amphotericin B ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antibiotics, polyene derivatives 197 1397-89-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • amphotericin B
  • abelcet
  • abelecet
  • amphocin
  • amphozone
  • apothecon
  • fungilin
  • Amphotericin B liposome
Macrolide antifungal antibiotic produced by Streptomyces nodosus obtained from soil of the Orinoco river region of Venezuela.
  • Molecular weight: 924.09
  • Formula: C47H73NO17
  • CLOGP: -3.65
  • LIPINSKI: 3
  • HAC: 18
  • HDO: 12
  • TPSA: 319.61
  • ALOGS: -4.05
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
40 mg O
0.40 g O
0.20 g V
210 mg P
35 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 3.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 4.33 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 3 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.62 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.17 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.03 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 40 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.869 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 27.353 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.646 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 5.224 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 3.260 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 22.380 % High 1
herg hERG pIC50 4.389 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.795 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 4.624 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 4.700 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,MAP2K6,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,TEK,TGFBR1,ZAP70 23
kinase-selectivity-class MAP2K6 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 4.677 High 1
mh-clint Mouse hepatocyte intrinsic clearance 3.837 High 1
mppb Mouse plasma protein binding (% unbound) 5.090 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 7.656 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 8.310 % High 1
rh-clint Rat hepatocyte intrinsic clearance 9.162 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 38.690 % High 1
rppb Rat plasma protein binding (% unbound) 13.280 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 756.833 uM High 1

Approvals:

DateAgencyCompanyOrphan
Nov. 12, 1964 FDA APOTHECON

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective 620.77 20.03 1284 25136 1383014 89219013
Multiple organ dysfunction syndrome 601.30 20.03 324 26096 68012 90534015
Mucormycosis 378.21 20.03 106 26314 3715 90598312
Septic shock 292.25 20.03 222 26198 83938 90518089
Aspergillus infection 291.16 20.03 112 26308 10711 90591316
Bronchopulmonary aspergillosis 257.65 20.03 104 26316 11294 90590733
Febrile neutropenia 248.70 20.03 267 26153 158082 90443945
Toxic epidermal necrolysis 207.09 20.03 125 26295 32403 90569624
Neutropenia 200.28 20.03 285 26135 224619 90377408
Sepsis 185.91 20.03 245 26175 179569 90422458
Hypokalaemia 181.45 20.03 207 26213 130909 90471118
Systemic candida 180.10 20.03 64 26356 4895 90597132
Respiratory failure 172.45 20.03 192 26228 118226 90483801
Acute kidney injury 172.17 20.03 323 26097 320064 90281963
Renal impairment 171.11 20.03 181 26239 105240 90496787
Haemophagocytic lymphohistiocytosis 163.43 20.03 83 26337 15376 90586651
Drug resistance 158.53 20.03 103 26317 30346 90571681
Pathogen resistance 152.81 20.03 65 26355 8050 90593977
Candida infection 152.75 20.03 105 26315 33952 90568075
Immune reconstitution inflammatory syndrome 141.44 20.03 59 26361 6960 90595067
Fatigue 137.08 20.03 84 26336 1153939 89448088
Pancytopenia 135.38 20.03 171 26249 120092 90481935
Off label use 134.94 20.03 655 25765 1101597 89500430
Nephropathy toxic 133.76 20.03 68 26352 12620 90589407
Drug ineffective for unapproved indication 131.09 20.03 127 26293 66517 90535510
Posterior reversible encephalopathy syndrome 129.80 20.03 81 26339 22258 90579769
Joint swelling 128.70 20.03 4 26416 503296 90098731
Arthralgia 127.23 20.03 35 26385 778487 89823540
Fusarium infection 125.46 20.03 34 26386 1048 90600979
Enterococcal infection 124.49 20.03 60 26360 9931 90592096
Pain 123.21 20.03 69 26351 996272 89605755
Fungaemia 120.76 20.03 43 26377 3307 90598720
Pneumonia fungal 118.24 20.03 52 26368 6979 90595048
Graft versus host disease 117.14 20.03 54 26366 8090 90593937
Hyperbilirubinaemia 116.58 20.03 64 26356 13872 90588155
Cholestasis 115.51 20.03 91 26329 36208 90565819
Leukopenia 114.60 20.03 144 26276 100566 90501461
Febrile bone marrow aplasia 113.88 20.03 56 26364 9682 90592345
Candida sepsis 111.22 20.03 34 26386 1619 90600408
Peripheral swelling 106.61 20.03 3 26417 413103 90188924
Fungal infection 104.66 20.03 92 26328 42569 90559458
Thrombocytopenia 102.81 20.03 203 26217 208522 90393505
Graft versus host disease in gastrointestinal tract 102.47 20.03 41 26379 4347 90597680
Headache 96.53 20.03 67 26353 862679 89739348
Renal failure 96.39 20.03 152 26268 130855 90471172
Rash maculo-papular 95.89 20.03 86 26334 40847 90561180
Mucosal inflammation 95.32 20.03 100 26320 57525 90544502
Swelling 92.60 20.03 8 26412 419050 90182977
Drug level below therapeutic 91.35 20.03 41 26379 5773 90596254
Brain oedema 90.94 20.03 59 26361 17326 90584701
Abdominal discomfort 88.83 20.03 16 26404 477312 90124715
Systemic mycosis 88.37 20.03 28 26392 1502 90600525
Alopecia 87.10 20.03 19 26401 495052 90106975
Nasopharyngitis 86.70 20.03 9 26411 407095 90194932
Dizziness 86.38 20.03 32 26388 589252 90012775
Cytomegalovirus infection 85.30 20.03 67 26353 26535 90575492
Shock 84.85 20.03 69 26351 28709 90573318
Product use in unapproved indication 81.59 20.03 249 26171 335987 90266040
Systemic inflammatory response syndrome 80.78 20.03 39 26381 6477 90595550
Hepatic cytolysis 80.53 20.03 69 26351 30847 90571180
Fungal endocarditis 79.52 20.03 19 26401 348 90601679
Pyelonephritis fungal 78.24 20.03 17 26403 199 90601828
Rheumatoid arthritis 77.24 20.03 8 26412 362606 90239421
Fungal sepsis 75.94 20.03 25 26395 1516 90600511
Scedosporium infection 73.08 20.03 21 26399 805 90601222
Disseminated mucormycosis 72.75 20.03 20 26400 651 90601376
Pyrexia 72.25 20.03 381 26039 660104 89941923
Brain abscess 71.70 20.03 28 26392 2784 90599243
Systemic lupus erythematosus 69.80 20.03 11 26409 361885 90240142
Premature delivery 69.02 20.03 70 26350 38692 90563335
Therapeutic product effect decreased 68.15 20.03 3 26417 277568 90324459
Meningitis cryptococcal 67.86 20.03 24 26396 1809 90600218
Perinephric abscess 66.71 20.03 16 26404 298 90601729
Cerebral aspergillosis 66.35 20.03 18 26402 557 90601470
Disease progression 66.10 20.03 143 26277 156472 90445555
Emphysematous pyelonephritis 64.63 20.03 16 26404 342 90601685
Agranulocytosis 63.77 20.03 64 26356 34938 90567089
Drug reaction with eosinophilia and systemic symptoms 63.32 20.03 70 26350 42688 90559339
Renal tubular disorder 61.41 20.03 26 26394 3181 90598846
Fall 61.35 20.03 32 26388 481778 90120249
Discomfort 61.22 20.03 5 26415 274330 90327697
Intracranial infection 60.91 20.03 14 26406 215 90601812
Bacteraemia 60.59 20.03 51 26369 22249 90579778
Drug level increased 60.46 20.03 56 26364 27706 90574321
Stenotrophomonas infection 60.34 20.03 24 26396 2505 90599522
Pseudomonal sepsis 60.23 20.03 28 26392 4274 90597753
Cardiac arrest 60.21 20.03 109 26311 104826 90497201
Graft versus host disease in skin 59.99 20.03 27 26393 3826 90598201
Pulmonary haemorrhage 59.41 20.03 34 26386 7979 90594048
Weight increased 57.42 20.03 25 26395 417902 90184125
Pericarditis 57.41 20.03 6 26414 270145 90331882
Aplastic anaemia 57.34 20.03 40 26380 13229 90588798
Cryptococcosis 57.29 20.03 20 26400 1451 90600576
Musculoskeletal stiffness 57.20 20.03 9 26411 296523 90305504
Bacterial sepsis 56.46 20.03 28 26392 4927 90597100
Dermatitis exfoliative 56.40 20.03 29 26391 5507 90596520
Staphylococcal infection 56.24 20.03 70 26350 48369 90553658
Drug hypersensitivity 54.42 20.03 34 26386 463575 90138452
Pain in extremity 54.34 20.03 32 26388 450497 90151530
Wheezing 54.07 20.03 4 26416 238076 90363951
Product dose omission issue 53.74 20.03 10 26410 291677 90310350
Hepatic function abnormal 52.32 20.03 66 26354 46222 90555805
Drug intolerance 52.30 20.03 33 26387 447558 90154469
Anxiety 52.22 20.03 13 26407 309759 90292268
Hyperammonaemia 52.13 20.03 29 26391 6446 90595581
Vesicoureteric reflux 51.77 20.03 13 26407 295 90601732
Bone marrow failure 51.64 20.03 55 26365 32166 90569861
Necrosis 51.57 20.03 29 26391 6581 90595446
Geotrichum infection 51.56 20.03 15 26405 601 90601426
Malaise 51.51 20.03 57 26363 585929 90016098
Pseudomonas infection 51.05 20.03 39 26381 14826 90587201
Gamma-glutamyltransferase increased 50.87 20.03 59 26361 37893 90564134
Insomnia 50.69 20.03 17 26403 333457 90268570
Foetal anaemia 50.45 20.03 11 26409 131 90601896
Disseminated aspergillosis 50.23 20.03 14 26406 480 90601547
Electrolyte imbalance 49.98 20.03 47 26373 23698 90578329
Ureaplasma infection 49.95 20.03 16 26404 889 90601138
Contusion 49.88 20.03 7 26413 251209 90350818
Klebsiella infection 49.13 20.03 33 26387 10264 90591763
Immunosuppressant drug level increased 49.08 20.03 25 26395 4655 90597372
Depression 48.06 20.03 14 26406 300587 90301440
Folliculitis 47.67 20.03 3 26417 204350 90397677
Pulmonary mucormycosis 47.53 20.03 14 26406 586 90601441
Rhinocerebral mucormycosis 47.48 20.03 15 26405 797 90601230
Lower respiratory tract infection 47.46 20.03 8 26412 250651 90351376
Endophthalmitis 46.17 20.03 24 26396 4661 90597366
Hepatosplenic candidiasis 45.94 20.03 12 26408 320 90601707
Blood cholesterol increased 45.83 20.03 4 26416 208008 90394019
Histoplasmosis disseminated 45.18 20.03 19 26401 2286 90599741
Coagulation test abnormal 44.84 20.03 15 26405 956 90601071
Escherichia infection 44.52 20.03 37 26383 15858 90586169
Encephalopathy 44.40 20.03 61 26359 46383 90555644
Fungal test positive 44.14 20.03 13 26407 544 90601483
Bronchial anastomosis complication 43.98 20.03 9 26411 77 90601950
Chronic graft versus host disease 43.09 20.03 22 26398 4117 90597910
Infusion related reaction 43.08 20.03 35 26385 416745 90185282
Dyspnoea 42.87 20.03 124 26296 880831 89721196
Drug interaction 42.24 20.03 176 26244 276277 90325750
Disseminated intravascular coagulation 42.23 20.03 41 26379 21497 90580530
Protothecosis 41.79 20.03 12 26408 459 90601568
Pneumonia moraxella 41.29 20.03 8 26412 50 90601977
Asthma 41.12 20.03 10 26410 242150 90359877
Graft versus host disease in liver 41.02 20.03 14 26406 949 90601078
Acute myeloid leukaemia recurrent 40.46 20.03 17 26403 2040 90599987
Urinary tract candidiasis 40.30 20.03 13 26407 739 90601288
Pericoronitis 40.20 20.03 9 26411 122 90601905
Neutropenic colitis 40.19 20.03 21 26399 4122 90597905
Cytomegalovirus test positive 40.05 20.03 20 26400 3571 90598456
Intermittent positive pressure breathing 40.02 20.03 8 26412 60 90601967
Acute graft versus host disease 40.00 20.03 23 26397 5445 90596582
Muscle spasms 39.76 20.03 12 26408 251871 90350156
Rash 39.49 20.03 111 26309 795989 89806038
Circulatory collapse 39.01 20.03 42 26378 24862 90577165
Disseminated coccidioidomycosis 38.99 20.03 9 26411 141 90601886
Central nervous system fungal infection 38.81 20.03 9 26411 144 90601883
Hepatocellular injury 38.77 20.03 45 26375 28913 90573114
Overgrowth fungal 38.70 20.03 9 26411 146 90601881
Asthenia 38.60 20.03 60 26360 533691 90068336
Paraspinal abscess 38.34 20.03 10 26410 265 90601762
Gait disturbance 38.34 20.03 14 26406 260482 90341545
Cerebral fungal infection 38.20 20.03 10 26410 269 90601758
Dehiscence 38.19 20.03 9 26411 155 90601872
Abdominal pain upper 38.19 20.03 25 26395 332649 90269378
Pruritus 38.09 20.03 62 26358 541463 90060564
Acute myeloid leukaemia 38.07 20.03 38 26382 20602 90581425
Urticaria 37.98 20.03 22 26398 312712 90289315
Bacterial infection 37.53 20.03 40 26380 23404 90578623
Upper airway necrosis 36.97 20.03 7 26413 38 90601989
Alanine aminotransferase increased 36.82 20.03 96 26324 118242 90483785
Dysbiosis 36.63 20.03 15 26405 1687 90600340
Blood beta-D-glucan increased 36.60 20.03 10 26410 318 90601709
Hypoproteinaemia 36.53 20.03 18 26402 3124 90598903
Keratitis fungal 36.02 20.03 9 26411 200 90601827
Delivery 35.88 20.03 15 26405 1778 90600249
Breast cancer metastatic 35.84 20.03 32 26388 15100 90586927
Acute respiratory distress syndrome 35.80 20.03 43 26377 28643 90573384
Staphylococcal bacteraemia 35.79 20.03 24 26396 7445 90594582
Hypoaesthesia 35.54 20.03 24 26396 314186 90287841
Epstein-Barr virus infection 35.21 20.03 27 26393 10317 90591710
Hepatic enzyme increased 35.19 20.03 32 26388 360704 90241323
Periventricular leukomalacia 35.13 20.03 9 26411 222 90601805
Trichosporon infection 35.12 20.03 10 26410 371 90601656
Pancreatitis acute 35.04 20.03 45 26375 32070 90569957
Pleural effusion 35.00 20.03 91 26329 111900 90490127
Stevens-Johnson syndrome 34.97 20.03 43 26377 29333 90572694
Arthritis 34.81 20.03 4 26416 167311 90434716
Ill-defined disorder 34.77 20.03 6 26414 184885 90417142
Metabolic acidosis 34.71 20.03 60 26360 55616 90546411
Gastrooesophageal reflux disease 34.55 20.03 4 26416 166333 90435694
Coagulopathy 34.25 20.03 38 26382 23251 90578776
Urinary tract infection enterococcal 34.24 20.03 17 26403 2999 90599028
Sinusitis 33.99 20.03 30 26390 343058 90258969
Hypersensitivity 33.93 20.03 50 26370 454627 90147400
Cortical visual impairment 33.61 20.03 6 26414 22 90602005
Idiopathic pneumonia syndrome 33.45 20.03 10 26410 441 90601586
Mixed liver injury 32.98 20.03 23 26397 7600 90594427
Streptococcal bacteraemia 32.75 20.03 15 26405 2212 90599815
Blood bilirubin increased 32.71 20.03 51 26369 43419 90558608
Acute graft versus host disease in skin 32.13 20.03 19 26401 4737 90597290
Psoriasis 32.11 20.03 3 26417 147751 90454276
Sleep disorder 32.05 20.03 9 26411 198021 90404006
Hepatotoxicity 32.04 20.03 52 26368 45790 90556237
Imprisonment 31.63 20.03 9 26411 333 90601694
Type 2 diabetes mellitus 31.50 20.03 10 26410 203234 90398793
Paraesthesia 31.27 20.03 17 26403 250309 90351718
Pneumothorax 31.21 20.03 33 26387 19134 90582893
Staphylococcal sepsis 30.87 20.03 24 26396 9359 90592668
Respiratory disorder 30.60 20.03 62 26358 64754 90537273
Hepatic failure 30.44 20.03 47 26373 39681 90562346
Multiple-drug resistance 30.27 20.03 22 26398 7754 90594273
Transplant rejection 30.25 20.03 27 26393 12731 90589296
Human herpesvirus 6 infection reactivation 30.10 20.03 10 26410 624 90601403
Memory impairment 30.05 20.03 10 26410 197234 90404793
Myocardial calcification 29.99 20.03 8 26412 232 90601795
Meningitis bacterial 29.85 20.03 13 26407 1704 90600323
Aplasia 29.76 20.03 17 26403 3974 90598053
Nervous system disorder 29.66 20.03 34 26386 21559 90580468
Hypoxia 29.26 20.03 65 26355 72334 90529693
Citrobacter infection 29.13 20.03 10 26410 690 90601337
Dry mouth 28.63 20.03 9 26411 184050 90417977
Fluorosis 28.30 20.03 7 26413 149 90601878
Pneumonia klebsiella 28.18 20.03 15 26405 3057 90598970
Polyomavirus-associated nephropathy 28.16 20.03 14 26406 2476 90599551
Hyperkalaemia 28.16 20.03 60 26360 64904 90537123
Pneumonia cytomegaloviral 28.00 20.03 15 26405 3096 90598931
BK virus infection 27.87 20.03 17 26403 4481 90597546
Gastrointestinal mucormycosis 27.86 20.03 8 26412 306 90601721
Respiratory tract infection fungal 27.81 20.03 9 26411 517 90601510
Septal panniculitis 27.25 20.03 6 26414 75 90601952
Hemianopia homonymous 27.06 20.03 10 26410 855 90601172
Dyspepsia 26.95 20.03 12 26408 198148 90403879
Kidney transplant rejection 26.67 20.03 17 26403 4840 90597187
Eosinophilia 26.56 20.03 37 26383 28496 90573531
Platelet count decreased 26.47 20.03 94 26326 136875 90465152
Cardiac valve vegetation 26.37 20.03 8 26412 371 90601656
Liver abscess 26.36 20.03 15 26405 3481 90598546
Brain herniation 26.35 20.03 16 26404 4184 90597843
Nail bed inflammation 26.08 20.03 12 26408 1789 90600238
Exophthalmos 26.07 20.03 12 26408 1790 90600237
Condition aggravated 25.76 20.03 276 26144 595269 90006758
Septic embolus 25.68 20.03 10 26410 987 90601040
Anaemia 25.42 20.03 183 26237 352619 90249408
Hypertransaminasaemia 25.33 20.03 27 26393 15798 90586229
Blood pressure increased 25.20 20.03 13 26407 197204 90404823
Herpes simplex 25.04 20.03 22 26398 10159 90591868
Intestinal infarction 25.02 20.03 10 26410 1057 90600970
Traumatic haemothorax 25 20.03 7 26413 244 90601783
Status epilepticus 24.72 20.03 29 26391 18845 90583182
Abscess 24.69 20.03 29 26391 18862 90583165
Hypercreatininaemia 24.64 20.03 9 26411 744 90601283
Periostitis 24.64 20.03 8 26412 464 90601563
Flavobacterium infection 24.52 20.03 4 26416 7 90602020
Torsade de pointes 24.47 20.03 26 26394 15156 90586871
Lung infiltration 24.33 20.03 26 26394 15256 90586771
Oliguria 24.24 20.03 22 26398 10602 90591425
Immune reconstitution inflammatory syndrome associated tuberculosis 24.14 20.03 8 26412 495 90601532
Capillary leak syndrome 23.95 20.03 13 26407 2754 90599273
Adverse event 23.95 20.03 3 26417 117415 90484612
Inappropriate schedule of product administration 23.91 20.03 7 26413 149926 90452101
Hyperthyroidism 23.76 20.03 28 26392 18282 90583745
Bone marrow transplant 23.48 20.03 9 26411 851 90601176
Venoocclusive liver disease 23.43 20.03 17 26403 5976 90596051
Streptococcal sepsis 23.38 20.03 14 26406 3570 90598457
Septic pulmonary embolism 23.38 20.03 6 26414 149 90601878
Gait inability 23.06 20.03 7 26413 146449 90455578
Eye infection fungal 23.01 20.03 6 26414 159 90601868
Feeling abnormal 22.94 20.03 10 26410 167225 90434802
Cytokine release syndrome 22.71 20.03 34 26386 27939 90574088
Nasal mucosal disorder 22.67 20.03 11 26409 1846 90600181
Corneal perforation 22.59 20.03 8 26412 605 90601422
Premature baby 22.57 20.03 32 26388 25045 90576982
Venoocclusive disease 22.55 20.03 12 26408 2443 90599584
Adenovirus infection 22.50 20.03 15 26405 4607 90597420
Streptococcal infection 22.49 20.03 18 26402 7315 90594712
Night sweats 22.48 20.03 5 26415 128761 90473266
Visceral leishmaniasis 22.15 20.03 8 26412 641 90601386
Sinusitis fungal 22.09 20.03 11 26409 1953 90600074
Drug level decreased 21.91 20.03 20 26400 9710 90592317
Respiratory distress 21.74 20.03 40 26380 38906 90563121
Electrocardiogram QT prolonged 21.74 20.03 58 26362 72398 90529629
Pulmonary cavitation 21.73 20.03 9 26411 1042 90600985
Acute graft versus host disease in intestine 21.47 20.03 11 26409 2072 90599955
Hypotension 21.29 20.03 165 26255 325232 90276795
Engraftment syndrome 21.28 20.03 8 26412 717 90601310
Infective aneurysm 21.16 20.03 7 26413 431 90601596
Neurological decompensation 21.10 20.03 13 26407 3488 90598539
Haemoptysis 20.89 20.03 36 26384 33284 90568743
Disseminated cryptococcosis 20.82 20.03 8 26412 761 90601266
Neck pain 20.77 20.03 4 26416 113959 90488068
Fungal skin infection 20.64 20.03 15 26405 5286 90596741
Coccidioidomycosis 20.63 20.03 9 26411 1184 90600843
Atrioventricular block second degree 20.60 20.03 14 26406 4438 90597589
Hypomagnesaemia 20.44 20.03 37 26383 35551 90566476
Renal tubular acidosis 20.38 20.03 11 26409 2304 90599723
Cholecystitis 20.37 20.03 25 26395 17015 90585012
Foetal malnutrition 20.28 20.03 5 26415 105 90601922
Hepatitis cholestatic 20.07 20.03 18 26402 8543 90593484
Bulimia nervosa 20.06 20.03 7 26413 507 90601520

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
Drug ineffective 1341.56 14.92 2218 37727 627979 41953411
Aspergillus infection 437.86 14.92 238 39707 15599 42565791
Multiple organ dysfunction syndrome 344.58 14.92 439 39506 96596 42484794
Immune reconstitution inflammatory syndrome 315.72 14.92 165 39780 9978 42571412
Bronchopulmonary aspergillosis 255.53 14.92 182 39763 19247 42562143
Mucormycosis 247.75 14.92 125 39820 7018 42574372
Drug resistance 236.01 14.92 220 39725 34028 42547362
Nephropathy toxic 185.96 14.92 142 39803 16696 42564694
Cerebral aspergillosis 178.57 14.92 66 39879 1711 42579679
Hypokalaemia 177.37 14.92 273 39672 71448 42509942
Fungal infection 168.25 14.92 143 39802 19579 42561811
Choroiditis 167.94 14.92 59 39886 1316 42580074
Septic shock 165.40 14.92 303 39642 91369 42490021
Condition aggravated 156.75 14.92 568 39377 260186 42321204
Drug ineffective for unapproved indication 154.40 14.92 203 39742 45960 42535430
Fatigue 143.63 14.92 119 39826 435522 42145868
Fall 126.57 14.92 32 39913 234488 42346902
Off label use 124.74 14.92 1020 38925 637315 41944075
Renal impairment 124.69 14.92 301 39644 109927 42471463
Systemic mycosis 117.02 14.92 53 39892 2334 42579056
Product dose omission issue 113.75 14.92 8 39937 154357 42427033
Respiratory failure 112.26 14.92 318 39627 127814 42453576
Trichosporon infection 109.24 14.92 39 39906 913 42580477
Disseminated intravascular coagulation 105.33 14.92 123 39822 24671 42556719
Pathogen resistance 103.79 14.92 86 39859 11364 42570026
Arthralgia 101.50 14.92 33 39912 205205 42376185
Meningitis cryptococcal 100.97 14.92 53 39892 3230 42578160
Pneumonia fungal 100.67 14.92 77 39868 9069 42572321
Scedosporium infection 100.56 14.92 42 39903 1516 42579874
Asthenia 99.61 14.92 71 39874 280722 42300668
Cryptococcosis 96.37 14.92 51 39894 3160 42578230
Fungaemia 91.84 14.92 49 39896 3087 42578303
Hepatosplenomegaly 86.20 14.92 54 39891 4606 42576784
Graft versus host disease 85.08 14.92 81 39864 12844 42568546
Sepsis 82.17 14.92 387 39558 198947 42382443
Pyrexia 82.14 14.92 640 39305 393402 42187988
Fungal endocarditis 80.80 14.92 26 39919 438 42580952
Acute kidney injury 80.66 14.92 604 39341 366733 42214657
Haemophagocytic lymphohistiocytosis 76.73 14.92 90 39855 18132 42563258
Uveitis 76.63 14.92 66 39879 9192 42572198
Fusarium infection 76.44 14.92 35 39910 1581 42579809
Pancytopenia 72.60 14.92 259 39686 117484 42463906
Disseminated cryptococcosis 70.60 14.92 35 39910 1890 42579500
Intraocular pressure increased 70.45 14.92 54 39891 6379 42575011
Death 70.34 14.92 218 39727 470967 42110423
Febrile neutropenia 69.66 14.92 351 39594 185352 42396038
Central nervous system lesion 69.02 14.92 58 39887 7812 42573578
Cytomegalovirus infection 68.84 14.92 115 39830 32191 42549199
Intracranial pressure increased 66.57 14.92 46 39899 4628 42576762
Systemic candida 65.72 14.92 48 39897 5271 42576119
Encephalitis 65.29 14.92 60 39885 9098 42572292
Renal failure 63.57 14.92 285 39660 143441 42437949
Pain in extremity 63.31 14.92 31 39914 150573 42430817
Candida infection 63.06 14.92 89 39856 21521 42559869
Treatment failure 62.33 14.92 163 39782 62461 42518929
Nephrogenic diabetes insipidus 61.86 14.92 30 39915 1544 42579846
Nausea 61.74 14.92 180 39765 396619 42184771
Malaise 61.38 14.92 65 39880 212091 42369299
Dizziness 60.94 14.92 87 39858 249167 42332223
Anxiety 58.67 14.92 19 39926 118541 42462849
Eye pain 58.61 14.92 76 39869 16954 42564436
Pseudomonas infection 57.86 14.92 73 39872 15850 42565540
Drug abuse 57.01 14.92 14 39931 104757 42476633
Rectal prolapse 56.71 14.92 21 39924 547 42580843
Brain abscess 55.99 14.92 40 39905 4244 42577146
Peripheral swelling 55.51 14.92 9 39936 90261 42491129
Delayed graft function 55.03 14.92 33 39912 2602 42578788
Constipation 54.93 14.92 43 39902 162248 42419142
Product use in unapproved indication 54.60 14.92 327 39618 184129 42397261
Renal cyst haemorrhage 52.74 14.92 21 39924 669 42580721
Nasopharyngitis 52.49 14.92 8 39937 83988 42497402
Cholestasis 52.18 14.92 103 39842 32776 42548614
Mucosal inflammation 51.69 14.92 131 39814 49243 42532147
Hospitalisation 51.54 14.92 5 39940 74325 42507065
Myocardial infarction 51.39 14.92 26 39919 123983 42457407
Necrotising retinitis 50.90 14.92 23 39922 1007 42580383
Osteomyelitis fungal 50.30 14.92 17 39928 336 42581054
Blood creatinine increased 49.26 14.92 219 39726 109784 42471606
Pain 49.17 14.92 97 39848 244751 42336639
Pulmonary mucormycosis 49.09 14.92 25 39920 1430 42579960
Diarrhoea 48.45 14.92 245 39700 460604 42120786
Acute graft versus host disease in skin 47.86 14.92 46 39899 7378 42574012
Feeling abnormal 47.59 14.92 5 39940 69781 42511609
Abdominal wall haemorrhage 47.52 14.92 18 39927 500 42580890
Joint swelling 46.07 14.92 5 39940 68017 42513373
Varicella zoster virus infection 45.26 14.92 29 39916 2572 42578818
Serratia sepsis 45.16 14.92 13 39932 147 42581243
Inappropriate schedule of product administration 44.64 14.92 17 39928 95885 42485505
Septic embolus 44.11 14.92 23 39922 1382 42580008
Depression 43.72 14.92 25 39920 111338 42470052
Abdominal discomfort 43.05 14.92 9 39936 75246 42506144
Vena cava injury 42.93 14.92 15 39930 329 42581061
Acute respiratory distress syndrome 42.65 14.92 90 39855 30018 42551372
Visual acuity reduced 42.18 14.92 66 39879 17484 42563906
Hypofibrinogenaemia 42.03 14.92 25 39920 1942 42579448
Dyspnoea 41.71 14.92 244 39701 442377 42139013
Oroantral fistula 41.68 14.92 13 39932 197 42581193
Disseminated mucormycosis 41.48 14.92 22 39923 1369 42580021
Infection in an immunocompromised host 41.10 14.92 20 39925 1037 42580353
Leukopenia 40.66 14.92 158 39787 74588 42506802
SARS-CoV-2 antibody test positive 40.57 14.92 15 39930 389 42581001
Muscle spasms 40.47 14.92 15 39930 86029 42495361
Vascular anastomotic haemorrhage 40.41 14.92 14 39931 299 42581091
Hyperhidrosis 38.98 14.92 18 39927 90494 42490896
Chest pain 38.94 14.92 44 39901 139486 42441904
Hepatotoxicity 38.91 14.92 78 39867 25089 42556301
Somnolence 38.83 14.92 45 39900 141060 42440330
Hyperbilirubinaemia 38.14 14.92 69 39876 20566 42560824
Pulmonary haemorrhage 37.88 14.92 50 39895 11347 42570043
Eye infection fungal 37.85 14.92 15 39930 472 42580918
Chronic obstructive pulmonary disease 37.25 14.92 7 39938 63107 42518283
Enterococcal infection 37.24 14.92 51 39894 11988 42569402
Actinic keratosis 37.07 14.92 34 39911 5142 42576248
Intentional overdose 36.92 14.92 3 39942 51453 42529937
Cardiac failure congestive 36.90 14.92 17 39928 85585 42495805
Pruritus 36.83 14.92 76 39869 188695 42392695
Hepatosplenic candidiasis 35.90 14.92 12 39933 229 42581161
Loss of personal independence in daily activities 35.48 14.92 3 39942 49813 42531577
Endophthalmitis 35.47 14.92 31 39914 4402 42576988
Graft versus host disease in gastrointestinal tract 35.31 14.92 33 39912 5110 42576280
Musculoskeletal stiffness 34.97 14.92 6 39939 57759 42523631
Serratia infection 34.84 14.92 19 39926 1250 42580140
Psoriasis 34.41 14.92 3 39942 48601 42532789
Fungal skin infection 34.31 14.92 27 39918 3314 42578076
Venoocclusive liver disease 33.93 14.92 45 39900 10257 42571133
Diaphragmatic injury 33.75 14.92 10 39935 126 42581264
Vascular compression 33.67 14.92 13 39932 381 42581009
Splenic embolism 33.37 14.92 12 39933 287 42581103
Rash 33.31 14.92 140 39805 276814 42304576
Tooth deposit 33.22 14.92 9 39936 80 42581310
Blood glucose increased 32.76 14.92 14 39931 73685 42507705
Asthma 32.60 14.92 9 39936 62305 42519085
Venoocclusive disease 32.58 14.92 28 39917 3887 42577503
Intentional product misuse 32.27 14.92 9 39936 61891 42519499
Blood pressure increased 32.01 14.92 29 39916 101899 42479491
Escherichia infection 31.87 14.92 46 39899 11350 42570040
Gingivitis ulcerative 31.84 14.92 11 39934 233 42581157
Varicella virus test positive 31.79 14.92 11 39934 234 42581156
Abscess fungal 31.73 14.92 12 39933 332 42581058
Perineal cyst 31.71 14.92 11 39934 236 42581154
Dry skin 31.62 14.92 4 39941 48334 42533056
Urticaria 31.45 14.92 15 39930 74021 42507369
Carotid arteriosclerosis 30.99 14.92 22 39923 2310 42579080
Adenovirus infection 30.96 14.92 35 39910 6774 42574616
Intraductal papillary mucinous neoplasm 30.90 14.92 13 39932 478 42580912
Pneumonia pseudomonal 30.86 14.92 30 39915 4879 42576511
Pulmonary mass 30.84 14.92 55 39890 16210 42565180
Central nervous system vasculitis 30.83 14.92 14 39931 620 42580770
Enterococcal bacteraemia 30.55 14.92 23 39922 2644 42578746
Posterior reversible encephalopathy syndrome 30.51 14.92 48 39897 12773 42568617
Electrocardiogram J wave abnormal 30.35 14.92 6 39939 9 42581381
Suicide attempt 29.71 14.92 4 39941 46096 42535294
Weight decreased 29.64 14.92 98 39847 207850 42373540
C-reactive protein increased 29.53 14.92 128 39817 63432 42517958
Aspergillus test positive 29.49 14.92 14 39931 687 42580703
Gait disturbance 29.46 14.92 29 39916 97971 42483419
Cerebral cyst 29.44 14.92 11 39934 294 42581096
Deep vein thrombosis 29.18 14.92 18 39927 76939 42504451
Toxic epidermal necrolysis 29.06 14.92 72 39873 26678 42554712
Pulmonary embolism 28.93 14.92 42 39903 119570 42461820
Geotrichum infection 28.88 14.92 13 39932 564 42580826
Renal artery stenosis 28.83 14.92 21 39924 2296 42579094
Memory impairment 28.73 14.92 6 39939 50216 42531174
Rectal haemorrhage 28.23 14.92 6 39939 49600 42531790
Blood 25-hydroxycholecalciferol decreased 28.18 14.92 11 39934 332 42581058
Organic brain syndrome 28.15 14.92 11 39934 333 42581057
Insomnia 28.13 14.92 42 39903 118211 42463179
Hepatic function abnormal 28.03 14.92 109 39836 51458 42529932
Retinitis viral 27.84 14.92 9 39936 154 42581236
Gamma-glutamyltransferase increased 27.75 14.92 80 39865 32417 42548973
Mucosal disorder 27.72 14.92 20 39925 2154 42579236
Dehiscence 27.48 14.92 13 39932 633 42580757
Pneumonia cytomegaloviral 27.42 14.92 26 39919 4100 42577290
Congenital pneumonia 27.28 14.92 8 39937 97 42581293
Renal tubular disorder 27.18 14.92 28 39917 4881 42576509
Drug level below therapeutic 27.00 14.92 32 39913 6513 42574877
Disseminated coccidioidomycosis 26.85 14.92 8 39937 103 42581287
Therapy non-responder 26.77 14.92 110 39835 53249 42528141
Adenovirus reactivation 26.68 14.92 11 39934 384 42581006
Rheumatoid arthritis 26.60 14.92 4 39941 42436 42538954
Mononeuropathy 26.56 14.92 10 39935 273 42581117
Acute graft versus host disease in intestine 26.45 14.92 25 39920 3926 42577464
Liver transplant failure 26.43 14.92 8 39937 109 42581281
Therapeutic product effect decreased 26.19 14.92 3 39942 39147 42542243
General physical health deterioration 26.17 14.92 236 39709 151010 42430380
Cardiac disorder 25.72 14.92 7 39938 48925 42532465
Dyspepsia 25.69 14.92 4 39941 41348 42540042
Muscle abscess 25.55 14.92 14 39931 930 42580460
Hydrocephalus 25.55 14.92 30 39915 6048 42575342
Neurological decompensation 25.42 14.92 24 39921 3765 42577625
Cerebral ventricle collapse 25.36 14.92 8 39937 126 42581264
Confusional state 25.26 14.92 77 39868 167520 42413870
Product use issue 25.22 14.92 140 39805 76611 42504779
Complications of transplanted kidney 25.18 14.92 28 39917 5322 42576068
Aortic dilatation 25.13 14.92 17 39928 1652 42579738
Drug hypersensitivity 24.93 14.92 34 39911 99355 42482035
Dyspnoea exertional 24.85 14.92 8 39937 50140 42531250
Periostitis 24.47 14.92 10 39935 341 42581049
Back pain 24.45 14.92 61 39884 141715 42439675
Mediastinitis 24.22 14.92 14 39931 1031 42580359
Chronic graft versus host disease 24.10 14.92 29 39916 5996 42575394
Contusion 24.05 14.92 5 39940 41980 42539410
Sideroblastic anaemia 24.04 14.92 10 39935 357 42581033
Bacterial pericarditis 24.02 14.92 7 39938 83 42581307
Histoplasmosis disseminated 23.88 14.92 18 39927 2073 42579317
Capillary leak syndrome 23.84 14.92 20 39925 2687 42578703
Drug level increased 23.83 14.92 66 39879 26134 42555256
Pruritus allergic 23.81 14.92 10 39935 366 42581024
Hyperparathyroidism secondary 23.61 14.92 17 39928 1825 42579565
Vitamin B1 decreased 23.53 14.92 10 39935 377 42581013
Organising pneumonia 23.43 14.92 32 39913 7500 42573890
Blood alkaline phosphatase increased 23.37 14.92 77 39868 33520 42547870
Toxoplasmosis 23.32 14.92 16 39929 1591 42579799
Bone marrow failure 23.16 14.92 76 39869 33017 42548373
Haematochezia 23.09 14.92 13 39932 58423 42522967
Abdominal pain upper 23.08 14.92 26 39919 82583 42498807
Intervertebral disc space narrowing 23.03 14.92 14 39931 1131 42580259
Hepatic failure 22.74 14.92 83 39862 38017 42543373
Urge incontinence 22.72 14.92 11 39934 564 42580826
Epileptic encephalopathy 22.56 14.92 9 39936 288 42581102
Polyomavirus-associated nephropathy 22.42 14.92 27 39918 5588 42575802
Adverse drug reaction 22.41 14.92 4 39941 37430 42543960
Brain herniation 22.28 14.92 25 39920 4798 42576592
Upper respiratory tract infection 22.23 14.92 6 39939 42167 42539223
Leishmaniasis 22.17 14.92 10 39935 436 42580954
Arthritis 22.14 14.92 6 39939 42059 42539331
Vomiting 22.05 14.92 170 39775 289553 42291837
Mycobacterial infection 22.04 14.92 19 39926 2649 42578741
Bradyarrhythmia 21.99 14.92 19 39926 2656 42578734
Infective keratitis 21.98 14.92 6 39939 55 42581335
Pneumonia cryptococcal 21.85 14.92 15 39930 1493 42579897
Fluorosis 21.79 14.92 6 39939 57 42581333
Odynophagia 21.42 14.92 29 39916 6741 42574649
Febrile infection 21.41 14.92 19 39926 2752 42578638
Shock 21.39 14.92 68 39877 29053 42552337
Encephalopathy 21.35 14.92 86 39859 41247 42540143
Hemiparesis 21.28 14.92 49 39896 17327 42564063
Moraxella infection 21.04 14.92 9 39936 345 42581045
Neutropenia 21.01 14.92 282 39663 199149 42382241
Gallbladder polyp 20.91 14.92 10 39935 499 42580891
Optic discs blurred 20.83 14.92 6 39939 68 42581322
Bacterial disease carrier 20.82 14.92 11 39934 679 42580711
Rhinocerebral mucormycosis 20.82 14.92 11 39934 679 42580711
Granulomatous liver disease 20.63 14.92 11 39934 692 42580698
Blood beta-D-glucan increased 20.52 14.92 10 39935 520 42580870
Microangiopathic haemolytic anaemia 20.48 14.92 13 39932 1134 42580256
Cardiac valve vegetation 20.33 14.92 10 39935 531 42580859
Blood bilirubin increased 20.32 14.92 86 39859 42166 42539224
Torsade de pointes 20.21 14.92 32 39913 8562 42572828
Meningitis 20.10 14.92 26 39919 5783 42575607
International normalised ratio increased 20.09 14.92 10 39935 48158 42533232
Epilepsy 20.04 14.92 62 39883 26109 42555281
Scopulariopsis infection 19.97 14.92 7 39938 155 42581235
Brain oedema 19.95 14.92 46 39899 16281 42565109
Skin necrosis 19.91 14.92 27 39918 6287 42575103
Pulpitis dental 19.82 14.92 11 39934 749 42580641
Unevaluable event 19.81 14.92 4 39941 34284 42547106
Cataract subcapsular 19.78 14.92 10 39935 563 42580827
Weight increased 19.77 14.92 45 39900 107938 42473452
Heart rate decreased 19.63 14.92 5 39940 36527 42544863
Productive cough 19.63 14.92 12 39933 51555 42529835
Mucosal haemorrhage 19.54 14.92 15 39930 1775 42579615
Fungal test positive 19.52 14.92 10 39935 579 42580811
Splenic infarction 19.45 14.92 17 39928 2414 42578976
Malabsorption 19.44 14.92 18 39927 2755 42578635
Swelling of eyelid 19.31 14.92 16 39929 2112 42579278
Mean cell volume increased 19.27 14.92 21 39924 3902 42577488
Lower respiratory tract infection fungal 19.24 14.92 10 39935 597 42580793
Graft versus host disease in skin 19.10 14.92 24 39921 5188 42576202
Neuropathy peripheral 19.01 14.92 42 39903 101811 42479579
Infective aneurysm 18.90 14.92 12 39933 1047 42580343
Blood immunoglobulin M abnormal 18.88 14.92 6 39939 97 42581293
Aspergilloma 18.87 14.92 9 39936 446 42580944
Granuloma 18.76 14.92 21 39924 4020 42577370
Blood immunoglobulin G abnormal 18.71 14.92 6 39939 100 42581290
Syncope 18.55 14.92 41 39904 99365 42482025
Acute graft versus host disease 18.51 14.92 30 39915 8185 42573205
Drug-induced liver injury 18.48 14.92 78 39867 38195 42543195
Urinary tract infection 18.48 14.92 41 39904 99243 42482147
Blindness unilateral 18.46 14.92 24 39921 5364 42576026
Vision blurred 18.43 14.92 14 39931 53685 42527705
Abdominal pain 18.39 14.92 104 39841 190367 42391023
Cytomegalovirus enterocolitis 18.27 14.92 13 39932 1370 42580020
Pulmonary resection 18.12 14.92 6 39939 111 42581279
Incorrect product formulation administered 18.11 14.92 5 39940 48 42581342
Retinal ischaemia 18.08 14.92 9 39936 490 42580900
Neurotoxicity 18.08 14.92 56 39889 23595 42557795
Arthropathy 18.07 14.92 3 39942 29594 42551796
Nasal congestion 17.99 14.92 3 39942 29498 42551892
Drug level decreased 17.97 14.92 33 39912 9944 42571446
Acute lymphocytic leukaemia 17.97 14.92 19 39926 3412 42577978
Soft tissue infection 17.95 14.92 17 39928 2676 42578714
Drug therapeutic incompatibility 17.93 14.92 6 39939 115 42581275
Wheezing 17.90 14.92 15 39930 54766 42526624
Diverticulum intestinal 17.87 14.92 23 39922 5090 42576300
Blastomycosis 17.85 14.92 10 39935 694 42580696
Cholangitis infective 17.84 14.92 8 39937 344 42581046
Disseminated aspergillosis 17.80 14.92 14 39931 1716 42579674
Electrocardiogram T wave biphasic 17.73 14.92 7 39938 218 42581172
Staphylococcal scalded skin syndrome 17.67 14.92 8 39937 352 42581038
Hypoglycaemia 17.65 14.92 18 39927 59836 42521554
Paraesthesia 17.55 14.92 26 39919 73433 42507957
Blood lactate dehydrogenase abnormal 17.52 14.92 8 39937 359 42581031
Troponin T increased 17.49 14.92 17 39928 2763 42578627
Carotid artery insufficiency 17.47 14.92 4 39941 16 42581374
Coagulation factor VII level decreased 17.46 14.92 6 39939 125 42581265
Cardiac pacemaker evaluation 17.41 14.92 6 39939 126 42581264
Mycotic endophthalmitis 17.41 14.92 7 39938 229 42581161
Transplant rejection 17.39 14.92 39 39906 13549 42567841
Acute myeloid leukaemia 17.30 14.92 53 39892 22203 42559187
Aplasia 17.27 14.92 22 39923 4821 42576569
Enamel anomaly 17.26 14.92 7 39938 234 42581156
Electrocardiogram T wave amplitude decreased 17.21 14.92 8 39937 374 42581016
Aggression 17.20 14.92 10 39935 44153 42537237
Disease progression 17.18 14.92 208 39737 143448 42437942
Amnesia 17.11 14.92 3 39942 28434 42552956
CNS ventriculitis 17.01 14.92 8 39937 384 42581006
Bladder hypertrophy 16.98 14.92 10 39935 763 42580627
Gout 16.79 14.92 3 39942 28052 42553338
Orthostatic hypotension 16.78 14.92 4 39941 30566 42550824
CARD9 deficiency 16.75 14.92 4 39941 20 42581370
Pulmonary sepsis 16.69 14.92 18 39927 3306 42578084
ADAMTS13 activity decreased 16.59 14.92 6 39939 146 42581244
Loss of consciousness 16.49 14.92 39 39906 92315 42489075
Respiratory tract infection fungal 16.44 14.92 10 39935 809 42580581
Device related infection 16.42 14.92 49 39896 20230 42561160
Aortic arteriosclerosis 16.30 14.92 22 39923 5098 42576292
Full blood count abnormal 16.22 14.92 4 39941 29872 42551518
CD4 lymphocytes increased 16.18 14.92 6 39939 157 42581233
Bronchostenosis 16.15 14.92 8 39937 431 42580959
Fungal sepsis 16.13 14.92 11 39934 1083 42580307
Angioedema 16.01 14.92 10 39935 42467 42538923
Endocarditis candida 15.89 14.92 5 39940 78 42581312
Atrial fibrillation 15.87 14.92 72 39873 139521 42441869
Infective corneal ulcer 15.86 14.92 4 39941 26 42581364
Skin mass 15.80 14.92 21 39924 4795 42576595
Escherichia sepsis 15.78 14.92 23 39922 5724 42575666
BK virus infection 15.76 14.92 29 39916 8755 42572635
Blood cholesterol increased 15.70 14.92 3 39942 26738 42554652
Inflammatory marker increased 15.67 14.92 25 39920 6731 42574659
Cardiogenic shock 15.47 14.92 7 39938 35633 42545757
Hypoaesthesia 15.47 14.92 27 39918 71436 42509954
Pseudomonas test positive 15.40 14.92 12 39933 1451 42579939
Mediastinal shift 15.38 14.92 3 39942 4 42581386
Toxicity to various agents 15.36 14.92 139 39806 228997 42352393
Retinitis 15.28 14.92 8 39937 485 42580905
Pneumocystis jirovecii infection 15.27 14.92 16 39929 2844 42578546
Lower respiratory tract infection 15.12 14.92 10 39935 41196 42540194
Chondritis 15.04 14.92 6 39939 192 42581198

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective 2210.77 15.20 3391 58286 1517149 109010473
Multiple organ dysfunction syndrome 894.53 15.20 713 60964 150997 110376625
Aspergillus infection 740.15 15.20 336 61341 25280 110502342
Mucormycosis 592.26 15.20 223 61454 10405 110517217
Immune reconstitution inflammatory syndrome 491.41 15.20 220 61457 16006 110511616
Bronchopulmonary aspergillosis 488.19 15.20 266 61411 29597 110498025
Septic shock 434.46 15.20 486 61191 157042 110370580
Drug resistance 314.81 15.20 257 61420 56117 110471505
Nephropathy toxic 314.03 15.20 194 61483 27284 110500338
Respiratory failure 306.20 15.20 480 61197 214852 110312770
Renal impairment 300.36 15.20 443 61234 188002 110339620
Hypokalaemia 298.17 15.20 434 61243 182014 110345608
Drug ineffective for unapproved indication 289.75 15.20 321 61356 102517 110425105
Fatigue 280.67 15.20 166 61511 1215792 109311830
Acute kidney injury 278.87 15.20 882 60795 634548 109893074
Arthralgia 257.12 15.20 60 61617 779572 109748050
Off label use 255.43 15.20 1564 60113 1498621 109029001
Fungal infection 253.39 15.20 217 61460 50589 110477033
Pathogen resistance 249.49 15.20 143 61534 17529 110510093
Sepsis 248.02 15.20 557 61120 326789 110200833
Febrile neutropenia 245.60 15.20 544 61133 316223 110211399
Systemic mycosis 219.33 15.20 82 61595 3747 110523875
Haemophagocytic lymphohistiocytosis 217.58 15.20 163 61514 31396 110496226
Pneumonia fungal 215.30 15.20 122 61555 14632 110512990
Systemic candida 212.07 15.20 106 61571 9868 110517754
Joint swelling 212.01 15.20 8 61669 442837 110084785
Cerebral aspergillosis 207.23 15.20 69 61608 2233 110525389
Pain 202.80 15.20 143 61534 954812 109572810
Pancytopenia 201.02 15.20 393 61284 209220 110318402
Candida infection 195.70 15.20 183 61494 47826 110479796
Renal failure 192.54 15.20 404 61273 226170 110301452
Peripheral swelling 184.56 15.20 10 61667 404024 110123598
Scedosporium infection 179.55 15.20 63 61614 2395 110525227
Meningitis cryptococcal 178.25 15.20 75 61602 4687 110522935
Choroiditis 176.20 15.20 56 61621 1559 110526063
Fusarium infection 175.89 15.20 64 61613 2707 110524915
Fall 173.72 15.20 60 61617 603422 109924200
Fungaemia 169.94 15.20 78 61599 6008 110521614
Nasopharyngitis 165.00 15.20 15 61662 394346 110133276
Toxic epidermal necrolysis 161.30 15.20 178 61499 56549 110471073
Cryptococcosis 160.30 15.20 69 61608 4562 110523060
Neutropenia 159.31 15.20 515 61162 374105 110153517
Cytomegalovirus infection 155.08 15.20 171 61506 54273 110473349
Condition aggravated 154.37 15.20 812 60865 734024 109793598
Enterococcal infection 148.93 15.20 109 61568 20257 110507365
Abdominal discomfort 147.35 15.20 22 61655 393836 110133786
Trichosporon infection 145.65 15.20 46 61631 1254 110526368
Graft versus host disease 142.86 15.20 103 61574 18703 110508919
Cholestasis 141.13 15.20 177 61500 64341 110463281
Dizziness 140.98 15.20 110 61567 698083 109829539
Disseminated intravascular coagulation 139.47 15.20 142 61535 41144 110486478
Pyrexia 139.16 15.20 916 60761 897349 109630273
Fungal endocarditis 138.56 15.20 40 61637 796 110526826
Brain abscess 135.25 15.20 69 61608 6705 110520917
Asthenia 132.33 15.20 114 61563 688885 109838737
Rheumatoid arthritis 132.01 15.20 9 61668 299604 110228018
Leukopenia 131.81 15.20 270 61407 148521 110379101
Malaise 130.44 15.20 110 61567 671709 109855913
Product dose omission issue 127.45 15.20 15 61662 321767 110205855
Product use in unapproved indication 127.12 15.20 540 61137 446837 110080785
Hyperbilirubinaemia 127.08 15.20 118 61559 30553 110497069
Pain in extremity 122.94 15.20 59 61618 487059 110040563
Mucosal inflammation 122.39 15.20 204 61473 95937 110431685
Mobility decreased 118.19 15.20 3 61674 237419 110290203
Alopecia 118.18 15.20 29 61648 364724 110162898
Posterior reversible encephalopathy syndrome 117.18 15.20 118 61559 33743 110493879
Wound 112.93 15.20 4 61673 234433 110293189
Therapeutic product effect decreased 111.66 15.20 6 61671 244310 110283312
Headache 110.93 15.20 202 61475 882175 109645447
Musculoskeletal stiffness 110.92 15.20 13 61664 279809 110247813
Drug level below therapeutic 109.99 15.20 73 61604 11600 110516022
Pseudomonas infection 109.34 15.20 104 61573 27749 110499873
Anxiety 108.79 15.20 29 61648 345049 110182573
Hepatosplenomegaly 108.52 15.20 60 61617 6859 110520763
Contraindicated product administered 107.79 15.20 8 61669 248259 110279363
Drug hypersensitivity 107.15 15.20 60 61617 454030 110073592
Disseminated mucormycosis 105.92 15.20 41 61636 2061 110525561
Graft versus host disease in gastrointestinal tract 104.17 15.20 64 61613 8904 110518718
Pulmonary mucormycosis 101.63 15.20 40 61637 2103 110525519
Disease progression 100.47 15.20 332 61345 243702 110283920
Systemic lupus erythematosus 100.35 15.20 12 61665 254326 110273296
Brain oedema 99.69 15.20 104 61573 30994 110496628
Glossodynia 96.82 15.20 7 61670 221997 110305625
Contusion 94.61 15.20 10 61667 233351 110294271
Swelling 94.06 15.20 39 61638 351002 110176620
Central nervous system lesion 93.34 15.20 74 61603 15479 110512143
Disseminated cryptococcosis 93.32 15.20 40 61637 2617 110525005
Endophthalmitis 91.48 15.20 57 61620 8130 110519492
Lower respiratory tract infection 89.92 15.20 14 61663 243092 110284530
Wheezing 89.35 15.20 17 61660 255213 110272409
Acute graft versus host disease in skin 88.91 15.20 62 61615 10678 110516944
Urticaria 87.75 15.20 34 61643 318823 110208799
Drug level increased 87.41 15.20 120 61557 47599 110480023
Nausea 87.38 15.20 374 61303 1235316 109292306
Depression 87.06 15.20 34 61643 317301 110210321
Asthma 86.92 15.20 17 61660 250274 110277348
Nephrogenic diabetes insipidus 86.50 15.20 37 61640 2408 110525214
Muscle spasms 86.48 15.20 24 61653 278133 110249489
Pruritus 86.37 15.20 119 61558 581441 109946181
Weight increased 86.00 15.20 65 61612 419579 110108043
Injection site pain 85.81 15.20 3 61674 177919 110349703
Discomfort 85.02 15.20 10 61667 214697 110312925
Hepatosplenic candidiasis 84.84 15.20 26 61651 640 110526982
Rash 83.12 15.20 212 61465 820752 109706870
Candida sepsis 82.83 15.20 38 61639 2923 110524699
Hepatic function abnormal 82.56 15.20 165 61512 89130 110438492
Abdominal pain upper 82.51 15.20 46 61631 349065 110178557
Migraine 82.41 15.20 3 61674 171649 110355973
Pulmonary haemorrhage 81.43 15.20 70 61607 16386 110511236
Shock 80.97 15.20 123 61554 53465 110474157
Acute respiratory distress syndrome 80.24 15.20 122 61555 53076 110474546
Pericarditis 80.17 15.20 13 61664 219101 110308521
Blood cholesterol increased 80.07 15.20 6 61671 184779 110342843
Injury 79.01 15.20 5 61672 177260 110350362
Type 2 diabetes mellitus 79.00 15.20 5 61672 177227 110350395
Dyspnoea 76.97 15.20 337 61340 1106535 109421087
Geotrichum infection 76.95 15.20 28 61649 1184 110526438
Insomnia 76.28 15.20 54 61623 360536 110167086
Encephalitis 75.19 15.20 71 61606 18768 110508854
Escherichia infection 75.18 15.20 79 61598 23737 110503885
Drug intolerance 74.65 15.20 70 61607 406442 110121180
Infection in an immunocompromised host 74.30 15.20 31 61646 1896 110525726
Renal tubular disorder 73.75 15.20 48 61629 7381 110520241
Osteomyelitis fungal 73.41 15.20 21 61656 404 110527218
Thrombocytopenia 73.29 15.20 386 61291 348499 110179123
Septic embolus 71.88 15.20 32 61645 2294 110525328
Loss of personal independence in daily activities 70.74 15.20 3 61674 150017 110377605
Histoplasmosis disseminated 70.05 15.20 37 61640 3862 110523760
Pseudomonal sepsis 69.74 15.20 50 61627 8996 110518626
Infusion related reaction 68.39 15.20 67 61610 381095 110146527
Arthritis 68.38 15.20 7 61670 167579 110360043
Fungal sepsis 66.65 15.20 30 61647 2207 110525415
Dyspepsia 66.23 15.20 13 61664 190952 110336670
Rash maculo-papular 66.05 15.20 135 61542 74087 110453535
Bone marrow failure 66.05 15.20 117 61560 57731 110469891
Intraocular pressure increased 65.81 15.20 52 61625 10824 110516798
Chronic graft versus host disease 65.51 15.20 49 61628 9408 110518214
Eye infection fungal 65.42 15.20 21 61656 604 110527018
Dehiscence 65.37 15.20 22 61655 736 110526886
Varicella zoster virus infection 65.32 15.20 42 61635 6326 110521296
Intracranial pressure increased 65.11 15.20 51 61626 10484 110517138
Memory impairment 65.05 15.20 15 61662 196929 110330693
Blood creatinine increased 64.12 15.20 236 61441 182653 110344969
Hypoaesthesia 63.93 15.20 49 61628 314174 110213448
Rhinocerebral mucormycosis 63.91 15.20 26 61651 1491 110526131
Gamma-glutamyltransferase increased 63.66 15.20 119 61558 61190 110466432
Uveitis 63.21 15.20 69 61608 21641 110505981
Impaired healing 62.98 15.20 16 61661 196701 110330921
Hepatic cytolysis 62.41 15.20 111 61566 54942 110472680
Paraesthesia 61.71 15.20 39 61638 276482 110251140
Drug abuse 61.69 15.20 12 61665 177399 110350223
Delayed graft function 61.56 15.20 35 61642 4222 110523400
Renal cyst haemorrhage 61.36 15.20 21 61656 740 110526882
Encephalopathy 61.29 15.20 138 61539 80917 110446705
Feeling abnormal 61.22 15.20 13 61664 180698 110346924
Venoocclusive disease 60.53 15.20 40 61637 6310 110521312
Pyelonephritis fungal 60.33 15.20 17 61660 309 110527313
Immunosuppressant drug level increased 60.31 15.20 51 61626 11673 110515949
Osteoarthritis 60.13 15.20 14 61663 182609 110345013
Gait disturbance 59.70 15.20 41 61636 278167 110249455
Psoriasis 59.38 15.20 5 61672 139988 110387634
Adenovirus infection 58.99 15.20 49 61628 10945 110516677
Stenotrophomonas infection 58.52 15.20 38 61639 5820 110521802
Hepatotoxicity 58.42 15.20 117 61560 63283 110464339
Acute graft versus host disease 58.13 15.20 52 61625 12829 110514793
Disseminated aspergillosis 57.61 15.20 28 61649 2452 110525170
Visual acuity reduced 57.56 15.20 80 61597 32093 110495529
Dry mouth 57.21 15.20 20 61657 199928 110327694
Sleep disorder 56.62 15.20 20 61657 198624 110328998
Necrotising retinitis 55.96 15.20 24 61653 1572 110526050
Blood pressure increased 55.54 15.20 38 61639 258335 110269287
Disseminated coccidioidomycosis 54.96 15.20 15 61662 241 110527381
Pneumonia cytomegaloviral 54.91 15.20 39 61638 6915 110520707
Venoocclusive liver disease 54.46 15.20 54 61623 15153 110512469
Diarrhoea 54.11 15.20 393 61284 1139112 109388510
Abdominal wall haemorrhage 53.85 15.20 19 61658 734 110526888
Serratia sepsis 53.69 15.20 15 61662 264 110527358
Aplastic anaemia 53.63 15.20 67 61610 24241 110503381
Necrosis 53.37 15.20 47 61630 11359 110516263
Fungal test positive 53.32 15.20 21 61656 1106 110526516
Graft versus host disease in skin 53.27 15.20 41 61636 8213 110519409
Blood beta-D-glucan increased 53.13 15.20 19 61658 764 110526858
Staphylococcal infection 52.79 15.20 119 61558 69825 110457797
Inappropriate schedule of product administration 52.33 15.20 24 61653 203613 110324009
Electrolyte imbalance 51.76 15.20 82 61595 36946 110490676
Perinephric abscess 51.56 15.20 16 61661 411 110527211
Pleural effusion 51.50 15.20 216 61461 177493 110350129
Bacterial sepsis 50.87 15.20 44 61633 10382 110517240
Emphysematous pyelonephritis 50.74 15.20 17 61660 561 110527061
Bronchial anastomosis complication 50.34 15.20 12 61665 108 110527514
Vena cava injury 50.24 15.20 15 61662 337 110527285
Hypersensitivity 50.16 15.20 93 61584 403905 110123717
Acute graft versus host disease in intestine 50.09 15.20 34 61643 5605 110522017
Febrile bone marrow aplasia 49.97 15.20 55 61622 17410 110510212
Dermatitis exfoliative 49.61 15.20 45 61632 11302 110516320
Polyomavirus-associated nephropathy 49.17 15.20 39 61638 8162 110519460
Klebsiella infection 48.77 15.20 58 61619 19951 110507671
Bacteraemia 48.73 15.20 86 61591 42304 110485318
Acute myeloid leukaemia 48.65 15.20 81 61596 38029 110489593
Periostitis 48.51 15.20 18 61659 805 110526817
Vesicoureteric reflux 48.28 15.20 13 61664 198 110527424
Acute myeloid leukaemia recurrent 48.08 15.20 32 61645 5107 110522515
Neck pain 48.08 15.20 6 61671 123124 110404498
Systemic inflammatory response syndrome 47.98 15.20 47 61630 12996 110514626
SARS-CoV-2 antibody test positive 47.81 15.20 15 61662 400 110527222
Aspergillus test positive 47.70 15.20 19 61658 1031 110526591
Vascular anastomotic haemorrhage 47.56 15.20 14 61663 299 110527323
Fluorosis 47.45 15.20 13 61664 212 110527410
Blood bilirubin increased 47.34 15.20 120 61557 75852 110451770
Adverse drug reaction 46.97 15.20 3 61674 105556 110422066
Hospitalisation 46.76 15.20 11 61666 142482 110385140
Intracranial infection 46.10 15.20 14 61663 334 110527288
Pneumonia pseudomonal 45.49 15.20 36 61641 7510 110520112
Musculoskeletal pain 44.85 15.20 23 61654 183000 110344622
Enterococcal bacteraemia 44.71 15.20 29 61648 4432 110523190
Chest pain 44.66 15.20 89 61588 376286 110151336
Fungal skin infection 44.60 15.20 35 61642 7214 110520408
Brain herniation 44.46 15.20 38 61639 8825 110518797
Hepatic failure 44.33 15.20 110 61567 68629 110458993
Folliculitis 44.27 15.20 19 61658 167634 110359988
Intentional overdose 43.93 15.20 10 61667 132491 110395131
Actinic keratosis 43.44 15.20 34 61643 6979 110520643
Coagulopathy 43.21 15.20 80 61597 40831 110486791
Suicide attempt 43.01 15.20 4 61673 103390 110424232
Drug interaction 42.95 15.20 447 61230 499736 110027886
Splenic embolism 42.80 15.20 12 61665 214 110527408
Abscess fungal 42.37 15.20 14 61663 442 110527180
BK virus infection 42.30 15.20 44 61633 13062 110514560
Central nervous system fungal infection 41.87 15.20 15 61662 606 110527016
Staphylococcal bacteraemia 41.71 15.20 49 61628 16639 110510983
Amnesia 41.49 15.20 5 61672 105403 110422219
Pneumothorax 41.09 15.20 72 61605 35213 110492409
Ill-defined disorder 41.06 15.20 18 61659 156835 110370787
Cardiac valve vegetation 41.01 15.20 17 61660 1023 110526599
Transplant rejection 40.86 15.20 59 61618 24508 110503114
Hepatocellular injury 40.28 15.20 88 61589 50554 110477068
Respiratory tract infection fungal 40.23 15.20 18 61659 1306 110526316
Torsade de pointes 40.13 15.20 56 61621 22544 110505078
Blood alkaline phosphatase increased 40.06 15.20 108 61569 70827 110456795
Sciatica 40.02 15.20 3 61674 92396 110435226
Aplasia 39.99 15.20 34 61643 7839 110519783
Cerebral fungal infection 39.81 15.20 15 61662 700 110526922
Neurological decompensation 39.70 15.20 32 61645 6851 110520771
Protothecosis 39.63 15.20 14 61663 543 110527079
Serratia infection 39.35 15.20 21 61656 2238 110525384
Hydrocephalus 39.31 15.20 38 61639 10337 110517285
Diaphragmatic injury 38.89 15.20 10 61667 126 110527496
Chronic obstructive pulmonary disease 38.76 15.20 7 61670 109151 110418471
Metabolic acidosis 38.61 15.20 133 61544 99611 110428011
Intentional product misuse 38.52 15.20 13 61664 132891 110394731
Staphylococcal sepsis 38.33 15.20 48 61629 17406 110510216
Injection site reaction 38.27 15.20 3 61674 89067 110438555
Pulmonary mass 38.22 15.20 72 61605 37229 110490393
Infective aneurysm 38.17 15.20 18 61659 1474 110526148
Hemiparesis 38.05 15.20 79 61598 43824 110483798
Respiratory distress 38.03 15.20 104 61573 68770 110458852
Stevens-Johnson syndrome 37.88 15.20 82 61595 46819 110480803
Rectal haemorrhage 37.86 15.20 10 61667 119823 110407799
Nasal congestion 37.86 15.20 5 61672 98277 110429345
Weight decreased 37.82 15.20 134 61543 467923 110059699
Perineal cyst 37.45 15.20 11 61666 233 110527389
Toxoplasmosis 37.33 15.20 23 61654 3216 110524406
Somnolence 37.33 15.20 68 61609 297381 110230241
Skin mass 37.29 15.20 36 61641 9780 110517842
Hyperhidrosis 37.08 15.20 30 61647 187268 110340354
Pneumonia cryptococcal 37.03 15.20 21 61656 2521 110525101
Cytomegalovirus test positive 37.00 15.20 31 61646 7005 110520617
Agranulocytosis 36.88 15.20 96 61581 61664 110465958
Rectal prolapse 36.87 15.20 21 61656 2542 110525080
Splenomegaly 36.68 15.20 56 61621 24442 110503180
Bacterial infection 36.62 15.20 80 61597 45956 110481666
Eye pain 36.43 15.20 84 61593 50015 110477607
Vomiting 36.30 15.20 329 61348 910346 109617276
Upper respiratory tract infection 36.11 15.20 14 61663 131314 110396308
Mediastinitis 36.06 15.20 17 61660 1391 110526231
Carotid arteriosclerosis 35.97 15.20 22 61655 3035 110524587
Oroantral fistula 35.90 15.20 12 61665 393 110527229
Peripheral venous disease 35.68 15.20 3 61674 84114 110443508
Suicidal ideation 35.66 15.20 5 61672 93932 110433690
Constipation 35.64 15.20 93 61584 357693 110169929
Neurotoxicity 35.47 15.20 75 61602 42132 110485490
Gastrooesophageal reflux disease 35.41 15.20 29 61648 179947 110347675
Mucosal disorder 35.40 15.20 25 61652 4392 110523230
Myocardial infarction 35.31 15.20 33 61644 192050 110335572
Device related infection 35.29 15.20 72 61605 39447 110488175
Pulmonary fibrosis 35.26 15.20 7 61670 102035 110425587
Febrile infection 35.24 15.20 25 61652 4423 110523199
Hypofibrinogenaemia 34.61 15.20 20 61657 2487 110525135
Anaemia 34.57 15.20 461 61216 546625 109980997
Drug level decreased 34.50 15.20 47 61630 18501 110509121
Hypertension 34.29 15.20 157 61520 509927 110017695
Organising pneumonia 34.24 15.20 41 61636 14202 110513420
Lower respiratory tract infection fungal 33.76 15.20 14 61663 843 110526779
Meningitis 33.73 15.20 37 61640 11665 110515957
Therapy non-responder 33.63 15.20 175 61502 157132 110370490
Grip strength decreased 33.62 15.20 3 61674 80171 110447451
Fluid retention 33.59 15.20 6 61671 94301 110433321
Hepatitis cholestatic 33.41 15.20 45 61632 17521 110510101
Idiopathic pneumonia syndrome 33.30 15.20 14 61663 873 110526749
Leishmaniasis 33.22 15.20 12 61665 497 110527125
Gingivitis ulcerative 32.96 15.20 12 61665 508 110527114
Confusional state 32.86 15.20 142 61535 468538 110059084
Cardiac failure congestive 32.72 15.20 22 61655 150978 110376644
Renal tubular necrosis 32.69 15.20 60 61617 30415 110497207
Red blood cell sedimentation rate increased 32.65 15.20 3 61674 78299 110449323
Overgrowth fungal 32.56 15.20 9 61668 152 110527470
General physical health deterioration 32.30 15.20 371 61306 424924 110102698
Palpitations 32.14 15.20 25 61652 159187 110368435
Pericoronitis 32.13 15.20 9 61668 160 110527462
Varicella virus test positive 32.05 15.20 11 61666 391 110527231
Upper airway necrosis 31.99 15.20 7 61670 41 110527581
Moraxella infection 31.76 15.20 13 61664 757 110526865
Pulmonary cavitation 31.62 15.20 18 61659 2176 110525446
Vascular compression 31.59 15.20 13 61664 768 110526854
Back pain 31.46 15.20 104 61573 370892 110156730
Neutropenic colitis 31.43 15.20 30 61647 8035 110519587
Aortic dilatation 31.23 15.20 18 61659 2228 110525394
Sinusitis 31.19 15.20 75 61602 296613 110231009
Pneumonia bacterial 31.12 15.20 54 61623 26207 110501415
Lung infiltration 30.97 15.20 52 61625 24576 110503046
Shock haemorrhagic 30.96 15.20 55 61622 27192 110500430
Adverse event 30.92 15.20 11 61666 108798 110418824
Capillary leak syndrome 30.85 15.20 24 61653 4884 110522738
Endocarditis candida 30.54 15.20 8 61669 109 110527513
Cytomegalovirus infection reactivation 30.45 15.20 44 61633 18289 110509333
Intraductal papillary mucinous neoplasm 30.39 15.20 13 61664 846 110526776
Blood 25-hydroxycholecalciferol decreased 30.23 15.20 11 61666 465 110527157
Blood pressure systolic increased 30.17 15.20 5 61672 82986 110444636
Multiple-drug resistance 30.03 15.20 37 61640 13198 110514424
Oliguria 29.86 15.20 44 61633 18613 110509009
Cerebral cyst 29.83 15.20 11 61666 483 110527139
Electrocardiogram J wave abnormal 29.72 15.20 6 61671 22 110527600
Visceral leishmaniasis 29.68 15.20 16 61661 1740 110525882
Graft versus host disease in liver 29.68 15.20 18 61659 2447 110525175
Renal artery stenosis 29.66 15.20 21 61656 3705 110523917
Product quality issue 29.61 15.20 4 61673 77295 110450327
Chest discomfort 29.52 15.20 32 61645 173816 110353806
Acute lymphocytic leukaemia 29.49 15.20 25 61652 5740 110521882
Pulmonary sepsis 29.31 15.20 24 61653 5254 110522368
Hyperammonaemia 28.94 15.20 37 61640 13695 110513927
Mononeuropathy 28.94 15.20 10 61667 363 110527259
Eye abscess 28.86 15.20 10 61667 366 110527256
Gastrointestinal mucormycosis 28.84 15.20 12 61665 729 110526893
Pneumocystis jirovecii infection 28.71 15.20 22 61655 4378 110523244
Hypoalbuminaemia 28.54 15.20 55 61622 28919 110498703
Pneumonia moraxella 28.41 15.20 8 61669 145 110527477
Coagulation test abnormal 28.35 15.20 15 61662 1571 110526051
Engraftment syndrome 28.25 15.20 16 61661 1916 110525706
Deep vein thrombosis 28.19 15.20 22 61655 139865 110387757
Microangiopathic haemolytic anaemia 28.16 15.20 16 61661 1927 110525695
Liver transplant failure 28.06 15.20 8 61669 152 110527470
Organic brain syndrome 27.99 15.20 11 61666 576 110527046
Aspergilloma 27.97 15.20 12 61665 787 110526835
Heart rate decreased 27.93 15.20 6 61671 82750 110444872
Central nervous system vasculitis 27.76 15.20 15 61662 1639 110525983
Paraspinal abscess 27.64 15.20 10 61667 416 110527206
Muscular weakness 27.57 15.20 61 61616 248407 110279215
Pancreatitis acute 27.49 15.20 85 61592 60189 110467433
Urinary tract infection enterococcal 27.48 15.20 20 61657 3682 110523940
Alanine aminotransferase increased 27.40 15.20 186 61491 183587 110344035
Cerebral infarction 27.36 15.20 77 61600 51761 110475861
Sideroblastic anaemia 27.12 15.20 10 61667 439 110527183
Scopulariopsis infection 27.00 15.20 8 61669 175 110527447
Cerebral ventricle collapse 26.83 15.20 8 61669 179 110527443
Dysbiosis 26.78 15.20 16 61661 2116 110525506
Influenza like illness 26.77 15.20 8 61669 88404 110439218
Splenic infarction 26.65 15.20 21 61656 4353 110523269
Frequent bowel movements 26.63 15.20 4 61673 71386 110456236
Respiratory gas exchange disorder 26.62 15.20 12 61665 886 110526736
Syncope 26.58 15.20 45 61632 202491 110325131
Muscle abscess 26.56 15.20 14 61663 1455 110526167
Cortical visual impairment 26.50 15.20 6 61671 42 110527580
Tooth deposit 26.38 15.20 9 61668 314 110527308
Drug reaction with eosinophilia and systemic symptoms 26.32 15.20 103 61574 81992 110445630
Angioedema 26.26 15.20 11 61666 98489 110429133
Urinary tract candidiasis 26.25 15.20 13 61664 1186 110526436
Nervous system disorder 26.23 15.20 56 61621 31665 110495957
Haematochezia 26.16 15.20 16 61661 115508 110412114
Heart rate increased 26.10 15.20 25 61652 143809 110383813
Transplant failure 25.93 15.20 23 61654 5612 110522010
Cystitis haemorrhagic 25.90 15.20 33 61644 12176 110515446
Ureaplasma infection 25.89 15.20 14 61663 1532 110526090
Complications of transplanted kidney 25.86 15.20 26 61651 7416 110520206
Bacterial pericarditis 25.85 15.20 7 61670 109 110527513
Cytomegalovirus enterocolitis 25.78 15.20 16 61661 2265 110525357
Infective keratitis 25.62 15.20 7 61670 113 110527509
Sinusitis fungal 25.60 15.20 17 61660 2703 110524919
Treatment failure 25.30 15.20 251 61426 276983 110250639
Haemothorax 25.24 15.20 25 61652 7006 110520616
Balance disorder 25.22 15.20 17 61660 116543 110411079
Corynebacterium infection 25.10 15.20 15 61662 1985 110525637
Cough 24.93 15.20 153 61524 461488 110066134
Cardiac arrest 24.64 15.20 191 61486 196562 110331060
Mixed liver injury 24.60 15.20 32 61645 12047 110515575
Pneumonia klebsiella 24.58 15.20 24 61653 6608 110521014
Abdominal pain 24.20 15.20 177 61500 512812 110014810
Renal injury 24.19 15.20 40 61637 18673 110508949
Blood glucose increased 24.07 15.20 23 61654 132473 110395149
Myocardial calcification 24.05 15.20 8 61669 258 110527364
Nephrolithiasis 24.05 15.20 4 61673 66208 110461414
Urinary tract infection 24.00 15.20 97 61580 326185 110201437
Neutropenic sepsis 23.97 15.20 53 61624 30693 110496929
Blastomycosis 23.94 15.20 12 61665 1123 110526499
Vision blurred 23.91 15.20 22 61655 129000 110398622
Wound infection 23.81 15.20 12 61665 96453 110431169
Escherichia sepsis 23.77 15.20 29 61648 10243 110517379
Optic discs blurred 23.76 15.20 6 61671 70 110527552
Keratitis fungal 23.69 15.20 9 61668 430 110527192
Odynophagia 23.65 15.20 34 61643 14067 110513555
CNS ventriculitis 23.46 15.20 10 61667 645 110526977
Exophthalmos 23.33 15.20 15 61662 2258 110525364
Retinitis viral 23.30 15.20 9 61668 450 110527172
Blindness unilateral 23.25 15.20 28 61649 9758 110517864
Toxic skin eruption 23.24 15.20 49 61628 27466 110500156
Hepatic enzyme increased 23.23 15.20 96 61581 320796 110206826
Intervertebral disc space narrowing 23.22 15.20 14 61663 1882 110525740
Lung transplant rejection 22.99 15.20 14 61663 1917 110525705
Granulomatous liver disease 22.84 15.20 13 61664 1571 110526051
Haemoperitoneum 22.84 15.20 21 61656 5367 110522255
Fungal disease carrier 22.69 15.20 9 61668 483 110527139
Hyperparathyroidism secondary 22.62 15.20 17 61660 3287 110524335
Infectious pleural effusion 22.58 15.20 20 61657 4871 110522751
Drug level above therapeutic 22.52 15.20 30 61647 11558 110516064
Thrombotic microangiopathy 22.44 15.20 50 61627 29099 110498523
Granuloma 22.29 15.20 27 61650 9463 110518159
Bone marrow transplant 22.27 15.20 13 61664 1647 110525975
Rhinorrhoea 22.18 15.20 15 61662 102651 110424971
Mucocutaneous leishmaniasis 22.02 15.20 9 61668 522 110527100
Blister 21.95 15.20 60 61617 227316 110300306
Phaeohyphomycosis 21.89 15.20 13 61664 1701 110525921
Citrobacter infection 21.88 15.20 12 61665 1350 110526272
Speech disorder 21.75 15.20 4 61673 61565 110466057
Dry skin 21.60 15.20 17 61660 107636 110419986
Live birth 21.57 15.20 6 61671 69478 110458144
Balamuthia infection 21.56 15.20 6 61671 104 110527518
Lymphopenia 21.52 15.20 60 61617 40110 110487512
Feeling hot 21.51 15.20 12 61665 91094 110436528
Chorioretinitis 21.45 15.20 12 61665 1403 110526219
Urge incontinence 21.45 15.20 12 61665 1403 110526219
Coagulation factor VII level decreased 21.40 15.20 7 61670 214 110527408
Intestinal infarction 21.33 15.20 12 61665 1418 110526204
Leukaemia recurrent 21.19 15.20 16 61661 3115 110524507
Human herpesvirus 6 infection reactivation 21.10 15.20 11 61666 1118 110526504
Pseudohyperphosphataemia 20.96 15.20 4 61673 10 110527612
Influenza 20.90 15.20 39 61638 169062 110358560
Electrocardiogram T wave biphasic 20.80 15.20 7 61670 234 110527388
Herpes simplex 20.78 15.20 34 61643 15730 110511892
Enamel anomaly 20.72 15.20 7 61670 237 110527385
Pulmonary necrosis 20.71 15.20 9 61668 609 110527013
Acute graft versus host disease in liver 20.42 15.20 14 61663 2345 110525277
Dyspnoea exertional 20.18 15.20 17 61660 104043 110423579
Inflammatory marker increased 20.16 15.20 32 61645 14437 110513185
Urinoma 20.15 15.20 7 61670 258 110527364
Skin lesion 20.11 15.20 69 61608 51562 110476060
Disease recurrence 20.09 15.20 77 61600 60707 110466915
Haemoptysis 20.08 15.20 86 61591 71268 110456354
Colitis ulcerative 20.05 15.20 9 61668 77354 110450268
Cardiac pacemaker evaluation 20.05 15.20 6 61671 136 110527486
Vitamin B1 decreased 20.02 15.20 10 61667 929 110526693
Cytokine release syndrome 19.99 15.20 85 61592 70221 110457401
Nail disorder 19.96 15.20 4 61673 57931 110469691
Circulatory collapse 19.95 15.20 61 61616 42932 110484690
Blood immunoglobulin G abnormal 19.92 15.20 6 61671 139 110527483
Abscess 19.90 15.20 46 61631 27423 110500199
Nail bed inflammation 19.86 15.20 13 61664 2017 110525605
Blast cell count increased 19.83 15.20 12 61665 1625 110525997
Epileptic encephalopathy 19.82 15.20 9 61668 676 110526946
Septal panniculitis 19.76 15.20 6 61671 143 110527479
Acute lymphocytic leukaemia recurrent 19.71 15.20 20 61657 5767 110521855
Burning sensation 19.66 15.20 7 61670 69205 110458417
Blood immunoglobulin M abnormal 19.57 15.20 6 61671 148 110527474
Carotid artery insufficiency 19.54 15.20 4 61673 16 110527606
Mucosal haemorrhage 19.49 15.20 15 61662 3005 110524617
Productive cough 19.45 15.20 21 61656 114284 110413338
Delivery 19.41 15.20 10 61667 991 110526631
Cerebral artery embolism 19.40 15.20 13 61664 2099 110525523
Retinal ischaemia 19.36 15.20 10 61667 997 110526625
Drug clearance decreased 19.31 15.20 17 61660 4105 110523517
Renal tubular acidosis 19.26 15.20 18 61659 4697 110522925
Candida test positive 19.22 15.20 11 61666 1344 110526278
Klebsiella sepsis 19.20 15.20 17 61660 4136 110523486
Drug therapeutic incompatibility 19.19 15.20 6 61671 158 110527464
Renal disorder 19.16 15.20 66 61611 49413 110478209
Adenovirus reactivation 19.15 15.20 9 61668 731 110526891
Myalgia 19.07 15.20 62 61615 222319 110305303
Full blood count abnormal 19.04 15.20 4 61673 56048 110471574
Necrotising colitis 18.99 15.20 12 61665 1753 110525869
Epstein-Barr virus infection 18.98 15.20 36 61641 18702 110508920
Imprisonment 18.94 15.20 9 61668 750 110526872
Pneumonia necrotising 18.93 15.20 12 61665 1763 110525859
Bulimia nervosa 18.86 15.20 7 61670 313 110527309
CARD9 deficiency 18.81 15.20 4 61673 20 110527602
Renal graft infection 18.71 15.20 9 61668 770 110526852
Troponin T increased 18.67 15.20 17 61660 4289 110523333
Lung consolidation 18.66 15.20 26 61651 10450 110517172
Cognitive disorder 18.62 15.20 13 61664 87498 110440124
Squamous cell carcinoma of skin 18.62 15.20 34 61643 17169 110510453
Unevaluable event 18.60 15.20 5 61672 59222 110468400
Bradyarrhythmia 18.56 15.20 18 61659 4916 110522706
Osteoporosis 18.47 15.20 13 61664 87139 110440483
Tachypnoea 18.38 15.20 56 61621 39339 110488283
Bladder hypertrophy 18.32 15.20 10 61667 1114 110526508
Transaminases increased 18.31 15.20 77 61600 63313 110464309
Mycobacterial infection 18.30 15.20 17 61660 4400 110523222
Night sweats 18.29 15.20 29 61648 133954 110393668
Nasal mucosal disorder 18.28 15.20 12 61665 1871 110525751
Electrocardiogram T wave amplitude decreased 18.26 15.20 9 61668 812 110526810
Accidental exposure to product 18.21 15.20 3 61674 50005 110477617
Pulmonary interstitial emphysema syndrome 18.06 15.20 8 61669 567 110527055
Pulmonary resection 18.02 15.20 6 61671 194 110527428
Maternal exposure during pregnancy 17.98 15.20 77 61600 254806 110272816
Activated partial thromboplastin time prolonged 17.93 15.20 39 61638 22329 110505293
Jaundice 17.93 15.20 73 61604 59163 110468459
Infective corneal ulcer 17.92 15.20 4 61673 26 110527596
Pulpitis dental 17.85 15.20 11 61666 1538 110526084
Throat irritation 17.83 15.20 4 61673 53548 110474074
Prescribed underdose 17.83 15.20 7 61670 65167 110462455
Renal abscess 17.81 15.20 11 61666 1545 110526077
CD4 lymphocytes increased 17.77 15.20 7 61670 369 110527253
Rhinovirus infection 17.72 15.20 27 61650 11762 110515860
Aspartate aminotransferase increased 17.72 15.20 151 61526 159785 110367837
Photosensitivity reaction 17.61 15.20 42 61635 25547 110502075
Renal tubular dysfunction 17.58 15.20 9 61668 881 110526741
Depressed mood 17.53 15.20 6 61671 60803 110466819
Cutaneous vasculitis 17.53 15.20 28 61649 12701 110514921
Tumour lysis syndrome 17.49 15.20 47 61630 30754 110496868
Hypoproteinaemia 17.49 15.20 19 61658 5926 110521696
Product administered to patient of inappropriate age 17.49 15.20 22 61655 8014 110519608
Paracoccidioides infection 17.49 15.20 5 61672 96 110527526
Kidney transplant rejection 17.38 15.20 27 61650 11960 110515662
Haemolytic anaemia 17.38 15.20 37 61640 20883 110506739
Coccidioidomycosis 17.29 15.20 11 61666 1626 110525996
Acinetobacter infection 17.27 15.20 15 61662 3558 110524064
Cataract subcapsular 17.25 15.20 10 61667 1251 110526371
Bronchostenosis 17.13 15.20 9 61668 929 110526693
Respiratory disorder 17.08 15.20 82 61595 71300 110456322
Gallbladder polyp 17.06 15.20 10 61667 1277 110526345
Haemophilus bacteraemia 16.93 15.20 6 61671 235 110527387
C-reactive protein increased 16.92 15.20 191 61486 217728 110309894
Hypercreatininaemia 16.90 15.20 10 61667 1299 110526323
Ischaemia 16.87 15.20 23 61654 9060 110518562
Blood urea increased 16.85 15.20 68 61609 54889 110472733
Orthostatic hypotension 16.71 15.20 8 61669 66241 110461381
Skin necrosis 16.67 15.20 37 61640 21475 110506147
Premature delivery 16.65 15.20 46 61631 30586 110497036
Nosocomial infection 16.63 15.20 14 61663 3185 110524437
Mycotic endophthalmitis 16.61 15.20 7 61670 439 110527183
Liver abscess 16.54 15.20 21 61656 7718 110519904
Pseudomonal bacteraemia 16.54 15.20 16 61661 4355 110523267
Bone erosion 16.40 15.20 3 61674 46368 110481254
Marrow hyperplasia 16.36 15.20 11 61666 1785 110525837
Malabsorption 16.28 15.20 19 61658 6406 110521216
Bacterial disease carrier 16.26 15.20 12 61665 2257 110525365
Soft tissue infection 16.22 15.20 17 61660 5090 110522532
Pythium insidiosum infection 16.18 15.20 3 61674 6 110527616
Benign prostatic hyperplasia 16.02 15.20 33 61644 18201 110509421
Cerebrovascular accident 15.92 15.20 50 61627 181234 110346388
Procedural pneumothorax 15.88 15.20 5 61672 135 110527487
Pseudomonas test positive 15.87 15.20 12 61665 2342 110525280
International normalised ratio increased 15.83 15.20 15 61662 86757 110440865
Hepatic cirrhosis 15.83 15.20 9 61668 67617 110460005
Traumatic haemothorax 15.81 15.20 8 61669 764 110526858
Inflammation 15.80 15.20 55 61622 193183 110334439
Enterobacter test positive 15.75 15.20 7 61670 500 110527122
Intentional product use issue 15.64 15.20 78 61599 247828 110279794
Abdominal distension 15.59 15.20 48 61629 175055 110352567
Graft complication 15.55 15.20 9 61668 1123 110526499
Underdose 15.54 15.20 8 61669 63546 110464076
Hallucination, visual 15.48 15.20 53 61624 39552 110488070
Electrocardiogram QT prolonged 15.47 15.20 109 61568 108851 110418771
Stupor 15.46 15.20 21 61656 8244 110519378
Hemianopia homonymous 15.44 15.20 10 61667 1525 110526097
Parasitic encephalitis 15.37 15.20 4 61673 53 110527569
Mean cell volume increased 15.33 15.20 21 61656 8309 110519313
Staphylococcal scalded skin syndrome 15.26 15.20 7 61670 538 110527084
Dysphonia 15.22 15.20 12 61665 75917 110451705
Endocarditis 15.20 15.20 27 61650 13344 110514278

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective 73.76 52.09 39 140 1594 112180
Hepatotoxicity 61.70 52.09 17 162 95 113679

Pharmacologic Action:

SourceCodeDescription
ATC A01AB04 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Antiinfectives and antiseptics for local oral treatment
ATC A07AA07 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
INTESTINAL ANTIINFECTIVES
Antibiotics
ATC G01AA03 GENITO URINARY SYSTEM AND SEX HORMONES
GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
Antibiotics
ATC J02AA01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIMYCOTICS FOR SYSTEMIC USE
ANTIMYCOTICS FOR SYSTEMIC USE
Antibiotics
FDA CS M0017172 Polyenes
FDA EPC N0000175498 Polyene Antifungal
FDA EPC N0000175510 Lipid-based Polyene Antifungal
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:35820 antiprotozoal drug
CHEBI has role CHEBI:70868 antileishmanial agent
CHEBI has role CHEBI:76969 bacterial metabolite
CHEBI has role CHEBI:171664 antiamoebic agent
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000935 Antifungal Agents
MeSH PA D000977 Antiparasitic Agents
MeSH PA D000981 Antiprotozoal Agents
MeSH PA D004337 Drug Carriers
MeSH PA D008081 Liposomes
MeSH PA D000563 Amebicides
MeSH PA D000900 Anti-Bacterial Agents

Related Drugs by ATC class:

A01AB Antiinfectives and antiseptics for local oral treatment 22 drugs
A07AA Antibiotics 12 drugs
G01AA Antibiotics 10 drugs
J02AA Antibiotics 1 drug

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

DiseaseRelationSNOMED_IDDOID
Trachoma indication 2576002 DOID:11265
Invasive pulmonary aspergillosis indication 3214003
Actinomycotic infection indication 11817007 DOID:8478
Histoplasmosis indication 12962009 DOID:1731
Gonorrhea indication 15628003 DOID:7551
Infection of skin AND/OR subcutaneous tissue indication 19824006
Gingivostomatitis indication 20607006
Candidiasis of the esophagus indication 20639004 DOID:13146
Acute gonococcal cervicitis indication 20943002 DOID:10615
Pulmonary cryptococcosis indication 20953001
Fungal meningitis indication 24321005 DOID:11608
Granuloma inguinale indication 28867007 DOID:9113
Acute gonococcal urethritis indication 29864006
Bronchitis indication 32398004 DOID:6132
Sinusitis indication 36971009
Cryptococcosis indication 42386007 DOID:12053
Gonorrhea of rectum indication 42746002
Candidal meningitis indication 45021001
Candidiasis of skin indication 49883006
Coccidioidomycosis indication 60826002 DOID:13450
Candidal endocarditis indication 63553008
Fungal infection of lung indication 63741006
Aspergillosis indication 65553006 DOID:13564
Urinary tract infectious disease indication 68566005
Blastomycosis indication 69996000 DOID:12663
Disseminated candidiasis indication 70572005
Yaws indication 70647001 DOID:10371
Gonorrhea of pharynx indication 74372003
Rickettsialpox indication 75096007 DOID:11103
Ornithosis indication 75116005 DOID:11262
Brucellosis indication 75702008 DOID:11077
Syphilis indication 76272004
Mucormycosis indication 76627001
Candidiasis indication 78048006 DOID:1508
Candidiasis of mouth indication 79740000 DOID:14262
Leishmaniasis indication 80612004 DOID:9065
Mycotic endocarditis indication 86348002
Acne vulgaris indication 88616000
Disseminated sporotrichosis indication 91051003
Diaper rash indication 91487003
Infectious disease of abdomen indication 128070006
Rocky Mountain spotted fever indication 186772009
Q fever indication 186788009 DOID:11100
Visceral leishmaniasis indication 186803007 DOID:9146
Lymphogranuloma venereum indication 186946009 DOID:13819
Candidal septicemia indication 187022007
Pneumonia indication 233604007 DOID:552
Inclusion conjunctivitis indication 266109000
Infective otitis media indication 312218008
Pharyngitis indication 405737000 DOID:2275
Anthrax indication 409498004 DOID:7427
Relapsing fever indication 420079008 DOID:13034
Chlamydia trachomatis infection of genital structure indication 428015005
Candidemia indication 432261003
Septicemia due to fungus indication 446903007
Fungal Urinary Tract Infection indication
Cryptococcal Septicemia indication
Candida Peritonitis indication
Refractory Aspergillosis indication
Sexually Transmitted Epididymo-Orchitis indication
Cryptococcal Meningitis in HIV indication
Rhinocerebral Phycomycosis indication
Female Urethral Syndrome indication
Rectal Chlamydia Trachomatis Infection indication
Opportunistic Fungal Infection indication
Inflammatory Disease of Female Pelvic Organs indication
Typhus Infections indication
Cryptococcal meningitis off-label use 14232007
Tularemia off-label use 19265001
Pneumonia due to Mycoplasma pneumoniae off-label use 46970008
Tropical sprue off-label use 47384003 DOID:10607
Meningoencephalitis due to Naegleria off-label use 52281009
Plague off-label use 58750007 DOID:3482
Paracoccidioidomycosis off-label use 59925007 DOID:12662
Malaria off-label use 61462000 DOID:12365
Cholangitis off-label use 82403002 DOID:9446
Chlamydial infection off-label use 105629000
Ocular rosacea off-label use 200933006
Selective decontamination of the digestive tract off-label use 235453002
Infection due to Penicillium marneffei off-label use 372936000
Rosacea off-label use 398909004 DOID:8881
Ventilator-acquired pneumonia off-label use 429271009
Helicobacter pylori-associated gastritis off-label use 708164002
Candidal Urinary Tract Infection off-label use
Oropharyngeal Candidiasis off-label use
Chloroquine Resistant Plasmodium Falciparum Malaria off-label use
Hypokalemia contraindication 43339004
Kidney disease contraindication 90708001 DOID:557
Hypomagnesemia contraindication 190855004
Disease of liver contraindication 235856003 DOID:409
Pregnancy, function contraindication 289908002
Pseudomembranous enterocolitis contraindication 397683000
Breastfeeding (mother) contraindication 413712001




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.46 acidic
pKa2 10.11 acidic
pKa3 12.11 acidic
pKa4 12.74 acidic
pKa5 13.7 acidic
pKa6 8.62 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
4017616 VUID
N0000145996 NUI
D00203 KEGG_DRUG
151803 RXNORM
C0002679 UMLSCUI
CHEBI:2682 CHEBI
4UH PDB_CHEM_ID
CHEMBL267345 ChEMBL_ID
D000666 MESH_DESCRIPTOR_UI
DB00681 DRUGBANK_ID
C068538 MESH_SUPPLEMENTAL_RECORD_UI
869 INN_ID
7XU7A7DROE UNII
5280965 PUBCHEM_CID
2715 MMSL
358341 MMSL
3777 MMSL
4190 MMSL
4193 MMSL
5754 MMSL
d00077 MMSL
d04238 MMSL
4017616 VANDF
4021053 VANDF
002887 NDDF
006390 NDDF
412088006 SNOMEDCT_US
714520003 SNOMEDCT_US
77703004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
AmBisome HUMAN PRESCRIPTION DRUG LABEL 1 0469-3051 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS NDA 20 sections
Amphotericin B HUMAN PRESCRIPTION DRUG LABEL 1 23155-594 INJECTABLE, LIPOSOMAL 50 mg INTRAVENOUS ANDA 19 sections
Amphotericin B HUMAN PRESCRIPTION DRUG LABEL 1 39822-1055 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS ANDA 24 sections
Amphotericin B Human Prescription Drug Label 1 55150-365 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS ANDA 20 sections
Amphotericin B Human Prescription Drug Label 1 62756-233 INJECTABLE, LIPOSOMAL 50 mg INTRAVENOUS ANDA 22 sections
Amphotericin B Human Prescription Drug Label 1 62756-954 INJECTABLE, LIPOSOMAL 50 mg INTRAVENOUS ANDA 22 sections
Amphotericin B liposome HUMAN PRESCRIPTION DRUG LABEL 1 67457-926 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 50 mg INTRAVENOUS ANDA 25 sections