posaconazole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
systemic antifungal agents, miconazole derivatives 3483 171228-49-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • posaconazole
  • noxafil
  • posaconazol
  • SCH 56592
  • SCH-56592
an antifungal medicine that belongs to the triazole group, it works by preventing the formation of ergosterol, which is an important part of fungal cell walls
  • Molecular weight: 700.79
  • Formula: C37H42F2N8O4
  • CLOGP: 5.32
  • LIPINSKI: 2
  • HAC: 12
  • HDO: 1
  • TPSA: 111.79
  • ALOGS: -4.77
  • ROTB: 12
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.30 g O
0.30 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.10 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 16.31 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) 3.80 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 4.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 10.60 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,CAMK2D,EIF2AK3,GRK2,ITK,MAPK10,PDK1,PDK2,PDK4 9
kinase-selectivity-class EIF2AK3,GRK2 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 35.892 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
rat-kpuu-brain Rat brain Kpuu 0.030 % High 1

Approvals:

DateAgencyCompanyOrphan
Jan. 23, 2020 PMDA MSD K.K.
April 26, 2019 EMA Accord Healthcare S.L.U.
Sept. 15, 2006 FDA SCHERING

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 640.47 21.60 386 16470 157963 90453628
Pseudoaldosteronism 273.30 21.60 43 16813 105 90611486
Acute myeloid leukaemia 259.90 21.60 109 16747 20531 90591060
Drug interaction 252.67 21.60 283 16573 276170 90335421
Product use in unapproved indication 247.40 21.60 308 16548 335928 90275663
Neutropenia 224.05 21.60 241 16615 224663 90386928
Septic shock 216.61 21.60 155 16701 84005 90527586
Systemic candida 195.73 21.60 61 16795 4898 90606693
Fusarium infection 171.93 21.60 40 16816 1042 90610549
Cholestasis 163.18 21.60 95 16761 36204 90575387
Graft versus host disease 158.69 21.60 59 16797 8085 90603506
Acute myeloid leukaemia recurrent 146.42 21.60 40 16816 2017 90609574
Aspergillus infection 145.80 21.60 60 16796 10763 90600828
Hepatic cytolysis 131.29 21.60 78 16778 30838 90580753
Pneumonia fungal 129.93 21.60 49 16807 6982 90604609
Bronchopulmonary aspergillosis 129.55 21.60 56 16800 11342 90600249
Graft versus host disease in gastrointestinal tract 124.38 21.60 42 16814 4346 90607245
Mucormycosis 121.97 21.60 40 16816 3781 90607810
Sepsis 116.59 21.60 155 16701 179659 90431932
Scedosporium infection 112.74 21.60 27 16829 799 90610792
Protothecosis 110.82 21.60 24 16832 447 90611144
Bacteraemia 107.23 21.60 61 16795 22239 90589352
Electrocardiogram QT prolonged 106.17 21.60 96 16760 72360 90539231
Differentiation syndrome 99.95 21.60 27 16829 1304 90610287
Hepatocellular injury 97.42 21.60 63 16793 28895 90582696
Thrombocytopenia 96.05 21.60 153 16703 208572 90403019
Pancytopenia 92.65 21.60 113 16743 120150 90491441
Myelosuppression 90.53 21.60 77 16779 53514 90558077
Hyperbilirubinaemia 88.95 21.60 46 16810 13890 90597701
Arthralgia 85.67 21.60 20 16836 778502 89833089
Multiple organ dysfunction syndrome 85.60 21.60 83 16773 68253 90543338
Hypokalaemia 84.89 21.60 113 16743 131003 90480588
Cytokine release syndrome 84.73 21.60 57 16799 27916 90583675
Cytomegalovirus infection reactivation 84.33 21.60 37 16819 7763 90603828
Cytopenia 79.27 21.60 46 16810 17403 90594188
Choroidal effusion 78.45 21.60 20 16836 769 90610822
Bone marrow failure 77.46 21.60 57 16799 32164 90579427
Joint swelling 74.19 21.60 5 16851 503295 90108296
Torsade de pointes 71.56 21.60 41 16815 15141 90596450
Pyrexia 70.97 21.60 276 16580 660209 89951382
Respiratory failure 70.49 21.60 98 16758 118320 90493271
Antibiotic level below therapeutic 69.58 21.60 11 16845 28 90611563
Adenoviral hepatitis 68.07 21.60 16 16840 436 90611155
Fungaemia 67.94 21.60 25 16831 3325 90608266
Pain 67.76 21.60 52 16804 996289 89615302
Staphylococcal bacteraemia 66.68 21.60 31 16825 7438 90604153
Left atrial hypertrophy 65.80 21.60 11 16845 44 90611547
Death 64.62 21.60 209 16647 456342 90155249
Acute kidney injury 64.00 21.60 166 16690 320221 90291370
Cytomegalovirus infection 61.57 21.60 46 16810 26556 90585035
Graft versus host disease in skin 61.00 21.60 24 16832 3829 90607762
Disease progression 60.23 21.60 106 16750 156509 90455082
Nasopharyngitis 60.11 21.60 4 16852 407100 90204491
Hypersensitivity 57.88 21.60 8 16848 454669 90156922
Atrioventricular block second degree 57.65 21.60 24 16832 4428 90607163
Off label use 56.72 21.60 374 16482 1101878 89509713
Rheumatoid arthritis 55.23 21.60 3 16853 362611 90248980
BK virus infection 54.07 21.60 23 16833 4475 90607116
Neurotoxicity 53.91 21.60 39 16817 21428 90590163
Pulmonary mucormycosis 53.77 21.60 14 16842 586 90611005
Chronic graft versus host disease 52.54 21.60 22 16834 4117 90607474
Swelling 51.87 21.60 8 16848 419050 90192541
Maternal exposure during pregnancy 51.81 21.60 4 16852 360059 90251532
Klebsiella infection 51.75 21.60 29 16827 10268 90601323
Infusion related reaction 51.49 21.60 8 16848 416772 90194819
Bacterial infection 50.85 21.60 39 16817 23405 90588186
Angle closure glaucoma 50.04 21.60 19 16837 2756 90608835
Aplasia 49.95 21.60 21 16835 3970 90607621
Enterococcal infection 49.83 21.60 28 16828 9963 90601628
Acute graft versus host disease in skin 49.60 21.60 22 16834 4734 90606857
Blood bilirubin increased 49.24 21.60 50 16806 43420 90568171
Adenovirus reactivation 49.05 21.60 11 16845 242 90611349
Staphylococcal sepsis 48.72 21.60 27 16829 9356 90602235
Fatigue 46.01 21.60 91 16765 1153932 89457659
Acute lymphocytic leukaemia 46.00 21.60 18 16838 2830 90608761
Electrocardiogram PR shortened 45.48 21.60 12 16844 529 90611062
Hepatotoxicity 45.26 21.60 49 16807 45793 90565798
Drug hypersensitivity 45.14 21.60 15 16841 463594 90147997
Pain in extremity 44.89 21.60 14 16842 450515 90161076
Venoocclusive liver disease 44.74 21.60 22 16834 5971 90605620
Bicytopenia 44.40 21.60 19 16837 3752 90607839
Herpes simplex 44.02 21.60 26 16830 10155 90601436
Haemophagocytic lymphohistiocytosis 43.25 21.60 30 16826 15429 90596162
Brain abscess 42.72 21.60 17 16839 2795 90608796
Escherichia bacteraemia 42.66 21.60 21 16835 5714 90605877
Sinoatrial block 42.34 21.60 13 16843 992 90610599
Soft tissue infection 42.22 21.60 17 16839 2880 90608711
Depression 41.44 21.60 4 16852 300597 90310994
Staphylococcal infection 41.36 21.60 48 16808 48391 90563200
Systemic mycosis 40.83 21.60 14 16842 1516 90610075
Abdominal discomfort 40.63 21.60 19 16837 477309 90134282
Malaise 40.47 21.60 30 16826 585956 90025635
Acute graft versus host disease in intestine 40.24 21.60 15 16841 2068 90609523
Ureaplasma infection 39.37 21.60 12 16844 893 90610698
Fungal infection 39.34 21.60 44 16812 42617 90568974
Drug ineffective 38.93 21.60 410 16446 1383888 89227703
Weight increased 38.17 21.60 15 16841 417912 90193679
Gastrointestinal toxicity 37.88 21.60 23 16833 9444 90602147
Leukaemia recurrent 37.51 21.60 13 16843 1454 90610137
Pericardial effusion 37.47 21.60 40 16816 36793 90574798
Transaminases increased 37.14 21.60 40 16816 37152 90574439
Overgrowth fungal 37.04 21.60 8 16848 147 90611444
Immune effector cell-associated neurotoxicity syndrome 36.69 21.60 19 16837 5749 90605842
Venous haemorrhage 36.49 21.60 9 16847 302 90611289
Rhinocerebral mucormycosis 36.33 21.60 11 16845 801 90610790
Cortical visual impairment 36.30 21.60 6 16850 22 90611569
Pericarditis 36.19 21.60 4 16852 270147 90341444
Graft versus host disease in lung 35.93 21.60 10 16846 540 90611051
Pathogen resistance 35.81 21.60 21 16835 8094 90603497
Hepatic necrosis 34.73 21.60 19 16837 6419 90605172
Encephalopathy 34.69 21.60 43 16813 46401 90565190
Hypoaesthesia 34.61 21.60 8 16848 314202 90297389
Graft versus host disease in liver 34.48 21.60 11 16845 952 90610639
Tumour lysis syndrome 34.42 21.60 23 16833 11129 90600462
Peripheral swelling 34.30 21.60 17 16839 413089 90198502
Toxic epidermal necrolysis 34.28 21.60 36 16820 32492 90579099
Hepatic failure 33.30 21.60 39 16817 39689 90571902
Mucosal inflammation 33.24 21.60 47 16809 57578 90554013
Drug resistance 32.63 21.60 34 16822 30415 90581176
Disseminated intravascular coagulation 32.43 21.60 29 16827 21509 90590082
Lung infiltration 32.21 21.60 25 16831 15257 90596334
Contraindicated product administered 31.78 21.60 10 16846 320129 90291462
Adenovirus infection 31.65 21.60 16 16840 4606 90606985
Renal failure 31.54 21.60 73 16783 130934 90480657
Cell death 31.43 21.60 14 16842 3041 90608550
Candida infection 31.19 21.60 35 16821 34022 90577569
BK polyomavirus test positive 31.08 21.60 7 16849 157 90611434
Hypogammaglobulinaemia 30.53 21.60 21 16835 10653 90600938
Mobility decreased 30.52 21.60 5 16851 250729 90360862
Cholecystitis acute 30.49 21.60 20 16836 9384 90602207
Geotrichum infection 30.39 21.60 9 16847 607 90610984
Coagulation test abnormal 30.32 21.60 10 16846 961 90610630
Acute pulmonary oedema 30.15 21.60 20 16836 9560 90602031
Pleural effusion 29.86 21.60 65 16791 111926 90499665
Pseudomonal sepsis 29.77 21.60 15 16841 4287 90607304
Growth failure 29.72 21.60 8 16848 381 90611210
Plasma cell myeloma refractory 29.50 21.60 10 16846 1046 90610545
Thrombotic microangiopathy 29.43 21.60 24 16832 15719 90595872
Seroconversion test positive 29.17 21.60 5 16851 24 90611567
Hypoxia 29.10 21.60 50 16806 72349 90539242
Clostridium difficile colitis 28.94 21.60 30 16826 26676 90584915
Urticaria 28.91 21.60 11 16845 312723 90298868
Epstein-Barr virus infection 28.76 21.60 20 16836 10324 90601267
Renal tubular acidosis 28.37 21.60 12 16844 2303 90609288
Musculoskeletal stiffness 28.14 21.60 10 16846 296522 90315069
Organ failure 28.06 21.60 13 16843 3092 90608499
Sinus bradycardia 27.88 21.60 24 16832 16928 90594663
Rhinovirus infection 27.82 21.60 16 16840 5947 90605644
Impaired healing 27.78 21.60 5 16851 234194 90377397
Bacterial sepsis 27.77 21.60 15 16841 4940 90606651
Enterobacter test positive 27.77 21.60 7 16849 257 90611334
Posterior reversible encephalopathy syndrome 27.70 21.60 27 16829 22312 90589279
Dyspnoea 27.43 21.60 79 16777 880876 89730715
Type 2 diabetes mellitus 27.24 21.60 3 16853 203241 90408350
Klebsiella bacteraemia 27.06 21.60 12 16844 2580 90609011
Infection reactivation 26.95 21.60 11 16845 1929 90609662
Cytomegalovirus viraemia 26.73 21.60 17 16839 7569 90604022
Cerebral toxoplasmosis 26.71 21.60 10 16846 1395 90610196
Pelvic venous thrombosis 26.63 21.60 11 16845 1990 90609601
Muscle spasms 26.59 21.60 7 16849 251876 90359715
Enterococcal bacteraemia 26.48 21.60 11 16845 2017 90609574
Hypophosphataemia 26.42 21.60 22 16834 14832 90596759
Hepatomegaly 26.36 21.60 21 16835 13305 90598286
Wheezing 26.33 21.60 6 16850 238074 90373517
Disseminated coccidioidomycosis 26.26 21.60 6 16850 144 90611447
Device related infection 26.22 21.60 28 16828 25758 90585833
Product administered to patient of inappropriate age 25.84 21.60 14 16842 4639 90606952
Cardiac arrest 25.83 21.60 59 16797 104876 90506715
Rash 25.81 21.60 70 16786 796030 89815561
Endophthalmitis 25.75 21.60 14 16842 4671 90606920
Mycobacterium abscessus infection 25.47 21.60 9 16847 1066 90610525
Epstein-Barr virus infection reactivation 25.23 21.60 10 16846 1627 90609964
Transformation to acute myeloid leukaemia 24.90 21.60 7 16849 392 90611199
Drug reaction with eosinophilia and systemic symptoms 24.84 21.60 35 16821 42723 90568868
Long QT syndrome 24.83 21.60 13 16843 4024 90607567
Ascites 24.71 21.60 37 16819 47703 90563888
Dizziness 24.67 21.60 45 16811 589239 90022352
Paraesthesia 24.51 21.60 8 16848 250318 90361273
Klebsiella sepsis 24.41 21.60 10 16846 1771 90609820
Electrocardiogram ST segment depression 24.28 21.60 12 16844 3291 90608300
Haemorrhage 24.15 21.60 45 16811 69324 90542267
Acquired apparent mineralocorticoid excess 24.13 21.60 4 16852 15 90611576
Skin maceration 24.02 21.60 6 16850 212 90611379
Hypomagnesaemia 23.50 21.60 31 16825 35557 90576034
Partial seizures with secondary generalisation 23.50 21.60 7 16849 482 90611109
Acute lymphocytic leukaemia recurrent 23.38 21.60 11 16845 2710 90608881
Gastric dilatation 23.10 21.60 9 16847 1398 90610193
Rash maculo-papular 23.03 21.60 33 16823 40900 90570691
Pruritus 22.98 21.60 41 16815 541484 90070107
Drug ineffective for unapproved indication 22.91 21.60 43 16813 66601 90544990
Blood lactate dehydrogenase increased 22.64 21.60 26 16830 25906 90585685
Pseudomonas infection 22.35 21.60 20 16836 14845 90596746
Kussmaul respiration 22.35 21.60 6 16850 283 90611308
HCoV-OC43 infection 22.31 21.60 4 16852 26 90611565
Leukaemia 22.24 21.60 13 16843 4979 90606612
Injection site pain 22.20 21.60 3 16853 173696 90437895
Acute respiratory distress syndrome 22.13 21.60 27 16829 28659 90582932
Pneumonia klebsiella 22.11 21.60 11 16845 3061 90608530
Oral disorder 21.97 21.60 17 16839 10328 90601263
Gastrointestinal mucormycosis 21.85 21.60 6 16850 308 90611283
Atypical pneumonia 21.83 21.60 13 16843 5151 90606440
Renal tubular disorder 21.66 21.60 11 16845 3196 90608395

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
Product use in unapproved indication 413.25 16.95 504 22687 183952 42414192
Febrile neutropenia 404.04 16.95 500 22691 185203 42412941
Pseudoaldosteronism 230.80 16.95 43 23148 93 42598051
Acute myeloid leukaemia recurrent 220.80 16.95 80 23111 3432 42594712
Aspergillus infection 218.23 16.95 125 23066 15712 42582432
Graft versus host disease 213.64 16.95 115 23076 12810 42585334
Drug interaction 183.65 16.95 430 22761 266569 42331575
Acute myeloid leukaemia 174.51 16.95 123 23068 22133 42576011
Pneumonia fungal 161.34 16.95 85 23106 9061 42589083
Mucormycosis 159.94 16.95 78 23113 7065 42591079
Septic shock 158.48 16.95 221 22970 91451 42506693
Bronchopulmonary aspergillosis 158.44 16.95 110 23081 19319 42578825
Fusarium infection 157.02 16.95 51 23140 1565 42596579
Drug ineffective 144.53 16.95 699 22492 629498 41968646
Microsporidia infection 143.72 16.95 44 23147 1108 42597036
Neutropenia 141.04 16.95 325 22866 199106 42399038
Cytomegalovirus infection reactivation 117.09 16.95 74 23117 11104 42587040
Drug resistance 105.90 16.95 111 23080 34137 42564007
Myositis 97.99 16.95 74 23117 14792 42583352
Device related infection 91.61 16.95 81 23110 20198 42577946
Antibiotic level below therapeutic 90.95 16.95 18 23173 60 42598084
Scedosporium infection 88.71 16.95 33 23158 1525 42596619
Labelled drug-drug interaction issue 88.14 16.95 34 23157 1737 42596407
Cerebral aspergillosis 88.03 16.95 34 23157 1743 42596401
Pseudomonas infection 87.10 16.95 71 23120 15852 42582292
Cytokine release syndrome 86.95 16.95 114 23077 44413 42553731
Fungal infection 85.57 16.95 77 23114 19645 42578499
Off label use 82.39 16.95 610 22581 637725 41960419
Systemic mycosis 81.61 16.95 35 23156 2352 42595792
Thrombocytopenia 80.70 16.95 257 22934 190022 42408122
Immune effector cell-associated neurotoxicity syndrome 80.48 16.95 55 23136 9406 42588738
Pancytopenia 79.87 16.95 189 23002 117554 42480590
Hepatic cytolysis 79.42 16.95 85 23106 26759 42571385
Immunosuppressant drug level increased 75.55 16.95 49 23142 7682 42590462
Hypokalaemia 75.54 16.95 138 23053 71583 42526561
Graft versus host disease in skin 74.07 16.95 42 23149 5170 42592974
Pathogen resistance 73.26 16.95 56 23135 11394 42586750
Graft versus host disease in gastrointestinal tract 71.90 16.95 41 23150 5102 42593042
Polymyositis 70.68 16.95 29 23162 1744 42596400
Drug level below therapeutic 70.22 16.95 44 23147 6501 42591643
Demodicidosis 66.48 16.95 17 23174 215 42597929
Primary adrenal insufficiency 61.27 16.95 17 23174 299 42597845
Acanthamoeba infection 61.12 16.95 19 23172 504 42597640
Acquired apparent mineralocorticoid excess 59.05 16.95 13 23178 81 42598063
Fall 57.35 16.95 28 23163 234492 42363652
Bacteraemia 56.62 16.95 69 23122 24971 42573173
Tumour lysis syndrome 54.78 16.95 64 23127 22167 42575977
Cytopenia 54.58 16.95 57 23134 17440 42580704
Enterococcal infection 54.19 16.95 48 23143 11991 42586153
Nephropathy toxic 52.78 16.95 55 23136 16783 42581361
Product use issue 49.62 16.95 121 23070 76630 42521514
Brain abscess 49.00 16.95 30 23161 4254 42593890
Dizziness 48.22 16.95 39 23152 249215 42348929
Candida infection 47.97 16.95 59 23132 21551 42576593
Pyrexia 47.93 16.95 372 22819 393670 42204474
Graft complication 47.36 16.95 17 23174 709 42597435
Product dose omission issue 46.85 16.95 13 23178 154352 42443792
Chronic graft versus host disease 46.50 16.95 33 23158 5992 42592152
Septic embolus 46.06 16.95 20 23171 1385 42596759
Multiple organ dysfunction syndrome 44.68 16.95 135 23056 96900 42501244
Acute graft versus host disease in skin 44.63 16.95 35 23156 7389 42590755
Differentiation syndrome 44.22 16.95 21 23170 1792 42596352
Pain 44.09 16.95 41 23150 244807 42353337
Thrombotic microangiopathy 44.05 16.95 47 23144 14735 42583409
Neurotoxicity 43.76 16.95 59 23132 23592 42574552
Geotrichum infection 43.32 16.95 15 23176 562 42597582
Malaise 42.53 16.95 32 23159 212124 42386020
Cardioactive drug level increased 42.00 16.95 20 23171 1717 42596427
Eye infection fungal 41.81 16.95 14 23177 473 42597671
Fatigue 41.41 16.95 112 23079 435529 42162615
Hepatotoxicity 40.91 16.95 59 23132 25108 42573036
Neutropenic colitis 40.44 16.95 27 23164 4443 42593701
Hyperbilirubinaemia 38.97 16.95 52 23139 20583 42577561
Blood pressure increased 38.49 16.95 5 23186 101923 42496221
Condition aggravated 38.45 16.95 258 22933 260496 42337648
Lip squamous cell carcinoma 37.97 16.95 10 23181 143 42598001
Parainfluenzae virus infection 37.85 16.95 24 23167 3619 42594525
Neutropenic infection 37.61 16.95 19 23172 1854 42596290
Ecthyma 37.48 16.95 14 23177 654 42597490
Graft versus host disease in liver 36.99 16.95 18 23173 1621 42596523
Cholestasis 36.80 16.95 65 23126 32814 42565330
BK virus infection 35.56 16.95 33 23158 8751 42589393
Sepsis 35.46 16.95 207 22984 199127 42399017
Hyperhidrosis 35.25 16.95 4 23187 90508 42507636
Arthralgia 35.04 16.95 36 23155 205202 42392942
NPM1 gene mutation 34.97 16.95 9 23182 117 42598027
Myocardial infarction 34.82 16.95 12 23179 123997 42474147
Depression 34.49 16.95 9 23182 111354 42486790
Cerebral ventricle collapse 34.42 16.95 9 23182 125 42598019
Acute graft versus host disease in intestine 33.67 16.95 23 23168 3928 42594216
Venoocclusive liver disease 32.91 16.95 34 23157 10268 42587876
Drug hypersensitivity 32.82 16.95 7 23184 99382 42498762
Pruritus 32.35 16.95 33 23158 188738 42409406
Sinusitis fungal 32.06 16.95 13 23178 758 42597386
Encephalopathy 32.02 16.95 70 23121 41263 42556881
Brain herniation 31.75 16.95 24 23167 4799 42593345
Cytomegalovirus infection 31.28 16.95 60 23131 32246 42565898
Bronchiolitis obliterans syndrome 30.96 16.95 10 23181 301 42597843
Dyspnoea 30.95 16.95 130 23061 442491 42155653
Central nervous system lesion 30.77 16.95 29 23162 7841 42590303
Pulmonary resection 30.73 16.95 8 23183 109 42598035
Weight decreased 29.63 16.95 42 23149 207906 42390238
Staphylococcal bacteraemia 29.04 16.95 33 23158 11088 42587056
Apparent mineralocorticoid excess 28.96 16.95 7 23184 69 42598075
Hypersensitivity 28.68 16.95 3 23188 72367 42525777
Chimerism 28.59 16.95 9 23182 249 42597895
Neutrophil Pelger-Huet anomaly present 28.25 16.95 9 23182 259 42597885
Disseminated toxoplasmosis 28.02 16.95 9 23182 266 42597878
Stenotrophomonas infection 27.92 16.95 20 23171 3684 42594460
Lower respiratory tract infection fungal 27.90 16.95 11 23180 596 42597548
Treatment failure 27.75 16.95 86 23105 62538 42535606
Product administered to patient of inappropriate age 27.66 16.95 22 23169 4739 42593405
Lymphopenia 27.25 16.95 45 23146 21518 42576626
Staphylococcal infection 27.19 16.95 62 23129 37581 42560563
Drug ineffective for unapproved indication 26.91 16.95 70 23121 46093 42552051
Retinal ischaemia 26.34 16.95 10 23181 489 42597655
Escherichia bacteraemia 26.15 16.95 22 23169 5127 42593017
Hypomagnesaemia 25.27 16.95 51 23140 28437 42569707
Sinusitis bacterial 25.08 16.95 10 23181 558 42597586
Muscle spasms 24.72 16.95 8 23183 86036 42512108
Hyperleukocytosis 24.19 16.95 16 23175 2592 42595552
Pulmonary mucormycosis 24.18 16.95 13 23178 1442 42596702
Enterococcal bacteraemia 23.86 16.95 16 23175 2651 42595493
Viral haemorrhagic cystitis 23.84 16.95 14 23177 1840 42596304
Fungaemia 23.79 16.95 17 23174 3119 42595025
Infection 23.67 16.95 122 23069 111946 42486198
Anxiety 23.58 16.95 18 23173 118542 42479602
Systemic candida 23.52 16.95 21 23170 5298 42592846
Cystitis viral 23.20 16.95 12 23179 1230 42596914
Acute graft versus host disease in liver 23.13 16.95 14 23177 1944 42596200
Aspergillus test positive 23.05 16.95 10 23181 691 42597453
Steroid diabetes 22.89 16.95 16 23175 2836 42595308
Feeling abnormal 22.86 16.95 5 23186 69781 42528363
Fungal skin infection 22.83 16.95 17 23174 3324 42594820
Microsporum infection 22.60 16.95 5 23186 32 42598112
Agitation 22.34 16.95 4 23187 64310 42533834
Necrotising retinitis 22.31 16.95 11 23180 1019 42597125
Skin necrosis 22.29 16.95 22 23169 6292 42591852
Abscess fungal 22.23 16.95 8 23183 336 42597808
Brain compression 21.79 16.95 7 23184 207 42597937
Drug level decreased 21.75 16.95 27 23164 9950 42588194
Enterobacter bacteraemia 21.25 16.95 9 23182 586 42597558
Rash maculo-papular 20.97 16.95 56 23135 37447 42560697
Incorrect product formulation administered 20.81 16.95 5 23186 48 42598096
Posterior reversible encephalopathy syndrome 20.75 16.95 30 23161 12791 42585353
Weight increased 20.71 16.95 17 23174 107966 42490178
Nasopharyngitis 20.54 16.95 10 23181 83986 42514158
Ileus paralytic 20.51 16.95 23 23168 7618 42590526
Vomiting 20.26 16.95 85 23106 289638 42308506
Hypoglycaemia 20.20 16.95 4 23187 59850 42538294
Respiratory failure 20.17 16.95 129 23062 128003 42470141
Nocardiosis 20.05 16.95 19 23172 5171 42592973
Insomnia 19.87 16.95 21 23170 118232 42479912
Somnolence 19.59 16.95 29 23162 141076 42457068
Electrocardiogram QT prolonged 19.55 16.95 64 23127 47881 42550263
Lung consolidation 19.48 16.95 21 23170 6656 42591488
Graft versus host disease in lung 19.27 16.95 9 23182 739 42597405
Lung transplant rejection 19.22 16.95 10 23181 1037 42597107
Cerebral artery embolism 19.17 16.95 10 23181 1043 42597101
Pneumonia 19.12 16.95 329 22862 421820 42176324
Bone marrow failure 19.09 16.95 50 23141 33043 42565101
Cerebrovascular accident 19.00 16.95 15 23176 97145 42500999
Folliculitis 18.95 16.95 19 23172 5539 42592605
CARD9 deficiency 18.91 16.95 4 23187 20 42598124
Blood immunoglobulin G decreased 18.61 16.95 13 23178 2301 42595843
Klebsiella bacteraemia 18.36 16.95 13 23178 2351 42595793
Septic encephalopathy 18.35 16.95 6 23185 188 42597956
Abdominal discomfort 18.33 16.95 9 23182 75246 42522898
Mycetoma mycotic 18.25 16.95 7 23184 352 42597792
Gastrointestinal tract mucosal pigmentation 18.19 16.95 8 23183 571 42597573
Hypofibrinogenaemia 18.08 16.95 12 23179 1955 42596189
Necrotising ulcerative gingivostomatitis 18.07 16.95 5 23186 87 42598057
Palpitations 17.99 16.95 3 23188 50794 42547350
Cytomegalovirus viraemia 17.85 16.95 25 23166 10352 42587792
Wheezing 17.79 16.95 4 23187 54777 42543367
Intracranial mass 17.62 16.95 10 23181 1233 42596911
Inappropriate antidiuretic hormone secretion 17.60 16.95 32 23159 16509 42581635
Asthma 17.53 16.95 6 23185 62308 42535836
SARS-CoV-2 RNA 17.41 16.95 4 23187 31 42598113
Secondary adrenocortical insufficiency 17.37 16.95 12 23179 2087 42596057
Coronary artery disease 17.29 16.95 4 23187 53716 42544428
Bilirubin conjugated increased 17.22 16.95 15 23176 3662 42594482
Gastroenteritis clostridial 17.22 16.95 7 23184 411 42597733
Oesophagitis ulcerative 17.19 16.95 9 23182 946 42597198
Nausea 17.19 16.95 136 23055 396663 42201481
Renal tubular disorder 17.14 16.95 17 23174 4892 42593252
Dehydration 17.03 16.95 32 23159 141735 42456409
Blood immunoglobulin A increased 16.99 16.95 7 23184 425 42597719

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 1003.19 17.34 845 37135 315922 110235397
Product use in unapproved indication 677.51 17.34 799 37181 446578 110104741
Drug interaction 494.82 17.34 725 37255 499458 110051861
Pseudoaldosteronism 478.95 17.34 85 37895 241 110551078
Neutropenia 387.38 17.34 555 37425 374065 110177254
Acute myeloid leukaemia 378.11 17.34 207 37773 37903 110513416
Septic shock 366.26 17.34 354 37626 157174 110394145
Aspergillus infection 354.48 17.34 174 37806 25442 110525877
Graft versus host disease 350.72 17.34 157 37823 18649 110532670
Acute myeloid leukaemia recurrent 338.23 17.34 108 37872 5031 110546288
Pneumonia fungal 306.87 17.34 133 37847 14621 110536698
Mucormycosis 306.46 17.34 121 37859 10507 110540812
Fusarium infection 288.92 17.34 83 37897 2688 110548631
Bronchopulmonary aspergillosis 271.02 17.34 153 37827 29710 110521609
Labelled drug-drug interaction issue 200.99 17.34 69 37911 4032 110547287
Scedosporium infection 200.99 17.34 61 37919 2397 110548922
Drug ineffective 200.87 17.34 1038 36942 1519502 109031817
Cytomegalovirus infection reactivation 199.72 17.34 106 37874 18227 110533092
Hepatic cytolysis 196.61 17.34 158 37822 54895 110496424
Systemic candida 178.73 17.34 81 37899 9893 110541426
Cytokine release syndrome 174.59 17.34 164 37816 70142 110481177
Pancytopenia 174.25 17.34 281 37699 209332 110341987
Graft versus host disease in gastrointestinal tract 174.01 17.34 77 37903 8891 110542428
Thrombocytopenia 173.54 17.34 375 37605 348510 110202809
Cholestasis 170.86 17.34 156 37824 64362 110486957
Microsporidia infection 154.04 17.34 44 37936 1395 110549924
Hypokalaemia 153.54 17.34 246 37734 182202 110369117
Bacteraemia 152.07 17.34 122 37858 42268 110509051
Sepsis 143.86 17.34 335 37645 327011 110224308
Arthralgia 141.38 17.34 46 37934 779586 109771733
Graft versus host disease in skin 138.37 17.34 64 37916 8190 110543129
Pain 134.50 17.34 81 37899 954874 109596445
Systemic mycosis 129.63 17.34 49 37931 3780 110547539
Multiple organ dysfunction syndrome 126.85 17.34 204 37776 151506 110399813
Immune effector cell-associated neurotoxicity syndrome 126.74 17.34 73 37907 14709 110536610
Device related infection 125.56 17.34 106 37874 39413 110511906
Drug resistance 123.92 17.34 123 37857 56251 110495068
Cytopenia 123.89 17.34 94 37886 30022 110521297
Pseudomonas infection 123.65 17.34 91 37889 27762 110523557
Differentiation syndrome 121.62 17.34 44 37936 3000 110548319
Pyrexia 119.05 17.34 615 37365 897650 109653669
Fungal infection 115.67 17.34 113 37867 50693 110500626
Pathogen resistance 114.70 17.34 73 37907 17599 110533720
Hyperbilirubinaemia 113.69 17.34 90 37890 30581 110520738
Electrocardiogram QT prolonged 107.19 17.34 158 37822 108802 110442517
Drug level below therapeutic 106.40 17.34 60 37920 11613 110539706
Hypersensitivity 105.35 17.34 9 37971 403989 110147330
Off label use 104.31 17.34 873 37107 1499312 109052007
Enterococcal infection 100.60 17.34 71 37909 20295 110531024
Joint swelling 100.30 17.34 16 37964 442829 110108490
Malaise 98.72 17.34 54 37926 671765 109879554
Fatigue 97.45 17.34 168 37812 1215790 109335529
Brain abscess 96.63 17.34 47 37933 6727 110544592
Drug hypersensitivity 95.12 17.34 20 37960 454070 110097249
Product administered to patient of inappropriate age 94.74 17.34 49 37931 7987 110543332
Nasopharyngitis 94.55 17.34 12 37968 394349 110156970
Neurotoxicity 94.44 17.34 93 37887 42114 110509205
Myositis 93.82 17.34 81 37899 31035 110520284
Staphylococcal bacteraemia 93.80 17.34 63 37917 16625 110534694
Chronic graft versus host disease 92.72 17.34 51 37929 9406 110541913
Protothecosis 92.17 17.34 24 37956 533 110550786
Cytomegalovirus infection 91.54 17.34 103 37877 54341 110496978
Tumour lysis syndrome 90.48 17.34 79 37901 30722 110520597
Drug level decreased 90.08 17.34 64 37916 18484 110532835
Bone marrow failure 88.12 17.34 104 37876 57744 110493575
Acquired apparent mineralocorticoid excess 87.69 17.34 17 37963 88 110551231
Immunosuppressant drug level increased 87.66 17.34 53 37927 11671 110539648
BK virus infection 87.20 17.34 55 37925 13051 110538268
Rheumatoid arthritis 86.04 17.34 4 37976 299609 110251710
Respiratory failure 85.48 17.34 212 37768 215120 110336199
Arthropathy 82.04 17.34 4 37976 287518 110263801
Infusion related reaction 81.45 17.34 16 37964 381146 110170173
Candida infection 81.01 17.34 91 37889 47918 110503401
Synovitis 80.90 17.34 3 37977 274089 110277230
Fungaemia 80.18 17.34 40 37940 6046 110545273
Primary adrenal insufficiency 80.11 17.34 22 37958 602 110550717
Nephropathy toxic 79.76 17.34 70 37910 27408 110523911
Venoocclusive liver disease 79.74 17.34 55 37925 15152 110536167
Swelling 78.76 17.34 13 37967 351028 110200291
Staphylococcal infection 76.96 17.34 107 37873 69837 110481482
Cerebral aspergillosis 76.27 17.34 29 37951 2273 110549046
Dizziness 75.67 17.34 77 37903 698116 109853203
Abdominal discomfort 75.32 17.34 21 37959 393837 110157482
Pulmonary mucormycosis 74.63 17.34 28 37952 2115 110549204
Thrombotic microangiopathy 74.26 17.34 69 37911 29080 110522239
Acute graft versus host disease in skin 73.79 17.34 46 37934 10694 110540625
Geotrichum infection 73.73 17.34 24 37956 1188 110550131
Demodicidosis 73.26 17.34 17 37963 229 110551090
Depression 72.88 17.34 11 37969 317324 110233995
Acute graft versus host disease in intestine 71.17 17.34 36 37944 5603 110545716
Acanthamoeba infection 70.97 17.34 20 37960 603 110550716
Graft versus host disease in liver 70.82 17.34 28 37952 2437 110548882
Myelosuppression 69.62 17.34 120 37860 94220 110457099
Torsade de pointes 68.47 17.34 59 37921 22541 110528778
Encephalopathy 66.34 17.34 108 37872 80947 110470372
Escherichia bacteraemia 65.99 17.34 42 37938 10122 110541197
Weight increased 65.65 17.34 31 37949 419613 110131706
Dyspnoea 65.36 17.34 181 37799 1106691 109444628
Therapeutic product effect decreased 64.89 17.34 5 37975 244311 110307008
Polymyositis 62.93 17.34 29 37951 3679 110547640
Discomfort 61.20 17.34 3 37977 214704 110336615
Hypoaesthesia 59.61 17.34 17 37963 314206 110237113
Hepatotoxicity 59.56 17.34 90 37890 63310 110488009
Pain in extremity 59.55 17.34 48 37932 487070 110064249
Neutropenic colitis 59.12 17.34 36 37944 8029 110543290
Muscle spasms 58.73 17.34 12 37968 278145 110273174
Pruritus 58.69 17.34 68 37912 581492 109969827
Fall 58.32 17.34 73 37907 603409 109947910
Wheezing 58.25 17.34 9 37971 255221 110296098
Blood pressure increased 56.99 17.34 10 37970 258363 110292956
Graft versus host disease in lung 56.83 17.34 20 37960 1258 110550061
Left atrial hypertrophy 56.57 17.34 11 37969 58 110551261
Hepatocellular injury 56.49 17.34 78 37902 50564 110500755
Klebsiella infection 56.13 17.34 50 37930 19959 110531360
Renal failure 54.93 17.34 187 37793 226387 110324932
Bacterial infection 54.53 17.34 73 37907 45963 110505356
Product dose omission issue 53.10 17.34 22 37958 321760 110229559
Peripheral swelling 52.99 17.34 37 37943 403997 110147322
Disease progression 52.80 17.34 194 37786 243840 110307479
Drug ineffective for unapproved indication 52.66 17.34 112 37868 102726 110448593
Asthma 52.42 17.34 11 37969 250280 110301039
Adenovirus reactivation 50.54 17.34 16 37964 724 110550595
Acute kidney injury 50.46 17.34 382 37598 635048 109916271
Hypomagnesaemia 50.16 17.34 81 37899 60289 110491030
Musculoskeletal stiffness 49.74 17.34 17 37963 279805 110271514
Injection site pain 49.11 17.34 3 37977 177919 110373400
Osteoarthritis 47.76 17.34 4 37976 182619 110368700
Urticaria 47.67 17.34 25 37955 318832 110232487
Graft complication 47.62 17.34 17 37963 1115 110550204
Bronchiolitis obliterans syndrome 47.46 17.34 15 37965 675 110550644
Duodenal ulcer perforation 46.17 17.34 4 37976 177696 110373623
Anxiety 46.04 17.34 31 37949 345047 110206272
Parainfluenzae virus infection 45.73 17.34 29 37951 6945 110544374
Septic embolus 45.21 17.34 20 37960 2306 110549013
Haemophagocytic lymphohistiocytosis 45.20 17.34 55 37925 31504 110519815
Stenotrophomonas infection 45.13 17.34 27 37953 5831 110545488
Mucosal inflammation 45.00 17.34 101 37879 96040 110455279
Staphylococcal sepsis 43.84 17.34 41 37939 17413 110533906
Cardioactive drug level increased 43.84 17.34 23 37957 3859 110547460
Enterococcal bacteraemia 43.57 17.34 24 37956 4437 110546882
Insomnia 43.46 17.34 36 37944 360554 110190765
NPM1 gene mutation 43.42 17.34 10 37970 130 110551189
Cytomegalovirus viraemia 43.23 17.34 41 37939 17723 110533596
Abdominal pain upper 43.15 17.34 34 37946 349077 110202242
Sleep disorder 43.12 17.34 8 37972 198636 110352683
Mobility decreased 42.93 17.34 14 37966 237408 110313911
Rash maculo-papular 42.91 17.34 85 37895 74137 110477182
Impaired healing 42.54 17.34 8 37972 196709 110354610
Anticoagulation drug level increased 42.22 17.34 15 37965 970 110550349
Electrocardiogram PR shortened 42.08 17.34 12 37968 378 110550941
Gastrooesophageal reflux disease 41.86 17.34 6 37974 179970 110371349
Adenoviral hepatitis 41.82 17.34 15 37965 997 110550322
Neutropenic infection 41.78 17.34 21 37959 3224 110548095
Pneumonia 41.67 17.34 472 37508 876242 109675077
Migraine 41.65 17.34 5 37975 171647 110379672
Renal tubular disorder 41.64 17.34 28 37952 7401 110543918
Posterior reversible encephalopathy syndrome 40.57 17.34 54 37926 33807 110517512
Eye infection fungal 40.57 17.34 13 37967 612 110550707
Aplasia 40.16 17.34 28 37952 7845 110543474
Central nervous system lesion 39.97 17.34 37 37943 15516 110535803
Leukaemia recurrent 39.54 17.34 20 37960 3111 110548208
Ill-defined disorder 39.50 17.34 4 37976 156849 110394470
Cerebral toxoplasmosis 39.48 17.34 20 37960 3122 110548197
Death 39.15 17.34 389 37591 698480 109852839
Memory impairment 38.57 17.34 10 37970 196934 110354385
Viral haemorrhagic cystitis 37.99 17.34 20 37960 3379 110547940
Weight decreased 37.93 17.34 64 37916 467993 110083326
Hyperhidrosis 37.66 17.34 9 37971 187289 110364030
Pericardial effusion 37.35 17.34 69 37911 57148 110494171
Drug level increased 36.91 17.34 62 37918 47657 110503662
Contusion 36.84 17.34 17 37963 233344 110317975
Klebsiella bacteraemia 36.37 17.34 22 37958 4847 110546472
Contraindicated product administered 36.32 17.34 20 37960 248247 110303072
Ileus paralytic 36.28 17.34 31 37949 11706 110539613
Sinusitis fungal 36.19 17.34 18 37962 2702 110548617
Enterocolitis 35.58 17.34 38 37942 18911 110532408
Cerebral ventricle collapse 35.55 17.34 9 37971 178 110551141
Disseminated toxoplasmosis 35.44 17.34 11 37969 466 110550853
Soft tissue infection 35.40 17.34 22 37958 5085 110546234
Blister 35.22 17.34 17 37963 227359 110323960
Chimerism 35.19 17.34 10 37970 311 110551008
Headache 35.00 17.34 170 37810 882207 109669112
Brain herniation 34.99 17.34 27 37953 8836 110542483
Lip squamous cell carcinoma 34.98 17.34 10 37970 318 110551001
Loss of personal independence in daily activities 34.89 17.34 5 37975 150015 110401304
Pericarditis 34.53 17.34 16 37964 219098 110332221
Rash 33.83 17.34 156 37824 820808 109730511
Arthritis 33.80 17.34 8 37972 167578 110383741
Hypogammaglobulinaemia 33.77 17.34 38 37942 20038 110531281
Lower respiratory tract infection 33.56 17.34 21 37959 243085 110308234
Acute respiratory distress syndrome 33.28 17.34 63 37917 53135 110498184
Hepatic failure 33.05 17.34 73 37907 68666 110482653
Acute lymphocytic leukaemia 32.96 17.34 22 37958 5743 110545576
Lower respiratory tract infection fungal 32.79 17.34 12 37968 845 110550474
Pneumonia klebsiella 32.47 17.34 23 37957 6609 110544710
Epstein-Barr virus infection 32.43 17.34 36 37944 18702 110532617
Transaminases increased 32.40 17.34 69 37911 63321 110487998
Lung infiltration 32.19 17.34 41 37939 24587 110526732
Nocardiosis 32.19 17.34 24 37956 7462 110543857
Herpes simplex 32.07 17.34 33 37947 15731 110535588
Overgrowth fungal 31.85 17.34 8 37972 153 110551166
Apparent mineralocorticoid excess 31.81 17.34 7 37973 73 110551246
Paraesthesia 31.62 17.34 29 37951 276492 110274827
Escherichia sepsis 31.49 17.34 27 37953 10245 110541074
Alpha haemolytic streptococcal infection 31.48 17.34 18 37962 3575 110547744
Gait inability 30.67 17.34 5 37975 136371 110414948
Brain oedema 30.42 17.34 45 37935 31053 110520266
Feeling abnormal 30.38 17.34 12 37968 180699 110370620
Endophthalmitis 30.28 17.34 24 37956 8163 110543156
Pseudomonal sepsis 30.25 17.34 25 37955 9021 110542298
Pulmonary resection 30.13 17.34 8 37972 192 110551127
Dyspepsia 30.00 17.34 14 37966 190951 110360368
Gastrointestinal toxicity 29.58 17.34 27 37953 11121 110540198
Enterobacter bacteraemia 29.57 17.34 13 37967 1477 110549842
Hyperleukocytosis 29.52 17.34 17 37963 3422 110547897
Lymphopenia 29.50 17.34 51 37929 40119 110511200
Cortical visual impairment 29.40 17.34 6 37974 42 110551277
Pleural effusion 29.39 17.34 130 37850 177579 110373740
Venous haemorrhage 29.30 17.34 9 37971 368 110550951
Nausea 29.07 17.34 278 37702 1235412 109315907
Klebsiella sepsis 29.07 17.34 18 37962 4135 110547184
Microsporum infection 29.04 17.34 6 37974 45 110551274
Hypoxia 28.86 17.34 104 37876 129411 110421908
Neutrophil Pelger-Huet anomaly present 28.85 17.34 9 37971 388 110550931
Joint range of motion decreased 28.47 17.34 4 37976 121828 110429491
Rhinovirus infection 28.29 17.34 27 37953 11762 110539557
Acute lymphocytic leukaemia recurrent 28.17 17.34 20 37960 5767 110545552
Cell death 28.16 17.34 20 37960 5771 110545548
Dry mouth 27.97 17.34 17 37963 199931 110351388
Adenovirus infection 27.95 17.34 26 37954 10968 110540351
Growth failure 27.61 17.34 8 37972 267 110551052
Inappropriate antidiuretic hormone secretion 27.55 17.34 45 37935 33806 110517513
Ecthyma 27.07 17.34 11 37969 1028 110550291
Atypical pneumonia 26.86 17.34 22 37958 7840 110543479
Stomatitis 26.79 17.34 32 37948 270210 110281109
Alopecia 26.75 17.34 53 37927 364700 110186619
Long QT syndrome 26.61 17.34 21 37959 7097 110544222
BK polyomavirus test positive 26.61 17.34 8 37972 304 110551015
Cystitis viral 26.50 17.34 12 37968 1461 110549858
Clostridium difficile colitis 26.35 17.34 51 37929 43727 110507592
Hepatic necrosis 26.26 17.34 24 37956 9898 110541421
Palpitations 26.06 17.34 11 37969 159201 110392118
Ureaplasma infection 25.95 17.34 12 37968 1534 110549785
Night sweats 25.85 17.34 7 37973 133976 110417343
Stress 25.73 17.34 3 37977 105345 110445974
Back pain 25.44 17.34 56 37924 370940 110180379
Peripheral sensory neuropathy 25.41 17.34 30 37950 16650 110534669
Disseminated mucormycosis 25.31 17.34 13 37967 2089 110549230
Pulmonary nocardiosis 25.28 17.34 14 37966 2615 110548704
Phaeohyphomycosis 24.77 17.34 12 37968 1702 110549617
Blood immunoglobulin G decreased 24.77 17.34 18 37962 5382 110545937
Renal tubular acidosis 24.59 17.34 17 37963 4698 110546621
Gait disturbance 24.45 17.34 36 37944 278172 110273147
Organ failure 24.26 17.34 17 37963 4800 110546519
Retinal ischaemia 23.99 17.34 10 37970 997 110550322
Cystitis haemorrhagic 23.84 17.34 25 37955 12184 110539135
Confusional state 23.74 17.34 82 37898 468598 110082721
Disseminated coccidioidomycosis 23.73 17.34 7 37973 249 110551070
Aspergillus test positive 23.59 17.34 10 37970 1040 110550279
Hypofibrinogenaemia 23.15 17.34 13 37967 2494 110548825
Drug level above therapeutic 23.11 17.34 24 37956 11564 110539755
Rhinocerebral mucormycosis 23.07 17.34 11 37969 1506 110549813
Vomiting 23.06 17.34 201 37779 910474 109640845
Toxic skin eruption 22.96 17.34 37 37943 27478 110523841
Wound infection 22.94 17.34 3 37977 96462 110454857
Seroconversion test positive 22.82 17.34 5 37975 51 110551268
Neck pain 22.71 17.34 7 37973 123123 110428196
HCoV-OC43 infection 22.56 17.34 5 37975 54 110551265
Necrotising retinitis 22.54 17.34 11 37969 1585 110549734
Bilirubin conjugated increased 22.49 17.34 18 37962 6206 110545113
Glucocorticoid deficiency 22.45 17.34 10 37970 1172 110550147
Pulmonary fibrosis 22.38 17.34 4 37976 102038 110449281
Musculoskeletal pain 22.37 17.34 18 37962 183005 110368314
Blood bilirubin increased 22.30 17.34 67 37913 75905 110475414
Injection site erythema 22.22 17.34 3 37977 94173 110457146
Atrioventricular block second degree 22.07 17.34 20 37960 8161 110543158
Mycobacterium abscessus infection 21.85 17.34 11 37969 1695 110549624
Acute pulmonary oedema 21.75 17.34 28 37952 16968 110534351
Bacterial sepsis 21.53 17.34 22 37958 10404 110540915
Bicytopenia 21.28 17.34 18 37962 6706 110544613
Hypercholesterolaemia 21.18 17.34 3 37977 90834 110460485
Citrobacter infection 21.09 17.34 10 37970 1352 110549967
Blast cell count decreased 20.92 17.34 4 37976 19 110551300
CARD9 deficiency 20.75 17.34 4 37976 20 110551299
Cerebrovascular accident 20.73 17.34 19 37961 181265 110370054
Aplastic anaemia 20.71 17.34 33 37947 24275 110527044
Corynebacterium bacteraemia 20.71 17.34 6 37974 200 110551119
Lung transplant rejection 20.56 17.34 11 37969 1920 110549399
Hallucination 20.55 17.34 79 37901 101353 110449966
Septic encephalopathy 20.54 17.34 7 37973 400 110550919
Intentional product misuse 20.48 17.34 10 37970 132894 110418425
Transplant rejection 20.45 17.34 33 37947 24534 110526785
Heart rate increased 20.44 17.34 12 37968 143822 110407497
Herpes simplex reactivation 20.38 17.34 10 37970 1458 110549861
Mineralocorticoid deficiency 20.28 17.34 4 37976 23 110551296
Platelet count decreased 20.21 17.34 142 37838 230301 110321018
Anaphylactic reaction 20.20 17.34 7 37973 114293 110437026
Fungal skin infection 20.10 17.34 18 37962 7231 110544088
Leukoencephalopathy 20.08 17.34 20 37960 9175 110542144
Transformation to acute myeloid leukaemia 20.03 17.34 10 37970 1513 110549806
Drug intolerance 19.99 17.34 72 37908 406440 110144879
Drug-induced liver injury 19.97 17.34 88 37892 119979 110431340
Gastrointestinal mucormycosis 19.84 17.34 8 37972 733 110550586
Myocardial infarction 19.83 17.34 22 37958 192061 110359258
Enterococcal sepsis 19.81 17.34 13 37967 3299 110548020
Type 2 diabetes mellitus 19.77 17.34 19 37961 177213 110374106
Abscess fungal 19.76 17.34 7 37973 449 110550870
Lung consolidation 19.65 17.34 21 37959 10455 110540864
Coagulation test abnormal 19.65 17.34 10 37970 1576 110549743
Cerebral artery embolism 19.64 17.34 11 37969 2101 110549218
Febrile bone marrow aplasia 19.62 17.34 27 37953 17438 110533881
Agranulocytosis 19.59 17.34 56 37924 61704 110489615
Retinal haemorrhage 19.53 17.34 20 37960 9481 110541838
Pneumonia pseudomonal 19.48 17.34 18 37962 7528 110543791
Skin necrosis 19.44 17.34 30 37950 21482 110529837
Amnesia 19.43 17.34 6 37974 105402 110445917
Allogenic stem cell transplantation 19.36 17.34 6 37974 253 110551066
SARS-CoV-2 RNA 19.02 17.34 4 37976 33 110551286
Blood pressure decreased 18.76 17.34 8 37972 115083 110436236
Respiratory syncytial virus infection 18.75 17.34 24 37956 14460 110536859
Acute myeloid leukaemia refractory 18.65 17.34 6 37974 286 110551033
Secondary adrenocortical insufficiency 18.58 17.34 14 37966 4420 110546899
Steroid diabetes 18.57 17.34 15 37965 5239 110546080
Illness 18.50 17.34 3 37977 82168 110469151
Acute graft versus host disease in liver 18.50 17.34 11 37969 2348 110548971
Injection site reaction 18.46 17.34 4 37976 89066 110462253
Sinusitis bacterial 18.14 17.34 11 37969 2433 110548886
Nephrogenic diabetes insipidus 18.14 17.34 11 37969 2434 110548885
Medication error 17.70 17.34 7 37973 105359 110445960
Blood alkaline phosphatase increased 17.57 17.34 59 37921 70876 110480443
Folliculitis 17.53 17.34 19 37961 167634 110383685
Hypoglycaemia 17.49 17.34 9 37971 116095 110435224
Chronic graft versus host disease in skin 17.44 17.34 11 37969 2608 110548711
Infectious pleural effusion 17.37 17.34 14 37966 4877 110546442
Infection reactivation 17.36 17.34 13 37967 4068 110547251
Epstein-Barr virus infection reactivation 17.35 17.34 13 37967 4071 110547248

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J02AC04 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
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000935 Antifungal Agents
MeSH PA D000977 Antiparasitic Agents
MeSH PA D000981 Antiprotozoal Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006727 Hormone Antagonists
MeSH PA D014344 Trypanocidal Agents
MeSH PA D058888 14-alpha Demethylase Inhibitors
MeSH PA D065088 Steroid Synthesis Inhibitors
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:36335 trypanocidal drug

Related Drugs by ATC class:

J02AC Triazole and tetrazole derivatives 5 drugs
fluconazoleisavuconazoniumitraconazoleoteseconazolevoriconazole

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

DiseaseRelationSNOMED_IDDOID
Mycosis indication 3218000 DOID:1564
Coccidioidomycosis indication 60826002 DOID:13450
Fusarium infection indication 64250002
Aspergillosis indication 65553006 DOID:13564
Mucormycosis indication 76627001
Candidiasis indication 78048006 DOID:1508
Candidiasis of mouth indication 79740000 DOID:14262
Chromoblastomycosis indication 187079000
Pharyngeal candidiasis indication 240704003
Mycetoma indication 410039003 DOID:13078




🐶 Veterinary Drug Use

SpeciesUseRelation
Dogs Otitis externa caused by yeast, Malassezia pachydermatis Indication
Dogs Otitis externa associated with bacteria coagulase positive staphylococci Indication
Dogs Otitis externa associated with Pseudomonas aeruginosa Indication
Dogs Otitis externa associated with Enterococcus faecalis Indication

🐶 Veterinary products

ProductApplicantIngredients
Posatex Otic Suspension Intervet Inc. 3

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.68 acidic
pKa2 5.12 Basic
pKa3 5.0 Basic
pKa4 2.66 Basic
pKa5 0.3 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
300MG/16.7ML (18MG/ML) NOXAFIL MERCK SHARP DOHME N205596 March 13, 2014 DISCN SOLUTION INTRAVENOUS 9358297 June 24, 2031 PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WHO ARE SEVERELY IMMUNOCOMPROMISED
300MG/16.7ML (18MG/ML) NOXAFIL MERCK SHARP DOHME N205596 March 13, 2014 DISCN SOLUTION INTRAVENOUS 9358297 June 24, 2031 PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WHO WEIGH 10 KG OR GREATER WHO ARE SEVERELY IMMUNOCOMPROMISED
300MG/16.7ML (18MG/ML) NOXAFIL MERCK SHARP DOHME N205596 March 13, 2014 DISCN SOLUTION INTRAVENOUS 9358297 June 24, 2031 TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER
300MG/16.7ML (18MG/ML) NOXAFIL MERCK SHARP DOHME N205596 March 13, 2014 DISCN SOLUTION INTRAVENOUS 9358297 June 24, 2031 TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WHO WEIGH 10 KG OR GREATER
300MG/16.7ML (18MG/ML) NOXAFIL MERCK SHARP DOHME N205596 March 13, 2014 DISCN SOLUTION INTRAVENOUS 9023790 July 4, 2031 PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS
300MG/16.7ML (18MG/ML) NOXAFIL MERCK SHARP DOHME N205596 March 13, 2014 DISCN SOLUTION INTRAVENOUS 9023790 July 4, 2031 PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WHO ARE SEVERELY IMMUNOCOMPROMISED
300MG/16.7ML (18MG/ML) NOXAFIL MERCK SHARP DOHME N205596 March 13, 2014 DISCN SOLUTION INTRAVENOUS 9023790 July 4, 2031 PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WHO WEIGH 10 KG OR GREATER WHO ARE SEVERELY IMMUNOCOMPROMISED
300MG/16.7ML (18MG/ML) NOXAFIL MERCK SHARP DOHME N205596 March 13, 2014 DISCN SOLUTION INTRAVENOUS 9023790 July 4, 2031 TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER
300MG/16.7ML (18MG/ML) NOXAFIL MERCK SHARP DOHME N205596 March 13, 2014 DISCN SOLUTION INTRAVENOUS 9023790 July 4, 2031 TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WHO WEIGH 10 KG OR GREATER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** NOXAFIL MERCK SHARP DOHME N205053 Nov. 25, 2013 DISCN TABLET, DELAYED RELEASE ORAL June 17, 2028 FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER
300MG/16.7ML (18MG/ML) NOXAFIL MERCK SHARP DOHME N205596 March 13, 2014 DISCN SOLUTION INTRAVENOUS June 17, 2028 FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** NOXAFIL MERCK SHARP DOHME N205053 Nov. 25, 2013 DISCN TABLET, DELAYED RELEASE ORAL Jan. 27, 2029 NEW PATIENT POPULATION
300MG/16.7ML (18MG/ML) NOXAFIL MERCK SHARP DOHME N205596 March 13, 2014 DISCN SOLUTION INTRAVENOUS Jan. 27, 2029 NEW PATIENT POPULATION
300MG NOXAFIL POWDERMIX KIT MSD MERCK CO N214770 May 31, 2021 RX FOR SUSPENSION, DELAYED RELEASE ORAL Jan. 27, 2029 TREATMENT OF INVASIVE ASPERGILLOSIS IN PATIENTS 2 YEARS OF AGE AND OLDER WHO WEIGH 10 KG TO 40 KG

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
ATP-binding cassette sub-family G member 2 Transporter IC50 5.22 CHEMBL
7-alpha-hydroxycholest-4-en-3-one 12-alpha-hydroxylase Enzyme IC50 5.42 CHEMBL
Cytochrome P450 3A4 Enzyme WOMBAT-PK
Lanosterol 14-alpha demethylase Enzyme INHIBITOR MIC 9.40 WOMBAT-PK CHEMBL
14-alpha sterol demethylase Cyp51A Enzyme Kd 5.57 CHEMBL
14-alpha sterol demethylase Enzyme Kd 7.14 CHEMBL
Sterol 14-alpha demethylase Enzyme IC50 7.32 CHEMBL
Sterol 14-alpha-demethylase Enzyme Kd 6.88 CHEMBL
14-alpha sterol demethylase Enzyme Kd 6.88 CHEMBL
14-alpha sterol demethylase Enzyme Kd 6.88 CHEMBL

External reference:

IDSource
4025699 VUID
N0000179745 NUI
D02555 KEGG_DRUG
4025699 VANDF
C0936148 UMLSCUI
CHEBI:64355 CHEBI
X2N PDB_CHEM_ID
CHEMBL1397 ChEMBL_ID
DB01263 DRUGBANK_ID
C101425 MESH_SUPPLEMENTAL_RECORD_UI
11428 IUPHAR_LIGAND_ID
7713 INN_ID
6TK1G07BHZ UNII
468595 PUBCHEM_CID
282446 RXNORM
21768 MMSL
320488 MMSL
83903 MMSL
d05853 MMSL
011210 NDDF
420282006 SNOMEDCT_US
421747003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
posaconazole HUMAN PRESCRIPTION DRUG LABEL 1 0054-0449 SUSPENSION 40 mg ORAL ANDA 29 sections
NOXAFIL HUMAN PRESCRIPTION DRUG LABEL 1 0085-1328 SUSPENSION 40 mg ORAL NDA 31 sections
NOXAFIL HUMAN PRESCRIPTION DRUG LABEL 1 0085-1328 SUSPENSION 40 mg ORAL NDA 31 sections
NOXAFIL HUMAN PRESCRIPTION DRUG LABEL 1 0085-2224 POWDER, FOR SUSPENSION 300 mg ORAL NDA 31 sections
NOXAFIL HUMAN PRESCRIPTION DRUG LABEL 1 0085-2224 POWDER, FOR SUSPENSION 300 mg ORAL NDA 31 sections
NOXAFIL HUMAN PRESCRIPTION DRUG LABEL 1 0085-4324 TABLET, COATED 100 mg ORAL NDA 31 sections
NOXAFIL HUMAN PRESCRIPTION DRUG LABEL 1 0085-4324 TABLET, COATED 100 mg ORAL NDA 31 sections
NOXAFIL HUMAN PRESCRIPTION DRUG LABEL 1 0085-4331 SOLUTION 18 mg INTRAVENOUS NDA 31 sections
NOXAFIL HUMAN PRESCRIPTION DRUG LABEL 1 0085-4331 SOLUTION 18 mg INTRAVENOUS NDA 31 sections
POSACONAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 0254-1016 SUSPENSION 40 mg ORAL NDA authorized generic 31 sections
POSACONAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 0254-2045 TABLET, COATED 100 mg ORAL NDA authorized generic 31 sections
POSACONAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 0406-7711 TABLET, DELAYED RELEASE 100 mg ORAL ANDA 33 sections
POSACONAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 0527-2133 TABLET, DELAYED RELEASE 100 mg ORAL ANDA 29 sections
POSACONAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 0904-7149 TABLET, DELAYED RELEASE 100 mg ORAL ANDA 25 sections
Posaconazole HUMAN PRESCRIPTION DRUG LABEL 1 16714-535 TABLET, DELAYED RELEASE 100 mg ORAL ANDA 26 sections
POSACONAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 17856-2133 TABLET, DELAYED RELEASE 100 mg ORAL ANDA 28 sections
POSACONAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 31722-370 SOLUTION 18 mg INTRAVENOUS ANDA 27 sections
Posaconazole HUMAN PRESCRIPTION DRUG LABEL 1 31722-677 TABLET, DELAYED RELEASE 100 mg ORAL ANDA 26 sections
Posaconazole HUMAN PRESCRIPTION DRUG LABEL 1 42023-195 INJECTION 18 mg INTRAVENOUS ANDA 28 sections
Posaconazole HUMAN PRESCRIPTION DRUG LABEL 1 42291-919 TABLET, DELAYED RELEASE 100 mg ORAL ANDA 32 sections
Posaconazole HUMAN PRESCRIPTION DRUG LABEL 1 43598-470 TABLET, DELAYED RELEASE 100 mg ORAL ANDA 26 sections
Posaconazole HUMAN PRESCRIPTION DRUG LABEL 1 50268-683 TABLET, DELAYED RELEASE 100 mg ORAL ANDA 27 sections
POSACONAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 51407-676 TABLET, DELAYED RELEASE 100 mg ORAL ANDA 33 sections
POSACONAZOLE Human Prescription Drug Label 1 55150-388 INJECTION 18 mg INTRAVENOUS ANDA 27 sections
POSACONAZOLE Human Prescription Drug Label 1 59651-596 TABLET, DELAYED RELEASE 100 mg ORAL ANDA 28 sections
Posaconazole HUMAN PRESCRIPTION DRUG LABEL 1 60687-523 TABLET, DELAYED RELEASE 100 mg ORAL ANDA 28 sections
POSACONAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 62135-429 TABLET 100 mg ORAL ANDA 19 sections
Posaconazole HUMAN PRESCRIPTION DRUG LABEL 1 63323-685 INJECTION, SOLUTION 18 mg INTRAVENOUS ANDA 33 sections
POSACONAZOLE HUMAN PRESCRIPTION DRUG LABEL 1 63629-2236 TABLET, COATED 100 mg ORAL NDA authorized generic 30 sections
posaconazole HUMAN PRESCRIPTION DRUG LABEL 1 67457-665 SOLUTION 18 mg INTRAVENOUS ANDA 29 sections