posaconazole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| systemic antifungal agents, miconazole derivatives | 3483 | 171228-49-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.30 | g | O |
| 0.30 | g | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 476.06 | 19.87 | 283 | 11019 | 118166 | 63359554 |
| Pseudoaldosteronism | 209.31 | 19.87 | 31 | 11271 | 44 | 63477676 |
| Acute myeloid leukaemia | 181.34 | 19.87 | 79 | 11223 | 17068 | 63460652 |
| Septic shock | 136.22 | 19.87 | 105 | 11197 | 66524 | 63411196 |
| Neutropenia | 133.69 | 19.87 | 160 | 11142 | 174845 | 63302875 |
| Drug interaction | 130.37 | 19.87 | 181 | 11121 | 228950 | 63248770 |
| Graft versus host disease | 122.87 | 19.87 | 46 | 11256 | 6717 | 63471003 |
| Fusarium infection | 115.09 | 19.87 | 26 | 11276 | 620 | 63477100 |
| Hepatocellular injury | 113.63 | 19.87 | 67 | 11235 | 27314 | 63450406 |
| Cholestasis | 111.72 | 19.87 | 68 | 11234 | 29366 | 63448354 |
| Bronchopulmonary aspergillosis | 98.53 | 19.87 | 42 | 11260 | 8593 | 63469127 |
| Product use in unapproved indication | 96.59 | 19.87 | 138 | 11164 | 178942 | 63298778 |
| Mucormycosis | 92.72 | 19.87 | 30 | 11272 | 2841 | 63474879 |
| Graft versus host disease in gastrointestinal tract | 89.15 | 19.87 | 30 | 11272 | 3211 | 63474509 |
| Pneumonia fungal | 87.91 | 19.87 | 34 | 11268 | 5421 | 63472299 |
| Scedosporium infection | 80.77 | 19.87 | 19 | 11283 | 544 | 63477176 |
| Aspergillus infection | 78.15 | 19.87 | 35 | 11267 | 8058 | 63469662 |
| Acute myeloid leukaemia recurrent | 77.99 | 19.87 | 23 | 11279 | 1600 | 63476120 |
| Multiple organ dysfunction syndrome | 71.91 | 19.87 | 68 | 11234 | 56684 | 63421036 |
| Antibiotic level below therapeutic | 71.25 | 19.87 | 11 | 11291 | 24 | 63477696 |
| Thrombocytopenia | 69.29 | 19.87 | 108 | 11194 | 151049 | 63326671 |
| Sepsis | 65.49 | 19.87 | 106 | 11196 | 153017 | 63324703 |
| Bone marrow failure | 63.85 | 19.87 | 48 | 11254 | 29242 | 63448478 |
| Differentiation syndrome | 63.54 | 19.87 | 18 | 11284 | 1085 | 63476635 |
| Cytomegalovirus infection | 63.49 | 19.87 | 42 | 11260 | 20910 | 63456810 |
| Fungaemia | 61.21 | 19.87 | 21 | 11281 | 2382 | 63475338 |
| Left atrial hypertrophy | 60.26 | 19.87 | 10 | 11292 | 40 | 63477680 |
| Adenoviral hepatitis | 59.98 | 19.87 | 14 | 11288 | 387 | 63477333 |
| Arthralgia | 58.08 | 19.87 | 15 | 11287 | 569695 | 62908025 |
| Myelosuppression | 54.24 | 19.87 | 40 | 11262 | 23663 | 63454057 |
| Bicytopenia | 52.75 | 19.87 | 19 | 11283 | 2486 | 63475234 |
| Blood bilirubin increased | 51.87 | 19.87 | 47 | 11255 | 37093 | 63440627 |
| Pyrexia | 51.57 | 19.87 | 192 | 11110 | 470286 | 63007434 |
| Hypokalaemia | 51.52 | 19.87 | 77 | 11225 | 103727 | 63373993 |
| Respiratory failure | 51.19 | 19.87 | 76 | 11226 | 101782 | 63375938 |
| Pancytopenia | 51.14 | 19.87 | 74 | 11228 | 96859 | 63380861 |
| Fatigue | 49.90 | 19.87 | 51 | 11251 | 887977 | 62589743 |
| Aplasia | 49.53 | 19.87 | 21 | 11281 | 4238 | 63473482 |
| Electrocardiogram QT prolonged | 47.92 | 19.87 | 56 | 11246 | 59474 | 63418246 |
| Acute kidney injury | 46.71 | 19.87 | 127 | 11175 | 263288 | 63214432 |
| Enterococcal infection | 45.67 | 19.87 | 24 | 11278 | 7824 | 63469896 |
| Hyperbilirubinaemia | 45.13 | 19.87 | 27 | 11275 | 11287 | 63466433 |
| Sinoatrial block | 44.49 | 19.87 | 13 | 11289 | 875 | 63476845 |
| Herpes simplex | 44.48 | 19.87 | 24 | 11278 | 8247 | 63469473 |
| Neurotoxicity | 44.20 | 19.87 | 31 | 11271 | 16959 | 63460761 |
| Joint swelling | 43.74 | 19.87 | 4 | 11298 | 327662 | 63150058 |
| Torsade de pointes | 43.47 | 19.87 | 28 | 11274 | 13323 | 63464397 |
| Electrocardiogram PR shortened | 42.96 | 19.87 | 10 | 11292 | 273 | 63477447 |
| Pain | 42.16 | 19.87 | 42 | 11260 | 740586 | 62737134 |
| Staphylococcal sepsis | 42.09 | 19.87 | 23 | 11279 | 8105 | 63469615 |
| Death | 41.97 | 19.87 | 154 | 11148 | 374227 | 63103493 |
| Cytokine release syndrome | 41.69 | 19.87 | 28 | 11274 | 14286 | 63463434 |
| Off label use | 40.12 | 19.87 | 230 | 11072 | 674232 | 62803488 |
| Graft versus host disease in skin | 39.44 | 19.87 | 16 | 11286 | 2889 | 63474831 |
| Leukaemia recurrent | 39.24 | 19.87 | 13 | 11289 | 1325 | 63476395 |
| Cytomegalovirus infection reactivation | 37.81 | 19.87 | 17 | 11285 | 3946 | 63473774 |
| Systemic candida | 37.73 | 19.87 | 16 | 11286 | 3229 | 63474491 |
| Gastrointestinal toxicity | 37.60 | 19.87 | 21 | 11281 | 7720 | 63470000 |
| Hypersensitivity | 35.48 | 19.87 | 5 | 11297 | 292680 | 63185040 |
| Chronic graft versus host disease | 35.09 | 19.87 | 15 | 11287 | 3087 | 63474633 |
| Transaminases increased | 34.86 | 19.87 | 35 | 11267 | 31332 | 63446388 |
| Bacteraemia | 34.66 | 19.87 | 27 | 11275 | 17321 | 63460399 |
| Acute lymphocytic leukaemia | 34.65 | 19.87 | 14 | 11288 | 2502 | 63475218 |
| Venoocclusive liver disease | 34.59 | 19.87 | 17 | 11285 | 4818 | 63472902 |
| Drug hypersensitivity | 33.94 | 19.87 | 7 | 11295 | 310680 | 63167040 |
| Geotrichum infection | 33.12 | 19.87 | 9 | 11293 | 465 | 63477255 |
| Adenovirus infection | 33.06 | 19.87 | 15 | 11287 | 3556 | 63474164 |
| Coagulation test abnormal | 32.69 | 19.87 | 10 | 11292 | 788 | 63476932 |
| Venous haemorrhage | 32.21 | 19.87 | 8 | 11294 | 289 | 63477431 |
| Cytopenia | 32.13 | 19.87 | 22 | 11280 | 11579 | 63466141 |
| Hepatic necrosis | 31.98 | 19.87 | 17 | 11285 | 5670 | 63472050 |
| Abdominal discomfort | 31.59 | 19.87 | 9 | 11293 | 320876 | 63156844 |
| BK virus infection | 31.08 | 19.87 | 14 | 11288 | 3265 | 63474455 |
| Acquired apparent mineralocorticoid excess | 30.54 | 19.87 | 4 | 11298 | 0 | 63477720 |
| Swelling | 30.50 | 19.87 | 6 | 11296 | 275372 | 63202348 |
| Allogenic stem cell transplantation | 30.20 | 19.87 | 6 | 11296 | 75 | 63477645 |
| Fungal infection | 30.18 | 19.87 | 35 | 11267 | 36839 | 63440881 |
| Mycobacterium abscessus infection | 30.12 | 19.87 | 9 | 11293 | 655 | 63477065 |
| Disease progression | 30.01 | 19.87 | 67 | 11235 | 122691 | 63355029 |
| Lung infiltration | 29.96 | 19.87 | 23 | 11279 | 14440 | 63463280 |
| Endophthalmitis | 29.86 | 19.87 | 14 | 11288 | 3578 | 63474142 |
| Seroconversion test positive | 29.39 | 19.87 | 5 | 11297 | 24 | 63477696 |
| Renal tubular acidosis | 28.88 | 19.87 | 11 | 11291 | 1681 | 63476039 |
| Systemic mycosis | 28.70 | 19.87 | 10 | 11292 | 1187 | 63476533 |
| Cholecystitis acute | 28.57 | 19.87 | 18 | 11284 | 8242 | 63469478 |
| Pelvic venous thrombosis | 28.49 | 19.87 | 11 | 11291 | 1744 | 63475976 |
| Enterobacter test positive | 28.37 | 19.87 | 7 | 11295 | 246 | 63477474 |
| Pain in extremity | 27.99 | 19.87 | 12 | 11290 | 331474 | 63146246 |
| Klebsiella infection | 27.97 | 19.87 | 18 | 11284 | 8548 | 63469172 |
| Long QT syndrome | 27.93 | 19.87 | 13 | 11289 | 3266 | 63474454 |
| Hepatic failure | 27.78 | 19.87 | 33 | 11269 | 35623 | 63442097 |
| Organ failure | 27.22 | 19.87 | 12 | 11290 | 2659 | 63475061 |
| Staphylococcal infection | 27.03 | 19.87 | 35 | 11267 | 41221 | 63436499 |
| Klebsiella sepsis | 26.80 | 19.87 | 10 | 11292 | 1445 | 63476275 |
| Enterococcal bacteraemia | 26.77 | 19.87 | 10 | 11292 | 1449 | 63476271 |
| Brain abscess | 26.49 | 19.87 | 11 | 11291 | 2107 | 63475613 |
| Growth failure | 26.34 | 19.87 | 7 | 11295 | 332 | 63477388 |
| Ureaplasma infection | 26.00 | 19.87 | 8 | 11294 | 643 | 63477077 |
| Graft versus host disease in liver | 25.92 | 19.87 | 8 | 11294 | 649 | 63477071 |
| Acute lymphocytic leukaemia recurrent | 25.76 | 19.87 | 11 | 11291 | 2258 | 63475462 |
| Atrioventricular block second degree | 25.75 | 19.87 | 13 | 11289 | 3901 | 63473819 |
| Neutropenic colitis | 25.53 | 19.87 | 12 | 11290 | 3083 | 63474637 |
| Graft versus host disease in lung | 25.51 | 19.87 | 7 | 11295 | 375 | 63477345 |
| Hepatotoxicity | 25.17 | 19.87 | 32 | 11270 | 37009 | 63440711 |
| Pseudomonal sepsis | 25.16 | 19.87 | 11 | 11291 | 2390 | 63475330 |
| Acute graft versus host disease in intestine | 25.01 | 19.87 | 10 | 11292 | 1739 | 63475981 |
| Partial seizures with secondary generalisation | 24.97 | 19.87 | 7 | 11295 | 406 | 63477314 |
| Depression | 24.66 | 19.87 | 3 | 11299 | 196489 | 63281231 |
| Disseminated intravascular coagulation | 24.44 | 19.87 | 23 | 11279 | 19028 | 63458692 |
| Alopecia | 24.36 | 19.87 | 15 | 11287 | 337521 | 63140199 |
| Posterior reversible encephalopathy syndrome | 24.30 | 19.87 | 22 | 11280 | 17323 | 63460397 |
| Acute graft versus host disease in skin | 24.28 | 19.87 | 12 | 11290 | 3440 | 63474280 |
| Malaise | 24.27 | 19.87 | 23 | 11279 | 415931 | 63061789 |
| Blood lactate dehydrogenase increased | 24.24 | 19.87 | 25 | 11277 | 23091 | 63454629 |
| Encephalopathy | 24.11 | 19.87 | 32 | 11270 | 38588 | 63439132 |
| Infusion related reaction | 23.95 | 19.87 | 7 | 11295 | 245514 | 63232206 |
| Kussmaul respiration | 23.38 | 19.87 | 6 | 11296 | 248 | 63477472 |
| Overgrowth fungal | 23.36 | 19.87 | 5 | 11297 | 92 | 63477628 |
| Electrocardiogram ST segment depression | 23.25 | 19.87 | 11 | 11291 | 2866 | 63474854 |
| Soft tissue infection | 23.08 | 19.87 | 10 | 11292 | 2127 | 63475593 |
| Dizziness | 22.58 | 19.87 | 26 | 11276 | 429899 | 63047821 |
| Tumour lysis syndrome | 22.45 | 19.87 | 16 | 11286 | 8974 | 63468746 |
| Bacterial infection | 22.11 | 19.87 | 22 | 11280 | 19477 | 63458243 |
| Leukaemia | 22.04 | 19.87 | 12 | 11290 | 4196 | 63473524 |
| Nodal arrhythmia | 21.44 | 19.87 | 8 | 11294 | 1155 | 63476565 |
| Atypical pneumonia | 21.44 | 19.87 | 12 | 11290 | 4428 | 63473292 |
| Cytomegalovirus viraemia | 21.28 | 19.87 | 13 | 11289 | 5636 | 63472084 |
| Stem cell transplant | 21.24 | 19.87 | 9 | 11293 | 1813 | 63475907 |
| Rhinovirus infection | 21.22 | 19.87 | 12 | 11290 | 4517 | 63473203 |
| Cell death | 21.19 | 19.87 | 10 | 11292 | 2591 | 63475129 |
| Angiokeratoma | 21.19 | 19.87 | 5 | 11297 | 145 | 63477575 |
| Adenovirus reactivation | 21.16 | 19.87 | 5 | 11297 | 146 | 63477574 |
| Clostridium difficile colitis | 21.13 | 19.87 | 22 | 11280 | 20547 | 63457173 |
| Pericardial effusion | 20.47 | 19.87 | 26 | 11276 | 30032 | 63447688 |
| Escherichia bacteraemia | 20.14 | 19.87 | 11 | 11291 | 3872 | 63473848 |
| Bacterial sepsis | 19.94 | 19.87 | 11 | 11291 | 3947 | 63473773 |
| Pruritus | 19.91 | 19.87 | 21 | 11281 | 361432 | 63116288 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 315.91 | 17.02 | 349 | 15640 | 136500 | 34804442 |
| Product use in unapproved indication | 230.89 | 17.02 | 276 | 15713 | 117223 | 34823719 |
| Aspergillus infection | 176.90 | 17.02 | 94 | 15895 | 12160 | 34928782 |
| Pseudoaldosteronism | 159.05 | 17.02 | 28 | 15961 | 49 | 34940893 |
| Bronchopulmonary aspergillosis | 135.24 | 17.02 | 84 | 15905 | 14575 | 34926367 |
| Septic shock | 129.84 | 17.02 | 162 | 15827 | 71672 | 34869270 |
| Acute myeloid leukaemia recurrent | 127.69 | 17.02 | 45 | 15944 | 2125 | 34938817 |
| Graft versus host disease | 127.44 | 17.02 | 72 | 15917 | 10497 | 34930445 |
| Mucormycosis | 125.40 | 17.02 | 59 | 15930 | 5883 | 34935059 |
| Fusarium infection | 120.63 | 17.02 | 37 | 15952 | 1123 | 34939819 |
| Microsporidia infection | 120.04 | 17.02 | 33 | 15956 | 673 | 34940269 |
| Pneumonia fungal | 115.43 | 17.02 | 59 | 15930 | 7041 | 34933901 |
| Off label use | 105.76 | 17.02 | 424 | 15565 | 419100 | 34521842 |
| Neutropenia | 104.73 | 17.02 | 225 | 15764 | 156553 | 34784389 |
| Acute myeloid leukaemia | 102.50 | 17.02 | 77 | 15912 | 18193 | 34922749 |
| Drug ineffective | 99.11 | 17.02 | 441 | 15548 | 456310 | 34484632 |
| Antibiotic level below therapeutic | 95.02 | 17.02 | 18 | 15971 | 56 | 34940886 |
| Drug resistance | 88.57 | 17.02 | 82 | 15907 | 25845 | 34915097 |
| Drug interaction | 86.81 | 17.02 | 263 | 15726 | 225683 | 34715259 |
| Cerebral aspergillosis | 85.41 | 17.02 | 30 | 15959 | 1402 | 34939540 |
| Pathogen resistance | 79.10 | 17.02 | 51 | 15938 | 9431 | 34931511 |
| Hepatic cytolysis | 76.68 | 17.02 | 59 | 15930 | 14437 | 34926505 |
| Systemic mycosis | 75.26 | 17.02 | 28 | 15961 | 1545 | 34939397 |
| Demodicidosis | 70.24 | 17.02 | 17 | 15972 | 204 | 34940738 |
| Myositis | 70.21 | 17.02 | 52 | 15937 | 12018 | 34928924 |
| Acanthamoeba infection | 68.54 | 17.02 | 19 | 15970 | 400 | 34940542 |
| Cytokine release syndrome | 67.97 | 17.02 | 67 | 15922 | 22810 | 34918132 |
| Immune effector cell-associated neurotoxicity syndrome | 63.68 | 17.02 | 32 | 15957 | 3681 | 34937261 |
| Enterococcal infection | 63.08 | 17.02 | 44 | 15945 | 9262 | 34931680 |
| Fungal infection | 57.53 | 17.02 | 52 | 15937 | 15883 | 34925059 |
| Cytomegalovirus infection reactivation | 56.69 | 17.02 | 33 | 15956 | 5085 | 34935857 |
| Graft versus host disease in skin | 56.30 | 17.02 | 30 | 15959 | 3895 | 34937047 |
| Graft versus host disease in gastrointestinal tract | 55.24 | 17.02 | 29 | 15960 | 3654 | 34937288 |
| Device related infection | 54.04 | 17.02 | 52 | 15937 | 17185 | 34923757 |
| Pseudomonas infection | 53.98 | 17.02 | 45 | 15944 | 12337 | 34928605 |
| Thrombocytopenia | 53.53 | 17.02 | 175 | 15814 | 156072 | 34784870 |
| Differentiation syndrome | 52.40 | 17.02 | 21 | 15968 | 1417 | 34939525 |
| Septic embolus | 51.45 | 17.02 | 20 | 15969 | 1245 | 34939697 |
| Scedosporium infection | 50.78 | 17.02 | 18 | 15971 | 864 | 34940078 |
| Hypokalaemia | 50.08 | 17.02 | 93 | 15896 | 58121 | 34882821 |
| Multiple organ dysfunction syndrome | 49.95 | 17.02 | 109 | 15880 | 76457 | 34864485 |
| Geotrichum infection | 47.87 | 17.02 | 15 | 15974 | 489 | 34940453 |
| Candida infection | 47.34 | 17.02 | 49 | 15940 | 17666 | 34923276 |
| Neurotoxicity | 46.66 | 17.02 | 49 | 15940 | 17961 | 34922981 |
| Fatigue | 45.53 | 17.02 | 62 | 15927 | 370591 | 34570351 |
| Thrombotic microangiopathy | 45.03 | 17.02 | 38 | 15951 | 10592 | 34930350 |
| Fall | 43.84 | 17.02 | 19 | 15970 | 202866 | 34738076 |
| Product use issue | 43.52 | 17.02 | 92 | 15897 | 63124 | 34877818 |
| Nephropathy toxic | 43.33 | 17.02 | 40 | 15949 | 12548 | 34928394 |
| Brain abscess | 42.34 | 17.02 | 23 | 15966 | 3102 | 34937840 |
| Polymyositis | 42.06 | 17.02 | 18 | 15971 | 1435 | 34939507 |
| Parainfluenzae virus infection | 41.63 | 17.02 | 22 | 15967 | 2808 | 34938134 |
| Bacteraemia | 41.32 | 17.02 | 48 | 15941 | 19669 | 34921273 |
| Acute graft versus host disease in skin | 40.99 | 17.02 | 27 | 15962 | 5174 | 34935768 |
| Eye infection fungal | 39.00 | 17.02 | 12 | 15977 | 368 | 34940574 |
| Sepsis | 38.94 | 17.02 | 165 | 15824 | 166396 | 34774546 |
| Arthralgia | 38.21 | 17.02 | 15 | 15974 | 170026 | 34770916 |
| Graft versus host disease in liver | 37.47 | 17.02 | 16 | 15973 | 1268 | 34939674 |
| NPM1 gene mutation | 36.52 | 17.02 | 9 | 15980 | 117 | 34940825 |
| Hyperbilirubinaemia | 35.29 | 17.02 | 41 | 15948 | 16802 | 34924140 |
| Malaise | 34.76 | 17.02 | 21 | 15968 | 185804 | 34755138 |
| Pyrexia | 34.47 | 17.02 | 265 | 15724 | 332748 | 34608194 |
| Central nervous system lesion | 33.50 | 17.02 | 26 | 15963 | 6437 | 34934505 |
| Pancytopenia | 32.90 | 17.02 | 107 | 15882 | 95050 | 34845892 |
| Condition aggravated | 32.26 | 17.02 | 173 | 15816 | 192023 | 34748919 |
| Bronchiolitis obliterans syndrome | 32.13 | 17.02 | 9 | 15980 | 197 | 34940745 |
| Neutropenic infection | 31.98 | 17.02 | 15 | 15974 | 1483 | 34939459 |
| Pain | 31.96 | 17.02 | 28 | 15961 | 204647 | 34736295 |
| Dizziness | 31.65 | 17.02 | 32 | 15957 | 218489 | 34722453 |
| Chimerism | 30.66 | 17.02 | 9 | 15980 | 234 | 34940708 |
| Immunosuppressant drug level increased | 30.61 | 17.02 | 24 | 15965 | 6031 | 34934911 |
| Retinal ischaemia | 30.52 | 17.02 | 10 | 15979 | 377 | 34940565 |
| Dyspnoea | 30.45 | 17.02 | 81 | 15908 | 376701 | 34564241 |
| Sinusitis fungal | 30.28 | 17.02 | 11 | 15978 | 567 | 34940375 |
| Neutrophil Pelger-Huet anomaly present | 30.23 | 17.02 | 9 | 15980 | 246 | 34940696 |
| Tumour lysis syndrome | 29.99 | 17.02 | 38 | 15951 | 17021 | 34923921 |
| Treatment failure | 29.88 | 17.02 | 66 | 15923 | 46631 | 34894311 |
| Brain herniation | 29.64 | 17.02 | 20 | 15969 | 3988 | 34936954 |
| Product dose omission issue | 29.57 | 17.02 | 9 | 15980 | 119702 | 34821240 |
| Fungal skin infection | 29.21 | 17.02 | 17 | 15972 | 2617 | 34938325 |
| Neutropenic colitis | 28.93 | 17.02 | 18 | 15971 | 3126 | 34937816 |
| Ecthyma | 28.58 | 17.02 | 10 | 15979 | 462 | 34940480 |
| Myocardial infarction | 28.33 | 17.02 | 10 | 15979 | 121075 | 34819867 |
| Inappropriate antidiuretic hormone secretion | 28.32 | 17.02 | 32 | 15957 | 12721 | 34928221 |
| Cholestasis | 28.27 | 17.02 | 47 | 15942 | 26901 | 34914041 |
| Acquired apparent mineralocorticoid excess | 27.69 | 17.02 | 6 | 15983 | 42 | 34940900 |
| Staphylococcal bacteraemia | 27.44 | 17.02 | 26 | 15963 | 8426 | 34932516 |
| Cardioactive drug level increased | 27.12 | 17.02 | 14 | 15975 | 1703 | 34939239 |
| Staphylococcal infection | 26.49 | 17.02 | 51 | 15938 | 32709 | 34908233 |
| Depression | 26.45 | 17.02 | 6 | 15983 | 97092 | 34843850 |
| Lip squamous cell carcinoma | 26.33 | 17.02 | 7 | 15982 | 125 | 34940817 |
| Necrotising retinitis | 26.26 | 17.02 | 11 | 15978 | 831 | 34940111 |
| Lower respiratory tract infection fungal | 25.95 | 17.02 | 10 | 15979 | 608 | 34940334 |
| Incorrect product formulation administered | 25.83 | 17.02 | 5 | 15984 | 18 | 34940924 |
| Escherichia bacteraemia | 25.78 | 17.02 | 17 | 15972 | 3263 | 34937679 |
| Acute graft versus host disease in liver | 25.40 | 17.02 | 13 | 15976 | 1553 | 34939389 |
| Skin necrosis | 24.94 | 17.02 | 21 | 15968 | 5832 | 34935110 |
| Blood pressure increased | 24.90 | 17.02 | 5 | 15984 | 88097 | 34852845 |
| Ileus paralytic | 24.50 | 17.02 | 21 | 15968 | 5976 | 34934966 |
| Stenotrophomonas infection | 24.42 | 17.02 | 14 | 15975 | 2096 | 34938846 |
| Drug ineffective for unapproved indication | 24.39 | 17.02 | 41 | 15948 | 23674 | 34917268 |
| Hyperhidrosis | 24.32 | 17.02 | 3 | 15986 | 75689 | 34865253 |
| Brain compression | 24.03 | 17.02 | 7 | 15982 | 177 | 34940765 |
| Steroid diabetes | 23.90 | 17.02 | 14 | 15975 | 2181 | 34938761 |
| Cytopenia | 23.41 | 17.02 | 29 | 15960 | 12694 | 34928248 |
| Cytomegalovirus infection | 22.76 | 17.02 | 42 | 15947 | 26093 | 34914849 |
| Cerebral artery embolism | 22.45 | 17.02 | 10 | 15979 | 878 | 34940064 |
| Septic encephalopathy | 22.42 | 17.02 | 6 | 15983 | 110 | 34940832 |
| Weight decreased | 22.07 | 17.02 | 29 | 15960 | 176272 | 34764670 |
| Drug hypersensitivity | 21.88 | 17.02 | 5 | 15984 | 80524 | 34860418 |
| Encephalopathy | 21.56 | 17.02 | 49 | 15940 | 35270 | 34905672 |
| Enterobacter bacteraemia | 21.45 | 17.02 | 8 | 15981 | 444 | 34940498 |
| Pruritus | 21.45 | 17.02 | 20 | 15969 | 141961 | 34798981 |
| Acute graft versus host disease in intestine | 21.20 | 17.02 | 14 | 15975 | 2694 | 34938248 |
| Gastrointestinal tract mucosal pigmentation | 20.83 | 17.02 | 8 | 15981 | 482 | 34940460 |
| Primary adrenal insufficiency | 20.81 | 17.02 | 5 | 15984 | 58 | 34940884 |
| Folliculitis | 20.74 | 17.02 | 17 | 15972 | 4549 | 34936393 |
| Nocardiosis | 20.71 | 17.02 | 16 | 15973 | 3935 | 34937007 |
| Lymphopenia | 20.60 | 17.02 | 31 | 15958 | 16304 | 34924638 |
| Renal tubular disorder | 20.49 | 17.02 | 17 | 15972 | 4626 | 34936316 |
| Blood immunoglobulin G decreased | 20.40 | 17.02 | 11 | 15978 | 1462 | 34939480 |
| Gastrointestinal wall thinning | 20.33 | 17.02 | 4 | 15985 | 16 | 34940926 |
| Cerebral ventricle collapse | 20.08 | 17.02 | 5 | 15984 | 68 | 34940874 |
| Necrotising ulcerative gingivostomatitis | 19.95 | 17.02 | 5 | 15984 | 70 | 34940872 |
| Hyperleukocytosis | 19.80 | 17.02 | 12 | 15977 | 1990 | 34938952 |
| Respiratory failure | 19.74 | 17.02 | 100 | 15889 | 108472 | 34832470 |
| Viral haemorrhagic cystitis | 19.74 | 17.02 | 10 | 15979 | 1170 | 34939772 |
| Intracranial mass | 19.72 | 17.02 | 10 | 15979 | 1172 | 34939770 |
| Muscle spasms | 19.70 | 17.02 | 5 | 15984 | 74996 | 34865946 |
| CARD9 deficiency | 19.60 | 17.02 | 4 | 15985 | 20 | 34940922 |
| Gastroenteritis clostridial | 19.38 | 17.02 | 7 | 15982 | 355 | 34940587 |
| Systemic candida | 19.33 | 17.02 | 15 | 15974 | 3711 | 34937231 |
| Hepatotoxicity | 19.30 | 17.02 | 35 | 15954 | 21450 | 34919492 |
| Donor leukocyte infusion | 18.99 | 17.02 | 4 | 15985 | 24 | 34940918 |
| Posterior reversible encephalopathy syndrome | 18.82 | 17.02 | 23 | 15966 | 9931 | 34931011 |
| SARS-CoV-2 RNA | 18.10 | 17.02 | 4 | 15985 | 31 | 34940911 |
| Stupor | 18.04 | 17.02 | 13 | 15976 | 2878 | 34938064 |
| Microsporum infection | 17.99 | 17.02 | 4 | 15985 | 32 | 34940910 |
| Chronic graft versus host disease in eye | 17.96 | 17.02 | 5 | 15984 | 107 | 34940835 |
| Drug level decreased | 17.96 | 17.02 | 20 | 15969 | 7826 | 34933116 |
| Bordetella infection | 17.91 | 17.02 | 5 | 15984 | 108 | 34940834 |
| Insomnia | 17.71 | 17.02 | 13 | 15976 | 103894 | 34837048 |
| Abscess fungal | 17.65 | 17.02 | 6 | 15983 | 254 | 34940688 |
| Hypomagnesaemia | 17.64 | 17.02 | 34 | 15955 | 21817 | 34919125 |
| Sinusitis bacterial | 17.57 | 17.02 | 7 | 15982 | 465 | 34940477 |
| Acute graft versus host disease | 17.39 | 17.02 | 18 | 15971 | 6485 | 34934457 |
| Aspergillus test positive | 17.25 | 17.02 | 7 | 15982 | 488 | 34940454 |
| Pulmonary mass | 17.14 | 17.02 | 25 | 15964 | 12787 | 34928155 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 729.00 | 16.94 | 595 | 24741 | 230404 | 79488648 |
| Pseudoaldosteronism | 344.89 | 16.94 | 58 | 25278 | 118 | 79718934 |
| Product use in unapproved indication | 335.82 | 16.94 | 405 | 24931 | 249954 | 79469098 |
| Neutropenia | 253.06 | 16.94 | 379 | 24957 | 287331 | 79431721 |
| Septic shock | 252.41 | 16.94 | 249 | 25087 | 122552 | 79596500 |
| Aspergillus infection | 241.11 | 16.94 | 119 | 25217 | 19042 | 79700010 |
| Mucormycosis | 235.79 | 16.94 | 92 | 25244 | 8377 | 79710675 |
| Acute myeloid leukaemia | 221.19 | 16.94 | 132 | 25204 | 30753 | 79688299 |
| Pneumonia fungal | 207.61 | 16.94 | 91 | 25245 | 11119 | 79707933 |
| Bronchopulmonary aspergillosis | 204.51 | 16.94 | 112 | 25224 | 22182 | 79696870 |
| Graft versus host disease | 200.06 | 16.94 | 97 | 25239 | 14929 | 79704123 |
| Drug interaction | 198.81 | 16.94 | 419 | 24917 | 414764 | 79304288 |
| Fusarium infection | 195.81 | 16.94 | 55 | 25281 | 1777 | 79717275 |
| Acute myeloid leukaemia recurrent | 174.46 | 16.94 | 58 | 25278 | 3325 | 79715727 |
| Scedosporium infection | 125.07 | 16.94 | 37 | 25299 | 1441 | 79717611 |
| Microsporidia infection | 121.69 | 16.94 | 33 | 25303 | 933 | 79718119 |
| Arthralgia | 115.87 | 16.94 | 21 | 25315 | 571782 | 79147270 |
| Graft versus host disease in gastrointestinal tract | 115.75 | 16.94 | 51 | 25285 | 6305 | 79712747 |
| Cholestasis | 115.04 | 16.94 | 110 | 25226 | 51999 | 79667053 |
| Multiple organ dysfunction syndrome | 110.54 | 16.94 | 162 | 25174 | 120084 | 79598968 |
| Thrombocytopenia | 109.96 | 16.94 | 253 | 25083 | 265006 | 79454046 |
| Cytokine release syndrome | 109.30 | 16.94 | 91 | 25245 | 35907 | 79683145 |
| Sepsis | 103.00 | 16.94 | 249 | 25087 | 269179 | 79449873 |
| Differentiation syndrome | 101.78 | 16.94 | 36 | 25300 | 2488 | 79716564 |
| Systemic mycosis | 99.86 | 16.94 | 36 | 25300 | 2630 | 79716422 |
| Enterococcal infection | 99.44 | 16.94 | 62 | 25274 | 15598 | 79703454 |
| Pathogen resistance | 96.71 | 16.94 | 59 | 25277 | 14283 | 79704769 |
| Hypokalaemia | 93.94 | 16.94 | 166 | 25170 | 143874 | 79575178 |
| Off label use | 93.68 | 16.94 | 548 | 24788 | 906667 | 78812385 |
| Fatigue | 93.42 | 16.94 | 95 | 25241 | 929632 | 78789420 |
| Pain | 87.89 | 16.94 | 58 | 25278 | 703744 | 79015308 |
| Hepatic cytolysis | 87.36 | 16.94 | 71 | 25265 | 27080 | 79691972 |
| Graft versus host disease in skin | 86.27 | 16.94 | 41 | 25295 | 6032 | 79713020 |
| Neurotoxicity | 86.08 | 16.94 | 76 | 25260 | 32442 | 79686610 |
| Drug ineffective | 85.88 | 16.94 | 611 | 24725 | 1080302 | 78638750 |
| Immune effector cell-associated neurotoxicity syndrome | 84.66 | 16.94 | 40 | 25296 | 5808 | 79713244 |
| Drug resistance | 83.62 | 16.94 | 84 | 25252 | 42129 | 79676923 |
| Geotrichum infection | 80.58 | 16.94 | 24 | 25312 | 957 | 79718095 |
| Pyrexia | 80.56 | 16.94 | 426 | 24910 | 678283 | 79040769 |
| Cytomegalovirus infection reactivation | 80.49 | 16.94 | 44 | 25292 | 8672 | 79710380 |
| Device related infection | 76.82 | 16.94 | 73 | 25263 | 34221 | 79684831 |
| Acanthamoeba infection | 76.68 | 16.94 | 20 | 25316 | 485 | 79718567 |
| Cytomegalovirus infection | 75.70 | 16.94 | 80 | 25256 | 42564 | 79676488 |
| Demodicidosis | 75.36 | 16.94 | 17 | 25319 | 218 | 79718834 |
| Fungal infection | 75.32 | 16.94 | 79 | 25257 | 41669 | 79677383 |
| Hepatocellular injury | 75.25 | 16.94 | 84 | 25252 | 47509 | 79671543 |
| Pseudomonas infection | 74.39 | 16.94 | 58 | 25278 | 20845 | 79698207 |
| Pancytopenia | 74.07 | 16.94 | 163 | 25173 | 165582 | 79553470 |
| Hyperbilirubinaemia | 72.39 | 16.94 | 61 | 25275 | 24457 | 79694595 |
| Brain abscess | 69.12 | 16.94 | 33 | 25303 | 4903 | 79714149 |
| Bacteraemia | 68.12 | 16.94 | 67 | 25269 | 32757 | 79686295 |
| Myositis | 67.81 | 16.94 | 53 | 25283 | 19115 | 79699937 |
| Hypersensitivity | 67.30 | 16.94 | 4 | 25332 | 262235 | 79456817 |
| Cerebral aspergillosis | 66.32 | 16.94 | 24 | 25312 | 1772 | 79717280 |
| Respiratory failure | 65.65 | 16.94 | 164 | 25172 | 180747 | 79538305 |
| Graft versus host disease in liver | 63.13 | 16.94 | 23 | 25313 | 1731 | 79717321 |
| Malaise | 62.93 | 16.94 | 39 | 25297 | 489830 | 79229222 |
| Joint swelling | 61.95 | 16.94 | 9 | 25327 | 288637 | 79430415 |
| Fungaemia | 59.18 | 16.94 | 29 | 25307 | 4562 | 79714490 |
| Staphylococcal infection | 58.60 | 16.94 | 82 | 25254 | 58213 | 79660839 |
| Drug hypersensitivity | 58.28 | 16.94 | 12 | 25324 | 298904 | 79420148 |
| Thrombotic microangiopathy | 57.12 | 16.94 | 49 | 25287 | 20120 | 79698932 |
| Nasopharyngitis | 56.66 | 16.94 | 7 | 25329 | 253874 | 79465178 |
| Dyspnoea | 56.09 | 16.94 | 118 | 25218 | 856907 | 78862145 |
| Acquired apparent mineralocorticoid excess | 55.97 | 16.94 | 10 | 25326 | 33 | 79719019 |
| Dizziness | 54.77 | 16.94 | 52 | 25284 | 526389 | 79192663 |
| Bone marrow failure | 54.54 | 16.94 | 74 | 25262 | 51033 | 79668019 |
| Rheumatoid arthritis | 54.03 | 16.94 | 3 | 25333 | 208467 | 79510585 |
| Tumour lysis syndrome | 53.69 | 16.94 | 51 | 25285 | 23888 | 79695164 |
| Abdominal discomfort | 53.38 | 16.94 | 8 | 25328 | 250719 | 79468333 |
| Fall | 53.30 | 16.94 | 46 | 25290 | 487583 | 79231469 |
| Left atrial hypertrophy | 52.65 | 16.94 | 10 | 25326 | 50 | 79719002 |
| Systemic candida | 51.49 | 16.94 | 30 | 25306 | 6676 | 79712376 |
| Cytopenia | 50.69 | 16.94 | 46 | 25290 | 20337 | 79698715 |
| Neutropenic colitis | 50.47 | 16.94 | 28 | 25308 | 5679 | 79713373 |
| Nephropathy toxic | 48.67 | 16.94 | 45 | 25291 | 20374 | 79698678 |
| Candida infection | 48.05 | 16.94 | 60 | 25276 | 38154 | 79680898 |
| Aplasia | 47.23 | 16.94 | 30 | 25306 | 7790 | 79711262 |
| Venoocclusive liver disease | 47.03 | 16.94 | 35 | 25301 | 11736 | 79707316 |
| Escherichia bacteraemia | 46.83 | 16.94 | 28 | 25308 | 6534 | 79712518 |
| Septic embolus | 45.74 | 16.94 | 19 | 25317 | 2032 | 79717020 |
| Acute graft versus host disease in skin | 45.31 | 16.94 | 29 | 25307 | 7629 | 79711423 |
| NPM1 gene mutation | 44.20 | 16.94 | 10 | 25326 | 130 | 79718922 |
| Depression | 43.73 | 16.94 | 8 | 25328 | 216782 | 79502270 |
| Pruritus | 43.38 | 16.94 | 37 | 25299 | 394611 | 79324441 |
| Leukaemia recurrent | 43.33 | 16.94 | 20 | 25316 | 2754 | 79716298 |
| Blood pressure increased | 42.20 | 16.94 | 8 | 25328 | 211352 | 79507700 |
| Staphylococcal sepsis | 42.16 | 16.94 | 36 | 25300 | 14690 | 79704362 |
| Acute graft versus host disease in intestine | 41.80 | 16.94 | 22 | 25314 | 4019 | 79715033 |
| Encephalopathy | 41.74 | 16.94 | 76 | 25260 | 67321 | 79651731 |
| BK virus infection | 41.63 | 16.94 | 29 | 25307 | 8775 | 79710277 |
| Swelling | 41.61 | 16.94 | 9 | 25327 | 216702 | 79502350 |
| Electrocardiogram QT prolonged | 41.60 | 16.94 | 90 | 25246 | 90296 | 79628756 |
| Infusion related reaction | 41.39 | 16.94 | 11 | 25325 | 230226 | 79488826 |
| Stenotrophomonas infection | 40.34 | 16.94 | 21 | 25315 | 3752 | 79715300 |
| Transaminases increased | 39.47 | 16.94 | 64 | 25272 | 51679 | 79667373 |
| Renal tubular disorder | 39.47 | 16.94 | 25 | 25311 | 6461 | 79712591 |
| Klebsiella infection | 38.16 | 16.94 | 35 | 25301 | 15685 | 79703367 |
| Myelosuppression | 38.01 | 16.94 | 55 | 25281 | 40241 | 79678811 |
| Pneumonia | 37.29 | 16.94 | 346 | 24990 | 659900 | 79059152 |
| Ileus paralytic | 37.09 | 16.94 | 28 | 25308 | 9592 | 79709460 |
| Chimerism | 36.76 | 16.94 | 10 | 25326 | 286 | 79718766 |
| Graft versus host disease in lung | 36.74 | 16.94 | 13 | 25323 | 899 | 79718153 |
| Adenoviral hepatitis | 36.53 | 16.94 | 13 | 25323 | 914 | 79718138 |
| Immunosuppressant drug level increased | 36.42 | 16.94 | 27 | 25309 | 9000 | 79710052 |
| Electrocardiogram PR shortened | 36.15 | 16.94 | 10 | 25326 | 305 | 79718747 |
| Bacterial infection | 35.99 | 16.94 | 47 | 25289 | 31233 | 79687819 |
| Inappropriate antidiuretic hormone secretion | 35.81 | 16.94 | 43 | 25293 | 26270 | 79692782 |
| Polymyositis | 35.65 | 16.94 | 18 | 25318 | 3018 | 79716034 |
| Pain in extremity | 35.59 | 16.94 | 38 | 25298 | 364500 | 79354552 |
| Bronchiolitis obliterans syndrome | 35.42 | 16.94 | 10 | 25326 | 329 | 79718723 |
| Eye infection fungal | 35.16 | 16.94 | 11 | 25325 | 518 | 79718534 |
| Drug ineffective for unapproved indication | 34.59 | 16.94 | 60 | 25276 | 51178 | 79667874 |
| Posterior reversible encephalopathy syndrome | 34.22 | 16.94 | 42 | 25294 | 26239 | 79692813 |
| Peripheral swelling | 33.84 | 16.94 | 22 | 25314 | 269595 | 79449457 |
| Neutropenic infection | 33.30 | 16.94 | 16 | 25320 | 2411 | 79716641 |
| Staphylococcal bacteraemia | 33.21 | 16.94 | 29 | 25307 | 12189 | 79706863 |
| Weight decreased | 32.52 | 16.94 | 39 | 25297 | 355159 | 79363893 |
| Parainfluenzae virus infection | 32.34 | 16.94 | 21 | 25315 | 5661 | 79713391 |
| Lung infiltration | 32.09 | 16.94 | 38 | 25298 | 22874 | 79696178 |
| Muscle spasms | 32.06 | 16.94 | 8 | 25328 | 174722 | 79544330 |
| Hyperhidrosis | 31.85 | 16.94 | 5 | 25331 | 151487 | 79567565 |
| Weight increased | 31.71 | 16.94 | 25 | 25311 | 277361 | 79441691 |
| Klebsiella sepsis | 31.65 | 16.94 | 17 | 25319 | 3235 | 79715817 |
| Renal failure | 31.55 | 16.94 | 137 | 25199 | 200831 | 79518221 |
| Sinusitis fungal | 30.61 | 16.94 | 15 | 25321 | 2359 | 79716693 |
| Injection site pain | 30.42 | 16.94 | 3 | 25333 | 129835 | 79589217 |
| Neutrophil Pelger-Huet anomaly present | 30.23 | 16.94 | 9 | 25327 | 358 | 79718694 |
| Enterococcal bacteraemia | 29.75 | 16.94 | 16 | 25320 | 3052 | 79716000 |
| Adenovirus reactivation | 29.72 | 16.94 | 9 | 25327 | 380 | 79718672 |
| Asthma | 29.46 | 16.94 | 4 | 25332 | 135091 | 79583961 |
| Hepatotoxicity | 29.41 | 16.94 | 56 | 25280 | 51296 | 79667756 |
| Brain herniation | 29.39 | 16.94 | 22 | 25314 | 7441 | 79711611 |
| Herpes simplex | 29.32 | 16.94 | 27 | 25309 | 12160 | 79706892 |
| Discomfort | 29.17 | 16.94 | 3 | 25333 | 125614 | 79593438 |
| Drug level decreased | 29.14 | 16.94 | 29 | 25307 | 14373 | 79704679 |
| Central nervous system lesion | 29.07 | 16.94 | 28 | 25308 | 13340 | 79705712 |
| Long QT syndrome | 29.06 | 16.94 | 20 | 25316 | 5935 | 79713117 |
| Product dose omission issue | 28.68 | 16.94 | 22 | 25314 | 247515 | 79471537 |
| Acute kidney injury | 28.67 | 16.94 | 271 | 25065 | 519133 | 79199919 |
| Bicytopenia | 28.41 | 16.94 | 18 | 25318 | 4652 | 79714400 |
| Pseudomonal sepsis | 28.41 | 16.94 | 20 | 25316 | 6154 | 79712898 |
| Acute lymphocytic leukaemia recurrent | 28.22 | 16.94 | 18 | 25318 | 4706 | 79714346 |
| Cytomegalovirus viraemia | 28.15 | 16.94 | 27 | 25309 | 12794 | 79706258 |
| Product administered to patient of inappropriate age | 27.93 | 16.94 | 19 | 25317 | 5534 | 79713518 |
| Feeling abnormal | 27.86 | 16.94 | 8 | 25328 | 159191 | 79559861 |
| Anxiety | 27.65 | 16.94 | 23 | 25313 | 248489 | 79470563 |
| Retinal ischaemia | 27.13 | 16.94 | 10 | 25326 | 778 | 79718274 |
| Torsade de pointes | 27 | 16.94 | 32 | 25304 | 19280 | 79699772 |
| Adenovirus infection | 26.98 | 16.94 | 22 | 25314 | 8425 | 79710627 |
| Nausea | 26.95 | 16.94 | 186 | 25150 | 957010 | 78762042 |
| Chronic graft versus host disease | 26.73 | 16.94 | 20 | 25316 | 6761 | 79712291 |
| Venous haemorrhage | 26.23 | 16.94 | 8 | 25328 | 346 | 79718706 |
| Mycobacterium abscessus infection | 26.18 | 16.94 | 11 | 25325 | 1211 | 79717841 |
| Blood bilirubin increased | 26.07 | 16.94 | 62 | 25274 | 66170 | 79652882 |
| Necrotising retinitis | 25.98 | 16.94 | 11 | 25325 | 1234 | 79717818 |
| Lower respiratory tract infection fungal | 25.96 | 16.94 | 10 | 25326 | 878 | 79718174 |
| Enterobacter bacteraemia | 25.92 | 16.94 | 10 | 25326 | 882 | 79718170 |
| Insomnia | 25.70 | 16.94 | 24 | 25312 | 245146 | 79473906 |
| Organ failure | 25.68 | 16.94 | 16 | 25320 | 4017 | 79715035 |
| Blood immunoglobulin G decreased | 25.51 | 16.94 | 15 | 25321 | 3394 | 79715658 |
| Musculoskeletal stiffness | 25.24 | 16.94 | 12 | 25324 | 174996 | 79544056 |
| Nocardiosis | 25.21 | 16.94 | 18 | 25318 | 5661 | 79713391 |
| Alopecia | 25.02 | 16.94 | 22 | 25314 | 231333 | 79487719 |
| Hepatic failure | 24.85 | 16.94 | 58 | 25278 | 61154 | 79657898 |
| Hypoaesthesia | 24.81 | 16.94 | 13 | 25323 | 179339 | 79539713 |
| Pneumonia klebsiella | 24.72 | 16.94 | 17 | 25319 | 5037 | 79714015 |
| Cardioactive drug level increased | 24.34 | 16.94 | 15 | 25321 | 3694 | 79715358 |
| Rash | 24.29 | 16.94 | 98 | 25238 | 578260 | 79140792 |
| Growth failure | 24.27 | 16.94 | 7 | 25329 | 249 | 79718803 |
| Hypomagnesaemia | 24.25 | 16.94 | 49 | 25287 | 46862 | 79672190 |
| Product use issue | 24.24 | 16.94 | 131 | 25205 | 209691 | 79509361 |
| Fungal skin infection | 24.23 | 16.94 | 18 | 25318 | 6018 | 79713034 |
| Leukoencephalopathy | 23.96 | 16.94 | 20 | 25316 | 7909 | 79711143 |
| Microsporum infection | 23.78 | 16.94 | 5 | 25331 | 45 | 79719007 |
| Seroconversion test positive | 23.68 | 16.94 | 5 | 25331 | 46 | 79719006 |
| Septic encephalopathy | 23.67 | 16.94 | 7 | 25329 | 272 | 79718780 |
| Gastrointestinal toxicity | 23.57 | 16.94 | 20 | 25316 | 8089 | 79710963 |
| Viral haemorrhagic cystitis | 23.56 | 16.94 | 12 | 25324 | 2049 | 79717003 |
| Disease progression | 23.29 | 16.94 | 118 | 25218 | 184244 | 79534808 |
| Lip squamous cell carcinoma | 22.90 | 16.94 | 7 | 25329 | 305 | 79718747 |
| Acute lymphocytic leukaemia | 22.64 | 16.94 | 16 | 25320 | 4953 | 79714099 |
| Death | 22.60 | 16.94 | 277 | 25059 | 566237 | 79152815 |
| Headache | 22.58 | 16.94 | 119 | 25217 | 653653 | 79065399 |
| Steroid diabetes | 22.55 | 16.94 | 14 | 25322 | 3492 | 79715560 |
| Pneumonia pseudomonal | 22.33 | 16.94 | 17 | 25319 | 5894 | 79713158 |
| Back pain | 22.32 | 16.94 | 39 | 25297 | 304141 | 79414911 |
| Clostridium difficile colitis | 22.04 | 16.94 | 38 | 25298 | 32245 | 79686807 |
| Coagulation test abnormal | 21.96 | 16.94 | 10 | 25326 | 1335 | 79717717 |
| Cerebral artery embolism | 21.58 | 16.94 | 11 | 25325 | 1880 | 79717172 |
| Hepatic necrosis | 21.58 | 16.94 | 20 | 25316 | 9080 | 79709972 |
| Blast cell count decreased | 21.23 | 16.94 | 4 | 25332 | 19 | 79719033 |
| CARD9 deficiency | 21.06 | 16.94 | 4 | 25332 | 20 | 79719032 |
| Gastrointestinal wall thinning | 21.06 | 16.94 | 4 | 25332 | 20 | 79719032 |
| Hyperleukocytosis | 20.90 | 16.94 | 12 | 25324 | 2598 | 79716454 |
| Haemophagocytic lymphohistiocytosis | 20.87 | 16.94 | 30 | 25306 | 21807 | 79697245 |
| Urticaria | 20.77 | 16.94 | 17 | 25319 | 185184 | 79533868 |
| Atypical pneumonia | 20.60 | 16.94 | 17 | 25319 | 6619 | 79712433 |
| Enterococcal sepsis | 20.41 | 16.94 | 12 | 25324 | 2714 | 79716338 |
| Overgrowth fungal | 20.23 | 16.94 | 5 | 25331 | 97 | 79718955 |
| Allogenic stem cell transplantation | 20.13 | 16.94 | 5 | 25331 | 99 | 79718953 |
| Pulmonary mucormycosis | 20.09 | 16.94 | 9 | 25327 | 1156 | 79717896 |
| Herpes simplex reactivation | 19.95 | 16.94 | 7 | 25329 | 472 | 79718580 |
| Mobility decreased | 19.85 | 16.94 | 7 | 25329 | 122168 | 79596884 |
| Gait disturbance | 19.82 | 16.94 | 22 | 25314 | 207484 | 79511568 |
| Bordetella infection | 19.68 | 16.94 | 5 | 25331 | 109 | 79718943 |
| SARS-CoV-2 RNA | 19.55 | 16.94 | 4 | 25332 | 31 | 79719021 |
| Retinal haemorrhage | 19.37 | 16.94 | 18 | 25318 | 8199 | 79710853 |
| Blood pressure decreased | 19.35 | 16.94 | 4 | 25332 | 99462 | 79619590 |
| Cerebral toxoplasmosis | 19.29 | 16.94 | 11 | 25325 | 2351 | 79716701 |
| Respiratory syncytial virus infection | 19.14 | 16.94 | 19 | 25317 | 9383 | 79709669 |
| Cerebral ventricle collapse | 19.14 | 16.94 | 5 | 25331 | 122 | 79718930 |
| Cerebrovascular accident | 19.03 | 16.94 | 13 | 25323 | 155279 | 79563773 |
| Endophthalmitis | 18.98 | 16.94 | 16 | 25320 | 6412 | 79712640 |
| Pericardial effusion | 18.98 | 16.94 | 44 | 25292 | 46193 | 79672859 |
| Toxic skin eruption | 18.97 | 16.94 | 29 | 25307 | 22264 | 79696788 |
| Brain oedema | 18.93 | 16.94 | 31 | 25305 | 25232 | 79693820 |
| Peripheral sensory neuropathy | 18.89 | 16.94 | 22 | 25314 | 13011 | 79706041 |
| Cell death | 18.83 | 16.94 | 14 | 25322 | 4685 | 79714367 |
| Soft tissue infection | 18.76 | 16.94 | 13 | 25323 | 3899 | 79715153 |
| Polyomavirus-associated nephropathy | 18.70 | 16.94 | 15 | 25321 | 5612 | 79713440 |
| Candida sepsis | 18.65 | 16.94 | 11 | 25325 | 2502 | 79716550 |
| Brain compression | 18.55 | 16.94 | 7 | 25329 | 581 | 79718471 |
| Blast cell count increased | 18.45 | 16.94 | 9 | 25327 | 1401 | 79717651 |
| Wheezing | 18.42 | 16.94 | 7 | 25329 | 116657 | 79602395 |
| Citrobacter infection | 18.36 | 16.94 | 8 | 25328 | 962 | 79718090 |
| Myocardial infarction | 18.16 | 16.94 | 19 | 25317 | 184110 | 79534942 |
| Acute respiratory distress syndrome | 18.16 | 16.94 | 42 | 25294 | 44025 | 79675027 |
| Pneumonia cytomegaloviral | 18.14 | 16.94 | 14 | 25322 | 4955 | 79714097 |
| Migraine | 18.13 | 16.94 | 3 | 25333 | 87490 | 79631562 |
| Osteoarthritis | 18.08 | 16.94 | 3 | 25333 | 87306 | 79631746 |
| Stupor | 18.06 | 16.94 | 16 | 25320 | 6856 | 79712196 |
| Arthritis | 17.96 | 16.94 | 7 | 25329 | 114873 | 79604179 |
| Palpitations | 17.77 | 16.94 | 9 | 25327 | 126601 | 79592451 |
| Ureaplasma infection | 17.75 | 16.94 | 8 | 25328 | 1042 | 79718010 |
| Gastrointestinal tract mucosal pigmentation | 17.75 | 16.94 | 8 | 25328 | 1042 | 79718010 |
| Chronic obstructive pulmonary disease | 17.54 | 16.94 | 3 | 25333 | 85416 | 79633636 |
| Skin necrosis | 17.51 | 16.94 | 25 | 25311 | 18062 | 79700990 |
| Bacterial sepsis | 17.50 | 16.94 | 17 | 25319 | 8181 | 79710871 |
| Hypoxia | 17.44 | 16.94 | 72 | 25264 | 103171 | 79615881 |
| Streptococcal bacteraemia | 17.34 | 16.94 | 12 | 25324 | 3594 | 79715458 |
| Renal tubular acidosis | 17.31 | 16.94 | 12 | 25324 | 3602 | 79715450 |
| Febrile bone marrow aplasia | 17.26 | 16.94 | 21 | 25315 | 12999 | 79706053 |
| Pelvic venous thrombosis | 17.20 | 16.94 | 10 | 25326 | 2215 | 79716837 |
| Mucosal inflammation | 17.18 | 16.94 | 58 | 25278 | 75522 | 79643530 |
| Memory impairment | 17.15 | 16.94 | 7 | 25329 | 111727 | 79607325 |
| Encephalitis fungal | 17.12 | 16.94 | 5 | 25331 | 186 | 79718866 |
| Lymphopenia | 17.10 | 16.94 | 33 | 25303 | 30524 | 79688528 |
| Drug-induced liver injury | 17.08 | 16.94 | 53 | 25283 | 66064 | 79652988 |
| Intracranial mass | 17.06 | 16.94 | 10 | 25326 | 2249 | 79716803 |
| Pulmonary mass | 17.04 | 16.94 | 32 | 25304 | 29002 | 79690050 |
| Escherichia sepsis | 16.97 | 16.94 | 17 | 25319 | 8491 | 79710561 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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 | D058888 | 14-alpha Demethylase Inhibitors |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000935 | Antifungal Agents |
| MeSH PA | D000977 | Antiparasitic Agents |
| MeSH PA | D000981 | Antiprotozoal Agents |
| 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 |
| MeSH PA | D014344 | Trypanocidal Agents |
| CHEBI has role | CHEBI:36335 | trypanocidal drugs |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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
| Species | Use | Relation |
|---|---|---|
| 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
| Product | Applicant | Ingredients |
|---|---|---|
| Posatex Otic Suspension | Intervet Inc. | 3 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 300MG/16.7ML (18MG/ML) | NOXAFIL | MERCK SHARP DOHME | N205596 | March 13, 2014 | RX | 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 | RX | 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 | RX | 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 | RX | 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 | RX | SOLUTION | INTRAVENOUS | 9023790 | July 4, 2031 | TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 300MG/16.7ML (18MG/ML) | POSACONAZOLE | PAR STERILE PRODUCTS | A208768 | May 25, 2022 | RX | SOLUTION | INTRAVENOUS | Dec. 26, 2023 | PATENT CHALLENGE |
| 100MG | NOXAFIL | MERCK SHARP DOHME | N205053 | Nov. 25, 2013 | RX | TABLET, DELAYED RELEASE | ORAL | May 31, 2024 | NEW PATIENT POPULATION |
| 300MG/16.7ML (18MG/ML) | NOXAFIL | MERCK SHARP DOHME | N205596 | March 13, 2014 | RX | SOLUTION | INTRAVENOUS | May 31, 2024 | NEW PATIENT POPULATION |
| 300MG | NOXAFIL POWDERMIX KIT | MSD MERCK CO | N214770 | May 31, 2021 | RX | FOR SUSPENSION, DELAYED RELEASE | ORAL | May 31, 2024 | NEW PRODUCT |
| 100MG | NOXAFIL | MERCK SHARP DOHME | N205053 | Nov. 25, 2013 | RX | TABLET, DELAYED RELEASE | ORAL | June 17, 2024 | FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN PATIENTS 13 YEARS OF AGE AND OLDER |
| 300MG/16.7ML (18MG/ML) | NOXAFIL | MERCK SHARP DOHME | N205596 | March 13, 2014 | RX | SOLUTION | INTRAVENOUS | June 17, 2024 | FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN PATIENTS 13 YEARS OF AGE AND OLDER |
| 100MG | NOXAFIL | MERCK SHARP DOHME | N205053 | Nov. 25, 2013 | RX | 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 | RX | SOLUTION | INTRAVENOUS | June 17, 2028 | FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| posaconazole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0054-0449 | SUSPENSION | 40 mg | ORAL | ANDA | 30 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 | 0085-1328 | 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 | 0085-2224 | 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 | 0085-4324 | 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 |
| 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 | 32 sections |
| POSACONAZOLE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0254-2045 | TABLET, COATED | 100 mg | ORAL | NDA authorized generic | 32 sections |
| POSACONAZOLE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0254-2045 | TABLET, COATED | 100 mg | ORAL | NDA authorized generic | 32 sections |
| POSACONAZOLE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0254-2045 | TABLET, COATED | 100 mg | ORAL | NDA authorized generic | 32 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 | 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 | 26 sections |
| POSACONAZOLE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7149 | TABLET, DELAYED RELEASE | 100 mg | ORAL | ANDA | 26 sections |
| POSACONAZOLE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7149 | TABLET, DELAYED RELEASE | 100 mg | ORAL | ANDA | 26 sections |
| POSACONAZOLE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-156 | TABLET, DELAYED RELEASE | 100 mg | ORAL | ANDA | 29 sections |
| POSACONAZOLE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-156 | TABLET, DELAYED RELEASE | 100 mg | ORAL | ANDA | 29 sections |
| Posaconazole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-535 | TABLET, DELAYED RELEASE | 100 mg | ORAL | ANDA | 26 sections |