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

Stem definitionDrug idCAS RN
immunosuppressants, rapamycin derivatives 2446 53123-88-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • sirolimus
  • rapamycin
  • rapammune
  • rapamune
  • supralimus
  • rapalimus
  • AY22989
  • AY-22989
A macrolide compound obtained from Streptomyces hygroscopicus that acts by selectively blocking the transcriptional activation of cytokines thereby inhibiting cytokine production. It is bioactive only when bound to IMMUNOPHILINS. Sirolimus is a potent immunosuppressant and possesses both antifungal and antineoplastic properties. Limited data describing efficacy in patients with COVID-19 is available. However, its efficacy and safety in the treatment of COVID-19 was not established.
  • Molecular weight: 914.19
  • Formula: C51H79NO13
  • CLOGP: 7.04
  • LIPINSKI: 3
  • HAC: 14
  • HDO: 3
  • TPSA: 195.43
  • ALOGS: -5.72
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
3 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.15 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 15 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility) 0.00 mg/mL Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 4.403 High 0.90
caco2-efflux Caco-2 efflux ratio (BA/AB) 6.427 High 0.90
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 25.763 10^-6 cm/s High 0.90
dh-clint Dog hepatocyte intrinsic clearance 124.738 uL/min/10^6 cells High 0.90
dppb Dog plasma protein binding (% unbound) 0.690 % High 0.90
fcs-ppb Fetal calf serum protein binding (% unbound) 2.480 % High 0.90
herg hERG pIC50 4.587 pIC50 High 0.90
hh-clint Human hepatocyte intrinsic clearance 34.834 uL/min/10^6 cells High 0.90
hlm-clint Human liver microsomal intrinsic clearance 254.683 uL/min/mg protein High 0.90
hppb Human plasma protein binding (% unbound) 1.030 % High 0.90
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK 17
kinase-selectivity-class GRK2 1
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 34.198 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 5.534 High 0.90
mh-clint Mouse hepatocyte intrinsic clearance 55.208 High 0.90
mppb Mouse plasma protein binding (% unbound) 0.470 High 0.90
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 37.670 High 0.90
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
pppb Pig plasma protein binding (% unbound) 0.940 % High 0.90
rat-kpuu-brain Rat brain Kpuu 0.017 % High 0.92
rh-clint Rat hepatocyte intrinsic clearance 95.940 uL/min/10^6 cells High 0.90
rh-fuinc Rat hepatocyte fraction unbound in incubation 3.790 % High 0.90
rppb Rat plasma protein binding (% unbound) 1.130 % High 0.90
solubility-dd Solubility at pH 7.4 in DMSO 10.990 uM High 0.90

Approvals:

DateAgencyCompanyOrphan
Sept. 15, 1999 FDA PF PRISM CV
July 4, 2014 PMDA NOBELPHARMA CO., LTD
March 13, 2001 EMA Pfizer Europe MA EEIG

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 dysfunction 2176.60 19.84 441 19836 4841 90603329
Transplant rejection 2143.87 19.84 510 19767 12248 90595922
Ovarian cyst 1513.95 19.84 411 19866 16907 90591263
Acne 1374.62 19.84 426 19851 28081 90580089
Thrombotic microangiopathy 413.03 19.84 149 20128 15594 90592576
Off label use 380.21 19.84 787 19490 1101465 89506705
Epstein-Barr virus infection 372.34 19.84 124 20153 10220 90597950
Post transplant lymphoproliferative disorder 364.62 19.84 111 20166 6838 90601332
Alopecia 300.15 19.84 454 19823 494617 90113553
Liver function test abnormal 261.73 19.84 155 20122 50690 90557480
Smooth muscle cell neoplasm 235.90 19.84 56 20221 1317 90606853
Product use in unapproved indication 215.64 19.84 317 19960 335919 90272251
Polyomavirus-associated nephropathy 184.51 19.84 52 20225 2438 90605732
Sleep disorder due to general medical condition, insomnia type 154.06 19.84 166 20111 128528 90479642
Kidney fibrosis 153.56 19.84 44 20233 2190 90605980
Graft versus host disease in skin 141.85 19.84 47 20230 3806 90604364
Hypertriglyceridaemia 139.44 19.84 56 20221 7833 90600337
Intussusception 134.93 19.84 34 20243 1031 90607139
Graft versus host disease 130.89 19.84 54 20223 8090 90600080
Epstein-Barr virus associated lymphoproliferative disorder 128.84 19.84 40 20237 2627 90605543
Graft versus host disease in gastrointestinal tract 124.34 19.84 44 20233 4344 90603826
Kidney transplant rejection 112.62 19.84 42 20235 4815 90603355
Posterior reversible encephalopathy syndrome 109.41 19.84 66 20211 22273 90585897
Drug ineffective for unapproved indication 109.23 19.84 102 20175 66542 90541628
Cytomegalovirus infection 106.13 19.84 69 20208 26533 90581637
Pneumonia 105.89 19.84 348 19929 637711 89970459
Infected neoplasm 100.21 19.84 22 20255 360 90607810
Drug ineffective 99.96 19.84 587 19690 1383711 89224459
Acute graft versus host disease 93.82 19.84 38 20239 5430 90602740
Linear IgA disease 92.84 19.84 30 20247 2244 90605926
Human herpesvirus 6 infection 91.90 19.84 33 20244 3399 90604771
Mouth ulceration 91.42 19.84 74 20203 39900 90568270
Immunosuppressant drug level increased 88.90 19.84 35 20242 4645 90603525
Multiple organ dysfunction syndrome 88.54 19.84 92 20185 68244 90539926
Cytomegalovirus infection reactivation 87.06 19.84 40 20237 7760 90600410
Arthralgia 85.13 19.84 34 20243 778488 89829682
Chronic graft versus host disease 82.31 19.84 32 20245 4107 90604063
Condition aggravated 79.89 19.84 303 19974 595242 90012928
Chronic allograft nephropathy 79.02 19.84 21 20256 788 90607382
MELAS syndrome 76.89 19.84 16 20261 200 90607970
Adenovirus infection 75.47 19.84 31 20246 4591 90603579
Infusion related reaction 73.81 19.84 5 20272 416775 90191395
Septic shock 71.32 19.84 91 20186 84069 90524101
Chronic kidney disease 71.25 19.84 71 20206 50120 90558050
Cryptosporidiosis infection 71.23 19.84 17 20260 409 90607761
Therapy partial responder 70.80 19.84 50 20227 21993 90586177
JC virus infection 68.52 19.84 25 20252 2694 90605476
BK virus infection 66.15 19.84 28 20249 4470 90603700
Pneumocystis jirovecii pneumonia 64.76 19.84 47 20230 21569 90586601
Polyomavirus viraemia 64.66 19.84 20 20257 1297 90606873
Alveolar proteinosis 63.57 19.84 18 20259 858 90607312
Liver transplant rejection 63.29 19.84 21 20256 1707 90606463
Pseudomonas infection 62.85 19.84 40 20237 14825 90593345
Rash 62.49 19.84 52 20225 796048 89812122
Product use issue 61.90 19.84 188 20089 329731 90278439
Joint swelling 61.83 19.84 18 20259 503282 90104888
Acute graft versus host disease in skin 61.39 19.84 27 20250 4729 90603441
Glossodynia 59.58 19.84 3 20274 321776 90286394
Proteinuria 59.43 19.84 46 20231 23245 90584925
Hypersensitivity 58.20 19.84 15 20262 454662 90153508
Respiratory failure 58.12 19.84 99 20178 118319 90489851
Fatigue 56.63 19.84 108 20169 1153915 89454255
Drug level increased 56.41 19.84 48 20229 27714 90580456
Diverticulum oesophageal 55.15 19.84 12 20265 188 90607982
Dizziness 53.38 19.84 33 20244 589251 90018919
Skin graft rejection 52.79 19.84 9 20268 33 90608137
Renal graft infection 52.27 19.84 13 20264 373 90607797
Lymphopenia 51.55 19.84 42 20235 22839 90585331
Pneumothorax 51.42 19.84 39 20238 19128 90589042
Drug effective for unapproved indication 51.08 19.84 28 20249 7890 90600280
Heart transplant rejection 50.82 19.84 15 20262 829 90607341
Skin squamous cell carcinoma metastatic 50.80 19.84 8 20269 15 90608155
IgA nephropathy 49.66 19.84 15 20262 898 90607272
Chronic graft versus host disease in skin 49.16 19.84 16 20261 1224 90606946
Renal impairment 48.94 19.84 86 20191 105335 90502835
Therapeutic product effect decreased 47.22 19.84 4 20273 277567 90330603
Loss of personal independence in daily activities 47.11 19.84 98 20179 136007 90472163
Focal segmental glomerulosclerosis 46.57 19.84 17 20260 1834 90606336
Epstein-Barr viraemia 46.49 19.84 16 20261 1454 90606716
Adrenal mass 46.18 19.84 15 20262 1140 90607030
Morphoea 46.01 19.84 12 20265 418 90607752
Blister 45.29 19.84 3 20274 254995 90353175
Mobility decreased 44.38 19.84 3 20274 250731 90357439
Weight increased 44.37 19.84 19 20258 417908 90190262
Drug interaction 44.04 19.84 149 20128 276304 90331866
Hypogammaglobulinaemia 43.33 19.84 28 20249 10646 90597524
Drug hypersensitivity 43.31 19.84 25 20252 463584 90144586
Swelling 42.99 19.84 20 20257 419038 90189132
Hypoaesthesia 42.89 19.84 9 20268 314201 90293969
Wound 42.78 19.84 8 20269 302972 90305198
Sinusitis 42.60 19.84 12 20265 343076 90265094
Human herpesvirus 8 infection 42.27 19.84 11 20266 380 90607790
Confusional state 41.89 19.84 17 20260 386188 90221982
Plasmablastic lymphoma 41.80 19.84 10 20267 243 90607927
Wheezing 41.70 19.84 3 20274 238077 90370093
Abdominal discomfort 41.47 19.84 28 20249 477300 90130870
Nephropathy toxic 41.25 19.84 29 20248 12659 90595511
Acute kidney injury 41.15 19.84 161 20116 320226 90287944
Insomnia 40.78 19.84 12 20265 333462 90274708
Urticaria 40.60 19.84 10 20267 312724 90295446
Avian influenza 40.26 19.84 8 20269 78 90608092
Gastrointestinal stromal tumour 39.78 19.84 14 20263 1359 90606811
Pain in extremity 39.71 19.84 26 20251 450503 90157667
Psoriatic arthropathy 39.64 19.84 3 20274 228332 90379838
Rheumatoid arthritis 39.34 19.84 173 20104 362441 90245729
Dyspnoea 39.25 19.84 87 20190 880868 89727302
PIK3CA related overgrowth spectrum 38.94 19.84 6 20271 9 90608161
Neurofibrosarcoma 38.78 19.84 9 20268 191 90607979
Chest pain 38.18 19.84 12 20265 319633 90288537
Musculoskeletal stiffness 37.50 19.84 10 20267 296522 90311648
Asthma 37.33 19.84 5 20272 242155 90366015
Globulins decreased 37.01 19.84 10 20267 400 90607770
Escherichia bacteraemia 36.22 19.84 20 20257 5715 90602455
Trichodysplasia spinulosa 35.87 19.84 11 20266 693 90607477
Incorrect route of product administration 35.61 19.84 50 20227 50576 90557594
Hepatitis E 35.36 19.84 14 20263 1885 90606285
Discomfort 35.17 19.84 9 20268 274326 90333844
Folliculitis 34.60 19.84 3 20274 204350 90403820
Lower respiratory tract infection 34.58 19.84 7 20270 250652 90357518
Gait disturbance 34.46 19.84 8 20269 260488 90347682
Microangiopathic haemolytic anaemia 34.23 19.84 11 20266 808 90607362
Disease recurrence 33.93 19.84 42 20235 37611 90570559
Anxiety 32.99 19.84 14 20263 309758 90298412
Constipation 32.65 19.84 11 20266 280384 90327786
Adjusted calcium decreased 32.49 19.84 8 20269 220 90607950
Klebsiella infection 32.24 19.84 23 20254 10274 90597896
Dysplasia 32.12 19.84 12 20265 1382 90606788
Jejunal perforation 32.03 19.84 7 20270 112 90608058
Jarisch-Herxheimer reaction 31.82 19.84 9 20268 427 90607743
Cystitis viral 31.42 19.84 8 20269 253 90607917
Fall 31.36 19.84 37 20240 481773 90126397
Blastomycosis 31.33 19.84 9 20268 452 90607718
Bacillary angiomatosis 31.00 19.84 7 20270 131 90608039
Muscle spasms 30.90 19.84 9 20268 251874 90356296
Babesiosis 30.72 19.84 8 20269 277 90607893
Blood creatinine increased 30.50 19.84 69 20208 101317 90506853
Hepatic fibrosis 30.39 19.84 16 20261 4159 90604011
Dry mouth 30.36 19.84 3 20274 184056 90424114
Glomerulosclerosis 30.25 19.84 9 20268 511 90607659
Oesophagitis ulcerative 30.22 19.84 10 20267 806 90607364
Headache 30.21 19.84 96 20181 862650 89745520
Streptococcal bacteraemia 29.90 19.84 13 20264 2214 90605956
Sepsis 29.57 19.84 98 20179 179716 90428454
Clostridial sepsis 29.39 19.84 9 20268 564 90607606
Scleroderma 29.37 19.84 18 20259 6243 90601927
Pericarditis 29.10 19.84 12 20265 270139 90338031
Contusion 29.00 19.84 10 20267 251206 90356964
Endocarditis Q fever 28.42 19.84 5 20272 23 90608147
Back pain 28.34 19.84 18 20259 317157 90291013
Alopecia scarring 28.28 19.84 7 20270 197 90607973
Disease progression 28.14 19.84 88 20189 156527 90451643
Hyperlipidaemia 28.14 19.84 30 20247 22886 90585284
Lung transplant rejection 27.83 19.84 10 20267 1031 90607139
Bronchiolitis obliterans syndrome 27.82 19.84 8 20269 403 90607767
Diabetes mellitus 27.64 19.84 51 20226 64824 90543346
Malaise 27.61 19.84 56 20221 585930 90022240
Rhinovirus infection 27.60 19.84 17 20260 5946 90602224
Chronic graft versus host disease in eye 27.57 19.84 7 20270 219 90607951
Liver injury 27.56 19.84 3 20274 170564 90437606
Fibrosarcoma 27.38 19.84 4 20273 3 90608167
Chronic graft versus host disease oral 27.23 19.84 7 20270 230 90607940
Nasopharyngitis 26.76 19.84 31 20246 407073 90201097
Immunosuppressant drug level decreased 26.64 19.84 10 20267 1166 90607004
Viraemia 26.59 19.84 11 20266 1658 90606512
Lymphatic disorder 26.35 19.84 8 20269 487 90607683
Sleep disorder 26.35 19.84 6 20271 198024 90410146
Lymphocele 26.32 19.84 9 20268 802 90607368
Product prescribing error 26.16 19.84 33 20244 30112 90578058
Haemophagocytic lymphohistiocytosis 25.96 19.84 24 20253 15435 90592735
Papilloma viral infection 25.89 19.84 11 20266 1771 90606399
Squamous cell carcinoma 25.88 19.84 20 20257 10081 90598089
Abdominal pain upper 25.69 19.84 22 20255 332652 90275518
Depression 25.59 19.84 18 20259 300583 90307587
Paraesthesia 25.57 19.84 12 20265 250314 90357856
Peripheral swelling 25.53 19.84 33 20244 413073 90195097
Drug level below therapeutic 25.46 19.84 16 20261 5798 90602372
Mucosal inflammation 25.43 19.84 46 20231 57579 90550591
Escherichia infection 25.39 19.84 24 20253 15871 90592299
Hypoalbuminaemia 25.39 19.84 24 20253 15873 90592297
Immune thrombocytopenia 24.96 19.84 22 20255 13304 90594866
Atypical mycobacterial pneumonia 24.87 19.84 5 20272 52 90608118
Transplant failure 24.84 19.84 11 20266 1958 90606212
Q fever 24.69 19.84 6 20271 156 90608014
Atypical haemolytic uraemic syndrome 24.56 19.84 9 20268 982 90607188
Obliterative bronchiolitis 24.56 19.84 12 20265 2669 90605501
Pancreas transplant rejection 24.37 19.84 6 20271 165 90608005
Squamous cell carcinoma of skin 24.15 19.84 17 20260 7432 90600738
Pruritus 23.63 19.84 54 20223 541471 90066699
Pulmonary toxicity 23.55 19.84 20 20257 11511 90596659
Cardiac ventricular thrombosis 23.37 19.84 9 20268 1125 90607045
Trichostasis spinulosa 23.19 19.84 4 20273 16 90608154
Immunosuppression 22.74 19.84 20 20257 12057 90596113
Acute hepatitis C 22.71 19.84 5 20272 83 90608087
Donor specific antibody present 22.61 19.84 6 20271 224 90607946
Aspergillus infection 22.57 19.84 19 20258 10804 90597366
Memory impairment 22.50 19.84 8 20269 197236 90410934
Overdose 22.49 19.84 82 20195 157627 90450543
Hepatic angiosarcoma 22.46 19.84 4 20273 20 90608150
Feeling abnormal 22.38 19.84 5 20272 167230 90440940
Renal-limited thrombotic microangiopathy 22.28 19.84 6 20271 237 90607933
Graft thrombosis 22.16 19.84 6 20271 242 90607928
Haemolysis 22.13 19.84 17 20260 8493 90599677
American trypanosomiasis 22.09 19.84 6 20271 245 90607925
Neuroendocrine carcinoma of the skin 22.03 19.84 8 20269 850 90607320
End stage renal disease 22.02 19.84 17 20260 8554 90599616
Maternal exposure during pregnancy 22.00 19.84 29 20248 360034 90248136
Nausea 21.98 19.84 152 20125 1110164 89498006
Moyamoya disease 21.97 19.84 5 20272 97 90608073
Infection reactivation 21.81 19.84 10 20267 1930 90606240
Enterococcal infection 21.79 19.84 18 20259 9973 90598197
Dermatitis acneiform 21.77 19.84 15 20262 6339 90601831
Salivary gland mass 21.60 19.84 5 20272 105 90608065
Splenic abscess 21.48 19.84 6 20271 272 90607898
Impaired healing 21.32 19.84 13 20264 234186 90373984
Cat scratch disease 21.31 19.84 6 20271 280 90607890
Kussmaul respiration 21.25 19.84 6 20271 283 90607887
Urinary tract infection pseudomonal 21.17 19.84 8 20269 950 90607220
Neutropenia 21.17 19.84 103 20174 224801 90383369
Renal failure 21.17 19.84 71 20206 130936 90477234
Enterovirus infection 21.09 19.84 9 20268 1465 90606705
Photodermatosis 20.87 19.84 7 20270 588 90607582
Pulmonary haemorrhage 20.82 19.84 16 20261 7997 90600173
Parvovirus B19 infection 20.79 19.84 8 20269 998 90607172
Varicella zoster virus infection 20.40 19.84 12 20265 3865 90604305
Pterygium 20.35 19.84 6 20271 330 90607840
Visceral leishmaniasis 20.28 19.84 7 20270 642 90607528
Mycobacterium chelonae infection 20.19 19.84 7 20270 650 90607520
Pleural effusion 20.18 19.84 63 20214 111928 90496242
Diffuse alveolar damage 20.13 19.84 8 20269 1087 90607083
Cardiac murmur functional 20.04 19.84 4 20273 40 90608130
Injection site pain 19.89 19.84 7 20270 173692 90434478

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
Off label use 562.89 15.99 1115 21585 637220 41961415
Transplant rejection 515.56 15.99 213 22487 13375 42585260
Product use in unapproved indication 352.86 15.99 461 22239 183995 42414640
Polyomavirus-associated nephropathy 326.34 15.99 120 22580 5495 42593140
Thrombotic microangiopathy 291.57 15.99 147 22553 14635 42584000
Cytomegalovirus infection 223.44 15.99 164 22536 32142 42566493
Post transplant lymphoproliferative disorder 222.79 15.99 105 22595 9015 42589620
Acute graft versus host disease 211.25 15.99 98 22602 8117 42590518
Kidney transplant rejection 187.91 15.99 92 22608 8591 42590044
Cytomegalovirus viraemia 183.76 15.99 96 22604 10281 42588354
Transplant failure 162.12 15.99 66 22634 3978 42594657
Adenovirus infection 162.02 15.99 77 22623 6732 42591903
Epstein-Barr virus infection 149.85 15.99 82 22618 9636 42588999
Drug ineffective for unapproved indication 135.44 15.99 144 22556 46019 42552616
Mouth ulceration 131.46 15.99 88 22612 14875 42583760
BK virus infection 129.61 15.99 72 22628 8712 42589923
Cytomegalovirus infection reactivation 126.17 15.99 77 22623 11101 42587534
Chronic graft versus host disease 124.88 15.99 62 22638 5963 42592672
Graft versus host disease in gastrointestinal tract 118.82 15.99 57 22643 5086 42593549
Renal tubular injury 118.23 15.99 42 22658 1737 42596898
Immunosuppressant drug level increased 113.05 15.99 63 22637 7668 42590967
Squamous cell carcinoma of skin 112.17 15.99 75 22625 12651 42585984
Nephropathy toxic 108.56 15.99 82 22618 16756 42581879
Graft versus host disease in skin 106.15 15.99 53 22647 5159 42593476
Liver transplant rejection 100.68 15.99 41 22659 2472 42596163
Chronic allograft nephropathy 99.69 15.99 36 22664 1562 42597073
Product use issue 99.53 15.99 160 22540 76591 42522044
Acute graft versus host disease in skin 99.11 15.99 57 22643 7367 42591268
Squamous cell carcinoma 94.44 15.99 68 22632 12914 42585721
Graft versus host disease in liver 80.56 15.99 31 22669 1608 42597027
Bronchopulmonary aspergillosis 78.10 15.99 72 22628 19357 42579278
Renal impairment 76.25 15.99 176 22524 110052 42488583
Epstein-Barr virus infection reactivation 75.90 15.99 34 22666 2593 42596042
Transitional cell carcinoma 75.52 15.99 34 22666 2624 42596011
Heart transplant rejection 75.35 15.99 29 22671 1505 42597130
Smooth muscle cell neoplasm 67.57 15.99 18 22682 276 42598359
Chronic graft versus host disease in skin 67.08 15.99 27 22673 1579 42597056
Skin squamous cell carcinoma metastatic 64.92 15.99 14 22686 80 42598555
Acute graft versus host disease in intestine 62.73 15.99 34 22666 3917 42594718
Kidney fibrosis 62.36 15.99 30 22670 2692 42595943
Human herpesvirus 8 infection 61.95 15.99 25 22675 1472 42597163
Nocardiosis 61.77 15.99 37 22663 5153 42593482
Central nervous system lymphoma 60.33 15.99 24 22676 1361 42597274
Pneumatosis intestinalis 59.49 15.99 35 22665 4717 42593918
Pneumonia cytomegaloviral 58.62 15.99 33 22667 4093 42594542
Graft versus host disease 58.06 15.99 51 22649 12874 42585761
Human ehrlichiosis 57.84 15.99 18 22682 490 42598145
Skin squamous cell carcinoma recurrent 56.60 15.99 13 22687 103 42598532
Hypotension 56.01 15.99 34 22666 257597 42341038
Propionibacterium infection 55.89 15.99 15 22685 237 42598398
Multiple organ dysfunction syndrome 53.39 15.99 142 22558 96893 42501742
Chronic graft versus host disease oral 52.89 15.99 16 22684 395 42598240
Dizziness 52.66 15.99 34 22666 249220 42349415
Brain abscess 52.18 15.99 31 22669 4253 42594382
Lung transplant rejection 52.16 15.99 20 22680 1027 42597608
Meningitis viral 51.11 15.99 20 22680 1085 42597550
Venoocclusive liver disease 51.05 15.99 43 22657 10259 42588376
Acute graft versus host disease in liver 49.21 15.99 23 22677 1935 42596700
Epidermodysplasia verruciformis 49.16 15.99 14 22686 278 42598357
Renal tubular atrophy 49.07 15.99 21 22679 1434 42597201
Constipation 48.93 15.99 13 22687 162278 42436357
Diarrhoea haemorrhagic 46.30 15.99 36 22664 7671 42590964
Proteinuria 46.08 15.99 59 22641 22924 42575711
Herpes zoster meningoencephalitis 45.25 15.99 15 22685 502 42598133
Tularaemia 45.16 15.99 12 22688 182 42598453
Drug resistance 45.16 15.99 72 22628 34176 42564459
Fatigue 44.13 15.99 105 22595 435536 42163099
Hypogammaglobulinaemia 43.82 15.99 42 22658 11849 42586786
Apoptosis 43.23 15.99 15 22685 578 42598057
Gastroenteritis norovirus 42.56 15.99 20 22680 1703 42596932
Polyomavirus viraemia 41.60 15.99 21 22679 2091 42596544
Retinal scar 41.29 15.99 13 22687 368 42598267
Drug level increased 40.06 15.99 59 22641 26141 42572494
Cow pox 39.86 15.99 8 22692 30 42598605
Type III immune complex mediated reaction 39.66 15.99 14 22686 568 42598067
Parvovirus B19 infection 39.39 15.99 19 22681 1715 42596920
Scleroderma 38.93 15.99 19 22681 1759 42596876
Diaphragmatic hernia 38.72 15.99 12 22688 322 42598313
Lymphocele 38.34 15.99 18 22682 1529 42597106
Pruritus 38.16 15.99 27 22673 188744 42409891
Gingivitis ulcerative 37.96 15.99 11 22689 233 42598402
Drug effective for unapproved indication 37.72 15.99 30 22670 6603 42592032
Transplant dysfunction 37.64 15.99 23 22677 3320 42595315
Depression 37.41 15.99 7 22693 111356 42487279
Alveolar proteinosis 36.57 15.99 14 22686 716 42597919
Staphylococcal mediastinitis 36.35 15.99 8 22692 51 42598584
Back pain 36.35 15.99 15 22685 141761 42456874
Fall 36.20 15.99 43 22657 234477 42364158
Hypertrophic cardiomyopathy 36.17 15.99 17 22683 1448 42597187
Chronic graft versus host disease in eye 36.08 15.99 11 22689 279 42598356
Somnolence 36.06 15.99 15 22685 141090 42457545
Escherichia infection 35.97 15.99 37 22663 11359 42587276
Cytomegalovirus chorioretinitis 35.48 15.99 25 22675 4586 42594049
Nausea 35.30 15.99 102 22598 396697 42201938
Nephrogenic diabetes insipidus 35.01 15.99 17 22683 1557 42597078
Epstein-Barr viraemia 34.41 15.99 19 22681 2270 42596365
Yersinia infection 34.23 15.99 8 22692 69 42598566
Pleocytosis 34.20 15.99 13 22687 652 42597983
Cytomegalovirus colitis 33.96 15.99 23 22677 3958 42594677
Abdominal wall abscess 33.80 15.99 13 22687 673 42597962
Hepatitis B 33.22 15.99 28 22672 6683 42591952
Drug ineffective 33.13 15.99 494 22206 629703 41968932
Impaired healing 32.97 15.99 43 22657 17010 42581625
Human herpesvirus 6 infection 32.67 15.99 19 22681 2506 42596129
Nephropathy 32.51 15.99 28 22672 6883 42591752
Focal segmental glomerulosclerosis 32.51 15.99 19 22681 2529 42596106
Renal-limited thrombotic microangiopathy 32.42 15.99 10 22690 264 42598371
Aspergillus infection 32.29 15.99 41 22659 15796 42582839
Diffuse large B-cell lymphoma 32.23 15.99 32 22668 9422 42589213
Therapy partial responder 31.94 15.99 46 22654 19975 42578660
Bradycardia 31.84 15.99 4 22696 85480 42513155
Mycobacterium haemophilum infection 31.29 15.99 11 22689 441 42598194
Tracheobronchitis 31.26 15.99 15 22685 1338 42597297
Periorbital infection 31.08 15.99 9 22691 190 42598445
Blood creatinine increased 30.73 15.99 128 22572 109875 42488760
Enterocolitis viral 30.71 15.99 11 22689 466 42598169
Overdose 30.65 15.99 9 22691 105255 42493380
Metastases to lung 30.60 15.99 34 22666 11390 42587245
Complications of transplanted kidney 30.00 15.99 24 22676 5326 42593309
CEC syndrome 29.59 15.99 6 22694 24 42598611
Viral haemorrhagic cystitis 29.56 15.99 16 22684 1838 42596797
Protothecosis 29.30 15.99 7 22693 67 42598568
Arthralgia 29.20 15.99 40 22660 205198 42393437
Drug interaction 29.09 15.99 242 22458 266757 42331878
Right ventricular diastolic collapse 28.93 15.99 7 22693 71 42598564
Philadelphia positive chronic myeloid leukaemia 28.78 15.99 8 22692 145 42598490
Livedo reticularis 28.54 15.99 18 22682 2746 42595889
Kaposi sarcoma inflammatory cytokine syndrome 28.52 15.99 8 22692 150 42598485
Aplastic anaemia 28.37 15.99 34 22666 12350 42586285
Malignant fibrous histiocytoma 28.08 15.99 9 22691 270 42598365
Syncope 28.04 15.99 9 22691 99397 42499238
Ophthalmic herpes zoster 27.77 15.99 13 22687 1097 42597538
Viraemia 27.45 15.99 15 22685 1755 42596880
Malacoplakia 26.82 15.99 12 22688 912 42597723
Chronic graft versus host disease in liver 26.82 15.99 11 22689 675 42597960
Insomnia 26.51 15.99 15 22685 118238 42480397
Scedosporium infection 26.39 15.99 14 22686 1544 42597091
Bacterial sepsis 26.00 15.99 24 22676 6458 42592177
Product administered to patient of inappropriate age 25.94 15.99 21 22679 4740 42593895
Ejection fraction abnormal 25.87 15.99 13 22687 1282 42597353
Drug level decreased 25.54 15.99 29 22671 9948 42588687
Pneumocystis jirovecii pneumonia 25.38 15.99 47 22653 25134 42573501
Histoplasmosis disseminated 25.12 15.99 15 22685 2076 42596559
Pain in extremity 24.99 15.99 26 22674 150578 42448057
Basal cell carcinoma 24.91 15.99 44 22656 22689 42575946
Interstitial lung disease 24.87 15.99 95 22605 78367 42520268
Disease recurrence 24.58 15.99 51 22649 29627 42569008
Varicella zoster virus infection 24.54 15.99 16 22684 2585 42596050
Obliterative bronchiolitis 24.39 15.99 13 22687 1448 42597187
Microangiopathic haemolytic anaemia 24.35 15.99 12 22688 1135 42597500
Posterior reversible encephalopathy syndrome 24.27 15.99 32 22668 12789 42585846
Herpes simplex 24.16 15.99 24 22676 7071 42591564
Bladder transitional cell carcinoma 24.12 15.99 16 22684 2660 42595975
Dyspnoea 24.06 15.99 138 22562 442483 42156152
Mycobacterium chelonae infection 24.04 15.99 12 22688 1166 42597469
Rash 23.99 15.99 72 22628 276882 42321753
Anxiety 23.88 15.99 17 22683 118543 42480092
Hypertriglyceridaemia 23.52 15.99 28 22672 10098 42588537
Confusional state 23.49 15.99 33 22667 167564 42431071
Pulmonary amyloidosis 23.43 15.99 5 22695 27 42598608
Decreased appetite 23.33 15.99 42 22658 193095 42405540
Neuroendocrine carcinoma of the skin 23.30 15.99 11 22689 946 42597689
Abdominal distension 23.06 15.99 5 22695 71730 42526905
Asthenia 22.91 15.99 75 22625 280718 42317917
Varicella 22.72 15.99 14 22686 2051 42596584
Inferior vena cava stenosis 22.58 15.99 6 22694 91 42598544
Necrotising retinitis 22.53 15.99 11 22689 1019 42597616
Muscle spasms 22.21 15.99 9 22691 86035 42512600
Mastication disorder 22.02 15.99 13 22687 1763 42596872
Pulmonary toxicity 21.89 15.99 25 22675 8630 42590005
Hypervolaemia 21.86 15.99 42 22658 23083 42575552
Fungal infection 21.38 15.99 38 22662 19684 42578951
Thoracic haemorrhage 21.12 15.99 7 22693 234 42598401
Chronic obstructive pulmonary disease 21.12 15.99 4 22696 63110 42535525
Toxoplasmosis 20.55 15.99 12 22688 1595 42597040
Ileal ulcer 20.41 15.99 10 22690 934 42597701
Acute kidney injury 20.38 15.99 291 22409 367046 42231589
Inappropriate schedule of product administration 20.32 15.99 13 22687 95889 42502746
Loss of consciousness 20.29 15.99 12 22688 92342 42506293
Aphthous ulcer 20.16 15.99 20 22680 5881 42592754
Mucosal inflammation 20.15 15.99 65 22635 49309 42549326
Paraesthesia 20.10 15.99 7 22693 73452 42525183
Human polyomavirus infection 20.09 15.99 11 22689 1292 42597343
Glomerulonephritis 19.94 15.99 14 22686 2552 42596083
Lung adenocarcinoma stage IV 19.80 15.99 6 22694 149 42598486
Encephalitis eastern equine 19.62 15.99 3 22697 0 42598635
Hepatocellular carcinoma 19.60 15.99 23 22677 8171 42590464
Hyperhidrosis 19.55 15.99 12 22688 90500 42508135
Joint swelling 19.46 15.99 6 22694 68016 42530619
Wheezing 19.37 15.99 3 22697 54778 42543857
Norovirus infection 19.24 15.99 9 22691 758 42597877
Septic shock 19.16 15.99 98 22602 91574 42507061
Immunosuppression 19.02 15.99 23 22677 8430 42590205
Splenic neoplasm malignancy unspecified 19.00 15.99 4 22696 20 42598615
Enteritis 18.95 15.99 26 22674 10790 42587845
Complications of transplanted heart 18.93 15.99 7 22693 325 42598310
Haemorrhagic pneumonia 18.92 15.99 6 22694 174 42598461
Pericarditis constrictive 18.74 15.99 8 22692 543 42598092
Venoocclusive disease 18.69 15.99 16 22684 3899 42594736
Injection site pain 18.64 15.99 4 22696 57794 42540841
Atypical haemolytic uraemic syndrome 18.63 15.99 8 22692 551 42598084
Metastatic malignant melanoma 18.57 15.99 13 22687 2360 42596275
Histology abnormal 18.57 15.99 7 22693 343 42598292
Cytomegalovirus oesophagitis 18.28 15.99 8 22692 577 42598058
Spirochaetal infection 18.11 15.99 4 22696 26 42598609
Pharyngitis 18.10 15.99 23 22677 8867 42589768
Therapy non-responder 18.06 15.99 66 22634 53293 42545342
Infusion related reaction 18.06 15.99 5 22695 60801 42537834
Haemolytic uraemic syndrome 18.06 15.99 13 22687 2466 42596169
Klebsiella infection 18.02 15.99 26 22674 11306 42587329
Alternaria infection 17.98 15.99 8 22692 600 42598035
Carotid artery thrombosis 17.95 15.99 7 22693 376 42598259
Nail discolouration 17.94 15.99 10 22690 1217 42597418
Lip haemorrhage 17.69 15.99 9 22691 911 42597724
Pain 17.57 15.99 69 22631 244779 42353856
Haemangioma-thrombocytopenia syndrome 17.54 15.99 3 22697 3 42598632
SARS-CoV-2 RNA 17.49 15.99 4 22696 31 42598604
Pneumonia pseudomonal 17.45 15.99 17 22683 4892 42593743
Hyponatraemia 17.41 15.99 17 22683 101445 42497190
Blood brain barrier defect 17.38 15.99 4 22696 32 42598603
Pulmonary cavitation 17.37 15.99 10 22690 1294 42597341
Pericardial effusion 17.26 15.99 44 22656 29231 42569404
Stem cell transplant 17.18 15.99 13 22687 2659 42595976
Cytomegalovirus gastrointestinal ulcer 17.16 15.99 5 22695 108 42598527
Malaise 17.06 15.99 57 22643 212099 42386536
Acne 17.05 15.99 28 22672 13616 42585019
Feeling abnormal 16.90 15.99 8 22692 69778 42528857
Osmotic demyelination syndrome 16.88 15.99 9 22691 1003 42597632
Pneumonia bacterial 16.71 15.99 30 22670 15662 42582973
Retroperitoneal lymphadenopathy 16.70 15.99 9 22691 1025 42597610
Staphylococcal infection 16.69 15.99 51 22649 37592 42561043
Hyperlipidaemia 16.68 15.99 36 22664 21480 42577155
Cystitis haemorrhagic 16.59 15.99 20 22680 7309 42591326
Alveolitis 16.45 15.99 11 22689 1854 42596781
Hepatic artery thrombosis 16.45 15.99 6 22694 268 42598367
Blood pressure increased 16.45 15.99 18 22682 101910 42496725
Severe acute respiratory syndrome 16.43 15.99 5 22695 126 42598509
Pleural effusion 16.37 15.99 98 22602 97068 42501567
Peritoneal hernia 16.32 15.99 3 22697 6 42598629
Leiomyosarcoma recurrent 16.32 15.99 3 22697 6 42598629
Suicidal ideation 16.22 15.99 3 22697 48158 42550477
Pneumonia influenzal 16.11 15.99 11 22689 1918 42596717
Disseminated varicella zoster virus infection 16.07 15.99 8 22692 773 42597862
Pneumonia fungal 16.05 15.99 22 22678 9124 42589511
Renal transplant failure 16.04 15.99 10 22690 1495 42597140
Macroglossia 15.99 15.99 7 22693 505 42598130

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 2328.62 15.51 687 38505 23880 110526227
Transplant dysfunction 1878.27 15.51 462 38730 7866 110542241
Ovarian cyst 1382.48 15.51 404 38788 13526 110536581
Acne 1185.28 15.51 446 38746 33074 110517033
Off label use 770.16 15.51 1653 37539 1498532 109051575
Thrombotic microangiopathy 678.42 15.51 287 38905 28862 110521245
Product use in unapproved indication 536.70 15.51 723 38469 446654 110103453
Post transplant lymphoproliferative disorder 505.63 15.51 195 38997 15418 110534689
Polyomavirus-associated nephropathy 504.68 15.51 165 39027 8036 110542071
Epstein-Barr virus infection 434.24 15.51 184 39008 18554 110531553
Acute graft versus host disease 385.68 15.51 152 39040 12729 110537378
Cytomegalovirus infection 345.04 15.51 224 38968 54220 110495887
Adenovirus infection 288.52 15.51 118 39074 10876 110539231
Alopecia 254.57 15.51 460 38732 364293 110185814
Kidney transplant rejection 242.60 15.51 107 39085 11880 110538227
Cytomegalovirus infection reactivation 236.60 15.51 120 39072 18213 110531894
BK virus infection 230.31 15.51 106 39086 13000 110537107
Chronic graft versus host disease 219.51 15.51 93 39099 9364 110540743
Graft versus host disease in skin 207.78 15.51 86 39106 8168 110541939
Graft versus host disease in gastrointestinal tract 207.52 15.51 88 39104 8880 110541227
Drug ineffective for unapproved indication 207.01 15.51 217 38975 102621 110447486
Smooth muscle cell neoplasm 203.83 15.51 55 39137 1362 110548745
Immunosuppressant drug level increased 200.33 15.51 93 39099 11631 110538476
Graft versus host disease 185.79 15.51 103 39089 18703 110531404
Cytomegalovirus viraemia 182.94 15.51 100 39092 17664 110532443
Transplant failure 177.48 15.51 69 39123 5566 110544541
Chronic allograft nephropathy 168.97 15.51 52 39140 2074 110548033
Acute graft versus host disease in skin 167.51 15.51 80 39112 10660 110539447
Liver function test abnormal 167.22 15.51 161 39031 68789 110481318
Drug ineffective 162.44 15.51 1004 38188 1519536 109030571
Product use issue 157.93 15.51 344 38848 311351 110238756
Nephropathy toxic 152.16 15.51 104 39088 27374 110522733
Multiple organ dysfunction syndrome 139.88 15.51 217 38975 151493 110398614
Squamous cell carcinoma of skin 129.54 15.51 79 39113 17124 110532983
Arthralgia 123.74 15.51 61 39131 779571 109770536
Squamous cell carcinoma 121.92 15.51 78 39114 18385 110531722
Sleep disorder due to general medical condition, insomnia type 121.87 15.51 168 39024 105475 110444632
Renal tubular injury 119.38 15.51 44 39148 3064 110547043
Human herpesvirus 6 infection 118.04 15.51 54 39138 6527 110543580
Chronic graft versus host disease in skin 115.26 15.51 41 39151 2578 110547529
Liver transplant rejection 112.94 15.51 45 39147 3873 110546234
Hypertriglyceridaemia 111.04 15.51 70 39122 16084 110534023
Renal impairment 110.56 15.51 221 38971 188224 110361883
Bronchopulmonary aspergillosis 109.05 15.51 88 39104 29775 110520332
Human herpesvirus 8 infection 108.48 15.51 36 39156 1835 110548272
Epstein-Barr virus associated lymphoproliferative disorder 107.39 15.51 46 39146 4756 110545351
Mouth ulceration 106.63 15.51 107 39085 48031 110502076
Infusion related reaction 101.91 15.51 9 39183 381153 110168954
Heart transplant rejection 101.85 15.51 35 39157 1986 110548121
Dizziness 98.69 15.51 63 39129 698130 109851977
Therapy partial responder 96.42 15.51 90 39102 36971 110513136
Alveolar proteinosis 94.86 15.51 31 39161 1505 110548602
Kidney fibrosis 94.69 15.51 41 39151 4351 110545756
Proteinuria 94.28 15.51 92 39100 39926 110510181
Skin squamous cell carcinoma metastatic 93.31 15.51 18 39174 87 110550020
Joint swelling 91.95 15.51 22 39170 442823 110107284
Posterior reversible encephalopathy syndrome 91.52 15.51 84 39108 33777 110516330
Drug level increased 91.18 15.51 98 39094 47621 110502486
Acute graft versus host disease in intestine 90.98 15.51 43 39149 5596 110544511
Polyomavirus viraemia 90.16 15.51 37 39155 3437 110546670
Transitional cell carcinoma 89.90 15.51 36 39156 3139 110546968
Fatigue 89.42 15.51 186 39006 1215772 109334335
Epstein-Barr viraemia 85.73 15.51 36 39156 3543 110546564
Rash 85.69 15.51 99 39093 820865 109729242
Nocardiosis 85.07 15.51 45 39147 7441 110542666
Pneumocystis jirovecii pneumonia 83.83 15.51 89 39103 42646 110507461
Pneumonia 80.81 15.51 559 38633 876155 109673952
Drug interaction 80.76 15.51 371 38821 499812 110050295
Infected neoplasm 80.46 15.51 22 39170 573 110549534
Chronic kidney disease 80.08 15.51 116 39076 76175 110473932
Drug effective for unapproved indication 79.32 15.51 54 39138 14113 110535994
Arthropathy 79.02 15.51 6 39186 287516 110262591
Septic shock 78.67 15.51 173 39019 157355 110392752
Drug resistance 76.32 15.51 97 39095 56277 110493830
Pruritus 76.12 15.51 57 39135 581503 109968604
Renal tubular atrophy 75.70 15.51 29 39163 2247 110547860
Intussusception 73.71 15.51 26 39166 1595 110548512
Lung transplant rejection 72.92 15.51 27 39165 1904 110548203
Acute kidney injury 72.57 15.51 428 38764 635002 109915105
Hypersensitivity 71.30 15.51 27 39165 403971 110146136
Wheezing 71.07 15.51 5 39187 255225 110294882
Asthma 69.41 15.51 5 39187 250286 110299821
Fall 69.38 15.51 67 39125 603415 109946692
Pneumatosis intestinalis 68.95 15.51 41 39151 8488 110541619
Contraindicated product administered 68.73 15.51 5 39187 248262 110301845
Mobility decreased 68.04 15.51 4 39188 237418 110312689
Therapeutic product effect decreased 67.41 15.51 5 39187 244311 110305796
JC virus infection 66.42 15.51 34 39158 5256 110544851
Constipation 66.40 15.51 22 39170 357764 110192343
Musculoskeletal stiffness 66.33 15.51 10 39182 279812 110270295
Focal segmental glomerulosclerosis 65.01 15.51 31 39161 4114 110545993
Pain in extremity 64.69 15.51 47 39145 487071 110063036
Venoocclusive liver disease 64.58 15.51 49 39143 15158 110534949
Nausea 64.34 15.51 224 38968 1235466 109314641
Drug hypersensitivity 64.05 15.51 41 39151 454049 110096058
Respiratory failure 63.50 15.51 194 38998 215138 110334969
MELAS syndrome 62.87 15.51 16 39176 313 110549794
Cytomegalovirus colitis 62.50 15.51 36 39156 7025 110543082
Cryptosporidiosis infection 62.32 15.51 21 39171 1122 110548985
Insomnia 62.14 15.51 25 39167 360565 110189542
Blood creatinine increased 60.83 15.51 172 39020 182717 110367390
Urticaria 60.24 15.51 19 39173 318838 110231269
Pseudomonas infection 60.00 15.51 61 39131 27792 110522315
Glossodynia 59.97 15.51 5 39187 221999 110328108
Confusional state 59.94 15.51 47 39145 468633 110081474
Propionibacterium infection 59.55 15.51 15 39177 281 110549826
Parvovirus B19 infection 59.20 15.51 26 39166 2855 110547252
Aspergillus infection 58.67 15.51 58 39134 25558 110524549
Microangiopathic haemolytic anaemia 58.39 15.51 23 39169 1920 110548187
Central nervous system lymphoma 57.83 15.51 26 39166 3018 110547089
Epidermodysplasia verruciformis 57.72 15.51 16 39176 439 110549668
Pneumonia cytomegaloviral 57.71 15.51 34 39158 6920 110543187
Back pain 57.28 15.51 30 39162 370966 110179141
Hypoaesthesia 57.13 15.51 20 39172 314203 110235904
Escherichia infection 56.56 15.51 55 39137 23761 110526346
Weight increased 56.34 15.51 40 39152 419604 110130503
Malaise 55.15 15.51 96 39096 671723 109878384
Depression 54.67 15.51 22 39170 317313 110232794
Linear IgA disease 54.50 15.51 28 39164 4361 110545746
Tularaemia 54.26 15.51 13 39179 196 110549911
Wound 54.15 15.51 9 39183 234428 110315679
Viraemia 53.35 15.51 27 39165 4075 110546032
Swelling 53.29 15.51 29 39163 351012 110199095
Graft versus host disease in liver 53.11 15.51 23 39169 2442 110547665
Musculoskeletal pain 52.69 15.51 3 39189 183020 110367087
Varicella zoster virus infection 52.49 15.51 31 39161 6337 110543770
Dyspnoea 52.11 15.51 209 38983 1106663 109443444
Chronic graft versus host disease oral 52.03 15.51 15 39177 476 110549631
Blister 51.92 15.51 9 39183 227367 110322740
Muscle spasms 51.78 15.51 17 39175 278140 110271967
Herpes zoster meningoencephalitis 51.73 15.51 18 39174 1060 110549047
Klebsiella infection 50.91 15.51 48 39144 19961 110530146
Skin squamous cell carcinoma recurrent 50.72 15.51 11 39181 103 110550004
Brain abscess 50.72 15.51 31 39161 6743 110543364
Epstein-Barr virus infection reactivation 50.55 15.51 26 39166 4058 110546049
Maternal exposure during pregnancy 50.30 15.51 14 39178 254869 110295238
Anxiety 50.25 15.51 30 39162 345048 110205059
Dry mouth 50.10 15.51 6 39186 199942 110350165
Chronic graft versus host disease in eye 49.60 15.51 14 39178 411 110549696
Paraesthesia 49.58 15.51 18 39174 276503 110273604
Disease recurrence 49.20 15.51 82 39110 60702 110489405
Diverticulum oesophageal 48.90 15.51 12 39180 201 110549906
Plasmablastic lymphoma 48.62 15.51 16 39176 794 110549313
Diffuse large B-cell lymphoma 48.02 15.51 42 39150 15856 110534251
Hyperlipidaemia 47.44 15.51 61 39131 35787 110514320
Osteoarthritis 46.96 15.51 5 39187 182618 110367489
Neuroendocrine carcinoma of the skin 46.70 15.51 19 39173 1726 110548381
Herpes simplex 46.32 15.51 41 39151 15723 110534384
Apoptosis 46.24 15.51 15 39177 711 110549396
PIK3CA related overgrowth spectrum 46.12 15.51 7 39185 3 110550104
Renal-limited thrombotic microangiopathy 46.09 15.51 14 39178 534 110549573
Pulmonary toxicity 45.97 15.51 43 39149 17703 110532404
Contusion 45.71 15.51 13 39179 233348 110316759
Staphylococcal mediastinitis 45.45 15.51 9 39183 51 110550056
Lower respiratory tract infection 45.00 15.51 15 39177 243091 110307016
Gastroenteritis norovirus 44.73 15.51 23 39169 3588 110546519
Acute graft versus host disease in liver 44.34 15.51 20 39172 2339 110547768
Asthenia 44.33 15.51 113 39079 688886 109861221
Syncope 44.14 15.51 9 39183 202527 110347580
Meningitis viral 44.02 15.51 20 39172 2379 110547728
Interstitial lung disease 43.38 15.51 128 39064 139206 110410901
Cow pox 43.11 15.51 8 39184 30 110550077
Injury 42.77 15.51 6 39186 177259 110372848
Type 2 diabetes mellitus 42.76 15.51 6 39186 177226 110372881
Scleroderma 42.38 15.51 27 39165 6314 110543793
Lymphocele 42.09 15.51 18 39174 1853 110548254
Chest pain 41.81 15.51 43 39149 376332 110173775
Mucosal inflammation 41.80 15.51 100 39092 96041 110454066
Disease progression 41.52 15.51 184 39008 243850 110306257
Skin graft rejection 41.05 15.51 9 39183 89 110550018
Hypotension 41.04 15.51 77 39115 523772 110026335
Abdominal pain upper 40.96 15.51 38 39154 349073 110201034
Sleep disorder 40.93 15.51 10 39182 198634 110351473
Complications of transplanted kidney 40.79 15.51 28 39164 7414 110542693
Drug level decreased 40.64 15.51 41 39151 18507 110531600
Lymphopenia 40.58 15.51 60 39132 40110 110509997
Dyspepsia 40.56 15.51 9 39183 190956 110359151
Somnolence 40.37 15.51 28 39164 297421 110252686
Vomiting 39.69 15.51 177 39015 910498 109639609
Condition aggravated 39.58 15.51 416 38776 734420 109815687
Enterocolitis viral 39.56 15.51 14 39178 867 110549240
Nephropathy 39.52 15.51 35 39157 13432 110536675
Cystitis viral 39.29 15.51 16 39176 1457 110548650
Retinal scar 39.27 15.51 12 39180 467 110549640
Atypical haemolytic uraemic syndrome 38.60 15.51 16 39176 1524 110548583
Human ehrlichiosis 38.45 15.51 13 39179 702 110549405
Discomfort 38.44 15.51 14 39178 214693 110335414
Pericardial effusion 38.29 15.51 71 39121 57146 110492961
Varicella 38.27 15.51 21 39171 3734 110546373
Headache 38.15 15.51 172 39020 882205 109667902
Aplastic anaemia 38.03 15.51 45 39147 24263 110525844
Glomerulosclerosis 37.97 15.51 15 39177 1262 110548845
Gastrooesophageal reflux disease 37.20 15.51 9 39183 179967 110370140
Type III immune complex mediated reaction 37.12 15.51 14 39178 1039 110549068
Diarrhoea haemorrhagic 36.91 15.51 36 39156 15603 110534504
Gait disturbance 36.69 15.51 27 39165 278181 110271926
Product administered to patient of inappropriate age 36.59 15.51 27 39165 8009 110542098
Injection site pain 36.57 15.51 9 39183 177913 110372194
Bacterial sepsis 36.53 15.51 30 39162 10396 110539711
Hepatitis B 36.52 15.51 29 39163 9583 110540524
Mycobacterium chelonae infection 36.49 15.51 19 39173 3041 110547066
Abdominal discomfort 36.33 15.51 52 39140 393806 110156301
Diaphragmatic hernia 36.32 15.51 12 39180 603 110549504
COVID-19 35.98 15.51 177 39015 244883 110305224
Periorbital infection 35.91 15.51 9 39183 165 110549942
Hypertrophic cardiomyopathy 35.90 15.51 19 39173 3144 110546963
Pleural effusion 35.70 15.51 141 39051 177568 110372539
Kaposi sarcoma inflammatory cytokine syndrome 35.66 15.51 9 39183 170 110549937
Folliculitis 35.41 15.51 8 39184 167645 110382462
Drug intolerance 35.25 15.51 56 39136 406456 110143651
Complications of transplanted heart 35.22 15.51 11 39181 461 110549646
Chronic graft versus host disease in liver 35.21 15.51 13 39179 909 110549198
Venoocclusive disease 35.06 15.51 24 39168 6326 110543781
Memory impairment 34.99 15.51 13 39179 196931 110353176
Bursitis 34.87 15.51 3 39189 129915 110420192
Cytomegalovirus chorioretinitis 34.84 15.51 25 39167 7103 110543004
Adrenal mass 34.68 15.51 15 39177 1587 110548520
Migraine 34.67 15.51 9 39183 171643 110378464
Nasopharyngitis 34.50 15.51 54 39138 394307 110155800
Nephrogenic diabetes insipidus 34.47 15.51 17 39175 2428 110547679
Gingivitis ulcerative 34.17 15.51 11 39181 509 110549598
Avian influenza 33.87 15.51 8 39184 113 110549994
Yersinia infection 33.30 15.51 8 39184 122 110549985
IgA nephropathy 33.04 15.51 18 39174 3155 110546952
Obliterative bronchiolitis 33.00 15.51 19 39173 3704 110546403
Human polyomavirus infection 32.99 15.51 15 39177 1787 110548320
Ill-defined disorder 32.11 15.51 8 39184 156845 110393262
Neurofibrosarcoma 32.06 15.51 9 39183 259 110549848
CEC syndrome 32.03 15.51 6 39186 24 110550083
Peripheral swelling 31.97 15.51 59 39133 403975 110146132
Viral haemorrhagic cystitis 31.89 15.51 18 39174 3381 110546726
Malignant fibrous histiocytoma 31.83 15.51 9 39183 266 110549841
Muscular weakness 31.63 15.51 25 39167 248443 110301664
Psoriasis 30.96 15.51 6 39186 139987 110410120
Mycobacterium haemophilum infection 30.67 15.51 11 39181 708 110549399
Decreased appetite 30.60 15.51 78 39114 475768 110074339
Pleocytosis 30.46 15.51 14 39178 1710 110548397
Feeling abnormal 30.35 15.51 13 39179 180698 110369409
Haemolytic uraemic syndrome 30.30 15.51 20 39172 4965 110545142
Renal transplant failure 30.14 15.51 16 39176 2664 110547443
Trichodysplasia spinulosa 30.06 15.51 12 39180 1038 110549069
Philadelphia positive chronic myeloid leukaemia 29.88 15.51 8 39184 192 110549915
Bradycardia 29.83 15.51 9 39183 155508 110394599
Immunosuppressant drug level decreased 29.64 15.51 16 39176 2755 110547352
Hepatocellular carcinoma 29.64 15.51 26 39166 9854 110540253
Right ventricular diastolic collapse 29.57 15.51 7 39185 100 110550007
Sinusitis 29.56 15.51 37 39155 296651 110253456
Hypogammaglobulinaemia 29.49 15.51 36 39156 20040 110530067
Bladder transitional cell carcinoma 29.40 15.51 16 39176 2800 110547307
Hyperhidrosis 29.10 15.51 15 39177 187283 110362824
Night sweats 29.09 15.51 6 39186 133977 110416130
Pancreas transplant rejection 29.05 15.51 9 39183 367 110549740
Blood triglycerides increased 29.00 15.51 39 39153 23887 110526220
Renal tubular necrosis 28.62 15.51 44 39148 30431 110519676
Abdominal wall abscess 28.51 15.51 13 39179 1559 110548548
Livedo reticularis 28.50 15.51 20 39172 5486 110544621
Morphoea 28.43 15.51 10 39182 608 110549499
Arthritis 28.23 15.51 12 39180 167574 110382533
Malacoplakia 28.02 15.51 12 39180 1240 110548867
Mucormycosis 28.00 15.51 26 39166 10602 110539505
Adjusted calcium decreased 27.90 15.51 8 39184 249 110549858
Drug level below therapeutic 27.79 15.51 27 39165 11646 110538461
Gastrointestinal stromal tumour 27.64 15.51 14 39178 2117 110547990
Rhinovirus infection 27.57 15.51 27 39165 11762 110538345
Stem cell transplant 27.49 15.51 18 39174 4409 110545698
Toxoplasmosis 27.31 15.51 16 39176 3223 110546884
Tracheobronchitis 27.16 15.51 15 39177 2701 110547406
Escherichia bacteraemia 27.04 15.51 25 39167 10139 110539968
Cytomegalovirus gastrointestinal infection 26.89 15.51 10 39182 714 110549393
Pericarditis 26.71 15.51 23 39169 219091 110331016
Ophthalmic herpes zoster 26.61 15.51 16 39176 3379 110546728
Flushing 26.59 15.51 3 39189 104733 110445374
Glomerulonephritis 26.41 15.51 18 39174 4712 110545395
Globulins decreased 26.30 15.51 10 39182 759 110549348
Blood pressure increased 25.97 15.51 32 39160 258341 110291766
Scedosporium infection 25.75 15.51 14 39178 2444 110547663
Oral disorder 25.33 15.51 26 39166 11977 110538130
Otitis media acute 25.33 15.51 12 39180 1570 110548537
Alopecia scarring 25.33 15.51 7 39185 190 110549917
Hyponatraemia 25.15 15.51 24 39168 217629 110332478
Pneumothorax 25.14 15.51 45 39147 35240 110514867
Bacillary angiomatosis 24.89 15.51 8 39184 368 110549739
Immune thrombocytopenia 24.76 15.51 35 39157 22459 110527648
Papilloma viral infection 24.71 15.51 13 39179 2125 110547982
Loss of consciousness 24.67 15.51 20 39172 196286 110353821
Hepatic artery thrombosis 24.49 15.51 8 39184 388 110549719
Pulmonary cavitation 24.40 15.51 13 39179 2181 110547926
Donor specific antibody present 24.29 15.51 8 39184 398 110549709
Sepsis 23.95 15.51 198 38994 327148 110222959
Bacterial colitis 23.70 15.51 7 39185 242 110549865
Inferior vena cava stenosis 23.64 15.51 6 39186 116 110549991
Norovirus infection 23.51 15.51 13 39179 2346 110547761
Clostridium difficile infection 23.49 15.51 55 39137 52074 110498033
Opportunistic infection 23.46 15.51 15 39177 3528 110546579
Therapeutic product effect incomplete 23.26 15.51 27 39165 223778 110326329
Injection site erythema 23.16 15.51 3 39189 94173 110455934
Pulmonary alveolar haemorrhage 23.15 15.51 32 39160 20118 110529989
Suicidal ideation 23.08 15.51 3 39189 93934 110456173
Enteritis 22.88 15.51 31 39161 19125 110530982
Viral infection 22.80 15.51 55 39137 53084 110497023
Babesiosis 22.74 15.51 8 39184 487 110549620
Renal graft infection 22.64 15.51 9 39183 770 110549337
Cytomegalovirus gastrointestinal ulcer 22.61 15.51 6 39186 139 110549968
Sciatica 22.59 15.51 3 39189 92396 110457711
Pneumonia fungal 22.56 15.51 27 39165 14727 110535380
Blastomycosis 22.54 15.51 10 39182 1125 110548982
Aplasia pure red cell 22.52 15.51 22 39170 9556 110540551
Depressed level of consciousness 22.45 15.51 6 39186 112272 110437835
Chylothorax 22.36 15.51 10 39182 1146 110548961
Delirium 22.22 15.51 10 39182 135015 110415092
Necrotising retinitis 22.21 15.51 11 39181 1585 110548522
Oesophagitis ulcerative 22.15 15.51 11 39181 1594 110548513
Inappropriate schedule of product administration 21.78 15.51 24 39168 203613 110346494
Organising pneumonia 21.67 15.51 26 39166 14217 110535890
Chronic obstructive pulmonary disease 21.52 15.51 6 39186 109152 110440955
Staphylococcal infection 21.51 15.51 64 39128 69880 110480227
Chest discomfort 21.49 15.51 18 39174 173830 110376277
Cystitis haemorrhagic 21.45 15.51 24 39168 12185 110537922
Trichostasis spinulosa 21.35 15.51 4 39188 16 110550091
Ejection fraction abnormal 21.32 15.51 14 39178 3446 110546661
Metastases to lung 21.24 15.51 33 39159 23030 110527077
Road traffic accident 20.99 15.51 6 39186 107392 110442715
Reticulocyte count decreased 20.77 15.51 9 39183 957 110549150
Pulmonary amyloidosis 20.71 15.51 5 39187 78 110550029
Dysplasia 20.69 15.51 11 39181 1837 110548270
Cytomegalovirus oesophagitis 20.59 15.51 9 39183 977 110549130
Drug level fluctuating 20.58 15.51 9 39183 978 110549129
Coma 20.56 15.51 8 39184 117861 110432246
Pneumocystis jirovecii infection 20.52 15.51 15 39177 4385 110545722
Cat scratch disease 20.46 15.51 8 39184 655 110549452
Pulmonary haemorrhage 20.22 15.51 27 39165 16429 110533678
Salivary gland mass 20.20 15.51 5 39187 87 110550020
Actinic keratosis 20.13 15.51 18 39174 6995 110543112
Complications of transplanted lung 20.07 15.51 8 39184 689 110549418
Jejunal perforation 19.96 15.51 7 39185 422 110549685
Clostridial sepsis 19.96 15.51 9 39183 1052 110549055
Peripheral venous disease 19.93 15.51 3 39189 84114 110465993
Lymphatic disorder 19.93 15.51 7 39185 424 110549683
Therapy non-responder 19.87 15.51 109 39083 157198 110392909
C-reactive protein increased 19.85 15.51 29 39163 217890 110332217
Photodermatosis 19.72 15.51 9 39183 1082 110549025
Haemophagocytic lymphohistiocytosis 19.67 15.51 38 39154 31521 110518586
Adverse event 19.63 15.51 7 39185 108802 110441305
Adenovirus reactivation 19.61 15.51 8 39184 732 110549375
Spirochaetal infection 19.60 15.51 4 39188 27 110550080
Wound infection 19.59 15.51 5 39187 96460 110453647
Rectal haemorrhage 19.52 15.51 9 39183 119824 110430283
Respiratory distress 19.30 15.51 61 39131 68813 110481294
Cutaneous T-cell lymphoma 19.18 15.51 13 39179 3371 110546736
Rheumatoid arthritis 19.18 15.51 176 39016 299437 110250670
Palpitations 19.05 15.51 17 39175 159195 110390912
Pneumonia pseudomonal 19.00 15.51 18 39174 7528 110542579
Loss of personal independence in daily activities 18.98 15.51 104 39088 149916 110400191
Product dose omission issue 18.98 15.51 55 39137 321727 110228380
Pneumonitis 18.95 15.51 65 39127 76466 110473641
SARS-CoV-2 RNA 18.90 15.51 4 39188 33 110550074
Epstein-Barr virus associated lymphoma 18.86 15.51 10 39182 1660 110548447
Jarisch-Herxheimer reaction 18.78 15.51 9 39183 1208 110548899
Encephalitis eastern equine 18.76 15.51 3 39189 3 110550104
Leukopenia 18.73 15.51 103 39089 148688 110401419
Mastication disorder 18.66 15.51 13 39179 3525 110546582
Balance disorder 18.61 15.51 9 39183 116551 110433556
Transaminases increased 18.55 15.51 57 39135 63333 110486774
Skin mass 18.46 15.51 20 39172 9796 110540311
Cardio-respiratory arrest 18.41 15.51 9 39183 115827 110434280
Disseminated varicella zoster virus infection 18.34 15.51 9 39183 1272 110548835
Cardiac murmur functional 18.30 15.51 4 39188 39 110550068
Gait inability 18.28 15.51 13 39179 136363 110413744
Post transplant distal limb syndrome 18.24 15.51 8 39184 876 110549231
Protothecosis 18.18 15.51 7 39185 550 110549557
Campylobacter infection 18.10 15.51 11 39181 2368 110547739
Pneumonia bacterial 18.08 15.51 33 39159 26228 110523879
Liver injury 18.07 15.51 16 39176 150397 110399710
Graft loss 18.03 15.51 9 39183 1319 110548788
Lung adenocarcinoma stage IV 18.01 15.51 7 39185 564 110549543
Feeling hot 17.97 15.51 5 39187 91101 110459006
Lymphangioma 17.86 15.51 4 39188 44 110550063
Cerebral toxoplasmosis 17.64 15.51 12 39180 3130 110546977
Histoplasmosis disseminated 17.52 15.51 13 39179 3886 110546221
Neck pain 17.49 15.51 11 39181 123119 110426988
Splenic neoplasm malignancy unspecified 17.39 15.51 4 39188 50 110550057
Retroperitoneal lymphadenopathy 17.36 15.51 9 39183 1427 110548680
American trypanosomiasis 17.30 15.51 7 39185 627 110549480
Viral oesophagitis 17.23 15.51 3 39189 7 110550100
Alternaria infection 17.20 15.51 8 39184 1004 110549103
Fibrosarcoma 17.17 15.51 4 39188 53 110550054
Pneumonia klebsiella 17.04 15.51 16 39176 6616 110543491
Thymus enlargement 17.04 15.51 5 39187 169 110549938
Infection reactivation 17.00 15.51 13 39179 4068 110546039
Diabetes mellitus 16.93 15.51 75 39117 99306 110450801
Metastatic malignant melanoma 16.76 15.51 12 39180 3397 110546710
Chronic graft versus host disease in intestine 16.73 15.51 7 39185 683 110549424
Bronchiolitis obliterans syndrome 16.73 15.51 7 39185 683 110549424
Acquired mitochondrial DNA mutation 16.68 15.51 3 39189 9 110550098
Urine protein/creatinine ratio increased 16.59 15.51 9 39183 1564 110548543
Streptococcal sepsis 16.54 15.51 14 39178 5058 110545049
Ureteric stenosis 16.47 15.51 9 39183 1588 110548519
Haemorrhagic pneumonia 16.45 15.51 5 39187 191 110549916
ABO incompatibility 16.44 15.51 3 39189 10 110550097
Aphthous ulcer 16.42 15.51 28 39164 21108 110528999
Myocarditis toxoplasmal 16.41 15.51 4 39188 65 110550042
Hypothyroidism 16.38 15.51 3 39189 72896 110477211
Wound dehiscence 16.35 15.51 17 39175 7945 110542162
Haemangioma-thrombocytopenia syndrome 16.22 15.51 3 39189 11 110550096
Alveolitis 16.03 15.51 13 39179 4426 110545681
Red blood cell sedimentation rate increased 16.01 15.51 4 39188 78298 110471809
Renal failure 16.00 15.51 136 39056 226438 110323669
Hepatitis E 15.98 15.51 13 39179 4446 110545661
Hallucination 15.94 15.51 8 39184 101424 110448683
Enterococcal infection 15.84 15.51 27 39165 20339 110529768
Joint range of motion decreased 15.82 15.51 12 39180 121820 110428287
Insulin resistance 15.77 15.51 9 39183 1725 110548382
Kussmaul respiration 15.75 15.51 6 39186 458 110549649
Pneumonia mycoplasmal 15.74 15.51 9 39183 1732 110548375
Pterygium 15.62 15.51 6 39186 468 110549639
Adverse drug reaction 15.60 15.51 9 39183 105550 110444557
Blood pressure systolic increased 15.56 15.51 5 39187 82986 110467121
Systemic mycosis 15.51 15.51 12 39180 3817 110546290

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01EG04 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
PROTEIN KINASE INHIBITORS
Mammalian target of rapamycin (mTOR) kinase inhibitors
ATC L04AH01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Mammalian target of rapamycin (mTOR) kinase inhibitors
ATC S01XA23 SENSORY ORGANS
OPHTHALMOLOGICALS
OTHER OPHTHALMOLOGICALS
Other ophthalmologicals
FDA MoA N0000175076 Protein Kinase Inhibitors
FDA PE N0000175550 Decreased Immunologic Activity
FDA EPC N0000175605 Kinase Inhibitor
FDA MoA N0000175624 mTOR Inhibitors
FDA EPC N0000175625 mTOR Inhibitor Immunosuppressant
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:36047 antibacterial drug
CHEBI has role CHEBI:68481 mTOR inhibitor
CHEBI has role CHEBI:76969 bacterial metabolite
CHEBI has role CHEBI:149553 anticoronaviral agent
CHEBI has role CHEBI:176497 geroprotector
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000903 Antibiotics, Antineoplastic
MeSH PA D000935 Antifungal Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents

Related Drugs by ATC class:

L01EG Mammalian target of rapamycin (mTOR) kinase inhibitors 3 drugs
everolimusridaforolimustemsirolimus
L04AH Mammalian target of rapamycin (mTOR) kinase inhibitors 1 drug
everolimus
S01XA Other ophthalmologicals 24 drugs
acetylcysteinealteplasealumascorbic acidavacincaptad pegolcenegerminciclosporindexpanthenoldiquafosolethylmorphineguaiazulenheparin show all 24 →

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

DiseaseRelationSNOMED_IDDOID
Gorham's disease indication 1515008
Tuberous sclerosis syndrome indication 7199000 DOID:13515
Lymphangiectasis indication 48087001
Pulmonary lymphangioleiomyomatosis indication 277844007 DOID:3319
Lymphangioma indication 400178008 DOID:1475
Lymphangiomatosis indication 403546006
Renal cell carcinoma indication 702391001 DOID:4450
Prevention of Kidney Transplant Rejection indication
Coronavirus infection off-label use 186747009
Prevention of Cardiac Transplant Rejection off-label use
Hypercholesterolemia contraindication 13644009
Hyperbilirubinemia contraindication 14783006 DOID:2741
Transplantation of liver contraindication 18027006
Progressive multifocal leukoencephalopathy contraindication 22255007 DOID:643
Cytomegalovirus infection contraindication 28944009
Proteinuria contraindication 29738008 DOID:576
Hypertensive disorder contraindication 38341003 DOID:10763
Infectious disease contraindication 40733004
Body fluid retention contraindication 43498006
Gastrointestinal perforation contraindication 51875005
Hyperlipidemia contraindication 55822004 DOID:1168
Acute infectious disease contraindication 63171007
Interstitial pneumonia contraindication 64667001
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperglycemia contraindication 80394007 DOID:4195
Transplant of lung contraindication 88039007
Kidney disease contraindication 90708001 DOID:557
Secondary malignant neoplasm of cerebrum contraindication 94248000
Malignant lymphoma contraindication 118600007 DOID:0060058
Perioperative care contraindication 133897009
Cerebrovascular accident contraindication 230690007
Interstitial lung disease contraindication 233703007 DOID:3082
Lymphedema contraindication 234097001 DOID:4977
Disease of liver contraindication 235856003 DOID:409
Impaired wound healing contraindication 271618001
Peripheral edema contraindication 271809000
Pregnancy, function contraindication 289908002
Hypertriglyceridemia contraindication 302870006
Primary malignant neoplasm contraindication 372087000
Malignant neoplasm of skin contraindication 372130007 DOID:4159
Pericardial effusion contraindication 373945007 DOID:118
Surgical procedure contraindication 387713003
Ascites contraindication 389026000
Breastfeeding (mother) contraindication 413712001
Pneumocystosis jiroveci pneumonia contraindication 415125002 DOID:11339
Malignant neoplasm of brain contraindication 428061005 DOID:1319
Bronchial Anastomotic Dehiscence in Lung Transplant contraindication
Pleural Effusions contraindication
Sirolimus Toxicity contraindication
Hepatic Artery Thrombosis in Liver Transplant contraindication
BK Polyomavirus Reactivation Nephropathy contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.5 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG/VIAL FYARRO AADI N213312 Nov. 22, 2021 RX POWDER INTRAVENOUS 8911786 Feb. 14, 2029 TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC MALIGNANT PERIVASCULAR EPITHELIOID CELL TUMOR (PECOMA)
100MG/VIAL FYARRO AADI N213312 Nov. 22, 2021 RX POWDER INTRAVENOUS 10973806 June 29, 2036 TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC MALIGNANT PERIVASCULAR EPITHELIOID CELL TUMOR (PECOMA) WITH A DOSE BETWEEN ABOUT 56 MG/M2 AND ABOUT 100 MG/M2 ADMINISTERED ON DAYS 1 AND 8 OF A 21-DAY CYCLE
100MG/VIAL FYARRO AADI N213312 Nov. 22, 2021 RX POWDER INTRAVENOUS 12133844 June 29, 2036 TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC MALIGNANT PERIVASCULAR EPITHELIOID CELL TUMOR (PECOMA) WITH A DOSE ADMINISTERED ON DAYS 1 AND 8 OF A 21-DAY CYCLE
100MG/VIAL FYARRO AADI N213312 Nov. 22, 2021 RX POWDER INTRAVENOUS 12133844 June 29, 2036 TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC MALIGNANT PERIVASCULAR EPITHELIOID CELL TUMOR (PECOMA) WITH A DOSE OF 45 MG/M2 ADMINISTERED ON DAYS 1 AND 8 OF A 21-DAY CYCLE
100MG/VIAL FYARRO AADI N213312 Nov. 22, 2021 RX POWDER INTRAVENOUS 12133844 June 29, 2036 TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC MALIGNANT PERIVASCULAR EPITHELIOID CELL TUMOR (PECOMA) WITH A DOSE OF 45 MG/M2 OR 56 MG/M2 ADMINISTERED ON DAYS 1 AND 8 OF A 21-DAY CYCLE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG/VIAL FYARRO AADI N213312 Nov. 22, 2021 RX POWDER INTRAVENOUS Nov. 22, 2028 FOR THE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC MALIGNANT PERIVASCULAR EPITHELIOID CELL TUMOR (PECOMA)
0.2% HYFTOR NOBELPHARMA N213478 March 22, 2022 RX GEL TOPICAL March 22, 2029 TREATMENT OF FACIAL ANGIOFIBROMA ASSOCIATED WITH TUBEROUS SCLEROSIS IN ADULTS AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Peptidyl-prolyl cis-trans isomerase FKBP1A Enzyme INHIBITOR Kd 8.96 WOMBAT-PK CHEMBL
Cytochrome P450 3A4 Enzyme IC50 5.70 DRUG MATRIX
Multidrug resistance protein 1 Transporter IC50 6.20 WOMBAT-PK
ATP-binding cassette sub-family G member 2 Transporter IC50 5.72 CHEMBL
Cytochrome P450 2C9 Enzyme IC50 5.70 DRUG MATRIX
Serine/threonine-protein kinase mTOR Kinase IC50 10 CHEMBL
Peptidyl-prolyl cis-trans isomerase FKBP3 Enzyme Kd 9.70 WOMBAT-PK
Cytochrome P450 2C19 Enzyme IC50 5.40 DRUG MATRIX
Peptidyl-prolyl cis-trans isomerase FKBP4 Enzyme Kd 8.38 CHEMBL
Peptidyl-prolyl cis-trans isomerase FKBP1B Enzyme Kd 9.70 CHEMBL
Peptidyl-prolyl cis-trans isomerase FKBP5 Enzyme Ki 8.52 CHEMBL
Programmed cell death protein 4 Nuclear other EC50 7.30 CHEMBL
Eukaryotic translation initiation factor 4E Nuclear other Kd 9.30 CHEMBL
Sodium/nucleoside cotransporter 1 Transporter Ki 6.43 DRUG MATRIX
Pyruvate kinase PKM Enzyme IC50 7.30 CHEMBL
Peptidyl-prolyl cis-trans isomerase FKBP1A Enzyme IC50 9 CHEMBL
Sarcoplasmic/endoplasmic reticulum calcium ATPase 1 Enzyme IC50 4.11 CHEMBL
Serine/threonine-protein kinase mTOR Kinase IC50 10.30 CHEMBL

External reference:

IDSource
4021176 VUID
N0000148624 NUI
D00753 KEGG_DRUG
4021176 VANDF
C0072980 UMLSCUI
CHEBI:9168 CHEBI
CHEMBL413 ChEMBL_ID
D020123 MESH_DESCRIPTOR_UI
DB00877 DRUGBANK_ID
6031 IUPHAR_LIGAND_ID
7104 INN_ID
W36ZG6FT64 UNII
5284616 PUBCHEM_CID
258355 RXNORM
210889 MMSL
31418 MMSL
8303 MMSL
d04453 MMSL
007885 NDDF
116109004 SNOMEDCT_US
387014003 SNOMEDCT_US
W36ZG6FT64 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 0904-7248 TABLET, FILM COATED 1 mg ORAL ANDA 29 sections
Sirolimus Human Prescription Drug Label 1 16571-806 SOLUTION 1 mg ORAL ANDA 32 sections
Sirolimus Human Prescription Drug Label 1 16571-806 SOLUTION 1 mg ORAL ANDA 32 sections
sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 16714-187 TABLET, FILM COATED 0.50 mg ORAL ANDA 29 sections
sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 16714-188 TABLET, FILM COATED 1 mg ORAL ANDA 29 sections
sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 16714-189 TABLET, FILM COATED 2 mg ORAL ANDA 29 sections
SIROLIMUS HUMAN PRESCRIPTION DRUG LABEL 1 31722-316 SOLUTION 1 mg ORAL ANDA 26 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 50268-718 TABLET 1 mg ORAL ANDA 29 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 50268-718 TABLET 1 mg ORAL ANDA 29 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 55111-653 TABLET 1 mg ORAL ANDA 27 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 55111-654 TABLET 2 mg ORAL ANDA 27 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 59762-1001 TABLET, SUGAR COATED 0.50 mg ORAL NDA AUTHORIZED GENERIC 33 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 59762-1002 TABLET, SUGAR COATED 1 mg ORAL NDA AUTHORIZED GENERIC 33 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 59762-1003 TABLET, SUGAR COATED 2 mg ORAL NDA AUTHORIZED GENERIC 33 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 59762-1205 SOLUTION 1 mg ORAL NDA authorized generic 33 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 60505-6197 SOLUTION 1 mg ORAL ANDA 31 sections
sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 60687-902 TABLET, FILM COATED 0.50 mg ORAL ANDA 27 sections
sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 65841-771 TABLET, FILM COATED 0.50 mg ORAL ANDA 1 sections
sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 65841-772 TABLET, FILM COATED 1 mg ORAL ANDA 1 sections
sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 65841-773 TABLET, FILM COATED 2 mg ORAL ANDA 1 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 66689-347 SOLUTION 1 mg ORAL ANDA 29 sections
Sirolimus Human Prescription Drug Label 1 67877-746 TABLET 0.50 mg ORAL ANDA 29 sections
Sirolimus Human Prescription Drug Label 1 67877-746 TABLET 0.50 mg ORAL ANDA 29 sections
Sirolimus Human Prescription Drug Label 1 67877-747 TABLET 1 mg ORAL ANDA 29 sections
Sirolimus Human Prescription Drug Label 1 67877-747 TABLET 1 mg ORAL ANDA 29 sections
Sirolimus Human Prescription Drug Label 1 67877-748 TABLET 2 mg ORAL ANDA 29 sections
Sirolimus Human Prescription Drug Label 1 67877-748 TABLET 2 mg ORAL ANDA 29 sections
Sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 68084-915 TABLET 1 mg ORAL ANDA 27 sections
sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 68382-351 TABLET, FILM COATED 1 mg ORAL ANDA 28 sections
sirolimus HUMAN PRESCRIPTION DRUG LABEL 1 68382-352 TABLET, FILM COATED 2 mg ORAL ANDA 28 sections