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

Stem definitionDrug idCAS RN
antibiotics, cefalosporanic acid derivatives 535 88040-23-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • cefepime dihydrochloride hydrate
  • cefepime
  • cefepime hydrochloride
  • cefimen
  • tsefepim
  • cefepime HCl
A fourth-generation cephalosporin antibacterial agent that is used in the treatment of infections, including those of the abdomen, urinary tract, respiratory tract, and skin. It is effective against PSEUDOMONAS AERUGINOSA and may also be used in the empiric treatment of FEBRILE NEUTROPENIA.
  • Molecular weight: 480.56
  • Formula: C19H24N6O5S2
  • CLOGP: -4.87
  • LIPINSKI: 1
  • HAC: 11
  • HDO: 2
  • TPSA: 150.04
  • ALOGS: -4.49
  • ROTB: 7
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
4 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 85 % Benet LZ, Broccatelli F, Oprea TI
BA (Bioavailability) 100 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.28 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.20 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.78 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.90 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -1.324 High 0.87
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.986 High 0.87
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.893 10^-6 cm/s High 0.87
dh-clint Dog hepatocyte intrinsic clearance 1.884 uL/min/10^6 cells High 0.87
dppb Dog plasma protein binding (% unbound) 81.080 % High 0.87
fcs-ppb Fetal calf serum protein binding (% unbound) 70.820 % High 0.87
herg hERG pIC50 4.412 pIC50 High 0.87
hh-clint Human hepatocyte intrinsic clearance 1.592 uL/min/10^6 cells High 0.87
hlm-clint Human liver microsomal intrinsic clearance 3.622 uL/min/mg protein High 0.87
hppb Human plasma protein binding (% unbound) 72.500 % High 0.87
kinase-safety-class ACVR2A,ACVR2B,ACVRL1,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GRK3,GSK3B,ITK,JAK2,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MARK4,MELK,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIM2,PRKCD,PRKDC,SIK2,STK33,SYK,TEK,TTK,ULK1 51
kinase-selectivity-class AXL,CDK4,EIF2AK3,GRK2,MAP2K6,MAPK7,STK33,TEK,TTK 9
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 4.624 Moderate 0.69
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.692 High 0.87
mh-clint Mouse hepatocyte intrinsic clearance 4.581 High 0.87
mppb Mouse plasma protein binding (% unbound) 71.290 High 0.87
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 4.130 High 0.87
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 81.500 % High 0.87
rat-kpuu-brain Rat brain Kpuu 0.007 % Moderate 0.69
rh-clint Rat hepatocyte intrinsic clearance 3.105 uL/min/10^6 cells High 0.87
rh-fuinc Rat hepatocyte fraction unbound in incubation 89.250 % High 0.87
rppb Rat plasma protein binding (% unbound) 67.330 % High 0.87
solubility-dd Solubility at pH 7.4 in DMSO 922.571 uM High 0.87

Approvals:

DateAgencyCompanyOrphan
Jan. 18, 1996 FDA HOSPIRA INC

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
Encephalopathy 637.55 20.09 280 21302 46164 90560701
Acute kidney injury 455.28 20.09 465 21117 319922 90286943
Febrile neutropenia 399.57 20.09 318 21264 158031 90448834
Neurotoxicity 286.46 20.09 127 21455 21340 90585525
Drug reaction with eosinophilia and systemic symptoms 285.92 20.09 158 21424 42600 90564265
Multiple organ dysfunction syndrome 252.78 20.09 173 21409 68163 90538702
Status epilepticus 224.30 20.09 103 21479 18771 90588094
Cytokine release syndrome 213.83 20.09 113 21469 27860 90579005
Sepsis 210.50 20.09 236 21346 179578 90427287
Acute generalised exanthematous pustulosis 208.66 20.09 89 21493 13614 90593251
Septic shock 192.88 20.09 160 21422 84000 90522865
Pyrexia 155.42 20.09 424 21158 660061 89946804
Myoclonus 145.25 20.09 77 21505 19091 90587774
Thrombocytopenia 144.36 20.09 211 21371 208514 90398351
Respiratory failure 134.30 20.09 153 21429 118265 90488600
Toxic encephalopathy 134.08 20.09 57 21525 8642 90598223
Immune effector cell-associated neurotoxicity syndrome 131.16 20.09 50 21532 5718 90601147
Mental status changes 130.41 20.09 98 21484 44581 90562284
Pain 121.70 20.09 43 21539 996298 89610567
Neutropenia 116.25 20.09 199 21383 224705 90382160
Tubulointerstitial nephritis 110.15 20.09 71 21511 25272 90581593
Arthralgia 108.91 20.09 26 21556 778496 89828369
Acute respiratory distress syndrome 104.50 20.09 72 21510 28614 90578251
Fungaemia 101.97 20.09 36 21546 3314 90603551
Drug ineffective for unapproved indication 101.96 20.09 101 21481 66543 90540322
Drug resistance 100.63 20.09 72 21510 30377 90576488
Clostridium difficile colitis 99.58 20.09 68 21514 26638 90580227
Eosinophilia 90.93 20.09 66 21516 28467 90578398
Shock 88.16 20.09 65 21517 28713 90578152
Drug ineffective 87.68 20.09 595 20987 1383703 89223162
Neutrophil count decreased 87.17 20.09 96 21486 71436 90535429
Alopecia 86.02 20.09 9 21573 495062 90111803
Hypoxia 84.51 20.09 95 21487 72304 90534561
Nasopharyngitis 83.73 20.09 3 21579 407101 90199764
Abdominal discomfort 82.10 20.09 9 21573 477319 90129546
Platelet count decreased 79.83 20.09 128 21454 136841 90470024
Hypotension 78.27 20.09 211 21371 325186 90281679
Klebsiella infection 76.97 20.09 41 21541 10256 90596609
Bacteraemia 72.00 20.09 52 21530 22248 90584617
Renal impairment 71.94 20.09 106 21476 105315 90501550
Pathogen resistance 71.25 20.09 36 21546 8079 90598786
Pancytopenia 70.91 20.09 113 21469 120150 90486715
Systemic lupus erythematosus 70.06 20.09 4 21578 361892 90244973
Fatigue 69.47 20.09 105 21477 1153918 89452947
Rheumatoid arthritis 67.26 20.09 5 21577 362609 90244256
Headache 61.60 20.09 69 21513 862677 89744188
Malaise 60.69 20.09 32 21550 585954 90020911
Drug intolerance 60.44 20.09 16 21566 447575 90159290
Candida infection 60.37 20.09 56 21526 34001 90572864
Mixed liver injury 58.81 20.09 31 21551 7592 90599273
Pneumonia 57.92 20.09 302 21280 637757 89969108
Respiratory distress 57.65 20.09 58 21524 38888 90567977
Acute myeloid leukaemia 57.39 20.09 44 21538 20596 90586269
Peripheral swelling 57.25 20.09 14 21568 413092 90193773
Leukocytosis 56.96 20.09 52 21530 30938 90575927
Cytomegalovirus test positive 56.90 20.09 24 21558 3567 90603298
Toxic epidermal necrolysis 56.72 20.09 53 21529 32475 90574390
Acute respiratory failure 56.48 20.09 60 21522 42858 90564007
Renal failure 56.21 20.09 107 21475 130900 90475965
Swelling 54.67 20.09 16 21566 419042 90187823
Renal tubular necrosis 54.10 20.09 37 21545 14518 90592347
Rash maculo-papular 53.46 20.09 57 21525 40876 90565989
Linear IgA disease 52.73 20.09 20 21562 2254 90604611
Aspartate aminotransferase increased 51.67 20.09 90 21492 102847 90504018
Off label use 51.58 20.09 442 21140 1101810 89505055
Henoch-Schonlein purpura 51.49 20.09 18 21564 1609 90605256
Disseminated intravascular coagulation 51.48 20.09 42 21540 21496 90585369
Nephropathy toxic 51.35 20.09 34 21548 12654 90594211
Weight increased 50.90 20.09 18 21564 417909 90188956
Discomfort 50.24 20.09 4 21578 274331 90332534
Anaemia 50.15 20.09 191 21391 352611 90254254
Pericarditis 49.31 20.09 4 21578 270147 90336718
Pneumonia necrotising 49.29 20.09 14 21568 633 90606232
Dizziness 49.11 20.09 41 21541 589243 90017622
Hypoaesthesia 49.04 20.09 8 21574 314202 90292663
Blood creatinine increased 48.76 20.09 87 21495 101299 90505566
Metabolic acidosis 48.50 20.09 63 21519 55613 90551252
Therapeutic product effect decreased 48.28 20.09 5 21577 277566 90329299
Clostridium difficile infection 48.27 20.09 51 21531 36194 90570671
Agranulocytosis 47.95 20.09 50 21532 34952 90571913
Musculoskeletal stiffness 47.53 20.09 7 21575 296525 90310340
Lactic acidosis 46.95 20.09 59 21523 50404 90556461
Sinusitis 46.80 20.09 12 21570 343076 90263789
Trichosporon infection 46.71 20.09 12 21570 369 90606496
Hepatic function abnormal 46.09 20.09 56 21526 46232 90560633
Metabolic encephalopathy 45.22 20.09 25 21557 6727 90600138
Bronchopulmonary aspergillosis 44.81 20.09 30 21552 11368 90595497
Rash morbilliform 44.77 20.09 21 21561 4008 90602857
Leukopenia 44.11 20.09 83 21499 100627 90506238
Staphylococcal infection 44.06 20.09 56 21526 48383 90558482
Antibiotic level above therapeutic 43.53 20.09 12 21570 486 90606379
Enterococcal infection 43.43 20.09 28 21554 9963 90596902
Cholestatic liver injury 42.84 20.09 20 21562 3777 90603088
Eosinophilic pneumonia 42.16 20.09 18 21564 2755 90604110
Weight decreased 41.94 20.09 19 21563 379891 90226974
Haemophagocytic lymphohistiocytosis 40.90 20.09 32 21550 15427 90591438
Herpes simplex 40.51 20.09 27 21555 10154 90596711
Alanine aminotransferase increased 40.47 20.09 88 21494 118250 90488615
Stenotrophomonas infection 40.39 20.09 17 21565 2512 90604353
Toxic skin eruption 40.33 20.09 32 21550 15742 90591123
Product dose omission issue 40.16 20.09 10 21572 291677 90315188
Mitochondrial toxicity 40.13 20.09 12 21570 651 90606214
Lower respiratory tract infection 39.97 20.09 6 21576 250653 90356212
Brain oedema 39.66 20.09 33 21549 17352 90589513
Mucormycosis 39.66 20.09 19 21563 3802 90603063
Tonsillitis bacterial 39.27 20.09 9 21573 169 90606696
Pneumonia fungal 38.95 20.09 23 21559 7008 90599857
Product use issue 38.82 20.09 15 21567 329904 90276961
White blood cell count decreased 38.73 20.09 107 21475 167002 90439863
Hypersensitivity 38.64 20.09 31 21551 454646 90152219
Hepatic enzyme increased 38.34 20.09 19 21563 360717 90246148
Graft versus host disease 38.33 20.09 24 21558 8120 90598745
Pleural effusion 37.98 20.09 83 21499 111908 90494957
Gait disturbance 37.72 20.09 8 21574 260488 90346377
Pseudomonal sepsis 37.52 20.09 19 21563 4283 90602582
Type 2 diabetes mellitus 37.11 20.09 3 21579 203241 90403624
Asthma 35.97 20.09 7 21575 242153 90364712
Sleep disorder 35.94 20.09 3 21579 198027 90408838
Muscle spasms 35.93 20.09 8 21574 251875 90354990
Pseudomonas infection 35.55 20.09 29 21553 14836 90592029
Venoocclusive liver disease 34.24 20.09 20 21562 5973 90600892
Pneumonia cytomegaloviral 33.91 20.09 16 21566 3095 90603770
Hyperbilirubinaemia 32.93 20.09 27 21555 13909 90592956
Osteoarthritis 32.83 20.09 4 21578 195726 90411139
Vascular device infection 32.18 20.09 25 21557 11927 90594938
Differentiation syndrome 31.93 20.09 12 21570 1319 90605546
Paraesthesia 31.82 20.09 10 21572 250316 90356549
Abdominal pain upper 31.77 20.09 20 21562 332654 90274211
Depression 31.68 20.09 16 21566 300585 90306280
Encephalitis Japanese B 31.23 20.09 6 21576 45 90606820
Infusion related reaction 31.14 20.09 32 21550 416748 90190117
Injury 30.83 20.09 5 21577 197344 90409521
Enterococcal bacteraemia 30.29 20.09 13 21569 2015 90604850
Acute graft versus host disease in skin 30.19 20.09 17 21565 4739 90602126
Hypertensive heart disease 30.08 20.09 14 21568 2626 90604239
Pulmonary trichosporonosis 30.06 20.09 6 21576 56 90606809
Cholestasis 29.95 20.09 40 21542 36259 90570606
Respiratory alkalosis 29.40 20.09 15 21567 3433 90603432
Nephritis allergic 29.06 20.09 8 21574 322 90606543
Meningitis bacterial 28.96 20.09 12 21570 1705 90605160
Pain in extremity 28.93 20.09 39 21543 450490 90156375
Rash pustular 28.83 20.09 20 21562 8029 90598836
Impaired healing 28.63 20.09 10 21572 234189 90372676
Nail bed inflammation 28.41 20.09 12 21570 1789 90605076
Haemodynamic instability 28.28 20.09 23 21559 11716 90595149
Thrombotic microangiopathy 28.11 20.09 26 21556 15717 90591148
Dry mouth 28.01 20.09 5 21577 184054 90422811
Engraft failure 28.01 20.09 8 21574 369 90606496
Altered state of consciousness 27.96 20.09 36 21546 31496 90575369
Symmetrical drug-related intertriginous and flexural exanthema 27.82 20.09 10 21572 969 90605896
Cardiac arrest 27.14 20.09 70 21512 104865 90502000
Contusion 27.03 20.09 13 21569 251203 90355662
Eosinophilic pneumonia acute 26.88 20.09 9 21573 706 90606159
Dyspepsia 26.87 20.09 7 21575 198153 90408712
Neutropenic colitis 26.81 20.09 15 21567 4128 90602737
Drug level increased 26.68 20.09 33 21549 27729 90579136
Arthritis 26.68 20.09 4 21578 167311 90439554
Pulmonary haemorrhage 26.58 20.09 19 21563 7994 90598871
Ill-defined disorder 26.10 20.09 6 21576 184885 90421980
Musculoskeletal pain 25.32 20.09 5 21577 171246 90435619
Stevens-Johnson syndrome 25.20 20.09 33 21549 29343 90577522
Cytomegalovirus viraemia 25.19 20.09 18 21564 7568 90599297
Laryngeal inflammation 25.15 20.09 6 21576 135 90606730
Tumour lysis syndrome 25.09 20.09 21 21561 11131 90595734
Psoriasis 24.82 20.09 3 21579 147751 90459114
Blister 24.80 20.09 15 21567 254983 90351882
Nasal mucosal disorder 24.80 20.09 11 21571 1846 90605019
Blood bilirubin increased 24.44 20.09 40 21542 43430 90563435
Klebsiella bacteraemia 24.23 20.09 12 21570 2580 90604285
Hyperkalaemia 24.15 20.09 50 21532 64914 90541951
Acute myeloid leukaemia recurrent 23.72 20.09 11 21571 2046 90604819
Insomnia 23.35 20.09 27 21555 333447 90273418
Hyperoxaluria 23.34 20.09 6 21576 185 90606680
Drug eruption 23.27 20.09 35 21547 35372 90571493
Streptococcal sepsis 23.26 20.09 13 21569 3571 90603294
Staphylococcal bacteraemia 23.16 20.09 17 21565 7452 90599413
Enterococcal sepsis 22.96 20.09 10 21572 1606 90605259
Clostridial infection 22.67 20.09 14 21568 4622 90602243
Chemotherapeutic drug level increased 22.61 20.09 6 21576 210 90606655
Dysbiosis 22.46 20.09 10 21572 1692 90605173
Pseudomembranous colitis 22.34 20.09 13 21569 3855 90603010
Sputum abnormal 22.32 20.09 8 21574 769 90606096
Neutrophilia 22.21 20.09 15 21567 5763 90601102
Aphasia 22.21 20.09 38 21544 42774 90564091
Mucosal inflammation 22.19 20.09 45 21537 57580 90549285
Injection site pain 21.96 20.09 7 21575 173692 90433173
Seizure 21.93 20.09 83 21499 152546 90454319
Bullous haemorrhagic dermatosis 21.93 20.09 6 21576 236 90606629
Osteomyelitis 21.93 20.09 30 21552 27816 90579049
Systemic candida 21.80 20.09 14 21568 4945 90601920
Drug interaction 21.71 20.09 126 21456 276327 90330538
Memory impairment 21.53 20.09 10 21572 197234 90409631
Brain herniation 21.35 20.09 13 21569 4187 90602678
Crystalluria 20.83 20.09 7 21575 555 90606310
Tachycardia 20.43 20.09 83 21499 157590 90449275
Septic embolus 20.38 20.09 8 21574 989 90605876
Angiokeratoma 20.19 20.09 5 21577 132 90606733
Gait inability 20.19 20.09 5 21577 146451 90460414

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
Encephalopathy 325.91 16.13 245 27253 41088 42552749
Acute kidney injury 319.12 16.13 718 26780 366619 42227218
Cytokine release syndrome 225.18 16.13 204 27294 44323 42549514
Drug reaction with eosinophilia and systemic symptoms 223.12 16.13 198 27300 41877 42551960
Neurotoxicity 199.30 16.13 146 27352 23505 42570332
Febrile neutropenia 172.74 16.13 374 27124 185329 42408508
Septic shock 168.73 16.13 249 27249 91423 42502414
Drug ineffective 134.03 16.13 775 26723 629422 41964415
Multiple organ dysfunction syndrome 119.55 16.13 220 27278 96815 42497022
Fatigue 117.40 16.13 68 27430 435573 42158264
Renal tubular necrosis 100.45 16.13 88 27410 18266 42575571
Respiratory failure 98.92 16.13 240 27258 127892 42465945
Clostridium difficile colitis 96.95 16.13 92 27406 21160 42572677
Pathogen resistance 94.87 16.13 70 27428 11380 42582457
Immune effector cell-associated neurotoxicity syndrome 92.56 16.13 64 27434 9397 42584440
Pyrexia 85.45 16.13 488 27010 393554 42200283
Mental status changes 79.68 16.13 116 27382 41999 42551838
Immune thrombocytopenia 78.47 16.13 62 27436 11154 42582683
Hypoxia 76.95 16.13 151 27347 69635 42524202
Product dose omission issue 76.90 16.13 6 27492 154359 42439478
Death 74.01 16.13 119 27379 471066 42122771
Dizziness 69.73 16.13 37 27461 249217 42344620
Tubulointerstitial nephritis 68.75 16.13 93 27405 31455 42562382
Neutrophil count decreased 66.05 16.13 134 27364 63281 42530556
Methaemoglobinaemia 65.94 16.13 43 27455 5731 42588106
Sepsis 65.32 16.13 278 27220 199056 42394781
Neutropenia 63.70 16.13 276 27222 199155 42394682
Acute generalised exanthematous pustulosis 63.35 16.13 49 27449 8546 42585291
Acute respiratory distress syndrome 62.95 16.13 87 27411 30021 42563816
Bronchopulmonary aspergillosis 61.28 16.13 69 27429 19360 42574477
Drug ineffective for unapproved indication 61.02 16.13 108 27390 46055 42547782
Disseminated intravascular coagulation 60.07 16.13 77 27421 24717 42569120
Myoclonus 59.71 16.13 64 27434 17001 42576836
Enterococcal infection 54.67 16.13 52 27446 11987 42581850
Nephropathy toxic 53.44 16.13 60 27438 16778 42577059
Drug resistance 53.04 16.13 86 27412 34162 42559675
Pseudomonas infection 52.71 16.13 58 27440 15865 42577972
Arthralgia 52.37 16.13 34 27464 205204 42388633
Toxic encephalopathy 52.03 16.13 40 27458 6913 42586924
Fall 51.94 16.13 45 27453 234475 42359362
Botulism 50.30 16.13 14 27484 208 42593629
Acute respiratory failure 50.18 16.13 90 27408 38768 42555069
Thrombocytopenia 50.15 16.13 249 27249 190030 42403807
Pain 49.52 16.13 51 27447 244797 42349040
Bacteraemia 48.85 16.13 70 27428 24970 42568867
Myocardial infarction 45.33 16.13 12 27486 123997 42469840
Haemophagocytic lymphohistiocytosis 44.78 16.13 57 27441 18165 42575672
Acute myeloid leukaemia recurrent 44.68 16.13 28 27470 3484 42590353
Aspergillus infection 44.50 16.13 53 27445 15784 42578053
Confusional state 43.91 16.13 219 27279 167378 42426459
Haemodialysis 42.24 16.13 42 27456 10218 42583619
Depression 42.20 16.13 10 27488 111353 42482484
Mucormycosis 40.59 16.13 35 27463 7108 42586729
Status epilepticus 40.30 16.13 50 27448 15528 42578309
Weight decreased 40.15 16.13 45 27453 207903 42385934
Candida infection 40.09 16.13 59 27439 21551 42572286
Septic embolus 39.72 16.13 19 27479 1386 42592451
Brain herniation 38.86 16.13 29 27469 4794 42589043
Eosinophilia 38.45 16.13 73 27425 32826 42561011
Cholestasis 37.25 16.13 72 27426 32807 42561030
Gait disturbance 36.74 16.13 9 27489 97991 42495846
Meningitis candida 35.78 16.13 10 27488 151 42593686
Blood culture positive 35.48 16.13 28 27470 5025 42588812
Off label use 35.26 16.13 592 26906 637743 41956094
Blood pressure increased 35.15 16.13 11 27487 101917 42491920
Cytomegalovirus enterocolitis 34.00 16.13 17 27481 1366 42592471
Antibiotic level above therapeutic 33.73 16.13 12 27486 409 42593428
Aspartate aminotransferase increased 33.70 16.13 118 27380 77045 42516792
Toxic epidermal necrolysis 33.31 16.13 61 27437 26689 42567148
Enterococcal bacteraemia 33.27 16.13 21 27477 2646 42591191
Cytomegalovirus viraemia 32.97 16.13 37 27461 10340 42583497
Rash maculo-papular 32.97 16.13 74 27424 37429 42556408
Platelet count decreased 32.75 16.13 176 27322 138405 42455432
Anxiety 32.51 16.13 18 27480 118542 42475295
Insomnia 32.36 16.13 18 27480 118235 42475602
Klebsiella infection 31.96 16.13 38 27460 11294 42582543
Inappropriate schedule of product administration 31.92 16.13 11 27487 95891 42497946
White blood cell count decreased 31.58 16.13 148 27350 110248 42483589
Glomerulosclerosis 31.54 16.13 14 27484 860 42592977
Malaise 30.95 16.13 56 27442 212100 42381737
Headache 30.79 16.13 68 27430 239301 42354536
Dyspnoea 30.33 16.13 165 27333 442456 42151381
Agranulocytosis 29.86 16.13 63 27435 30549 42563288
Asthenia 29.78 16.13 88 27410 280705 42313132
Phrenic nerve paralysis 29.61 16.13 9 27489 185 42593652
Drug level increased 29.22 16.13 57 27441 26143 42567694
Peripheral swelling 28.95 16.13 11 27487 90259 42503578
Clostridium difficile infection 28.63 16.13 52 27446 22607 42571230
Metabolic encephalopathy 28.31 16.13 25 27473 5240 42588597
Joint swelling 28.05 16.13 5 27493 68017 42525820
Corynebacterium bacteraemia 27.91 16.13 8 27490 133 42593704
Pain in extremity 27.54 16.13 34 27464 150570 42443267
Staphylococcal infection 27.37 16.13 69 27429 37574 42556263
Cerebral aspergillosis 27.33 16.13 16 27482 1761 42592076
Delirium 27.11 16.13 85 27413 52434 42541403
CNS ventriculitis 27.03 16.13 10 27488 382 42593455
Feeling abnormal 26.96 16.13 6 27492 69780 42524057
Tumour lysis syndrome 26.81 16.13 50 27448 22181 42571656
Intentional product misuse 26.76 16.13 4 27494 61896 42531941
Injection site pain 26.75 16.13 3 27495 57795 42536042
Uraemic encephalopathy 26.26 16.13 10 27488 414 42593423
Systemic candida 26.12 16.13 24 27474 5295 42588542
Procalcitonin increased 26.11 16.13 17 27481 2259 42591578
Burkholderia test positive 26.09 16.13 13 27485 1037 42592800
Renal failure 25.88 16.13 170 27328 143556 42450281
Alanine aminotransferase increased 25.62 16.13 119 27379 88287 42505550
Fungaemia 25.58 16.13 19 27479 3117 42590720
Acute myeloid leukaemia 25.53 16.13 49 27449 22207 42571630
Drug intolerance 25.45 16.13 10 27488 80414 42513423
Disseminated mucormycosis 25.36 16.13 14 27484 1377 42592460
Muscle spasms 25.17 16.13 12 27486 86032 42507805
Asthma 24.80 16.13 5 27493 62309 42531528
Drug-induced liver injury 24.60 16.13 67 27431 38206 42555631
Musculoskeletal stiffness 24.36 16.13 4 27494 57761 42536076
Enterocolitis 24.30 16.13 31 27467 9898 42583939
Hypotension 24.07 16.13 263 27235 257368 42336469
Hypercapnia 24.04 16.13 23 27475 5338 42588499
Pulmonary haemorrhage 23.91 16.13 33 27465 11364 42582473
Cerebral ventricle collapse 23.85 16.13 7 27491 127 42593710
Pancytopenia 23.51 16.13 143 27355 117600 42476237
Acidosis 23.46 16.13 34 27464 12245 42581592
Stevens-Johnson syndrome 23.23 16.13 47 27451 22131 42571706
Bacterial toxaemia 23.21 16.13 7 27491 140 42593697
Cholestatic liver injury 22.76 16.13 19 27479 3690 42590147
Masked fever 22.32 16.13 5 27493 28 42593809
Cutaneous mucormycosis 22.21 16.13 10 27488 635 42593202
Corynebacterium infection 22.14 16.13 11 27487 872 42592965
Pleural effusion 21.99 16.13 122 27376 97044 42496793
Drug eruption 21.94 16.13 47 27451 23028 42570809
Choluria 21.89 16.13 7 27491 171 42593666
Cytokine storm 21.85 16.13 11 27487 897 42592940
Neutropenic colitis 21.62 16.13 20 27478 4450 42589387
Nausea 20.97 16.13 160 27338 396639 42197198
Rash morbilliform 20.90 16.13 19 27479 4134 42589703
Hypersensitivity vasculitis 20.71 16.13 17 27481 3227 42590610
Systemic mycosis 20.69 16.13 15 27483 2372 42591465
Aphasia 20.58 16.13 47 27451 24036 42569801
Aeromonas infection 20.55 16.13 8 27490 352 42593485
Pneumonia 20.50 16.13 384 27114 421765 42172072
Chest pain 20.17 16.13 37 27461 139493 42454344
Back pain 20.14 16.13 38 27460 141738 42452099
Nasopharyngitis 19.95 16.13 15 27483 83981 42509856
Suicide attempt 19.87 16.13 3 27495 46097 42547740
Loss of personal independence in daily activities 19.82 16.13 4 27494 49812 42544025
Hepatosplenic candidiasis 19.81 16.13 7 27491 234 42593603
Blood creatinine increased 19.72 16.13 130 27368 109873 42483964
Fungal infection 19.71 16.13 41 27457 19681 42574156
Leukoerythroblastosis 19.69 16.13 5 27493 51 42593786
Transaminases increased 19.59 16.13 56 27442 32829 42561008
Differentiation syndrome 19.48 16.13 13 27485 1800 42592037
Pelvic haemorrhage 19.38 16.13 4 27494 14 42593823
Unresponsive to stimuli 19.22 16.13 54 27444 31349 42562488
Device related infection 18.93 16.13 41 27457 20238 42573599
Acute lymphocytic leukaemia recurrent 18.80 16.13 17 27481 3674 42590163
Haemodynamic instability 18.71 16.13 31 27467 12526 42581311
Trichosporon infection 18.52 16.13 10 27488 942 42592895
Pneumonia fungal 18.47 16.13 26 27472 9120 42584717
Eye infection fungal 18.21 16.13 8 27490 479 42593358
Coronary artery disease 18.15 16.13 6 27492 53714 42540123
Memory impairment 18.07 16.13 5 27493 50217 42543620
Gallbladder fistula 17.76 16.13 4 27494 23 42593814
Neuropathy peripheral 17.57 16.13 24 27474 101829 42492008
Respiratory distress 17.43 16.13 63 27435 41757 42552080
Sputum culture positive 17.40 16.13 12 27486 1754 42592083
Adenoviral haemorrhagic cystitis 17.38 16.13 8 27490 535 42593302
Dysbiosis 17.23 16.13 9 27489 792 42593045
Weight increased 17.11 16.13 27 27471 107956 42485881
Hyperhidrosis 16.99 16.13 20 27478 90492 42503345
Geotrichum infection 16.91 16.13 8 27490 569 42593268
Diaphragmatic paralysis 16.89 16.13 8 27490 571 42593266
Staphylococcus test positive 16.86 16.13 16 27482 3676 42590161
Kidney fibrosis 16.82 16.13 14 27484 2708 42591129
Stenotrophomonas infection 16.82 16.13 16 27482 3688 42590149
Lactobacillus infection 16.82 16.13 7 27491 367 42593470
Staphylococcal sepsis 16.77 16.13 28 27470 11386 42582451
Hospitalisation 16.74 16.13 14 27484 74316 42519521
Cerebrovascular accident 16.65 16.13 23 27475 97137 42496700
Vomiting 16.65 16.13 114 27384 289609 42304228
Flavobacterium infection 16.62 16.13 5 27493 99 42593738
Abscess bacterial 16.55 16.13 6 27492 216 42593621
Cardiac arrest 16.55 16.13 124 27374 109196 42484641
Diarrhoea 16.26 16.13 205 27293 460644 42133193
Blood bilirubin increased 16.23 16.13 62 27436 42190 42551647
Clostridial infection 16.21 16.13 16 27482 3858 42589979

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
Encephalopathy 890.64 16.30 505 46213 80550 110462031
Acute kidney injury 772.15 16.30 1131 45587 634299 109908282
Febrile neutropenia 496.60 16.30 639 46079 316128 110226453
Drug reaction with eosinophilia and systemic symptoms 485.61 16.30 346 46372 81749 110460832
Neurotoxicity 479.52 16.30 269 46449 41938 110500643
Cytokine release syndrome 447.62 16.30 310 46408 69996 110472585
Septic shock 358.44 16.30 385 46333 157143 110385438
Multiple organ dysfunction syndrome 310.85 16.30 351 46367 151359 110391222
Drug ineffective 285.49 16.30 1330 45388 1519210 109023371
Sepsis 237.13 16.30 464 46254 326882 110215699
Immune effector cell-associated neurotoxicity syndrome 223.48 16.30 114 46604 14668 110527913
Respiratory failure 222.83 16.30 357 46361 214975 110327606
Status epilepticus 221.72 16.30 148 46570 31423 110511158
Mental status changes 210.94 16.30 207 46511 75915 110466666
Pyrexia 206.05 16.30 836 45882 897429 109645152
Thrombocytopenia 197.30 16.30 447 46271 348438 110194143
Pain 190.29 16.30 83 46635 954872 109587709
Myoclonus 185.62 16.30 135 46583 32863 110509718
Acute generalised exanthematous pustulosis 185.33 16.30 115 46603 21549 110521032
Neutropenia 178.39 16.30 449 46269 374171 110168410
Clostridium difficile colitis 176.40 16.30 147 46571 43631 110498950
Arthralgia 174.94 16.30 56 46662 779576 109763005
Fatigue 170.76 16.30 158 46560 1215800 109326781
Renal tubular necrosis 167.61 16.30 123 46595 30352 110512229
Tubulointerstitial nephritis 166.22 16.30 156 46562 54128 110488453
Drug resistance 164.99 16.30 158 46560 56216 110486365
Hypoxia 158.21 16.30 232 46486 129283 110413298
Joint swelling 157.43 16.30 7 46711 442838 110099743
Acute respiratory distress syndrome 155.50 16.30 149 46569 53049 110489532
Drug ineffective for unapproved indication 153.69 16.30 203 46515 102635 110439946
Pathogen resistance 151.65 16.30 94 46624 17578 110525003
Neutrophil count decreased 149.68 16.30 218 46500 120723 110421858
Toxic encephalopathy 146.17 16.30 87 46631 15127 110527454
Dizziness 130.70 16.30 66 46652 698127 109844454
Platelet count decreased 122.12 16.30 288 46430 230155 110312426
Eosinophilia 118.43 16.30 134 46584 57802 110484779
Headache 117.43 16.30 120 46598 882257 109660324
Disseminated intravascular coagulation 111.96 16.30 111 46607 41175 110501406
Alopecia 109.16 16.30 13 46705 364740 110177841
Drug intolerance 108.97 16.30 20 46698 406492 110136089
Nasopharyngitis 108.78 16.30 18 46700 394343 110148238
Malaise 108.14 16.30 76 46642 671743 109870838
Acute respiratory failure 106.97 16.30 145 46573 75115 110467466
Fungaemia 106.96 16.30 52 46666 6034 110536547
Rheumatoid arthritis 105.57 16.30 5 46713 299608 110242973
Bronchopulmonary aspergillosis 105.47 16.30 93 46625 29770 110512811
Arthropathy 103.96 16.30 4 46714 287518 110255063
Peripheral swelling 103.85 16.30 22 46696 404012 110138569
Product dose omission issue 102.67 16.30 9 46709 321773 110220808
Bacteraemia 100.48 16.30 106 46612 42284 110500297
Nephropathy toxic 99.91 16.30 87 46631 27391 110515190
Pancytopenia 98.30 16.30 250 46468 209363 110333218
Enterococcal infection 98.22 16.30 76 46642 20290 110522291
Abdominal discomfort 98.09 16.30 23 46695 393835 110148746
Haemophagocytic lymphohistiocytosis 91.46 16.30 88 46630 31471 110511110
Contraindicated product administered 91.33 16.30 3 46715 248264 110294317
Klebsiella infection 90.73 16.30 72 46646 19937 110522644
Hypotension 89.11 16.30 447 46271 523402 110019179
Renal failure 88.90 16.30 253 46465 226321 110316260
Therapeutic product effect decreased 86.31 16.30 4 46714 244312 110298269
Toxic epidermal necrolysis 84.75 16.30 112 46606 56615 110485966
Candida infection 84.73 16.30 103 46615 47906 110494675
Methaemoglobinaemia 84.37 16.30 51 46667 9117 110533464
Mobility decreased 83.51 16.30 4 46714 237418 110305163
Mucormycosis 82.35 16.30 53 46665 10575 110532006
Rash maculo-papular 82.10 16.30 127 46591 74095 110468486
Systemic lupus erythematosus 81.44 16.30 7 46711 254331 110288250
Musculoskeletal stiffness 81.21 16.30 11 46707 279811 110262770
Off label use 80.47 16.30 976 45742 1499209 109043372
Pseudomonas infection 79.46 16.30 77 46641 27776 110514805
Aspartate aminotransferase increased 77.31 16.30 193 46525 159743 110382838
Shock 77.28 16.30 104 46614 53484 110489097
Hypoaesthesia 76.95 16.30 19 46699 314204 110228377
Weight increased 74.99 16.30 42 46676 419602 110122979
Asthma 74.66 16.30 9 46709 250282 110292299
Agranulocytosis 74.45 16.30 110 46608 61650 110480931
Acute myeloid leukaemia 74.25 16.30 86 46632 38024 110504557
Immune thrombocytopenia 73.40 16.30 67 46651 22427 110520154
Blood creatinine increased 72.48 16.30 205 46513 182684 110359897
Depression 72.43 16.30 22 46696 317313 110225268
Staphylococcal infection 72.27 16.30 116 46602 69828 110472753
Pneumonia 72.05 16.30 623 46095 876091 109666490
Lower respiratory tract infection 71.88 16.30 9 46709 243097 110299484
Gait disturbance 71.76 16.30 15 46703 278193 110264388
Weight decreased 71.30 16.30 56 46662 468001 110074580
White blood cell count decreased 71.18 16.30 236 46482 229154 110313427
Clostridium difficile infection 70.39 16.30 98 46620 52031 110490550
Cholestasis 69.41 16.30 109 46609 64409 110478172
Antibiotic level above therapeutic 68.63 16.30 23 46695 1010 110541571
Pain in extremity 68.43 16.30 63 46655 487055 110055526
Sleep disorder 67.81 16.30 4 46714 198640 110343941
Fall 67.43 16.30 94 46624 603388 109939193
Pleural effusion 67.32 16.30 196 46522 177513 110365068
Metabolic encephalopathy 66.19 16.30 47 46671 11013 110531568
Swelling 65.85 16.30 33 46685 351008 110191573
Dry mouth 65.40 16.30 5 46713 199943 110342638
Blood cholesterol increased 65.35 16.30 3 46715 184782 110357799
Renal impairment 64.00 16.30 200 46518 188245 110354336
Muscle spasms 63.99 16.30 19 46699 278138 110264443
Aspergillus infection 62.39 16.30 65 46653 25551 110517030
Discomfort 60.98 16.30 9 46709 214698 110327883
Brain herniation 60.89 16.30 41 46677 8822 110533759
Leukocytosis 60.78 16.30 93 46625 53735 110488846
Drug level increased 60.42 16.30 87 46631 47632 110494949
Insomnia 60.33 16.30 39 46679 360551 110182030
Haemodialysis 60.22 16.30 54 46664 17665 110524916
Cholestatic liver injury 60.17 16.30 38 46680 7338 110535243
Rash morbilliform 60.00 16.30 39 46679 7912 110534669
Trichosporon infection 59.74 16.30 22 46696 1278 110541303
Tumour lysis syndrome 59.16 16.30 69 46649 30732 110511849
Acute myeloid leukaemia recurrent 58.99 16.30 33 46685 5106 110537475
Alanine aminotransferase increased 58.72 16.30 191 46527 183582 110358999
Pericarditis 58.21 16.30 11 46707 219103 110323478
Septic embolus 56.90 16.30 25 46693 2301 110540280
Paraesthesia 56.53 16.30 23 46695 276498 110266083
Pneumonia fungal 56.24 16.30 48 46670 14706 110527875
Respiratory distress 55.10 16.30 102 46616 68772 110473809
Enterococcal bacteraemia 54.92 16.30 30 46688 4431 110538150
Neutropenic colitis 54.67 16.30 37 46681 8028 110534553
Cytomegalovirus viraemia 54.26 16.30 51 46667 17713 110524868
Sinusitis 53.99 16.30 29 46689 296659 110245922
Osteoarthritis 53.40 16.30 7 46711 182616 110359965
Arthritis 52.59 16.30 5 46713 167581 110375000
Contusion 51.77 16.30 17 46701 233344 110309237
Pulmonary haemorrhage 51.72 16.30 48 46670 16408 110526173
Abdominal pain upper 50.38 16.30 44 46674 349067 110193514
Stevens-Johnson syndrome 50.12 16.30 79 46639 46822 110495759
Gastrooesophageal reflux disease 50.07 16.30 8 46710 179968 110362613
Folliculitis 50.06 16.30 6 46712 167647 110374934
Anxiety 49.18 16.30 44 46674 345034 110197547
Blood pressure increased 48.88 16.30 24 46694 258349 110284232
Hepatic function abnormal 47.67 16.30 112 46606 89183 110453398
Differentiation syndrome 47.53 16.30 24 46694 3020 110539561
Type 2 diabetes mellitus 46.85 16.30 9 46709 177223 110365358
Nausea 46.85 16.30 318 46400 1235372 109307209
Confusional state 46.50 16.30 348 46370 468332 110074249
Dyspnoea 46.48 16.30 276 46442 1106596 109435985
Memory impairment 46.12 16.30 13 46705 196931 110345650
Lactic acidosis 45.88 16.30 113 46605 92698 110449883
Cardiac arrest 45.45 16.30 184 46534 196569 110346012
Injection site pain 45.04 16.30 10 46708 177912 110364669
Muscle injury 44.72 16.30 4 46714 140803 110401778
Blood bilirubin increased 44.66 16.30 99 46619 75873 110466708
Linear IgA disease 44.52 16.30 26 46692 4363 110538218
Leukopenia 44.28 16.30 151 46567 148640 110393941
Impaired healing 44.22 16.30 14 46704 196703 110345878
Hypersensitivity 44.02 16.30 64 46654 403934 110138647
Dyspepsia 43.99 16.30 13 46705 190952 110351629
Botulism 43.94 16.30 14 46704 523 110542058
Eosinophilic pneumonia 43.92 16.30 31 46687 7196 110535385
Mixed liver injury 43.41 16.30 38 46680 12041 110530540
Pneumonia necrotising 43.17 16.30 19 46699 1756 110540825
Cytomegalovirus test positive 42.34 16.30 30 46688 7006 110535575
Pseudomonal sepsis 41.98 16.30 33 46685 9013 110533568
Ill-defined disorder 41.39 16.30 8 46710 156845 110385736
Injury 40.96 16.30 12 46706 177253 110365328
Myocardial infarction 40.87 16.30 15 46703 192068 110350513
Infusion related reaction 39.95 16.30 62 46656 381100 110161481
Hepatic enzyme increased 39.93 16.30 46 46672 320846 110221735
Drug eruption 39.86 16.30 77 46641 53582 110488999
Chest pain 39.66 16.30 61 46657 376314 110166267
Night sweats 39.50 16.30 5 46713 133978 110408603
Musculoskeletal pain 39.44 16.30 14 46704 183009 110359572
Systemic candida 39.14 16.30 33 46685 9941 110532640
Enterocolitis 39.00 16.30 44 46674 18905 110523676
Cytomegalovirus enterocolitis 38.62 16.30 19 46699 2262 110540319
Blood culture positive 37.94 16.30 31 46687 8945 110533636
Nephritis allergic 37.86 16.30 15 46703 1064 110541517
CNS ventriculitis 37.33 16.30 13 46705 642 110541939
Aphasia 37.09 16.30 79 46639 58918 110483663
Feeling abnormal 36.97 16.30 15 46703 180696 110361885
Loss of personal independence in daily activities 36.84 16.30 9 46709 150011 110392570
Obesity 36.60 16.30 3 46715 113348 110429233
Acidosis 36.00 16.30 46 46672 22485 110520096
Venoocclusive liver disease 35.98 16.30 38 46680 15169 110527412
Clostridial infection 35.92 16.30 26 46692 6276 110536305
Graft versus host disease 35.90 16.30 42 46676 18764 110523817
Procalcitonin increased 35.87 16.30 22 46696 4034 110538547
Meningitis candida 35.81 16.30 10 46708 235 110542346
Wheezing 35.81 16.30 33 46685 255197 110287384
Meningitis bacterial 35.60 16.30 20 46698 3119 110539462
Gastrointestinal disorder 35.49 16.30 30 46688 241922 110300659
Balance disorder 35.22 16.30 4 46714 116556 110426025
Pneumonia bacterial 34.90 16.30 49 46669 26212 110516369
Asthenia 34.32 16.30 162 46556 688837 109853744
Unresponsive to stimuli 34.03 16.30 80 46638 63710 110478871
Haemodynamic instability 33.88 16.30 45 46673 22843 110519738
Gait inability 33.84 16.30 8 46710 136368 110406213
Device related infection 33.47 16.30 60 46658 39459 110503122
Stenotrophomonas infection 33.01 16.30 24 46694 5834 110536747
Henoch-Schonlein purpura 32.76 16.30 20 46698 3637 110538944
Brain oedema 32.70 16.30 52 46666 31046 110511535
Suicide attempt 32.66 16.30 3 46715 103391 110439190
Engraftment syndrome 32.43 16.30 16 46702 1916 110540665
Drug-induced liver injury 32.40 16.30 118 46600 119949 110422632
Delirium 31.75 16.30 127 46591 134898 110407683
Vascular device infection 31.72 16.30 37 46681 16475 110526106
Blood urea increased 31.61 16.30 71 46647 54886 110487695
Pneumonia cytomegaloviral 31.47 16.30 25 46693 6929 110535652
Lip dry 31.36 16.30 3 46715 100080 110442501
Tonsillitis bacterial 31.22 16.30 9 46709 238 110542343
Liver abscess 31.19 16.30 26 46692 7713 110534868
Pulmonary trichosporonosis 31.10 16.30 7 46711 65 110542516
Intentional product misuse 30.69 16.30 9 46709 132895 110409686
Staphylococcus test positive 30.20 16.30 25 46693 7345 110535236
Inappropriate schedule of product administration 30.17 16.30 25 46693 203612 110338969
Pruritus 29.98 16.30 135 46583 581425 109961156
Cerebral aspergillosis 29.78 16.30 16 46702 2286 110540295
Anaemia 29.52 16.30 357 46361 546729 109995852
Enterococcal sepsis 29.38 16.30 18 46700 3294 110539287
Organising pneumonia 29.19 16.30 33 46685 14210 110528371
Glomerulosclerosis 28.91 16.30 13 46705 1264 110541317
Tachycardia 28.82 16.30 179 46539 226466 110316115
Serum ferritin increased 28.74 16.30 30 46688 11817 110530764
Eosinophilic pneumonia acute 28.58 16.30 14 46704 1651 110540930
Hypercapnia 28.41 16.30 29 46689 11130 110531451
Disseminated mucormycosis 28.29 16.30 15 46703 2087 110540494
Corynebacterium bacteraemia 28.26 16.30 8 46710 198 110542383
Crystalluria 28.17 16.30 13 46705 1342 110541239
Staphylococcal bacteraemia 28.14 16.30 35 46683 16653 110525928
Back pain 28.03 16.30 73 46645 370923 110171658
Rectal haemorrhage 27.88 16.30 8 46710 119825 110422756
Vomiting 27.59 16.30 249 46469 910426 109632155
Toxic skin eruption 27.55 16.30 45 46673 27470 110515111
Uraemic encephalopathy 27.49 16.30 11 46707 801 110541780
COVID-19 pneumonia 27.22 16.30 53 46665 37090 110505491
Maternal exposure during pregnancy 27.14 16.30 41 46677 254842 110287739
Inflammation 27.08 16.30 25 46693 193213 110349368
Product use issue 27.01 16.30 57 46661 311638 110230943
Systemic mycosis 26.99 16.30 18 46700 3811 110538770
Nervous system disorder 26.66 16.30 48 46670 31673 110510908
Acute lymphocytic leukaemia recurrent 26.61 16.30 21 46697 5766 110536815
Hyperbilirubinaemia 26.53 16.30 47 46671 30624 110511957
Wrong technique in product usage process 26.38 16.30 3 46715 87345 110455236
Systemic inflammatory response syndrome 26.36 16.30 30 46688 13013 110529568
Heparin-induced thrombocytopenia 26.06 16.30 28 46690 11396 110531185
Blister 25.76 16.30 35 46683 227341 110315240
Encephalitis Japanese B 25.58 16.30 6 46712 68 110542513
Hypercholesterolaemia 25.34 16.30 4 46714 90833 110451748
Blood lactate dehydrogenase increased 25.19 16.30 57 46661 44277 110498304
Cutaneous mucormycosis 25.10 16.30 10 46708 720 110541861
Tachypnoea 25.05 16.30 53 46665 39342 110503239
Transaminases increased 25.03 16.30 71 46647 63319 110479262
Bacterial toxaemia 24.97 16.30 7 46711 167 110542414
Coagulopathy 24.82 16.30 54 46664 40857 110501724
Pseudomembranous colitis 24.78 16.30 21 46697 6370 110536211
Respiratory alkalosis 24.69 16.30 20 46698 5701 110536880
Muscular weakness 24.54 16.30 42 46676 248426 110294155
Cerebral ventricle collapse 24.47 16.30 7 46711 180 110542401
Autoimmune haemolytic anaemia 24.28 16.30 26 46692 10541 110532040
Nocardiosis 23.84 16.30 22 46696 7464 110535117
Chest discomfort 23.77 16.30 23 46695 173825 110368756
Dialysis 23.72 16.30 35 46683 19584 110522997
Masked fever 23.59 16.30 5 46713 34 110542547
Dry skin 23.59 16.30 8 46710 107645 110434936
Phrenic nerve paralysis 23.57 16.30 9 46709 578 110542003
Corynebacterium infection 23.38 16.30 13 46705 1987 110540594
Escherichia bacteraemia 23.34 16.30 25 46693 10139 110532442
Nail bed inflammation 23.20 16.30 13 46705 2017 110540564
Mucosal inflammation 23.06 16.30 91 46627 96050 110446531
Burkholderia test positive 23.04 16.30 9 46709 615 110541966
Lung infiltration 22.95 16.30 39 46679 24589 110517992
Adverse drug reaction 22.86 16.30 8 46710 105551 110437030
Hepatosplenic candidiasis 22.47 16.30 9 46709 657 110541924
Injection site erythema 22.45 16.30 6 46712 94170 110448411
Histoplasmosis disseminated 22.03 16.30 16 46702 3883 110538698
Brain abscess 21.75 16.30 20 46698 6754 110535827
Activated partial thromboplastin time prolonged 21.61 16.30 36 46682 22332 110520249
Nasal mucosal disorder 21.36 16.30 12 46706 1871 110540710
Feeling hot 21.35 16.30 6 46712 91100 110451481
Symmetrical drug-related intertriginous and flexural exanthema 21.28 16.30 12 46706 1885 110540696
Small intestinal obstruction 21.25 16.30 44 46674 32169 110510412
Pneumocystis jirovecii pneumonia 21.08 16.30 52 46666 42683 110499898
Therapeutic product effect incomplete 21.04 16.30 39 46679 223766 110318815
Blastomycosis 20.86 16.30 10 46708 1125 110541456
Dermatitis bullous 20.80 16.30 31 46687 17498 110525083
Peripheral venous disease 20.74 16.30 5 46713 84112 110458469
Aeromonas infection 20.73 16.30 8 46710 529 110542052
Osteomyelitis 20.73 16.30 47 46671 36553 110506028
Pneumonitis 20.46 16.30 75 46643 76456 110466125
Laryngeal inflammation 20.41 16.30 7 46711 330 110542251
Pulseless electrical activity 20.41 16.30 30 46688 16727 110525854
Herpes simplex 20.33 16.30 29 46689 15735 110526846
Altered state of consciousness 20.32 16.30 62 46656 57564 110485017
Enterobacter infection 20.32 16.30 18 46700 5793 110536788
Subcutaneous emphysema 20.30 16.30 13 46705 2571 110540010
Bacillus infection 20.27 16.30 11 46707 1603 110540978
Geotrichum infection 20.23 16.30 10 46708 1202 110541379
Rash pustular 20.19 16.30 26 46692 12803 110529778
Fungal infection 20.15 16.30 57 46661 50749 110491832
Disseminated cryptococcosis 19.97 16.30 13 46705 2644 110539937
Pulmonary mucormycosis 19.92 16.30 12 46706 2131 110540450
Wound infection 19.74 16.30 8 46710 96457 110446124
Drug hypersensitivity 19.63 16.30 112 46606 453978 110088603
Amnesia 19.61 16.30 10 46708 105398 110437183
Palpitations 19.60 16.30 23 46695 159189 110383392
Eye infection fungal 19.55 16.30 8 46710 617 110541964
Hypertension 19.36 16.30 131 46587 509953 110032628
Purpura 19.35 16.30 36 46682 24352 110518229
Intestinal perforation 19.29 16.30 33 46685 20911 110521670
Product use in unapproved indication 19.15 16.30 280 46438 447097 110095484
Gallbladder fistula 19.03 16.30 4 46714 26 110542555
Sputum abnormal 18.97 16.30 10 46708 1376 110541205
Metabolic acidosis 18.96 16.30 88 46630 99656 110442925
Klebsiella bacteraemia 18.88 16.30 16 46702 4853 110537728
Capillary leak syndrome 18.77 16.30 16 46702 4892 110537689
SJS-TEN overlap 18.74 16.30 11 46707 1863 110540718
Red blood cell sedimentation rate increased 18.64 16.30 5 46713 78297 110464284
Human ehrlichiosis 18.52 16.30 8 46710 707 110541874
Hypoalbuminaemia 18.44 16.30 39 46679 28935 110513646
Neck pain 18.38 16.30 15 46703 123115 110419466
Hepatocellular injury 18.34 16.30 55 46663 50587 110491994
General physical health deterioration 18.33 16.30 105 46613 425190 110117391
Cytokine storm 18.29 16.30 10 46708 1480 110541101
Hot flush 18.21 16.30 3 46715 66033 110476548
Product contamination microbial 18.19 16.30 9 46709 1085 110541496
Vertigo 18.11 16.30 7 46711 86863 110455718
Staphylococcal sepsis 18.09 16.30 29 46689 17425 110525156
Transformation to acute myeloid leukaemia 18.08 16.30 10 46708 1513 110541068
Haemolytic anaemia 18.02 16.30 32 46686 20888 110521693
Necrotising fasciitis 18.01 16.30 19 46699 7572 110535009
Choluria 17.99 16.30 7 46711 473 110542108
Cytarabine syndrome 17.93 16.30 5 46713 117 110542464
Prescribed underdose 17.89 16.30 3 46715 65171 110477410
Nosocomial infection 17.78 16.30 13 46705 3186 110539395
Vision blurred 17.71 16.30 17 46701 129005 110413576
Blood alkaline phosphatase increased 17.70 16.30 68 46650 70867 110471714
Cerebral haemorrhage 17.65 16.30 64 46654 64904 110477677
Haemolysis 17.62 16.30 27 46691 15612 110526969
Hypertensive heart disease 17.61 16.30 15 46703 4581 110538000
Chemotherapeutic drug level increased 17.43 16.30 7 46711 515 110542066
Engraft failure 17.41 16.30 8 46710 818 110541763
Flavobacterium infection 17.39 16.30 5 46713 131 110542450
Hypervolaemia 17.24 16.30 53 46665 49407 110493174
Subdiaphragmatic abscess 17.14 16.30 5 46713 138 110542443
Depressed level of consciousness 17.07 16.30 93 46625 112185 110430396
Malacoplakia 17.04 16.30 9 46709 1243 110541338
Seizure 16.93 16.30 155 46563 221030 110321551
Angina pectoris 16.81 16.30 3 46715 62292 110480289
Serotonin syndrome 16.69 16.30 59 46659 59094 110483487
Acute febrile neutrophilic dermatosis 16.69 16.30 15 46703 4921 110537660
Strongyloidiasis 16.56 16.30 15 46703 4971 110537610
Illness 16.51 16.30 7 46711 82164 110460417
Acinetobacter infection 16.50 16.30 13 46705 3560 110539021
Product quality issue 16.50 16.30 6 46712 77293 110465288
Posterior reversible encephalopathy syndrome 16.49 16.30 41 46677 33820 110508761
Pneumonia klebsiella 16.46 16.30 17 46701 6615 110535966
Pseudomonas test positive 16.43 16.30 11 46707 2343 110540238
Hyperhidrosis 16.43 16.30 34 46684 187264 110355317
Pneumomediastinum 16.43 16.30 15 46703 5021 110537560
Pneumothorax 16.42 16.30 42 46676 35243 110507338
Neutrophilia 16.36 16.30 21 46697 10308 110532273
Pasteurella infection 16.32 16.30 5 46713 164 110542417

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01DE01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
OTHER BETA-LACTAM ANTIBACTERIALS
Fourth-generation cephalosporins
ATC J01DE51 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
OTHER BETA-LACTAM ANTIBACTERIALS
Fourth-generation cephalosporins
ATC J01RA06 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
FDA CS M0003827 Cephalosporins
FDA EPC N0000175488 Cephalosporin Antibacterial
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000900 Anti-Bacterial Agents
CHEBI has role CHEBI:33281 antimicrobial agent
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:36047 antibacterial drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

J01DE Fourth-generation cephalosporins 2 drugs
cefozoprancefpirome
J01RA Combinations of antibacterials 18 drugs
amikacinazithromycincefiximecefuroximeciprofloxacinfluconazolelevofloxacinmetronidazolenitazoxanidenorfloxacinnystatinofloxacin show all 18 →

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

DiseaseRelationSNOMED_IDDOID
Infection due to Pseudomonas aeruginosa indication 11218009
Pneumonia due to Streptococcus indication 34020007
Pneumonia due to Pseudomonas indication 41381004
Bacterial pneumonia indication 53084003 DOID:874
Klebsiella cystitis indication 60867007
Infectious disease of abdomen indication 128070006
Bacterial infection due to Klebsiella pneumoniae indication 186435004
Bacterial peritonitis indication 197171003
Pneumococcal pneumonia indication 233607000
Escherichia coli urinary tract infection indication 301011002
Proteus urinary tract infection indication 301012009
Streptococcus pyogenes infection indication 302809008
Bacterial urinary infection indication 312124009
Infection due to Staphylococcus aureus indication 406602003
Urinary tract infection caused by Klebsiella indication 369001000119100
Complicated Proteus UTI indication
E. Coli Pyelonephritis indication
Complicated Urinary Tract Infections indication
Complicated Bacteroides Peritonitis indication
Complicated Streptococcus Peritonitis indication
Klebsiella Pyelonephritis indication
Complicated E. Coli Peritonitis indication
Enterobacter Pneumonia indication
Complicated Klebsiella Peritonitis indication
Proteus Pyelonephritis indication
Myoclonus contraindication 17450006
Colitis contraindication 64226004 DOID:0060180
Blood coagulation disorder contraindication 64779008 DOID:1247
Factor II deficiency contraindication 73975000
Disorder of brain contraindication 81308009 DOID:936
Seizure disorder contraindication 128613002
Impaired renal function disorder contraindication 197663003
Pseudomembranous enterocolitis contraindication 397683000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.32 acidic
pKa2 13.31 acidic
pKa3 3.1 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 2GM BASE/VIAL;0.5GM/VIAL EXBLIFEP ORCHID PHARMA N216165 Feb. 22, 2024 DISCN POWDER INTRAVENOUS 7687488 Dec. 3, 2027 USE OF EXBLIFEP (CEFEPIME AND ENMETAZOBACTAM) FOR TREATING COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY DESIGNATED SUSCEPTIBLE MICROORGANISMS
EQ 2GM BASE/VIAL;1GM/VIAL ZAYNICH WOCKHARDT BIO AG N220787 May 29, 2026 RX POWDER INTRAVENOUS 9132133 Aug. 24, 2032 COMPLICATED URINARY TRACT INFECTIONS, INCLUDING PYELONEPHRITIS
EQ 2GM BASE/VIAL;1GM/VIAL ZAYNICH WOCKHARDT BIO AG N220787 May 29, 2026 RX POWDER INTRAVENOUS 9827235 Aug. 24, 2032 COMPLICATED URINARY TRACT INFECTIONS, INCLUDING PYELONEPHRITIS
EQ 2GM BASE/VIAL;0.5GM/VIAL EXBLIFEP ORCHID PHARMA N216165 Feb. 22, 2024 DISCN POWDER INTRAVENOUS 11124526 Nov. 7, 2034 USE OF SPECIFIED POLYMORPHS OF EXBLIFEP (CEFEPIME AND ENMETAZOBACTAM) FOR TREATING COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY DESIGNATED SUSCEPTIBLE MICROORGANISMS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 2GM BASE/VIAL;0.5GM/VIAL EXBLIFEP ORCHID PHARMA N216165 Feb. 22, 2024 DISCN POWDER INTRAVENOUS Feb. 22, 2029 NEW CHEMICAL ENTITY
EQ 2GM BASE/VIAL;1GM/VIAL ZAYNICH WOCKHARDT BIO AG N220787 May 29, 2026 RX POWDER INTRAVENOUS May 29, 2031 NEW CHEMICAL ENTITY
EQ 2GM BASE/VIAL;0.5GM/VIAL EXBLIFEP ORCHID PHARMA N216165 Feb. 22, 2024 DISCN POWDER INTRAVENOUS Feb. 22, 2034 GENERATING ANTIBIOTIC INCENTIVES NOW
EQ 2GM BASE/VIAL;1GM/VIAL ZAYNICH WOCKHARDT BIO AG N220787 May 29, 2026 RX POWDER INTRAVENOUS May 29, 2036 GENERATING ANTIBIOTIC INCENTIVES NOW

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Bacterial penicillin-binding protein Enzyme INHIBITOR CHEMBL CHEMBL

External reference:

IDSource
4024049 VUID
N0000022054 NUI
D01157 KEGG_DRUG
123171-59-5 SECONDARY_CAS_RN
20481 RXNORM
C0055003 UMLSCUI
CHEBI:478164 CHEBI
9WT PDB_CHEM_ID
CHEMBL186 ChEMBL_ID
CHEMBL1200962 ChEMBL_ID
D000077723 MESH_DESCRIPTOR_UI
DB01413 DRUGBANK_ID
10772 IUPHAR_LIGAND_ID
6092 INN_ID
807PW4VQE3 UNII
5479537 PUBCHEM_CID
116681 MMSL
42651 MMSL
4373 MMSL
d03882 MMSL
370370003 SNOMEDCT_US
370371004 SNOMEDCT_US
96048006 SNOMEDCT_US
4020908 VANDF
4024049 VANDF
004974 NDDF
004975 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cefepime Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9382 INJECTION, POWDER, FOR SOLUTION 1 g INTRAMUSCULAR ANDA 26 sections
Cefepime Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9383 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 26 sections
Cefepime Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9477 INJECTION, POWDER, FOR SOLUTION 1 g INTRAMUSCULAR ANDA 26 sections
Cefepime Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9478 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 26 sections
CEFEPIME HYDROCHLORIDE AND DEXTROSE HUMAN PRESCRIPTION DRUG LABEL 1 0264-3193 INJECTION, SOLUTION 1 g INTRAVENOUS NDA 27 sections
CEFEPIME HYDROCHLORIDE AND DEXTROSE HUMAN PRESCRIPTION DRUG LABEL 1 0264-3195 INJECTION, SOLUTION 2 g INTRAVENOUS NDA 27 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 0338-1301 INJECTION, SOLUTION 1 g INTRAVENOUS NDA 28 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 0409-9566 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 27 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 0409-9735 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 27 sections
Cefepime Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-3222 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 27 sections
Cefepime Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-3223 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 27 sections
cefepime HUMAN PRESCRIPTION DRUG LABEL 1 25021-121 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 29 sections
cefepime HUMAN PRESCRIPTION DRUG LABEL 1 25021-122 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 29 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 44567-130 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 26 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 44567-131 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 26 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 44567-240 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 26 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 44567-241 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 26 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 60505-6144 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 27 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 60505-6145 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 27 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 60505-6146 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 27 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 60505-6147 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 27 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 60505-6245 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 27 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 60505-6246 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 27 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 63323-326 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 26 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 63323-340 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 26 sections
CEFEPIME HUMAN PRESCRIPTION DRUG LABEL 1 66288-8100 INJECTION, POWDER, FOR SOLUTION 100 g INTRAVENOUS ANDA 18 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 67184-1002 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 27 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 67184-1003 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 27 sections
Cefepime HUMAN PRESCRIPTION DRUG LABEL 1 67184-1004 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS ANDA 27 sections
ZAYNICH HUMAN PRESCRIPTION DRUG LABEL 2 87706-866 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS NDA 25 sections