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

Stem definitionDrug idCAS RN
chimeric origin 4940 179045-86-4

Description:

MoleculeDescription

Synonyms:

  • basiliximab
  • simulect
  • chRFT5
  • SDZ-CHI-621
Basiliximab functions as an IL-2 receptor antagonist by binding with high affinity to the alpha chain of the high affinity IL-2 receptor complex and inhibiting IL-2 binding. Basiliximab is specifically targeted against IL-2Ralpha, which is selectively expressed on the surface of activated T-lymphocytes. This specific high affinity binding of basiliximab to IL-2Ralpha competitively inhibits IL-2-mediated activation of lymphocytes, a critical pathway in the cellular immune response involved in allograft rejection.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
40 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
May 12, 1998 FDA NOVARTIS
Oct. 9, 1998 EMA

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
Transplant rejection 975.52 31.86 254 14244 12504 90601445
Cytomegalovirus infection 928.66 31.86 287 14211 26315 90587634
Kidney transplant rejection 901.16 31.86 198 14300 4659 90609290
Polyomavirus-associated nephropathy 509.12 31.86 110 14388 2380 90611569
Thrombotic microangiopathy 503.46 31.86 159 14339 15584 90598365
Complications of transplanted kidney 471.39 31.86 106 14392 2772 90611177
Post transplant lymphoproliferative disorder 328.98 31.86 95 14403 6854 90607095
Cytomegalovirus viraemia 307.70 31.86 92 14406 7494 90606455
BK virus infection 255.91 31.86 71 14427 4427 90609522
Delayed graft function 247.06 31.86 55 14443 1370 90612579
Renal impairment 233.54 31.86 167 14331 105254 90508695
Multiple organ dysfunction syndrome 228.50 31.86 140 14358 68196 90545753
Aspergillus infection 194.57 31.86 71 14427 10752 90603197
Posterior reversible encephalopathy syndrome 194.55 31.86 87 14411 22252 90591697
Immunosuppressant drug level increased 190.81 31.86 57 14441 4623 90609326
Nephropathy toxic 176.49 31.86 69 14429 12619 90601330
Liver transplant rejection 174.36 31.86 43 14455 1685 90612264
Blood creatinine increased 174.20 31.86 138 14360 101248 90512701
Transplant dysfunction 171.44 31.86 54 14444 5228 90608721
Escherichia infection 154.87 31.86 67 14431 15828 90598121
Mucormycosis 153.44 31.86 46 14452 3775 90610174
Focal segmental glomerulosclerosis 151.69 31.86 39 14459 1812 90612137
Renal tubular necrosis 150.54 31.86 64 14434 14491 90599458
Renal transplant failure 149.47 31.86 35 14463 1097 90612852
Epstein-Barr virus infection 139.46 31.86 55 14443 10289 90603660
Parvovirus B19 infection 137.56 31.86 32 14466 974 90612975
Leukopenia 137.45 31.86 120 14378 100590 90513359
Fatigue 135.52 31.86 14 14484 1154009 89459940
Enterococcal infection 123.83 31.86 50 14448 9941 90604008
Herpes simplex 122.92 31.86 50 14448 10131 90603818
Cytomegalovirus infection reactivation 121.25 31.86 46 14452 7754 90606195
Hyperammonaemia 118.32 31.86 43 14455 6432 90607517
Cerebral aspergillosis 115.24 31.86 25 14473 550 90613399
Renal graft infection 113.24 31.86 23 14475 363 90613586
Transplant failure 111.61 31.86 31 14467 1938 90612011
Pseudomonas infection 107.80 31.86 51 14447 14814 90599135
Pain 107.32 31.86 16 14482 996325 89617624
Intracranial infection 106.10 31.86 20 14478 209 90613740
Haemolytic uraemic syndrome 104.96 31.86 32 14466 2779 90611170
Mycoplasma infection 104.15 31.86 25 14473 873 90613076
Disseminated aspergillosis 101.93 31.86 22 14476 472 90613477
Bronchopulmonary aspergillosis 97.96 31.86 44 14454 11354 90602595
Atypical haemolytic uraemic syndrome 96.66 31.86 24 14474 967 90612982
Biloma 93.62 31.86 16 14482 90 90613859
Anuria 92.85 31.86 46 14452 14772 90599177
Diffuse large B-cell lymphoma 92.67 31.86 39 14459 8606 90605343
Chronic allograft nephropathy 91.13 31.86 22 14476 787 90613162
Arthralgia 87.30 31.86 11 14487 778511 89835438
Kidney fibrosis 85.84 31.86 26 14472 2208 90611741
Klebsiella infection 82.96 31.86 38 14460 10259 90603690
Scedosporium infection 80.54 31.86 20 14478 806 90613143
Brain abscess 79.95 31.86 26 14472 2786 90611163
Ureaplasma infection 78.73 31.86 20 14478 885 90613064
Pathogen resistance 78.36 31.86 34 14464 8081 90605868
Human herpesvirus 8 infection 78.36 31.86 17 14481 374 90613575
Ureteric stenosis 78.35 31.86 19 14479 693 90613256
Mycotic endophthalmitis 77.44 31.86 15 14483 183 90613766
Infectious pleural effusion 76.53 31.86 23 14475 1902 90612047
Fusarium infection 75.18 31.86 20 14478 1062 90612887
Complications of transplanted lung 73.58 31.86 16 14482 356 90613593
Brain oedema 72.15 31.86 41 14457 17344 90596605
Acute respiratory distress syndrome 71.70 31.86 49 14449 28637 90585312
Cytomegalovirus colitis 71.36 31.86 25 14473 3361 90610588
Lymphocele 70.93 31.86 18 14480 793 90613156
Genital herpes simplex 70.86 31.86 16 14482 425 90613524
Pancreatitis haemorrhagic 69.79 31.86 17 14481 632 90613317
Pneumonia cytomegaloviral 69.54 31.86 24 14474 3087 90610862
Acute kidney injury 69.28 31.86 156 14342 320231 90293718
Microsporidia infection 69.10 31.86 15 14483 331 90613618
Urinary tract infection 67.40 31.86 150 14348 305482 90308467
Human herpesvirus 6 infection 67.23 31.86 24 14474 3408 90610541
Rash 67.11 31.86 22 14476 796078 89817871
Glomerulonephritis 66.84 31.86 22 14476 2448 90611501
Viraemia 66.61 31.86 20 14478 1649 90612300
Respiratory failure 66.27 31.86 88 14410 118330 90495619
Proteinuria 65.95 31.86 43 14455 23248 90590701
Graft complication 64.88 31.86 14 14484 300 90613649
Renal cell carcinoma 64.53 31.86 24 14474 3827 90610122
Periostitis 64.46 31.86 15 14483 457 90613492
Bacteraemia 62.73 31.86 41 14457 22259 90591690
Graft thrombosis 62.34 31.86 13 14485 235 90613714
Rhodococcus infection 62.29 31.86 12 14486 142 90613807
Polyomavirus viraemia 62.28 31.86 18 14480 1299 90612650
Squamous cell carcinoma 62.22 31.86 31 14467 10070 90603879
Passenger lymphocyte syndrome 60.89 31.86 11 14487 89 90613860
Reversible cerebral vasoconstriction syndrome 59.33 31.86 23 14475 4107 90609842
Fall 58.58 31.86 5 14493 481805 90132144
Headache 58.18 31.86 33 14465 862713 89751236
Hypersensitivity 57.30 31.86 4 14494 454673 90159276
Smooth muscle cell neoplasm 57.16 31.86 17 14481 1356 90612593
Herpes simplex hepatitis 55.91 31.86 14 14484 584 90613365
Dizziness 55.74 31.86 13 14485 589271 90024678
Drug resistance 55.57 31.86 43 14455 30406 90583543
Anaemia 55.35 31.86 152 14346 352650 90261299
Hepatic artery stenosis 54.70 31.86 10 14488 87 90613862
Haemolytic anaemia 52.38 31.86 29 14469 11668 90602281
Oedematous pancreatitis 52.13 31.86 14 14484 771 90613178
Infusion related reaction 51.56 31.86 4 14494 416776 90197173
Diabetic macroangiopathy 51.55 31.86 10 14488 123 90613826
Shock 51.13 31.86 40 14458 28738 90585211
Intestine transplant rejection 50.84 31.86 9 14489 64 90613885
Abdominal discomfort 50.47 31.86 8 14490 477320 90136629
Strongyloidiasis 50.41 31.86 16 14482 1586 90612363
Urine output decreased 50.36 31.86 29 14469 12574 90601375
Oedematous kidney 49.96 31.86 10 14488 146 90613803
Disseminated tuberculosis 49.63 31.86 19 14479 3280 90610669
Pneumocystis jirovecii pneumonia 49.51 31.86 35 14463 21581 90592368
Graft loss 49.24 31.86 12 14486 447 90613502
Swelling 49.19 31.86 5 14493 419053 90194896
Pruritus 49.16 31.86 13 14485 541512 90072437
End stage renal disease 48.97 31.86 25 14473 8546 90605403
Product use in unapproved indication 48.93 31.86 141 14357 336095 90277854
Epstein-Barr viraemia 47.58 31.86 15 14483 1455 90612494
Viral vasculitis 47.24 31.86 9 14489 100 90613849
Diabetes mellitus 47.17 31.86 55 14443 64820 90549129
Acid base balance abnormal 46.84 31.86 11 14487 349 90613600
Tubulointerstitial nephritis 46.71 31.86 36 14462 25307 90588642
Acute graft versus host disease 46.63 31.86 21 14477 5447 90608502
Immunosuppressant drug level decreased 46.53 31.86 14 14484 1162 90612787
Alternaria infection 46.36 31.86 11 14487 365 90613584
Mastitis bacterial 44.82 31.86 8 14490 60 90613889
Pain in extremity 44.49 31.86 9 14489 450520 90163429
Peripheral swelling 43.49 31.86 7 14491 413099 90200850
Renal amyloidosis 43.35 31.86 10 14488 293 90613656
Sinusitis 43.26 31.86 3 14495 343085 90270864
Urinary fistula 43.13 31.86 7 14491 27 90613922
Nocardiosis 43.00 31.86 16 14482 2554 90611395
Gastrointestinal mucormycosis 42.99 31.86 10 14488 304 90613645
Nasopharyngitis 42.63 31.86 7 14491 407097 90206852
Cervical dysplasia 42.57 31.86 18 14480 4016 90609933
Ascites 42.50 31.86 45 14453 47695 90566254
JC virus infection 42.13 31.86 16 14482 2703 90611246
Pericarditis constrictive 41.66 31.86 11 14487 567 90613382
Dyspnoea 41.53 31.86 48 14450 880907 89733042
Transient acantholytic dermatosis 41.35 31.86 8 14490 97 90613852
Drug hypersensitivity 40.44 31.86 12 14486 463597 90150352
Pneumonia necrotising 40.43 31.86 11 14487 636 90613313
Complications of transplanted liver 40.31 31.86 10 14488 401 90613548
Incision site pain 40.23 31.86 13 14485 1365 90612584
Thrombocytopenia 39.98 31.86 97 14401 208628 90405321
Varicella zoster virus infection 39.92 31.86 17 14481 3860 90610089
Ureteral necrosis 39.27 31.86 7 14491 52 90613897
Hypoaesthesia 38.89 31.86 3 14495 314207 90299742
Septic shock 38.79 31.86 57 14441 84103 90529846
Urticaria 38.66 31.86 3 14495 312731 90301218
Distributive shock 38.55 31.86 16 14482 3408 90610541
Pancytopenia 38.45 31.86 69 14429 120194 90493755
Central nervous system viral infection 37.84 31.86 8 14490 155 90613794
Bladder hypertrophy 37.70 31.86 10 14488 525 90613424
Ventricular remodelling 37.42 31.86 6 14492 21 90613928
Malacoplakia 37.25 31.86 9 14489 323 90613626
Imprisonment 36.98 31.86 9 14489 333 90613616
Hepatitis C 36.73 31.86 18 14480 5642 90608307
Oliguria 36.05 31.86 22 14476 10602 90603347
Sepsis 35.97 31.86 85 14413 179729 90434220
Infection reactivation 35.87 31.86 13 14485 1927 90612022
Extremity necrosis 35.76 31.86 13 14485 1944 90612005
Gastrointestinal viral infection 35.73 31.86 12 14486 1421 90612528
Nausea 34.95 31.86 79 14419 1110237 89503712
Infective aneurysm 34.77 31.86 9 14489 429 90613520
Cytomegalovirus test positive 34.52 31.86 15 14483 3576 90610373
Hepatitis B 34.28 31.86 16 14482 4503 90609446
Depression 34.21 31.86 4 14494 300597 90313352
Hyperuricaemia 33.81 31.86 18 14480 6701 90607248
Encephalitis Japanese B 33.61 31.86 6 14492 45 90613904
Lung infiltration 33.28 31.86 24 14474 15258 90598691
Drug intolerance 33.27 31.86 15 14483 447576 90166373
Graft versus host disease 33.23 31.86 19 14479 8125 90605824
Heart transplant rejection 33.19 31.86 10 14488 834 90613115
Shock haemorrhagic 33.18 31.86 22 14476 12223 90601726
Toxoplasmosis 33.15 31.86 12 14486 1773 90612176
Red blood cells urine positive 32.74 31.86 14 14484 3211 90610738
Fluorosis 32.48 31.86 7 14491 149 90613800
Haemolysis 32.46 31.86 19 14479 8491 90605458
IgA nephropathy 32.41 31.86 10 14488 903 90613046
Chest pain 32.35 31.86 6 14492 319639 90294310
Renal tubular atrophy 32.13 31.86 10 14488 930 90613019
Malaise 32.06 31.86 28 14470 585958 90027991
Disseminated intravascular coagulation 32.05 31.86 27 14471 21511 90592438
Cerebral toxoplasmosis 32.03 31.86 11 14487 1394 90612555
Pantoea agglomerans infection 31.98 31.86 6 14492 61 90613888
Candida infection 31.92 31.86 33 14465 34024 90579925

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
Kidney transplant rejection 1025.74 19.76 321 23939 8362 42588713
Transplant rejection 986.81 19.76 348 23912 13240 42583835
Cytomegalovirus infection 822.48 19.76 390 23870 31916 42565159
Polyomavirus-associated nephropathy 647.90 19.76 204 24056 5411 42591664
Complications of transplanted kidney 553.90 19.76 179 24081 5171 42591904
Delayed graft function 317.48 19.76 99 24161 2536 42594539
Thrombotic microangiopathy 314.24 19.76 158 24102 14624 42582451
BK virus infection 298.88 19.76 130 24130 8654 42588421
Multiple organ dysfunction syndrome 286.56 19.76 313 23947 96722 42500353
Cytomegalovirus viraemia 275.02 19.76 129 24131 10248 42586827
Strongyloidiasis 237.83 19.76 85 24175 3346 42593729
Mucormycosis 237.42 19.76 104 24156 7039 42590036
Aspergillus infection 231.61 19.76 132 24128 15705 42581370
Post transplant lymphoproliferative disorder 225.21 19.76 108 24152 9012 42588063
Renal tubular necrosis 223.79 19.76 136 24124 18218 42578857
Parvovirus B19 infection 220.90 19.76 68 24192 1666 42595409
Graft versus host disease 200.54 19.76 112 24148 12813 42584262
Transplant dysfunction 195.25 19.76 73 24187 3270 42593805
Chronic allograft nephropathy 192.33 19.76 60 24200 1538 42595537
Focal segmental glomerulosclerosis 187.52 19.76 66 24194 2482 42594593
Epstein-Barr virus infection 186.54 19.76 97 24163 9621 42587454
Bronchopulmonary aspergillosis 170.29 19.76 117 24143 19312 42577763
Blood creatinine increased 153.92 19.76 246 24014 109757 42487318
Immunosuppressant drug level increased 145.03 19.76 76 24184 7655 42589420
Nephropathy toxic 144.26 19.76 100 24160 16738 42580337
Fatigue 141.50 19.76 37 24223 435604 42161471
Tubulointerstitial nephritis 139.64 19.76 127 24133 31421 42565654
Incision site pain 135.11 19.76 48 24212 1855 42595220
Renal transplant failure 134.16 19.76 45 24215 1460 42595615
Death 127.00 19.76 55 24205 471130 42125945
Polyomavirus viraemia 126.55 19.76 47 24213 2065 42595010
Liver transplant rejection 122.11 19.76 48 24212 2465 42594610
Fall 115.80 19.76 4 24256 234516 42362559
Kidney fibrosis 114.97 19.76 47 24213 2675 42594400
Enterococcal infection 111.41 19.76 75 24185 11964 42585111
Human herpesvirus 8 infection 111.00 19.76 39 24221 1458 42595617
Dizziness 108.42 19.76 9 24251 249245 42347830
Renal tubular atrophy 104.43 19.76 37 24223 1418 42595657
Cytomegalovirus colitis 103.93 19.76 49 24211 3932 42593143
Complications of transplanted lung 101.85 19.76 26 24234 311 42596764
Pseudomonas infection 101.22 19.76 79 24181 15844 42581231
Renal impairment 100.88 19.76 205 24055 110023 42487052
Nausea 99.60 19.76 51 24209 396748 42200327
Haemophagocytic lymphohistiocytosis 98.02 19.76 82 24178 18140 42578935
Viraemia 97.36 19.76 37 24223 1733 42595342
Pneumocystis jirovecii pneumonia 97.25 19.76 94 24166 25087 42571988
Leukopenia 96.10 19.76 161 24099 74585 42522490
Adenovirus infection 94.82 19.76 55 24205 6754 42590321
Lymphocyte count decreased 94.81 19.76 97 24163 27712 42569363
Ureaplasma infection 94.13 19.76 28 24232 608 42596467
Dyspnoea 89.18 19.76 73 24187 442548 42154527
Hydronephrosis 89.00 19.76 65 24195 11800 42585275
Malacoplakia 87.83 19.76 29 24231 895 42596180
Asthenia 85.18 19.76 27 24233 280766 42316309
Ureteric stenosis 82.88 19.76 30 24230 1224 42595851
JC virus infection 81.58 19.76 38 24222 2966 42594109
Ventricular remodelling 79.95 19.76 17 24243 83 42596992
Rash 79.89 19.76 29 24231 276925 42320150
Septic shock 79.72 19.76 167 24093 91505 42505570
Cytomegalovirus test positive 79.69 19.76 42 24218 4277 42592798
Transplant failure 79.41 19.76 41 24219 4003 42593072
Pneumonia cytomegaloviral 78.63 19.76 41 24219 4085 42592990
Candida infection 76.62 19.76 77 24183 21533 42575542
Pruritus 76.33 19.76 9 24251 188762 42408313
Pain 75.21 19.76 23 24237 244825 42352250
Drug resistance 75.07 19.76 95 24165 34153 42562922
Lymphocele 73.24 19.76 29 24231 1518 42595557
Scedosporium infection 73.04 19.76 29 24231 1529 42595546
Product dose omission issue 71.65 19.76 4 24256 154361 42442714
Stenotrophomonas infection 71.14 19.76 37 24223 3667 42593408
Neutrophil count increased 71.01 19.76 71 24189 19733 42577342
Red blood cells urine positive 70.63 19.76 30 24230 1880 42595195
Cryptococcosis 70.18 19.76 35 24225 3176 42593899
Human ehrlichiosis 69.29 19.76 21 24239 487 42596588
Klebsiella infection 67.24 19.76 54 24206 11278 42585797
Abdominal wall abscess 67.09 19.76 22 24238 664 42596411
Cytomegalovirus infection reactivation 65.76 19.76 53 24207 11125 42585950
Glomerulosclerosis 65.68 19.76 23 24237 851 42596224
Graft versus host disease in gastrointestinal tract 62.37 19.76 38 24222 5105 42591970
Respiratory failure 62.28 19.76 187 24073 127945 42469130
Hepatitis E 62.19 19.76 32 24228 3102 42593973
Graft loss 60.89 19.76 22 24238 893 42596182
Mycobacterium haemophilum infection 58.73 19.76 18 24242 434 42596641
Cutaneous mucormycosis 56.36 19.76 19 24241 626 42596449
Febrile neutropenia 56.00 19.76 18 24242 185685 42411390
Protein urine present 55.73 19.76 37 24223 5764 42591311
Product use in unapproved indication 55.68 19.76 230 24030 184226 42412849
Disseminated intravascular coagulation 54.68 19.76 69 24191 24725 42572350
Hyperammonaemia 54.30 19.76 41 24219 7825 42589250
Renal tubular injury 53.00 19.76 24 24236 1755 42595320
Pulmonary nocardiosis 52.57 19.76 24 24236 1788 42595287
Systemic mycosis 52.11 19.76 26 24234 2361 42594714
Renal arteriosclerosis 52.02 19.76 15 24245 291 42596784
Disseminated mucormycosis 51.94 19.76 22 24238 1369 42595706
Arthralgia 51.93 19.76 26 24234 205212 42391863
Posterior reversible encephalopathy syndrome 51.64 19.76 49 24211 12772 42584303
Sphincter of Oddi dysfunction 51.37 19.76 14 24246 219 42596856
Blood urea increased 50.85 19.76 77 24183 32716 42564359
Herpes simplex hepatitis 50.73 19.76 13 24247 158 42596917
Skin necrosis 50.57 19.76 36 24224 6278 42590797
Epstein-Barr viraemia 50.17 19.76 25 24235 2264 42594811
Acute respiratory distress syndrome 49.99 19.76 73 24187 30035 42567040
Arteritis infective 49.83 19.76 11 24249 66 42597009
Acute graft versus host disease in skin 49.71 19.76 38 24222 7386 42589689
Enterobacter infection 46.49 19.76 26 24234 2978 42594097
Sepsis 45.56 19.76 229 24031 199105 42397970
Fungaemia 45.44 19.76 26 24234 3110 42593965
Parvovirus B19 infection reactivation 45.30 19.76 9 24251 29 42597046
Headache 45.01 19.76 42 24218 239327 42357748
Graft versus host disease in skin 44.73 19.76 31 24229 5181 42591894
Glomerulonephritis 44.65 19.76 24 24236 2542 42594533
Insomnia 44.54 19.76 7 24253 118246 42478829
Proteinuria 44.51 19.76 60 24200 22923 42574152
Malignant neoplasm progression 44.20 19.76 5 24255 108395 42488680
Renal artery stenosis 44.08 19.76 23 24237 2294 42594781
Renal tubular disorder 44.02 19.76 30 24230 4879 42592196
Renal adenoma 43.99 19.76 9 24251 35 42597040
Mediastinitis 43.98 19.76 18 24242 1027 42596048
Lung transplant rejection 43.95 19.76 18 24242 1029 42596046
Hepatitis C 43.26 19.76 40 24220 10093 42586982
Schistosomiasis 43.21 19.76 9 24251 39 42597036
Gastrointestinal stromal tumour 42.50 19.76 18 24242 1120 42595955
Renal haemorrhage 42.48 19.76 20 24240 1599 42595476
Back pain 42.27 19.76 14 24246 141762 42455313
Gait disturbance 41.30 19.76 4 24256 97996 42499079
Depression 41.03 19.76 7 24253 111356 42485719
Urine output decreased 40.86 19.76 40 24220 10833 42586242
Immunosuppressant drug level decreased 40.21 19.76 20 24240 1804 42595271
Inappropriate schedule of product administration 40.19 19.76 4 24256 95898 42501177
Cerebral ventricle collapse 38.84 19.76 10 24250 124 42596951
Somnolence 38.59 19.76 16 24244 141089 42455986
Wound dehiscence 38.36 19.76 25 24235 3775 42593300
Oliguria 38.28 19.76 36 24224 9277 42587798
Aplasia pure red cell 38.01 19.76 32 24228 7134 42589941
Constipation 37.50 19.76 23 24237 162268 42434807
Hyperhidrosis 37.34 19.76 4 24256 90508 42506567
Nephrosclerosis 37.24 19.76 16 24244 1031 42596044
Intestine transplant rejection 37.14 19.76 8 24252 42 42597033
Tongue necrosis 37.14 19.76 8 24252 42 42597033
Infective aneurysm 37.07 19.76 16 24244 1043 42596032
Nephropathy 36.95 19.76 31 24229 6880 42590195
Vomiting 36.86 19.76 68 24192 289655 42307420
Tooth hypoplasia 36.54 19.76 11 24249 249 42596826
Small intestinal perforation 36.35 19.76 22 24238 2919 42594156
Renal-limited thrombotic microangiopathy 35.98 19.76 11 24249 263 42596812
Fungal infection 35.95 19.76 50 24210 19672 42577403
Microsporidia infection 35.77 19.76 16 24244 1136 42595939
Argentine haemorrhagic fever 35.61 19.76 7 24253 21 42597054
Pain in extremity 35.27 19.76 21 24239 150583 42446492
Cardiac failure congestive 34.77 19.76 4 24256 85598 42511477
Disseminated tuberculosis 34.58 19.76 21 24239 2803 42594272
Heart transplant rejection 34.35 19.76 17 24243 1517 42595558
Urinary fistula 34.28 19.76 9 24251 121 42596954
Hypocomplementaemia 34.13 19.76 8 24252 65 42597010
Weight decreased 34.02 19.76 41 24219 207907 42389168
Myocardial infarction 34.00 19.76 14 24246 123995 42473080
Escherichia infection 33.93 19.76 37 24223 11359 42585716
Nocardiosis 33.51 19.76 26 24234 5164 42591911
Renal vein thrombosis 33.38 19.76 12 24248 480 42596595
Condition aggravated 33.34 19.76 61 24199 260693 42336382
Chest pain 33.32 19.76 19 24241 139511 42457564
Cholangitis infective 33.26 19.76 11 24249 341 42596734
Enamel anomaly 33.03 19.76 10 24250 231 42596844
Drug hypersensitivity 32.97 19.76 8 24252 99381 42497694
Acute graft versus host disease in intestine 32.73 19.76 23 24237 3928 42593147
Cough 32.58 19.76 32 24228 178071 42419004
Graft complication 32.25 19.76 13 24247 713 42596362
Herpes simplex 32.22 19.76 29 24231 7066 42590009
Pulmonary mucormycosis 32.21 19.76 16 24244 1439 42595636
Renal graft infection 32.16 19.76 11 24249 379 42596696
Trichosporon infection 32.07 19.76 14 24246 938 42596137
Cerebral aspergillosis 31.99 19.76 17 24243 1760 42595315
Bacterial infection 31.79 19.76 57 24203 27822 42569253
Hepatitis A 31.70 19.76 12 24248 556 42596519
Donor specific antibody present 31.58 19.76 9 24251 167 42596908
Acinetobacter infection 31.44 19.76 16 24244 1515 42595560
Fungal skin infection 31.35 19.76 21 24239 3320 42593755
Pancytopenia 31.01 19.76 141 24119 117602 42479473
Enterovirus infection 30.96 19.76 15 24245 1278 42595797
Paraesthesia 30.94 19.76 3 24257 73456 42523619
Systemic candida 30.82 19.76 25 24235 5294 42591781
Cytomegalovirus gastritis 30.74 19.76 10 24250 294 42596781
Malaise 30.48 19.76 46 24214 212110 42384965
Disease recurrence 30.47 19.76 58 24202 29620 42567455
Peripheral swelling 30.47 19.76 7 24253 90263 42506812
Complications of transplanted liver 30.36 19.76 10 24250 306 42596769
Pancreas transplant rejection 29.81 19.76 9 24251 206 42596869
Myalgia 29.49 19.76 9 24251 96071 42501004
Restrictive allograft syndrome 29.39 19.76 6 24254 23 42597052
Rhodococcus infection 29.36 19.76 10 24250 340 42596735
Syncope 29.30 19.76 10 24250 99396 42497679
Haemolytic uraemic syndrome 29.25 19.76 18 24242 2461 42594614
American trypanosomiasis 29.19 19.76 10 24250 346 42596729
Pyelonephritis acute 29.11 19.76 18 24242 2482 42594593
Procedural pain 29.00 19.76 25 24235 5754 42591321
Pneumonia cryptococcal 28.77 19.76 15 24245 1493 42595582
Erythema 28.68 19.76 13 24247 108780 42488295
Infection reactivation 28.64 19.76 17 24243 2177 42594898
Adenoviral haemorrhagic cystitis 28.60 19.76 11 24249 532 42596543
Diffuse alveolar damage 28.51 19.76 18 24242 2574 42594501
Progressive multifocal leukoencephalopathy 28.49 19.76 34 24226 11502 42585573
Right ventricular diastolic collapse 28.47 19.76 7 24253 71 42597004
Ureteritis 28.30 19.76 8 24252 144 42596931
Disseminated blastomycosis 28.10 19.76 10 24250 388 42596687
Joint swelling 28.07 19.76 3 24257 68019 42529056
Locked-in syndrome 27.88 19.76 10 24250 397 42596678
Off label use 27.76 19.76 513 23747 637822 41959253
Urinary tract infection 27.72 19.76 121 24139 99163 42497912
Decreased appetite 27.62 19.76 42 24218 193095 42403980
Anal squamous cell carcinoma 27.46 19.76 8 24252 161 42596914
Respiratory tract infection fungal 27.45 19.76 12 24248 807 42596268
Herpes simplex pneumonia 27.40 19.76 9 24251 273 42596802
Graft thrombosis 27.09 19.76 9 24251 283 42596792
Cytomegalovirus enterocolitis 27.09 19.76 14 24246 1369 42595706
Lymphopenia 27.07 19.76 46 24214 21517 42575558
Hyperuricaemia 27.02 19.76 30 24230 9394 42587681
Anuria 26.87 19.76 33 24227 11499 42585576
Mycoplasma infection 26.77 19.76 11 24249 634 42596441
Passenger lymphocyte syndrome 26.74 19.76 7 24253 93 42596982
Diabetes mellitus 26.64 19.76 85 24175 60002 42537073
Cerebrovascular accident 26.58 19.76 11 24249 97149 42499926
Confusional state 26.40 19.76 34 24226 167563 42429512
Escherichia urinary tract infection 26.32 19.76 21 24239 4342 42592733
Sinusitis aspergillus 25.96 19.76 7 24253 105 42596970
Drug ineffective for unapproved indication 25.89 19.76 71 24189 46092 42550983
Dysphagia 25.85 19.76 5 24255 72714 42524361
Gastroenteritis Escherichia coli 25.73 19.76 12 24248 939 42596136
Renal artery thrombosis 25.50 19.76 9 24251 341 42596734
Weight increased 25.35 19.76 15 24245 107968 42489107
Acute graft versus host disease 25.03 19.76 27 24233 8188 42588887
Haemothorax 24.97 19.76 22 24238 5214 42591861
Disease progression 24.91 19.76 27 24233 143629 42453446
IgA nephropathy 24.90 19.76 16 24244 2358 42594717
Glomerulonephropathy 24.73 19.76 8 24252 231 42596844
Neutropenia 24.71 19.76 196 24064 199235 42397840
Viral test positive 24.60 19.76 8 24252 235 42596840
Diffuse mesangial sclerosis 24.57 19.76 6 24254 59 42597016
Urinary tract infection enterococcal 24.52 19.76 12 24248 1045 42596030
Rhabdomyolysis 24.51 19.76 7 24253 78012 42519063
Urticaria 24.47 19.76 6 24254 74030 42523045
Hepatitis cholestatic 24.34 19.76 29 24231 9795 42587280
Neurosyphilis 24.21 19.76 6 24254 63 42597012
Intra-abdominal haemorrhage 24.15 19.76 17 24243 2911 42594164
Pyelonephritis 24.09 19.76 26 24234 7888 42589187
Human herpesvirus 6 infection 24 19.76 16 24244 2509 42594566
Post procedural urine leak 23.98 19.76 7 24253 142 42596933
Pathogen resistance 23.88 19.76 31 24229 11419 42585656
Urinoma 23.83 19.76 8 24252 260 42596815
Optic discs blurred 23.80 19.76 6 24254 68 42597007
Cervical spinal cord paralysis 23.76 19.76 5 24255 23 42597052
Erosive duodenitis 23.72 19.76 14 24246 1775 42595300
Hypersensitivity 23.66 19.76 6 24254 72364 42524711
Abscess rupture 23.64 19.76 6 24254 70 42597005
Giant cell myocarditis 23.58 19.76 5 24255 24 42597051
Corynebacterium infection 23.45 19.76 11 24249 872 42596203
Central nervous system infection 23.32 19.76 11 24249 883 42596192
Hypoaesthesia 23.22 19.76 6 24254 71457 42525618
Pneumonia bacterial 23.13 19.76 36 24224 15656 42581419
Lymphorrhoea 23.04 19.76 6 24254 78 42596997
Therapeutic product effect incomplete 22.96 19.76 6 24254 70933 42526142
Blood pressure increased 22.77 19.76 15 24245 101913 42495162
Asthma 22.76 19.76 4 24256 62310 42534765
Optic perineuritis 22.65 19.76 5 24255 30 42597045
Neuroendocrine carcinoma of the skin 22.61 19.76 11 24249 946 42596129
Hallucination 22.58 19.76 3 24257 57504 42539571
Retinitis 22.49 19.76 9 24251 484 42596591
General physical health deterioration 22.48 19.76 32 24228 151214 42445861
Hyperplasia 22.48 19.76 10 24250 701 42596374
Keratouveitis 22.37 19.76 5 24255 32 42597043
B-cell lymphoma 22.15 19.76 20 24240 4893 42592182
Cytomegalovirus gastroenteritis 22.13 19.76 8 24252 325 42596750
Bacterial pyelonephritis 22.04 19.76 8 24252 329 42596746
Bone marrow failure 21.73 19.76 54 24206 33039 42564036
Cryptosporidiosis infection 21.51 19.76 10 24250 777 42596298
Transitional cell carcinoma metastatic 21.49 19.76 6 24254 103 42596972
Abdominal discomfort 21.44 19.76 8 24252 75247 42521828
Splenic infection fungal 21.39 19.76 6 24254 105 42596970
Meningioma malignant 21.29 19.76 5 24255 41 42597034
Wheezing 21.17 19.76 3 24257 54778 42542297
White blood cell count increased 21.10 19.76 65 24195 45022 42552053
Squamous cell carcinoma 20.85 19.76 31 24229 12951 42584124
Orchitis 20.76 19.76 14 24246 2237 42594838
Splenic necrosis 20.68 19.76 6 24254 119 42596956
Gonococcal infection 20.68 19.76 5 24255 47 42597028
Pelvic fluid collection 20.55 19.76 7 24253 238 42596837
Tuberculosis 20.53 19.76 27 24233 10072 42587003
Cystitis haemorrhagic 20.44 19.76 23 24237 7306 42589769
Hyperglycaemia 20.44 19.76 65 24195 45794 42551281
Meningitis cryptococcal 20.23 19.76 16 24244 3267 42593808
Haemodynamic instability 20.19 19.76 30 24230 12527 42584548
Renal haematoma 20.04 19.76 9 24251 645 42596430
Pseudomonal bacteraemia 19.97 19.76 14 24246 2382 42594693
Pneumocystis jirovecii infection 19.94 19.76 15 24245 2845 42594230
Bradycardia 19.89 19.76 12 24248 85472 42511603
Endocarditis bacterial 19.81 19.76 11 24249 1242 42595833
Hepatic artery thrombosis 19.79 19.76 7 24253 267 42596808
Drug level fluctuating 19.78 19.76 9 24251 665 42596410
Agitation 19.78 19.76 6 24254 64308 42532767
Lymphocytic infiltration 19.76 19.76 10 24250 936 42596139

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
Transplant rejection 1886.14 23.31 576 36310 23991 110528422
Kidney transplant rejection 1701.20 23.31 454 36432 11533 110540880
Cytomegalovirus infection 1681.21 23.31 645 36241 53799 110498614
Polyomavirus-associated nephropathy 1146.21 23.31 307 36579 7894 110544519
Complications of transplanted kidney 934.18 23.31 256 36630 7186 110545227
Thrombotic microangiopathy 739.67 23.31 300 36586 28849 110523564
Delayed graft function 583.54 23.31 157 36729 4100 110548313
BK virus infection 558.08 23.31 197 36689 12909 110539504
Multiple organ dysfunction syndrome 531.96 23.31 425 36461 151285 110401128
Cytomegalovirus viraemia 527.95 23.31 205 36681 17559 110534854
Post transplant lymphoproliferative disorder 495.49 23.31 189 36697 15424 110536989
Aspergillus infection 445.99 23.31 202 36684 25414 110526999
Mucormycosis 430.66 23.31 154 36732 10474 110541939
Parvovirus B19 infection 360.95 23.31 99 36787 2782 110549631
Renal tubular necrosis 353.65 23.31 182 36704 30293 110522120
Focal segmental glomerulosclerosis 338.23 23.31 102 36784 4043 110548370
Immunosuppressant drug level increased 336.66 23.31 132 36754 11592 110540821
Strongyloidiasis 319.67 23.31 102 36784 4884 110547529
Renal impairment 318.42 23.31 352 36534 188093 110364320
Transplant dysfunction 316.13 23.31 115 36771 8213 110544200
Epstein-Barr virus infection 311.13 23.31 143 36743 18595 110533818
Blood creatinine increased 294.19 23.31 333 36553 182556 110369857
Nephropathy toxic 292.80 23.31 155 36731 27323 110525090
Bronchopulmonary aspergillosis 267.03 23.31 150 36736 29713 110522700
Chronic allograft nephropathy 266.08 23.31 73 36813 2053 110550360
Fatigue 263.41 23.31 45 36841 1215913 109336500
Renal transplant failure 249.36 23.31 73 36813 2607 110549806
Graft versus host disease 246.53 23.31 122 36764 18684 110533729
Liver transplant rejection 234.18 23.31 76 36810 3842 110548571
Leukopenia 232.55 23.31 267 36619 148524 110403889
Enterococcal infection 228.69 23.31 119 36767 20247 110532166
Polyomavirus viraemia 210.13 23.31 68 36818 3406 110549007
Pseudomonas infection 209.39 23.31 125 36761 27728 110524685
Posterior reversible encephalopathy syndrome 208.96 23.31 134 36752 33727 110518686
Pain 205.12 23.31 36 36850 954919 109597494
Cytomegalovirus infection reactivation 194.12 23.31 103 36783 18230 110534183
Tubulointerstitial nephritis 194.03 23.31 154 36732 54130 110498283
Incision site pain 184.08 23.31 60 36826 3075 110549338
Fall 178.33 23.31 5 36881 603477 109948936
Cytomegalovirus colitis 176.67 23.31 72 36814 6989 110545424
Ureaplasma infection 170.16 23.31 48 36838 1498 110550915
Kidney fibrosis 167.99 23.31 61 36825 4331 110548082
Complications of transplanted lung 166.17 23.31 40 36846 657 110551756
Arthralgia 163.82 23.31 31 36855 779601 109772812
Hyperammonaemia 162.12 23.31 83 36803 13649 110538764
Dizziness 161.96 23.31 21 36865 698172 109854241
Escherichia infection 161.34 23.31 100 36786 23716 110528697
Transplant failure 160.19 23.31 63 36823 5572 110546841
Drug resistance 158.06 23.31 139 36747 56235 110496178
Nausea 156.78 23.31 111 36775 1235579 109316834
Human herpesvirus 8 infection 156.77 23.31 47 36839 1824 110550589
Klebsiella infection 153.52 23.31 91 36795 19918 110532495
Viraemia 153.27 23.31 56 36830 4046 110548367
Scedosporium infection 152.28 23.31 49 36837 2409 110550004
Rash 151.95 23.31 43 36843 820921 109731492
Pneumocystis jirovecii pneumonia 145.81 23.31 118 36768 42617 110509796
Hydronephrosis 143.11 23.31 88 36798 20577 110531836
Respiratory failure 142.93 23.31 257 36629 215075 110337338
Ureteric stenosis 141.99 23.31 42 36844 1555 110550858
Lymphocele 139.66 23.31 43 36843 1828 110550585
Pruritus 133.60 23.31 18 36868 581542 109970871
Joint swelling 133.30 23.31 3 36883 442842 110109571
Pneumonia cytomegaloviral 131.07 23.31 58 36828 6896 110545517
Septic shock 131.06 23.31 208 36678 157320 110395093
Malacoplakia 129.35 23.31 37 36849 1215 110551198
JC virus infection 129.13 23.31 53 36833 5237 110547176
Lymphocyte count decreased 127.24 23.31 124 36762 57119 110495294
Renal graft infection 127.13 23.31 33 36853 746 110551667
Herpes simplex 127.00 23.31 74 36812 15690 110536723
Cerebral aspergillosis 126.87 23.31 42 36844 2260 110550153
Headache 125.92 23.31 69 36817 882308 109670105
Dyspnoea 120.94 23.31 115 36771 1106757 109445656
Adenovirus infection 119.87 23.31 63 36823 10931 110541482
Renal tubular atrophy 119.36 23.31 40 36846 2236 110550177
Ventricular remodelling 118.68 23.31 23 36863 123 110552290
Hypersensitivity 116.91 23.31 4 36882 403994 110148419
Mycoplasma infection 116.62 23.31 35 36851 1363 110551050
Acute respiratory distress syndrome 112.22 23.31 112 36774 53086 110499327
Drug hypersensitivity 111.88 23.31 11 36875 454079 110098334
Neutrophil count increased 110.49 23.31 92 36794 34560 110517853
Sepsis 109.87 23.31 297 36589 327049 110225364
Haemophagocytic lymphohistiocytosis 107.35 23.31 87 36799 31472 110520941
Product use in unapproved indication 104.23 23.31 357 36529 447020 110105393
Candida infection 102.97 23.31 102 36784 47907 110504506
Proteinuria 102.92 23.31 94 36792 39924 110512489
Haemolytic uraemic syndrome 101.82 23.31 44 36842 4941 110547472
Anxiety 101.33 23.31 3 36883 345075 110207338
Intracranial infection 98.77 23.31 23 36863 325 110552088
Disseminated intravascular coagulation 98.49 23.31 93 36793 41193 110511220
Herpes simplex hepatitis 98.31 23.31 27 36859 762 110551651
Epstein-Barr viraemia 98.19 23.31 39 36847 3540 110548873
Glomerulonephritis 97.43 23.31 42 36844 4688 110547725
Red blood cells urine positive 96.93 23.31 43 36843 5142 110547271
Anuria 95.51 23.31 73 36813 24268 110528145
Pain in extremity 94.77 23.31 23 36863 487095 110065318
Pathogen resistance 94.57 23.31 64 36822 17608 110534805
Disseminated tuberculosis 94.03 23.31 42 36844 5104 110547309
Graft versus host disease in gastrointestinal tract 93.84 23.31 50 36836 8918 110543495
Insomnia 93.54 23.31 7 36879 360583 110191830
Squamous cell carcinoma 89.70 23.31 63 36823 18400 110534013
Infusion related reaction 89.40 23.31 11 36875 381151 110171262
Peripheral swelling 89.26 23.31 14 36872 404020 110148393
Systemic mycosis 88.85 23.31 37 36849 3792 110548621
Pulmonary nocardiosis 87.61 23.31 33 36853 2596 110549817
Disseminated mucormycosis 87.18 23.31 31 36855 2071 110550342
Abdominal discomfort 86.21 23.31 14 36872 393844 110158569
Death 85.48 23.31 65 36821 698804 109853609
Malaise 85.39 23.31 60 36826 671759 109880654
Rhodococcus infection 85.32 23.31 22 36864 484 110551929
Cytomegalovirus test positive 84.42 23.31 43 36843 6993 110545420
Human herpesvirus 6 infection 84.18 23.31 42 36844 6539 110545874
Product dose omission issue 84.16 23.31 6 36880 321776 110230637
Biloma 84.08 23.31 19 36867 233 110552180
Hepatitis C 83.14 23.31 52 36834 12521 110539892
Asthenia 81.83 23.31 66 36820 688933 109863480
Blood urea increased 81.37 23.31 96 36790 54861 110497552
Graft versus host disease in skin 80.72 23.31 44 36842 8210 110544203
Urticaria 80.44 23.31 7 36879 318850 110233563
Graft loss 80.34 23.31 26 36860 1302 110551111
Protein urine present 79.75 23.31 49 36837 11435 110540978
Hypoaesthesia 78.99 23.31 7 36879 314216 110238197
Immunosuppressant drug level decreased 78.83 23.31 31 36855 2740 110549673
Renal tubular injury 78.80 23.31 32 36854 3076 110549337
Microsporidia infection 78.28 23.31 26 36860 1413 110551000
Nasopharyngitis 77.91 23.31 18 36868 394343 110158070
Passenger lymphocyte syndrome 77.78 23.31 17 36869 177 110552236
Depression 77.31 23.31 8 36878 317327 110235086
Diabetes mellitus 76.86 23.31 127 36759 99254 110453159
Atypical haemolytic uraemic syndrome 76.55 23.31 26 36860 1514 110550899
Abdominal wall abscess 76.03 23.31 26 36860 1546 110550867
Swelling 75.66 23.31 13 36873 351028 110201385
Graft thrombosis 75.21 23.31 20 36866 498 110551915
Lung transplant rejection 74.52 23.31 27 36859 1904 110550509
Vomiting 73.70 23.31 119 36767 910556 109641857
Infective aneurysm 73.43 23.31 25 36861 1467 110550946
Heart transplant rejection 73.32 23.31 27 36859 1994 110550419
Human ehrlichiosis 73.28 23.31 21 36865 694 110551719
Renal cell carcinoma 73.25 23.31 40 36846 7490 110544923
Glomerulosclerosis 73.19 23.31 24 36862 1253 110551160
Acute kidney injury 73.01 23.31 410 36476 635020 109917393
Cryptococcosis 72.67 23.31 34 36852 4597 110547816
Diffuse large B-cell lymphoma 72.05 23.31 52 36834 15846 110536567
Graft complication 71.90 23.31 23 36863 1109 110551304
Urinary tract infection 71.25 23.31 255 36631 326027 110226386
Oliguria 71.11 23.31 55 36831 18602 110533811
Stenotrophomonas infection 70.86 23.31 36 36850 5822 110546591
Urinary fistula 69.26 23.31 14 36872 96 110552317
Enterobacter infection 68.23 23.31 35 36851 5776 110546637
Disseminated aspergillosis 67.95 23.31 27 36859 2453 110549960
Infectious pleural effusion 67.88 23.31 33 36853 4858 110547555
Weight increased 67.08 23.31 28 36858 419616 110132797
Pancytopenia 67.08 23.31 187 36699 209426 110342987
Wheezing 66.04 23.31 5 36881 255225 110297188
Off label use 65.04 23.31 774 36112 1499411 109053002
Cutaneous mucormycosis 64.03 23.31 19 36867 711 110551702
Urine output decreased 63.83 23.31 53 36833 19823 110532590
Acute graft versus host disease in skin 62.54 23.31 41 36845 10699 110541714
Wound 62.38 23.31 4 36882 234433 110317980
Aplasia pure red cell 61.79 23.31 39 36847 9539 110542874
Sinusitis 61.74 23.31 12 36874 296676 110255737
Nephropathy 60.92 23.31 44 36842 13423 110538990
Gait disturbance 60.61 23.31 10 36876 278198 110274215
Acute graft versus host disease 60.36 23.31 43 36843 12838 110539575
Chest pain 60.33 23.31 25 36861 376350 110176063
Mycobacterium haemophilum infection 59.97 23.31 18 36868 701 110551712
Shock 59.33 23.31 81 36805 53507 110498906
Lymphopenia 59.18 23.31 70 36816 40100 110512313
Neutropenia 58.69 23.31 264 36622 374356 110178057
Pancreatitis haemorrhagic 57.85 23.31 19 36867 997 110551416
Bacterial infection 57.78 23.31 74 36812 45962 110506451
Bacteraemia 57.76 23.31 71 36815 42319 110510094
Nocardiosis 57.30 23.31 34 36852 7452 110544961
Disease recurrence 57.16 23.31 85 36801 60699 110491714
Oedematous kidney 56.74 23.31 14 36872 256 110552157
Arteritis infective 56.55 23.31 13 36873 173 110552240
Intestine transplant rejection 56.48 23.31 12 36874 108 110552305
Abdominal pain upper 56.26 23.31 23 36863 349088 110203325
Discomfort 56.14 23.31 4 36882 214703 110337710
Hyperuricaemia 55.73 23.31 43 36843 14488 110537925
Mediastinitis 55.51 23.31 20 36866 1388 110551025
Brain abscess 55.09 23.31 32 36854 6742 110545671
Renal tubular disorder 54.93 23.31 33 36853 7396 110545017
Mycotic endophthalmitis 54.35 23.31 15 36871 431 110551982
Back pain 54.26 23.31 28 36858 370968 110181445
Pulmonary mucormycosis 54.11 23.31 22 36864 2121 110550292
Condition aggravated 53.08 23.31 103 36783 734733 109817680
Diffuse alveolar damage 52.27 23.31 26 36860 4021 110548392
Acute graft versus host disease in intestine 52.22 23.31 29 36857 5610 110546803
Renal cortical necrosis 51.96 23.31 15 36871 509 110551904
Renal artery stenosis 51.29 23.31 25 36861 3701 110548712
Alopecia 51.19 23.31 29 36857 364724 110187689
Therapeutic product effect incomplete 51.14 23.31 7 36879 223798 110328615
Drug level increased 51.13 23.31 71 36815 47648 110504765
Distributive shock 50.98 23.31 29 36857 5875 110546538
Anaemia 50.70 23.31 334 36552 546752 110005661
Renal haemorrhage 50.63 23.31 22 36864 2503 110549910
Brain oedema 50.52 23.31 57 36829 31041 110521372
Fungal skin infection 50.51 23.31 31 36855 7218 110545195
Parvovirus B19 infection reactivation 49.64 23.31 9 36877 31 110552382
Weight decreased 49.34 23.31 50 36836 468007 110084406
Pyelonephritis 49.30 23.31 51 36835 25199 110527214
Cough 49.02 23.31 49 36837 461592 110090821
Bone marrow failure 48.91 23.31 77 36809 57771 110494642
IgA nephropathy 48.88 23.31 23 36863 3150 110549263
Cystitis haemorrhagic 48.74 23.31 37 36849 12172 110540241
Stomatitis 48.31 23.31 15 36871 270227 110282186
Pneumonia bacterial 47.63 23.31 51 36835 26210 110526203
Viral haemorrhagic cystitis 47.37 23.31 23 36863 3376 110549037
Drug intolerance 46.88 23.31 40 36846 406472 110145941
Donor specific antibody present 46.47 23.31 13 36873 393 110552020
Schistosomiasis 46.30 23.31 9 36877 49 110552364
Systemic candida 46.06 23.31 33 36853 9941 110542472
Sphincter of Oddi dysfunction 45.95 23.31 14 36872 574 110551839
Blister 45.64 23.31 10 36876 227366 110325047
Decreased appetite 45.57 23.31 55 36831 475791 110076622
Fusarium infection 45.52 23.31 21 36865 2750 110549663
Renal adenoma 45.42 23.31 9 36877 55 110552358
General physical health deterioration 45.32 23.31 45 36841 425250 110127163
Inappropriate schedule of product administration 45.06 23.31 7 36879 203630 110348783
Paraesthesia 44.90 23.31 18 36868 276503 110275910
Hyperhidrosis 44.89 23.31 5 36881 187293 110365120
Fungal infection 44.86 23.31 69 36817 50737 110501676
Mycobacterium abscessus infection 44.75 23.31 18 36868 1688 110550725
Renal vein thrombosis 44.42 23.31 16 36870 1109 110551304
Smooth muscle cell neoplasm 44.38 23.31 17 36869 1400 110551013
Gastrointestinal stromal tumour 44.15 23.31 19 36867 2112 110550301
Dyspepsia 43.57 23.31 6 36880 190959 110361454
Complications of transplanted liver 43.49 23.31 13 36873 499 110551914
Infection reactivation 43.39 23.31 23 36863 4058 110548355
Helicobacter infection 43.23 23.31 5 36881 181872 110370541
Diabetic macroangiopathy 42.90 23.31 10 36876 142 110552271
Constipation 42.75 23.31 34 36852 357752 110194661
Fungaemia 42.34 23.31 26 36860 6060 110546353
Type 2 diabetes mellitus 41.80 23.31 5 36881 177227 110375186
Nephrosclerosis 41.80 23.31 18 36868 2003 110550410
Drug ineffective 41.53 23.31 724 36162 1519816 109032597
Sleep disorder 41.39 23.31 8 36878 198636 110353777
Periostitis 41.32 23.31 14 36872 809 110551604
Varicella zoster virus infection 41.26 23.31 26 36860 6342 110546071
Hepatic artery stenosis 41.17 23.31 11 36875 279 110552134
Ureteral necrosis 40.98 23.31 9 36877 96 110552317
Cerebral ventricle collapse 40.84 23.31 10 36876 177 110552236
Pneumonia necrotising 40.67 23.31 17 36869 1758 110550655
Cytopenia 40.31 23.31 50 36836 30066 110522347
Reversible cerebral vasoconstriction syndrome 40.07 23.31 23 36863 4738 110547675
Acid base balance abnormal 39.94 23.31 12 36874 469 110551944
Disseminated blastomycosis 39.84 23.31 12 36874 473 110551940
Cytomegalovirus enterocolitis 39.71 23.31 18 36868 2263 110550150
Escherichia urinary tract infection 39.68 23.31 37 36849 16125 110536288
End stage renal disease 39.47 23.31 42 36844 21431 110530982
Mastitis bacterial 38.95 23.31 8 36878 60 110552353
Tooth hypoplasia 38.91 23.31 11 36875 346 110552067
Glomerulonephropathy 38.61 23.31 11 36875 356 110552057
Myalgia 38.59 23.31 13 36873 222368 110330045
Renal-limited thrombotic microangiopathy 38.40 23.31 12 36874 536 110551877
Enamel anomaly 38.19 23.31 10 36876 234 110552179
Necrosis 37.85 23.31 31 36855 11375 110541038
Progressive multifocal leukoencephalopathy 37.60 23.31 44 36842 24912 110527501
Acinetobacter infection 37.60 23.31 20 36866 3553 110548860
Kidney rupture 37.38 23.31 10 36876 255 110552158
Post procedural urine leak 37.21 23.31 9 36877 151 110552262
Leiomyosarcoma 36.93 23.31 11 36875 417 110551996
Syncope 36.63 23.31 11 36875 202525 110349888
Folliculitis 36.56 23.31 6 36880 167647 110384766
Erosive duodenitis 36.51 23.31 17 36869 2274 110550139
Confusional state 36.19 23.31 63 36823 468617 110083796
Renal failure 35.68 23.31 160 36726 226414 110325999
Transient acantholytic dermatosis 35.23 23.31 10 36876 319 110552094
Renal haematoma 35.17 23.31 13 36873 970 110551443
Drug level fluctuating 35.12 23.31 13 36873 974 110551439
Renal amyloidosis 35.11 23.31 10 36876 323 110552090
Oedematous pancreatitis 35.10 23.31 15 36871 1639 110550774
Trichosporon infection 35.08 23.31 14 36872 1286 110551127
Gastroenteritis Escherichia coli 34.91 23.31 14 36872 1303 110551110
Tuberculosis 34.88 23.31 36 36850 17738 110534675
Renal arteriosclerosis 34.74 23.31 11 36875 513 110551900
Malignant neoplasm progression 34.38 23.31 8 36878 174559 110377854
Small intestinal perforation 33.82 23.31 20 36866 4356 110548057
Viral vasculitis 33.77 23.31 9 36877 226 110552187
Tongue necrosis 33.49 23.31 8 36878 127 110552286
Renal injury 33.34 23.31 36 36850 18677 110533736
Blood pressure increased 32.85 23.31 23 36863 258350 110294063
Restrictive allograft syndrome 32.59 23.31 6 36880 23 110552390
Dyslipidaemia 32.53 23.31 33 36853 15932 110536481
Capillaritis 32.48 23.31 16 36870 2423 110549990
Thrombocytopenia 32.26 23.31 213 36673 348672 110203741
Somnolence 32.21 23.31 31 36855 297418 110254995
Gastrooesophageal reflux disease 32.14 23.31 10 36876 179966 110372447
Drug ineffective for unapproved indication 32.13 23.31 91 36795 102747 110449666
Haemothorax 31.86 23.31 23 36863 7008 110545405
Pneumonia cryptococcal 31.85 23.31 16 36870 2526 110549887
Cardiac failure congestive 31.63 23.31 6 36880 150994 110401419
Cytomegalovirus chorioretinitis 31.58 23.31 23 36863 7105 110545308
Wound dehiscence 31.50 23.31 24 36862 7938 110544475
Respiratory tract infection fungal 31.41 23.31 13 36873 1311 110551102
Pancreatitis acute 31.41 23.31 65 36821 60209 110492204
Gastrointestinal mucormycosis 31.00 23.31 11 36875 730 110551683
Skin necrosis 30.88 23.31 37 36849 21475 110530938
Arterial disorder 30.88 23.31 15 36871 2204 110550209
Ascites 30.85 23.31 84 36802 92724 110459689
Hepatic enzyme increased 30.80 23.31 37 36849 320855 110231558
Enterovirus infection 30.56 23.31 16 36870 2754 110549659
Arthritis 30.49 23.31 9 36877 167577 110384836
Complications of transplant surgery 30.46 23.31 11 36875 768 110551645
Neck pain 30.24 23.31 3 36883 123127 110429286
Haemolytic anaemia 30.06 23.31 36 36850 20884 110531529
Right ventricular diastolic collapse 29.99 23.31 7 36879 100 110552313
Human herpesvirus 6 infection reactivation 29.92 23.31 12 36874 1117 110551296
Renal arteritis 29.89 23.31 5 36881 9 110552404
Blastomycosis 29.86 23.31 12 36874 1123 110551290
Hepatitis A 29.65 23.31 12 36874 1143 110551270
Maternal exposure during pregnancy 29.46 23.31 25 36861 254858 110297555
Herpes simplex pneumonia 29.20 23.31 9 36877 384 110552029
Pneumonia fungal 29.16 23.31 30 36856 14724 110537689
Lymphocytic infiltration 29.12 23.31 14 36872 2011 110550402
Guillain-Barre syndrome 29.12 23.31 26 36860 10718 110541695
Post transplant distal limb syndrome 29.11 23.31 11 36875 873 110551540
Cerebrovascular accident 29.09 23.31 12 36874 181272 110371141
Arterial rupture 28.96 23.31 11 36875 885 110551528
Febrile neutropenia 28.86 23.31 38 36848 316729 110235684
Haemoglobin decreased 28.79 23.31 161 36725 248566 110303847
American trypanosomiasis 28.78 23.31 10 36876 624 110551789
Coccidioidomycosis 28.76 23.31 13 36873 1624 110550789
COVID-19 28.62 23.31 159 36727 244901 110307512
Argentine haemorrhagic fever 28.36 23.31 5 36881 14 110552399
Herpes simplex viraemia 28.25 23.31 10 36876 659 110551754
Hepatitis cholestatic 28.20 23.31 32 36854 17534 110534879
Hypoglycaemia 28.07 23.31 3 36883 116101 110436312
West Nile viral infection 28.05 23.31 12 36874 1314 110551099
Ureteritis 28.04 23.31 8 36878 260 110552153
Blood albumin decreased 27.92 23.31 40 36846 27612 110524801
Adenoviral haemorrhagic cystitis 27.89 23.31 10 36876 684 110551729
Ureteric dilatation 27.87 23.31 8 36878 266 110552147
Hepatic failure 27.80 23.31 67 36819 68672 110483741
White blood cell count increased 27.67 23.31 83 36803 96759 110455654
Toxicity to various agents 27.67 23.31 263 36623 480292 110072121
Alternaria infection 27.66 23.31 11 36875 1001 110551412
Pleural effusion 27.60 23.31 125 36761 177584 110374829
Bronchitis 27.55 23.31 9 36877 157023 110395390
Erythema 27.55 23.31 34 36852 291413 110261000
Cytomegalovirus gastrointestinal infection 27.48 23.31 10 36876 714 110551699
Haemodynamic instability 27.48 23.31 36 36850 22852 110529561
Pericarditis constrictive 27.42 23.31 11 36875 1024 110551389
Trichodysplasia spinulosa 27.27 23.31 11 36875 1039 110551374
Encephalitis Japanese B 26.99 23.31 6 36880 68 110552345
Optic discs blurred 26.83 23.31 6 36880 70 110552343
Muscular weakness 26.78 23.31 26 36860 248442 110303971
Renal necrosis 26.67 23.31 8 36878 311 110552102
Graft infection 26.65 23.31 10 36876 778 110551635
Bladder hypertrophy 26.55 23.31 11 36875 1113 110551300
Diffuse mesangial sclerosis 26.52 23.31 6 36880 74 110552339
Hyperplasia 26.49 23.31 12 36874 1506 110550907
Psoriasis 26.43 23.31 7 36879 139986 110412427
Corynebacterium infection 26.28 23.31 13 36873 1987 110550426
Hypocomplementaemia 26.23 23.31 8 36878 329 110552084
Urinary tract infection enterococcal 26.23 23.31 16 36870 3686 110548727
Renal artery thrombosis 26.14 23.31 9 36877 546 110551867
Pneumocystis jirovecii infection 26.11 23.31 17 36869 4383 110548030
Cervical spinal cord paralysis 25.92 23.31 5 36881 26 110552387
Glomerulonephritis membranoproliferative 25.92 23.31 10 36876 840 110551573
Myocardial infarction 25.90 23.31 16 36870 192067 110360346
Impaired healing 25.69 23.31 17 36869 196700 110355713
Peritonitis 25.64 23.31 42 36844 32565 110519848
Toxoplasmosis 25.55 23.31 15 36871 3224 110549189
Intra-abdominal haemorrhage 25.42 23.31 18 36868 5324 110547089
Gait inability 25.41 23.31 7 36879 136369 110416044
Gastrointestinal viral infection 25.14 23.31 12 36874 1697 110550716
Ureteric anastomosis complication 25.03 23.31 5 36881 32 110552381
Central nervous system infection 24.98 23.31 12 36874 1720 110550693
Neurotoxicity 24.97 23.31 48 36838 42159 110510254
Hepatic artery thrombosis 24.96 23.31 8 36878 388 110552025
Keratouveitis 24.90 23.31 5 36881 33 110552380
Fluorosis 24.83 23.31 7 36879 218 110552195
Locked-in syndrome 24.82 23.31 10 36876 942 110551471
Stress 24.77 23.31 3 36883 105345 110447068
Epstein-Barr virus associated lymphoproliferative disorder 24.76 23.31 17 36869 4785 110547628
Rectal haemorrhage 24.59 23.31 5 36881 119828 110432585
New onset diabetes after transplantation 24.48 23.31 8 36878 413 110552000
Lower respiratory tract infection 24.43 23.31 27 36859 243079 110309334
Neurosyphilis 24.25 23.31 6 36880 111 110552302
Acute graft versus host disease in liver 24.25 23.31 13 36873 2346 110550067
Orchitis 24.16 23.31 12 36874 1850 110550563
Pyrexia 24.12 23.31 427 36459 897838 109654575
Gastroenteritis norovirus 24.04 23.31 15 36871 3596 110548817
Bacterial sepsis 23.93 23.31 23 36863 10403 110542010
Pseudomonal bacteraemia 23.79 23.31 16 36870 4355 110548058
Hallucination 23.58 23.31 3 36883 101429 110450984
Liver abscess 23.53 23.31 20 36866 7719 110544694
Blood glucose increased 23.49 23.31 97 36789 132399 110420014
Acute hepatic failure 23.48 23.31 43 36843 36425 110515988
Renal lymphocele 23.44 23.31 6 36880 128 110552285
Imprisonment 23.39 23.31 9 36877 750 110551663
Dysphagia 23.33 23.31 11 36875 153589 110398824

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AC02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Interleukin inhibitors
FDA MoA N0000010279 Interleukin 2 Receptor Antagonists
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
FDA MoA N0000175621 Interleukin 2 Receptor-directed Antibody Interactions
FDA EPC N0000175622 Interleukin-2 Receptor Blocking Antibody

Related Drugs by ATC class:

L04AC Interleukin inhibitors 18 drugs
anakinrabimekizumabbrodalumabcanakinumabdaclizumabguselkumabixekizumabmirikizumabrilonaceptrisankizumabsarilumabsatralizumab show all 18 →

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

DiseaseRelationSNOMED_IDDOID
Renal transplant rejection indication 236570004




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Interleukin-2 receptor subunit alpha Membrane receptor ANTIBODY BINDING Kd 10 DRUG LABEL DRUG LABEL

External reference:

IDSource
D03058 KEGG_DRUG
4021113 VUID
N0000148568 NUI
4021113 VANDF
CHEMBL1201439 ChEMBL_ID
6879 IUPHAR_LIGAND_ID
DB00074 DRUGBANK_ID
196102 RXNORM
11703 MMSL
4246 MMSL
d04314 MMSL
007552 NDDF
109135008 SNOMEDCT_US
386978004 SNOMEDCT_US
C0676831 UMLSCUI
D000077552 MESH_DESCRIPTOR_UI
7578 INN_ID
9927MT646M UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Simulect HUMAN PRESCRIPTION DRUG LABEL 1 0078-0331 INJECTION, POWDER, FOR SOLUTION 20 mg INTRAVENOUS BLA 24 sections
Simulect HUMAN PRESCRIPTION DRUG LABEL 1 0078-0393 INJECTION, POWDER, FOR SOLUTION 10 mg INTRAVENOUS BLA 24 sections