levofloxacin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antibacterials, nalidixic acid derivatives 1569 100986-85-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • levofloxacin anhydrous
  • levofloxacin hydrate
  • levaquin
  • oftaquix
  • quixin
  • (S)-Ofloxacin
  • levofloxacin
The L-isomer of Ofloxacin.
  • Molecular weight: 361.37
  • Formula: C18H20FN3O4
  • CLOGP: -0.26
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 1
  • TPSA: 73.32
  • ALOGS: -2.40
  • ROTB: 2
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.24 g Inhal.solution
0.50 g O
0.50 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 74 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 29.65 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 97.50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.90 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.75 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 8.80 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 20, 1996 FDA JANSSEN PHARMS

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
Drug hypersensitivity 1249.32 10.27 1865 89982 308822 63088353
Tendon pain 588.02 10.27 210 91637 3116 63394059
Sedation complication 571.18 10.27 314 91533 13508 63383667
Creatinine renal clearance decreased 554.16 10.27 326 91521 15982 63381193
Orthostatic hypotension 452.47 10.27 393 91454 35767 63361408
Blood calcium decreased 443.65 10.27 341 91506 26110 63371065
Sedation 405.29 10.27 381 91466 38428 63358747
Cognitive disorder 401.13 10.27 448 91399 55367 63341808
Tendonitis 357.98 10.27 266 91581 19349 63377826
Drug reaction with eosinophilia and systemic symptoms 341.50 10.27 326 91521 33510 63363665
Tendon rupture 312.62 10.27 177 91670 8062 63389113
Tendon disorder 310.29 10.27 157 91690 5686 63391489
Depressed level of consciousness 299.91 10.27 408 91439 61670 63335505
Febrile neutropenia 293.36 10.27 575 91272 117874 63279301
Balance disorder 250.49 10.27 443 91404 83979 63313196
Arthropathy 247.39 10.27 26 91821 234766 63162409
Pemphigus 245.38 10.27 4 91843 183722 63213453
Glossodynia 213.37 10.27 11 91836 178865 63218310
Hand deformity 210.74 10.27 4 91843 159453 63237722
Systemic lupus erythematosus 201.04 10.27 31 91816 208887 63188288
Maternal exposure during pregnancy 183.77 10.27 46 91801 220016 63177159
Constipation 163.91 10.27 702 91145 224241 63172934
International normalised ratio fluctuation 162.78 10.27 77 91770 2401 63394774
Completed suicide 153.70 10.27 16 91831 145657 63251518
Pneumonia 149.30 10.27 1150 90697 455617 62941558
Contrast media allergy 143.73 10.27 70 91777 2331 63394844
Pericarditis 139.98 10.27 14 91833 131565 63265610
Alopecia 139.48 10.27 170 91677 337366 63059809
Wound 136.51 10.27 34 91813 163229 63233946
Bloody discharge 136.16 10.27 59 91788 1492 63395683
Synovitis 131.29 10.27 53 91794 186865 63210310
Toxic epidermal necrolysis 129.13 10.27 171 91676 25163 63372012
Drug ineffective 126.79 10.27 940 90907 1043825 62353350
Discomfort 125.03 10.27 43 91804 167331 63229844
Pyrexia 119.03 10.27 1119 90728 469359 62927816
Joint swelling 115.41 10.27 185 91662 327481 63069694
Computerised tomogram thorax abnormal 113.41 10.27 54 91793 1709 63395466
Helicobacter infection 112.87 10.27 5 91842 92780 63304395
Atelectasis 112.58 10.27 147 91700 21336 63375839
Neuropathy peripheral 111.53 10.27 390 91457 113277 63283898
Hypotension 108.97 10.27 721 91126 271883 63125292
Mobility decreased 104.77 10.27 399 91448 120760 63276415
Electrocardiogram QT prolonged 102.70 10.27 250 91597 59280 63337895
Drug interaction 102.05 10.27 623 91224 228508 63168667
Abdominal discomfort 95.35 10.27 201 91646 320684 63076491
Loss of employment 92.73 10.27 51 91796 2193 63394982
Therapeutic product effect decreased 91.15 10.27 87 91760 193100 63204075
Contraindicated product administered 90.47 10.27 109 91738 217539 63179636
Weight increased 89.21 10.27 150 91697 260642 63136533
Lyme disease 86.84 10.27 57 91790 3392 63393783
Pseudomembranous colitis 84.68 10.27 54 91793 3058 63394117
Irritable bowel syndrome 84.50 10.27 10 91837 82402 63314773
Intentional overdose 84.03 10.27 6 91841 74146 63323029
Blood cholesterol increased 83.76 10.27 17 91830 94015 63303160
Neurotoxicity 82.48 10.27 112 91735 16878 63380297
Computerised tomogram thorax 81.82 10.27 29 91818 420 63396755
Vanishing bile duct syndrome 81.56 10.27 33 91814 699 63396476
Thrombocytopenia 81.05 10.27 432 91415 150725 63246450
Swelling 80.52 10.27 174 91673 275204 63121971
Rash maculo-papular 80.24 10.27 156 91691 31740 63365435
Folliculitis 78.79 10.27 6 91841 70311 63326864
Acute generalised exanthematous pustulosis 76.10 10.27 87 91760 11012 63386163
Clostridium difficile colitis 75.74 10.27 119 91728 20450 63376725
Impaired healing 75.42 10.27 27 91820 102515 63294660
Muscle injury 72.03 10.27 6 91841 65339 63331836
Neutropenia 71.73 10.27 466 91381 174539 63222636
Neutrophil count decreased 71.15 10.27 211 91636 56195 63340980
Hepatic function abnormal 70.58 10.27 162 91685 36980 63360195
Respiratory failure 69.55 10.27 312 91535 101546 63295629
Peripheral swelling 69.00 10.27 179 91668 265763 63131412
Exposure during pregnancy 67.74 10.27 75 91772 155472 63241703
Psoriatic arthropathy 67.48 10.27 24 91823 91496 63305679
Musculoskeletal stiffness 67.05 10.27 102 91745 184516 63212659
Rheumatoid arthritis 65.72 10.27 171 91676 253648 63143527
Dysbiosis 65.24 10.27 30 91817 876 63396299
Hypoxia 64.63 10.27 212 91635 59580 63337595
Infusion related reaction 63.88 10.27 165 91682 245356 63151819
Tendon discomfort 61.27 10.27 19 91828 176 63396999
Crystal nephropathy 61.22 10.27 29 91818 907 63396268
Musculoskeletal injury 60.42 10.27 17 91830 108 63397067
Sleep disorder due to general medical condition, insomnia type 59.82 10.27 4 91843 52213 63344962
Lower respiratory tract infection 59.61 10.27 62 91785 132245 63264930
Trimethylaminuria 59.21 10.27 18 91829 155 63397020
Product use issue 59.06 10.27 146 91701 220374 63176801
Lip oedema 58.03 10.27 47 91800 3877 63393298
Tongue oedema 57.63 10.27 50 91797 4536 63392639
Drug resistance 57.48 10.27 112 91735 22821 63374354
Torsade de pointes 57.35 10.27 83 91764 13268 63383907
Factor XIII deficiency 56.17 10.27 15 91832 76 63397099
Injection site reaction 55.52 10.27 9 91838 58515 63338660
Skin reaction 54.80 10.27 86 91761 14763 63382412
Hypokalaemia 54.47 10.27 295 91552 103509 63293666
Septic shock 53.95 10.27 215 91632 66414 63330761
Injection site pain 53.90 10.27 65 91782 129735 63267440
Respiratory muscle weakness 53.78 10.27 16 91831 127 63397048
Obliterative bronchiolitis 53.67 10.27 35 91812 2060 63395115
Nasopharyngitis 53.15 10.27 189 91658 254068 63143107
Suicide attempt 52.23 10.27 12 91835 60906 63336269
Status epilepticus 50.46 10.27 84 91763 15149 63382026
Ill-defined disorder 49.97 10.27 28 91819 81727 63315448
Bronchopulmonary aspergillosis 49.83 10.27 62 91785 8573 63388602
Disseminated mucormycosis 49.30 10.27 16 91831 174 63397001
Hypocoagulable state 48.69 10.27 27 91820 1180 63395995
Platelet count decreased 48.64 10.27 311 91536 115811 63281364
Haemophagocytic lymphohistiocytosis 48.50 10.27 68 91779 10559 63386616
Myoclonus 47.95 10.27 84 91763 15784 63381391
Stevens-Johnson syndrome 47.59 10.27 109 91738 24841 63372334
Eosinophilic pneumonia 47.22 10.27 33 91814 2178 63394997
Respiratory syncytial virus infection 46.41 10.27 54 91793 6964 63390211
Cholestasis 45.91 10.27 119 91728 29315 63367860
Pathogen resistance 45.30 10.27 51 91796 6347 63390828
Eosinophilia 45.17 10.27 101 91746 22655 63374520
Sepsis 45.12 10.27 377 91470 152746 63244429
Pneumonia fungal 44.77 10.27 47 91800 5408 63391767
Headache 44.48 10.27 647 91200 632594 62764581
Megacolon 44.24 10.27 30 91817 1885 63395290
Arthritis 44.07 10.27 62 91785 115859 63281316
Toxic skin eruption 43.95 10.27 72 91775 12813 63384362
Cough 43.95 10.27 630 91217 292113 63105062
Knee arthroplasty 43.92 10.27 12 91835 54194 63342981
Anaemia 43.46 10.27 630 91217 292800 63104375
Hepatic enzyme increased 43.21 10.27 149 91698 202179 63194996
Type 2 diabetes mellitus 41.82 10.27 20 91827 63848 63333327
Vascular purpura 41.09 10.27 26 91821 1452 63395723
Hypoglycaemia 40.99 10.27 184 91663 59881 63337294
Contusion 40.42 10.27 99 91748 149945 63247230
Hip arthroplasty 39.64 10.27 10 91837 47636 63349539
Osteoarthritis 38.26 10.27 49 91798 95294 63301881
Delirium 37.68 10.27 159 91688 50382 63346793
Chronic fatigue syndrome 37.05 10.27 22 91825 1096 63396079
Multiple organ dysfunction syndrome 35.88 10.27 170 91677 56582 63340593
Intentional product use issue 35.54 10.27 83 91764 127809 63269366
Immune reconstitution inflammatory syndrome associated tuberculosis 35.53 10.27 15 91832 355 63396820
Collagen disorder 35.49 10.27 13 91834 208 63396967
Pneumonia bacterial 35.18 10.27 55 91792 9410 63387765
Face oedema 34.96 10.27 85 91762 20127 63377048
Drug eruption 34.91 10.27 106 91741 28588 63368587
Therapeutic response decreased 34.91 10.27 23 91824 61502 63335673
Fibromyalgia 34.75 10.27 39 91808 80381 63316794
Factor V inhibition 34.49 10.27 12 91835 164 63397011
Condition aggravated 34.44 10.27 394 91453 401823 62995352
Keratopathy 34.02 10.27 17 91830 599 63396576
Ectropion 33.84 10.27 12 91835 174 63397001
Acquired macroglossia 33.72 10.27 12 91835 176 63396999
Drug-induced liver injury 32.72 10.27 130 91717 40092 63357083
Blister 32.39 10.27 89 91758 129725 63267450
Bronchitis 32.33 10.27 299 91548 124636 63272539
Purpura fulminans 32.29 10.27 9 91838 55 63397120
Wrong technique in product usage process 31.87 10.27 26 91821 62314 63334861
Cystic fibrosis pancreatic 31.75 10.27 9 91838 59 63397116
Mucormycosis 31.52 10.27 29 91818 2842 63394333
Clostridium difficile infection 31.35 10.27 105 91742 29817 63367358
Cytokine release syndrome 31.22 10.27 66 91781 14248 63382927
Erythema 31.20 10.27 390 91457 175361 63221814
Erythema multiforme 30.94 10.27 54 91793 10115 63387060
Upper respiratory tract infection 30.88 10.27 214 91633 81833 63315342
Tendon injury 30.21 10.27 24 91823 1926 63395249
Injection site erythema 30.12 10.27 46 91801 83128 63314047
Liver injury 30.01 10.27 26 91821 60494 63336681
Tumour associated fever 29.99 10.27 13 91834 329 63396846
Pneumonitis 29.59 10.27 115 91732 35107 63362068
Weight decreased 29.57 10.27 257 91590 276541 63120634
Dysentery 29.49 10.27 18 91829 943 63396232
Drug abuse 29.37 10.27 37 91810 72481 63324694
Pancytopenia 29.25 10.27 240 91607 96693 63300482
Sense of oppression 28.57 10.27 18 91829 998 63396177
Acute myeloid leukaemia 28.48 10.27 71 91776 17076 63380099
Band sensation 28.46 10.27 17 91830 856 63396319
Pregnancy 28.29 10.27 9 91838 36827 63360348
Hypoglycaemic coma 28.25 10.27 26 91821 2549 63394626
Injection site swelling 28.06 10.27 17 91830 47555 63349620
Migraine 27.97 10.27 68 91779 103278 63293897
C-reactive protein abnormal 27.86 10.27 16 91831 46080 63351095
Cerebrovascular accident 27.75 10.27 73 91774 107951 63289224
General physical health deterioration 27.74 10.27 174 91673 201228 63195947
Muscle atrophy 27.73 10.27 42 91805 6991 63390184
Fatigue 27.68 10.27 1029 90818 886999 62510176
Hypomagnesaemia 27.63 10.27 98 91749 28639 63368536
Confabulation 27.53 10.27 12 91835 308 63396867
Multiple drug therapy 27.43 10.27 30 91817 3616 63393559
Lacunar stroke 27.30 10.27 10 91837 160 63397015
Basal cell carcinoma 27.24 10.27 4 91843 27987 63369188
Acute febrile neutrophilic dermatosis 26.90 10.27 27 91820 2947 63394228
Plasma cell myeloma 26.79 10.27 113 91734 35792 63361383
Weber tuning fork test abnormal 26.78 10.27 9 91838 110 63397065
Laryngeal oedema 26.70 10.27 37 91810 5681 63391494
Inflammation 26.56 10.27 49 91798 82224 63314951
Pulmonary renal syndrome 26.47 10.27 13 91834 441 63396734
International normalised ratio increased 26.44 10.27 135 91712 46290 63350885
Colitis microscopic 26.37 10.27 48 91799 9291 63387884
Complex regional pain syndrome 26.25 10.27 24 91823 2333 63394842
Cryopyrin associated periodic syndrome 26.17 10.27 12 91835 348 63396827
Palatal oedema 26.13 10.27 14 91833 571 63396604
Injection site bruising 26.12 10.27 14 91833 41896 63355279
Blood pressure increased 26.11 10.27 133 91714 161929 63235246
Umbilical erythema 26.00 10.27 8 91839 72 63397103
Influenza B virus test positive 25.99 10.27 11 91836 262 63396913
Myalgia 25.93 10.27 325 91522 146204 63250971
Intentional product misuse 25.82 10.27 30 91817 60887 63336288
Hepatic cytolysis 25.81 10.27 64 91783 15343 63381832
Stress 25.44 10.27 36 91811 67131 63330044
Foreign body aspiration 25.34 10.27 10 91837 198 63396977
Respiratory tract infection 25.30 10.27 123 91724 41360 63355815
Overdose 25.06 10.27 84 91763 114994 63282181
Upper respiratory tract inflammation 24.85 10.27 24 91823 2499 63394676
Recall phenomenon 24.75 10.27 14 91833 636 63396539
Graft versus host disease 24.72 10.27 39 91808 6724 63390451
White blood cell count decreased 24.39 10.27 308 91539 138796 63258379
Acute graft versus host disease 24.29 10.27 31 91816 4397 63392778
Suicidal ideation 24.10 10.27 33 91814 62388 63334787
Glaucoma 24.09 10.27 71 91776 18834 63378341
Disseminated strongyloidiasis 24.03 10.27 6 91841 22 63397153
Blood bilirubin increased 24.02 10.27 112 91735 37028 63360147
Glomerulonephritis rapidly progressive 23.97 10.27 16 91831 979 63396196
Inappropriate schedule of product administration 23.95 10.27 74 91773 103891 63293284
Anti-neutrophil cytoplasmic antibody positive vasculitis 23.83 10.27 25 91822 2874 63394301
Myocardial infarction 23.80 10.27 70 91777 99823 63297352
Acute kidney injury 23.76 10.27 523 91324 262892 63134283
Rhinovirus infection 23.74 10.27 31 91816 4498 63392677
Type I hypersensitivity 23.52 10.27 25 91822 2917 63394258
Pneumococcal infection 23.50 10.27 12 91835 443 63396732
Japanese spotted fever 23.42 10.27 6 91841 25 63397150
Renal necrosis 23.37 10.27 7 91840 57 63397118
Epilepsy 23.25 10.27 89 91758 26976 63370199
Infective pulmonary exacerbation of cystic fibrosis 23.24 10.27 44 91803 8773 63388402
Connective tissue disorder 23.24 10.27 18 91829 1392 63395783
Blood lactate dehydrogenase increased 23.23 10.27 80 91767 23036 63374139
Mucosal inflammation 23.02 10.27 131 91716 46797 63350378
Respiratory tract infection fungal 22.80 10.27 12 91835 472 63396703
Hyperpyrexia 22.45 10.27 27 91820 3605 63393570
Hallucination 22.44 10.27 146 91701 54671 63342504
Product quality issue 22.32 10.27 12 91835 35853 63361322
Accidental exposure to product 22.32 10.27 6 91841 27399 63369776
Aspartate aminotransferase increased 22.32 10.27 214 91633 90063 63307112
Conjunctival hyperaemia 22.26 10.27 22 91825 2357 63394818
Premature delivery 22.21 10.27 8 91839 30273 63366902
Enterocolitis 21.70 10.27 40 91807 7818 63389357
Product name confusion 21.66 10.27 7 91840 75 63397100
Dyspnoea 21.63 10.27 1166 90681 660147 62737028
Plantar fasciitis 21.62 10.27 27 91820 3748 63393427
Staphylococcal infection 21.46 10.27 117 91730 41139 63356036
Systemic inflammatory response syndrome 21.36 10.27 33 91814 5588 63391587
Stenotrophomonas infection 21.33 10.27 20 91827 2007 63395168
Long QT syndrome 21.30 10.27 25 91822 3254 63393921
Optic neuropathy 21.29 10.27 20 91827 2012 63395163
Chronic kidney disease 21.14 10.27 125 91722 45273 63351902
Generalised onset non-motor seizure 20.79 10.27 5 91842 15 63397160
Ventricular fibrillation 20.62 10.27 50 91797 11817 63385358
Femur fracture 20.62 10.27 18 91829 41738 63355437
Blood pressure fluctuation 20.51 10.27 22 91825 46295 63350880
Therapy non-responder 20.49 10.27 50 91797 75851 63321324
Excessive eye blinking 20.36 10.27 16 91831 1264 63395911
Postural tremor 20.31 10.27 10 91837 341 63396834
Bronchial obstruction 20.10 10.27 17 91830 1490 63395685
Arthralgia 20.03 10.27 650 91197 569060 62828115
Kounis syndrome 20.02 10.27 18 91829 1712 63395463
Hyperbilirubinaemia 20.02 10.27 48 91799 11266 63385909
Long QT syndrome congenital 19.97 10.27 7 91840 98 63397077
Hyperuricaemia 19.67 10.27 31 91816 5339 63391836
Liver disorder 19.59 10.27 139 91708 53548 63343627
Cytomegalovirus test positive 19.59 10.27 23 91824 2995 63394180
Gastritis fungal 19.52 10.27 7 91840 105 63397070
Agranulocytosis 19.46 10.27 80 91767 25054 63372121
Sensory processing disorder 19.39 10.27 4 91843 4 63397171
Boutonneuse fever 19.39 10.27 4 91843 4 63397171
Sciatica 19.24 10.27 13 91834 34311 63362864
Incorrect dose administered 19.10 10.27 36 91811 59932 63337243
Epidermolysis 19.02 10.27 12 91835 667 63396508
Nervous system disorder 18.91 10.27 65 91782 18701 63378474
Vascular device infection 18.67 10.27 36 91811 7276 63389899
Macular degeneration 18.64 10.27 6 91841 24370 63372805
Corneal erosion 18.64 10.27 9 91838 294 63396881
Injection site haemorrhage 18.57 10.27 6 91841 24308 63372867
Loss of personal independence in daily activities 18.56 10.27 75 91772 97215 63299960
Muscle contractions involuntary 18.55 10.27 20 91827 2372 63394803
Staphylococcal scalded skin syndrome 18.45 10.27 7 91840 124 63397051
Thyroid disorder 18.43 10.27 56 91791 15106 63382069
Clostridial infection 18.42 10.27 27 91820 4365 63392810
Muscle tension dysphonia 18.33 10.27 8 91839 206 63396969
Streptococcal sepsis 18.21 10.27 18 91829 1928 63395247
Urinary tract infection enterococcal 18.15 10.27 21 91826 2692 63394483
Hepatic steatosis 18.05 10.27 86 91761 28683 63368492
Nocardiosis 17.98 10.27 18 91829 1958 63395217
Cystic fibrosis 17.96 10.27 23 91824 3273 63393902
Grip strength decreased 17.93 10.27 5 91842 22282 63374893
Skin injury 17.92 10.27 17 91830 1731 63395444
Meningitis tuberculous 17.92 10.27 11 91836 582 63396593
Chordae tendinae rupture 17.87 10.27 5 91842 31 63397144
Pain 17.83 10.27 883 90964 739745 62657430
Altered state of consciousness 17.74 10.27 78 91769 25152 63372023
Therapy naive 17.61 10.27 5 91842 33 63397142
Osteonecrosis of jaw 17.52 10.27 15 91832 35108 63362067
Acute respiratory distress syndrome 17.51 10.27 74 91773 23460 63373715
Disseminated intravascular coagulation 17.49 10.27 64 91783 18987 63378188
Factor XIII Inhibition 17.48 10.27 5 91842 34 63397141
Circumoral oedema 17.38 10.27 8 91839 234 63396941
Adverse event 17.08 10.27 46 91801 67513 63329662
Leukopenia 17.07 10.27 179 91668 77111 63320064
Peripheral sensory neuropathy 17.00 10.27 35 91812 7416 63389759
Enterococcal infection 16.90 10.27 36 91811 7812 63389363
Hepatitis B 16.81 10.27 24 91823 3788 63393387
Enterocolitis bacterial 16.72 10.27 8 91839 256 63396919
Functional residual capacity increased 16.67 10.27 6 91841 91 63397084
Road traffic accident 16.67 10.27 17 91830 36615 63360560
Acquired haemophilia 16.64 10.27 13 91834 1018 63396157
Encephalopathy 16.50 10.27 104 91743 38516 63358659
Dizziness 16.43 10.27 485 91362 429440 62967735
Endophthalmitis 16.41 10.27 23 91824 3569 63393606
Arteritis infective 16.35 10.27 5 91842 44 63397131
Rash morbilliform 16.26 10.27 22 91825 3303 63393872
Fall 16.20 10.27 708 91139 391626 63005549
Feeling abnormal 16.17 10.27 137 91710 148255 63248920
Tongue exfoliation 16.15 10.27 6 91841 100 63397075
Pseudomonas infection 16.13 10.27 44 91803 11169 63386006
Spinal cord haematoma 16.12 10.27 7 91840 178 63396997
Toxicity to various agents 16.10 10.27 470 91377 246780 63150395
Osteoporosis 16.09 10.27 37 91810 57301 63339874
Sputum purulent 16.03 10.27 13 91834 1074 63396101
Septic embolus 15.99 10.27 12 91835 885 63396290
Sputum discoloured 15.93 10.27 56 91791 16291 63380884
Incorrect route of product administration 15.93 10.27 10 91837 27442 63369733
Portal fibrosis 15.93 10.27 8 91839 285 63396890
Drug tolerance decreased 15.89 10.27 3 91844 17470 63379705
Product dose omission issue 15.81 10.27 241 91606 234072 63163103
Trichoglossia 15.77 10.27 8 91839 291 63396884
Diabetic ketoacidosis 15.77 10.27 5 91842 20500 63376675
Early retirement 15.75 10.27 4 91843 16 63397159
Angioedema 15.69 10.27 121 91726 47844 63349331
Pneumocystis jirovecii pneumonia 15.68 10.27 57 91790 16857 63380318
Somnolence 15.66 10.27 174 91673 178511 63218664
Quadriplegia 15.65 10.27 16 91831 1784 63395391
Foetal exposure during pregnancy 15.52 10.27 14 91833 31948 63365227
Rheumatoid nodule 15.48 10.27 3 91844 17152 63380023
Hallucination, visual 15.39 10.27 62 91785 19236 63377939
Blast cell count increased 15.36 10.27 9 91838 437 63396738
Foot deformity 15.02 10.27 11 91836 27842 63369333
Splenic vein thrombosis 15.01 10.27 8 91839 323 63396852
Interstitial lung disease 14.93 10.27 146 91701 61762 63335413
Cross sensitivity reaction 14.91 10.27 17 91830 2145 63395030
Generalised tonic-clonic seizure 14.89 10.27 82 91765 28934 63368241
Cytokine storm 14.89 10.27 8 91839 328 63396847
Myoclonic dystonia 14.86 10.27 4 91843 21 63397154
Mechanical urticaria 14.82 10.27 9 91838 467 63396708
Lymphomatoid papulosis 14.75 10.27 6 91841 129 63397046
Purpura 14.74 10.27 43 91804 11342 63385833
Treatment failure 14.74 10.27 201 91646 198842 63198333
Antibiotic associated colitis 14.55 10.27 3 91844 3 63397172
Gastrointestinal amyloidosis 14.53 10.27 5 91842 66 63397109
Paranasal sinus inflammation 14.50 10.27 9 91838 486 63396689
Injection site pruritus 14.44 10.27 27 91820 45089 63352086
Dysphonia 14.41 10.27 118 91729 47496 63349679
Bronchitis chronic 14.41 10.27 24 91823 4329 63392846
Device malfunction 14.37 10.27 4 91843 17853 63379322
Red blood cell sedimentation rate increased 14.37 10.27 26 91821 43956 63353219
Cerebral hypoperfusion 14.36 10.27 8 91839 353 63396822
Bacterial infection 14.26 10.27 61 91786 19438 63377737
Iron deficiency 14.25 10.27 32 91815 7198 63389977
Adverse drug reaction 14.25 10.27 63 91784 79651 63317524
Acute graft versus host disease in skin 14.16 10.27 21 91826 3431 63393744
Oral pruritus 14.11 10.27 17 91830 2274 63394901
Bacteraemia 14.05 10.27 56 91791 17292 63379883
Intestinal polyp 14.00 10.27 14 91833 1521 63395654
Toxic encephalopathy 13.96 10.27 30 91817 6549 63390626
Gastroenteritis staphylococcal 13.95 10.27 5 91842 75 63397100
Blood pressure systolic increased 13.78 10.27 30 91817 47367 63349808
Breast cancer 13.76 10.27 31 91816 48352 63348823
Cholangitis 13.74 10.27 27 91820 5534 63391641
SJS-TEN overlap 13.72 10.27 8 91839 385 63396790
Anterior chamber flare 13.71 10.27 5 91842 79 63397096
Coronary artery disease 13.66 10.27 16 91831 32361 63364814
Acute sinusitis 13.64 10.27 22 91825 3865 63393310
Lividity 13.59 10.27 7 91840 263 63396912
Hot flush 13.57 10.27 34 91813 51125 63346050
Injection site mass 13.56 10.27 5 91842 18651 63378524
Administration site oedema 13.53 10.27 4 91843 31 63397144
Obesity 13.52 10.27 14 91833 29938 63367237
Haematoma muscle 13.49 10.27 12 91835 1125 63396050
Hypercholesterolaemia 13.48 10.27 7 91840 21327 63375848
Thrombophlebitis septic 13.48 10.27 6 91841 162 63397013
Septic pulmonary embolism 13.48 10.27 5 91842 83 63397092
Enteritis infectious 13.47 10.27 16 91831 2108 63395067
Hydrocephalus 13.42 10.27 26 91821 5274 63391901
Mitochondrial enzyme deficiency 13.42 10.27 4 91843 32 63397143
Lip dry 13.35 10.27 3 91844 15467 63381708
Acute myeloid leukaemia recurrent 13.35 10.27 14 91833 1609 63395566
Prescribed underdose 13.26 10.27 14 91833 29675 63367500
Osteopenia 13.25 10.27 6 91841 19779 63377396
Sputum increased 13.15 10.27 17 91830 2442 63394733
Gastrooesophageal reflux disease 12.96 10.27 83 91764 95556 63301619
Neutrophilic dermatosis 12.96 10.27 6 91841 178 63396997
Drug dependence 12.78 10.27 10 91837 24473 63372702
Microscopic polyangiitis 12.74 10.27 6 91841 185 63396990
Joint stiffness 12.59 10.27 26 91821 41843 63355332
Subretinal fluid 12.53 10.27 8 91839 454 63396721
Perihepatic discomfort 12.47 10.27 3 91844 9 63397166
Infective exacerbation of chronic obstructive airways disease 12.46 10.27 12 91835 1245 63395930
Bronchial wall thickening 12.45 10.27 13 91834 1486 63395689
Gastric cyst 12.44 10.27 5 91842 104 63397071
Blastomycosis 12.42 10.27 7 91840 316 63396859
Creatinine renal clearance increased 12.41 10.27 9 91838 630 63396545
Nodular rash 12.34 10.27 6 91841 199 63396976
Vitreous opacities 12.33 10.27 7 91840 320 63396855
Bone density decreased 12.28 10.27 3 91844 14609 63382566
Multiple sclerosis relapse 12.26 10.27 33 91814 48445 63348730
Hyperamylasaemia 12.25 10.27 8 91839 472 63396703
Arteritis 12.25 10.27 9 91838 643 63396532
Blood glucose increased 12.23 10.27 71 91776 83685 63313490
Underdose 12.20 10.27 13 91834 27443 63369732
Nasal polyps 12.20 10.27 27 91820 6012 63391163
Petechiae 12.18 10.27 46 91801 13851 63383324
Injection site rash 12.14 10.27 6 91841 18803 63378372
Dysphemia 12.03 10.27 17 91830 2658 63394517
Strangury 12.01 10.27 3 91844 11 63397164
Vomiting 11.96 10.27 952 90895 558665 62838510
Drug withdrawal syndrome 11.95 10.27 13 91834 27181 63369994
Device related infection 11.93 10.27 66 91781 23326 63373849
Dry mouth 11.92 10.27 65 91782 77798 63319377
Fungaemia 11.90 10.27 16 91831 2387 63394788
Purpura non-thrombocytopenic 11.90 10.27 5 91842 117 63397058
Aspergillus infection 11.89 10.27 32 91815 8061 63389114
Engraftment syndrome 11.84 10.27 8 91839 500 63396675
Pupillary block 11.81 10.27 3 91844 12 63397163
Nodule 11.74 10.27 8 91839 21018 63376157
CNS ventriculitis 11.70 10.27 5 91842 122 63397053
Injection site urticaria 11.62 10.27 3 91844 14070 63383105
Intentional self-injury 11.60 10.27 12 91835 25675 63371500
Prurigo 11.57 10.27 10 91837 902 63396273
Mitral valve disease 11.51 10.27 16 91831 2464 63394711
Connective tissue inflammation 11.47 10.27 4 91843 55 63397120
Tonsillitis bacterial 11.44 10.27 5 91842 129 63397046
Eye irritation 11.43 10.27 9 91838 21962 63375213
Coma 11.42 10.27 51 91796 64313 63332862
Incision site pain 11.38 10.27 11 91836 1147 63396028
Ventricular tachycardia 11.31 10.27 58 91789 19921 63377254
Lower limb fracture 11.30 10.27 11 91836 24210 63372965
Enterobacter infection 11.30 10.27 15 91832 2212 63394963
Muscle spasticity 11.25 10.27 9 91838 21785 63375390
Influenza like illness 11.24 10.27 54 91793 66770 63330405
Blood alkaline phosphatase increased 11.19 10.27 103 91744 42864 63354311
Walking disability 11.19 10.27 12 91835 1415 63395760
Corynebacterium infection 11.14 10.27 8 91839 551 63396624
Kussmaul respiration 11.13 10.27 6 91841 248 63396927
Cardiovascular disorder 11.11 10.27 40 91807 11772 63385403
Eye infection fungal 11.10 10.27 5 91842 139 63397036
Asteatosis 11.10 10.27 4 91843 61 63397114
Rhonchi 11.04 10.27 16 91831 2560 63394615
Immune reconstitution inflammatory syndrome 10.97 10.27 26 91821 6058 63391117
Polyneuropathy 10.95 10.27 46 91801 14543 63382632
Cerebellar ischaemia 10.92 10.27 4 91843 64 63397111
Ulcer 10.91 10.27 13 91834 26094 63371081
Haemoptysis 10.85 10.27 75 91772 28651 63368524
Lip erosion 10.84 10.27 10 91837 983 63396192
Polymerase chain reaction positive 10.81 10.27 5 91842 148 63397027
Withdrawal syndrome 10.65 10.27 8 91839 19989 63377186
Trunk injury 10.54 10.27 3 91844 20 63397155
Pericarditis tuberculous 10.54 10.27 3 91844 20 63397155
Exposure to fungus 10.51 10.27 5 91842 158 63397017
Haematidrosis 10.49 10.27 4 91843 72 63397103
Anal candidiasis 10.41 10.27 3 91844 21 63397154
Drug intolerance 10.37 10.27 354 91493 308307 63088868
Genital burning sensation 10.34 10.27 6 91841 286 63396889

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
Tendon rupture 416.17 10.65 232 75420 6780 34874499
Tendonitis 394.20 10.65 246 75406 8894 34872385
Tendon pain 343.67 10.65 155 75497 2840 34878439
Drug reaction with eosinophilia and systemic symptoms 260.78 10.65 339 75313 32673 34848606
Tendon disorder 212.26 10.65 110 75542 2765 34878514
Febrile neutropenia 208.10 10.65 710 74942 136139 34745140
Pneumonia 153.60 10.65 1321 74331 361306 34519973
Pyrexia 140.85 10.65 1213 74439 331800 34549479
Completed suicide 138.55 10.65 23 75629 98145 34783134
Drug abuse 138.14 10.65 24 75628 99072 34782207
Drug hypersensitivity 125.00 10.65 421 75231 80108 34801171
Toxicity to various agents 124.92 10.65 150 75502 200212 34681067
Tendon discomfort 113.47 10.65 36 75616 230 34881049
Electrocardiogram QT prolonged 93.93 10.65 246 75406 40706 34840573
Drug resistance 91.93 10.65 185 75467 25742 34855537
Congenital hiatus hernia 88.39 10.65 41 75611 803 34880476
Neuropathy peripheral 80.28 10.65 375 75277 82888 34798391
Rash maculo-papular 80.20 10.65 185 75467 28266 34853013
Mycotic allergy 77.89 10.65 34 75618 574 34880705
Pathogen resistance 77.36 10.65 99 75553 9383 34871896
Cytokine release syndrome 74.94 10.65 158 75494 22719 34858560
Mite allergy 73.20 10.65 34 75618 668 34880611
Spirometry abnormal 72.20 10.65 34 75618 690 34880589
Cholestasis 67.09 10.65 167 75485 26781 34854498
Intentional overdose 66.81 10.65 8 75644 43666 34837613
Neutropenia 66.40 10.65 572 75080 156206 34725073
Dust allergy 64.97 10.65 34 75618 872 34880407
Myocardial infarction 63.97 10.65 102 75550 120983 34760296
Eosinophilia 63.71 10.65 161 75491 26061 34855218
Foetal exposure during pregnancy 63.48 10.65 5 75647 38096 34843183
Weight increased 62.97 10.65 65 75587 92968 34788311
Acute myeloid leukaemia 61.96 10.65 128 75524 18142 34863137
Conjunctivitis allergic 59.46 10.65 35 75617 1135 34880144
Hepatocellular injury 58.86 10.65 141 75511 22070 34859209
Lip oedema 58.19 10.65 47 75605 2566 34878713
Pancytopenia 57.70 10.65 378 75274 94779 34786500
Eosinophilic pneumonia acute 55.65 10.65 26 75626 518 34880761
Vertebral artery dissection 55.35 10.65 14 75638 32 34881247
Inappropriate schedule of product administration 52.68 10.65 35 75617 62261 34819018
Tracheobronchomegaly 51.96 10.65 12 75640 15 34881264
Immune reconstitution inflammatory syndrome 51.32 10.65 78 75574 8681 34872598
Aortitis 51.20 10.65 23 75629 417 34880862
Chorea 50.01 10.65 31 75621 1106 34880173
Purpura 49.69 10.65 84 75568 10227 34871052
Cerebrovascular accident 49.11 10.65 67 75585 84744 34796535
Blood bilirubin increased 48.12 10.65 187 75465 38109 34843170
Fixed eruption 47.53 10.65 35 75617 1665 34879614
Cross sensitivity reaction 46.53 10.65 32 75620 1365 34879914
Platelet count decreased 45.11 10.65 426 75226 119291 34761988
Toxic skin eruption 44.92 10.65 85 75567 11300 34869979
Tubulointerstitial nephritis 44.86 10.65 123 75529 20901 34860378
Dizziness 44.33 10.65 284 75368 218237 34663042
Fall 43.58 10.65 259 75393 202626 34678653
Full blood count abnormal 42.64 10.65 112 75540 18556 34862723
Delusion of grandeur 42.04 10.65 28 75624 1132 34880147
Fatigue 41.66 10.65 559 75093 370094 34511185
Therapeutic product effect decreased 41.19 10.65 12 75640 34731 34846548
Neurotoxicity 41.08 10.65 108 75544 17902 34863377
Bronchopulmonary aspergillosis 40.95 10.65 95 75557 14564 34866715
Myoclonus 40.66 10.65 95 75557 14630 34866649
Degenerative mitral valve disease 40.17 10.65 17 75635 265 34881014
Somnolence 40.01 10.65 116 75536 111000 34770279
Septic shock 39.73 10.65 279 75373 71555 34809724
Vascular purpura 39.64 10.65 32 75620 1746 34879533
Ballismus 39.24 10.65 13 75639 97 34881182
Chest pain 38.94 10.65 142 75510 126620 34754659
Aspartate aminotransferase increased 38.50 10.65 265 75387 67518 34813761
Affective disorder 37.91 10.65 47 75605 4313 34876966
Hepatitis cholestatic 37.31 10.65 64 75588 7883 34873396
Suicide attempt 37.29 10.65 19 75633 39097 34842182
Neutrophil count decreased 37.27 10.65 213 75439 50891 34830388
Drug-induced liver injury 37.21 10.65 142 75510 28690 34852589
Breath sounds abnormal 37.13 10.65 59 75593 6822 34874457
Blood pressure increased 37.07 10.65 85 75567 88017 34793262
Headache 37.07 10.65 268 75384 200367 34680912
Product dose omission issue 36.83 10.65 134 75518 119577 34761702
Respiratory failure 36.35 10.65 377 75275 108195 34773084
Death 36.28 10.65 625 75027 397424 34483855
Dermatitis exfoliative generalised 35.56 10.65 42 75610 3665 34877614
Thrombocytopenia 35.48 10.65 504 75148 155743 34725536
Tracheal oedema 35.09 10.65 8 75644 9 34881270
Lymphocyte count decreased 34.80 10.65 118 75534 22504 34858775
Productive cough 34.72 10.65 168 75484 37645 34843634
Encephalopathy 34.68 10.65 160 75492 35159 34846120
Pulmonary alveolar haemorrhage 34.62 10.65 60 75592 7452 34873827
Overdose 34.30 10.65 93 75559 90966 34790313
Malignant melanoma in situ 34.15 10.65 29 75623 1699 34879580
Bradycardia 34.01 10.65 70 75582 75348 34805931
Chronic pigmented purpura 33.78 10.65 12 75640 113 34881166
Pneumonitis 33.65 10.65 154 75498 33724 34847555
Clostridium difficile colitis 33.53 10.65 92 75560 15638 34865641
Agranulocytosis 32.97 10.65 120 75532 23701 34857578
Fusarium infection 32.70 10.65 24 75628 1136 34880143
Toxic epidermal necrolysis 32.50 10.65 112 75540 21534 34859745
Alanine aminotransferase increased 32.14 10.65 291 75361 80524 34800755
Plasma cell myeloma 31.83 10.65 177 75475 41860 34839419
Stress 31.64 10.65 13 75639 30334 34850945
Acute myocardial infarction 31.53 10.65 42 75610 53677 34827602
Drug dependence 31.33 10.65 7 75645 24210 34857069
Aortic rupture 31.02 10.65 11 75641 103 34881176
Klebsiella infection 30.38 10.65 61 75591 8470 34872809
Pneumothorax spontaneous 30.21 10.65 18 75634 597 34880682
Rhinalgia 30.16 10.65 22 75630 1031 34880248
Dysbiosis 30.16 10.65 17 75635 507 34880772
Aminoaciduria 30.10 10.65 14 75638 276 34881003
Sleep disorder due to a general medical condition 29.89 10.65 46 75606 5175 34876104
Delirium 29.27 10.65 179 75473 43812 34837467
Rheumatoid arthritis 29.07 10.65 24 75628 38214 34843065
Musculoskeletal injury 28.74 10.65 11 75641 130 34881149
Myoclonic dystonia 28.04 10.65 9 75643 60 34881219
Normochromic normocytic anaemia 27.74 10.65 40 75612 4247 34877032
Clostridium difficile infection 27.69 10.65 97 75555 18801 34862478
Nicotine dependence 27.56 10.65 17 75635 601 34880678
Palatal oedema 26.95 10.65 19 75633 844 34880435
Candida infection 26.89 10.65 92 75560 17623 34863656
Bronchostenosis 26.86 10.65 13 75639 281 34880998
General physical health deterioration 26.84 10.65 165 75487 128104 34753175
Injection site pain 26.66 10.65 27 75625 38978 34842301
Feeling abnormal 26.60 10.65 61 75591 63174 34818105
Intentional product misuse 26.42 10.65 36 75616 45575 34835704
White blood cell count decreased 26.28 10.65 319 75333 95126 34786153
Eosinophilic pneumonia 26.14 10.65 35 75617 3466 34877813
Joint noise 26.12 10.65 17 75635 661 34880618
Blood pressure fluctuation 26.02 10.65 11 75641 25238 34856041
Pulmonary vascular disorder 25.75 10.65 17 75635 677 34880602
Psoriasis 25.26 10.65 28 75624 38784 34842495
Haematoma muscle 25.09 10.65 22 75630 1346 34879933
Small fibre neuropathy 25.04 10.65 9 75643 88 34881191
Respiratory depression 24.78 10.65 3 75649 16242 34865037
Respiratory arrest 24.74 10.65 15 75637 28028 34853251
Eye injury 24.73 10.65 18 75634 841 34880438
Tuberculosis of central nervous system 24.66 10.65 11 75641 196 34881083
Gluten sensitivity 24.57 10.65 7 75645 29 34881250
Inferior vena cava dilatation 24.35 10.65 17 75635 743 34880536
Conjunctival hyperaemia 24.35 10.65 28 75624 2374 34878905
Ulcerative keratitis 24.35 10.65 24 75628 1705 34879574
Ventricular enlargement 24.00 10.65 16 75636 648 34880631
Haematotoxicity 23.87 10.65 54 75598 8140 34873139
Sepsis 23.87 10.65 499 75153 166062 34715217
Lactobacillus infection 23.43 10.65 12 75640 294 34880985
Diabetes mellitus 23.32 10.65 41 75611 46832 34834447
Acute kidney injury 23.27 10.65 842 74810 304146 34577133
Prostate cancer 23.27 10.65 31 75621 39618 34841661
Normocytic anaemia 23.22 10.65 27 75625 2317 34878962
Hypocoagulable state 23.18 10.65 18 75634 928 34880351
Mucosal inflammation 23.12 10.65 153 75499 38469 34842810
Drug intolerance 23.06 10.65 60 75592 59510 34821769
Haemophagocytic lymphohistiocytosis 22.96 10.65 71 75581 12902 34868377
Cardiac aneurysm 22.94 10.65 18 75634 942 34880337
Pseudomembranous colitis 22.54 10.65 29 75623 2762 34878517
Nervous system disorder 22.49 10.65 76 75576 14467 34866812
Cardiogenic shock 22.43 10.65 15 75637 26603 34854676
Nodule 22.21 10.65 47 75605 6772 34874507
Helicobacter test positive 22.21 10.65 17 75635 858 34880421
Tuberculoma of central nervous system 22.11 10.65 11 75641 253 34881026
Weight decreased 21.92 10.65 260 75392 176041 34705238
Sedation 21.89 10.65 9 75643 20997 34860282
Nephrolithiasis 21.89 10.65 20 75632 30313 34850966
Nephrogenic diabetes insipidus 21.77 10.65 20 75632 1301 34879978
Torsade de pointes 21.55 10.65 48 75604 7161 34874118
Unmasking of previously unidentified disease 21.55 10.65 17 75635 897 34880382
Crystal nephropathy 21.48 10.65 13 75639 444 34880835
Lymphocyte count abnormal 21.44 10.65 19 75633 1179 34880100
Tendon injury 21.29 10.65 17 75635 913 34880366
Respiratory muscle weakness 21.25 10.65 8 75644 90 34881189
Neuritis 21.22 10.65 17 75635 917 34880362
Blood cholesterol increased 21.09 10.65 9 75643 20534 34860745
Lateral medullary syndrome 21.04 10.65 7 75645 53 34881226
Long QT syndrome 20.90 10.65 28 75624 2775 34878504
Demodicidosis 20.88 10.65 10 75642 211 34881068
Hepatotoxicity 20.84 10.65 97 75555 21388 34859891
Drug ineffective for unapproved indication 20.79 10.65 104 75548 23611 34857668
Sebaceous adenitis 20.55 10.65 4 75648 0 34881279
Gallbladder empyema 20.39 10.65 7 75645 59 34881220
Cardiac failure congestive 20.20 10.65 102 75550 83168 34798111
Time perception altered 20.15 10.65 8 75644 105 34881174
Botulism 20.09 10.65 9 75643 162 34881117
Benign prostatic hyperplasia 20.04 10.65 73 75579 14422 34866857
Linear IgA disease 20.04 10.65 21 75631 1605 34879674
Paradoxical drug reaction 19.85 10.65 30 75622 3321 34877958
Subacute endocarditis 19.79 10.65 7 75645 65 34881214
Hypoxia 19.71 10.65 194 75458 54901 34826378
Angular cheilitis 19.70 10.65 9 75643 170 34881109
Allergic cough 19.67 10.65 6 75646 33 34881246
Musculoskeletal stiffness 19.65 10.65 45 75607 46635 34834644
Bronchiectasis 19.59 10.65 56 75596 9745 34871534
Leukopenia 19.49 10.65 215 75437 62641 34818638
Hyperbilirubinaemia 19.35 10.65 80 75572 16763 34864516
Hepatic function abnormal 19.32 10.65 163 75489 44200 34837079
Sensitisation 19.28 10.65 9 75643 179 34881100
Eosinophilic myocarditis 19.23 10.65 13 75639 539 34880740
Ligament pain 19.09 10.65 6 75646 37 34881242
Hypertension 19.02 10.65 196 75456 136247 34745032
Factor V inhibition 18.88 10.65 9 75643 188 34881091
Weight bearing difficulty 18.87 10.65 17 75635 1078 34880201
Distributive shock 18.77 10.65 18 75634 1236 34880043
Acute respiratory distress syndrome 18.76 10.65 108 75544 25861 34855418
Pain 18.68 10.65 321 75331 204354 34676925
Retinal pigment epithelial tear 18.54 10.65 10 75642 273 34881006
Anaphylactoid reaction 18.53 10.65 24 75628 2301 34878978
Corneal opacity 18.53 10.65 13 75639 573 34880706
Wheezing 18.49 10.65 153 75499 41249 34840030
Pulmonary vasculitis 18.27 10.65 13 75639 586 34880693
Tubulointerstitial nephritis and uveitis syndrome 18.19 10.65 7 75645 84 34881195
Neuroleptic malignant syndrome 18.18 10.65 8 75644 17926 34863353
Hydrocephalus 18.14 10.65 37 75615 5195 34876084
Malaise 18.08 10.65 288 75364 185537 34695742
Fat tissue decreased 17.69 10.65 7 75645 91 34881188
Arthritis fungal 17.49 10.65 7 75645 94 34881185
Pneumonia bacterial 17.45 10.65 61 75591 11811 34869468
Mixed liver injury 17.42 10.65 26 75626 2847 34878432
Drug eruption 17.26 10.65 87 75565 19811 34861468
Stenotrophomonas infection 17.16 10.65 22 75630 2088 34879191
Serotonin syndrome 17.11 10.65 11 75641 19922 34861357
Hypoglycaemia 16.99 10.65 187 75465 54453 34826826
Suicidal ideation 16.95 10.65 39 75613 40349 34840930
Thrombotic microangiopathy 16.83 10.65 56 75596 10574 34870705
Diabetic bullosis 16.79 10.65 5 75647 25 34881254
Hepatic cytolysis 16.77 10.65 69 75583 14427 34866852
Infective pulmonary exacerbation of cystic fibrosis 16.76 10.65 42 75610 6759 34874520
Acute myeloid leukaemia recurrent 16.67 10.65 22 75630 2148 34879131
Vasculitis 16.56 10.65 58 75594 11238 34870041
Sleep apnoea syndrome 16.40 10.65 12 75640 20309 34860970
Muscle discomfort 16.32 10.65 7 75645 113 34881166
Bronchial haemorrhage 16.31 10.65 13 75639 696 34880583
Immune effector cell-associated neurotoxicity syndrome 16.26 10.65 29 75623 3684 34877595
Rash 16.23 10.65 612 75040 222140 34659139
Henoch-Schonlein purpura 16.22 10.65 19 75633 1643 34879636
Coma 16.19 10.65 48 75604 45630 34835649
Occult blood 16 10.65 14 75638 854 34880425
Accidental exposure to product 15.97 10.65 4 75648 12798 34868481
Pneumonia legionella 15.94 10.65 20 75632 1857 34879422
Migraine 15.91 10.65 9 75643 17469 34863810
Burn oesophageal 15.90 10.65 6 75646 68 34881211
Transaminases increased 15.89 10.65 106 75546 26717 34854562
Ciliary hyperaemia 15.89 10.65 5 75647 31 34881248
Oedema 15.84 10.65 160 75492 45581 34835698
Micturition urgency 15.77 10.65 40 75612 6485 34874794
Hypoalbuminaemia 15.74 10.65 60 75592 12114 34869165
Vitreous detachment 15.72 10.65 14 75638 874 34880405
Wrong technique in product usage process 15.71 10.65 34 75618 35952 34845327
Systolic dysfunction 15.70 10.65 24 75628 2684 34878595
Drug withdrawal syndrome 15.64 10.65 12 75640 19822 34861457
Cranial nerve injury 15.41 10.65 3 75649 0 34881279
Diabetic ketoacidosis 15.41 10.65 10 75642 18022 34863257
Multiple organ dysfunction syndrome 15.40 10.65 242 75410 76324 34804955
Anterior chamber flare 15.37 10.65 6 75646 75 34881204
Persistent corneal epithelial defect 15.37 10.65 5 75647 35 34881244
Diabetes mellitus inadequate control 15.33 10.65 5 75647 13459 34867820
Disseminated intravascular coagulation 15.29 10.65 90 75562 21726 34859553
Oesophageal oedema 15.29 10.65 4 75648 11 34881268
Glycosylated haemoglobin increased 15.28 10.65 3 75649 11357 34869922
Dermatitis bullous 15.27 10.65 41 75611 6881 34874398
Blast cell count increased 15.25 10.65 15 75637 1063 34880216
Cataract subcapsular 15.20 10.65 10 75642 396 34880883
Colour blindness acquired 15.09 10.65 6 75646 79 34881200
Cystitis haemorrhagic 14.98 10.65 36 75616 5643 34875636
Haemarthrosis 14.98 10.65 26 75626 3233 34878046
Peripheral sensory neuropathy 14.87 10.65 40 75612 6720 34874559
Disseminated mucormycosis 14.83 10.65 11 75641 529 34880750
Phlebosclerosis 14.73 10.65 7 75645 145 34881134
Heart rate decreased 14.70 10.65 29 75623 31716 34849563
Paranoia 14.62 10.65 4 75648 12064 34869215
Pneumonia fungal 14.61 10.65 41 75611 7059 34874220
Respiratory distress 14.46 10.65 129 75523 35536 34845743
Peptic ulcer haemorrhage 14.46 10.65 11 75641 550 34880729
Erectile dysfunction 14.43 10.65 14 75638 20623 34860656
Pancreatitis 14.42 10.65 40 75612 38851 34842428
Respiratory alkalosis 14.18 10.65 18 75634 1691 34879588
Syncope 14.16 10.65 128 75524 91323 34789956
Bronchitis 14.15 10.65 146 75506 41817 34839462
Gastrointestinal haemorrhage 14.07 10.65 123 75529 88354 34792925
Duodenal stenosis 14.06 10.65 8 75644 243 34881036
Cholangitis 13.96 10.65 46 75606 8643 34872636
Amoebic colitis 13.92 10.65 6 75646 98 34881181
Pneumonia pseudomonal 13.91 10.65 28 75624 3894 34877385
COVID-19 pneumonia 13.89 10.65 73 75579 16894 34864385
Fungaemia 13.83 10.65 22 75630 2546 34878733
Cell death 13.82 10.65 21 75631 2336 34878943
Acute generalised exanthematous pustulosis 13.82 10.65 39 75613 6737 34874542
Bacterial translocation 13.80 10.65 9 75643 351 34880928
Irritability 13.79 10.65 20 75632 24670 34856609
Exercise tolerance decreased 13.77 10.65 33 75619 5165 34876114
Rectal haemorrhage 13.76 10.65 43 75609 40206 34841073
Accidental overdose 13.69 10.65 14 75638 20126 34861153
Injection site swelling 13.63 10.65 4 75648 11523 34869756
Muscle atrophy 13.55 10.65 41 75611 7363 34873916
Abdominal pain 13.54 10.65 261 75391 163357 34717922
Dehydration 13.46 10.65 199 75453 129770 34751509
Eczema asteatotic 13.36 10.65 8 75644 268 34881011
Epididymal disorder 13.34 10.65 3 75649 3 34881276
Hypersensitivity vasculitis 13.28 10.65 25 75627 3310 34877969
Corynebacterium test positive 13.27 10.65 4 75648 21 34881258
Thalamic infarction 13.21 10.65 12 75640 769 34880510
Precancerous condition 13.15 10.65 5 75647 58 34881221
Ascites 13.10 10.65 54 75598 46517 34834762
Peripheral venous disease 13.08 10.65 22 75630 2666 34878613
Type 2 lepra reaction 13.08 10.65 7 75645 188 34881091
Candida endophthalmitis 13.05 10.65 6 75646 115 34881164
Morganella infection 12.94 10.65 10 75642 512 34880767
Product substitution issue 12.89 10.65 3 75649 10092 34871187
Infusion related reaction 12.85 10.65 65 75587 52992 34828287
Muscle rupture 12.81 10.65 20 75632 2278 34879001
Intentional self-injury 12.67 10.65 7 75645 13764 34867515
Coronary artery occlusion 12.61 10.65 4 75648 10958 34870321
Eye haematoma 12.57 10.65 5 75647 66 34881213
Meningitis tuberculous 12.53 10.65 11 75641 674 34880605
Pseudomonas bronchitis 12.42 10.65 4 75648 27 34881252
Dystonia 12.40 10.65 4 75648 10841 34870438
Laryngeal oedema 12.39 10.65 25 75627 3483 34877796
Haemorrhagic pneumonia 12.38 10.65 6 75646 130 34881149
Haemoptysis 12.38 10.65 123 75529 34883 34846396
Device issue 12.30 10.65 3 75649 9774 34871505
CD4/CD8 ratio decreased 12.30 10.65 4 75648 28 34881251
Pneumothorax 12.26 10.65 77 75575 19015 34862264
Laryngotracheal oedema 12.13 10.65 3 75649 6 34881273
Interleukin-2 receptor increased 12.10 10.65 6 75646 137 34881142
Hyposmia 12.09 10.65 7 75645 220 34881059
Ischaemic stroke 12.05 10.65 13 75639 18237 34863042
Lethargy 12 10.65 47 75605 41075 34840204
Intentional product use issue 11.95 10.65 78 75574 59738 34821541
Withdrawal syndrome 11.94 10.65 6 75646 12449 34868830
Stevens-Johnson syndrome 11.86 10.65 75 75577 18564 34862715
Immune reconstitution inflammatory syndrome associated tuberculosis 11.85 10.65 9 75643 449 34880830
FEV1/FVC ratio abnormal 11.83 10.65 4 75648 32 34881247
Organising pneumonia 11.79 10.65 34 75618 5945 34875334
Neuropsychiatric symptoms 11.75 10.65 12 75640 890 34880389
Wound 11.71 10.65 9 75643 14855 34866424
Liver disorder 11.70 10.65 116 75536 32881 34848398
Joint injury 11.68 10.65 45 75607 9128 34872151
Axonal neuropathy 11.68 10.65 13 75639 1064 34880215
Hiccups 11.67 10.65 48 75604 10034 34871245
Multiple sclerosis relapse 11.62 10.65 7 75645 13126 34868153
Ecthyma 11.61 10.65 9 75643 463 34880816
Malabsorption from administration site 11.59 10.65 5 75647 82 34881197
Flushing 11.54 10.65 34 75618 32386 34848893
Hyperuricaemia 11.54 10.65 41 75611 8002 34873277
Erythema multiforme 11.49 10.65 43 75609 8606 34872673
Abdominal discomfort 11.47 10.65 79 75573 59756 34821523
Keratic precipitates 11.46 10.65 6 75646 154 34881125
No adverse event 11.45 10.65 20 75632 22907 34858372
Lip haemorrhage 11.43 10.65 11 75641 759 34880520
Lower respiratory tract infection 11.39 10.65 33 75619 31604 34849675
Tongue oedema 11.36 10.65 22 75630 2975 34878304
Vitreous opacities 11.27 10.65 8 75644 359 34880920
Dementia 11.25 10.65 8 75644 13740 34867539
International normalised ratio increased 11.25 10.65 154 75498 47173 34834106
Coronary artery disease 11.24 10.65 60 75592 48245 34833034
Chronic fatigue syndrome 11.20 10.65 8 75644 363 34880916
Eye abscess 11.19 10.65 6 75646 162 34881117
Adverse reaction 11.18 10.65 22 75630 3009 34878270
Face oedema 11.17 10.65 52 75600 11464 34869815
Ocular pemphigoid 11.16 10.65 5 75647 90 34881189
Duodenitis 11.06 10.65 29 75623 4799 34876480
Rotator cuff syndrome 11.02 10.65 32 75620 5617 34875662
Endocarditis enterococcal 11.01 10.65 5 75647 93 34881186
Vasodilatation 10.96 10.65 13 75639 1139 34880140
Escherichia infection 10.96 10.65 41 75611 8204 34873075
Substance-induced psychotic disorder 10.93 10.65 16 75636 1722 34879557
Urinary tract inflammation 10.92 10.65 6 75646 170 34881109
Eosinophilic pleural effusion 10.92 10.65 7 75645 265 34881014
Alveolar lung disease 10.91 10.65 8 75644 378 34880901
Head injury 10.85 10.65 14 75638 18146 34863133
Corneal oedema 10.85 10.65 14 75638 1337 34879942
Optic neuropathy 10.81 10.65 17 75635 1948 34879331
Liver function test decreased 10.73 10.65 5 75647 99 34881180
Viral haemorrhagic cystitis 10.71 10.65 13 75639 1167 34880112

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
Tendon pain 807.43 9.90 326 146442 5332 79592288
Tendon rupture 691.74 9.90 370 146398 11756 79585864
Tendonitis 598.26 9.90 431 146337 23399 79574221
Drug reaction with eosinophilia and systemic symptoms 597.58 9.90 662 146106 63582 79534038
Drug hypersensitivity 564.87 9.90 1507 145261 297409 79300211
Sedation complication 493.75 9.90 326 146442 15343 79582277
Creatinine renal clearance decreased 468.58 9.90 340 146428 18662 79578958
Tendon disorder 451.71 9.90 234 146534 6952 79590668
Febrile neutropenia 422.29 9.90 1151 145617 229848 79367772
Blood calcium decreased 367.27 9.90 368 146400 31451 79566169
Completed suicide 318.33 9.90 39 146729 245728 79351892
Cognitive disorder 286.25 9.90 484 146284 69442 79528178
Orthostatic hypotension 285.26 9.90 429 146339 55735 79541885
Pneumonia 258.98 9.90 2086 144682 658160 78939460
Sedation 254.50 9.90 390 146378 51505 79546115
Pyrexia 237.83 9.90 2091 144677 676618 78921002
Arthropathy 210.94 9.90 36 146732 177075 79420545
Electrocardiogram QT prolonged 186.90 9.90 472 146296 89914 79507706
Depressed level of consciousness 185.73 9.90 491 146277 96161 79501459
Weight increased 170.00 9.90 156 146612 277230 79320390
Balance disorder 164.02 9.90 476 146292 98381 79499239
Pemphigus 160.38 9.90 5 146763 99577 79498043
Rash maculo-papular 158.12 9.90 331 146437 55747 79541873
Drug resistance 152.97 9.90 277 146491 41936 79555684
Neuropathy peripheral 152.93 9.90 589 146179 140716 79456904
Synovitis 152.59 9.90 44 146724 150690 79446930
Maternal exposure during pregnancy 149.45 9.90 34 146734 136504 79461116
Drug abuse 146.43 9.90 58 146710 162633 79434987
Glossodynia 142.42 9.90 13 146755 103324 79494296
Intentional overdose 141.65 9.90 15 146753 105945 79491675
Pathogen resistance 140.55 9.90 152 146616 14190 79583430
Systemic lupus erythematosus 137.01 9.90 28 146740 121121 79476499
Tendon discomfort 136.80 9.90 46 146722 433 79597187
Toxic epidermal necrolysis 132.57 9.90 269 146499 44312 79553308
International normalised ratio fluctuation 128.97 9.90 80 146688 3374 79594246
Contrast media allergy 124.60 9.90 70 146698 2452 79595168
Wound 121.16 9.90 32 146736 116147 79481473
Neurotoxicity 118.60 9.90 214 146554 32304 79565316
Bloody discharge 118.17 9.90 62 146706 1891 79595729
Discomfort 115.99 9.90 43 146725 125574 79472046
Cholestasis 114.95 9.90 279 146489 51830 79545790
Neutropenia 110.59 9.90 906 145862 286804 79310816
Cytokine release syndrome 110.36 9.90 220 146548 35778 79561842
Therapeutic product effect decreased 107.84 9.90 86 146682 163777 79433843
Duodenal ulcer perforation 107.80 9.90 3 146765 66208 79531412
Thrombocytopenia 107.76 9.90 846 145922 264413 79333207
Respiratory failure 106.93 9.90 633 146135 180278 79417342
Eosinophilia 106.74 9.90 249 146519 45096 79552524
Helicobacter infection 103.97 9.90 6 146762 69698 79527922
Blood cholesterol increased 101.91 9.90 16 146752 83704 79513916
Clostridium difficile colitis 98.61 9.90 197 146571 32086 79565534
Neutrophil count decreased 97.02 9.90 386 146382 93573 79504047
Headache 96.60 9.90 756 146012 653016 78944604
Exposure during pregnancy 94.41 9.90 34 146734 101098 79496522
Joint swelling 93.83 9.90 249 146519 288397 79309223
Congenital hiatus hernia 92.42 9.90 40 146728 784 79596836
Rheumatoid arthritis 91.13 9.90 152 146616 208318 79389302
Pericarditis 90.79 9.90 39 146729 104197 79493423
Psoriatic arthropathy 90.34 9.90 17 146751 77982 79519638
Septic shock 90.26 9.90 456 146312 122345 79475275
Computerised tomogram thorax abnormal 90.25 9.90 56 146712 2363 79595257
Pancytopenia 89.14 9.90 566 146202 165179 79432441
Myoclonus 87.15 9.90 171 146597 27489 79570131
Constipation 86.98 9.90 849 145919 282201 79315419
Abdominal discomfort 86.35 9.90 210 146558 250517 79347103
Lip oedema 85.95 9.90 80 146688 6236 79591384
Peripheral swelling 84.32 9.90 237 146531 269380 79328240
Nasopharyngitis 84.04 9.90 217 146551 253664 79343956
Musculoskeletal stiffness 83.75 9.90 120 146648 174888 79422732
Clostridium difficile infection 83.12 9.90 218 146550 42467 79555153
Platelet count decreased 82.98 9.90 628 146140 194036 79403584
Pseudomembranous colitis 80.83 9.90 72 146696 5302 79592318
Irritable bowel syndrome 80.21 9.90 10 146758 62231 79535389
Vascular purpura 79.94 9.90 57 146711 3041 79594579
Suicide attempt 78.92 9.90 27 146741 82905 79514715
Hypoxia 78.43 9.90 387 146381 102856 79494764
Injection site pain 78.31 9.90 74 146694 129764 79467856
Lyme disease 78.18 9.90 58 146710 3292 79594328
Spirometry abnormal 77.35 9.90 37 146731 922 79596698
Atelectasis 76.86 9.90 178 146590 32079 79565541
Crystal nephropathy 76.29 9.90 42 146726 1413 79596207
Mobility decreased 75.74 9.90 433 146335 121742 79475878
Toxic skin eruption 75.36 9.90 142 146626 22151 79575469
Computerised tomogram thorax 74.95 9.90 29 146739 421 79597199
Impaired healing 74.44 9.90 34 146734 87621 79509999
Acute myeloid leukaemia 74.22 9.90 171 146597 30714 79566906
Acute generalised exanthematous pustulosis 73.99 9.90 122 146646 17132 79580488
Alopecia 71.86 9.90 204 146564 231151 79366469
Fatigue 71.59 9.90 1243 145525 928484 78669136
Blood bilirubin increased 71.53 9.90 276 146492 65956 79531664
Lower respiratory tract infection 70.75 9.90 80 146688 129140 79468480
Hepatic function abnormal 69.66 9.90 293 146475 72814 79524806
Inappropriate schedule of product administration 68.62 9.90 87 146681 133541 79464079
Blood pressure increased 68.15 9.90 183 146585 211177 79386443
Pneumonitis 66.86 9.90 255 146513 60605 79537015
Haemophagocytic lymphohistiocytosis 66.38 9.90 133 146635 21704 79575916
Loss of employment 65.38 9.90 47 146721 2540 79595080
Torsade de pointes 65.27 9.90 123 146645 19189 79578431
Myocardial infarction 65.13 9.90 152 146616 183977 79413643
Bronchopulmonary aspergillosis 64.47 9.90 133 146635 22161 79575459
Infusion related reaction 63.70 9.90 214 146554 230023 79367597
Dizziness 63.45 9.90 641 146127 525800 79071820
Dysbiosis 63.40 9.90 35 146733 1184 79596436
Hypocoagulable state 63.39 9.90 43 146725 2116 79595504
Delirium 62.69 9.90 315 146453 84312 79513308
Eosinophilic pneumonia 62.33 9.90 62 146706 5248 79592372
Respiratory muscle weakness 61.81 9.90 23 146745 298 79597322
Injection site reaction 61.23 9.90 13 146755 54772 79542848
Sepsis 61.06 9.90 761 146007 268667 79328953
Mite allergy 60.38 9.90 34 146734 1196 79596424
Cerebrovascular accident 60.04 9.90 122 146646 155170 79442450
Overdose 59.75 9.90 159 146609 184047 79413573
Conjunctivitis allergic 59.61 9.90 38 146730 1682 79595938
Purpura 59.44 9.90 119 146649 19408 79578212
Product dose omission issue 59.38 9.90 244 146524 247293 79350327
Stress 58.64 9.90 37 146731 79575 79518045
Sleep disorder due to general medical condition, insomnia type 58.63 9.90 6 146762 43550 79554070
Immune reconstitution inflammatory syndrome 58.19 9.90 97 146671 13744 79583876
Trimethylaminuria 56.68 9.90 19 146749 177 79597443
Aspartate aminotransferase increased 56.67 9.90 443 146325 138198 79459422
Mycotic allergy 56.25 9.90 35 146733 1484 79596136
Drug-induced liver injury 56.14 9.90 256 146512 65861 79531759
Vanishing bile duct syndrome 56.02 9.90 37 146731 1741 79595879
Contraindicated product administered 55.75 9.90 130 146638 157408 79440212
Muscle injury 55.35 9.90 11 146757 48550 79549070
Multiple organ dysfunction syndrome 55.25 9.90 395 146373 119851 79477769
Disseminated mucormycosis 54.74 9.90 27 146741 721 79596899
Cross sensitivity reaction 54.38 9.90 49 146719 3663 79593957
Contusion 54.08 9.90 121 146647 148655 79448965
Dust allergy 53.39 9.90 34 146734 1502 79596118
Factor XIII deficiency 52.59 9.90 15 146753 76 79597544
Ill-defined disorder 52.24 9.90 28 146740 65847 79531773
Tubulointerstitial nephritis 52.13 9.90 172 146596 38063 79559557
Affective disorder 51.72 9.90 70 146698 8249 79589371
General physical health deterioration 51.68 9.90 296 146472 274942 79322678
Drug interaction 51.35 9.90 1060 145708 414123 79183497
Factor V inhibition 51.09 9.90 21 146747 360 79597260
Hypoglycaemia 50.96 9.90 341 146427 101253 79496367
Tracheobronchomegaly 50.69 9.90 11 146757 11 79597609
Tongue oedema 50.64 9.90 64 146704 7053 79590567
Plasma cell myeloma 50.38 9.90 213 146555 53046 79544574
Eosinophilic pneumonia acute 50.27 9.90 29 146739 1069 79596551
Encephalopathy 50.01 9.90 251 146517 67146 79530474
Blood pressure fluctuation 49.74 9.90 31 146737 67114 79530506
Folliculitis 49.38 9.90 20 146748 55360 79542260
Fixed eruption 49.31 9.90 42 146726 2912 79594708
Pneumonia fungal 49.06 9.90 80 146688 11130 79586490
Intentional product misuse 48.81 9.90 62 146706 95103 79502517
Weight decreased 48.54 9.90 419 146349 354779 79242841
Agranulocytosis 48.09 9.90 187 146581 44843 79552777
Mucosal inflammation 46.91 9.90 268 146500 75312 79522308
Dermatitis exfoliative generalised 46.65 9.90 62 146706 7179 79590441
Aortitis 46.61 9.90 31 146737 1476 79596144
Intentional product use issue 46.57 9.90 135 146633 151977 79445643
Somnolence 46.49 9.90 254 146514 238727 79358893
Myoclonic dystonia 46.40 9.90 13 146755 61 79597559
C-reactive protein abnormal 45.58 9.90 16 146752 48351 79549269
Stevens-Johnson syndrome 45.42 9.90 167 146601 38999 79558621
Product use issue 45.36 9.90 215 146553 209607 79388013
Swelling 45.15 9.90 225 146543 216486 79381134
Hepatocellular injury 44.75 9.90 190 146578 47403 79550217
Tendon injury 44.01 9.90 34 146734 2051 79595569
Acute kidney injury 43.95 9.90 1259 145509 518145 79079475
Immune reconstitution inflammatory syndrome associated tuberculosis 43.47 9.90 24 146744 812 79596808
Hepatic cytolysis 43.33 9.90 129 146639 27022 79570598
Injection site bruising 43.29 9.90 11 146757 40991 79556629
Hepatitis cholestatic 42.86 9.90 85 146683 13767 79583853
Osteoarthritis 42.61 9.90 59 146709 87250 79510370
Pulmonary alveolar haemorrhage 42.54 9.90 76 146692 11381 79586239
Injection site swelling 42.06 9.90 17 146751 47115 79550505
Feeling abnormal 41.97 9.90 151 146617 159048 79438572
Migraine 41.83 9.90 60 146708 87433 79510187
Knee arthroplasty 41.28 9.90 14 146754 43234 79554386
Degenerative mitral valve disease 41.01 9.90 17 146751 298 79597322
Delusion of grandeur 40.81 9.90 28 146740 1404 79596216
Drug ineffective 39.87 9.90 1607 145161 1079306 78518314
Skin reaction 39.75 9.90 90 146678 15978 79581642
Injection site erythema 39.01 9.90 52 146716 78145 79519475
Muscle atrophy 38.53 9.90 72 146696 11160 79586460
Long QT syndrome 38.38 9.90 51 146717 5904 79591716
Bradycardia 38.16 9.90 125 146643 135432 79462188
Hyperbilirubinaemia 37.72 9.90 115 146653 24403 79573217
International normalised ratio increased 37.58 9.90 276 146492 84445 79513175
Drug dependence 37.54 9.90 14 146754 40755 79556865
Musculoskeletal injury 37.38 9.90 14 146754 185 79597435
Erythema multiforme 37.31 9.90 93 146675 17558 79580062
Haematoma muscle 37.29 9.90 34 146734 2581 79595039
Chest pain 37.23 9.90 336 146432 281968 79315652
Drug eruption 37.21 9.90 170 146598 43765 79553855
Face oedema 36.96 9.90 125 146643 28011 79569609
Hydrocephalus 36.91 9.90 62 146706 8838 79588782
Kounis syndrome 36.16 9.90 42 146726 4240 79593380
Malaise 35.30 9.90 662 146106 489207 79108413
Chronic fatigue syndrome 35.26 9.90 25 146743 1322 79596298
Hip arthroplasty 35.14 9.90 11 146757 35745 79561875
Conjunctival hyperaemia 35.14 9.90 42 146726 4371 79593249
Acute respiratory distress syndrome 34.75 9.90 167 146601 43900 79553720
Vertebral artery dissection 34.44 9.90 14 146754 233 79597387
Acute febrile neutrophilic dermatosis 34.42 9.90 39 146729 3833 79593787
Hypotension 34.42 9.90 1057 145711 439260 79158360
Lymphocyte count decreased 34.30 9.90 175 146593 47114 79550506
Aminoaciduria 34.23 9.90 16 146752 378 79597242
Alanine aminotransferase increased 34.17 9.90 453 146315 162117 79435503
Coma 34.06 9.90 85 146683 100564 79497056
Pneumonia bacterial 33.89 9.90 95 146673 19236 79578384
Blister 33.74 9.90 110 146658 119366 79478254
Anaemia 33.65 9.90 1064 145704 443951 79153669
Nervous system disorder 33.26 9.90 117 146651 26739 79570881
Adverse event 33.25 9.90 37 146731 60177 79537443
Obliterative bronchiolitis 33.06 9.90 34 146734 2994 79594626
Fibromyalgia 32.90 9.90 42 146726 64298 79533322
Fusarium infection 32.55 9.90 27 146741 1805 79595815
Optic neuropathy 32.53 9.90 36 146732 3448 79594172
Epilepsy 32.33 9.90 155 146613 40705 79556915
Peripheral sensory neuropathy 32.24 9.90 73 146695 12960 79584660
Hypokalaemia 32.22 9.90 406 146362 143634 79453986
Benign prostatic hyperplasia 32.09 9.90 68 146700 11544 79586076
Blast cell count increased 31.98 9.90 24 146744 1386 79596234
Status epilepticus 31.80 9.90 110 146658 24931 79572689
Chorea 31.71 9.90 30 146738 2387 79595233
Klebsiella infection 31.33 9.90 81 146687 15639 79581981
Wrong technique in product usage process 31.21 9.90 55 146713 73820 79523800
Respiratory distress 31.19 9.90 199 146569 58140 79539480
Bronchostenosis 30.97 9.90 18 146750 673 79596947
Hepatic enzyme increased 30.80 9.90 203 146565 182407 79415213
Pregnancy 30.77 9.90 6 146762 26845 79570775
Dysentery 30.75 9.90 22 146746 1180 79596440
Respiratory syncytial virus infection 30.68 9.90 59 146709 9343 79588277
Arthritis 30.25 9.90 109 146659 114771 79482849
Normocytic anaemia 30.20 9.90 38 146730 4169 79593451
Accidental exposure to product 30.14 9.90 10 146758 31312 79566308
Staphylococcal infection 30.03 9.90 197 146571 58098 79539522
Myalgia 29.88 9.90 494 146274 185147 79412473
Therapeutic response decreased 29.88 9.90 48 146720 66805 79530815
Cystic fibrosis pancreatic 29.60 9.90 9 146759 59 79597561
Inflammation 29.57 9.90 82 146686 93671 79503949
Type 2 diabetes mellitus 29.51 9.90 37 146731 57085 79540535
Palatal oedema 29.48 9.90 23 146745 1408 79596212
Ulcerative keratitis 29.19 9.90 35 146733 3654 79593966
Red blood cell sedimentation rate increased 29.10 9.90 25 146743 45917 79551703
Haematotoxicity 28.93 9.90 78 146690 15441 79582179
Pneumothorax 28.93 9.90 116 146652 28207 79569413
White blood cell count decreased 28.83 9.90 497 146271 187791 79409829
Acquired macroglossia 28.81 9.90 12 146756 213 79597407
Cholangitis 28.80 9.90 69 146699 12707 79584913
Suicidal ideation 28.63 9.90 61 146707 76279 79521341
Keratopathy 28.60 9.90 21 146747 1173 79596447
Productive cough 28.57 9.90 268 146500 88063 79509557
Leukopenia 28.49 9.90 334 146434 116179 79481441
Therapy non-responder 28.18 9.90 82 146686 92223 79505397
Clostridial infection 28.08 9.90 43 146725 5671 79591949
Chronic pigmented purpura 27.97 9.90 12 146756 230 79597390
Malignant melanoma in situ 27.62 9.90 28 146740 2424 79595196
Cardiogenic shock 27.55 9.90 22 146746 41892 79555728
Infective pulmonary exacerbation of cystic fibrosis 27.47 9.90 68 146700 12783 79584837
Mucormycosis 27.46 9.90 53 146715 8416 79589204
Megacolon 27.40 9.90 33 146735 3462 79594158
Immune effector cell-associated neurotoxicity syndrome 27.33 9.90 43 146725 5805 79591815
Pain 27.23 9.90 1040 145728 702762 78894858
Respiratory arrest 26.98 9.90 40 146728 57510 79540110
Stenotrophomonas infection 26.95 9.90 34 146734 3739 79593881
Linear IgA disease 26.92 9.90 31 146737 3101 79594519
Injection site pruritus 26.80 9.90 23 146745 42260 79555360
Product substitution issue 26.73 9.90 3 146765 20253 79577367
Heart rate decreased 26.52 9.90 56 146712 70260 79527360
Laryngeal oedema 26.51 9.90 51 146717 8078 79589542
Drug intolerance 26.47 9.90 335 146433 263784 79333836
Diabetic ketoacidosis 26.33 9.90 15 146753 34107 79563513
Band sensation 26.30 9.90 17 146751 771 79596849
Poisoning 26.26 9.90 7 146761 25265 79572355
Meningitis tuberculous 26.20 9.90 20 146748 1185 79596435
Cystic fibrosis 26.20 9.90 34 146734 3846 79593774
Road traffic accident 26.18 9.90 25 146743 43639 79553981
Connective tissue disorder 26.13 9.90 21 146747 1342 79596278
Arthralgia 26.00 9.90 828 145940 570975 79026645
Disseminated intravascular coagulation 25.54 9.90 132 146636 35710 79561910
Tuberculoma of central nervous system 25.54 9.90 15 146753 572 79597048
Tracheal oedema 25.39 9.90 8 146760 60 79597560
Aortic rupture 25.30 9.90 11 146757 218 79597402
Ballismus 25.27 9.90 12 146756 294 79597326
Anterior chamber flare 25.25 9.90 10 146758 155 79597465
Abdominal pain 25.17 9.90 536 146232 389033 79208587
Haemoptysis 25.15 9.90 183 146585 55816 79541804
Sciatica 25.07 9.90 15 146753 33207 79564413
Obesity 24.95 9.90 17 146751 35108 79562512
Ventricular enlargement 24.94 9.90 16 146752 716 79596904
Pneumothorax spontaneous 24.94 9.90 21 146747 1433 79596187
Inferior vena cava dilatation 24.75 9.90 17 146751 854 79596766
Blood pressure systolic increased 24.72 9.90 54 146714 66932 79530688
Weber tuning fork test abnormal 24.66 9.90 9 146759 110 79597510
Paradoxical drug reaction 24.57 9.90 46 146722 7139 79590481
Complex regional pain syndrome 24.20 9.90 24 146744 2024 79595596
Multiple sclerosis relapse 24.18 9.90 30 146738 46503 79551117
Sleep apnoea syndrome 24.16 9.90 19 146749 36459 79561161
Enterocolitis 24.16 9.90 70 146698 14442 79583178
Device malfunction 24.15 9.90 5 146763 21443 79576177
Trichoglossia 23.94 9.90 15 146753 644 79596976
Mechanical urticaria 23.93 9.90 13 146755 426 79597194
Respiratory tract infection fungal 23.92 9.90 19 146749 1194 79596426
Pulmonary vascular disorder 23.90 9.90 18 146750 1045 79596575
Muscle contractions involuntary 23.89 9.90 32 146736 3733 79593887
Hyperuricaemia 23.72 9.90 61 146707 11738 79585882
Enterococcal infection 23.67 9.90 73 146695 15587 79582033
Vitreous opacities 23.61 9.90 15 146753 660 79596960
Cystitis haemorrhagic 23.39 9.90 52 146716 9120 79588500
Thrombotic microangiopathy 23.38 9.90 86 146682 20083 79577537
Candida infection 23.37 9.90 135 146633 38079 79559541
Nicotine dependence 23.34 9.90 17 146751 938 79596682
Purpura fulminans 23.29 9.90 10 146758 192 79597428
Death 23.26 9.90 831 145937 565683 79031937
Blood lactate dehydrogenase increased 23.07 9.90 137 146631 39033 79558587
Liver disorder 23.06 9.90 219 146549 72198 79525422
Toxic encephalopathy 22.85 9.90 59 146709 11381 79586239
Dry mouth 22.85 9.90 84 146684 87935 79509685
Grip strength decreased 22.83 9.90 6 146762 21863 79575757
Joint stiffness 22.64 9.90 25 146743 40805 79556815
Transaminases increased 22.62 9.90 168 146600 51575 79546045
COVID-19 pneumonia 22.50 9.90 109 146659 28740 79568880
Lymphocyte count abnormal 22.33 9.90 20 146748 1483 79596137
Cryopyrin associated periodic syndrome 22.26 9.90 12 146756 387 79597233
Cardiac aneurysm 22.16 9.90 20 146748 1498 79596122
Hyperpyrexia 22.09 9.90 40 146728 6052 79591568
Product quality issue 22.08 9.90 18 146750 33922 79563698
Tumour associated fever 21.99 9.90 16 146752 881 79596739
Japanese spotted fever 21.99 9.90 6 146762 25 79597595
Hypersensitivity vasculitis 21.96 9.90 43 146725 6900 79590720
Sinusitis 21.87 9.90 242 146526 195259 79402361
Occult blood 21.87 9.90 21 146747 1702 79595918
Acute myeloid leukaemia recurrent 21.85 9.90 29 146739 3354 79594266
Demodicidosis 21.84 9.90 10 146758 225 79597395
Fungaemia 21.79 9.90 34 146734 4557 79593063
Toxicity to various agents 21.74 9.90 600 146168 420940 79176680
Basal cell carcinoma 21.72 9.90 22 146746 37353 79560267
Premature delivery 21.71 9.90 8 146760 23459 79574161
Sense of oppression 21.63 9.90 20 146748 1546 79596074
Erythema 21.60 9.90 551 146217 222739 79374881
Ectropion 21.47 9.90 12 146756 416 79597204
Bacteraemia 21.42 9.90 118 146650 32706 79564914
Foreign body aspiration 21.41 9.90 11 146757 321 79597299
Osteoporosis 21.34 9.90 42 146726 54070 79543550
Tubulointerstitial nephritis and uveitis syndrome 21.31 9.90 11 146757 324 79597296
Rhinalgia 21.31 9.90 24 146744 2343 79595277
Osteonecrosis of jaw 21.30 9.90 29 146739 43197 79554423
Small fibre neuropathy 21.29 9.90 13 146755 533 79597087
Candida endophthalmitis 21.24 9.90 9 146759 167 79597453
Sebaceous adenitis 21.20 9.90 4 146764 0 79597620
Lateral medullary syndrome 21.10 9.90 7 146761 63 79597557
Normochromic normocytic anaemia 21.06 9.90 45 146723 7682 79589938
Aspergillus infection 20.80 9.90 80 146688 19081 79578539
Upper respiratory tract inflammation 20.73 9.90 31 146737 4004 79593616
Drug withdrawal syndrome 20.67 9.90 20 146748 34698 79562922
Rash morbilliform 20.57 9.90 39 146729 6111 79591509
Mixed liver injury 20.50 9.90 44 146724 7534 79590086
Multiple drug therapy 20.48 9.90 31 146737 4047 79593573
Injection site haemorrhage 20.46 9.90 13 146755 27857 79569763
Withdrawal syndrome 20.44 9.90 12 146756 26842 79570778
Nocardiosis 20.23 9.90 37 146731 5642 79591978
Gastritis fungal 20.23 9.90 9 146759 189 79597431
Collagen disorder 20.21 9.90 10 146758 269 79597351
Type I hypersensitivity 20.08 9.90 32 146736 4366 79593254
Accidental overdose 20.07 9.90 26 146742 39555 79558065
Corneal erosion 20.01 9.90 11 146757 369 79597251
Influenza B virus test positive 19.96 9.90 11 146757 371 79597249
Heart rate increased 19.95 9.90 135 146633 120589 79477031
Weight bearing difficulty 19.87 9.90 27 146741 3194 79594426
Cytokine storm 19.81 9.90 16 146752 1030 79596590
Incorrect route of product administration 19.80 9.90 21 146747 34908 79562712
Guillain-Barre syndrome 19.76 9.90 48 146720 8917 79588703
Diabetes mellitus 19.58 9.90 76 146692 78314 79519306
Breast cancer 19.50 9.90 20 146748 33761 79563859
Glaucoma 19.44 9.90 80 146688 19681 79577939
Pulmonary renal syndrome 19.39 9.90 13 146755 627 79596993
Endophthalmitis 19.36 9.90 39 146729 6389 79591231
Early retirement 19.35 9.90 5 146763 16 79597604
Pseudomonas infection 19.30 9.90 83 146685 20820 79576800
Eye injury 19.17 9.90 24 146744 2619 79595001
Phlebosclerosis 19.06 9.90 8 146760 145 79597475
Femur fracture 18.98 9.90 26 146742 38626 79558994
Intentional self-injury 18.93 9.90 19 146749 32400 79565220
Adverse drug reaction 18.83 9.90 61 146707 66331 79531289
Abortion spontaneous 18.76 9.90 16 146752 29491 79568129
Gamma-glutamyltransferase increased 18.74 9.90 168 146600 54512 79543108
Polyneuropathy 18.66 9.90 91 146677 24060 79573560
Disorientation 18.60 9.90 187 146581 62589 79535031
Diabetic bullosis 18.49 9.90 5 146763 20 79597600
Respiratory tract infection 18.47 9.90 153 146615 48536 79549084
Injection site mass 18.47 9.90 7 146761 20177 79577443
Dermatitis bullous 18.45 9.90 63 146705 14182 79583438
Boutonneuse fever 18.43 9.90 4 146764 4 79597616
Gallbladder empyema 18.39 9.90 7 146761 97 79597523
Helicobacter test positive 18.31 9.90 17 146751 1321 79596299
Ulcer 18.16 9.90 17 146751 29955 79567665
Nephrogenic diabetes insipidus 18.14 9.90 21 146747 2113 79595507
Device issue 18.11 9.90 14 146754 27094 79570526
Blood alkaline phosphatase increased 18.08 9.90 188 146580 63476 79534144
Nasal congestion 18.00 9.90 76 146692 76476 79521144
Pneumonia pseudomonal 17.96 9.90 36 146732 5875 79591745
Ligament pain 17.95 9.90 9 146759 249 79597371
Upper respiratory tract infection 17.90 9.90 251 146517 90917 79506703
Incision site pain 17.88 9.90 24 146744 2806 79594814
Respiratory alkalosis 17.84 9.90 30 146738 4281 79593339
Therapy partial responder 17.74 9.90 5 146763 17392 79580228
Keratic precipitates 17.73 9.90 10 146758 353 79597267
Hepatotoxicity 17.72 9.90 158 146610 51194 79546426
Full blood count abnormal 17.45 9.90 131 146637 40343 79557277
Pulmonary vasculitis 17.37 9.90 13 146755 748 79596872
Tuberculosis of central nervous system 17.35 9.90 11 146757 482 79597138
Angular cheilitis 17.35 9.90 13 146755 749 79596871
Time perception altered 17.27 9.90 8 146760 185 79597435
Confabulation 17.25 9.90 11 146757 487 79597133
Prescribed overdose 17.11 9.90 27 146741 37856 79559764
Lacunar stroke 17.11 9.90 10 146758 378 79597242
Axonal neuropathy 17.10 9.90 20 146748 2034 79595586
Fat tissue decreased 17.03 9.90 7 146761 120 79597500
Escherichia infection 16.99 9.90 72 146696 17945 79579675
Bronchitis chronic 16.98 9.90 30 146738 4452 79593168
Multiple sclerosis 16.90 9.90 10 146758 22272 79575348
Anti-neutrophil cytoplasmic antibody positive vasculitis 16.85 9.90 27 146741 3702 79593918
Pneumococcal infection 16.77 9.90 14 146754 944 79596676
Ciliary hyperaemia 16.77 9.90 6 146762 69 79597551
Breath sounds abnormal 16.75 9.90 66 146702 15918 79581702
Underdose 16.58 9.90 22 146746 33129 79564491
Hot flush 16.57 9.90 49 146719 54828 79542792
Therapeutic response unexpected 16.52 9.90 8 146760 19938 79577682
Haemorrhagic pneumonia 16.42 9.90 7 146761 132 79597488
Arthritis fungal 16.32 9.90 7 146761 134 79597486
Neuroleptic malignant syndrome 16.27 9.90 16 146752 27543 79570077
Pneumocystis jirovecii pneumonia 16.22 9.90 109 146659 32399 79565221
Circumoral oedema 16.10 9.90 9 146759 312 79597308
Prurigo 16.10 9.90 16 146752 1353 79596267
Factor XIII Inhibition 16.04 9.90 5 146763 36 79597584
Hepatitis B e antigen positive 15.81 9.90 5 146763 38 79597582
Pneumonia legionella 15.80 9.90 23 146745 2899 79594721
Sensory processing disorder 15.68 9.90 4 146764 12 79597608
Long QT syndrome congenital 15.60 9.90 7 146761 150 79597470
Joint noise 15.58 9.90 27 146741 3947 79593673
Septic embolus 15.48 9.90 19 146749 2032 79595588
Conductive deafness 15.46 9.90 8 146760 237 79597383
Foot deformity 15.37 9.90 13 146755 24061 79573559
Drug ineffective for unapproved indication 15.36 9.90 153 146615 51085 79546535
Glomerulonephritis rapidly progressive 15.34 9.90 17 146751 1631 79595989
Device difficult to use 15.32 9.90 3 146765 13382 79584238
Bronchitis 15.27 9.90 331 146437 130313 79467307
Ecthyma 15.25 9.90 12 146756 744 79596876
Respiratory depression 15.23 9.90 17 146751 27613 79570007
Altered state of consciousness 15.20 9.90 135 146633 43687 79553933
Injection site rash 15.18 9.90 7 146761 17947 79579673
Cytopenia 15.18 9.90 76 146692 20307 79577313
Haemolytic anaemia 15.12 9.90 69 146699 17751 79579869
Systemic inflammatory response syndrome 15.11 9.90 51 146717 11414 79586206
Urinary tract infection enterococcal 15.08 9.90 24 146744 3271 79594349
Product administration error 15.06 9.90 22 146746 31824 79565796
Functional residual capacity increased 15.03 9.90 6 146762 95 79597525
Bronchiectasis 14.96 9.90 81 146687 22305 79575315
Acquired haemophilia 14.91 9.90 18 146750 1893 79595727
Haemarthrosis 14.88 9.90 33 146735 5779 79591841
Hypertensive crisis 14.82 9.90 10 146758 20760 79576860
Walking disability 14.82 9.90 19 146749 2124 79595496
Bilirubin conjugated increased 14.80 9.90 32 146736 5507 79592113
Device related infection 14.79 9.90 111 146657 34183 79563437
Corneal oedema 14.72 9.90 21 146747 2599 79595021
Recall phenomenon 14.70 9.90 14 146754 1123 79596497
Lip dry 14.70 9.90 5 146763 15413 79582207
Drug tolerance decreased 14.66 9.90 3 146765 12975 79584645
Depression 14.65 9.90 296 146472 216494 79381126
Product name confusion 14.65 9.90 7 146761 174 79597446
Substance-induced psychotic disorder 14.58 9.90 24 146744 3365 79594255
Haematochezia 14.48 9.90 98 146670 87547 79510073
Geotrichum infection 14.47 9.90 13 146755 968 79596652
Cytomegalovirus infection reactivation 14.47 9.90 42 146726 8674 79588946
Botulism 14.46 9.90 9 146759 382 79597238
Renal necrosis 14.40 9.90 8 146760 274 79597346
Lactobacillus infection 14.39 9.90 9 146759 385 79597235
Dystonia 14.36 9.90 11 146757 21388 79576232
Syncope 14.32 9.90 238 146530 179211 79418409
Osteopenia 14.27 9.90 8 146760 18356 79579264
Muscle rupture 14.19 9.90 25 146743 3702 79593918
Amoebic colitis 14.18 9.90 6 146762 111 79597509
Corneal opacity 14.03 9.90 13 146755 1007 79596613
Blood pressure diastolic abnormal 14.03 9.90 9 146759 19193 79578427
Hypomagnesaemia 14.02 9.90 140 146628 46771 79550849
Persistent corneal epithelial defect 14.01 9.90 5 146763 57 79597563
Atrioventricular block first degree 13.88 9.90 3 146765 12488 79585132
Unmasking of previously unidentified disease 13.85 9.90 18 146750 2039 79595581
Eosinophilic myocarditis 13.85 9.90 14 146754 1208 79596412
Splenic infection 13.83 9.90 3 146765 3 79597617
Injection site warmth 13.78 9.90 5 146763 14802 79582818
Myosclerosis 13.73 9.90 7 146761 201 79597419
Irritability 13.72 9.90 35 146733 41109 79556511
CD4/CD8 ratio decreased 13.71 9.90 5 146763 61 79597559
Bicytopenia 13.67 9.90 28 146740 4642 79592978
Tooth disorder 13.54 9.90 17 146751 26216 79571404
Anterior chamber inflammation 13.53 9.90 10 146758 564 79597056
Enteritis infectious 13.51 9.90 23 146745 3315 79594305
Ankylosing spondylitis 13.43 9.90 3 146765 12202 79585418
Condition aggravated 13.41 9.90 770 145998 500354 79097266
Keratitis fungal 13.37 9.90 8 146760 316 79597304
Graft versus host disease 13.36 9.90 59 146709 14967 79582653
Pleural effusion 13.33 9.90 356 146412 144906 79452714
Product complaint 13.31 9.90 4 146764 13345 79584275
Rectal haemorrhage 13.27 9.90 84 146684 76216 79521404
Muscle spasticity 13.22 9.90 12 146756 21463 79576157
Therapy naive 13.22 9.90 5 146763 68 79597552
Blood pressure diastolic decreased 13.21 9.90 22 146746 30194 79567426
Trunk injury 13.19 9.90 4 146764 26 79597594
Bursitis 13.14 9.90 29 146739 35815 79561805
Thalamic infarction 13.06 9.90 14 146754 1293 79596327
Postural tremor 13.06 9.90 11 146757 751 79596869
Visual acuity reduced 13.06 9.90 96 146672 29373 79568247
Corneal perforation 13.05 9.90 11 146757 752 79596868
Eosinophilic pleural effusion 13.03 9.90 8 146760 331 79597289
Cutaneous vasculitis 12.97 9.90 39 146729 8213 79589407
Prostate cancer 12.96 9.90 26 146742 33242 79564378
HIV infection 12.93 9.90 13 146755 1114 79596506
Mitochondrial enzyme deficiency 12.93 9.90 4 146764 28 79597592
Coronary artery occlusion 12.91 9.90 6 146762 15309 79582311
Hypoalbuminaemia 12.87 9.90 75 146693 21222 79576398
Duodenitis 12.85 9.90 38 146730 7929 79589691
Retinal pigment epithelial tear 12.84 9.90 9 146759 467 79597153
Neuritis 12.81 9.90 16 146752 1742 79595878
Jarisch-Herxheimer reaction 12.79 9.90 12 146756 945 79596675
Intracranial pressure increased 12.77 9.90 39 146729 8283 79589337
Henoch-Schonlein purpura 12.76 9.90 20 146748 2690 79594930
Cataract subcapsular 12.75 9.90 12 146756 949 79596671
Hyperamylasaemia 12.74 9.90 13 146755 1134 79596486
Epidermolysis 12.67 9.90 12 146756 956 79596664
Generalised onset non-motor seizure 12.65 9.90 5 146763 77 79597543
Systolic dysfunction 12.61 9.90 24 146744 3771 79593849
Tongue disorder 12.53 9.90 5 146763 13970 79583650
Hypothermia 12.53 9.90 14 146754 22732 79574888
Peripheral sensorimotor neuropathy 12.52 9.90 21 146747 2989 79594631
Skin necrosis 12.52 9.90 9 146759 18078 79579542
Hallucination, visual 12.50 9.90 103 146665 32626 79564994
Angioedema 12.47 9.90 203 146565 75832 79521788
Prescribed underdose 12.44 9.90 22 146746 29492 79568128
Feeling hot 12.43 9.90 62 146706 59672 79537948
Differentiation syndrome 12.41 9.90 19 146749 2505 79595115
Arteritis infective 12.37 9.90 5 146763 82 79597538
Orbital infection 12.37 9.90 5 146763 82 79597538
Lupus-like syndrome 12.36 9.90 5 146763 13852 79583768
Tooth fracture 12.35 9.90 3 146765 11527 79586093
Disseminated strongyloidiasis 12.34 9.90 7 146761 250 79597370
Enterocolitis bacterial 12.31 9.90 10 146758 649 79596971
Oliguria 12.28 9.90 61 146707 16248 79581372
Diabetes mellitus inadequate control 12.24 9.90 16 146752 24248 79573372
Engraftment syndrome 12.20 9.90 14 146754 1395 79596225
FEV1/FVC ratio abnormal 12.15 9.90 4 146764 35 79597585
Hypoglycaemic coma 12.15 9.90 27 146741 4733 79592887
Rash erythematous 12.14 9.90 161 146607 57608 79540012
Aplastic anaemia 12.11 9.90 65 146703 17840 79579780
Metastases to liver 12.03 9.90 21 146747 28293 79569327
Haematospermia 12.01 9.90 7 146761 263 79597357
Subacute endocarditis 12.00 9.90 6 146762 165 79597455
Rhinovirus infection 11.95 9.90 37 146731 7916 79589704
Sleep disorder due to a general medical condition 11.91 9.90 55 146713 14222 79583398
Muscle tension dysphonia 11.90 9.90 6 146762 168 79597452
Malabsorption from administration site 11.87 9.90 6 146762 169 79597451
Skin laceration 11.84 9.90 22 146746 28940 79568680
Systemic candida 11.80 9.90 33 146735 6673 79590947
Perihepatic discomfort 11.76 9.90 3 146765 9 79597611
Pudendal canal syndrome 11.76 9.90 3 146765 9 79597611
Amnesia 11.71 9.90 68 146700 62989 79534631
Forearm fracture 11.68 9.90 9 146759 541 79597079
Excessive eye blinking 11.63 9.90 15 146753 1686 79595934
Bone density decreased 11.61 9.90 5 146763 13342 79584278
Flatulence 11.60 9.90 40 146728 42684 79554936
Gastric cyst 11.60 9.90 5 146763 97 79597523
Second primary malignancy 11.52 9.90 6 146762 14344 79583276
Antibiotic associated colitis 11.52 9.90 3 146765 10 79597610
Hypertransaminasaemia 11.51 9.90 48 146720 11876 79585744
Acute graft versus host disease 11.49 9.90 43 146725 10124 79587496
Blood creatinine increased 11.49 9.90 370 146398 154687 79442933
Oral pruritus 11.44 9.90 18 146750 2430 79595190
Gluten sensitivity 11.42 9.90 8 146760 415 79597205
Rhabdomyolysis 11.32 9.90 259 146509 102872 79494748
Device leakage 11.29 9.90 3 146765 10853 79586767
Pupillary block 11.26 9.90 4 146764 45 79597575
Strangury 11.26 9.90 6 146762 189 79597431
Bronchial haemorrhage 11.24 9.90 13 146755 1307 79596313
Injury 11.20 9.90 90 146678 77406 79520214
Corneal infiltrates 11.12 9.90 7 146761 303 79597317
Skin erosion 11.11 9.90 25 146743 4420 79593200
Bronchial obstruction 11.11 9.90 19 146749 2749 79594871
Blood glucose increased 11.07 9.90 147 146621 114828 79482792
Lip erosion 11.05 9.90 14 146754 1546 79596074
Sputum purulent 11.01 9.90 13 146755 1336 79596284
Skin hyperpigmentation 11.00 9.90 34 146734 7269 79590351
Chronic kidney disease 10.99 9.90 177 146591 65977 79531643
Dysarthria 10.98 9.90 76 146692 67546 79530074
Enterococcal bacteraemia 10.94 9.90 20 146748 3048 79594572
Coronary artery disease 10.92 9.90 73 146695 65401 79532219
Colitis microscopic 10.91 9.90 44 146724 10724 79586896
Oesophageal oedema 10.88 9.90 4 146764 50 79597570
Quadriplegia 10.86 9.90 21 146747 3339 79594281
Injection site urticaria 10.85 9.90 5 146763 12821 79584799
Spinal cord haematoma 10.82 9.90 7 146761 318 79597302
Ascites 10.81 9.90 88 146680 75474 79522146
Hyperhidrosis 10.79 9.90 205 146563 151287 79446333
Hepatic cancer 10.78 9.90 3 146765 10526 79587094
Genital burning sensation 10.76 9.90 7 146761 321 79597299
Diplopia 10.75 9.90 29 146739 33437 79564183
Hyperaemia 10.75 9.90 20 146748 3090 79594530
Renal failure 10.65 9.90 462 146306 200506 79397114
Neoplasm malignant 10.65 9.90 27 146741 31783 79565837
Malignant melanoma 10.65 9.90 7 146761 14734 79582886
Acute sinusitis 10.65 9.90 25 146743 4545 79593075
Interstitial lung disease 10.63 9.90 277 146491 112323 79485297
Ovarian cyst 10.60 9.90 5 146763 12650 79584970
Fluid retention 10.59 9.90 80 146688 69729 79527891
Erectile dysfunction 10.54 9.90 7 146761 14657 79582963
Dysphonia 10.53 9.90 155 146613 56717 79540903
Jaundice 10.52 9.90 147 146621 53202 79544418
Forced expiratory volume decreased 10.51 9.90 35 146733 7779 79589841
Neuropsychiatric symptoms 10.51 9.90 13 146755 1402 79596218
Colitis ulcerative 10.50 9.90 31 146737 34711 79562909
Eye abscess 10.49 9.90 7 146761 335 79597285
Arteritis coronary 10.47 9.90 4 146764 56 79597564
Glycosylated haemoglobin increased 10.45 9.90 12 146756 19248 79578372
Streptococcal sepsis 10.43 9.90 19 146749 2888 79594732
Plantar fasciitis 10.43 9.90 21 146747 3439 79594181
Colour blindness acquired 10.40 9.90 5 146763 126 79597494
Type 2 lepra reaction 10.38 9.90 6 146762 222 79597398
Device dislocation 10.38 9.90 20 146748 25950 79571670
Burn oesophageal 10.33 9.90 6 146762 224 79597396
Petechiae 10.29 9.90 69 146699 20496 79577124
Coeliac disease 10.28 9.90 4 146764 11347 79586273
Blood iron decreased 10.27 9.90 8 146760 15426 79582194
Toothache 10.25 9.90 13 146755 19957 79577663
Panniculitis 10.19 9.90 5 146763 12366 79585254
Emotional disorder 10.17 9.90 7 146761 14380 79583240
Skin hyperplasia 10.09 9.90 3 146765 18 79597602
Product storage error 10.07 9.90 9 146759 16217 79581403
Exposure to fungus 10.05 9.90 5 146763 136 79597484
Tumour lysis syndrome 10.05 9.90 77 146691 23862 79573758
Chordae tendinae rupture 10.04 9.90 4 146764 63 79597557
Lactic acidosis 10.04 9.90 82 146686 70277 79527343
Influenza like illness 10.03 9.90 84 146684 71623 79525997
Acute myocardial infarction 10.00 9.90 92 146676 76944 79520676
Flushing 9.97 9.90 109 146659 88159 79509461
Polyneuropathy chronic 9.96 9.90 3 146765 19 79597601
Intestinal obstruction 9.93 9.90 43 146725 42977 79554643

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A02BD10 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC J01MA12 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
QUINOLONE ANTIBACTERIALS
Fluoroquinolones
ATC J01RA05 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
ATC S01AE05 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Fluoroquinolones
FDA CS M0023650 Quinolones
FDA CS M0372253 Fluoroquinolones
FDA EPC N0000175937 Quinolone Antimicrobial
FDA EPC N0000193223 Fluoroquinolone Antibacterial
CHEBI has role CHEBI:36047 antibacterial drugs
CHEBI has role CHEBI:50750 inhibitors of type II topoisomerase
CHEBI has role CHEBI:53559 topoisomerase IV inhibitors
CHEBI has role CHEBI:59517 DNA synthesis inhibitors
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000892 Anti-Infective Agents, Urinary
MeSH PA D000970 Antineoplastic Agents
MeSH PA D065609 Cytochrome P-450 CYP1A2 Inhibitors
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D059005 Topoisomerase II Inhibitors
MeSH PA D059003 Topoisomerase Inhibitors

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

DiseaseRelationSNOMED_IDDOID
Otitis media caused by Pseudomonas aeruginosa indication 16664009
Haemophilus Influenzae Acute Otitis Media indication 19021002
Infection of skin AND/OR subcutaneous tissue indication 19824006
Staphylococcal pneumonia indication 22754005
Pneumonia due to Streptococcus indication 34020007
Pyelonephritis indication 45816000 DOID:11400
Pneumonia due to Mycoplasma pneumoniae indication 46970008
Bacterial pneumonia indication 53084003 DOID:874
Klebsiella cystitis indication 60867007
Otitis media caused by Streptococcus spp. indication 65363002 DOID:10754
Acute maxillary sinusitis indication 68272006 DOID:2050
Haemophilus influenzae pneumonia indication 70036007
Acute bacterial sinusitis indication 75498004
Bacterial conjunctivitis indication 128350005 DOID:9700
Bacterial infection due to Klebsiella pneumoniae indication 186435004
Acute Moraxella catarrhalis bronchitis indication 195722003
Acute bacterial bronchitis indication 233598009
Pneumococcal pneumonia indication 233607000
Chlamydial pneumonia indication 233609002
Escherichia coli urinary tract infection indication 301011002
Proteus urinary tract infection indication 301012009
Streptococcus pyogenes infection indication 302809008
Bacterial urinary infection indication 312124009
Infection due to Staphylococcus aureus indication 406602003
Anthrax indication 409498004 DOID:7427
Acute exacerbation of chronic bronchitis indication 425748003
Otitis media caused by Moraxella (Branhamella) catarrhalis indication 703469002
Otitis media caused by Enterobacter spp. indication 703469002
Otitis media caused by Serratia spp. indication 703469002
Otitis media caused by Acinetobacter spp. indication 703469002
Otitis media caused by Staphylococcus spp. indication 703469002
Otitis media caused by Klebsiella pneumoniae indication 703469002
Otitis media caused by Streptococcus pneumoniae indication 721742004
Otitis externa caused by Acinetobacter spp. indication 280221000009107
Otitis externa caused by Streptococcus pneumoniae indication 280221000009107
Otitis externa caused by Staphylococcus spp. indication 280221000009107
Otitis externa caused by Serratia spp. indication 280221000009107
Otitis externa caused by Pseudomonas aeruginosa indication 280221000009107
Otitis externa caused by Streptococcus spp. indication 280221000009107
Otitis externa caused by Moraxella (Branhamella) catarrhalis indication 280221000009107
Otitis externa caused by Klebsiella pneumoniae indication 280221000009107
Otitis externa caused by Haemophilus influenzae indication 280221000009107
Otitis externa caused by Enterobacter spp. indication 280221000009107
Chronic Staphylococcus epidermidis Prostatitis indication
Complicated Skin and Skin Structure Proteus Infection indication
Nosocomial Pneumonia due to Methicillin-Sensitive Staphylococcus Aureus indication
Haemophilus Influenzae Bronchitis indication
Chronic Enterococcus faecalis Prostatitis indication
Nosocomial Pneumonia due to Streptococcus Pneumoniae indication
Haemophilus Parainfluenzae Bronchitis indication
Synergy for Nosocomial Pneumonia due to Pseudomonas Aeruginosa indication
Haemophilus Parainfluenzae Pneumonia indication
Complicated Skin and Skin Structure Streptococcus Pyogenes Infection indication
Nosocomial Pneumonia due to Klebsiella Pneumoniae indication
Bacterial Corneal Ulcer Infection indication
Chronic Escherichia coli Prostatitis indication
Complicated Skin and Skin Structure Staphylococcus Aureus Infection indication
Complicated Urinary Tract Infections indication
Enterococcus Urinary Tract Infection indication
Complicated Skin and Skin Structure Enterococcus Faecalis Infection indication
Legionella Pneumophila Pneumonia indication
Gram-Negative Aerobic Bacillary Pneumonia indication
Nosocomial Pneumonia due to Haemophilus Influenzae indication
Nosocomial Pneumonia due to Serratia Marcescens indication
E. Coli Pyelonephritis indication
Streptococcus Pneumoniae Bronchitis indication
Nosocomial Pneumonia due to Escherichia Coli indication
Complicated Skin and Skin Structure Infection indication
Staphylococcus Saprophyticus Urinary Tract Infection indication
Staphylococcus Aureus Bronchitis indication
Moraxella Catarrhalis Pneumonia indication
Pseudomonas Aeruginosa Urinary Tract Infection indication
Traveler's diarrhea off-label use 11840006
Acute tuberculosis off-label use 25629007
Pulmonary tuberculosis off-label use 154283005 DOID:2957
Diabetic Foot Infection off-label use
Hallucinations contraindication 7011001
Agranulocytosis contraindication 17182001 DOID:12987
Lowered convulsive threshold contraindication 19260006
Torsades de pointes contraindication 31722008
Transplantation of heart contraindication 32413006
Tendinitis contraindication 34840004 DOID:971
Hypokalemia contraindication 43339004
Bradycardia contraindication 48867003
Transplant of kidney contraindication 70536003
Diabetes mellitus contraindication 73211009 DOID:9351
Epilepsy contraindication 84757009 DOID:1826
Leukopenia contraindication 84828003 DOID:615
Transplant of lung contraindication 88039007
Myasthenia gravis contraindication 91637004 DOID:437
Prolonged QT interval contraindication 111975006
Pancytopenia contraindication 127034005 DOID:12450
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Drug-induced hepatitis contraindication 235876009
Rhabdomyolysis contraindication 240131006
Anemia contraindication 271737000 DOID:2355
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Peripheral nerve disease contraindication 302226006
Pseudomembranous enterocolitis contraindication 397683000
Myocardial ischemia contraindication 414795007 DOID:3393
Traumatic rupture of tendon contraindication 415749005
Congenital long QT syndrome contraindication 442917000
Severe Cerebral Arteriosclerosis contraindication
Tremors contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 6.12 acidic
pKa2 8.29 Basic
pKa3 1.12 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
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 3.04 WOMBAT-PK
Multidrug and toxin extrusion protein 1 Transporter IC50 4.75 CHEMBL
CAAX prenyl protease 2 Enzyme AC50 4.39 CHEMBL
DNA topoisomerase 4 Enzyme INHIBITOR CHEMBL CHEMBL
DNA gyrase Enzyme INHIBITOR CHEMBL CHEMBL
DNA gyrase subunit A Enzyme IC50 4.28 CHEMBL

External reference:

IDSource
D00588 KEGG_DRUG
138199-71-0 SECONDARY_CAS_RN
4021005 VANDF
CHEBI:63598 CHEBI
LFX PDB_CHEM_ID
CHEMBL33 ChEMBL_ID
10911 IUPHAR_LIGAND_ID
DB01137 DRUGBANK_ID
6GNT3Y5LMF UNII
1546009 RXNORM
182289 MMSL
37941 MMSL
4972 MMSL
6466 MMSL
d04109 MMSL
006299 NDDF
387552007 SNOMEDCT_US
785695006 SNOMEDCT_US
96087006 SNOMEDCT_US
C0282386 UMLSCUI
D064704 MESH_DESCRIPTOR_UI
6708 INN_ID
149096 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0121-0872 SOLUTION 25 mg ORAL ANDA 29 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9315 INJECTION, SOLUTION 250 mg INTRAVENOUS ANDA 28 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9316 INJECTION, SOLUTION 500 mg INTRAVENOUS ANDA 28 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9317 INJECTION, SOLUTION 750 mg INTRAVENOUS ANDA 28 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9720 INJECTION, SOLUTION 750 mg INTRAVENOUS ANDA 28 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9721 INJECTION, SOLUTION 500 mg INTRAVENOUS ANDA 28 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9722 INJECTION, SOLUTION 250 mg INTRAVENOUS ANDA 28 sections
LEVOFLOXACIN HUMAN PRESCRIPTION DRUG LABEL 1 0409-0528 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 30 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0527-1948 SOLUTION 25 mg ORAL ANDA 29 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0527-1948 SOLUTION 25 mg ORAL ANDA 29 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0527-1948 SOLUTION 25 mg ORAL ANDA 29 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0781-5790 TABLET, FILM COATED 250 mg ORAL ANDA 27 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0781-5790 TABLET, FILM COATED 250 mg ORAL ANDA 27 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0781-5791 TABLET, FILM COATED 500 mg ORAL ANDA 27 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0781-5791 TABLET, FILM COATED 500 mg ORAL ANDA 27 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0781-5792 TABLET, FILM COATED 750 mg ORAL ANDA 27 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0781-5792 TABLET, FILM COATED 750 mg ORAL ANDA 27 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6351 TABLET, FILM COATED 250 mg ORAL ANDA 26 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6352 TABLET, FILM COATED 500 mg ORAL ANDA 26 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6353 TABLET, FILM COATED 750 mg ORAL ANDA 26 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-143 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-245 TABLET, FILM COATED 750 mg ORAL ANDA 30 sections
levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-451 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-558 TABLET, FILM COATED 500 mg ORAL ANDA 30 sections
Levofloxacin Human Prescription Drug Label 1 10544-624 TABLET, FILM COATED 500 mg ORAL ANDA 30 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 10544-906 TABLET, FILM COATED 750 mg ORAL ANDA 28 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 12634-674 TABLET, FILM COATED 750 mg ORAL ANDA 28 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 12634-675 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
LEVOFLOXACIN HUMAN PRESCRIPTION DRUG LABEL 1 13668-082 TABLET 250 mg ORAL ANDA 27 sections
LEVOFLOXACIN HUMAN PRESCRIPTION DRUG LABEL 1 13668-083 TABLET 500 mg ORAL ANDA 27 sections