meropenem 🐶 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 µM/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 683.41 17.94 409 33888 56343 63398382
Septic shock 567.58 17.94 386 33911 66243 63388482
Drug reaction with eosinophilia and systemic symptoms 438.81 17.94 256 34041 33580 63421145
Drug resistance 403.01 17.94 212 34085 22721 63432004
Pathogen resistance 367.17 17.94 136 34161 6262 63448463
Sepsis 291.11 17.94 385 33912 152738 63301987
Respiratory failure 246.18 17.94 289 34008 101569 63353156
Febrile neutropenia 234.57 17.94 304 33993 118145 63336580
Thrombocytopenia 224.76 17.94 338 33959 150819 63303906
Pain 218.62 17.94 65 34232 740563 62714162
Systemic candida 197.33 17.94 72 34225 3173 63451552
Pyrexia 189.93 17.94 621 33676 469857 62984868
Fatigue 175.30 17.94 135 34162 887893 62566832
Arthralgia 173.44 17.94 47 34250 569663 62885062
Bronchopulmonary aspergillosis 166.48 17.94 85 34212 8550 63446175
Acute kidney injury 166.16 17.94 409 33888 263006 63191719
Pancytopenia 161.71 17.94 229 34068 96704 63358021
Toxic epidermal necrolysis 156.57 17.94 121 34176 25213 63429512
Off label use 156.56 17.94 748 33549 673714 62781011
Haemophagocytic lymphohistiocytosis 155.33 17.94 87 34210 10540 63444185
Joint swelling 151.13 17.94 6 34291 327660 63127065
Headache 142.52 17.94 83 34214 633158 62821567
Abdominal discomfort 138.12 17.94 9 34288 320876 63133849
Clostridium difficile colitis 135.37 17.94 102 34195 20467 63434258
Enterococcal infection 119.48 17.94 66 34231 7782 63446943
Rheumatoid arthritis 119.24 17.94 4 34293 253815 63200910
Drug intolerance 118.40 17.94 14 34283 308647 63146078
Neutropenia 115.80 17.94 277 34020 174728 63279997
Candida infection 114.50 17.94 106 34191 28245 63426480
Agranulocytosis 109.38 17.94 98 34199 25036 63429689
Fall 109.07 17.94 38 34259 392296 63062429
Acinetobacter infection 107.05 17.94 38 34259 1545 63453180
Candida sepsis 104.34 17.94 36 34261 1344 63453381
Cytokine release syndrome 103.20 17.94 75 34222 14239 63440486
Shock 103.13 17.94 92 34205 23371 63431354
Dysbiosis 102.27 17.94 32 34265 874 63453851
Drug ineffective for unapproved indication 99.88 17.94 107 34190 33956 63420769
Acute respiratory distress syndrome 98.95 17.94 90 34207 23444 63431281
Nasopharyngitis 98.81 17.94 11 34286 254246 63200479
Eosinophilia 97.59 17.94 88 34209 22668 63432057
Swelling 97.34 17.94 16 34281 275362 63179363
Peripheral swelling 97.31 17.94 14 34283 265928 63188797
Fungaemia 95.02 17.94 39 34258 2364 63452361
Disseminated intravascular coagulation 94.42 17.94 80 34217 18971 63435754
Aspergillus infection 93.78 17.94 57 34240 8036 63446689
Brain abscess 92.78 17.94 37 34260 2081 63452644
Contraindicated product administered 91.01 17.94 7 34290 217641 63237084
Stenotrophomonas infection 90.85 17.94 36 34261 1991 63452734
Klebsiella infection 90.80 17.94 57 34240 8509 63446216
Mucormycosis 88.34 17.94 39 34258 2832 63451893
Drug ineffective 87.49 17.94 903 33394 1043862 62410863
Product dose omission issue 86.50 17.94 12 34285 234301 63220424
Hepatic function abnormal 82.39 17.94 101 34196 37041 63417684
Therapeutic product effect decreased 81.37 17.94 6 34291 193181 63261544
Systemic lupus erythematosus 81.26 17.94 9 34288 208909 63245816
Dizziness 81.12 17.94 68 34229 429857 63024868
Pain in extremity 75.00 17.94 43 34254 331443 63123282
Weight increased 74.60 17.94 24 34273 260768 63193957
Cardiac arrest 73.98 17.94 158 34139 92387 63362338
Renal failure 73.24 17.94 182 34115 117470 63337255
Stevens-Johnson syndrome 72.48 17.94 78 34219 24872 63429853
Pseudomonas infection 72.43 17.94 55 34242 11158 63443567
Sinusitis 72.04 17.94 17 34280 226636 63228089
Pneumonia fungal 69.92 17.94 41 34256 5414 63449311
Rash maculo-papular 69.56 17.94 86 34211 31810 63422915
Wound 68.95 17.94 5 34292 163258 63291467
Musculoskeletal stiffness 66.85 17.94 10 34287 184608 63270117
Alopecia 66.62 17.94 51 34246 337485 63117240
Acute generalised exanthematous pustulosis 66.36 17.94 52 34245 11047 63443678
Renal impairment 63.99 17.94 145 34152 88210 63366515
Drug eruption 63.59 17.94 78 34219 28616 63426109
Lactic acidosis 63.10 17.94 90 34207 38197 63416528
Geotrichum infection 63.09 17.94 19 34278 455 63454270
Muscle spasms 62.58 17.94 6 34291 156144 63298581
Encephalopathy 59.59 17.94 88 34209 38532 63416193
Discomfort 58.49 17.94 10 34287 167364 63287361
Pseudomembranous colitis 58.15 17.94 30 34267 3082 63451643
Depression 58.13 17.94 17 34280 196475 63258250
Immune effector cell-associated neurotoxicity syndrome 57.64 17.94 27 34270 2250 63452475
Leukopenia 57.26 17.94 128 34169 77162 63377563
Systemic inflammatory response syndrome 56.07 17.94 36 34261 5585 63449140
Coagulopathy 55.80 17.94 62 34235 20482 63434243
Pericarditis 55.64 17.94 4 34293 131575 63323150
Asthenia 55.24 17.94 76 34221 383528 63071197
Excessive eye blinking 54.82 17.94 22 34275 1258 63453467
Malaise 54.48 17.94 88 34209 415866 63038859
Acute respiratory failure 53.82 17.94 79 34218 34406 63420319
Weight decreased 53.10 17.94 43 34254 276755 63177970
Haemodynamic instability 52.67 17.94 42 34255 9148 63445577
Neutropenic sepsis 52.39 17.94 54 34243 16384 63438341
Peritonitis 52.25 17.94 55 34242 17099 63437626
Pneumonia 52.20 17.94 423 33874 456344 62998381
Blood bilirubin increased 52.16 17.94 81 34216 37059 63417666
Anaemia 52.13 17.94 303 33994 293127 63161598
Bacteraemia 51.73 17.94 55 34242 17293 63437432
Infusion related reaction 51.14 17.94 35 34262 245486 63209239
Acute myeloid leukaemia 50.49 17.94 54 34243 17093 63437632
Hepatic failure 50.40 17.94 78 34219 35578 63419147
Gait disturbance 50.37 17.94 18 34279 183160 63271565
Insomnia 49.97 17.94 27 34270 215225 63239500
Procalcitonin increased 49.91 17.94 20 34277 1139 63453586
Platelet count decreased 49.89 17.94 157 34140 115965 63338760
Emphysematous pyelonephritis 49.69 17.94 14 34283 263 63454462
Neurotoxicity 49.14 17.94 53 34244 16937 63437788
Mixed liver injury 48.91 17.94 31 34266 4704 63450021
Anuria 48.88 17.94 46 34251 12505 63442220
Linear IgA disease 48.84 17.94 21 34276 1430 63453295
Perinephric abscess 48.82 17.94 13 34284 196 63454529
Hypoxia 47.66 17.94 102 34195 59690 63395035
Acute hepatic failure 47.54 17.94 54 34243 18273 63436452
Drug level decreased 47.12 17.94 37 34260 7882 63446843
Fungal infection 47.08 17.94 77 34220 36797 63417928
Myelosuppression 47.06 17.94 61 34236 23642 63431083
Blood lactate dehydrogenase increased 46.70 17.94 60 34237 23056 63431669
Rhinocerebral mucormycosis 46.60 17.94 15 34282 450 63454275
Multiple-drug resistance 46.42 17.94 31 34266 5139 63449586
Clostridium test positive 46.21 17.94 26 34271 3175 63451550
Enterococcal sepsis 46.02 17.94 20 34277 1398 63453327
Mucosal inflammation 45.69 17.94 87 34210 46841 63407884
Graft versus host disease 45.51 17.94 34 34263 6729 63447996
Hyperbilirubinaemia 45.08 17.94 42 34255 11272 63443453
Hepatic infarction 44.76 17.94 16 34281 664 63454061
Disease progression 44.74 17.94 157 34140 122601 63332124
Contusion 44.33 17.94 13 34284 150031 63304694
Asthma 43.74 17.94 8 34289 127553 63327172
Pleural effusion 42.80 17.94 129 34168 93081 63361644
Oliguria 42.61 17.94 37 34260 9064 63445661
Arthritis 42.60 17.94 6 34291 115915 63338810
Meningitis candida 41.82 17.94 9 34288 50 63454675
Guillain-Barre syndrome 41.49 17.94 26 34271 3867 63450858
Pneumonia bacterial 41.36 17.94 37 34260 9428 63445297
Premature delivery 41.07 17.94 65 34232 30216 63424509
Enterocolitis 41 17.94 34 34263 7824 63446901
Seizure 40.31 17.94 160 34137 132474 63322251
Anxiety 40.22 17.94 35 34262 217506 63237219
Trichosporon infection 40.14 17.94 12 34285 280 63454445
Blood pressure increased 39.59 17.94 19 34278 162043 63292682
Metabolic acidosis 39.56 17.94 80 34217 44989 63409736
Nausea 39.14 17.94 286 34011 854185 62600540
Neutropenic colitis 38.97 17.94 23 34274 3072 63451653
Clostridium difficile infection 38.90 17.94 63 34234 29859 63424866
Anticonvulsant drug level decreased 38.49 17.94 17 34280 1235 63453490
Drug interaction 38.34 17.94 233 34064 228898 63225827
Tumour associated fever 38.27 17.94 12 34285 330 63454395
Hyperlactacidaemia 38.06 17.94 22 34275 2827 63451898
Product deposit 37.45 17.94 11 34286 241 63454484
Bone marrow failure 37.17 17.94 61 34236 29229 63425496
Cytomegalovirus viraemia 37.12 17.94 28 34269 5621 63449104
Weissella infection 37.05 17.94 7 34290 17 63454708
Cholestasis 36.95 17.94 61 34236 29373 63425352
Toxic skin eruption 36.92 17.94 40 34257 12845 63441880
Blood cholesterol increased 36.66 17.94 4 34293 94028 63360697
Factor V inhibition 36.65 17.94 10 34287 166 63454559
Posterior reversible encephalopathy syndrome 36.58 17.94 46 34251 17299 63437426
Hyperchloraemia 35.77 17.94 14 34283 749 63453976
Eosinophilic pneumonia acute 35.68 17.94 12 34285 414 63454311
Toxic encephalopathy 35.44 17.94 29 34268 6550 63448175
Brain oedema 35.42 17.94 41 34256 14154 63440571
Feeling abnormal 35.33 17.94 18 34279 148374 63306351
Hypotension 35.25 17.94 260 34037 272344 63182381
Type IV hypersensitivity reaction 35.09 17.94 21 34276 2877 63451848
Fungal sepsis 35.08 17.94 16 34281 1254 63453471
Migraine 34.33 17.94 7 34290 103339 63351386
Transaminases increased 34.11 17.94 61 34236 31306 63423419
Injection site erythema 33.84 17.94 3 34294 83171 63371554
Umbilical erythema 33.81 17.94 8 34289 72 63454653
Abdominal pain upper 33.78 17.94 37 34260 206407 63248318
Nephropathy toxic 33.62 17.94 33 34264 9446 63445279
Pyelonephritis fungal 33.59 17.94 9 34288 139 63454586
Enterococcal bacteraemia 32.96 17.94 16 34281 1443 63453282
Hyperkalaemia 32.80 17.94 83 34214 54120 63400605
Cytomegalovirus infection 32.69 17.94 48 34249 20904 63433821
Haemorrhage intracranial 32.22 17.94 38 34259 13381 63441344
Escherichia infection 32.10 17.94 37 34260 12717 63442008
Renal abscess 31.84 17.94 13 34284 777 63453948
Alanine aminotransferase increased 31.37 17.94 125 34172 103645 63351080
Dry mouth 31.16 17.94 3 34294 77860 63376865
Urinary tract infection enterococcal 31.15 17.94 19 34278 2694 63452031
Fusarium infection 30.80 17.94 12 34285 634 63454091
Neutrophil count decreased 30.68 17.94 83 34214 56323 63398402
Blood alkaline phosphatase increased 30.51 17.94 70 34227 42897 63411828
Product use in unapproved indication 30.50 17.94 183 34114 178897 63275828
Ejection fraction decreased 30.37 17.94 48 34249 22284 63432441
Abscess neck 30.33 17.94 12 34285 661 63454064
Leukocytosis 30.23 17.94 52 34245 25883 63428842
Cerebral mass effect 30.03 17.94 13 34284 900 63453825
Rash morbilliform 30.00 17.94 20 34277 3305 63451420
Aspartate aminotransferase increased 29.95 17.94 112 34185 90165 63364560
Hydrocephalus 29.90 17.94 24 34273 5276 63449449
Diabetic macroangiopathy 29.77 17.94 8 34289 125 63454600
Aplastic anaemia 29.71 17.94 31 34266 9538 63445187
Hypersensitivity 29.58 17.94 72 34225 292613 63162112
Eosinophilic pneumonia 29.34 17.94 17 34280 2194 63452531
Diffuse large B-cell lymphoma refractory 29.34 17.94 14 34283 1216 63453509
Noninfectious peritonitis 29.26 17.94 8 34289 134 63454591
Hypertransaminasaemia 29.20 17.94 26 34271 6583 63448142
Haemostasis 28.93 17.94 9 34288 241 63454484
Central nervous system injury 28.77 17.94 8 34289 143 63454582
Respiratory distress 28.30 17.94 59 34238 33892 63420833
Colitis 28.01 17.94 73 34224 48455 63406270
Staphylococcal infection 27.97 17.94 66 34231 41190 63413535
Hypernatraemia 27.94 17.94 27 34270 7582 63447143
Drug hypersensitivity 27.93 17.94 81 34216 310606 63144119
Pneumothorax 27.93 17.94 39 34258 16222 63438503
Nosocomial infection 27.65 17.94 15 34282 1706 63453019
Epilepsy 27.36 17.94 51 34246 27014 63427711
Pulmonary haemorrhage 27.35 17.94 26 34271 7155 63447570
Adverse drug reaction 27.32 17.94 5 34292 79709 63375016
Cross sensitivity reaction 27.05 17.94 16 34281 2146 63452579
Mycobacterium abscessus infection 27.02 17.94 11 34286 653 63454072
Adjusted calcium decreased 26.95 17.94 8 34289 182 63454543
Status epilepticus 26.86 17.94 37 34260 15196 63439529
Hyperchlorhydria 26.68 17.94 15 34282 1829 63452896
Inflammatory marker increased 26.50 17.94 25 34272 6814 63447911
Tubulointerstitial nephritis 26.00 17.94 42 34255 19861 63434864
Stress 25.82 17.94 3 34294 67164 63387561
Splenic injury 25.80 17.94 8 34289 212 63454513
Hyperhidrosis 25.79 17.94 13 34284 107823 63346902
Myocardial infarction 25.50 17.94 11 34286 99882 63354843
Musculoskeletal pain 25.47 17.94 9 34288 92268 63362457
CNS ventriculitis 25.45 17.94 7 34290 120 63454605
Venoocclusive liver disease 25.39 17.94 21 34276 4814 63449911
Liver abscess 25.35 17.94 17 34280 2837 63451888
Folate deficiency 25.06 17.94 16 34281 2459 63452266
Clostridial infection 25.01 17.94 20 34277 4372 63450353
Abdominal compartment syndrome 24.73 17.94 10 34287 583 63454142
Intentional overdose 24.67 17.94 5 34292 74147 63380578
Bacterial sepsis 24.65 17.94 19 34278 3939 63450786
Hypoalbuminaemia 24.41 17.94 31 34266 11774 63442951
Haemorrhagic disorder 24.33 17.94 11 34286 845 63453880
Mobility decreased 24.25 17.94 18 34279 121141 63333584
Globulins decreased 24.21 17.94 8 34289 261 63454464
Acid base balance abnormal 24.21 17.94 8 34289 261 63454464
Type 2 diabetes mellitus 24.19 17.94 3 34294 63865 63390860
Enterobacter infection 24.05 17.94 15 34282 2212 63452513
C-reactive protein increased 23.90 17.94 108 34189 94599 63360126
Graft versus host disease in liver 23.74 17.94 10 34287 647 63454078
Compartment syndrome 23.71 17.94 15 34282 2269 63452456
Gamma-glutamyltransferase increased 23.68 17.94 55 34242 33976 63420749
Brain herniation 23.66 17.94 18 34279 3659 63451066
Device related infection 23.55 17.94 44 34253 23348 63431377
Morganella infection 23.54 17.94 10 34287 661 63454064
Hypotonia 23.47 17.94 27 34270 9258 63445467
Wrong technique in product usage process 23.44 17.94 3 34294 62337 63392388
Cytopenia 23.25 17.94 30 34267 11571 63443154
Hyperamylasaemia 23.18 17.94 9 34288 471 63454254
Dermatitis exfoliative generalised 23.11 17.94 18 34279 3789 63450936
Pseudomonal sepsis 23.02 17.94 15 34282 2386 63452339
Neurodevelopmental disorder 23.00 17.94 7 34290 174 63454551
Hyperoxaluria 22.92 17.94 7 34290 176 63454549
Myoclonus 22.82 17.94 35 34262 15833 63438892
Escherichia bacteraemia 22.79 17.94 18 34279 3865 63450860
Venoocclusive disease 22.58 17.94 14 34283 2044 63452681
Generalised tonic-clonic seizure 22.54 17.94 49 34248 28967 63425758
Herpes simplex 22.52 17.94 25 34272 8246 63446479
Liver disorder 22.50 17.94 72 34225 53615 63401110
Overgrowth fungal 22.50 17.94 6 34291 91 63454634
Herpes simplex viraemia 22.47 17.94 8 34289 328 63454397
Vulvovaginitis 22.45 17.94 8 34289 329 63454396
Hospitalisation 22.31 17.94 9 34288 85072 63369653
Thrombotic microangiopathy 22.26 17.94 28 34269 10533 63444192
Endocarditis 22.25 17.94 21 34276 5729 63448996
Impaired healing 22.16 17.94 14 34283 102528 63352197
Relapsing fever 22.14 17.94 7 34290 198 63454527
Hypochromasia 22.11 17.94 8 34289 344 63454381
Acute graft versus host disease in intestine 22.03 17.94 13 34284 1736 63452989
Osteomyelitis bacterial 22.00 17.94 7 34290 202 63454523
Metabolic alkalosis 21.97 17.94 16 34281 3045 63451680
Pneumonia acinetobacter 21.77 17.94 5 34292 39 63454686
Delayed graft function 21.77 17.94 11 34286 1082 63453643
Capillary leak syndrome 21.72 17.94 14 34283 2186 63452539
Antibiotic level above therapeutic 21.63 17.94 8 34289 366 63454359
Injection site reaction 21.56 17.94 3 34294 58521 63396204
Cardiac tamponade 21.52 17.94 19 34278 4756 63449969
Hyperaemia 21.38 17.94 14 34283 2245 63452480
Hypoglossal nerve paresis 21.28 17.94 6 34291 113 63454612
Lung abscess 21.24 17.94 13 34284 1855 63452870
Suicidal ideation 21.21 17.94 4 34293 62417 63392308
Candida endophthalmitis 21.03 17.94 5 34292 46 63454679
Staphylococcal bacteraemia 21.02 17.94 20 34277 5510 63449215
Bronchitis 20.86 17.94 22 34275 124913 63329812
Post infection glomerulonephritis 20.82 17.94 4 34293 11 63454714
Herpes simplex hepatitis 20.77 17.94 8 34289 410 63454315
Ischaemic enteritis 20.75 17.94 5 34292 49 63454676
Exfoliative rash 20.71 17.94 15 34282 2832 63451893
Cerebral haemorrhage 20.65 17.94 49 34248 30680 63424045
Infectious pleural effusion 20.55 17.94 12 34285 1571 63453154
Ureaplasma infection 20.53 17.94 9 34288 642 63454083
Bronchopulmonary dysplasia 20.49 17.94 8 34289 425 63454300
Renal graft infection 20.45 17.94 7 34290 255 63454470
Cytomegalovirus infection reactivation 20.37 17.94 17 34280 3946 63450779
Sepsis syndrome 20.29 17.94 10 34287 932 63453793
Acute myeloid leukaemia recurrent 20.28 17.94 12 34285 1611 63453114
Acute graft versus host disease in skin 20.26 17.94 16 34281 3436 63451289
Amnesia 20.13 17.94 3 34294 55582 63399143
Mediastinal effusion 20.06 17.94 5 34292 57 63454668
Pneumonia pseudomonal 19.93 17.94 14 34283 2519 63452206
Klebsiella bacteraemia 19.91 17.94 12 34285 1666 63453059
Electrocardiogram QT prolonged 19.86 17.94 74 34223 59456 63395269
Abdominal sepsis 19.82 17.94 11 34286 1308 63453417
Anisocytosis 19.69 17.94 9 34288 709 63454016
Cardiogenic shock 19.66 17.94 35 34262 17897 63436828
Somnolence 19.62 17.94 42 34255 178643 63276082
Septal panniculitis 19.53 17.94 5 34292 64 63454661
Hepatosplenomegaly 19.53 17.94 14 34283 2600 63452125
Influenza 19.47 17.94 18 34279 108704 63346021
Cardiac failure congestive 19.46 17.94 13 34284 92420 63362305
Meningitis bacterial 19.45 17.94 11 34286 1356 63453369
Immune reconstitution inflammatory syndrome 19.41 17.94 20 34277 6064 63448661
Acidosis 19.38 17.94 27 34270 11206 63443519
Ill-defined disorder 19.33 17.94 10 34287 81745 63372980
Pneumonia cytomegaloviral 19.22 17.94 13 34284 2201 63452524
Skin exfoliation 19.16 17.94 59 34238 43043 63411682
Cholangitis 19.05 17.94 19 34278 5542 63449183
Pancreatitis acute 19.00 17.94 44 34253 27122 63427603
Oedema peripheral 18.83 17.94 47 34250 189464 63265261
Rhinorrhoea 18.78 17.94 6 34291 65571 63389154
Coagulation test abnormal 18.78 17.94 9 34288 789 63453936
Drug-induced liver injury 18.76 17.94 56 34241 40166 63414559
Pulmonary hypertensive crisis 18.59 17.94 7 34290 337 63454388
Disseminated mucormycosis 18.51 17.94 6 34291 184 63454541
Low birth weight baby 18.48 17.94 21 34276 7108 63447617
Eosinophil count increased 18.46 17.94 26 34271 10902 63443823
Megacolon 18.45 17.94 12 34285 1903 63452822
Blood creatinine increased 18.43 17.94 95 34202 87749 63366976
Serum sickness 18.40 17.94 14 34283 2846 63451879
Cytarabine syndrome 18.27 17.94 5 34292 84 63454641
Blood fibrinogen decreased 18.21 17.94 9 34288 844 63453881
Hyperammonaemia 18.16 17.94 18 34279 5214 63449511
Hepatitis fulminant 18.10 17.94 15 34282 3449 63451276
Incorrect dose administered 18.06 17.94 5 34292 59963 63394762
Systemic mycosis 18.03 17.94 10 34287 1187 63453538
Pulmonary sepsis 18 17.94 11 34286 1565 63453160
Pulmonary alveolar haemorrhage 17.97 17.94 17 34280 4651 63450074
Vision blurred 17.95 17.94 14 34283 91910 63362815

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 572.48 14.90 594 44565 75972 34835800
Septic shock 493.69 14.90 533 44626 71301 34840471
Drug resistance 407.48 14.90 307 44852 25620 34886152
Pathogen resistance 393.75 14.90 208 44951 9274 34902498
Drug ineffective 350.48 14.90 1334 43825 455417 34456355
Drug reaction with eosinophilia and systemic symptoms 340.43 14.90 306 44853 32706 34879066
Bronchopulmonary aspergillosis 235.58 14.90 176 44983 14483 34897289
Off label use 219.10 14.90 1093 44066 418431 34493341
Fatigue 211.53 14.90 108 45051 370545 34541227
Respiratory failure 206.61 14.90 442 44717 108130 34803642
Systemic candida 193.24 14.90 95 45064 3631 34908141
Candida infection 192.02 14.90 169 44990 17546 34894226
Pyrexia 191.05 14.90 892 44267 332121 34579651
Enterococcal infection 182.21 14.90 126 45033 9180 34902592
Sepsis 178.82 14.90 546 44613 166015 34745757
Disseminated intravascular coagulation 172.98 14.90 175 44984 21641 34890131
Dizziness 159.02 14.90 43 45116 218478 34693294
Eosinophilia 151.43 14.90 178 44981 26044 34885728
Haemophagocytic lymphohistiocytosis 147.10 14.90 127 45032 12846 34898926
Drug ineffective for unapproved indication 147.04 14.90 167 44992 23548 34888224
Hepatic function abnormal 145.86 14.90 229 44930 44134 34867638
Fall 136.57 14.90 46 45113 202839 34708933
Klebsiella infection 133.86 14.90 101 45058 8430 34903342
Rash maculo-papular 128.85 14.90 171 44988 28280 34883492
Product dose omission issue 126.22 14.90 7 45152 119704 34792068
Toxic epidermal necrolysis 121.76 14.90 145 45014 21501 34890271
Aspergillus infection 115.31 14.90 108 45051 12146 34899626
Drug abuse 106.97 14.90 5 45154 99091 34812681
Thrombocytopenia 96.87 14.90 429 44730 155818 34755954
Pseudomonas infection 95.71 14.90 98 45061 12284 34899488
Myocardial infarction 95.49 14.90 20 45139 121065 34790707
Trichosporon infection 92.26 14.90 35 45124 699 34911073
Pancytopenia 90.93 14.90 300 44859 94857 34816915
Death 87.64 14.90 246 44913 397803 34513969
Arthralgia 87.43 14.90 56 45103 169985 34741787
Geotrichum infection 85.57 14.90 30 45129 474 34911298
Headache 83.17 14.90 82 45077 200553 34711219
Drug-induced liver injury 81.41 14.90 139 45020 28693 34883079
Acute respiratory distress syndrome 81.10 14.90 131 45028 25838 34885934
Pain 79.94 14.90 88 45071 204587 34707185
Asthenia 76.92 14.90 124 45035 245127 34666645
Dysbiosis 73.21 14.90 27 45132 497 34911275
Febrile neutropenia 71.75 14.90 358 44801 136491 34775281
Mucormycosis 71.08 14.90 60 45099 5882 34905890
Agranulocytosis 70.11 14.90 117 45042 23704 34888068
Clostridium test positive 69.55 14.90 47 45112 3295 34908477
Spinal muscular atrophy 68.88 14.90 24 45135 372 34911400
Bone marrow failure 68.50 14.90 130 45029 29123 34882649
Herpes simplex oesophagitis 67.34 14.90 20 45139 179 34911593
Pseudomembranous colitis 67.21 14.90 43 45116 2748 34909024
Depression 67.02 14.90 21 45138 97077 34814695
Aplastic anaemia 66.36 14.90 72 45087 9644 34902128
Anxiety 66.01 14.90 23 45136 99405 34812367
Cholestasis 65.89 14.90 122 45037 26826 34884946
Pneumococcal sepsis 65.01 14.90 31 45128 1106 34910666
Clostridium difficile colitis 64.31 14.90 90 45069 15640 34896132
Renal impairment 63.46 14.90 266 44893 94247 34817525
Fungaemia 62.92 14.90 40 45119 2528 34909244
Weight decreased 61.21 14.90 83 45076 176218 34735554
Blood pressure increased 60.90 14.90 19 45140 88083 34823689
Pain in extremity 60.55 14.90 45 45114 126468 34785304
Stenotrophomonas infection 59.65 14.90 36 45123 2074 34909698
Nausea 58.93 14.90 233 44926 339675 34572097
Drug eruption 58.91 14.90 98 45061 19800 34891972
Pneumonia bacterial 57.84 14.90 74 45085 11798 34899974
Inappropriate schedule of product administration 56.44 14.90 7 45152 62289 34849483
Joint swelling 53.61 14.90 7 45152 59883 34851889
Sputum increased 53.35 14.90 35 45124 2335 34909437
Systemic mycosis 52.81 14.90 30 45129 1543 34910229
Hepatomegaly 52.54 14.90 66 45093 10330 34901442
Rash morbilliform 51.67 14.90 38 45121 3049 34908723
Gait disturbance 51.08 14.90 23 45136 85117 34826655
Feeling abnormal 50.74 14.90 10 45149 63225 34848547
Clostridium difficile infection 50.58 14.90 89 45070 18809 34892963
Inflammatory marker increased 50.56 14.90 46 45113 4982 34906790
Shock 50.00 14.90 102 45057 24077 34887695
Hyphaema 49.51 14.90 21 45138 566 34911206
Cardiac failure congestive 49.17 14.90 23 45136 83247 34828525
Liver injury 49.12 14.90 77 45082 14801 34896971
Chest pain 48.88 14.90 55 45104 126707 34785065
Hepatic failure 47.45 14.90 124 45035 34407 34877365
Urinary tract infection fungal 47.39 14.90 19 45140 442 34911330
Muscle spasms 47.00 14.90 19 45140 74982 34836790
Rhinocerebral mucormycosis 46.84 14.90 20 45139 548 34911224
Back pain 46.79 14.90 53 45106 121736 34790036
Pulmonary haemorrhage 46.73 14.90 62 45097 10242 34901530
Hyperhidrosis 46.11 14.90 20 45139 75672 34836100
Tachypnoea 46.01 14.90 84 45075 18268 34893504
Dyspnoea 45.96 14.90 292 44867 376490 34535282
Weight increased 45.93 14.90 32 45127 93001 34818771
Myelosuppression 45.57 14.90 86 45073 19179 34892593
Immune effector cell-associated neurotoxicity syndrome 45.46 14.90 38 45121 3675 34908097
Motor neurone disease 45.29 14.90 19 45140 498 34911274
Stoma closure 45.05 14.90 16 45143 263 34911509
Brain abscess 44.64 14.90 35 45124 3090 34908682
Product use in unapproved indication 44.03 14.90 281 44878 117218 34794554
Cardiac disorder 43.98 14.90 3 45156 43123 34868649
Hospitalisation 43.61 14.90 10 45149 56892 34854880
Nasopharyngitis 43.40 14.90 18 45141 69950 34841822
Increased bronchial secretion 42.88 14.90 28 45131 1853 34909919
Pneumothorax 42.42 14.90 83 45076 19009 34892763
Coronary artery disease 42.39 14.90 6 45153 48299 34863473
Cough 41.50 14.90 82 45077 150058 34761714
Leukopenia 41.45 14.90 176 44983 62680 34849092
Syncope 40.64 14.90 35 45124 91416 34820356
Bacteraemia 40.56 14.90 83 45076 19634 34892138
Acinetobacter infection 40.46 14.90 23 45136 1184 34910588
Neutropenia 40.45 14.90 343 44816 156435 34755337
Coagulopathy 40.35 14.90 83 45076 19706 34892066
Cytomegalovirus infection 40.24 14.90 98 45061 26037 34885735
Neutropenic colitis 40.20 14.90 33 45126 3111 34908661
Hypoalbuminaemia 40.18 14.90 63 45096 12111 34899661
Fungal infection 40.02 14.90 73 45086 15862 34895910
Abdominal discomfort 39.42 14.90 14 45145 59821 34851951
Musculoskeletal stiffness 38.26 14.90 7 45152 46673 34865099
Incorrect dose administered 38.08 14.90 4 45155 40511 34871261
Rheumatoid arthritis 38.02 14.90 3 45156 38235 34873537
Rectal haemorrhage 37.76 14.90 4 45155 40245 34871527
Tumour lysis syndrome 37.71 14.90 74 45085 16985 34894787
Ischaemic cerebral infarction 37.13 14.90 22 45137 1225 34910547
Intentional overdose 37.00 14.90 6 45153 43668 34868104
Tubulointerstitial nephritis 36.91 14.90 83 45076 20941 34890831
Lymphadenectomy 36.52 14.90 15 45144 372 34911400
Insomnia 35.93 14.90 49 45110 103858 34807914
Hypofibrinogenaemia 35.77 14.90 24 45135 1662 34910110
Myalgia 35.22 14.90 34 45125 84076 34827696
Portal fibrosis 35.19 14.90 14 45145 319 34911453
Intentional product misuse 34.98 14.90 8 45151 45603 34866169
Procalcitonin increased 34.95 14.90 24 45135 1727 34910045
Treatment failure 34.94 14.90 136 45023 46561 34865211
Enterococcus test positive 34.84 14.90 20 45139 1049 34910723
Hyperferritinaemia 34.41 14.90 15 45144 433 34911339
Therapeutic product effect decreased 33.79 14.90 3 45156 34740 34877032
Strongyloidiasis 33.72 14.90 28 45131 2683 34909089
Condition aggravated 33.72 14.90 388 44771 191808 34719964
Vision blurred 33.43 14.90 9 45150 45954 34865818
Cytokine release syndrome 33.33 14.90 84 45075 22793 34888979
Hypoxia 33.07 14.90 150 45009 54945 34856827
Ototoxicity 32.99 14.90 24 45135 1893 34909879
Lower respiratory tract infection bacterial 32.80 14.90 15 45144 486 34911286
Wrong technique in product usage process 32.70 14.90 4 45155 35982 34875790
Leukocytosis 32.63 14.90 86 45073 23979 34887793
Dehydration 32.56 14.90 75 45084 129894 34781878
Disseminated cryptococcosis 32.50 14.90 21 45138 1365 34910407
Intestinal ischaemia 32.46 14.90 45 45114 7749 34904023
Hypertension 32.38 14.90 81 45078 136362 34775410
Endocarditis 32.37 14.90 41 45118 6470 34905302
Acute kidney injury 32.27 14.90 563 44596 304425 34607347
Respiratory tract infection bacterial 32.25 14.90 23 45136 1759 34910013
Acute myeloid leukaemia 31.93 14.90 72 45087 18198 34893574
Encephalopathy 31.59 14.90 109 45050 35210 34876562
Disease complication 31.44 14.90 27 45132 2709 34909063
Enterocolitis 31.44 14.90 45 45114 7981 34903791
Balance disorder 31.44 14.90 7 45152 40647 34871125
Eosinophilic pneumonia 31.29 14.90 30 45129 3471 34908301
Constipation 31.22 14.90 83 45076 136899 34774873
Staphylococcal sepsis 31.19 14.90 50 45109 9794 34901978
Aortoenteric fistula 31.11 14.90 10 45149 119 34911653
Acute generalised exanthematous pustulosis 31.07 14.90 41 45118 6735 34905037
C-reactive protein increased 30.78 14.90 145 45014 53953 34857819
Chest X-ray abnormal 30.75 14.90 33 45126 4365 34907407
Pseudo-Bartter syndrome 30.68 14.90 7 45152 18 34911754
Dyspnoea exertional 30.50 14.90 9 45150 43270 34868502
Respiratory gas exchange disorder 30.48 14.90 14 45145 458 34911314
Circulatory collapse 30.39 14.90 77 45082 20961 34890811
Cryptococcal meningoencephalitis 30.38 14.90 10 45149 129 34911643
Hepatitis cholestatic 30.31 14.90 44 45115 7903 34903869
Venoocclusive liver disease 30.23 14.90 44 45115 7922 34903850
CNS ventriculitis 30.06 14.90 12 45147 276 34911496
Drug intolerance 30.04 14.90 20 45139 59550 34852222
Cross sensitivity reaction 29.92 14.90 20 45139 1377 34910395
Bronchial disorder 29.84 14.90 20 45139 1383 34910389
Peripheral swelling 29.71 14.90 33 45126 76508 34835264
Chronic obstructive pulmonary disease 29.67 14.90 13 45146 48905 34862867
Aggression 29.55 14.90 7 45152 38957 34872815
Toxicity to various agents 29.38 14.90 146 45013 200216 34711556
Hepatotoxicity 29.35 14.90 77 45082 21408 34890364
Cerebrovascular accident 29.31 14.90 40 45119 84771 34827001
Serum sickness-like reaction 29.31 14.90 10 45149 145 34911627
Blood glucose increased 29.07 14.90 26 45133 66692 34845080
Blood bilirubin increased 29.03 14.90 112 45047 38184 34873588
Lung consolidation 28.91 14.90 37 45122 5899 34905873
Liver abscess 28.60 14.90 30 45129 3865 34907907
Oedema peripheral 28.53 14.90 71 45088 119741 34792031
Gastrooesophageal reflux disease 28.39 14.90 7 45152 37917 34873855
Nocardiosis 28.25 14.90 30 45129 3921 34907851
Acute respiratory failure 28.14 14.90 96 45063 30832 34880940
Metabolic disorder 27.96 14.90 31 45128 4252 34907520
Stevens-Johnson syndrome 27.74 14.90 69 45090 18570 34893202
Epidermolysis bullosa 27.42 14.90 9 45150 115 34911657
Renal failure 27.26 14.90 273 44886 130284 34781488
Arthritis 27.25 14.90 4 45155 31342 34880430
Dyspepsia 27.07 14.90 7 45152 36725 34875047
Haemodynamic instability 26.98 14.90 46 45113 9477 34902295
Resuscitation 26.86 14.90 19 45140 1434 34910338
Aspergillus test positive 26.80 14.90 13 45146 482 34911290
Platelet count decreased 26.78 14.90 254 44905 119463 34792309
Pneumonia fungal 26.63 14.90 39 45120 7061 34904711
Anal inflammation 26.38 14.90 18 45141 1282 34910490
Neurotoxicity 26.10 14.90 66 45093 17944 34893828
Dermatitis bullous 25.93 14.90 38 45121 6884 34904888
Injection site pain 25.91 14.90 9 45150 38996 34872776
Granulocyte count decreased 25.90 14.90 15 45144 800 34910972
Dry mouth 25.88 14.90 4 45155 30161 34881611
Suicidal ideation 25.68 14.90 10 45149 40378 34871394
Transient ischaemic attack 25.26 14.90 3 45156 27610 34884162
Vascular pseudoaneurysm thrombosis 25.20 14.90 7 45152 48 34911724
Staphylococcal infection 24.98 14.90 96 45063 32664 34879108
Pneumonia pseudomonal 24.94 14.90 28 45131 3894 34907878
Asthma 24.83 14.90 12 45147 42644 34869128
Contusion 24.83 14.90 8 45151 36356 34875416
Hypokalaemia 24.80 14.90 144 45015 58070 34853702
Paraesthesia 24.54 14.90 28 45131 64144 34847628
COVID-19 pneumonia 24.40 14.90 62 45097 16905 34894867
Staphylococcus test positive 24.22 14.90 25 45134 3161 34908611
Rectal perforation 24.18 14.90 12 45147 468 34911304
Acute hepatic failure 24.08 14.90 55 45104 14019 34897753
Chest discomfort 24.06 14.90 21 45138 54509 34857263
Cardiac valve vegetation 23.92 14.90 12 45147 479 34911293
Nephrogenic diabetes insipidus 23.79 14.90 17 45142 1304 34910468
Mechanical ventilation 23.78 14.90 20 45139 1950 34909822
Heart rate decreased 23.49 14.90 6 45153 31739 34880033
Epilepsy 23.44 14.90 71 45088 21424 34890348
Aeromonas infection 23.42 14.90 10 45149 274 34911498
Vomiting 23.37 14.90 206 44953 247415 34664357
Factor V inhibition 23.35 14.90 9 45150 188 34911584
Hypoaesthesia 23.29 14.90 27 45132 61417 34850355
Angina pectoris 23.07 14.90 6 45153 31357 34880415
Multiple-drug resistance 22.95 14.90 31 45128 5208 34906564
Respiratory paralysis 22.88 14.90 7 45152 70 34911702
Faeces pale 22.87 14.90 17 45142 1386 34910386
Disseminated mucormycosis 22.84 14.90 12 45147 528 34911244
Pruritus 22.84 14.90 100 45059 141881 34769891
Vanishing bile duct syndrome 22.83 14.90 15 45144 1003 34910769
SARS-CoV-2 test negative 22.80 14.90 15 45144 1005 34910767
Linear IgA disease 22.77 14.90 18 45141 1608 34910164
Eosinophilic pneumonia acute 22.76 14.90 12 45147 532 34911240
Device related infection 22.76 14.90 61 45098 17176 34894596
Haemorrhagic pneumonia 22.72 14.90 8 45151 128 34911644
Necrotising fasciitis 22.70 14.90 26 45133 3696 34908076
Neck pain 22.59 14.90 3 45156 25346 34886426
Systemic inflammatory response syndrome 22.53 14.90 35 45124 6674 34905098
Transaminases increased 22.45 14.90 81 45078 26742 34885030
Interleukin-2 receptor increased 22.33 14.90 8 45151 135 34911637
Nephrolithiasis 21.94 14.90 6 45153 30327 34881445
Decreased appetite 21.74 14.90 126 45033 166266 34745506
Wound dehiscence 21.68 14.90 24 45135 3287 34908485
Pneumonia 21.64 14.90 617 44542 362010 34549762
Hyperbilirubinaemia 21.63 14.90 59 45100 16784 34894988
Sleep disorder 21.59 14.90 7 45152 31681 34880091
Dysarthria 21.48 14.90 9 45150 34773 34876999
Endotracheal intubation 21.43 14.90 23 45136 3042 34908730
Hyperpyrexia 21.42 14.90 22 45137 2766 34909006
Blood alkaline phosphatase increased 21.08 14.90 88 45071 31087 34880685
Hepatic cytolysis 20.88 14.90 53 45106 14443 34897329
Nosocomial infection 20.70 14.90 15 45144 1176 34910596
Hepatic necrosis 20.64 14.90 25 45134 3769 34908003
Disseminated sporotrichosis 20.45 14.90 5 45154 19 34911753
Infection in an immunocompromised host 20.44 14.90 12 45147 657 34911115
Tremor 20.39 14.90 48 45111 82539 34829233
Alanine aminotransferase increased 20.37 14.90 176 44983 80639 34831133
Antinuclear antibody negative 20.24 14.90 5 45154 20 34911752
Acute myeloid leukaemia recurrent 20.17 14.90 19 45140 2151 34909621
Candida test positive 20.10 14.90 10 45149 392 34911380
Radiation fibrosis - lung 20.05 14.90 5 45154 21 34911751
Fungal sepsis 20.03 14.90 13 45146 851 34910921
Cardiac arrest 20.02 14.90 201 44958 95958 34815814
Mobility decreased 19.92 14.90 7 45152 30121 34881651
Infectious pleural effusion 19.90 14.90 20 45139 2450 34909322
Blood pressure systolic increased 19.79 14.90 3 45156 22949 34888823
Product prescribing error 19.76 14.90 3 45156 22924 34888848
Blood lactate dehydrogenase increased 19.73 14.90 70 45089 22920 34888852
Amnesia 19.69 14.90 5 45154 26558 34885214
Loss of consciousness 19.66 14.90 49 45110 82618 34829154
Hypogonadism 19.55 14.90 19 45140 2236 34909536
Sinusitis 19.43 14.90 15 45144 41387 34870385
Palpitations 19.39 14.90 14 45145 39972 34871800
Shock haemorrhagic 19.01 14.90 44 45115 11310 34900462
Abdominal compartment syndrome 18.87 14.90 13 45146 940 34910832
Infective aneurysm 18.87 14.90 11 45148 594 34911178
Medication error 18.60 14.90 5 45154 25560 34886212
Deep vein thrombosis 18.56 14.90 35 45124 65213 34846559
Cerebral ischaemia 18.52 14.90 31 45128 6291 34905481
Escherichia infection 18.50 14.90 36 45123 8209 34903563
Pneumonia klebsiella 18.37 14.90 22 45137 3278 34908494
Type IV hypersensitivity reaction 18.23 14.90 15 45144 1419 34910353
Chimerism 18.22 14.90 8 45151 235 34911537
Nephropathy toxic 18.10 14.90 46 45113 12542 34899230
Drug interaction 18.06 14.90 400 44759 225546 34686226
Flavobacterium infection 18.05 14.90 6 45153 80 34911692
Myocardial calcification 18.04 14.90 5 45154 34 34911738
Dermatitis exfoliative generalised 17.88 14.90 23 45136 3684 34908088
Toxic skin eruption 17.85 14.90 43 45116 11342 34900430
Hypernatraemia 17.76 14.90 36 45123 8454 34903318
Liver disorder 17.72 14.90 87 45072 32910 34878862
Septic embolus 17.71 14.90 14 45145 1251 34910521
Fungal endocarditis 17.67 14.90 9 45150 371 34911401
Candida sepsis 17.57 14.90 14 45145 1265 34910507
ADAMTS13 activity decreased 17.46 14.90 6 45153 89 34911683
Intra-abdominal fluid collection 17.46 14.90 14 45145 1277 34910495
Mediastinitis 17.45 14.90 11 45148 685 34911087
Dermatitis exfoliative 17.42 14.90 31 45128 6608 34905164
Somnolence 17.41 14.90 79 45080 111037 34800735
Coagulation time prolonged 17.35 14.90 14 45145 1288 34910484
Influenza like illness 17.30 14.90 7 45152 27627 34884145
Anticonvulsant drug level decreased 17.28 14.90 13 45146 1079 34910693
Overdose 17.28 14.90 60 45099 90999 34820773
Anuria 17.12 14.90 40 45119 10345 34901427
Cytomegalovirus test positive 17.03 14.90 23 45136 3863 34907909
Gastrointestinal fungal infection 17.03 14.90 7 45152 174 34911598
Catheter site pain 17.02 14.90 14 45145 1324 34910448
Blood cholesterol increased 17.01 14.90 3 45156 20540 34891232
Oliguria 16.90 14.90 35 45124 8345 34903427
Bilirubin conjugated increased 16.90 14.90 21 45138 3250 34908522
Graft versus host disease 16.66 14.90 40 45119 10529 34901243
Fusarium infection 16.59 14.90 13 45146 1147 34910625
Splenomegaly 16.55 14.90 50 45109 15067 34896705
Brain injury 16.53 14.90 29 45130 6113 34905659
Vascular pseudoaneurysm 16.47 14.90 17 45142 2150 34909622
Graft versus host disease in gastrointestinal tract 16.45 14.90 22 45137 3661 34908111
Neuropathy peripheral 16.38 14.90 54 45105 83209 34828563
Hypoperfusion 16.36 14.90 13 45146 1170 34910602
Conductive deafness 16.36 14.90 8 45151 302 34911470
Arterial angioplasty 16.34 14.90 5 45154 50 34911722
Enterococcal sepsis 16.23 14.90 15 45144 1657 34910115
Hypoproteinaemia 16.23 14.90 17 45142 2187 34909585
Dysphonia 16.22 14.90 5 45154 23378 34888394
Flushing 16.19 14.90 11 45148 32409 34879363
Scoliosis 16.17 14.90 19 45140 2774 34908998
Drug level decreased 16.10 14.90 33 45126 7813 34903959
Adverse drug reaction 15.97 14.90 9 45150 29333 34882439
Corynebacterium infection 15.97 14.90 10 45149 615 34911157
Myasthenia gravis crisis 15.94 14.90 10 45149 617 34911155
Heart rate increased 15.86 14.90 22 45137 46321 34865451
Musculoskeletal pain 15.75 14.90 11 45148 31952 34879820
Respiratory distress 15.69 14.90 89 45070 35576 34876196
Soft tissue necrosis 15.61 14.90 8 45151 334 34911438
Alveolitis necrotising 15.47 14.90 4 45155 20 34911752
Red blood cell sedimentation rate decreased 15.44 14.90 5 45154 61 34911711
Potentiating drug interaction 15.38 14.90 25 45134 4952 34906820
Lung infiltration 15.38 14.90 44 45115 12861 34898911
Cholangiolitis 15.31 14.90 4 45155 21 34911751
Agitation 15.28 14.90 32 45127 57367 34854405
Cholestatic liver injury 15.24 14.90 17 45142 2347 34909425
Megacolon 15.22 14.90 15 45144 1795 34909977
Acute myocardial infarction 15.11 14.90 29 45130 53690 34858082
Motor dysfunction 15.10 14.90 30 45129 6944 34904828
Scedosporium infection 15.08 14.90 11 45148 871 34910901
Abdominal pain upper 15.03 14.90 45 45114 71445 34840327
Hepatitis 15.02 14.90 66 45093 23838 34887934
Fluid retention 15.00 14.90 8 45151 26879 34884893
Red blood cell schistocytes present 14.99 14.90 7 45152 238 34911534
Abdominal infection 14.98 14.90 15 45144 1830 34909942
Hepatosplenic candidiasis 14.96 14.90 7 45152 239 34911533
Gamma-glutamyltransferase increased 14.94 14.90 76 45083 29155 34882617
Cryptococcosis 14.92 14.90 17 45142 2402 34909370

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 1163.22 14.06 936 73754 119310 79550388
Septic shock 972.80 14.06 852 73838 121949 79547749
Drug resistance 781.78 14.06 489 74201 41724 79627974
Drug reaction with eosinophilia and systemic symptoms 751.06 14.06 560 74130 63684 79606014
Pathogen resistance 711.83 14.06 321 74369 14021 79655677
Drug ineffective 468.40 14.06 2121 72569 1078792 78590906
Sepsis 411.60 14.06 829 73861 268599 79401099
Respiratory failure 394.89 14.06 650 74040 180261 79489437
Bronchopulmonary aspergillosis 379.51 14.06 245 74445 22049 79647649
Pyrexia 361.11 14.06 1420 73270 677289 78992409
Off label use 355.70 14.06 1731 72959 905484 78764214
Fatigue 350.99 14.06 220 74470 929507 78740191
Pain 311.97 14.06 135 74555 703667 78966031
Systemic candida 307.20 14.06 142 74548 6564 79663134
Enterococcal infection 306.42 14.06 188 74502 15472 79654226
Thrombocytopenia 292.84 14.06 717 73973 264542 79405156
Haemophagocytic lymphohistiocytosis 292.81 14.06 207 74483 21630 79648068
Candida infection 277.89 14.06 253 74437 37961 79631737
Arthralgia 275.84 14.06 96 74594 571707 79097991
Headache 261.38 14.06 144 74546 653628 79016070
Disseminated intravascular coagulation 250.31 14.06 232 74458 35610 79634088
Eosinophilia 250.25 14.06 258 74432 45087 79624611
Toxic epidermal necrolysis 248.47 14.06 255 74435 44326 79625372
Fall 243.61 14.06 77 74613 487552 79182146
Dizziness 237.79 14.06 98 74592 526343 79143355
Drug ineffective for unapproved indication 225.92 14.06 259 74431 50979 79618719
Pancytopenia 224.62 14.06 486 74204 165259 79504439
Febrile neutropenia 223.23 14.06 594 74096 230405 79439293
Joint swelling 221.42 14.06 12 74678 288634 79381064
Klebsiella infection 220.02 14.06 153 74537 15567 79654131
Hepatic function abnormal 206.14 14.06 296 74394 72811 79596887
Aspergillus infection 201.59 14.06 157 74533 19004 79650694
Rash maculo-papular 186.62 14.06 246 74444 55832 79613866
Pseudomonas infection 185.40 14.06 155 74535 20748 79648950
Rheumatoid arthritis 175.95 14.06 4 74686 208466 79461232
Product dose omission issue 170.74 14.06 17 74673 247520 79422178
Clostridium difficile colitis 167.93 14.06 178 74512 32105 79637593
Agranulocytosis 164.67 14.06 207 74483 44823 79624875
Abdominal discomfort 158.70 14.06 23 74667 250704 79418994
Acute kidney injury 158.48 14.06 927 73763 518477 79151221
Drug intolerance 156.53 14.06 29 74661 264090 79405608
Acute respiratory distress syndrome 153.91 14.06 198 74492 43869 79625829
Pain in extremity 153.24 14.06 75 74615 364463 79305235
Nasopharyngitis 152.35 14.06 27 74663 253854 79415844
Mucormycosis 148.86 14.06 95 74595 8374 79661324
Acinetobacter infection 146.83 14.06 65 74625 2712 79666986
Dysbiosis 140.13 14.06 50 74640 1169 79668529
Geotrichum infection 138.87 14.06 47 74643 934 79668764
Clostridium test positive 132.71 14.06 80 74610 6374 79663324
Drug abuse 130.44 14.06 5 74685 162686 79507012
Peripheral swelling 130.20 14.06 45 74645 269572 79400126
Nausea 127.52 14.06 465 74225 956731 78712967
Renal impairment 126.08 14.06 379 74311 157404 79512294
Trichosporon infection 125.99 14.06 44 74646 964 79668734
Brain abscess 124.87 14.06 70 74620 4866 79664832
Neutropenia 124.85 14.06 567 74123 287143 79382555
Weight increased 124.44 14.06 52 74638 277334 79392364
Fungaemia 124.07 14.06 68 74622 4523 79665175
Therapeutic product effect decreased 121.99 14.06 8 74682 163855 79505843
Pseudomembranous colitis 119.33 14.06 70 74620 5304 79664394
Asthenia 116.84 14.06 187 74503 511502 79158196
Stenotrophomonas infection 116.31 14.06 61 74629 3712 79665986
Swelling 115.82 14.06 30 74660 216681 79453017
Blood pressure increased 115.39 14.06 28 74662 211332 79458366
Cytokine release syndrome 112.22 14.06 153 74537 35845 79633853
Shock 110.71 14.06 168 74522 43380 79626318
Clostridium difficile infection 108.99 14.06 165 74525 42520 79627178
Musculoskeletal stiffness 108.54 14.06 17 74673 174991 79494707
Depression 108.48 14.06 34 74656 216756 79452942
Anxiety 104.56 14.06 51 74639 248461 79421237
Bone marrow failure 103.76 14.06 178 74512 50929 79618769
Sinusitis 102.69 14.06 28 74662 195473 79474225
Drug eruption 101.25 14.06 162 74528 43773 79625925
Weight decreased 97.99 14.06 113 74577 355085 79314613
Leukopenia 97.93 14.06 285 74405 116228 79553470
Immune effector cell-associated neurotoxicity syndrome 96.38 14.06 63 74627 5785 79663913
Hepatic failure 96.30 14.06 191 74499 61021 79608677
Gait disturbance 96.15 14.06 37 74653 207469 79462229
Muscle spasms 95.66 14.06 23 74667 174707 79494991
Aplastic anaemia 93.59 14.06 99 74591 17806 79651892
Alopecia 93.56 14.06 50 74640 231305 79438393
Cholestasis 92.31 14.06 171 74519 51938 79617760
Rhinocerebral mucormycosis 90.75 14.06 35 74655 1023 79668675
Myocardial infarction 90.13 14.06 30 74660 184099 79485599
Injection site pain 89.26 14.06 9 74681 129829 79539869
Feeling abnormal 89.04 14.06 20 74670 159179 79510519
Drug-induced liver injury 88.43 14.06 193 74497 65924 79603774
Memory impairment 87.66 14.06 4 74686 111730 79557968
Pneumonia fungal 84.96 14.06 76 74614 11134 79658564
Contusion 84.61 14.06 18 74672 148758 79520940
Bacteraemia 83.96 14.06 127 74563 32697 79637001
Encephalopathy 83.70 14.06 191 74499 67206 79602492
Coagulopathy 83.29 14.06 133 74557 35873 79633825
Neutropenic colitis 83.27 14.06 57 74633 5650 79664048
Cardiac arrest 82.80 14.06 350 74340 171746 79497952
Wound 82.68 14.06 7 74683 116172 79553526
Myelosuppression 82.65 14.06 141 74549 40155 79629543
Pneumonia bacterial 82.29 14.06 96 74594 19235 79650463
Rash morbilliform 81.73 14.06 58 74632 6092 79663606
Insomnia 81.52 14.06 66 74624 245104 79424594
Candida sepsis 81.39 14.06 42 74648 2471 79667227
Acute generalised exanthematous pustulosis 80.75 14.06 90 74600 17164 79652534
Renal failure 79.71 14.06 386 74304 200582 79469116
Systemic lupus erythematosus 79.25 14.06 10 74680 121139 79548559
Arthritis 78.87 14.06 8 74682 114872 79554826
Pneumothorax 78.79 14.06 114 74576 28209 79641489
Discomfort 78.34 14.06 12 74678 125605 79544093
Stevens-Johnson syndrome 77.65 14.06 135 74555 39031 79630667
Procalcitonin increased 77.05 14.06 43 74647 2963 79666735
Spinal muscular atrophy 76.04 14.06 24 74666 379 79669319
Inflammatory marker increased 75.88 14.06 70 74620 10670 79659028
Platelet count decreased 75.84 14.06 372 74318 194292 79475406
Infusion related reaction 75.28 14.06 63 74627 230174 79439524
Fungal infection 75.20 14.06 138 74552 41610 79628088
Malaise 73.86 14.06 225 74465 489644 79180054
Asthma 73.51 14.06 18 74672 135077 79534621
Systemic inflammatory response syndrome 71.99 14.06 70 74620 11395 79658303
Psoriasis 70.96 14.06 3 74687 89584 79580114
Acute respiratory failure 70.92 14.06 166 74524 59375 79610323
Pneumonia 70.62 14.06 935 73755 659311 79010387
Lung consolidation 70.48 14.06 62 74628 8885 79660813
Tubulointerstitial nephritis 69.64 14.06 127 74563 38108 79631590
Product use in unapproved indication 69.18 14.06 436 74254 249923 79419775
Leukocytosis 68.83 14.06 136 74554 43319 79626379
Neurotoxicity 68.30 14.06 115 74575 32403 79637295
Cytomegalovirus infection 68.20 14.06 134 74556 42510 79627188
Hypoalbuminaemia 67.10 14.06 91 74599 21206 79648492
Hyperhidrosis 66.93 14.06 29 74661 151463 79518235
Intentional overdose 66.35 14.06 10 74680 105950 79563748
Multiple-drug resistance 65.34 14.06 59 74631 8749 79660949
Herpes simplex oesophagitis 65.15 14.06 21 74669 356 79669342
Enterocolitis 65.02 14.06 74 74616 14438 79655260
Linear IgA disease 64.85 14.06 39 74651 3093 79666605
Acute myeloid leukaemia 64.57 14.06 109 74581 30776 79638922
Hypoxia 63.52 14.06 227 74463 103016 79566682
Dry mouth 63.47 14.06 5 74685 88014 79581684
Systemic mycosis 62.57 14.06 36 74654 2630 79667068
Blood bilirubin increased 62.49 14.06 169 74521 66063 79603635
Stress 61.96 14.06 3 74687 79609 79590089
Inappropriate schedule of product administration 61.59 14.06 24 74666 133604 79536094
Tachypnoea 61.59 14.06 109 74581 31954 79637744
Hyperbilirubinaemia 61.48 14.06 94 74596 24424 79645274
Toxic skin eruption 60.95 14.06 89 74601 22204 79647494
Pericarditis 60.52 14.06 12 74678 104224 79565474
Haemodynamic instability 60.51 14.06 78 74612 17304 79652394
Hyphaema 60.48 14.06 25 74665 879 79668819
Staphylococcal infection 60.35 14.06 154 74536 58141 79611557
Drug interaction 60.34 14.06 624 74066 414559 79255139
Pneumococcal sepsis 60.32 14.06 30 74660 1632 79668066
Migraine 60.30 14.06 6 74684 87487 79582211
Acute hepatic failure 59.95 14.06 104 74586 30009 79639689
Blood cholesterol increased 59.69 14.06 5 74685 83715 79585983
Contraindicated product administered 58.08 14.06 38 74652 157500 79512198
Blood lactate dehydrogenase increased 57.76 14.06 119 74571 39051 79630647
Pulmonary haemorrhage 57.55 14.06 70 74620 14647 79655051
Eosinophilic pneumonia 56.91 14.06 44 74646 5266 79664432
Factor V inhibition 56.88 14.06 19 74671 362 79669336
Abdominal pain upper 56.64 14.06 76 74614 223743 79445955
Epilepsy 56.60 14.06 121 74569 40739 79628959
Anticonvulsant drug level decreased 56.03 14.06 30 74660 1904 79667794
Dyspnoea 55.75 14.06 524 74166 856501 78813197
Cardiac failure congestive 54.35 14.06 33 74657 142369 79527329
Drug level decreased 53.90 14.06 67 74623 14335 79655363
Liver abscess 53.90 14.06 45 74645 6009 79663689
Cough 53.44 14.06 171 74519 366618 79303080
Helicobacter infection 53.07 14.06 3 74687 69701 79599997
Chest pain 52.99 14.06 116 74574 282188 79387510
Eosinophilic pneumonia acute 52.63 14.06 24 74666 1074 79668624
Endocarditis 52.57 14.06 57 74633 10540 79659158
Back pain 52.28 14.06 131 74559 304049 79365649
Injection site erythema 52.26 14.06 6 74684 78191 79591507
Vision blurred 52.25 14.06 17 74673 105881 79563817
Anuria 52.04 14.06 80 74610 20883 79648815
Transaminases increased 51.82 14.06 135 74555 51608 79618090
Sleep disorder 51.59 14.06 9 74681 85668 79584030
Enterococcal sepsis 51.47 14.06 32 74658 2694 79667004
Mobility decreased 51.46 14.06 25 74665 122150 79547548
Wrong technique in product usage process 51.08 14.06 5 74685 73870 79595828
CNS ventriculitis 50.48 14.06 18 74672 420 79669278
Hospitalisation 50.40 14.06 13 74677 94223 79575475
C-reactive protein increased 49.81 14.06 246 74444 128781 79540917
Oliguria 48.84 14.06 68 74622 16241 79653457
Type IV hypersensitivity reaction 48.57 14.06 36 74654 4045 79665653
Stoma closure 48.49 14.06 16 74674 293 79669405
Motor neurone disease 48.21 14.06 19 74671 589 79669109
Tumour lysis syndrome 48.08 14.06 83 74607 23856 79645842
Myalgia 48.02 14.06 62 74628 185579 79484119
Nephropathy toxic 48.01 14.06 76 74614 20343 79649355
Escherichia infection 47.91 14.06 71 74619 17946 79651752
Blood pressure systolic increased 47.75 14.06 4 74686 66982 79602716
Syncope 47.39 14.06 59 74631 179390 79490308
Pleural effusion 47.17 14.06 264 74426 144998 79524700
Cross sensitivity reaction 47.01 14.06 34 74656 3678 79666020
Perinephric abscess 46.89 14.06 15 74675 248 79669450
Sputum increased 46.79 14.06 37 74653 4576 79665122
Musculoskeletal pain 46.15 14.06 19 74671 102335 79567363
Nocardiosis 46.03 14.06 40 74650 5639 79664059
Heart rate decreased 45.51 14.06 6 74684 70310 79599388
Hepatomegaly 45.41 14.06 71 74619 18803 79650895
Hypertension 45 14.06 159 74531 330833 79338865
Drug hypersensitivity 44.48 14.06 138 74552 298778 79370920
Hypofibrinogenaemia 44.24 14.06 26 74664 1976 79667722
Incorrect dose administered 44.11 14.06 9 74681 76621 79593077
Nosocomial infection 43.02 14.06 29 74661 2803 79666895
Dyspnoea exertional 42.91 14.06 14 74676 87059 79582639
Venoocclusive liver disease 42.83 14.06 54 74636 11717 79657981
Paraesthesia 42.48 14.06 62 74628 176261 79493437
Device related infection 42.36 14.06 97 74593 34197 79635501
Oedema peripheral 42.30 14.06 110 74580 252178 79417520
Pruritus 41.64 14.06 209 74481 394439 79275259
Dry skin 41.25 14.06 7 74683 67988 79601710
Urinary tract infection fungal 41.18 14.06 20 74670 1033 79668665
Disseminated mucormycosis 41.13 14.06 18 74672 730 79668968
Fusarium infection 41.03 14.06 24 74666 1808 79667890
Respiratory distress 40.89 14.06 134 74556 58205 79611493
Pneumonia pseudomonal 40.74 14.06 38 74652 5873 79663825
Dermatitis bullous 40.59 14.06 58 74632 14187 79655511
Chest discomfort 40.12 14.06 42 74648 138002 79531696
Nasal congestion 40.10 14.06 11 74679 76541 79593157
Infectious pleural effusion 40.07 14.06 31 74659 3713 79665985
Blood alkaline phosphatase increased 40.02 14.06 141 74549 63523 79606175
Peritonitis 39.96 14.06 84 74606 27952 79641746
Brain oedema 39.92 14.06 79 74611 25184 79644514
Metabolic acidosis 39.77 14.06 168 74522 82361 79587337
Rhinorrhoea 39.73 14.06 11 74679 76063 79593635
Dermatitis exfoliative generalised 39.56 14.06 41 74649 7200 79662498
Dehydration 39.51 14.06 111 74579 248076 79421622
Hypoaesthesia 39.47 14.06 67 74623 179285 79490413
Coronary artery disease 39.15 14.06 7 74683 65467 79604231
Hypersensitivity 39.06 14.06 121 74569 262118 79407580
Balance disorder 39.01 14.06 22 74668 98835 79570863
Emphysematous pyelonephritis 38.85 14.06 14 74676 337 79669361
Increased bronchial secretion 38.81 14.06 29 74661 3298 79666400
Alanine aminotransferase increased 38.75 14.06 273 74417 162297 79507401
Abdominal compartment syndrome 38.64 14.06 22 74668 1575 79668123
Circulatory collapse 38.46 14.06 99 74591 37569 79632129
Mixed liver injury 38.01 14.06 41 74649 7537 79662161
Unevaluable event 37.81 14.06 4 74686 55581 79614117
Meningitis candida 37.55 14.06 11 74679 133 79669565
Neck pain 37.39 14.06 12 74678 75405 79594293
Urticaria 37.35 14.06 73 74617 185128 79484570
Strongyloidiasis 36.84 14.06 30 74660 3868 79665830
Graft versus host disease 36.82 14.06 57 74633 14969 79654729
Impaired healing 36.81 14.06 18 74672 87637 79582061
Bronchitis 36.58 14.06 41 74649 130603 79539095
Intentional product misuse 36.38 14.06 22 74668 95143 79574555
Enterococcal bacteraemia 36.37 14.06 27 74663 3041 79666657
Suicidal ideation 36.36 14.06 13 74677 76327 79593371
Neutropenic sepsis 36.17 14.06 79 74611 26985 79642713
Cerebrovascular accident 36.05 14.06 56 74634 155236 79514462
Seizure 36.02 14.06 301 74389 188533 79481165
Influenza 35.93 14.06 41 74649 129565 79540133
Vomiting 35.92 14.06 425 74265 665403 79004295
Gait inability 35.89 14.06 6 74684 58911 79610787
Constipation 35.83 14.06 140 74550 282910 79386788
Disseminated cryptococcosis 35.82 14.06 22 74668 1812 79667886
Respiratory tract infection bacterial 35.76 14.06 23 74667 2054 79667644
Megacolon 35.38 14.06 28 74662 3467 79666231
COVID-19 pneumonia 34.97 14.06 81 74609 28768 79640930
Hyperferritinaemia 34.94 14.06 16 74674 723 79668975
Anaemia 34.89 14.06 598 74092 444417 79225281
Staphylococcal sepsis 34.88 14.06 55 74635 14671 79655027
Excessive eye blinking 34.75 14.06 21 74669 1680 79668018
Neutrophil count decreased 34.74 14.06 177 74513 93782 79575916
Toxic encephalopathy 34.70 14.06 48 74642 11392 79658306
Gastrooesophageal reflux disease 34.70 14.06 28 74662 104218 79565480
Injection site reaction 34.68 14.06 5 74685 54780 79614918
Hepatitis cholestatic 34.57 14.06 53 74637 13799 79655899
Shock haemorrhagic 34.48 14.06 65 74625 19995 79649703
Type 2 diabetes mellitus 34.39 14.06 6 74684 57116 79612582
Somnolence 34.37 14.06 112 74578 238869 79430829
Staphylococcus test positive 34.16 14.06 36 74654 6445 79663253
Liver disorder 33.80 14.06 146 74544 72271 79597427
Hepatic cytolysis 33.75 14.06 77 74613 27074 79642624
Fungal sepsis 33.34 14.06 21 74669 1809 79667889
Weissella infection 33.21 14.06 7 74683 17 79669681
Amnesia 33.15 14.06 9 74681 63048 79606650
Aortoenteric fistula 32.60 14.06 10 74680 143 79669555
Multiple sclerosis relapse 32.57 14.06 3 74687 46530 79623168
Hepatosplenomegaly 32.50 14.06 34 74656 6035 79663663
Gastrointestinal disorder 32.44 14.06 40 74650 122165 79547533
Drug level increased 32.33 14.06 96 74594 39555 79630143
Red blood cell sedimentation rate increased 32.05 14.06 3 74687 45939 79623759
Dyspepsia 31.66 14.06 33 74657 108654 79561044
Cardiac valve vegetation 31.62 14.06 16 74674 903 79668795
Hypernatraemia 31.54 14.06 52 74638 14399 79655299
Fluid retention 31.40 14.06 13 74677 69796 79599902
Vanishing bile duct syndrome 31.38 14.06 20 74670 1758 79667940
Hyperlactacidaemia 31.14 14.06 32 74658 5563 79664135
Lower respiratory tract infection bacterial 31.03 14.06 16 74674 940 79668758
Hyperamylasaemia 31.02 14.06 17 74673 1130 79668568
Gamma-glutamyltransferase increased 30.90 14.06 117 74573 54563 79615135
Enterococcus test positive 30.66 14.06 21 74669 2083 79667615
Intestinal ischaemia 30.66 14.06 49 74641 13221 79656477
Cholangitis 30.65 14.06 48 74642 12728 79656970
Immunosuppressant drug level increased 30.63 14.06 40 74650 8987 79660711
Ototoxicity 30.53 14.06 25 74665 3249 79666449
Immune reconstitution inflammatory syndrome 30.47 14.06 50 74640 13791 79655907
Nephrogenic diabetes insipidus 30.39 14.06 21 74669 2113 79667585
Klebsiella bacteraemia 30.22 14.06 24 74666 2986 79666712
Blood glucose increased 30.14 14.06 38 74652 114937 79554761
Ill-defined disorder 30.07 14.06 12 74678 65863 79603835
Brain herniation 30.00 14.06 36 74654 7427 79662271
Death 30.00 14.06 363 74327 566151 79103547
Bronchial disorder 29.72 14.06 22 74668 2467 79667231
Scedosporium infection 29.56 14.06 18 74672 1460 79668238
Liver injury 29.44 14.06 118 74572 56496 79613202
Ischaemic cerebral infarction 29.36 14.06 22 74668 2513 79667185
Haemorrhagic pneumonia 29.26 14.06 9 74681 130 79669568
Hepatotoxicity 29.12 14.06 110 74580 51242 79618456
Adverse event 29.11 14.06 10 74680 60204 79609494
Tumour associated fever 29.08 14.06 15 74675 882 79668816
Renal abscess 29.01 14.06 16 74674 1077 79668621
Enterobacter infection 28.91 14.06 28 74662 4534 79665164
Disease complication 28.87 14.06 29 74661 4908 79664790
Adverse drug reaction 28.85 14.06 13 74677 66379 79603319
Candida test positive 28.84 14.06 16 74674 1090 79668608
Hepatic infarction 28.79 14.06 15 74675 900 79668798
Blood creatinine increased 28.42 14.06 245 74445 154812 79514886
Pneumonia klebsiella 28.30 14.06 29 74661 5025 79664673
Aspergillus test positive 28.11 14.06 14 74676 764 79668934
Serum sickness 28.07 14.06 25 74665 3641 79666057
Portal fibrosis 27.97 14.06 13 74677 608 79669090
Serum ferritin increased 27.92 14.06 40 74650 9807 79659891
Burning sensation 27.90 14.06 10 74680 58622 79611076
White blood cell count increased 27.87 14.06 141 74549 74492 79595206
Acute myeloid leukaemia recurrent 27.77 14.06 24 74666 3359 79666339
Road traffic accident 27.61 14.06 4 74686 43660 79626038
Anal inflammation 27.54 14.06 17 74673 1413 79668285
Flavobacterium infection 27.44 14.06 8 74682 95 79669603
Infective aneurysm 27.43 14.06 15 74675 993 79668705
Cryptococcal meningoencephalitis 27.40 14.06 10 74680 250 79669448
Knee arthroplasty 27.26 14.06 4 74686 43244 79626454
Cataract 27.25 14.06 12 74678 62108 79607590
Palpitations 27.21 14.06 48 74642 126562 79543136
Blood fibrinogen decreased 27.08 14.06 19 74671 1960 79667738
Hyperammonaemia 27.06 14.06 42 74648 11051 79658647
Vascular pseudoaneurysm thrombosis 26.72 14.06 7 74683 54 79669644
Hydrocephalus 26.48 14.06 37 74653 8863 79660835
Dermatitis exfoliative 26.42 14.06 41 74649 10788 79658910
ADAMTS13 activity decreased 26.40 14.06 9 74681 183 79669515
Endotracheal intubation 26.39 14.06 27 74663 4670 79665028
Urinary tract infection enterococcal 26.29 14.06 23 74667 3272 79666426
Granulocyte count decreased 26.24 14.06 18 74672 1790 79667908
Relapsing fever 26.16 14.06 11 74679 404 79669294
Angina pectoris 26.06 14.06 8 74682 51724 79617974
Medication error 26.05 14.06 16 74674 68626 79601072
Pseudomonas test positive 25.85 14.06 18 74672 1834 79667864
Product deposit 25.67 14.06 12 74678 569 79669129
Lactic acidosis 25.63 14.06 132 74558 70227 79599471
Mucosal inflammation 25.61 14.06 139 74551 75441 79594257
Hyperpyrexia 25.50 14.06 30 74660 6062 79663636
Clostridial sepsis 25.47 14.06 14 74676 936 79668762
Herpes simplex 25.45 14.06 43 74647 12144 79657554
Decreased appetite 25.43 14.06 202 74488 342216 79327482
Muscle injury 25.39 14.06 7 74683 48554 79621144
Staphylococcal bacteraemia 25.37 14.06 43 74647 12175 79657523
Abscess 25.18 14.06 62 74628 22889 79646809
Cryptococcosis 25.13 14.06 23 74667 3470 79666228
Exfoliative rash 25.05 14.06 24 74666 3835 79665863
Epidermolysis bullosa 24.88 14.06 9 74681 219 79669479
Heart rate increased 24.84 14.06 47 74643 120677 79549021
Flatulence 24.63 14.06 5 74685 42719 79626979
Osteomyelitis bacterial 24.58 14.06 11 74679 471 79669227
Hypokalaemia 24.54 14.06 224 74466 143816 79525882
Pyelonephritis fungal 24.47 14.06 9 74681 230 79669468
Diabetic macroangiopathy 24.37 14.06 8 74682 144 79669554
Hepatitis fulminant 24.36 14.06 32 74658 7230 79662468
Lymphadenectomy 24.33 14.06 15 74675 1244 79668454
Respiratory paralysis 24.18 14.06 7 74683 81 79669617
Hypoproteinaemia 24.09 14.06 24 74666 4022 79665676
Respiratory gas exchange disorder 24.09 14.06 13 74677 838 79668860
Interleukin-2 receptor increased 24.08 14.06 9 74681 241 79669457
Cardiac disorder 24.04 14.06 16 74674 65741 79603957
Necrotising fasciitis 24.02 14.06 29 74661 6021 79663677
Oropharyngeal pain 23.91 14.06 41 74649 109312 79560386
Pseudo-Bartter syndrome 23.87 14.06 7 74683 85 79669613
Cytomegalovirus viraemia 23.87 14.06 43 74647 12778 79656920
Central nervous system injury 23.82 14.06 8 74682 155 79669543
Folliculitis 23.82 14.06 11 74679 55369 79614329
Aspartate aminotransferase increased 23.82 14.06 216 74474 138425 79531273
Aeromonas infection 23.82 14.06 10 74680 366 79669332
Resuscitation 23.78 14.06 19 74671 2385 79667313
Meningitis bacterial 23.68 14.06 20 74670 2712 79666986
Rectal haemorrhage 23.56 14.06 22 74668 76278 79593420
Depressed mood 23.53 14.06 8 74682 48472 79621226
Intentional product use issue 23.48 14.06 69 74621 152043 79517655
Acidosis 23.42 14.06 55 74635 19707 79649991
Rectal perforation 23.34 14.06 13 74677 892 79668806
Premature delivery 23.26 14.06 61 74629 23406 79646292
SARS-CoV-2 test negative 23.16 14.06 15 74675 1356 79668342
Meningitis 22.99 14.06 36 74654 9546 79660152
Differentiation syndrome 22.96 14.06 19 74671 2505 79667193
Bacterial sepsis 22.80 14.06 33 74657 8165 79661533
Metabolic disorder 22.77 14.06 35 74655 9135 79660563
Injection site swelling 22.49 14.06 8 74682 47124 79622574
Organ failure 22.33 14.06 23 74667 4010 79665688
Chest X-ray abnormal 22.32 14.06 32 74658 7851 79661847
Nephrolithiasis 22.29 14.06 11 74679 53280 79616418
Hypertransaminasaemia 22.21 14.06 40 74650 11884 79657814
Ear infection 22.13 14.06 3 74687 34429 79635269
Pulmonary alveolar haemorrhage 22.06 14.06 39 74651 11418 79658280
Graft versus host disease in liver 22.06 14.06 16 74674 1738 79667960
Hypogonadism 22.01 14.06 16 74674 1744 79667954
Petechiae 21.98 14.06 55 74635 20510 79649188
Antinuclear antibody negative 21.84 14.06 5 74685 20 79669678
Posterior reversible encephalopathy syndrome 21.78 14.06 64 74626 26217 79643481
Sepsis syndrome 21.77 14.06 15 74675 1502 79668196
Influenza like illness 21.76 14.06 21 74669 71686 79598012
Status epilepticus 21.73 14.06 62 74628 24979 79644719
Chorioretinitis 21.66 14.06 13 74677 1027 79668671
Stomatitis 21.63 14.06 68 74622 146689 79523009
Mechanical ventilation 21.46 14.06 19 74671 2745 79666953
Osteoporosis 21.40 14.06 12 74678 54100 79615598
Graft versus host disease in gastrointestinal tract 21.31 14.06 28 74662 6328 79663370
Adjusted calcium decreased 21.30 14.06 8 74682 217 79669481
Disease progression 21.24 14.06 265 74425 184097 79485601
Feeling hot 21.21 14.06 15 74675 59719 79609979
Mediastinitis 21.17 14.06 12 74678 852 79668846
Coagulation time prolonged 21.09 14.06 18 74672 2477 79667221
Encephalitis 20.77 14.06 44 74646 14716 79654982
Surgery 20.72 14.06 3 74687 32763 79636935
Clostridial infection 20.45 14.06 26 74664 5688 79664010
Noninfectious peritonitis 20.27 14.06 8 74682 249 79669449
Cytopenia 20.22 14.06 53 74637 20330 79649368
Interstitial lung disease 20.15 14.06 177 74513 112423 79557275
Haemostasis 19.94 14.06 9 74681 393 79669305
Dry eye 19.93 14.06 5 74685 36926 79632772
Ascites 19.84 14.06 130 74560 75432 79594266
Septic embolus 19.84 14.06 16 74674 2035 79667663
Splenic injury 19.83 14.06 8 74682 264 79669434
Condition aggravated 19.63 14.06 611 74079 500513 79169185
Cytomegalovirus test positive 19.63 14.06 26 74664 5921 79663777
Therapy interrupted 19.52 14.06 3 74687 31338 79638360
Extravasation blood 19.48 14.06 9 74681 415 79669283
Mucosal disorder 19.32 14.06 20 74670 3508 79666190
Guillain-Barre syndrome 19.21 14.06 32 74658 8933 79660765
Lung infiltration 19.18 14.06 56 74634 22856 79646842
Hypotension 19.18 14.06 544 74146 439773 79229925
Chimerism 19.18 14.06 8 74682 288 79669410
Aggression 19.17 14.06 12 74678 50946 79618752
Escherichia bacteraemia 19.11 14.06 27 74663 6535 79663163
Joint range of motion decreased 18.96 14.06 4 74686 33278 79636420
Vulvovaginitis 18.95 14.06 8 74682 297 79669401
Overgrowth fungal 18.94 14.06 6 74684 96 79669602
Injury 18.90 14.06 27 74663 77469 79592229
Enterocolitis haemorrhagic 18.89 14.06 16 74674 2178 79667520
HIV viraemia 18.88 14.06 6 74684 97 79669601
Gastroenteritis staphylococcal 18.87 14.06 8 74682 300 79669398
Pseudomonal sepsis 18.87 14.06 26 74664 6148 79663550
Hepatic necrosis 18.86 14.06 32 74658 9068 79660630
Serum sickness-like reaction 18.82 14.06 10 74680 625 79669073
Acute graft versus host disease in intestine 18.77 14.06 21 74669 4020 79665678
Anticonvulsant drug level below therapeutic 18.68 14.06 12 74678 1069 79668629
Pneumonia acinetobacter 18.64 14.06 7 74683 190 79669508
Myocardial calcification 18.60 14.06 5 74685 43 79669655
Encephalitis viral 18.59 14.06 17 74673 2562 79667136
Lung abscess 18.47 14.06 21 74669 4091 79665607
Cognitive disorder 18.44 14.06 23 74667 69903 79599795
Venoocclusive disease 18.29 14.06 22 74668 4551 79665147
Hyperchloraemia 18.29 14.06 12 74678 1109 79668589
Potentiating drug interaction 18.26 14.06 31 74659 8788 79660910
Electrocardiogram QT prolonged 18.25 14.06 146 74544 90240 79579458
Organising pneumonia 18.25 14.06 35 74655 10904 79658794
Endocarditis candida 18.18 14.06 6 74684 110 79669588
Acanthosis 18.09 14.06 9 74681 490 79669208
Blast cell count increased 18.05 14.06 13 74677 1397 79668301
Angioedema 18.04 14.06 27 74663 76008 79593690
Toxicity to various agents 18.01 14.06 282 74408 421258 79248440
Arterial angioplasty 17.93 14.06 5 74685 50 79669648
Disseminated sporotrichosis 17.93 14.06 5 74685 50 79669648
Adenovirus infection 17.90 14.06 30 74660 8417 79661281
Viral infection 17.81 14.06 9 74681 43007 79626691
Renal injury 17.81 14.06 45 74645 16882 79652816
Product administration error 17.80 14.06 4 74686 31842 79637856
Neoplasm malignant 17.77 14.06 4 74686 31806 79637892
Hypoglossal nerve paresis 17.74 14.06 6 74684 119 79669579
Viral haemorrhagic cystitis 17.69 14.06 15 74675 2046 79667652
Drug dependence 17.69 14.06 8 74682 40761 79628937
Product prescribing error 17.64 14.06 10 74680 44803 79624895
Convulsive threshold lowered 17.58 14.06 11 74679 936 79668762
Orthostatic hypotension 17.57 14.06 16 74674 56148 79613550
Abscess neck 17.57 14.06 12 74678 1185 79668513
Muscular weakness 17.56 14.06 84 74606 160645 79509053
Radiation fibrosis - lung 17.50 14.06 5 74685 55 79669643
Acid base balance abnormal 17.42 14.06 8 74682 364 79669334
Antibiotic level above therapeutic 17.39 14.06 10 74680 730 79668968
Intervertebral discitis 17.33 14.06 22 74668 4806 79664892
Mediastinal effusion 17.18 14.06 5 74685 59 79669639
Conductive deafness 17.16 14.06 7 74683 238 79669460
SJS-TEN overlap 17.15 14.06 10 74680 749 79668949
Pneumocystis jirovecii pneumonia 17.10 14.06 68 74622 32440 79637258
Diverticulitis 17.03 14.06 11 74679 45925 79623773
Vesicoureteric reflux 16.99 14.06 6 74684 136 79669562
Liver function test abnormal 16.98 14.06 111 74579 64364 79605334
Overdose 16.95 14.06 102 74588 184104 79485594
Ischaemic hepatitis 16.95 14.06 19 74671 3645 79666053
Urinary tract candidiasis 16.93 14.06 10 74680 767 79668931
Bacterial infection 16.91 14.06 66 74624 31214 79638484
Acute lymphocytic leukaemia 16.83 14.06 22 74668 4947 79664751
Ischaemic enteritis 16.83 14.06 6 74684 140 79669558
Sopor 16.81 14.06 5 74685 33005 79636693
Bladder irrigation 16.81 14.06 5 74685 64 79669634
Alveolitis necrotising 16.75 14.06 4 74686 20 79669678
Hot flush 16.74 14.06 16 74674 54861 79614837
Pollakiuria 16.70 14.06 7 74683 37310 79632388
Haemolysis 16.67 14.06 37 74653 12775 79656923
Burkholderia pseudomallei infection 16.67 14.06 5 74685 66 79669632
Refractoriness to platelet transfusion 16.67 14.06 6 74684 144 79669554
Neutrophilic dermatosis 16.67 14.06 9 74681 581 79669117
Faeces pale 16.65 14.06 17 74673 2933 79666765
Low cardiac output syndrome 16.59 14.06 11 74679 1034 79668664
Therapeutic response decreased 16.59 14.06 23 74667 66830 79602868
Atelectasis 16.58 14.06 67 74623 32190 79637508
Cytokine storm 16.58 14.06 11 74679 1035 79668663
Amylase increased 16.46 14.06 34 74656 11175 79658523
Haemorrhage intracranial 16.45 14.06 58 74632 26135 79643563
Generalised tonic-clonic seizure 16.42 14.06 83 74607 43827 79625871
Corynebacterium infection 16.36 14.06 12 74678 1326 79668372
Disseminated trichosporonosis 16.36 14.06 6 74684 152 79669546
Depressed level of consciousness 16.30 14.06 150 74540 96502 79573196
Treatment noncompliance 16.22 14.06 15 74675 52253 79617445
Cytomegalovirus enterocolitis 16.20 14.06 13 74677 1642 79668056
Body temperature decreased 16.14 14.06 5 74685 32140 79637558
Chronic obstructive pulmonary disease 16.08 14.06 35 74655 85384 79584314
Acne 16.05 14.06 3 74687 27187 79642511
Acinetobacter bacteraemia 16.04 14.06 7 74683 282 79669416
Herpes simplex viraemia 15.95 14.06 8 74682 443 79669255
Hepatitis 15.95 14.06 98 74592 55629 79614069
Cytomegalovirus infection reactivation 15.93 14.06 29 74661 8687 79661011
Limb injury 15.93 14.06 4 74686 29524 79640174
Hyperaemia 15.90 14.06 17 74673 3093 79666605
Vascular pseudoaneurysm 15.89 14.06 18 74672 3492 79666206
Capillary leak syndrome 15.89 14.06 19 74671 3906 79665792
Cholangiolitis 15.86 14.06 4 74686 26 79669672
Abdominal pain 15.84 14.06 263 74427 389306 79280392
Morganella infection 15.84 14.06 11 74679 1116 79668582
White blood cell count decreased 15.80 14.06 256 74434 188032 79481666
Pregnancy 15.77 14.06 3 74687 26848 79642850
Tracheobronchitis 15.76 14.06 14 74676 2032 79667666
Splenomegaly 15.75 14.06 49 74641 20705 79648993
Candida endophthalmitis 15.73 14.06 6 74684 170 79669528
Retroperitoneal haematoma 15.73 14.06 22 74668 5275 79664423
Perforation 15.68 14.06 12 74678 1414 79668284
Thrombotic microangiopathy 15.66 14.06 48 74642 20121 79649577
Globulins decreased 15.62 14.06 8 74682 463 79669235
Hyperchlorhydria 15.57 14.06 14 74676 2065 79667633
Pulmonary mucormycosis 15.51 14.06 11 74679 1154 79668544
Dehiscence 15.51 14.06 6 74684 177 79669521
Skin laceration 15.47 14.06 4 74686 28958 79640740
Hypovolaemic shock 15.46 14.06 35 74655 12241 79657457
Neuralgia 15.37 14.06 6 74684 33378 79636320
Pneumonia cytomegaloviral 15.30 14.06 21 74669 4948 79664750
Hyperoxaluria 15.29 14.06 7 74683 316 79669382
Device related bacteraemia 15.21 14.06 9 74681 693 79669005
Intracranial infection 15.18 14.06 5 74685 91 79669607
Haemothorax 15.16 14.06 22 74668 5456 79664242
Altered state of consciousness 15.12 14.06 81 74609 43741 79625957
Ileus paralytic 15.10 14.06 30 74660 9590 79660108
Pulmonary sepsis 15.08 14.06 18 74672 3694 79666004
Upper respiratory tract infection 15.07 14.06 40 74650 91128 79578570
Weaning failure 15.05 14.06 9 74681 706 79668992
Irritability 15.05 14.06 10 74680 41134 79628564
Hyperthermia 15.02 14.06 44 74646 17993 79651705
Vertigo 15.01 14.06 26 74664 69056 79600642
Night sweats 14.96 14.06 16 74674 52079 79617619
Metastases to liver 14.96 14.06 4 74686 28310 79641388
Basilar artery aneurysm 14.92 14.06 4 74686 34 79669664
Vitamin K deficiency 14.90 14.06 9 74681 719 79668979
Ocular hyperaemia 14.87 14.06 4 74686 28202 79641496
Gastrointestinal fungal infection 14.85 14.06 8 74682 514 79669184
Colony stimulating factor therapy 14.82 14.06 8 74682 516 79669182
Cardiovascular insufficiency 14.73 14.06 16 74674 2965 79666733
Post infection glomerulonephritis 14.70 14.06 5 74685 101 79669597
Cytarabine syndrome 14.70 14.06 5 74685 101 79669597
Acute graft versus host disease in skin 14.66 14.06 26 74664 7632 79662066
Splenic embolism 14.65 14.06 6 74684 206 79669492
Haemorrhagic disorder 14.61 14.06 12 74678 1566 79668132
Cerebral mass effect 14.60 14.06 13 74677 1893 79667805
Ecthyma 14.59 14.06 9 74681 747 79668951
Purpura non-thrombocytopenic 14.54 14.06 6 74684 210 79669488
Herpes simplex hepatitis 14.53 14.06 8 74682 537 79669161
Respiratory alkalosis 14.47 14.06 19 74671 4292 79665406
Renal graft infection 14.46 14.06 8 74682 542 79669156
Ulcer 14.45 14.06 5 74685 29967 79639731
Pseudomonal bacteraemia 14.29 14.06 16 74674 3066 79666632
Product quality issue 14.20 14.06 7 74683 33933 79635765
Cerebral ischaemia 14.19 14.06 32 74658 11163 79658535
Hypercapnia 14.19 14.06 28 74662 8907 79660791
Abdominal pain lower 14.16 14.06 6 74684 31776 79637922
Blood culture positive 14.10 14.06 27 74663 8402 79661296
Abortion spontaneous 14.09 14.06 5 74685 29502 79640196

FDA Adverse Event Reporting System (Pediatric)

None

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
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




🐶 Veterinary Drug Use

None

🐶 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 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

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 0264-3183 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 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 0409-1390 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 0409-1391 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 0781-3000 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 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 44567-145 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 44567-146 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 55150-207 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 55150-208 INJECTION, POWDER, FOR SOLUTION 1 g INTRAVENOUS ANDA 26 sections