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

Stem definitionDrug idCAS RN
oxazolidinone antibacterials 1584 165800-03-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • linezolid
  • linospan
  • linox
  • zyvox
  • zyvoxid
  • linezolid sodium chloride
  • linezolide
  • U-100766
  • U 100766
An oxazolidinone and acetamide derived ANTI-BACTERIAL AGENT and PROTEIN SYNTHESIS INHIBITOR that is used in the treatment of GRAM-POSITIVE BACTERIAL INFECTIONS of the skin and respiratory tract.
  • Molecular weight: 337.35
  • Formula: C16H20FN3O4
  • CLOGP: 0.42
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 1
  • TPSA: 71.11
  • ALOGS: -2.37
  • ROTB: 4

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1.20 g O
1.20 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 8 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 30 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 50.82 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.58 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.69 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 4.50 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
April 18, 2000 FDA PHARMACIA AND UPJOHN

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
Lactic acidosis 629.31 17.62 300 21391 33055 50550378
Serotonin syndrome 593.82 17.62 263 21428 24450 50558983
Thrombocytopenia 537.44 17.62 441 21250 127232 50456201
Anaemia 309.49 17.62 455 21236 252001 50331432
Drug resistance 304.49 17.62 153 21538 18836 50564597
Pathogen resistance 223.02 17.62 86 21605 5603 50577830
Drug interaction 196.98 17.62 326 21365 199295 50384138
Electrocardiogram QT prolonged 186.37 17.62 164 21527 51722 50531711
Pancytopenia 169.26 17.62 194 21497 83836 50499597
Neuropathy peripheral 167.90 17.62 207 21484 96550 50486883
Optic neuropathy 166.63 17.62 51 21640 1643 50581790
Multiple organ dysfunction syndrome 162.82 17.62 150 21541 50187 50533246
Septic shock 157.65 17.62 156 21535 57019 50526414
Fatigue 130.46 17.62 71 21620 707530 49875903
Myelosuppression 122.96 17.62 75 21616 13442 50569991
Platelet count decreased 122.03 17.62 181 21510 100545 50482888
Pain 112.66 17.62 54 21637 578849 50004584
Off label use 102.70 17.62 438 21253 473988 50109445
Mitochondrial toxicity 97.43 17.62 24 21667 334 50583099
Bone marrow failure 88.64 17.62 82 21609 27542 50555891
Drug reaction with eosinophilia and systemic symptoms 86.64 17.62 82 21609 28342 50555091
Respiratory failure 85.76 17.62 146 21545 91035 50492398
Metabolic acidosis 85.53 17.62 94 21597 38731 50544702
Acute kidney injury 82.10 17.62 249 21442 227809 50355624
Sepsis 75.32 17.62 172 21519 132753 50450680
Optic neuritis 72.49 17.62 42 21649 6848 50576585
Skin candida 70.18 17.62 25 21666 1301 50582132
Nasopharyngitis 69.89 17.62 3 21688 192924 50390509
Renal failure 64.89 17.62 142 21549 106491 50476942
Hypertransaminasaemia 63.48 17.62 31 21660 3580 50579853
Staphylococcal infection 62.95 17.62 77 21614 35539 50547894
Arthralgia 58.74 17.62 61 21630 438641 50144792
Alopecia 57.26 17.62 17 21674 245030 50338403
Product use in unapproved indication 57.08 17.62 142 21549 115677 50467756
Polyneuropathy 55.20 17.62 44 21647 12087 50571346
Ototoxicity 54.96 17.62 20 21671 1107 50582326
Joint swelling 53.80 17.62 19 21672 245267 50338166
Hepatotoxicity 53.28 17.62 62 21629 27164 50556269
Rheumatoid arthritis 53.23 17.62 11 21680 202539 50380894
Hyperlactacidaemia 52.32 17.62 24 21667 2409 50581024
Sinusitis 52.21 17.62 6 21685 170552 50412881
Enterococcal infection 52.02 17.62 34 21657 6864 50576569
Acute generalised exanthematous pustulosis 50.76 17.62 37 21654 8901 50574532
Geotrichum infection 49.86 17.62 15 21676 455 50582978
Infusion related reaction 49.40 17.62 7 21684 169550 50413883
Posterior reversible encephalopathy syndrome 49.21 17.62 45 21646 14883 50568550
Systemic lupus erythematosus 48.35 17.62 3 21688 140619 50442814
Swelling 46.79 17.62 14 21677 200858 50382575
Product dose omission issue 46.25 17.62 11 21680 183827 50399606
Weight increased 45.37 17.62 15 21676 201876 50381557
Candida infection 45.08 17.62 53 21638 23470 50559963
Eosinophilia 44.28 17.62 47 21644 18605 50564828
Hepatocellular injury 44.08 17.62 55 21636 25892 50557541
Headache 43.94 17.62 95 21596 506440 50076993
Tongue discolouration 43.02 17.62 22 21669 2802 50580631
Fall 42.10 17.62 49 21642 334883 50248550
Vomiting 41.03 17.62 337 21354 460421 50123012
Clostridium difficile colitis 40.87 17.62 44 21647 17698 50565735
Pneumothorax 39.94 17.62 39 21652 13995 50569438
Pain in extremity 39.89 17.62 35 21656 272830 50310603
Drug level decreased 39.29 17.62 28 21663 6505 50576928
Hypomagnesaemia 39.20 17.62 49 21642 23107 50560326
Infective pulmonary exacerbation of cystic fibrosis 38.82 17.62 30 21661 7879 50575554
Synovitis 38.81 17.62 4 21687 123861 50459572
Aspergillus infection 38.20 17.62 28 21663 6793 50576640
Peripheral swelling 37.22 17.62 21 21670 205915 50377518
Multiple-drug resistance 36.99 17.62 21 21670 3293 50580140
Diabetic macroangiopathy 36.68 17.62 9 21682 123 50583310
Blood disorder 35.97 17.62 25 21666 5580 50577853
Cholestasis 35.63 17.62 49 21642 25352 50558081
Leukopenia 35.59 17.62 85 21606 67443 50515990
Toxic optic neuropathy 33.81 17.62 9 21682 173 50583260
Brain abscess 33.37 17.62 16 21675 1775 50581658
Dysbiosis 33.26 17.62 12 21679 648 50582785
Respiratory distress 32.92 17.62 52 21639 30437 50552996
Enterovesical fistula 32.49 17.62 11 21680 491 50582942
Hypokalaemia 32.43 17.62 97 21594 87895 50495538
Rash maculo-papular 32.37 17.62 48 21643 26593 50556840
Bicytopenia 32.18 17.62 16 21675 1920 50581513
Hyperbilirubinaemia 31.84 17.62 29 21662 9541 50573892
Rash morbilliform 31.68 17.62 18 21673 2828 50580605
Kussmaul respiration 31.57 17.62 9 21682 225 50583208
Blood lactic acid increased 31.44 17.62 23 21668 5562 50577871
Back pain 31.21 17.62 29 21662 220001 50363432
Transaminases abnormal 31.01 17.62 11 21680 565 50582868
Hepatic failure 30.71 17.62 52 21639 32231 50551202
Toxic epidermal necrolysis 30.20 17.62 41 21650 20951 50562482
Nervous system disorder 30.17 17.62 36 21655 16187 50567246
Toxic leukoencephalopathy 29.83 17.62 11 21680 632 50582801
Staphylococcal sepsis 28.81 17.62 24 21667 7012 50576421
Cholecystitis acute 28.60 17.62 24 21667 7082 50576351
Bacteraemia 28.45 17.62 33 21658 14400 50569033
Klebsiella infection 28.34 17.62 24 21667 7170 50576263
Discomfort 28.21 17.62 6 21685 108374 50475059
Neutropenia 27.55 17.62 131 21560 147834 50435599
Aplasia pure red cell 27.52 17.62 19 21672 4196 50579237
Hallucination 27.07 17.62 61 21630 46596 50536837
Hyperoxaluria 26.78 17.62 7 21684 125 50583308
Escherichia infection 26.73 17.62 28 21663 10913 50572520
Acid base balance abnormal 26.71 17.62 8 21683 239 50583194
Malaise 26.55 17.62 66 21625 335466 50247967
Tooth discolouration 26.49 17.62 11 21680 868 50582565
Pancreatitis acute 26.24 17.62 41 21650 23771 50559662
Wound 25.30 17.62 7 21684 105787 50477646
Bronchopulmonary aspergillosis 25.24 17.62 23 21668 7569 50575864
Eosinophilic pneumonia acute 24.92 17.62 8 21683 302 50583131
Aplasia 24.45 17.62 17 21674 3796 50579637
Procalcitonin increased 24.44 17.62 10 21681 760 50582673
Contraindicated product administered 24.40 17.62 17 21674 148941 50434492
Toxic skin eruption 24.34 17.62 27 21664 11224 50572209
Meningitis tuberculous 24.20 17.62 9 21682 530 50582903
Acute respiratory distress syndrome 24.19 17.62 37 21654 21062 50562371
Systemic candida 24.14 17.62 15 21676 2775 50580658
Contusion 24.04 17.62 9 21682 112174 50471259
Mobility decreased 23.98 17.62 3 21688 79945 50503488
Herbal toxicity 23.92 17.62 5 21686 31 50583402
Drug-induced liver injury 23.79 17.62 43 21648 28052 50555381
Glossodynia 23.57 17.62 10 21681 115559 50467874
Hepatic infarction 23.31 17.62 9 21682 587 50582846
Wound infection staphylococcal 23.16 17.62 14 21677 2465 50580968
Sideroblastic anaemia 22.98 17.62 4 21687 7 50583426
Bronchitis 22.92 17.62 8 21683 104151 50479282
Exfoliative rash 22.90 17.62 14 21677 2516 50580917
Pseudomonas infection 22.80 17.62 24 21667 9406 50574027
Inappropriate antidiuretic hormone secretion 22.54 17.62 28 21663 13115 50570318
Electrolyte imbalance 22.41 17.62 32 21659 17137 50566296
Abdominal rigidity 22.32 17.62 12 21679 1692 50581741
Abdominal discomfort 22.11 17.62 41 21650 231600 50351833
Metabolic encephalopathy 22.08 17.62 18 21673 5103 50578330
Therapeutic product effect incomplete 21.99 17.62 6 21685 91509 50491924
Musculoskeletal stiffness 21.94 17.62 14 21677 128467 50454966
Blood creatine phosphokinase increased 21.88 17.62 40 21651 26327 50557106
Hyponatraemia 21.57 17.62 90 21601 96049 50487384
Mediastinal effusion 21.55 17.62 5 21686 53 50583380
Leuconostoc infection 21.48 17.62 4 21687 12 50583421
Septal panniculitis 20.90 17.62 5 21686 61 50583372
Immune effector cell-associated neurotoxicity syndrome 20.60 17.62 10 21681 1140 50582293
Haemoglobin decreased 20.40 17.62 108 21583 127108 50456325
Tuberculoma of central nervous system 20.39 17.62 7 21684 326 50583107
Epstein-Barr virus test positive 20.28 17.62 8 21683 553 50582880
Hepatic cytolysis 20.27 17.62 21 21670 8082 50575351
Cough 20.23 17.62 46 21645 241218 50342215
Acute hepatic failure 20.14 17.62 29 21662 15648 50567785
Impaired healing 20.03 17.62 3 21688 69783 50513650
Pruritus 19.99 17.62 59 21632 283509 50299924
Migraine 19.94 17.62 4 21687 75276 50508157
Drug ineffective for unapproved indication 19.87 17.62 34 21657 21247 50562186
Pancreatitis 19.66 17.62 51 21640 42563 50540870
Delayed graft function 19.45 17.62 9 21682 921 50582512
Maternal exposure during pregnancy 19.37 17.62 24 21667 159754 50423679
Hepatitis cholestatic 19.30 17.62 18 21673 6099 50577334
Shock 19.29 17.62 33 21658 20617 50562816
Pericarditis 19.20 17.62 5 21686 78684 50504749
Neutrophil count decreased 19.13 17.62 53 21638 45973 50537460
SJS-TEN overlap 18.99 17.62 6 21685 215 50583218
Mixed liver injury 18.95 17.62 14 21677 3437 50579996
Pyelonephritis chronic 18.93 17.62 6 21685 217 50583216
Hallucination, olfactory 18.80 17.62 6 21685 222 50583211
Acinetobacter infection 18.56 17.62 10 21681 1417 50582016
Arthritis 18.51 17.62 7 21684 86714 50496719
Gastrooesophageal reflux disease 18.38 17.62 5 21686 76423 50507010
Disseminated intravascular coagulation 18.18 17.62 29 21662 17106 50566327
Hyperpyrexia 18.18 17.62 13 21678 3036 50580397
Hyperalbuminaemia 18.14 17.62 4 21687 33 50583400
Antibiotic level above therapeutic 18.03 17.62 6 21685 254 50583179
Transaminases increased 17.98 17.62 38 21653 27786 50555647
Drug level below therapeutic 17.95 17.62 14 21677 3726 50579707

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
Thrombocytopenia 771.37 15.54 772 26437 134051 29413267
Serotonin syndrome 499.94 15.54 267 26942 17245 29530073
Optic neuropathy 328.00 15.54 103 27106 1632 29545686
Lactic acidosis 325.39 15.54 249 26960 29998 29517320
Anaemia 245.87 15.54 558 26651 200393 29346925
Electrocardiogram QT prolonged 244.94 15.54 228 26981 35909 29511409
Pancytopenia 243.39 15.54 339 26870 82829 29464489
Drug resistance 213.45 15.54 169 27040 21371 29525947
Off label use 175.77 15.54 640 26569 300160 29247158
Neuropathy peripheral 160.96 15.54 257 26952 70770 29476548
Choroiditis 159.38 15.54 52 27157 936 29546382
Pathogen resistance 159.35 15.54 97 27112 8019 29539299
Platelet count decreased 159.09 15.54 318 26891 104354 29442964
Enterococcal infection 150.09 15.54 94 27115 8174 29539144
Bone marrow failure 144.58 15.54 151 27058 27298 29520020
Fatigue 144.13 15.54 56 27153 316765 29230553
Drug interaction 144.05 15.54 453 26756 196932 29350386
Drug reaction with eosinophilia and systemic symptoms 138.59 15.54 149 27060 27843 29519475
Product use in unapproved indication 106.51 15.54 242 26967 86633 29460685
Septic shock 98.41 15.54 193 27016 62367 29484951
Optic neuritis 84.67 15.54 46 27163 3063 29544255
Bronchopulmonary aspergillosis 81.81 15.54 77 27132 12267 29535051
Myelosuppression 80.52 15.54 76 27133 12151 29535167
Bicytopenia 79.09 15.54 37 27172 1790 29545528
Polyneuropathy 77.11 15.54 74 27135 12078 29535240
Multiple organ dysfunction syndrome 75.27 15.54 174 27035 62942 29484376
Visual acuity reduced 75.02 15.54 80 27129 14796 29532522
Hepatotoxicity 74.50 15.54 87 27122 17780 29529538
Alveolar lung disease 74.31 15.54 23 27186 346 29546972
Pain 73.39 15.54 33 27176 171399 29375919
Antimicrobial susceptibility test resistant 71.54 15.54 21 27188 261 29547057
Trichoglossia 71.00 15.54 17 27192 88 29547230
Hypertransaminasaemia 67.96 15.54 42 27167 3564 29543754
Fall 67.09 15.54 40 27169 177138 29370180
Candida infection 66.61 15.54 76 27133 15149 29532169
Rash maculo-papular 66.38 15.54 96 27113 24193 29523125
Intraocular pressure increased 66.34 15.54 46 27163 4743 29542575
Uveitis 66.13 15.54 50 27159 5897 29541421
Hypersensitivity vasculitis 64.10 15.54 39 27170 3218 29544100
Eosinophilia 61.16 15.54 88 27121 22073 29525245
Hyperlactacidaemia 60.36 15.54 35 27174 2643 29544675
Eosinophilic pneumonia 58.39 15.54 35 27174 2811 29544507
Eye pain 57.83 15.54 62 27147 11533 29535785
Tooth discolouration 57.48 15.54 18 27191 282 29547036
Toxic optic neuropathy 55.12 15.54 22 27187 719 29546599
Respiratory failure 53.99 15.54 204 27005 96927 29450391
Ototoxicity 53.60 15.54 27 27182 1538 29545780
Cardiac valve vegetation 53.35 15.54 19 27190 450 29546868
Enterococcus test positive 51.84 15.54 21 27188 714 29546604
Geotrichum infection 50.52 15.54 18 27191 427 29546891
Back pain 48.12 15.54 17 27192 102267 29445051
Arthralgia 48.10 15.54 35 27174 139582 29407736
Tongue discolouration 47.96 15.54 22 27187 1017 29546301
Renal impairment 47.84 15.54 174 27035 81159 29466159
Mitochondrial toxicity 47.78 15.54 29 27180 2382 29544936
Treatment failure 47.52 15.54 105 27104 36834 29510484
Incorrect product administration duration 47.21 15.54 35 27174 4006 29543312
Product use issue 46.80 15.54 128 27081 51316 29496002
Dizziness 46.54 15.54 64 27145 189620 29357698
Pulmonary interstitial emphysema syndrome 46.00 15.54 17 27192 449 29546869
Klebsiella infection 45.20 15.54 44 27165 7305 29540013
Staphylococcal infection 44.46 15.54 89 27120 29151 29518167
Tubulointerstitial nephritis 44.27 15.54 67 27142 17576 29529742
Intentional product use issue 44.02 15.54 111 27098 42387 29504931
Systemic candida 43.99 15.54 29 27180 2751 29544567
Product dose omission issue 43.69 15.54 17 27192 96366 29450952
Sepsis 42.58 15.54 250 26959 142432 29404886
Hypolipidaemia 41.95 15.54 7 27202 0 29547318
Completed suicide 40.77 15.54 16 27193 90230 29457088
Differentiation syndrome 40.47 15.54 20 27189 1093 29546225
Myocardial infarction 40.18 15.54 26 27183 110270 29437048
Drug ineffective for unapproved indication 40.03 15.54 57 27152 14157 29533161
Disseminated intravascular coagulation 39.38 15.54 68 27141 19912 29527406
Deafness neurosensory 38.64 15.54 26 27183 2552 29544766
Sideroblastic anaemia 37.30 15.54 12 27197 206 29547112
Malaise 37.01 15.54 56 27153 159546 29387772
Reticulocytopenia 36.50 15.54 10 27199 95 29547223
Constipation 36.30 15.54 31 27178 114129 29433189
Death 36.20 15.54 177 27032 341907 29205411
Drug ineffective 35.78 15.54 499 26710 362671 29184647
Headache 35.77 15.54 66 27143 173941 29373377
Nasopharyngitis 35.66 15.54 6 27203 59659 29487659
Acute kidney injury 33.11 15.54 381 26828 264886 29282432
Drug-induced liver injury 33.02 15.54 66 27143 21589 29525729
Myoclonus 31.22 15.54 49 27160 13260 29534058
Deafness 30.82 15.54 42 27167 10013 29537305
Leukopenia 29.85 15.54 115 27094 55088 29492230
Gastrointestinal disorder 29.73 15.54 75 27134 28631 29518687
Toxic epidermal necrolysis 29.70 15.54 57 27152 18096 29529222
Nutritional condition abnormal 29.62 15.54 12 27197 408 29546910
Hepatitis cholestatic 29.45 15.54 34 27175 6859 29540459
Condition aggravated 29.09 15.54 232 26977 146063 29401255
Respiratory gas exchange disorder 29.05 15.54 12 27197 429 29546889
Malignant neoplasm progression 28.86 15.54 16 27193 73843 29473475
Staphylococcal bacteraemia 28.72 15.54 34 27175 7045 29540273
Axonal neuropathy 27.75 15.54 14 27195 800 29546518
Aortoenteric fistula 27.66 15.54 8 27201 94 29547224
Botulism 27.63 15.54 9 27200 161 29547157
Vascular pseudoaneurysm thrombosis 27.56 15.54 7 27202 48 29547270
Cholangiolitis 27.41 15.54 6 27203 19 29547299
Diffuse alveolar damage 26.84 15.54 19 27190 2024 29545294
Dehydration 26.83 15.54 40 27169 114708 29432610
Weight increased 26.66 15.54 19 27190 76648 29470670
Haemophagocytic lymphohistiocytosis 26.50 15.54 40 27169 10464 29536854
Chest pain 26.21 15.54 39 27170 111934 29435384
Hyperleukocytosis 25.73 15.54 17 27192 1618 29545700
Muscle spasms 25.57 15.54 14 27195 65068 29482250
Intentional overdose 25.06 15.54 3 27206 38525 29508793
Aplasia pure red cell 25.01 15.54 28 27181 5463 29541855
Normocytic anaemia 24.96 15.54 18 27191 1974 29545344
Nocardiosis 24.85 15.54 22 27187 3238 29544080
CNS ventriculitis 24.81 15.54 9 27200 225 29547093
Acinetobacter infection 24.75 15.54 14 27195 1008 29546310
Mucormycosis 24.70 15.54 27 27182 5131 29542187
Hepatic failure 24.37 15.54 74 27135 31438 29515880
Cardiac failure congestive 24.08 15.54 21 27188 76560 29470758
Cardiac disorder 23.99 15.54 3 27206 37260 29510058
Cholestasis 23.98 15.54 61 27148 23401 29523917
Pulmonary mucormycosis 23.30 15.54 11 27198 543 29546775
Hypoacusis 23.24 15.54 45 27164 14378 29532940
Coronary artery disease 23.20 15.54 6 27203 44184 29503134
Splenic necrosis 23.15 15.54 6 27203 45 29547273
Cytopenia 22.71 15.54 36 27173 9823 29537495
Endocarditis 22.44 15.54 27 27182 5689 29541629
Asthenia 22.34 15.54 112 27097 215138 29332180
Optic nerve disorder 22.33 15.54 11 27198 597 29546721
Shock haemorrhagic 22.17 15.54 35 27174 9516 29537802
Aspergillus infection 22.15 15.54 37 27172 10544 29536774
Joint swelling 22.07 15.54 9 27200 49621 29497697
Generalised oedema 22.00 15.54 38 27171 11127 29536191
Peripheral swelling 21.89 15.54 16 27193 63723 29483595
Clostridium test positive 21.78 15.54 17 27192 2100 29545218
Metastases to muscle 21.58 15.54 8 27201 213 29547105
Inappropriate schedule of product administration 21.58 15.54 7 27202 44465 29502853
Pseudomonas infection 21.47 15.54 37 27172 10815 29536503
Myasthenia gravis crisis 21.43 15.54 10 27199 481 29546837
Syncope 21.41 15.54 26 27183 81345 29465973
Metastases to retroperitoneum 21.38 15.54 8 27201 219 29547099
Acute myocardial infarction 21.19 15.54 9 27200 48429 29498889
Foetal exposure during pregnancy 21.15 15.54 3 27206 33864 29513454
Memory impairment 21.06 15.54 4 27205 36466 29510852
Organ failure 20.91 15.54 16 27193 1920 29545398
Haemodynamic instability 20.73 15.54 31 27178 8042 29539276
Wound dehiscence 20.33 15.54 19 27190 2998 29544320
Rectal perforation 20.08 15.54 9 27200 394 29546924
Pain in extremity 20.01 15.54 45 27164 110388 29436930
Musculoskeletal stiffness 19.83 15.54 5 27204 37453 29509865
Hypofibrinogenaemia 19.81 15.54 14 27195 1487 29545831
Splenic infection fungal 19.72 15.54 6 27203 85 29547233
Toxic neuropathy 19.62 15.54 9 27200 416 29546902
Intentional product misuse 19.60 15.54 4 27205 34657 29512661
Cough 19.59 15.54 56 27153 126671 29420647
Bronchitis 19.36 15.54 5 27204 36863 29510455
Pruritus 19.29 15.54 50 27159 116799 29430519
Atrial fibrillation 19.18 15.54 43 27166 105603 29441715
Wrong technique in product usage process 19.13 15.54 3 27206 31425 29515893
Infective pulmonary exacerbation of cystic fibrosis 19.03 15.54 26 27183 6210 29541108
Tuberculosis 19.01 15.54 28 27181 7168 29540150
Disseminated strongyloidiasis 18.93 15.54 6 27203 98 29547220
Acute respiratory distress syndrome 18.81 15.54 55 27154 22880 29524438
Metastases to bone marrow 18.54 15.54 9 27200 473 29546845
Peripheral sensory neuropathy 18.49 15.54 25 27184 5914 29541404
Brain abscess 18.43 15.54 17 27192 2638 29544680
Renal failure 18.31 15.54 178 27031 118421 29428897
Spontaneous haematoma 18.28 15.54 9 27200 488 29546830
Insomnia 17.91 15.54 34 27175 88727 29458591
Dyspnoea 17.69 15.54 204 27005 326528 29220790
Metastases to spleen 17.39 15.54 8 27201 372 29546946
Blood disorder 17.07 15.54 17 27192 2900 29544418
Gastrooesophageal reflux disease 17.07 15.54 4 27205 31492 29515826
Feeling abnormal 17.03 15.54 15 27194 54430 29492888
Depression 16.85 15.54 33 27176 85114 29462204
Chondritis 16.77 15.54 6 27203 144 29547174
Retinopathy hypertensive 16.75 15.54 7 27202 258 29547060
Aplastic anaemia 16.72 15.54 27 27182 7483 29539835
Gait disturbance 16.72 15.54 26 27183 73323 29473995
Nephropathy toxic 16.65 15.54 33 27176 10723 29536595
Extradural abscess 16.65 15.54 9 27200 593 29546725
Herpes zoster meningoencephalitis 16.60 15.54 7 27202 264 29547054
Mycobacterium chelonae infection 16.56 15.54 9 27200 599 29546719
Hepatocellular injury 16.53 15.54 50 27159 21193 29526125
Allodynia 16.50 15.54 9 27200 604 29546714
Angular cheilitis 16.18 15.54 6 27203 160 29547158
Purpura non-thrombocytopenic 16.17 15.54 5 27204 75 29547243
Staphylococcus test positive 16.13 15.54 16 27193 2717 29544601
Hypocapnia 16.07 15.54 6 27203 163 29547155
Nail bed inflammation 16.04 15.54 6 27203 164 29547154
Mixed liver injury 15.95 15.54 14 27195 2037 29545281
Red blood cell vacuolisation 15.90 15.54 3 27206 3 29547315
Rheumatoid arthritis 15.70 15.54 5 27204 32147 29515171
Diarrhoea 15.66 15.54 214 26995 332484 29214834
Glomerular filtration rate decreased 15.59 15.54 33 27176 11233 29536085
Aspartate aminotransferase 15.59 15.54 5 27204 85 29547233

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
Thrombocytopenia 1263.78 14.81 1129 44215 222672 64230716
Serotonin syndrome 914.74 14.81 478 44866 38804 64414584
Lactic acidosis 804.82 14.81 514 44830 60896 64392492
Anaemia 529.96 14.81 950 44394 377730 64075658
Optic neuropathy 491.47 14.81 150 45194 2861 64450527
Drug resistance 447.55 14.81 289 45055 34813 64418575
Electrocardiogram QT prolonged 396.05 14.81 375 44969 79073 64374315
Pancytopenia 392.28 14.81 493 44851 142816 64310572
Neuropathy peripheral 332.19 14.81 411 44933 117114 64336274
Pathogen resistance 324.47 14.81 164 45180 12379 64441009
Drug interaction 294.03 14.81 728 44616 361355 64092033
Off label use 288.54 14.81 1036 44308 631770 63821618
Platelet count decreased 250.59 14.81 434 44910 167277 64286111
Fatigue 244.52 14.81 111 45233 748619 63704769
Drug reaction with eosinophilia and systemic symptoms 223.74 14.81 231 45113 53986 64399402
Septic shock 222.82 14.81 320 45024 105117 64348271
Multiple organ dysfunction syndrome 204.40 14.81 301 45043 101112 64352276
Bone marrow failure 202.72 14.81 207 45137 47745 64405643
Pain 201.91 14.81 69 45275 553442 63899946
Myelosuppression 189.20 14.81 147 45197 23683 64429705
Enterococcal infection 188.62 14.81 119 45225 13747 64439641
Product use in unapproved indication 163.24 14.81 374 44970 176244 64277144
Choroiditis 155.67 14.81 49 45295 1038 64452350
Optic neuritis 142.32 14.81 82 45262 8034 64445354
Polyneuropathy 139.29 14.81 114 45230 19780 64433608
Hypertransaminasaemia 127.02 14.81 73 45271 7118 64446270
Arthralgia 125.66 14.81 78 45266 442182 64011206
Mitochondrial toxicity 125.27 14.81 53 45291 2653 64450735
Fall 119.12 14.81 73 45271 416753 64036635
Hepatotoxicity 117.94 14.81 143 45201 39819 64413569
Hyperlactacidaemia 115.58 14.81 60 45284 4784 64448604
Completed suicide 110.09 14.81 14 45330 224400 64228988
Respiratory failure 108.73 14.81 303 45041 160880 64292508
Eosinophilia 108.72 14.81 134 45210 37942 64415446
Bicytopenia 107.44 14.81 52 45292 3570 64449818
Nasopharyngitis 107.26 14.81 8 45336 196065 64257323
Bronchopulmonary aspergillosis 104.44 14.81 95 45249 18990 64434398
Geotrichum infection 97.49 14.81 33 45311 885 64452503
Acute kidney injury 97.27 14.81 593 44751 448647 64004741
Staphylococcal infection 97.11 14.81 147 45197 50531 64402857
Candida infection 96.92 14.81 115 45229 31304 64422084
Ototoxicity 92.74 14.81 43 45301 2680 64450708
Rash maculo-papular 92.37 14.81 138 45206 46888 64406500
Headache 89.22 14.81 147 45197 529320 63924068
Antimicrobial susceptibility test resistant 86.46 14.81 23 45321 260 64453128
Sepsis 85.21 14.81 354 44990 229987 64223401
Toxic optic neuropathy 84.92 14.81 30 45314 917 64452471
Joint swelling 81.57 14.81 25 45319 215357 64238031
Product dose omission issue 80.54 14.81 19 45325 194728 64258660
Rheumatoid arthritis 78.76 14.81 11 45333 164283 64289105
Trichoglossia 76.79 14.81 22 45322 333 64453055
Malaise 76.47 14.81 100 45244 396147 64057241
Weight increased 75.16 14.81 28 45316 213320 64240068
Tooth discolouration 73.15 14.81 27 45317 938 64452450
Back pain 72.50 14.81 43 45301 250128 64203260
Klebsiella infection 72.45 14.81 66 45278 13215 64440173
Arthropathy 72.08 14.81 3 45341 120964 64332424
Alveolar lung disease 71.90 14.81 23 45321 514 64452874
Visual acuity reduced 71.87 14.81 92 45252 27049 64426339
Renal impairment 70.47 14.81 232 45112 134785 64318603
Pain in extremity 67.64 14.81 68 45276 303017 64150371
Metabolic acidosis 66.24 14.81 151 45193 70807 64382581
Renal failure 65.40 14.81 277 45067 181411 64271977
Sinusitis 64.93 14.81 12 45332 145916 64307472
Dizziness 63.84 14.81 129 45215 430034 64023354
Therapeutic product effect decreased 62.23 14.81 5 45339 115346 64338042
Peripheral swelling 61.94 14.81 35 45309 209118 64244270
Infusion related reaction 60.63 14.81 20 45324 164447 64288941
Leukopenia 59.25 14.81 181 45163 101061 64352327
Eosinophilic pneumonia 59.05 14.81 38 45306 4539 64448849
Systemic candida 58.48 14.81 40 45304 5289 64448099
Incorrect product administration duration 58.19 14.81 51 45293 9707 64443681
Drug ineffective for unapproved indication 57.78 14.81 89 45255 31044 64422344
Aspergillus infection 57.32 14.81 64 45280 16315 64437073
Aplasia pure red cell 57.25 14.81 44 45300 6970 64446418
Sideroblastic anaemia 57.20 14.81 16 45328 221 64453167
Synovitis 54.28 14.81 4 45340 99086 64354302
Acute generalised exanthematous pustulosis 52.79 14.81 57 45287 14001 64439387
Skin candida 52.18 14.81 25 45319 1678 64451710
Hypersensitivity vasculitis 52.11 14.81 41 45303 6720 64446668
Contusion 51.50 14.81 9 45335 113956 64339432
Tongue discolouration 51.11 14.81 31 45313 3337 64450051
Cardiac valve vegetation 50.75 14.81 20 45324 833 64452555
Intraocular pressure increased 50.74 14.81 44 45300 8258 64445130
Pulmonary interstitial emphysema syndrome 50.57 14.81 17 45327 446 64452942
Swelling 50.09 14.81 25 45319 160193 64293195
Hepatocellular injury 49.91 14.81 103 45241 45132 64408256
Disseminated intravascular coagulation 49.85 14.81 85 45259 32263 64421125
Intentional product use issue 49.85 14.81 164 45180 95200 64358188
Blood disorder 49.47 14.81 40 45304 6817 64446571
Bronchitis 48.24 14.81 9 45335 108734 64344654
Cholestasis 48.13 14.81 101 45243 44771 64408617
Differentiation syndrome 47.74 14.81 25 45319 2029 64451359
Toxic epidermal necrolysis 47.48 14.81 90 45254 37076 64416312
Brain abscess 47.35 14.81 32 45312 4149 64449239
Hepatitis cholestatic 46.90 14.81 50 45294 12105 64441283
Hepatic failure 46.38 14.81 113 45231 55281 64398107
Hypomagnesaemia 45.90 14.81 89 45255 37287 64416101
Cough 45.30 14.81 90 45254 302058 64151330
Pseudomonas infection 44.81 14.81 59 45285 17824 64435564
Uveitis 43.35 14.81 49 45295 12659 64440729
Pneumothorax 43.05 14.81 68 45276 24230 64429158
Drug-induced liver injury 42.92 14.81 100 45244 47543 64405845
Systemic lupus erythematosus 42.89 14.81 3 45341 77609 64375779
Drug level decreased 42.07 14.81 46 45298 11457 64441931
Infective pulmonary exacerbation of cystic fibrosis 41.12 14.81 46 45298 11750 64441638
Tuberculosis 40.66 14.81 48 45296 12990 64440398
Enterococcus test positive 40.22 14.81 21 45323 1694 64451694
Myoclonus 40.03 14.81 67 45277 25051 64428337
Musculoskeletal stiffness 38.84 14.81 19 45325 123187 64330201
Multiple-drug resistance 38.81 14.81 34 45310 6468 64446920
Clostridium difficile colitis 38.65 14.81 69 45275 27154 64426234
Myocardial infarction 38.35 14.81 36 45308 165785 64287603
Alopecia 38.28 14.81 36 45308 165654 64287734
Deafness 37.65 14.81 55 45289 18304 64435084
Hypolipidaemia 37.57 14.81 6 45338 0 64453388
Deafness neurosensory 37.38 14.81 33 45311 6341 64447047
Feeling abnormal 37.23 14.81 24 45320 133578 64319810
Mucormycosis 37.17 14.81 35 45309 7306 64446082
Staphylococcal bacteraemia 37.16 14.81 41 45303 10314 64443074
Hyperbilirubinaemia 37.09 14.81 59 45285 21146 64432242
Intentional product misuse 36.68 14.81 4 45340 72291 64381097
Gastrooesophageal reflux disease 36.63 14.81 7 45337 83136 64370252
Acute respiratory distress syndrome 36.48 14.81 83 45261 38852 64414536
Dysbiosis 36.41 14.81 16 45328 879 64452509
Mobility decreased 36.21 14.81 8 45336 85832 64367556
Acinetobacter infection 35.94 14.81 22 45322 2407 64450981
Pruritus 35.82 14.81 107 45237 312293 64141095
Memory impairment 34.16 14.81 9 45335 85673 64367715
Psoriasis 33.88 14.81 5 45339 71698 64381690
Endocarditis 33.43 14.81 37 45307 9341 64444047
Syncope 33.29 14.81 37 45307 157598 64295790
Reticulocytopenia 33.19 14.81 10 45334 182 64453206
Rash morbilliform 32.95 14.81 28 45316 5113 64448275
Nocardiosis 32.69 14.81 27 45317 4740 64448648
Cytopenia 32.68 14.81 47 45297 15424 64437964
Therapeutic product effect incomplete 32.56 14.81 16 45328 103466 64349922
Neck pain 32.27 14.81 3 45341 61530 64391858
Muscle spasms 32.15 14.81 31 45313 140992 64312396
Impaired healing 31.58 14.81 3 45341 60470 64392918
Mixed liver injury 31.39 14.81 28 45316 5453 64447935
Diabetic macroangiopathy 31.31 14.81 9 45335 138 64453250
Fluid retention 31.01 14.81 3 45341 59603 64393785
Respiratory distress 31.01 14.81 94 45250 52237 64401151
Hypokalaemia 30.86 14.81 168 45176 121735 64331653
Bacteraemia 30.53 14.81 62 45282 26849 64426539
Eosinophilic pneumonia acute 30.18 14.81 14 45330 873 64452515
Toxic skin eruption 30.14 14.81 51 45293 19233 64434155
Meningitis tuberculous 30.11 14.81 15 45329 1096 64452292
Blood pressure increased 29.80 14.81 47 45297 172505 64280883
Urinary tract infection 29.77 14.81 75 45269 231521 64221867
Vascular pseudoaneurysm thrombosis 29.43 14.81 7 45337 48 64453340
Red blood cell vacuolisation 28.96 14.81 5 45339 3 64453385
Rhinorrhoea 28.76 14.81 4 45340 59965 64393423
Insomnia 28.71 14.81 60 45284 197776 64255612
Wound 28.70 14.81 9 45335 76468 64376920
Nervous system disorder 28.39 14.81 55 45289 23023 64430365
Chest pain 28.37 14.81 79 45265 235901 64217487
Haemophagocytic lymphohistiocytosis 28.10 14.81 47 45297 17562 64435826
Musculoskeletal pain 28.05 14.81 11 45333 81283 64372105
Aortoenteric fistula 27.99 14.81 8 45336 120 64453268
Diffuse alveolar damage 27.96 14.81 21 45323 3214 64450174
Cholangiolitis 27.93 14.81 6 45338 24 64453364
Malignant neoplasm progression 27.90 14.81 23 45321 112848 64340540
Discomfort 27.81 14.81 11 45333 80867 64372521
Hypoglycaemia 27.74 14.81 131 45213 89761 64363627
SJS-TEN overlap 27.64 14.81 11 45333 470 64452918
Normocytic anaemia 27.59 14.81 21 45323 3278 64450110
CNS ventriculitis 27.49 14.81 10 45334 333 64453055
Transaminases increased 27.26 14.81 81 45263 44513 64408875
Contraindicated product administered 26.62 14.81 22 45322 107807 64345581
Hyperleukocytosis 26.47 14.81 17 45327 2023 64451365
Neurotoxicity 26.32 14.81 59 45285 27345 64426043
Arthritis 26.30 14.81 13 45331 83801 64369587
Treatment failure 26.28 14.81 156 45188 116660 64336728
Blood lactic acid increased 25.57 14.81 34 45310 10367 64443021
Haematotoxicity 25.53 14.81 38 45306 12858 64440530
Inappropriate schedule of product administration 25.14 14.81 17 45327 92269 64361119
Erythropoiesis abnormal 25.07 14.81 10 45334 430 64452958
Flushing 24.98 14.81 12 45332 78636 64374752
Rhabdomyolysis 24.98 14.81 129 45215 91597 64361791
Shock 24.86 14.81 71 45273 38169 64415219
Hyponatraemia 24.83 14.81 184 45160 148155 64305233
Acid base balance abnormal 24.51 14.81 9 45335 308 64453080
Hepatic cytolysis 24.45 14.81 39 45305 14010 64439378
Optic nerve disorder 24.41 14.81 13 45331 1092 64452296
Vomiting 24.36 14.81 532 44812 550585 63902803
Nasal congestion 24.29 14.81 6 45338 59652 64393736
Axonal neuropathy 24.21 14.81 15 45329 1677 64451711
Pericarditis 24.11 14.81 7 45337 62509 64390879
Generalised tonic-clonic seizure 23.99 14.81 72 45272 39785 64413603
Stomatitis 23.94 14.81 25 45319 109580 64343808
Suicide attempt 23.86 14.81 10 45334 70997 64382391
Angular cheilitis 23.76 14.81 10 45334 494 64452894
Encephalopathy 23.76 14.81 93 45251 58726 64394662
Organ failure 23.72 14.81 20 45324 3613 64449775
Pneumonia necrotising 23.66 14.81 12 45332 911 64452477
Influenza like illness 23.62 14.81 7 45337 61695 64391693
Oropharyngeal pain 23.37 14.81 17 45327 88850 64364538
Botulism 23.37 14.81 9 45335 352 64453036
Nutritional condition abnormal 23.14 14.81 12 45332 954 64452434
Otitis media fungal 23.08 14.81 5 45339 21 64453367
Stress 22.94 14.81 7 45337 60527 64392861
Respiratory gas exchange disorder 22.74 14.81 11 45333 754 64452634
Influenza 22.49 14.81 25 45319 106506 64346882
Blood creatine phosphokinase increased 22.38 14.81 91 45253 58467 64394921
Wound dehiscence 22.37 14.81 24 45320 5850 64447538
Cerebrovascular accident 22.34 14.81 39 45305 137544 64315844
Escherichia infection 22.25 14.81 39 45305 15129 64438259
Pulmonary mucormycosis 22.12 14.81 11 45333 801 64452587
Anxiety 22.08 14.81 71 45273 202578 64250810
Condition aggravated 22.05 14.81 376 44968 372050 64081338
Agranulocytosis 22.02 14.81 68 45276 38161 64415227
Product use issue 21.98 14.81 182 45162 151533 64301855
Glossodynia 21.92 14.81 9 45335 64687 64388701
Enterocolitis 21.80 14.81 34 45310 11984 64441404
Pancreatitis acute 21.75 14.81 73 45271 42782 64410606
Asthma 21.62 14.81 21 45323 95204 64358184
Acute myocardial infarction 21.59 14.81 11 45333 69707 64383681
Posterior reversible encephalopathy syndrome 21.59 14.81 49 45295 22897 64430491
Cognitive disorder 21.55 14.81 6 45338 55081 64398307
Pulmonary tuberculosis 21.49 14.81 26 45318 7218 64446170
Dyspnoea 21.46 14.81 366 44978 718308 63735080
Cardiopulmonary failure 21.40 14.81 24 45320 6146 64447242
Myasthenia gravis crisis 21.23 14.81 11 45333 873 64452515
Hypofibrinogenaemia 21.08 14.81 14 45330 1764 64451624
Drug ineffective 21.03 14.81 754 44590 839493 63613895
Hallucination 20.96 14.81 104 45240 72684 64380704
Eye pain 20.83 14.81 59 45285 31566 64421822
Maternal exposure during pregnancy 20.80 14.81 22 45322 95862 64357526
Herpes zoster meningoencephalitis 20.75 14.81 10 45334 680 64452708
Metastases to muscle 20.65 14.81 8 45336 318 64453070
Shock haemorrhagic 20.63 14.81 40 45304 16751 64436637
Immune effector cell-associated neurotoxicity syndrome 20.57 14.81 16 45328 2579 64450809
Pericarditis tuberculous 20.52 14.81 6 45338 98 64453290
Gait disturbance 20.41 14.81 58 45286 172097 64281291
Splenic necrosis 20.41 14.81 6 45338 100 64453288
Somnolence 20.38 14.81 74 45270 203571 64249817
Reticulocyte count decreased 20.36 14.81 10 45334 709 64452679
Disseminated strongyloidiasis 20.19 14.81 6 45338 104 64453284
Splenic infection fungal 20.13 14.81 6 45338 105 64453283
Depression 20.12 14.81 64 45280 183227 64270161
Pancreatitis 19.97 14.81 89 45255 59518 64393870
Relapsing fever 19.88 14.81 8 45336 352 64453036
Transaminases abnormal 19.88 14.81 10 45334 746 64452642
Rectal perforation 19.83 14.81 10 45334 750 64452638
Haemoglobin decreased 19.80 14.81 217 45127 194846 64258542
Hypoacusis 19.79 14.81 51 45293 25816 64427572
Abdominal discomfort 19.77 14.81 64 45280 182258 64271130
Drug hypersensitivity 19.70 14.81 93 45251 237722 64215666
Immune reconstitution inflammatory syndrome associated tuberculosis 19.67 14.81 10 45334 763 64452625
Clostridium test positive 19.66 14.81 19 45325 4096 64449292
Staphylococcus test positive 19.65 14.81 22 45322 5623 64447765
Metastases to retroperitoneum 19.61 14.81 8 45336 365 64453023
Coronary artery disease 19.53 14.81 9 45335 60424 64392964
Pulmonary function test 19.51 14.81 4 45340 12 64453376
Oedema peripheral 19.39 14.81 79 45265 210238 64243150
Toxic neuropathy 19.39 14.81 10 45334 786 64452602
Hypersensitivity 19.26 14.81 72 45272 196380 64257008
Peripheral sensory neuropathy 19 14.81 31 45313 11347 64442041
Mediastinal effusion 18.92 14.81 5 45339 55 64453333
Constipation 18.81 14.81 90 45254 229247 64224141
Antibiotic level above therapeutic 18.78 14.81 9 45335 604 64452784
Purpura 18.70 14.81 39 45305 17207 64436181
Peripheral motor neuropathy 18.67 14.81 16 45328 2954 64450434
Injury 18.63 14.81 8 45336 55984 64397404
Cystic fibrosis 18.60 14.81 17 45327 3417 64449971
Hepatitis toxic 18.59 14.81 19 45325 4381 64449007
Respiratory arrest 18.56 14.81 7 45337 52978 64400410
Neutropenia 18.43 14.81 253 45091 239371 64214017
Pulmonary haemorrhage 18.32 14.81 33 45311 13076 64440312
Nephropathy toxic 18.29 14.81 39 45305 17475 64435913
Confusional state 18.21 14.81 271 45073 260873 64192515
Inappropriate antidiuretic hormone secretion 18.15 14.81 45 45299 22244 64431144
Muscular weakness 18.14 14.81 39 45305 127299 64326089
Weight decreased 18.11 14.81 122 45222 285617 64167771
Metastases to bone marrow 18.05 14.81 9 45335 659 64452729
Drug level fluctuating 18.04 14.81 9 45335 660 64452728
Wheezing 18.03 14.81 18 45326 80561 64372827
Thrombosis 17.95 14.81 14 45330 70628 64382760
Septal panniculitis 17.95 14.81 5 45339 68 64453320
Leuconostoc infection 17.89 14.81 4 45340 20 64453368
Tubulointerstitial nephritis 17.82 14.81 55 45289 30854 64422534
Dehydration 17.82 14.81 85 45259 216678 64236710
Enterovesical fistula 17.76 14.81 10 45334 937 64452451
Systemic mycosis 17.72 14.81 14 45330 2309 64451079
Haemodynamic instability 17.68 14.81 35 45309 14877 64438511
Cataract 17.58 14.81 7 45337 51255 64402133
Hepatitis 17.55 14.81 71 45273 45511 64407877
Angina pectoris 17.47 14.81 5 45339 45076 64408312
Metastases to spleen 17.26 14.81 8 45336 498 64452890
Bone pain 17.14 14.81 6 45338 47566 64405822
Bradycardia 17.02 14.81 36 45308 118183 64335205
Cardiac disorder 17.00 14.81 9 45335 55807 64397581
Depressed mood 16.94 14.81 4 45340 41008 64412380
Neoplasm progression 16.91 14.81 4 45340 40960 64412428
Generalised oedema 16.88 14.81 42 45302 20811 64432577
Status epilepticus 16.87 14.81 43 45301 21620 64431768
Pain in jaw 16.78 14.81 4 45340 40751 64412637
Orthostatic hypotension 16.66 14.81 6 45338 46732 64406656
Herbal toxicity 16.62 14.81 4 45340 29 64453359
Hepatitis acute 16.58 14.81 32 45312 13357 64440031
Tuberculoma of central nervous system 16.57 14.81 8 45336 546 64452842
Hyperammonaemia 16.56 14.81 27 45317 9877 64443511
Drug level below therapeutic 16.43 14.81 23 45321 7361 64446027
Myalgia 16.29 14.81 57 45287 158560 64294828
Exfoliative rash 16.24 14.81 16 45328 3530 64449858
Cardiac failure congestive 16.22 14.81 43 45301 130537 64322851
Anuria 16.20 14.81 39 45305 18925 64434463
Aplasia 15.99 14.81 22 45322 6931 64446457
Atrial fibrillation 15.94 14.81 64 45280 171025 64282363
Cytokine release syndrome 15.86 14.81 41 45303 20788 64432600
Hypoalbuminaemia 15.81 14.81 37 45307 17637 64435751
Vestibular disorder 15.75 14.81 13 45331 2280 64451108
Flatulence 15.71 14.81 3 45341 35663 64417725
Enterobacter infection 15.68 14.81 16 45328 3680 64449708
Extradural abscess 15.64 14.81 10 45334 1181 64452207
Hyperamylasaemia 15.61 14.81 9 45335 882 64452506
Diverticulitis 15.50 14.81 4 45340 38614 64414774
Disseminated cryptococcosis 15.42 14.81 11 45333 1556 64451832
Hyperalbuminaemia 15.39 14.81 4 45340 41 64453347
Toxic leukoencephalopathy 15.39 14.81 9 45335 906 64452482
Fungaemia 15.37 14.81 16 45328 3769 64449619
Abdominal pain upper 15.36 14.81 67 45277 174963 64278425
Presyncope 15.35 14.81 3 45341 35086 64418302
Infectious pleural effusion 15.17 14.81 14 45330 2848 64450540
Ill-defined disorder 15.13 14.81 6 45338 44046 64409342
Pneumonia staphylococcal 15.04 14.81 17 45327 4389 64448999
Wound infection staphylococcal 15.03 14.81 14 45330 2883 64450505
Blood bilirubin increased 15.01 14.81 80 45264 57473 64395915
Staphylococcal sepsis 14.97 14.81 30 45314 12869 64440519
Pyelonephritis chronic 14.95 14.81 6 45338 262 64453126
Urinary tract infection enterococcal 14.94 14.81 14 45330 2904 64450484
Hyperoxaluria 14.89 14.81 6 45338 265 64453123
Dysphonia 14.84 14.81 7 45337 46375 64407013
Procalcitonin increased 14.81 14.81 13 45331 2478 64450910

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01XX08 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
OTHER ANTIBACTERIALS
Other antibacterials
FDA CS M0361132 Oxazolidinones
FDA EPC N0000175495 Oxazolidinone Antibacterial
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D011500 Protein Synthesis Inhibitors
CHEBI has role CHEBI:36047 antibacterial drugs
CHEBI has role CHEBI:48001 protein synthesis inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Staphylococcal pneumonia indication 22754005
Pneumonia due to Streptococcus indication 34020007
Vancomycin resistant enterococcus indication 113727004
Streptococcus pyogenes infection indication 302809008
Infection due to Staphylococcus aureus indication 406602003
Complicated Skin and Skin Structure Staphylococcus Aureus Infection indication
Diabetic Foot Infection Due to Gram-Positive Bacteria indication
Complicated Skin and Skin Structure Streptococcus Agalactiae Infection indication
Complicated Skin and Skin Structure Streptococcus Pyogenes Infection indication
Vancomycin-Resistant Enterococcus Faecium Infection indication
Pyrexia of unknown origin off-label use 7520000
Infection of bone off-label use 111253001
Carcinoid syndrome contraindication 35868009
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of optic nerve contraindication 77157004 DOID:1891
Leukopenia contraindication 84828003 DOID:615
Thyrotoxicosis contraindication 90739004 DOID:7997
Lactic acidosis contraindication 91273001 DOID:3650
Pancytopenia contraindication 127034005 DOID:12450
Seizure disorder contraindication 128613002
Anemia contraindication 271737000 DOID:2355
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Peripheral nerve disease contraindication 302226006
Pheochromocytoma contraindication 302835009
Bone marrow depression contraindication 307762000
Serotonin syndrome contraindication 371089000
Visual impairment contraindication 397540003
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 11.4 acidic
pKa2 1.59 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Amine oxidase [flavin-containing] B Enzyme Ki 4.50 WOMBAT-PK
Amine oxidase [flavin-containing] A Enzyme Ki 5.10 CHEMBL
Succinate dehydrogenase [ubiquinone] flavoprotein subunit, mitochondrial Enzyme IC50 5.09 CHEMBL
Amine oxidase [flavin-containing] B Enzyme IC50 4.77 CHEMBL

External reference:

IDSource
4021218 VUID
N0000148664 NUI
D00947 KEGG_DRUG
4021218 VANDF
C0663241 UMLSCUI
CHEBI:63607 CHEBI
ZLD PDB_CHEM_ID
CHEMBL126 ChEMBL_ID
DB00601 DRUGBANK_ID
D000069349 MESH_DESCRIPTOR_UI
441401 PUBCHEM_CID
10827 IUPHAR_LIGAND_ID
7584 INN_ID
ISQ9I6J12J UNII
190376 RXNORM
229070 MMSL
31932 MMSL
8840 MMSL
d04534 MMSL
008223 NDDF
125695009 SNOMEDCT_US
387056004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Zyvox HUMAN PRESCRIPTION DRUG LABEL 1 0009-4992 INJECTION, SOLUTION 600 mg INTRAVENOUS NDA 32 sections
Zyvox HUMAN PRESCRIPTION DRUG LABEL 1 0009-5136 GRANULE, FOR SUSPENSION 100 mg ORAL NDA 32 sections
Zyvox HUMAN PRESCRIPTION DRUG LABEL 1 0009-5137 INJECTION, SOLUTION 200 mg INTRAVENOUS NDA 32 sections
Zyvox HUMAN PRESCRIPTION DRUG LABEL 1 0009-5138 TABLET, FILM COATED 600 mg ORAL NDA 32 sections
Zyvox HUMAN PRESCRIPTION DRUG LABEL 1 0009-5140 INJECTION, SOLUTION 600 mg INTRAVENOUS NDA 32 sections
Zyvox HUMAN PRESCRIPTION DRUG LABEL 1 0009-7807 INJECTION, SOLUTION 600 mg INTRAVENOUS NDA 32 sections
Linezolid HUMAN PRESCRIPTION DRUG LABEL 1 0054-0319 POWDER, FOR SUSPENSION 100 mg ORAL ANDA 27 sections
Linezolid HUMAN PRESCRIPTION DRUG LABEL 1 0409-4883 INJECTION, SOLUTION 2 mg INTRAVENOUS NDA 30 sections
Linezolid HUMAN PRESCRIPTION DRUG LABEL 1 0409-4883 INJECTION, SOLUTION 2 mg INTRAVENOUS NDA 30 sections
Linezolid HUMAN PRESCRIPTION DRUG LABEL 1 0781-3431 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 29 sections
Linezolid HUMAN PRESCRIPTION DRUG LABEL 1 0781-3433 INJECTION, SOLUTION 600 mg INTRAVENOUS ANDA 29 sections
Linezolid Human Prescription Drug Label 1 0904-6553 TABLET, FILM COATED 600 mg ORAL ANDA 28 sections
Zyvox HUMAN PRESCRIPTION DRUG LABEL 1 21695-399 TABLET, FILM COATED 600 mg ORAL NDA 28 sections
linezolid HUMAN PRESCRIPTION DRUG LABEL 1 25021-169 INJECTION, SOLUTION 2 mg INTRAVENOUS ANDA 29 sections
Linezolid Human Prescription Drug Label 1 31722-749 TABLET, FILM COATED 600 mg ORAL ANDA 27 sections
Linezolid HUMAN PRESCRIPTION DRUG LABEL 1 40032-022 TABLET 600 mg ORAL ANDA 26 sections
Linezolid Human Prescription Drug Label 1 46708-183 TABLET, FILM COATED 600 mg ORAL ANDA 27 sections
Linezolid Human Prescription Drug Label 1 55150-242 INJECTION, SOLUTION 600 mg INTRAVENOUS ANDA 28 sections
Zyvox HUMAN PRESCRIPTION DRUG LABEL 1 55695-009 SUSPENSION 100 mg ORAL NDA 31 sections
Linezolid HUMAN PRESCRIPTION DRUG LABEL 1 57664-682 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 30 sections
Linezolid HUMAN PRESCRIPTION DRUG LABEL 1 57664-683 INJECTION, SOLUTION 600 mg INTRAVENOUS ANDA 30 sections
Linezolid HUMAN PRESCRIPTION DRUG LABEL 1 59762-1307 TABLET, FILM COATED 600 mg ORAL NDA AUTHORIZED GENERIC 32 sections
Linezolid HUMAN PRESCRIPTION DRUG LABEL 1 59762-1308 SUSPENSION 100 mg ORAL NDA AUTHORIZED GENERIC 32 sections
Linezolid HUMAN PRESCRIPTION DRUG LABEL 1 60687-309 TABLET, FILM COATED 600 mg ORAL ANDA 26 sections
Linezolid Human Prescription Drug Label 1 62332-183 TABLET, FILM COATED 600 mg ORAL ANDA 28 sections
Linezolid HUMAN PRESCRIPTION DRUG LABEL 1 63323-713 INJECTION, SOLUTION 2 mg INTRAVENOUS ANDA 29 sections
Linezolid HUMAN PRESCRIPTION DRUG LABEL 1 63629-8576 TABLET, FILM COATED 600 mg ORAL ANDA 27 sections
Linezolid HUMAN PRESCRIPTION DRUG LABEL 1 65162-777 TABLET 600 mg ORAL ANDA 27 sections
Zyvox HUMAN PRESCRIPTION DRUG LABEL 1 66298-5137 INJECTION, SOLUTION 200 mg INTRAVENOUS NDA 31 sections
Zyvox HUMAN PRESCRIPTION DRUG LABEL 1 66298-5140 INJECTION, SOLUTION 600 mg INTRAVENOUS NDA 31 sections