058 18343 29873071
Acute generalised exanthematous pustulosis 20.36 10.46 41 61023 6057 29885357
Drug dependence 20.26 10.46 9 61055 21286 29870128
Coagulopathy 20.23 10.46 83 60981 18404 29873010
Acute lymphocytic leukaemia 20.20 10.46 28 61036 3044 29888370
Road traffic accident 20.11 10.46 5 61059 17066 29874348
Respiratory tract infection fungal 20.08 10.46 14 61050 649 29890765
Graft versus host disease in skin 20.06 10.46 29 61035 3278 29888136
Prostate cancer 20.01 10.46 12 61052 23945 29867469
Choreoathetosis 19.83 10.46 16 61048 927 29890487
Wound dehiscence 19.83 10.46 29 61035 3312 29888102
Skin necrosis 19.78 10.46 35 61029 4692 29886722
Acute hepatic failure 19.74 10.46 61 61003 11766 29879648
Encephalitis fungal 19.61 10.46 9 61055 183 29891231
Pseudomonal sepsis 19.21 10.46 27 61037 2973 29888441
Klebsiella infection 19.18 10.46 43 61021 6844 29884570
Arthritis fungal 19.07 10.46 7 61057 78 29891336
HIV infection 18.84 10.46 20 61044 1648 29889766
Nephropathy toxic 18.82 10.46 56 61008 10583 29880831
Therapy cessation 18.69 10.46 4 61060 15133 29876281
Therapeutic product effect decreased 18.67 10.46 19 61045 29057 29862357
Cough 18.65 10.46 165 60899 125477 29765937
Streptococcal infection 18.61 10.46 34 61030 4674 29886740
Blast cell count increased 18.34 10.46 16 61048 1033 29890381
Dysbiosis 18.34 10.46 11 61053 393 29891021
Mycobacterium avium complex infection 18.26 10.46 25 61039 2686 29888728
Pulmonary alveolar haemorrhage 18.22 10.46 41 61023 6540 29884874
Multiple chemical sensitivity 18.03 10.46 4 61060 4 29891410
Hepatic necrosis 18.00 10.46 30 61034 3833 29887581
Hepatic failure 17.98 10.46 125 60939 33918 29857496
Sleep apnoea syndrome 17.90 10.46 6 61058 16851 29874563
Stenotrophomonas test positive 17.83 10.46 10 61054 314 29891100
Drug reaction with eosinophilia and systemic symptoms 17.72 10.46 109 60955 28379 29863035
Muscle spasms 17.72 10.46 70 60994 64768 29826646
Loss of personal independence in daily activities 17.69 10.46 11 61053 21524 29869890
Drug-induced liver injury 17.65 10.46 88 60976 21186 29870228
Central venous pressure increased 17.60 10.46 5 61059 22 29891392
Pulmonary mucormycosis 17.49 10.46 11 61053 428 29890986
Vision blurred 17.39 10.46 37 61027 41779 29849635
Brachycephaly 17.38 10.46 6 61058 55 29891359
Musculoskeletal stiffness 17.34 10.46 29 61035 35852 29855562
Ocular icterus 17.33 10.46 26 61038 3038 29888376
Atelectasis 17.30 10.46 72 60992 16066 29875348
Elbow synostosis 17.25 10.46 5 61059 24 29891390
Engraftment syndrome 17.23 10.46 14 61050 819 29890595
Opportunistic infection 17.20 10.46 17 61047 1287 29890127
Swelling face 17.18 10.46 11 61053 21193 29870221
Engraft failure 17.18 10.46 11 61053 442 29890972
Odynophagia 17.02 10.46 32 61032 4495 29886919
Enterococcus test positive 16.96 10.46 14 61050 838 29890576
Synostosis 16.95 10.46 7 61057 109 29891305
Rash maculo-papular 16.93 10.46 99 60965 25319 29866095
Gamma-glutamyltransferase increased 16.83 10.46 110 60954 29240 29862174
Eschar 16.75 10.46 12 61052 581 29890833
HIV associated nephropathy 16.67 10.46 9 61055 262 29891152
Klebsiella sepsis 16.64 10.46 19 61045 1698 29889716
Gastrooesophageal reflux disease 16.59 10.46 25 61039 32230 29859184
Geotrichum infection 16.59 10.46 11 61053 469 29890945
Cytomegalovirus test positive 16.58 10.46 28 61036 3617 29887797
Acanthamoeba infection 16.45 10.46 11 61053 476 29890938
Jaundice 16.40 10.46 118 60946 32368 29859046
Idiosyncratic drug reaction 16.19 10.46 11 61053 489 29890925
Anticonvulsant drug level abnormal 16.18 10.46 5 61059 31 29891383
Epstein-Barr viraemia 16.07 10.46 14 61050 902 29890512
Irritability 16.05 10.46 14 61050 23036 29868378
Plasma cell myeloma 15.95 10.46 173 60891 53289 29838125
Transplant rejection 15.85 10.46 48 61016 9158 29882256
Oedema 15.67 10.46 145 60919 42848 29848566
Heart rate irregular 15.64 10.46 3 61061 12256 29879158
Disseminated coccidioidomycosis 15.59 10.46 3 61061 0 29891414
Stiff person syndrome 15.50 10.46 7 61057 137 29891277
Sedation 15.45 10.46 7 61057 16366 29875048
Culture stool positive 15.36 10.46 8 61056 216 29891198
Hypertransaminasaemia 15.28 10.46 28 61036 3857 29887557
Swollen tongue 15.28 10.46 4 61060 13188 29878226
Blood glucose increased 15.22 10.46 69 60995 61461 29829953
Central nervous system lesion 15.22 10.46 32 61032 4874 29886540
Pulmonary valve disease 15.11 10.46 6 61058 84 29891330
Neurological symptom 15.05 10.46 26 61038 3421 29887993
Haemodynamic instability 14.95 10.46 43 61021 7972 29883442
Product quality issue 14.86 10.46 10 61054 18764 29872650
Pseudomonas test positive 14.83 10.46 14 61050 1002 29890412
Hypokalaemia 14.78 10.46 162 60902 50030 29841384
Escherichia sepsis 14.73 10.46 28 61036 3966 29887448
Sputum purulent 14.73 10.46 10 61054 444 29890970
Nosocomial infection 14.66 10.46 15 61049 1184 29890230
Osteonecrosis of jaw 14.62 10.46 10 61054 18608 29872806
Familial periodic paralysis 14.61 10.46 6 61058 92 29891322
Mobility decreased 14.52 10.46 19 61045 25980 29865434
Gastrointestinal wall thinning 14.39 10.46 4 61060 16 29891398
Cytomegalovirus test 14.37 10.46 5 61059 47 29891367
Blood pressure fluctuation 14.29 10.46 9 61055 17494 29873920
Hyperadrenocorticism 14.27 10.46 6 61058 98 29891316
Unevaluable event 14.17 10.46 27 61037 31758 29859656
Application site haematoma 14.10 10.46 5 61059 50 29891364
Flushing 14.10 10.46 24 61040 29468 29861946
Incorrect dose administered 14.06 10.46 27 61037 31659 29859755
Ventricular tachycardia 14.03 10.46 90 60974 23772 29867642
Contraindicated product administered 13.88 10.46 9 61055 17222 29874192
Hepatic enzyme increased 13.77 10.46 116 60948 33378 29858036
Angina unstable 13.75 10.46 4 61060 12306 29879108
Cardio-respiratory arrest 13.74 10.46 65 60999 57241 29834173
Peritoneal candidiasis 13.66 10.46 4 61060 20 29891394
Drug ineffective for unapproved indication 13.65 10.46 51 61013 10829 29880585
Anger 13.61 10.46 3 61061 11117 29880297
Intracranial pressure increased 13.53 10.46 25 61039 3465 29887949
Generalised oedema 13.51 10.46 54 61010 11831 29879583
Arthritis 13.46 10.46 18 61046 24383 29867031
Diabetic ketoacidosis 13.36 10.46 8 61056 15978 29875436
Strabismus 13.34 10.46 14 61050 1138 29890276
Meningism 13.28 10.46 7 61057 194 29891220
Venoocclusive disease 13.27 10.46 21 61043 2569 29888845
Oral mucosal erythema 13.11 10.46 9 61055 407 29891007
Neutropenic sepsis 13.10 10.46 52 61012 11357 29880057
Cytomegalovirus enterocolitis 13.08 10.46 12 61052 828 29890586
Viraemia 13.07 10.46 14 61050 1165 29890249
Ischaemic hepatitis 13.04 10.46 16 61048 1543 29889871
Angioedema 13.02 10.46 32 61032 34352 29857062
Organ failure 12.98 10.46 19 61045 2172 29889242
Enterobacter test positive 12.83 10.46 7 61057 208 29891206
Psychotic disorder 12.77 10.46 15 61049 21500 29869914
Brain abscess 12.73 10.46 21 61043 2660 29888754
Dermatitis 12.68 10.46 41 61023 8101 29883313
Bradycardia 12.59 10.46 80 60984 65446 29825968
Respiratory paralysis 12.59 10.46 5 61059 70 29891344
Epstein-Barr virus infection 12.53 10.46 36 61028 6670 29884744
Hepatomegaly 12.53 10.46 47 61017 10000 29881414
Viral test positive 12.51 10.46 7 61057 219 29891195
Macule 12.45 10.46 12 61052 881 29890533
Proteus infection 12.41 10.46 11 61053 725 29890689
Haemophagocytic lymphohistiocytosis 12.37 10.46 46 61018 9745 29881669
Periorbital cellulitis 12.34 10.46 7 61057 225 29891189
Product administration error 12.29 10.46 7 61057 14370 29877044
Streptococcal bacteraemia 12.17 10.46 16 61048 1654 29889760
Pneumonia pseudomonal 12.16 10.46 24 61040 3494 29887920
Faeces pale 12.10 10.46 15 61049 1462 29889952
Pleocytosis 12.08 10.46 9 61055 463 29890951
Heart rate decreased 12.08 10.46 15 61049 20979 29870435
End stage AIDS 12.07 10.46 4 61060 32 29891382
Mucosal infection 12.06 10.46 7 61057 235 29891179
Lung neoplasm malignant 12.06 10.46 8 61056 15124 29876290
Gastroduodenal ulcer 12.05 10.46 8 61056 342 29891072
Drug hypersensitivity 12.00 10.46 86 60978 68433 29822981
Strongyloidiasis 11.99 10.46 19 61045 2327 29889087
Oral fungal infection 11.88 10.46 14 61050 1294 29890120
Somnolence 11.87 10.46 133 60931 96630 29794784
Renal impairment 11.81 10.46 239 60825 83945 29807469
Mycobacterial infection 11.79 10.46 16 61048 1705 29889709
Skull malformation 11.71 10.46 8 61056 359 29891055
Constipation 11.67 10.46 161 60903 112745 29778669
Accidental overdose 11.67 10.46 12 61052 18263 29873151
Nightmare 11.65 10.46 5 61059 12071 29879343
Acute graft versus host disease in intestine 11.64 10.46 19 61045 2386 29889028
Sleep disorder 11.63 10.46 20 61044 24459 29866955
Blood creatine phosphokinase increased 11.56 10.46 48 61016 43800 29847614
Haemodialysis 11.56 10.46 49 61015 11024 29880390
Prostatic specific antigen increased 11.54 10.46 5 61059 11999 29879415
Liver transplant rejection 11.51 10.46 18 61046 2180 29889234
Oral herpes 11.50 10.46 27 61037 4428 29886986
Eosinophilia 11.48 10.46 81 60983 22079 29869335
Back pain 11.44 10.46 144 60920 102452 29788962
Central nervous system fungal infection 11.38 10.46 7 61057 262 29891152
Cholangitis infective 11.38 10.46 7 61057 262 29891152
Citrobacter infection 11.33 10.46 9 61055 510 29890904
Hyperuricaemia 11.30 10.46 37 61027 7357 29884057
Prothrombin time prolonged 11.17 10.46 43 61021 9260 29882154
Paraesthesia 11.13 10.46 65 60999 54262 29837152
Type 2 diabetes mellitus 11.13 10.46 7 61057 13615 29877799
Cholestasis 11.11 10.46 88 60976 24862 29866552
Hyperleukocytosis 11.08 10.46 15 61049 1594 29889820
Candida pneumonia 11.05 10.46 7 61057 276 29891138
Monocytopenia 11.02 10.46 5 61059 99 29891315
Diffuse alopecia 10.99 10.46 3 61061 11 29891403
Transmission of an infectious agent via transplant 10.99 10.46 3 61061 11 29891403
Stenotrophomonas infection 10.98 10.46 15 61049 1609 29889805
Liver abscess 10.97 10.46 22 61042 3240 29888174
Enterobacter infection 10.93 10.46 17 61047 2049 29889365
Asthenia 10.90 10.46 356 60708 220934 29670480
Basal cell carcinoma 10.90 10.46 10 61054 16058 29875356
Candida endophthalmitis 10.88 10.46 5 61059 102 29891312
Precocious puberty 10.88 10.46 5 61059 102 29891312
Candida test positive 10.85 10.46 8 61056 405 29891009
Graft loss 10.85 10.46 11 61053 859 29890555
Eyelid ptosis congenital 10.83 10.46 5 61059 103 29891311
Pneumonia cytomegaloviral 10.81 10.46 20 61044 2776 29888638
Product prescribing error 10.67 10.46 11 61053 16722 29874692
Autonomic neuropathy 10.66 10.46 11 61053 877 29890537
Pleural effusion 10.63 10.46 211 60853 73855 29817559
Addison's disease 10.60 10.46 3 61061 13 29891401
Hepatitis 10.60 10.46 80 60984 22276 29869138
Loss of consciousness 10.58 10.46 107 60957 79268 29812146
Drug withdrawal syndrome 10.53 10.46 15 61049 19794 29871620
Poisoning 10.53 10.46 5 61059 11377 29880037
Gastroenteritis cryptosporidial 10.51 10.46 6 61058 195 29891219
HIV wasting syndrome 10.49 10.46 5 61059 111 29891303
Congenital eyelid malformation 10.48 10.46 4 61060 50 29891364
T-cell lymphoma recurrent 10.48 10.46 4 61060 50 29891364
Staphylococcal bacteraemia 10.46 10.46 34 61030 6734 29884680

Pharmacologic Action:

SourceCodeDescription
ATC D01AC15 DERMATOLOGICALS
ANTIFUNGALS FOR DERMATOLOGICAL USE
ANTIFUNGALS FOR TOPICAL USE
Imidazole and triazole derivatives
ATC J01RA07 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC J02AC01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIMYCOTICS FOR SYSTEMIC USE
ANTIMYCOTICS FOR SYSTEMIC USE
Triazole derivatives
FDA CS M0002083 Azoles
MeSH PA D058888 14-alpha Demethylase Inhibitors
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000935 Antifungal Agents
MeSH PA D065689 Cytochrome P-450 CYP2C19 Inhibitors
MeSH PA D065688 Cytochrome P-450 CYP2C9 Inhibitors
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006727 Hormone Antagonists
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D065088 Steroid Synthesis Inhibitors
FDA EPC N0000175487 Azole Antifungal
FDA MoA N0000182140 Cytochrome P450 2C19 Inhibitors
FDA MoA N0000182141 Cytochrome P450 3A4 Inhibitors
FDA MoA N0000185504 Cytochrome P450 2C9 Inhibitors
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:50183 cytochrome p450 inhibitor
CHEBI has role CHEBI:78298 environmental contaminants

Drug Use (View source of the data)

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

Acid dissociation constants calculated using MoKa v3.0.0

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

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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

External reference:

IDSource
4019493 VUID
N0000147613 NUI
D00322 KEGG_DRUG
4019493 VANDF
C0699601 UMLSCUI
CHEBI:46081 CHEBI
TPF PDB_CHEM_ID
CHEMBL106 ChEMBL_ID
DB00196 DRUGBANK_ID
D015725 MESH_DESCRIPTOR_UI
3365 PUBCHEM_CID
5851 INN_ID
8VZV102JFY UNII
202813 RXNORM
3884 MMSL
4732 MMSL
59176 MMSL
d00071 MMSL
003534 NDDF
31865003 SNOMEDCT_US
387174006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3410 TABLET 50 mg ORAL NDA 26 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3420 TABLET 100 mg ORAL NDA 26 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3430 TABLET 200 mg ORAL NDA 26 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3440 POWDER, FOR SUSPENSION 350 mg ORAL NDA 26 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3450 POWDER, FOR SUSPENSION 1400 mg ORAL NDA 26 sections
Diflucan HUMAN PRESCRIPTION DRUG LABEL 1 0049-3500 TABLET 150 mg ORAL NDA 26 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0143-9666 INJECTION 2 mg INTRAVENOUS ANDA 21 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0143-9667 INJECTION 2 mg INTRAVENOUS ANDA 21 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0143-9668 INJECTION 2 mg INTRAVENOUS ANDA 21 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0143-9669 INJECTION 2 mg INTRAVENOUS ANDA 21 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0143-9899 INJECTION 2 mg INTRAVENOUS ANDA 21 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0172-5410 TABLET 50 mg ORAL ANDA 13 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0172-5411 TABLET 100 mg ORAL ANDA 13 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0172-5412 TABLET 150 mg ORAL ANDA 13 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0172-5413 TABLET 200 mg ORAL ANDA 13 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0338-6045 INJECTION, SOLUTION 400 mg INTRAVENOUS ANDA 25 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0338-6046 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 25 sections
Fluconazole in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0409-4688 INJECTION, SOLUTION 2 mg INTRAVENOUS ANDA 25 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0904-6500 TABLET 100 mg ORAL ANDA 25 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 0904-6501 TABLET 200 mg ORAL ANDA 25 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 10544-178 TABLET 200 mg ORAL ANDA 15 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 10544-610 TABLET 200 mg ORAL ANDA 24 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 10544-855 TABLET 150 mg ORAL ANDA 22 sections
Fluconazole HUMAN PRESCRIPTION DRUG LABEL 1 12634-780 TABLET 150 mg ORAL ANDA 23 sections
Fluconazole Human Prescription Drug Label 1 16571-210 TABLET 50 mg ORAL ANDA 18 sections
Fluconazole Human Prescription Drug Label 1 16571-211 TABLET 100 mg ORAL ANDA 18 sections
Fluconazole Human Prescription Drug Label 1 16571-212 TABLET 150 mg ORAL ANDA 18 sections
Fluconazole Human Prescription Drug Label 1 16571-213 TABLET 200 mg ORAL ANDA 18 sections
FLUCONULLZOLE HUMAN PRESCRIPTION DRUG LABEL 1 16590-282 TABLET 150 mg ORAL ANDA 24 sections
FLUCONULLZOLE HUMAN PRESCRIPTION DRUG LABEL 1 16590-283 TABLET 200 mg ORAL ANDA 14 sections