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 767.65 17.20 351 24911 37936 63425824
Thrombocytopenia 709.94 17.20 540 24722 150617 63313143
Serotonin syndrome 609.67 17.20 274 24988 28408 63435352
Anaemia 354.33 17.20 505 24757 292925 63170835
Drug resistance 345.67 17.20 173 25089 22760 63441000
Pathogen resistance 299.52 17.20 108 25154 6290 63457470
Multiple organ dysfunction syndrome 270.45 17.20 205 25057 56547 63407213
Pancytopenia 239.98 17.20 241 25021 96692 63367068
Electrocardiogram QT prolonged 225.67 17.20 188 25074 59342 63404418
Drug interaction 222.89 17.20 357 24905 228774 63234986
Neuropathy peripheral 209.89 17.20 242 25020 113425 63350335
Septic shock 199.48 17.20 184 25078 66445 63397315
Optic neuropathy 173.75 17.20 54 25208 1978 63461782
Fatigue 151.57 17.20 83 25179 887945 62575815
Pain 140.30 17.20 60 25202 740568 62723192
Myelosuppression 138.66 17.20 97 25165 23606 63440154
Platelet count decreased 135.33 17.20 197 25065 115925 63347835
Off label use 129.57 17.20 570 24692 673892 62789868
Drug reaction with eosinophilia and systemic symptoms 114.13 17.20 100 25162 33736 63430024
Mitochondrial toxicity 106.84 17.20 27 25235 454 63463306
Acute kidney injury 103.54 17.20 283 24979 263132 63200628
Hypertransaminasaemia 99.93 17.20 50 25212 6559 63457201
Respiratory failure 99.14 17.20 159 25103 101699 63362061
Bone marrow failure 91.70 17.20 83 25179 29207 63434553
Skin candida 89.08 17.20 31 25231 1624 63462136
Optic neuritis 88.46 17.20 50 25212 8385 63455375
Nasopharyngitis 87.80 17.20 3 25259 254254 63209506
Sepsis 86.21 17.20 189 25073 152934 63310826
Metabolic acidosis 84.80 17.20 97 25165 44972 63418788
Alopecia 78.41 17.20 19 25243 337517 63126243
Acute generalised exanthematous pustulosis 78.23 17.20 51 25211 11048 63452712
Hyperlactacidaemia 76.04 17.20 32 25230 2817 63460943
Hepatotoxicity 75.29 17.20 83 25179 36958 63426802
Bicytopenia 73.15 17.20 30 25232 2475 63461285
Joint swelling 73.13 17.20 20 25242 327646 63136114
Arthralgia 72.59 17.20 72 25190 569638 62894122
Renal failure 70.53 17.20 149 25113 117503 63346257
Staphylococcal infection 69.64 17.20 84 25178 41172 63422588
Eosinophilia 68.32 17.20 63 25199 22693 63441067
Clostridium difficile colitis 67.77 17.20 60 25202 20509 63443251
Infusion related reaction 67.39 17.20 9 25253 245512 63218248
Swelling 64.92 17.20 15 25247 275363 63188397
Ototoxicity 63.76 17.20 23 25239 1339 63462421
Rheumatoid arthritis 63.59 17.20 12 25250 253807 63209953
Polyneuropathy 63.51 17.20 50 25212 14539 63449221
Sinusitis 62.94 17.20 8 25254 226645 63237115
Candida infection 61.93 17.20 66 25196 28285 63435475
Aspergillus infection 61.52 17.20 39 25223 8054 63455706
Synovitis 58.78 17.20 4 25258 186914 63276846
Weight increased 58.01 17.20 16 25246 260776 63202984
Pancreatitis haemorrhagic 53.39 17.20 16 25246 517 63463243
Geotrichum infection 50.84 17.20 15 25247 459 63463301
Enterococcal infection 50.32 17.20 34 25228 7814 63455946
Product use in unapproved indication 50.15 17.20 171 25091 178909 63284851
Disseminated intravascular coagulation 50.06 17.20 49 25213 19002 63444758
Leukopenia 49.95 17.20 101 25161 77189 63386571
Hepatocellular injury 49.92 17.20 58 25204 27323 63436437
Pain in extremity 49.33 17.20 36 25226 331450 63132310
Product dose omission issue 49.15 17.20 16 25246 234297 63229463
Toxic optic neuropathy 48.58 17.20 12 25250 183 63463577
Posterior reversible encephalopathy syndrome 48.19 17.20 46 25216 17299 63446461
Aplasia pure red cell 48.14 17.20 27 25235 4460 63459300
Peripheral swelling 47.85 17.20 23 25239 265919 63197841
Multiple-drug resistance 47.18 17.20 28 25234 5142 63458618
Pancreatitis acute 46.97 17.20 56 25206 27110 63436650
Headache 46.35 17.20 116 25146 633125 62830635
Tongue discolouration 45.23 17.20 23 25239 3120 63460640
Hypomagnesaemia 44.44 17.20 56 25206 28681 63435079
Drug ineffective for unapproved indication 44.36 17.20 61 25201 34002 63429758
Discomfort 43.90 17.20 7 25255 167367 63296393
Cholestasis 43.38 17.20 56 25206 29378 63434382
Nervous system disorder 43.32 17.20 45 25217 18721 63445039
Hepatic cytolysis 43.07 17.20 41 25221 15366 63448394
Systemic lupus erythematosus 42.54 17.20 15 25247 208903 63254857
Vomiting 41.00 17.20 370 24892 559247 62904513
Klebsiella infection 40.86 17.20 31 25231 8535 63455225
Contraindicated product administered 40.42 17.20 18 25244 217630 63246130
Glossodynia 39.71 17.20 11 25251 178865 63284895
Pneumothorax 39.36 17.20 40 25222 16221 63447539
Paradoxical drug reaction 39.23 17.20 23 25239 4129 63459631
Toxic epidermal necrolysis 38.59 17.20 49 25213 25285 63438475
Rash maculo-papular 38.38 17.20 55 25207 31841 63431919
Oedematous kidney 38.20 17.20 9 25253 111 63463649
Fall 37.97 17.20 61 25201 392273 63071487
Infective pulmonary exacerbation of cystic fibrosis 37.91 17.20 30 25232 8787 63454973
Dysbiosis 37.60 17.20 14 25248 892 63462868
Blood creatine phosphokinase increased 37.39 17.20 53 25209 30377 63433383
Diabetic macroangiopathy 37.28 17.20 9 25253 124 63463636
Blood lactic acid increased 36.83 17.20 27 25235 7059 63456701
Tooth discolouration 36.69 17.20 14 25248 954 63462806
Drug level decreased 36.33 17.20 28 25234 7891 63455869
Wound 36.31 17.20 10 25252 163253 63300507
Pericarditis 35.66 17.20 5 25257 131574 63332186
Hepatic failure 35.11 17.20 56 25206 35600 63428160
Abdominal discomfort 34.85 17.20 46 25216 320839 63142921
Respiratory distress 34.37 17.20 54 25208 33897 63429863
Mobility decreased 34.29 17.20 4 25258 121155 63342605
Hepatic infarction 33.78 17.20 12 25250 668 63463092
Malaise 33.75 17.20 72 25190 415882 63047878
Bacteraemia 33.74 17.20 38 25224 17310 63446450
Contusion 33.72 17.20 9 25253 150035 63313725
Hypokalaemia 33.42 17.20 104 25158 103700 63360060
Blood disorder 33.40 17.20 25 25237 6746 63457014
Systemic candida 33.39 17.20 19 25243 3226 63460534
Musculoskeletal stiffness 33.14 17.20 16 25246 184602 63279158
Rash morbilliform 32.96 17.20 19 25243 3306 63460454
Toxic leukoencephalopathy 32.62 17.20 12 25250 739 63463021
Immune reconstitution inflammatory syndrome associated tuberculosis 32.33 17.20 10 25252 360 63463400
Haematotoxicity 32.18 17.20 28 25234 9348 63454412
Bronchopulmonary aspergillosis 32.11 17.20 27 25235 8608 63455152
Enterovesical fistula 32.06 17.20 11 25251 552 63463208
Brain abscess 31.95 17.20 16 25246 2102 63461658
Distributive shock 31.86 17.20 14 25248 1369 63462391
Encephalopathy 31.82 17.20 56 25206 38564 63425196
Oedematous pancreatitis 31.72 17.20 11 25251 570 63463190
Kussmaul respiration 31.51 17.20 9 25253 245 63463515
Hyponatraemia 31.42 17.20 107 25155 111793 63351967
Hyperbilirubinaemia 31.42 17.20 30 25232 11284 63452476
Aplasia 31.07 17.20 20 25242 4239 63459521
Acute respiratory distress syndrome 30.42 17.20 42 25220 23492 63440268
Acute hepatic failure 30.40 17.20 37 25225 18290 63445470
Transaminases abnormal 30.25 17.20 11 25251 655 63463105
Impaired healing 30.00 17.20 3 25259 102539 63361221
Toxic skin eruption 29.92 17.20 31 25231 12854 63450906
Back pain 29.57 17.20 37 25225 264108 63199652
Staphylococcal sepsis 29.37 17.20 25 25237 8103 63455657
Cholecystitis acute 29.02 17.20 25 25237 8235 63455525
Immune effector cell-associated neurotoxicity syndrome 28.01 17.20 15 25247 2262 63461498
Maternal exposure during pregnancy 27.71 17.20 28 25234 220034 63243726
Exfoliative rash 27.50 17.20 16 25246 2831 63460929
Mediastinal effusion 26.99 17.20 6 25256 56 63463704
Hypersensitivity 26.91 17.20 47 25215 292638 63171122
Neutropenia 26.81 17.20 139 25123 174866 63288894
Hallucination 26.74 17.20 64 25198 54753 63409007
Acid base balance abnormal 26.62 17.20 8 25254 261 63463499
Mycobacterium abscessus infection 26.60 17.20 10 25252 654 63463106
Transaminases increased 26.51 17.20 46 25216 31321 63432439
Electrolyte imbalance 26.20 17.20 36 25226 20040 63443720
Stevens-Johnson syndrome 25.69 17.20 40 25222 24910 63438850
Dermatitis exfoliative generalised 25.62 17.20 17 25245 3790 63459970
Migraine 25.61 17.20 5 25257 103341 63360419
Hyperoxaluria 25.03 17.20 7 25255 176 63463584
Enterococcal bacteraemia 24.93 17.20 12 25250 1447 63462313
Escherichia infection 24.91 17.20 28 25234 12726 63451034
Disseminated tuberculosis 24.79 17.20 15 25247 2852 63460908
Shock 24.69 17.20 38 25224 23425 63440335
Herbal toxicity 24.29 17.20 5 25257 31 63463729
Drug-induced liver injury 24.14 17.20 51 25211 40171 63423589
Meningitis tuberculous 24.01 17.20 9 25253 584 63463176
Therapeutic product effect incomplete 23.74 17.20 10 25252 125046 63338714
Bronchitis 23.71 17.20 10 25252 124925 63338835
Neutrophil count decreased 23.47 17.20 62 25200 56344 63407416
Metabolic encephalopathy 23.34 17.20 19 25243 5790 63457970
Sideroblastic anaemia 23.28 17.20 4 25258 7 63463753
Wound infection staphylococcal 23.16 17.20 14 25248 2658 63461102
Eosinophilic pneumonia acute 23.01 17.20 8 25254 418 63463342
Pyelonephritis chronic 22.99 17.20 7 25255 239 63463521
Gastrooesophageal reflux disease 22.93 17.20 5 25257 95634 63368126
Portal vein cavernous transformation 22.86 17.20 6 25256 118 63463642
Butterfly rash 22.71 17.20 12 25250 1761 63461999
Cough 22.63 17.20 52 25210 292691 63171069
Myopathy 22.60 17.20 25 25237 11166 63452594
Inappropriate antidiuretic hormone secretion 22.13 17.20 29 25233 15433 63448327
Psoriasis 21.99 17.20 4 25258 86953 63376807
Haemophagocytic lymphohistiocytosis 21.91 17.20 24 25238 10603 63453157
Leuconostoc infection 21.78 17.20 4 25258 12 63463748
Pancreatitis 21.52 17.20 55 25207 49000 63414760
Neurotoxicity 21.48 17.20 30 25232 16960 63446800
Vascular device infection 21.47 17.20 20 25242 7292 63456468
Procalcitonin increased 21.23 17.20 10 25252 1149 63462611
Abdominal rigidity 21.23 17.20 12 25250 2012 63461748
Dysmetria 21.20 17.20 8 25254 529 63463231
Infectious pleural effusion 21.09 17.20 11 25251 1572 63462188
Septal panniculitis 21.05 17.20 5 25257 64 63463696
Hypoglycaemia 21.03 17.20 62 25200 60003 63403757
Renal impairment 20.97 17.20 80 25182 88275 63375485
Pseudomonas infection 20.85 17.20 24 25238 11189 63452571
Blood fibrinogen decreased 20.84 17.20 9 25253 844 63462916
Tuberculoma of central nervous system 20.62 17.20 7 25255 340 63463420
Haemoglobin decreased 20.53 17.20 113 25149 145372 63318388
Peripheral motor neuropathy 20.47 17.20 11 25251 1670 63462090
Memory impairment 20.34 17.20 8 25254 104250 63359510
Agranulocytosis 20.13 17.20 36 25226 25098 63438662
Epstein-Barr virus test positive 20.02 17.20 8 25254 617 63463143
Mouth ulceration 20.00 17.20 42 25220 32942 63430818
Muscle spasms 19.50 17.20 20 25242 156130 63307630
Pruritus 19.44 17.20 76 25186 361377 63102383
Hyperpyrexia 19.24 17.20 14 25248 3618 63460142
Hypotension 19.23 17.20 179 25083 272425 63191335
Wheezing 19.21 17.20 7 25255 95588 63368172
Pyrexia 18.90 17.20 277 24985 470201 62993559
Pneumonia necrotising 18.74 17.20 7 25255 450 63463310
Delayed graft function 18.71 17.20 9 25253 1084 63462676
Hepatitis cholestatic 18.65 17.20 18 25244 6860 63456900
Feeling abnormal 18.53 17.20 19 25243 148373 63315387
Insomnia 18.50 17.20 36 25226 215216 63248544
Hyperalbuminaemia 18.43 17.20 4 25258 33 63463727
Hallucination, olfactory 18.35 17.20 6 25256 259 63463501
Hepatitis toxic 18.29 17.20 13 25249 3240 63460520
Acinetobacter infection 18.28 17.20 10 25252 1573 63462187
Ill-defined disorder 18.18 17.20 5 25257 81750 63382010
Dizziness 18.02 17.20 99 25163 429826 63033934
Mixed liver injury 18.01 17.20 15 25247 4720 63459040
Mental status changes 18.00 17.20 45 25217 39554 63424206
Aspartate aminotransferase increased 17.67 17.20 77 25185 90200 63373560
Generalised tonic-clonic seizure 17.65 17.20 37 25225 28979 63434781
Trichoglossia 17.64 17.20 6 25256 293 63463467
Lower respiratory tract infection 17.62 17.20 16 25246 132291 63331469
Tuberculosis 17.57 17.20 22 25240 11189 63452571
Tuberculin test positive 17.40 17.20 13 25249 3498 63460262
Deafness 17.40 17.20 28 25234 17929 63445831

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 928.14 15.62 905 30632 155342 34770052
Serotonin syndrome 583.40 15.62 307 31230 19626 34905768
Lactic acidosis 389.64 15.62 291 31246 34481 34890913
Electrocardiogram QT prolonged 345.49 15.62 290 31247 40662 34884732
Optic neuropathy 321.41 15.62 104 31433 1861 34923533
Drug resistance 281.47 15.62 213 31324 25714 34899680
Anaemia 276.16 15.62 632 30905 232703 34692691
Pancytopenia 266.55 15.62 376 31161 94781 34830613
Off label use 208.36 15.62 836 30701 418688 34506706
Choroiditis 193.39 15.62 63 31474 1152 34924242
Platelet count decreased 170.45 15.62 350 31187 119367 34806027
Pathogen resistance 169.51 15.62 106 31431 9376 34916018
Fatigue 169.10 15.62 62 31475 370591 34554803
Neuropathy peripheral 168.18 15.62 283 31254 82980 34842414
Drug reaction with eosinophilia and systemic symptoms 157.96 15.62 171 31366 32841 34892553
Enterococcal infection 151.34 15.62 98 31439 9208 34916186
Drug interaction 149.37 15.62 495 31042 225451 34699943
Bone marrow failure 140.77 15.62 152 31385 29101 34896293
Antimicrobial susceptibility test resistant 123.19 15.62 34 31503 340 34925054
Optic neuritis 118.69 15.62 60 31477 3514 34921880
Hepatotoxicity 114.68 15.62 118 31419 21367 34904027
Septic shock 114.08 15.62 220 31317 71614 34853780
Rash maculo-papular 106.74 15.62 130 31407 28321 34897073
Trichoglossia 104.27 15.62 29 31508 299 34925095
Eosinophilia 101.94 15.62 122 31415 26100 34899294
Bicytopenia 97.07 15.62 46 31491 2338 34923056
Multiple organ dysfunction syndrome 95.14 15.62 212 31325 76354 34849040
Product use in unapproved indication 87.00 15.62 268 31269 117231 34808163
Visual acuity reduced 86.72 15.62 89 31448 16060 34909334
Bronchopulmonary aspergillosis 86.45 15.62 85 31452 14574 34910820
Pain 85.35 15.62 39 31498 204636 34720758
Myelosuppression 82.14 15.62 94 31443 19171 34906223
Candida infection 81.62 15.62 90 31447 17625 34907769
Drug ineffective for unapproved indication 78.80 15.62 102 31435 23613 34901781
Intraocular pressure increased 78.56 15.62 53 31484 5330 34920064
Fall 76.62 15.62 44 31493 202841 34722553
Polyneuropathy 76.22 15.62 80 31457 14816 34910578
Systemic candida 75.13 15.62 45 31492 3681 34921713
Alveolar lung disease 73.74 15.62 23 31514 363 34925031
Uveitis 71.05 15.62 57 31480 7478 34917916
Hyperlactacidaemia 67.58 15.62 39 31498 2977 34922417
Hypersensitivity vasculitis 63.95 15.62 39 31498 3296 34922098
Ototoxicity 63.12 15.62 32 31505 1885 34923509
Eye pain 63.06 15.62 69 31468 13393 34912001
Toxic optic neuropathy 62.89 15.62 25 31512 825 34924569
Back pain 61.29 15.62 17 31520 121772 34803622
Respiratory failure 61.17 15.62 226 31311 108346 34817048
Sideroblastic anaemia 60.44 15.62 18 31519 241 34925153
Product dose omission issue 59.70 15.62 17 31520 119694 34805700
Minimum inhibitory concentration 57.44 15.62 16 31521 166 34925228
Mitochondrial toxicity 55.47 15.62 33 31504 2666 34922728
Tooth discolouration 55.42 15.62 19 31518 409 34924985
Hypertransaminasaemia 54.11 15.62 43 31494 5563 34919831
Cardiac valve vegetation 52.86 15.62 19 31518 472 34924922
Drug ineffective 52.47 15.62 635 30902 456116 34469278
Eosinophilic pneumonia 52.36 15.62 35 31502 3466 34921928
Cholestasis 50.87 15.62 89 31448 26859 34898535
Arthralgia 49.81 15.62 48 31489 169993 34755401
Klebsiella infection 49.43 15.62 49 31488 8482 34916912
Product use issue 49.34 15.62 147 31390 63069 34862325
Reticulocytopenia 48.73 15.62 13 31524 113 34925281
Geotrichum infection 48.67 15.62 18 31519 486 34924908
Tongue discolouration 48.11 15.62 23 31514 1192 34924202
Hypolipidaemia 48.09 15.62 8 31529 0 34925394
Dizziness 47.05 15.62 78 31459 218443 34706951
Disseminated intravascular coagulation 46.41 15.62 76 31461 21740 34903654
Deafness neurosensory 46.09 15.62 30 31507 2841 34922553
Treatment failure 45.76 15.62 118 31419 46579 34878815
Completed suicide 45.27 15.62 16 31521 98152 34827242
Enterococcus test positive 44.67 15.62 21 31516 1048 34924346
Incorrect product administration duration 44.52 15.62 36 31501 4775 34920619
Pulmonary interstitial emphysema syndrome 44.38 15.62 17 31520 507 34924887
Renal impairment 43.72 15.62 185 31352 94328 34831066
Death 43.64 15.62 198 31339 397851 34527543
Staphylococcal infection 43.23 15.62 93 31444 32667 34892727
Acute kidney injury 42.62 15.62 441 31096 304547 34620847
Differentiation syndrome 41.58 15.62 22 31515 1416 34923978
Sepsis 41.11 15.62 274 31263 166287 34759107
Drug dispensed to wrong patient 40.83 15.62 16 31521 508 34924886
Tubulointerstitial nephritis 39.11 15.62 69 31468 20955 34904439
Nasopharyngitis 38.65 15.62 8 31529 69960 34855434
Deafness 38.27 15.62 49 31488 11216 34914178
Therapeutic response delayed 37.78 15.62 16 31521 622 34924772
Drug-induced liver injury 37.07 15.62 81 31456 28751 34896643
Myocardial infarction 36.83 15.62 33 31504 121052 34804342
Malignant neoplasm progression 36.29 15.62 17 31520 88029 34837365
Headache 35.85 15.62 80 31457 200555 34724839
Acute generalised exanthematous pustulosis 35.75 15.62 37 31500 6739 34918655
Aortoenteric fistula 34.65 15.62 10 31527 119 34925275
Hepatic failure 34.59 15.62 88 31449 34443 34890951
Constipation 34.24 15.62 44 31493 136938 34788456
Leukopenia 33.82 15.62 129 31408 62727 34862667
Muscle spasms 31.65 15.62 14 31523 74987 34850407
Pulmonary mucormycosis 31.54 15.62 15 31522 768 34924626
Hepatitis cholestatic 30.90 15.62 37 31500 7910 34917484
Mucormycosis 30.55 15.62 32 31505 5910 34919484
CNS ventriculitis 30.46 15.62 11 31526 277 34925117
Dehydration 30.21 15.62 44 31493 129925 34795469
Myoclonus 29.58 15.62 50 31487 14675 34910719
Chest pain 29.38 15.62 43 31494 126719 34798675
Cytopenia 29.35 15.62 46 31491 12677 34912717
Aspergillus infection 29.24 15.62 45 31492 12209 34913185
Nutritional condition abnormal 29.17 15.62 12 31525 433 34924961
Inappropriate schedule of product administration 28.97 15.62 10 31527 62286 34863108
Weight increased 28.71 15.62 25 31512 93008 34832386
Intentional overdose 28.70 15.62 3 31534 43671 34881723
Respiratory gas exchange disorder 28.49 15.62 12 31525 460 34924934
Peripheral swelling 28.27 15.62 17 31520 76524 34848870
Cardiac disorder 28.24 15.62 3 31534 43123 34882271
Toxic epidermal necrolysis 28.04 15.62 61 31476 21585 34903809
Aplasia pure red cell 27.97 15.62 31 31506 6101 34919293
Botulism 27.75 15.62 9 31528 162 34925232
Vascular pseudoaneurysm thrombosis 27.70 15.62 7 31530 48 34925346
Mixed liver injury 27.65 15.62 22 31515 2851 34922543
Intentional product use issue 27.57 15.62 117 31420 59699 34865695
Cholangiolitis 27.53 15.62 6 31531 19 34925375
Staphylococcal bacteraemia 27.51 15.62 36 31501 8416 34916978
Optic nerve disorder 27.46 15.62 13 31524 659 34924735
Joint swelling 27.19 15.62 10 31527 59880 34865514
Haematotoxicity 26.83 15.62 35 31502 8159 34917235
Gastrointestinal disorder 26.52 15.62 79 31458 33869 34891525
Musculoskeletal stiffness 26.48 15.62 5 31532 46675 34878719
Memory impairment 25.98 15.62 4 31533 43314 34882080
Coronary artery disease 25.71 15.62 6 31531 48299 34877095
Shock 25.66 15.62 63 31474 24116 34901278
Haemodynamic instability 25.63 15.62 37 31500 9486 34915908
Acinetobacter infection 25.44 15.62 15 31522 1192 34924202
Cough 25.09 15.62 62 31475 150078 34775316
Diffuse alveolar damage 25.05 15.62 19 31518 2295 34923099
Malaise 25.02 15.62 85 31452 185740 34739654
Rectal perforation 25.02 15.62 11 31526 469 34924925
Condition aggravated 24.93 15.62 274 31263 191922 34733472
Normocytic anaemia 24.83 15.62 19 31518 2325 34923069
Injection site pain 24.82 15.62 3 31534 39002 34886392
Haemophagocytic lymphohistiocytosis 24.68 15.62 43 31494 12930 34912464
Psoriasis 24.66 15.62 3 31534 38809 34886585
Pain in extremity 24.63 15.62 48 31489 126465 34798929
Transaminases increased 24.45 15.62 66 31471 26757 34898637
Axonal neuropathy 24.32 15.62 14 31523 1063 34924331
Insomnia 24.32 15.62 35 31502 103872 34821522
Foetal exposure during pregnancy 24.07 15.62 3 31534 38098 34887296
Cardiac failure congestive 23.78 15.62 24 31513 83246 34842148
Intervertebral discitis 23.71 15.62 18 31519 2177 34923217
Hypoacusis 23.50 15.62 48 31489 16253 34909141
Pseudomonas infection 23.50 15.62 41 31496 12341 34913053
Nocardiosis 23.45 15.62 23 31514 3928 34921466
Generalised oedema 23.43 15.62 41 31496 12367 34913027
Pruritus 23.43 15.62 59 31478 141922 34783472
Hypofibrinogenaemia 23.18 15.62 16 31521 1670 34923724
Dyspnoea 23.14 15.62 223 31314 376559 34548835
Hyperleukocytosis 22.92 15.62 17 31520 1985 34923409
Asthenia 22.80 15.62 129 31408 245122 34680272
Clostridium test positive 22.78 15.62 21 31516 3321 34922073
Bronchitis 22.75 15.62 5 31532 41958 34883436
Tuberculosis 22.61 15.62 33 31504 8544 34916850
Wrong technique in product usage process 22.33 15.62 3 31534 35983 34889411
Peripheral sensory neuropathy 22.33 15.62 29 31508 6731 34918663
Gait disturbance 21.62 15.62 27 31510 85113 34840281
Endocarditis 21.61 15.62 28 31509 6483 34918911
Hepatitis acute 21.14 15.62 30 31507 7571 34917823
Dysbiosis 20.99 15.62 10 31527 514 34924880
Metastases to muscle 20.93 15.62 8 31529 237 34925157
Atrial fibrillation 20.86 15.62 50 31487 122343 34803051
Metastases to retroperitoneum 20.59 15.62 8 31529 248 34925146
Toxic neuropathy 20.38 15.62 10 31527 549 34924845
Syncope 20.24 15.62 32 31505 91419 34833975
Organ failure 20.10 15.62 16 31521 2075 34923319
Rheumatoid arthritis 19.85 15.62 5 31532 38233 34887161
Acute myocardial infarction 19.73 15.62 12 31525 53707 34871687
Mycobacterium chelonae infection 19.50 15.62 11 31526 804 34924590
Splenic infection fungal 19.33 15.62 6 31531 93 34925301
Myasthenia gravis crisis 19.29 15.62 10 31527 617 34924777
Chorioretinitis 19.28 15.62 9 31528 442 34924952
Wound dehiscence 19.14 15.62 19 31518 3292 34922102
Acute respiratory distress syndrome 18.94 15.62 59 31478 25910 34899484
Herpes zoster meningoencephalitis 18.79 15.62 8 31529 315 34925079
Depression 18.75 15.62 37 31500 97061 34828333
Somnolence 18.46 15.62 46 31491 111070 34814324
Feeling abnormal 18.31 15.62 18 31519 63217 34862177
Shock haemorrhagic 18.26 15.62 35 31502 11319 34914075
Brain abscess 18.19 15.62 18 31519 3107 34922287
Toxic skin eruption 18.19 15.62 35 31502 11350 34914044
Blood glucose increased 18.18 15.62 20 31517 66698 34858696
Balance disorder 18.10 15.62 7 31530 40647 34884747
Nosocomial infection 18.03 15.62 12 31525 1179 34924215
Splenic necrosis 18.01 15.62 6 31531 118 34925276
Spontaneous haematoma 17.86 15.62 9 31528 523 34924871
Encephalopathy 17.77 15.62 71 31466 35248 34890146
Renal failure 17.77 15.62 188 31349 130369 34795025
Metastases to bone marrow 17.77 15.62 9 31528 529 34924865
Stress 17.75 15.62 3 31534 30344 34895050
Infective pulmonary exacerbation of cystic fibrosis 17.69 15.62 26 31511 6775 34918619
Endocarditis bacterial 17.67 15.62 11 31526 964 34924430
Blood pressure increased 17.51 15.62 33 31504 88069 34837325
Agranulocytosis 17.26 15.62 54 31483 23767 34901627
Musculoskeletal pain 16.94 15.62 4 31533 31959 34893435
Nephropathy toxic 16.90 15.62 36 31501 12552 34912842
Hepatitis toxic 16.82 15.62 15 31522 2272 34923122
Wrong patient received product 16.79 15.62 16 31521 2638 34922756
Hepatic cytolysis 16.70 15.62 39 31498 14457 34910937
Hepatocellular injury 16.70 15.62 51 31486 22160 34903234
Cerebrovascular accident 16.65 15.62 32 31505 84779 34840615
Immune reconstitution inflammatory syndrome 16.61 15.62 29 31508 8730 34916664
Urinary retention 16.57 15.62 6 31531 36282 34889112
Extradural abscess 16.44 15.62 10 31527 841 34924553
Cognitive disorder 16.43 15.62 3 31534 28690 34896704
Dry skin 16.42 15.62 4 31533 31283 34894111
Retinopathy hypertensive 16.34 15.62 7 31530 280 34925114
Spinal cord disorder 16.33 15.62 10 31527 851 34924543
Purpura non-thrombocytopenic 16.26 15.62 5 31532 75 34925319
Hyperhidrosis 16.26 15.62 27 31510 75665 34849729
Confusional state 16.20 15.62 200 31337 143960 34781434
Chondritis 16.15 15.62 6 31531 164 34925230
Pericarditis tuberculous 16.14 15.62 5 31532 77 34925317
Gastrooesophageal reflux disease 16.12 15.62 7 31530 37917 34887477
Enterobacter infection 16.04 15.62 15 31522 2415 34922979
Hypocapnia 15.99 15.62 6 31531 169 34925225
Red blood cell vacuolisation 15.96 15.62 3 31534 3 34925391
Metastases to spleen 15.94 15.62 8 31529 461 34924933
Hyperbilirubinaemia 15.91 15.62 42 31495 16801 34908593
Nail bed inflammation 15.89 15.62 6 31531 172 34925222
Angular cheilitis 15.85 15.62 6 31531 173 34925221
Hypoperfusion 15.73 15.62 11 31526 1172 34924222
Bilirubin conjugated increased 15.72 15.62 17 31520 3254 34922140

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 1579.73 14.96 1345 51548 263914 79427581
Serotonin syndrome 1020.84 14.96 528 52365 44499 79646996
Lactic acidosis 976.77 14.96 598 52295 69761 79621734
Anaemia 608.92 14.96 1070 51823 443945 79247550
Electrocardiogram QT prolonged 536.76 14.96 459 52434 89927 79601568
Drug resistance 520.38 14.96 333 52560 41880 79649615
Optic neuropathy 495.23 14.96 154 52739 3330 79688165
Pancytopenia 488.31 14.96 575 52318 165170 79526325
Pathogen resistance 397.77 14.96 193 52700 14149 79677346
Neuropathy peripheral 374.81 14.96 465 52428 140840 79550655
Off label use 347.97 14.96 1350 51543 905865 78785630
Drug interaction 330.09 14.96 799 52094 414384 79277111
Multiple organ dysfunction syndrome 311.26 14.96 391 52502 119855 79571640
Fatigue 294.47 14.96 125 52768 929602 78761893
Platelet count decreased 281.88 14.96 481 52412 194183 79497312
Septic shock 278.33 14.96 374 52519 122427 79569068
Drug reaction with eosinophilia and systemic symptoms 271.60 14.96 270 52623 63974 79627521
Pain 248.91 14.96 79 52814 703723 78987772
Choroiditis 212.99 14.96 65 52828 1316 79690179
Bone marrow failure 205.35 14.96 209 52684 50898 79640597
Myelosuppression 203.76 14.96 187 52706 40109 79651386
Optic neuritis 193.77 14.96 104 52789 9416 79682079
Enterococcal infection 191.52 14.96 123 52770 15537 79675958
Hepatotoxicity 177.81 14.96 194 52699 51158 79640337
Eosinophilia 175.94 14.96 182 52711 45163 79646332
Bicytopenia 167.16 14.96 75 52818 4595 79686900
Polyneuropathy 150.01 14.96 126 52767 24025 79667470
Arthralgia 146.70 14.96 100 52793 571703 79119792
Mitochondrial toxicity 144.24 14.96 60 52833 3054 79688441
Hypertransaminasaemia 144.19 14.96 93 52800 11831 79679664
Hyperlactacidaemia 142.30 14.96 71 52822 5524 79685971
Antimicrobial susceptibility test resistant 142.14 14.96 36 52857 352 79691143
Product use in unapproved indication 141.09 14.96 425 52468 249934 79441561
Rash maculo-papular 139.63 14.96 179 52714 55899 79635596
Acute kidney injury 130.72 14.96 684 52209 518720 79172775
Respiratory failure 130.40 14.96 336 52557 180575 79510920
Nasopharyngitis 130.40 14.96 10 52883 253871 79437624
Candida infection 123.02 14.96 139 52754 38075 79653420
Fall 121.42 14.96 88 52805 487541 79203954
Drug ineffective for unapproved indication 120.47 14.96 159 52734 51079 79640416
Bronchopulmonary aspergillosis 119.63 14.96 107 52786 22187 79669308
Trichoglossia 118.85 14.96 35 52858 624 79690871
Completed suicide 114.86 14.96 14 52879 245753 79445742
Joint swelling 111.82 14.96 27 52866 288619 79402876
Ototoxicity 105.89 14.96 49 52844 3225 79688270
Arthropathy 103.60 14.96 3 52890 177108 79514387
Toxic optic neuropathy 103.44 14.96 36 52857 1117 79690378
Acute generalised exanthematous pustulosis 100.97 14.96 87 52806 17167 79674328
Systemic candida 100.59 14.96 60 52833 6646 79684849
Staphylococcal infection 100.40 14.96 156 52737 58139 79633356
Geotrichum infection 97.23 14.96 33 52860 948 79690547
Rheumatoid arthritis 97.09 14.96 12 52881 208458 79483037
Product dose omission issue 96.17 14.96 23 52870 247514 79443981
Headache 95.98 14.96 180 52713 653592 79037903
Sepsis 95.06 14.96 392 52501 269036 79422459
Weight increased 91.11 14.96 35 52858 277351 79414144
Disseminated intravascular coagulation 87.00 14.96 113 52780 35729 79655766
Visual acuity reduced 86.13 14.96 102 52791 29367 79662128
Klebsiella infection 85.43 14.96 76 52817 15644 79675851
Therapeutic product effect decreased 85.41 14.96 6 52887 163857 79527638
Cholestasis 84.96 14.96 136 52757 51973 79639522
Sinusitis 84.64 14.96 14 52879 195487 79496008
Infusion related reaction 84.46 14.96 24 52869 230213 79461282
Tooth discolouration 84.44 14.96 31 52862 1126 79690369
Aspergillus infection 83.64 14.96 82 52811 19079 79672416
Synovitis 83.19 14.96 4 52889 150730 79540765
Sideroblastic anaemia 83.15 14.96 22 52871 259 79691236
Pain in extremity 82.84 14.96 72 52821 364466 79327029
Peripheral swelling 82.16 14.96 38 52855 269579 79421916
Back pain 80.84 14.96 51 52842 304129 79387366
Aplasia pure red cell 80.14 14.96 55 52838 7755 79683740
Leukopenia 78.38 14.96 211 52682 116302 79575193
Renal impairment 76.97 14.96 255 52638 157528 79533967
Malaise 75.28 14.96 131 52762 489738 79201757
Injection site pain 73.11 14.96 3 52890 129835 79561660
Dizziness 72.81 14.96 150 52743 526291 79165204
Alveolar lung disease 71.60 14.96 23 52870 554 79690941
Renal failure 71.30 14.96 293 52600 200675 79490820
Swelling 70.07 14.96 28 52865 216683 79474812
Contusion 68.21 14.96 9 52884 148767 79542728
Skin candida 66.77 14.96 31 52862 2056 79689439
Alopecia 63.95 14.96 37 52856 231318 79460177
Intraocular pressure increased 63.38 14.96 51 52842 9154 79682341
Hepatic failure 63.13 14.96 131 52762 61081 79630414
Metabolic acidosis 62.21 14.96 156 52737 82373 79609122
Eosinophilic pneumonia 60.73 14.96 40 52853 5270 79686225
Haematotoxicity 59.65 14.96 62 52831 15457 79676038
Musculoskeletal stiffness 59.26 14.96 21 52872 174987 79516508
Differentiation syndrome 58.26 14.96 30 52863 2494 79689001
Clostridium difficile colitis 57.83 14.96 88 52805 32195 79659300
Minimum inhibitory concentration 57.62 14.96 15 52878 165 79691330
Incorrect product administration duration 57.29 14.96 54 52839 11968 79679527
Multiple-drug resistance 56.86 14.96 47 52846 8761 79682734
Hepatic cytolysis 55.85 14.96 79 52814 27072 79664423
Uveitis 55.49 14.96 62 52831 16768 79674727
Hepatocellular injury 55.24 14.96 107 52786 47486 79644009
Dysbiosis 54.82 14.96 23 52870 1196 79690299
Cough 54.57 14.96 100 52793 366689 79324806
Toxic epidermal necrolysis 53.92 14.96 102 52791 44479 79647016
Hypersensitivity vasculitis 53.26 14.96 41 52852 6902 79684593
Bronchitis 53.00 14.96 11 52882 130633 79560862
Mobility decreased 52.31 14.96 9 52884 122166 79569329
Tongue discolouration 52.30 14.96 32 52861 3711 79687784
Cardiac valve vegetation 50.43 14.96 20 52873 899 79690596
Pulmonary interstitial emphysema syndrome 49.51 14.96 17 52876 506 79690989
Hepatitis cholestatic 49.08 14.96 53 52840 13799 79677696
Encephalopathy 48.30 14.96 125 52768 67272 79624223
Hypomagnesaemia 46.74 14.96 99 52794 46812 79644683
Drug-induced liver injury 46.74 14.96 122 52771 65995 79625500
Tuberculosis 46.73 14.96 54 52839 15144 79676351
Brain abscess 46.53 14.96 33 52860 4903 79686592
Impaired healing 46.28 14.96 3 52890 87652 79603843
Pseudomonas infection 46.26 14.96 63 52830 20840 79670655
Discomfort 46.22 14.96 13 52880 125604 79565891
Memory impairment 46.18 14.96 9 52884 111725 79579770
Migraine 46.17 14.96 3 52890 87490 79604005
Shock 45.84 14.96 94 52799 43454 79648041
Drug ineffective 45.51 14.96 985 51908 1079928 78611567
Blood disorder 44.96 14.96 40 52853 8233 79683262
Pneumothorax 44.90 14.96 73 52820 28250 79663245
Toxic skin eruption 44.58 14.96 64 52829 22229 79669266
Transaminases increased 44.56 14.96 103 52790 51640 79639855
Deafness 44.44 14.96 62 52831 20975 79670520
Hypolipidaemia 44.23 14.96 7 52886 0 79691495
Mucormycosis 44.15 14.96 40 52853 8429 79683066
Hyperbilirubinaemia 44.15 14.96 67 52826 24451 79667044
Reticulocytopenia 44.13 14.96 13 52880 232 79691263
Muscle spasms 44.08 14.96 31 52862 174699 79516796
Deafness neurosensory 42.85 14.96 36 52857 6862 79684633
Wound 42.78 14.96 12 52881 116167 79575328
Acute respiratory distress syndrome 42.76 14.96 92 52801 43975 79647520
Haemophagocytic lymphohistiocytosis 42.66 14.96 62 52831 21775 79669720
Systemic lupus erythematosus 41.93 14.96 14 52879 121135 79570360
Mixed liver injury 41.90 14.96 37 52856 7541 79683954
Feeling abnormal 41.83 14.96 27 52866 159172 79532323
Gastrooesophageal reflux disease 41.83 14.96 9 52884 104237 79587258
Pericarditis 41.82 14.96 9 52884 104227 79587268
Therapeutic product effect incomplete 41.54 14.96 21 52872 141624 79549871
Contraindicated product administered 41.01 14.96 27 52866 157511 79533984
Drug dispensed to wrong patient 40.97 14.96 16 52877 690 79690805
Drug level decreased 40.68 14.96 49 52844 14353 79677142
Infective pulmonary exacerbation of cystic fibrosis 40.08 14.96 46 52847 12805 79678690
Blood pressure increased 39.76 14.96 49 52844 211311 79480184
Psoriasis 39.69 14.96 6 52887 89581 79601914
Bacteraemia 39.57 14.96 75 52818 32749 79658746
Myoclonus 39.46 14.96 68 52825 27592 79663903
Glossodynia 39.33 14.96 10 52883 103327 79588168
Pruritus 38.87 14.96 133 52760 394515 79296980
Neck pain 38.60 14.96 3 52890 75414 79616081
Pancreatitis haemorrhagic 38.46 14.96 16 52877 814 79690681
Nervous system disorder 38.28 14.96 66 52827 26790 79664705
Insomnia 38.10 14.96 65 52828 245105 79446390
Enterococcus test positive 37.34 14.96 21 52872 2083 79689412
Acinetobacter infection 36.91 14.96 23 52870 2754 79688741
Musculoskeletal pain 36.90 14.96 11 52882 102343 79589152
Abdominal discomfort 36.69 14.96 69 52824 250658 79440837
Therapeutic response delayed 36.65 14.96 17 52876 1125 79690370
Pancreatitis acute 36.57 14.96 93 52800 49511 79641984
Rhinorrhoea 36.34 14.96 4 52889 76070 79615425
Hepatitis acute 36.16 14.96 48 52845 15494 79676001
Aortoenteric fistula 36.01 14.96 10 52883 143 79691352
Rash morbilliform 35.96 14.96 31 52862 6119 79685376
Cytopenia 35.71 14.96 55 52838 20328 79671167
Staphylococcal bacteraemia 35.22 14.96 42 52851 12176 79679319
Chest pain 35.22 14.96 85 52808 282219 79409276
Inappropriate schedule of product administration 34.65 14.96 23 52870 133605 79557890
Malignant neoplasm progression 34.47 14.96 24 52869 135966 79555529
Hypokalaemia 34.20 14.96 187 52706 143853 79547642
Agranulocytosis 33.80 14.96 85 52808 44945 79646550
Blood pressure fluctuation 33.46 14.96 3 52890 67142 79624353
Stomatitis 33.27 14.96 29 52864 146728 79544767
Myocardial infarction 33.27 14.96 44 52849 184085 79507410
Endocarditis 33.17 14.96 38 52855 10559 79680936
CNS ventriculitis 32.94 14.96 12 52881 426 79691069
Neurotoxicity 32.83 14.96 69 52824 32449 79659046
Meningitis tuberculous 32.75 14.96 16 52877 1189 79690306
Respiratory distress 32.73 14.96 99 52794 58240 79633255
Fluid retention 32.52 14.96 4 52889 69805 79621690
Syncope 32.30 14.96 43 52850 179406 79512089
Blood lactic acid increased 32.21 14.96 41 52852 12703 79678792
Maternal exposure during pregnancy 32.16 14.96 26 52867 136512 79554983
Nasal congestion 31.98 14.96 6 52887 76546 79614949
Nocardiosis 31.94 14.96 28 52865 5651 79685844
Stress 31.68 14.96 7 52886 79605 79611890
Urinary tract infection 31.66 14.96 86 52807 274426 79417069
Diabetic macroangiopathy 31.53 14.96 9 52884 143 79691352
Pulmonary mucormycosis 30.26 14.96 15 52878 1150 79690345
Hepatitis toxic 30.21 14.96 26 52867 5121 79686374
Peripheral sensory neuropathy 29.93 14.96 40 52853 12993 79678502
Anxiety 29.30 14.96 77 52816 248435 79443060
Red blood cell vacuolisation 29.25 14.96 5 52888 3 79691492
Organ failure 29.16 14.96 23 52870 4010 79687485
Vascular pseudoaneurysm thrombosis 29.11 14.96 7 52886 54 79691441
Hypoglycaemia 29.08 14.96 139 52754 101455 79590040
Asthma 29.07 14.96 28 52865 135067 79556428
Optic nerve disorder 28.96 14.96 15 52878 1262 79690233
Hypersensitivity 28.87 14.96 84 52809 262155 79429340
Blood creatine phosphokinase increased 28.86 14.96 103 52790 65987 79625508
Dyspnoea 28.86 14.96 398 52495 856627 78834868
Injury 28.54 14.96 8 52885 77488 79614007
Oedematous kidney 28.37 14.96 9 52884 208 79691287
Cholangiolitis 28.27 14.96 6 52887 24 79691471
Eosinophilic pneumonia acute 28.12 14.96 14 52879 1084 79690411
Wheezing 27.74 14.96 22 52871 116642 79574853
Hyponatraemia 27.44 14.96 207 52686 177641 79513854
Hepatitis 27.08 14.96 90 52803 55637 79635858
Diffuse alveolar damage 27.03 14.96 21 52872 3583 79687912
Oropharyngeal pain 26.79 14.96 20 52873 109333 79582162
Pancreatitis 26.70 14.96 103 52790 68472 79623023
Rhabdomyolysis 26.60 14.96 137 52756 102994 79588501
Paradoxical drug reaction 26.35 14.96 28 52865 7157 79684338
Normocytic anaemia 26.22 14.96 22 52871 4185 79687310
Peripheral motor neuropathy 26.08 14.96 20 52873 3347 79688148
Flushing 26.00 14.96 13 52880 88255 79603240
Somnolence 25.98 14.96 77 52816 238904 79452591
Cardiopulmonary failure 25.83 14.96 27 52866 6774 79684721
Ill-defined disorder 25.79 14.96 6 52887 65869 79625626
Hallucination 25.77 14.96 119 52774 85626 79605869
Hypocapnia 25.18 14.96 11 52882 632 79690863
Hypofibrinogenaemia 25.15 14.96 16 52877 1986 79689509
Weight decreased 24.96 14.96 136 52757 355062 79336433
Pericarditis tuberculous 24.96 14.96 7 52886 104 79691391
Erythropoiesis abnormal 24.91 14.96 10 52883 464 79691031
Rectal perforation 24.55 14.96 12 52881 893 79690602
Posterior reversible encephalopathy syndrome 24.50 14.96 54 52839 26227 79665268
Arthritis 24.50 14.96 24 52869 114856 79576639
Generalised tonic-clonic seizure 24.15 14.96 74 52819 43836 79647659
Purpura 24.01 14.96 45 52848 19482 79672013
Pneumonia necrotising 23.84 14.96 13 52880 1214 79690281
Mediastinal effusion 23.75 14.96 6 52887 58 79691437
Antibiotic level above therapeutic 23.70 14.96 11 52882 729 79690766
Acid base balance abnormal 23.62 14.96 9 52884 363 79691132
Influenza like illness 23.59 14.96 9 52884 71698 79619797
Hyperleukocytosis 23.57 14.96 17 52876 2593 79688902
Leuconostoc infection 23.56 14.96 5 52888 20 79691475
SJS-TEN overlap 23.43 14.96 11 52882 748 79690747
Herpes zoster meningoencephalitis 23.40 14.96 11 52882 750 79690745
Influenza 23.38 14.96 31 52862 129575 79561920
Otitis media fungal 23.37 14.96 5 52888 21 79691474
Cerebrovascular accident 23.36 14.96 42 52851 155250 79536245
Enterococcal bacteraemia 23.28 14.96 18 52875 3050 79688445
Suicide attempt 23.27 14.96 13 52880 82919 79608576
Eye pain 23.21 14.96 66 52827 37512 79653983
Botulism 23.18 14.96 9 52884 382 79691113
Wound dehiscence 22.96 14.96 25 52868 6570 79684925
Blood fibrinogen decreased 22.86 14.96 15 52878 1964 79689531
Muscular weakness 22.83 14.96 45 52848 160684 79530811
Enterobacter infection 22.71 14.96 21 52872 4541 79686954
Osteoarthritis 22.67 14.96 15 52878 87294 79604201
Cognitive disorder 22.64 14.96 9 52884 69917 79621578
Pulmonary tuberculosis 22.61 14.96 27 52866 7838 79683657
Haemodynamic instability 22.55 14.96 41 52852 17341 79674154
Stevens-Johnson syndrome 22.47 14.96 67 52826 39099 79652396
Immune reconstitution inflammatory syndrome associated tuberculosis 22.42 14.96 11 52882 825 79690670
Axonal neuropathy 22.35 14.96 15 52878 2039 79689456
Intentional product use issue 22.32 14.96 175 52718 151937 79539558
Disseminated tuberculosis 22.28 14.96 20 52873 4163 79687332
Respiratory gas exchange disorder 22.23 14.96 11 52882 840 79690655
Blood bilirubin increased 22.23 14.96 95 52798 66137 79625358
Nutritional condition abnormal 22.16 14.96 12 52881 1105 79690390
Hypertension 22.03 14.96 129 52764 330863 79360632
Confusional state 21.97 14.96 314 52579 317683 79373812
Vomiting 21.01 14.96 584 52309 665244 79026251
Drug intolerance 20.90 14.96 97 52796 264022 79427473
Toxic neuropathy 20.77 14.96 11 52882 969 79690526
Depression 20.68 14.96 74 52819 216716 79474779
Condition aggravated 20.40 14.96 455 52438 500669 79190826
Angular cheilitis 20.36 14.96 10 52883 752 79690743
Metastases to muscle 20.33 14.96 8 52885 352 79691143
Orthostatic hypotension 20.31 14.96 6 52887 56158 79635337
Escherichia infection 20.28 14.96 40 52853 17977 79673518
Coronary artery disease 20.27 14.96 9 52884 65465 79626030
Nephropathy toxic 20.23 14.96 43 52850 20376 79671119
Generalised oedema 20.19 14.96 47 52846 23662 79667833
Splenic infection fungal 20.17 14.96 6 52887 111 79691384
Intentional product misuse 20.15 14.96 20 52873 95145 79596350
Infectious pleural effusion 20.14 14.96 18 52875 3726 79687769
Cataract 20.10 14.96 8 52885 62112 79629383
Bone pain 20.07 14.96 6 52887 55736 79635759
Immune effector cell-associated neurotoxicity syndrome 20.06 14.96 22 52871 5826 79685669
Dry skin 20.05 14.96 10 52883 67985 79623510
Clostridium test positive 19.96 14.96 23 52870 6431 79685064
Vestibular disorder 19.94 14.96 15 52878 2440 79689055
Folliculitis 19.87 14.96 6 52887 55374 79636121
Intervertebral discitis 19.84 14.96 20 52873 4808 79686687
Thrombosis 19.82 14.96 16 52877 84084 79607411
Pseudomembranous colitis 19.81 14.96 21 52872 5353 79686142
Oedema peripheral 19.76 14.96 93 52800 252195 79439300
Pulmonary function test 19.74 14.96 4 52889 12 79691483
Exfoliative rash 19.67 14.96 18 52875 3841 79687654
Hypoacusis 19.65 14.96 54 52839 30096 79661399
Portal vein cavernous transformation 19.54 14.96 6 52887 124 79691371
Aplasia 19.51 14.96 25 52868 7795 79683700
Myasthenia gravis crisis 19.47 14.96 11 52882 1100 79690395
Metastases to retroperitoneum 19.44 14.96 8 52885 396 79691099
Respiratory arrest 19.31 14.96 7 52886 57543 79633952
Relapsing fever 19.23 14.96 8 52885 407 79691088
Transaminases abnormal 19.19 14.96 10 52883 852 79690643
Inappropriate antidiuretic hormone secretion 19.05 14.96 49 52844 26264 79665231
Acute myocardial infarction 18.98 14.96 14 52879 77022 79614473
Oedematous pancreatitis 18.96 14.96 11 52882 1157 79690338
Knee arthroplasty 18.92 14.96 3 52890 43245 79648250
Cardiac disorder 18.90 14.96 10 52883 65747 79625748
Reticulocyte count decreased 18.64 14.96 10 52883 904 79690591
Hepatic infarction 18.63 14.96 10 52883 905 79690590
Flatulence 18.61 14.96 3 52890 42721 79648774
Enterocolitis 18.54 14.96 34 52859 14478 79677017
Haemoglobin decreased 18.52 14.96 227 52666 221892 79469603
Status epilepticus 18.51 14.96 47 52846 24994 79666501
Pain in jaw 18.48 14.96 4 52889 46147 79645348
Constipation 18.46 14.96 111 52782 282939 79408556
Cutaneous vasculitis 18.45 14.96 25 52868 8227 79683268
Pyelonephritis chronic 18.33 14.96 7 52886 284 79691211
Staphylococcus test positive 18.22 14.96 22 52871 6459 79685036
Blood pressure systolic increased 18.09 14.96 11 52882 66975 79624520
Myalgia 17.95 14.96 63 52830 185578 79505917
Depressed mood 17.86 14.96 5 52888 48475 79643020
Neoplasm progression 17.83 14.96 6 52887 51676 79639819
Abdominal pain upper 17.83 14.96 82 52811 223737 79467758
Cholecystitis acute 17.80 14.96 32 52861 13419 79678076
Cystic fibrosis 17.67 14.96 17 52876 3863 79687632
Splenic necrosis 17.66 14.96 6 52887 173 79691322
Presyncope 17.62 14.96 3 52890 41051 79650444
Bilirubin conjugated increased 17.57 14.96 20 52873 5519 79685976
Neutropenia 17.50 14.96 278 52615 287432 79404063
Chorioretinitis 17.43 14.96 10 52883 1030 79690465
Aspartate aminotransferase increased 17.40 14.96 154 52739 138487 79553008
Shock haemorrhagic 17.34 14.96 40 52853 20020 79671475
Dysphonia 17.32 14.96 8 52885 56864 79634631
Anuria 17.25 14.96 41 52852 20922 79670573
Drug level fluctuating 17.24 14.96 9 52884 770 79690725
Product prescribing issue 17.07 14.96 17 52876 4028 79687467
Loss of personal independence in daily activities 17.04 14.96 26 52867 102554 79588941
Heart rate decreased 17.04 14.96 13 52880 70303 79621192
Visual impairment 16.99 14.96 112 52781 92019 79599476
Pulmonary haemorrhage 16.96 14.96 33 52860 14684 79676811
Hallucination, visual 16.93 14.96 54 52839 32675 79658820
Herbal toxicity 16.85 14.96 4 52889 29 79691466
Metastases to bone marrow 16.78 14.96 9 52884 813 79690682
Accidental overdose 16.75 14.96 3 52890 39578 79651917
Systemic mycosis 16.74 14.96 14 52879 2652 79688843
Distributive shock 16.64 14.96 14 52879 2673 79688822
Tuberculoma of central nervous system 16.57 14.96 8 52885 579 79690916
Gait disturbance 16.54 14.96 76 52817 207430 79484065
Toxic leukoencephalopathy 16.47 14.96 10 52883 1144 79690351
Product use issue 16.45 14.96 212 52681 209610 79481885
Diverticulitis 16.44 14.96 5 52888 45931 79645564
Night sweats 16.39 14.96 7 52886 52088 79639407
Mediastinitis 16.36 14.96 9 52884 855 79690640
Extradural abscess 16.35 14.96 11 52882 1501 79689994
Procalcitonin decreased 16.35 14.96 5 52888 102 79691393
Enterovesical fistula 16.24 14.96 10 52883 1172 79690323
Upper respiratory tract infection 16.24 14.96 22 52871 91146 79600349
Angina pectoris 16.19 14.96 7 52886 51725 79639770
Tubulointerstitial nephritis 16.19 14.96 59 52834 38176 79653319
Electrolyte imbalance 16.02 14.96 51 52842 30830 79660665
Mycobacterium abscessus infection 15.94 14.96 10 52883 1212 79690283
Metastases to spleen 15.87 14.96 8 52885 636 79690859
Acute hepatic failure 15.86 14.96 50 52843 30063 79661432
Feeling hot 15.86 14.96 10 52883 59724 79631771
Dehydration 15.83 14.96 98 52795 248089 79443406
Mycobacterium chelonae infection 15.63 14.96 13 52880 2443 79689052
Disseminated strongyloidiasis 15.54 14.96 6 52887 251 79691244
Drug eruption 15.50 14.96 64 52829 43871 79647624
Hyperammonaemia 15.46 14.96 27 52866 11066 79680429
Atrial fibrillation 15.46 14.96 73 52820 197813 79493682
Cardiac failure congestive 15.38 14.96 46 52847 142356 79549139
Benign soft tissue neoplasm 15.31 14.96 5 52888 127 79691368
Hyperalbuminaemia 15.28 14.96 4 52889 45 79691450
Full blood count abnormal 15.24 14.96 4 52889 40470 79651025
Butterfly rash 15.21 14.96 11 52882 1685 79689810
Unevaluable event 15.19 14.96 9 52884 55576 79635919
Transient ischaemic attack 15.16 14.96 8 52885 52687 79638808
Septal panniculitis 15.09 14.96 5 52888 133 79691362
Suicidal ideation 15.09 14.96 17 52876 76323 79615172
Drug level increased 14.98 14.96 59 52834 39592 79651903

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 | Suggest Off label Use Form| |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 0009-4992 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 0009-5136 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 0009-5137 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 0009-5138 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 0009-5140 INJECTION, SOLUTION 600 mg INTRAVENOUS NDA 32 sections
Zyvox HUMAN PRESCRIPTION DRUG LABEL 1 0009-7807 INJECTION, SOLUTION 600 mg INTRAVENOUS NDA 32 sections
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 0054-0319 POWDER, FOR SUSPENSION 100 mg ORAL ANDA 27 sections
Linezolid HUMAN PRESCRIPTION DRUG LABEL 1 0143-9534 INJECTION, SOLUTION 600 mg INTRAVENOUS ANDA 29 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 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 31722-865 GRANULE, FOR SUSPENSION 100 mg ORAL ANDA 28 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 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
Linezolid Human Prescription Drug Label 1 55150-242 INJECTION, SOLUTION 600 mg INTRAVENOUS ANDA 28 sections