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 1267.20 10.34 1808 83815 273397 55933047
Tendon pain 565.01 10.34 203 85420 2908 56203536
Sedation complication 521.52 10.34 284 85339 11388 56195056
Creatinine renal clearance decreased 483.68 10.34 292 85331 14267 56192177
Orthostatic hypotension 402.11 10.34 362 85261 32837 56173607
Blood calcium decreased 386.28 10.34 307 85316 23462 56182982
Cognitive disorder 373.59 10.34 416 85207 48717 56157727
Sedation 364.11 10.34 350 85273 34504 56171940
Tendonitis 324.99 10.34 248 85375 17849 56188595
Drug reaction with eosinophilia and systemic symptoms 319.72 10.34 306 85317 29998 56176446
Tendon rupture 293.96 10.34 168 85455 7402 56199042
Tendon disorder 268.93 10.34 142 85481 5343 56201101
Depressed level of consciousness 267.22 10.34 377 85246 56056 56150388
Febrile neutropenia 253.63 10.34 521 85102 105024 56101420
Rheumatoid arthritis 226.98 10.34 152 85471 382452 55823992
Pneumonia 220.53 10.34 1208 84415 405890 55800554
Balance disorder 219.39 10.34 407 85216 76113 56130331
Pemphigus 219.09 10.34 4 85619 157208 56049236
Arthropathy 215.10 10.34 26 85597 200249 56006195
Glossodynia 190.75 10.34 10 85613 152448 56053996
Hand deformity 185.07 10.34 4 85619 134488 56071956
Systemic lupus erythematosus 182.41 10.34 28 85595 180050 56026394
Maternal exposure during pregnancy 158.23 10.34 46 85577 189507 56016937
International normalised ratio fluctuation 154.96 10.34 75 85548 2339 56204105
Constipation 148.11 10.34 654 84969 201289 56005155
Completed suicide 147.08 10.34 16 85607 133817 56072627
Drug ineffective 144.61 10.34 816 84807 918173 55288271
Contrast media allergy 140.37 10.34 68 85555 2125 56204319
Toxic epidermal necrolysis 126.81 10.34 162 85461 21880 56184564
Bloody discharge 126.80 10.34 56 85567 1409 56205035
Pyrexia 125.18 10.34 1074 84549 417699 55788745
Pericarditis 119.73 10.34 13 85610 108910 56097534
Alopecia 118.62 10.34 164 85459 293294 55913150
Wound 117.07 10.34 33 85590 138771 56067673
Synovitis 111.35 10.34 53 85570 161252 56045192
Mobility decreased 108.15 10.34 364 85259 98627 56107817
Neuropathy peripheral 107.73 10.34 373 85250 102520 56103924
Discomfort 105.10 10.34 42 85581 141719 56064725
Joint swelling 99.99 10.34 180 85443 289620 55916824
Hypotension 94.84 10.34 679 84944 249829 55956615
Electrocardiogram QT prolonged 93.70 10.34 236 85387 54352 56152092
Therapeutic product effect decreased 90.35 10.34 75 85548 169377 56037067
Abdominal discomfort 89.69 10.34 179 85444 277095 55929349
Helicobacter infection 87.98 10.34 6 85617 73262 56133182
Drug interaction 86.71 10.34 581 85042 209174 55997270
Contraindicated product administered 85.84 10.34 94 85529 186192 56020252
Lyme disease 84.71 10.34 54 85569 2904 56203540
Atelectasis 84.03 10.34 124 85499 19184 56187260
Weight increased 83.46 10.34 138 85485 229565 55976879
Vanishing bile duct syndrome 82.08 10.34 33 85590 652 56205792
Pseudomembranous colitis 80.67 10.34 52 85571 2851 56203593
Intentional overdose 80.57 10.34 6 85617 68111 56138333
Computerised tomogram thorax abnormal 80.38 10.34 41 85582 1434 56205010
Neurotoxicity 75.41 10.34 106 85517 15689 56190755
Loss of employment 75.22 10.34 43 85580 1894 56204550
Thrombocytopenia 73.86 10.34 405 85218 135819 56070625
Irritable bowel syndrome 70.75 10.34 10 85613 68448 56137996
Rash maculo-papular 69.68 10.34 143 85480 28764 56177680
Hepatic function abnormal 68.52 10.34 158 85465 34400 56172044
Acute generalised exanthematous pustulosis 67.23 10.34 79 85544 9790 56196654
Peripheral swelling 65.66 10.34 164 85459 234562 55971882
Impaired healing 65.54 10.34 25 85598 86816 56119628
Blood cholesterol increased 65.51 10.34 15 85608 72564 56133880
Swelling 65.17 10.34 170 85453 239601 55966843
Folliculitis 64.58 10.34 5 85618 54974 56151470
Tendon discomfort 63.69 10.34 19 85604 144 56206300
Clostridium difficile colitis 63.09 10.34 107 85516 18631 56187813
Crystal nephropathy 62.63 10.34 29 85594 817 56205627
Neutrophil count decreased 62.35 10.34 192 85431 49630 56156814
Exposure during pregnancy 61.47 10.34 70 85553 136272 56070172
Product use issue 61.05 10.34 119 85504 185922 56020522
Lip oedema 60.96 10.34 47 85576 3431 56203013
Neutropenia 59.92 10.34 429 85194 157738 56048706
Skin reaction 59.90 10.34 86 85537 12977 56193467
Musculoskeletal injury 59.71 10.34 17 85606 107 56206337
Torsade de pointes 58.66 10.34 83 85540 12357 56194087
Respiratory failure 58.65 10.34 293 85330 94769 56111675
Muscle injury 58.36 10.34 6 85617 52494 56153950
Factor XIII deficiency 55.42 10.34 15 85608 76 56206368
Respiratory muscle weakness 55.11 10.34 16 85607 109 56206335
Hypokalaemia 54.72 10.34 286 85337 94151 56112293
Injection site reaction 54.50 10.34 8 85615 53239 56153205
Septic shock 53.90 10.34 209 85414 60626 56145818
Trimethylaminuria 53.21 10.34 16 85607 125 56206319
Dysbiosis 53.10 10.34 25 85598 732 56205712
Psoriatic arthropathy 53.09 10.34 23 85600 73985 56132459
Lower respiratory tract infection 52.77 10.34 58 85565 114736 56091708
Musculoskeletal stiffness 52.74 10.34 98 85525 155909 56050535
Suicide attempt 52.10 10.34 12 85611 57824 56148620
Injection site pain 51.85 10.34 61 85562 117057 56089387
Hypoxia 51.75 10.34 190 85433 53707 56152737
Hypocoagulable state 51.07 10.34 27 85596 1018 56205426
Disseminated mucormycosis 51.02 10.34 16 85607 146 56206298
Infusion related reaction 50.95 10.34 156 85467 208775 55997669
Sleep disorder due to general medical condition, insomnia type 50.73 10.34 4 85619 43334 56163110
Bronchitis 49.32 10.34 316 85307 111995 56094449
Obliterative bronchiolitis 49.20 10.34 33 85590 1935 56204509
Cholestasis 47.89 10.34 118 85505 26795 56179649
Upper respiratory tract infection 47.76 10.34 225 85398 71063 56135381
Drug resistance 46.44 10.34 99 85524 20443 56186001
Toxic skin eruption 46.27 10.34 72 85551 11667 56194777
Nasopharyngitis 45.74 10.34 177 85446 220782 55985662
Tongue oedema 45.31 10.34 42 85581 3950 56202494
Platelet count decreased 45.29 10.34 297 85326 106086 56100358
Respiratory syncytial virus infection 44.52 10.34 48 85575 5413 56201031
Sepsis 44.40 10.34 364 85259 139476 56066968
Delirium 44.34 10.34 154 85469 42363 56164081
Haemophagocytic lymphohistiocytosis 43.86 10.34 63 85560 9509 56196935
Myoclonus 43.68 10.34 81 85542 15122 56191322
Ill-defined disorder 43.59 10.34 25 85598 68518 56137926
Hepatic enzyme increased 42.46 10.34 127 85496 171257 56035187
Vascular purpura 42.06 10.34 26 85597 1324 56205120
Eosinophilic pneumonia 42.02 10.34 30 85593 1947 56204497
Computerised tomogram thorax 41.47 10.34 15 85608 219 56206225
Eosinophilia 41.13 10.34 93 85530 19984 56186460
Headache 40.78 10.34 602 85021 558442 55648002
Hypoglycaemia 40.22 10.34 180 85443 55635 56150809
Arthritis 40.06 10.34 56 85567 99796 56106648
Stevens-Johnson syndrome 38.89 10.34 98 85525 22565 56183879
Anaemia 37.82 10.34 594 85029 266917 55939527
Stenotrophomonas infection 37.79 10.34 27 85596 1754 56204690
Chronic fatigue syndrome 37.01 10.34 22 85601 1043 56205401
Pneumonia fungal 36.41 10.34 41 85582 4852 56201592
Megacolon 35.91 10.34 26 85597 1725 56204719
Tumour associated fever 35.47 10.34 14 85609 263 56206181
Ectropion 35.17 10.34 12 85611 146 56206298
Drug eruption 34.79 10.34 102 85521 25661 56180783
Drug abuse 34.69 10.34 31 85592 67579 56138865
Keratopathy 34.66 10.34 17 85606 546 56205898
Knee arthroplasty 34.64 10.34 12 85611 44247 56162197
Immune reconstitution inflammatory syndrome associated tuberculosis 34.54 10.34 15 85608 362 56206082
Drug-induced liver injury 34.36 10.34 123 85500 34339 56172105
Pathogen resistance 34.35 10.34 44 85579 5956 56200488
Status epilepticus 34.26 10.34 73 85550 15068 56191376
Factor V inhibition 33.90 10.34 12 85611 164 56206280
Contusion 33.39 10.34 93 85530 128337 56078107
Cough 33.31 10.34 568 85055 259393 55947051
Hip arthroplasty 32.88 10.34 9 85614 38614 56167830
Erythema 32.71 10.34 372 85251 155567 56050877
Hepatic cytolysis 32.46 10.34 59 85564 10847 56195597
Purpura fulminans 32.27 10.34 9 85614 52 56206392
Tendon injury 31.96 10.34 24 85599 1684 56204760
Overdose 31.90 10.34 71 85552 105759 56100685
Hypomagnesaemia 31.85 10.34 97 85526 24918 56181526
Bronchopulmonary aspergillosis 31.61 10.34 50 85573 8214 56198230
Dysentery 31.44 10.34 18 85605 795 56205649
Cytokine release syndrome 31.32 10.34 58 85565 10817 56195627
Pneumonia bacterial 31.30 10.34 49 85574 7979 56198465
Cystic fibrosis pancreatic 31.30 10.34 9 85614 59 56206385
Face oedema 30.84 10.34 79 85544 18373 56188071
Wrong technique in product usage process 30.66 10.34 26 85597 58142 56148302
Injection site erythema 30.50 10.34 44 85579 77404 56129040
Acquired macroglossia 30.14 10.34 11 85612 165 56206279
Therapeutic response decreased 29.80 10.34 22 85601 52736 56153708
Band sensation 29.71 10.34 17 85606 750 56205694
Infective pulmonary exacerbation of cystic fibrosis 29.36 10.34 48 85575 8109 56198335
Osteoarthritis 29.34 10.34 48 85575 80248 56126196
Injection site swelling 29.01 10.34 15 85608 43563 56162881
Multiple organ dysfunction syndrome 28.63 10.34 157 85466 52613 56153831
Condition aggravated 28.46 10.34 362 85261 344536 55861908
Sense of oppression 28.38 10.34 18 85605 959 56205485
Migraine 28.03 10.34 56 85567 86741 56119703
Upper respiratory tract inflammation 27.99 10.34 26 85597 2451 56203993
Colitis microscopic 27.88 10.34 46 85577 7829 56198615
Acute febrile neutrophilic dermatosis 27.75 10.34 27 85596 2698 56203746
Basal cell carcinoma 27.72 10.34 3 85620 25218 56181226
Blood pressure increased 27.70 10.34 120 85503 145056 56061388
Injection site bruising 27.58 10.34 12 85611 38509 56167935
Erythema multiforme 27.57 10.34 51 85572 9503 56196941
Hypoglycaemic coma 27.05 10.34 25 85598 2342 56204102
Pneumonitis 26.78 10.34 107 85516 31457 56174987
Respiratory tract infection 26.49 10.34 117 85506 35954 56170490
Weight decreased 26.15 10.34 237 85386 240477 55965967
Type I hypersensitivity 26.07 10.34 25 85598 2453 56203991
International normalised ratio increased 25.92 10.34 134 85489 43907 56162537
Laryngeal oedema 25.88 10.34 36 85587 5274 56201170
Blood bilirubin increased 25.88 10.34 110 85513 33244 56173200
Type 2 diabetes mellitus 25.88 10.34 20 85603 46842 56159602
Pregnancy 25.78 10.34 9 85614 33024 56173420
Stress 25.72 10.34 31 85592 58879 56147565
Cerebrovascular accident 25.71 10.34 72 85551 99198 56107246
Muscle atrophy 25.70 10.34 40 85583 6481 56199963
Acute myeloid leukaemia 25.65 10.34 70 85553 16902 56189542
Umbilical erythema 25.61 10.34 8 85615 72 56206372
Recall phenomenon 25.59 10.34 14 85609 566 56205878
Fatigue 25.56 10.34 962 84661 787590 55418854
Mucormycosis 25.50 10.34 26 85597 2748 56203696
Influenza B virus test positive 25.50 10.34 11 85612 261 56206183
Hyperpyrexia 25.38 10.34 28 85595 3240 56203204
Glomerulonephritis rapidly progressive 25.37 10.34 16 85607 844 56205600
Hallucination 25.19 10.34 144 85479 49005 56157439
Long QT syndrome congenital 25.02 10.34 7 85616 41 56206403
Foreign body aspiration 24.76 10.34 10 85613 200 56206244
Blister 24.63 10.34 84 85539 108803 56097641
Myalgia 24.62 10.34 308 85315 131717 56074727
Accidental exposure to product 24.55 10.34 4 85619 24643 56181801
Acute graft versus host disease 24.50 10.34 31 85592 4144 56202300
Enterocolitis 24.49 10.34 41 85582 7063 56199381
Confabulation 24.32 10.34 11 85612 293 56206151
Red blood cell sedimentation rate increased 23.80 10.34 13 85610 36610 56169834
Kounis syndrome 23.76 10.34 18 85605 1280 56205164
Pneumococcal infection 23.65 10.34 12 85611 415 56206029
Myocardial infarction 23.58 10.34 68 85555 92802 56113642
White blood cell count decreased 23.52 10.34 294 85329 125696 56080748
Pancytopenia 23.51 10.34 222 85401 88493 56117951
Graft versus host disease 23.19 10.34 39 85584 6742 56199702
Renal necrosis 23.03 10.34 7 85616 57 56206387
Conjunctival hyperaemia 22.64 10.34 22 85601 2194 56204250
Suicidal ideation 22.54 10.34 33 85590 57709 56148735
Mucosal inflammation 22.31 10.34 126 85497 42684 56163760
Product name confusion 22.02 10.34 7 85616 67 56206377
Glaucoma 21.87 10.34 67 85556 17262 56189182
Blood lactate dehydrogenase increased 21.65 10.34 75 85548 20600 56185844
Hyperbilirubinaemia 21.62 10.34 48 85575 10187 56196257
Long QT syndrome 21.58 10.34 25 85598 3051 56203393
Optic neuropathy 21.05 10.34 20 85603 1940 56204504
Nervous system disorder 21.04 10.34 65 85558 16824 56189620
Product quality issue 21.01 10.34 11 85612 31725 56174719
Liver disorder 20.80 10.34 127 85496 44243 56162201
Infective keratitis 20.78 10.34 6 85617 40 56206404
Respiratory tract infection fungal 20.77 10.34 11 85612 416 56206028
Arthralgia 20.71 10.34 593 85030 501076 55705368
Weber tuning fork test abnormal 20.60 10.34 7 85616 84 56206360
Meningitis tuberculous 20.60 10.34 12 85611 548 56205896
Bronchial obstruction 20.57 10.34 17 85606 1371 56205073
Clostridium difficile infection 20.57 10.34 89 85534 27109 56179335
Generalised onset non-motor seizure 20.54 10.34 5 85618 15 56206429
Fibromyalgia 20.52 10.34 37 85586 59566 56146878
Nocardiosis 20.48 10.34 19 85604 1789 56204655
Muscle contractions involuntary 20.28 10.34 20 85603 2031 56204413
Femur fracture 20.18 10.34 18 85605 39277 56167167
Blood pressure fluctuation 20.12 10.34 19 85604 40341 56166103
Osteoporosis 20.07 10.34 30 85593 52022 56154422
Premature delivery 20.06 10.34 8 85615 27052 56179392
C-reactive protein abnormal 19.96 10.34 16 85607 36793 56169651
Intentional product use issue 19.91 10.34 81 85542 99652 56106792
Cytomegalovirus test positive 19.88 10.34 23 85600 2803 56203641
Acute kidney injury 19.87 10.34 493 85130 240270 55966174
Inappropriate schedule of product administration 19.78 10.34 63 85560 83324 56123120
Gastritis fungal 19.69 10.34 7 85616 97 56206347
Thyroid disorder 19.60 10.34 56 85567 13882 56192562
Aspartate aminotransferase increased 19.59 10.34 202 85421 82400 56124044
Incorrect dose administered 19.58 10.34 31 85592 52516 56153928
Intentional product misuse 19.56 10.34 30 85593 51474 56154970
Inflammation 19.48 10.34 48 85575 69023 56137421
Chronic kidney disease 19.48 10.34 120 85503 41936 56164508
Foetal exposure during pregnancy 19.23 10.34 14 85609 33809 56172635
Corneal erosion 19.20 10.34 9 85614 261 56206183
Sensory processing disorder 19.19 10.34 4 85619 4 56206440
Boutonneuse fever 19.19 10.34 4 85619 4 56206440
Cholangitis 19.01 10.34 30 85593 4919 56201525
Systemic inflammatory response syndrome 18.91 10.34 31 85592 5247 56201197
Epilepsy 18.65 10.34 82 85541 25149 56181295
Hyperuricaemia 18.46 10.34 30 85593 5043 56201401
Pulmonary renal syndrome 18.44 10.34 10 85613 397 56206047
Enterocolitis bacterial 18.35 10.34 8 85615 195 56206249
Skin injury 18.25 10.34 17 85606 1609 56204835
Rhinovirus infection 18.24 10.34 26 85597 3896 56202548
General physical health deterioration 18.18 10.34 168 85455 169842 56036602
Disseminated intravascular coagulation 17.97 10.34 64 85559 17821 56188623
Urinary tract infection enterococcal 17.96 10.34 21 85602 2588 56203856
Staphylococcal scalded skin syndrome 17.81 10.34 7 85616 130 56206314
Dizziness 17.77 10.34 436 85187 375704 55830740
Chordae tendinae rupture 17.63 10.34 5 85618 31 56206413
Osteonecrosis of jaw 17.47 10.34 15 85608 33343 56173101
Injection site haemorrhage 17.41 10.34 6 85617 22195 56184249
Trichoglossia 17.39 10.34 8 85615 222 56206222
Ventricular fibrillation 17.39 10.34 46 85577 10906 56195538
Therapy naive 17.36 10.34 5 85618 33 56206411
Pain 17.25 10.34 829 84794 662355 55544089
Factor XIII Inhibition 17.23 10.34 5 85618 34 56206410
Rash morbilliform 17.13 10.34 22 85601 2985 56203459
Circumoral oedema 17.13 10.34 8 85615 230 56206214
Streptococcal sepsis 17.10 10.34 17 85606 1743 56204701
Breast cancer 17.09 10.34 30 85593 48803 56157641
Enteritis infectious 17.01 10.34 18 85605 1986 56204458
Loss of personal independence in daily activities 16.93 10.34 65 85558 81304 56125140
Sputum discoloured 16.88 10.34 54 85569 14238 56192206
Japanese spotted fever 16.47 10.34 3 85620 0 56206444
Somnolence 16.41 10.34 164 85459 163249 56043195
Endophthalmitis 16.37 10.34 22 85601 3121 56203323
Peripheral sensory neuropathy 16.27 10.34 34 85589 6922 56199522
Cystic fibrosis 16.27 10.34 23 85600 3421 56203023
Agranulocytosis 16.26 10.34 73 85550 22586 56183858
Liver injury 16.25 10.34 24 85599 41824 56164620
Spinal cord haematoma 16.19 10.34 7 85616 167 56206277
Complex regional pain syndrome 16.16 10.34 18 85605 2105 56204339
Acquired haemophilia 16.14 10.34 13 85610 1011 56205433
Arteritis infective 16.11 10.34 5 85618 44 56206400
Portal fibrosis 16.05 10.34 8 85615 266 56206178
Tongue exfoliation 16.03 10.34 6 85617 97 56206347
Acute respiratory distress syndrome 16.01 10.34 71 85552 21855 56184589
Septic embolus 15.99 10.34 12 85611 841 56205603
Product dose omission issue 15.73 10.34 218 85405 204535 56001909
Bacterial infection 15.72 10.34 60 85563 17270 56189174
Early retirement 15.55 10.34 4 85619 16 56206428
Blast cell count increased 15.53 10.34 9 85614 407 56206037
Enterococcal infection 15.52 10.34 34 85589 7150 56199294
Quadriplegia 15.45 10.34 16 85607 1722 56204722
Cytokine storm 15.34 10.34 8 85615 293 56206151
Encephalopathy 15.25 10.34 99 85524 35226 56171218
Cross sensitivity reaction 15.12 10.34 17 85606 2008 56204436
Vascular device infection 15.09 10.34 29 85594 5561 56200883
Toxic encephalopathy 15.05 10.34 30 85593 5908 56200536
Diabetic ketoacidosis 14.97 10.34 5 85618 18866 56187578
Generalised tonic-clonic seizure 14.94 10.34 82 85541 27484 56178960
Bacteraemia 14.91 10.34 55 85568 15576 56190868
Ventricular tachycardia 14.91 10.34 58 85565 16843 56189601
Intestinal polyp 14.86 10.34 14 85609 1344 56205100
Mechanical urticaria 14.85 10.34 9 85614 442 56206002
Therapy non-responder 14.80 10.34 46 85577 61309 56145135
Coronary artery disease 14.77 10.34 15 85608 30781 56175663
Splenic vein thrombosis 14.77 10.34 8 85615 317 56206127
Cerebral hypoperfusion 14.72 10.34 8 85615 319 56206125
Lymphomatoid papulosis 14.72 10.34 6 85617 123 56206321
Interstitial lung disease 14.72 10.34 142 85481 56921 56149523
Foot deformity 14.71 10.34 9 85614 23816 56182628
Myoclonic dystonia 14.66 10.34 4 85619 21 56206423
Disseminated strongyloidiasis 14.66 10.34 4 85619 21 56206423
Haematoma muscle 14.55 10.34 12 85611 965 56205479
Obesity 14.54 10.34 8 85615 22440 56184004
Sciatica 14.49 10.34 11 85612 25999 56180445
Clostridial infection 14.43 10.34 24 85599 4111 56202333
Antibiotic associated colitis 14.40 10.34 3 85620 3 56206441
Hot flush 14.36 10.34 31 85592 46695 56159749
Feeling abnormal 14.29 10.34 132 85491 133470 56072974
Road traffic accident 14.09 10.34 13 85610 27914 56178530
Osteopenia 14.06 10.34 5 85618 18136 56188308
Gastrointestinal amyloidosis 14.02 10.34 5 85618 70 56206374
Acute sinusitis 14.01 10.34 22 85601 3591 56202853
Purpura 13.96 10.34 41 85582 10321 56196123
Pneumocystis jirovecii pneumonia 13.94 10.34 54 85569 15647 56190797
Functional residual capacity increased 13.89 10.34 5 85618 72 56206372
Hallucination, visual 13.85 10.34 58 85565 17410 56189034
Gastroenteritis staphylococcal 13.82 10.34 5 85618 73 56206371
Anterior chamber flare 13.82 10.34 5 85618 73 56206371
Bronchitis chronic 13.72 10.34 23 85600 3965 56202479
Staphylococcal infection 13.62 10.34 101 85522 37517 56168927
Injection site pruritus 13.58 10.34 27 85596 41904 56164540
Rheumatoid nodule 13.54 10.34 3 85620 14854 56191590
Altered state of consciousness 13.51 10.34 70 85553 22951 56183493
Hyperamylasaemia 13.50 10.34 8 85615 377 56206067
Acute myeloid leukaemia recurrent 13.47 10.34 14 85609 1514 56204930
Cryopyrin associated periodic syndrome 13.44 10.34 6 85617 155 56206289
Macular degeneration 13.36 10.34 6 85617 18902 56187542
Administration site oedema 13.33 10.34 4 85619 31 56206413
Anti-neutrophil cytoplasmic antibody positive vasculitis 13.33 10.34 18 85605 2565 56203879
Underdose 13.29 10.34 10 85613 23747 56182697
Device malfunction 13.29 10.34 4 85619 16132 56190312
Enterobacter infection 13.27 10.34 16 85607 2036 56204408
Mitochondrial enzyme deficiency 13.22 10.34 4 85619 32 56206412
Device related infection 13.17 10.34 67 85556 21813 56184631
Muscle spasticity 13.09 10.34 7 85616 19953 56186491
Muscle tension dysphonia 13.07 10.34 5 85618 86 56206358
Adverse event 13.01 10.34 42 85581 55334 56151110
Blastomycosis 12.98 10.34 7 85616 275 56206169
Vitreous opacities 12.88 10.34 7 85616 279 56206165
Immune effector cell-associated neurotoxicity syndrome 12.87 10.34 14 85609 1594 56204850
Sputum increased 12.83 10.34 16 85607 2108 56204336
Multiple sclerosis 12.82 10.34 14 85609 27788 56178656
Pseudomonas infection 12.77 10.34 39 85584 10032 56196412
CNS ventriculitis 12.76 10.34 5 85618 92 56206352
Polymerase chain reaction positive 12.76 10.34 5 85618 92 56206352
Neutrophilic dermatosis 12.73 10.34 6 85617 176 56206268
Angioedema 12.65 10.34 107 85516 41346 56165098
Blood pressure systolic increased 12.63 10.34 27 85596 40809 56165635
Hepatitis B 12.60 10.34 21 85602 3603 56202841
Leukopenia 12.58 10.34 164 85459 70776 56135668
Pyometra 12.57 10.34 5 85618 96 56206348
Plantar fasciitis 12.44 10.34 20 85603 3330 56203114
Creatinine renal clearance increased 12.40 10.34 9 85614 599 56205845
Hydrocephalus 12.40 10.34 25 85598 4964 56201480
Injection site mass 12.39 10.34 5 85618 16788 56189656
Perihepatic discomfort 12.32 10.34 3 85620 9 56206435
Sputum purulent 12.32 10.34 11 85612 985 56205459
Dyspnoea 12.23 10.34 1053 84570 591524 55614920
Gastric cyst 12.20 10.34 5 85618 104 56206340
Small fibre neuropathy 12.17 10.34 6 85617 195 56206249
Eye infection fungal 12.15 10.34 5 85618 105 56206339
Collagen disorder 12.14 10.34 6 85617 196 56206248
Microscopic polyangiitis 12.11 10.34 6 85617 197 56206247
Septic pulmonary embolism 12.09 10.34 4 85619 44 56206400
Nodular rash 12.06 10.34 6 85617 199 56206245
Drug dependence 11.96 10.34 10 85613 22523 56183921
Drug withdrawal syndrome 11.94 10.34 13 85610 25844 56180600
Strangury 11.87 10.34 3 85620 11 56206433
Hepatic cyst infection 11.86 10.34 5 85618 112 56206332
Treatment failure 11.84 10.34 185 85438 170207 56036237
Excessive eye blinking 11.83 10.34 11 85612 1038 56205406
Acute graft versus host disease in skin 11.74 10.34 19 85604 3183 56203261
Grip strength decreased 11.74 10.34 5 85618 16251 56190193
Mitral valve disease 11.73 10.34 16 85607 2301 56204143
Palatal oedema 11.70 10.34 8 85615 484 56205960
Pupillary block 11.66 10.34 3 85620 12 56206432
Purpura non-thrombocytopenic 11.66 10.34 5 85618 117 56206327
Blood alkaline phosphatase increased 11.61 10.34 100 85523 38845 56167599
Incision site pain 11.60 10.34 11 85612 1064 56205380
Prurigo 11.60 10.34 10 85613 855 56205589
C-reactive protein increased 11.57 10.34 176 85447 78508 56127936
Corynebacterium infection 11.56 10.34 8 85615 494 56205950
Nodule 11.54 10.34 7 85616 18612 56187832
Walking disability 11.46 10.34 12 85611 1308 56205136
Asteatosis 11.41 10.34 4 85619 53 56206391
Tonsillitis bacterial 11.39 10.34 5 85618 124 56206320
Vomiting 11.34 10.34 892 84731 497336 55709108
Epidermolysis 11.33 10.34 6 85617 227 56206217
Postural tremor 11.33 10.34 6 85617 227 56206217
Lip erosion 11.31 10.34 10 85613 884 56205560
Joint stiffness 11.31 10.34 23 85600 35402 56171042
Immune reconstitution inflammatory syndrome 11.31 10.34 26 85597 5648 56200796
Kussmaul respiration 11.31 10.34 6 85617 228 56206216
Multiple sclerosis relapse 11.30 10.34 33 85590 44870 56161574
Rhonchi 11.27 10.34 16 85607 2388 56204056
Fungaemia 11.26 10.34 15 85608 2109 56204335
Productive cough 11.26 10.34 133 85490 56099 56150345
Device related bacteraemia 11.24 10.34 5 85618 128 56206316
Connective tissue inflammation 11.21 10.34 4 85619 56 56206388
Injection site rash 11.05 10.34 6 85617 16952 56189492
Hepatic steatosis 11.03 10.34 73 85550 26141 56180303
Pancreatitis necrotising 10.99 10.34 12 85611 1372 56205072
Cardiovascular disorder 10.97 10.34 39 85584 10850 56195594
Petechiae 10.90 10.34 44 85579 12995 56193449
Fracture 10.86 10.34 7 85616 18011 56188433
Injection site urticaria 10.84 10.34 3 85620 12780 56193664
Multiple drug therapy 10.83 10.34 17 85606 2775 56203669
Bone density decreased 10.81 10.34 3 85620 12757 56193687
Pericarditis tuberculous 10.80 10.34 3 85620 17 56206427
SJS-TEN overlap 10.80 10.34 6 85617 250 56206194
Connective tissue disorder 10.79 10.34 11 85612 1163 56205281
Incorrect route of product administration 10.68 10.34 10 85613 21319 56185125
Exposure to fungus 10.66 10.34 5 85618 145 56206299
Eye irritation 10.66 10.34 8 85615 19020 56187424
Haematidrosis 10.56 10.34 4 85619 67 56206377
Aspergillus infection 10.50 10.34 30 85593 7435 56199009
Hallucination, tactile 10.50 10.34 6 85617 264 56206180
Thrombophlebitis septic 10.48 10.34 5 85618 151 56206293
Illusion 10.40 10.34 10 85613 984 56205460
Trunk injury 10.39 10.34 3 85620 20 56206424
Gastrooesophageal reflux disease 10.37 10.34 79 85544 83178 56123266
Coma 10.36 10.34 51 85572 59604 56146840
Genital burning sensation 10.36 10.34 6 85617 271 56206173

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 422.35 10.73 230 69683 6289 31621142
Tendonitis 392.04 10.73 241 69672 8317 31619114
Tendon pain 327.70 10.73 148 69765 2667 31624764
Drug reaction with eosinophilia and systemic symptoms 224.45 10.73 303 69610 29715 31597716
Pneumonia 218.93 10.73 1373 68540 333939 31293492
Febrile neutropenia 202.83 10.73 660 69253 121189 31506242
Tendon disorder 202.25 10.73 103 69810 2445 31624986
Pyrexia 155.07 10.73 1172 68741 302668 31324763
Drug hypersensitivity 131.36 10.73 405 69508 72194 31555237
Completed suicide 129.12 10.73 23 69890 91491 31535940
Drug abuse 113.58 10.73 27 69886 87731 31539700
Toxicity to various agents 107.51 10.73 146 69767 181341 31446090
Tendon discomfort 102.07 10.73 33 69880 221 31627210
Electrocardiogram QT prolonged 83.18 10.73 227 69686 37760 31589671
Drug resistance 79.37 10.73 166 69747 23287 31604144
Myocardial infarction 79.22 10.73 80 69833 113374 31514057
Cytokine release syndrome 78.90 10.73 136 69777 16506 31610925
Rash maculo-papular 74.50 10.73 171 69742 25548 31601883
Pathogen resistance 68.31 10.73 90 69823 8611 31618820
Foetal exposure during pregnancy 67.95 10.73 6 69907 40870 31586561
Neuropathy peripheral 67.67 10.73 338 69575 75311 31552120
Congenital hiatus hernia 65.64 10.73 30 69883 556 31626875
Intentional overdose 63.86 10.73 8 69905 41381 31586050
Pancytopenia 61.81 10.73 366 69547 86950 31540481
Neutropenia 61.67 10.73 524 69389 139840 31487591
Hepatocellular injury 57.78 10.73 139 69774 21405 31606026
Cholestasis 57.04 10.73 152 69761 24923 31602508
Vertebral artery dissection 54.78 10.73 14 69899 33 31627398
Chorea 53.14 10.73 31 69882 969 31626462
Eosinophilia 52.94 10.73 141 69772 23112 31604319
Weight increased 52.89 10.73 63 69850 82884 31544547
Tracheobronchomegaly 51.73 10.73 12 69901 15 31627416
Mycotic allergy 51.58 10.73 22 69891 343 31627088
Aortitis 50.90 10.73 22 69891 355 31627076
Rheumatoid arthritis 50.61 10.73 21 69892 47788 31579643
Tubulointerstitial nephritis 50.31 10.73 120 69793 18376 31609055
Acute myeloid leukaemia 49.56 10.73 120 69793 18552 31608879
Lip oedema 49.39 10.73 41 69872 2283 31625148
Eosinophilic pneumonia acute 48.50 10.73 23 69890 465 31626966
Mite allergy 48.47 10.73 22 69891 401 31627030
Blood bilirubin increased 48.42 10.73 179 69734 34957 31592474
Cerebrovascular accident 47.93 10.73 63 69850 79421 31548010
Fixed eruption 47.16 10.73 33 69880 1420 31626011
Purpura 46.15 10.73 79 69834 9531 31617900
Spirometry abnormal 46.03 10.73 22 69891 453 31626978
Ballismus 45.54 10.73 13 69900 53 31627378
Neurotoxicity 44.92 10.73 106 69807 16120 31611311
Overdose 44.33 10.73 74 69839 84590 31542841
Cross sensitivity reaction 42.83 10.73 30 69883 1293 31626138
Inappropriate schedule of product administration 42.60 10.73 30 69883 50793 31576638
Dust allergy 41.55 10.73 22 69891 567 31626864
Fall 40.80 10.73 242 69671 185847 31441584
Aspartate aminotransferase increased 40.62 10.73 257 69656 62462 31564969
Dermatitis exfoliative generalised 39.99 10.73 42 69871 3157 31624274
Toxic skin eruption 39.14 10.73 76 69837 10104 31617327
Conjunctivitis allergic 38.69 10.73 23 69890 745 31626686
Psoriasis 38.60 10.73 28 69885 46691 31580740
Platelet count decreased 37.78 10.73 391 69522 110044 31517387
Immune reconstitution inflammatory syndrome 37.67 10.73 66 69847 8112 31619319
Dizziness 37.57 10.73 271 69642 198876 31428555
Fatigue 37.40 10.73 518 69395 334688 31292743
Chest pain 36.97 10.73 133 69780 116824 31510607
Therapeutic product effect decreased 36.65 10.73 12 69901 31610 31595821
Pneumonitis 36.40 10.73 149 69764 30503 31596928
Tracheal oedema 34.94 10.73 8 69905 9 31627422
Somnolence 34.91 10.73 108 69805 99337 31528094
Bronchopulmonary aspergillosis 34.46 10.73 86 69827 13548 31613883
Chronic pigmented purpura 34.43 10.73 12 69901 104 31627327
Drug-induced liver injury 34.30 10.73 125 69788 24238 31603193
Pneumonia legionella 34.05 10.73 29 69884 1673 31625758
Dysbiosis 33.98 10.73 17 69896 388 31627043
Fusarium infection 33.71 10.73 24 69889 1062 31626369
Degenerative mitral valve disease 33.31 10.73 14 69899 210 31627221
Headache 33.16 10.73 253 69660 183399 31444032
Alanine aminotransferase increased 32.88 10.73 279 69634 74377 31553054
Death 32.85 10.73 579 69334 359990 31267441
Blood pressure increased 32.79 10.73 80 69833 79553 31547878
Respiratory failure 32.73 10.73 355 69558 101094 31526337
Aortic rupture 31.10 10.73 11 69902 100 31627331
Acute myocardial infarction 30.92 10.73 40 69873 50783 31576648
Toxic epidermal necrolysis 30.79 10.73 104 69809 19420 31608011
Eosinophilic pneumonia 30.67 10.73 36 69877 3061 31624370
Septic shock 30.60 10.73 250 69663 65908 31561523
Product dose omission issue 30.19 10.73 125 69788 105461 31521970
Neutrophil count decreased 29.96 10.73 190 69723 46204 31581227
Suicide attempt 29.90 10.73 23 69890 37225 31590206
Musculoskeletal injury 29.66 10.73 11 69902 116 31627315
Candida infection 29.63 10.73 91 69822 16167 31611264
Palatal oedema 29.32 10.73 19 69894 719 31626712
Bronchitis 29.12 10.73 165 69748 38552 31588879
Drug dependence 29.08 10.73 7 69906 22572 31604859
White blood cell count decreased 28.73 10.73 307 69606 87091 31540340
Bradycardia 28.27 10.73 70 69843 69257 31558174
Delirium 28.23 10.73 172 69741 41249 31586182
Pneumothorax spontaneous 28.21 10.73 17 69896 565 31626866
Thrombocytopenia 27.90 10.73 456 69457 142291 31485140
Haematoma muscle 27.13 10.73 22 69891 1185 31626246
Myoclonus 27.09 10.73 80 69833 13910 31613521
Hepatitis cholestatic 27.05 10.73 53 69860 7093 31620338
Hypertension 26.78 10.73 169 69744 127931 31499500
Pancreatitis 26.36 10.73 24 69889 35747 31591684
Breath sounds abnormal 26.31 10.73 47 69866 5865 31621566
Klebsiella infection 26.12 10.73 55 69858 7748 31619683
Nervous system disorder 25.83 10.73 76 69837 13187 31614244
Sepsis 25.61 10.73 474 69439 151455 31475976
Acute kidney injury 25.58 10.73 802 69111 278912 31348519
Clostridium difficile infection 25.47 10.73 90 69823 17189 31610242
Demodicidosis 25.09 10.73 10 69903 130 31627301
Agranulocytosis 25.00 10.73 103 69810 21144 31606287
Gluten sensitivity 24.63 10.73 7 69906 28 31627403
Prostate cancer 24.55 10.73 28 69885 37573 31589858
Feeling abnormal 23.67 10.73 57 69856 56945 31570486
Injection site pain 23.49 10.73 25 69888 34609 31592822
Lymphocyte count decreased 23.43 10.73 99 69814 20550 31606881
Joint noise 23.40 10.73 15 69898 557 31626874
Stress 23.27 10.73 13 69900 24928 31602503
Crystal nephropathy 23.26 10.73 13 69900 374 31627057
Unmasking of previously unidentified disease 23.01 10.73 17 69896 797 31626634
Pseudomembranous colitis 22.91 10.73 29 69884 2666 31624765
Lateral medullary syndrome 22.74 10.73 7 69906 39 31627392
Long QT syndrome 22.69 10.73 27 69886 2329 31625102
Nicotine dependence 22.68 10.73 14 69899 486 31626945
Respiratory arrest 22.66 10.73 15 69898 26242 31601189
Torsade de pointes 22.60 10.73 48 69865 6802 31620629
Blood pressure fluctuation 22.47 10.73 11 69902 22725 31604706
Tendon injury 22.09 10.73 17 69896 848 31626583
Hepatotoxicity 21.94 10.73 92 69821 19034 31608397
Intentional product misuse 21.93 10.73 31 69882 37920 31589511
Respiratory depression 21.91 10.73 3 69910 14507 31612924
Cardiac failure congestive 21.45 10.73 96 69817 79291 31548140
Tuberculoma of central nervous system 21.45 10.73 11 69902 265 31627166
Clostridium difficile colitis 21.40 10.73 74 69839 13982 31613449
Hypocoagulable state 21.25 10.73 17 69896 898 31626533
Nephrogenic diabetes insipidus 21.18 10.73 19 69894 1175 31626256
Respiratory muscle weakness 21.11 10.73 8 69905 90 31627341
Ventricular enlargement 21.07 10.73 13 69900 451 31626980
Eye injury 21.04 10.73 15 69898 665 31626766
Weight decreased 20.82 10.73 239 69674 159713 31467718
Eosinophilic myocarditis 20.74 10.73 13 69900 464 31626967
Weight bearing difficulty 20.64 10.73 17 69896 936 31626495
Diabetes mellitus 20.63 10.73 39 69874 42517 31584914
Full blood count abnormal 20.63 10.73 81 69832 16266 31611165
Normocytic anaemia 20.59 10.73 24 69889 2025 31625406
Gallbladder empyema 20.58 10.73 7 69906 56 31627375
Nephrolithiasis 20.55 10.73 18 69895 27321 31600110
Sebaceous adenitis 20.48 10.73 4 69909 0 31627431
Acanthamoeba keratitis 20.42 10.73 8 69905 99 31627332
Linear IgA disease 20.41 10.73 21 69892 1541 31625890
Malaise 20.32 10.73 256 69657 168255 31459176
Drug intolerance 20.08 10.73 54 69859 51979 31575452
Anaphylactoid reaction 20.03 10.73 24 69889 2085 31625346
Allergic cough 20.03 10.73 6 69907 30 31627401
Haemophagocytic lymphohistiocytosis 20.02 10.73 64 69849 11614 31615817
Coronary artery disease 20.00 10.73 45 69868 46042 31581389
Time perception altered 20 10.73 8 69905 105 31627326
Botulism 19.98 10.73 9 69904 161 31627270
Pulmonary vascular disorder 19.89 10.73 14 69899 608 31626823
Rash 19.80 10.73 583 69330 200903 31426528
Sensitisation 19.78 10.73 9 69904 165 31627266
Infective pulmonary exacerbation of cystic fibrosis 19.76 10.73 44 69869 6440 31620991
Encephalopathy 19.74 10.73 131 69782 32343 31595088
Factor V inhibition 19.68 10.73 9 69904 167 31627264
General physical health deterioration 19.63 10.73 158 69755 113277 31514154
Ligament pain 19.41 10.73 6 69907 34 31627397
Angular cheilitis 19.39 10.73 9 69904 173 31627258
Pneumonia bacterial 19.10 10.73 58 69855 10238 31617193
Conjunctival hyperaemia 19.08 10.73 24 69889 2192 31625239
Haematotoxicity 19.08 10.73 46 69867 7091 31620340
Sedation 19.01 10.73 9 69904 18956 31608475
Inferior vena cava dilatation 18.68 10.73 14 69899 671 31626760
Pulmonary alveolar haemorrhage 18.51 10.73 44 69869 6722 31620709
Distributive shock 18.46 10.73 17 69896 1088 31626343
Affective disorder 18.32 10.73 31 69882 3705 31623726
Hyperbilirubinaemia 18.25 10.73 76 69837 15674 31611757
Hypoglycaemia 18.17 10.73 182 69731 50764 31576667
Tubulointerstitial nephritis and uveitis syndrome 18.14 10.73 7 69906 83 31627348
Paradoxical drug reaction 18.12 10.73 28 69885 3101 31624330
Acute respiratory distress syndrome 18.06 10.73 104 69809 24436 31602995
Cardiac aneurysm 18.02 10.73 15 69898 838 31626593
Acute myeloid leukaemia recurrent 18.00 10.73 22 69891 1952 31625479
Small fibre neuropathy 17.86 10.73 6 69907 46 31627385
Cardiogenic shock 17.77 10.73 14 69899 22394 31605037
Thrombotic microangiopathy 17.65 10.73 53 69860 9298 31618133
Hypoalbuminaemia 17.61 10.73 59 69854 10969 31616462
Hepatic function abnormal 17.58 10.73 153 69760 41069 31586362
Arthritis fungal 17.49 10.73 7 69906 92 31627339
Musculoskeletal stiffness 17.41 10.73 41 69872 41284 31586147
Tuberculosis 17.41 10.73 49 69864 8292 31619139
Escherichia infection 17.34 10.73 45 69868 7259 31620172
Coma 17.20 10.73 41 69872 41109 31586322
Pneumonia fungal 17.14 10.73 41 69872 6288 31621143
Oedema 17.13 10.73 156 69757 42405 31585026
Hypoxia 17.11 10.73 178 69735 50135 31577296
Malignant melanoma in situ 17.10 10.73 18 69895 1356 31626075
Blood cholesterol increased 16.96 10.73 8 69905 16885 31610546
Neuroleptic malignant syndrome 16.92 10.73 8 69905 16861 31610570
Helicobacter test positive 16.90 10.73 14 69899 777 31626654
Henoch-Schonlein purpura 16.86 10.73 19 69894 1546 31625885
Diabetic bullosis 16.86 10.73 5 69908 24 31627407
Drug eruption 16.76 10.73 82 69831 18105 31609326
Wrong technique in product usage process 16.66 10.73 30 69883 33313 31594118
Retinal pigment epithelial tear 16.45 10.73 9 69904 248 31627183
Dermatitis bullous 16.42 10.73 40 69873 6205 31621226
Bronchial haemorrhage 16.39 10.73 13 69900 678 31626753
Cystitis haemorrhagic 16.24 10.73 36 69877 5253 31622178
Acute generalised exanthematous pustulosis 16.22 10.73 39 69874 6001 31621430
Vitreous detachment 15.98 10.73 14 69899 839 31626592
Delusion of grandeur 15.97 10.73 13 69900 704 31626727
Lactobacillus infection 15.93 10.73 8 69905 184 31627247
Transaminases increased 15.90 10.73 100 69813 24241 31603190
Serotonin syndrome 15.83 10.73 11 69902 18762 31608669
Peptic ulcer haemorrhage 15.83 10.73 11 69902 468 31626963
Ciliary hyperaemia 15.79 10.73 5 69908 31 31627400
Productive cough 15.63 10.73 127 69786 33413 31594018
Blast cell count increased 15.62 10.73 15 69898 1012 31626419
Anterior chamber flare 15.56 10.73 6 69907 71 31627360
Persistent corneal epithelial defect 15.53 10.73 5 69908 33 31627398
Stenotrophomonas infection 15.45 10.73 20 69893 1880 31625551
Cell death 15.41 10.73 21 69892 2075 31625356
Cranial nerve injury 15.36 10.73 3 69910 0 31627431
Epididymal disorder 15.36 10.73 3 69910 0 31627431
Cataract subcapsular 15.28 10.73 10 69903 385 31627046
Oesophageal oedema 15.21 10.73 4 69909 11 31627420
Pain 15.05 10.73 306 69607 186453 31440978
Colour blindness acquired 14.98 10.73 6 69907 79 31627352
Ulcerative keratitis 14.90 10.73 18 69895 1578 31625853
Mucosal inflammation 14.79 10.73 128 69785 34299 31593132
Hydrocephalus 14.69 10.73 32 69881 4613 31622818
Respiratory alkalosis 14.65 10.73 18 69895 1605 31625826
Phlebosclerosis 14.65 10.73 7 69906 144 31627287
Suicidal ideation 14.64 10.73 37 69876 36369 31591062
Tuberculosis of central nervous system 14.54 10.73 8 69905 223 31627208
Drug withdrawal syndrome 14.51 10.73 12 69901 18738 31608693
Corynebacterium test positive 14.49 10.73 4 69909 14 31627417
Diabetes mellitus inadequate control 14.47 10.73 5 69908 12736 31614695
Aspergillus infection 14.45 10.73 57 69856 11471 31615960
Eczema asteatotic 14.35 10.73 8 69905 229 31627202
Bronchiectasis 14.34 10.73 43 69870 7537 31619894
Sleep apnoea syndrome 14.32 10.73 12 69901 18613 31608818
Diabetic ketoacidosis 14.13 10.73 10 69903 16895 31610536
Immune effector cell-associated neurotoxicity syndrome 14.10 10.73 22 69891 2457 31624974
Erectile dysfunction 14.06 10.73 13 69900 19222 31608209
Respiratory distress 14.03 10.73 124 69789 33429 31594002
Accidental exposure to product 13.97 10.73 4 69909 11491 31615940
Cholangitis 13.90 10.73 44 69869 7942 31619489
Disseminated intravascular coagulation 13.81 10.73 85 69828 20452 31606979
Migraine 13.80 10.73 7 69906 14173 31613258
Coronary artery occlusion 13.76 10.73 3 69910 10353 31617078
Multiple organ dysfunction syndrome 13.71 10.73 219 69694 67984 31559447
Amoebic colitis 13.70 10.73 6 69907 100 31627331
Syncope 13.67 10.73 121 69792 85061 31542370
Disseminated mucormycosis 13.67 10.73 10 69903 462 31626969
Laryngeal oedema 13.58 10.73 25 69888 3192 31624239
Fungaemia 13.44 10.73 21 69892 2348 31625083
Muscle rupture 13.44 10.73 20 69893 2143 31625288
Systolic dysfunction 13.33 10.73 21 69892 2365 31625066
Leukopenia 13.30 10.73 190 69723 57638 31569793
Hypersensitivity vasculitis 13.26 10.73 25 69888 3250 31624181
Injection site swelling 13.24 10.73 3 69910 10084 31617347
Morganella infection 13.15 10.73 10 69903 490 31626941
Organising pneumonia 13.14 10.73 34 69879 5476 31621955
Peripheral sensory neuropathy 13.08 10.73 37 69876 6278 31621153
Ischaemic stroke 12.97 10.73 11 69902 16960 31610471
Keratitis fungal 12.94 10.73 6 69907 115 31627316
Irritability 12.93 10.73 19 69894 22870 31604561
Vascular purpura 12.92 10.73 16 69897 1438 31625993
Face oedema 12.91 10.73 52 69861 10564 31616867
Urticaria 12.84 10.73 188 69725 57329 31570102
Normochromic normocytic anaemia 12.81 10.73 27 69886 3805 31623626
Candida endophthalmitis 12.71 10.73 6 69907 120 31627311
Abdominal pain 12.70 10.73 236 69677 145716 31481715
Eye haematoma 12.68 10.73 5 69908 63 31627368
Withdrawal syndrome 12.63 10.73 5 69908 11712 31615719
Haemarthrosis 12.61 10.73 23 69890 2916 31624515
Contraindicated product administered 12.61 10.73 15 69898 19757 31607674
Hyposmia 12.60 10.73 7 69906 199 31627232
Kounis syndrome 12.56 10.73 19 69894 2065 31625366
Hiccups 12.52 10.73 47 69866 9240 31618191
Gastrointestinal haemorrhage 12.49 10.73 119 69794 82430 31545001
Interleukin-2 receptor increased 12.49 10.73 6 69907 125 31627306
Malabsorption from administration site 12.47 10.73 5 69908 66 31627365
Chronic fatigue syndrome 12.46 10.73 8 69905 298 31627133
Intentional self-injury 12.33 10.73 7 69906 13308 31614123
Haemorrhagic pneumonia 12.28 10.73 6 69907 130 31627301
Paranoia 12.24 10.73 4 69909 10551 31616880
Liver function test decreased 12.21 10.73 5 69908 70 31627361
Neuritis 12.20 10.73 11 69902 685 31626746
Substance-induced psychotic disorder 12.19 10.73 16 69897 1524 31625907
Drug ineffective for unapproved indication 12.19 10.73 74 69839 17716 31609715
Rotator cuff syndrome 12.13 10.73 32 69881 5213 31622218
Laryngotracheal oedema 12.07 10.73 3 69910 6 31627425
Pruritus genital 12.07 10.73 10 69903 555 31626876
Pleural effusion 12.00 10.73 232 69681 74688 31552743
Product substitution issue 12.00 10.73 3 69910 9429 31618002
Pneumonia pseudomonal 11.96 10.73 25 69888 3504 31623927
Heart rate decreased 11.94 10.73 28 69885 28238 31599193
Viral haemorrhagic cystitis 11.94 10.73 13 69900 1018 31626413
Ecthyma 11.93 10.73 9 69904 436 31626995
Muscle atrophy 11.79 10.73 38 69875 6923 31620508
Skin injury 11.79 10.73 17 69896 1770 31625661
Optic neuropathy 11.75 10.73 17 69896 1776 31625655
Immune reconstitution inflammatory syndrome associated tuberculosis 11.66 10.73 9 69904 451 31626980
Adverse reaction 11.65 10.73 22 69891 2865 31624566
Rectal haemorrhage 11.64 10.73 41 69872 36263 31591168
Dystonia 11.64 10.73 4 69909 10221 31617210
Accidental overdose 11.62 10.73 14 69899 18336 31609095
Fat tissue decreased 11.61 10.73 5 69908 80 31627351
Hepatic cytolysis 11.59 10.73 51 69862 10772 31616659
Corneal oedema 11.59 10.73 14 69899 1227 31626204
Liver disorder 11.51 10.73 108 69805 29599 31597832
Eosinophilic pleural effusion 11.50 10.73 7 69906 237 31627194
Eye abscess 11.50 10.73 6 69907 150 31627281
Exercise tolerance decreased 11.37 10.73 29 69884 4629 31622802
Sleep disorder due to a general medical condition 11.35 10.73 26 69887 3876 31623555
Infusion related reaction 11.31 10.73 61 69852 47994 31579437
Vasculitis 11.31 10.73 43 69870 8507 31618924
Lip haemorrhage 11.30 10.73 11 69902 755 31626676
Benign prostatic hyperplasia 11.26 10.73 58 69855 13067 31614364
Bacteraemia 11.24 10.73 72 69841 17562 31609869
Epididymitis 11.15 10.73 19 69894 2284 31625147
Bicytopenia 11.14 10.73 18 69895 2071 31625360
Blood triglycerides increased 11.10 10.73 8 69905 13389 31614042
Mixed liver injury 10.94 10.73 19 69894 2318 31625113
Lethargy 10.87 10.73 46 69867 38595 31588836
Tricuspid valve incompetence 10.86 10.73 3 69910 8826 31618605
Trichoglossia 10.85 10.73 7 69906 263 31627168
Colitis ulcerative 10.84 10.73 15 69898 18514 31608917
Alveolar lung disease 10.83 10.73 8 69905 375 31627056
Occult blood 10.79 10.73 10 69903 645 31626786
Endocarditis enterococcal 10.78 10.73 5 69908 96 31627335
Pneumothorax 10.75 10.73 69 69844 16841 31610590
Eyelid oedema 10.74 10.73 29 69884 4791 31622640

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 769.92 9.75 313 135707 4993 70787431
Tendon rupture 674.88 9.75 359 135661 10810 70781614
Drug hypersensitivity 591.94 9.75 1451 134569 261008 70531416
Tendonitis 562.99 9.75 410 135610 21712 70770712
Drug reaction with eosinophilia and systemic symptoms 540.18 9.75 610 135410 57403 70735021
Sedation complication 465.45 9.75 301 135719 13109 70779315
Creatinine renal clearance decreased 420.08 9.75 311 135709 16889 70775535
Tendon disorder 402.62 9.75 213 135807 6338 70786086
Pneumonia 386.68 9.75 2199 133821 594033 70198391
Febrile neutropenia 379.44 9.75 1051 134969 203267 70589157
Blood calcium decreased 329.37 9.75 338 135682 28508 70763916
Completed suicide 303.05 9.75 39 135981 227096 70565328
Cognitive disorder 277.95 9.75 453 135567 60503 70731921
Orthostatic hypotension 258.58 9.75 401 135619 51342 70741082
Pyrexia 251.39 9.75 2004 134016 604948 70187476
Sedation 237.49 9.75 365 135655 46366 70746058
Rheumatoid arthritis 229.06 9.75 138 135882 291667 70500757
Arthropathy 177.17 9.75 36 135984 150021 70642403
Depressed level of consciousness 170.22 9.75 458 135562 86973 70705451
Electrocardiogram QT prolonged 164.10 9.75 439 135581 83078 70709346
Weight increased 151.22 9.75 145 135875 242186 70550238
Balance disorder 148.95 9.75 445 135575 89683 70702741
Neuropathy peripheral 142.18 9.75 550 135470 126346 70666078
Rash maculo-papular 140.57 9.75 304 135716 50241 70742183
Drug abuse 137.61 9.75 55 135965 147201 70645223
Pemphigus 137.02 9.75 5 136015 83031 70709393
Intentional overdose 135.89 9.75 15 136005 98420 70694004
Drug resistance 132.76 9.75 252 135768 37938 70754486
Synovitis 127.92 9.75 44 135976 129184 70663240
Toxic epidermal necrolysis 127.72 9.75 253 135767 39304 70753120
Tendon discomfort 126.79 9.75 43 135977 398 70792026
International normalised ratio fluctuation 126.04 9.75 78 135942 3141 70789283
Maternal exposure during pregnancy 123.66 9.75 34 135986 115311 70677113
Contrast media allergy 122.72 9.75 68 135952 2222 70790202
Glossodynia 122.43 9.75 12 136008 86475 70705949
Pathogen resistance 120.72 9.75 138 135882 13141 70779283
Systemic lupus erythematosus 119.12 9.75 25 135995 101877 70690547
Neurotoxicity 115.24 9.75 206 135814 29620 70762804
Cytokine release syndrome 111.63 9.75 190 135830 26277 70766147
Bloody discharge 111.18 9.75 58 135962 1675 70790749
Cholestasis 105.72 9.75 263 135757 47609 70744815
Wound 104.16 9.75 30 135990 98702 70693722
Therapeutic product effect decreased 103.47 9.75 74 135946 142944 70649480
Discomfort 95.87 9.75 41 135979 105395 70687029
Neutropenia 93.60 9.75 826 135194 256330 70536094
Eosinophilia 89.55 9.75 222 135798 40097 70752327
Respiratory failure 88.84 9.75 591 135429 168144 70624280
Thrombocytopenia 88.54 9.75 771 135249 238339 70554085
Headache 86.72 9.75 705 135315 579700 70212724
Duodenal ulcer perforation 84.59 9.75 3 136017 51109 70741315
Constipation 84.32 9.75 796 135224 251642 70540782
Pancytopenia 84.27 9.75 537 135483 150570 70641854
Exposure during pregnancy 83.18 9.75 32 135988 87685 70704739
Joint swelling 81.72 9.75 233 135787 252978 70539446
Peripheral swelling 80.59 9.75 212 135808 236351 70556073
Myocardial infarction 80.41 9.75 128 135892 171517 70620907
Neutrophil count decreased 79.94 9.75 345 135675 83211 70709213
Lip oedema 79.78 9.75 74 135946 5509 70786915
Crystal nephropathy 79.42 9.75 42 135978 1248 70791176
Mobility decreased 79.21 9.75 399 135621 102600 70689824
Septic shock 78.83 9.75 424 135596 111834 70680590
Overdose 78.19 9.75 128 135892 169617 70622807
Helicobacter infection 78.04 9.75 8 136012 55648 70736776
Pseudomembranous colitis 77.43 9.75 70 135950 5041 70787383
Lyme disease 76.79 9.75 55 135965 2834 70789590
Abdominal discomfort 76.49 9.75 188 135832 214470 70577954
Blood cholesterol increased 75.19 9.75 16 136004 64588 70727836
Suicide attempt 73.76 9.75 30 135990 79480 70712944
Injection site pain 73.74 9.75 70 135950 117549 70674875
Psoriatic arthropathy 73.45 9.75 17 136003 64754 70727670
Clostridium difficile colitis 73.41 9.75 168 135852 28828 70763596
Blood bilirubin increased 72.31 9.75 266 135754 59635 70732789
Nasopharyngitis 71.30 9.75 205 135815 222001 70570423
Toxic skin eruption 71.25 9.75 134 135886 20028 70772396
Acute generalised exanthematous pustulosis 69.56 9.75 114 135906 15283 70777141
Pericarditis 69.29 9.75 38 135982 84667 70707757
Platelet count decreased 68.73 9.75 580 135440 177642 70614782
Fatigue 68.52 9.75 1141 134879 823178 69969246
Delirium 67.52 9.75 303 135717 74311 70718113
Alopecia 67.50 9.75 178 135842 198312 70594112
Congenital hiatus hernia 67.36 9.75 29 135991 537 70791887
Clostridium difficile infection 67.28 9.75 195 135825 38621 70753803
Torsade de pointes 67.27 9.75 123 135897 17993 70774431
Myoclonus 67.05 9.75 153 135867 26202 70766222
Pneumonitis 66.37 9.75 243 135777 54354 70738070
Musculoskeletal stiffness 65.67 9.75 114 135906 147646 70644778
Blood pressure increased 64.91 9.75 168 135852 188349 70604075
Irritable bowel syndrome 64.77 9.75 10 136010 50840 70741584
Hepatic function abnormal 63.69 9.75 279 135741 67717 70724707
Respiratory muscle weakness 63.17 9.75 23 135997 267 70792157
Computerised tomogram thorax abnormal 62.90 9.75 43 135977 2055 70790369
Hypocoagulable state 62.88 9.75 42 135978 1931 70790493
Impaired healing 62.85 9.75 32 135988 74342 70718082
Contraindicated product administered 62.46 9.75 101 135919 134511 70657913
Hypoxia 62.46 9.75 348 135672 92996 70699428
Sepsis 61.37 9.75 728 135292 243817 70548607
Eosinophilic pneumonia 60.59 9.75 60 135960 4845 70787579
Acute myeloid leukaemia 60.09 9.75 162 135858 30778 70761646
Dysbiosis 58.87 9.75 31 135989 913 70791511
Injection site reaction 58.72 9.75 12 136008 49840 70742584
Vanishing bile duct syndrome 58.52 9.75 35 135985 1324 70791100
Haemophagocytic lymphohistiocytosis 58.03 9.75 121 135899 19491 70772933
Atelectasis 57.61 9.75 153 135867 28809 70763615
Dizziness 57.40 9.75 591 135429 463550 70328874
Cerebrovascular accident 57.33 9.75 118 135902 143352 70649072
Inappropriate schedule of product administration 56.47 9.75 74 135946 107481 70684943
Aspartate aminotransferase increased 54.77 9.75 424 135596 126554 70665870
Drug-induced liver injury 54.67 9.75 233 135787 55880 70736544
Disseminated mucormycosis 54.12 9.75 26 135994 627 70791797
Product dose omission issue 53.95 9.75 224 135796 217244 70575180
Lower respiratory tract infection 53.79 9.75 82 135938 111831 70680593
Stress 53.43 9.75 32 135988 67934 70724490
Purpura 53.30 9.75 111 135909 17864 70774560
Factor XIII deficiency 51.98 9.75 15 136005 76 70792348
Tubulointerstitial nephritis 51.50 9.75 160 135860 32916 70759508
Cross sensitivity reaction 51.45 9.75 47 135973 3431 70788993
Factor V inhibition 51.41 9.75 21 135999 339 70792085
Bronchopulmonary aspergillosis 51.31 9.75 120 135900 20882 70771542
Infusion related reaction 51.19 9.75 200 135820 197334 70595090
Trimethylaminuria 51.15 9.75 17 136003 147 70792277
Hypoglycaemia 51.13 9.75 333 135687 94031 70698393
Drug ineffective 51.05 9.75 1393 134627 938359 69854065
Loss of employment 51.04 9.75 39 135981 2220 70790204
Dermatitis exfoliative generalised 50.60 9.75 62 135958 6352 70786072
Tracheobronchomegaly 50.24 9.75 11 136009 11 70792413
Fixed eruption 49.71 9.75 40 135980 2456 70789968
Spirometry abnormal 49.56 9.75 25 135995 672 70791752
Vascular purpura 48.42 9.75 41 135979 2705 70789719
Immune reconstitution inflammatory syndrome 47.98 9.75 88 135932 12902 70779522
Sleep disorder due to general medical condition, insomnia type 47.93 9.75 6 136014 35726 70756698
Tendon injury 46.59 9.75 34 135986 1804 70790620
Blood pressure fluctuation 46.09 9.75 28 135992 58984 70733440
Multiple organ dysfunction syndrome 46.05 9.75 361 135659 108154 70684270
Ill-defined disorder 45.59 9.75 24 135996 54717 70737707
Eosinophilic pneumonia acute 45.58 9.75 26 135994 899 70791525
Skin reaction 45.51 9.75 90 135930 13959 70778465
Pneumonia fungal 45.37 9.75 74 135946 9879 70782545
Pneumonia legionella 45.16 9.75 39 135981 2643 70789781
Aortitis 44.88 9.75 30 135990 1381 70791043
Somnolence 44.69 9.75 237 135783 215369 70577055
Product use issue 44.21 9.75 186 135834 179751 70612673
Injection site swelling 43.90 9.75 14 136006 43143 70749281
Muscle injury 43.85 9.75 10 136010 38484 70753940
Contusion 43.37 9.75 115 135905 127921 70664503
Injection site bruising 43.08 9.75 10 136010 38022 70754402
Hepatic cytolysis 42.95 9.75 106 135914 19086 70773338
Immune reconstitution inflammatory syndrome associated tuberculosis 42.71 9.75 24 135996 806 70791618
Kounis syndrome 42.65 9.75 42 135978 3369 70789055
Drug interaction 41.94 9.75 992 135028 380449 70411975
Weight decreased 41.85 9.75 387 135633 310101 70482323
Malaise 41.00 9.75 584 135436 432348 70360076
Hepatocellular injury 40.07 9.75 185 135835 45906 70746518
Conjunctivitis allergic 39.99 9.75 26 135994 1142 70791282
Haematoma muscle 39.76 9.75 34 135986 2273 70790151
Acute kidney injury 39.74 9.75 1191 134829 473433 70318991
Long QT syndrome 39.63 9.75 50 135970 5277 70787147
Intentional product misuse 39.53 9.75 57 135963 79538 70712886
Injection site erythema 39.49 9.75 49 135971 72875 70719549
Musculoskeletal injury 38.81 9.75 14 136006 158 70792266
Red blood cell sedimentation rate increased 38.49 9.75 13 136007 38629 70753795
Drug eruption 38.47 9.75 164 135856 39332 70753092
Computerised tomogram thorax 38.03 9.75 15 136005 220 70792204
Hyperbilirubinaemia 37.79 9.75 112 135908 22456 70769968
Nervous system disorder 37.77 9.75 117 135903 24029 70768395
Tongue oedema 37.72 9.75 53 135967 6206 70786218
Migraine 37.61 9.75 50 135970 72188 70720236
Feeling abnormal 37.56 9.75 143 135877 142176 70650248
Mucosal inflammation 37.09 9.75 240 135780 67610 70724814
Mite allergy 36.58 9.75 22 135998 841 70791583
Folliculitis 36.44 9.75 18 136002 42552 70749872
General physical health deterioration 36.37 9.75 284 135736 235747 70556677
Agranulocytosis 35.96 9.75 163 135857 40135 70752289
Bronchitis 35.79 9.75 363 135657 116880 70675544
Muscle atrophy 35.50 9.75 68 135952 10302 70782122
Face oedema 35.37 9.75 119 135901 25520 70766904
Drug dependence 34.74 9.75 14 136006 37307 70755117
Coma 34.63 9.75 78 135942 91766 70700658
Chorea 34.55 9.75 30 135990 2048 70790376
International normalised ratio increased 34.49 9.75 269 135751 80457 70711967
Acute febrile neutrophilic dermatosis 34.43 9.75 38 135982 3481 70788943
Vertebral artery dissection 34.39 9.75 14 136006 224 70792200
Swelling 34.37 9.75 216 135804 188323 70604101
Bradycardia 34.33 9.75 123 135897 124492 70667932
Chronic fatigue syndrome 34.18 9.75 24 135996 1198 70791226
Stevens-Johnson syndrome 34.12 9.75 148 135872 35759 70756665
Mycotic allergy 33.98 9.75 23 135997 1081 70791343
Hepatitis cholestatic 33.92 9.75 75 135945 12575 70779849
Dysentery 33.72 9.75 22 135998 972 70791452
Infective pulmonary exacerbation of cystic fibrosis 33.64 9.75 73 135947 12085 70780339
Optic neuropathy 33.53 9.75 36 135984 3197 70789227
C-reactive protein abnormal 33.50 9.75 16 136004 38563 70753861
Chest pain 33.48 9.75 314 135706 250946 70541478
Alanine aminotransferase increased 33.48 9.75 431 135589 147049 70645375
Degenerative mitral valve disease 33.35 9.75 14 136006 243 70792181
Hydrocephalus 32.72 9.75 57 135963 8028 70784396
Acute respiratory distress syndrome 32.53 9.75 161 135859 41093 70751331
Encephalopathy 32.42 9.75 216 135804 61445 70730979
Wrong technique in product usage process 32.37 9.75 51 135969 68647 70723777
Respiratory syncytial virus infection 32.33 9.75 55 135965 7600 70784824
Enterocolitis 32.29 9.75 75 135945 12991 70779433
Blast cell count increased 32.24 9.75 24 135996 1313 70791111
Osteoarthritis 32.21 9.75 58 135962 74089 70718335
Hypokalaemia 32.18 9.75 389 135631 130799 70661625
Pneumonia bacterial 32.18 9.75 87 135933 16554 70775870
Upper respiratory tract infection 32.13 9.75 261 135759 79013 70713411
Affective disorder 31.94 9.75 54 135966 7425 70784999
Cholangitis 31.57 9.75 69 135951 11480 70780944
Anaemia 31.00 9.75 1002 135018 402421 70390003
Fusarium infection 30.82 9.75 26 135994 1706 70790718
Stenotrophomonas infection 30.77 9.75 35 135985 3314 70789110
Accidental exposure to product 30.56 9.75 8 136012 28043 70764381
Erythema multiforme 30.44 9.75 85 135935 16479 70775945
Dust allergy 30.23 9.75 22 135998 1162 70791262
Knee arthroplasty 30.13 9.75 14 136006 34287 70758137
Chronic pigmented purpura 30.12 9.75 12 136008 181 70792243
Obliterative bronchiolitis 29.96 9.75 32 135988 2825 70789599
Conjunctival hyperaemia 29.79 9.75 38 135982 4055 70788369
Peripheral sensory neuropathy 29.37 9.75 69 135951 12041 70780383
Keratopathy 29.36 9.75 20 136000 950 70791474
Ballismus 29.36 9.75 12 136008 194 70792230
Cystic fibrosis pancreatic 29.24 9.75 9 136011 59 70792365
Hypotension 28.92 9.75 996 135024 403385 70389039
Accidental overdose 28.36 9.75 16 136004 35105 70757319
Adverse event 28.10 9.75 32 135988 49429 70742995
Hepatic enzyme increased 28.02 9.75 181 135839 156809 70635615
White blood cell count decreased 27.90 9.75 470 135550 169671 70622753
Immune effector cell-associated neurotoxicity syndrome 27.49 9.75 36 135984 3942 70788482
Pregnancy 27.44 9.75 6 136014 23775 70768649
Band sensation 27.24 9.75 17 136003 695 70791729
Hip arthroplasty 26.96 9.75 10 136010 28030 70764394
Myalgia 26.87 9.75 462 135558 167430 70624994
Arthritis 26.79 9.75 97 135923 97883 70694541
Laryngeal oedema 26.71 9.75 50 135970 7445 70784979
Trichoglossia 26.50 9.75 15 136005 511 70791913
Suicidal ideation 26.32 9.75 59 135961 69537 70722887
Respiratory distress 26.11 9.75 187 135833 54463 70737961
Tumour associated fever 26.00 9.75 17 136003 754 70791670
Hyperpyrexia 25.93 9.75 41 135979 5333 70787091
Acquired macroglossia 25.63 9.75 11 136009 202 70792222
Aspergillus infection 25.60 9.75 84 135936 17784 70774640
Meningitis tuberculous 25.59 9.75 20 136000 1177 70791247
Tracheal oedema 25.54 9.75 8 136012 56 70792368
Poisoning 25.52 9.75 6 136014 22616 70769808
Demodicidosis 25.52 9.75 10 136010 144 70792280
Respiratory arrest 25.44 9.75 40 135980 53893 70738531
Blister 25.25 9.75 103 135917 100423 70692001
Product substitution issue 25.09 9.75 3 136017 18510 70773914
Pulmonary alveolar haemorrhage 25.06 9.75 59 135961 10310 70782114
Aortic rupture 25.01 9.75 11 136009 215 70792209
Anterior chamber flare 24.97 9.75 10 136010 153 70792271
Injection site pruritus 24.96 9.75 23 135997 39187 70753237
Tuberculoma of central nervous system 24.92 9.75 15 136005 574 70791850
Intentional product use issue 24.91 9.75 132 135888 120010 70672414
Clostridial infection 24.81 9.75 40 135980 5289 70787135
Thrombotic microangiopathy 24.76 9.75 83 135937 17765 70774659
Mechanical urticaria 24.62 9.75 13 136007 385 70792039
Diabetic ketoacidosis 24.54 9.75 15 136005 31497 70760927
Purpura fulminans 24.34 9.75 10 136010 164 70792260
Disseminated intravascular coagulation 24.31 9.75 128 135892 33470 70758954
Therapeutic response decreased 24.26 9.75 47 135973 58406 70734018
Cystitis haemorrhagic 24.24 9.75 52 135968 8541 70783883
Klebsiella infection 24.00 9.75 71 135949 14221 70778203
Toxicity to various agents 23.98 9.75 554 135466 381618 70410806
Heart rate decreased 23.93 9.75 52 135968 61963 70730461
Therapy non-responder 23.89 9.75 72 135948 76843 70715581
Death 23.83 9.75 771 135249 509290 70283134
Lymphocyte count decreased 23.79 9.75 154 135866 43385 70749039
Sleep apnoea syndrome 23.55 9.75 17 136003 32696 70759728
Liver disorder 23.50 9.75 200 135820 61368 70731056
Cardiogenic shock 23.46 9.75 21 135999 36286 70756138
Pneumothorax spontaneous 23.44 9.75 20 136000 1333 70791091
Staphylococcal infection 23.38 9.75 179 135841 53225 70739199
Acute myeloid leukaemia recurrent 23.25 9.75 29 135991 3025 70789399
Upper respiratory tract inflammation 23.19 9.75 33 135987 3909 70788515
Mucormycosis 23.19 9.75 49 135971 7965 70784459
Erythema 23.12 9.75 523 135497 199040 70593384
Transaminases increased 23.11 9.75 162 135858 46856 70745568
Type I hypersensitivity 23.08 9.75 32 135988 3700 70788724
Pain 23.02 9.75 979 135041 627837 70164587
Blood lactate dehydrogenase increased 22.84 9.75 130 135890 34997 70757427
Toxic encephalopathy 22.78 9.75 57 135963 10349 70782075
Multiple sclerosis 22.71 9.75 10 136010 25275 70767149
Candida infection 22.70 9.75 128 135892 34345 70758079
Long QT syndrome congenital 22.60 9.75 7 136013 47 70792377
Cystic fibrosis 22.53 9.75 34 135986 4247 70788177
Megacolon 22.49 9.75 29 135991 3127 70789297
Osteoporosis 22.39 9.75 37 135983 48870 70743554
Basal cell carcinoma 22.37 9.75 19 136001 33679 70758745
Arthralgia 22.32 9.75 766 135254 502624 70289800
Epilepsy 22.31 9.75 139 135881 38645 70753779
Abdominal pain 22.30 9.75 493 135527 341634 70450790
Lateral medullary syndrome 22.23 9.75 7 136013 50 70792374
Multiple sclerosis relapse 22.16 9.75 30 135990 42987 70749437
Vitreous opacities 22.16 9.75 14 136006 585 70791839
Bacteraemia 22.13 9.75 113 135907 29196 70763228
Haematotoxicity 22.08 9.75 67 135953 13607 70778817
Respiratory tract infection fungal 21.96 9.75 18 136002 1135 70791289
Guillain-Barre syndrome 21.93 9.75 48 135972 7992 70784432
Obesity 21.90 9.75 12 136008 26759 70765665
Escherichia infection 21.82 9.75 75 135945 16256 70776168
Sense of oppression 21.78 9.75 20 136000 1470 70790954
Status epilepticus 21.73 9.75 99 135921 24427 70767997
Device malfunction 21.65 9.75 5 136015 19079 70773345
Foreign body aspiration 21.53 9.75 11 136009 304 70792120
Ectropion 21.49 9.75 12 136008 398 70792026
Rash morbilliform 21.48 9.75 38 135982 5417 70787007
Road traffic accident 21.31 9.75 21 135999 34661 70757763
Blood pressure systolic increased 21.28 9.75 49 135971 57210 70735214
Hypersensitivity vasculitis 21.25 9.75 43 135977 6779 70785645
Ventricular enlargement 21.24 9.75 13 136007 513 70791911
Tubulointerstitial nephritis and uveitis syndrome 21.20 9.75 11 136009 314 70792110
Pneumothorax 21.19 9.75 102 135918 25744 70766680
Weight bearing difficulty 21.13 9.75 27 135993 2885 70789539
Muscle contractions involuntary 21.13 9.75 29 135991 3322 70789102
Sebaceous adenitis 21.03 9.75 4 136016 0 70792424
Breast cancer 20.98 9.75 20 136000 33529 70758895
Corneal erosion 20.95 9.75 11 136009 322 70792102
Fungaemia 20.89 9.75 32 135988 4050 70788374
Joint stiffness 20.82 9.75 22 135998 35154 70757270
Inflammation 20.77 9.75 79 135941 78586 70713838
Acanthamoeba keratitis 20.68 9.75 8 136012 111 70792313
Candida endophthalmitis 20.65 9.75 9 136011 172 70792252
Haemoptysis 20.63 9.75 169 135851 51283 70741141
Withdrawal syndrome 20.61 9.75 11 136009 24893 70767531
Nocardiosis 20.55 9.75 36 135984 5093 70787331
Small fibre neuropathy 20.48 9.75 10 136010 250 70792174
Pseudomonas infection 20.17 9.75 81 135939 18913 70773511
Influenza B virus test positive 20.12 9.75 11 136009 350 70792074
Gastritis fungal 20.09 9.75 9 136011 184 70792240
Coronary artery disease 20.01 9.75 58 135962 62678 70729746
Hyperuricaemia 19.88 9.75 56 135964 10910 70781514
Drug withdrawal syndrome 19.88 9.75 20 136000 32695 70759729
Premature delivery 19.81 9.75 8 136012 21296 70771128
Ulcerative keratitis 19.79 9.75 28 135992 3299 70789125
Type 2 diabetes mellitus 19.58 9.75 34 135986 44046 70748378
Eye injury 19.55 9.75 20 136000 1679 70790745
Linear IgA disease 19.49 9.75 26 135994 2898 70789526
Enteritis infectious 19.39 9.75 27 135993 3135 70789289
Product quality issue 19.36 9.75 18 136002 30543 70761881
Early retirement 19.15 9.75 5 136015 16 70792408
Respiratory tract infection 19.06 9.75 143 135877 42255 70750169
Ulcer 19.04 9.75 13 136007 25741 70766683
Weber tuning fork test abnormal 19.02 9.75 7 136013 84 70792340
Palatal oedema 18.84 9.75 17 136003 1221 70791203
Phlebosclerosis 18.84 9.75 8 136012 143 70792281
Femur fracture 18.81 9.75 25 135995 36107 70756317
Osteonecrosis of jaw 18.78 9.75 31 135989 40971 70751453
Drug intolerance 18.75 9.75 312 135708 225375 70567049
Injection site haemorrhage 18.72 9.75 13 136007 25514 70766910
Cytokine storm 18.71 9.75 15 136005 916 70791508
Angular cheilitis 18.67 9.75 13 136007 640 70791784
Inferior vena cava dilatation 18.65 9.75 14 136006 776 70791648
Enterococcal infection 18.65 9.75 66 135954 14516 70777908
Benign prostatic hyperplasia 18.61 9.75 53 135967 10390 70782034
Gallbladder empyema 18.44 9.75 7 136013 92 70792332
Diabetes mellitus 18.41 9.75 73 135947 71751 70720673
Pulmonary vascular disorder 18.39 9.75 15 136005 939 70791485
Diabetic bullosis 18.28 9.75 5 136015 20 70792404
Boutonneuse fever 18.27 9.75 4 136016 4 70792420
Respiratory alkalosis 18.25 9.75 30 135990 4031 70788393
Gamma-glutamyltransferase increased 17.97 9.75 162 135858 50523 70741901
Normocytic anaemia 17.93 9.75 28 135992 3602 70788822
Hepatotoxicity 17.92 9.75 145 135875 43841 70748583
Fibromyalgia 17.77 9.75 41 135979 47833 70744591
Blood alkaline phosphatase increased 17.76 9.75 181 135839 58340 70734084
Leukopenia 17.69 9.75 295 135725 106265 70686159
Ligament pain 17.64 9.75 9 136011 248 70792176
Nicotine dependence 17.61 9.75 14 136006 845 70791579
Incision site pain 17.57 9.75 24 135996 2737 70789687
Abortion spontaneous 17.49 9.75 15 136005 26464 70765960
Sciatica 17.46 9.75 13 136007 24614 70767810
Infective keratitis 17.46 9.75 6 136014 58 70792366
Paradoxical drug reaction 17.41 9.75 39 135981 6597 70785827
Pneumococcal infection 17.23 9.75 14 136006 872 70791552
Nephrogenic diabetes insipidus 17.17 9.75 20 136000 1943 70790481
Time perception altered 17.16 9.75 8 136012 180 70792244
Heart rate increased 17.14 9.75 126 135894 106022 70686402
Eosinophilic myocarditis 17.07 9.75 14 136006 883 70791541
Cardiac aneurysm 16.98 9.75 17 136003 1391 70791033
Injection site mass 16.88 9.75 7 136013 18336 70774088
Glomerulonephritis rapidly progressive 16.83 9.75 17 136003 1406 70791018
Psoriasis 16.80 9.75 115 135905 98318 70694106
Therapeutic response unexpected 16.71 9.75 7 136013 18224 70774200
Bronchitis chronic 16.69 9.75 29 135991 4075 70788349
Ciliary hyperaemia 16.69 9.75 6 136014 67 70792357
Endophthalmitis 16.68 9.75 37 135983 6218 70786206
Device issue 16.63 9.75 13 136007 24012 70768412
Arthritis fungal 16.59 9.75 7 136013 123 70792301
Productive cough 16.54 9.75 226 135794 78111 70714313
Pancreatitis 16.50 9.75 63 135957 62605 70729819
Polyneuropathy 16.48 9.75 83 135937 21332 70771092
Circumoral oedema 16.47 9.75 9 136011 286 70792138
Septic embolus 16.35 9.75 19 136001 1841 70790583
Prurigo 16.31 9.75 16 136004 1277 70791147
Haemorrhagic pneumonia 16.14 9.75 7 136013 132 70792292
Glaucoma 16.00 9.75 73 135947 18019 70774405
Substance-induced psychotic disorder 15.90 9.75 24 135996 2999 70789425
Keratic precipitates 15.86 9.75 9 136011 308 70792116
Factor XIII Inhibition 15.84 9.75 5 136015 36 70792388
Bicytopenia 15.79 9.75 28 135992 4000 70788424
Japanese spotted fever 15.78 9.75 3 136017 0 70792424
Hot flush 15.69 9.75 46 135974 49538 70742886
Neuroleptic malignant syndrome 15.69 9.75 16 136004 25991 70766433
Underdose 15.64 9.75 20 136000 29363 70763061
Hepatitis B e antigen positive 15.61 9.75 5 136015 38 70792386
Walking disability 15.55 9.75 19 136001 1940 70790484
Flushing 15.55 9.75 93 135927 82079 70710345
Enterocolitis bacterial 15.53 9.75 11 136009 557 70791867
Sensory processing disorder 15.51 9.75 4 136016 12 70792412
Keratitis fungal 15.48 9.75 9 136011 323 70792101
Intentional self-injury 15.38 9.75 23 135997 31627 70760797
Bilirubin conjugated increased 15.37 9.75 32 135988 5149 70787275
Hypertensive crisis 15.23 9.75 9 136011 19253 70773171
Urinary tract infection enterococcal 15.19 9.75 24 135996 3120 70789304
Complex regional pain syndrome 15.18 9.75 18 136002 1782 70790642
Ecthyma 15.17 9.75 12 136008 719 70791705
Pneumonia pseudomonal 15.09 9.75 32 135988 5214 70787210
Corneal oedema 15.08 9.75 21 135999 2439 70789985
Recall phenomenon 15.06 9.75 14 136006 1045 70791379
Pneumocystis jirovecii pneumonia 14.99 9.75 104 135916 29978 70762446
Muscle rupture 14.99 9.75 25 135995 3400 70789024
Confabulation 14.97 9.75 10 136010 460 70791964
Joint noise 14.95 9.75 25 135995 3406 70789018
Delusion of grandeur 14.89 9.75 13 136007 894 70791530
Epididymitis 14.85 9.75 18 136002 1823 70790601
Dermatitis bullous 14.84 9.75 56 135964 12701 70779723
Myoclonic dystonia 14.83 9.75 4 136016 15 70792409
Unmasking of previously unidentified disease 14.81 9.75 18 136002 1829 70790595
Prostate cancer 14.81 9.75 23 135997 31140 70761284
Disorientation 14.74 9.75 173 135847 57750 70734674
Acquired haemophilia 14.73 9.75 18 136002 1839 70790585
Therapy partial responder 14.70 9.75 3 136017 12471 70779953
Bacterial infection 14.65 9.75 94 135926 26398 70766026
Foot deformity 14.52 9.75 11 136009 20644 70771780
Amoebic colitis 14.51 9.75 6 136014 100 70792324
Muscle spasticity 14.48 9.75 10 136010 19679 70772745
Product name confusion 14.45 9.75 7 136013 172 70792252
Botulism 14.42 9.75 9 136011 368 70792056
Grip strength decreased 14.41 9.75 6 136014 15679 70776745
Osteopenia 14.38 9.75 7 136013 16690 70775734
Renal necrosis 14.34 9.75 8 136012 265 70792159
Bronchiectasis 14.27 9.75 65 135955 16032 70776392
Persistent corneal epithelial defect 14.22 9.75 5 136015 52 70792372
C-reactive protein increased 14.18 9.75 294 135726 110223 70682201
Myosclerosis 14.16 9.75 7 136013 180 70792244
Systemic inflammatory response syndrome 14.14 9.75 49 135971 10663 70781761
Blood pressure diastolic abnormal 14.13 9.75 6 136014 15498 70776926
Syncope 14.11 9.75 228 135792 165481 70626943
Coronary artery occlusion 13.99 9.75 5 136015 14340 70778084
Connective tissue disorder 13.98 9.75 14 136006 1146 70791278
Injection site rash 13.95 9.75 7 136013 16403 70776021
Cytopenia 13.94 9.75 68 135952 17255 70775169
Hypoalbuminaemia 13.94 9.75 73 135947 19049 70773375
Depression 13.74 9.75 284 135736 198690 70593734
Nasal congestion 13.69 9.75 72 135948 65600 70726824
Device related infection 13.60 9.75 107 135913 32078 70760346
Haemolytic anaemia 13.57 9.75 66 135954 16728 70775696
Hyperamylasaemia 13.54 9.75 13 136007 1011 70791413
Anterior chamber inflammation 13.48 9.75 10 136010 544 70791880
Peripheral sensorimotor neuropathy 13.45 9.75 21 135999 2701 70789723
Trunk injury 13.44 9.75 4 136016 23 70792401
COVID-19 pneumonia 13.44 9.75 80 135940 21889 70770535
Helicobacter test positive 13.40 9.75 14 136006 1205 70791219
Henoch-Schonlein purpura 13.39 9.75 20 136000 2475 70789949
Eosinophilic pleural effusion 13.37 9.75 8 136012 303 70792121
Sinusitis 13.37 9.75 236 135784 168959 70623465
Atrioventricular block first degree 13.36 9.75 3 136017 11670 70780754
Ankylosing spondylitis 13.31 9.75 3 136017 11643 70780781
Dystonia 13.22 9.75 11 136009 19695 70772729
Haemarthrosis 13.20 9.75 31 135989 5408 70787016
Irritability 13.19 9.75 34 135986 38191 70754233
Injection site warmth 13.17 9.75 5 136015 13820 70778604
Respiratory depression 13.11 9.75 17 136003 24814 70767610
Corneal perforation 13.08 9.75 11 136009 719 70791705
Therapy naive 13.02 9.75 5 136015 68 70792356
Pulmonary renal syndrome 12.98 9.75 10 136010 576 70791848
Product administration error 12.90 9.75 23 135997 29500 70762924
Mitochondrial enzyme deficiency 12.77 9.75 4 136016 28 70792396
Altered state of consciousness 12.73 9.75 125 135895 39897 70752527
Cataract subcapsular 12.65 9.75 12 136008 919 70791505
Plasma cell myeloma 12.64 9.75 204 135816 72997 70719427
Lactic acidosis 12.62 9.75 73 135947 64951 70727473
Colitis microscopic 12.60 9.75 42 135978 8963 70783461
Axonal neuropathy 12.52 9.75 17 136003 1927 70790497
Malabsorption from administration site 12.51 9.75 6 136014 144 70792280
Orbital infection 12.51 9.75 5 136015 76 70792348
Functional residual capacity increased 12.51 9.75 5 136015 76 70792348
Tuberculosis 12.46 9.75 59 135961 14789 70777635
Generalised onset non-motor seizure 12.45 9.75 5 136015 77 70792347
Bronchostenosis 12.40 9.75 10 136010 616 70791808
Product complaint 12.38 9.75 4 136016 12227 70780197
Acute sinusitis 12.35 9.75 26 135994 4215 70788209
Hypomagnesaemia 12.33 9.75 126 135894 40638 70751786
Tongue disorder 12.25 9.75 5 136015 13222 70779202
Ventricular tachycardia 12.20 9.75 115 135905 36308 70756116
Arteritis infective 12.17 9.75 5 136015 82 70792342
Incorrect route of product administration 12.16 9.75 20 136000 26472 70765952
Breath sounds abnormal 12.16 9.75 54 135966 13177 70779247
Skin erosion 12.14 9.75 25 135995 3991 70788433
Gluten sensitivity 12.09 9.75 8 136012 362 70792062
Lip erosion 12.04 9.75 14 136006 1358 70791066
Tooth disorder 12.02 9.75 17 136003 23921 70768503
Device difficult to use 12.00 9.75 3 136017 10846 70781578
Malignant melanoma in situ 11.96 9.75 17 136003 2012 70790412
Body temperature increased 11.86 9.75 38 135982 39796 70752628
Hypoglycaemic coma 11.86 9.75 26 135994 4335 70788089
Haematospermia 11.84 9.75 7 136013 259 70792165
Colitis ulcerative 11.84 9.75 30 135990 33893 70758531
Bronchial obstruction 11.79 9.75 19 136001 2511 70789913
Malignant melanoma 11.71 9.75 6 136014 13894 70778530
Skin injury 11.68 9.75 20 136000 2778 70789646
Perihepatic discomfort 11.63 9.75 3 136017 9 70792415
Pudendal canal syndrome 11.63 9.75 3 136017 9 70792415
Cholelithiasis 11.57 9.75 49 135971 47291 70745133
Hallucination, visual 11.57 9.75 96 135924 29241 70763183
Gastrooesophageal reflux disease 11.46 9.75 115 135905 90724 70701700
Diabetes mellitus inadequate control 11.45 9.75 16 136004 22629 70769795
Metastases to liver 11.45 9.75 20 136000 25858 70766566
Gastric cyst 11.45 9.75 5 136015 96 70792328
Fat tissue decreased 11.45 9.75 5 136015 96 70792328
Quadriplegia 11.44 9.75 21 135999 3081 70789343
Hyperaemia 11.41 9.75 20 136000 2831 70789593
Antibiotic associated colitis 11.40 9.75 3 136017 10 70792414
Interstitial lung disease 11.39 9.75 272 135748 104413 70688011
Spinal stenosis 11.37 9.75 7 136013 14646 70777778
Cardiac failure congestive 11.32 9.75 187 135833 135270 70657154
Bronchial haemorrhage 11.23 9.75 13 136007 1254 70791170
Fracture 11.22 9.75 13 136007 19931 70772493
Erectile dysfunction 11.21 9.75 6 136014 13556 70778868
Dry mouth 11.20 9.75 84 135936 70373 70722051
Atypical mycobacterial infection 11.18 9.75 14 136006 1466 70790958
Tuberculosis of central nervous system 11.12 9.75 9 136011 557 70791867
Pupillary block 11.10 9.75 4 136016 45 70792379
Pruritus genital 11.04 9.75 12 136008 1080 70791344
Skin necrosis 11.04 9.75 9 136011 16282 70776142
Strangury 11.03 9.75 6 136014 189 70792235
Oesophageal oedema 11.02 9.75 4 136016 46 70792378
Duodenitis 11.02 9.75 34 135986 6968 70785456
Hypothermia 10.98 9.75 14 136006 20580 70771844
Impaired work ability 10.97 9.75 61 135959 16279 70776145
Genital burning sensation 10.96 9.75 7 136013 298 70792126
Aplastic anaemia 10.96 9.75 62 135958 16654 70775770
Retinal pigment epithelial tear 10.89 9.75 8 136012 429 70791995
Spinal cord haematoma 10.86 9.75 7 136013 303 70792121
Cryopyrin associated periodic syndrome 10.83 9.75 6 136014 196 70792228
Visual acuity reduced 10.80 9.75 91 135929 27839 70764585
Condition aggravated 10.80 9.75 691 135329 426944 70365480
Eye abscess 10.77 9.75 7 136013 307 70792117
Jaundice 10.76 9.75 145 135875 49963 70742461
Corneal infiltrates 10.75 9.75 7 136013 308 70792116
Enterococcal bacteraemia 10.75 9.75 19 136001 2707 70789717
Tumour lysis syndrome 10.73 9.75 74 135946 21286 70771138
Emotional disorder 10.72 9.75 6 136014 13220 70779204
Pleural effusion 10.69 9.75 332 135688 132532 70659892
Oliguria 10.65 9.75 57 135963 14994 70777430
Differentiation syndrome 10.64 9.75 17 136003 2230 70790194
Acute myocardial infarction 10.61 9.75 89 135931 72798 70719626
Colour blindness acquired 10.58 9.75 5 136015 116 70792308
Ureaplasma infection 10.58 9.75 10 136010 762 70791662
Skin laceration 10.57 9.75 21 135999 25857 70766567
Infective exacerbation of chronic obstructive airways disease 10.55 9.75 18 136002 2493 70789931
Angioedema 10.54 9.75 183 135837 66427 70725997
Anaphylactoid reaction 10.52 9.75 27 135993 4980 70787444
Blood pressure diastolic decreased 10.46 9.75 21 135999 25759 70766665
Second primary malignancy 10.46 9.75 6 136014 13045 70779379
Mixed liver injury 10.45 9.75 31 135989 6218 70786206
Rash erythematous 10.43 9.75 148 135872 51570 70740854
Neoplasm malignant 10.39 9.75 25 135995 28749 70763675
Jarisch-Herxheimer reaction 10.39 9.75 10 136010 780 70791644
Eye haematoma 10.35 9.75 5 136015 122 70792302
Arteritis coronary 10.31 9.75 4 136016 56 70792368
Flatulence 10.30 9.75 38 135982 38143 70754281
Chest discomfort 10.30 9.75 172 135848 124209 70668215
Adverse drug reaction 10.29 9.75 60 135960 53284 70739140
Interleukin-2 receptor increased 10.28 9.75 6 136014 217 70792207
Hyposmia 10.27 9.75 9 136011 622 70791802
Corneal opacity 10.26 9.75 11 136009 975 70791449
Intestinal obstruction 10.24 9.75 39 135981 38786 70753638
Sensory disturbance 10.21 9.75 53 135967 13779 70778645
Exposure to fungus 10.21 9.75 5 136015 126 70792298
Hypertransaminasaemia 10.19 9.75 39 135981 8904 70783520
Sinusitis fungal 10.19 9.75 16 136004 2069 70790355
Hallucination 10.16 9.75 204 135816 76056 70716368
Glycosylated haemoglobin increased 10.15 9.75 11 136009 17380 70775044
Influenza A virus test positive 10.12 9.75 9 136011 634 70791790
Hepatic cancer 10.10 9.75 3 136017 9680 70782744
Forearm fracture 10.07 9.75 8 136012 482 70791942
Dysarthria 10.04 9.75 74 135946 62239 70730185
Ovarian cyst 10.04 9.75 5 136015 11767 70780657
Graft versus host disease 10.03 9.75 56 135964 14967 70777457
Pulmonary arterial hypertension 10.02 9.75 31 135989 32824 70759600
Geotrichum infection 10.00 9.75 11 136009 1004 70791420
Coagulation factor deficiency 9.99 9.75 5 136015 132 70792292
Organising pneumonia 9.99 9.75 42 135978 10008 70782416
Petechiae 9.98 9.75 67 135953 19105 70773319
Skin hyperplasia 9.97 9.75 3 136017 18 70792406
Allergic transfusion reaction 9.94 9.75 4 136016 62 70792362
Tongue exfoliation 9.93 9.75 5 136015 134 70792290
Pain in jaw 9.92 9.75 45 135975 42624 70749800
Chordae tendinae rupture 9.88 9.75 4 136016 63 70792361
Haematochezia 9.86 9.75 91 135929 72990 70719434
Injection site urticaria 9.84 9.75 5 136015 11633 70780791
Cranial nerve injury 9.84 9.75 3 136017 19 70792405
Polyneuropathy chronic 9.84 9.75 3 136017 19 70792405
Systolic dysfunction 9.83 9.75 21 135999 3440 70788984
Cytomegalovirus infection reactivation 9.82 9.75 32 135988 6749 70785675
Thalamic infarction 9.80 9.75 12 136008 1228 70791196
Skin cancer 9.79 9.75 7 136013 13529 70778895

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 EPC N0000175937 Quinolone Antimicrobial
CHEBI has role CHEBI:36047 antibacterial drugs
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

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

DiseaseRelationSNOMED_IDDOID
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
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
E. Coli Pyelonephritis indication
Pseudomonas Aeruginosa Urinary Tract Infection indication
Moraxella Catarrhalis Pneumonia indication
Complicated Skin and Skin Structure Proteus Infection indication
Staphylococcus Aureus Bronchitis 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
Chronic Staphylococcus epidermidis Prostatitis indication
Staphylococcus Saprophyticus Urinary Tract Infection 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
Nosocomial Pneumonia due to Klebsiella Pneumoniae indication
Complicated Skin and Skin Structure Enterococcus Faecalis Infection indication
Nosocomial Pneumonia due to Escherichia Coli indication
Streptococcus Pneumoniae Bronchitis indication
Legionella Pneumophila Pneumonia indication
Complicated Skin and Skin Structure Infection indication
Gram-Negative Aerobic Bacillary Pneumonia indication
Nosocomial Pneumonia due to Haemophilus Influenzae indication
Nosocomial Pneumonia due to Serratia Marcescens 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 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 0781-5792 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
LEVOFLOXACIN HUMAN PRESCRIPTION DRUG LABEL 1 13668-084 TABLET 750 mg ORAL ANDA 27 sections
LEVOFLOXACIN HUMAN PRESCRIPTION DRUG LABEL 1 16571-150 SOLUTION/ DROPS 5 mg TOPICAL ANDA 21 sections
LEVOFLOXACIN HUMAN PRESCRIPTION DRUG LABEL 1 16590-992 TABLET, FILM COATED 500 mg ORAL ANDA 30 sections
Levofloxacin HUMAN PRESCRIPTION DRUG LABEL 1 17478-106 SOLUTION 5 mg OPHTHALMIC ANDA 24 sections