nystatin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antibiotics, polyene derivatives 1977 1400-61-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • nystatin A1
  • nystatin
  • nystatine
Macrolide antifungal antibiotic complex produced by Streptomyces noursei, S. aureus, and other Streptomyces species. The biologically active components of the complex are nystatin A1, A2, and A3.
  • Molecular weight: 926.11
  • Formula: C47H75NO17
  • CLOGP: -3.20
  • LIPINSKI: 3
  • HAC: 18
  • HDO: 12
  • TPSA: 319.61
  • ALOGS: -4.03
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1.50 MU O
0.10 MU V

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 4 mg/mL Benet LZ, Broccatelli F, Oprea TI
BA (Bioavailability) 1 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
July 8, 1964 FDA DELCOR ASSET CORP

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 159.57 10.76 217 36386 819116 49749405
Hypomania 157.30 10.76 73 36530 4432 50564089
Jaundice cholestatic 151.51 10.76 74 36529 5037 50563484
Candida infection 131.57 10.76 120 36483 23403 50545118
Schizophrenia 131.09 10.76 76 36527 7321 50561200
Febrile neutropenia 117.27 10.76 234 36369 97433 50471088
Oral candidiasis 105.93 10.76 92 36511 16823 50551698
Pneumonia 98.90 10.76 536 36067 377865 50190656
Blood bilirubin increased 86.16 10.76 111 36492 31927 50536594
Sputum increased 77.05 10.76 34 36569 1833 50566688
Salpingo-oophorectomy unilateral 75.19 10.76 24 36579 517 50568004
Sepsis 73.24 10.76 237 36366 132688 50435833
Sinusitis fungal 71.26 10.76 29 36574 1277 50567244
Maternal exposure during pregnancy 70.08 10.76 15 36588 159763 50408758
Rheumatoid arthritis 69.12 10.76 30 36573 202520 50366001
Respiratory symptom 65.75 10.76 33 36570 2381 50566140
Synovitis 64.84 10.76 7 36596 123858 50444663
Hiatus hernia 63.09 10.76 72 36531 18272 50550249
Embolism venous 61.47 10.76 32 36571 2493 50566028
Drug intolerance 60.89 10.76 42 36561 219062 50349459
Hepatotoxicity 60.53 10.76 86 36517 27140 50541381
Pemphigus 59.92 10.76 8 36595 120158 50448363
Fungal infection 59.87 10.76 90 36513 29875 50538646
Nasal polyps 58.29 10.76 31 36572 2523 50565998
Systemic lupus erythematosus 56.22 10.76 16 36587 140606 50427915
Mucosal inflammation 55.27 10.76 102 36501 40040 50528481
Treatment failure 54.40 10.76 16 36587 137621 50430900
Psychotic disorder 51.61 10.76 71 36532 21741 50546780
Arthropathy 49.84 10.76 26 36577 157880 50410641
Obstructive airways disorder 49.75 10.76 59 36544 15593 50552928
BK virus infection 46.84 10.76 28 36575 2853 50565668
Diastolic dysfunction 46.24 10.76 35 36568 5267 50563254
Cholelithiasis 45.53 10.76 91 36512 37882 50530639
Female genital tract fistula 45.44 10.76 30 36573 3636 50564885
Pericarditis 45.13 10.76 3 36600 78686 50489835
Chronic sinusitis 43.76 10.76 36 36567 6109 50562412
Venous pressure jugular increased 43.54 10.76 16 36587 533 50567988
Abdominal discomfort 43.08 10.76 63 36540 231578 50336943
Therapeutic product effect decreased 42.05 10.76 23 36580 136027 50432494
Infusion related reaction 41.40 10.76 37 36566 169520 50399001
Discomfort 40.33 10.76 14 36589 108366 50460155
Joint swelling 38.86 10.76 74 36529 245212 50323309
Emphysema 38.80 10.76 40 36563 9053 50559468
Toxicity to various agents 38.33 10.76 59 36544 212440 50356081
Glossodynia 38.01 10.76 18 36585 115551 50452970
Toxic epidermal necrolysis 37.66 10.76 60 36543 20932 50547589
Neutropenia 37.38 10.76 208 36395 147757 50420764
Wound 37.13 10.76 15 36588 105779 50462742
Autonomic dysreflexia 35.22 10.76 12 36591 319 50568202
Parainfluenzae virus infection 35.18 10.76 20 36583 1855 50566666
Tonsillar haemorrhage 34.50 10.76 11 36592 236 50568285
Respiratory failure 34.48 10.76 144 36459 91037 50477484
Thrombocytopenia 33.26 10.76 181 36422 127492 50441029
Urinary tract infection 33.21 10.76 276 36327 223744 50344777
Polyomavirus-associated nephropathy 33.07 10.76 18 36585 1534 50566987
Exposure during pregnancy 32.53 10.76 24 36579 120991 50447530
Drug abuse 32.30 10.76 3 36600 59843 50508678
Alopecia 31.40 10.76 83 36520 244964 50323557
Rectal prolapse 31.06 10.76 18 36585 1731 50566790
Tricuspid valve incompetence 30.86 10.76 42 36561 12728 50555793
Off label use 29.78 10.76 211 36392 474215 50094306
Cellulitis 29.30 10.76 115 36488 70683 50497838
Diverticulum 28.88 10.76 37 36566 10577 50557944
Transplant rejection 28.54 10.76 35 36568 9574 50558947
Vulvovaginal candidiasis 28.54 10.76 20 36583 2672 50565849
Sepsis syndrome 27.84 10.76 13 36590 800 50567721
Kyphosis 26.57 10.76 18 36585 2277 50566244
Septic shock 26.24 10.76 96 36507 57079 50511442
Pseudomonas infection 25.86 10.76 33 36570 9397 50559124
Oedema peripheral 25.77 10.76 199 36404 157762 50410759
Oropharyngeal candidiasis 25.68 10.76 13 36590 955 50567566
Helicobacter infection 25.51 10.76 3 36600 49699 50518822
Abscess neck 24.89 10.76 11 36592 595 50567926
Skin infection 24.66 10.76 37 36566 12254 50556267
Asthma 24.17 10.76 128 36475 89209 50479312
Hysterectomy 23.86 10.76 29 36574 7861 50560660
Pulmonary embolism 23.71 10.76 140 36463 101564 50466957
Failure to thrive 23.65 10.76 26 36577 6332 50562189
Herpes simplex oesophagitis 23.27 10.76 7 36596 123 50568398
Lip swelling 22.46 10.76 53 36550 24683 50543838
Lung transplant rejection 22.39 10.76 11 36592 758 50567763
Iron deficiency anaemia 22.19 10.76 42 36561 16792 50551729
Musculoskeletal stiffness 21.90 10.76 37 36566 128444 50440077
Dyspnoea exertional 21.83 10.76 84 36519 51149 50517372
Disease recurrence 21.57 10.76 46 36557 20035 50548486
Pulmonary oedema 21.48 10.76 81 36522 48857 50519664
Wheezing 21.16 10.76 95 36508 61952 50506569
Cough 20.33 10.76 265 36338 240999 50327522
Pleural effusion 20.21 10.76 114 36489 81340 50487181
Stevens-Johnson syndrome 20.18 10.76 47 36556 21705 50546816
Blood test abnormal 19.82 10.76 32 36571 11287 50557234
Arthralgia 19.56 10.76 213 36390 438489 50130032
Diarrhoea 19.52 10.76 560 36043 587916 49980605
Sleep apnoea syndrome 19.40 10.76 49 36554 23819 50544702
Dehydration 19.04 10.76 181 36422 152268 50416253
Injection site erythema 18.70 10.76 16 36587 74920 50493601
Clostridium difficile colitis 18.32 10.76 40 36563 17702 50550819
Acute respiratory failure 18.30 10.76 54 36549 28728 50539793
Dysphagia 18.25 10.76 107 36496 77411 50491110
Atrial fibrillation 18.18 10.76 131 36472 101614 50466907
Acute kidney injury 18.17 10.76 248 36355 227810 50340711
Herpes simplex 17.98 10.76 24 36579 7138 50561383
Culture stool positive 17.69 10.76 7 36596 286 50568235
Bartonellosis 17.62 10.76 4 36599 21 50568500
Haematemesis 17.62 10.76 52 36551 27673 50540848
Pneumonitis 17.48 10.76 54 36549 29456 50539065
Intentional overdose 17.31 10.76 12 36591 62492 50506029
Deep vein thrombosis 17.14 10.76 101 36502 73203 50495318
Injection site pain 17.11 10.76 34 36569 110990 50457531
Renal artery stenosis 16.75 10.76 12 36591 1660 50566861
Tongue blistering 16.56 10.76 11 36592 1347 50567174
Otitis media 16.55 10.76 18 36585 4331 50564190
Coronavirus infection 16.48 10.76 15 36588 2914 50565607
Neuropathy peripheral 16.38 10.76 123 36480 96634 50471887
Onychalgia 16.33 10.76 9 36594 786 50567735
Neutropenic infection 16.22 10.76 10 36593 1077 50567444
Complications of transplanted kidney 16.04 10.76 13 36590 2160 50566361
Product use issue 15.98 10.76 55 36548 149420 50419101
Cytokine release syndrome 15.93 10.76 25 36578 8609 50559912
Respiratory tract infection viral 15.90 10.76 12 36591 1797 50566724
Bundle branch block left 15.83 10.76 21 36582 6209 50562312
Mouth ulceration 15.43 10.76 50 36553 27974 50540547
Conjunctivitis 15.10 10.76 35 36568 16110 50552411
Blood culture positive 14.96 10.76 17 36586 4291 50564230
Hydronephrosis 14.75 10.76 24 36579 8517 50560004
Heart transplant rejection 14.75 10.76 7 36596 447 50568074
Supraventricular tachycardia 14.53 10.76 30 36573 12771 50555750
Knee arthroplasty 14.46 10.76 4 36599 35842 50532679
Nocardiosis 14.35 10.76 11 36592 1687 50566834
Vomiting 14.29 10.76 435 36168 460323 50108198
Acute generalised exanthematous pustulosis 13.95 10.76 24 36579 8914 50559607
Nausea 13.92 10.76 633 35970 704765 49863756
Urosepsis 13.89 10.76 33 36570 15432 50553089
Eczema 13.87 10.76 42 36561 22660 50545861
Pharyngotonsillitis 13.83 10.76 5 36598 159 50568362
Tracheitis 13.74 10.76 8 36595 776 50567745
Mucosal toxicity 13.73 10.76 6 36597 316 50568205
Wrong technique in product usage process 13.67 10.76 12 36591 55498 50513023
General physical health deterioration 13.54 10.76 55 36548 142379 50426142
Fungal skin infection 13.34 10.76 15 36588 3744 50564777
Strongyloidiasis 13.07 10.76 8 36595 851 50567670
Anorexia nervosa 13.06 10.76 5 36598 187 50568334
Distal intestinal obstruction syndrome 13.01 10.76 6 36597 359 50568162
Abortion spontaneous 12.99 10.76 7 36596 41765 50526756
Suicide attempt 12.96 10.76 11 36592 51721 50516800
Oesophageal candidiasis 12.95 10.76 17 36586 4977 50563544
Hypertensive emergency 12.93 10.76 10 36593 1553 50566968
Impaired healing 12.93 10.76 19 36584 69767 50498754
Pain 12.81 10.76 320 36283 578583 49989938
Mental status changes 12.71 10.76 56 36547 36216 50532305
Pancytopenia 12.67 10.76 104 36499 83926 50484595
Osteoporosis 12.61 10.76 65 36538 44814 50523707
Ureteric obstruction 12.57 10.76 10 36593 1618 50566903
Neutropenic sepsis 12.51 10.76 30 36573 14117 50554404
Oesophagitis 12.51 10.76 29 36574 13354 50555167
Atelectasis 12.31 10.76 35 36568 18235 50550286
Breast cancer 12.19 10.76 8 36595 42882 50525639
Odynophagia 12.17 10.76 19 36584 6513 50562008
Anaemia 12.17 10.76 253 36350 252203 50316318
Radiation pneumonitis 12.06 10.76 9 36594 1326 50567195
Anaemia of malignant disease 11.91 10.76 6 36597 436 50568085
Irritable bowel syndrome 11.64 10.76 12 36591 51429 50517092
Leukopenia 11.52 10.76 86 36517 67442 50501079
Oral pain 11.45 10.76 42 36561 24991 50543530
Blood cholesterol increased 11.27 10.76 14 36589 55201 50513320
Aplastic anaemia 11.14 10.76 20 36583 7683 50560838
Overdose 11.13 10.76 36 36567 99691 50468830
Gastrointestinal stoma complication 11.07 10.76 9 36594 1501 50567020
Coma 11.02 10.76 15 36588 56864 50511657
Upper-airway cough syndrome 10.86 10.76 21 36582 8529 50559992
Swelling 10.84 10.76 93 36510 200779 50367742
Klebsiella infection 10.81 10.76 19 36584 7175 50561346
Tendon pain 10.77 10.76 12 36591 2966 50565555

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
Transplant rejection 75.94 12.08 60 22425 9152 29542890
Oral candidiasis 74.05 12.08 63 22422 10659 29541383
Pelvic mass 67.05 12.08 18 22467 194 29551848
Candida infection 64.05 12.08 68 22417 15157 29536885
Febrile neutropenia 58.57 12.08 203 22282 112037 29440005
Sepsis 54.72 12.08 234 22251 142448 29409594
Mucosal inflammation 54.33 12.08 91 22394 31504 29520538
Completed suicide 53.34 12.08 4 22481 90242 29461800
Blood electrolytes abnormal 48.26 12.08 20 22465 877 29551165
Blood urea abnormal 44.65 12.08 18 22467 735 29551307
Granulomatous dermatitis 43.08 12.08 13 22472 219 29551823
Malignant transformation 42.87 12.08 18 22467 816 29551226
Prostate cancer recurrent 41.26 12.08 18 22467 897 29551145
Toxicity to various agents 40.97 12.08 43 22442 173618 29378424
Mouth ulceration 39.62 12.08 44 22441 10311 29541731
Pyrexia 39.61 12.08 362 22123 287260 29264782
Drug ineffective 39.42 12.08 143 22342 363027 29189015
Kidney transplant rejection 38.14 12.08 36 22449 6969 29545073
Infection reactivation 35.24 12.08 17 22468 1070 29550972
Dermatophytosis 35.07 12.08 11 22474 212 29551830
Chronic papillomatous dermatitis 33.79 12.08 8 22477 49 29551993
Hydronephrosis 33.23 12.08 37 22448 8693 29543349
Aplasia 32.49 12.08 26 22459 4037 29548005
Pneumonia 32.19 12.08 378 22107 319794 29232248
Fungal skin infection 32.15 12.08 21 22464 2377 29549665
Neutropenia 31.37 12.08 189 22296 131522 29420520
Klebsiella infection 31.21 12.08 33 22452 7316 29544726
Fungal infection 29.88 12.08 44 22441 13641 29538401
Disseminated trichosporonosis 29.55 12.08 7 22478 43 29551999
Trichoglossia 28.94 12.08 8 22477 97 29551945
Trichophytosis 28.92 12.08 10 22475 264 29551778
Urinary tract infection 28.70 12.08 120 22365 72234 29479808
Cytomegalovirus infection 26.34 12.08 56 22429 23159 29528883
American trypanosomiasis 25.77 12.08 9 22476 245 29551797
Pericarditis fungal 25.61 12.08 8 22477 152 29551890
Gastritis fungal 25.31 12.08 7 22478 85 29551957
Immunosuppressant drug level increased 25.01 12.08 24 22461 4741 29547301
Human ehrlichiosis 23.74 12.08 8 22477 195 29551847
Cryptococcosis 23.53 12.08 16 22469 1936 29550106
BK virus infection 23.38 12.08 23 22462 4684 29547358
Cryptococcal meningoencephalitis 22.92 12.08 7 22478 123 29551919
Pneumonia fungal 22.88 12.08 25 22460 5752 29546290
Complications of transplanted kidney 22.83 12.08 21 22464 3933 29548109
Stomatitis 22.77 12.08 71 22414 37042 29515000
Dysphagia 21.70 12.08 91 22394 54835 29497207
Odynophagia 21.69 12.08 22 22463 4648 29547394
Cerebral haemorrhage neonatal 21.63 12.08 8 22477 258 29551784
Mucormycosis 21.62 12.08 23 22462 5135 29546907
Toxic epidermal necrolysis 20.84 12.08 44 22441 18109 29533933
Interstitial lung disease 20.65 12.08 9 22476 57709 29494333
Transposition of the great vessels 20.58 12.08 9 22476 451 29551591
IVth nerve paralysis 19.78 12.08 6 22479 103 29551939
Cutaneous mucormycosis 19.36 12.08 6 22479 111 29551931
Neutrophilic dermatosis 19.09 12.08 7 22478 220 29551822
Granuloma 18.08 12.08 15 22470 2449 29549593
Disseminated cryptococcosis 17.49 12.08 11 22474 1167 29550875
Hypervolaemia 17.28 12.08 40 22445 17505 29534537
Facial paresis 17.18 12.08 15 22470 2626 29549416
Parainfluenzae virus infection 17.15 12.08 14 22471 2235 29549807
Thrombocytopenia 17.11 12.08 167 22318 134656 29417386
Pharyngeal ulceration 16.49 12.08 7 22478 326 29551716
Overdose 16.40 12.08 22 22463 79797 29472245
Oral pain 16.24 12.08 27 22458 9280 29542762
Aspergillus infection 16.24 12.08 29 22456 10552 29541490
Hepatic function abnormal 15.93 12.08 5 22480 39254 29512788
Meningitis fungal 15.91 12.08 5 22480 97 29551945
Failure to thrive 15.76 12.08 24 22461 7660 29544382
Heart transplant 15.76 12.08 9 22476 801 29551241
Leukopenia 15.60 12.08 83 22402 55120 29496922
Rhabdomyolysis 15.53 12.08 14 22471 60794 29491248
Documented hypersensitivity to administered product 15.21 12.08 6 22479 231 29551811
Hepatic artery thrombosis 15.09 12.08 6 22479 236 29551806
Dehydration 14.98 12.08 143 22342 114605 29437437
Cytomegalovirus viraemia 14.78 12.08 21 22464 6299 29545743
Respiratory failure 14.70 12.08 125 22360 97006 29455036
Glossodynia 14.55 12.08 15 22470 3228 29548814
Postoperative wound infection 14.51 12.08 17 22468 4219 29547823
Liver transplant rejection 14.45 12.08 12 22473 1962 29550080
Meningitis cryptococcal 13.80 12.08 12 22473 2088 29549954
Lymphadenopathy 13.63 12.08 46 22439 25003 29527039
Neutrophil morphology abnormal 13.63 12.08 4 22481 61 29551981
Stevens-Johnson syndrome 13.47 12.08 35 22450 16462 29535580
Right ventricular systolic pressure increased 13.35 12.08 6 22479 321 29551721
Enterococcal infection 13.13 12.08 23 22462 8245 29543797
Graft versus host disease 13.03 12.08 25 22460 9603 29542439
Cellulitis 13.01 12.08 69 22416 45771 29506271
Coma 12.82 12.08 7 22478 39443 29512599
Blood creatinine increased 12.60 12.08 109 22376 84993 29467049
Clostridial infection 12.53 12.08 14 22471 3301 29548741
Drug intolerance 12.52 12.08 11 22474 48368 29503674
Mental status changes 12.36 12.08 56 22429 34871 29517171

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 161.17 10.72 405 48588 187252 64262487
Candida infection 159.04 10.72 155 48838 31264 64418475
Drug ineffective 139.99 10.72 267 48726 839980 63609759
Hypomania 138.16 10.72 73 48920 5581 64444158
Oral candidiasis 135.62 10.72 124 48869 23088 64426651
Pneumonia 127.97 10.72 793 48200 558783 63890956
Jaundice cholestatic 118.97 10.72 77 48916 8593 64441146
Sepsis 109.58 10.72 404 48589 229937 64219802
Schizophrenia 94.81 10.72 74 48919 11094 64438645
Mucosal inflammation 86.76 10.72 164 48829 62420 64387319
Drug abuse 83.75 10.72 4 48989 132370 64317369
Toxicity to various agents 83.36 10.72 92 48901 363421 64086318
Transplant rejection 77.30 10.72 80 48913 17321 64432418
Sinusitis fungal 71.92 10.72 32 48961 1674 64448065
Fungal infection 70.39 10.72 107 48886 34144 64415595
Sputum increased 67.04 10.72 39 48954 3596 64446143
Salpingo-oophorectomy unilateral 63.82 10.72 21 48972 475 64449264
Neutropenia 61.81 10.72 351 48642 239273 64210466
Blood bilirubin increased 61.02 10.72 135 48858 57418 64392321
BK virus infection 60.52 10.72 48 48945 7364 64442375
Drug intolerance 55.94 10.72 37 48956 187955 64261784
Rheumatoid arthritis 55.05 10.72 28 48965 164266 64285473
Toxic epidermal necrolysis 53.50 10.72 99 48894 37067 64412672
Respiratory symptom 51.71 10.72 31 48962 3022 64446717
Urinary tract infection 50.02 10.72 324 48669 231272 64218467
Synovitis 49.38 10.72 8 48985 99082 64350657
Female genital tract fistula 47.66 10.72 28 48965 2630 64447109
Therapeutic product effect decreased 46.20 10.72 15 48978 115336 64334403
Parainfluenzae virus infection 45.93 10.72 34 48959 4709 64445030
Mouth ulceration 44.92 10.72 85 48908 32359 64417380
Prostate cancer recurrent 44.84 10.72 18 48975 727 64449012
Nasal polyps 44.38 10.72 30 48963 3599 64446140
Infection reactivation 43.43 10.72 24 48969 2006 64447733
Hiatus hernia 43.36 10.72 64 48929 19893 64429846
Autonomic dysreflexia 43.33 10.72 15 48978 398 64449341
Intentional overdose 43.20 10.72 8 48985 89936 64359803
Embolism venous 42.91 10.72 29 48964 3478 64446261
Kidney transplant rejection 42.73 10.72 44 48949 9467 64440272
Neutrophilic dermatosis 42.61 10.72 16 48977 539 64449200
Pelvic mass 41.20 10.72 19 48974 1081 64448658
Cellulitis 39.29 10.72 158 48835 93499 64356240
Hydronephrosis 39.25 10.72 51 48942 14074 64435665
Klebsiella infection 38.55 10.72 49 48944 13232 64436507
Thrombocytopenia 38.31 10.72 296 48697 223505 64226234
Hepatotoxicity 38.21 10.72 90 48903 39872 64409867
Granulomatous dermatitis 37.98 10.72 13 48980 333 64449406
Dysphagia 37.71 10.72 171 48822 106641 64343098
Complications of transplanted kidney 37.67 10.72 32 48961 5403 64444336
Respiratory failure 37.57 10.72 230 48763 160953 64288786
Treatment failure 37.52 10.72 21 48972 116795 64332944
Malignant transformation 37.47 10.72 18 48975 1123 64448616
Maternal exposure during pregnancy 37.47 10.72 13 48980 95871 64353868
Arthropathy 37.08 10.72 23 48970 120944 64328795
Blood urea abnormal 36.50 10.72 18 48975 1190 64448549
Cholelithiasis 35.65 10.72 95 48898 45411 64404328
Psychotic disorder 35.40 10.72 80 48913 34498 64415241
Fungal skin infection 35.16 10.72 30 48963 5095 64444644
Blood electrolytes abnormal 35.12 10.72 20 48973 1771 64447968
Pericarditis 33.61 10.72 4 48989 62512 64387227
Odynophagia 33.56 10.72 39 48954 9602 64440137
Septic shock 32.99 10.72 163 48830 105274 64344465
Diastolic dysfunction 32.75 10.72 37 48956 8838 64440901
Stevens-Johnson syndrome 32.60 10.72 77 48916 34172 64415567
Exposure during pregnancy 31.28 10.72 10 48983 77665 64372074
Systemic lupus erythematosus 31.24 10.72 10 48983 77602 64372137
Chronic papillomatous dermatitis 31.20 10.72 8 48985 71 64449668
Obstructive airways disorder 31.18 10.72 60 48933 23125 64426614
Venous pressure jugular increased 29.99 10.72 16 48977 1247 64448492
Mucormycosis 29.50 10.72 32 48961 7309 64442430
Abdominal discomfort 29.21 10.72 59 48934 182263 64267476
Emphysema 28.97 10.72 44 48949 14025 64435714
Dermatophytosis 28.63 10.72 11 48982 395 64449344
Chronic sinusitis 28.07 10.72 29 48964 6263 64443476
Overdose 27.88 10.72 49 48944 159517 64290222
Cytomegalovirus infection 27.48 10.72 76 48917 37123 64412616
Joint swelling 27.17 10.72 79 48914 215303 64234436
Vulvovaginal candidiasis 26.99 10.72 18 48975 2112 64447627
Trichophytosis 26.85 10.72 10 48983 329 64449410
Pyrexia 26.79 10.72 583 48410 558061 63891678
Discomfort 26.75 10.72 14 48979 80864 64368875
Tricuspid valve incompetence 26.64 10.72 47 48946 16956 64432783
Polyomavirus-associated nephropathy 26.39 10.72 25 48968 4863 64444876
Immunosuppressant drug level increased 26.34 10.72 30 48963 7229 64442510
Pseudomonas infection 26.19 10.72 48 48945 17835 64431904
Leukopenia 25.85 10.72 148 48845 101094 64348645
Suicide attempt 25.47 10.72 11 48982 70996 64378743
Disseminated trichosporonosis 25.39 10.72 7 48986 84 64449655
Rectal prolapse 25.34 10.72 16 48977 1710 64448029
Aspergillus infection 25.31 10.72 45 48948 16334 64433405
Kyphosis 25.09 10.72 18 48975 2375 64447364
Infusion related reaction 24.86 10.72 55 48938 164412 64285327
Pericarditis fungal 24.82 10.72 8 48985 169 64449570
Rhabdomyolysis 24.74 10.72 20 48973 91706 64358033
Oropharyngeal candidiasis 24.67 10.72 15 48978 1500 64448239
Pemphigus 24.11 10.72 8 48985 60693 64389046
American trypanosomiasis 23.37 10.72 9 48984 325 64449414
Granuloma 23.34 10.72 27 48966 6614 64443125
Intentional product misuse 23.20 10.72 13 48980 72282 64377457
Oral pain 23.17 10.72 59 48934 27434 64422305
Off label use 23.16 10.72 340 48653 632466 63817273
Dehydration 23.07 10.72 259 48734 216504 64233235
Pulmonary embolism 23.07 10.72 190 48803 146166 64303573
Coma 22.53 10.72 20 48973 87595 64362144
Failure to thrive 22.08 10.72 33 48960 10371 64439368
Tonsillar haemorrhage 21.96 10.72 8 48985 247 64449492
Pneumonitis 21.94 10.72 86 48907 50279 64399460
Sepsis syndrome 21.67 10.72 13 48980 1268 64448471
Acanthosis 21.67 10.72 9 48984 397 64449342
Respiratory tract infection viral 21.56 10.72 17 48976 2586 64447153
Acute respiratory failure 21.54 10.72 85 48908 49849 64399890
Hepatic function abnormal 21.47 10.72 11 48982 64302 64385437
Abscess neck 21.24 10.72 12 48981 1047 64448692
Interstitial lung disease 20.98 10.72 26 48967 97706 64352033
Aplasia 20.73 10.72 26 48967 6927 64442812
Cryptococcosis 20.71 10.72 17 48976 2738 64447001
Lip swelling 20.49 10.72 62 48931 31845 64417894
Wound 20.22 10.72 17 48976 76460 64373279
Gastritis fungal 20.21 10.72 7 48986 186 64449553
Hysterectomy 20.14 10.72 22 48971 5063 64444676
Pneumonia fungal 20.05 10.72 29 48964 8848 64440891
Cytokine release syndrome 20.00 10.72 47 48946 20782 64428957
Hypervolaemia 19.72 10.72 69 48924 38216 64411523
Cryptococcal meningoencephalitis 19.57 10.72 7 48986 205 64449534
Trichoglossia 19.39 10.72 8 48985 347 64449392
Human ehrlichiosis 18.76 10.72 8 48985 377 64449362
Cutaneous mucormycosis 18.74 10.72 6 48987 124 64449615
Extravasation blood 18.69 10.72 8 48985 381 64449358
Blood creatinine increased 18.64 10.72 171 48822 135611 64314128
Injection site erythema 18.40 10.72 16 48977 70784 64378955
Cough 18.37 10.72 327 48666 301821 64147918
Herpes simplex oesophagitis 18.12 10.72 7 48986 255 64449484
Blood test abnormal 18.02 10.72 34 48959 12909 64436830
Oedema peripheral 17.91 10.72 241 48752 210076 64239663
Injection site pain 17.88 10.72 36 48957 111372 64338367
Diverticulum 17.55 10.72 34 48959 13164 64436575
Mental status changes 17.34 10.72 92 48901 61070 64388669
Pleural effusion 17.18 10.72 159 48834 126400 64323339
IVth nerve paralysis 17.16 10.72 6 48987 164 64449575
Disseminated cryptococcosis 16.92 10.72 12 48981 1555 64448184
Heart transplant 16.89 10.72 11 48982 1240 64448499
Duodenal ulcer perforation 16.79 10.72 3 48990 34622 64415117
Blood culture positive 16.76 10.72 25 48968 7843 64441896
Skin infection 16.76 10.72 36 48957 15001 64434738
Alopecia 16.65 10.72 67 48926 165623 64284116
Neutropenic sepsis 16.65 10.72 47 48946 23225 64426514
Serum sickness 16.63 10.72 16 48977 3173 64446566
Heart transplant rejection 16.61 10.72 11 48982 1276 64448463
Tracheitis 16.58 10.72 11 48982 1279 64448460
Tongue blistering 16.56 10.72 11 48982 1282 64448457
Staphylococcal infection 16.31 10.72 79 48914 50599 64399140
Haemolytic anaemia 16.27 10.72 37 48956 16016 64433723
Viral skin infection 16.26 10.72 5 48988 90 64449649
Lung transplant rejection 16.26 10.72 11 48982 1321 64448418
Pain 16.10 10.72 310 48683 553201 63896538
Bradycardia 15.91 10.72 42 48951 118177 64331562
Onychalgia 15.90 10.72 9 48984 788 64448951
Diarrhoea 15.81 10.72 685 48308 722019 63727720
General physical health deterioration 15.70 10.72 91 48902 204334 64245405
Renal artery stenosis 15.68 10.72 15 48978 2954 64446785
Pancytopenia 15.58 10.72 172 48821 143137 64306602
Stomatitis 15.53 10.72 139 48854 109466 64340273
Somnolence 15.45 10.72 91 48902 203554 64246185
Dizziness 15.39 10.72 232 48761 429931 64019808
Oesophageal oedema 15.36 10.72 4 48989 38 64449701
Aplastic anaemia 15.14 10.72 33 48960 13887 64435852
Oesophageal candidiasis 15.01 10.72 24 48969 7993 64441746
Fall 14.85 10.72 225 48768 416601 64033138
Wheezing 14.56 10.72 108 48885 80471 64369268
Colitis 14.46 10.72 85 48908 58589 64391150
Enterococcal infection 14.10 10.72 32 48961 13834 64435905
Vomiting 13.78 10.72 530 48463 550587 63899152
Therapeutic product effect incomplete 13.74 10.72 37 48956 103445 64346294
Respiratory arrest 13.73 10.72 12 48981 52973 64396766
Meningitis cryptococcal 13.66 10.72 14 48979 2995 64446744
Asthma 13.61 10.72 121 48872 95104 64354635
Musculoskeletal stiffness 13.56 10.72 48 48945 123158 64326581
Conjunctivitis 13.49 10.72 40 48953 20314 64429425
Graft versus host disease 13.08 10.72 31 48962 13782 64435957
Blood pressure systolic increased 13.06 10.72 11 48982 49442 64400297
Anorexia nervosa 13.05 10.72 5 48988 178 64449561
Sleep apnoea syndrome 13.04 10.72 51 48942 29781 64419958
Meningitis fungal 13.03 10.72 5 48988 179 64449560
Culture stool positive 13.00 10.72 7 48986 556 64449183
Pharyngeal ulceration 12.92 10.72 8 48985 826 64448913
Hypersensitivity 12.76 10.72 92 48901 196360 64253379
Arthralgia 12.75 10.72 248 48745 442012 64007727
Gastrointestinal disorder 12.74 10.72 31 48962 89678 64360061
Restrictive cardiomyopathy 12.60 10.72 8 48985 863 64448876
Neutrophil morphology abnormal 12.48 10.72 4 48989 83 64449656
Urosepsis 12.41 10.72 41 48952 22053 64427686
Ureteric obstruction 12.34 10.72 12 48981 2410 64447329
Aphthous ulcer 12.26 10.72 29 48964 12877 64436862
Wrong technique in product usage process 12.23 10.72 19 48974 64955 64384784
Atrial fibrillation 12.16 10.72 190 48803 170899 64278840
Suicidal ideation 12.01 10.72 20 48973 66522 64383217
Drug hypersensitivity 12.01 10.72 119 48874 237696 64212043
Product use issue 11.93 10.72 67 48926 151648 64298091
Altered state of consciousness 11.90 10.72 7 48986 37895 64411844
Headache 11.83 10.72 309 48684 529158 63920581
Corynebacterium infection 11.79 10.72 8 48985 965 64448774
Iron deficiency anaemia 11.75 10.72 40 48953 21849 64427890
Oral mucosal blistering 11.67 10.72 17 48976 5220 64444519
Chronic respiratory failure 11.61 10.72 12 48981 2594 64447145
Tongue ulceration 11.52 10.72 14 48979 3612 64446127
Herpes simplex 11.48 10.72 25 48968 10511 64439228
Clostridium difficile colitis 11.46 10.72 46 48947 27177 64422562
Accidental exposure to product 11.33 10.72 3 48990 26361 64423378
Lymphadenopathy 11.10 10.72 67 48926 46619 64403120
Glossitis 11.08 10.72 13 48980 3234 64446505
Fungaemia 11.04 10.72 14 48979 3771 64445968
Pharyngotonsillitis 11.03 10.72 5 48988 273 64449466
Medication error 11.03 10.72 13 48980 49953 64399786
Mucosal toxicity 11.03 10.72 6 48987 486 64449253
Skin oedema 11.02 10.72 9 48984 1439 64448300
Abscess 11.00 10.72 36 48957 19268 64430471
Coronavirus infection 10.97 10.72 17 48976 5513 64444226
Haematemesis 10.89 10.72 67 48926 46932 64402807
Loss of consciousness 10.88 10.72 67 48926 148298 64301441
Dermatitis diaper 10.83 10.72 5 48988 285 64449454
Systemic inflammatory response syndrome 10.83 10.72 24 48969 10211 64439528
Pulmonary oedema 10.75 10.72 99 48894 78575 64371164

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
Sepsis neonatal 115.50 75.80 24 38 99 84517

Pharmacologic Action:

SourceCodeDescription
ATC A07AA02 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
INTESTINAL ANTIINFECTIVES
Antibiotics
ATC D01AA01 DERMATOLOGICALS
ANTIFUNGALS FOR DERMATOLOGICAL USE
ANTIFUNGALS FOR TOPICAL USE
Antibiotics
ATC G01AA01 GENITO URINARY SYSTEM AND SEX HORMONES
GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
Antibiotics
ATC G01AA51 GENITO URINARY SYSTEM AND SEX HORMONES
GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
Antibiotics
FDA CS M0017172 Polyenes
FDA EPC N0000175498 Polyene Antifungal
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000935 Antifungal Agents
MeSH PA D007476 Ionophores
MeSH PA D049990 Membrane Transport Modulators

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Mucocutaneous candidiasis indication 29147005
Candidiasis of skin indication 49883006
Candidal vulvovaginitis indication 72605008 DOID:2272
Candidiasis of mouth indication 79740000 DOID:14262
Gastrointestinal candidiasis indication 84679006
Diaper rash off-label use 91487003
Telangiectasia disorder contraindication 247479008
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Atrophoderma contraindication 399979006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

ProductApplicantIngredients
Panolog Ointment Zoetis Inc. 4
Pharmastatin-20 Type A Medicated Article Zoetis Inc. 1
Panolog Cream Zoetis Inc. 4
DERMA-VET Ointment Med-Pharmex Inc. 4
Animax Ointment Fougera Pharmaceuticals Inc. 4
Derma 4 Ointment Zoetis Inc. 4
Derm-Otic Ointment Zoetis Inc. 4
Derma-Vet Cream Med-Pharmex Inc. 4
Animax Cream Fougera Pharmaceuticals Inc. 4

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.46 acidic
pKa2 10.11 acidic
pKa3 11.73 acidic
pKa4 12.54 acidic
pKa5 13.88 acidic
pKa6 13.96 acidic
pKa7 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
4017580 VUID
N0000145961 NUI
D00202 KEGG_DRUG
34786-70-4 SECONDARY_CAS_RN
4017580 VANDF
C0028741 UMLSCUI
CHEMBL450895 ChEMBL_ID
D009761 MESH_DESCRIPTOR_UI
DB00646 DRUGBANK_ID
539 INN_ID
BDF1O1C72E UNII
6433272 PUBCHEM_CID
7597 RXNORM
2828 MMSL
29922 MMSL
5194 MMSL
d01233 MMSL
002889 NDDF
12096000 SNOMEDCT_US
387048002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Nystatin HUMAN PRESCRIPTION DRUG LABEL 1 0093-0983 TABLET, FILM COATED 500000 [USPU] ORAL ANDA 16 sections
Nystatin HUMAN PRESCRIPTION DRUG LABEL 1 0121-0810 SUSPENSION 100000 [USPU] ORAL ANDA 19 sections
Nystatin HUMAN PRESCRIPTION DRUG LABEL 1 0121-0868 SUSPENSION 100000 [USPU] ORAL ANDA 19 sections
Nystatin HUMAN PRESCRIPTION DRUG LABEL 1 0121-4785 SUSPENSION 100000 [USPU] ORAL ANDA 19 sections
Nystatin HUMAN PRESCRIPTION DRUG LABEL 1 0121-4810 SUSPENSION 100000 [USPU] ORAL ANDA 19 sections
Nystatin HUMAN PRESCRIPTION DRUG LABEL 1 0168-0007 OINTMENT 100000 [USPU] TOPICAL ANDA 9 sections
nystatin HUMAN PRESCRIPTION DRUG LABEL 1 0168-0037 SUSPENSION 100000 [USPU] ORAL ANDA 17 sections
nystatin HUMAN PRESCRIPTION DRUG LABEL 1 0168-0054 CREAM 100000 [USPU] TOPICAL ANDA 20 sections
Nystatin and Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 2 0168-0081 CREAM 100000 [USPU] TOPICAL ANDA 16 sections
Nystatin and Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 2 0168-0089 OINTMENT 100000 [USPU] TOPICAL ANDA 19 sections
Nystatin Cream HUMAN PRESCRIPTION DRUG LABEL 1 0316-0221 CREAM 100000 [USPU] TOPICAL ANDA 18 sections
Nystatin and Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 2 0316-0223 CREAM 100000 [USPU] TOPICAL ANDA 18 sections
Nystatin and Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 2 0472-0150 CREAM 100000 [USPU] TOPICAL ANDA 11 sections
Nystatin and Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 2 0472-0150 CREAM 100000 [USPU] TOPICAL ANDA 11 sections
Nystatin and Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 2 0472-0155 OINTMENT 100000 [USPU] TOPICAL ANDA 11 sections
Nystatin and Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 2 0472-0155 OINTMENT 100000 [USPU] TOPICAL ANDA 11 sections
Nystatin HUMAN PRESCRIPTION DRUG LABEL 1 0472-0166 OINTMENT 100000 [USPU] TOPICAL ANDA 9 sections
Nystatin Oral Suspension HUMAN PRESCRIPTION DRUG LABEL 1 0527-5121 SOLUTION 100000 [USPU] ORAL ANDA 17 sections
Nystop HUMAN PRESCRIPTION DRUG LABEL 1 0574-2008 POWDER 100000 [USPU] TOPICAL ANDA 21 sections
Nystatin HUMAN PRESCRIPTION DRUG LABEL 1 0713-0678 CREAM 100000 [USPU] TOPICAL ANDA 18 sections
Nystatin HUMAN PRESCRIPTION DRUG LABEL 1 0713-0686 OINTMENT 100000 [USPU] TOPICAL ANDA 13 sections
Nyamyc HUMAN PRESCRIPTION DRUG LABEL 1 0832-0465 POWDER 100000 [USPU] TOPICAL ANDA 22 sections
Nystatin HUMAN PRESCRIPTION DRUG LABEL 1 13668-534 OINTMENT 100000 U TOPICAL ANDA 17 sections
Nystatin HUMAN PRESCRIPTION DRUG LABEL 1 13668-595 CREAM 100000 U TOPICAL ANDA 11 sections
Nystatin and Triamcinolone Acetonide HUMAN PRESCRIPTION DRUG LABEL 2 13668-610 CREAM 100000 [USPU] TOPICAL ANDA 10 sections
NYSTATIN AND TRIAMCINOLONE HUMAN PRESCRIPTION DRUG LABEL 2 16590-173 CREAM 100000 U TOPICAL ANDA 18 sections
NYSTATIN HUMAN PRESCRIPTION DRUG LABEL 1 16590-174 SUSPENSION 100000 [USPU] ORAL ANDA 19 sections
Nystatin HUMAN PRESCRIPTION DRUG LABEL 1 16714-769 POWDER 100000 [USPU] TOPICAL ANDA 22 sections
Nystatin HUMAN PRESCRIPTION DRUG LABEL 1 17856-0037 SUSPENSION 100000 [USPU] ORAL ANDA 19 sections
Nystatin HUMAN PRESCRIPTION DRUG LABEL 1 17856-0538 SUSPENSION 100000 [USPU] ORAL ANDA 19 sections