leflunomide Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
1552 75706-12-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • leflunomide medac
  • leflunomide
  • arava
  • avara
  • leflunomida
  • leflunomidum
  • lefumide
  • repso
An isoxazole derivative that inhibits dihydroorotate dehydrogenase, the fourth enzyme in the pyrimidine biosynthetic pathway. It is used an immunosuppressive agent in the treatment of RHEUMATOID ARTHRITIS and PSORIATIC ARTHRITIS.
  • Molecular weight: 270.21
  • Formula: C12H9F3N2O2
  • CLOGP: 2.32
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 55.13
  • ALOGS: -3.51
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
20 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.02 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 1 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.23 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 80 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Sept. 10, 1998 FDA SANOFI AVENTIS US

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
Rheumatoid arthritis 8768.78 12.53 7959 213135 232256 46232712
Drug ineffective 8054.52 12.53 12607 208487 665231 45799737
Drug intolerance 4918.76 12.53 4654 216440 142395 46322573
Contraindicated product administered 3430.15 12.53 2916 218178 77031 46387937
Treatment failure 2989.20 12.53 2885 218209 90202 46374766
Joint swelling 2962.75 12.53 3781 217313 162292 46302676
Synovitis 2455.92 12.53 2148 218946 58927 46406041
Arthropathy 1683.54 12.53 2039 219055 82661 46382307
Therapeutic product effect decreased 1644.17 12.53 1990 219104 80611 46384357
Therapeutic product effect incomplete 1302.81 12.53 1724 219370 76429 46388539
Pemphigus 1238.37 12.53 1288 219806 43986 46420982
Abdominal discomfort 1160.52 12.53 2346 218748 148819 46316149
Drug hypersensitivity 1043.21 12.53 3017 218077 240808 46224160
Systemic lupus erythematosus 1041.77 12.53 1409 219685 63771 46401197
Arthralgia 962.87 12.53 3836 217258 360767 46104201
C-reactive protein abnormal 961.65 12.53 801 220293 20469 46444499
Pain 946.70 12.53 4605 216489 472343 45992625
Hand deformity 945.95 12.53 984 220110 33590 46431378
Alopecia 945.77 12.53 2256 218838 160158 46304810
Death 916.79 12.53 231 220863 335317 46129651
Rheumatoid factor positive 831.86 12.53 725 220369 19736 46445232
Hepatic enzyme increased 826.30 12.53 1429 219665 80358 46384610
Swelling 822.07 12.53 1818 219276 122693 46342275
Glossodynia 790.37 12.53 1012 220082 43361 46421607
Loss of personal independence in daily activities 748.19 12.53 1124 219970 56059 46408909
Musculoskeletal stiffness 707.52 12.53 1484 219610 96509 46368459
Red blood cell sedimentation rate abnormal 631.41 12.53 521 220573 13128 46451840
Completed suicide 612.09 12.53 17 221077 145903 46319065
Condition aggravated 597.17 12.53 2518 218576 242534 46222434
Anti-cyclic citrullinated peptide antibody positive 595.04 12.53 584 220510 18561 46446407
Peripheral swelling 573.32 12.53 1848 219246 156223 46308745
Acute kidney injury 566.29 12.53 205 220889 235650 46229318
Dyspnoea 528.85 12.53 1028 220066 514520 45950448
Hypotension 527.26 12.53 221 220873 232368 46232600
Bone erosion 490.98 12.53 386 220708 9057 46455911
Red blood cell sedimentation rate increased 466.81 12.53 559 220535 22330 46442638
Toxicity to various agents 464.40 12.53 211 220883 211555 46253413
Drug interaction 447.45 12.53 201 220893 202893 46262075
Constipation 399.88 12.53 162 220932 173935 46291033
Psoriatic arthropathy 393.90 12.53 656 220438 35723 46429245
C-reactive protein increased 389.96 12.53 859 220235 57731 46407237
Dehydration 377.03 12.53 142 220952 159398 46305570
Infection 376.84 12.53 1438 219656 132154 46332814
Rash 373.70 12.53 2924 218170 353588 46111380
Blood iron abnormal 369.72 12.53 214 220880 2956 46462012
Mobility decreased 362.87 12.53 852 220242 59742 46405226
Anaemia 352.14 12.53 416 220678 255363 46209605
Febrile neutropenia 351.38 12.53 25 221069 94602 46370366
Overdose 346.26 12.53 39 221055 101940 46363028
Knee arthroplasty 340.85 12.53 487 220607 23178 46441790
Confusional state 334.04 12.53 170 220924 159722 46305246
Rheumatoid nodule 331.53 12.53 302 220792 8718 46456250
Hyponatraemia 331.18 12.53 44 221050 101288 46363680
Seizure 314.16 12.53 96 220998 122958 46342010
Tremor 310.42 12.53 82 221012 115557 46349411
Anxiety 305.68 12.53 248 220846 181709 46283259
Wound 294.37 12.53 636 220458 42166 46422802
Pyrexia 282.30 12.53 788 220306 348014 46116954
Hypersensitivity 279.10 12.53 1428 219666 148893 46316075
Dizziness 278.50 12.53 765 220329 339649 46125319
Cardiac arrest 277.60 12.53 47 221047 90352 46374616
Intentional overdose 274.28 12.53 7 221087 64937 46400031
Pericarditis 263.71 12.53 435 220659 23492 46441476
Osteoarthritis 260.54 12.53 764 220330 61261 46403707
Bradycardia 259.78 12.53 13 221081 66285 46398683
Osteoporosis 251.82 12.53 579 220515 40029 46424939
Arthritis 244.48 12.53 864 220230 76452 46388516
Somnolence 242.68 12.53 230 220864 156291 46308677
Product use issue 236.28 12.53 981 220113 93663 46371305
Hip arthroplasty 235.18 12.53 355 220739 17757 46447211
Product dose omission issue 232.84 12.53 273 220821 168247 46296721
Hypokalaemia 229.50 12.53 66 221028 87958 46377010
Liver function test increased 229.05 12.53 398 220696 22428 46442540
Disability 221.67 12.53 257 220837 9910 46455058
Gastrointestinal disorder 219.52 12.53 701 220393 58875 46406093
Abdominal pain 219.30 12.53 477 220617 229554 46235414
Electrocardiogram QT prolonged 218.77 12.53 5 221089 51320 46413648
Foot deformity 215.62 12.53 313 220781 15112 46449856
Musculoskeletal disorder 215.21 12.53 314 220780 15231 46449737
Tenosynovitis 214.60 12.53 219 220875 7296 46457672
Oedema peripheral 211.86 12.53 267 220827 159439 46305529
Deformity 206.35 12.53 211 220883 7046 46457922
Infusion related reaction 204.39 12.53 985 220109 100223 46364745
Asthenia 204.09 12.53 771 220323 310304 46154664
Inflammation 202.08 12.53 598 220496 48183 46416785
Joint stiffness 196.97 12.53 412 220682 26696 46438272
Joint range of motion decreased 194.32 12.53 295 220799 14829 46450139
Finger deformity 193.95 12.53 175 220919 4987 46459981
Granuloma skin 193.76 12.53 148 220946 3322 46461646
Cardio-respiratory arrest 193.19 12.53 27 221067 59842 46405126
Panniculitis 186.57 12.53 179 220915 5525 46459443
Thrombocytopenia 184.72 12.53 196 220898 126385 46338583
Therapeutic response decreased 184.54 12.53 535 220559 42610 46422358
Disease progression 183.30 12.53 102 220992 91198 46373770
Atrial fibrillation 181.67 12.53 135 220959 103455 46361513
Blood parathyroid hormone decreased 181.53 12.53 157 220937 4224 46460744
Suicide attempt 179.52 12.53 24 221070 55012 46409956
Hyperkalaemia 178.24 12.53 17 221077 50692 46414276
Chest pain 172.65 12.53 360 220734 175964 46289004
Tachycardia 170.64 12.53 133 220961 99489 46365479
Plasma cell myeloma 170.25 12.53 10 221084 44468 46420500
Fall 169.21 12.53 893 220201 328204 46136764
Adverse drug reaction 167.98 12.53 527 220567 43835 46421133
Deafness transitory 166.34 12.53 101 220993 1531 46463437
Haemoglobin decreased 164.38 12.53 222 220872 128727 46336241
Chest discomfort 164.36 12.53 113 220981 90156 46374812
Limb deformity 164.29 12.53 136 220958 3440 46461528
Skin ulcer 163.15 12.53 427 220667 32031 46432937
Cardiac failure congestive 162.92 12.53 118 220976 91632 46373336
Muscle spasms 162 12.53 207 220887 122906 46342062
Agitation 157.04 12.53 35 221059 55380 46409588
Hallucination 155.48 12.53 25 221069 49926 46415042
Vision blurred 154.38 12.53 93 221001 79615 46385353
Pulmonary fibrosis 150.22 12.53 309 220785 19783 46445185
Drug tolerance decreased 148.22 12.53 120 220974 2939 46462029
Urinary tract infection 148.16 12.53 540 220554 219726 46245242
Depressed level of consciousness 147.63 12.53 24 221070 47545 46417423
Sepsis 144.98 12.53 264 220830 135750 46329218
Pulmonary embolism 143.45 12.53 182 220912 108403 46356565
Adverse reaction 143.09 12.53 184 220910 7906 46457062
Lower respiratory tract infection 142.11 12.53 577 220517 54512 46410456
Hypoglycaemia 141.17 12.53 41 221053 54308 46410660
Musculoskeletal deformity 140.96 12.53 71 221023 728 46464240
Epistaxis 140.83 12.53 64 221030 64241 46400727
Helicobacter infection 139.70 12.53 221 220873 11515 46453453
Gastrointestinal haemorrhage 139.34 12.53 98 220996 77275 46387693
Neutropenia 138.78 12.53 294 220800 142910 46322058
Breast cancer stage III 137.67 12.53 84 221010 1285 46463683
Unresponsive to stimuli 137.64 12.53 3 221091 32171 46432797
Impaired work ability 136.89 12.53 228 220866 12408 46452560
Rheumatoid lung 135.33 12.53 90 221004 1610 46463358
Cerebrovascular accident 133.83 12.53 169 220925 100870 46364098
Discomfort 132.66 12.53 504 220590 46166 46418802
Fibromyalgia 132.41 12.53 427 220667 36036 46428932
Respiratory failure 131.50 12.53 153 220941 94663 46370305
Rhabdomyolysis 130.37 12.53 21 221073 41888 46423080
Metabolic acidosis 128.67 12.53 16 221078 38764 46426204
Lactic acidosis 128.64 12.53 8 221086 33901 46431067
Sciatica 127.72 12.53 280 220814 18740 46446228
Platelet count decreased 127.65 12.53 172 220922 99852 46365116
Balance disorder 126.74 12.53 74 221020 64447 46400521
Respiratory arrest 125.29 12.53 9 221085 33807 46431161
Maternal exposure during pregnancy 124.96 12.53 873 220221 101676 46363292
Blood glucose increased 123.48 12.53 96 220998 71917 46393051
Hypoxia 122.55 12.53 46 221048 51792 46413176
Decreased appetite 121.41 12.53 489 220605 193347 46271621
Skin necrosis 120.84 12.53 175 220919 8429 46456539
Oral mucosal exfoliation 120.70 12.53 81 221013 1472 46463496
International normalised ratio increased 120.61 12.53 36 221058 46847 46418121
Lethargy 119.98 12.53 46 221048 51125 46413843
Nodule 119.03 12.53 242 220852 15363 46449605
Shoulder arthroplasty 118.02 12.53 106 220988 3002 46461966
Mental status changes 116.45 12.53 20 221074 38068 46426900
Neutrophil count decreased 116.07 12.53 31 221063 43395 46421573
Pneumonia aspiration 115.42 12.53 9 221085 31596 46433372
Grip strength decreased 115.02 12.53 171 220923 8435 46456533
Duodenal ulcer perforation 113.72 12.53 169 220925 8333 46456635
Encephalopathy 113.56 12.53 13 221081 33576 46431392
Syncope 112.93 12.53 202 220892 104601 46360367
Product quality issue 112.85 12.53 17 221077 35631 46429337
Retinal toxicity 110.89 12.53 67 221027 1006 46463962
Pulmonary oedema 110.14 12.53 52 221042 51053 46413915
Cardiac failure 109.79 12.53 130 220964 79818 46385150
Joint laxity 109.63 12.53 86 221008 2010 46462958
Coma 107.59 12.53 72 221022 58277 46406691
Ill-defined disorder 107.40 12.53 325 220769 26502 46438466
Asthma 107.37 12.53 167 220927 91375 46373593
Tuberculin test positive 107.31 12.53 99 220995 2905 46462063
Depression 107.22 12.53 428 220666 169676 46295292
Renal failure 106.89 12.53 237 220857 113357 46351611
Wrong technique in product usage process 104.66 12.53 64 221030 54358 46410610
Pulmonary toxicity 104.60 12.53 120 220974 4573 46460395
Myalgia 103.81 12.53 272 220822 122816 46342152
Spinal column injury 102.71 12.53 78 221016 1735 46463233
Vomiting 102.51 12.53 1519 219575 451275 46013693
Drug withdrawal syndrome 102.28 12.53 7 221087 27377 46437591
Cognitive disorder 101.12 12.53 25 221069 36858 46428110
Hyperglycaemia 99.66 12.53 22 221072 35049 46429919
Gastrointestinal pain 98.02 12.53 147 220947 7308 46457660
Pleural effusion 97.60 12.53 151 220943 82801 46382167
Blood pressure decreased 96.97 12.53 77 221017 57082 46407886
Deep vein thrombosis 95.99 12.53 143 220951 79630 46385338
Arthrodesis 95.56 12.53 82 221012 2182 46462786
Pancytopenia 95.22 12.53 160 220934 84898 46380070
Sedation 94.76 12.53 3 221091 22907 46442061
Bone pain 94.64 12.53 52 221042 46838 46418130
Rheumatoid factor negative 93.90 12.53 48 221046 509 46464459
Surgical failure 93.67 12.53 58 221036 912 46464056
Feeling abnormal 93.26 12.53 293 220801 124767 46340201
Fluid overload 93.22 12.53 10 221084 27175 46437793
Disturbance in attention 91.31 12.53 19 221075 31541 46433427
Restlessness 91.18 12.53 8 221086 25516 46439452
Joint destruction 90.60 12.53 91 221003 2973 46461995
Physical disability 90.19 12.53 73 221021 1787 46463181
Hypocalcaemia 88.98 12.53 11 221083 26774 46438194
Foot operation 88.94 12.53 111 220983 4626 46460342
Gastrooesophageal reflux disease 87.78 12.53 135 220959 74209 46390759
Fluid retention 86.30 12.53 69 221025 50977 46413991
Blood cholesterol increased 86.21 12.53 397 220697 39616 46425352
Flushing 85.61 12.53 108 220986 64506 46400462
Disorientation 85.21 12.53 34 221060 36884 46428084
Chills 84.21 12.53 208 220886 95824 46369144
Hospitalisation 83.92 12.53 106 220988 63279 46401689
Dyskinesia 82.48 12.53 18 221076 28907 46436061
Ascites 82.32 12.53 35 221059 36549 46428419
Joint effusion 82.14 12.53 178 220916 11817 46453151
Full blood count decreased 82.02 12.53 6 221088 22205 46442763
Gait disturbance 81.80 12.53 1049 220045 144214 46320754
Altered state of consciousness 81.59 12.53 8 221086 23340 46441628
Thrombosis 81.53 12.53 87 221007 55982 46408986
Pulmonary mass 80.77 12.53 226 220868 17631 46447337
Pneumonia viral 80.59 12.53 126 220968 6498 46458470
Seronegative arthritis 80.30 12.53 48 221046 706 46464262
Chronic kidney disease 80.08 12.53 47 221047 40824 46424144
Impaired healing 79.48 12.53 365 220729 36378 46428590
Hyperhidrosis 79.43 12.53 192 220902 89116 46375852
Respiratory distress 79.42 12.53 26 221068 31890 46433078
Intentional product misuse 79.30 12.53 64 221030 47064 46417904
Ankylosing spondylitis 78.99 12.53 126 220968 6611 46458357
Cerebral haemorrhage 78.22 12.53 19 221075 28352 46436616
Dysarthria 78.00 12.53 40 221054 37458 46427510
Loose body in joint 77.12 12.53 53 221041 1003 46463965
Urinary incontinence 76.93 12.53 20 221074 28510 46436458
Abnormal behaviour 76.88 12.53 6 221088 21052 46443916
Urinary retention 76.83 12.53 15 221079 26046 46438922
Dysphagia 76.29 12.53 157 220937 77155 46387813
White blood cell count decreased 76.10 12.53 274 220820 111957 46353011
Epilepsy 75.87 12.53 11 221083 23727 46441241
Psychotic disorder 75.86 12.53 9 221085 22612 46442356
X-ray abnormal 75.74 12.53 55 221039 1140 46463828
Sensitivity to weather change 75.73 12.53 111 220983 5405 46459563
Suicidal ideation 74.94 12.53 94 221000 56288 46408680
Red blood cell sedimentation rate 74.39 12.53 64 221030 1709 46463259
Aggression 73.96 12.53 10 221084 22734 46442234
Melaena 73.88 12.53 20 221074 27752 46437216
Premature delivery 73.47 12.53 9 221085 22060 46442908
Musculoskeletal pain 73.42 12.53 576 220518 69552 46395416
Pruritus allergic 72.66 12.53 51 221043 1000 46463968
Dry skin 72.45 12.53 53 221041 40963 46424005
Blood creatinine increased 71.36 12.53 160 220934 76243 46388725
Cutaneous vasculitis 70.94 12.53 91 221003 3900 46461068
Haematoma 70.90 12.53 31 221063 31841 46433127
Off label use 70.76 12.53 2324 218770 377517 46087451
Red cell distribution width decreased 70.61 12.53 47 221047 842 46464126
Drug eruption 70.50 12.53 242 220852 21087 46443881
Sinusitis 70.49 12.53 931 220163 128837 46336131
Blood potassium decreased 70.12 12.53 47 221047 38016 46426952
Enthesopathy 69.69 12.53 98 220996 4592 46460376
Rectal haemorrhage 69.45 12.53 48 221046 38207 46426761
Pharyngitis 69.42 12.53 212 220882 17371 46447597
Mouth ulceration 69.13 12.53 281 220813 26551 46438417
Adverse event 69.13 12.53 333 220761 33851 46431117
Paraesthesia 68.68 12.53 304 220790 117133 46347835
Folliculitis 68.63 12.53 113 220981 6090 46458878
Back injury 68.53 12.53 120 220974 6801 46458167
Hepatotoxicity 68.52 12.53 267 220827 24742 46440226
Muscle injury 68.37 12.53 99 220995 4767 46460201
Ear infection 68.26 12.53 252 220842 22761 46442207
Oedema 68.06 12.53 134 220960 66937 46398031
Ulcer 68.02 12.53 209 220885 17183 46447785
Generalised tonic-clonic seizure 67.65 12.53 22 221072 27100 46437868
Interstitial lung disease 67.27 12.53 462 220632 53487 46411481
Vascular access complication 67.07 12.53 47 221047 919 46464049
Drug reaction with eosinophilia and systemic symptoms 66.91 12.53 28 221066 29520 46435448
Dysgeusia 66.87 12.53 56 221038 40435 46424533
Aphasia 66.43 12.53 26 221068 28541 46436427
Wheezing 65.88 12.53 94 221000 53292 46411676
Bone density abnormal 65.62 12.53 77 221017 3007 46461961
Sleep disorder due to general medical condition, insomnia type 65.47 12.53 101 220993 5148 46459820
Orthostatic hypotension 65.14 12.53 18 221076 24640 46440328
Localised infection 65.13 12.53 254 220840 23547 46441421
Hypomagnesaemia 65.02 12.53 13 221081 22197 46442771
Emotional distress 65.01 12.53 32 221062 30675 46434293
Cardiac disorder 64.94 12.53 67 221027 43791 46421177
Haemorrhage 64.41 12.53 100 220994 54769 46410199
Flatulence 64.38 12.53 28 221066 28850 46436118
Neuropathy peripheral 64.24 12.53 218 220876 90675 46374293
Chronic obstructive pulmonary disease 63.95 12.53 109 220985 57524 46407444
Incorrect dose administered 63.67 12.53 73 221021 45477 46419491
Right ventricular failure 63.52 12.53 3 221091 16090 46448878
Lymphocyte count decreased 63.40 12.53 21 221073 25568 46439400
Bronchitis chronic 63.30 12.53 88 221006 4079 46460889
Tuberculosis 63.19 12.53 146 220948 10119 46454849
Drug level increased 62.68 12.53 7 221087 18434 46446534
Accidental overdose 62.53 12.53 10 221084 20056 46444912
Presyncope 62.49 12.53 19 221075 24435 46440533
Fine motor skill dysfunction 62.08 12.53 82 221012 3618 46461350
Pruritus 61.83 12.53 793 220301 241559 46223409
Depressed mood 61.57 12.53 41 221053 33278 46431690
Irritability 61.53 12.53 30 221064 28916 46436052
Device dislocation 61.29 12.53 14 221080 21788 46443180
Wrist surgery 61.00 12.53 41 221053 747 46464221
Metastases to liver 60.49 12.53 10 221084 19575 46445393
Dislocation of vertebra 60.45 12.53 50 221044 1263 46463705
Hallucination, visual 60.21 12.53 7 221087 17866 46447102
Vaginal haemorrhage 60.04 12.53 23 221071 25581 46439387
Pustular psoriasis 59.79 12.53 84 221010 3933 46461035
Memory impairment 59.18 12.53 179 220915 77158 46387810
Sleep disorder 58.49 12.53 401 220693 46394 46418574
Gastric disorder 58.28 12.53 266 220828 26439 46438529
Soft tissue disorder 57.12 12.53 84 221010 4102 46460866
Mean cell volume decreased 57.11 12.53 64 221030 2376 46462592
Mean platelet volume decreased 56.98 12.53 52 221042 1504 46463464
Panic attack 56.90 12.53 13 221081 20229 46444739
Infusion site reaction 56.88 12.53 55 221039 1714 46463254
Pulmonary hypertension 56.75 12.53 52 221042 35941 46429027
Circulatory collapse 56.72 12.53 16 221078 21608 46443360
Withdrawal syndrome 56.59 12.53 9 221085 18125 46446843
Arrhythmia 56.54 12.53 49 221045 34792 46430176
Eye pain 56.35 12.53 31 221063 27909 46437059
Delirium 56.11 12.53 56 221038 37172 46427796
Femur fracture 56.11 12.53 333 220761 36664 46428304
Metastases to bone 56.08 12.53 8 221086 17468 46447500
Joint arthroplasty 55.93 12.53 58 221036 1969 46462999
Ejection fraction decreased 55.76 12.53 9 221085 17928 46447040
Demyelination 55.61 12.53 98 220996 5582 46459386
Upper gastrointestinal haemorrhage 55.29 12.53 7 221087 16731 46448237
Irritable bowel syndrome 55.12 12.53 188 220906 16327 46448641
Spinal stenosis 55.02 12.53 157 220937 12386 46452582
Abdominal pain lower 54.95 12.53 16 221078 21165 46443803
Ankle arthroplasty 54.94 12.53 35 221059 580 46464388
Inappropriate antidiuretic hormone secretion 54.48 12.53 3 221091 14099 46450869
Ventricular tachycardia 53.91 12.53 8 221086 16959 46448009
Bedridden 53.91 12.53 128 220966 9031 46455937
Oxygen saturation decreased 53.70 12.53 159 220935 69005 46395963
Sinus bradycardia 53.04 12.53 3 221091 13779 46451189
Bone swelling 52.90 12.53 45 221049 1183 46463785
Blood urea increased 52.79 12.53 27 221067 25325 46439643
Electrolyte imbalance 52.75 12.53 9 221085 17217 46447751
Pulmonary arterial hypertension 51.96 12.53 29 221065 25899 46439069
Multiple organ dysfunction syndrome 51.87 12.53 104 220990 51606 46413362
Dysuria 51.76 12.53 34 221060 27799 46437169
Basal cell carcinoma 51.55 12.53 213 220881 20274 46444694
Erythema 51.28 12.53 431 220663 142389 46322579
Swollen joint count increased 51.20 12.53 60 221034 2340 46462628
Poisoning 51.05 12.53 4 221090 13990 46450978
Transaminases abnormal 51.04 12.53 32 221062 515 46464453
Cough 51.01 12.53 775 220319 229474 46235494
Acute respiratory failure 51.01 12.53 38 221056 29100 46435868
Transient ischaemic attack 50.91 12.53 54 221040 34849 46430119
Ovarian neoplasm 50.62 12.53 37 221057 775 46464193
Diabetic ketoacidosis 50.58 12.53 12 221082 18198 46446770
Investigation abnormal 50.47 12.53 41 221053 1009 46463959
International normalised ratio fluctuation 50.44 12.53 57 221037 2136 46462832
Wrist deformity 50.17 12.53 48 221046 1476 46463492
Clostridium difficile colitis 50.04 12.53 13 221081 18540 46446428
Liver function test abnormal 49.29 12.53 383 220711 46104 46418864
Neck deformity 49.28 12.53 52 221042 1802 46463166
Secretion discharge 49.11 12.53 124 220970 9095 46455873
Toxic epidermal necrolysis 49.03 12.53 22 221072 22256 46442712
Hemiparesis 48.80 12.53 17 221077 20052 46444916
Face oedema 48.72 12.53 15 221079 19138 46445830
Haematochezia 48.28 12.53 64 221030 37429 46427539
Fear of injection 47.85 12.53 77 221017 4070 46460898
Bone marrow failure 47.81 12.53 42 221052 29627 46435341
Foetal exposure during pregnancy 47.79 12.53 45 221049 30702 46434266
Septic shock 47.21 12.53 130 220964 57763 46407205
Heart rate increased 47.18 12.53 188 220906 74603 46390365
Neurotoxicity 47.15 12.53 5 221089 13712 46451256
Acute myocardial infarction 47.00 12.53 49 221045 31875 46433093
Pain in jaw 46.91 12.53 68 221026 38304 46426664
Pancreatitis acute 46.78 12.53 30 221064 24842 46440126
Product use in unapproved indication 46.75 12.53 244 220850 90029 46374939
Neutropenic sepsis 46.47 12.53 3 221091 12321 46452647
Joint injury 46.21 12.53 197 220897 19012 46445956
Blood creatine phosphokinase increased 46.20 12.53 38 221056 27686 46437282
Injection site reaction 45.73 12.53 385 220709 47464 46417504
Product substitution issue 45.71 12.53 8 221086 15023 46449945
Cerebral infarction 45.59 12.53 27 221067 23339 46441629
Bone disorder 45.56 12.53 202 220892 19831 46445137
Adjustment disorder with depressed mood 45.51 12.53 40 221054 1100 46463868
Dementia 45.28 12.53 8 221086 14922 46450046
Sinus tachycardia 45.16 12.53 23 221071 21626 46443342
Hair follicle tumour benign 45.11 12.53 26 221068 356 46464612
Myoclonus 45.06 12.53 7 221087 14345 46450623
Nonalcoholic fatty liver disease 44.82 12.53 34 221060 755 46464213
Peritonitis 44.74 12.53 21 221073 20693 46444275
Cholestasis 44.64 12.53 37 221057 26856 46438112
Product label confusion 44.63 12.53 25 221069 323 46464645
Acute myeloid leukaemia 44.62 12.53 10 221084 15768 46449200
Accidental exposure to product 44.57 12.53 22 221072 21059 46443909
Speech disorder 44.30 12.53 64 221030 36103 46428865
Small intestinal obstruction 44.25 12.53 11 221083 16161 46448807
Agranulocytosis 44.19 12.53 25 221069 22160 46442808
Blood sodium decreased 43.97 12.53 24 221070 21702 46443266
Inappropriate schedule of product administration 43.87 12.53 159 220935 64854 46400114
Underdose 43.54 12.53 19 221075 19539 46445429
Status epilepticus 43.48 12.53 7 221087 13972 46450996
Muscle spasticity 43.37 12.53 136 220958 11304 46453664
Allergic oedema 43.15 12.53 33 221061 742 46464226
Injection site hypersensitivity 43.10 12.53 44 221050 1466 46463502
Disseminated intravascular coagulation 43.04 12.53 18 221076 18987 46445981
Exostosis 42.64 12.53 126 220968 10137 46454831
Dyspnoea exertional 42.46 12.53 111 220983 50178 46414790
Product administration error 42.44 12.53 20 221074 19661 46445307
Haemoptysis 42.29 12.53 37 221057 26152 46438816
Blood calcium decreased 42.23 12.53 11 221083 15662 46449306
Extremity contracture 42.11 12.53 39 221055 1150 46463818
Head injury 42.01 12.53 33 221061 24603 46440365
Neck mass 41.96 12.53 64 221030 3229 46461739
Polyomavirus-associated nephropathy 41.77 12.53 43 221051 1447 46463521
Nervousness 41.59 12.53 44 221050 28431 46436537
Joint dislocation 41.50 12.53 132 220962 11054 46453914
Sleep apnoea syndrome 41.45 12.53 27 221067 22174 46442794
Synovial cyst 41.45 12.53 101 220993 7245 46457723
Therapy cessation 41.36 12.53 39 221055 26590 46438378
Blood glucose decreased 41.04 12.53 19 221075 18873 46446095
Haematuria 40.94 12.53 40 221054 26818 46438150
Vertigo 40.87 12.53 119 220975 51929 46413039
Vasculitic rash 40.76 12.53 40 221054 1270 46463698
Immobile 40.69 12.53 76 221018 4530 46460438
Mean cell haemoglobin decreased 40.56 12.53 59 221035 2853 46462115
Blood count abnormal 40.38 12.53 17 221077 17861 46447107
Transfusion 40.32 12.53 7 221087 13224 46451744
Anti-cyclic citrullinated peptide antibody 40.26 12.53 22 221072 270 46464698
Shock 40.20 12.53 27 221067 21818 46443150
Rash erythematous 39.93 12.53 63 221031 34287 46430681
Lip swelling 39.67 12.53 37 221057 25358 46439610
Pollakiuria 39.51 12.53 34 221060 24227 46440741
Osteoporotic fracture 39.14 12.53 59 221035 2946 46462022
Pericardial effusion 38.98 12.53 38 221056 25505 46439463
Metastases to central nervous system 38.80 12.53 4 221090 11217 46453751
Paranoia 38.74 12.53 3 221091 10594 46454374
Accident 38.74 12.53 79 221015 5025 46459943
Cholecystitis chronic 38.30 12.53 3 221091 10496 46454472
Haemorrhage intracranial 38.20 12.53 7 221087 12717 46452251
Hypothermia 38.12 12.53 6 221088 12177 46452791
Hypermobility syndrome 38.00 12.53 29 221065 650 46464318
Product prescribing error 37.95 12.53 24 221070 20023 46444945
Colitis microscopic 37.91 12.53 91 221003 6465 46458503
Myocardial infarction 37.91 12.53 288 220806 97240 46367728
Multiple sclerosis 37.70 12.53 37 221057 24754 46440214
Infiltration anaesthesia 37.69 12.53 17 221077 133 46464835
Stevens-Johnson syndrome 37.51 12.53 33 221061 23264 46441704
Hepatic function abnormal 37.36 12.53 66 221028 34355 46430613
Fear 37.14 12.53 15 221079 16157 46448811
Skin papilloma 37.01 12.53 69 221025 4107 46460861
Cholelithiasis 36.93 12.53 80 221014 38601 46426367
Skin exfoliation 36.80 12.53 62 221032 32876 46432092
Renal tubular necrosis 36.78 12.53 4 221090 10755 46454213
Bronchiectasis 36.47 12.53 112 220982 9204 46455764
Muscle twitching 36.42 12.53 12 221082 14660 46450308
Muscular weakness 36.27 12.53 270 220824 91574 46373394
Breast cancer metastatic 36.10 12.53 10 221084 13668 46451300
Caesarean section 35.60 12.53 17 221077 16586 46448382
Thyroid neoplasm 35.53 12.53 63 221031 3606 46461362
Leukocytosis 35.49 12.53 35 221059 23363 46441605
Incontinence 35.47 12.53 3 221091 9859 46455109
Blood magnesium decreased 35.35 12.53 5 221089 10987 46453981
Disease susceptibility 35.28 12.53 18 221076 190 46464778
Multiple fractures 35.17 12.53 80 221014 5487 46459481
Coordination abnormal 35.16 12.53 5 221089 10944 46454024
Skin reaction 35.13 12.53 123 220971 10823 46454145
Anuria 34.94 12.53 6 221088 11425 46453543
Cardiogenic shock 34.79 12.53 17 221077 16367 46448601
Coronary artery disease 34.61 12.53 67 221027 33685 46431283
Premature labour 34.39 12.53 6 221088 11293 46453675
Palpitations 34.39 12.53 287 220807 94972 46369996
Hypersomnia 34.36 12.53 15 221079 15424 46449544
Diabetes mellitus inadequate control 34.25 12.53 10 221084 13204 46451764
Incorrect product administration duration 34.21 12.53 3 221091 9574 46455394
Ocular hyperaemia 34.12 12.53 26 221068 19684 46445284
Malnutrition 33.81 12.53 12 221082 13991 46450977
Mitral valve incompetence 33.76 12.53 24 221070 18828 46446140
Onychomycosis 33.69 12.53 66 221028 4077 46460891
Urticarial vasculitis 33.66 12.53 23 221071 431 46464537
Visual acuity reduced 33.63 12.53 33 221061 22080 46442888
Blood bilirubin increased 33.22 12.53 70 221024 34114 46430854
Limb operation 33.21 12.53 58 221036 3280 46461688
Night sweats 33.15 12.53 232 220862 27018 46437950
Rheumatic fever 33.09 12.53 53 221041 2790 46462178
Diplopia 33.08 12.53 26 221068 19379 46445589
Lacrimation increased 32.86 12.53 17 221077 15844 46449124
Complication associated with device 32.82 12.53 16 221078 15425 46449543
White blood cell count abnormal 32.70 12.53 74 221020 5058 46459910
Eye disorder 32.64 12.53 171 220923 17970 46446998
Weight increased 32.61 12.53 565 220529 163908 46301060
Emotional disorder 32.54 12.53 9 221085 12315 46452653
Device issue 32.54 12.53 28 221066 19952 46445016
Ileus 32.37 12.53 13 221081 14051 46450917
Mental disorder 32.36 12.53 35 221059 22390 46442578
Therapeutic response unexpected 31.97 12.53 17 221077 15599 46449369
Colitis 31.86 12.53 82 221012 37265 46427703
Intestinal sepsis 31.84 12.53 18 221076 237 46464731
Delusion 31.82 12.53 7 221087 11181 46453787
Subdural haematoma 31.62 12.53 11 221083 12986 46451982
Infusion site pain 31.57 12.53 5 221089 10102 46454866
COVID-19 31.52 12.53 25 221069 18550 46446418
Diarrhoea 31.40 12.53 2255 218839 557347 45907621
Brain oedema 31.33 12.53 10 221084 12468 46452500
Mydriasis 31.26 12.53 6 221088 10547 46454421
Nausea 31.12 12.53 2819 218275 684635 45780333
Intestinal obstruction 31.10 12.53 47 221047 26028 46438940
Supraventricular tachycardia 30.98 12.53 12 221082 13258 46451710
Muscle rigidity 30.96 12.53 5 221089 9956 46455012
Angioedema 30.85 12.53 90 221004 39252 46425716
Ankle deformity 30.71 12.53 21 221073 394 46464574
Haematemesis 30.57 12.53 56 221038 28750 46436218
Pneumonia 30.49 12.53 1464 219630 374856 46090112
Pallor 30.38 12.53 39 221055 23127 46441841
Peritonitis bacterial 30.14 12.53 3 221091 8650 46456318
Tinnitus 30.09 12.53 53 221041 27620 46437348
Left ventricular dysfunction 30.02 12.53 6 221088 10249 46454719
Eosinophilia 30.01 12.53 28 221066 19189 46445779
Mucosal inflammation 29.96 12.53 90 221004 38886 46426082
Abortion spontaneous 29.93 12.53 106 220988 43540 46421428
Acidosis 29.81 12.53 8 221086 11166 46453802
Metastases to lung 29.80 12.53 7 221087 10689 46454279
Bacteraemia 29.67 12.53 15 221079 14164 46450804
Respiratory depression 29.66 12.53 9 221085 11591 46453377
Hepatic encephalopathy 29.62 12.53 6 221088 10151 46454817
Colitis ischaemic 29.51 12.53 6 221088 10126 46454842
Incorrect dosage administered 29.18 12.53 38 221056 1653 46463315
Joint space narrowing 29.18 12.53 14 221080 128 46464840
Aspiration 29.14 12.53 5 221089 9526 46455442
Renal disorder 29.11 12.53 51 221043 26635 46438333
Labile blood pressure 28.97 12.53 38 221056 1665 46463303
Hyperbilirubinaemia 28.75 12.53 7 221087 10431 46454537
Myopathy 28.65 12.53 4 221090 8877 46456091
Fracture delayed union 28.65 12.53 43 221051 2139 46462829
Atelectasis 28.62 12.53 28 221066 18762 46446206
Ear pain 28.61 12.53 191 220903 21901 46443067
Dysphonia 28.60 12.53 90 221004 38324 46426644
Pancreatitis 28.57 12.53 108 220986 43519 46421449
Extrapyramidal disorder 28.35 12.53 9 221085 11259 46453709
Hypercholesterolaemia 28.32 12.53 119 220975 11411 46453557
Carpal tunnel syndrome 28.19 12.53 149 220945 15710 46449258
Drug ineffective for unapproved indication 27.97 12.53 22 221072 16391 46448577
Pain in extremity 27.94 12.53 1495 219599 257185 46207783
Impaired gastric emptying 27.92 12.53 93 221001 7979 46456989
Oropharyngeal pain 27.89 12.53 221 220873 73947 46391021
Ischaemic stroke 27.76 12.53 23 221071 16699 46448269
Cyanosis 27.73 12.53 21 221073 15950 46449018
Urine output decreased 27.68 12.53 9 221085 11088 46453880
Mass excision 27.64 12.53 17 221077 264 46464704
Ventricular extrasystoles 27.54 12.53 9 221085 11054 46453914
Ventricular fibrillation 27.50 12.53 10 221084 11486 46453482
Tachypnoea 27.41 12.53 17 221077 14334 46450634
Hepatocellular injury 27.41 12.53 62 221032 29460 46435508
Abdominal distension 27.38 12.53 219 220875 73132 46391836
Pre-eclampsia 27.26 12.53 3 221091 7991 46456977
Oral discomfort 27.18 12.53 91 221003 7827 46457141
Labelled drug-drug interaction medication error 27.17 12.53 5 221089 9056 46455912
Retinitis 27.05 12.53 19 221075 373 46464595
Bloody discharge 26.71 12.53 28 221066 963 46464005
Alanine aminotransferase abnormal 26.57 12.53 45 221049 2482 46462486
Tricuspid valve incompetence 26.55 12.53 16 221078 13701 46451267
Burning sensation 26.52 12.53 114 220980 44297 46420671
Stress at work 26.33 12.53 28 221066 979 46463989
Injury 26.30 12.53 113 220981 43914 46421054
Abnormal dreams 26.24 12.53 8 221086 10271 46454697
Viral upper respiratory tract infection 26.20 12.53 83 221011 6935 46458033
Intervertebral disc space narrowing 26.09 12.53 26 221068 841 46464127
Toxic skin eruption 26.08 12.53 13 221081 12374 46452594
Therapy non-responder 26.08 12.53 304 220790 40848 46424120
Rheumatic disorder 26.07 12.53 33 221061 1395 46463573
Ataxia 25.92 12.53 17 221077 13913 46451055
Body temperature increased 25.89 12.53 204 220890 24657 46440311
Systemic lupus erythematosus rash 25.81 12.53 31 221063 1241 46463727
Pleural thickening 25.70 12.53 45 221049 2550 46462418
Cardiomegaly 25.55 12.53 27 221067 17455 46447513
Renal impairment 25.53 12.53 227 220867 74145 46390823
Haematocrit decreased 25.50 12.53 83 221011 34974 46429994
Central nervous system lesion 25.43 12.53 7 221087 9608 46455360
Paraesthesia oral 25.33 12.53 12 221082 11761 46453207
Gastritis 25.27 12.53 81 221013 34297 46430671
Haemorrhoids 25.26 12.53 31 221063 18746 46446222
Renal injury 25.13 12.53 7 221087 9534 46455434
Leukopenia 25.06 12.53 459 220635 67884 46397084
Mental impairment 24.86 12.53 14 221080 12442 46452526
Deafness 24.60 12.53 145 220949 15923 46449045
C-reactive protein 24.45 12.53 17 221077 328 46464640
Amenorrhoea 24.43 12.53 6 221088 8889 46456079
Diabetic eye disease 24.26 12.53 13 221081 153 46464815
Herpes zoster 24.25 12.53 454 220640 67418 46397550
Retching 24.21 12.53 16 221078 13041 46451927
Eye swelling 24.20 12.53 36 221058 20067 46444901
Respiratory disorder 24.17 12.53 216 220878 27084 46437884
Stress cardiomyopathy 23.98 12.53 4 221090 7780 46457188
Tumour lysis syndrome 23.96 12.53 3 221091 7233 46457735
Clostridium difficile infection 23.89 12.53 52 221042 25051 46439917
Nightmare 23.85 12.53 26 221068 16572 46448396
Blindness 23.78 12.53 28 221066 17241 46447727
Hypercalcaemia 23.76 12.53 176 220918 20870 46444098
Exposure during pregnancy 23.75 12.53 676 220418 107536 46357432
Infusion site erythema 23.38 12.53 4 221090 7638 46457330
Dry mouth 23.37 12.53 158 220936 54768 46410200
Lupus-like syndrome 23.35 12.53 86 221008 7758 46457210
Headache 23.27 12.53 1950 219144 476402 45988566
Gastroenteritis viral 23.25 12.53 31 221063 18088 46446880
Lymphopenia 23.05 12.53 23 221071 15270 46449698
Tardive dyskinesia 22.97 12.53 4 221090 7539 46457429
Walking aid user 22.94 12.53 62 221032 4738 46460230
Flank pain 22.91 12.53 14 221080 11899 46453069
Skin discolouration 22.65 12.53 79 221015 32601 46432367
Creatinine renal clearance decreased 22.60 12.53 3 221091 6917 46458051
Middle lobe syndrome 22.54 12.53 8 221086 30 46464938
Anal incontinence 22.43 12.53 14 221080 11764 46453204
Oesophagitis 22.39 12.53 19 221075 13632 46451336
Loss of consciousness 22.35 12.53 369 220725 107869 46357099
Cytomegalovirus infection 22.32 12.53 32 221062 18112 46446856
Neck surgery 22.31 12.53 31 221063 1436 46463532
Osteopenia 22.18 12.53 147 220947 16814 46448154
Atrioventricular block 22.13 12.53 3 221091 6808 46458160
Apnoea 22.11 12.53 4 221090 7335 46457633
Haemodialysis 22.08 12.53 8 221086 9209 46455759
Stress 22.07 12.53 355 220739 51196 46413772
Lower gastrointestinal haemorrhage 22.03 12.53 4 221090 7316 46457652
Oliguria 22.03 12.53 7 221087 8752 46456216
Swelling face 21.90 12.53 154 220940 52905 46412063
Thyroid disorder 21.84 12.53 114 220980 11962 46453006
Pelvic pain 21.81 12.53 14 221080 11588 46453380
Mycotic allergy 21.75 12.53 19 221075 518 46464450
Drug dependence 21.74 12.53 38 221056 19863 46445105
Hepatic failure 21.70 12.53 83 221011 33333 46431635
Intervertebral disc compression 21.66 12.53 25 221069 959 46464009
Steatohepatitis 21.65 12.53 18 221076 458 46464510
Eyelid oedema 21.61 12.53 11 221083 10346 46454622
Arthritis bacterial 21.57 12.53 68 221026 5668 46459300
Polyarthritis 21.42 12.53 74 221020 6468 46458500
Blood loss anaemia 21.24 12.53 7 221087 8550 46456418
Haemolytic anaemia 21.22 12.53 10 221084 9832 46455136
Mycobacterium marinum infection 21.17 12.53 11 221083 121 46464847
Road traffic accident 20.99 12.53 51 221043 23640 46441328
Clear cell renal cell carcinoma 20.95 12.53 25 221069 994 46463974
Electrocardiogram abnormal 20.74 12.53 4 221090 7008 46457960
Rheumatoid factor 20.68 12.53 9 221085 64 46464904
Lung disorder 20.37 12.53 303 220791 43001 46421967
Psychomotor hyperactivity 20.37 12.53 10 221084 9603 46455365
Viral infection 20.35 12.53 74 221020 30161 46434807
Therapy interrupted 20.31 12.53 13 221081 10778 46454190
Mood altered 20.26 12.53 19 221075 12988 46451980
Hepatic enzyme abnormal 20.24 12.53 55 221039 4217 46460751
Sensory disturbance 20.21 12.53 17 221077 12250 46452718
Amyotrophic lateral sclerosis 20.10 12.53 25 221069 1038 46463930
Atrial septal defect 20.08 12.53 3 221091 6329 46458639
Myelodysplastic syndrome 20.04 12.53 27 221067 15684 46449284
Ageusia 20.03 12.53 15 221079 11457 46453511
Hypotonia 19.96 12.53 7 221087 8222 46456746
Blood triglycerides increased 19.82 12.53 16 221078 11767 46453201
Inflammatory marker increased 19.76 12.53 64 221030 5411 46459557
Haemodynamic instability 19.74 12.53 6 221088 7719 46457249
Hyperlipidaemia 19.71 12.53 36 221058 18503 46446465
Bradyphrenia 19.65 12.53 3 221091 6227 46458741
Arthritis infective 19.58 12.53 61 221033 5052 46459916
Gestational diabetes 19.58 12.53 5 221089 7214 46457754
Feeling cold 19.47 12.53 37 221057 18734 46446234
Atrioventricular block first degree 19.46 12.53 3 221091 6183 46458785
Throat tightness 19.44 12.53 43 221051 20596 46444372
Restless legs syndrome 19.44 12.53 28 221066 15815 46449153
Premature baby 19.41 12.53 35 221059 18077 46446891
C-reactive protein decreased 19.38 12.53 20 221074 675 46464293
Feeling hot 19.35 12.53 103 220991 37825 46427143
Dactylitis 19.34 12.53 26 221068 1167 46463801
Aplastic anaemia 19.31 12.53 5 221089 7148 46457820
Failure to thrive 19.30 12.53 4 221090 6660 46458308
Osteomyelitis 19.25 12.53 176 220918 22207 46442761
Hip fracture 19.22 12.53 63 221031 26493 46438475
Functional gastrointestinal disorder 19.19 12.53 45 221049 3149 46461819
Mycobacterium tuberculosis complex test positive 19.17 12.53 30 221064 1548 46463420
Neck pain 19.08 12.53 368 220726 54938 46410030
Angina unstable 19.04 12.53 6 221088 7542 46457426
Wound infection 18.88 12.53 98 220996 10261 46454707
Bronchopulmonary aspergillosis 18.84 12.53 6 221088 7490 46457478
Hypoaesthesia 18.80 12.53 424 220670 118445 46346523
Menstruation irregular 18.78 12.53 4 221090 6535 46458433
Injection site pain 18.76 12.53 376 220718 106776 46358192
Pharyngeal oedema 18.67 12.53 125 220969 14346 46450622
Muscle tightness 18.61 12.53 13 221081 10292 46454676
Photophobia 18.55 12.53 25 221069 14519 46450449
Anaphylactic reaction 18.53 12.53 354 220740 52758 46412210
Sudden death 18.51 12.53 11 221083 9493 46455475
Intentional product use issue 18.49 12.53 352 220742 52428 46412540
Intervertebral disc protrusion 18.34 12.53 162 220932 20243 46444725
Hypophosphataemia 18.33 12.53 6 221088 7361 46457607
Presbyacusis 18.33 12.53 41 221053 2781 46462187
Rhinitis allergic 18.32 12.53 5 221089 6903 46458065
Spinal disorder 18.31 12.53 81 221013 7943 46457025
Pulmonary congestion 18.31 12.53 26 221068 14773 46450195
Acute coronary syndrome 18.26 12.53 13 221081 10191 46454777
Nail disorder 18.24 12.53 80 221014 7816 46457152
Thinking abnormal 18.23 12.53 12 221082 9802 46455166
Shock haemorrhagic 18.23 12.53 9 221085 8615 46456353
End stage renal disease 18.19 12.53 3 221091 5883 46459085
Acute generalised exanthematous pustulosis 18.16 12.53 11 221083 9394 46455574
Taste disorder 18.16 12.53 3 221091 5875 46459093
Device related infection 18.10 12.53 46 221048 20995 46443973
Eructation 18.05 12.53 6 221088 7289 46457679
Coagulopathy 17.87 12.53 38 221056 18461 46446507
Malignant neoplasm of conjunctiva 17.66 12.53 7 221087 38 46464930
Bipolar disorder 17.59 12.53 6 221088 7171 46457797
Red blood cell count decreased 17.55 12.53 87 221007 32536 46432432
Blood magnesium increased 17.49 12.53 42 221052 2985 46461983
Rash macular 17.43 12.53 41 221053 19219 46445749
Nystagmus 17.40 12.53 3 221091 5696 46459272
Multiple allergies 17.27 12.53 75 221019 7296 46457672
Jaundice 17.25 12.53 74 221020 28771 46436197
Unintended pregnancy 17.24 12.53 3 221091 5657 46459311
Obstructive airways disorder 17.16 12.53 23 221071 13389 46451579
Hot flush 17.14 12.53 128 220966 43389 46421579
Migraine 17.12 12.53 231 220863 69795 46395173
Peripheral coldness 17.06 12.53 13 221081 9842 46455126
Device malfunction 17.04 12.53 23 221071 13351 46451617
Acute pulmonary oedema 17.04 12.53 8 221086 7883 46457085
Ear infection bacterial 17.01 12.53 6 221088 22 46464946
Rash maculo-papular 16.98 12.53 71 221023 27803 46437165
White blood cell count increased 16.97 12.53 131 220963 44088 46420880
Petechiae 16.96 12.53 21 221073 12649 46452319
Productive cough 16.88 12.53 156 220938 50559 46414409
Frequent bowel movements 16.84 12.53 21 221073 12611 46452357
Gait inability 16.83 12.53 247 220847 34956 46430012
Soft tissue swelling 16.79 12.53 21 221073 877 46464091
Hepatic ischaemia 16.78 12.53 16 221078 490 46464478
Troponin increased 16.76 12.53 8 221086 7808 46457160
Neutrophil count increased 16.70 12.53 26 221068 14227 46450741
Hemiplegia 16.66 12.53 6 221088 6932 46458036
Faeces discoloured 16.63 12.53 34 221060 16753 46448215
Device breakage 16.50 12.53 13 221081 9679 46455289
Exposure to communicable disease 16.43 12.53 16 221078 503 46464465
Increased appetite 16.43 12.53 10 221084 8517 46456451
Cellulitis 16.42 12.53 234 220860 70054 46394914
Dermatitis contact 16.40 12.53 9 221085 8114 46456854
Sinusitis bacterial 16.33 12.53 19 221075 735 46464233
Monocyte count increased 16.33 12.53 57 221037 5007 46459961
Hepatic steatosis 16.31 12.53 180 220914 23862 46441106
Malaise 16.26 12.53 1349 219745 329883 46135085
Glaucoma 16.22 12.53 130 220964 15791 46449177
Ovarian cyst 16.22 12.53 26 221068 14061 46450907
Nasopharyngitis 16.19 12.53 888 220206 153110 46311858
Spinal fusion surgery 16.09 12.53 40 221054 2906 46462062
Epstein-Barr virus infection 16.06 12.53 6 221088 6778 46458190
Glomerular filtration rate decreased 16.06 12.53 19 221075 11675 46453293
Progressive multifocal leukoencephalopathy 16.05 12.53 18 221076 11328 46453640
Musculoskeletal chest pain 16.03 12.53 39 221055 18067 46446901
Systemic inflammatory response syndrome 16.02 12.53 3 221091 5368 46459600
Cerebral ischaemia 16.00 12.53 5 221089 6320 46458648
Hyperthermia 16.00 12.53 9 221085 8005 46456963
Anti-neutrophil cytoplasmic antibody positive vasculitis 15.95 12.53 31 221063 1904 46463064
Atrial flutter 15.92 12.53 12 221082 9136 46455832
Acute respiratory distress syndrome 15.87 12.53 52 221042 21870 46443098
Fatigue 15.84 12.53 3188 217906 605509 45859459
Muscle relaxant therapy 15.82 12.53 9 221085 120 46464848
Embolism 15.78 12.53 7 221087 7131 46457837
Nocturia 15.76 12.53 7 221087 7125 46457843
Deafness neurosensory 15.74 12.53 52 221042 4442 46460526
Smear cervix abnormal 15.72 12.53 36 221058 2480 46462488
Latent tuberculosis 15.67 12.53 31 221063 1929 46463039
Pharyngeal abscess 15.66 12.53 11 221083 216 46464752
Hepatitis cholestatic 15.65 12.53 6 221088 6671 46458297
Granulocytopenia 15.62 12.53 3 221091 5270 46459698
Ocular toxicity 15.55 12.53 15 221079 466 46464502
Parotid gland enlargement 15.54 12.53 19 221075 775 46464193
Rash pruritic 15.53 12.53 295 220799 43920 46421048
Insomnia 15.49 12.53 631 220463 164293 46300675
Cholecystitis 15.46 12.53 28 221066 14438 46450530
Subarachnoid haemorrhage 15.44 12.53 18 221076 11135 46453833
Foot fracture 15.36 12.53 151 220943 19431 46445537
Overwork 15.28 12.53 7 221087 57 46464911
Enterococcal infection 15.22 12.53 7 221087 6980 46457988
Blood lactic acid increased 15.18 12.53 4 221090 5653 46459315
Arteriosclerosis coronary artery 15.11 12.53 10 221084 8146 46456822
Throat irritation 15.02 12.53 78 221016 28823 46436145
Pleural fibrosis 15.00 12.53 44 221050 3525 46461443
Hiatus hernia 14.99 12.53 41 221053 18261 46446707
Prothrombin time prolonged 14.96 12.53 14 221080 9582 46455386
Sensory loss 14.90 12.53 7 221087 6895 46458073
Localised oedema 14.77 12.53 3 221091 5066 46459902
Toxic encephalopathy 14.74 12.53 3 221091 5059 46459909
Pleuritic pain 14.65 12.53 6 221088 6410 46458558
Hereditary angioedema 14.62 12.53 4 221090 5512 46459456
Swollen tongue 14.57 12.53 80 221014 29152 46435816
Breast pain 14.50 12.53 9 221085 7585 46457383
Rib fracture 14.40 12.53 44 221050 18910 46446058
Drug level decreased 14.39 12.53 5 221089 5907 46459061
Dialysis 14.36 12.53 16 221078 10100 46454868
Feeding disorder 14.34 12.53 90 221004 10104 46454864
Refusal of treatment by patient 14.21 12.53 4 221090 5411 46459557
Concomitant disease aggravated 14.16 12.53 10 221084 7872 46457096
Major depression 14.12 12.53 7 221087 6683 46458285
Breast cyst excision 14.05 12.53 7 221087 70 46464898
Pulmonary sarcoidosis 14.03 12.53 19 221075 859 46464109
Head discomfort 14.02 12.53 17 221077 10334 46454634
Ocular hypertension 13.95 12.53 18 221076 776 46464192
Asphyxia 13.86 12.53 4 221090 5322 46459646
Pre-existing condition improved 13.83 12.53 7 221087 6605 46458363
Post procedural complication 13.83 12.53 34 221060 15695 46449273
Blood pressure systolic decreased 13.83 12.53 4 221090 5314 46459654
Back disorder 13.68 12.53 82 221012 9059 46455909
Foetal growth restriction 13.66 12.53 7 221087 6560 46458408
Brain injury 13.65 12.53 6 221088 6144 46458824
Osteonecrosis of jaw 13.64 12.53 101 220993 34301 46430667
Eye movement disorder 13.63 12.53 3 221091 4790 46460178
Injection site mass 13.63 12.53 32 221062 15008 46449960
Alanine aminotransferase increased 13.61 12.53 530 220564 87921 46377047
Personality change 13.59 12.53 4 221090 5254 46459714
Blood albumin decreased 13.48 12.53 28 221066 13717 46451251
Gingival pain 13.47 12.53 6 221088 6097 46458871
Hyperventilation 13.36 12.53 5 221089 5642 46459326
No adverse event 13.33 12.53 101 220993 34130 46430838
Hypoalbuminaemia 13.33 12.53 17 221077 10110 46454858
Fistula 13.32 12.53 11 221083 7999 46456969
Product complaint 13.31 12.53 23 221071 12078 46452890
Expired product administered 13.26 12.53 5 221089 5617 46459351
Vaginal haematoma 13.25 12.53 8 221086 120 46464848
Pseudomonas infection 13.24 12.53 16 221078 9742 46455226
Coeliac disease 13.22 12.53 68 221026 7093 46457875
Salivary hypersecretion 13.22 12.53 7 221087 6438 46458530
Aspartate aminotransferase increased 13.17 12.53 476 220618 78224 46386744
Suspected suicide 13.09 12.53 3 221091 4658 46460310
Humerus fracture 13.06 12.53 10 221084 7552 46457416
Bundle branch block left 13.05 12.53 7 221087 6392 46458576
Carotid artery stenosis 13.04 12.53 4 221090 5116 46459852
Skin burning sensation 13.01 12.53 19 221075 10673 46454295
Forced expiratory volume decreased 12.98 12.53 4 221090 5100 46459868
Infective tenosynovitis 12.96 12.53 10 221084 228 46464740
Scleroderma 12.96 12.53 3 221091 4626 46460342
Angina pectoris 12.95 12.53 74 221020 26701 46438267
Weber tuning fork test abnormal 12.95 12.53 7 221087 84 46464884
Laryngeal disorder 12.94 12.53 18 221076 835 46464133
Enteritis 12.90 12.53 8 221086 6747 46458221
Spinal compression fracture 12.89 12.53 26 221068 12877 46452091
Thirst 12.88 12.53 20 221074 10956 46454012
Eosinophil count increased 12.84 12.53 11 221083 7855 46457113
Cold sweat 12.79 12.53 20 221074 10925 46454043
Chromaturia 12.79 12.53 33 221061 14986 46449982
Generalised oedema 12.76 12.53 31 221063 14368 46450600
Exercise tolerance decreased 12.74 12.53 3 221091 4574 46460394
Neuralgia 12.70 12.53 55 221039 21328 46443640
Acute hepatitis C 12.66 12.53 7 221087 88 46464880
Skin laceration 12.64 12.53 45 221049 18457 46446511
Hypoaesthesia oral 12.62 12.53 19 221075 10540 46454428
Pregnancy 12.60 12.53 76 221018 27061 46437907
Blood thyroid stimulating hormone increased 12.60 12.53 6 221088 5863 46459105
Glycosylated haemoglobin increased 12.59 12.53 20 221074 10856 46454112
Nephropathy 12.59 12.53 4 221090 5001 46459967
Thrombophlebitis superficial 12.58 12.53 4 221090 4999 46459969

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
Drug ineffective 2369.28 14.79 2831 46467 337556 29565624
Rheumatoid arthritis 2337.75 14.79 1203 48095 39994 29863186
Joint swelling 1428.51 14.79 914 48384 46032 29857148
Drug intolerance 1328.95 14.79 862 48436 44429 29858751
Contraindicated product administered 865.93 14.79 465 48833 16766 29886414
Treatment failure 655.10 14.79 505 48793 34174 29869006
Apparent death 599.62 14.79 224 49074 3318 29899862
Synovitis 591.45 14.79 299 48999 9484 29893696
C-reactive protein abnormal 555.62 14.79 241 49057 5352 29897828
Arthralgia 471.75 14.79 819 48479 134972 29768208
Bone erosion 424.88 14.79 155 49143 2138 29901042
Diverticulitis 424.02 14.79 296 49002 17149 29886031
Arthropathy 400.19 14.79 306 48992 20421 29882759
Therapeutic product effect decreased 395.20 14.79 350 48948 28726 29874454
Drug hypersensitivity 344.05 14.79 490 48808 68029 29835151
Loss of personal independence in daily activities 343.08 14.79 284 49014 21251 29881929
Pain 335.07 14.79 819 48479 171822 29731358
Musculoskeletal stiffness 334.51 14.79 351 48947 35530 29867650
Red blood cell sedimentation rate abnormal 332.63 14.79 121 49177 1654 29901526
Drug eruption 317.06 14.79 249 49049 17277 29885903
Stomatitis 300.88 14.79 338 48960 36941 29866239
Urticaria 268.80 14.79 387 48911 54219 29848961
Death 256.49 14.79 135 49163 357148 29546032
Psoriatic arthropathy 247.12 14.79 206 49092 15555 29887625
Pain in extremity 238.38 14.79 546 48752 109675 29793505
Mobility decreased 236.28 14.79 251 49047 25748 29877432
Hypersensitivity 230.27 14.79 358 48940 53670 29849510
Disability 221.02 14.79 119 49179 4299 29898881
Sleep disorder due to general medical condition, insomnia type 217.76 14.79 80 49218 1126 29902054
Red blood cell sedimentation rate increased 216.04 14.79 140 49158 7155 29896025
Hand deformity 190.18 14.79 82 49216 1791 29901389
Impaired work ability 183.77 14.79 115 49183 5528 29897652
Hypotension 180.94 14.79 53 49245 200512 29702668
Chondropathy 165.99 14.79 60 49238 804 29902376
Acute kidney injury 163.92 14.79 127 49171 273715 29629465
Therapeutic product effect incomplete 162.27 14.79 237 49061 33597 29869583
Knee arthroplasty 161.69 14.79 106 49192 5524 29897656
C-reactive protein increased 157.86 14.79 268 49030 43205 29859975
Pulmonary thrombosis 154.88 14.79 108 49190 6235 29896945
Onychoclasis 150.19 14.79 67 49231 1592 29901588
Anti-cyclic citrullinated peptide antibody positive 144.59 14.79 52 49246 686 29902494
Febrile neutropenia 143.18 14.79 8 49290 106685 29796495
Limb discomfort 139.15 14.79 117 49181 8933 29894247
Hepatic function abnormal 137.22 14.79 247 49051 41698 29861482
Rheumatoid factor negative 135.38 14.79 46 49252 507 29902673
Drug specific antibody present 130.79 14.79 65 49233 1982 29901198
Peripheral swelling 130.05 14.79 301 48997 60773 29842407
Alanine aminotransferase abnormal 129.48 14.79 70 49228 2549 29900631
Arthritis 128.87 14.79 179 49119 24222 29878958
Confusional state 128.32 14.79 32 49266 134802 29768378
Tenosynovitis 128.15 14.79 77 49221 3438 29899742
Atlantoaxial instability 128.01 14.79 39 49259 293 29902887
Anaemia 127.47 14.79 94 49204 207898 29695282
Spinal instability 126.42 14.79 39 49259 307 29902873
Mineral metabolism disorder 125.98 14.79 39 49259 311 29902869
Toxicity to various agents 123.67 14.79 69 49229 177114 29726066
Dislocation of vertebra 121.24 14.79 39 49259 357 29902823
Rheumatoid nodule 120.98 14.79 58 49240 1632 29901548
Bone cyst 120.46 14.79 42 49256 503 29902677
Intervertebral disc space narrowing 120.23 14.79 44 49254 612 29902568
Sarcoidosis 118.60 14.79 67 49231 2662 29900518
Drug interaction 117.42 14.79 94 49204 199474 29703706
Overdose 117.37 14.79 5 49293 84332 29818848
Enthesopathy 117.33 14.79 68 49230 2838 29900342
Acne cystic 117.06 14.79 40 49258 449 29902731
Osteoarthritis 114.40 14.79 146 49152 18203 29884977
Lymphoma 114.38 14.79 110 49188 10011 29893169
Terminal state 113.71 14.79 72 49226 3532 29899648
Drug tolerance decreased 112.93 14.79 49 49249 1087 29902093
Herpes zoster 110.51 14.79 186 49112 29757 29873423
Dehydration 108.81 14.79 34 49264 123505 29779675
Tooth loss 104.97 14.79 71 49227 3898 29899282
Thrombocytopenia 102.06 14.79 49 49249 136995 29766185
Malignant neoplasm progression 101.54 14.79 4 49294 72283 29830897
Gastrointestinal disorder 101.48 14.79 173 49125 27964 29875216
Epistaxis 99.73 14.79 249 49049 52732 29850448
Joint ankylosis 98.42 14.79 32 49266 304 29902876
Alopecia 98.20 14.79 139 49159 19136 29884044
Swelling 94.44 14.79 193 49105 35782 29867398
Constipation 92.63 14.79 35 49263 112871 29790309
Muscle spasms 91.37 14.79 274 49024 64564 29838616
Rheumatoid factor positive 88.45 14.79 33 49265 486 29902694
Rhabdomyolysis 87.69 14.79 4 49294 63576 29839604
Tongue disorder 85.95 14.79 65 49233 4257 29898923
Osteosclerosis 82.70 14.79 40 49258 1148 29902032
Foot deformity 82.68 14.79 58 49240 3379 29899801
Dizziness 81.25 14.79 122 49176 194787 29708393
Vomiting 81.07 14.79 149 49149 219669 29683511
Drug use disorder 80.92 14.79 56 49242 3192 29899988
Pyrexia 78.04 14.79 238 49060 294251 29608929
Cytology abnormal 77.67 14.79 28 49270 372 29902808
Decreased appetite 76.91 14.79 80 49218 149830 29753350
Inflammation 76.23 14.79 133 49165 21893 29881287
Somnolence 76.07 14.79 32 49266 96731 29806449
Tooth fracture 76.05 14.79 54 49244 3208 29899972
Joint arthroplasty 75.52 14.79 31 49267 596 29902584
Hyperkalaemia 74.89 14.79 10 49288 66000 29837180
Liver function test increased 74.28 14.79 92 49206 11124 29892056
Nodule 73.80 14.79 62 49236 4726 29898454
Seizure 73.60 14.79 35 49263 98440 29804740
Deep vein thrombosis 73.57 14.79 243 49055 60258 29842922
Hip arthroplasty 71.63 14.79 55 49243 3685 29899495
Bradycardia 69.59 14.79 12 49286 65514 29837666
Fall 69.06 14.79 121 49177 181751 29721429
Joint stiffness 68.88 14.79 81 49217 9280 29893900
Plasma cell myeloma 68.72 14.79 5 49293 53457 29849723
Infection 66.04 14.79 279 49019 77795 29825385
Neutropenia 64.34 14.79 70 49228 128470 29774710
Intestinal sepsis 64.33 14.79 25 49273 414 29902766
Agitation 64.27 14.79 7 49291 54066 29849114
Photosensitivity reaction 63.37 14.79 79 49219 9615 29893565
Pulmonary fibrosis 63.04 14.79 102 49196 15788 29887392
Cardiac arrest 62.07 14.79 38 49260 92812 29810368
Joint lock 59.54 14.79 31 49267 1044 29902136
Osteolysis 59.01 14.79 35 49263 1525 29901655
Ill-defined disorder 58.48 14.79 79 49219 10405 29892775
Atrial fibrillation 57.36 14.79 56 49242 108068 29795112
International normalised ratio increased 57.19 14.79 6 49292 47733 29855447
Intentional overdose 55.94 14.79 3 49295 41478 29861702
Prerenal failure 55.61 14.79 36 49262 1835 29901345
Mass 54.57 14.79 63 49235 7077 29896103
Disease progression 54.35 14.79 32 49266 79842 29823338
Exposure via body fluid 53.30 14.79 15 49283 82 29903098
Pulmonary embolism 52.52 14.79 261 49037 77874 29825306
Hallucination 52.05 14.79 9 49289 49050 29854130
Platelet count decreased 51.77 14.79 59 49239 106070 29797110
Cardiac failure congestive 51.77 14.79 38 49260 84369 29818811
Haemorrhage 49.89 14.79 8 49290 46071 29857109
Mental status changes 49.02 14.79 3 49295 37076 29866104
Ankle deformity 48.65 14.79 17 49281 205 29902975
Suicide attempt 48.43 14.79 3 49295 36694 29866486
Oral surgery 48.28 14.79 22 49276 550 29902630
Musculoskeletal pain 47.61 14.79 135 49163 30805 29872375
Blood glucose increased 47.30 14.79 21 49277 61509 29841671
Fine motor skill dysfunction 46.42 14.79 27 49271 1134 29902046
Dyspnoea 45.41 14.79 342 48956 332953 29570227
Polyomavirus-associated nephropathy 44.52 14.79 39 49259 3146 29900034
Tendonitis 43.98 14.79 60 49238 7976 29895204
Musculoskeletal discomfort 43.86 14.79 53 49245 6247 29896933
Hypokalaemia 43.81 14.79 14 49284 50178 29853002
Seronegative arthritis 43.76 14.79 23 49275 790 29902390
Gait inability 43.54 14.79 96 49202 18745 29884435
Medical device implantation 43.34 14.79 20 49278 515 29902665
Tachycardia 42.92 14.79 35 49263 73704 29829476
Cardio-respiratory arrest 41.83 14.79 21 49277 57285 29845895
Physical disability 41.68 14.79 25 49273 1112 29902068
Syncope 41.61 14.79 47 49251 84856 29818324
Urinary tract infection 41.60 14.79 36 49262 73623 29829557
End stage renal disease 41.43 14.79 56 49242 7379 29895801
Intentional product use issue 41.30 14.79 143 49155 36297 29866883
Pulmonary mass 40.75 14.79 68 49230 10794 29892386
Pneumonia aspiration 39.92 14.79 7 49291 37773 29865407
Skin mass 39.63 14.79 38 49260 3444 29899736
Myalgia 39.17 14.79 41 49257 76626 29826554
Hyponatraemia 38.98 14.79 32 49266 67170 29836010
Joint range of motion decreased 38.79 14.79 48 49250 5797 29897383
Hyperglycaemia 38.36 14.79 6 49292 35194 29867986
Hypoglycaemia 38.24 14.79 18 49280 50963 29852217
Renal impairment 37.67 14.79 50 49248 84134 29819046
X-ray abnormal 37.65 14.79 18 49280 503 29902677
Cerebrovascular accident 36.93 14.79 50 49248 83427 29819753
Blood creatinine increased 36.27 14.79 59 49239 91316 29811864
Abdominal pain 35.53 14.79 110 49188 135544 29767636
Suicidal ideation 35.42 14.79 8 49290 36106 29867074
Soft tissue swelling 35.31 14.79 14 49284 245 29902935
Condition aggravated 35.13 14.79 364 48934 137502 29765678
Pyopneumothorax 35.04 14.79 10 49288 58 29903122
Electrocardiogram QT prolonged 35.02 14.79 8 49290 35827 29867353
Flushing 34.58 14.79 4 49294 29488 29873692
Tuberculin test positive 34.30 14.79 21 49277 970 29902210
Delirium 34.29 14.79 12 49286 40619 29862561
Finger deformity 34.28 14.79 21 49277 971 29902209
Neoplasm malignant 33.77 14.79 84 49214 17730 29885450
Immobile 33.74 14.79 28 49270 2098 29901082
Loss of consciousness 33.66 14.79 49 49249 79326 29823854
Blood creatine phosphokinase increased 33.64 14.79 15 49283 43833 29859347
Surgery 32.72 14.79 64 49234 11487 29891693
Limb deformity 32.71 14.79 16 49282 471 29902709
Hospitalisation 32.70 14.79 16 49282 44303 29858877
Haematemesis 32.15 14.79 3 49295 26200 29876980
Neutrophil count decreased 31.83 14.79 15 49283 42439 29860741
Rheumatoid lung 31.64 14.79 14 49284 326 29902854
Skin laceration 31.46 14.79 62 49236 11189 29891991
Pulmonary toxicity 31.45 14.79 38 49260 4478 29898702
Product dose omission issue 31.18 14.79 65 49233 91566 29811614
Human polyomavirus infection 31.09 14.79 17 49281 633 29902547
Chest pain 31.07 14.79 95 49203 117532 29785648
Urinary retention 30.90 14.79 8 49290 32909 29870271
Blood cholesterol abnormal 30.69 14.79 22 49276 1326 29901854
Interstitial lung disease 30.31 14.79 186 49112 60011 29843169
Tooth disorder 29.98 14.79 54 49244 9107 29894073
Therapeutic response decreased 29.74 14.79 98 49200 24251 29878929
Skin ulcer 29.73 14.79 83 49215 18766 29884414
Respiratory arrest 29.68 14.79 6 49292 29252 29873928
Lacrimal disorder 28.75 14.79 13 49285 319 29902861
Hepatic enzyme abnormal 28.54 14.79 26 49272 2208 29900972
Lactic acidosis 28.51 14.79 8 49290 31205 29871975
Coronary artery disease 28.42 14.79 24 49274 49688 29853492
Bursitis 27.80 14.79 36 49262 4550 29898630
Haematuria 27.71 14.79 20 49278 44814 29858366
Unresponsive to stimuli 27.68 14.79 5 49293 26414 29876766
Renal failure 27.58 14.79 329 48969 128637 29774543
Dysarthria 27.51 14.79 8 49290 30482 29872698
Hypoxia 27.48 14.79 23 49275 47831 29855349
Joint effusion 27.45 14.79 32 49266 3631 29899549
Dysphagia 27.11 14.79 32 49266 56666 29846514
Gastrointestinal haemorrhage 26.89 14.79 61 49237 83385 29819795
Pulmonary cavitation 26.71 14.79 16 49282 710 29902470
Blood pressure decreased 26.58 14.79 23 49275 47052 29856128
Depressed level of consciousness 26.43 14.79 15 49283 38207 29864973
Intentional product misuse 26.37 14.79 12 49286 34655 29868525
Musculoskeletal disorder 25.99 14.79 36 49262 4853 29898327
Hepatic cirrhosis 25.78 14.79 71 49227 15928 29887252
Aortic bruit 25.71 14.79 10 49288 166 29903014
Thrombosis 25.52 14.79 137 49161 42094 29861086
Dyskinesia 25.50 14.79 3 49295 21831 29881349
Respiratory failure 25.36 14.79 83 49215 100559 29802621
Wrist deformity 25.28 14.79 12 49286 330 29902850
Coma 25.06 14.79 18 49280 40431 29862749
Fibromyalgia 25.05 14.79 26 49272 2592 29900588
Speech disorder 24.92 14.79 5 49293 24507 29878673
Heart block congenital 24.76 14.79 7 49291 39 29903141
Asthenia 24.69 14.79 239 49059 221051 29682129
Elbow operation 24.60 14.79 9 49289 125 29903055
Pancreatitis acute 24.59 14.79 6 49292 25689 29877491
Cutaneous symptom 24.55 14.79 11 49287 264 29902916
Diarrhoea 24.46 14.79 395 48903 333708 29569472
Rash maculo-papular 24.20 14.79 6 49292 25412 29877768
Fatigue 24.18 14.79 377 48921 320296 29582884
Metabolic acidosis 24.09 14.79 16 49282 37445 29865735
Therapy partial responder 23.99 14.79 30 49268 3661 29899519
Lymphoedema 23.64 14.79 29 49269 3470 29899710
Oral disorder 23.25 14.79 31 49267 4031 29899149
Cytomegalovirus viraemia 23.02 14.79 37 49261 5692 29897488
White blood cell count increased 22.86 14.79 19 49279 39654 29863526
Respiratory distress 22.71 14.79 13 49285 32959 29870221
Hypocalcaemia 22.50 14.79 4 49294 21372 29881808
Ankylosing spondylitis 22.06 14.79 32 49266 4502 29898678
Product use in unapproved indication 22.05 14.79 56 49242 73637 29829543
Steatorrhoea 22.01 14.79 14 49284 692 29902488
Cytomegalovirus syndrome 21.81 14.79 8 49290 112 29903068
Abdominal distension 21.63 14.79 26 49272 45683 29857497
Multiple organ dysfunction syndrome 21.62 14.79 45 49253 63442 29839738
Spina bifida occulta 21.58 14.79 5 49293 10 29903170
C-reactive protein decreased 21.41 14.79 19 49279 1559 29901621
Subdural haematoma 21.21 14.79 3 49295 18969 29884211
Abdominal discomfort 21.03 14.79 145 49153 48646 29854534
Injury 20.94 14.79 5 49293 21726 29881454
Septic shock 20.90 14.79 46 49252 63561 29839619
Irritability 20.88 14.79 6 49292 23044 29880136
Oedema 20.83 14.79 24 49274 42969 29860211
Disorientation 20.78 14.79 13 49285 31405 29871775
Histoplasmosis 20.77 14.79 17 49281 1249 29901931
Cell-mediated cytotoxicity 20.58 14.79 6 49292 38 29903142
Fracture 20.42 14.79 36 49262 5970 29897210
Haematoma 20.34 14.79 7 49291 23946 29879234
Arthrodesis 20.06 14.79 11 49287 412 29902768
Cerebral haemorrhage 19.89 14.79 15 49283 32872 29870308
Haematocrit decreased 19.89 14.79 13 49285 30686 29872494
Unevaluable event 19.87 14.79 14 49284 31771 29871409
Generalised tonic-clonic seizure 19.85 14.79 4 49294 19547 29883633
Grip strength decreased 19.79 14.79 21 49277 2147 29901033
Dysgeusia 19.79 14.79 8 49290 24793 29878387
Dermatitis psoriasiform 19.79 14.79 16 49282 1155 29902025
Oral pustule 19.71 14.79 9 49289 226 29902954
Toxic epidermal necrolysis 19.67 14.79 3 49295 17937 29885243
Hernia pain 19.60 14.79 9 49289 229 29902951
Arthritis bacterial 19.56 14.79 30 49268 4434 29898746
Shoulder arthroplasty 19.54 14.79 11 49287 434 29902746
Cartilage injury 19.49 14.79 11 49287 436 29902744
Neck pain 19.37 14.79 77 49221 20867 29882313
Melaena 19.36 14.79 15 49283 32422 29870758
Exostosis 19.21 14.79 26 49272 3429 29899751
Arrhythmia 18.97 14.79 16 49282 33153 29870027
Paternal drugs affecting foetus 18.94 14.79 6 49292 52 29903128
Restlessness 18.51 14.79 7 49291 22592 29880588
Dental caries 18.33 14.79 29 49269 4402 29898778
Soft tissue inflammation 18.27 14.79 6 49292 59 29903121
Cardiac failure 18.23 14.79 73 49225 83345 29819835
Therapy non-responder 18.09 14.79 96 49202 29357 29873823
Accidental overdose 18.02 14.79 4 49294 18271 29884909
Tooth extraction 17.88 14.79 30 49268 4781 29898399
Wrong technique in product usage process 17.85 14.79 15 49283 31140 29872040
Impaired healing 17.76 14.79 58 49240 14282 29888898
Stent placement 17.54 14.79 29 49269 4567 29898613
Blood pressure fluctuation 17.54 14.79 66 49232 17437 29885743
Otospondylomegaepiphyseal dysplasia 17.53 14.79 7 49291 125 29903055
Chills 17.30 14.79 61 49237 72277 29830903
Exposure via father 17.27 14.79 7 49291 130 29903050
Fluid overload 17.24 14.79 5 49293 19087 29884093
Drug reaction with eosinophilia and systemic symptoms 17.22 14.79 13 49285 28475 29874705
Orthostatic hypotension 17.17 14.79 9 49289 23970 29879210
Lethargy 17.13 14.79 24 49274 39495 29863685
Ventricular tachycardia 17.02 14.79 9 49289 23853 29879327
Epilepsy 16.94 14.79 6 49292 20163 29883017
Sensitivity to weather change 16.80 14.79 16 49282 1438 29901742
Encephalopathy 16.69 14.79 17 49281 32188 29870992
Acute respiratory failure 16.68 14.79 11 49287 25839 29877341
Vision blurred 16.58 14.79 27 49271 41789 29861391
Granuloma 16.45 14.79 20 49278 2372 29900808
Full blood count decreased 16.41 14.79 3 49295 15714 29887466
Dactylitis 16.41 14.79 10 49288 458 29902722
Head injury 16.23 14.79 4 49294 17016 29886164
Vasculitic rash 16.18 14.79 13 49285 930 29902250
Pleural effusion 16.06 14.79 65 49233 74001 29829179
Central nervous system infection 16.02 14.79 10 49288 478 29902702
Cerebral infarction 15.99 14.79 12 49286 26361 29876819
Mycobacterium tuberculosis complex test positive 15.97 14.79 13 49285 948 29902232
Axial spondyloarthritis 15.90 14.79 7 49291 161 29903019
Single functional kidney 15.68 14.79 6 49292 95 29903085
Lung adenocarcinoma stage III 15.44 14.79 4 49294 15 29903165
Haemoptysis 15.44 14.79 17 49281 31061 29872119
Chronic kidney disease 15.41 14.79 24 49274 37814 29865366
Acute myocardial infarction 15.25 14.79 41 49257 52898 29850282
Blood potassium increased 15.10 14.79 4 49294 16209 29886971
Product quality issue 15.07 14.79 6 49292 18768 29884412
Lupus-like syndrome 14.96 14.79 18 49280 2111 29901069
Vitello-intestinal duct remnant 14.88 14.79 6 49292 110 29903070

Pharmacologic Action:

SourceCodeDescription
ATC L04AA13 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Selective immunosuppressants
FDA EPC N0000175713 Antirheumatic Agent
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
CHEBI has role CHEBI:35442 parasiticides
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory drugs
CHEBI has role CHEBI:35610 cytostatic
CHEBI has role CHEBI:35705 immunosuppressant
CHEBI has role CHEBI:37153 protein serine/threonine phosphatase inhibitors
CHEBI has role CHEBI:38637 tyrosine kinase inhibitors
CHEBI has role CHEBI:50266 prodrugs
CHEBI has role CHEBI:50908 agente hepatotoxico
CHEBI has role CHEBI:68542 dhodh inhibitors
CHEBI has role CHEBI:68543 pyrimidine synthesis inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Psoriasis with arthropathy indication 33339001
Rheumatoid arthritis indication 69896004 DOID:7148
Inactive tuberculosis contraindication 11999007
Agranulocytosis contraindication 17182001 DOID:12987
Acute tuberculosis contraindication 25629007
Immunosuppression contraindication 38013005
Hepatic failure contraindication 59927004
Chronic type B viral hepatitis contraindication 61977001
Acute infectious disease contraindication 63171007
Interstitial pneumonia contraindication 64667001
Aspergillosis contraindication 65553006 DOID:13564
Viral hepatitis type B contraindication 66071002 DOID:2043
Kidney disease contraindication 90708001 DOID:557
Pancytopenia contraindication 127034005 DOID:12450
Chronic hepatitis C contraindication 128302006
Liver function tests abnormal contraindication 166603001
Disease of liver contraindication 235856003 DOID:409
Acute hepatitis C contraindication 235866006
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Peripheral nerve disease contraindication 302226006
Neutropenic disorder contraindication 303011007 DOID:1227
Breastfeeding (mother) contraindication 413712001
Pneumocystosis jiroveci pneumonia contraindication 415125002 DOID:11339
Severe Bone Marrow Depression contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.31 acidic

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
Dihydroorotate dehydrogenase (quinone), mitochondrial Enzyme INHIBITOR IC50 5 CHEMBL CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 5.64 DRUG MATRIX
Cytochrome P450 1A2 Enzyme IC50 6.30 DRUG MATRIX
Amine oxidase [flavin-containing] A Enzyme IC50 4.68 DRUG MATRIX
Sodium/nucleoside cotransporter 1 Transporter Ki 5.29 DRUG MATRIX
Sodium-dependent noradrenaline transporter Transporter Ki 5.34 DRUG MATRIX
Dihydroorotate dehydrogenase (quinone), mitochondrial Enzyme IC50 8.05 CHEMBL
Dihydroorotate dehydrogenase (quinone), mitochondrial Enzyme IC50 7.52 CHEMBL

External reference:

IDSource
4021132 VUID
N0000148586 NUI
D00749 KEGG_DRUG
4021132 VANDF
C0063041 UMLSCUI
CHEBI:6402 CHEBI
CHEMBL960 ChEMBL_ID
D000077339 MESH_DESCRIPTOR_UI
3899 PUBCHEM_CID
DB01097 DRUGBANK_ID
6825 IUPHAR_LIGAND_ID
5079 INN_ID
G162GK9U4W UNII
215393 RXNORM
11870 MMSL
63949 MMSL
7491 MMSL
d04349 MMSL
007642 NDDF
109143003 SNOMEDCT_US
386981009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Arava HUMAN PRESCRIPTION DRUG LABEL 1 0088-2160 TABLET, FILM COATED 10 mg ORAL NDA 27 sections
Arava HUMAN PRESCRIPTION DRUG LABEL 1 0088-2161 TABLET, FILM COATED 20 mg ORAL NDA 27 sections
Arava HUMAN PRESCRIPTION DRUG LABEL 1 0088-2162 TABLET, FILM COATED 100 mg ORAL NDA 27 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 0955-1735 TABLET, FILM COATED 10 mg ORAL NDA authorized generic 27 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 0955-1737 TABLET, FILM COATED 20 mg ORAL NDA authorized generic 27 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 10702-277 TABLET 10 mg ORAL ANDA 18 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 10702-278 TABLET 20 mg Oral ANDA 18 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 23155-043 TABLET 10 mg ORAL ANDA 18 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 23155-044 TABLET 20 mg ORAL ANDA 18 sections
LEFLUNOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 42291-420 TABLET 10 mg ORAL ANDA 18 sections
LEFLUNOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 42291-421 TABLET 20 mg ORAL ANDA 18 sections
Leflunomide Human Prescription Drug Label 1 46708-436 TABLET 10 mg ORAL ANDA 26 sections
Leflunomide Human Prescription Drug Label 1 46708-437 TABLET 20 mg ORAL ANDA 26 sections
LEFLUNOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 50268-477 TABLET 10 mg ORAL ANDA 18 sections
LEFLUNOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 50268-478 TABLET 20 mg ORAL ANDA 18 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 54868-2319 TABLET, FILM COATED 20 mg ORAL ANDA 26 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 54868-6170 TABLET, FILM COATED 10 mg ORAL ANDA 26 sections
Leflunomide Human Prescription Drug Label 1 59651-348 TABLET, FILM COATED 10 mg ORAL ANDA 26 sections
Leflunomide Human Prescription Drug Label 1 59651-349 TABLET, FILM COATED 20 mg ORAL ANDA 26 sections
LEFLUNOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 60505-2502 TABLET 10 mg ORAL ANDA 18 sections
LEFLUNOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 60505-2503 TABLET 20 mg ORAL ANDA 18 sections
Leflunomide Human Prescription Drug Label 1 62332-061 TABLET 10 mg ORAL ANDA 26 sections
Leflunomide Human Prescription Drug Label 1 62332-062 TABLET 20 mg ORAL ANDA 26 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 68258-2992 TABLET 20 mg ORAL ANDA 20 sections
leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 70710-1157 TABLET, FILM COATED 10 mg ORAL ANDA 23 sections
leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 70710-1158 TABLET, FILM COATED 20 mg ORAL ANDA 23 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 70748-129 TABLET, FILM COATED 10 mg ORAL ANDA 24 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 70748-130 TABLET, FILM COATED 20 mg ORAL ANDA 24 sections
leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 70771-1491 TABLET, FILM COATED 10 mg ORAL ANDA 23 sections
leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 70771-1492 TABLET, FILM COATED 20 mg ORAL ANDA 23 sections