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) 500 mg/mL Benet LZ, Broccatelli F, Oprea TI
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 1043.77 12.04 993 52193 157174 56081707
Neuropathy peripheral 549.98 12.04 577 52609 102316 56136565
Neurotoxicity 475.73 12.04 252 52934 15543 56223338
Mucosal inflammation 427.27 12.04 341 52845 42469 56196412
Thrombocytopenia 414.76 12.04 574 52612 135650 56103231
Diarrhoea 320.17 12.04 1318 51868 637189 55601692
Disease progression 301.80 12.04 431 52755 104742 56134139
Skin toxicity 280.88 12.04 116 53070 4037 56234844
Febrile neutropenia 273.12 12.04 412 52774 105133 56133748
Haematotoxicity 219.66 12.04 122 53064 8261 56230620
Leukopenia 206.71 12.04 293 52893 70647 56168234
Polyneuropathy 200.56 12.04 135 53051 12915 56225966
Colorectal cancer metastatic 200.28 12.04 60 53126 781 56238100
Dermatitis acneiform 179.81 12.04 86 53100 4258 56234623
Vomiting 162.39 12.04 910 52276 497318 55741563
Systemic lupus erythematosus 144.33 12.04 6 53180 180072 56058809
Stomatitis 130.68 12.04 326 52860 120484 56118397
Pancytopenia 128.81 12.04 269 52917 88446 56150435
Palmar-plantar erythrodysaesthesia syndrome 128.38 12.04 127 53059 20938 56217943
Posterior reversible encephalopathy syndrome 127.75 12.04 112 53074 15848 56223033
Nausea 127.19 12.04 1187 51999 762991 55475890
Arteriospasm coronary 126.47 12.04 64 53122 3583 56235298
Anaemia 123.48 12.04 540 52646 266971 55971910
Glossodynia 122.42 12.04 5 53181 152453 56086428
Metastases to liver 120.32 12.04 124 53062 21462 56217419
Pulmonary embolism 120.00 12.04 293 52893 106831 56132050
Myelosuppression 111.53 12.04 108 53078 17347 56221534
Malignant neoplasm progression 108.99 12.04 225 52961 73362 56165519
Bone marrow failure 107.26 12.04 133 53053 28153 56210728
Abdominal pain 106.41 12.04 505 52681 258300 55980581
Non-cirrhotic portal hypertension 104.95 12.04 26 53160 154 56238727
Enteritis 104.89 12.04 73 53113 7370 56231511
Arthropathy 104.21 12.04 30 53156 200245 56038636
Swelling 96.84 12.04 53 53133 239718 55999163
Gastrointestinal toxicity 95.33 12.04 64 53122 6092 56232789
Drug clearance decreased 95.29 12.04 39 53147 1325 56237556
Focal nodular hyperplasia 89.71 12.04 29 53157 492 56238389
Portal hypertension 88.59 12.04 50 53136 3491 56235390
Therapy partial responder 86.21 12.04 66 53120 7719 56231162
Product dose omission issue 86.00 12.04 43 53143 204710 56034171
Peripheral swelling 82.28 12.04 61 53125 234665 56004216
Peripheral sensory neuropathy 79.29 12.04 60 53126 6896 56231985
Loss of employment 79.10 12.04 38 53148 1899 56236982
Proteinuria 77.10 12.04 89 53097 17481 56221400
Synovitis 75.43 12.04 29 53157 161276 56077605
Hand deformity 72.08 12.04 19 53167 134473 56104408
Gastrointestinal perforation 71.56 12.04 42 53144 3157 56235724
Adenocarcinoma of colon 70.08 12.04 38 53148 2452 56236429
Hypomagnesaemia 69.38 12.04 101 53085 24914 56213967
Paronychia 68.75 12.04 48 53138 4870 56234011
Pericarditis 67.40 12.04 11 53175 108912 56129969
Wound 66.50 12.04 24 53162 138780 56100101
Discomfort 65.43 12.04 26 53160 141735 56097146
Human bocavirus infection 64.97 12.04 21 53165 356 56238525
Dysarthria 64.59 12.04 126 53060 39424 56199457
Leukoencephalopathy 64.56 12.04 43 53143 4039 56234842
Dehydration 63.77 12.04 308 52878 158517 56080364
Neoplasm progression 63.62 12.04 111 53075 31905 56206976
Secondary immunodeficiency 62.05 12.04 28 53158 1212 56237669
Fall 57.78 12.04 161 53025 357349 55881532
Abdominal discomfort 55.87 12.04 111 53075 277163 55961718
Insomnia 55.07 12.04 60 53126 191800 56047081
Lower respiratory tract infection 54.72 12.04 20 53166 114774 56124107
Pneumatosis intestinalis 54.43 12.04 31 53155 2202 56236679
Hypertension 54.40 12.04 406 52780 243872 55995009
Metastases to lung 54.19 12.04 61 53125 11657 56227224
General physical health deterioration 54.00 12.04 309 52877 169701 56069180
Pain 53.65 12.04 387 52799 662797 55576084
Hepatic enzyme increased 53.29 12.04 50 53136 171334 56067547
Helicobacter infection 51.12 12.04 5 53181 73263 56165618
Pyrexia 51.04 12.04 612 52574 418161 55820720
Hyperammonaemia 50.61 12.04 40 53146 4900 56233981
Intestinal perforation 50.60 12.04 57 53129 10902 56227979
Splenomegaly 50.59 12.04 55 53131 10113 56228768
Duodenal ulcer perforation 49.48 12.04 4 53182 68338 56170543
Hyperammonaemic encephalopathy 47.08 12.04 28 53158 2157 56236724
Off label use 46.82 12.04 761 52425 555419 55683462
Drug abuse 46.17 12.04 5 53181 67605 56171276
Gene mutation 46.11 12.04 24 53162 1425 56237456
Ileus 45.90 12.04 61 53125 13821 56225060
Joint swelling 45.69 12.04 132 53054 289668 55949213
Contraindicated product administered 45.38 12.04 66 53120 186220 56052661
Thrombocytopenic purpura 45.19 12.04 23 53163 1303 56237578
Cholangitis 44.22 12.04 37 53149 4912 56233969
Hepatocellular injury 43.93 12.04 85 53101 26429 56212452
Metastases to meninges 43.54 12.04 27 53159 2243 56236638
Enterobacter infection 43.44 12.04 26 53160 2026 56236855
Blood cholesterol increased 43.42 12.04 8 53178 72571 56166310
Hospitalisation 43.33 12.04 9 53177 74991 56163890
Neutrophil count decreased 42.27 12.04 123 53063 49699 56189182
Crystal nephropathy 42.00 12.04 19 53167 827 56238054
Injury 41.98 12.04 4 53182 59847 56179034
Hypersensitivity vasculitis 41.95 12.04 33 53153 4015 56234866
Steatohepatitis 41.18 12.04 16 53170 473 56238408
Cystitis radiation 39.97 12.04 10 53176 62 56238819
Herpes simplex 39.75 12.04 42 53144 7476 56231405
Pharyngeal dyskinesia 39.24 12.04 9 53177 36 56238845
Colon cancer metastatic 38.84 12.04 20 53166 1161 56237720
Bladder tamponade 38.80 12.04 10 53176 71 56238810
Drug hypersensitivity 38.68 12.04 132 53054 275073 55963808
Epistaxis 38.51 12.04 145 53041 66878 56172003
Hypokalaemia 38.48 12.04 184 53002 94253 56144628
Rash pustular 38.43 12.04 39 53147 6624 56232257
Venous thrombosis 38.38 12.04 33 53153 4547 56234334
Gastroenteritis norovirus 38.18 12.04 23 53163 1814 56237067
Septic shock 37.81 12.04 135 53051 60700 56178181
Cardiotoxicity 37.40 12.04 41 53145 7609 56231272
Blister 37.21 12.04 29 53157 108858 56130023
Atypical haemolytic uraemic syndrome 37.16 12.04 16 53170 618 56238263
Embolism 36.93 12.04 40 53146 7324 56231557
Depression 36.34 12.04 72 53114 180045 56058836
Factor VII deficiency 36.17 12.04 8 53178 26 56238855
Neuromyotonia 36.09 12.04 9 53177 55 56238826
Leukoerythroblastosis 35.90 12.04 12 53174 227 56238654
T-cell lymphoma refractory 35.81 12.04 9 53177 57 56238824
Sepsis 35.49 12.04 240 52946 139600 56099281
Asthma 34.92 12.04 33 53153 112737 56126144
Gastric varices haemorrhage 34.59 12.04 10 53176 114 56238767
Mucosal toxicity 34.53 12.04 13 53173 352 56238529
Neoplasm recurrence 34.33 12.04 24 53162 2440 56236441
Venous pressure jugular decreased 34.12 12.04 8 53178 36 56238845
Ascites 34.09 12.04 95 53091 37449 56201432
Interstitial lung disease 34.08 12.04 125 53061 56938 56181943
Trichomegaly 33.77 12.04 8 53178 38 56238843
Second primary malignancy 33.32 12.04 38 53148 7364 56231517
Laryngospasm 33.14 12.04 25 53161 2859 56236022
Folliculitis 33.02 12.04 6 53180 54973 56183908
Immune thrombocytopenia 32.91 12.04 43 53143 9582 56229299
Chills 32.88 12.04 187 52999 102417 56136464
Cholestasis 32.66 12.04 76 53110 26837 56212044
Device related infection 32.48 12.04 67 53119 21813 56217068
Short-bowel syndrome 31.70 12.04 13 53173 444 56238437
Stress cardiomyopathy 31.28 12.04 39 53147 8297 56230584
Nicotinic acid deficiency 31.27 12.04 8 53178 55 56238826
Contusion 30.78 12.04 46 53140 128384 56110497
Mobility decreased 30.61 12.04 29 53157 98962 56139919
Sleep disorder 30.25 12.04 13 53173 67650 56171231
Myelodysplastic syndrome 30.17 12.04 55 53131 16351 56222530
Dizziness 30.05 12.04 220 52966 375920 55862961
Rheumatoid arthritis 29.99 12.04 225 52961 382379 55856502
Aortic thrombosis 29.96 12.04 16 53170 1001 56237880
Nasal septum perforation 29.13 12.04 14 53172 700 56238181
Large intestinal obstruction 29.05 12.04 20 53166 1983 56236898
Injection site pain 28.99 12.04 41 53145 117077 56121804
Intestinal obstruction 28.64 12.04 74 53112 27897 56210984
Vena cava thrombosis 28.47 12.04 20 53166 2049 56236832
Anastomotic leak 28.43 12.04 12 53174 441 56238440
Sinusitis 28.27 12.04 94 53092 197487 56041394
Encapsulating peritoneal sclerosis 28.07 12.04 11 53175 333 56238548
Neutropenic colitis 27.65 12.04 22 53164 2721 56236160
Drug ineffective 27.40 12.04 661 52525 918328 55320553
Haemolytic anaemia 26.70 12.04 39 53147 9646 56229235
Rhinovirus infection 26.44 12.04 25 53161 3897 56234984
Catabolic state 26.32 12.04 7 53179 57 56238824
Wrong technique in product usage process 26.28 12.04 11 53175 58157 56180724
Memory impairment 26.02 12.04 26 53160 86531 56152350
Weight increased 26.01 12.04 120 53066 229583 56009298
Hip arthroplasty 26.01 12.04 3 53183 38620 56200261
Aortic intramural haematoma 25.90 12.04 7 53179 61 56238820
Chronic obstructive pulmonary disease 25.71 12.04 11 53175 57404 56181477
Portal vein thrombosis 25.64 12.04 20 53166 2403 56236478
Carcinoembryonic antigen increased 25.54 12.04 17 53169 1595 56237286
Blood pressure fluctuation 25.44 12.04 90 53096 40270 56198611
ECG signs of myocardial ischaemia 25.32 12.04 7 53179 67 56238814
Maternal exposure during pregnancy 25.22 12.04 93 53093 189460 56049421
Pain in extremity 25.19 12.04 171 53015 297260 55941621
Treatment failure 25.11 12.04 80 53106 170312 56068569
Clostridium difficile colitis 25.06 12.04 55 53131 18683 56220198
Myeloid leukaemia 24.96 12.04 10 53176 321 56238560
Tumour lysis syndrome 24.95 12.04 34 53152 7889 56230992
Fluid retention 24.80 12.04 10 53176 54068 56184813
Arthralgia 24.70 12.04 330 52856 501339 55737542
Suicidal ideation 24.40 12.04 12 53174 57730 56181151
Type II hypersensitivity 24.34 12.04 5 53181 10 56238871
Meningitis streptococcal 24.20 12.04 8 53178 146 56238735
Impaired healing 23.97 12.04 28 53158 86813 56152068
Human herpesvirus 6 infection 23.86 12.04 20 53166 2662 56236219
Haemolytic uraemic syndrome 23.60 12.04 19 53167 2389 56236492
Electrocardiogram QT prolonged 23.60 12.04 11 53175 54577 56184304
Depilation 23.44 12.04 5 53181 13 56238868
Metastases to ovary 23.35 12.04 10 53176 381 56238500
Peritonitis 23.33 12.04 49 53137 16153 56222728
Respiratory symptom 23.17 12.04 20 53166 2770 56236111
Deep vein thrombosis 23.16 12.04 138 53048 76839 56162042
Cholinergic syndrome 22.71 12.04 10 53176 408 56238473
Adverse drug reaction 22.69 12.04 17 53169 65115 56173766
K-ras gene mutation 22.44 12.04 5 53181 17 56238864
Plasma cell myeloma 22.43 12.04 8 53178 46638 56192243
Acute kidney injury 22.26 12.04 335 52851 240428 55998453
Inferior vena cava stenosis 22.21 12.04 5 53181 18 56238863
Venoocclusive liver disease 22.14 12.04 24 53162 4397 56234484
Metastases to lymph nodes 22.09 12.04 31 53155 7392 56231489
Gastrointestinal anastomotic leak 21.89 12.04 8 53178 199 56238682
Petechiae 21.84 12.04 42 53144 12997 56225884
Female genital tract fistula 21.83 12.04 24 53162 4468 56234413
Hepatic steatosis 21.54 12.04 64 53122 26150 56212731
Exposure during pregnancy 21.52 12.04 62 53124 136280 56102601
Psoriasis 21.44 12.04 34 53152 92658 56146223
Peripheral sensorimotor neuropathy 21.15 12.04 14 53172 1301 56237580
Gastrointestinal stoma complication 21.15 12.04 15 53171 1560 56237321
Superior vena cava syndrome 21.10 12.04 11 53175 655 56238226
Ocular toxicity 21.06 12.04 11 53175 658 56238223
Asthenia 20.98 12.04 447 52739 342526 55896355
Portal vein dilatation 20.73 12.04 5 53181 26 56238855
Multiple-drug resistance 20.65 12.04 22 53164 3952 56234929
Knee arthroplasty 20.60 12.04 8 53178 44251 56194630
Confusional state 20.57 12.04 114 53072 208041 56030840
Subileus 20.29 12.04 19 53167 2925 56235956
Oesophageal fistula 20.22 12.04 7 53179 148 56238733
Abortion spontaneous 20.21 12.04 8 53178 43745 56195136
Acute promyelocytic leukaemia 20.20 12.04 12 53174 922 56237959
Cutaneous tuberculosis 20.09 12.04 7 53179 151 56238730
Tumour necrosis 19.97 12.04 11 53175 732 56238149
Pruritus 19.95 12.04 197 52989 316426 55922455
Migraine 19.92 12.04 32 53154 86765 56152116
Subacute cutaneous lupus erythematosus 19.83 12.04 17 53169 2332 56236549
Administration site extravasation 19.74 12.04 11 53175 749 56238132
Occult blood 19.68 12.04 13 53173 1204 56237677
Cytopenia 19.60 12.04 34 53152 9721 56229160
Vitiligo 19.42 12.04 13 53173 1231 56237650
Large intestine perforation 19.34 12.04 30 53156 7821 56231060
Red cell fragmentation syndrome 19.34 12.04 5 53181 36 56238845
Paraesthesia 19.13 12.04 198 52988 130316 56108565
Encephalopathy 19.12 12.04 75 53111 35250 56203631
Venous thrombosis limb 19.11 12.04 18 53168 2791 56236090
Overdose 19.09 12.04 45 53141 105785 56133096
Soft tissue necrosis 18.90 12.04 9 53177 441 56238440
Post procedural diarrhoea 18.84 12.04 9 53177 444 56238437
Ovarian fibroma 18.83 12.04 6 53180 97 56238784
Pelvic fluid collection 18.70 12.04 11 53175 830 56238051
Drug resistance 18.67 12.04 52 53134 20490 56218391
Mouth ulceration 18.60 12.04 66 53120 29574 56209307
Varices oesophageal 18.54 12.04 18 53168 2898 56235983
Hypertrichosis 18.52 12.04 12 53174 1076 56237805
Intentional product misuse 18.52 12.04 13 53173 51491 56187390
Haemoglobin increased 18.36 12.04 19 53167 3301 56235580
Endometrial dysplasia 18.33 12.04 4 53182 12 56238869
Hemiparesis 18.17 12.04 53 53133 21437 56217444
Colitis 18.14 12.04 83 53103 41728 56197153
Gait disturbance 18.08 12.04 86 53100 163235 56075646
Joint noise 17.93 12.04 20 53166 3784 56235097
Wheezing 17.84 12.04 27 53159 74999 56163882
Portal shunt 17.64 12.04 4 53182 15 56238866
Hypertransaminasaemia 17.62 12.04 22 53164 4685 56234196
Hypocapnia 17.52 12.04 8 53178 356 56238525
Feeling abnormal 17.47 12.04 66 53120 133536 56105345
Jugular vein thrombosis 17.26 12.04 17 53169 2786 56236095
Mixed adenoneuroendocrine carcinoma 17.25 12.04 4 53182 17 56238864
Coronary artery disease 17.17 12.04 4 53182 30792 56208089
Rash maculo-papular 16.98 12.04 63 53123 28844 56210037
Reticulocytosis 16.86 12.04 6 53180 138 56238743
Balance disorder 16.82 12.04 29 53157 76491 56162390
Productive cough 16.77 12.04 17 53169 56215 56182666
Sedation 16.72 12.04 6 53180 34848 56204033
Small intestinal obstruction 16.70 12.04 44 53142 16781 56222100
Cardiomyopathy 16.63 12.04 43 53143 16215 56222666
C-reactive protein abnormal 16.56 12.04 7 53179 36802 56202079
Autoimmune retinopathy 16.55 12.04 4 53182 21 56238860
Proctalgia 16.38 12.04 23 53163 5486 56233395
Adverse event 16.22 12.04 17 53169 55359 56183522
Rectal cancer metastatic 16.22 12.04 7 53179 272 56238609
Endothelial dysfunction 16.17 12.04 6 53180 156 56238725
Enterocolitis 15.93 12.04 26 53160 7078 56231803
Pneumothorax 15.91 12.04 40 53146 14827 56224054
Dysphagia 15.87 12.04 132 53054 81815 56157066
Anxiety 15.87 12.04 112 53074 193060 56045821
Liver abscess 15.80 12.04 16 53170 2710 56236171
Upper respiratory tract infection 15.69 12.04 27 53159 71261 56167620
Hallucination 15.66 12.04 14 53172 49135 56189746
Acquired gene mutation 15.63 12.04 10 53176 877 56238004
Rotator cuff syndrome 15.52 12.04 35 53151 12108 56226773
Thrombotic microangiopathy 15.38 12.04 30 53156 9381 56229500
Product intolerance 15.33 12.04 4 53182 30 56238851
Cardiac arrest 15.33 12.04 37 53149 86277 56152604
Pelvic abscess 15.25 12.04 12 53174 1460 56237421
Optic nerve disorder 15.13 12.04 9 53177 693 56238188
Overgrowth fungal 15.09 12.04 5 53181 92 56238789
Toxic encephalopathy 15.06 12.04 23 53163 5915 56232966
Rectal cancer recurrent 14.89 12.04 4 53182 34 56238847
Hepatic vein stenosis 14.89 12.04 4 53182 34 56238847
Condition aggravated 14.79 12.04 233 52953 344665 55894216
Hyperbilirubinaemia 14.79 12.04 31 53155 10204 56228677
Hepatitis toxic 14.74 12.04 16 53170 2936 56235945
Headache 14.73 12.04 409 52777 558635 55680246
No adverse event 14.71 12.04 8 53178 36366 56202515
Unevaluable event 14.70 12.04 14 53172 47673 56191208
Depressed mood 14.70 12.04 8 53178 36351 56202530
Periportal sinus dilatation 14.61 12.04 3 53183 6 56238875
Accessory spleen 14.61 12.04 3 53183 6 56238875
Optic disc hyperaemia 14.61 12.04 3 53183 6 56238875
Metastases to peritoneum 14.51 12.04 16 53170 2988 56235893
Pneumothorax spontaneous 14.47 12.04 9 53177 751 56238130
Tumour perforation 14.43 12.04 5 53181 106 56238775
Irritability 14.35 12.04 5 53181 29583 56209298
Escherichia bacteraemia 14.30 12.04 17 53169 3443 56235438
Pneumonia 14.28 12.04 285 52901 406813 55832068
Multiple organ dysfunction syndrome 14.24 12.04 92 53094 52678 56186203
Hepatic failure 14.18 12.04 66 53120 33420 56205461
Throat tightness 14.15 12.04 50 53136 22357 56216524
Tumour rupture 14.13 12.04 5 53181 113 56238768
Vaginal infection 14.12 12.04 24 53162 6753 56232128
Psychiatric decompensation 14.06 12.04 11 53175 1327 56237554
Cardiomyopathy acute 14.05 12.04 6 53180 227 56238654
Benign hydatidiform mole 14.01 12.04 5 53181 116 56238765
Rectal perforation 13.93 12.04 7 53179 386 56238495
Hypocalcaemia 13.93 12.04 59 53127 28701 56210180
Hemianaesthesia 13.91 12.04 7 53179 387 56238494
Amnesia 13.82 12.04 14 53172 46308 56192573
Tubular breast carcinoma 13.80 12.04 4 53182 46 56238835
Cachexia 13.77 12.04 20 53166 4922 56233959
Myalgia 13.76 12.04 71 53115 131954 56106927
Peripheral nerve injury 13.65 12.04 7 53179 403 56238478
Bradycardia 13.58 12.04 27 53159 67477 56171404
Loss of personal independence in daily activities 13.58 12.04 36 53150 81333 56157548
Medication error 13.56 12.04 12 53174 42323 56196558
Intracranial pressure increased 13.55 12.04 19 53167 4526 56234355
Vaginal fistula 13.54 12.04 7 53179 410 56238471
Agitation 13.48 12.04 20 53166 56016 56182865
Muscle atrophy 13.46 12.04 23 53163 6498 56232383
Cognitive disorder 13.39 12.04 16 53170 49117 56189764
Chronic kidney disease 13.38 12.04 12 53174 42044 56196837
Colon cancer recurrent 13.36 12.04 4 53182 52 56238829
Ill-defined disorder 13.30 12.04 28 53158 68515 56170366
Somnolence 13.29 12.04 95 53091 163318 56075563
Gastroenteropancreatic neuroendocrine tumour disease 13.22 12.04 4 53182 54 56238827
Disease recurrence 13.19 12.04 51 53135 23809 56215072
Drug eruption 13.12 12.04 4 53182 25759 56213122
Therapeutic product effect decreased 13.07 12.04 100 53086 169352 56069529
Eczema asteatotic 13.06 12.04 6 53180 271 56238610
Product use in unapproved indication 13.02 12.04 196 52990 140626 56098255
Hepatic lesion 13.01 12.04 18 53168 4237 56234644
Bone pain 12.99 12.04 17 53169 50168 56188713
Visual acuity reduced transiently 12.93 12.04 5 53181 146 56238735
Metastases to spleen 12.89 12.04 5 53181 147 56238734
Anaemia of malignant disease 12.88 12.04 7 53179 454 56238427
Nodular regenerative hyperplasia 12.86 12.04 7 53179 455 56238426
Ovarian cystectomy 12.83 12.04 5 53181 149 56238732
Metastasis 12.80 12.04 19 53167 4765 56234116
Colorectal cancer 12.80 12.04 16 53170 3413 56235468
Granulomatous lymphadenitis 12.77 12.04 5 53181 151 56238730
Blood glucose increased 12.73 12.04 33 53153 75118 56163763
Fibromyalgia 12.73 12.04 23 53163 59580 56179301
Gastrointestinal necrosis 12.71 12.04 14 53172 2612 56236269
Tubal rupture 12.71 12.04 3 53183 14 56238867
Basal cell carcinoma 12.70 12.04 4 53182 25217 56213664
Acute myeloid leukaemia 12.60 12.04 40 53146 16932 56221949
Acute lymphocytic leukaemia recurrent 12.44 12.04 13 53173 2284 56236597
Orthostatic hypotension 12.44 12.04 8 53178 33191 56205690
Pharyngotonsillitis 12.38 12.04 5 53181 164 56238717
Rhinocerebral mucormycosis 12.38 12.04 6 53180 306 56238575
Blood phosphorus decreased 12.35 12.04 17 53169 3980 56234901
Obesity 12.35 12.04 3 53183 22445 56216436
Visual impairment 12.25 12.04 33 53153 74169 56164712
Hypertensive crisis 12.23 12.04 35 53151 14001 56224880
Prescribed overdose 12.22 12.04 3 53183 22293 56216588
Metastases to bone marrow 12.18 12.04 6 53180 317 56238564
Granulomatous liver disease 12.16 12.04 8 53178 736 56238145
Gait inability 12.07 12.04 13 53173 41805 56197076

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 966.63 12.65 1259 59162 139105 31497818
Skin toxicity 635.04 12.65 254 60167 3905 31633018
Neuropathy peripheral 620.68 12.65 742 59679 74907 31562016
Diarrhoea 497.09 12.65 1633 58788 350776 31286147
Mucosal inflammation 402.31 12.65 407 60014 34020 31602903
Neurotoxicity 392.80 12.65 291 60130 15935 31620988
Dermatitis acneiform 377.04 12.65 195 60226 5572 31631351
Disease progression 364.37 12.65 633 59788 89831 31547092
Metastases to liver 332.39 12.65 239 60182 12488 31624435
Colorectal cancer metastatic 314.37 12.65 109 60312 1093 31635830
Thrombocytopenia 304.09 12.65 769 59652 141978 31494945
Stomatitis 303.58 12.65 375 60046 39063 31597860
Palmar-plantar erythrodysaesthesia syndrome 303.42 12.65 245 60176 15238 31621685
Polyneuropathy 246.58 12.65 202 60219 12820 31624103
Arteriospasm coronary 207.11 12.65 104 60317 2787 31634136
Gastrointestinal toxicity 190.42 12.65 91 60330 2183 31634740
Paronychia 182.55 12.65 99 60322 3119 31633804
Haematotoxicity 179.41 12.65 131 60290 7006 31629917
Skin reaction 169.19 12.65 108 60313 4626 31632297
Proteinuria 154.71 12.65 175 60246 16588 31620335
Febrile neutropenia 153.77 12.65 546 59875 121303 31515620
Completed suicide 151.92 12.65 5 60416 91509 31545414
Leukopenia 145.80 12.65 333 60088 57495 31579428
Product dose omission issue 135.36 12.65 20 60401 105566 31531357
Portal hypertension 120.89 12.65 80 60341 3645 31633278
Metastases to lung 117.83 12.65 110 60311 8312 31628611
Pyrexia 117.02 12.65 982 59439 302858 31334065
Nausea 111.61 12.65 982 59439 306965 31329958
Therapy partial responder 110.18 12.65 95 60326 6467 31630456
Cardiotoxicity 110.16 12.65 85 60336 4942 31631981
Drug abuse 109.34 12.65 18 60403 87740 31549183
Chills 109.06 12.65 350 60071 73800 31563123
Bone marrow failure 107.29 12.65 192 60229 27816 31609107
Decreased appetite 107.24 12.65 575 59846 152642 31484281
Vomiting 106.14 12.65 760 59661 223213 31413710
Peripheral sensory neuropathy 105.17 12.65 91 60330 6224 31630699
Cardiac failure congestive 101.81 12.65 15 60406 79372 31557551
Myelosuppression 100.69 12.65 133 60288 14787 31622136
Carcinoembryonic antigen increased 100.35 12.65 40 60381 608 31636315
Rash pustular 98.36 12.65 79 60342 4870 31632053
Hyperammonaemia 97.03 12.65 84 60337 5749 31631174
Neoplasm progression 94.92 12.65 152 60269 20120 31616803
Alopecia 92.58 12.65 152 60269 20543 31616380
Plasma cell myeloma 87.49 12.65 5 60416 56526 31580397
General physical health deterioration 87.11 12.65 437 59984 112998 31523925
Drug interaction 83.55 12.65 170 60251 208373 31428550
Rhabdomyolysis 81.55 12.65 12 60409 63569 31573354
Intestinal obstruction 81.13 12.65 143 60278 20467 31616456
Abdominal pain 80.81 12.65 515 59906 145437 31491486
Myalgia 79.85 12.65 24 60397 77234 31559689
Drug ineffective 77.31 12.65 441 59980 395132 31241791
Metastases to peritoneum 75.00 12.65 44 60377 1616 31635307
Hyperammonaemic encephalopathy 72.70 12.65 48 60373 2178 31634745
Focal nodular hyperplasia 72.03 12.65 22 60399 141 31636782
Adenocarcinoma of colon 70.86 12.65 55 60366 3225 31633698
Malignant neoplasm progression 70.53 12.65 318 60103 78680 31558243
Pulmonary embolism 70.18 12.65 325 60096 81321 31555602
Gastrointestinal perforation 70.11 12.65 57 60364 3575 31633348
Pneumonia 68.61 12.65 368 60053 334944 31301979
Myocardial infarction 66.36 12.65 71 60350 113383 31523540
Fall 66.06 12.65 162 60259 185927 31450996
Febrile bone marrow aplasia 65.81 12.65 78 60343 7768 31629155
Asthma 65.23 12.65 4 60417 42607 31594316
Insomnia 64.12 12.65 52 60369 94784 31542139
Ascites 61.52 12.65 195 60226 40818 31596105
Anxiety 61.44 12.65 50 60371 90983 31545940
Hypomagnesaemia 60.98 12.65 121 60300 18937 31617986
Enteritis 60.25 12.65 71 60350 7028 31629895
Interstitial lung disease 59.99 12.65 254 60167 61149 31575774
Death 56.67 12.65 429 59992 360140 31276783
Somnolence 55.12 12.65 65 60356 99380 31537543
Psoriasis 55.10 12.65 11 60410 46708 31590215
Headache 53.99 12.65 175 60246 183477 31453446
Device related infection 52.76 12.65 104 60317 16195 31620728
Leukoencephalopathy 52.72 12.65 50 60371 3852 31633071
Colorectal cancer 52.54 12.65 55 60366 4774 31632149
Small intestinal obstruction 52.40 12.65 93 60328 13379 31623544
Conjunctivitis 52.30 12.65 73 60348 8550 31628373
Paraesthesia 51.74 12.65 228 60193 55843 31581080
Recall phenomenon 51.62 12.65 24 60397 540 31636383
Mucosal toxicity 51.14 12.65 19 60402 236 31636687
Drug clearance decreased 50.71 12.65 34 60387 1583 31635340
Cholangitis 50.53 12.65 69 60352 7917 31629006
Hospitalisation 50.50 12.65 16 60405 49791 31587132
Intentional overdose 50.40 12.65 9 60412 41380 31595543
Coronary artery disease 50.06 12.65 13 60408 46074 31590849
Transdifferentiation of neoplasm 49.78 12.65 14 60407 64 31636859
Weight increased 49.50 12.65 51 60370 82896 31554027
Ileus 49.36 12.65 97 60324 15072 31621851
Influenza 49.11 12.65 12 60409 44313 31592610
Hiccups 48.15 12.65 73 60348 9214 31627709
Aggression 47.89 12.65 7 60414 37284 31599639
Dizziness 47.33 12.65 207 60214 198940 31437983
Tumour necrosis 47.24 12.65 29 60392 1158 31635765
Blood glucose increased 47.19 12.65 29 60392 61054 31575869
Dehydration 47.17 12.65 388 60033 118723 31518200
Metastases to lymph nodes 47.13 12.65 49 60372 4219 31632704
Chronic obstructive pulmonary disease 46.71 12.65 14 60407 45152 31591771
Anastomotic leak 46.53 12.65 23 60398 595 31636328
Subileus 45.61 12.65 41 60380 2949 31633974
Peripheral swelling 44.88 12.65 38 60383 67827 31569096
Neoplasm recurrence 44.70 12.65 35 60386 2079 31634844
Subclavian vein thrombosis 44.57 12.65 25 60396 842 31636081
Rectal tenesmus 44.42 12.65 24 60397 750 31636173
Bradycardia 44.42 12.65 40 60381 69287 31567636
Arthralgia 43.99 12.65 145 60276 151279 31485644
Peripheral sensorimotor neuropathy 43.97 12.65 30 60391 1438 31635485
Erythema 43.96 12.65 283 60138 80122 31556801
Carbohydrate antigen 19-9 increased 43.94 12.65 16 60405 187 31636736
Injection site pain 43.34 12.65 7 60414 34627 31602296
Febrile infection 43.30 12.65 34 60387 2028 31634895
Colon cancer metastatic 43.17 12.65 31 60390 1614 31635309
Proteus infection 42.69 12.65 25 60396 915 31636008
Intravascular haemolysis 42.32 12.65 19 60402 393 31636530
Feeling abnormal 41.40 12.65 29 60392 56973 31579950
Anastomotic complication 40.79 12.65 18 60403 357 31636566
Depression 40.73 12.65 69 60352 90746 31546177
Ileal perforation 40.59 12.65 22 60399 692 31636231
Tumour lysis syndrome 40.28 12.65 90 60331 15295 31621628
Administration site extravasation 39.78 12.65 20 60401 537 31636386
Intentional product misuse 38.81 12.65 12 60409 37939 31598984
Sinusitis 38.63 12.65 11 60410 36685 31600238
Type II hypersensitivity 38.60 12.65 10 60411 31 31636892
Pain in extremity 38.24 12.65 105 60316 116098 31520825
Suicidal ideation 38.16 12.65 11 60410 36395 31600528
Epistaxis 37.74 12.65 202 60219 53505 31583418
Nicotinic acid deficiency 37.10 12.65 12 60409 95 31636828
Hypersensitivity 36.72 12.65 206 60215 55537 31581386
Unevaluable event 36.47 12.65 7 60414 30568 31606355
Hallucination 35.89 12.65 22 60399 46388 31590535
Pelvic abscess 35.74 12.65 22 60399 883 31636040
Wheezing 35.70 12.65 12 60409 35974 31600949
Cellulitis 35.44 12.65 24 60397 47994 31588929
Muscle spasms 35.39 12.65 47 60374 68271 31568652
Intestinal perforation 35.35 12.65 60 60361 8329 31628594
Colon cancer recurrent 34.90 12.65 12 60409 117 31636806
Pneumatosis intestinalis 34.66 12.65 39 60382 3672 31633251
Contusion 34.58 12.65 10 60411 33018 31603905
Hypoglycaemia 34.33 12.65 28 60393 50918 31586005
Asthenia 34.24 12.65 610 59811 224145 31412778
Adverse drug reaction 34.11 12.65 4 60417 25197 31611726
Necrotising fasciitis 33.18 12.65 37 60384 3449 31633474
Colitis 32.93 12.65 140 60281 33747 31603176
Foetal disorder 32.77 12.65 20 60401 790 31636133
Anal haemorrhage 32.70 12.65 31 60390 2387 31634536
Treatment noncompliance 32.57 12.65 5 60416 25679 31611244
Jugular vein thrombosis 32.40 12.65 25 60396 1453 31635470
Vena cava thrombosis 32.31 12.65 22 60399 1051 31635872
Anaemia of malignant disease 31.64 12.65 16 60405 435 31636488
Colitis microscopic 31.53 12.65 28 60393 1982 31634941
Hyperbilirubinaemia 31.45 12.65 83 60338 15667 31621256
Portal vein thrombosis 31.30 12.65 36 60385 3471 31633452
Blood creatine phosphokinase increased 30.95 12.65 21 60400 41953 31594970
Induration 30.52 12.65 20 60401 896 31636027
Cholinergic syndrome 30.09 12.65 16 60405 484 31636439
Vascular access complication 29.99 12.65 14 60407 318 31636605
Venoocclusive liver disease 29.90 12.65 52 60369 7360 31629563
Rectal adenocarcinoma 29.79 12.65 19 60402 812 31636111
Prothrombin level decreased 29.78 12.65 21 60400 1062 31635861
Proctalgia 29.75 12.65 40 60381 4522 31632401
Confusional state 29.60 12.65 142 60279 133192 31503731
Acute coronary syndrome 29.30 12.65 71 60350 12718 31624205
Peritonitis 28.82 12.65 79 60342 15248 31621675
Intentional product use issue 28.69 12.65 31 60390 49316 31587607
Wrong technique in product usage process 28.40 12.65 14 60407 33329 31603594
Hypokalaemia 28.31 12.65 187 60234 53387 31583536
Memory impairment 28.22 12.65 19 60402 38111 31598812
Neutropenia neonatal 28.03 12.65 17 60404 664 31636259
Electrocardiogram QT prolonged 28.01 12.65 19 60402 37968 31598955
Circulatory collapse 27.89 12.65 92 60329 19652 31617271
Pulmonary infarction 27.76 12.65 21 60400 1185 31635738
Sarcoidosis 27.68 12.65 30 60391 2709 31634214
Electrocardiogram ST segment elevation 27.65 12.65 39 60382 4612 31632311
Overdose 27.47 12.65 77 60344 84587 31552336
Abdominal pain lower 27.41 12.65 57 60364 9219 31627704
Small intestinal perforation 27.38 12.65 26 60395 2006 31634917
Hypoalbuminaemia 27.18 12.65 63 60358 10965 31625958
Disturbance in attention 27.07 12.65 5 60416 22445 31614478
Injury 27.00 12.65 3 60418 19706 31617217
Splenomegaly 26.99 12.65 72 60349 13677 31623246
Anal fissure 26.97 12.65 33 60388 3396 31633527
Fluid retention 26.92 12.65 7 60414 24795 31612128
Onycholysis 26.75 12.65 16 60405 609 31636314
Perihepatic abscess 26.43 12.65 9 60412 85 31636838
Koebner phenomenon 26.36 12.65 8 60413 50 31636873
Anaemia 26.22 12.65 561 59860 212961 31423962
Evans syndrome 26.14 12.65 12 60409 262 31636661
Toxic erythema of chemotherapy 25.97 12.65 9 60412 90 31636833
Cardiac disorder 25.86 12.65 22 60399 39192 31597731
Catheter site thrombosis 25.71 12.65 8 60413 55 31636868
Rheumatoid arthritis 25.67 12.65 32 60389 47777 31589146
Dyspnoea 25.66 12.65 481 59940 342998 31293925
Cerebral vasoconstriction 25.50 12.65 11 60410 206 31636717
Perforation 25.45 12.65 11 60410 207 31636716
Sleep apnoea syndrome 25.10 12.65 3 60418 18622 31618301
Ocular toxicity 25.07 12.65 11 60410 215 31636708
Large intestine perforation 25.04 12.65 49 60372 7587 31629336
Prostate cancer 24.92 12.65 21 60400 37580 31599343
Enterovesical fistula 24.77 12.65 16 60405 699 31636224
Cerebrovascular accident 24.53 12.65 74 60347 79410 31557513
Oesophagobronchial fistula 24.51 12.65 10 60411 162 31636761
Product prescribing error 24.51 12.65 4 60417 19638 31617285
Liver function test abnormal 24.49 12.65 13 60408 29679 31607244
Enterocutaneous fistula 24.40 12.65 17 60404 843 31636080
Influenza like illness 24.34 12.65 9 60412 25428 31611495
Adenocarcinoma 24.29 12.65 23 60398 1768 31635155
Perioral dermatitis 24.14 12.65 9 60412 113 31636810
Interventricular septum rupture 24.10 12.65 6 60415 15 31636908
Seizure 24.08 12.65 103 60318 99665 31537258
Peritoneal neoplasm 23.90 12.65 7 60414 38 31636885
Clostridial infection 23.90 12.65 31 60390 3384 31633539
Rectal cancer metastatic 23.84 12.65 11 60410 243 31636680
Rectal cancer 23.82 12.65 25 60396 2176 31634747
Pulmonary oedema 23.67 12.65 30 60391 44472 31592451
Stoma site haemorrhage 23.65 12.65 16 60405 756 31636167
Astringent therapy 23.56 12.65 6 60415 17 31636906
ECG signs of myocardial ischaemia 23.25 12.65 10 60411 186 31636737
Superior vena cava syndrome 23.19 12.65 14 60407 542 31636381
Nail disorder 23.19 12.65 23 60398 1872 31635051
Rectal perforation 23.14 12.65 13 60408 439 31636484
Productive cough 23.14 12.65 18 60403 33522 31603401
Embolism 23.13 12.65 46 60375 7207 31629716
Anal erythema 22.74 12.65 8 60413 84 31636839
Stoma site pain 22.67 12.65 14 60407 565 31636358
Pelvic fluid collection 22.63 12.65 9 60412 136 31636787
Pancreatic carcinoma metastatic 22.62 12.65 28 60393 2916 31634007
International normalised ratio increased 22.52 12.65 32 60389 45191 31591732
Incorrect dose administered 22.45 12.65 21 60400 35731 31601192
Oesophagitis 22.36 12.65 63 60358 12353 31624570
Acute abdomen 22.30 12.65 22 60399 1779 31635144
Device related thrombosis 22.18 12.65 17 60404 978 31635945
Pneumoperitoneum 22.10 12.65 21 60400 1622 31635301
Product use issue 22.04 12.65 47 60374 56712 31580211
Perforation bile duct 21.98 12.65 6 60415 24 31636899
Trichomegaly 21.78 12.65 6 60415 25 31636898
Mucocutaneous rash 21.78 12.65 6 60415 25 31636898
Liver abscess 21.44 12.65 30 60391 3521 31633402
Sedation 21.27 12.65 5 60416 18960 31617963
Full blood count abnormal 21.15 12.65 3 60418 16344 31620579
Oesophageal haemorrhage 21.13 12.65 18 60403 1205 31635718
Pulmonary artery thrombosis 20.99 12.65 14 60407 646 31636277
Haematopoietic stem cell mobilisation 20.99 12.65 9 60412 166 31636757
Lung neoplasm malignant 20.94 12.65 3 60418 16227 31620696
Nipple swelling 20.93 12.65 8 60413 108 31636815
Respiratory arrest 20.93 12.65 12 60409 26245 31610678
Agitation 20.91 12.65 45 60376 54124 31582799
Ischiorectal hernia 20.85 12.65 5 60416 10 31636913
Chronic kidney disease 20.83 12.65 25 60396 37950 31598973
Angioedema 20.81 12.65 20 60401 33598 31603325
Cranial nerve disorder 20.74 12.65 13 60408 539 31636384
Skin fissures 20.71 12.65 33 60388 4347 31632576
Contraindicated product administered 20.67 12.65 6 60415 19766 31617157
Nephrotic syndrome 20.66 12.65 43 60378 6960 31629963
Onychoclasis 20.53 12.65 21 60400 1774 31635149
Mouth ulceration 20.48 12.65 56 60365 10792 31626131
Portal venous gas 20.35 12.65 11 60410 344 31636579
Aplasia 20.33 12.65 32 60389 4171 31632752
Non-cirrhotic portal hypertension 20.33 12.65 10 60411 256 31636667
Hepatectomy 20.29 12.65 7 60414 69 31636854
Cardiac arrest 20.25 12.65 94 60327 88968 31547955
Neurosarcoidosis 20.14 12.65 9 60412 184 31636739
Organising pneumonia 20.10 12.65 37 60384 5473 31631450
Hepatic lesion 20.08 12.65 28 60393 3275 31633648
Thrombotic thrombocytopenic purpura 20.02 12.65 28 60393 3285 31633638
Deep vein thrombosis 19.94 12.65 190 60231 60546 31576377
Eyelash changes 19.94 12.65 5 60416 13 31636910
Cholecystitis chronic 19.82 12.65 15 60406 847 31636076
Arthritis 19.79 12.65 14 60407 27371 31609552
Acne 19.73 12.65 53 60368 10107 31626816
Klebsiella infection 19.70 12.65 45 60376 7758 31629165
Cachexia 19.69 12.65 41 60380 6638 31630285
Varices oesophageal 19.68 12.65 28 60393 3338 31633585
Acute motor-sensory axonal neuropathy 19.58 12.65 8 60413 130 31636793
Visceral venous thrombosis 19.42 12.65 5 60416 15 31636908
Allodynia 19.38 12.65 13 60408 606 31636317
Hepatitis B surface antigen positive 19.36 12.65 8 60413 134 31636789
Dysaesthesia 19.33 12.65 22 60399 2097 31634826
Haematoma 19.28 12.65 11 60410 24128 31612795
Product administration error 19.26 12.65 3 60418 15244 31621679
K-ras gene mutation 19.18 12.65 5 60416 16 31636907
Anastomotic fistula 19.06 12.65 7 60414 84 31636839
Neck pain 18.94 12.65 10 60411 22900 31614023
Venous thrombosis 18.91 12.65 27 60394 3228 31633695
Xerosis 18.90 12.65 12 60409 509 31636414
Abnormal behaviour 18.83 12.65 11 60410 23817 31613106
Catheter site extravasation 18.76 12.65 7 60414 88 31636835
Cerebral haemorrhage 18.64 12.65 21 60400 32791 31604132
Heart rate increased 18.63 12.65 31 60390 41079 31595844
Multiple organ dysfunction syndrome 18.63 12.65 67 60354 68136 31568787
Renal disorder 18.57 12.65 11 60410 23634 31613289
Balanoposthitis 18.50 12.65 16 60405 1093 31635830
Off label use 18.38 12.65 823 59598 346451 31290472
Bladder cancer 18.37 12.65 3 60418 14722 31622201
Bacterial colitis 18.18 12.65 6 60415 51 31636872
Pseudocirrhosis 18.12 12.65 5 60416 21 31636902
Performance status decreased 18.04 12.65 29 60392 3849 31633074
Oral pain 18.03 12.65 50 60371 9715 31627208
Rectal abscess 17.96 12.65 15 60406 977 31635946
Rectosigmoid cancer 17.89 12.65 8 60413 164 31636759
Fatigue 17.87 12.65 795 59626 334411 31302512
Electromyogram abnormal 17.78 12.65 6 60415 55 31636868
B-cell small lymphocytic lymphoma 17.75 12.65 8 60413 167 31636756
Emotional distress 17.74 12.65 3 60418 14353 31622570
Red blood cell sedimentation rate abnormal 17.46 12.65 25 60396 2997 31633926
Urticaria 17.42 12.65 54 60367 57463 31579460
Eczema impetiginous 17.41 12.65 5 60416 25 31636898
Radiation interaction 17.41 12.65 5 60416 25 31636898
Pelvic inflammatory disease 17.41 12.65 4 60417 6 31636917
Posterior reversible encephalopathy syndrome 17.33 12.65 48 60373 9319 31627604
Streptococcal bacteraemia 17.30 12.65 19 60402 1741 31635182
Candida infection 17.23 12.65 69 60352 16189 31620734
Perineal disorder 17.14 12.65 6 60415 62 31636861
Gastrointestinal haemorrhage 17.11 12.65 90 60331 82459 31554464
Organic brain syndrome 17.08 12.65 9 60412 267 31636656
Haemolytic anaemia 16.95 12.65 49 60372 9747 31627176
Dysphonia 16.95 12.65 81 60340 20510 31616413
Soft tissue swelling 16.90 12.65 10 60411 373 31636550
Haemorrhage intracranial 16.88 12.65 4 60417 15084 31621839
Bronchitis 16.81 12.65 30 60391 38687 31598236
Crystal nephropathy 16.81 12.65 10 60411 377 31636546
Faeces discoloured 16.77 12.65 3 60418 13783 31623140
Metastasis 16.72 12.65 27 60394 3597 31633326
Neutrophil count decreased 16.68 12.65 148 60273 46246 31590677
Oesophageal irritation 16.64 12.65 6 60415 68 31636855
Psychotic disorder 16.64 12.65 11 60410 22282 31614641
Hypervolaemia 16.57 12.65 7 60414 18244 31618679
Intestinal strangulation 16.51 12.65 5 60416 31 31636892
Vocal cord paralysis 16.51 12.65 14 60407 931 31635992
Malignant ascites 16.34 12.65 10 60411 397 31636526
Proctitis 16.31 12.65 21 60400 2276 31634647
Brief psychotic disorder with marked stressors 16.29 12.65 8 60413 204 31636719
Hepatic cancer recurrent 16.16 12.65 9 60412 299 31636624
Irritability 16.15 12.65 12 60409 22877 31614046
Tumour fistulisation 16.07 12.65 4 60417 10 31636913
Medication error 15.99 12.65 12 60409 22760 31614163
Drug ineffective for unapproved indication 15.87 12.65 7 60414 17783 31619140
Gastrooesophageal reflux disease 15.86 12.65 25 60396 33846 31603077
Injection site erythema 15.85 12.65 4 60417 14458 31622465
Sepsis 15.76 12.65 390 60031 151539 31485384
Gene mutation 15.73 12.65 15 60406 1163 31635760
Change of bowel habit 15.69 12.65 14 60407 997 31635926
Limbic encephalitis 15.69 12.65 10 60411 427 31636496
Laboratory test interference 15.60 12.65 10 60411 431 31636492
Temperature difference of extremities 15.54 12.65 4 60417 12 31636911
Portal shunt 15.52 12.65 5 60416 39 31636884
Hypertension 15.50 12.65 336 60085 127764 31509159
Tremor 15.46 12.65 84 60337 76336 31560587
Colorectal cancer recurrent 15.41 12.65 5 60416 40 31636883
Tumour marker increased 15.41 12.65 11 60410 567 31636356
Dry skin 15.35 12.65 92 60329 25389 31611534
Road traffic accident 15.33 12.65 6 60415 16375 31620548
Folliculitis 15.32 12.65 28 60393 4120 31632803
Duodenal perforation 15.16 12.65 15 60406 1217 31635706
Mobility decreased 15.15 12.65 18 60403 27451 31609472
Retinitis viral 15.12 12.65 6 60415 90 31636833
Retroperitoneal abscess 15.12 12.65 7 60414 156 31636767
Oedema 15.10 12.65 37 60384 42524 31594399
Heart rate decreased 15.09 12.65 19 60402 28247 31608676
Cardiac failure 15.00 12.65 99 60322 85854 31551069
Ductal adenocarcinoma of pancreas 15.00 12.65 5 60416 44 31636879
Gout 14.92 12.65 8 60413 18166 31618757
Joint ankylosis 14.90 12.65 14 60407 1066 31635857
Therapy non-responder 14.86 12.65 26 60395 33785 31603138
Toxicity to various agents 14.82 12.65 250 60171 181237 31455686
Acinetobacter sepsis 14.80 12.65 5 60416 46 31636877
Ventricular tachycardia 14.79 12.65 14 60407 23687 31613236
Bladder hypertrophy 14.79 12.65 11 60410 605 31636318
Blood pressure increased 14.78 12.65 90 60331 79543 31557380
Dyskinesia 14.70 12.65 11 60410 20899 31616024
Oesophageal carcinoma recurrent 14.65 12.65 4 60417 16 31636907
Paraesthesia mucosal 14.65 12.65 4 60417 16 31636907
Gastrointestinal anastomotic leak 14.58 12.65 9 60412 363 31636560
Hypersplenism 14.58 12.65 9 60412 363 31636560
Stomal hernia 14.53 12.65 7 60414 171 31636752
Balance disorder 14.51 12.65 31 60390 37391 31599532
Diffuse alveolar damage 14.46 12.65 19 60402 2100 31634823
Fistula 14.45 12.65 33 60388 5688 31631235
Prostatic calcification 14.44 12.65 6 60415 102 31636821
Laryngospasm 14.34 12.65 15 60406 1301 31635622
Nasopharyngitis 14.22 12.65 67 60354 63178 31573745
Peritoneal disorder 14.19 12.65 8 60413 272 31636651
Rectal cancer recurrent 14.10 12.65 4 60417 19 31636904
Palmar erythema 14.09 12.65 8 60413 276 31636647
Bone cyst 14.04 12.65 14 60407 1147 31635776
Drug clearance increased 14.03 12.65 6 60415 110 31636813
Nightmare 14.01 12.65 3 60418 12134 31624789
Lip swelling 14.01 12.65 4 60417 13319 31623604
Hyperkalaemia 13.99 12.65 69 60352 64282 31572641
Blood pressure decreased 13.97 12.65 46 60375 48045 31588878
Metastases to pelvis 13.93 12.65 8 60413 282 31636641
Incorrect drug administration rate 13.84 12.65 15 60406 1355 31635568
Renal impairment 13.82 12.65 102 60319 86247 31550676
Jaundice 13.80 12.65 102 60319 30185 31606738
Malaise 13.79 12.65 232 60189 168279 31468644
VIth nerve disorder 13.77 12.65 4 60417 21 31636902
Pancreatic carcinoma recurrent 13.77 12.65 5 60416 58 31636865
Hypocalcaemia 13.66 12.65 80 60341 21898 31615025
Bacteriuria 13.63 12.65 8 60413 294 31636629
Swelling 13.63 12.65 32 60389 37326 31599597
Gait inability 13.55 12.65 10 60411 19134 31617789
Polyserositis 13.49 12.65 7 60414 201 31636722
Colon cancer stage III 13.49 12.65 7 60414 201 31636722
Iatrogenic infection 13.47 12.65 5 60416 62 31636861
Toxic leukoencephalopathy 13.41 12.65 8 60413 303 31636620
Chemotherapeutic drug level increased 13.40 12.65 7 60414 204 31636719
Volvulus of small bowel 13.39 12.65 5 60416 63 31636860
Intestinal mucosal hypertrophy 13.39 12.65 5 60416 63 31636860
Tracheal inflammation 13.39 12.65 5 60416 63 31636860
Immune thrombocytopenia 13.28 12.65 41 60380 8457 31628466
Neuropathic muscular atrophy 13.18 12.65 4 60417 25 31636898
Pleural fistula 13.18 12.65 4 60417 25 31636898
Rectal discharge 13.15 12.65 7 60414 212 31636711
Obstruction gastric 13.15 12.65 12 60409 880 31636043
Peritoneal adhesions 13.11 12.65 6 60415 130 31636793
Eosinophilia 13.08 12.65 15 60406 23238 31613685
Electric shock 12.94 12.65 6 60415 134 31636789
COVID-19 pneumonia 12.94 12.65 4 60417 12651 31624272
Visual impairment 12.90 12.65 25 60396 31254 31605669
Adverse event 12.80 12.65 8 60413 16697 31620226
Splenic abscess 12.75 12.65 8 60413 332 31636591
Toxoplasmosis 12.75 12.65 14 60407 1283 31635640
Pneumonia aspiration 12.71 12.65 35 60386 38691 31598232
Colitis ulcerative 12.71 12.65 10 60411 18519 31618404
Gastrointestinal necrosis 12.66 12.65 22 60399 3112 31633811

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 1954.86 11.17 2118 100373 255038 70570915
Neuropathy peripheral 1305.54 11.17 1233 101258 125663 70700290
Skin toxicity 825.23 11.17 331 102160 6867 70819086
Neurotoxicity 814.20 11.17 518 101973 29308 70796645
Mucosal inflammation 775.79 11.17 700 101791 67150 70758803
Disease progression 741.86 11.17 1018 101473 155654 70670299
Diarrhoea 705.60 11.17 2601 99890 780740 70045213
Thrombocytopenia 705.57 11.17 1249 101242 237861 70588092
Dermatitis acneiform 506.73 11.17 251 102240 8694 70817259
Colorectal cancer metastatic 444.03 11.17 146 102345 1663 70824290
Polyneuropathy 405.97 11.17 297 102194 21118 70804835
Febrile neutropenia 380.20 11.17 882 101609 203436 70622517
Palmar-plantar erythrodysaesthesia syndrome 365.14 11.17 322 102169 29925 70796028
Metastases to liver 364.50 11.17 301 102190 25577 70800376
Haematotoxicity 361.89 11.17 233 102258 13441 70812512
Neoplasm progression 332.07 11.17 367 102124 44861 70781092
Leukopenia 329.54 11.17 569 101922 105991 70719962
Arteriospasm coronary 326.33 11.17 164 102327 5860 70820093
Stomatitis 321.38 11.17 626 101865 127885 70698068
Completed suicide 302.80 11.17 5 102486 227130 70598823
Proteinuria 259.38 11.17 263 102228 29111 70796842
Gastrointestinal toxicity 246.93 11.17 139 102352 6266 70819687
Bone marrow failure 224.74 11.17 314 102177 48696 70777257
Myelosuppression 220.18 11.17 244 102247 29901 70796052
Secondary immunodeficiency 206.08 11.17 95 102396 2794 70823159
Paronychia 200.77 11.17 126 102365 6948 70819005
Therapy partial responder 194.48 11.17 154 102337 12320 70813633
Malignant neoplasm progression 192.49 11.17 494 101997 121245 70704708
Vomiting 182.01 11.17 1470 101021 591641 70234312
Portal hypertension 172.70 11.17 111 102380 6381 70819572
Product dose omission issue 170.84 11.17 51 102440 217417 70608536
Peripheral sensory neuropathy 164.56 11.17 138 102353 11972 70813981
Nausea 161.26 11.17 1908 100583 850180 69975773
Cardiotoxicity 158.43 11.17 130 102361 10940 70815013
Enteritis 157.62 11.17 138 102353 12693 70813260
Pulmonary embolism 157.05 11.17 539 101952 155328 70670625
Metastases to lung 155.47 11.17 153 102338 16331 70809622
Focal nodular hyperplasia 150.76 11.17 51 102440 638 70825315
Pyrexia 147.64 11.17 1430 101061 605522 70220431
Hyperammonaemia 139.25 11.17 117 102374 10176 70815777
Peripheral swelling 138.86 11.17 85 102406 236478 70589475
Drug abuse 138.79 11.17 23 102468 147233 70678720
Drug clearance decreased 131.58 11.17 71 102420 2942 70823011
Fall 128.48 11.17 282 102209 443814 70382139
Rash pustular 124.88 11.17 110 102381 10198 70815755
Swelling 121.87 11.17 60 102431 188479 70637474
Chills 121.58 11.17 472 102019 144314 70681639
Abdominal pain 121.38 11.17 878 101613 341249 70484704
General physical health deterioration 121.28 11.17 666 101825 235365 70590588
Systemic lupus erythematosus 119.02 11.17 7 102484 101895 70724058
Adenocarcinoma of colon 116.47 11.17 81 102410 5311 70820642
Leukoencephalopathy 113.59 11.17 90 102401 7204 70818749
Hyperammonaemic encephalopathy 110.91 11.17 73 102418 4370 70821583
Intestinal obstruction 109.16 11.17 199 102292 38626 70787327
Posterior reversible encephalopathy syndrome 108.35 11.17 154 102337 24248 70801705
Non-cirrhotic portal hypertension 108.11 11.17 35 102456 378 70825575
Anaemia 107.61 11.17 970 101521 402453 70423500
Carcinoembryonic antigen increased 106.24 11.17 54 102437 1976 70823977
Mycobacterium chelonae infection 104.06 11.17 56 102435 2308 70823645
Insomnia 103.79 11.17 97 102394 217709 70608244
Gastrointestinal perforation 103.60 11.17 77 102414 5604 70820349
Intentional overdose 103.17 11.17 11 102480 98424 70727529
Hypomagnesaemia 102.26 11.17 199 102292 40565 70785388
Asthma 99.15 11.17 26 102465 120767 70705186
Venoocclusive liver disease 98.63 11.17 98 102393 10580 70815373
Joint swelling 98.56 11.17 133 102358 253078 70572875
Arthropathy 98.11 11.17 47 102444 150010 70675943
Cholangitis 97.57 11.17 101 102390 11448 70814505
Arthralgia 96.75 11.17 387 102104 503003 70322950
Glossodynia 95.05 11.17 8 102483 86479 70739474
Pneumatosis intestinalis 92.45 11.17 73 102418 5814 70820139
Rhabdomyolysis 92.38 11.17 14 102477 95746 70730207
Synovitis 88.34 11.17 38 102453 129190 70696763
Device related infection 88.00 11.17 163 102328 32022 70793931
Pain 87.78 11.17 541 101950 628275 70197678
Interstitial lung disease 86.80 11.17 340 102151 104345 70721608
Intestinal perforation 86.06 11.17 111 102380 15933 70810020
Ascites 84.74 11.17 252 102239 67295 70758658
Skin reaction 84.61 11.17 103 102388 13946 70812007
Ileus 82.23 11.17 135 102356 24102 70801851
Splenomegaly 82.18 11.17 118 102373 18752 70807201
Decreased appetite 80.74 11.17 732 101759 304048 70521905
Headache 80.11 11.17 501 101990 579904 70246049
Epistaxis 80.03 11.17 327 102164 102300 70723653
Administration site extravasation 79.33 11.17 37 102454 1118 70824835
Weight increased 78.42 11.17 144 102347 242187 70583766
Anxiety 77.63 11.17 124 102367 220206 70605747
Mucosal toxicity 77.38 11.17 30 102461 566 70825387
Tumour lysis syndrome 76.58 11.17 122 102369 21238 70804715
Rheumatoid arthritis 76.53 11.17 195 102296 291610 70534343
Bacterial infection 76.01 11.17 137 102354 26355 70799598
Dizziness 75.78 11.17 379 102112 463762 70362191
Febrile bone marrow aplasia 75.63 11.17 90 102401 11901 70814052
Plasma cell myeloma 74.64 11.17 9 102482 73192 70752761
Injury 74.63 11.17 5 102486 65240 70760713
Hepatic enzyme increased 73.49 11.17 71 102420 156919 70669034
Depression 72.95 11.17 109 102382 198865 70627088
Myalgia 71.78 11.17 82 102409 167810 70658143
Dehydration 71.42 11.17 565 101926 225577 70600376
Contusion 71 11.17 49 102442 127987 70697966
Human bocavirus infection 69.90 11.17 28 102463 578 70825375
Drug ineffective 68.64 11.17 952 101539 938800 69887153
Injection site pain 67.94 11.17 43 102448 117576 70708377
Anastomotic leak 67.70 11.17 32 102459 997 70824956
Pain in extremity 67.61 11.17 245 102246 327837 70498116
Intentional product misuse 67.50 11.17 16 102475 79579 70746374
Nicotinic acid deficiency 67.33 11.17 20 102471 158 70825795
Pseudomonal sepsis 66.89 11.17 59 102432 5478 70820475
Subileus 65.77 11.17 57 102434 5170 70820783
Metastases to peritoneum 65.73 11.17 50 102441 3769 70822184
Somnolence 64.65 11.17 134 102357 215472 70610481
Tumour necrosis 64.48 11.17 37 102454 1730 70824223
Myocardial infarction 63.92 11.17 93 102398 171552 70654401
Pancytopenia 63.11 11.17 404 102087 150703 70675250
Contraindicated product administered 62.86 11.17 61 102430 134551 70691402
Maternal exposure during pregnancy 62.82 11.17 45 102446 115300 70710653
Cardiac failure congestive 62.55 11.17 62 102429 135395 70690558
Sinusitis 61.71 11.17 93 102398 169102 70656851
Wheezing 60.77 11.17 30 102461 94140 70731813
Lower respiratory tract infection 60.51 11.17 44 102447 111869 70714084
Hospitalisation 60.16 11.17 22 102469 82546 70743407
Neoplasm recurrence 60.02 11.17 48 102443 3893 70822060
Parainfluenzae virus infection 59.13 11.17 53 102438 5027 70820926
Peripheral sensorimotor neuropathy 59.05 11.17 41 102450 2681 70823272
Helicobacter infection 58.88 11.17 6 102485 55650 70770303
Paraesthesia 58.87 11.17 386 102105 145151 70680802
Vena cava thrombosis 58.24 11.17 40 102451 2570 70823383
Colon cancer metastatic 57.81 11.17 37 102454 2111 70823842
Embolism 57.70 11.17 82 102409 12906 70813047
Psoriasis 56.83 11.17 36 102455 98397 70727556
Hyperbilirubinaemia 56.38 11.17 110 102381 22458 70803495
Mobility decreased 56.33 11.17 40 102451 102959 70722994
Loss of employment 56.10 11.17 37 102454 2222 70823731
Chronic obstructive pulmonary disease 56.04 11.17 21 102470 77620 70748333
Anti-cyclic citrullinated peptide antibody positive 55.91 11.17 16 102475 70169 70755784
Diffuse alveolar damage 55.62 11.17 43 102448 3320 70822633
Discomfort 55.02 11.17 43 102448 105393 70720560
Hypertension 54.69 11.17 661 101830 295372 70530581
Abdominal discomfort 54.29 11.17 146 102345 214512 70611441
Small intestinal obstruction 54.25 11.17 114 102377 24541 70801412
Sepsis 53.75 11.17 565 101926 243980 70581973
Electrocardiogram QT prolonged 53.30 11.17 27 102464 83490 70742463
Gene mutation 53.23 11.17 36 102455 2255 70823698
Colorectal cancer 52.48 11.17 63 102428 8407 70817546
Blister 52.45 11.17 41 102450 100485 70725468
Hiccups 52.31 11.17 65 102426 8987 70816966
Pelvic abscess 52.08 11.17 33 102458 1850 70824103
Memory impairment 51.96 11.17 35 102456 92606 70733347
Suicidal ideation 51.63 11.17 18 102473 69578 70756375
Colitis 51.05 11.17 205 102286 63609 70762344
Wound 50.59 11.17 41 102450 98691 70727262
Feeling abnormal 50.20 11.17 80 102411 142239 70683714
Abscess bacterial 50.13 11.17 24 102467 770 70825183
Neutrophil count decreased 49.90 11.17 246 102245 83310 70742643
Crystal nephropathy 49.73 11.17 28 102463 1262 70824691
Metastases to lymph nodes 49.68 11.17 64 102427 9174 70816779
Transdifferentiation of neoplasm 49.63 11.17 14 102477 90 70825863
Metastases to meninges 49.49 11.17 39 102452 3097 70822856
Dysarthria 48.91 11.17 199 102292 62114 70763839
Asthenia 48.75 11.17 930 101561 456736 70369217
Pneumonia 48.53 11.17 590 101901 595642 70230311
Drug hypersensitivity 47.67 11.17 206 102285 262253 70563700
Confusional state 47.62 11.17 230 102261 284168 70541785
Blood cholesterol increased 47.43 11.17 17 102474 64587 70761366
Wrong technique in product usage process 47.26 11.17 20 102471 68678 70757275
Lymphoid tissue hypoplasia 46.94 11.17 21 102470 575 70825378
Bradycardia 46.89 11.17 67 102424 124548 70701405
Drug interaction 46.66 11.17 341 102150 381100 70444853
Hypokalaemia 46.56 11.17 337 102154 130851 70695102
Steatohepatitis 46.43 11.17 23 102468 796 70825157
Recall phenomenon 46.37 11.17 25 102466 1034 70824919
Overdose 46.36 11.17 111 102380 169634 70656319
Fluid retention 45.99 11.17 17 102474 63368 70762585
Thymus hypoplasia 45.54 11.17 21 102470 618 70825335
Portal vein thrombosis 45.48 11.17 47 102444 5315 70820638
Type II hypersensitivity 45.27 11.17 11 102480 35 70825918
Coronary artery disease 45.22 11.17 17 102474 62719 70763234
Cholinergic syndrome 44.72 11.17 23 102468 863 70825090
Sedation 44.68 11.17 7 102484 46724 70779229
Enterobacter infection 44.59 11.17 41 102450 4019 70821934
Deep vein thrombosis 44.58 11.17 294 102197 110748 70715205
Peritonitis 44.26 11.17 109 102382 26050 70799903
Hand deformity 44.20 11.17 36 102455 86446 70739507
Duodenal ulcer perforation 43.88 11.17 10 102481 51102 70774851
Human herpesvirus 6 infection 43.78 11.17 44 102447 4815 70821138
Rectal tenesmus 43.01 11.17 26 102465 1340 70824613
ECG signs of myocardial ischaemia 42.71 11.17 17 102474 345 70825608
Hallucination 42.51 11.17 29 102462 76231 70749722
Trichomegaly 42.43 11.17 12 102479 78 70825875
Anastomotic complication 42.39 11.17 18 102473 433 70825520
Pericarditis 42.38 11.17 36 102455 84669 70741284
Drug dependence 42.27 11.17 3 102488 37318 70788635
Haemolytic anaemia 42.13 11.17 82 102409 16712 70809241
Venous thrombosis 42.09 11.17 50 102441 6599 70819354
Superior vena cava syndrome 41.79 11.17 24 102467 1124 70824829
Influenza 40.96 11.17 63 102428 113637 70712316
Productive cough 40.80 11.17 32 102459 78305 70747648
Stress 40.42 11.17 24 102467 67942 70758011
Proteus infection 40.40 11.17 27 102464 1658 70824295
Treatment noncompliance 40.21 11.17 9 102482 46565 70779388
Ocular toxicity 40.06 11.17 21 102470 820 70825133
Exposure during pregnancy 39.51 11.17 41 102450 87676 70738277
Jugular vein thrombosis 39.27 11.17 38 102453 3972 70821981
K-ras gene mutation 39.18 11.17 10 102481 41 70825912
Intentional product use issue 39.18 11.17 71 102420 120071 70705882
Blood glucose increased 39.11 11.17 55 102436 102927 70723026
Clostridium difficile colitis 39.07 11.17 111 102380 28885 70797068
Gastrooesophageal reflux disease 38.12 11.17 45 102446 90794 70735159
Norovirus test positive 37.51 11.17 17 102474 480 70825473
Cystitis bacterial 37.35 11.17 17 102474 485 70825468
Carbohydrate antigen 19-9 increased 37.07 11.17 16 102475 401 70825552
Gait disturbance 36.92 11.17 140 102351 184966 70640987
Pancreatic carcinoma metastatic 36.87 11.17 36 102455 3804 70822149
Product prescribing error 36.87 11.17 6 102485 38946 70787007
Septic shock 36.79 11.17 283 102208 111975 70713978
Off label use 36.77 11.17 1365 101126 741695 70084258
Neutropenic colitis 36.65 11.17 41 102450 5073 70820880
Acute coronary syndrome 36.48 11.17 86 102405 19993 70805960
Rectal cancer metastatic 36.44 11.17 17 102474 514 70825439
Balance disorder 36.40 11.17 46 102445 90082 70735871
Unevaluable event 36.06 11.17 15 102476 52048 70773905
Adverse drug reaction 35.94 11.17 16 102475 53328 70772625
Immune thrombocytopenia 35.36 11.17 75 102416 16249 70809704
Febrile infection 35.32 11.17 32 102459 3077 70822876
International normalised ratio increased 34.95 11.17 39 102452 80687 70745266
Large intestinal obstruction 34.81 11.17 31 102460 2915 70823038
Rectal perforation 34.67 11.17 19 102472 812 70825141
Oesophageal atresia 34.60 11.17 10 102481 71 70825882
Emotional distress 34.59 11.17 6 102485 37182 70788771
Intentional self-injury 34.57 11.17 3 102488 31647 70794306
Cardiac arrest 34.46 11.17 117 102374 159717 70666236
Proctalgia 34.43 11.17 51 102440 8332 70817621
Subclavian vein thrombosis 34.22 11.17 28 102463 2346 70823607
Pelvic fluid collection 33.98 11.17 18 102473 718 70825235
Arthritis 33.68 11.17 56 102435 97924 70728029
Pulmonary arterial hypertension 33.59 11.17 4 102487 32851 70793102
Respiratory arrest 33.57 11.17 18 102473 53915 70772038
Knee arthroplasty 33.11 11.17 5 102486 34296 70791657
Varices oesophageal 33.08 11.17 40 102451 5377 70820576
Factor VII deficiency 32.79 11.17 8 102483 26 70825927
Ileal perforation 32.75 11.17 19 102472 907 70825046
Medication error 32.59 11.17 21 102470 56891 70769062
Klebsiella infection 32.51 11.17 67 102424 14225 70811728
Hypoglycaemia 32.37 11.17 54 102437 94310 70731643
Hepatic lesion 32.30 11.17 42 102449 6075 70819878
Small intestinal perforation 32.30 11.17 30 102461 2979 70822974
Migraine 32.27 11.17 34 102457 72204 70753749
Gastrointestinal anastomotic leak 32.11 11.17 15 102476 455 70825498
Gait inability 32.02 11.17 14 102477 47161 70778792
Injection site erythema 31.82 11.17 35 102456 72889 70753064
Nodular regenerative hyperplasia 31.68 11.17 21 102470 1272 70824681
Intravascular haemolysis 31.53 11.17 17 102474 703 70825250
T-cell lymphoma refractory 31.50 11.17 9 102482 61 70825892
Anal haemorrhage 31.42 11.17 33 102458 3803 70822150
Adenocarcinoma 30.95 11.17 32 102459 3621 70822332
Enterocutaneous fistula 30.93 11.17 23 102468 1675 70824278
Portal shunt 30.88 11.17 9 102482 66 70825887
Electrocardiogram ST segment elevation 30.86 11.17 46 102445 7558 70818395
Liver abscess 30.44 11.17 39 102452 5560 70820393
Hypersensitivity vasculitis 30.20 11.17 43 102448 6779 70819174
Anastomotic fistula 30.16 11.17 10 102481 117 70825836
Enterovesical fistula 30.00 11.17 19 102472 1064 70824889
Nasopharyngitis 29.93 11.17 193 102298 222013 70603940
Rectal adenocarcinoma 29.90 11.17 21 102470 1399 70824554
Colon cancer recurrent 29.79 11.17 10 102481 122 70825831
Cystitis radiation 29.64 11.17 10 102481 124 70825829
Encephalopathy 29.61 11.17 171 102320 61490 70764463
Urticaria 29.57 11.17 128 102363 162921 70663032
Blood creatine phosphokinase increased 29.48 11.17 27 102464 61236 70764717
Dyspnoea 29.43 11.17 868 101623 769192 70056761
Acute abdomen 29.43 11.17 28 102463 2866 70823087
Leukoerythroblastosis 29.42 11.17 12 102479 260 70825693
Necrotising fasciitis 29.27 11.17 38 102453 5488 70820465
Koebner phenomenon 28.69 11.17 8 102483 49 70825904
Hypoalbuminaemia 28.54 11.17 76 102415 19046 70806907
Liver function test abnormal 28.20 11.17 28 102463 61118 70764835
Nasal septum perforation 28.18 11.17 16 102475 733 70825220
Aortic thrombosis 28.09 11.17 21 102470 1542 70824411
Obesity 28.02 11.17 3 102488 26768 70799185
Agitation 27.99 11.17 58 102433 93317 70732636
Condition aggravated 27.98 11.17 442 102049 427193 70398760
Aggression 27.57 11.17 18 102473 48428 70777525
Pharyngeal dyskinesia 27.53 11.17 8 102483 58 70825895
Erythema 27.52 11.17 423 102068 199140 70626813
Treatment failure 27.47 11.17 111 102380 144031 70681922
Neuromyotonia 27.41 11.17 9 102482 102 70825851
Cardio-respiratory arrest 27.34 11.17 66 102425 100611 70725342
Viraemia 27.05 11.17 25 102466 2467 70823486
Type 2 diabetes mellitus 27.02 11.17 15 102476 44065 70781888
Oesophageal candidiasis 27.00 11.17 46 102445 8461 70817492
Loss of personal independence in daily activities 26.95 11.17 51 102440 84859 70741094
Acute kidney injury 26.92 11.17 886 101605 473738 70352215
Large intestine perforation 26.72 11.17 59 102432 13136 70812817
Visual impairment 26.54 11.17 47 102444 80203 70745750
Encapsulating peritoneal sclerosis 26.53 11.17 16 102475 821 70825132
Stoma site haemorrhage 26.42 11.17 21 102470 1688 70824265
Injection site haemorrhage 26.36 11.17 3 102488 25524 70800429
Organising pneumonia 26.35 11.17 50 102441 10000 70815953
Metastasis 26.28 11.17 38 102453 6076 70819877
Prothrombin level decreased 26.16 11.17 20 102471 1519 70824434
Rectal cancer recurrent 26.13 11.17 7 102484 36 70825917
Conjunctivitis 26.09 11.17 82 102409 22554 70803399
Impaired healing 26.03 11.17 42 102449 74332 70751621
Cytopenia 26.01 11.17 69 102422 17254 70808699
Cytomegalovirus chorioretinitis 25.86 11.17 35 102456 5263 70820690
Portal venous gas 25.81 11.17 12 102479 360 70825593
Laryngospasm 25.75 11.17 29 102462 3614 70822339
Induration 25.71 11.17 21 102470 1755 70824198
Influenza like illness 25.70 11.17 34 102457 65297 70760656
Cachexia 25.64 11.17 49 102442 9851 70816102
Cerebral haemorrhage 25.61 11.17 24 102467 53840 70772113
Nephrotic syndrome 25.54 11.17 51 102440 10589 70815364
Short-bowel syndrome 25.32 11.17 13 102478 486 70825467
Perihepatic abscess 25.24 11.17 9 102482 133 70825820
Injection site reaction 25.16 11.17 21 102470 49831 70776122
Venous pressure jugular decreased 25.00 11.17 8 102483 83 70825870
Irritability 24.92 11.17 12 102479 38213 70787740
Loss of consciousness 24.85 11.17 128 102363 155588 70670365
Chronic kidney disease 24.82 11.17 31 102460 61026 70764927
Thrombocytopenic purpura 24.78 11.17 23 102468 2281 70823672
Adverse event 24.76 11.17 21 102470 49440 70776513
Venous thrombosis limb 24.74 11.17 30 102461 4045 70821908
Gastrointestinal stoma complication 24.65 11.17 23 102468 2297 70823656
Haemolytic uraemic syndrome 24.42 11.17 30 102461 4100 70821853
Performance status decreased 24.35 11.17 35 102456 5566 70820387
Mixed adenoneuroendocrine carcinoma 24.25 11.17 6 102485 21 70825932
Oesophagobronchial fistula 24.13 11.17 10 102481 226 70825727
Device related thrombosis 24.07 11.17 23 102468 2367 70823586
Evans syndrome 24.05 11.17 12 102479 422 70825531
Atypical haemolytic uraemic syndrome 23.96 11.17 15 102476 823 70825130
Teratogenicity 23.84 11.17 10 102481 233 70825720
Interventricular septum rupture 23.83 11.17 6 102485 23 70825930
Muscle spasms 23.81 11.17 128 102363 153918 70672035
Gastrointestinal necrosis 23.76 11.17 33 102458 5085 70820868
Joint ankylosis 23.66 11.17 19 102472 1550 70824403
Nipple swelling 23.65 11.17 8 102483 100 70825853
Hepatocellular injury 23.57 11.17 130 102361 45961 70779992
Pulmonary congestion 23.53 11.17 4 102487 25150 70800803
Toxic erythema of chemotherapy 23.49 11.17 10 102481 242 70825711
Perineal disorder 23.43 11.17 6 102485 25 70825928
Meningitis streptococcal 23.35 11.17 9 102482 167 70825786
Musculoskeletal stiffness 23.27 11.17 122 102369 147638 70678315
Fibromyalgia 23.15 11.17 21 102470 47853 70778100
Full blood count abnormal 23.08 11.17 10 102481 33868 70792085
Tumour fistulisation 23.06 11.17 6 102485 27 70825926
Rectal cancer 23.04 11.17 26 102465 3248 70822705
Anaemia of malignant disease 23.03 11.17 14 102477 729 70825224
Eczema impetiginous 22.88 11.17 6 102485 28 70825925
Astringent therapy 22.88 11.17 6 102485 28 70825925
Psychotic disorder 22.86 11.17 13 102478 37688 70788265
Jaundice 22.79 11.17 137 102354 49971 70775982
Oesophageal fistula 22.55 11.17 11 102480 368 70825585
Poisoning 22.53 11.17 3 102488 22619 70803334
Illness 22.27 11.17 9 102482 31782 70794171
Ischiorectal hernia 22.23 11.17 5 102486 10 70825943
Hepatic failure 22.17 11.17 151 102340 57474 70768479
Incorrect dose administered 22.13 11.17 39 102452 66680 70759273
Hypoacusis 22.12 11.17 6 102485 27263 70798690
Therapeutic product effect decreased 22.02 11.17 119 102372 142899 70683054
Prescribed overdose 22.01 11.17 6 102485 27175 70798778
Hepatic steatosis 21.95 11.17 102 102389 33711 70792242
Nightmare 21.92 11.17 3 102488 22153 70803800
Injection site bruising 21.82 11.17 14 102477 38018 70787935
Swelling face 21.80 11.17 36 102455 63128 70762825
Vasospasm 21.78 11.17 15 102476 968 70824985
Pregnancy 21.77 11.17 4 102487 23777 70802176
Sleep apnoea syndrome 21.74 11.17 10 102481 32703 70793250
Oesophagitis 21.61 11.17 77 102414 22575 70803378
Joint stiffness 21.51 11.17 12 102479 35164 70790789
Haematopoietic stem cell mobilisation 21.49 11.17 9 102482 209 70825744
Periportal sinus dilatation 21.48 11.17 6 102485 37 70825916
Aplasia 21.44 11.17 38 102453 7213 70818740
Depilation 21.32 11.17 5 102486 13 70825940
Allodynia 21.29 11.17 17 102474 1376 70824577
Clostridial infection 21.29 11.17 32 102459 5297 70820656
Proctitis 21.28 11.17 26 102465 3532 70822421
Lymphopenia 21.17 11.17 87 102404 27272 70798681
Skin discolouration 21.06 11.17 14 102477 37311 70788642
Stress cardiomyopathy 21.00 11.17 45 102446 9817 70816136
Product use issue 20.94 11.17 163 102328 179774 70646179
Biliary tract infection 20.88 11.17 16 102475 1219 70824734
Laboratory test interference 20.81 11.17 15 102476 1041 70824912
Oesophageal haemorrhage 20.73 11.17 18 102473 1637 70824316
Obstructive airways disorder 20.71 11.17 6 102485 26107 70799846
Hypocalcaemia 20.63 11.17 123 102368 44736 70781217
Injection site pruritus 20.44 11.17 16 102475 39194 70786759
Mouth ulceration 20.40 11.17 101 102390 34248 70791705
Visceral venous thrombosis 20.32 11.17 5 102486 17 70825936
Catabolic state 20.31 11.17 7 102484 93 70825860
Depressed mood 20.28 11.17 20 102471 43800 70782153
Bronchitis 20.07 11.17 94 102397 117149 70708804
Portal vein dilatation 20.02 11.17 6 102485 49 70825904
Cholestasis 19.96 11.17 128 102363 47744 70778209
Mucocutaneous rash 19.92 11.17 6 102485 50 70825903
Chemotherapy cardiotoxicity attenuation 19.89 11.17 5 102486 19 70825934
Bacteriuria 19.89 11.17 15 102476 1116 70824837
Hepatitis B surface antigen positive 19.76 11.17 8 102483 170 70825783
Breast cancer 19.73 11.17 12 102479 33537 70792416
Multiple sclerosis 19.70 11.17 6 102485 25279 70800674
Myeloid leukaemia 19.68 11.17 12 102479 628 70825325
Panic attack 19.65 11.17 4 102487 22115 70803838
Adrenal insufficiency 19.59 11.17 6 102485 25189 70800764
Oedema 19.58 11.17 80 102411 103501 70722452
Tremor 19.53 11.17 138 102353 155486 70670467
Cardiac disorder 19.46 11.17 35 102456 59380 70766573
Heart rate increased 19.44 11.17 83 102408 106065 70719888
Hypertrichosis 19.39 11.17 15 102476 1159 70824794
Abortion spontaneous 19.38 11.17 7 102484 26472 70799481
Skin injury 19.31 11.17 22 102469 2776 70823177
Hepatectomy 19.25 11.17 8 102483 182 70825771
Hyperthyroidism 19.23 11.17 3 102488 20088 70805865
Pneumonitis 19.21 11.17 140 102351 54457 70771496
Cerebrovascular accident 19.11 11.17 125 102366 143345 70682608
Hypotension 19.04 11.17 442 102049 403939 70422014
Anal erythema 18.97 11.17 8 102483 189 70825764
Radiation interaction 18.95 11.17 6 102485 60 70825893
Pneumoperitoneum 18.87 11.17 22 102469 2847 70823106
Anal fissure 18.86 11.17 33 102458 6200 70819753
Sleep disorder 18.82 11.17 46 102445 69826 70756127
Endometrial dysplasia 18.78 11.17 5 102486 25 70825928
Aortic intramural haematoma 18.78 11.17 7 102484 118 70825835
Psoriatic arthropathy 18.77 11.17 41 102450 64730 70761223
Restlessness 18.62 11.17 20 102471 42108 70783845
Prostatic calcification 18.60 11.17 6 102485 64 70825889
Injection site swelling 18.51 11.17 21 102470 43136 70782817
Perioral dermatitis 18.48 11.17 9 102482 300 70825653
Pulmonary artery thrombosis 18.42 11.17 15 102476 1248 70824705
Cranial nerve disorder 18.32 11.17 14 102477 1062 70824891
Rhinovirus infection 18.27 11.17 34 102457 6699 70819254
Road traffic accident 18.27 11.17 14 102477 34668 70791285
Joint injury 18.27 11.17 8 102483 26924 70799029
Thrombotic microangiopathy 18.18 11.17 62 102429 17786 70808167
Product administration error 18.16 11.17 10 102481 29513 70796440
Balanoposthitis 18.15 11.17 13 102478 893 70825060
Faeces discoloured 18.12 11.17 8 102483 26801 70799152
Hypertransaminasaemia 18.12 11.17 40 102451 8903 70817050
Viral hepatitis carrier 18.02 11.17 5 102486 30 70825923
Bladder hypertrophy 17.90 11.17 11 102480 584 70825369
Product quality issue 17.88 11.17 11 102480 30550 70795403
Head injury 17.71 11.17 14 102477 34127 70791826
Adenocarcinoma pancreas 17.68 11.17 18 102473 2000 70823953
Cerebral vasoconstriction 17.65 11.17 15 102476 1325 70824628
Duodenal perforation 17.52 11.17 18 102473 2022 70823931
Coronavirus infection 17.51 11.17 32 102459 6220 70819733
Onycholysis 17.49 11.17 17 102474 1786 70824167
Multiple-drug resistance 17.35 11.17 35 102456 7320 70818633
Cough 17.23 11.17 349 102142 325028 70500925
Joint range of motion decreased 17.23 11.17 8 102483 26018 70799935
Perforation bile duct 17.12 11.17 5 102486 37 70825916
Abnormal behaviour 17.05 11.17 15 102476 34694 70791259
Tumour perforation 17.04 11.17 9 102482 357 70825596
Pancreatic carcinoma recurrent 16.90 11.17 7 102484 158 70825795
Anal erosion 16.78 11.17 5 102486 40 70825913
Pruritus 16.74 11.17 376 102115 345184 70480769
Neurosarcoidosis 16.72 11.17 9 102482 371 70825582
Rectal abscess 16.67 11.17 16 102475 1655 70824298
Second primary malignancy 16.65 11.17 49 102442 13002 70812951
Enterocolitis 16.62 11.17 49 102442 13017 70812936
Blood pressure decreased 16.48 11.17 72 102419 91443 70734510
Catheter site extravasation 16.41 11.17 9 102482 385 70825568
Full blood count decreased 16.39 11.17 7 102484 23911 70802042
Peritoneal neoplasm 16.27 11.17 6 102485 98 70825855
Dysstasia 16.27 11.17 8 102483 25171 70800782
Perineal abscess 16.27 11.17 10 102481 531 70825422
Pulmonary toxicity 16.20 11.17 43 102448 10755 70815198
Bladder tamponade 16.17 11.17 10 102481 537 70825416
Obstruction gastric 16.15 11.17 15 102476 1489 70824464
Therapy non-responder 16.09 11.17 57 102434 76858 70749095
Brief psychotic disorder with marked stressors 16.07 11.17 8 102483 280 70825673
Dermatitis 16.02 11.17 63 102428 19354 70806599
Vascular access complication 15.96 11.17 16 102475 1745 70824208
Delusion 15.96 11.17 4 102487 19161 70806792
Temperature difference of extremities 15.95 11.17 4 102487 15 70825938
Intestinal metastasis 15.94 11.17 8 102483 285 70825668
Pulmonary infarction 15.78 11.17 22 102469 3401 70822552
Cognitive disorder 15.74 11.17 41 102450 60915 70765038
Volvulus of small bowel 15.64 11.17 6 102485 110 70825843
Red cell fragmentation syndrome 15.61 11.17 5 102486 52 70825901
Inferior vena cava stenosis 15.61 11.17 5 102486 52 70825901
Bladder cancer 15.57 11.17 3 102488 17239 70808714
Portal vein embolisation 15.56 11.17 4 102487 17 70825936
Cataract 15.49 11.17 36 102455 55609 70770344
Mania 15.48 11.17 3 102488 17171 70808782
Encephalitis 15.46 11.17 49 102442 13536 70812417
Systemic scleroderma 15.45 11.17 13 102478 1132 70824821
Haematoma 15.43 11.17 29 102462 48389 70777564
Dysaesthesia pharynx 15.37 11.17 7 102484 200 70825753
Subacute cutaneous lupus erythematosus 15.34 11.17 21 102470 3192 70822761
Underdose 15.30 11.17 12 102479 29371 70796582
Intestinal strangulation 15.28 11.17 5 102486 56 70825897
Soft tissue necrosis 15.25 11.17 11 102480 764 70825189
Lip swelling 15.24 11.17 16 102475 34038 70791915
Nephropathy toxic 15.22 11.17 60 102431 18454 70807499
Bacteraemia 15.21 11.17 83 102408 29226 70796727
Product substitution issue 15.15 11.17 4 102487 18509 70807444
Herpes simplex 15.13 11.17 43 102448 11189 70814764
Metastases to central nervous system 15.12 11.17 52 102439 14982 70810971
Acinetobacter sepsis 15.04 11.17 5 102486 59 70825894
Cutaneous tuberculosis 15.02 11.17 7 102484 211 70825742
Malaise 15.01 11.17 494 101997 432438 70393515
Organic brain syndrome 15.01 11.17 9 102482 457 70825496
Palpitations 15.00 11.17 96 102395 110657 70715296
Hypersplenism 14.99 11.17 9 102482 458 70825495
Device issue 14.98 11.17 8 102483 24017 70801936
Microangiopathic haemolytic anaemia 14.97 11.17 14 102477 1402 70824551
Injection site mass 14.94 11.17 4 102487 18339 70807614
Portal tract inflammation 14.93 11.17 6 102485 125 70825828
Neck pain 14.90 11.17 48 102443 66609 70759344
Angioedema 14.87 11.17 48 102443 66562 70759391
Disseminated aspergillosis 14.64 11.17 11 102480 814 70825139
Mood altered 14.59 11.17 3 102488 16472 70809481
Metastatic neoplasm 14.58 11.17 25 102466 4623 70821330
Gastric varices haemorrhage 14.57 11.17 8 102483 343 70825610
Dyskinesia 14.55 11.17 23 102468 41051 70784902
Catheter site thrombosis 14.55 11.17 7 102484 227 70825726
Iatrogenic infection 14.54 11.17 5 102486 66 70825887
Dysaesthesia 14.44 11.17 27 102464 5341 70820612
Pleural fistula 14.42 11.17 4 102487 24 70825929
Female genital tract fistula 14.39 11.17 20 102471 3083 70822870
Retinitis viral 14.38 11.17 6 102485 138 70825815
Cancer fatigue 14.38 11.17 6 102485 138 70825815
Splenic abscess 14.33 11.17 9 102482 497 70825456
Adenocarcinoma metastatic 14.30 11.17 6 102485 140 70825813
C-reactive protein abnormal 14.25 11.17 21 102470 38558 70787395
Peritoneal disorder 14.24 11.17 10 102481 666 70825287
Electromyogram abnormal 14.22 11.17 6 102485 142 70825811
Mydriasis 14.19 11.17 3 102488 16150 70809803
Neuralgia 14.17 11.17 80 102411 28523 70797430
Streptococcal bacteraemia 14.14 11.17 20 102471 3133 70822820
Mental disorder 14.12 11.17 12 102479 28228 70797725
Drug eruption 14.11 11.17 22 102469 39474 70786479
Thrombotic thrombocytopenic purpura 14.10 11.17 29 102462 6148 70819805
Pain in jaw 14.10 11.17 25 102466 42644 70783309
Hypothyroidism 14.07 11.17 28 102463 45727 70780226
Hallucination, visual 14.03 11.17 13 102478 29324 70796629
Transaminases increased 14.01 11.17 116 102375 46902 70779051
Escherichia bacteraemia 13.93 11.17 28 102463 5841 70820112
Cardiomyopathy 13.89 11.17 75 102416 26298 70799655
Product intolerance 13.89 11.17 4 102487 28 70825925
Gout 13.85 11.17 8 102483 22998 70802955
Vocal cord paralysis 13.83 11.17 17 102474 2324 70823629
Therapy cessation 13.79 11.17 17 102474 33659 70792294
Respiratory disorder 13.78 11.17 22 102469 39101 70786852
VIth nerve disorder 13.77 11.17 4 102487 29 70825924
Cerebral toxoplasmosis 13.76 11.17 16 102475 2064 70823889
Fistula of small intestine 13.76 11.17 10 102481 703 70825250
Optic neuropathy 13.76 11.17 20 102471 3213 70822740
Blood glucose decreased 13.71 11.17 9 102482 24150 70801803
Post procedural diarrhoea 13.64 11.17 9 102482 541 70825412
Chemotherapeutic drug level above therapeutic 13.60 11.17 5 102486 81 70825872
Muscle rigidity 13.53 11.17 5 102486 18645 70807308
Amnesia 13.53 11.17 35 102456 52120 70773833
Prescribed underdose 13.51 11.17 7 102484 21378 70804575
Disseminated intravascular coagulation 13.50 11.17 89 102402 33509 70792444
Ovarian fibroma 13.49 11.17 5 102486 83 70825870
Rectal haemorrhage 13.46 11.17 150 102341 65681 70760272
Anal inflammation 13.45 11.17 9 102482 554 70825399
Benign hydatidiform mole 13.43 11.17 5 102486 84 70825869
No adverse event 13.41 11.17 16 102475 32137 70793816
Hepatotoxicity 13.36 11.17 109 102382 43877 70782076
Hypervolaemia 13.36 11.17 23 102468 39683 70786270
Radiation hepatitis 13.34 11.17 3 102488 6 70825947
Ovarian cystectomy 13.32 11.17 5 102486 86 70825867
Heart rate irregular 13.28 11.17 14 102477 29729 70796224
Ulcerative gastritis 13.27 11.17 5 102486 87 70825866
Vitiligo 13.25 11.17 15 102476 1880 70824073
Toxic encephalopathy 13.21 11.17 39 102452 10367 70815586
Parkinsonism 13.15 11.17 3 102488 15322 70810631
Rash maculo-papular 13.13 11.17 121 102370 50424 70775529
Pancreatic fistula 13.11 11.17 5 102486 90 70825863
Accidental overdose 13.09 11.17 19 102472 35102 70790851
Therapy interrupted 13.08 11.17 10 102481 24792 70801161
Biliary obstruction 13.08 11.17 22 102469 4005 70821948
Schizophrenia 13.03 11.17 4 102487 16764 70809189
Lung neoplasm malignant 13.02 11.17 10 102481 24732 70801221
Metastases to ovary 12.97 11.17 7 102484 290 70825663
Sciatica 12.90 11.17 10 102481 24617 70801336
Limbic encephalitis 12.89 11.17 10 102481 776 70825177
Fear 12.87 11.17 7 102484 20804 70805149
Hypocapnia 12.86 11.17 9 102482 596 70825357
Eye disorder 12.84 11.17 7 102484 20778 70805175
Necrotising colitis 12.82 11.17 11 102480 984 70824969
Acute endocarditis 12.81 11.17 4 102487 38 70825915
Toxic leukoencephalopathy 12.77 11.17 11 102480 989 70824964
Overgrowth fungal 12.77 11.17 5 102486 97 70825856
Bacterial colitis 12.77 11.17 5 102486 97 70825856
Upper respiratory tract infection 12.73 11.17 65 102426 79209 70746744
Disability 12.72 11.17 3 102488 14980 70810973
Fluid balance positive 12.72 11.17 4 102487 39 70825914
Sarcoidosis 12.71 11.17 29 102462 6598 70819355
Granulomatous liver disease 12.68 11.17 12 102479 1220 70824733
Oesophageal varices haemorrhage 12.65 11.17 21 102470 3782 70822171
Hypothermia 12.63 11.17 7 102484 20587 70805366
Sopor 12.58 11.17 16 102475 31251 70794702
Paraesthesia mucosal 12.54 11.17 4 102487 41 70825912
Occult blood 12.50 11.17 13 102478 1481 70824472
Gastric ulcer perforation, obstructive 12.48 11.17 3 102488 9 70825944
Stomal hernia 12.42 11.17 7 102484 316 70825637
Drug ineffective for unapproved indication 12.35 11.17 23 102468 38515 70787438
Ventricular tachycardia 12.34 11.17 21 102470 36402 70789551
Hemianaesthesia 12.32 11.17 8 102483 468 70825485
Cellulitis 12.27 11.17 88 102403 98840 70727113
Pseudocirrhosis 12.27 11.17 9 102482 642 70825311
Nasal congestion 12.24 11.17 51 102440 65621 70760332
Dyspnoea exertional 12.21 11.17 65 102426 78365 70747588
Dysphagia 12.20 11.17 230 102261 112604 70713349
Anal fistula 12.19 11.17 27 102464 6023 70819930
Sputum discoloured 12.16 11.17 6 102485 18845 70807108
Onychoclasis 12.09 11.17 24 102467 4960 70820993
Endothelial dysfunction 12.00 11.17 6 102485 212 70825741
Exfoliative rash 11.99 11.17 20 102471 3617 70822336
Bacterial disease carrier 11.96 11.17 11 102480 1078 70824875
Oesophageal carcinoma recurrent 11.90 11.17 4 102487 49 70825904
Fanconi syndrome 11.86 11.17 17 102474 2696 70823257
Malignant ascites 11.86 11.17 11 102480 1090 70824863
Sinus bradycardia 11.86 11.17 10 102481 23613 70802340
Device occlusion 11.86 11.17 38 102453 10557 70815396
Hand-foot-genital syndrome 11.81 11.17 3 102488 12 70825941
Axonal and demyelinating polyneuropathy 11.81 11.17 3 102488 12 70825941
Skin laceration 11.76 11.17 12 102479 25866 70800087
Abdominal abscess 11.76 11.17 28 102463 6550 70819403
Neuropathic muscular atrophy 11.75 11.17 4 102487 51 70825902
Pneumomediastinum 11.74 11.17 19 102472 3351 70822602
Colitis microscopic 11.67 11.17 34 102457 8971 70816982
Hyponatraemia 11.64 11.17 162 102329 159925 70666028
Muscle spasticity 11.64 11.17 7 102484 19682 70806271
Hepatitis B DNA increased 11.57 11.17 9 102482 701 70825252
Middle insomnia 11.57 11.17 3 102488 14050 70811903
Dysphonia 11.57 11.17 117 102374 49983 70775970
Hepatic fibrosis 11.55 11.17 27 102464 6240 70819713
Hypercalcaemia 11.49 11.17 20 102471 34365 70791588
Joint effusion 11.48 11.17 4 102487 15473 70810480
Dihydropyrimidine dehydrogenase deficiency 11.45 11.17 5 102486 129 70825824
Granulomatous lymphadenitis 11.43 11.17 6 102485 235 70825718
Hydronephrosis 11.42 11.17 48 102443 15194 70810759
Endocarditis 11.41 11.17 36 102455 9918 70816035
Cytomegalovirus viraemia 11.39 11.17 40 102451 11645 70814308
Peripheral motor neuropathy 11.38 11.17 18 102473 3114 70822839
Retroperitoneal abscess 11.35 11.17 7 102484 374 70825579
Hyperthermia 11.35 11.17 51 102440 16620 70809333
Glaucoma 11.31 11.17 6 102485 18086 70807867
Axonal neuropathy 11.30 11.17 14 102477 1930 70824023
Nephrectasia 11.27 11.17 3 102488 15 70825938
Drug clearance increased 11.27 11.17 6 102485 242 70825711
Procedural pain 11.22 11.17 6 102485 18003 70807950
Movement disorder 11.18 11.17 11 102480 24118 70801835

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 0703-5145 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 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 25021-815 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 25021-828 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
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 42806-134 TABLET 15 mg ORAL ANDA 16 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 42806-358 TABLET 5 mg ORAL ANDA 16 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 42806-359 TABLET 25 mg ORAL ANDA 16 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 50742-181 TABLET 5 mg ORAL ANDA 17 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 50742-182 TABLET 10 mg ORAL ANDA 17 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 50742-183 TABLET 15 mg ORAL ANDA 17 sections
Leucovorin Calcium HUMAN PRESCRIPTION DRUG LABEL 1 50742-184 TABLET 25 mg ORAL ANDA 17 sections