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

Stem definitionDrug idCAS RN
analogues of penicillanic acid antibiotics modified in the five-membered ring 1709 96036-03-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • meropenem hydrate
  • meropenem
  • merrem
  • meropenem trihydrate
an antibacterial drug readily penetrates the cell wall of most Gram-positive and Gram-negative bacteria to reach penicillin-binding-protein (PBP) targets, the bactericidal activity of meropenem results from the inhibition of cell wall synthesis
  • Molecular weight: 383.46
  • Formula: C17H25N3O5S
  • CLOGP: -2.29
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 3
  • TPSA: 110.18
  • ALOGS: -1.83
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
3 g P
3 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 70 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 111.76 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 0 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.90 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.87 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -1.298 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.923 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.589 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 3.013 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 78.170 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 54.820 % High 1
herg hERG pIC50 4.474 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.352 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.681 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 63.210 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK4,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,JAK3,MAP2K6,MAPK10,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PRKDC,STK33,SYK,TEK,TGFBR1,ZAP70 28
kinase-selectivity-class AXL,GRK2,MAP2K6 3
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.493 High 1
mh-clint Mouse hepatocyte intrinsic clearance 6.209 High 1
mppb Mouse plasma protein binding (% unbound) 71.760 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 2.838 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 63.850 % High 1
rh-clint Rat hepatocyte intrinsic clearance 2.729 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 85.680 % High 1
rppb Rat plasma protein binding (% unbound) 60.600 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 853.100 uM High 1

Approvals:

DateAgencyCompanyOrphan
June 21, 1996 FDA ASTRAZENECA

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
Multiple organ dysfunction syndrome 952.93 19.84 529 45174 67807 90514937
Septic shock 711.87 19.84 473 45230 83687 90499057
Drug reaction with eosinophilia and systemic symptoms 673.45 19.84 359 45344 42399 90540345
Pathogen resistance 501.74 19.84 179 45524 7936 90574808
Drug resistance 480.30 19.84 256 45447 30193 90552551
Drug ineffective 441.92 19.84 1609 44094 1382689 89200055
Sepsis 434.20 19.84 493 45210 179321 90403423
Respiratory failure 421.73 19.84 400 45303 118018 90464726
Febrile neutropenia 327.11 19.84 401 45302 157948 90424796
Thrombocytopenia 305.97 19.84 447 45256 208278 90374466
Acute kidney injury 286.98 19.84 550 45153 319837 90262907
Systemic candida 278.86 19.84 102 45601 4857 90577887
Pain 266.56 19.84 86 45617 996255 89586489
Off label use 256.29 19.84 1164 44539 1101088 89481656
Haemophagocytic lymphohistiocytosis 235.36 19.84 127 45576 15332 90567412
Joint swelling 226.01 19.84 6 45697 503294 90079450
Toxic epidermal necrolysis 223.34 19.84 161 45542 32367 90550377
Pancytopenia 220.32 19.84 287 45416 119976 90462768
Arthralgia 217.37 19.84 62 45641 778460 89804284
Clostridium difficile colitis 215.63 19.84 146 45557 26560 90556184
Neutropenia 209.67 19.84 393 45310 224511 90358233
Pyrexia 208.77 19.84 768 44935 659717 89923027
Drug ineffective for unapproved indication 208.74 19.84 210 45493 66434 90516310
Fatigue 208.38 19.84 167 45536 1153856 89428888
Dysbiosis 204.26 19.84 62 45641 1640 90581104
Bronchopulmonary aspergillosis 202.99 19.84 104 45599 11294 90571450
Candida infection 198.99 19.84 153 45550 33904 90548840
Eosinophilia 190.81 19.84 139 45564 28394 90554350
Headache 189.28 19.84 100 45603 862646 89720098
Fungaemia 185.01 19.84 68 45635 3282 90579462
Aspergillus infection 184.81 19.84 96 45607 10727 90572017
Abdominal discomfort 184.64 19.84 15 45688 477313 90105431
Enterococcal infection 171.68 19.84 89 45614 9902 90572842
Acute respiratory distress syndrome 167.86 19.84 129 45574 28557 90554187
Drug intolerance 167.85 19.84 16 45687 447575 90135169
Rheumatoid arthritis 163.92 19.84 4 45699 362610 90220134
Mucormycosis 162.16 19.84 64 45639 3757 90578987
Nasopharyngitis 159.63 19.84 12 45691 407092 90175652
Brain abscess 151.31 19.84 56 45647 2756 90579988
Swelling 146.96 19.84 19 45684 419039 90163705
Peripheral swelling 146.65 19.84 18 45685 413088 90169656
Disseminated intravascular coagulation 146.45 19.84 106 45597 21432 90561312
Shock 141.83 19.84 117 45586 28661 90554083
Systemic lupus erythematosus 140.93 19.84 11 45692 361885 90220859
Agranulocytosis 139.43 19.84 126 45577 34876 90547868
Rash maculo-papular 139.31 19.84 135 45568 40798 90541946
Pseudomonas infection 138.78 19.84 89 45614 14776 90567968
Renal impairment 134.68 19.84 212 45491 105209 90477535
Wound 134.46 19.84 4 45699 302976 90279768
Hepatic function abnormal 127.17 19.84 136 45567 46152 90536592
Clostridium test positive 125.22 19.84 59 45644 5342 90577402
Stenotrophomonas infection 123.82 19.84 47 45656 2482 90580262
Candida sepsis 123.48 19.84 42 45661 1611 90581133
Cardiac arrest 123.09 19.84 203 45500 104732 90478012
Acinetobacter infection 122.99 19.84 44 45659 1964 90580780
Linear IgA disease 121.31 19.84 45 45658 2229 90580515
Cytokine release syndrome 119.97 19.84 105 45598 27868 90554876
Alopecia 119.69 19.84 50 45653 495021 90087723
Premature delivery 119.24 19.84 121 45582 38641 90544103
Contraindicated product administered 118.50 19.84 12 45691 320127 90262617
Renal failure 118.30 19.84 226 45477 130781 90451963
Dizziness 118.08 19.84 76 45627 589208 89993536
Stevens-Johnson syndrome 115.53 19.84 105 45598 29271 90553473
Weight increased 115.07 19.84 34 45669 417893 90164851
Fall 112.76 19.84 51 45652 481759 90100985
Therapeutic product effect decreased 112.20 19.84 7 45696 277564 90305180
Pericarditis 111.69 19.84 6 45697 270145 90312599
Drug eruption 109.77 19.84 111 45592 35296 90547448
Sinusitis 107.98 19.84 21 45682 343067 90239677
Musculoskeletal stiffness 107.47 19.84 12 45691 296520 90286224
Infusion related reaction 105.81 19.84 39 45664 416741 90166003
Encephalopathy 104.53 19.84 123 45580 46321 90536423
Klebsiella infection 104.50 19.84 65 45638 10232 90572512
Pain in extremity 103.38 19.84 49 45654 450480 90132264
Muscle spasms 102.87 19.84 6 45697 251877 90330867
Product dose omission issue 102.75 19.84 13 45690 291674 90291070
Leukopenia 102.56 19.84 183 45520 100527 90482217
Bacteraemia 100.26 19.84 86 45617 22214 90560530
Depression 99.81 19.84 16 45687 300585 90282159
Discomfort 99.67 19.84 11 45692 274324 90308420
Pneumonia fungal 99.36 19.84 55 45648 6976 90575768
Clostridium difficile infection 95.18 19.84 104 45599 36141 90546603
Rhinocerebral mucormycosis 94.96 19.84 29 45674 783 90581961
Lactic acidosis 94.77 19.84 122 45581 50341 90532403
Pseudomembranous colitis 91.97 19.84 43 45660 3825 90578919
Coagulopathy 91.10 19.84 83 45620 23206 90559538
Fusarium infection 90.77 19.84 30 45673 1052 90581692
Asthma 89.79 19.84 9 45694 242151 90340593
Blood cholesterol increased 87.94 19.84 4 45699 208008 90374736
Sleep disorder 86.45 19.84 3 45700 198027 90384717
Hypoxia 86.15 19.84 141 45562 72258 90510486
Insomnia 83.28 19.84 32 45671 333442 90249302
Memory impairment 82.71 19.84 4 45699 197240 90385504
Gait disturbance 81.83 19.84 16 45687 260480 90322264
Systemic inflammatory response syndrome 81.35 19.84 47 45656 6469 90576275
Contusion 79.82 19.84 15 45688 251201 90331543
Immune effector cell-associated neurotoxicity syndrome 78.45 19.84 44 45659 5724 90577020
Acute respiratory failure 77.84 19.84 102 45601 42816 90539928
Acute myeloid leukaemia 77.70 19.84 72 45631 20568 90562176
Symmetrical drug-related intertriginous and flexural exanthema 77.56 19.84 26 45677 953 90581791
Toxic skin eruption 77.44 19.84 64 45639 15710 90567034
Weight decreased 76.00 19.84 49 45654 379861 90202883
Haemodynamic instability 75.78 19.84 56 45647 11683 90571061
Staphylococcal bacteraemia 75.42 19.84 47 45656 7422 90575322
Fungal infection 75.23 19.84 100 45603 42561 90540183
Abdominal pain upper 75.02 19.84 37 45666 332637 90250107
Anaemia 74.87 19.84 364 45339 352438 90230306
Platelet count decreased 74.56 19.84 193 45510 136776 90445968
Disseminated mucormycosis 74.38 19.84 23 45680 648 90582096
Oliguria 73.85 19.84 53 45650 10571 90572173
Multiple-drug resistance 73.68 19.84 47 45656 7729 90575015
Dry mouth 73.30 19.84 5 45698 184054 90398690
Intracranial infection 73.00 19.84 18 45685 211 90582533
Asthenia 72.47 19.84 98 45605 533653 90049091
Malaise 72.33 19.84 115 45588 585871 89996873
Folliculitis 72.21 19.84 9 45694 204344 90378400
Myelosuppression 71.51 19.84 110 45593 53481 90529263
Hyperbilirubinaemia 71.47 19.84 58 45645 13878 90568866
Emphysematous pyelonephritis 69.65 19.84 19 45684 339 90582405
Graft versus host disease 69.26 19.84 46 45657 8098 90574646
Procalcitonin increased 69.19 19.84 27 45676 1537 90581207
Protothecosis 68.91 19.84 20 45683 451 90582293
Toxic encephalopathy 68.87 19.84 47 45656 8652 90574092
Impaired healing 68.26 19.84 17 45686 234182 90348562
Migraine 68.22 19.84 8 45695 190384 90392360
Acute generalised exanthematous pustulosis 68.11 19.84 56 45647 13647 90569097
Geotrichum infection 67.80 19.84 21 45682 595 90582149
Hypotension 67.79 19.84 334 45369 325063 90257681
Disease progression 67.78 19.84 203 45500 156412 90426332
Neutropenic sepsis 67.78 19.84 63 45640 18067 90564677
Perinephric abscess 67.36 19.84 18 45685 296 90582448
Drug interaction 66.55 19.84 296 45407 276157 90306587
Anuria 66.31 19.84 57 45646 14761 90567983
Anxiety 66.08 19.84 37 45666 309735 90273009
Staphylococcal infection 65.44 19.84 100 45603 48339 90534405
Cholestasis 65.41 19.84 86 45617 36213 90546531
Pleural effusion 65.31 19.84 162 45541 111829 90470915
Cytomegalovirus infection 64.12 19.84 73 45630 26529 90556215
Ill-defined disorder 63.28 19.84 9 45694 184882 90397862
Metabolic acidosis 62.96 19.84 106 45597 55570 90527174
Arthritis 62.58 19.84 6 45697 167309 90415435
Hepatic failure 62.32 19.84 88 45615 39640 90543104
Musculoskeletal pain 61.84 19.84 7 45696 171244 90411500
Nephropathy toxic 61.29 19.84 51 45652 12637 90570107
Hypersensitivity 61.17 19.84 84 45619 454593 90128151
Pneumonia bacterial 60.93 19.84 51 45652 12739 90570005
Alanine aminotransferase increased 60.58 19.84 163 45540 118175 90464569
Bacterial sepsis 59.90 19.84 35 45668 4920 90577824
Fungal sepsis 59.11 19.84 24 45679 1517 90581227
Mucosal inflammation 59.01 19.84 105 45598 57520 90525224
Pyelonephritis fungal 58.99 19.84 15 45688 201 90582543
Brain oedema 58.50 19.84 57 45646 17328 90565416
Completed suicide 57.58 19.84 4 45699 145054 90437690
Blood lactate dehydrogenase increased 57.22 19.84 68 45635 25864 90556880
Aspartate aminotransferase increased 56.99 19.84 146 45557 102791 90479953
Loss of personal independence in daily activities 56.29 19.84 3 45700 136102 90446642
Drug level decreased 55.26 19.84 43 45660 9687 90573057
Urticaria 55.17 19.84 46 45657 312688 90270056
Trichosporon infection 54.95 19.84 16 45687 365 90582379
Excessive eye blinking 54.80 19.84 22 45681 1350 90581394
Neutropenic colitis 54.71 19.84 31 45672 4112 90578632
Enterococcal sepsis 54.64 19.84 23 45680 1593 90581151
Hepatic infarction 53.48 19.84 18 45685 668 90582076
Seizure 53.46 19.84 184 45519 152445 90430299
Mobility decreased 53.39 19.84 30 45673 250704 90332040
Cytomegalovirus infection reactivation 52.13 19.84 38 45665 7762 90574982
Neurotoxicity 51.89 19.84 59 45644 21408 90561336
Eosinophilic pneumonia 51.40 19.84 26 45677 2747 90579997
Type IV hypersensitivity reaction 50.83 19.84 29 45674 3897 90578847
Peritonitis 50.79 19.84 56 45647 19649 90563095
Neutrophil count decreased 49.90 19.84 111 45592 71421 90511323
Hypoaesthesia 49.76 19.84 51 45652 314159 90268585
Escherichia infection 49.57 19.84 50 45653 15845 90566899
Acute hepatic failure 49.51 19.84 59 45644 22502 90560242
Blood bilirubin increased 49.47 19.84 83 45620 43387 90539357
Cytopenia 49.20 19.84 52 45651 17397 90565347
Mixed liver injury 48.39 19.84 36 45667 7587 90575157
Posterior reversible encephalopathy syndrome 48.34 19.84 58 45645 22281 90560463
Hepatic cytolysis 47.77 19.84 68 45635 30848 90551896
Hypoalbuminaemia 47.74 19.84 49 45654 15848 90566896
Bacterial infection 47.69 19.84 59 45644 23385 90559359
Leukocytosis 47.65 19.84 68 45635 30922 90551822
Night sweats 47.16 19.84 5 45698 128761 90453983
Hyperlactacidaemia 46.81 19.84 28 45675 4108 90578636
Haemorrhagic disorder 46.65 19.84 18 45685 994 90581750
Drug hypersensitivity 46.55 19.84 103 45600 463506 90119238
Urinary tract infection enterococcal 46.52 19.84 25 45678 2991 90579753
Thrombotic microangiopathy 46.33 19.84 48 45655 15695 90567049
Cytomegalovirus viraemia 46.31 19.84 35 45668 7551 90575193
Premature baby 46.09 19.84 60 45643 25017 90557727
Blood pressure increased 45.86 19.84 21 45682 197196 90385548
Pseudomonal sepsis 45.79 19.84 28 45675 4274 90578470
Bone marrow failure 45.62 19.84 68 45635 32153 90550591
Hyperkalaemia 45.53 19.84 101 45602 64863 90517881
Ureaplasma infection 44.96 19.84 17 45686 888 90581856
Vesicoureteric reflux 44.71 19.84 13 45690 295 90582449
Adverse event 44.47 19.84 4 45699 117414 90465330
Foetal anaemia 44.45 19.84 11 45692 131 90582613
Blister 44.36 19.84 38 45665 254960 90327784
Guillain-Barre syndrome 44.00 19.84 28 45675 4584 90578160
Gastrointestinal haemorrhage 43.88 19.84 122 45581 90126 90492618
Nausea 43.62 19.84 355 45348 1109961 89472783
Blood lactate dehydrogenase decreased 43.38 19.84 12 45691 226 90582518
Tumour associated fever 43.37 19.84 14 45689 455 90582289
Pneumocystis jirovecii pneumonia 43.33 19.84 54 45649 21562 90561182
Disseminated aspergillosis 42.66 19.84 14 45689 480 90582264
Respiratory distress 42.51 19.84 73 45630 38873 90543871
Pulmonary haemorrhage 42.47 19.84 34 45669 7979 90574765
Rash morbilliform 42.32 19.84 26 45677 4003 90578741
Hyperchloraemia 41.67 19.84 16 45687 872 90581872
Adverse drug reaction 41.56 19.84 5 45698 116696 90466048
Eosinophilic pneumonia acute 41.29 19.84 15 45688 700 90582044
Pneumonia 41.18 19.84 497 45206 637562 89945182
Anticonvulsant drug level decreased 41.00 19.84 18 45685 1382 90581362
Intentional product use issue 40.64 19.84 30 45673 216862 90365882
Enterococcal bacteraemia 40.49 19.84 20 45683 2008 90580736
Meningitis candida 40.05 19.84 9 45694 68 90582676
Wound infection 39.30 19.84 4 45699 106398 90476346
Joint range of motion decreased 39.21 19.84 10 45693 135633 90447111
Tracheobronchitis 38.86 19.84 18 45685 1567 90581177
Nosocomial infection 38.60 19.84 19 45684 1894 90580850
Transaminases increased 38.37 19.84 68 45635 37124 90545620
Injection site erythema 38.28 19.84 3 45700 98499 90484245
Graft versus host disease in gastrointestinal tract 37.83 19.84 25 45678 4363 90578381
Amnesia 37.78 19.84 5 45698 108500 90474244
Factor V inhibition 37.62 19.84 10 45693 161 90582583
Status epilepticus 37.59 19.84 47 45656 18827 90563917
Weissella infection 37.53 19.84 7 45696 17 90582727
Pancreatitis acute 37.45 19.84 62 45641 32053 90550691
Wheezing 37.28 19.84 39 45664 238041 90344703
Hypertension 37.22 19.84 113 45590 457419 90125325
Nervous system disorder 37.12 19.84 50 45653 21543 90561201
Urinary tract candidiasis 36.90 19.84 14 45689 738 90582006
Coagulation test abnormal 36.82 19.84 15 45688 956 90581788
Polyneuropathy 36.68 19.84 47 45656 19294 90563450
Adenovirus infection 36.65 19.84 25 45678 4597 90578147
Tubulointerstitial nephritis 36.62 19.84 54 45649 25289 90557455
Enterocolitis 36.43 19.84 35 45668 10455 90572289
Brain herniation 36.39 19.84 24 45679 4176 90578568
Hospitalisation 35.98 19.84 10 45693 128090 90454654
Hypernatraemia 35.82 19.84 33 45670 9354 90573390
Stomatitis 35.66 19.84 52 45651 274646 90308098
Intermittent positive pressure breathing 35.65 19.84 8 45695 60 90582684
Feeling abnormal 35.60 19.84 20 45683 167215 90415529
Haemorrhage intracranial 35.51 19.84 41 45662 15121 90567623
Necrotising colitis 35.33 19.84 16 45687 1322 90581422
Pericoronitis 35.30 19.84 9 45694 122 90582622
Aplastic anaemia 34.70 19.84 38 45665 13231 90569513
Meningitis bacterial 34.48 19.84 17 45686 1700 90581044
Acute myeloid leukaemia recurrent 34.41 19.84 18 45685 2039 90580705
Delayed graft function 34.37 19.84 16 45687 1409 90581335
Umbilical erythema 34.36 19.84 8 45695 72 90582672
Acid base balance abnormal 34.33 19.84 11 45692 349 90582395
Clostridial infection 34.23 19.84 24 45679 4612 90578132
Product deposit 34.12 19.84 11 45692 356 90582388
Hepatic enzyme increased 33.89 19.84 83 45620 360653 90222091
Overgrowth fungal 33.79 19.84 9 45694 146 90582598
Graft versus host disease in skin 33.34 19.84 22 45681 3831 90578913
Systemic mycosis 33.29 19.84 16 45687 1514 90581230
Abscess neck 33.18 19.84 13 45690 748 90581996
Venoocclusive liver disease 32.98 19.84 26 45677 5967 90576777
Paraspinal abscess 32.92 19.84 10 45693 265 90582479
Blood alkaline phosphatase increased 32.84 19.84 74 45629 48005 90534739
Liver abscess 32.80 19.84 21 45682 3475 90579269
Pneumothorax 32.37 19.84 44 45659 19123 90563621
Product use in unapproved indication 32.18 19.84 284 45419 335952 90246792
Gastrointestinal disorder 31.95 19.84 50 45653 256637 90326107
Paraesthesia 31.89 19.84 48 45655 250278 90332466
Hepatotoxicity 31.81 19.84 71 45632 45771 90536973
Low birth weight baby 31.78 19.84 31 45672 9436 90573308
Pruritus 31.60 19.84 153 45550 541372 90041372
Renal abscess 31.50 19.84 14 45689 1107 90581637
Tissue infiltration 31.50 19.84 13 45690 857 90581887
Cross sensitivity reaction 31.45 19.84 19 45684 2838 90579906
Encephalitis 31.07 19.84 33 45670 11101 90571643
Hyperhidrosis 30.94 19.84 15 45688 136290 90446454
Diffuse large B-cell lymphoma refractory 30.82 19.84 16 45687 1784 90580960
Inflammatory marker increased 30.61 19.84 30 45673 9184 90573560
Hydrocephalus 30.48 19.84 25 45678 6069 90576675
Device related infection 30.36 19.84 50 45653 25736 90557008
Diabetic macroangiopathy 30.32 19.84 8 45695 125 90582619
Periventricular leukomalacia 30.24 19.84 9 45694 222 90582522
Graft versus host disease in liver 30.22 19.84 13 45690 950 90581794
Blood creatinine increased 30.21 19.84 116 45587 101270 90481474
Haemoperitoneum 30.18 19.84 20 45683 3508 90579236
Ejection fraction decreased 29.70 19.84 50 45653 26203 90556541
Chest pain 29.67 19.84 74 45629 319571 90263173
Central nervous system injury 29.21 19.84 8 45695 145 90582599
Altered state of consciousness 29.17 19.84 55 45648 31477 90551267
Inappropriate schedule of product administration 29.05 19.84 20 45683 149913 90432831
Noninfectious peritonitis 29.00 19.84 8 45695 149 90582595
Cerebral mass effect 28.95 19.84 13 45690 1053 90581691
Drug level increased 28.95 19.84 51 45652 27711 90555033
Gamma-glutamyltransferase increased 28.87 19.84 61 45642 37891 90544853
Dehiscence 28.66 19.84 8 45695 156 90582588
Knee arthroplasty 28.56 19.84 4 45699 83178 90499566
Eosinophil count increased 28.36 19.84 34 45669 13047 90569697
Nocardiosis 28.06 19.84 17 45686 2553 90580191
Tonsillitis bacterial 28.01 19.84 8 45695 170 90582574
Enterobacter infection 27.98 19.84 17 45686 2566 90580178
Stress 27.75 19.84 4 45699 81391 90501353
Epstein-Barr virus infection 27.71 19.84 30 45673 10314 90572430
Metabolic alkalosis 27.68 19.84 19 45684 3530 90579214
Pulmonary sepsis 27.60 19.84 16 45687 2215 90580529
Pseudomonas test positive 27.55 19.84 12 45691 904 90581840
Pseudo-Bartter syndrome 27.51 19.84 7 45696 94 90582650
Interstitial lung disease 27.51 19.84 93 45610 76312 90506432
Gastrooesophageal reflux disease 27.47 19.84 26 45677 166311 90416433
Antibiotic level above therapeutic 27.10 19.84 10 45693 488 90582256
Intentional overdose 26.96 19.84 7 45696 93827 90488917
Oedema peripheral 26.93 19.84 56 45647 257859 90324885
Hyperchlorhydria 26.92 19.84 15 45688 1926 90580818
Splenic injury 26.56 19.84 8 45695 206 90582538
Skin maceration 26.41 19.84 8 45695 210 90582534
Bronchitis 26.33 19.84 23 45680 152904 90429840
Osteoporosis 26.25 19.84 8 45695 96523 90486221
Cytomegalovirus colitis 26.11 19.84 18 45685 3368 90579376
Adjusted calcium decreased 26.06 19.84 8 45695 220 90582524
Complications of transplanted lung 26.03 19.84 9 45694 363 90582381
Abdominal compartment syndrome 25.99 19.84 11 45692 772 90581972
Haemostasis 25.75 19.84 9 45694 375 90582369
Renal graft infection 25.70 19.84 9 45694 377 90582367
Pulmonary fibrosis 25.69 19.84 11 45692 107492 90475252
Wrong technique in product usage process 25.64 19.84 3 45700 71568 90511176
Abscess 25.51 19.84 39 45664 18852 90563892
Immune reconstitution inflammatory syndrome 25.48 19.84 24 45679 6995 90575749
Puncture site haemorrhage 25.43 19.84 9 45694 389 90582355
Klebsiella bacteraemia 25.39 19.84 16 45687 2576 90580168
Cerebral infarction 25.36 19.84 47 45656 26549 90556195
Vulvovaginitis 25.34 19.84 9 45694 393 90582351
Herpes simplex hepatitis 25.32 19.84 10 45693 588 90582156
Adenovirus reactivation 25.24 19.84 8 45695 245 90582499
Neurodevelopmental disorder 25.24 19.84 8 45695 245 90582499
Dyspepsia 25.23 19.84 38 45665 198122 90384622
Endocarditis 25.21 19.84 24 45679 7089 90575655
Cytomegalovirus test positive 25.15 19.84 18 45685 3573 90579171
Myoclonus 25.08 19.84 39 45664 19129 90563615
Relapsing fever 24.90 19.84 8 45695 256 90582488
Ear infection 24.81 19.84 3 45700 69772 90512972
Puncture site haematoma 24.77 19.84 6 45697 65 90582679
Herpes simplex 24.64 19.84 28 45675 10153 90572591
Fluid retention 24.50 19.84 7 45696 88084 90494660
Dry skin 24.50 19.84 7 45696 88066 90494678
Mediastinal effusion 24.28 19.84 6 45697 71 90582673
BK polyomavirus test positive 24.15 19.84 7 45696 157 90582587
Pulseless electrical activity 24.09 19.84 26 45677 8906 90573838
Hypokalaemia 24.05 19.84 130 45573 130986 90451758
Dermatitis exfoliative generalised 23.98 19.84 21 45682 5572 90577172
Septal panniculitis 23.98 19.84 6 45697 75 90582669
Immunosuppression 23.93 19.84 30 45673 12047 90570697
Wound haemorrhage 23.91 19.84 16 45687 2851 90579893
Tracheal injury 23.78 19.84 7 45696 166 90582578
Bronchial anastomosis complication 23.62 19.84 6 45697 80 90582664
Acute graft versus host disease in intestine 23.31 19.84 14 45689 2069 90580675
Hypertransaminasaemia 23.27 19.84 34 45669 15791 90566953
Hepatosplenomegaly 23.21 19.84 16 45687 2993 90579751
White blood cell count decreased 23.17 19.84 154 45549 166955 90415789
Hyperoxaluria 23.10 19.84 7 45696 184 90582560
Generalised tonic-clonic seizure 23.04 19.84 53 45650 34850 90547894
Cardiogenic shock 23.03 19.84 43 45660 24425 90558319
Candida test positive 23.01 19.84 11 45692 1028 90581716
Immunosuppressant drug level increased 22.99 19.84 19 45684 4661 90578083
Imprisonment 22.87 19.84 8 45695 334 90582410
Renal injury 22.83 19.84 27 45676 10216 90572528
Electrolyte imbalance 22.69 19.84 42 45661 23703 90559041
Acidosis 22.67 19.84 30 45673 12706 90570038
Drug-induced liver injury 22.67 19.84 98 45605 90220 90492524
Hyperamylasaemia 22.66 19.84 9 45694 537 90582207
Mycobacterium abscessus infection 22.66 19.84 11 45692 1064 90581680
Hyperaemia 22.65 19.84 15 45688 2627 90580117
Hypochromasia 22.60 19.84 8 45695 346 90582398
Mediastinitis 22.53 19.84 8 45695 349 90582395
Folate deficiency 22.48 19.84 16 45687 3149 90579595
Crystalluria 22.41 19.84 9 45694 553 90582191
Exfoliative rash 22.36 19.84 16 45687 3176 90579568
Neck pain 22.34 19.84 15 45688 113948 90468796
Vision blurred 22.33 19.84 14 45689 110279 90472465
Morganella infection 22.32 19.84 10 45693 806 90581938
Pneumonia pseudomonal 22.31 19.84 16 45687 3187 90579557
Shock haemorrhagic 22.04 19.84 29 45674 12216 90570528
Cardiac tamponade 21.88 19.84 20 45683 5612 90577132
Foetal exposure during pregnancy 21.78 19.84 59 45644 42916 90539828
Blood fibrinogen decreased 21.77 19.84 11 45692 1159 90581585
Hypoglossal nerve paresis 21.69 19.84 6 45697 113 90582631
Pancreatitis necrotising 21.59 19.84 14 45689 2367 90580377
Bronchopulmonary dysplasia 21.50 19.84 9 45694 615 90582129
Apgar score low 21.48 19.84 11 45692 1192 90581552
Globulins decreased 21.45 19.84 8 45695 402 90582342
CNS ventriculitis 21.44 19.84 7 45696 236 90582508
Compartment syndrome 21.33 19.84 15 45688 2897 90579847
Pregnancy 21.26 19.84 3 45700 62044 90520700
Cerebral haemorrhage 21.24 19.84 51 45652 34471 90548273
Osteomyelitis bacterial 21.22 19.84 7 45696 244 90582500
Venoocclusive disease 21.20 19.84 14 45689 2441 90580303
Candida endophthalmitis 21.09 19.84 5 45698 49 90582695
Herpes simplex viraemia 21.08 19.84 8 45695 422 90582322
Tachycardia 21.08 19.84 144 45559 157529 90425215
Condition aggravated 21.01 19.84 419 45284 595126 89987618
Large intestine perforation 20.66 19.84 25 45678 9687 90573057
Sepsis syndrome 20.64 19.84 10 45693 963 90581781
Pneumonia klebsiella 20.61 19.84 15 45688 3057 90579687
Tracheal ulcer 20.59 19.84 4 45699 13 90582731
Hypotonia 20.47 19.84 27 45676 11399 90571345
Prescribed overdose 20.31 19.84 12 45691 97613 90485131
Suicidal ideation 20.30 19.84 6 45697 73849 90508895
Pulmonary hypertensive crisis 20.28 19.84 8 45695 469 90582275
Oropharyngeal pain 20.22 19.84 17 45686 115170 90467574
Arterial perforation 20.15 19.84 4 45699 15 90582729
Pericardial effusion 20.12 19.84 52 45651 36781 90545963
Lung abscess 20.04 19.84 13 45690 2200 90580544

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
Multiple organ dysfunction syndrome 759.42 14.98 798 58430 96237 42465870
Drug ineffective 715.51 14.98 2198 57030 627999 41934108
Septic shock 680.17 14.98 733 58495 90939 42471168
Drug resistance 547.73 14.98 422 58806 33826 42528281
Pathogen resistance 488.37 14.98 262 58966 11188 42550919
Drug reaction with eosinophilia and systemic symptoms 475.65 14.98 424 58804 41651 42520456
Fatigue 298.10 14.98 117 59111 435524 42126583
Bronchopulmonary aspergillosis 285.79 14.98 228 59000 19201 42542906
Candida infection 276.81 14.98 234 58994 21376 42540731
Off label use 270.55 14.98 1657 57571 636678 41925429
Drug ineffective for unapproved indication 262.21 14.98 322 58906 45841 42516266
Respiratory failure 249.53 14.98 550 58678 127582 42434525
Systemic candida 247.39 14.98 129 59099 5190 42556917
Enterococcal infection 229.56 14.98 165 59063 11874 42550233
Eosinophilia 229.38 14.98 255 58973 32644 42529463
Sepsis 227.46 14.98 700 58528 198634 42363473
Toxic epidermal necrolysis 215.79 14.98 224 59004 26526 42535581
Pyrexia 213.98 14.98 1095 58133 392947 42169160
Dizziness 202.29 14.98 49 59179 249205 42312902
Disseminated intravascular coagulation 191.73 14.98 203 59025 24591 42537516
Product dose omission issue 180.56 14.98 8 59220 154357 42407750
Fall 179.10 14.98 52 59176 234468 42327639
Haemophagocytic lymphohistiocytosis 173.51 14.98 167 59061 18055 42544052
Hepatic function abnormal 166.84 14.98 275 58953 51292 42510815
Aspergillus infection 160.03 14.98 150 59078 15687 42546420
Klebsiella infection 151.88 14.98 126 59102 11206 42550901
Rash maculo-papular 150.64 14.98 221 59007 37282 42524825
Pancytopenia 138.23 14.98 418 58810 117325 42444782
Pseudomembranous colitis 134.40 14.98 72 59156 3061 42559046
Dysbiosis 133.81 14.98 48 59180 753 42561354
Pseudomonas infection 133.19 14.98 136 59092 15787 42546320
Arthralgia 130.55 14.98 61 59167 205177 42356930
Drug abuse 123.90 14.98 5 59223 104766 42457341
Thrombocytopenia 123.13 14.98 557 58671 189722 42372385
Death 120.91 14.98 301 58927 470884 42091223
Acute respiratory distress syndrome 117.41 14.98 175 59053 29933 42532174
Trichosporon infection 108.04 14.98 43 59185 909 42561198
Drug-induced liver injury 107.82 14.98 192 59036 38081 42524026
Headache 107 14.98 105 59123 239264 42322843
Myocardial infarction 105.23 14.98 22 59206 123987 42438120
Pain 103.13 14.98 113 59115 244735 42317372
Fungal infection 103.01 14.98 132 59096 19590 42542517
Geotrichum infection 97.98 14.98 35 59193 542 42561565
Asthenia 97.29 14.98 150 59078 280643 42281464
Agranulocytosis 97.28 14.98 162 59066 30450 42531657
Inappropriate schedule of product administration 94.96 14.98 11 59217 95891 42466216
Anxiety 94.69 14.98 24 59204 118536 42443571
Clostridium difficile colitis 92.28 14.98 130 59098 21122 42540985
Weight decreased 88.61 14.98 95 59133 207853 42354254
Systemic mycosis 86.28 14.98 49 59179 2338 42559769
Depression 86.17 14.98 24 59204 111339 42450768
Clostridium test positive 86.07 14.98 67 59161 5438 42556669
Drug eruption 85.52 14.98 131 59097 22944 42539163
Cholestasis 85.08 14.98 159 59069 32720 42529387
Nausea 85.04 14.98 276 58952 396523 42165584
Pain in extremity 80.99 14.98 55 59173 150549 42411558
Condition aggravated 79.75 14.98 627 58601 260127 42301980
Mucormycosis 76.69 14.98 70 59158 7073 42555034
Fungaemia 76.38 14.98 50 59178 3086 42559021
Brain abscess 75.49 14.98 56 59172 4228 42557879
Pneumonia bacterial 74.16 14.98 100 59128 15592 42546515
Tachypnoea 73.37 14.98 118 59110 21544 42540563
Blood pressure increased 70.00 14.98 27 59201 101901 42460206
Bone marrow failure 69.90 14.98 147 59081 32946 42529161
Febrile neutropenia 68.43 14.98 467 58761 185236 42376871
Aplastic anaemia 68.01 14.98 85 59143 12299 42549808
Joint swelling 66.83 14.98 8 59220 68014 42494093
Feeling abnormal 66.65 14.98 9 59219 69777 42492330
Renal impairment 66.23 14.98 316 58912 109912 42452195
Rash morbilliform 65.92 14.98 51 59177 4102 42558005
Nasopharyngitis 65.16 14.98 18 59210 83978 42478129
Procalcitonin increased 64.67 14.98 40 59188 2236 42559871
Herpes simplex oesophagitis 64.36 14.98 21 59207 243 42561864
Stenotrophomonas infection 64.34 14.98 48 59180 3656 42558451
Clostridium difficile infection 64.22 14.98 114 59114 22545 42539562
Immune effector cell-associated neurotoxicity syndrome 63.61 14.98 72 59156 9389 42552718
Coagulopathy 63.45 14.98 112 59116 22050 42540057
Dyspnoea 62.80 14.98 360 58868 442261 42119846
Gait disturbance 62.43 14.98 29 59199 97971 42464136
Acinetobacter infection 62.36 14.98 34 59194 1497 42560610
Spinal muscular atrophy 62.30 14.98 23 59205 393 42561714
Weight increased 61.36 14.98 37 59191 107946 42454161
Chest pain 60.22 14.98 63 59165 139467 42422640
Cough 58.90 14.98 98 59130 178005 42384102
Muscle spasms 58.74 14.98 23 59205 86021 42476086
Myelosuppression 58.49 14.98 155 59073 40306 42521801
Hepatic failure 57.16 14.98 148 59080 37952 42524155
Abdominal discomfort 56.76 14.98 17 59211 75238 42486869
Hepatitis cholestatic 56.47 14.98 69 59159 9755 42552352
Hospitalisation 55.68 14.98 17 59211 74313 42487794
Syncope 55.18 14.98 35 59193 99371 42462736
Cardiac failure congestive 55.03 14.98 25 59203 85577 42476530
Shock 54.26 14.98 123 59105 28998 42533109
Hepatomegaly 54.01 14.98 74 59154 11711 42550396
Musculoskeletal stiffness 53.87 14.98 8 59220 57757 42504350
Coronary artery disease 53.56 14.98 6 59222 53714 42508393
Cardiac disorder 52.70 14.98 4 59224 48928 42513179
Injection site pain 51.66 14.98 9 59219 57789 42504318
Acute kidney injury 51.48 14.98 755 58473 366582 42195525
Insomnia 51.46 14.98 53 59175 118200 42443907
Bacteraemia 51.45 14.98 110 59118 24930 42537177
Hyperhidrosis 51.44 14.98 31 59197 90481 42471626
Cytokine release syndrome 51.14 14.98 157 59071 44370 42517737
Conductive deafness 50.60 14.98 21 59207 496 42561611
Pneumonia fungal 50.58 14.98 63 59165 9083 42553024
Pneumococcal sepsis 50.26 14.98 29 59199 1426 42560681
C-reactive protein increased 50.26 14.98 198 59030 63362 42498745
Pruritus 50.23 14.98 118 59110 188653 42373454
Encephalopathy 48.65 14.98 147 59081 41186 42520921
Constipation 48.54 14.98 95 59133 162196 42399911
Intentional product misuse 48.50 14.98 13 59215 61887 42500220
Pulmonary haemorrhage 48.41 14.98 69 59159 11328 42550779
Urinary tract infection fungal 48.24 14.98 21 59207 560 42561547
Liver abscess 48.14 14.98 46 59182 4924 42557183
Chronic obstructive pulmonary disease 48.06 14.98 14 59214 63100 42499007
Incorrect dose administered 47.90 14.98 8 59220 52966 42509141
Methaemoglobinaemia 47.70 14.98 49 59179 5725 42556382
Rheumatoid arthritis 47.07 14.98 3 59225 42437 42519670
Psoriasis 47.05 14.98 6 59222 48598 42513509
Myalgia 46.60 14.98 39 59189 96041 42466066
Hepatotoxicity 46.56 14.98 106 59122 25061 42537046
Sputum increased 46.23 14.98 37 59191 3126 42558981
Cytomegalovirus infection 45.92 14.98 123 59105 32183 42529924
Cerebrovascular accident 45.23 14.98 41 59187 97119 42464988
Back pain 45.03 14.98 80 59148 141696 42420411
Rhinocerebral mucormycosis 44.78 14.98 21 59207 669 42561438
Ototoxicity 44.61 14.98 32 59196 2293 42559814
Neutropenia 44.55 14.98 448 58780 198983 42363124
Liver injury 43.90 14.98 88 59140 19060 42543047
Tumour lysis syndrome 43.78 14.98 96 59132 22135 42539972
Dry mouth 43.69 14.98 3 59225 39876 42522231
Inflammatory marker increased 43.03 14.98 50 59178 6706 42555401
Epilepsy 42.74 14.98 105 59123 26066 42536041
Therapeutic product effect decreased 42.73 14.98 3 59225 39147 42522960
Acute myeloid leukaemia 42.57 14.98 95 59133 22161 42539946
Gastrooesophageal reflux disease 42.53 14.98 6 59222 45017 42517090
Treatment failure 42.39 14.98 186 59042 62438 42499669
Leukopenia 41.80 14.98 210 59018 74536 42487571
Rectal haemorrhage 41.64 14.98 9 59219 49597 42512510
Toxic skin eruption 41.40 14.98 71 59157 13659 42548448
Hyphaema 40.91 14.98 20 59208 700 42561407
Renal failure 40.77 14.98 340 58888 143386 42418721
Dyspnoea exertional 40.30 14.98 10 59218 50138 42511969
Shock haemorrhagic 40.09 14.98 77 59151 16165 42545942
Hypofibrinogenaemia 39.89 14.98 28 59200 1939 42560168
Increased bronchial secretion 39.85 14.98 30 59198 2316 42559791
Sleep disorder 39.82 14.98 9 59219 48086 42514021
Hypoalbuminaemia 39.76 14.98 75 59153 15535 42546572
Strongyloidiasis 39.55 14.98 35 59193 3396 42558711
Wrong technique in product usage process 39.53 14.98 6 59222 42629 42519478
Pseudo-Bartter syndrome 39.42 14.98 9 59219 21 42562086
Motor neurone disease 39.35 14.98 18 59210 541 42561566
Aggression 39.20 14.98 7 59221 44156 42517951
Leukocytosis 39.13 14.98 110 59118 29598 42532509
Pneumothorax 39.02 14.98 95 59133 23448 42538659
Dehydration 39 14.98 87 59141 141680 42420427
Anal inflammation 38.97 14.98 29 59199 2200 42559907
Arthritis 38.82 14.98 6 59222 42059 42520048
Stoma closure 38.78 14.98 15 59213 293 42561814
Vascular pseudoaneurysm thrombosis 38.74 14.98 11 59217 76 42562031
Endocarditis 38.59 14.98 52 59176 8100 42554007
Blood glucose increased 38.15 14.98 28 59200 73671 42488436
Intentional overdose 38.12 14.98 12 59216 51444 42510663
Suicidal ideation 37.94 14.98 10 59218 48151 42513956
SARS-CoV-2 test negative 37.71 14.98 26 59202 1749 42560358
Device related sepsis 37.70 14.98 36 59192 3851 42558256
Platelet count decreased 37.28 14.98 324 58904 138257 42423850
Chest discomfort 37.26 14.98 21 59207 63595 42498512
Vision blurred 37.23 14.98 14 59214 53685 42508422
Hypoaesthesia 37.19 14.98 27 59201 71436 42490671
Product use in unapproved indication 36.78 14.98 405 58823 184051 42378056
Stevens-Johnson syndrome 36.23 14.98 89 59139 22089 42540018
Drug intolerance 36.17 14.98 35 59193 80389 42481718
Hyperbilirubinaemia 36.07 14.98 85 59143 20550 42541557
Fungal endocarditis 36.03 14.98 16 59212 448 42561659
Meningitis candida 36.01 14.98 12 59216 149 42561958
Acute myeloid leukaemia recurrent 34.96 14.98 33 59195 3479 42558628
Anti factor V antibody 34.95 14.98 14 59214 301 42561806
Toxicity to various agents 34.77 14.98 182 59046 228954 42333153
Peripheral swelling 34.36 14.98 45 59183 90225 42471882
Dermatitis bullous 34.17 14.98 50 59178 8406 42553701
Dyspepsia 33.71 14.98 8 59220 41344 42520763
Portal fibrosis 33.68 14.98 14 59214 332 42561775
Cardiac valve vegetation 33.68 14.98 16 59212 525 42561582
Circulatory collapse 33.59 14.98 90 59138 23546 42538561
Multiple-drug resistance 33.59 14.98 46 59182 7276 42554831
Scedosporium infection 33.52 14.98 23 59205 1535 42560572
Venoocclusive liver disease 33.36 14.98 55 59173 10247 42551860
Congenital multiplex arthrogryposis 33.33 14.98 13 59215 260 42561847
Hepatic cytolysis 33.03 14.98 97 59131 26747 42535360
Loss of personal independence in daily activities 32.88 14.98 14 59214 49802 42512305
Device related infection 32.73 14.98 81 59147 20198 42541909
Eosinophilic pneumonia 32.61 14.98 37 59191 4837 42557270
Ischaemic cerebral infarction 32.42 14.98 23 59205 1620 42560487
Enterococcal sepsis 32.22 14.98 25 59203 2019 42560088
Balance disorder 32.07 14.98 13 59215 47632 42514475
CNS ventriculitis 32.00 14.98 14 59214 378 42561729
Hepatic necrosis 31.95 14.98 33 59195 3880 42558227
Hypertension 31.86 14.98 122 59106 167082 42395025
Paraesthesia 31.86 14.98 33 59195 73426 42488681
Neutropenic colitis 31.73 14.98 35 59193 4435 42557672
Oedema peripheral 31.62 14.98 91 59137 135985 42426122
Neurotoxicity 31.56 14.98 88 59140 23563 42538544
Decreased appetite 31.24 14.98 150 59078 192987 42369120
Neonatal candida infection 31.24 14.98 8 59220 35 42562072
Respiratory gas exchange disorder 31.19 14.98 15 59213 506 42561601
Disseminated mucormycosis 31.03 14.98 21 59207 1370 42560737
Neck pain 30.83 14.98 3 59225 30011 42532096
Contusion 30.73 14.98 10 59218 41975 42520132
Transient ischaemic attack 30.71 14.98 5 59223 33734 42528373
Haemodynamic instability 30.34 14.98 59 59169 12498 42549609
Aortoenteric fistula 30.10 14.98 10 59218 123 42561984
Aeromonas infection 29.85 14.98 13 59215 347 42561760
Enterococcus test positive 29.63 14.98 22 59206 1663 42560444
Hypoxia 29.61 14.98 182 59046 69604 42492503
Acute hepatic failure 29.48 14.98 70 59158 17003 42545104
Loss of consciousness 29.41 14.98 52 59176 92302 42469805
Asthma 29.34 14.98 26 59202 62288 42499819
Acute generalised exanthematous pustulosis 29.34 14.98 47 59181 8548 42553559
Epidermolysis bullosa 29.32 14.98 10 59218 134 42561973
Lung consolidation 29.21 14.98 41 59187 6636 42555471
Disseminated cryptococcosis 29.16 14.98 23 59205 1902 42560205
Hyperferritinaemia 29.11 14.98 15 59213 588 42561519
Nocardiosis 29.10 14.98 36 59192 5154 42556953
Mediastinitis 28.77 14.98 18 59210 1027 42561080
Nephrogenic diabetes insipidus 28.69 14.98 21 59207 1553 42560554
Lymphadenectomy 28.69 14.98 14 59214 488 42561619
Cerebral palsy 28.57 14.98 13 59215 386 42561721
Infective aneurysm 28.55 14.98 18 59210 1041 42561066
Mobility decreased 28.45 14.98 7 59221 35299 42526808
Flavobacterium infection 28.33 14.98 9 59219 95 42562012
Staphylococcus test positive 28.12 14.98 30 59198 3662 42558445
Palpitations 28.02 14.98 18 59210 50779 42511328
Heart rate decreased 28.00 14.98 8 59220 36524 42525583
Hypernatraemia 27.81 14.98 50 59178 9982 42552125
Jarisch-Herxheimer reaction 27.73 14.98 16 59212 787 42561320
Megacolon 27.72 14.98 24 59204 2261 42559846
Gingivitis ulcerative 27.61 14.98 11 59217 233 42561874
Intestinal ischaemia 27.59 14.98 48 59180 9340 42552767
Acute respiratory failure 27.50 14.98 117 59111 38741 42523366
Dermatitis exfoliative generalised 27.34 14.98 37 59191 5787 42556320
Respiratory tract infection bacterial 27.20 14.98 22 59206 1887 42560220
Lower respiratory tract infection bacterial 27.14 14.98 14 59214 550 42561557
Haemorrhagic pneumonia 27.13 14.98 10 59218 170 42561937
Cutaneous T-cell lymphoma stage I 26.85 14.98 9 59219 114 42561993
Blood bilirubin increased 26.71 14.98 123 59105 42129 42519978
Blood cholesterol increased 26.62 14.98 3 59225 26738 42535369
Chest X-ray abnormal 26.46 14.98 32 59196 4476 42557631
Anuria 26.43 14.98 53 59175 11479 42550628
Type IV hypersensitivity reaction 26.39 14.98 24 59204 2413 42559694
Bronchial disorder 26.27 14.98 19 59209 1379 42560728
Thrombosis 26.23 14.98 34 59194 68477 42493630
Colitis ulcerative 25.90 14.98 3 59225 26172 42535935
Pneumonia pseudomonal 25.85 14.98 33 59195 4876 42557231
Product prescribing error 25.82 14.98 3 59225 26109 42535998
Blood pressure systolic increased 25.78 14.98 4 59224 27964 42534143
Bacterial sepsis 25.72 14.98 38 59190 6444 42555663
Vomiting 25.69 14.98 268 58960 289455 42272652
Wound dehiscence 25.68 14.98 29 59199 3771 42558336
Cryptococcal meningoencephalitis 25.64 14.98 10 59218 200 42561907
Angina pectoris 25.59 14.98 7 59221 32889 42529218
Somnolence 25.57 14.98 105 59123 141000 42421107
Fungal sepsis 25.57 14.98 17 59211 1077 42561030
Hypokalaemia 25.54 14.98 179 59049 71542 42490565
Cross sensitivity reaction 25.35 14.98 20 59208 1655 42560452
Disease complication 25.26 14.98 26 59202 3044 42559063
Drug level increased 25.22 14.98 87 59141 26113 42535994
Malaise 25.14 14.98 182 59046 211974 42350133
Splenic abscess 25.12 14.98 14 59214 644 42561463
Nephrolithiasis 24.87 14.98 10 59218 36820 42525287
Eosinophilic pneumonia acute 24.85 14.98 15 59213 802 42561305
Drug interaction 24.74 14.98 514 58714 266485 42295622
Discomfort 24.68 14.98 3 59225 25216 42536891
Systemic inflammatory response syndrome 24.67 14.98 40 59188 7350 42554757
Tremor 24.64 14.98 62 59166 96867 42465240
Cardiac arrest 24.57 14.98 246 58982 109074 42453033
Staphylococcal sepsis 24.44 14.98 51 59177 11363 42550744
Influenza like illness 24.35 14.98 7 59221 31833 42530274
Illness 24.31 14.98 3 59225 24927 42537180
Aspergillus test positive 24.29 14.98 14 59214 687 42561420
Amnesia 24.19 14.98 5 59223 28432 42533675
Abdominal pain upper 24.12 14.98 49 59179 82560 42479547
Medication error 24.08 14.98 8 59220 33146 42528961
Hepatitis fulminant 24.03 14.98 32 59196 4927 42557180
Oliguria 24.03 14.98 45 59183 9268 42552839
Serum sickness-like reaction 23.95 14.98 10 59218 240 42561867
Gamma-glutamyltransferase increased 23.89 14.98 99 59129 32398 42529709
Mechanical ventilation 23.83 14.98 22 59206 2255 42559852
Anticonvulsant drug level decreased 23.83 14.98 17 59211 1208 42560899
Infection in an immunocompromised host 23.68 14.98 16 59212 1041 42561066
Osteoarthritis 23.65 14.98 3 59225 24402 42537705
Eczema 23.43 14.98 9 59219 34077 42528030
Swelling 23.41 14.98 25 59203 54860 42507247
Pulmonary mucormycosis 23.38 14.98 18 59210 1437 42560670
Metabolic disorder 23.36 14.98 31 59197 4757 42557350
Linear IgA disease 23.34 14.98 21 59207 2082 42560025
Pneumonia klebsiella 23.17 14.98 29 59199 4200 42557907
Necrotising fasciitis 23.06 14.98 30 59198 4516 42557591
Respiratory paralysis 23.00 14.98 8 59220 114 42561993
Blood alkaline phosphatase increased 22.88 14.98 100 59128 33497 42528610
Staphylococcal infection 22.63 14.98 108 59120 37535 42524572
Microangiopathic haemolytic anaemia 22.50 14.98 16 59212 1131 42560976
Adverse drug reaction 22.43 14.98 12 59216 37422 42524685
Tubulointerstitial nephritis 22.33 14.98 95 59133 31453 42530654
Dysphonia 22.23 14.98 6 59222 28444 42533663
Granulocyte count decreased 22.17 14.98 18 59210 1552 42560555
Enterocolitis 22.00 14.98 45 59183 9884 42552223
COVID-19 pneumonia 21.88 14.98 73 59155 21540 42540567
Metabolic acidosis 21.84 14.98 135 59093 51723 42510384
Soft tissue necrosis 21.81 14.98 11 59217 412 42561695
Obstructive airways disorder 21.81 14.98 4 59224 24755 42537352
Diabetes mellitus 21.81 14.98 31 59197 60056 42502051
Rectal perforation 21.77 14.98 12 59216 540 42561567
Gout 21.77 14.98 6 59222 28049 42534058
Septic embolus 21.75 14.98 17 59211 1388 42560719
Fusarium infection 21.71 14.98 18 59210 1598 42560509
Factor V inhibition 21.36 14.98 9 59219 221 42561886
Blood lactate dehydrogenase increased 21.21 14.98 82 59146 25999 42536108
Cataract 21.17 14.98 8 59220 30596 42531511
Drug dependence 21.16 14.98 7 59221 29087 42533020
Pneumonia 21.12 14.98 750 58478 421399 42140708
Tinnitus 20.99 14.98 7 59221 28931 42533176
Respiratory distress 20.95 14.98 114 59114 41706 42520401
Bacillus infection 20.91 14.98 13 59215 733 42561374
Neuropathy peripheral 20.91 14.98 72 59156 101781 42460326
Rhinorrhoea 20.87 14.98 9 59219 31785 42530322
Pneumonia necrotising 20.76 14.98 15 59213 1087 42561020
Urticaria 20.70 14.98 45 59183 73991 42488116
Drug level decreased 20.69 14.98 44 59184 9933 42552174
Cholangitis infective 20.67 14.98 10 59218 342 42561765
Hyperpyrexia 20.57 14.98 25 59203 3515 42558592
Hepatocellular injury 20.54 14.98 76 59152 23602 42538505
Deep vein thrombosis 20.52 14.98 48 59180 76909 42485198
Pulmonary embolism 20.44 14.98 91 59137 119521 42442586
Interleukin-2 receptor increased 20.02 14.98 8 59220 171 42561936
Hepatitis 19.94 14.98 83 59145 27217 42534890
Resuscitation 19.81 14.98 18 59210 1807 42560300
Toxic encephalopathy 19.72 14.98 35 59193 6918 42555189
Encephalitis 19.70 14.98 41 59187 9117 42552990
Radiation fibrosis - lung 19.69 14.98 5 59223 21 42562086
Cholangiolitis 19.69 14.98 5 59223 21 42562086
Faeces pale 19.68 14.98 17 59211 1597 42560510
Laboratory test abnormal 19.63 14.98 4 59224 22974 42539133
Psychotic disorder 19.61 14.98 8 59220 29200 42532907
Musculoskeletal pain 19.52 14.98 11 59217 33329 42528778
Transaminases increased 19.51 14.98 94 59134 32791 42529316
Vanishing bile duct syndrome 19.43 14.98 18 59210 1853 42560254
Klebsiella bacteraemia 19.41 14.98 20 59208 2344 42559763
Psoas abscess 19.40 14.98 13 59215 834 42561273
Alanine aminotransferase increased 19.40 14.98 198 59030 88208 42473899
Neoplasm malignant 19.34 14.98 4 59224 22739 42539368
Bronchopleural fistula 19.33 14.98 12 59216 675 42561432
Basal cell carcinoma 19.33 14.98 4 59224 22729 42539378
Antinuclear antibody negative 19.32 14.98 5 59223 23 42562084
Muscular weakness 19.27 14.98 56 59172 83442 42478665
Vertigo 19.17 14.98 12 59216 34335 42527772
Fluid retention 19.15 14.98 10 59218 31609 42530498
Disseminated sporotrichosis 19.15 14.98 5 59223 24 42562083
Obliterative bronchiolitis 19.06 14.98 16 59212 1445 42560662
Depressed level of consciousness 19.03 14.98 123 59105 47847 42514260
Peritonitis 18.92 14.98 63 59165 18570 42543537
Escherichia infection 18.90 14.98 46 59182 11350 42550757
Organ failure 18.89 14.98 20 59208 2420 42559687
Catheter site pain 18.85 14.98 17 59211 1690 42560417
Vitamin K deficiency 18.75 14.98 10 59218 421 42561686
Therapy interrupted 18.75 14.98 4 59224 22246 42539861
Angioedema 18.50 14.98 19 59209 42458 42519649
Abdominal compartment syndrome 18.48 14.98 14 59214 1091 42561016
Dermatitis exfoliative 18.47 14.98 34 59194 6913 42555194
Penicillium infection 18.41 14.98 9 59219 315 42561792
Feeling hot 18.26 14.98 5 59223 23477 42538630
Hypoproteinaemia 18.22 14.98 21 59207 2791 42559316
Malignant neoplasm progression 18.21 14.98 83 59145 108317 42453790
Alopecia 18.11 14.98 9 59219 29267 42532840
Cholestatic liver injury 18.08 14.98 24 59204 3685 42558422
Nephropathy toxic 18.06 14.98 58 59170 16780 42545327
Influenza 18.04 14.98 37 59191 62138 42499969
Immune reconstitution inflammatory syndrome 17.96 14.98 42 59186 10101 42552006
Heart rate increased 17.85 14.98 29 59199 53226 42508881
Blood fibrinogen decreased 17.78 14.98 16 59212 1587 42560520
Abdominal pain 17.76 14.98 174 59054 190297 42371810
Red blood cell schistocytes present 17.75 14.98 9 59219 341 42561766
Acoustic neuroma 17.72 14.98 7 59221 145 42561962
Endotracheal intubation 17.69 14.98 24 59204 3761 42558346
Myocardial calcification 17.68 14.98 5 59223 34 42562073
Infectious pleural effusion 17.65 14.98 22 59206 3173 42558934
Abdominal wound dehiscence 17.58 14.98 7 59221 148 42561959
Urinary tract inflammation 17.50 14.98 8 59220 240 42561867
Gait inability 17.50 14.98 5 59223 22828 42539279
Listeriosis 17.48 14.98 15 59213 1396 42560711
Pseudomonal bacteraemia 17.42 14.98 19 59209 2377 42559730
Neuralgia 17.25 14.98 7 59221 25640 42536467
Nosocomial infection 17.25 14.98 15 59213 1421 42560686
Chimerism 17.20 14.98 8 59220 250 42561857
Hypogonadism 17.18 14.98 19 59209 2415 42559692
Hepatic haemorrhage 17.17 14.98 11 59217 654 42561453
Dysarthria 17.12 14.98 18 59210 39789 42522318
Urinary tract candidiasis 17.09 14.98 10 59218 505 42561602
Fungal abscess central nervous system 17.00 14.98 7 59221 162 42561945
Road traffic accident 17.00 14.98 3 59225 19090 42543017
Diarrhoea 16.83 14.98 500 58728 460349 42101758
Flushing 16.78 14.98 16 59212 37012 42525095
Herpes simplex 16.73 14.98 33 59195 7062 42555045
Bilirubin conjugated increased 16.71 14.98 23 59205 3654 42558453
Flatulence 16.70 14.98 7 59221 25145 42536962
Bifidobacterium infection 16.67 14.98 6 59222 95 42562012
Corynebacterium infection 16.59 14.98 12 59216 871 42561236
Acute myocardial infarction 16.55 14.98 35 59193 58130 42503977
Embolic cerebral infarction 16.52 14.98 12 59216 877 42561230
Accidental exposure to product 16.51 14.98 4 59224 20389 42541718
Agitation 16.44 14.98 41 59187 64273 42497834
Pulmonary cavitation 16.44 14.98 14 59214 1290 42560817
Potentiating drug interaction 16.37 14.98 31 59197 6437 42555670
Depressed mood 16.37 14.98 6 59222 23378 42538729
Overdose 16.28 14.98 83 59145 105181 42456926
Pulmonary necrosis 16.25 14.98 9 59219 409 42561698
Graft versus host disease in gastrointestinal tract 16.04 14.98 27 59201 5116 42556991
Immunosuppressant drug level decreased 16.02 14.98 16 59212 1808 42560299
Arterial angioplasty 15.98 14.98 5 59223 50 42562057
Muscle abscess 15.88 14.98 12 59216 932 42561175
Frequent bowel movements 15.84 14.98 5 59223 21402 42540705
Blood culture negative 15.72 14.98 5 59223 53 42562054
Diverticulitis 15.68 14.98 6 59222 22767 42539340
Hypoperfusion 15.53 14.98 14 59214 1391 42560716
Pyroglutamic acidosis 15.51 14.98 11 59217 774 42561333
Therapy non-responder 15.51 14.98 127 59101 53232 42508875
Vascular pseudoaneurysm 15.51 14.98 19 59209 2693 42559414
Burning sensation 15.38 14.98 5 59223 21008 42541099
Pollakiuria 15.37 14.98 6 59222 22499 42539608
Intentional product use issue 15.27 14.98 50 59178 71783 42490324
Cytomegalovirus test positive 15.27 14.98 24 59204 4295 42557812
Skin discolouration 15.24 14.98 5 59223 20885 42541222
Sedation 15.22 14.98 12 59216 30463 42531644
Candida sepsis 15.20 14.98 14 59214 1431 42560676
Alveolitis necrotising 15.18 14.98 4 59224 20 42562087
Haemolysis 15.15 14.98 38 59190 9551 42552556
Urinary retention 15.10 14.98 22 59206 42192 42519915
Pseudomonas test positive 15.05 14.98 14 59214 1449 42560658
Accident 15.04 14.98 30 59198 6473 42555634

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
Multiple organ dysfunction syndrome 1657.64 14.92 1247 97959 150463 110339630
Septic shock 1371.80 14.92 1133 98073 156395 110333698
Drug ineffective 1321.51 14.92 3638 95568 1516902 108973191
Drug reaction with eosinophilia and systemic symptoms 1134.63 14.92 779 98427 81316 110408777
Drug resistance 1051.99 14.92 646 98560 55728 110434365
Pathogen resistance 959.87 14.92 416 98790 17256 110472837
Sepsis 627.23 14.92 1083 98123 326263 110163830
Respiratory failure 625.73 14.92 864 98342 214468 110275625
Off label use 493.92 14.92 2641 96565 1497544 108992549
Bronchopulmonary aspergillosis 491.02 14.92 316 98890 29547 110460546
Fatigue 471.66 14.92 253 98953 1215705 109274388
Drug ineffective for unapproved indication 460.32 14.92 513 98693 102325 110387768
Eosinophilia 446.55 14.92 389 98817 57547 110432546
Systemic candida 446.13 14.92 205 99001 9769 110480324
Candida infection 445.85 14.92 359 98847 47650 110442443
Pyrexia 431.75 14.92 1768 97438 896497 109593596
Toxic epidermal necrolysis 423.41 14.92 374 98832 56353 110433740
Thrombocytopenia 416.51 14.92 947 98259 347938 110142155
Enterococcal infection 412.15 14.92 246 98960 20120 110469973
Haemophagocytic lymphohistiocytosis 404.09 14.92 286 98920 31273 110458820
Pain 401.31 14.92 178 99028 954777 109535316
Arthralgia 382.15 14.92 113 99093 779519 109710574
Pancytopenia 354.09 14.92 657 98549 208956 110281137
Headache 345.38 14.92 181 99025 882196 109607897
Aspergillus infection 341.58 14.92 238 98968 25378 110464715
Joint swelling 340.55 14.92 13 99193 442832 110047261
Disseminated intravascular coagulation 338.01 14.92 287 98919 40999 110449094
Dizziness 322.87 14.92 112 99094 698081 109792012
Febrile neutropenia 307.35 14.92 794 98412 315973 110174120
Acute kidney injury 303.11 14.92 1249 97957 634181 109855912
Rash maculo-papular 294.49 14.92 348 98858 73874 110416219
Pseudomonas infection 283.75 14.92 220 98986 27633 110462460
Hepatic function abnormal 282.85 14.92 374 98832 88921 110401172
Fall 278.58 14.92 97 99109 603385 109886708
Clostridium difficile colitis 269.07 14.92 259 98947 43519 110446574
Dysbiosis 262.43 14.92 91 99115 2041 110488052
Acute respiratory distress syndrome 259.89 14.92 278 98928 52920 110437173
Nasopharyngitis 255.28 14.92 28 99178 394333 110095760
Klebsiella infection 248.45 14.92 178 99028 19831 110470262
Rheumatoid arthritis 248.30 14.92 4 99202 299609 110190484
Abdominal discomfort 244.99 14.92 32 99174 393826 110096267
Agranulocytosis 230.93 14.92 281 98925 61479 110428614
Drug intolerance 226.03 14.92 45 99161 406467 110083626
Clostridium test positive 224.09 14.92 133 99073 10760 110479333
Pseudomembranous colitis 223.71 14.92 111 99095 6280 110483813
Mucormycosis 219.25 14.92 130 99076 10498 110479595
Product dose omission issue 218.33 14.92 19 99187 321763 110168330
Neutropenia 215.52 14.92 782 98424 373838 110116255
Brain abscess 214.69 14.92 110 99096 6664 110483429
Pain in extremity 203.80 14.92 91 99115 487027 110003066
Renal impairment 203.18 14.92 492 98714 187953 110302140
Fungaemia 202.12 14.92 102 99104 5984 110484109
Swelling 199.07 14.92 37 99169 351004 110139089
Completed suicide 197.68 14.92 4 99202 242377 110247716
Weight increased 196.02 14.92 66 99140 419578 110070515
Peripheral swelling 195.00 14.92 60 99146 403974 110086119
Acinetobacter infection 190.32 14.92 83 99123 3490 110486603
Clostridium difficile infection 181.73 14.92 229 98977 51900 110438193
Therapeutic product effect decreased 181.66 14.92 9 99197 244307 110245786
Systemic lupus erythematosus 181.05 14.92 12 99194 254326 110235767
Musculoskeletal stiffness 180.69 14.92 20 99186 279802 110210291
Alopecia 179.94 14.92 52 99154 364701 110125392
Wound 179.70 14.92 7 99199 234430 110255663
Depression 174.54 14.92 36 99170 317299 110172794
Drug eruption 173.36 14.92 227 98979 53432 110436661
Fungal infection 170.49 14.92 219 98987 50587 110439506
Cytokine release syndrome 168.71 14.92 258 98948 70048 110420045
Anxiety 163.35 14.92 53 99153 345025 110145068
Muscle spasms 162.74 14.92 27 99179 278130 110211963
Trichosporon infection 161.99 14.92 56 99150 1244 110488849
Geotrichum infection 161.91 14.92 55 99151 1157 110488936
Asthenia 158.52 14.92 233 98973 688766 109801327
Nausea 158.18 14.92 574 98632 1235116 109254977
Immune effector cell-associated neurotoxicity syndrome 153.25 14.92 118 99088 14664 110475429
Dry mouth 153.13 14.92 6 99200 199942 110290151
Infusion related reaction 151.99 14.92 76 99130 381086 110109007
Stenotrophomonas infection 151.34 14.92 83 99123 5775 110484318
Memory impairment 150.52 14.92 6 99200 196938 110293155
Renal failure 150.18 14.92 496 98710 226078 110264015
Coagulopathy 149.45 14.92 184 99022 40727 110449366
Shock 149.31 14.92 211 98995 53377 110436716
Helicobacter infection 148.30 14.92 3 99203 181874 110308219
Cholestasis 148.14 14.92 232 98974 64286 110425807
Encephalopathy 148.02 14.92 263 98943 80792 110409301
Bacteraemia 147.40 14.92 186 99020 42204 110447889
Blood cholesterol increased 143.39 14.92 5 99201 184780 110305313
Pericarditis 143.13 14.92 15 99191 219099 110270994
Pneumonia fungal 142.61 14.92 113 99093 14641 110475452
Discomfort 142.07 14.92 14 99192 214693 110275400
Osteoarthritis 141.51 14.92 5 99201 182618 110307475
Insomnia 139.16 14.92 75 99131 360515 110129578
Leukopenia 137.95 14.92 367 98839 148424 110341669
Cardiac arrest 136.94 14.92 438 98768 196315 110293778
Gait disturbance 136.56 14.92 40 99166 278168 110211925
Contusion 135.72 14.92 23 99183 233338 110256755
Weight decreased 134.40 14.92 133 99073 467924 110022169
Sleep disorder 133.96 14.92 12 99194 198632 110291461
Drug abuse 133.60 14.92 6 99200 177405 110312688
Platelet count decreased 133.15 14.92 482 98724 229961 110260132
Sinusitis 132.78 14.92 50 99156 296638 110193455
Toxic skin eruption 131.21 14.92 142 99064 27373 110462720
Hepatic failure 129.34 14.92 226 98980 68513 110421580
Asthma 128.44 14.92 33 99173 250258 110239835
Blood pressure increased 127.08 14.92 37 99169 258336 110231757
Linear IgA disease 126.85 14.92 67 99139 4322 110485771
Stevens-Johnson syndrome 126.73 14.92 182 99024 46719 110443374
Abdominal pain upper 125.65 14.92 79 99127 349032 110141061
Migraine 125.46 14.92 7 99199 171645 110318448
Injection site pain 124.84 14.92 9 99197 177913 110312180
Type 2 diabetes mellitus 124.26 14.92 9 99197 177223 110312870
Systemic mycosis 120.83 14.92 62 99144 3767 110486326
Multiple-drug resistance 120.76 14.92 98 99108 13137 110476956
Myelosuppression 120.00 14.92 263 98943 94077 110396016
Malaise 119.69 14.92 266 98940 671553 109818540
Bone marrow failure 117.80 14.92 197 99009 57651 110432442
Pneumonia bacterial 117.38 14.92 131 99075 26130 110463963
Rhinocerebral mucormycosis 113.81 14.92 45 99161 1472 110488621
Arthritis 113.33 14.92 10 99196 167576 110322517
Hypoaesthesia 113.21 14.92 71 99135 314152 110175941
Procalcitonin increased 111.82 14.92 60 99146 3996 110486097
Mobility decreased 111.38 14.92 37 99169 237385 110252708
Rash morbilliform 110.98 14.92 76 99130 7875 110482218
Cytomegalovirus infection 110.32 14.92 185 99021 54259 110435834
Musculoskeletal pain 108.74 14.92 17 99189 183006 110307087
Folliculitis 108.15 14.92 12 99194 167641 110322452
Drug interaction 107.89 14.92 793 98413 499390 109990703
Aplastic anaemia 104.79 14.92 119 99087 24189 110465904
Acute myeloid leukaemia 104.60 14.92 149 99057 37961 110452132
Ill-defined disorder 104.35 14.92 10 99196 156843 110333250
Urticaria 103.05 14.92 81 99125 318776 110171317
Leukocytosis 99.99 14.92 176 99030 53652 110436441
Drug-induced liver injury 99.22 14.92 284 98922 119783 110370310
Impaired healing 98.89 14.92 27 99179 196690 110293403
Psoriasis 98.45 14.92 7 99199 139986 110350107
Gait inability 98.32 14.92 6 99200 136370 110353723
Feeling abnormal 98.29 14.92 21 99185 180690 110309403
Tachypnoea 97.94 14.92 147 99059 39248 110450845
Systemic inflammatory response syndrome 97.27 14.92 86 99120 12957 110477136
Acute respiratory failure 97.06 14.92 211 98995 75049 110415044
Inappropriate schedule of product administration 96.81 14.92 31 99175 203606 110286487
Contraindicated product administered 96.68 14.92 51 99155 248216 110241877
Fusarium infection 96.61 14.92 48 99158 2723 110487370
Disseminated mucormycosis 96.49 14.92 44 99162 2058 110488035
Muscle injury 96.31 14.92 8 99198 140799 110349294
Hypoalbuminaemia 95.79 14.92 124 99082 28850 110461243
Acute generalised exanthematous pustulosis 94.99 14.92 107 99099 21557 110468536
Hyperbilirubinaemia 93.28 14.92 126 99080 30545 110459548
Hypoxia 92.52 14.92 291 98915 129224 110360869
Paraesthesia 92.22 14.92 68 99138 276453 110213640
Staphylococcal infection 91.23 14.92 197 99009 69747 110420346
Candida sepsis 90.71 14.92 47 99159 2914 110487179
Hypersensitivity 90.46 14.92 139 99067 403859 110086234
Neutropenic colitis 89.38 14.92 67 99139 7998 110482095
Drug hypersensitivity 88.20 14.92 171 99035 453919 110036174
Haemodynamic instability 86.93 14.92 105 99101 22783 110467310
Pneumothorax 86.77 14.92 131 99075 35154 110454939
Neurotoxicity 84.95 14.92 143 99063 42064 110448029
Loss of personal independence in daily activities 84.58 14.92 16 99190 150004 110340089
Injury 84.23 14.92 27 99179 177238 110312855
Oliguria 83.26 14.92 93 99113 18564 110471529
Liver abscess 82.90 14.92 63 99143 7676 110482417
Pruritus 82.39 14.92 258 98948 581302 109908791
Obesity 81.67 14.92 5 99201 113346 110376747
Myocardial infarction 81.62 14.92 35 99171 192048 110298045
Chest pain 80.94 14.92 133 99073 376242 110113851
Enterococcal sepsis 80.28 14.92 45 99161 3267 110486826
Eosinophilic pneumonia 80.01 14.92 60 99146 7167 110482926
Road traffic accident 79.66 14.92 4 99202 107394 110382699
Suicide attempt 79.50 14.92 3 99203 103391 110386702
Gastrooesophageal reflux disease 79.38 14.92 31 99175 179945 110310148
Hypertension 78.98 14.92 217 98989 509867 109980226
Hepatic cytolysis 78.71 14.92 161 99045 54892 110435201
Inflammatory marker increased 78.49 14.92 80 99126 14389 110475704
Dyspnoea 76.53 14.92 631 98575 1106241 109383852
Hepatitis cholestatic 75.73 14.92 86 99120 17480 110472613
Pulmonary haemorrhage 75.11 14.92 83 99123 16373 110473720
Stress 74.85 14.92 5 99201 105343 110384750
Metabolic acidosis 74.84 14.92 228 98978 99516 110390577
Anuria 74.03 14.92 100 99106 24241 110465852
Blood lactate dehydrogenase increased 73.51 14.92 138 99068 44196 110445897
Toxic encephalopathy 73.38 14.92 79 99127 15135 110474958
Type IV hypersensitivity reaction 73.35 14.92 53 99153 5980 110484113
Nephropathy toxic 73.30 14.92 106 99100 27372 110462721
Acute hepatic failure 72.65 14.92 123 99083 36345 110453748
Intracranial infection 71.93 14.92 22 99184 326 110489767
Spinal muscular atrophy 71.57 14.92 23 99183 404 110489689
Dry skin 71.24 14.92 7 99199 107646 110382447
Pneumonia 71.06 14.92 1142 98064 875572 109614521
Tumour lysis syndrome 71.02 14.92 111 99095 30690 110459403
Joint range of motion decreased 70.83 14.92 12 99194 121820 110368273
Drug level decreased 70.29 14.92 85 99121 18463 110471630
Lung consolidation 70.12 14.92 65 99141 10411 110479682
Condition aggravated 69.93 14.92 984 98222 733852 109756241
Hepatotoxicity 69.82 14.92 167 99039 63233 110426860
Shock haemorrhagic 69.63 14.92 103 99103 27144 110462949
Staphylococcal bacteraemia 69.07 14.92 80 99126 16608 110473485
Hospitalisation 68.95 14.92 21 99185 142472 110347621
Dyspepsia 68.95 14.92 43 99163 190922 110299171
Drug level increased 68.75 14.92 140 99066 47579 110442514
Tubulointerstitial nephritis 68.63 14.92 151 99055 54133 110435960
Blood bilirubin increased 67.97 14.92 185 99021 75787 110414306
Hyperhidrosis 67.87 14.92 42 99164 187256 110302837
Product use in unapproved indication 67.51 14.92 655 98551 446722 110043371
Pleural effusion 67.49 14.92 327 98879 177382 110312711
Intentional overdose 66.94 14.92 18 99188 132483 110357610
Gastrointestinal disorder 66.82 14.92 71 99135 241881 110248212
Device related infection 66.75 14.92 124 99082 39395 110450698
Escherichia infection 66.66 14.92 94 99112 23722 110466371
Bacterial sepsis 66.54 14.92 63 99143 10363 110479730
Night sweats 66.20 14.92 19 99187 133964 110356129
Meningitis candida 65.95 14.92 19 99187 226 110489867
Anticonvulsant drug level decreased 65.71 14.92 34 99172 2102 110487991
Herpes simplex oesophagitis 65.70 14.92 22 99184 442 110489651
Endocarditis 65.49 14.92 70 99136 13301 110476792
Injection site erythema 65.38 14.92 5 99201 94171 110395922
Respiratory distress 64.92 14.92 171 99035 68703 110421390
Anaemia 64.84 14.92 763 98443 546323 109943770
Premature delivery 64.61 14.92 106 99100 30526 110459567
Stomatitis 64.36 14.92 89 99117 270153 110219940
Injection site reaction 63.95 14.92 4 99202 89066 110401027
Nocardiosis 63.22 14.92 53 99153 7433 110482660
Intentional product use issue 62.77 14.92 78 99128 247828 110242265
Amnesia 62.13 14.92 10 99196 105398 110384695
Wound infection 61.97 14.92 7 99199 96458 110393635
Wheezing 61.85 14.92 83 99123 255147 110234946
Neck pain 61.69 14.92 17 99189 123113 110366980
Eosinophilic pneumonia acute 61.50 14.92 30 99176 1635 110488458
Fungal sepsis 61.41 14.92 33 99173 2204 110487889
Illness 61.13 14.92 3 99203 82168 110407925
Peritonitis 61.05 14.92 107 99099 32500 110457593
Acute myeloid leukaemia recurrent 59.88 14.92 44 99162 5095 110484998
Perinephric abscess 59.49 14.92 20 99186 407 110489686
Alanine aminotransferase increased 59.23 14.92 323 98883 183450 110306643
Ototoxicity 58.87 14.92 40 99166 4091 110486002
Scedosporium infection 58.50 14.92 33 99173 2425 110487668
Brain oedema 58.16 14.92 102 99104 30996 110459097
Venoocclusive liver disease 58.13 14.92 70 99136 15137 110474956
Protothecosis 58.01 14.92 21 99185 536 110489557
Cough 57.73 14.92 216 98990 461425 110028668
Vision blurred 57.26 14.92 22 99184 129000 110361093
Emphysematous pyelonephritis 57.25 14.92 21 99185 557 110489536
Factor V inhibition 56.73 14.92 19 99187 382 110489711
Hyphaema 56.64 14.92 25 99181 1082 110489011
Strongyloidiasis 56.55 14.92 42 99164 4944 110485149
Enterocolitis 56.34 14.92 77 99129 18872 110471221
Transaminases increased 56.34 14.92 154 99052 63236 110426857
Myalgia 56.27 14.92 70 99136 222311 110267782
Neutrophil count decreased 55.98 14.92 236 98970 120705 110369388
Disease progression 55.44 14.92 392 98814 243642 110246451
Syncope 55.29 14.92 60 99146 202476 110287617
Graft versus host disease in gastrointestinal tract 54.97 14.92 53 99153 8915 110481178
Symmetrical drug-related intertriginous and flexural exanthema 54.94 14.92 29 99177 1868 110488225
Wrong technique in product usage process 54.48 14.92 7 99199 87341 110402752
Mediastinitis 53.90 14.92 26 99180 1382 110488711
Neutropenic sepsis 53.85 14.92 98 99108 30648 110459445
Hypernatraemia 53.83 14.92 73 99133 17760 110472333
Vomiting 53.77 14.92 540 98666 910135 109579958
Oedema peripheral 53.73 14.92 136 99070 328524 110161569
Circulatory collapse 53.68 14.92 119 99087 42874 110447219
Pneumococcal sepsis 53.47 14.92 30 99176 2182 110487911
Blood pressure systolic increased 53.36 14.92 6 99200 82985 110407108
Dermatitis bullous 53.28 14.92 72 99134 17457 110472636
Dermatitis exfoliative generalised 52.97 14.92 57 99149 10915 110479178
Adverse event 52.71 14.92 16 99190 108793 110381300
Hypofibrinogenaemia 52.58 14.92 31 99175 2476 110487617
Gamma-glutamyltransferase increased 52.56 14.92 147 99059 61162 110428931
Lower limb fracture 52.30 14.92 4 99202 75344 110414749
Nasal congestion 52.26 14.92 12 99194 98270 110391823
Mixed liver injury 51.83 14.92 59 99147 12020 110478073
Urinary tract candidiasis 51.60 14.92 24 99182 1175 110488918
Intentional product misuse 50.70 14.92 28 99178 132876 110357217
Megacolon 50.48 14.92 37 99169 4268 110485825
Nosocomial infection 50.47 14.92 33 99173 3166 110486927
Adverse drug reaction 50.28 14.92 16 99190 105543 110384550
Back pain 50.10 14.92 168 99038 370828 110119265
Hypotension 49.95 14.92 702 98504 523147 109966946
Blood alkaline phosphatase increased 49.37 14.92 158 99048 70777 110419316
Sputum increased 49.15 14.92 41 99165 5710 110484383
Hepatomegaly 49.13 14.92 77 99129 21337 110468756
Hyperlactacidaemia 48.97 14.92 48 99158 8238 110481855
Pneumonia pseudomonal 48.92 14.92 46 99160 7500 110482593
Seizure 48.90 14.92 353 98853 220832 110269261
Product quality issue 48.68 14.92 6 99200 77293 110412800
Anti factor V antibody 48.52 14.92 16 99190 306 110489787
Cardiac failure congestive 47.95 14.92 39 99167 150961 110339132
Constipation 47.64 14.92 163 99043 357623 110132470
Incorrect dose administered 47.12 14.92 17 99189 103624 110386469
Chest discomfort 46.90 14.92 52 99154 173796 110316297
Autoimmune disorder 46.84 14.92 3 99203 65480 110424613
COVID-19 pneumonia 46.59 14.92 103 99103 37040 110453053
Decreased appetite 46.57 14.92 244 98962 475602 110014491
Encephalitis 46.40 14.92 70 99136 18769 110471324
Heart rate decreased 46.27 14.92 9 99197 82747 110407346
Cerebrovascular accident 45.92 14.92 57 99149 181227 110308866
Immune reconstitution inflammatory syndrome 45.35 14.92 64 99142 16162 110473931
Anal inflammation 44.97 14.92 28 99178 2468 110487625
Red blood cell sedimentation rate increased 44.88 14.92 8 99198 78294 110411799
Pseudo-Bartter syndrome 44.87 14.92 12 99194 106 110489987
Ear infection 44.49 14.92 3 99203 62729 110427364
Pyelonephritis fungal 44.36 14.92 15 99191 311 110489782
Pneumocystis jirovecii pneumonia 44.31 14.92 110 99096 42625 110447468
Klebsiella bacteraemia 44.31 14.92 36 99170 4833 110485260
CNS ventriculitis 44.19 14.92 18 99188 637 110489456
Staphylococcus test positive 44.13 14.92 43 99163 7327 110482766
Dyspnoea exertional 44.13 14.92 19 99187 104041 110386052
Urinary tract infection fungal 43.87 14.92 22 99184 1273 110488820
Fluid retention 43.68 14.92 15 99191 94292 110395801
Muscular weakness 43.63 14.92 99 99107 248369 110241724
Knee arthroplasty 43.56 14.92 4 99202 64944 110425149
SARS-CoV-2 test negative 43.53 14.92 26 99180 2127 110487966
Suicidal ideation 43.40 14.92 15 99191 93922 110396171
Rhinorrhoea 43.14 14.92 19 99187 102647 110387446
Vascular pseudoaneurysm thrombosis 43.02 14.92 11 99195 80 110490013
Blister 42.91 14.92 87 99119 227289 110262804
Motor neurone disease 42.45 14.92 18 99188 706 110489387
Bronchitis 42.32 14.92 47 99159 156985 110333108
Graft versus host disease 42.29 14.92 67 99139 18739 110471354
Cardiac valve vegetation 42.24 14.92 20 99186 1020 110489073
Pneumonia klebsiella 42.18 14.92 40 99166 6592 110483501
Vesicoureteric reflux 42.17 14.92 13 99193 198 110489895
Cross sensitivity reaction 42.10 14.92 37 99169 5530 110484563
Pseudomonal sepsis 41.93 14.92 46 99160 9000 110481093
Osteoporosis 41.88 14.92 13 99193 87139 110402954
Coronary artery disease 41.80 14.92 7 99199 71683 110418410
Blood creatinine increased 41.65 14.92 294 98912 182595 110307498
Frequent bowel movements 41.56 14.92 7 99199 71383 110418710
Unevaluable event 41.52 14.92 3 99203 59224 110430869
Methaemoglobinaemia 41.42 14.92 46 99160 9122 110480971
Pseudomonas test positive 41.39 14.92 26 99180 2328 110487765
Lactic acidosis 41.32 14.92 179 99027 92632 110397461
Prescribed underdose 41.19 14.92 5 99201 65169 110424924
Device related sepsis 40.97 14.92 42 99164 7605 110482488
Brain herniation 40.96 14.92 45 99161 8818 110481275
Infective aneurysm 40.93 14.92 22 99184 1470 110488623
Blood fibrinogen decreased 40.76 14.92 27 99179 2648 110487445
Enterococcal bacteraemia 40.63 14.92 33 99173 4428 110485665
Stoma closure 40.61 14.92 15 99191 406 110489687
Hepatitis fulminant 40.50 14.92 44 99162 8516 110481577
Increased bronchial secretion 39.80 14.92 31 99175 3917 110486176
Balance disorder 39.70 14.92 28 99178 116532 110373561
Necrotising fasciitis 39.42 14.92 41 99165 7550 110482543
Rectal haemorrhage 39.24 14.92 30 99176 119803 110370290
Bacterial infection 39.09 14.92 110 99096 45926 110444167
Medication error 39.04 14.92 23 99183 105343 110384750
Flavobacterium infection 38.64 14.92 11 99195 125 110489968
Hypokalaemia 38.50 14.92 288 98918 182160 110307933
Immunosuppressant drug level increased 38.48 14.92 50 99156 11674 110478419
Lung disorder 38.32 14.92 64 99142 179983 110310110
Abdominal compartment syndrome 38.26 14.92 23 99183 1904 110488189
Cytomegalovirus viraemia 38.18 14.92 62 99144 17702 110472391
Nephrogenic diabetes insipidus 38.03 14.92 25 99181 2420 110487673
Herpes simplex 38.01 14.92 58 99148 15706 110474387
Infectious pleural effusion 37.98 14.92 33 99173 4858 110485235
Cataract 37.94 14.92 12 99194 79473 110410620
Blepharospasm 37.82 14.92 3 99203 54848 110435245
Abscess 37.69 14.92 79 99127 27390 110462703
White blood cell count decreased 37.61 14.92 342 98864 229048 110261045
Aspartate aminotransferase increased 37.53 14.92 259 98947 159677 110330416
Depressed level of consciousness 37.28 14.92 199 99007 112079 110378014
Hepatic infarction 37.21 14.92 18 99188 963 110489130
Urinary tract infection enterococcal 37.17 14.92 29 99177 3673 110486420
Haemoperitoneum 37.17 14.92 34 99172 5354 110484739
Lower respiratory tract infection 37.14 14.92 104 99102 243002 110247091
Hepatosplenomegaly 37.07 14.92 38 99168 6881 110483212
Meningitis bacterial 36.85 14.92 27 99179 3112 110486981
Fungal endocarditis 36.81 14.92 17 99189 819 110489274
Staphylococcal sepsis 36.27 14.92 60 99146 17394 110472699
Thrombotic microangiopathy 35.62 14.92 80 99126 29069 110461024
Cytomegalovirus infection reactivation 35.41 14.92 61 99145 18272 110471821
Feeling hot 35.03 14.92 19 99187 91087 110399006
Serum ferritin increased 35.01 14.92 48 99158 11799 110478294
Pregnancy 34.64 14.92 3 99203 51064 110439029
Blood pressure fluctuation 34.48 14.92 12 99194 74812 110415281
Organ failure 34.41 14.92 31 99175 4786 110485307
Dehydration 34.12 14.92 132 99074 279379 110210714
Multiple sclerosis relapse 33.95 14.92 3 99203 50237 110439856
Disseminated cryptococcosis 33.81 14.92 24 99182 2633 110487460
Exfoliative rash 33.79 14.92 30 99176 4544 110485549
Excessive eye blinking 33.75 14.92 21 99185 1849 110488244
Aeromonas infection 33.66 14.92 14 99192 523 110489570
Hepatic necrosis 33.64 14.92 43 99163 9879 110480214
Dermatitis exfoliative 33.57 14.92 46 99160 11301 110478792
Dry eye 33.54 14.92 5 99201 55788 110434305
Weissella infection 33.51 14.92 7 99199 17 110490076
Palpitations 33.50 14.92 57 99149 159155 110330938
Hepatic enzyme increased 33.39 14.92 161 99045 320731 110169362
Respiratory paralysis 33.35 14.92 10 99196 138 110489955
Graft versus host disease in skin 33.21 14.92 39 99167 8215 110481878
Posterior reversible encephalopathy syndrome 32.86 14.92 85 99121 33776 110456317
Aortoenteric fistula 32.64 14.92 10 99196 149 110489944
Hypoproteinaemia 32.48 14.92 33 99173 5912 110484181
Confusional state 32.33 14.92 267 98939 468413 110021680
Burning sensation 32.06 14.92 11 99195 69201 110420892
Injection site swelling 31.96 14.92 8 99198 61782 110428311
Enterococcus test positive 31.90 14.92 24 99182 2880 110487213
C-reactive protein increased 31.80 14.92 317 98889 217602 110272491
Eosinophil count increased 31.78 14.92 63 99143 20995 110469098
Candida test positive 31.73 14.92 18 99188 1337 110488756
Interstitial lung disease 31.72 14.92 224 98982 139110 110350983
Ischaemic cerebral infarction 31.60 14.92 24 99182 2921 110487172
Tumour associated fever 31.52 14.92 17 99189 1144 110488949
Intestinal ischaemia 31.47 14.92 54 99152 16125 110473968
Colitis ulcerative 31.44 14.92 15 99191 77348 110412745
Status epilepticus 31.41 14.92 80 99126 31491 110458602
Blood glucose increased 31.16 14.92 44 99162 132452 110357641
Respiratory tract infection bacterial 31.16 14.92 22 99184 2394 110487699
Splenic abscess 31.00 14.92 16 99190 984 110489109
Mucosal inflammation 30.97 14.92 169 99037 95972 110394121
Pancreatitis necrotising 30.91 14.92 31 99175 5470 110484623
Influenza 30.81 14.92 66 99140 169035 110321058
Hyperamylasaemia 30.71 14.92 17 99189 1204 110488889
Bronchial disorder 30.62 14.92 23 99183 2753 110487340
Joint stiffness 30.61 14.92 11 99195 67232 110422861
Hydrocephalus 30.60 14.92 42 99164 10333 110479760
Haemorrhagic pneumonia 30.59 14.92 10 99196 186 110489907
Live birth 30.57 14.92 12 99194 69472 110420621
Upper respiratory tract infection 30.50 14.92 44 99162 131284 110358809
Somnolence 30.50 14.92 150 99056 297299 110192794
Adenovirus infection 30.18 14.92 43 99163 10951 110479142
Transient ischaemic attack 29.93 14.92 10 99196 63972 110426121
Hyperferritinaemia 29.80 14.92 16 99190 1067 110489026
Pneumonia necrotising 29.70 14.92 19 99187 1756 110488337
Renal abscess 29.42 14.92 18 99188 1538 110488555
Adenovirus reactivation 29.35 14.92 14 99192 726 110489367
Haemorrhagic disorder 29.33 14.92 19 99187 1794 110488299
Gastrointestinal haemorrhage 29.31 14.92 251 98955 165267 110324826
Taste disorder 29.26 14.92 11 99195 65376 110424717
Clostridial infection 29.13 14.92 32 99174 6270 110483823
Pancreatitis acute 28.96 14.92 119 99087 60155 110429938
Cutaneous T-cell lymphoma stage I 28.90 14.92 9 99197 142 110489951
Accidental exposure to product 28.90 14.92 5 99201 50003 110440090
Oropharyngeal pain 28.86 14.92 48 99158 135228 110354865
Tracheobronchitis 28.85 14.92 22 99184 2694 110487399
Mucosal disorder 28.78 14.92 27 99179 4390 110485703
Pulmonary mucormycosis 28.77 14.92 20 99186 2123 110487970
Therapy interrupted 28.75 14.92 5 99201 49817 110440276
Angina pectoris 28.69 14.92 10 99196 62285 110427808
Relapsing fever 28.65 14.92 12 99194 456 110489637
Cholangitis 28.52 14.92 52 99154 16283 110473810
Immunosuppressant drug level decreased 28.46 14.92 22 99184 2749 110487344
Overgrowth fungal 28.34 14.92 9 99197 152 110489941
Renal injury 28.26 14.92 56 99150 18657 110471436
Microangiopathic haemolytic anaemia 28.13 14.92 19 99187 1924 110488169
Jarisch-Herxheimer reaction 28.05 14.92 16 99190 1201 110488892
Head injury 27.93 14.92 3 99203 43014 110447079
Pericoronitis 27.91 14.92 9 99197 160 110489933
Exostosis 27.90 14.92 4 99202 45952 110444141
Influenza like illness 27.86 14.92 23 99183 88389 110401704
Ecthyma 27.61 14.92 15 99191 1024 110489069
Depressed mood 27.59 14.92 10 99196 60799 110429294
Hepatocellular injury 27.58 14.92 104 99102 50538 110439555
Aspergillus test positive 27.46 14.92 15 99191 1035 110489058
Clostridial sepsis 27.32 14.92 15 99191 1046 110489047
Mechanical ventilation 27.07 14.92 23 99183 3284 110486809
Lower respiratory tract infection bacterial 27.00 14.92 15 99191 1070 110489023
Portal fibrosis 26.93 14.92 13 99193 692 110489401
Chronic obstructive pulmonary disease 26.93 14.92 35 99171 109123 110380970
Serum sickness 26.93 14.92 26 99180 4380 110485713
Bronchopleural fistula 26.85 14.92 14 99192 879 110489214
Respiratory gas exchange disorder 26.78 14.92 14 99192 884 110489209
Meningitis 26.74 14.92 42 99164 11660 110478433
Coagulation test abnormal 26.60 14.92 17 99189 1569 110488524
Heart rate increased 26.31 14.92 56 99150 143778 110346315
Petechiae 26.29 14.92 62 99144 23255 110466838
Cytomegalovirus test positive 26.26 14.92 32 99174 7004 110483089
Graft versus host disease in liver 26.26 14.92 20 99186 2445 110487648
Liver function test abnormal 26.24 14.92 127 99079 68823 110421270
Intra-abdominal haemorrhage 26.22 14.92 28 99178 5314 110484779
Prescribed overdose 26.12 14.92 24 99182 87557 110402536
Enterobacter infection 25.99 14.92 29 99177 5782 110484311
Lung abscess 25.90 14.92 27 99179 4985 110485108
Ascites 25.87 14.92 157 99049 92651 110397442
Vanishing bile duct syndrome 25.87 14.92 22 99184 3146 110486947
Hyperpyrexia 25.84 14.92 34 99172 8035 110482058
Cryptococcosis 25.84 14.92 26 99180 4605 110485488
Metabolic disorder 25.81 14.92 39 99167 10471 110479622
Hyperammonaemia 25.62 14.92 45 99161 13687 110476406
Acidosis 25.50 14.92 60 99146 22471 110467622
Coagulation time prolonged 25.35 14.92 21 99185 2896 110487197
Fungal abscess central nervous system 25.30 14.92 9 99197 218 110489875
Electrocardiogram QT prolonged 25.29 14.92 176 99030 108784 110381309
Ileus paralytic 25.27 14.92 41 99165 11696 110478397
Lung infiltration 25.12 14.92 63 99143 24565 110465528
Cardiac disorder 25.10 14.92 19 99187 76261 110413832
Product use issue 25.08 14.92 170 99036 311525 110178568
Haemolysis 25.08 14.92 48 99158 15591 110474502
Septic embolus 25.06 14.92 19 99187 2307 110487786
Acid base balance abnormal 25.06 14.92 11 99195 470 110489623
Antibiotic level above therapeutic 24.94 14.92 14 99192 1019 110489074
Penicillium infection 24.86 14.92 12 99194 639 110489454
Underdose 24.80 14.92 13 99193 63541 110426552
Pyroglutamic acidosis 24.76 14.92 18 99188 2050 110488043
Diabetic macroangiopathy 24.71 14.92 8 99198 144 110489949
Cytopenia 24.63 14.92 71 99135 30045 110460048
Differentiation syndrome 24.57 14.92 21 99185 3023 110487070
Haemorrhage intracranial 24.38 14.92 69 99137 28900 110461193
Death 24.34 14.92 461 98745 698408 109791685
Gingivitis ulcerative 24.23 14.92 11 99195 509 110489584
Bicytopenia 24.16 14.92 30 99176 6694 110483399
Surgery 24.14 14.92 4 99202 41279 110448814
Complications of transplanted lung 24.08 14.92 12 99194 685 110489408
Central nervous system injury 24.07 14.92 8 99198 157 110489936
Hypercapnia 24.05 14.92 39 99167 11120 110478973
Altered state of consciousness 24.03 14.92 109 99097 57517 110432576
SJS-TEN overlap 24.02 14.92 17 99189 1857 110488236
Disseminated aspergillosis 23.98 14.92 19 99187 2461 110487632
Product deposit 23.95 14.92 12 99194 693 110489400
Atelectasis 23.95 14.92 80 99126 36632 110453461
Bacillus infection 23.89 14.92 16 99190 1598 110488495
Cryptococcal meningoencephalitis 23.88 14.92 10 99196 380 110489713
Epidermolysis bullosa 23.85 14.92 10 99196 381 110489712
Pulmonary cavitation 23.81 14.92 18 99188 2176 110487917
Ear pain 23.74 14.92 9 99197 53217 110436876
Pneumonia aspiration 23.66 14.92 139 99067 81094 110408999
Infection in an immunocompromised host 23.59 14.92 17 99189 1910 110488183
Aplasia 23.42 14.92 32 99174 7841 110482252
Pseudomonal bacteraemia 23.40 14.92 24 99182 4347 110485746
Osteomyelitis bacterial 23.21 14.92 11 99195 562 110489531
Drug dependence 23.08 14.92 8 99198 50012 110440081
Paraspinal abscess 23.03 14.92 10 99196 416 110489677
Endotracheal intubation 23.02 14.92 28 99178 6116 110483977
Pulmonary nocardiosis 23.00 14.92 19 99187 2610 110487483
Polyneuropathy 22.91 14.92 72 99134 31940 110458153
Laryngitis 22.90 14.92 5 99201 42406 110447687
Tachycardia 22.88 14.92 307 98899 226338 110263755
Muscle abscess 22.80 14.92 15 99191 1454 110488639
Cognitive disorder 22.70 14.92 27 99179 87484 110402609
Conductive deafness 22.63 14.92 9 99197 299 110489794
Viral haemorrhagic cystitis 22.57 14.92 21 99185 3378 110486715
Disease complication 22.56 14.92 27 99179 5800 110484293
Pulmonary necrosis 22.42 14.92 11 99195 607 110489486
Pneumomediastinum 22.29 14.92 25 99181 5011 110485082
Rectal perforation 22.22 14.92 13 99193 1024 110489069
Ischaemic hepatitis 22.18 14.92 24 99182 4624 110485469
Epilepsy 22.17 14.92 160 99046 100049 110390044
Tissue infiltration 22.15 14.92 13 99193 1030 110489063
Ureaplasma infection 22.10 14.92 15 99191 1531 110488562
Necrosis 22.10 14.92 38 99168 11368 110478725
ADAMTS13 activity decreased 22.05 14.92 9 99197 320 110489773
Heparin-induced thrombocytopenia 22.05 14.92 38 99168 11386 110478707
Interleukin-2 receptor increased 21.97 14.92 9 99197 323 110489770
Cholestatic liver injury 21.97 14.92 30 99176 7346 110482747
Onychomycosis 21.94 14.92 4 99202 38527 110451566
Hyperchloraemia 21.90 14.92 14 99192 1292 110488801
Intervertebral discitis 21.69 14.92 29 99177 6961 110483132
Visual impairment 21.66 14.92 56 99150 134372 110355721
Acute graft versus host disease in intestine 21.62 14.92 26 99180 5613 110484480
Acinetobacter bacteraemia 21.62 14.92 9 99197 337 110489756
Granulocyte count decreased 21.60 14.92 22 99184 3952 110486141
Chest X-ray abnormal 21.56 14.92 32 99174 8455 110481638
Clostridium bacteraemia 21.53 14.92 10 99196 488 110489605
Rhabdomyolysis 21.53 14.92 183 99023 120218 110369875
Hyperkalaemia 21.51 14.92 201 99005 135595 110354498
Trichoglossia 21.45 14.92 12 99194 868 110489225
Extravasation blood 21.25 14.92 10 99196 503 110489590
Resuscitation 21.20 14.92 19 99187 2914 110487179
Upper gastrointestinal haemorrhage 21.07 14.92 95 99111 50001 110440092
Cytomegalovirus enterocolitis 21.04 14.92 17 99189 2264 110487829
Cholangiolitis 20.99 14.92 5 99201 26 110490067
Vulvovaginitis 20.96 14.92 9 99197 364 110489729
Vitamin K deficiency 20.94 14.92 12 99194 909 110489184
Tonsillitis bacterial 20.91 14.92 8 99198 239 110489854
Anticonvulsant drug level below therapeutic 20.85 14.92 13 99193 1149 110488944
Hypogonadism 20.85 14.92 16 99190 1978 110488115
Neoplasm malignant 20.85 14.92 4 99202 37139 110452954
Encephalitis viral 20.79 14.92 19 99187 2988 110487105
Amylase increased 20.79 14.92 39 99167 12480 110477613
Product prescribing error 20.78 14.92 10 99196 51321 110438772
Venoocclusive disease 20.71 14.92 27 99179 6323 110483770
Hypertransaminasaemia 20.63 14.92 58 99148 24197 110465896
Adjusted calcium decreased 20.61 14.92 8 99198 249 110489844
Nervous system disorder 20.58 14.92 69 99137 31652 110458441
Viral infection 20.55 14.92 11 99195 53128 110436965
Abdominal pain 20.53 14.92 330 98876 512659 109977434
Abdominal distension 20.53 14.92 84 99122 175019 110315074
Mediastinal effusion 20.48 14.92 6 99200 76 110490017
Aggression 20.46 14.92 14 99192 59196 110430897
Sopor 20.37 14.92 4 99202 36542 110453551
Necrotising colitis 20.31 14.92 15 99191 1750 110488343
Potentiating drug interaction 20.25 14.92 37 99169 11606 110478487
Wound dehiscence 20.20 14.92 30 99176 7932 110482161
Metabolic alkalosis 20.16 14.92 25 99181 5570 110484523
Acne 20.16 14.92 3 99203 33517 110456576
Electrolyte imbalance 20.13 14.92 76 99130 36952 110453141
Acanthosis 20.05 14.92 10 99196 572 110489521
Splenic injury 20.02 14.92 8 99198 269 110489824
Renal graft infection 20.02 14.92 11 99195 768 110489325
Orthostatic hypotension 19.94 14.92 18 99188 66231 110423862
White blood cell count increased 19.93 14.92 152 99054 96690 110393403
Cardiac failure acute 19.92 14.92 57 99149 24021 110466072
Swollen tongue 19.90 14.92 15 99191 60347 110429746
Therapeutic response decreased 19.89 14.92 35 99171 96464 110393629
Escherichia bacteraemia 19.87 14.92 34 99172 10130 110479963
Myoclonus 19.86 14.92 70 99136 32928 110457165
Neutrophilic dermatosis 19.85 14.92 11 99195 781 110489312
Sleep disorder due to a general medical condition 19.84 14.92 11 99195 52101 110437992
Lymphadenectomy 19.84 14.92 14 99192 1522 110488571
Hot flush 19.81 14.92 18 99188 66018 110424075
Guillain-Barre syndrome 19.78 14.92 35 99171 10709 110479384
Pulmonary sepsis 19.69 14.92 24 99182 5254 110484839
Stenotrophomonas bacteraemia 19.67 14.92 8 99198 282 110489811
Blood albumin decreased 19.61 14.92 62 99144 27590 110462503
Generalised tonic-clonic seizure 19.59 14.92 99 99107 54581 110435512
X-ray abnormal 19.59 14.92 5 99201 38112 110451981
Acute lymphocytic leukaemia 19.57 14.92 25 99181 5740 110484353
Sinus disorder 19.52 14.92 3 99203 32725 110457368
Diverticulitis 19.38 14.92 12 99194 53510 110436583
Sepsis syndrome 19.36 14.92 14 99192 1582 110488511
Vertigo 19.30 14.92 30 99176 86840 110403253
Cholangitis infective 19.26 14.92 11 99195 828 110489265
Limb injury 19.22 14.92 5 99201 37631 110452462
Malnutrition 19.19 14.92 61 99145 27218 110462875
Noninfectious peritonitis 19.13 14.92 8 99198 303 110489790
BK polyomavirus test positive 19.10 14.92 8 99198 304 110489789
Enterocolitis haemorrhagic 19.08 14.92 17 99189 2587 110487506
Eczema 19.08 14.92 22 99184 72271 110417822
Gastroenteritis staphylococcal 18.93 14.92 8 99198 311 110489782
Drug level below therapeutic 18.93 14.92 36 99170 11637 110478456
Abscess neck 18.91 14.92 13 99193 1355 110488738
Vascular pseudoaneurysm 18.89 14.92 21 99185 4169 110485924
Chimerism 18.88 14.92 8 99198 313 110489780
Bifidobacterium infection 18.80 14.92 6 99200 103 110489990
Neuralgia 18.80 14.92 10 99196 48468 110441625
Nephrolithiasis 18.75 14.92 19 99187 66193 110423900
Ocular hyperaemia 18.62 14.92 6 99200 39280 110450813
Haemothorax 18.57 14.92 27 99179 7004 110483089
Joint dislocation 18.53 14.92 4 99202 34186 110455907
Large intestine perforation 18.52 14.92 44 99162 16585 110473508
Chorioretinitis 18.51 14.92 13 99193 1402 110488691
Hepatic infection fungal 18.46 14.92 8 99198 331 110489762
Endocarditis candida 18.38 14.92 6 99200 111 110489982
Splenomegaly 18.36 14.92 56 99150 24442 110465651
Nightmare 18.31 14.92 6 99200 38857 110451236
Pulseless electrical activity 18.29 14.92 44 99162 16713 110473380
Bronchial anastomosis complication 18.23 14.92 6 99200 114 110489979
Hyperthermia 18.22 14.92 51 99155 21221 110468872
Skin maceration 18.21 14.92 7 99199 212 110489881
Skin laceration 18.19 14.92 4 99202 33749 110456344
Arterial angioplasty 18.14 14.92 5 99201 50 110490043
Hypoglossal nerve paresis 18.13 14.92 6 99200 116 110489977
Lacrimation increased 18.09 14.92 3 99203 30947 110459146
Respiratory acidosis 18.09 14.92 39 99167 13787 110476306
HIV viraemia 18.04 14.92 6 99200 118 110489975
Extravasation 18.03 14.92 22 99184 4823 110485270
Cerebral infarction 17.97 14.92 93 99113 51745 110438348
Cytokine storm 17.91 14.92 13 99193 1477 110488616
Disseminated trichosporonosis 17.85 14.92 7 99199 224 110489869
Rash erythematous 17.72 14.92 130 99076 81702 110408391
Tracheal injury 17.67 14.92 7 99199 230 110489863
Transformation to acute myeloid leukaemia 17.66 14.92 13 99193 1510 110488583
Face oedema 17.62 14.92 68 99138 33401 110456692
Colonic fistula 17.61 14.92 10 99196 744 110489349
Sedation 17.54 14.92 22 99184 69661 110420432
Haemostasis 17.54 14.92 9 99197 547 110489546
Metastases to liver 17.51 14.92 5 99201 35381 110454712
Angioedema 17.48 14.92 39 99167 98461 110391632
Refractoriness to platelet transfusion 17.37 14.92 7 99199 241 110489852
Pneumonia cytomegaloviral 17.35 14.92 26 99180 6928 110483165
Klebsiella sepsis 17.34 14.92 20 99186 4133 110485960
Pneumonia acinetobacter 17.33 14.92 8 99198 385 110489708
Gastrointestinal fungal infection 17.31 14.92 10 99196 769 110489324
Pollakiuria 17.31 14.92 9 99197 44186 110445907
Acute graft versus host disease in skin 17.27 14.92 33 99173 10707 110479386
Bladder irrigation 17.24 14.92 5 99201 61 110490032
Urinary tract inflammation 17.23 14.92 8 99198 390 110489703
Subcutaneous emphysema 17.23 14.92 16 99190 2568 110487525
Serum sickness-like reaction 17.20 14.92 10 99196 778 110489315
Intestinal pseudo-obstruction 17.20 14.92 18 99188 3338 110486755
Herpes simplex hepatitis 17.19 14.92 10 99196 779 110489314
Hyperaemia 17.17 14.92 19 99187 3754 110486339
Diabetes mellitus inadequate control 17.15 14.92 3 99203 29772 110460321
Flatulence 17.14 14.92 13 99193 52136 110437957
Dysphonia 17.08 14.92 26 99180 75903 110414190
Candida pneumonia 17.05 14.92 11 99195 1032 110489061
Convulsive threshold lowered 17.02 14.92 11 99195 1035 110489058
Septal panniculitis 16.96 14.92 6 99200 143 110489950
Respiratory tract infection fungal 16.94 14.92 12 99194 1312 110488781
H1N1 influenza 16.94 14.92 17 99189 3001 110487092
Delayed graft function 16.94 14.92 20 99186 4237 110485856
Alveolitis necrotising 16.92 14.92 4 99202 20 110490073
Body temperature decreased 16.88 14.92 6 99200 36929 110453164
Hepatic haemorrhage 16.86 14.92 12 99194 1322 110488771
Retroperitoneal haematoma 16.86 14.92 24 99182 6107 110483986
Blast cell count increased 16.82 14.92 13 99193 1624 110488469
Disseminated sporotrichosis 16.81 14.92 5 99201 67 110490026
Lymphopenia 16.76 14.92 76 99130 40094 110449999
Cystitis haemorrhagic 16.62 14.92 35 99171 12174 110477919
Dementia 16.57 14.92 4 99202 31669 110458424
Ulcer 16.56 14.92 9 99197 43107 110446986
Corynebacterium infection 16.56 14.92 14 99192 1986 110488107
Oesophagitis 16.50 14.92 60 99146 28655 110461438
Acute graft versus host disease 16.47 14.92 36 99170 12845 110477248
Eye disorder 16.46 14.92 3 99203 28903 110461190
Hypereosinophilic syndrome 16.46 14.92 10 99196 844 110489249
Low cardiac output syndrome 16.46 14.92 11 99195 1095 110488998
Extrapyramidal disorder 16.43 14.92 3 99203 28864 110461229
Febrile convulsion 16.42 14.92 11 99195 1099 110488994
Musculoskeletal chest pain 16.42 14.92 3 99203 28844 110461249
Pneumocystis jirovecii infection 16.40 14.92 20 99186 4380 110485713
Incorrect route of product administration 16.37 14.92 20 99186 64041 110426052
Psychotic disorder 16.36 14.92 13 99193 50924 110439169
Intestinal haemorrhage 16.29 14.92 26 99180 7315 110482778
Superinfection bacterial 16.27 14.92 15 99191 2386 110487707
Gastroenteritis viral 16.23 14.92 4 99202 31222 110458871
Organising pneumonia 16.20 14.92 38 99168 14205 110475888
Hypoperfusion 16.19 14.92 17 99189 3164 110486929
Neurological decompensation 16.14 14.92 25 99181 6858 110483235
Epstein-Barr virus infection 16.13 14.92 45 99161 18693 110471400
Renal tubular necrosis 16.11 14.92 62 99144 30413 110459680
Idiopathic pneumonia syndrome 16.11 14.92 10 99196 877 110489216
Hepatitis acute 16.08 14.92 45 99161 18721 110471372
Throat tightness 16.08 14.92 5 99201 33484 110456609
Listeriosis 16.07 14.92 16 99190 2798 110487295
Gallbladder fistula 16.03 14.92 4 99202 26 110490067
Hepatosplenic candidiasis 16.01 14.92 9 99197 657 110489436
Pulmonary alveolar haemorrhage 15.99 14.92 47 99159 20103 110469990
Herpes simplex viraemia 15.97 14.92 9 99197 660 110489433
Infection reactivation 15.95 14.92 19 99187 4062 110486031
Tracheal ulcer 15.90 14.92 4 99202 27 110490066
Obstructive airways disorder 15.82 14.92 11 99195 46138 110443955
Hypersomnia 15.79 14.92 3 99203 28058 110462035
Diplopia 15.72 14.92 9 99197 41885 110448208
Acoustic neuroma 15.69 14.92 7 99199 311 110489782
Gastrointestinal oedema 15.68 14.92 17 99189 3281 110486812
Obliterative bronchiolitis 15.66 14.92 18 99188 3705 110486388
Soft tissue necrosis 15.66 14.92 11 99195 1187 110488906
Hypovolaemic shock 15.61 14.92 38 99168 14545 110475548
Radiation fibrosis - lung 15.60 14.92 5 99201 87 110490006
Psoas abscess 15.59 14.92 12 99194 1490 110488603
Hyperchlorhydria 15.57 14.92 14 99192 2155 110487938
Embolic cerebral infarction 15.56 14.92 12 99194 1494 110488599
Thrombocytosis 15.47 14.92 31 99175 10413 110479680
Faeces pale 15.44 14.92 17 99189 3340 110486753
Device related bacteraemia 15.40 14.92 11 99195 1219 110488874
Abdominal wound dehiscence 15.24 14.92 7 99199 333 110489760
Puncture site haemorrhage 15.22 14.92 9 99197 723 110489370
Blood creatine phosphokinase increased 15.20 14.92 115 99091 72962 110417131
Respiratory alkalosis 15.16 14.92 22 99184 5699 110484394
Device issue 15.13 14.92 6 99200 34529 110455564
Meningitis enterococcal 15.12 14.92 6 99200 198 110489895
Gastrointestinal mucormycosis 15.12 14.92 9 99197 732 110489361
Delivery 15 14.92 10 99196 991 110489102
Gout 14.99 14.92 7 99199 36559 110453534
Blood culture positive 14.95 14.92 28 99178 8948 110481145
Dehiscence 14.93 14.92 9 99197 749 110489344

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective 94.88 40.66 51 190 1582 112130

Pharmacologic Action:

SourceCodeDescription
ATC J01DH02 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
OTHER BETA-LACTAM ANTIBACTERIALS
Carbapenems
ATC J01DH52 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
OTHER BETA-LACTAM ANTIBACTERIALS
Carbapenems
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000900 Anti-Bacterial Agents
CHEBI has role CHEBI:36047 antibacterial drug
CHEBI has role CHEBI:33231 antitubercular agent
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:35610 antineoplastic agent
CHEBI has role CHEBI:88188 drug allergen

Related Drugs by ATC class:

J01DH Carbapenems 10 drugs

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

DiseaseRelationSNOMED_IDDOID
Streptococcal meningitis indication 4510004 DOID:11574
Infection due to Pseudomonas aeruginosa indication 11218009
Peritonitis indication 48661000
Pneumococcal meningitis indication 51169003
Abdominal abscess indication 75100008
Bacterial meningitis indication 95883001 DOID:9470
Infectious disease of abdomen indication 128070006
Neisseria meningitidis meningitis indication 192644005
Complicated appendicitis indication 418171008
Peptostreptococcus Complicated Appendicitis indication
Pseudomonas Aeruginosa Complicated Appendicitis indication
E. Coli Complicated Appendicitis indication
Streptococcal Peritonitis indication
Bacteroides Peritonitis indication
Streptococcus Complicated Appendicitis indication
Klebsiella Pneumoniae Peritonitis indication
Bacteroides Complicated Appendicitis indication
Complicated Skin and Skin Structure Infection indication
E. Coli Peritonitis indication
H. Influenzae Meningitis indication
Peptostreptococcus Peritonitis indication
Klebsiella Complicated Appendicitis indication
Pyrexia of unknown origin off-label use 7520000
Bacterial septicemia off-label use 10001005 DOID:0040085
Inhalational anthrax off-label use 11389007
Nocardiosis off-label use 29227009 DOID:2312
Bacterial pneumonia off-label use 53084003 DOID:874
Cholangitis off-label use 82403002 DOID:9446
Gastrointestinal anthrax off-label use 111798006 DOID:13386
Infection by Campylobacter fetus off-label use 111835002
Sepsis of the newborn off-label use 206376005
Sepsis syndrome off-label use 238150007
Diverticulitis of gastrointestinal tract off-label use 271366000
Neonatal meningitis off-label use 276674008
Anthrax off-label use 409498004 DOID:7427
Nosocomial pneumonia off-label use 425464007
Melioidosis off-label use 428111003 DOID:5052
Pneumonia due to Gram negative bacteria off-label use 430395005
Complicated Urinary Tract Infections off-label use
Diabetic Foot Infection off-label use
Clostridium Perfringens Empyema off-label use
Pseudomonas Respiratory Tract Infection in Cystic Fibrosis off-label use
Kidney disease contraindication 90708001 DOID:557
Seizure disorder contraindication 128613002
Lesion of brain contraindication 301766008
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Pseudomembranous enterocolitis contraindication 397683000




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.79 acidic
pKa2 8.04 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1GM/VIAL;1GM/VIAL VABOMERE REMPEX N209776 Aug. 29, 2017 RX POWDER INTRAVENOUS 10183034 Aug. 8, 2031 TREATMENT OF COMPLICATED URINARY TRACT INFECTION (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI, KLEBSIELLA PNEUMONIA, AND ENTEROBACTER CLOACAE SPECIES COMPLEX
1GM/VIAL;1GM/VIAL VABOMERE REMPEX N209776 Aug. 29, 2017 RX POWDER INTRAVENOUS 10561675 Aug. 8, 2031 TREATMENT OF COMPLICATED URINARY TRACT INFECTION (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI, KLEBSIELLA PNEUMONIA, AND ENTEROBACTER CLOACAE SPECIES COMPLEX
1GM/VIAL;1GM/VIAL VABOMERE REMPEX N209776 Aug. 29, 2017 RX POWDER INTRAVENOUS 11007206 Aug. 8, 2031 TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI, KLEBSIELLA PNEUMONIA, ENTEROBACTER CLOACAE SPECIES COMPLEX WITH MEROPENEM & VABORBACTAM AS SPECIFIED
1GM/VIAL;1GM/VIAL VABOMERE REMPEX N209776 Aug. 29, 2017 RX POWDER INTRAVENOUS 9694025 Aug. 8, 2031 TREATMENT OF PATIENTS 18 YEARS OF AGE AND OLDER WITH COMPLICATED URINARY TRACT INFECTIONS CAUSED BY SUSCEPTIBLE MICROORGANISMS
1GM/VIAL;1GM/VIAL VABOMERE REMPEX N209776 Aug. 29, 2017 RX POWDER INTRAVENOUS 12478606 Jan. 8, 2038 TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI,KLEBSIELLA PNEUMONIA,ENTEROBACTER CLOACAE SPECIES COMPLEX WITH MEROPENEM & VABORBACTAM AS SPECIFIED
1GM/VIAL;1GM/VIAL VABOMERE REMPEX N209776 Aug. 29, 2017 RX POWDER INTRAVENOUS 11376237 April 6, 2039 TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI,KLEBSIELLA PNEUMONIA,ENTEROBACTER CLOACAE SPECIES COMPLEX WITH MEROPENEM & VABORBACTAM AS SPECIFIED
1GM/VIAL;1GM/VIAL VABOMERE REMPEX N209776 Aug. 29, 2017 RX POWDER INTRAVENOUS 12533342 April 6, 2039 TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI,KLEBSIELLA PNEUMONIA,ENTEROBACTER CLOACAE SPECIES COMPLEX WITH MEROPENEM & VABORBACTAM AS SPECIFIED

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1GM/VIAL;1GM/VIAL VABOMERE REMPEX N209776 Aug. 29, 2017 RX POWDER INTRAVENOUS Aug. 29, 2022 NEW CHEMICAL ENTITY
1GM/VIAL;1GM/VIAL VABOMERE REMPEX N209776 Aug. 29, 2017 RX POWDER INTRAVENOUS Aug. 29, 2027 GENERATING ANTIBIOTIC INCENTIVES NOW

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
D-alanyl-D-alanine carboxypeptidase DacB Enzyme INHIBITOR DRUGBANK CHEMBL
Penicillin-binding protein 4 Enzyme WOMBAT-PK
D-ala-D-ala-carboxypeptidase; D-alanyl-D-alanine carboxypeptidase; D-alanyl-D-alanine carboxypeptidase family protein; Penicillin-binding protein 5 Enzyme WOMBAT-PK
Penicillin-binding protein 1 Enzyme WOMBAT-PK
D-alanyl-D-alanine carboxypeptidase; D-alanyl-D-alanine carboxypeptidase penicillin-binding protein 6 Enzyme WOMBAT-PK
Streptokinase A Enzyme EC50 6.90 WOMBAT-PK
Beta-lactamase class B VIM-2 Enzyme Kd 4.92 CHEMBL
Beta-lactamase NDM-1 Enzyme Kd 4.96 CHEMBL
Penicillin-binding protein 2 Enzyme WOMBAT-PK
Beta-lactamase Enzyme Kd 6.07 CHEMBL

External reference:

IDSource
4021008 VUID
N0000148477 NUI
D02222 KEGG_DRUG
119478-56-7 SECONDARY_CAS_RN
4021008 VANDF
C0066005 UMLSCUI
CHEBI:43968 CHEBI
MEM PDB_CHEM_ID
CHEMBL127 ChEMBL_ID
DB00760 DRUGBANK_ID
D000077731 MESH_DESCRIPTOR_UI
441130 PUBCHEM_CID
10829 IUPHAR_LIGAND_ID
FV9J3JU8B1 UNII
29561 RXNORM
173661 MMSL
5055 MMSL
6047 MMSL
d04027 MMSL
005166 NDDF
387540000 SNOMEDCT_US
725669004 SNOMEDCT_US
96062004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 0143-9430 INJECTION 500 mg INTRAVENOUS ANDA 30 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 0143-9431 INJECTION 1 g INTRAVENOUS ANDA 30 sections
Meropenem and Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0264-3183 INJECTION, SOLUTION 500 mg INTRAVENOUS NDA 26 sections
Meropenem and Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0264-3185 INJECTION, SOLUTION 1 g INTRAVENOUS NDA 26 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 0409-0222 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 27 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 0409-1390 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 27 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 0409-1391 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 27 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 0409-3412 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 27 sections
MEROPENEM HUMAN PRESCRIPTION DRUG LABEL 1 0781-3000 INJECTION 500 mg INTRAVENOUS ANDA 30 sections
MEROPENEM HUMAN PRESCRIPTION DRUG LABEL 1 0781-3098 INJECTION 1 g INTRAVENOUS ANDA 30 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 25021-160 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 30 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 25021-161 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 30 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 44567-145 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 28 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 44567-146 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 28 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 44567-400 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 28 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 44567-401 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 28 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 44567-402 INJECTION, POWDER, FOR SOLUTION 2 g INTRAVENOUS NDA 27 sections
MEROPENEM HUMAN PRESCRIPTION DRUG LABEL 1 44647-032 INJECTION 500 mg INTRAVENOUS ANDA 30 sections
MEROPENEM HUMAN PRESCRIPTION DRUG LABEL 1 44647-033 INJECTION 1 g INTRAVENOUS ANDA 30 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 51810-502 INJECTION 500 mg INTRAVENOUS ANDA 30 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 51810-503 INJECTION 1 g INTRAVENOUS ANDA 30 sections
Meropenem Human Prescription Drug Label 1 55150-207 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 27 sections
Meropenem Human Prescription Drug Label 1 55150-208 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 27 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 63323-507 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 28 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 63323-507 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 28 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 63323-507 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 28 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 63323-508 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 28 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 63323-508 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 28 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 63323-508 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 28 sections
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 68001-323 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 27 sections