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

Stem definitionDrug idCAS RN
1232 58-05-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • sodium folinate
  • folinic acid
  • leucovorin
  • calcium folinate
  • leucovorin calcium
  • folinic acid calcium salt
  • folinic acid calcium
  • wellcovorin
  • folinic acid calcium salt pentahydrate
The active metabolite of FOLIC ACID. Leucovorin is used principally as an antidote to FOLIC ACID ANTAGONISTS.
  • Molecular weight: 473.45
  • Formula: C20H23N7O7
  • CLOGP: -1.98
  • LIPINSKI: 2
  • HAC: 14
  • HDO: 7
  • TPSA: 215.55
  • ALOGS: -3.20
  • ROTB: 9
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
60 mg O
60 mg P
60 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 100 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 10 % Benet LZ, Broccatelli F, Oprea TI
BA (Bioavailability) 4 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.25 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.09 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.30 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 20, 1952 FDA
Nov. 25, 2021 PMDA PFIZER JAPAN INC

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
Neutropenia 1084.25 11.42 1048 57275 173957 63256742
Neuropathy peripheral 643.72 11.42 649 57674 113018 63317681
Neurotoxicity 495.95 11.42 263 58060 16727 63413972
Mucosal inflammation 450.15 11.42 361 57962 46567 63384132
Thrombocytopenia 438.05 11.42 613 57710 150544 63280155
Disease progression 378.31 11.42 513 57810 122245 63308454
Febrile neutropenia 371.10 11.42 499 57824 117950 63312749
Diarrhoea 341.04 11.42 1426 56897 713940 62716759
Skin toxicity 309.92 11.42 128 58195 4586 63426113
Dermatitis acneiform 225.22 11.42 104 58219 4892 63425807
Leukopenia 224.33 11.42 314 58009 76976 63353723
Polyneuropathy 223.43 11.42 149 58174 14440 63416259
Haematotoxicity 220.79 11.42 126 58197 9250 63421449
Vomiting 178.82 11.42 996 57327 558621 62872078
Nausea 147.77 11.42 1309 57014 853162 62577537
Systemic lupus erythematosus 146.93 11.42 12 58311 208906 63221793
Arteriospasm coronary 140.54 11.42 70 58253 3898 63426801
Anaemia 139.48 11.42 586 57737 292844 63137855
Glossodynia 138.68 11.42 6 58317 178870 63251829
Malignant neoplasm progression 136.21 11.42 259 58064 81862 63348837
Stomatitis 135.55 11.42 354 57969 138371 63292328
Palmar-plantar erythrodysaesthesia syndrome 132.85 11.42 133 58190 22882 63407817
Non-cirrhotic portal hypertension 132.37 11.42 33 58290 208 63430491
Therapy partial responder 128.47 11.42 94 58229 10564 63420135
Posterior reversible encephalopathy syndrome 128.32 11.42 115 58208 17230 63413469
Pancytopenia 127.85 11.42 278 58045 96655 63334044
Metastases to liver 119.11 11.42 127 58196 23512 63407187
Abdominal pain 117.51 11.42 557 57766 292899 63137800
Pulmonary embolism 117.30 11.42 301 58022 116383 63314316
Swelling 114.38 11.42 55 58268 275323 63155376
Enteritis 113.50 11.42 79 58244 8207 63422492
Arthropathy 111.98 11.42 38 58285 234754 63195945
Myelosuppression 111.83 11.42 123 58200 23580 63407119
Paronychia 110.54 11.42 67 58256 5498 63425201
Drug clearance decreased 110.25 11.42 44 58279 1440 63429259
Bone marrow failure 106.53 11.42 133 58190 29157 63401542
Gastrointestinal toxicity 104.15 11.42 73 58250 7668 63423031
Product dose omission issue 98.51 11.42 46 58277 234267 63196432
Loss of employment 92.75 11.42 44 58279 2200 63428499
Colorectal cancer metastatic 89.83 11.42 30 58293 583 63430116
Anti-cyclic citrullinated peptide antibody positive 89.71 11.42 4 58319 116208 63314491
Portal hypertension 89.04 11.42 51 58272 3768 63426931
Peripheral swelling 88.33 11.42 69 58254 265873 63164826
Neoplasm progression 88.25 11.42 136 58187 36292 63394407
Focal nodular hyperplasia 87.90 11.42 29 58294 542 63430157
Synovitis 86.11 11.42 32 58291 186886 63243813
Hand deformity 82.91 11.42 22 58301 159435 63271264
Peripheral sensory neuropathy 81.50 11.42 62 58261 7389 63423310
Wound 76.81 11.42 27 58296 163236 63267463
Pericarditis 76.79 11.42 14 58309 131565 63299134
Discomfort 76.52 11.42 29 58294 167345 63263354
Hyperammonaemic encephalopathy 74.74 11.42 39 58284 2395 63428304
Proteinuria 72.94 11.42 89 58234 19056 63411643
Leukoencephalopathy 72.24 11.42 47 58276 4366 63426333
Human bocavirus infection 71.79 11.42 23 58300 390 63430309
Rash pustular 69.70 11.42 56 58267 7226 63423473
Gastrointestinal perforation 69.26 11.42 42 58281 3449 63427250
Hypomagnesaemia 67.81 11.42 106 58217 28631 63402068
Dysarthria 67.45 11.42 132 58191 42579 63388120
Secondary immunodeficiency 66.13 11.42 30 58293 1353 63429346
Dehydration 65.61 11.42 324 57999 173030 63257669
Rheumatoid factor positive 64.83 11.42 3 58320 84403 63346296
Fall 63.74 11.42 169 58154 392165 63038534
Irritable bowel syndrome 59.99 11.42 4 58319 82408 63348291
Splenomegaly 59.87 11.42 62 58261 11095 63419604
Insomnia 59.47 11.42 66 58257 215186 63215513
Duodenal ulcer perforation 58.61 11.42 6 58317 87203 63343496
Abdominal discomfort 58.58 11.42 130 58193 320755 63109944
Pneumatosis intestinalis 58.34 11.42 33 58290 2380 63428319
Trichomegaly 57.93 11.42 14 58309 76 63430623
Gene mutation 57.86 11.42 29 58294 1636 63429063
General physical health deterioration 57.74 11.42 349 57974 201053 63229646
Pain 57.39 11.42 422 57901 740206 62690493
Ductal adenocarcinoma of pancreas 56.84 11.42 15 58308 122 63430577
Thrombocytopenic purpura 56.65 11.42 27 58296 1364 63429335
Helicobacter infection 56.05 11.42 9 58314 92776 63337923
Lower respiratory tract infection 55.52 11.42 26 58297 132281 63298418
Metastases to lung 54.73 11.42 63 58260 12687 63418012
Hypertension 53.64 11.42 439 57884 278864 63151835
Hyperammonaemia 51.71 11.42 41 58282 5191 63425508
Joint swelling 51.04 11.42 144 58179 327522 63103177
Blood cholesterol increased 50.74 11.42 12 58311 94020 63336679
Ileus 50.58 11.42 65 58258 14660 63416039
Septic shock 49.38 11.42 154 58169 66475 63364224
Drug abuse 48.70 11.42 5 58318 72513 63358186
Pyrexia 48.69 11.42 652 57671 469826 62960873
Hepatic enzyme increased 48.61 11.42 69 58254 202259 63228440
Intestinal perforation 47.84 11.42 57 58266 11906 63418793
Enterobacter infection 47.31 11.42 28 58295 2199 63428500
Injury 46.82 11.42 6 58317 73241 63357458
Hypersensitivity vasculitis 46.71 11.42 35 58288 4077 63426622
Cholangitis 45.39 11.42 39 58284 5522 63425177
Blister 45.22 11.42 32 58291 129782 63300917
Muscle injury 45.22 11.42 4 58319 65341 63365358
Contraindicated product administered 44.97 11.42 82 58241 217566 63213133
Sepsis 44.92 11.42 267 58056 152856 63277843
Hepatocellular injury 44.91 11.42 86 58237 27295 63403404
Herpes simplex 44.45 11.42 46 58277 8225 63422474
Neutrophil count decreased 44.25 11.42 133 58190 56273 63374426
Cystitis radiation 44.17 11.42 11 58312 69 63430630
Crystal nephropathy 43.80 11.42 20 58303 916 63429783
Hospitalisation 43.71 11.42 12 58311 85069 63345630
Venous thrombosis 43.35 11.42 36 58287 4866 63425833
Mucosal toxicity 41.80 11.42 15 58308 364 63430335
Off label use 41.41 11.42 858 57465 673604 62757095
Hypokalaemia 41.38 11.42 197 58126 103607 63327092
Gastroenteritis norovirus 41.33 11.42 25 58298 2043 63428656
Large intestinal obstruction 41.18 11.42 26 58297 2293 63428406
Drug hypersensitivity 41.04 11.42 147 58176 310540 63120159
Metastases to meninges 40.86 11.42 27 58296 2575 63428124
Neoplasm recurrence 40.52 11.42 27 58296 2611 63428088
Interstitial lung disease 39.50 11.42 136 58187 61772 63368927
Pharyngeal dyskinesia 39.49 11.42 9 58314 36 63430663
Bladder tamponade 39.08 11.42 10 58313 71 63430628
Epistaxis 38.19 11.42 150 58173 72575 63358124
Depression 38.00 11.42 77 58246 196415 63234284
Device related infection 37.79 11.42 73 58250 23319 63407380
Ascites 37.75 11.42 102 58221 40626 63390073
Asthma 37.58 11.42 37 58286 127524 63303175
Sleep disorder 37.48 11.42 14 58309 81552 63349147
Steatohepatitis 37.43 11.42 16 58307 625 63430074
Embolism 37.24 11.42 41 58282 7865 63422834
Myelodysplastic syndrome 37.04 11.42 60 58263 16694 63414005
Second primary malignancy 37.04 11.42 41 58282 7912 63422787
Cardiotoxicity 36.73 11.42 42 58281 8396 63422303
Factor VII deficiency 36.40 11.42 8 58315 26 63430673
Neuromyotonia 36.34 11.42 9 58314 55 63430644
Leukoerythroblastosis 36.23 11.42 12 58311 227 63430472
Tumour lysis syndrome 36.22 11.42 43 58280 8947 63421752
T-cell lymphoma refractory 36.06 11.42 9 58314 57 63430642
Folliculitis 35.97 11.42 10 58313 70307 63360392
Mobility decreased 35.86 11.42 35 58288 121124 63309575
Ocular toxicity 35.85 11.42 16 58307 694 63430005
Metastases to ovary 35.49 11.42 14 58309 444 63430255
Atypical haemolytic uraemic syndrome 35.32 11.42 16 58307 719 63429980
Laryngospasm 34.90 11.42 26 58297 3002 63427697
Venous pressure jugular decreased 34.34 11.42 8 58315 36 63430663
Memory impairment 33.38 11.42 28 58295 104230 63326469
Gastric varices haemorrhage 32.60 11.42 10 58313 146 63430553
Injection site pain 32.43 11.42 43 58280 129757 63300942
Immune thrombocytopenia 32.25 11.42 44 58279 10512 63420187
Chills 32.15 11.42 196 58127 113182 63317517
Anastomotic leak 31.51 11.42 13 58310 464 63430235
Maternal exposure during pregnancy 31.16 11.42 101 58222 219961 63210738
Hepatic steatosis 30.73 11.42 76 58247 28693 63402006
Short-bowel syndrome 30.72 11.42 13 58310 495 63430204
Cholestasis 30.64 11.42 77 58246 29357 63401342
Cholinergic syndrome 30.48 11.42 13 58310 505 63430194
Nicotinic acid deficiency 30.43 11.42 8 58315 64 63430635
Colitis 30.43 11.42 106 58217 48422 63382277
Dizziness 30.35 11.42 251 58072 429674 63001025
Vena cava thrombosis 30.30 11.42 21 58302 2166 63428533
Intestinal obstruction 30.27 11.42 79 58244 30820 63399879
Neutropenic colitis 30.04 11.42 24 58299 3071 63427628
Aortic thrombosis 29.22 11.42 16 58307 1083 63429616
Contusion 28.83 11.42 59 58264 149985 63280714
Impaired healing 28.78 11.42 31 58292 102511 63328188
Nasal septum perforation 28.75 11.42 14 58309 742 63429957
Weight increased 28.40 11.42 133 58190 260659 63170040
Stress cardiomyopathy 28.28 11.42 39 58284 9411 63421288
Encapsulating peritoneal sclerosis 28.18 11.42 11 58312 339 63430360
Wrong technique in product usage process 28.14 11.42 11 58312 62329 63368370
Sinusitis 28.11 11.42 110 58213 226543 63204156
Blood pressure fluctuation 28.03 11.42 100 58223 46217 63384482
Fluid retention 27.83 11.42 10 58313 59676 63371023
Rhinovirus infection 27.66 11.42 27 58296 4502 63426197
Haemolytic anaemia 27.66 11.42 40 58283 10085 63420614
Varices oesophageal 27.59 11.42 23 58300 3125 63427574
Exposure during pregnancy 27.54 11.42 64 58259 155483 63275216
Nodular regenerative hyperplasia 27.48 11.42 12 58311 494 63430205
Clostridium difficile colitis 27.09 11.42 59 58264 20510 63410189
Carcinoembryonic antigen increased 26.95 11.42 18 58305 1747 63428952
Pain in extremity 26.94 11.42 186 58137 331300 63099399
Chronic obstructive pulmonary disease 26.78 11.42 12 58311 62674 63368025
Human herpesvirus 6 infection 26.74 11.42 22 58301 2935 63427764
Wheezing 26.72 11.42 29 58294 95566 63335133
Pleuroparenchymal fibroelastosis 26.66 11.42 8 58315 108 63430591
Catabolic state 26.52 11.42 7 58316 57 63430642
Treatment failure 26.37 11.42 94 58229 198949 63231750
Electrocardiogram QT prolonged 26.06 11.42 11 58312 59519 63371180
Confusional state 26.06 11.42 120 58203 236260 63194439
Migraine 26.06 11.42 34 58289 103312 63327387
Adverse drug reaction 26.02 11.42 21 58302 79693 63351006
Hip arthroplasty 25.86 11.42 6 58317 47640 63383059
ECG signs of myocardial ischaemia 25.51 11.42 7 58316 67 63430632
Knee arthroplasty 25.41 11.42 9 58314 54197 63376502
Suicidal ideation 25.07 11.42 13 58310 62408 63368291
Portal vein thrombosis 24.69 11.42 20 58303 2610 63428089
Meningitis streptococcal 24.27 11.42 8 58315 149 63430550
Intentional product misuse 24 11.42 13 58310 60904 63369795
Large intestine perforation 23.89 11.42 34 58289 8448 63422251
Superior vena cava syndrome 23.78 11.42 12 58311 687 63430012
Colon cancer recurrent 23.71 11.42 7 58316 89 63430610
Depilation 23.58 11.42 5 58318 13 63430686
Aortic intramural haematoma 23.57 11.42 7 58316 91 63430608
Myeloid leukaemia 23.55 11.42 10 58313 384 63430315
Haemolytic uraemic syndrome 23.43 11.42 19 58304 2484 63428215
Pruritus 23.28 11.42 216 58107 361237 63069462
Petechiae 23.22 11.42 44 58279 13853 63416846
Laryngeal dyspnoea 23.20 11.42 8 58315 172 63430527
Overdose 23.18 11.42 44 58279 115034 63315665
Adverse event 23.07 11.42 17 58306 67542 63363157
Arthralgia 22.88 11.42 377 57946 569333 62861366
Deep vein thrombosis 22.58 11.42 143 58180 83657 63347042
Type II hypersensitivity 22.58 11.42 5 58318 17 63430682
Mouth ulceration 22.39 11.42 74 58249 32910 63397789
Peritonitis 22.36 11.42 49 58274 17105 63413594
Inferior vena cava stenosis 22.35 11.42 5 58318 18 63430681
Metastases to lymph nodes 21.95 11.42 32 58291 8126 63422573
Metastases to peritoneum 21.93 11.42 21 58302 3421 63427278
Abortion spontaneous 21.85 11.42 8 58315 47187 63383512
Asthenia 21.82 11.42 483 57840 383121 63047578
Acute kidney injury 21.63 11.42 351 57972 263064 63167635
Growth of eyelashes 21.56 11.42 8 58315 214 63430485
K-ras gene mutation 21.56 11.42 5 58318 22 63430677
Gastrointestinal anastomotic leak 21.53 11.42 8 58315 215 63430484
Subileus 21.40 11.42 20 58303 3159 63427540
Encephalopathy 21.37 11.42 81 58242 38539 63392160
Pneumonitis 21.27 11.42 76 58247 35146 63395553
Rash maculo-papular 21.16 11.42 71 58252 31825 63398874
Venoocclusive liver disease 20.93 11.42 24 58299 4811 63425888
Hypertransaminasaemia 20.88 11.42 28 58295 6581 63424118
Portal vein dilatation 20.87 11.42 5 58318 26 63430673
Drug resistance 20.81 11.42 57 58266 22876 63407823
Upper respiratory tract infection 20.67 11.42 27 58296 82020 63348679
Type 2 diabetes mellitus 20.63 11.42 17 58306 63851 63366848
Respiratory symptom 20.53 11.42 20 58303 3327 63427372
Stomal varices 20.32 11.42 4 58319 6 63430693
Cutaneous tuberculosis 20.28 11.42 7 58316 151 63430548
Peripheral sensorimotor neuropathy 19.81 11.42 14 58309 1489 63429210
Fibromyalgia 19.72 11.42 27 58296 80393 63350306
Cytopenia 19.72 11.42 37 58286 11564 63419135
Oesophageal fistula 19.70 11.42 7 58316 165 63430534
Gastrointestinal stoma complication 19.33 11.42 15 58308 1840 63428859
Tumour necrosis 19.26 11.42 11 58312 808 63429891
Occult blood 19.22 11.42 13 58310 1288 63429411
Haemoglobin increased 19.09 11.42 20 58303 3626 63427073
Pneumothorax spontaneous 19.07 11.42 11 58312 823 63429876
Ovarian fibroma 18.99 11.42 6 58317 97 63430602
Sedation 18.97 11.42 6 58317 38803 63391896
Red cell fragmentation syndrome 18.80 11.42 5 58318 42 63430657
Pelvic fluid collection 18.57 11.42 11 58312 865 63429834
Enterocolitis 18.55 11.42 29 58294 7829 63422870
Subacute cutaneous lupus erythematosus 18.52 11.42 17 58306 2626 63428073
Venous thrombosis limb 18.50 11.42 18 58305 2990 63427709
Vitiligo 18.45 11.42 13 58310 1376 63429323
Hallucination 18.45 11.42 14 58309 54803 63375896
Endometrial dysplasia 18.44 11.42 4 58319 12 63430687
Disease recurrence 18.24 11.42 62 58261 27968 63402731
Condition aggravated 18.22 11.42 260 58063 401957 63028742
Anxiety 18.19 11.42 121 58202 217420 63213279
Hypertrichosis 18.18 11.42 12 58311 1142 63429557
Balance disorder 18.15 11.42 31 58292 84391 63346308
Loss of personal independence in daily activities 18.05 11.42 39 58284 97251 63333448
Medication error 18.05 11.42 13 58310 52271 63378428
Multiple-drug resistance 18.03 11.42 23 58300 5147 63425552
Acute promyelocytic leukaemia 18.00 11.42 11 58312 916 63429783
Jugular vein thrombosis 17.95 11.42 18 58305 3100 63427599
C-reactive protein abnormal 17.92 11.42 10 58313 46086 63384613
Portal shunt 17.76 11.42 4 58319 15 63430684
Coronary artery disease 17.72 11.42 4 58319 32373 63398326
Joint noise 17.68 11.42 21 58302 4371 63426328
Prescribed underdose 17.66 11.42 3 58320 29686 63401013
Administration site extravasation 17.59 11.42 11 58312 954 63429745
Cystitis bacterial 17.54 11.42 7 58316 229 63430470
Hemiparesis 17.41 11.42 54 58269 23228 63407471
Dysphagia 17.36 11.42 140 58183 88445 63342254
Mixed adenoneuroendocrine carcinoma 17.36 11.42 4 58319 17 63430682
Hepatitis toxic 17.31 11.42 18 58305 3235 63427464
Multiple organ dysfunction syndrome 17.29 11.42 100 58223 56652 63374047
Rheumatic fever 17.28 11.42 9 58314 43102 63387597
Prescribed overdose 17.20 11.42 5 58318 34148 63396551
Hypocapnia 17.19 11.42 8 58315 383 63430316
Feeling abnormal 17.14 11.42 74 58249 148318 63282381
Thrombotic microangiopathy 17.11 11.42 33 58290 10528 63420171
Reticulocytosis 17.02 11.42 6 58317 138 63430561
Soft tissue necrosis 16.87 11.42 9 58314 578 63430121
Post procedural diarrhoea 16.80 11.42 9 58314 583 63430116
Product use in unapproved indication 16.75 11.42 244 58079 178836 63251863
Systemic infection 16.68 11.42 21 58302 4639 63426060
Cognitive disorder 16.65 11.42 16 58307 55799 63374900
Proctalgia 16.49 11.42 24 58299 6086 63424613
Metastasis 16.39 11.42 22 58301 5175 63425524
Pneumothorax 16.36 11.42 42 58281 16219 63414480
Gait disturbance 16.27 11.42 100 58223 183078 63247621
Endothelial dysfunction 16.22 11.42 6 58317 159 63430540
Unevaluable event 16.20 11.42 14 58309 51372 63379327
Pelvic abscess 16.13 11.42 13 58310 1685 63429014
Entropion 16.11 11.42 5 58318 76 63430623
Hepatic lesion 16.10 11.42 21 58302 4804 63425895
Lymphopenia 16.09 11.42 45 58278 18282 63412417
Small intestinal obstruction 16.07 11.42 45 58278 18292 63412407
Psoriasis 16.02 11.42 35 58288 86922 63343777
Acute myeloid leukaemia 15.94 11.42 43 58280 17104 63413595
Hepatic failure 15.93 11.42 70 58253 35586 63395113
Rotator cuff syndrome 15.85 11.42 37 58286 13465 63417234
Colon cancer metastatic 15.82 11.42 11 58312 1140 63429559
Bradycardia 15.64 11.42 27 58296 73200 63357499
Gastrooesophageal reflux disease 15.63 11.42 41 58282 95598 63335101
Liver abscess 15.56 11.42 16 58307 2838 63427861
Hyperbilirubinaemia 15.52 11.42 33 58290 11281 63419418
Adenocarcinoma of colon 15.43 11.42 15 58308 2489 63428210
Amnesia 15.38 11.42 17 58306 55568 63375131
Irritability 15.31 11.42 5 58318 31689 63399010
Cardiomyopathy 15.26 11.42 43 58280 17541 63413158
Overgrowth fungal 15.23 11.42 5 58318 92 63430607
Depressed mood 15.22 11.42 9 58314 40182 63390517
Myalgia 15.19 11.42 76 58247 146453 63284246
Blood glucose increased 15.19 11.42 34 58289 83722 63346977
Somnolence 15.12 11.42 99 58224 178586 63252113
Product intolerance 15.11 11.42 4 58319 33 63430666
Headache 15.07 11.42 455 57868 632786 62797913
Hepatic vein stenosis 15 11.42 4 58319 34 63430665
Ill-defined disorder 14.98 11.42 33 58290 81722 63348977
Acquired gene mutation 14.95 11.42 10 58313 973 63429726
Gastric cancer 14.90 11.42 20 58303 4703 63425996
Hypocalcaemia 14.73 11.42 63 58260 31650 63399049
Illness 14.71 11.42 14 58309 49045 63381654
Optic disc hyperaemia 14.69 11.42 3 58320 6 63430693
Periportal sinus dilatation 14.69 11.42 3 58320 6 63430693
Vasospasm 14.69 11.42 9 58314 753 63429946
Bacteraemia 14.64 11.42 42 58281 17306 63413393
Urticaria 14.47 11.42 91 58232 165711 63264988
Basal cell carcinoma 14.28 11.42 4 58319 27987 63402712
Norovirus test positive 14.19 11.42 6 58317 228 63430471
Tumour perforation 14.18 11.42 5 58318 115 63430584
Klebsiella infection 14.16 11.42 27 58296 8539 63422160
Cardiac arrest 14.13 11.42 41 58282 92504 63338195
Hemianaesthesia 14.08 11.42 7 58316 388 63430311
Gastrointestinal necrosis 14.03 11.42 15 58308 2783 63427916
Female genital tract fistula 13.97 11.42 25 58298 7534 63423165
Muscle atrophy 13.96 11.42 24 58299 7009 63423690
Drug ineffective 13.96 11.42 802 57521 1043963 62386736
Benign hydatidiform mole 13.95 11.42 5 58318 121 63430578
Tubular breast carcinoma 13.91 11.42 4 58319 46 63430653
Psychiatric decompensation 13.89 11.42 11 58312 1390 63429309
Orthostatic hypotension 13.83 11.42 8 58315 36152 63394547
Toxic encephalopathy 13.79 11.42 23 58300 6556 63424143
Gait inability 13.78 11.42 17 58306 52942 63377757
Productive cough 13.78 11.42 23 58300 63185 63367514
Bone pain 13.74 11.42 18 58305 54623 63376076
Joint injury 13.71 11.42 5 58318 29567 63401132
Throat tightness 13.60 11.42 52 58271 24835 63405864
Electrolyte imbalance 13.59 11.42 45 58278 20031 63410668
Loss of consciousness 13.58 11.42 59 58264 118062 63312637
Escherichia pyelonephritis 13.57 11.42 7 58316 420 63430279
Chronic kidney disease 13.56 11.42 13 58310 45385 63385314
Failure to thrive 13.55 11.42 24 58299 7174 63423525
Pneumonia 13.52 11.42 318 58005 456449 62974250
Cardiomyopathy acute 13.52 11.42 6 58317 257 63430442
No adverse event 13.40 11.42 11 58312 41394 63389305
Mucosal disorder 13.38 11.42 13 58310 2156 63428543
Macular degeneration 13.37 11.42 3 58320 24373 63406326
Cachexia 13.33 11.42 21 58302 5705 63424994
Optic nerve disorder 13.32 11.42 9 58314 890 63429809
Rectal perforation 13.29 11.42 7 58316 438 63430261
Peripheral nerve injury 13.20 11.42 7 58316 444 63430255
Vaginal fistula 13.13 11.42 7 58316 449 63430250
Respiratory disorder 13.13 11.42 10 58313 39072 63391627
Escherichia bacteraemia 13.11 11.42 17 58306 3866 63426833
Nasopharyngitis 13.09 11.42 160 58163 254097 63176602
Drug eruption 13.05 11.42 5 58318 28689 63402010
Metastases to bone marrow 13.05 11.42 7 58316 455 63430244
Acute lymphocytic leukaemia recurrent 12.88 11.42 13 58310 2256 63428443
Eczema asteatotic 12.84 11.42 6 58317 290 63430409
Paraesthesia 12.81 11.42 209 58114 156757 63273942
Vaginal infection 12.80 11.42 24 58299 7494 63423205
Tubal rupture 12.79 11.42 3 58320 14 63430685
Agitation 12.79 11.42 22 58301 59735 63370964
Pharyngotonsillitis 12.66 11.42 5 58318 159 63430540
Alopecia 12.66 11.42 226 58097 337310 63093389
Cerebral toxoplasmosis 12.64 11.42 9 58314 969 63429730
Therapeutic product effect decreased 12.61 11.42 115 58208 193072 63237627
Metastases to spleen 12.60 11.42 5 58318 161 63430538
Bacterial infection 12.57 11.42 43 58280 19456 63411243
Visual acuity reduced transiently 12.52 11.42 5 58318 164 63430535
Granulomatous lymphadenitis 12.52 11.42 5 58318 164 63430535
Obesity 12.38 11.42 6 58317 29946 63400753
Tumour rupture 12.29 11.42 5 58318 172 63430527
Product quality issue 12.27 11.42 9 58314 35856 63394843
Blood pressure systolic increased 12.22 11.42 80 58243 47317 63383382
Ovarian cystectomy 12.21 11.42 5 58318 175 63430524
Anaemia of malignant disease 12.09 11.42 7 58316 528 63430171
Granulomatous liver disease 12.04 11.42 8 58315 770 63429929
Treatment noncompliance 11.97 11.42 10 58313 37315 63393384
Pulmonary arterial hypertension 11.94 11.42 3 58320 22574 63408125
Intracranial pressure increased 11.94 11.42 19 58304 5208 63425491
Bicytopenia 11.81 11.42 13 58310 2492 63428207
Aortitis 11.79 11.42 9 58314 1078 63429621
Dihydropyrimidine dehydrogenase deficiency 11.78 11.42 4 58319 82 63430617
Dyspepsia 11.78 11.42 51 58272 102145 63328554
Drug dependence 11.59 11.42 4 58319 24479 63406220
Cancer fatigue 11.56 11.42 4 58319 87 63430612
Retroperitoneal lymphadenopathy 11.51 11.42 7 58316 578 63430121
Klebsiella sepsis 11.46 11.42 10 58313 1445 63429254
Evans syndrome 11.42 11.42 5 58318 207 63430492

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
Neutropenia 978.39 12.76 1328 64117 155450 34736036
Skin toxicity 752.50 12.76 297 65148 4487 34886999
Neuropathy peripheral 654.36 12.76 792 64653 82471 34809015
Diarrhoea 535.20 12.76 1769 63676 388143 34503343
Disease progression 458.51 12.76 766 64679 107311 34784175
Dermatitis acneiform 445.45 12.76 222 65223 5967 34885519
Neurotoxicity 420.97 12.76 314 65131 17696 34873790
Mucosal inflammation 413.50 12.76 432 65013 38190 34853296
Metastases to liver 332.26 12.76 244 65201 13419 34878067
Thrombocytopenia 326.15 12.76 826 64619 155421 34736065
Palmar-plantar erythrodysaesthesia syndrome 308.47 12.76 254 65191 16541 34874945
Polyneuropathy 306.98 12.76 241 65204 14655 34876831
Stomatitis 302.19 12.76 385 65060 42129 34849357
Arteriospasm coronary 266.29 12.76 129 65316 3253 34888233
Gastrointestinal toxicity 194.05 12.76 97 65348 2622 34888864
Paronychia 190.03 12.76 103 65342 3302 34888184
Febrile neutropenia 179.84 12.76 614 64831 136235 34755251
Haematotoxicity 178.41 12.76 137 65308 8057 34883429
Skin reaction 178.17 12.76 115 65330 5115 34886371
Completed suicide 161.01 12.76 5 65440 98163 34793323
Leukopenia 151.78 12.76 352 65093 62504 34828982
Product dose omission issue 151.37 12.76 22 65423 119689 34771797
Therapy partial responder 149.08 12.76 132 65313 9484 34882002
Proteinuria 143.82 12.76 176 65269 18466 34873020
Neoplasm progression 143.81 12.76 197 65248 23103 34868383
Peripheral sensory neuropathy 142.76 12.76 111 65334 6649 34884837
Rash pustular 139.21 12.76 100 65345 5308 34886178
Metastases to lung 128.92 12.76 120 65325 9200 34882286
Drug abuse 125.75 12.76 18 65427 99078 34792408
Portal hypertension 120.64 12.76 82 65363 3980 34887506
Malignant neoplasm progression 118.98 12.76 399 65046 87647 34803839
Carcinoembryonic antigen increased 118.69 12.76 46 65399 659 34890827
Nausea 112.49 12.76 1048 64397 338860 34552626
Myelosuppression 111.58 12.76 158 65287 19107 34872379
Cardiotoxicity 111.21 12.76 89 65356 5559 34885927
Pyrexia 107.80 12.76 1022 64423 331991 34559495
Decreased appetite 104.13 12.76 598 64847 165794 34725692
Bone marrow failure 103.76 12.76 192 65253 29061 34862425
Cardiac failure congestive 103.62 12.76 16 65429 83254 34808232
Chills 101.38 12.76 358 65087 80685 34810801
Hyperammonaemia 97.89 12.76 87 65358 6280 34885206
General physical health deterioration 91.62 12.76 478 64967 127791 34763695
Vomiting 90.72 12.76 781 64664 246840 34644646
Rhabdomyolysis 85.02 12.76 13 65432 68150 34823336
Myalgia 82.99 12.76 27 65418 84083 34807403
Colorectal cancer metastatic 82.67 12.76 36 65409 704 34890782
Hypomagnesaemia 82.02 12.76 147 65298 21704 34869782
Metastases to peritoneum 79.19 12.76 47 65398 1797 34889689
Alopecia 76.70 12.76 152 65293 24203 34867283
Drug interaction 76.63 12.76 196 65249 225750 34665736
Pneumonia 76.18 12.76 385 65060 362242 34529244
Intestinal obstruction 74.98 12.76 145 65300 22677 34868809
Focal nodular hyperplasia 72.42 12.76 22 65423 141 34891345
Hyperammonaemic encephalopathy 71.61 12.76 48 65397 2276 34889210
Pulmonary embolism 71.48 12.76 345 65100 89401 34802085
Myocardial infarction 71.15 12.76 73 65372 121012 34770474
Fall 71.11 12.76 173 65272 202712 34688774
Insomnia 70.20 12.76 55 65390 103852 34787634
Abdominal pain 70.06 12.76 535 64910 163083 34728403
Gastrointestinal perforation 67.93 12.76 57 65388 3806 34887680
Febrile bone marrow aplasia 67.38 12.76 80 65365 8129 34883357
Enteritis 64.61 12.76 78 65367 8064 34883422
Asthma 63.93 12.76 4 65441 42652 34848834
Leukoencephalopathy 63.62 12.76 57 65388 4158 34887328
Ductal adenocarcinoma of pancreas 63.15 12.76 15 65430 29 34891457
Interstitial lung disease 62.46 12.76 265 65180 65017 34826469
Somnolence 60.85 12.76 71 65374 111045 34780441
Anxiety 60.64 12.76 58 65387 99370 34792116
Death 60.56 12.76 467 64978 397582 34493904
Headache 58.47 12.76 187 65258 200448 34691038
Conjunctivitis 56.78 12.76 80 65365 9625 34881861
Weight increased 55.88 12.76 55 65390 92978 34798508
Tumour lysis syndrome 55.56 12.76 108 65337 16951 34874535
Metastases to lymph nodes 54.34 12.76 55 65390 4673 34886813
Neoplasm recurrence 54.27 12.76 40 65405 2209 34889277
Nipple swelling 53.86 12.76 21 65424 306 34891180
Subileus 53.73 12.76 46 65399 3157 34888329
Blood glucose increased 53.63 12.76 29 65416 66689 34824797
Dizziness 53.53 12.76 219 65226 218302 34673184
Intentional overdose 52.95 12.76 9 65436 43665 34847821
Toxic leukoencephalopathy 52.80 12.76 22 65423 384 34891102
Influenza 52.52 12.76 14 65431 49652 34841834
Ascites 52.51 12.76 199 65246 46372 34845114
Plasma cell myeloma 52.45 12.76 8 65437 42029 34849457
Peripheral swelling 52.34 12.76 40 65405 76501 34814985
Recall phenomenon 51.75 12.76 24 65421 547 34890939
Drug ineffective 51.72 12.76 577 64868 456174 34435312
Hospitalisation 51.48 12.76 21 65424 56881 34834605
Cholangitis 51.39 12.76 72 65373 8617 34882869
Chronic obstructive pulmonary disease 51.33 12.76 14 65431 48904 34842582
Device related infection 51.19 12.76 105 65340 17132 34874354
Mucosal toxicity 51.04 12.76 19 65426 242 34891244
Drug clearance decreased 49.98 12.76 35 65410 1783 34889703
Injection site pain 49.64 12.76 7 65438 38998 34852488
Aggression 49.57 12.76 7 65438 38957 34852529
Peripheral sensorimotor neuropathy 49.52 12.76 33 65412 1549 34889937
Transdifferentiation of neoplasm 49.51 12.76 14 65431 67 34891419
Anastomotic leak 49.46 12.76 24 65421 607 34890879
Coronary artery disease 48.53 12.76 15 65430 48290 34843196
Small intestinal obstruction 48.28 12.76 94 65351 14772 34876714
Rectal tenesmus 48.17 12.76 26 65419 826 34890660
Intentional product misuse 47.96 12.76 13 65432 45598 34845888
Erythema 46.51 12.76 305 65140 88475 34803011
Hiccups 46.00 12.76 74 65371 10008 34881478
Feeling abnormal 45.91 12.76 31 65414 63204 34828282
Tumour necrosis 45.54 12.76 29 65416 1259 34890227
Sinusitis 45.07 12.76 11 65434 41391 34850095
Stress 45.01 12.76 3 65442 30344 34861142
Ileus 44.92 12.76 97 65348 16402 34875084
Pain in extremity 44.17 12.76 108 65337 126405 34765081
Depression 44.13 12.76 71 65374 97027 34794459
Subclavian vein thrombosis 44.09 12.76 25 65420 876 34890610
Pneumatosis intestinalis 43.93 12.76 45 65400 3878 34887608
Hypersensitivity 43.87 12.76 228 65217 60807 34830679
Dehydration 43.85 12.76 403 65042 129566 34761920
Wheezing 43.16 12.76 12 65433 41390 34850096
Colitis 43.12 12.76 162 65283 37588 34853898
Carbohydrate antigen 19-9 increased 42.97 12.76 16 65429 204 34891282
Paraesthesia 42.91 12.76 235 65210 63937 34827549
Bradycardia 42.56 12.76 47 65398 75371 34816115
Muscle spasms 42.04 12.76 47 65398 74954 34816532
Hallucination 41.95 12.76 22 65423 51476 34840010
Febrile infection 41.74 12.76 34 65411 2177 34889309
Administration site extravasation 41.46 12.76 21 65424 584 34890902
Asthenia 40.80 12.76 665 64780 244586 34646900
Intravascular haemolysis 40.41 12.76 19 65426 447 34891039
Anastomotic complication 39.77 12.76 18 65427 387 34891099
Suicidal ideation 39.75 12.76 13 65432 40375 34851111
Ileal perforation 39.51 12.76 22 65423 744 34890742
Proteus infection 39.35 12.76 25 65420 1081 34890405
Psoriasis 39.08 12.76 12 65433 38800 34852686
Type II hypersensitivity 38.77 12.76 10 65435 31 34891455
Nipple pain 37.95 12.76 23 65422 914 34890572
Intentional product use issue 37.50 12.76 34 65411 59782 34831704
Contusion 37.05 12.76 11 65434 36353 34855133
Arthralgia 37.02 12.76 178 65267 169863 34721623
Unevaluable event 36.78 12.76 8 65437 32582 34858904
Hypoglycaemia 36.78 12.76 29 65416 54611 34836875
Nicotinic acid deficiency 36.36 12.76 12 65433 104 34891382
Vascular access complication 36.09 12.76 16 65429 327 34891159
Treatment noncompliance 35.86 12.76 5 65440 28095 34863391
Cellulitis 35.77 12.76 28 65417 52923 34838563
Pelvic abscess 35.35 12.76 22 65423 917 34890569
Intestinal perforation 35.34 12.76 62 65383 8998 34882488
Epistaxis 34.15 12.76 206 65239 58045 34833441
Troponin T increased 33.70 12.76 31 65414 2340 34889146
Adverse drug reaction 33.53 12.76 7 65438 29335 34862151
Circulatory collapse 33.53 12.76 101 65344 20937 34870549
Necrotising fasciitis 33.43 12.76 38 65407 3684 34887802
Memory impairment 33.13 12.76 20 65425 43298 34848188
Adenocarcinoma 32.82 12.76 28 65417 1912 34889574
Foetal disorder 32.75 12.76 20 65425 806 34890680
Blood creatine phosphokinase increased 32.54 12.76 22 65423 44835 34846651
Colon cancer recurrent 31.76 12.76 11 65434 112 34891374
Venoocclusive liver disease 31.70 12.76 55 65390 7911 34883575
Jugular vein thrombosis 31.60 12.76 26 65419 1689 34889797
Anal haemorrhage 31.49 12.76 31 65414 2547 34888939
Joint ankylosis 31.43 12.76 25 65420 1547 34889939
Anaemia of malignant disease 31.16 12.76 16 65429 458 34891028
Red blood cell sedimentation rate abnormal 31.15 12.76 36 65409 3553 34887933
Bone cyst 31.04 12.76 25 65420 1575 34889911
Oesophagobronchial fistula 30.83 12.76 12 65433 174 34891312
Acute coronary syndrome 30.63 12.76 74 65371 13471 34878015
Enterovesical fistula 30.53 12.76 19 65426 792 34890694
Electrocardiogram ST segment elevation 30.38 12.76 43 65402 5195 34886291
Proctalgia 30.30 12.76 45 65400 5678 34885808
Skin fissures 30.24 12.76 43 65402 5216 34886270
Vena cava thrombosis 30.09 12.76 22 65423 1200 34890286
Wrong technique in product usage process 29.86 12.76 15 65430 35971 34855515
Hyperbilirubinaemia 29.86 12.76 84 65361 16759 34874727
Induration 29.71 12.76 20 65425 955 34890531
Portal vein thrombosis 29.58 12.76 36 65409 3752 34887734
Gene mutation 29.46 12.76 23 65422 1385 34890101
Peritonitis 29.39 12.76 82 65363 16283 34875203
Prothrombin level decreased 29.35 12.76 21 65424 1107 34890379
Overdose 29.26 12.76 81 65364 90978 34800508
Colon cancer metastatic 28.34 12.76 24 65421 1623 34889863
Small intestinal perforation 28.19 12.76 27 65418 2144 34889342
Hypokalaemia 28.08 12.76 196 65249 58018 34833468
Injury 28.07 12.76 3 65442 20684 34870802
Anti-cyclic citrullinated peptide antibody positive 27.96 12.76 25 65420 1818 34889668
Cholinergic syndrome 27.95 12.76 16 65429 571 34890915
Fluid retention 27.64 12.76 8 65437 26879 34864607
Neutropenia neonatal 27.61 12.76 17 65428 695 34890791
Sleep apnoea syndrome 27.43 12.76 3 65442 20318 34871168
Splenomegaly 27.39 12.76 76 65369 15041 34876445
Product prescribing error 27.18 12.76 5 65440 22922 34868564
Hypoalbuminaemia 26.98 12.76 66 65379 12108 34879378
Cerebrovascular accident 26.84 12.76 76 65369 84735 34806751
Productive cough 26.82 12.76 19 65426 37794 34853692
Sarcoidosis 26.82 12.76 30 65415 2858 34888628
Drug withdrawal syndrome 26.59 12.76 3 65442 19831 34871655
Colitis microscopic 26.52 12.76 27 65418 2310 34889176
Evans syndrome 26.51 12.76 12 65433 258 34891228
Confusional state 26.33 12.76 160 65285 144000 34747486
Disturbance in attention 26.16 12.76 8 65437 25937 34865549
Toxic erythema of chemotherapy 26.13 12.76 9 65436 90 34891396
Koebner phenomenon 26.11 12.76 8 65437 53 34891433
Mouth ulceration 25.79 12.76 64 65381 11846 34879640
Liver function test abnormal 25.71 12.76 13 65432 31061 34860425
Anaemia 25.57 12.76 594 64851 232741 34658745
Prostate cancer 25.50 12.76 22 65423 39627 34851859
Large intestine perforation 25.48 12.76 52 65393 8451 34883035
Hand deformity 25.27 12.76 33 65412 3692 34887794
Pulmonary infarction 25.22 12.76 21 65424 1387 34890099
Angioedema 24.94 12.76 20 65425 37354 34854132
Electrocardiogram QT prolonged 24.82 12.76 24 65421 40928 34850558
Ocular toxicity 24.72 12.76 11 65434 227 34891259
Skin injury 24.64 12.76 26 65419 2319 34889167
Clostridial infection 24.40 12.76 32 65413 3595 34887891
Oesophagitis 24.36 12.76 67 65378 13194 34878292
Pulmonary oedema 24.28 12.76 32 65413 47497 34843989
Incorrect dose administered 24.25 12.76 24 65421 40491 34850995
Cerebral vasoconstriction 24.16 12.76 11 65434 240 34891246
Stoma site haemorrhage 24.15 12.76 17 65428 873 34890613
Enterocutaneous fistula 24.06 12.76 18 65427 1017 34890469
International normalised ratio increased 24.04 12.76 32 65413 47295 34844191
Peritoneal neoplasm 24.02 12.76 7 65438 38 34891448
Sedation 24.02 12.76 5 65440 21001 34870485
Cachexia 24.01 12.76 46 65399 7140 34884346
Perihepatic abscess 24.01 12.76 9 65436 117 34891369
Perforation 23.95 12.76 11 65434 245 34891241
Onycholysis 23.92 12.76 16 65429 756 34890730
Hepatic lesion 23.82 12.76 32 65413 3680 34887806
Influenza like illness 23.72 12.76 11 65434 27623 34863863
Astringent therapy 23.67 12.76 6 65439 17 34891469
ECG signs of myocardial ischaemia 23.37 12.76 10 65435 187 34891299
Agitation 23.32 12.76 45 65400 57354 34834132
Arthritis 23.24 12.76 15 65430 31331 34860155
Dysaesthesia 23.24 12.76 25 65420 2280 34889206
Cardiac disorder 23.11 12.76 28 65417 43098 34848388
Abdominal pain lower 23.10 12.76 57 65388 10514 34880972
Pancreatic carcinoma metastatic 23.06 12.76 28 65417 2912 34888574
Dyspnoea 22.98 12.76 534 64911 376248 34515238
Chronic kidney disease 22.89 12.76 26 65419 41184 34850302
Heart rate increased 22.87 12.76 32 65413 46311 34845175
Contraindicated product administered 22.81 12.76 6 65439 21475 34870011
Respiratory arrest 22.80 12.76 12 65433 28031 34863455
Anastomotic fistula 22.71 12.76 8 65437 86 34891400
Rectal perforation 22.63 12.76 13 65432 467 34891019
Perioral dermatitis 22.60 12.76 9 65436 139 34891347
Interventricular septum rupture 22.49 12.76 6 65439 22 34891464
Embolism 22.43 12.76 47 65398 7782 34883704
Lung neoplasm malignant 22.42 12.76 3 65442 17392 34874094
Portal venous gas 22.35 12.76 12 65433 377 34891109
Device related thrombosis 22.31 12.76 18 65427 1137 34890349
Anal erythema 22.31 12.76 8 65437 91 34891395
Oesophageal carcinoma recurrent 22.08 12.76 6 65439 24 34891462
Perforation bile duct 22.08 12.76 6 65439 24 34891462
Trichomegaly 21.89 12.76 6 65439 25 34891461
Mucocutaneous rash 21.89 12.76 6 65439 25 34891461
Multiple organ dysfunction syndrome 21.81 12.76 72 65373 76494 34814992
Superior vena cava syndrome 21.80 12.76 14 65431 617 34890869
Nail disorder 21.76 12.76 23 65422 2056 34889430
Anal fissure 21.67 12.76 33 65412 4257 34887229
Thrombotic thrombocytopenic purpura 21.55 12.76 29 65416 3341 34888145
Acne 21.42 12.76 57 65388 11009 34880477
Hepatic fibrosis 21.27 12.76 34 65411 4573 34886913
Pelvic fluid collection 21.25 12.76 9 65436 164 34891322
Haematopoietic stem cell mobilisation 21.25 12.76 9 65436 164 34891322
Liver abscess 21.16 12.76 31 65414 3864 34887622
Acute abdomen 21.12 12.76 22 65423 1933 34889553
Nephrotic syndrome 21.11 12.76 44 65401 7259 34884227
Toxicity to various agents 21.03 12.76 257 65188 200105 34691381
Diaphragmatic operation 21.00 12.76 6 65439 30 34891456
Ischiorectal hernia 20.94 12.76 5 65440 10 34891476
Bladder hypertrophy 20.94 12.76 14 65431 661 34890825
Pneumoperitoneum 20.89 12.76 21 65424 1769 34889717
Rectosigmoid cancer 20.85 12.76 9 65436 172 34891314
Catheter site thrombosis 20.81 12.76 8 65437 112 34891374
Klebsiella infection 20.80 12.76 48 65397 8483 34883003
Stoma site pain 20.77 12.76 14 65431 670 34890816
Colorectal cancer recurrent 20.68 12.76 6 65439 32 34891454
Renal disorder 20.58 12.76 11 65434 25469 34866017
Cerebral haemorrhage 20.56 12.76 21 65424 34916 34856570
Cranial nerve disorder 20.36 12.76 13 65432 567 34890919
Neurosarcoidosis 20.34 12.76 9 65436 183 34891303
Hepatectomy 20.32 12.76 7 65438 70 34891416
Oesophageal haemorrhage 20.24 12.76 18 65427 1300 34890186
Full blood count abnormal 20.23 12.76 5 65440 18663 34872823
Non-cirrhotic portal hypertension 20.15 12.76 10 65435 266 34891220
Cardiac arrest 20.12 12.76 102 65343 96057 34795429
Eyelash changes 20.03 12.76 5 65440 13 34891473
Aplasia 20.01 12.76 33 65412 4555 34886931
Posterior reversible encephalopathy syndrome 20.01 12.76 52 65393 9902 34881584
Laboratory test interference 20.00 12.76 12 65433 468 34891018
Gastrooesophageal reflux disease 19.92 12.76 25 65420 37899 34853587
Onychoclasis 19.85 12.76 21 65424 1879 34889607
Abnormal behaviour 19.84 12.76 11 65434 24958 34866528
Acute motor-sensory axonal neuropathy 19.72 12.76 8 65437 130 34891356
Pulmonary artery thrombosis 19.63 12.76 14 65431 734 34890752
Cholecystitis chronic 19.63 12.76 15 65430 875 34890611
Hepatitis B surface antigen positive 19.56 12.76 8 65437 133 34891353
Visceral venous thrombosis 19.51 12.76 5 65440 15 34891471
Seizure 19.33 12.76 116 65329 104741 34786745
Oral pain 19.19 12.76 54 65391 10773 34880713
Varices oesophageal 19.13 12.76 29 65416 3726 34887760
Inappropriate schedule of product administration 18.85 12.76 57 65388 62239 34829247
Malaise 18.51 12.76 241 65204 185584 34705902
Neutrophil count decreased 18.50 12.76 161 65284 50943 34840543
Product administration error 18.47 12.76 4 65441 16340 34875146
Organising pneumonia 18.44 12.76 37 65408 5942 34885544
Emotional distress 18.42 12.76 3 65442 15023 34876463
Catheter site extravasation 18.40 12.76 7 65438 95 34891391
Deep vein thrombosis 18.40 12.76 195 65250 65053 34826433
Growth of eyelashes 18.34 12.76 7 65438 96 34891390
Bacterial colitis 18.28 12.76 6 65439 51 34891435
Pseudocirrhosis 18.21 12.76 5 65440 21 34891465
Tremor 18.21 12.76 86 65359 82501 34808985
Venous thrombosis 18.17 12.76 27 65418 3408 34888078
Irritability 18.05 12.76 12 65433 24678 34866808
Lip swelling 18.04 12.76 4 65441 16076 34875410
Hypertension 18.02 12.76 357 65088 136086 34755400
Haematoma 17.98 12.76 13 65432 25592 34865894
Medication error 17.93 12.76 13 65432 25552 34865934
Electromyogram abnormal 17.88 12.76 6 65439 55 34891431
Mobility decreased 17.86 12.76 18 65427 30110 34861376
Fatigue 17.81 12.76 856 64589 369797 34521689
Injection site erythema 17.74 12.76 4 65441 15895 34875591
Psychotic disorder 17.72 12.76 12 65433 24440 34867046
Renal impairment 17.72 12.76 104 65341 94409 34797077
Heart rate decreased 17.66 12.76 20 65425 31725 34859761
Balanoposthitis 17.66 12.76 16 65429 1184 34890302
Eczema impetiginous 17.50 12.76 5 65440 25 34891461
Radiation interaction 17.50 12.76 5 65440 25 34891461
K-ras gene mutation 17.50 12.76 5 65440 25 34891461
Xerosis 17.48 12.76 12 65433 592 34890894
Pelvic inflammatory disease 17.48 12.76 4 65441 6 34891480
Visual impairment 17.39 12.76 25 65420 35777 34855709
Nightmare 17.36 12.76 3 65442 14388 34877098
Organic brain syndrome 17.24 12.76 9 65436 267 34891219
Performance status decreased 17.04 12.76 29 65416 4108 34887378
Osteolysis 17.02 12.76 25 65420 3123 34888363
Blood pressure increased 17.02 12.76 96 65349 88006 34803480
Pancreatic carcinoma recurrent 16.99 12.76 6 65439 65 34891421
Oedema 16.78 12.76 38 65407 45703 34845783
Oesophageal irritation 16.75 12.76 6 65439 68 34891418
Hypervolaemia 16.68 12.76 8 65437 19701 34871785
B-cell small lymphocytic lymphoma 16.61 12.76 8 65437 199 34891287
Intestinal strangulation 16.60 12.76 5 65440 31 34891455
Migraine 16.55 12.76 6 65439 17472 34874014
Tumour marker increased 16.53 12.76 12 65433 647 34890839
Swelling 16.53 12.76 34 65411 42332 34849154
Perineal disorder 16.52 12.76 6 65439 71 34891415
Road traffic accident 16.51 12.76 6 65439 17444 34874042
Encephalopathy 16.49 12.76 118 65327 35201 34856285
Vocal cord paralysis 16.46 12.76 14 65431 952 34890534
Balance disorder 16.40 12.76 32 65413 40622 34850864
Rectal cancer metastatic 16.39 12.76 8 65437 205 34891281
Peritoneal adhesions 16.31 12.76 7 65438 132 34891354
Hypocalcaemia 16.25 12.76 89 65356 24200 34867286
Candida infection 16.22 12.76 71 65374 17644 34873842
Off label use 16.17 12.76 949 64496 418575 34472911
Allodynia 16.16 12.76 13 65432 818 34890668
Faeces discoloured 16.10 12.76 4 65441 14874 34876612
Gout 16.01 12.76 8 65437 19245 34872241
Nasopharyngitis 15.93 12.76 72 65373 69896 34821590
Haemorrhage intracranial 15.92 12.76 5 65440 15941 34875545
Hepatic cancer recurrent 15.91 12.76 9 65436 314 34891172
Brief psychotic disorder with marked stressors 15.77 12.76 8 65437 223 34891263
Limbic encephalitis 15.73 12.76 10 65435 433 34891053
Metastasis 15.70 12.76 28 65417 4116 34887370
Blood pressure decreased 15.68 12.76 47 65398 51468 34840018
Palpitations 15.68 12.76 32 65413 39954 34851532
Product use issue 15.65 12.76 63 65382 63153 34828333
Ventricular tachycardia 15.62 12.76 16 65429 26563 34864923
Portal shunt 15.61 12.76 5 65440 39 34891447
Malignant ascites 15.58 12.76 10 65435 440 34891046
Urticaria 15.55 12.76 62 65383 62315 34829171
Proctitis 15.54 12.76 21 65424 2428 34889058
Change of bowel habit 15.53 12.76 14 65431 1029 34890457
Streptococcal bacteraemia 15.49 12.76 19 65426 1996 34889490
Haemolytic anaemia 15.48 12.76 49 65396 10430 34881056
Crystal nephropathy 15.44 12.76 10 65435 447 34891039
Gait inability 15.29 12.76 10 65435 20748 34870738
Bronchitis 15.28 12.76 35 65410 41928 34849558
Tumour fistulisation 15.14 12.76 4 65441 14 34891472
Retinitis viral 15.11 12.76 6 65439 92 34891394
Bone erosion 15.05 12.76 27 65418 3988 34887498
Dyskinesia 14.95 12.76 12 65433 22401 34869085
Duodenal perforation 14.93 12.76 15 65430 1263 34890223
Temperature difference of extremities 14.93 12.76 4 65441 15 34891471
Nephrolithiasis 14.91 12.76 21 65424 30312 34861174
Paraesthesia mucosal 14.72 12.76 4 65441 16 34891470
Toxic cardiomyopathy 14.68 12.76 8 65437 259 34891227
Acinetobacter sepsis 14.61 12.76 5 65440 49 34891437
Pneumatosis 14.37 12.76 10 65435 504 34890982
Rectal adenocarcinoma 14.11 12.76 12 65433 816 34890670
Peritoneal disorder 14.09 12.76 8 65437 281 34891205
Proctectomy 14.08 12.76 6 65439 111 34891375
Neck pain 14.07 12.76 16 65429 25333 34866153
Retroperitoneal abscess 13.97 12.76 7 65438 190 34891296
Rectal abscess 13.90 12.76 15 65430 1373 34890113
VIth nerve disorder 13.84 12.76 4 65441 21 34891465
Drug clearance increased 13.84 12.76 6 65439 116 34891370
Cardiac failure 13.80 12.76 107 65338 91141 34800345
Prostatic calcification 13.79 12.76 6 65439 117 34891369
Folliculitis 13.77 12.76 28 65417 4538 34886948
Rectal cancer recurrent 13.68 12.76 4 65441 22 34891464
Soft tissue swelling 13.67 12.76 10 65435 546 34890940
Pneumonia aspiration 13.66 12.76 37 65408 41866 34849620
Pustule 13.65 12.76 10 65435 547 34890939
Iatrogenic infection 13.55 12.76 5 65440 62 34891424
Palmar erythema 13.55 12.76 8 65437 303 34891183
Liver operation 13.54 12.76 4 65441 23 34891463
Volvulus of small bowel 13.48 12.76 5 65440 63 34891423
Tracheal inflammation 13.48 12.76 5 65440 63 34891423
Cardiac pacemaker evaluation 13.47 12.76 6 65439 124 34891362
Diffuse alveolar damage 13.42 12.76 19 65426 2295 34889191
Metastases to pelvis 13.40 12.76 8 65437 309 34891177
Blepharitis 13.40 12.76 15 65430 1430 34890056
Cholangitis acute 13.38 12.76 12 65433 876 34890610
Chemotherapeutic drug level increased 13.30 12.76 7 65438 211 34891275
Pain 13.30 12.76 287 65158 204388 34687098
Gastrointestinal obstruction 13.28 12.76 12 65433 885 34890601
Gastrointestinal anastomotic leak 13.27 12.76 9 65436 435 34891051
Pleural fistula 13.25 12.76 4 65441 25 34891461
Dysphonia 13.25 12.76 82 65363 23301 34868185
Hypoacusis 13.22 12.76 7 65438 16294 34875192
Hypersplenism 13.20 12.76 9 65436 439 34891047
Hyperkalaemia 13.19 12.76 76 65369 69313 34822173
Therapy non-responder 13.19 12.76 34 65411 39112 34852374
Accidental overdose 13.16 12.76 11 65434 20129 34871357
Neuropathic muscular atrophy 13.12 12.76 4 65441 26 34891460
Bacteriuria 13.08 12.76 8 65437 323 34891163
Intestinal mucosal hypertrophy 13.07 12.76 5 65440 69 34891417
Central pain syndrome 13.00 12.76 5 65440 70 34891416
Incorrect drug administration rate 12.98 12.76 16 65429 1689 34889797
Full blood count decreased 12.94 12.76 9 65436 18079 34873407
Jaundice 12.90 12.76 103 65342 31779 34859707
Neutropenic colitis 12.89 12.76 22 65423 3122 34888364
Diabetic ketoacidosis 12.87 12.76 9 65436 18023 34873463
Laryngospasm 12.77 12.76 15 65430 1506 34889980

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
Neutropenia 2017.62 11.12 2242 109839 285468 79346839
Neuropathy peripheral 1449.60 11.12 1354 110727 139951 79492356
Skin toxicity 983.35 11.12 388 111693 7926 79624381
Disease progression 913.24 11.12 1207 110874 183155 79449152
Neurotoxicity 862.60 11.12 549 111532 31969 79600338
Mucosal inflammation 810.26 11.12 743 111338 74837 79557470
Diarrhoea 764.10 11.12 2835 109246 877654 78754653
Thrombocytopenia 756.47 11.12 1344 110737 263915 79368392
Dermatitis acneiform 639.00 11.12 302 111779 9691 79622616
Polyneuropathy 498.68 11.12 349 111732 23802 79608505
Febrile neutropenia 483.72 11.12 1028 111053 229971 79402336
Arteriospasm coronary 393.00 11.12 191 111890 6525 79625782
Palmar-plantar erythrodysaesthesia syndrome 378.90 11.12 338 111743 32796 79599511
Neoplasm progression 376.19 11.12 412 111669 51270 79581037
Metastases to liver 368.55 11.12 311 111770 28003 79604304
Haematotoxicity 359.99 11.12 241 111840 15278 79617029
Leukopenia 352.89 11.12 607 111474 115906 79516401
Completed suicide 319.77 11.12 5 112076 245762 79386545
Stomatitis 317.15 11.12 662 111419 146095 79486212
Therapy partial responder 281.37 11.12 217 111864 17180 79615127
Gastrointestinal toxicity 258.44 11.12 154 111927 7955 79624352
Proteinuria 245.02 11.12 264 111817 32238 79600069
Paronychia 237.75 11.12 144 111937 7664 79624643
Secondary immunodeficiency 232.42 11.12 106 111975 3128 79629179
Myelosuppression 230.77 11.12 284 111797 40012 79592295
Bone marrow failure 221.27 11.12 314 111767 50793 79581514
Malignant neoplasm progression 207.33 11.12 535 111546 135455 79496852
Peripheral sensory neuropathy 203.01 11.12 159 111922 12874 79619433
Rash pustular 198.17 11.12 148 111933 11163 79621144
Product dose omission issue 191.84 11.12 55 112026 247482 79384825
Enteritis 183.23 11.12 157 111924 14426 79617881
Nausea 181.22 11.12 2096 109985 955100 78677207
Vomiting 181.01 11.12 1572 110509 664256 78968051
Portal hypertension 173.58 11.12 114 111967 6994 79625313
Metastases to lung 170.40 11.12 166 111915 17997 79614310
Cardiotoxicity 160.40 11.12 135 111946 12104 79620203
Pulmonary embolism 158.37 11.12 566 111515 171088 79461219
Peripheral swelling 155.67 11.12 93 111988 269524 79362783
Drug abuse 153.03 11.12 23 112058 162668 79469639
Focal nodular hyperplasia 148.44 11.12 51 112030 691 79631616
Colorectal cancer metastatic 143.64 11.12 57 112024 1181 79631126
Hyperammonaemia 142.58 11.12 121 111960 10972 79621335
Swelling 141.00 11.12 64 112017 216647 79415660
Drug clearance decreased 140.61 11.12 76 112005 3251 79629056
Fall 135.71 11.12 303 111778 487326 79144981
Pyrexia 135.60 11.12 1503 110578 677206 78955101
Hyperammonaemic encephalopathy 134.90 11.12 84 111997 4698 79627609
Leukoencephalopathy 132.80 11.12 101 111980 7828 79624479
Non-cirrhotic portal hypertension 131.60 11.12 42 112039 445 79631862
General physical health deterioration 130.66 11.12 745 111336 274493 79357814
Systemic lupus erythematosus 126.56 11.12 12 112069 121137 79511170
Anaemia 122.85 11.12 1055 111026 443960 79188347
Hypomagnesaemia 120.93 11.12 228 111853 46683 79585624
Carcinoembryonic antigen increased 120.80 11.12 60 112021 2149 79630158
Abdominal pain 118.43 11.12 944 111137 388625 79243682
Pneumatosis intestinalis 117.22 11.12 86 111995 6311 79625996
Chills 114.11 11.12 487 111594 159747 79472560
Insomnia 113.88 11.12 106 111975 245064 79387243
Posterior reversible encephalopathy syndrome 111.56 11.12 160 111921 26121 79606186
Intentional overdose 109.35 11.12 11 112070 105949 79526358
Glossodynia 108.56 11.12 10 112071 103327 79528980
Asthma 108.40 11.12 28 112053 135067 79497240
Tumour lysis syndrome 107.92 11.12 150 111931 23789 79608518
Intestinal obstruction 107.08 11.12 206 111875 42814 79589493
Mycobacterium chelonae infection 106.30 11.12 57 112024 2399 79629908
Gastrointestinal perforation 100.21 11.12 77 112004 6060 79626247
Joint swelling 98.97 11.12 158 111923 288488 79343819
Cholangitis 98.42 11.12 105 111976 12671 79619636
Venoocclusive liver disease 98.29 11.12 101 111980 11670 79620637
Rhabdomyolysis 96.00 11.12 15 112066 103116 79529191
Interstitial lung disease 95.97 11.12 362 111719 112238 79520069
Arthropathy 95.46 11.12 66 112015 177045 79455262
Pain 93.98 11.12 592 111489 703210 78929097
Device related infection 92.54 11.12 170 111911 34124 79598183
Human bocavirus infection 92.40 11.12 36 112045 709 79631598
Splenomegaly 89.04 11.12 127 111954 20627 79611680
Bacterial infection 88.14 11.12 158 111923 31122 79601185
Weight increased 87.60 11.12 160 111921 277226 79355081
Skin reaction 86.78 11.12 110 111971 15958 79616349
Injury 85.58 11.12 6 112075 77490 79554817
Synovitis 85.53 11.12 53 112028 150681 79481626
Arthralgia 85.31 11.12 464 111617 571339 79060968
Intestinal perforation 84.31 11.12 113 111968 17313 79614994
Headache 83.14 11.12 558 111523 653214 78979093
Ileus 82.46 11.12 139 111942 26072 79606235
Dizziness 81.97 11.12 421 111660 526020 79106287
Intentional product misuse 81.75 11.12 17 112064 95148 79537159
Anxiety 81.49 11.12 140 111941 248372 79383935
Wheezing 81.41 11.12 31 112050 116633 79515674
Ascites 80.90 11.12 262 111819 75300 79557007
Metastases to peritoneum 78.36 11.12 58 112023 4314 79627993
Mucosal toxicity 78.00 11.12 30 112051 570 79631737
Administration site extravasation 77.98 11.12 38 112043 1305 79631002
Gene mutation 77.84 11.12 48 112033 2638 79629669
Depression 77.81 11.12 115 111966 216675 79415632
Myalgia 77.41 11.12 88 111993 185553 79446754
Epistaxis 77.10 11.12 336 111745 111179 79521128
Febrile bone marrow aplasia 76.52 11.12 93 111988 12927 79619380
Subileus 75.39 11.12 63 112018 5591 79626716
Pain in extremity 74.92 11.12 262 111819 364276 79268031
Colitis 74.73 11.12 250 111831 73057 79559250
Injection site pain 74.57 11.12 45 112036 129793 79502514
Decreased appetite 74.46 11.12 772 111309 341646 79290661
Anastomotic leak 73.68 11.12 34 112047 1031 79631276
Neoplasm recurrence 73.50 11.12 55 112026 4159 79628148
Hepatic enzyme increased 72.47 11.12 90 111991 182520 79449787
Maternal exposure during pregnancy 72.09 11.12 52 112029 136486 79495821
Contusion 71.83 11.12 62 112019 148714 79483593
Dehydration 71.82 11.12 595 111486 247592 79384715
Irritable bowel syndrome 71.17 11.12 4 112077 62237 79570070
Somnolence 70.94 11.12 143 111938 238838 79393469
Myocardial infarction 68.71 11.12 95 111986 184034 79448273
Pseudomonal sepsis 68.61 11.12 62 112019 6112 79626195
Lower respiratory tract infection 68.50 11.12 49 112032 129171 79503136
Sinusitis 67.94 11.12 106 111975 195395 79436912
Loss of employment 66.87 11.12 43 112038 2544 79629763
Pancytopenia 66.69 11.12 430 111651 165315 79466992
Memory impairment 66.62 11.12 37 112044 111697 79520610
Nicotinic acid deficiency 66.38 11.12 20 112061 172 79632135
Discomfort 66.11 11.12 48 112033 125569 79506738
Contraindicated product administered 65.32 11.12 75 112006 157463 79474844
Mobility decreased 65.20 11.12 46 112035 122129 79510178
Helicobacter infection 65.18 11.12 10 112071 69694 79562613
Parainfluenzae virus infection 65.00 11.12 58 112023 5624 79626683
Trichomegaly 64.54 11.12 18 112063 114 79632193
Blister 63.73 11.12 45 112036 119431 79512876
Peripheral sensorimotor neuropathy 63.28 11.12 44 112037 2966 79629341
Cystitis bacterial 63.05 11.12 27 112054 683 79631624
Tumour necrosis 62.54 11.12 37 112044 1885 79630422
Lymphoid tissue hypoplasia 62.20 11.12 29 112052 901 79631406
Norovirus test positive 61.52 11.12 26 112055 636 79631671
Enterobacter infection 61.18 11.12 51 112030 4511 79627796
Hospitalisation 60.99 11.12 28 112053 94208 79538099
Thymus hypoplasia 60.95 11.12 29 112052 944 79631363
Chronic obstructive pulmonary disease 60.77 11.12 22 112059 85397 79546910
Diffuse alveolar damage 60.56 11.12 46 112035 3558 79628749
Blood cholesterol increased 60.52 11.12 21 112060 83699 79548608
Nipple swelling 60.10 11.12 21 112060 300 79632007
Duodenal ulcer perforation 58.60 11.12 11 112070 66200 79566107
Vena cava thrombosis 57.79 11.12 41 112040 2854 79629453
Embolism 57.69 11.12 84 111997 13898 79618409
Pericarditis 57.28 11.12 38 112043 104198 79528109
Hypertension 56.93 11.12 713 111368 330279 79302028
Human herpesvirus 6 infection 55.92 11.12 52 112029 5318 79626989
Muscle injury 55.90 11.12 3 112078 48558 79583749
Metastases to lymph nodes 55.86 11.12 71 112010 10326 79621981
Asthenia 55.67 11.12 1019 111062 510670 79121637
Wound 55.37 11.12 49 112032 116130 79516177
Sepsis 54.58 11.12 599 111482 268829 79363478
Hyperbilirubinaemia 54.50 11.12 112 111969 24406 79607901
Ocular toxicity 54.40 11.12 26 112055 855 79631452
Intentional product use issue 54.26 11.12 81 112000 152031 79480276
Suicidal ideation 53.73 11.12 20 112061 76320 79555987
Neutrophil count decreased 53.11 11.12 267 111814 93692 79538615
Abscess bacterial 52.68 11.12 25 112056 809 79631498
Cardiac failure congestive 52.59 11.12 74 112007 142328 79489979
Dysarthria 52.38 11.12 211 111870 67411 79564896
Feeling abnormal 51.87 11.12 90 111991 159109 79473198
Hiccups 51.54 11.12 67 112014 9964 79622343
Overdose 51.49 11.12 114 111967 184092 79448215
Pelvic abscess 51.34 11.12 34 112047 2115 79630192
Electrocardiogram QT prolonged 50.96 11.12 32 112049 90354 79541953
Small intestinal obstruction 50.81 11.12 116 111965 27156 79605151
Confusional state 50.72 11.12 252 111829 317745 79314562
Toxic leukoencephalopathy 50.55 11.12 27 112054 1127 79631180
Hallucination 50.24 11.12 29 112052 85716 79546591
Crystal nephropathy 49.95 11.12 29 112052 1426 79630881
Fluid retention 49.62 11.12 18 112063 69791 79562516
Sedation 49.55 11.12 7 112074 51888 79580419
Transdifferentiation of neoplasm 49.49 11.12 14 112067 94 79632213
Wrong technique in product usage process 49.30 11.12 21 112060 73854 79558453
Cholinergic syndrome 49.22 11.12 26 112055 1061 79631246
Anti-cyclic citrullinated peptide antibody positive 48.89 11.12 28 112053 83115 79549192
Gastrooesophageal reflux disease 48.44 11.12 45 112036 104201 79528106
Pneumonia 48.35 11.12 646 111435 659600 78972707
Clostridium difficile colitis 48.09 11.12 126 111955 32157 79600150
Exposure during pregnancy 47.77 11.12 43 112038 101089 79531218
Hypokalaemia 47.50 11.12 356 111725 143684 79488623
Bradycardia 46.60 11.12 74 112007 135483 79496824
Blood glucose increased 46.30 11.12 56 112025 114919 79517388
Drug hypersensitivity 45.89 11.12 240 111841 298676 79333631
Metastases to meninges 45.70 11.12 39 112042 3562 79628745
Drug interaction 45.63 11.12 369 111712 414814 79217493
Drug dependence 45.47 11.12 3 112078 40766 79591541
Venous thrombosis 45.39 11.12 53 112028 7063 79625244
Recall phenomenon 45.35 11.12 25 112056 1112 79631195
Abdominal discomfort 45.15 11.12 190 111891 250537 79381770
Stress 45.14 11.12 28 112053 79584 79552723
Large intestinal obstruction 44.49 11.12 37 112044 3262 79629045
Peritonitis 44.43 11.12 112 111969 27924 79604383
Adverse drug reaction 44.10 11.12 19 112062 66373 79565934
Migraine 44.03 11.12 35 112046 87458 79544849
Type II hypersensitivity 44.02 11.12 11 112070 42 79632265
Nodular regenerative hyperplasia 43.76 11.12 26 112055 1335 79630972
Rectal tenesmus 43.69 11.12 28 112053 1647 79630660
Treatment noncompliance 43.54 11.12 10 112071 52258 79580049
Medication error 43.48 11.12 21 112060 68621 79563686
Influenza 43.38 11.12 72 112009 129534 79502773
Portal vein thrombosis 43.32 11.12 47 112034 5780 79626527
Superior vena cava syndrome 43.16 11.12 25 112056 1224 79631083
Coronary artery disease 43.07 11.12 19 112062 65455 79566852
ECG signs of myocardial ischaemia 42.98 11.12 17 112064 349 79631958
Steatohepatitis 42.91 11.12 23 112058 967 79631340
Deep vein thrombosis 42.81 11.12 304 111777 120615 79511692
Psoriasis 42.43 11.12 38 112043 89549 79542758
Neutropenic colitis 42.37 11.12 46 112035 5661 79626646
Anastomotic complication 42.15 11.12 18 112063 452 79631855
Encephalopathy 42.02 11.12 197 111884 67200 79565107
Joint ankylosis 41.51 11.12 30 112051 2150 79630157
Haemolytic anaemia 41.51 11.12 83 111998 17737 79614570
Hand deformity 41.44 11.12 51 112030 103868 79528439
Growth of eyelashes 41.13 11.12 14 112067 184 79632123
Knee arthroplasty 40.91 11.12 6 112075 43242 79589065
Anastomotic fistula 40.79 11.12 13 112068 137 79632170
Septic shock 40.76 11.12 304 111777 122497 79509810
Varices oesophageal 40.53 11.12 46 112035 5945 79626362
Gait inability 40.53 11.12 16 112065 58901 79573406
Paraesthesia 40.39 11.12 402 111679 175921 79456386
Productive cough 40.02 11.12 39 112042 88292 79544015
Balance disorder 39.96 11.12 48 112033 98809 79533498
Jugular vein thrombosis 39.82 11.12 40 112041 4498 79627809
Hepatic lesion 39.75 11.12 49 112032 6910 79625397
Acute coronary syndrome 39.49 11.12 90 111991 21043 79611264
Nipple pain 38.70 11.12 21 112060 905 79631402
Type 2 diabetes mellitus 38.50 11.12 16 112065 57106 79575201
Viraemia 38.32 11.12 32 112049 2837 79629470
Colon cancer recurrent 37.95 11.12 12 112069 123 79632184
K-ras gene mutation 37.68 11.12 10 112071 51 79632256
Hepatic steatosis 36.95 11.12 127 111954 37611 79594696
Proctalgia 36.86 11.12 57 112024 9944 79622363
Unevaluable event 36.77 11.12 16 112065 55569 79576738
International normalised ratio increased 36.57 11.12 39 112042 84682 79547625
Enterovesical fistula 36.50 11.12 22 112059 1160 79631147
Arthritis 36.46 11.12 66 112015 114814 79517493
Klebsiella infection 36.35 11.12 73 112008 15647 79616660
Loss of personal independence in daily activities 36.21 11.12 55 112026 102525 79529782
Febrile infection 36.00 11.12 33 112048 3313 79628994
Respiratory arrest 35.86 11.12 18 112063 57532 79574775
Carbohydrate antigen 19-9 increased 35.82 11.12 16 112065 449 79631858
Plasma cell myeloma 35.76 11.12 15 112066 53244 79579063
Proteus infection 35.51 11.12 27 112054 2091 79630216
Skin injury 35.50 11.12 33 112048 3373 79628934
Nasopharyngitis 35.07 11.12 211 111870 253670 79378637
Injection site erythema 34.88 11.12 35 112046 78162 79554145
Colon cancer metastatic 34.81 11.12 27 112054 2154 79630153
Drug withdrawal syndrome 34.80 11.12 4 112077 34714 79597593
Condition aggravated 34.59 11.12 496 111585 500628 79131679
Gait disturbance 34.48 11.12 162 111919 207344 79424963
Intentional self-injury 34.41 11.12 3 112078 32416 79599891
Hypoglycaemia 34.41 11.12 56 112025 101538 79530769
Subclavian vein thrombosis 34.06 11.12 28 112053 2429 79629878
Electrocardiogram ST segment elevation 34.00 11.12 50 112031 8347 79623960
Impaired healing 33.92 11.12 44 112037 87611 79544696
Hip arthroplasty 33.73 11.12 5 112076 35751 79596556
Rectal perforation 33.65 11.12 19 112062 886 79631421
Drug ineffective 33.60 11.12 1213 110868 1079700 78552607
Hypersensitivity vasculitis 33.55 11.12 45 112036 6898 79625409
Immune thrombocytopenia 33.46 11.12 76 112005 17729 79614578
Fibromyalgia 33.31 11.12 25 112056 64315 79567992
Factor VII deficiency 33.01 11.12 8 112073 26 79632281
Obesity 32.93 11.12 5 112076 35120 79597187
Urticaria 32.92 11.12 141 111940 185060 79447247
Pelvic fluid collection 32.65 11.12 18 112063 801 79631506
Emotional distress 32.59 11.12 8 112073 39961 79592346
Small intestinal perforation 32.56 11.12 31 112050 3266 79629041
Cardiac arrest 32.48 11.12 128 111953 171968 79460339
T-cell lymphoma refractory 32.27 11.12 9 112072 57 79632250
Oesophageal atresia 32.12 11.12 10 112071 97 79632210
Conjunctivitis 32.01 11.12 94 111987 25621 79606686
Thrombocytopenic purpura 31.87 11.12 27 112054 2442 79629865
Large intestine perforation 31.74 11.12 66 112015 14501 79617806
Adverse event 31.68 11.12 23 112058 60191 79572116
Ileal perforation 31.45 11.12 19 112062 1006 79631301
Portal shunt 31.01 11.12 9 112072 67 79632240
Troponin T increased 30.83 11.12 31 112050 3491 79628816
Enterocutaneous fistula 30.70 11.12 24 112057 1937 79630370
Oesophagobronchial fistula 30.45 11.12 12 112069 244 79632063
Liver abscess 30.42 11.12 40 112041 6014 79626293
Cytomegalovirus chorioretinitis 30.30 11.12 38 112043 5452 79626855
Gastrointestinal anastomotic leak 30.26 11.12 15 112066 535 79631772
Erythema 30.20 11.12 461 111620 222829 79409478
Sleep disorder 30.18 11.12 46 112035 85631 79546676
Blood creatine phosphokinase increased 30.15 11.12 29 112052 66061 79566246
Second primary malignancy 30.08 11.12 64 112017 14286 79618021
Cachexia 29.97 11.12 55 112026 11028 79621279
Illness 29.81 11.12 14 112067 46497 79585810
Liver function test abnormal 29.75 11.12 28 112053 64447 79567860
Intravascular haemolysis 29.71 11.12 17 112064 813 79631494
Cystitis radiation 29.67 11.12 11 112070 188 79632119
Anal haemorrhage 29.48 11.12 33 112048 4201 79628106
Off label use 29.45 11.12 1557 110524 905658 78726649
Metastasis 29.36 11.12 42 112039 6838 79625469
Agitation 29.28 11.12 60 112021 99655 79532652
Koebner phenomenon 28.91 11.12 8 112073 49 79632258
Necrotising fasciitis 28.91 11.12 39 112042 6011 79626296
Nephrotic syndrome 28.40 11.12 54 112027 11120 79621187
Nasal septum perforation 28.24 11.12 16 112065 751 79631556
Acute abdomen 28.17 11.12 28 112053 3109 79629198
Leukoerythroblastosis 28.15 11.12 12 112069 300 79632007
Acute kidney injury 28.11 11.12 941 111140 518463 79113844
Organising pneumonia 27.97 11.12 53 112028 10886 79621421
Pharyngeal dyskinesia 27.75 11.12 8 112073 58 79632249
Influenza like illness 27.74 11.12 36 112045 71671 79560636
Neuromyotonia 27.65 11.12 9 112072 102 79632205
Hypoalbuminaemia 27.61 11.12 79 112002 21218 79611089
Mouth ulceration 27.52 11.12 117 111964 38277 79594030
Lymphopenia 27.48 11.12 100 111981 30457 79601850
Aggression 27.42 11.12 19 112062 50939 79581368
Cardio-respiratory arrest 27.26 11.12 71 112010 108439 79523868
Aortic thrombosis 27.09 11.12 21 112060 1674 79630633
Irritability 26.97 11.12 12 112069 41132 79591175
Stoma site haemorrhage 26.90 11.12 22 112059 1894 79630413
Encapsulating peritoneal sclerosis 26.69 11.12 16 112065 835 79631472
Cerebral haemorrhage 26.67 11.12 25 112056 57648 79574659
Treatment failure 26.64 11.12 136 111945 170350 79461957
Oedema 26.54 11.12 83 111998 119497 79512810
Oesophageal candidiasis 26.53 11.12 47 112034 9171 79623136
Laboratory test interference 26.29 11.12 18 112063 1183 79631124
Obstructive airways disorder 26.24 11.12 6 112075 31453 79600854
Full blood count abnormal 26.22 11.12 12 112069 40462 79591845
Injection site reaction 26.22 11.12 23 112058 54762 79577545
Injection site haemorrhage 26.05 11.12 4 112077 27866 79604441
Musculoskeletal stiffness 26.01 11.12 142 111939 174866 79457441
Hepatectomy 25.95 11.12 10 112071 191 79632116
Skin fissures 25.91 11.12 57 112024 13016 79619291
Laryngospasm 25.88 11.12 30 112051 3967 79628340
Nightmare 25.87 11.12 3 112078 25858 79606449
Chronic kidney disease 25.81 11.12 33 112048 66121 79566186
Prothrombin level decreased 25.48 11.12 20 112061 1624 79630683
Hepatocellular injury 25.32 11.12 133 111948 47460 79584847
Aplasia 25.30 11.12 42 112039 7778 79624529
Muscle spasms 25.30 11.12 143 111938 174587 79457720
Hypertrichosis 25.23 11.12 18 112063 1264 79631043
Venous pressure jugular decreased 25.22 11.12 8 112073 83 79632224
Poisoning 25.11 11.12 3 112078 25269 79607038
Pulmonary congestion 25.08 11.12 4 112077 27096 79605211
Portal venous gas 24.96 11.12 12 112069 400 79631907
Bladder hypertrophy 24.95 11.12 14 112067 645 79631662
Sleep apnoea syndrome 24.93 11.12 10 112071 36468 79595839
Visual impairment 24.93 11.12 58 112023 92073 79540234
Haemolytic uraemic syndrome 24.88 11.12 31 112050 4418 79627889
Cytopenia 24.88 11.12 74 112007 20309 79611998
Vasospasm 24.84 11.12 17 112064 1117 79631190
Rhinovirus infection 24.78 11.12 42 112039 7911 79624396
Hypoacusis 24.65 11.12 6 112075 30144 79602163
Induration 24.49 11.12 21 112060 1931 79630376
Stomal varices 24.47 11.12 8 112073 92 79632215
Incorrect dose administered 24.33 11.12 44 112037 76586 79555721
Device related thrombosis 24.19 11.12 24 112057 2659 79629648
Hypocalcaemia 24.19 11.12 136 111945 49788 79582519
Evans syndrome 24.18 11.12 12 112069 429 79631878
Performance status decreased 24.17 11.12 36 112045 6077 79626230
Short-bowel syndrome 24.05 11.12 13 112068 556 79631751
Loss of consciousness 24.01 11.12 138 111943 167805 79464502
Oesophagitis 24.01 11.12 82 111999 24207 79608100
Pneumonitis 23.90 11.12 157 111924 60703 79571604
Adenocarcinoma of colon 23.90 11.12 34 112047 5507 79626800
Teratogenicity 23.80 11.12 10 112071 241 79632066
Gastrointestinal necrosis 23.79 11.12 34 112047 5531 79626776
Product prescribing error 23.73 11.12 17 112064 44796 79587511
Tremor 23.66 11.12 141 111940 169942 79462365
Toxic erythema of chemotherapy 23.65 11.12 10 112071 245 79632062
Joint stiffness 23.65 11.12 14 112067 40816 79591491
Meningitis streptococcal 23.50 11.12 9 112072 169 79632138
Perihepatic abscess 23.50 11.12 9 112072 169 79632138
Dyspnoea 23.44 11.12 976 111105 856049 78776258
Swelling face 23.42 11.12 40 112041 71172 79561135
Systemic infection 23.41 11.12 46 112035 9706 79622601
Venous thrombosis limb 23.26 11.12 30 112051 4427 79627880
Adenocarcinoma 23.23 11.12 28 112053 3858 79628449
Perineal disorder 23.04 11.12 6 112075 28 79632279
Eczema impetiginous 23.04 11.12 6 112075 28 79632279
Astringent therapy 23.04 11.12 6 112075 28 79632279
Hepatic failure 22.89 11.12 156 111925 61056 79571251
Tumour fistulisation 22.87 11.12 6 112075 29 79632278
Bacteraemia 22.74 11.12 99 111982 32725 79599582
Diaphragmatic operation 22.70 11.12 6 112075 30 79632277
Gastrointestinal stoma complication 22.69 11.12 23 112058 2614 79629693
Pregnancy 22.64 11.12 5 112076 26846 79605461
Interventricular septum rupture 22.54 11.12 6 112075 31 79632276
Pulmonary arterial hypertension 22.51 11.12 6 112075 28360 79603947
Transaminases increased 22.51 11.12 137 111944 51606 79580701
Lower limb fracture 22.47 11.12 3 112078 23212 79609095
Injection site bruising 22.45 11.12 15 112066 40987 79591320
Injection site pruritus 22.44 11.12 16 112065 42267 79590040
Jaundice 22.42 11.12 140 111941 53209 79579098
Joint injury 22.40 11.12 8 112073 31327 79600980
Ischiorectal hernia 22.37 11.12 5 112076 10 79632297
Hepatic fibrosis 22.09 11.12 38 112043 7242 79625065
Anaemia of malignant disease 22.04 11.12 14 112067 811 79631496
Prescribed underdose 22.03 11.12 7 112074 29507 79602800
Abortion spontaneous 22.02 11.12 7 112074 29500 79602807
Nephropathy toxic 22.02 11.12 71 112010 20348 79611959
Prescribed overdose 21.92 11.12 13 112068 37870 79594437
Haematopoietic stem cell mobilisation 21.81 11.12 9 112072 207 79632100
Multiple-drug resistance 21.69 11.12 42 112039 8766 79623541
Clostridial infection 21.67 11.12 33 112048 5681 79626626
Atypical haemolytic uraemic syndrome 21.49 11.12 15 112066 1017 79631290
Depilation 21.46 11.12 5 112076 13 79632294
Joint range of motion decreased 21.36 11.12 10 112071 33272 79599035
Road traffic accident 21.30 11.12 18 112063 43646 79588661
Skin discolouration 21.17 11.12 16 112065 41018 79591289
Injection site swelling 21.13 11.12 21 112060 47111 79585196
Dermatitis 21.09 11.12 72 112009 21249 79611058
Pleuroparenchymal fibroelastosis 21.05 11.12 8 112073 147 79632160
Lip swelling 21.04 11.12 16 112065 40895 79591412
Myeloid leukaemia 20.99 11.12 13 112068 720 79631587
Bone cyst 20.95 11.12 25 112056 3408 79628899
Palpitations 20.93 11.12 99 111982 126511 79505796
Thrombotic microangiopathy 20.74 11.12 69 112012 20100 79612207
Oesophageal fistula 20.62 11.12 11 112070 458 79631849
Product quality issue 20.57 11.12 11 112070 33929 79598378
Restlessness 20.52 11.12 21 112060 46471 79585836
Catabolic state 20.50 11.12 7 112074 93 79632214
Angioedema 20.46 11.12 48 112033 75987 79556320
Visceral venous thrombosis 20.46 11.12 5 112076 17 79632290
Metastases to ovary 20.42 11.12 10 112071 347 79631960
Cerebrovascular accident 20.42 11.12 131 111950 155161 79477146
Mucocutaneous rash 20.41 11.12 6 112075 47 79632260
Psychotic disorder 20.28 11.12 17 112064 41385 79590922
Heart rate increased 20.19 11.12 94 111987 120630 79511677
Oesophageal haemorrhage 20.14 11.12 18 112063 1749 79630558
Product use issue 20.13 11.12 193 111888 209629 79422678
Mixed adenoneuroendocrine carcinoma 20.03 11.12 5 112076 19 79632288
Chemotherapy cardiotoxicity attenuation 20.03 11.12 5 112076 19 79632288
Coronavirus infection 20.01 11.12 37 112044 7460 79624847
Hepatitis B surface antigen positive 19.93 11.12 8 112073 171 79632136
Malaise 19.69 11.12 531 111550 489338 79142969
Biliary tract infection 19.62 11.12 16 112065 1372 79630935
Pancreatic carcinoma recurrent 19.59 11.12 8 112073 179 79632128
Pneumoperitoneum 19.58 11.12 23 112058 3085 79629222
Panic attack 19.45 11.12 5 112076 24211 79608096
Portal vein dilatation 19.29 11.12 6 112075 58 79632249
Therapy interrupted 19.23 11.12 10 112071 31331 79600976
Allodynia 19.20 11.12 17 112064 1631 79630676
Oesophageal carcinoma recurrent 19.11 11.12 6 112075 60 79632247
Radiation interaction 19.11 11.12 6 112075 60 79632247
Rectal cancer recurrent 19.09 11.12 5 112076 24 79632283
Cholestasis 19.01 11.12 132 111949 51977 79580330
Escherichia pyelonephritis 18.98 11.12 11 112070 539 79631768
Breast cancer 18.98 11.12 12 112069 33769 79598538
Enterocolitis 18.98 11.12 54 112027 14458 79617849
Endometrial dysplasia 18.92 11.12 5 112076 25 79632282
Full blood count decreased 18.91 11.12 7 112074 26812 79605495
Bacteriuria 18.71 11.12 15 112066 1256 79631051
Xeroderma 18.63 11.12 9 112072 303 79632004
Anal erythema 18.58 11.12 8 112073 205 79632102
Sciatica 18.40 11.12 12 112069 33210 79599097
Therapeutic response unexpected 18.33 11.12 3 112078 19943 79612364
Product administration error 18.33 11.12 11 112070 31835 79600472
Hypotension 18.29 11.12 475 111606 439842 79192465
Cranial nerve disorder 18.28 11.12 14 112067 1096 79631211
Therapeutic product effect decreased 18.25 11.12 145 111936 163718 79468589
Hypertransaminasaemia 18.23 11.12 47 112034 11877 79620430
Viral hepatitis carrier 18.16 11.12 5 112076 30 79632277
Stress cardiomyopathy 18.10 11.12 45 112036 11121 79621186
Depressed mood 18.08 11.12 25 112056 48455 79583852
Pustule 18.05 11.12 18 112063 2007 79630300
Anorectal disorder 17.93 11.12 19 112062 2274 79630033
Respiratory disorder 17.89 11.12 22 112059 44834 79587473
Abnormal behaviour 17.78 11.12 15 112066 36406 79595901
Balanoposthitis 17.68 11.12 13 112068 957 79631350
Rheumatic fever 17.65 11.12 9 112072 28516 79603791
Device issue 17.62 11.12 8 112073 27100 79605207
Toxic skin eruption 17.61 11.12 70 112011 22223 79610084
Herpes simplex 17.57 11.12 47 112034 12140 79620167
Pulmonary artery thrombosis 17.51 11.12 15 112066 1377 79630930
Blood pressure decreased 17.50 11.12 76 112005 99390 79532917
Folliculitis 17.40 11.12 32 112049 55348 79576959
Frequent bowel movements 17.29 11.12 10 112071 29529 79602778
Prostatic calcification 17.28 11.12 6 112075 84 79632223
Bronchitis 17.28 11.12 110 111971 130534 79501773
Perforation bile duct 17.26 11.12 5 112076 37 79632270
Aortic intramural haematoma 17.25 11.12 7 112074 154 79632153
Osteolysis 17.09 11.12 26 112055 4472 79627835
Dysaesthesia 17.06 11.12 30 112051 5818 79626489
Hyperthyroidism 17.06 11.12 5 112076 22204 79610103
Neurosarcoidosis 17.00 11.12 9 112072 369 79631938
Duodenal perforation 16.99 11.12 18 112063 2154 79630153
Vascular access complication 16.92 11.12 18 112063 2164 79630143
Perioral dermatitis 16.91 11.12 9 112072 373 79631934
Faeces discoloured 16.85 11.12 10 112071 29117 79603190
Delusion 16.82 11.12 4 112077 20419 79611888
Amnesia 16.82 11.12 40 112041 63017 79569290
Dysstasia 16.81 11.12 9 112072 27737 79604570
Cerebral vasoconstriction 16.80 11.12 15 112066 1455 79630852
Product substitution issue 16.62 11.12 4 112077 20252 79612055
Intracardiac thrombus 16.57 11.12 25 112056 4268 79628039
Injection site mass 16.54 11.12 4 112077 20180 79612127
Mental disorder 16.41 11.12 12 112069 31290 79601017
Pneumatosis 16.40 11.12 12 112069 877 79631430
Toxic encephalopathy 16.38 11.12 44 112037 11396 79620911
Head injury 16.35 11.12 17 112064 37352 79594955
Peritoneal neoplasm 16.32 11.12 6 112075 100 79632207
Procedural pain 16.32 11.12 6 112075 23078 79609229
Mania 16.23 11.12 3 112078 18257 79614050
Anal erosion 16.11 11.12 5 112076 48 79632259
Tumour perforation 16.09 11.12 9 112072 412 79631895
Troponin I increased 16.08 11.12 26 112055 4712 79627595
Psoriatic arthropathy 16.02 11.12 56 112025 77943 79554364
Laryngeal dyspnoea 15.94 11.12 8 112073 293 79632014
Cognitive disorder 15.89 11.12 48 112033 69878 79562429
Onycholysis 15.83 11.12 17 112064 2066 79630241
Pruritus 15.79 11.12 428 111653 394220 79238087
Inferior vena cava stenosis 15.75 11.12 5 112076 52 79632255
Brief psychotic disorder with marked stressors 15.74 11.12 8 112073 301 79632006
Mood altered 15.72 11.12 3 112078 17844 79614463
Nasal congestion 15.70 11.12 55 112026 76497 79555810
Bladder tamponade 15.70 11.12 10 112071 582 79631725
Portal vein embolisation 15.67 11.12 4 112077 17 79632290
Haematoma 15.67 11.12 31 112050 52164 79580143
Encephalitis 15.62 11.12 51 112030 14709 79617598
Volvulus of small bowel 15.50 11.12 6 112075 116 79632191
Temperature difference of extremities 15.48 11.12 4 112077 18 79632289
Lung neoplasm malignant 15.44 11.12 10 112071 27782 79604525
Therapy cessation 15.43 11.12 18 112063 37544 79594763
Intestinal strangulation 15.42 11.12 5 112076 56 79632251
Multiple sclerosis 15.41 11.12 6 112075 22276 79610031
Catheter site extravasation 15.37 11.12 9 112072 450 79631857
Hallucination, visual 15.35 11.12 14 112067 32715 79599592
Systemic scleroderma 15.27 11.12 13 112068 1184 79631123
Dysaesthesia pharynx 15.24 11.12 7 112074 210 79632097
Thrombotic thrombocytopenic purpura 15.21 11.12 30 112051 6346 79625961
Blood glucose decreased 15.18 11.12 9 112072 26225 79606082
Portal tract inflammation 15.09 11.12 6 112075 125 79632182
Rectal cancer metastatic 15.06 11.12 9 112072 467 79631840
Gout 15.03 11.12 8 112073 24741 79607566
Proctitis 15.03 11.12 30 112051 6402 79625905
Inappropriate schedule of product administration 14.99 11.12 118 111963 133510 79498797
Grip strength decreased 14.94 11.12 6 112075 21863 79610444
Dysphagia 14.93 11.12 248 111833 121888 79510419
Neck pain 14.93 11.12 55 112026 75362 79556945
Organic brain syndrome 14.92 11.12 9 112072 475 79631832
Acinetobacter sepsis 14.88 11.12 5 112076 63 79632244
Cardiac pacemaker evaluation 14.83 11.12 6 112075 131 79632176
Disability 14.82 11.12 3 112078 17117 79615190
Perineal abscess 14.80 11.12 10 112071 643 79631664
Sputum discoloured 14.80 11.12 6 112075 21737 79610570
Therapy non-responder 14.77 11.12 73 112008 92232 79540075
Cutaneous tuberculosis 14.76 11.12 7 112074 226 79632081
Transposition of the great vessels 14.74 11.12 5 112076 65 79632242
Anal fissure 14.61 11.12 33 112048 7670 79624637
Red cell fragmentation syndrome 14.60 11.12 5 112076 67 79632240
Underdose 14.60 11.12 15 112066 33136 79599171
Hyperthermia 14.54 11.12 57 112024 17980 79614327
Pleural fistula 14.53 11.12 4 112077 24 79632283
Obstruction gastric 14.44 11.12 15 112066 1755 79630552
Dyspnoea exertional 14.44 11.12 68 112013 87005 79545302
Retinitis viral 14.42 11.12 6 112075 141 79632166
Microangiopathic haemolytic anaemia 14.40 11.12 14 112067 1513 79630794
Rash maculo-papular 14.39 11.12 131 111950 55947 79576360
Muscle rigidity 14.34 11.12 5 112076 19877 79612430
Hypothermia 14.34 11.12 7 112074 22739 79609568
Entropion 14.34 11.12 5 112076 71 79632236
Pulmonary infarction 14.27 11.12 22 112059 3827 79628480
Iatrogenic infection 14.27 11.12 5 112076 72 79632235
Mucosal disorder 14.27 11.12 21 112060 3507 79628800
Electromyogram abnormal 14.26 11.12 6 112075 145 79632162
Periportal sinus dilatation 14.26 11.12 6 112075 145 79632162
Metastases to central nervous system 14.23 11.12 53 112028 16322 79615985
Accidental overdose 14.18 11.12 21 112060 39560 79592747
Heart rate irregular 14.15 11.12 15 112066 32664 79599643
Subacute cutaneous lupus erythematosus 14.12 11.12 21 112060 3540 79628767
Cerebral toxoplasmosis 14.09 11.12 17 112064 2345 79629962
Nephrolithiasis 14.06 11.12 34 112047 53257 79579050
No adverse event 14.05 11.12 19 112062 37173 79595134
Hypervolaemia 14.02 11.12 24 112057 42666 79589641
Disseminated aspergillosis 13.97 11.12 12 112069 1106 79631201
Dyskinesia 13.95 11.12 26 112055 44747 79587560
Soft tissue necrosis 13.90 11.12 11 112070 904 79631403
Product intolerance 13.88 11.12 4 112077 29 79632278
VIth nerve disorder 13.88 11.12 4 112077 29 79632278
Peritoneal disorder 13.73 11.12 10 112071 725 79631582
Rectal abscess 13.72 11.12 16 112065 2129 79630178
Cardiac disorder 13.65 11.12 47 112034 65710 79566597
Ovarian fibroma 13.62 11.12 5 112076 83 79632224
Eye disorder 13.60 11.12 8 112073 23404 79608903
Tinnitus 13.59 11.12 26 112055 44307 79588000
Movement disorder 13.59 11.12 11 112070 27248 79605059
Failure to thrive 13.52 11.12 42 112039 11802 79620505
Mydriasis 13.50 11.12 4 112077 17639 79614668
Ovarian cystectomy 13.46 11.12 5 112076 86 79632221
Escherichia bacteraemia 13.45 11.12 29 112052 6533 79625774
Radiation hepatitis 13.42 11.12 3 112078 6 79632301
Chemotherapeutic drug level above therapeutic 13.40 11.12 5 112076 87 79632220
Cancer fatigue 13.38 11.12 6 112075 170 79632137
Sopor 13.37 11.12 16 112065 32994 79599313
Cellulitis 13.33 11.12 94 111987 108966 79523341
Hypersplenism 13.32 11.12 9 112072 579 79631728
Benign hydatidiform mole 13.30 11.12 5 112076 89 79632218
Drug eruption 13.27 11.12 26 112055 43909 79588398
Granulomatous lymphadenitis 13.24 11.12 7 112074 286 79632021
Basal cell carcinoma 13.22 11.12 20 112061 37355 79594952
Liver operation 13.22 11.12 4 112077 35 79632272
Splenic abscess 13.21 11.12 9 112072 587 79631720
Disseminated intravascular coagulation 13.20 11.12 91 111990 35751 79596556
Pulmonary toxicity 13.12 11.12 44 112037 12870 79619437
Catheter site thrombosis 13.07 11.12 7 112074 294 79632013
Optic neuropathy 13.04 11.12 20 112061 3464 79628843
Neuralgia 13.03 11.12 86 111995 33298 79599009
Gastric varices haemorrhage 13.03 11.12 8 112073 436 79631871
Myelodysplastic syndrome 13.03 11.12 80 112001 30221 79602086
Ulcerative gastritis 13.00 11.12 5 112076 95 79632212
Muscle spasticity 12.96 11.12 7 112074 21468 79610839
Rectal adenocarcinoma 12.96 11.12 13 112068 1460 79630847
Acute endocarditis 12.92 11.12 4 112077 38 79632269
Adenocarcinoma metastatic 12.91 11.12 6 112075 185 79632122
Overgrowth fungal 12.90 11.12 5 112076 97 79632210
Vocal cord paralysis 12.86 11.12 17 112064 2570 79629737
Exfoliative rash 12.85 11.12 21 112060 3838 79628469
Blood loss anaemia 12.84 11.12 3 112078 15495 79616812
Fluid balance positive 12.83 11.12 4 112077 39 79632268
Sinus bradycardia 12.82 11.12 10 112071 25237 79607070
Traumatic fracture 12.81 11.12 11 112070 1013 79631294
Oral herpes 12.78 11.12 74 112007 27380 79604927
Labelled drug-drug interaction medication error 12.76 11.12 12 112069 27638 79604669
Metastases to bone marrow 12.74 11.12 10 112071 812 79631495
Pancreatic fistula 12.72 11.12 5 112076 101 79632206
Bacterial colitis 12.72 11.12 5 112076 101 79632206
Fistula of small intestine 12.68 11.12 10 112071 817 79631490
Necrotising colitis 12.66 11.12 11 112070 1029 79631278
Paraesthesia mucosal 12.65 11.12 4 112077 41 79632266
Renal disorder 12.64 11.12 25 112056 42080 79590227
Hemiparesis 12.63 11.12 86 111995 33647 79598660
Hypocapnia 12.59 11.12 9 112072 634 79631673
Glaucoma 12.58 11.12 6 112075 19755 79612552
Gastric ulcer perforation, obstructive 12.56 11.12 3 112078 9 79632298
Pain in jaw 12.53 11.12 29 112052 46122 79586185
Streptococcal bacteraemia 12.52 11.12 20 112061 3586 79628721
Agranulocytosis 12.49 11.12 107 111974 44923 79587384
Scar 12.47 11.12 3 112078 15193 79617114
Hemianaesthesia 12.46 11.12 8 112073 472 79631835
Hyperlipidaemia 12.43 11.12 11 112070 26082 79606225
Cytomegalovirus viraemia 12.42 11.12 43 112038 12778 79619529
Ill-defined disorder 12.42 11.12 49 112032 65826 79566481
Proctectomy 12.37 11.12 6 112075 204 79632103
Autoimmune disorder 12.29 11.12 4 112077 16608 79615699
Vitiligo 12.29 11.12 15 112066 2094 79630213
Parkinsonism 12.26 11.12 4 112077 16580 79615727
Post procedural diarrhoea 12.21 11.12 9 112072 665 79631642
Limbic encephalitis 12.19 11.12 10 112071 865 79631442
Granulomatous liver disease 12.16 11.12 12 112069 1321 79630986
Pseudocirrhosis 12.14 11.12 9 112072 671 79631636
Diverticulum 12.11 11.12 3 112078 14893 79617414
Upper gastrointestinal haemorrhage 12.06 11.12 25 112056 41355 79590952
Seasonal allergy 12.05 11.12 4 112077 16402 79615905
Eye pruritus 11.99 11.12 7 112074 20563 79611744
Neutropenic sepsis 11.98 11.12 72 112009 26992 79605315
Kidney infection 11.95 11.12 8 112073 21843 79610464
Upper respiratory tract infection 11.93 11.12 77 112004 91091 79541216
Hand-foot-genital syndrome 11.90 11.12 3 112078 12 79632295
Gastroenteritis norovirus 11.87 11.12 18 112063 3088 79629219
Abdominal abscess 11.85 11.12 29 112052 7098 79625209
Onychoclasis 11.83 11.12 25 112056 5553 79626754
B-cell small lymphocytic lymphoma 11.80 11.12 5 112076 123 79632184
Presyncope 11.80 11.12 25 112056 41029 79591278
Cardiomyopathy 11.77 11.12 75 112006 28699 79603608
Skin laceration 11.77 11.12 14 112067 28948 79603359
Rectal haemorrhage 11.67 11.12 161 111920 76139 79556168
Stomal hernia 11.67 11.12 7 112074 366 79631941
Middle insomnia 11.66 11.12 4 112077 16065 79616242
Blood culture positive 11.65 11.12 32 112049 8397 79623910
Head discomfort 11.64 11.12 3 112078 14499 79617808
Endothelial dysfunction 11.63 11.12 6 112075 233 79632074
Fanconi syndrome 11.55 11.12 17 112064 2839 79629468
Glomerular filtration rate decreased 11.52 11.12 9 112072 22693 79609614
Extrapyramidal disorder 11.50 11.12 9 112072 22670 79609637
Neuropathic muscular atrophy 11.46 11.12 4 112077 57 79632250
Oesophageal varices haemorrhage 11.43 11.12 21 112060 4215 79628092
Malignant ascites 11.38 11.12 11 112070 1181 79631126
Oedema peripheral 11.31 11.12 269 111812 252019 79380288
Coagulopathy 11.30 11.12 88 111993 35918 79596389
Disease recurrence 11.29 11.12 103 111978 44006 79588301
Sinus congestion 11.27 11.12 7 112074 19889 79612418
Occult blood 11.27 11.12 13 112068 1710 79630597
Renal impairment 11.27 11.12 155 111926 157628 79474679
Rash pruritic 11.26 11.12 57 112024 71572 79560735
Tubulointerstitial nephritis 11.23 11.12 23 112058 38212 79594095
Cough 11.22 11.12 412 111669 366377 79265930
Musculoskeletal discomfort 11.21 11.12 7 112074 19828 79612479
Optic disc hyperaemia 11.19 11.12 3 112078 16 79632291
Metastatic neoplasm 11.17 11.12 23 112058 5019 79627288
Biliary obstruction 11.16 11.12 22 112059 4652 79627655
Surgery 11.15 11.12 18 112063 32748 79599559
Electrolyte imbalance 11.13 11.12 78 112003 30803 79601504

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC V03AF03 VARIOUS
ALL OTHER THERAPEUTIC PRODUCTS
ALL OTHER THERAPEUTIC PRODUCTS
Detoxifying agents for antineoplastic treatment
ATC V03AF06 VARIOUS
ALL OTHER THERAPEUTIC PRODUCTS
ALL OTHER THERAPEUTIC PRODUCTS
Detoxifying agents for antineoplastic treatment
FDA CS M0008658 Folic Acid
MeSH PA D000931 Antidotes
MeSH PA D018977 Micronutrients
MeSH PA D020011 Protective Agents
MeSH PA D014803 Vitamin B Complex
MeSH PA D014815 Vitamins
CHEBI has role CHEBI:75771 Mus musculus metabolites
CHEBI has role CHEBI:76971 Escherichia coli metabolites
FDA EPC N0000178369 Folate Analog

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

DiseaseRelationSNOMED_IDDOID
Megaloblastic anemia indication 53165003 DOID:13382
Folic acid deficiency indication 190633005
Bone Marrow Suppression due to Folic Acid Antagonism indication
Methotrexate Toxicity indication
Trimethoprim Toxicity indication
Trimetrexate Toxicity indication
Sulfadiazine Toxicity indication
Pyrimethamine Toxicity indication
Adjunct to Fluorouracil Treatment of Colorectal Cancer indication
Pernicious anemia contraindication 84027009 DOID:13381
Cobalamin deficiency contraindication 190634004




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.61 acidic
pKa2 5.29 acidic
pKa3 10.26 acidic
pKa4 12.96 acidic
pKa5 4.59 Basic
pKa6 2.23 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
Thymidylate synthase Enzyme Ki 4.07 WOMBAT-PK
Dihydrofolate reductase Enzyme Ki 5.63 CHEMBL

External reference:

IDSource
4019798 VUID
N0000147887 NUI
D01211 KEGG_DRUG
1492-18-8 SECONDARY_CAS_RN
4018768 VANDF
4019798 VANDF
4031236 VANDF
C0023413 UMLSCUI
CHEBI:15640 CHEBI
CHEMBL1679 ChEMBL_ID
CHEMBL3707260 ChEMBL_ID
CHEMBL1232801 ChEMBL_ID
CHEMBL1201138 ChEMBL_ID
D002955 MESH_DESCRIPTOR_UI
DB00650 DRUGBANK_ID
4816 IUPHAR_LIGAND_ID
Q573I9DVLP UNII
135403648 PUBCHEM_CID
225852 RXNORM
1728 MMSL
39896 MMSL
4964 MMSL
51342 MMSL
d00275 MMSL
001050 NDDF
001051 NDDF
009520 NDDF
126223008 SNOMEDCT_US
1528001 SNOMEDCT_US
396065004 SNOMEDCT_US
768550004 SNOMEDCT_US
690 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0054-4496 TABLET 5 mg ORAL ANDA 15 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0054-4497 TABLET 10 mg ORAL ANDA 15 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0054-4498 TABLET 15 mg ORAL ANDA 15 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0054-4499 TABLET 25 mg ORAL ANDA 15 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0054-8496 TABLET 5 mg ORAL ANDA 15 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0143-9368 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAMUSCULAR ANDA 19 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0143-9368 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAMUSCULAR ANDA 19 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0143-9552 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 350 mg INTRAMUSCULAR ANDA 19 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0143-9553 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAMUSCULAR ANDA 19 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0143-9554 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAMUSCULAR ANDA 19 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0143-9555 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAMUSCULAR ANDA 19 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0555-0484 TABLET 5 mg ORAL ANDA 17 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0555-0485 TABLET 25 mg ORAL ANDA 17 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0703-5140 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAMUSCULAR ANDA 18 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0703-5140 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAMUSCULAR ANDA 18 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0703-5145 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 350 mg INTRAMUSCULAR ANDA 18 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0703-5145 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 350 mg INTRAMUSCULAR ANDA 18 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0703-5145 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 350 mg INTRAMUSCULAR ANDA 18 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0904-6703 TABLET 25 mg ORAL ANDA 15 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 0904-6703 TABLET 25 mg ORAL ANDA 15 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 25021-813 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS ANDA 21 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 25021-813 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS ANDA 21 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 25021-814 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 21 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 25021-814 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 21 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 25021-815 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAVENOUS ANDA 21 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 25021-815 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRAVENOUS ANDA 21 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 25021-816 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 350 mg INTRAVENOUS ANDA 21 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 25021-816 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 350 mg INTRAVENOUS ANDA 21 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 25021-828 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 21 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 42806-133 TABLET 10 mg ORAL ANDA 16 sections