meropenem ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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

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 542.38 17.48 347 29048 49990 50525739
Septic shock 453.26 17.48 326 29069 56849 50518880
Drug reaction with eosinophilia and systemic symptoms 333.57 17.48 207 29188 28217 50547512
Drug resistance 325.77 17.48 177 29218 18812 50556917
Pathogen resistance 303.85 17.48 117 29278 5572 50570157
Sepsis 248.40 17.48 344 29051 132581 50443148
Respiratory failure 205.78 17.48 259 29136 90922 50484807
Febrile neutropenia 205.61 17.48 268 29127 97399 50478330
Thrombocytopenia 194.30 17.48 300 29095 127373 50448356
Pyrexia 172.71 17.48 548 28847 379655 50196074
Pain 172.44 17.48 61 29334 578842 49996887
Bronchopulmonary aspergillosis 156.36 17.48 80 29315 7512 50568217
Acute kidney injury 149.74 17.48 376 29019 227682 50348047
Toxic epidermal necrolysis 148.73 17.48 112 29283 20880 50554849
Fatigue 148.50 17.48 117 29278 707484 49868245
Systemic candida 147.61 17.48 57 29338 2733 50572996
Haemophagocytic lymphohistiocytosis 135.70 17.48 76 29319 8557 50567172
Arthralgia 134.31 17.48 44 29351 438658 50137071
Pancytopenia 132.69 17.48 201 29194 83829 50491900
Headache 126.03 17.48 69 29326 506466 50069263
Off label use 121.33 17.48 570 28825 473856 50101873
Joint swelling 117.79 17.48 6 29389 245280 50330449
Clostridium difficile colitis 111.14 17.48 88 29307 17654 50558075
Neutropenia 107.66 17.48 254 29141 147711 50428018
Enterococcal infection 106.44 17.48 60 29335 6838 50568891
Abdominal discomfort 104.25 17.48 8 29387 231633 50344096
Candida infection 101.06 17.48 94 29301 23429 50552300
Rheumatoid arthritis 100.35 17.48 4 29391 202546 50373183
Fall 99.95 17.48 35 29360 334897 50240832
Candida sepsis 93.26 17.48 33 29362 1234 50574495
Acinetobacter infection 93.12 17.48 34 29361 1393 50574336
Drug intolerance 92.07 17.48 10 29385 219094 50356635
Fungaemia 88.58 17.48 36 29359 1976 50573753
Aspergillus infection 85.87 17.48 52 29343 6769 50568960
Shock 85.78 17.48 81 29314 20569 50555160
Peripheral swelling 80.23 17.48 12 29383 205924 50369805
Dysbiosis 79.83 17.48 25 29370 635 50575094
Acute respiratory distress syndrome 78.69 17.48 78 29317 21021 50554708
Disseminated intravascular coagulation 78.52 17.48 71 29324 17064 50558665
Nasopharyngitis 75.71 17.48 11 29384 192916 50382813
Hepatic function abnormal 75.45 17.48 94 29301 32587 50543142
Stenotrophomonas infection 73.95 17.48 30 29365 1639 50574090
Product dose omission issue 73.26 17.48 10 29385 183828 50391901
Swelling 73.18 17.48 14 29381 200858 50374871
Agranulocytosis 72.24 17.48 75 29320 21346 50554383
Eosinophilia 69.64 17.48 69 29326 18583 50557146
Stevens-Johnson syndrome 65.99 17.48 72 29323 21680 50554049
Mucormycosis 65.56 17.48 31 29364 2452 50573277
Contraindicated product administered 64.62 17.48 6 29389 148952 50426777
Acute generalised exanthematous pustulosis 63.98 17.48 48 29347 8890 50566839
Pseudomonas infection 63.88 17.48 49 29346 9381 50566348
Pain in extremity 63.66 17.48 40 29355 272825 50302904
Renal impairment 62.86 17.48 137 29258 75524 50500205
Renal failure 62.77 17.48 169 29226 106464 50469265
Rash maculo-papular 62.09 17.48 77 29318 26564 50549165
Weight increased 62.06 17.48 20 29375 201871 50373858
Dizziness 61.94 17.48 66 29329 346303 50229426
Myelosuppression 61.91 17.48 56 29339 13461 50562268
Geotrichum infection 61.89 17.48 19 29376 451 50575278
Drug eruption 61.17 17.48 72 29323 23534 50552195
Pseudomembranous colitis 59.24 17.48 30 29365 2755 50572974
Therapeutic product effect decreased 57.65 17.48 6 29389 136044 50439685
Muscle spasms 57.40 17.48 4 29391 125549 50450180
Lactic acidosis 57.20 17.48 83 29312 33272 50542457
Cytokine release syndrome 56.60 17.48 44 29351 8590 50567139
Sinusitis 55.88 17.48 15 29380 170543 50405186
Klebsiella infection 54.56 17.48 40 29355 7154 50568575
Systemic lupus erythematosus 52.92 17.48 9 29386 140613 50435116
Pneumonia fungal 51.99 17.48 32 29363 4288 50571441
Depression 51.52 17.48 16 29379 165407 50410322
Acute respiratory failure 51.37 17.48 73 29322 28709 50547020
Drug level decreased 51.07 17.48 37 29358 6496 50569233
Cardiac arrest 50.65 17.48 134 29261 83517 50492212
Linear IgA disease 50.33 17.48 21 29374 1233 50574496
Coagulopathy 50.30 17.48 57 29338 17887 50557842
Encephalopathy 49.45 17.48 78 29317 33633 50542096
Alopecia 49.25 17.48 42 29353 245005 50330724
Platelet count decreased 48.93 17.48 149 29246 100577 50475152
Neutropenic sepsis 48.54 17.48 50 29345 14097 50561632
Peritonitis 48.26 17.48 52 29343 15434 50560295
Pneumonia 47.72 17.48 379 29016 378022 50197707
Blood bilirubin increased 46.81 17.48 74 29321 31964 50543765
Musculoskeletal stiffness 46.67 17.48 9 29386 128472 50447257
Haemodynamic instability 46.42 17.48 38 29357 7986 50567743
Fungal infection 46.27 17.48 71 29324 29894 50545835
Bacteraemia 45.92 17.48 49 29346 14384 50561345
Acute myeloid leukaemia 45.90 17.48 50 29345 15024 50560705
Asthenia 45.47 17.48 72 29323 318970 50256759
Excessive eye blinking 45.36 17.48 18 29377 928 50574801
Systemic inflammatory response syndrome 45.05 17.48 31 29364 5018 50570711
Malaise 44.79 17.48 79 29316 335453 50240276
Anuria 44.59 17.48 43 29352 11201 50564528
Hyperbilirubinaemia 44.52 17.48 40 29355 9530 50566199
Acute hepatic failure 44.29 17.48 50 29345 15627 50560102
Enterocolitis 44.21 17.48 34 29361 6533 50569196
Gait disturbance 44.10 17.48 16 29379 149989 50425740
Drug ineffective for unapproved indication 44.06 17.48 58 29337 21223 50554506
Wound 43.96 17.48 5 29390 105789 50469940
Rhinocerebral mucormycosis 43.36 17.48 12 29383 195 50575534
Brain abscess 43.15 17.48 21 29374 1770 50573959
Blood lactate dehydrogenase increased 43.13 17.48 55 29340 19507 50556222
Insomnia 43.05 17.48 24 29371 174841 50400888
Neutropenic colitis 42.72 17.48 23 29372 2394 50573335
Weight decreased 41.96 17.48 40 29355 221205 50354524
Anaemia 41.72 17.48 270 29125 252186 50323543
Procalcitonin increased 41.69 17.48 16 29379 754 50574975
Graft versus host disease 41.67 17.48 32 29363 6134 50569595
Neurotoxicity 41.62 17.48 47 29348 14693 50561036
Oliguria 41.53 17.48 36 29359 8180 50567549
Meningitis candida 41.17 17.48 9 29386 50 50575679
Multiple-drug resistance 41.03 17.48 25 29370 3289 50572440
Pleural effusion 40.97 17.48 122 29273 81332 50494397
Enterococcal sepsis 40.18 17.48 18 29377 1257 50574472
Hyperlactacidaemia 39.81 17.48 22 29373 2411 50573318
Eosinophilic pneumonia acute 38.57 17.48 12 29383 298 50575431
Anticonvulsant drug level decreased 38.40 17.48 17 29378 1154 50574575
Mucosal inflammation 38.35 17.48 77 29318 40065 50535664
Drug interaction 37.68 17.48 221 29174 199400 50376329
Guillain-Barre syndrome 37.43 17.48 24 29371 3453 50572276
Pneumonia bacterial 36.89 17.48 32 29363 7277 50568452
Trichosporon infection 36.75 17.48 11 29384 239 50575490
Weissella infection 36.55 17.48 7 29388 17 50575712
Discomfort 36.50 17.48 9 29386 108371 50467358
Perinephric abscess 36.22 17.48 10 29385 161 50575568
Hyperchloraemia 35.94 17.48 14 29381 687 50575042
Factor V inhibition 35.94 17.48 10 29385 166 50575563
Toxic encephalopathy 35.92 17.48 28 29367 5487 50570242
Leukopenia 35.73 17.48 103 29292 67425 50508304
Fungal sepsis 35.44 17.48 16 29379 1138 50574591
Asthma 35.23 17.48 5 29390 89332 50486397
Mixed liver injury 35.13 17.48 23 29372 3428 50572301
C-reactive protein increased 34.79 17.48 101 29294 66373 50509356
Hepatic failure 34.59 17.48 65 29330 32218 50543511
Pericarditis 34.57 17.48 3 29392 78686 50497043
Hepatic infarction 34.48 17.48 13 29382 583 50575146
Bone marrow failure 33.90 17.48 59 29336 27565 50548164
Anxiety 33.79 17.48 32 29363 177574 50398155
Product use in unapproved indication 33.73 17.48 145 29250 115674 50460055
Transaminases increased 33.59 17.48 59 29336 27765 50547964
Umbilical erythema 33.24 17.48 8 29387 72 50575657
Metabolic acidosis 33.02 17.48 71 29324 38754 50536975
Contusion 32.91 17.48 12 29383 112171 50463558
Feeling abnormal 32.69 17.48 16 29379 125476 50450253
Injection site erythema 32.53 17.48 3 29392 74933 50500796
Clostridium difficile infection 32.09 17.48 55 29340 25384 50550345
Blood pressure increased 31.72 17.48 19 29376 133113 50442616
Arthritis 31.64 17.48 6 29389 86715 50489014
Alanine aminotransferase increased 31.64 17.48 118 29277 88241 50487488
Product deposit 31.45 17.48 9 29386 166 50575563
Nausea 31.41 17.48 261 29134 705137 49870592
Emphysematous pyelonephritis 31.30 17.48 9 29386 169 50575560
Escherichia infection 31.08 17.48 35 29360 10906 50564823
Disease progression 31.04 17.48 124 29271 95742 50479987
Cholestasis 30.84 17.48 54 29341 25347 50550382
Abscess neck 30.70 17.48 12 29383 594 50575135
Nephropathy toxic 30.52 17.48 30 29365 7999 50567730
Pyelonephritis fungal 30.49 17.48 8 29387 105 50575624
Hypotension 30.23 17.48 237 29158 235232 50340497
Seizure 30.14 17.48 142 29253 117732 50457997
Renal abscess 29.92 17.48 12 29383 636 50575093
Infusion related reaction 29.48 17.48 33 29362 169524 50406205
Diabetic macroangiopathy 29.26 17.48 8 29387 124 50575605
Brain oedema 29.21 17.48 36 29359 12334 50563395
Haemorrhage intracranial 29.20 17.48 36 29359 12338 50563391
Adjusted calcium decreased 29.14 17.48 8 29387 126 50575603
Hypoxia 29.02 17.48 80 29315 51043 50524686
Blood alkaline phosphatase increased 28.95 17.48 66 29329 37460 50538269
Noninfectious peritonitis 28.68 17.48 8 29387 134 50575595
Pneumothorax 28.66 17.48 38 29357 13996 50561733
Aspartate aminotransferase increased 28.62 17.48 105 29290 77893 50497836
Central nervous system injury 28.57 17.48 8 29387 136 50575593
Haemostasis 28.39 17.48 9 29386 238 50575491
Posterior reversible encephalopathy syndrome 28.33 17.48 39 29356 14889 50560840
Cytopenia 28.28 17.48 30 29365 8745 50566984
Staphylococcal infection 27.87 17.48 63 29332 35553 50540176
Toxic skin eruption 26.98 17.48 33 29362 11218 50564511
Hypernatraemia 26.64 17.48 25 29370 6296 50569433
Respiratory distress 26.20 17.48 56 29339 30433 50545296
Gamma-glutamyltransferase increased 26.14 17.48 55 29340 29568 50546161
Splenic injury 26.09 17.48 8 29387 189 50575540
Drug hypersensitivity 26.04 17.48 68 29327 250942 50324787
Migraine 25.84 17.48 6 29389 75274 50500455
Liver abscess 25.71 17.48 17 29378 2576 50573153
Abdominal pain upper 25.57 17.48 33 29362 159276 50416453
Hyperchlorhydria 25.51 17.48 14 29381 1514 50574215
Hypoalbuminaemia 25.42 17.48 30 29365 9830 50565899
Globulins decreased 25.22 17.48 8 29387 212 50575517
Mycobacterium abscessus infection 25.10 17.48 10 29385 521 50575208
Hypersensitivity 24.92 17.48 55 29340 215106 50360623
Tubulointerstitial nephritis 24.84 17.48 37 29358 15174 50560555
Death neonatal 24.81 17.48 8 29387 224 50575505
Hypotonia 24.80 17.48 27 29368 8107 50567622
Cross sensitivity reaction 24.75 17.48 15 29380 1954 50573775
Haemorrhagic disorder 24.72 17.48 11 29384 756 50574973
Hyperoxaluria 24.68 17.48 7 29388 125 50575604
Acid base balance abnormal 24.31 17.48 8 29387 239 50575490
Rash morbilliform 24.28 17.48 17 29378 2829 50572900
Morganella infection 24.16 17.48 10 29385 575 50575154
Cerebral mass effect 23.99 17.48 11 29384 811 50574918
Type IV hypersensitivity reaction 23.95 17.48 16 29379 2466 50573263
Drug ineffective 23.89 17.48 633 28762 818700 49757029
Myocardial infarction 23.72 17.48 11 29384 89016 50486713
Herpes simplex viraemia 23.70 17.48 7 29388 145 50575584
Hyperkalaemia 23.20 17.48 71 29324 48018 50527711
Neutrophil count decreased 23.19 17.48 69 29326 45957 50529772
Relapsing fever 23.13 17.48 7 29388 158 50575571
Escherichia bacteraemia 22.89 17.48 17 29378 3099 50572630
Dermatitis exfoliative generalised 22.84 17.48 17 29378 3109 50572620
Nosocomial infection 22.83 17.48 13 29382 1509 50574220
Hypertransaminasaemia 22.80 17.48 18 29377 3593 50572136
Venoocclusive disease 22.70 17.48 14 29381 1882 50573847
Delayed graft function 22.69 17.48 11 29384 919 50574810
Epilepsy 22.57 17.48 43 29352 21524 50554205
Colitis 22.57 17.48 61 29334 38468 50537261
Metabolic alkalosis 22.57 17.48 16 29379 2715 50573014
Cytomegalovirus viraemia 22.53 17.48 20 29375 4689 50571040
Aplastic anaemia 22.49 17.48 25 29370 7678 50568051
Dry mouth 22.49 17.48 3 29392 56175 50519554
Status epilepticus 22.45 17.48 33 29362 13373 50562356
Vulvovaginitis 22.41 17.48 8 29387 307 50575422
Hyperhidrosis 22.39 17.48 12 29383 89414 50486315
Pulmonary haemorrhage 22.37 17.48 23 29372 6469 50569260
Lung abscess 22.33 17.48 13 29382 1573 50574156
Folate deficiency 22.31 17.48 14 29381 1941 50573788
Overgrowth fungal 22.13 17.48 6 29389 90 50575639
Hypochromasia 22.04 17.48 8 29387 322 50575407
Somnolence 22.01 17.48 35 29360 154950 50420779
Herpes simplex hepatitis 21.97 17.48 8 29387 325 50575404
Osteomyelitis bacterial 21.91 17.48 7 29388 190 50575539
Hyperaemia 21.70 17.48 14 29381 2036 50573693
Diffuse large B-cell lymphoma refractory 21.47 17.48 11 29384 1035 50574694
Hyperamylasaemia 21.45 17.48 8 29387 348 50575381
Intentional overdose 21.41 17.48 5 29390 62499 50513230
Pseudomonal sepsis 21.35 17.48 14 29381 2093 50573636
Exfoliative rash 21.32 17.48 15 29380 2515 50573214
Clostridial infection 21.22 17.48 18 29377 3972 50571757
Endocarditis 21.14 17.48 20 29375 5087 50570642
Sepsis syndrome 21.00 17.48 10 29385 803 50574926
Premature delivery 20.96 17.48 44 29351 23619 50552110
Anisocytosis 20.89 17.48 9 29386 572 50575157
Bronchitis 20.71 17.48 18 29377 104141 50471588
Candida endophthalmitis 20.67 17.48 5 29390 46 50575683
Bacterial sepsis 20.67 17.48 17 29378 3595 50572134
Hydrocephalus 20.30 17.48 19 29376 4769 50570960
Venoocclusive liver disease 20.19 17.48 18 29377 4243 50571486
Hepatosplenomegaly 20.16 17.48 14 29381 2298 50573431
Cardiac failure congestive 20.15 17.48 12 29383 84370 50491359
Mediastinal effusion 20.03 17.48 5 29390 53 50575676
Antibiotic level above therapeutic 20.01 17.48 7 29388 253 50575476
Blood fibrinogen decreased 19.91 17.48 9 29386 642 50575087
Suicidal ideation 19.85 17.48 4 29391 55381 50520348
Blood cholesterol increased 19.76 17.48 4 29391 55211 50520518
Abdominal sepsis 19.75 17.48 11 29384 1224 50574505
Coagulation test abnormal 19.58 17.48 9 29386 667 50575062
Enterococcal bacteraemia 19.56 17.48 11 29384 1247 50574482
Low cardiac output syndrome 19.52 17.48 7 29388 272 50575457
Klebsiella bacteraemia 19.41 17.48 11 29384 1266 50574463
Septal panniculitis 19.39 17.48 5 29390 61 50575668
Acute graft versus host disease in intestine 19.36 17.48 12 29383 1627 50574102
Injection site reaction 19.26 17.48 3 29392 50029 50525700
Myoclonus 19.20 17.48 32 29363 14438 50561291
Clostridium test positive 19.14 17.48 13 29382 2059 50573670
Musculoskeletal pain 19.10 17.48 9 29386 72168 50503561
Wound haemorrhage 19.04 17.48 13 29382 2077 50573652
Cytomegalovirus infection 19.03 17.48 36 29359 17926 50557803
Serum sickness 19.02 17.48 14 29381 2518 50573211
Acute graft versus host disease in skin 18.96 17.48 15 29380 3003 50572726
Leukocytosis 18.86 17.48 41 29354 22538 50553191
Herpes simplex 18.81 17.48 22 29373 7140 50568589
Cytomegalovirus test positive 18.73 17.48 14 29381 2578 50573151
Hospitalisation 18.71 17.48 8 29387 67929 50507800
Immunosuppressant drug level increased 18.68 17.48 15 29380 3067 50572662
Hyperammonaemia 18.61 17.48 18 29377 4706 50571023
Influenza 18.38 17.48 15 29380 89523 50486206
Encephalitis 18.27 17.48 22 29373 7358 50568371
Thrombotic microangiopathy 18.25 17.48 24 29371 8767 50566962
Systemic mycosis 18.17 17.48 10 29385 1087 50574642
Abdominal compartment syndrome 18.14 17.48 8 29387 538 50575191
Fusarium infection 18.09 17.48 8 29387 542 50575187
Cerebrovascular accident 18.06 17.48 17 29378 94663 50481066
Liver disorder 17.99 17.48 55 29340 37167 50538562
Pulseless electrical activity 17.94 17.48 21 29374 6820 50568909
Rhinorrhoea 17.92 17.48 4 29391 51579 50524150
Calcification of muscle 17.90 17.48 4 29391 25 50575704
Generalised tonic-clonic seizure 17.83 17.48 44 29351 26266 50549463
Cardiomyopathy acute 17.75 17.48 6 29389 195 50575534
Immune effector cell-associated neurotoxicity syndrome 17.73 17.48 10 29385 1140 50574589
Vision blurred 17.66 17.48 12 29383 78635 50497094
Hypokalaemia 17.60 17.48 99 29296 87893 50487836
Clostridial sepsis 17.51 17.48 7 29388 368 50575361

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 486.72 14.92 501 38227 62615 29473184
Septic shock 454.40 14.92 481 38247 62079 29473720
Drug resistance 346.39 14.92 260 38468 21280 29514519
Pathogen resistance 337.47 14.92 179 38549 7937 29527862
Drug reaction with eosinophilia and systemic symptoms 304.51 14.92 269 38459 27723 29508076
Bronchopulmonary aspergillosis 220.92 14.92 159 38569 12185 29523614
Drug ineffective 209.70 14.92 983 37745 362187 29173612
Sepsis 178.31 14.92 498 38230 142184 29393615
Enterococcal infection 174.84 14.92 118 38610 8150 29527649
Fatigue 173.89 14.92 100 38628 316721 29219078
Candida infection 172.86 14.92 150 38578 15075 29520724
Respiratory failure 169.46 14.92 385 38343 96746 29439053
Off label use 162.15 14.92 799 37929 300001 29235798
Pyrexia 160.74 14.92 772 37956 286850 29248949
Disseminated intravascular coagulation 157.94 14.92 161 38567 19819 29515980
Eosinophilia 152.77 14.92 166 38562 21995 29513804
Haemophagocytic lymphohistiocytosis 147.36 14.92 117 38611 10387 29525412
Hepatic function abnormal 144.38 14.92 215 38513 39044 29496755
Dizziness 139.62 14.92 38 38690 189646 29346153
Fall 127.58 14.92 37 38691 177141 29358658
Klebsiella infection 125.41 14.92 92 38636 7257 29528542
Rash maculo-papular 122.48 14.92 155 38573 24134 29511665
Systemic candida 109.02 14.92 59 38669 2721 29533078
Product dose omission issue 105.26 14.92 5 38723 96378 29439421
Toxic epidermal necrolysis 99.80 14.92 121 38607 18032 29517767
Pseudomonas infection 90.41 14.92 90 38638 10762 29525037
Pancytopenia 89.92 14.92 276 38452 82892 29452907
Aspergillus infection 88.61 14.92 88 38640 10493 29525306
Thrombocytopenia 87.61 14.92 379 38349 134444 29401355
Myocardial infarction 87.10 14.92 19 38709 110277 29425522
Drug abuse 84.53 14.92 5 38723 79878 29455921
Death 83.48 14.92 205 38523 341879 29193920
Geotrichum infection 81.02 14.92 28 38700 417 29535382
Drug ineffective for unapproved indication 78.54 14.92 95 38633 14119 29521680
Pain 78.02 14.92 66 38662 171366 29364433
Herpes simplex oesophagitis 74.17 14.92 20 38708 119 29535680
Dysbiosis 72.29 14.92 25 38703 373 29535426
Acute respiratory distress syndrome 70.88 14.92 116 38612 22819 29512980
Bone marrow failure 70.62 14.92 128 38600 27321 29508478
Headache 68.71 14.92 76 38652 173931 29361868
Febrile neutropenia 67.92 14.92 309 38419 111931 29423868
Renal impairment 65.02 14.92 244 38484 81089 29454710
Arthralgia 64.42 14.92 53 38675 139564 29396235
Depression 62.64 14.92 17 38711 85130 29450669
Asthenia 61.47 14.92 118 38610 215132 29320667
Fungaemia 60.65 14.92 37 38691 2144 29533655
Drug-induced liver injury 59.58 14.92 104 38624 21551 29514248
Pseudomembranous colitis 59.56 14.92 39 38689 2558 29533241
Anxiety 59.23 14.92 19 38709 85346 29450453
Mucormycosis 58.88 14.92 51 38677 5107 29530692
Stenotrophomonas infection 57.91 14.92 33 38695 1684 29534115
Trichosporon infection 57.36 14.92 24 38704 616 29535183
Back pain 56.26 14.92 32 38696 102252 29433547
Inflammatory marker increased 56.08 14.92 43 38685 3624 29532175
Cholestasis 56.07 14.92 106 38622 23356 29512443
Spinal muscular atrophy 55.92 14.92 19 38709 268 29535531
Pain in extremity 54.65 14.92 39 38689 110394 29425405
Pneumonia bacterial 54.16 14.92 64 38664 9279 29526520
Weight decreased 54.14 14.92 71 38657 150834 29384965
Hyphaema 52.98 14.92 21 38707 467 29535332
Hepatomegaly 52.66 14.92 63 38665 9254 29526545
Agranulocytosis 51.23 14.92 94 38634 20246 29515553
Clostridium difficile colitis 50.89 14.92 74 38654 13138 29522661
Pneumococcal sepsis 50.40 14.92 24 38704 842 29534957
Clostridium difficile infection 49.00 14.92 81 38647 16060 29519739
Liver injury 48.76 14.92 71 38657 12619 29523180
Blood pressure increased 48.47 14.92 18 38710 73785 29462014
Feeling abnormal 48.10 14.92 7 38721 54438 29481361
Joint swelling 47.21 14.92 5 38723 49625 29486174
Drug eruption 46.83 14.92 81 38647 16660 29519139
Pulmonary haemorrhage 46.45 14.92 59 38669 9211 29526588
Inappropriate schedule of product administration 46.38 14.92 3 38725 44469 29491330
Tachypnoea 46.08 14.92 76 38652 15039 29520760
Nausea 45.88 14.92 209 38519 289046 29246753
Myalgia 45.44 14.92 20 38708 73999 29461800
Cardiac failure congestive 44.99 14.92 22 38706 76559 29459240
Product use in unapproved indication 44.44 14.92 228 38500 86647 29449152
Systemic mycosis 43.51 14.92 25 38703 1296 29534503
Gait disturbance 43.20 14.92 21 38707 73328 29462471
Muscle spasms 42.52 14.92 16 38712 65066 29470733
Pneumothorax 42.17 14.92 75 38653 15767 29520032
Fungal infection 41.98 14.92 69 38659 13616 29522183
Aplastic anaemia 41.16 14.92 50 38678 7460 29528339
Coagulopathy 40.44 14.92 79 38649 17828 29517971
Brain abscess 40.31 14.92 31 38697 2624 29533175
Hepatic failure 39.18 14.92 110 38618 31402 29504397
Chest pain 38.80 14.92 54 38674 111919 29423880
Hypoalbuminaemia 38.64 14.92 57 38671 10248 29525551
Enterococcus test positive 38.64 14.92 19 38709 716 29535083
Coronary artery disease 38.30 14.92 6 38722 44184 29491615
Hypofibrinogenaemia 38.03 14.92 24 38704 1477 29534322
Hyperhidrosis 37.21 14.92 19 38709 64521 29471278
Sputum increased 37.18 14.92 26 38702 1901 29533898
Leukopenia 37.15 14.92 157 38571 55046 29480753
Nasopharyngitis 36.81 14.92 16 38712 59649 29476150
Weight increased 36.71 14.92 28 38700 76639 29459160
Syncope 36.13 14.92 32 38696 81339 29454460
Respiratory tract infection bacterial 35.71 14.92 17 38711 596 29535203
Cough 35.65 14.92 70 38658 126657 29409142
Portal fibrosis 35.50 14.92 14 38714 307 29535492
Acinetobacter infection 35.43 14.92 20 38708 1002 29534797
Acute generalised exanthematous pustulosis 35.31 14.92 40 38688 5543 29530256
Hyperferritinaemia 34.80 14.92 14 38714 324 29535475
Ototoxicity 34.67 14.92 23 38705 1542 29534257
Dyspnoea 33.88 14.92 270 38458 326462 29209337
C-reactive protein increased 33.85 14.92 131 38597 44132 29491667
Serum sickness-like reaction 33.10 14.92 10 38718 94 29535705
Tubulointerstitial nephritis 32.98 14.92 72 38656 17571 29518228
Enterocolitis 32.73 14.92 42 38686 6624 29529175
Abdominal discomfort 32.61 14.92 11 38717 47892 29487907
Hepatotoxicity 32.36 14.92 72 38656 17795 29518004
Hospitalisation 32.30 14.92 10 38718 45978 29489821
Treatment failure 32.16 14.92 114 38614 36825 29498974
Increased bronchial secretion 32.07 14.92 22 38706 1559 29534240
Intentional overdose 31.70 14.92 6 38722 38522 29497277
Rectal haemorrhage 31.56 14.92 4 38724 34545 29501254
Cross sensitivity reaction 31.53 14.92 20 38708 1242 29534557
Myelosuppression 31.41 14.92 57 38671 12170 29523629
Hypoxia 31.29 14.92 134 38594 47245 29488554
Respiratory gas exchange disorder 31.21 14.92 14 38714 427 29535372
Rheumatoid arthritis 31.20 14.92 3 38725 32149 29503650
Shock 30.92 14.92 79 38649 21325 29514474
Cryptococcal meningoencephalitis 30.90 14.92 10 38718 120 29535679
Liver abscess 30.26 14.92 29 38699 3309 29532490
Bacteraemia 29.81 14.92 66 38662 16257 29519542
Incorrect dose administered 29.70 14.92 4 38724 32980 29502819
Vision blurred 29.57 14.92 8 38720 40168 29495631
Neutropenia 29.28 14.92 282 38446 131429 29404370
Dehydration 29.24 14.92 67 38661 114681 29421118
Rash morbilliform 29.16 14.92 25 38703 2468 29533331
Procalcitonin increased 29.01 14.92 21 38707 1621 29534178
Encephalopathy 28.93 14.92 98 38630 30945 29504854
Cytomegalovirus infection 28.81 14.92 81 38647 23134 29512665
Cytokine release syndrome 28.56 14.92 57 38671 13062 29522737
Venoocclusive liver disease 28.48 14.92 40 38688 6877 29528922
Musculoskeletal stiffness 28.45 14.92 7 38721 37451 29498348
Clostridium test positive 28.44 14.92 23 38705 2094 29533705
Platelet count decreased 28.34 14.92 234 38494 104438 29431361
Therapeutic product effect decreased 27.92 14.92 3 38725 29448 29506351
Wrong technique in product usage process 27.85 14.92 4 38724 31424 29504375
Neutropenic colitis 27.84 14.92 24 38704 2387 29533412
Epidermolysis bullosa 27.81 14.92 9 38719 108 29535691
Insomnia 27.66 14.92 46 38682 88715 29447084
Vomiting 27.60 14.92 164 38564 212096 29323703
Oedema peripheral 27.58 14.92 59 38669 103498 29432301
Dermatitis bullous 27.11 14.92 36 38692 5870 29529929
Balance disorder 27.00 14.92 7 38721 36163 29499636
Cerebrovascular accident 26.72 14.92 37 38691 76874 29458925
Granulocyte count decreased 26.59 14.92 14 38714 610 29535189
Endocarditis 26.48 14.92 35 38693 5681 29530118
Constipation 26.46 14.92 70 38658 114090 29421709
Tumour lysis syndrome 26.33 14.92 57 38671 13827 29521972
Eosinophilic pneumonia 26.32 14.92 25 38703 2821 29532978
Aggression 26.30 14.92 7 38721 35534 29500265
Acute myeloid leukaemia 26.01 14.92 63 38665 16450 29519349
Renal failure 25.40 14.92 252 38476 118347 29417452
Condition aggravated 25.38 14.92 298 38430 145997 29389802
Blood glucose increased 25.22 14.92 24 38704 58960 29476839
CNS ventriculitis 25.16 14.92 10 38718 224 29535575
Vascular pseudoaneurysm thrombosis 25.11 14.92 7 38721 48 29535751
Aortoenteric fistula 24.88 14.92 8 38720 94 29535705
Toxicity to various agents 24.84 14.92 130 38598 173531 29362268
Pneumonia fungal 24.67 14.92 34 38694 5743 29530056
Factor V inhibition 24.37 14.92 9 38719 164 29535635
Cardiac valve vegetation 24.29 14.92 12 38716 457 29535342
Transaminases increased 24.24 14.92 75 38653 22587 29513212
Motor neurone disease 24.03 14.92 11 38717 352 29535447
Drug intolerance 24.02 14.92 17 38711 48362 29487437
Stevens-Johnson syndrome 23.94 14.92 61 38667 16436 29519363
Dyspnoea exertional 23.78 14.92 9 38719 36481 29499318
Hypertension 23.75 14.92 76 38652 116538 29419261
Respiratory paralysis 23.74 14.92 7 38721 60 29535739
Chest X-ray abnormal 23.68 14.92 27 38701 3767 29532032
Liver disorder 23.60 14.92 85 38643 27664 29508135
Intentional product misuse 23.52 14.92 8 38720 34653 29501146
Stoma closure 23.47 14.92 8 38720 114 29535685
Interleukin-2 receptor increased 23.47 14.92 8 38720 114 29535685
Neurotoxicity 23.29 14.92 56 38672 14557 29521242
Wound dehiscence 23.26 14.92 24 38704 2993 29532806
Contusion 23.25 14.92 6 38722 31089 29504710
Multiple-drug resistance 23.07 14.92 27 38701 3873 29531926
Disseminated cryptococcosis 22.97 14.92 16 38712 1162 29534637
Ischaemic cerebral infarction 22.82 14.92 15 38713 990 29534809
Peripheral swelling 22.81 14.92 30 38698 63709 29472090
Shock haemorrhagic 22.62 14.92 43 38685 9508 29526291
Haemorrhagic pneumonia 22.62 14.92 8 38720 128 29535671
Acute respiratory failure 22.56 14.92 81 38647 26321 29509478
Acute kidney injury 22.50 14.92 479 38249 264788 29271011
Blood alkaline phosphatase increased 22.47 14.92 85 38643 28321 29507478
Staphylococcal sepsis 22.36 14.92 41 38687 8821 29526978
Chronic obstructive pulmonary disease 22.23 14.92 13 38715 40942 29494857
Aspergillus test positive 22.16 14.92 11 38717 423 29535376
Disease complication 22.14 14.92 21 38707 2365 29533434
Nosocomial infection 22.12 14.92 15 38713 1043 29534756
Circulatory collapse 22.05 14.92 64 38664 18609 29517190
Lung consolidation 22.02 14.92 30 38698 5013 29530786
Faeces pale 22.01 14.92 16 38712 1243 29534556
Suicidal ideation 21.90 14.92 9 38719 34707 29501092
Gastrooesophageal reflux disease 21.84 14.92 7 38721 31489 29504310
Hepatic necrosis 21.76 14.92 25 38703 3517 29532282
Leukocytosis 21.72 14.92 69 38659 21073 29514726
Nocardiosis 21.71 14.92 24 38704 3236 29532563
Blood bilirubin increased 21.71 14.92 95 38633 33798 29502001
Epilepsy 21.60 14.92 63 38665 18369 29517430
Deep vein thrombosis 21.59 14.92 26 38702 57373 29478426
Hepatic cytolysis 21.55 14.92 39 38689 8308 29527491
Immune effector cell-associated neurotoxicity syndrome 21.42 14.92 17 38711 1507 29534292
Mobility decreased 21.24 14.92 4 38724 25776 29510023
Eosinophilic pneumonia acute 21.22 14.92 11 38717 464 29535335
Dysarthria 21.21 14.92 7 38721 30904 29504895
Injection site pain 21.15 14.92 8 38720 32438 29503361
Acute myeloid leukaemia recurrent 21.13 14.92 18 38710 1762 29534037
Rhinocerebral mucormycosis 21.12 14.92 9 38719 242 29535557
Nephrogenic diabetes insipidus 21.12 14.92 15 38713 1124 29534675
Urinary tract infection fungal 20.94 14.92 10 38718 353 29535446
Aeromonas infection 20.91 14.92 9 38719 248 29535551
Metabolic disorder 20.90 14.92 25 38703 3670 29532129
Intestinal ischaemia 20.87 14.92 34 38694 6658 29529141
Paraesthesia 20.67 14.92 24 38704 53821 29481978
Candida test positive 20.58 14.92 10 38718 367 29535432
Transient ischaemic attack 20.53 14.92 3 38725 23267 29512532
Alanine aminotransferase increased 20.49 14.92 161 38567 70783 29465016
Arthritis 20.36 14.92 4 38724 25015 29510784
Dyspepsia 20.36 14.92 7 38721 30118 29505681
Dermatitis exfoliative generalised 20.35 14.92 22 38706 2894 29532905
Resuscitation 20.28 14.92 15 38713 1197 29534602
Heart rate decreased 20.24 14.92 4 38724 24908 29510891
Antinuclear antibody negative 20.18 14.92 5 38723 20 29535779
Radiation fibrosis - lung 19.98 14.92 5 38723 21 29535778
Haemodynamic instability 19.93 14.92 37 38691 8036 29527763
Pneumonia 19.88 14.92 554 38174 319618 29216181
Septic embolus 19.87 14.92 14 38714 1036 29534763
Drug level decreased 19.84 14.92 32 38696 6215 29529584
Angina pectoris 19.65 14.92 6 38722 27844 29507955
Sleep disorder 19.63 14.92 4 38724 24382 29511417
Toxic skin eruption 19.59 14.92 41 38687 9716 29526083
Staphylococcal infection 19.53 14.92 83 38645 29157 29506642
Necrotising fasciitis 19.42 14.92 23 38705 3342 29532457
Hypokalaemia 19.21 14.92 122 38606 50081 29485718
Intra-abdominal fluid collection 19.11 14.92 14 38714 1101 29534698
Strongyloidiasis 18.93 14.92 19 38709 2293 29533506
Hepatitis cholestatic 18.81 14.92 33 38695 6860 29528939
Lower respiratory tract infection bacterial 18.79 14.92 9 38719 320 29535479
Nephrolithiasis 18.72 14.92 5 38723 25329 29510470
Chimerism 18.50 14.92 8 38720 223 29535576
Type IV hypersensitivity reaction 18.47 14.92 14 38714 1160 29534639
Hyperbilirubinaemia 18.42 14.92 52 38676 14882 29520917
Hypoaesthesia 18.28 14.92 26 38702 53441 29482358
Loss of consciousness 18.24 14.92 44 38684 74012 29461787
Acute hepatic failure 18.19 14.92 45 38683 11907 29523892
Fungal sepsis 18.19 14.92 12 38716 797 29535002
Lymphadenectomy 18.15 14.92 8 38720 234 29535565
Mediastinitis 18.14 14.92 11 38717 630 29535169
Coagulation time prolonged 18.09 14.92 14 38714 1196 29534603
Myasthenia gravis crisis 18.09 14.92 10 38718 481 29535318
Asthma 18.01 14.92 11 38717 33838 29501961
Myocardial calcification 17.97 14.92 5 38723 34 29535765
Flavobacterium infection 17.97 14.92 6 38722 80 29535719
ADAMTS13 activity decreased 17.90 14.92 6 38722 81 29535718
Drug interaction 17.88 14.92 360 38368 197025 29338774
Tremor 17.87 14.92 44 38684 73494 29462305
Infective aneurysm 17.86 14.92 10 38718 493 29535306
Dermatitis exfoliative 17.85 14.92 31 38697 6394 29529405
Malaise 17.84 14.92 129 38599 159473 29376326
Vascular pseudoaneurysm 17.79 14.92 17 38711 1932 29533867
Decreased appetite 17.46 14.92 115 38613 145227 29390572
Enterococcal sepsis 17.44 14.92 15 38713 1487 29534312
Potentiating drug interaction 17.29 14.92 25 38703 4413 29531386
Gamma-glutamyltransferase increased 17.17 14.92 75 38653 26662 29509137
Chest discomfort 17.11 14.92 21 38707 45962 29489837
Rectal perforation 17.06 14.92 9 38719 394 29535405
Soft tissue necrosis 17.03 14.92 8 38720 272 29535527
Overdose 16.96 14.92 51 38677 79768 29456031
Device related infection 16.95 14.92 52 38676 15584 29520215
Cardiac arrest 16.94 14.92 179 38549 85412 29450387
Candida sepsis 16.80 14.92 13 38715 1110 29534689
Graft versus host disease in gastrointestinal tract 16.74 14.92 21 38707 3237 29532562
Dry mouth 16.68 14.92 4 38724 21780 29514019
Blood lactate dehydrogenase increased 16.47 14.92 59 38669 19150 29516649
Bronchial disorder 16.42 14.92 13 38715 1148 29534651
Catheter site pain 16.39 14.92 13 38715 1151 29534648
Staphylococcus test positive 16.30 14.92 19 38709 2714 29533085
Splenomegaly 16.15 14.92 46 38682 13233 29522566
Scedosporium infection 16.10 14.92 11 38717 774 29535025
Candida pneumonia 16.09 14.92 8 38720 309 29535490
Influenza like illness 16 14.92 6 38722 24464 29511335
Mechanical ventilation 16.00 14.92 15 38713 1665 29534134
Hypernatraemia 15.97 14.92 32 38696 7354 29528445
Amnesia 15.76 14.92 5 38723 22638 29513161
Macule 15.73 14.92 12 38716 1004 29534795
Linear IgA disease 15.71 14.92 14 38714 1455 29534344
Drug level increased 15.51 14.92 57 38671 18730 29517069
Systemic inflammatory response syndrome 15.51 14.92 28 38700 5953 29529846
Hypoproteinaemia 15.46 14.92 15 38713 1737 29534062
Escherichia infection 15.46 14.92 30 38698 6734 29529065
Graft versus host disease 15.45 14.92 37 38691 9591 29526208
Alveolitis necrotising 15.42 14.92 4 38724 20 29535779
Red blood cell sedimentation rate decreased 15.38 14.92 5 38723 61 29535738
Cholangiolitis 15.26 14.92 4 38724 21 29535778
Intestinal pseudo-obstruction 15.24 14.92 13 38715 1275 29534524
Hypovolaemic shock 15.21 14.92 28 38700 6044 29529755
Pneumonia klebsiella 15.14 14.92 18 38710 2626 29533173
Endotracheal intubation 15 14.92 18 38710 2651 29533148
Red blood cell schistocytes present 14.98 14.92 7 38721 235 29535564
Acute graft versus host disease in skin 14.96 14.92 24 38704 4640 29531159

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 930.89 13.80 785 63308 100628 64334011
Septic shock 824.37 13.80 745 63348 104692 64329947
Drug resistance 643.73 13.80 413 63680 34689 64399950
Drug reaction with eosinophilia and systemic symptoms 625.11 13.80 480 63613 53737 64380902
Pathogen resistance 585.73 13.80 274 63819 12269 64422370
Sepsis 364.00 13.80 744 63349 229597 64205042
Bronchopulmonary aspergillosis 345.89 13.80 223 63870 18862 64415777
Respiratory failure 317.60 13.80 572 63521 160611 64274028
Pyrexia 312.94 13.80 1237 62856 557407 63877232
Fatigue 287.59 13.80 197 63896 748533 63686106
Enterococcal infection 283.77 13.80 175 63918 13691 64420948
Off label use 271.39 13.80 1293 62800 631513 63803126
Haemophagocytic lymphohistiocytosis 269.00 13.80 185 63908 17424 64417215
Pain 261.29 13.80 112 63981 553399 63881240
Thrombocytopenia 252.85 13.80 633 63460 223168 64211471
Candida infection 244.98 13.80 222 63871 31197 64403442
Drug ineffective 240.37 13.80 1538 62555 838709 63595930
Fall 226.10 13.80 67 64026 416759 64017880
Eosinophilia 219.62 13.80 228 63865 37848 64396791
Toxic epidermal necrolysis 215.18 13.80 223 63870 36943 64397696
Disseminated intravascular coagulation 214.66 13.80 209 63884 32139 64402500
Headache 214.22 13.80 131 63962 529336 63905303
Arthralgia 209.31 13.80 89 64004 442171 63992468
Febrile neutropenia 195.49 13.80 515 63578 187142 64247497
Dizziness 195.02 13.80 92 64001 430071 64004568
Pancytopenia 192.70 13.80 434 63659 142875 64291764
Hepatic function abnormal 190.57 13.80 275 63818 64038 64370601
Klebsiella infection 176.12 13.80 128 63965 13153 64421486
Joint swelling 173.72 13.80 10 64083 215372 64219267
Systemic candida 173.16 13.80 91 64002 5238 64429401
Pseudomonas infection 173.09 13.80 143 63950 17740 64416899
Rash maculo-papular 167.80 13.80 220 63873 46806 64387833
Aspergillus infection 162.77 13.80 133 63960 16246 64418393
Product dose omission issue 145.67 13.80 13 64080 194734 64239905
Rheumatoid arthritis 144.62 13.80 4 64089 164290 64270349
Pain in extremity 133.91 13.80 67 64026 303018 64131621
Clostridium difficile colitis 132.39 13.80 149 63944 27074 64407565
Acinetobacter infection 132.02 13.80 59 64034 2370 64432269
Geotrichum infection 131.36 13.80 45 64048 873 64433766
Acute respiratory distress syndrome 129.46 13.80 176 63917 38759 64395880
Acute kidney injury 123.07 13.80 815 63278 448425 63986214
Renal impairment 122.06 13.80 352 63741 134665 64299974
Abdominal discomfort 119.54 13.80 19 64074 182303 64252336
Fungaemia 118.35 13.80 63 64030 3722 64430917
Dysbiosis 116.97 13.80 41 64052 854 64433785
Nasopharyngitis 116.70 13.80 26 64067 196047 64238592
Mucormycosis 114.16 13.80 78 64015 7263 64427376
Agranulocytosis 111.06 13.80 162 63931 38067 64396572
Pseudomembranous colitis 110.74 13.80 66 64027 4850 64429789
Drug abuse 110.32 13.80 5 64088 132369 64302270
Drug intolerance 109.74 13.80 26 64067 187966 64246673
Drug ineffective for unapproved indication 105.42 13.80 142 63951 30991 64403648
Nausea 102.68 13.80 418 63675 785382 63649257
Peripheral swelling 100.50 13.80 41 64052 209112 64225527
Neutropenia 99.33 13.80 486 63607 239138 64195501
Bone marrow failure 99.13 13.80 174 63919 47778 64386861
Clostridium difficile infection 98.95 13.80 149 63944 36014 64398625
Stenotrophomonas infection 98.38 13.80 52 64041 3028 64431611
Weight increased 97.48 13.80 45 64048 213303 64221336
Depression 96.42 13.80 31 64062 183260 64251379
Asthenia 93.65 13.80 177 63916 427867 64006772
Blood pressure increased 92.89 13.80 28 64065 172524 64262115
Drug eruption 87.85 13.80 141 63952 35995 64398644
Anxiety 87.64 13.80 46 64047 202603 64232036
Trichosporon infection 87.26 13.80 33 64060 859 64433780
Swelling 86.23 13.80 26 64067 160192 64274447
Myocardial infarction 85.54 13.80 29 64064 165792 64268847
Therapeutic product effect decreased 85.42 13.80 8 64085 115343 64319296
Muscle spasms 85.31 13.80 18 64075 141005 64293634
Gait disturbance 83.92 13.80 33 64060 172122 64262517
Feeling abnormal 83.01 13.80 16 64077 133586 64301053
Acute generalised exanthematous pustulosis 82.50 13.80 85 64008 13973 64420666
Injection site pain 81.77 13.80 8 64085 111400 64323239
Brain abscess 81.06 13.80 51 64042 4130 64430509
Weight decreased 79.85 13.80 100 63993 285639 64149000
Myelosuppression 78.11 13.80 107 63986 23723 64410916
Pneumothorax 77.99 13.80 108 63985 24190 64410449
Coagulopathy 76.84 13.80 124 63969 31796 64402843
Shock 75.49 13.80 136 63957 38104 64396535
Sinusitis 74.43 13.80 26 64067 145902 64288737
Fungal infection 74.33 13.80 127 63966 34124 64400515
Cholestasis 74.23 13.80 148 63945 44724 64389915
Musculoskeletal stiffness 73.96 13.80 16 64077 123190 64311449
Platelet count decreased 72.93 13.80 345 63748 167366 64267273
Pneumonia bacterial 72.59 13.80 82 64011 14953 64419686
Candida sepsis 72.25 13.80 38 64055 2190 64432449
Memory impairment 72.16 13.80 3 64090 85679 64348960
Cytokine release syndrome 72.04 13.80 96 63997 20733 64413906
Leukopenia 71.17 13.80 242 63851 101000 64333639
Encephalopathy 71.12 13.80 171 63922 58648 64375991
Hepatic failure 70.18 13.80 164 63929 55230 64379409
Malaise 70.11 13.80 184 63909 396063 64038576
Neutropenic colitis 69.64 13.80 48 64045 4533 64430106
Enterocolitis 69.32 13.80 72 64021 11946 64422693
Stevens-Johnson syndrome 69.13 13.80 123 63970 34126 64400513
Product use in unapproved indication 68.73 13.80 352 63741 176266 64258373
Alopecia 68.17 13.80 40 64053 165650 64268989
Pneumonia fungal 67.74 13.80 62 64031 8815 64425824
Herpes simplex oesophagitis 67.09 13.80 20 64073 242 64434397
Hyphaema 66.86 13.80 25 64068 630 64434009
C-reactive protein increased 66.83 13.80 227 63866 94682 64339957
Contusion 66.01 13.80 16 64077 113949 64320690
Hypoalbuminaemia 65.06 13.80 84 64009 17590 64417049
Tubulointerstitial nephritis 64.97 13.80 113 63980 30796 64403843
Drug-induced liver injury 64.72 13.80 145 63948 47498 64387141
Renal failure 64.46 13.80 353 63740 181335 64253304
Insomnia 64.35 13.80 61 64032 197775 64236864
Bacteraemia 64.04 13.80 104 63989 26807 64407832
Procalcitonin increased 62.86 13.80 36 64057 2455 64432184
Inflammatory marker increased 62.50 13.80 58 64035 8393 64426246
Clostridium test positive 62.27 13.80 43 64050 4072 64430567
Drug level decreased 61.18 13.80 66 64027 11437 64423202
Spinal muscular atrophy 60.62 13.80 19 64074 275 64434364
Acute respiratory failure 60.18 13.80 145 63948 49789 64384850
Pneumonia 59.92 13.80 832 63261 558744 63875895
Cardiac arrest 59.89 13.80 307 63786 153757 64280882
Aplastic anaemia 58.99 13.80 71 64022 13849 64420790
Psoriasis 58.79 13.80 3 64090 71700 64362939
Rhinocerebral mucormycosis 58.58 13.80 21 64072 468 64434171
Intentional overdose 57.52 13.80 10 64083 89934 64344705
Hyperbilirubinaemia 57.47 13.80 87 64006 21118 64413521
Liver injury 57.23 13.80 105 63988 29827 64404812
Factor V inhibition 56.99 13.80 19 64074 338 64434301
Multiple-drug resistance 56.75 13.80 49 64044 6453 64428186
Linear IgA disease 56.71 13.80 35 64058 2739 64431900
Arthritis 56.59 13.80 8 64085 83806 64350833
Neurotoxicity 56.06 13.80 99 63994 27305 64407334
Tachypnoea 55.66 13.80 97 63996 26474 64408165
Liver abscess 54.83 13.80 44 64049 5236 64429403
Hyperhidrosis 54.51 13.80 28 64065 124892 64309747
Pulmonary haemorrhage 54.14 13.80 66 64027 13043 64421596
Back pain 54.13 13.80 104 63989 250067 64184572
Asthma 53.93 13.80 14 64079 95211 64339428
Drug interaction 53.79 13.80 573 63520 361510 64073129
Toxic skin eruption 53.52 13.80 80 64013 19204 64415435
Inappropriate schedule of product administration 53.36 13.80 13 64080 92273 64342366
Systemic inflammatory response syndrome 53.16 13.80 58 64035 10177 64424462
Lung consolidation 53.08 13.80 51 64042 7707 64426932
Cardiac failure congestive 53.04 13.80 32 64061 130548 64304091
Eosinophilic pneumonia acute 52.91 13.80 23 64070 864 64433775
Wound 52.34 13.80 7 64086 76470 64358169
Acute myeloid leukaemia 52.08 13.80 96 63997 27367 64407272
Systemic mycosis 51.84 13.80 31 64062 2292 64432347
Rash morbilliform 51.60 13.80 42 64051 5099 64429540
Staphylococcal infection 51.53 13.80 138 63955 50540 64384099
Epilepsy 51.20 13.80 107 63986 33424 64401215
Chest pain 51.14 13.80 98 63995 235882 64198757
Transaminases increased 51.09 13.80 127 63966 44467 64390172
Myalgia 50.30 13.80 50 64043 158567 64276072
Cough 49.90 13.80 145 63948 302003 64132636
Injection site erythema 49.62 13.80 6 64087 70794 64363845
Wrong technique in product usage process 49.47 13.80 4 64089 64970 64369669
Blood bilirubin increased 49.03 13.80 147 63946 57406 64377233
Hypoxia 48.74 13.80 195 63898 87954 64346685
Cross sensitivity reaction 48.19 13.80 34 64059 3333 64431306
Stress 48.18 13.80 3 64090 60531 64374108
Dyspnoea 47.99 13.80 470 63623 718204 63716435
Acute hepatic failure 47.92 13.80 90 64003 26022 64408617
Anticonvulsant drug level decreased 47.67 13.80 27 64066 1803 64432836
Blood lactate dehydrogenase increased 47.55 13.80 103 63990 32975 64401664
Discomfort 47.53 13.80 11 64082 80867 64353772
Haemodynamic instability 47.43 13.80 66 64027 14846 64419793
Contraindicated product administered 47.30 13.80 24 64069 107805 64326834
Enterococcal sepsis 47.29 13.80 30 64063 2464 64432175
Hepatomegaly 46.80 13.80 70 64023 16812 64417827
Systemic lupus erythematosus 46.73 13.80 10 64083 77602 64357037
Vision blurred 46.20 13.80 16 64077 90300 64344339
Hypofibrinogenaemia 45.68 13.80 26 64067 1752 64432887
Endocarditis 45.02 13.80 51 64042 9327 64425312
Migraine 44.70 13.80 5 64088 62672 64371967
Pneumococcal sepsis 44.46 13.80 23 64070 1281 64433358
Leukocytosis 43.78 13.80 108 63985 37632 64397007
Pleural effusion 43.59 13.80 244 63849 126315 64308324
Infusion related reaction 43.39 13.80 60 64033 164407 64270232
Anuria 43.38 13.80 72 64021 18892 64415747
Syncope 43.12 13.80 56 64037 157579 64277060
Cytomegalovirus infection 42.67 13.80 106 63987 37093 64397546
Dry mouth 42.63 13.80 5 64088 60413 64374226
Escherichia infection 42.20 13.80 63 64030 15105 64419534
Nephropathy toxic 42.10 13.80 68 64025 17446 64417193
Abdominal pain upper 41.22 13.80 69 64024 174961 64259678
Dermatitis bullous 40.83 13.80 55 64038 11999 64422640
Hospitalisation 40.82 13.80 12 64081 75195 64359444
Dermatitis exfoliative generalised 40.68 13.80 39 64054 5877 64428762
Death 40.56 13.80 297 63796 482408 63952231
Heart rate decreased 40.28 13.80 4 64089 55063 64379576
Sleep disorder 39.61 13.80 6 64087 59703 64374936
Nosocomial infection 39.55 13.80 27 64066 2510 64432129
Blood alkaline phosphatase increased 39.07 13.80 134 63959 56145 64378494
Unevaluable event 38.74 13.80 3 64090 50486 64384153
Type IV hypersensitivity reaction 38.72 13.80 30 64063 3392 64431247
Oedema peripheral 38.41 13.80 96 63997 210221 64224418
Coronary artery disease 38.03 13.80 7 64086 60426 64374213
Liver disorder 37.89 13.80 128 63965 53223 64381416
Cerebrovascular accident 37.50 13.80 49 64044 137534 64297105
Dehydration 37.25 13.80 102 63991 216661 64217978
Bronchitis 37.16 13.80 32 64061 108711 64325928
Alanine aminotransferase increased 37.12 13.80 251 63842 138780 64295859
Oliguria 36.97 13.80 58 64035 14518 64420121
Eosinophilic pneumonia 36.95 13.80 33 64060 4544 64430095
Vomiting 36.90 13.80 360 63733 550757 63883882
Respiratory distress 36.67 13.80 125 63968 52206 64382433
Mobility decreased 36.32 13.80 20 64073 85820 64348819
Dyspnoea exertional 36.12 13.80 14 64079 73716 64360923
Venoocclusive liver disease 35.92 13.80 47 64046 9968 64424671
Nocardiosis 35.80 13.80 33 64060 4734 64429905
Hyperferritinaemia 35.79 13.80 15 64078 514 64434125
Musculoskeletal pain 35.79 13.80 18 64075 81276 64353363
Pericarditis 35.76 13.80 9 64084 62507 64372132
Respiratory tract infection bacterial 35.40 13.80 17 64076 806 64433833
Blood pressure systolic increased 35.12 13.80 4 64089 49449 64385190
Sputum increased 35.02 13.80 29 64064 3606 64431033
Shock haemorrhagic 34.78 13.80 61 64032 16730 64417909
CNS ventriculitis 34.68 13.80 13 64080 330 64434309
Metabolic acidosis 34.55 13.80 151 63942 70807 64363832
Drug hypersensitivity 34.43 13.80 121 63972 237694 64196945
Immune effector cell-associated neurotoxicity syndrome 34.37 13.80 25 64068 2570 64432069
Brain oedema 34.35 13.80 71 64022 22004 64412635
Incorrect dose administered 34.27 13.80 9 64084 60756 64373883
Gamma-glutamyltransferase increased 34.10 13.80 116 63977 48394 64386245
Peritonitis 33.80 13.80 76 64017 24947 64409692
Rhinorrhoea 33.60 13.80 9 64084 59960 64374679
Enterococcus test positive 33.45 13.80 21 64072 1694 64432945
Hyperlactacidaemia 33.44 13.80 32 64061 4812 64429827
Influenza 33.29 13.80 34 64059 106497 64328142
Blood cholesterol increased 33.28 13.80 5 64088 50061 64384578
Chest discomfort 33.05 13.80 40 64053 116066 64318573
Gastrooesophageal reflux disease 32.89 13.80 21 64072 83122 64351517
Weissella infection 32.80 13.80 7 64086 17 64434622
Meningitis candida 32.75 13.80 10 64083 132 64434507
Somnolence 32.67 13.80 99 63994 203546 64231093
Drug level increased 32.65 13.80 91 64002 34105 64400534
Hepatosplenomegaly 32.61 13.80 33 64060 5310 64429329
Perinephric abscess 32.32 13.80 11 64082 209 64434430
Balance disorder 32.11 13.80 22 64071 83904 64350735
Toxic encephalopathy 32.05 13.80 44 64049 9771 64424868
Suicidal ideation 32 13.80 13 64080 66529 64368110
Neutropenic sepsis 31.79 13.80 71 64022 23201 64411438
Fungal sepsis 31.58 13.80 20 64073 1638 64433001
Nasal congestion 31.50 13.80 10 64083 59648 64374991
Neck pain 31.30 13.80 11 64082 61522 64373117
Hyperamylasaemia 31.20 13.80 16 64077 875 64433764
Hypersensitivity 31.16 13.80 96 63997 196356 64238283
Graft versus host disease 31.00 13.80 52 64041 13761 64420878
Tumour lysis syndrome 30.81 13.80 63 64030 19377 64415262
Seizure 30.52 13.80 276 63817 166616 64268023
Hepatotoxicity 30.27 13.80 98 63995 39864 64394775
Injection site reaction 30.25 13.80 5 64088 46659 64387980
Anaemia 30.11 13.80 536 63557 378144 64056495
Multiple sclerosis relapse 30.05 13.80 3 64090 41132 64393507
Dry skin 29.98 13.80 7 64086 51154 64383485
Influenza like illness 29.76 13.80 12 64081 61690 64372949
Constipation 29.75 13.80 122 63971 229215 64205424
Fluid retention 29.73 13.80 11 64082 59595 64375044
Pruritus 29.28 13.80 186 63907 312214 64122425
Cardiac valve vegetation 28.95 13.80 15 64078 838 64433801
Ototoxicity 28.93 13.80 23 64070 2700 64431939
Cholangitis 28.82 13.80 44 64049 10758 64423881
Cryptococcal meningoencephalitis 28.81 13.80 10 64083 202 64434437
Hyperammonaemia 28.79 13.80 42 64051 9862 64424777
Haemorrhagic pneumonia 28.79 13.80 9 64084 129 64434510
Scedosporium infection 28.67 13.80 17 64076 1237 64433402
Excessive eye blinking 28.60 13.80 17 64076 1243 64433396
Megacolon 28.48 13.80 24 64069 3058 64431581
Granulocyte count decreased 28.40 13.80 17 64076 1259 64433380
Hypertension 28.25 13.80 147 63946 259114 64175525
Increased bronchial secretion 28.07 13.80 23 64070 2819 64431820
Portal fibrosis 27.87 13.80 13 64080 577 64434062
Pneumonia pseudomonal 27.61 13.80 29 64064 4874 64429765
Hypernatraemia 27.51 13.80 46 64047 12143 64422496
Helicobacter infection 27.50 13.80 3 64090 38359 64396280
Immunosuppressant drug level increased 27.50 13.80 35 64058 7224 64427415
ADAMTS13 activity decreased 27.43 13.80 9 64084 152 64434487
Clostridial sepsis 27.36 13.80 14 64079 762 64433877
Neutrophil count decreased 27.34 13.80 150 63943 77046 64357593
Vascular pseudoaneurysm thrombosis 27.02 13.80 7 64086 48 64434591
Staphylococcal sepsis 26.89 13.80 47 64046 12852 64421787
Burning sensation 26.81 13.80 8 64085 49656 64384983
Paraesthesia 26.46 13.80 59 64034 134463 64300176
Blood fibrinogen decreased 26.31 13.80 17 64076 1441 64433198
Intentional product misuse 26.29 13.80 20 64073 72275 64362364
Enterococcal bacteraemia 26.28 13.80 21 64072 2484 64432155
Dermatitis exfoliative 25.99 13.80 41 64052 10311 64424328
White blood cell count increased 25.93 13.80 132 63961 65882 64368757
Staphylococcus test positive 25.92 13.80 30 64063 5615 64429024
Pyelonephritis fungal 25.90 13.80 8 64085 110 64434529
Device related infection 25.86 13.80 78 64015 30548 64404091
Interleukin-2 receptor increased 25.83 13.80 9 64084 184 64434455
Candida test positive 25.77 13.80 15 64078 1055 64433584
Infective aneurysm 25.73 13.80 14 64079 864 64433775
Respiratory paralysis 25.65 13.80 7 64086 60 64434579
Amnesia 25.65 13.80 8 64085 48261 64386378
Blood glucose increased 25.63 13.80 36 64057 98037 64336602
Renal abscess 25.30 13.80 14 64079 893 64433746
Aortoenteric fistula 25.26 13.80 8 64085 120 64434519
Disseminated cryptococcosis 25.20 13.80 17 64076 1550 64433089
Hypoaesthesia 24.99 13.80 64 64029 139044 64295595
Pseudomonas test positive 24.99 13.80 17 64076 1571 64433068
Motor neurone disease 24.94 13.80 11 64082 428 64434211
Circulatory collapse 24.89 13.80 82 64011 33650 64400989
Urticaria 24.79 13.80 70 64023 147247 64287392
Stoma closure 24.73 13.80 8 64085 129 64434510
Epidermolysis bullosa 24.68 13.80 9 64084 211 64434428
Respiratory gas exchange disorder 24.67 13.80 13 64080 752 64433887
Toxicity to various agents 24.47 13.80 237 63856 363276 64071363
Aspartate aminotransferase increased 24.45 13.80 203 63890 119585 64315054
Osteomyelitis bacterial 24.42 13.80 11 64082 450 64434189
Gait inability 24.42 13.80 6 64087 42362 64392277
Acute myeloid leukaemia recurrent 24.34 13.80 21 64072 2763 64431876
Abdominal compartment syndrome 24.18 13.80 16 64077 1412 64433227
Diabetic macroangiopathy 24.17 13.80 8 64085 139 64434500
Hepatic cytolysis 24.02 13.80 47 64046 14002 64420637
Emphysematous pyelonephritis 23.95 13.80 9 64084 230 64434409
Central nervous system injury 23.71 13.80 8 64085 148 64434491
Hepatitis cholestatic 23.69 13.80 43 64050 12112 64422527
Gastrointestinal disorder 23.38 13.80 33 64060 89676 64344963
Adjusted calcium decreased 23.31 13.80 8 64085 156 64434483
Cytopenia 23.18 13.80 49 64044 15422 64419217
Heart rate increased 23.13 13.80 39 64054 98636 64336003
Flavobacterium infection 23.09 13.80 7 64086 90 64434549
Cataract 23.09 13.80 11 64082 51251 64383388
Angina pectoris 23.03 13.80 8 64085 45073 64389566
Fusarium infection 22.82 13.80 16 64077 1553 64433086
Aspergillus test positive 22.74 13.80 12 64081 696 64433943
Product deposit 22.67 13.80 10 64083 389 64434250
Haemostasis 22.63 13.80 9 64084 269 64434370
Coagulation time prolonged 22.53 13.80 18 64075 2128 64432511
Strongyloidiasis 22.45 13.80 21 64072 3069 64431570
Product prescribing error 22.37 13.80 4 64089 35265 64399374
Nephrogenic diabetes insipidus 22.35 13.80 17 64076 1870 64432769
Hot flush 22.28 13.80 9 64084 46226 64388413
Abscess 22.13 13.80 55 64038 19249 64415390
Blood creatinine increased 22.05 13.80 219 63874 135563 64299076
Injection site swelling 21.71 13.80 7 64086 41346 64393293
Adverse drug reaction 21.67 13.80 9 64084 45455 64389184
Deep vein thrombosis 21.63 13.80 45 64048 105137 64329502
Antinuclear antibody negative 21.55 13.80 5 64088 20 64434619
Dyspepsia 21.47 13.80 29 64064 80283 64354356
Depressed mood 21.43 13.80 7 64086 41005 64393634
Encephalitis 21.43 13.80 42 64051 12529 64422110
Rectal haemorrhage 21.35 13.80 18 64075 61799 64372840
Mediastinitis 21.24 13.80 12 64081 797 64433842
Palpitations 21.23 13.80 45 64048 104443 64330196
Pneumonia klebsiella 21.18 13.80 23 64070 4014 64430625
Hepatic infarction 21.17 13.80 12 64081 802 64433837
Graft versus host disease in gastrointestinal tract 21.17 13.80 27 64066 5585 64429054
Klebsiella bacteraemia 21.17 13.80 18 64075 2322 64432317
Septic embolus 21.15 13.80 16 64077 1746 64432893
COVID-19 pneumonia 21.04 13.80 49 64044 16455 64418184
Red blood cell sedimentation rate increased 21.04 13.80 3 64090 31232 64403407
Meningitis 20.92 13.80 33 64060 8296 64426343
SJS-TEN overlap 20.89 13.80 10 64083 471 64434168
Cardiac disorder 20.86 13.80 15 64078 55801 64378838
Lactic acidosis 20.86 13.80 118 63975 61292 64373347
Aeromonas infection 20.85 13.80 9 64084 332 64434307
Hypoproteinaemia 20.84 13.80 21 64072 3361 64431278
Sepsis syndrome 20.84 13.80 14 64079 1267 64433372
Acidosis 20.71 13.80 51 64042 17744 64416895
Flatulence 20.66 13.80 5 64088 35661 64398978
Overdose 20.61 13.80 85 64008 159481 64275158
Road traffic accident 20.60 13.80 3 64090 30742 64403897
Immune reconstitution inflammatory syndrome 20.46 13.80 41 64052 12429 64422210
Osteonecrosis of jaw 20.46 13.80 7 64086 39818 64394821
Impaired healing 20.41 13.80 18 64075 60455 64374184
Escherichia bacteraemia 20.39 13.80 26 64067 5377 64429262
Hydrocephalus 20.36 13.80 31 64062 7560 64427079
Hepatitis fulminant 20.30 13.80 28 64065 6246 64428393
Nephrolithiasis 20.26 13.80 9 64084 43674 64390965
Disease complication 20.19 13.80 23 64070 4232 64430407
Herpes simplex 20.19 13.80 37 64056 10499 64424140
Splenic injury 20.12 13.80 8 64085 239 64434400
Endotracheal intubation 20.10 13.80 22 64071 3873 64430766
Mixed liver injury 20.09 13.80 26 64067 5455 64429184
Noninfectious peritonitis 20.06 13.80 8 64085 241 64434398
Adenovirus infection 19.99 13.80 30 64063 7225 64427414
Hypokalaemia 19.98 13.80 197 63896 121706 64312933
Lung abscess 19.91 13.80 21 64072 3545 64431094
HIV viraemia 19.73 13.80 6 64087 78 64434561
Extravasation blood 19.72 13.80 9 64084 380 64434259
Venoocclusive disease 19.69 13.80 22 64071 3963 64430676
Serum sickness-like reaction 19.62 13.80 10 64083 540 64434099
Potentiating drug interaction 19.57 13.80 31 64062 7821 64426818
Enterocolitis haemorrhagic 19.50 13.80 16 64077 1964 64432675
Acanthosis 19.35 13.80 9 64084 397 64434242
Chimerism 19.26 13.80 8 64085 268 64434371
Serum ferritin increased 19.16 13.80 32 64061 8436 64426203
Hepatic necrosis 19.15 13.80 32 64061 8441 64426198
Gastroenteritis staphylococcal 19.15 13.80 8 64085 272 64434367
Oropharyngeal pain 19.14 13.80 37 64056 88830 64345809
Meningitis bacterial 19.13 13.80 17 64076 2326 64432313
Hyperchloraemia 19.12 13.80 12 64081 967 64433672
Necrotising fasciitis 19.11 13.80 25 64068 5301 64429338
Endocarditis candida 19.07 13.80 6 64087 88 64434551
Vulvovaginitis 19.04 13.80 8 64085 276 64434363
Encephalitis viral 18.90 13.80 17 64076 2363 64432276
Organising pneumonia 18.89 13.80 33 64060 9022 64425617
Low cardiac output syndrome 18.76 13.80 11 64082 784 64433855
Overgrowth fungal 18.65 13.80 6 64087 95 64434544
Pulmonary alveolar haemorrhage 18.41 13.80 34 64059 9704 64424935
Myocardial calcification 18.31 13.80 5 64088 43 64434596
Abscess neck 18.26 13.80 12 64081 1047 64433592
Vertigo 18.24 13.80 19 64074 58992 64375647
Petechiae 18.21 13.80 50 64043 18576 64416063
Acid base balance abnormal 18.19 13.80 8 64085 309 64434330
White blood cell count decreased 18.15 13.80 238 63855 157599 64277040
Infectious pleural effusion 18.06 13.80 18 64075 2844 64431795
Acute graft versus host disease in intestine 17.96 13.80 20 64073 3589 64431050
Aggression 17.84 13.80 12 64081 46220 64388419
Faeces pale 17.78 13.80 17 64076 2554 64432085
Lower respiratory tract infection bacterial 17.71 13.80 10 64083 664 64433975
Cytokine storm 17.65 13.80 11 64082 876 64433763
Enterobacter infection 17.57 13.80 20 64073 3676 64430963
Urinary tract infection fungal 17.56 13.80 11 64082 884 64433755
Osteoporosis 17.52 13.80 10 64083 42070 64392569
Convulsive threshold lowered 17.51 13.80 11 64082 888 64433751
Guillain-Barre syndrome 17.48 13.80 29 64064 7606 64427033
Radiation fibrosis - lung 17.46 13.80 5 64088 52 64434587
Type 2 diabetes mellitus 17.44 13.80 6 64087 34014 64400625
Metabolic disorder 17.30 13.80 29 64064 7668 64426971
Generalised tonic-clonic seizure 17.29 13.80 82 64011 39775 64394864
Hypotension 17.23 13.80 498 63595 380476 64054163
Relapsing fever 17.22 13.80 8 64085 352 64434287
Mediastinal effusion 17.21 13.80 5 64088 55 64434584
Hypovolaemic shock 17.14 13.80 34 64059 10232 64424407
Hepatitis 17.11 13.80 90 64003 45492 64389147
Mucosal disorder 17.04 13.80 18 64075 3044 64431595
Hyperaemia 17.02 13.80 17 64076 2692 64431947
Resuscitation 16.98 13.80 15 64078 2036 64432603
Hyperpyrexia 16.94 13.80 23 64070 5054 64429585
Dry eye 16.94 13.80 4 64089 29015 64405624
Globulins decreased 16.93 13.80 8 64085 366 64434273
Orthostatic hypotension 16.90 13.80 13 64080 46725 64387914
Ischaemic cerebral infarction 16.85 13.80 15 64078 2057 64432582
Vascular pseudoaneurysm 16.74 13.80 18 64075 3106 64431533
Cognitive disorder 16.73 13.80 18 64075 55069 64379570
Neutrophilic dermatosis 16.68 13.80 9 64084 546 64434093
Bladder irrigation 16.66 13.80 5 64088 62 64434577
Intestinal ischaemia 16.64 13.80 36 64057 11513 64423126
Bacterial sepsis 16.64 13.80 28 64065 7429 64427210
Rectal perforation 16.59 13.80 10 64083 750 64433889
Neuralgia 16.54 13.80 3 64090 26181 64408458
Exfoliative rash 16.54 13.80 19 64074 3527 64431112
Alveolitis necrotising 16.51 13.80 4 64089 20 64434619
Hyperthermia 16.47 13.80 43 64050 15507 64419132
Acute lymphocytic leukaemia 16.44 13.80 21 64072 4350 64430289
Serum sickness 16.44 13.80 18 64075 3171 64431468
Herpes simplex viraemia 16.43 13.80 7 64086 250 64434389
Morganella infection 16.38 13.80 11 64082 995 64433644
Irritability 16.38 13.80 8 64085 36738 64397901
Graft versus host disease in liver 16.34 13.80 13 64080 1528 64433111
Diverticulitis 16.33 13.80 9 64084 38609 64396030
Body temperature decreased 16.32 13.80 3 64090 25925 64408714
Ill-defined disorder 16.25 13.80 12 64081 44040 64390599
Septal panniculitis 16.24 13.80 5 64088 68 64434571
Posterior reversible encephalopathy syndrome 16.24 13.80 55 64038 22891 64411748
Blast cell count increased 16.21 13.80 12 64081 1267 64433372
Organ failure 16.17 13.80 19 64074 3614 64431025
Chest X-ray abnormal 16.14 13.80 26 64067 6655 64427984
Hyperoxaluria 16.08 13.80 7 64086 264 64434375
Hypertransaminasaemia 16.04 13.80 27 64066 7164 64427475
Viral infection 15.91 13.80 8 64085 36132 64398507
Decreased appetite 15.85 13.80 191 63902 281098 64153541
Antibiotic level above therapeutic 15.85 13.80 9 64084 604 64434035
Candida endophthalmitis 15.84 13.80 6 64087 157 64434482
Night sweats 15.83 13.80 8 64085 36038 64398601
Product administration error 15.77 13.80 4 64089 27639 64407000
Ependymitis 15.67 13.80 3 64090 3 64434636
Renal injury 15.66 13.80 42 64051 15387 64419252
Viral haemorrhagic cystitis 15.66 13.80 13 64080 1622 64433017
Cardiovascular insufficiency 15.64 13.80 16 64077 2608 64432031
Abortion spontaneous 15.63 13.80 3 64090 25140 64409499
Cholangiolitis 15.63 13.80 4 64089 26 64434613
Sopor 15.61 13.80 5 64088 29656 64404983
Herpes simplex hepatitis 15.61 13.80 8 64085 437 64434202
Cytomegalovirus enterocolitis 15.60 13.80 12 64081 1343 64433296
Adverse event 15.58 13.80 10 64083 39479 64395160
Rash erythematous 15.57 13.80 92 64001 48541 64386098
Depressed level of consciousness 15.55 13.80 136 63957 81300 64353339
Medication error 15.54 13.80 16 64077 49950 64384689
Mucosal inflammation 15.52 13.80 111 63982 62473 64372166
Ileus paralytic 15.43 13.80 29 64064 8386 64426253
Pollakiuria 15.42 13.80 6 64087 31524 64403115
Splenomegaly 15.41 13.80 46 64047 17915 64416724
Cholangitis infective 15.37 13.80 8 64085 451 64434188
Basilar artery aneurysm 15.37 13.80 4 64089 28 64434611
Intestinal pseudo-obstruction 15.32 13.80 14 64079 1986 64432653
Clostridial infection 15.31 13.80 22 64071 5097 64429542
Haemorrhagic disorder 15.26 13.80 12 64081 1387 64433252
Bacterial infection 15.25 13.80 57 64036 24893 64409746
Pulmonary sepsis 15.23 13.80 17 64076 3058 64431581
Neoplasm malignant 15.23 13.80 3 64090 24685 64409954
Cytomegalovirus test positive 15.22 13.80 22 64071 5122 64429517
Candida pneumonia 15.21 13.80 8 64085 461 64434178
Myasthenia gravis crisis 15.20 13.80 10 64083 874 64433765
Pneumocystis jirovecii pneumonia 15.16 13.80 61 64032 27573 64407066
Perforation 15.07 13.80 11 64082 1137 64433502
Differentiation syndrome 15 13.80 14 64079 2040 64432599
Vitamin K deficiency 14.99 13.80 9 64084 670 64433969
Metabolic alkalosis 14.98 13.80 19 64074 3909 64430730
Cytotoxic oedema 14.92 13.80 7 64086 315 64434324
Cytomegalovirus viraemia 14.75 13.80 33 64060 10795 64423844
Cytomegalovirus infection reactivation 14.73 13.80 23 64070 5733 64428906
Thrombotic microangiopathy 14.61 13.80 43 64050 16612 64418027
Disseminated mucormycosis 14.61 13.80 8 64085 500 64434139
Hyperchlorhydria 14.58 13.80 13 64080 1786 64432853
Graft versus host disease in skin 14.57 13.80 22 64071 5325 64429314
Skin necrosis 14.54 13.80 39 64054 14290 64420349
Speech disorder 14.52 13.80 16 64077 48425 64386214
Colony stimulating factor therapy 14.51 13.80 8 64085 507 64434132
Wound dehiscence 14.38 13.80 23 64070 5851 64428788
Acute graft versus host disease in skin 14.32 13.80 25 64068 6830 64427809
Haemolysis 14.32 13.80 33 64060 11006 64423633
Aspartate aminotransferase 14.31 13.80 6 64087 206 64434433
Blood culture positive 14.28 13.80 27 64066 7841 64426798
Vesicoureteric reflux 14.27 13.80 5 64088 104 64434535
Normocytic anaemia 14.26 13.80 17 64076 3282 64431357
Limb injury 14.20 13.80 3 64090 23502 64411137
Purpura non-thrombocytopenic 14.20 13.80 6 64087 210 64434429
Injury 14.19 13.80 21 64072 55971 64378668
Ear infection 14.12 13.80 3 64090 23401 64411238
Arterial rupture 14.08 13.80 9 64084 749 64433890
Leukoencephalopathy 14.03 13.80 25 64068 6942 64427697
Vanishing bile duct syndrome 14.03 13.80 11 64082 1266 64433373
Hypoglossal nerve paresis 14.01 13.80 5 64088 110 64434529
Refractoriness to platelet transfusion 13.92 13.80 5 64088 112 64434527
Brain herniation 13.87 13.80 24 64069 6509 64428130
Anticonvulsant drug level below therapeutic 13.87 13.80 10 64083 1014 64433625
Acne 13.84 13.80 3 64090 23078 64411561

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 89.67 78.30 35 77 882 83684

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 D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
CHEBI has role CHEBI:36047 antibacterial drugs
CHEBI has role CHEBI:33282 bactericides
CHEBI has role CHEBI:88188 allergenic drug

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
Meningococcal 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
Complicated Skin and Skin Structure Infection indication
E. Coli Peritonitis indication
Peptostreptococcus Peritonitis indication
H. Influenzae Meningitis indication
Klebsiella Complicated Appendicitis indication
Bacteroides 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
Clostridium Perfringens Empyema off-label use
Pseudomonas Respiratory Tract Infection in Cystic Fibrosis off-label use
Diabetic Foot Infection off-label use
Complicated Urinary Tract Infections 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

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 Unclassified 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
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
119478-56-7 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
MERREM IV HUMAN PRESCRIPTION DRUG LABEL 1 0069-0313 INJECTION 500 mg INTRAVENOUS NDA 30 sections
MERREM IV HUMAN PRESCRIPTION DRUG LABEL 1 0069-0314 INJECTION 1 g INTRAVENOUS NDA 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 0409-1390 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 0781-3000 INJECTION 500 mg INTRAVENOUS ANDA 30 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 0781-3098 INJECTION 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 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 55150-207 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 26 sections
Meropenem Human Prescription Drug Label 1 55150-208 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 26 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
Meropenem HUMAN PRESCRIPTION DRUG LABEL 1 68001-324 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 27 sections
MEROPENEM HUMAN PRESCRIPTION DRUG LABEL 1 68001-446 INJECTION 500 mg INTRAVENOUS ANDA 29 sections
MEROPENEM HUMAN PRESCRIPTION DRUG LABEL 1 68001-447 INJECTION 1 g INTRAVENOUS ANDA 29 sections
Meropenem Human Prescription Drug Label 1 68083-146 INJECTION 500 mg INTRAVENOUS ANDA 27 sections
Meropenem Human Prescription Drug Label 1 68083-147 INJECTION 1 g INTRAVENOUS ANDA 27 sections