lactulose ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
1536 4618-18-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • lactulose
  • bifiteral
  • cephulac
  • D-Lactulose
  • isolactose
  • lactulose hydrate
A synthetic disaccharide used in the treatment of constipation and hepatic encephalopathy. It has also been used in the diagnosis of gastrointestinal disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p887)
  • Molecular weight: 342.30
  • Formula: C12H22O11
  • CLOGP: -3.59
  • LIPINSKI: 2
  • HAC: 11
  • HDO: 8
  • TPSA: 189.53
  • ALOGS: 0.36
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
6.70 g O

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 1669.38 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 3 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
March 25, 1976 FDA
Sept. 21, 2018 PMDA Sanwa Kagaku Kenkyusho Co., Ltd.

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
Sedation complication 541.21 10.82 228 46607 8538 50549751
Orthostatic hypotension 518.38 10.82 329 46506 29152 50529137
Creatinine renal clearance decreased 493.05 10.82 234 46601 11647 50546642
Sedation 441.82 10.82 302 46533 30308 50527981
Cognitive disorder 405.48 10.82 332 46503 43791 50514498
Blood calcium decreased 391.39 10.82 242 46593 20464 50537825
Balance disorder 313.82 10.82 356 46479 70234 50488055
Drug ineffective 313.03 10.82 187 46648 819146 49739143
Depressed level of consciousness 309.10 10.82 306 46529 51647 50506642
Hepatic encephalopathy 302.45 10.82 157 46678 9479 50548810
Constipation 240.10 10.82 530 46305 185178 50373111
Fall 193.48 10.82 714 46121 334218 50224071
Ammonia increased 159.15 10.82 78 46757 4163 50554126
Mobility decreased 153.91 10.82 270 46565 79678 50478611
Jaundice cholestatic 151.04 10.82 80 46755 5031 50553258
Hypotension 144.19 10.82 512 46323 234957 50323332
Hypomania 137.34 10.82 72 46763 4433 50553856
Hyponatraemia 128.07 10.82 278 46557 95861 50462428
Blood bilirubin increased 124.60 10.82 151 46684 31887 50526402
Schizophrenia 123.57 10.82 80 46755 7317 50550972
Drug hypersensitivity 120.59 10.82 41 46794 250969 50307320
Drug intolerance 110.17 10.82 33 46802 219071 50339218
Faecaloma 109.31 10.82 73 46762 7035 50551254
Rheumatoid arthritis 106.49 10.82 28 46807 202522 50355767
Treatment failure 100.23 10.82 7 46828 137630 50420659
Systemic lupus erythematosus 99.99 10.82 8 46827 140614 50417675
Arthropathy 99.49 10.82 14 46821 157892 50400397
Synovitis 97.35 10.82 4 46831 123861 50434428
Hepatic cirrhosis 96.13 10.82 99 46736 17478 50540811
Maternal exposure during pregnancy 86.06 10.82 21 46814 159757 50398532
Inability to afford medication 85.16 10.82 37 46798 1493 50556796
Completed suicide 82.36 10.82 12 46823 131877 50426412
Psychotic disorder 81.88 10.82 101 46734 21711 50536578
Swelling 80.17 10.82 43 46792 200829 50357460
Joint swelling 78.53 10.82 67 46768 245219 50313070
Glossodynia 78.32 10.82 8 46827 115561 50442728
Ascites 78.06 10.82 128 46707 35733 50522556
Contraindicated product administered 77.49 10.82 21 46814 148937 50409352
Hyperkalaemia 76.88 10.82 150 46685 47939 50510350
Hand deformity 76.24 10.82 4 46831 100195 50458094
Sinusitis 74.95 10.82 32 46803 170526 50387763
Alopecia 72.44 10.82 72 46763 244975 50313314
Infusion related reaction 71.09 10.82 34 46801 169523 50388766
Confusional state 68.08 10.82 346 46489 185582 50372707
Haematemesis 67.27 10.82 104 46731 27621 50530668
Therapeutic product effect decreased 65.65 10.82 22 46813 136028 50422261
Neutropenic sepsis 65.57 10.82 73 46762 14074 50544215
Injection site pain 65.07 10.82 12 46823 111012 50447277
Arthralgia 64.15 10.82 201 46634 438501 50119788
Cholelithiasis 60.14 10.82 118 46717 37855 50520434
Skin candida 57.69 10.82 27 46808 1299 50556990
General physical health deterioration 57.06 10.82 272 46563 142162 50416127
Toxicity to various agents 55.22 10.82 361 46474 212138 50346151
Discomfort 55.01 10.82 16 46819 108364 50449925
Pericarditis 54.48 10.82 5 46830 78684 50479605
Abdominal discomfort 53.77 10.82 82 46753 231559 50326730
Lymphatic fistula 51.30 10.82 21 46814 729 50557560
Intestinal pseudo-obstruction 51.19 10.82 21 46814 733 50557556
Femoral hernia incarcerated 51.01 10.82 21 46814 740 50557549
Product use issue 50.07 10.82 39 46796 149436 50408853
Wound infection pseudomonas 49.52 10.82 24 46811 1249 50557040
Pancreatic steatosis 46.97 10.82 21 46814 908 50557381
Rash 46.87 10.82 227 46608 437244 50121045
Abdominal pain 46.77 10.82 376 46459 235852 50322437
Vomiting 46.37 10.82 639 46196 460119 50098170
Hepatotoxicity 46.05 10.82 87 46748 27139 50531150
Off label use 45.87 10.82 255 46580 474171 50084118
Therapeutic product effect incomplete 43.78 10.82 15 46820 91500 50466789
Hepatic failure 43.66 10.82 94 46741 32189 50526100
Nasopharyngitis 43.13 10.82 70 46765 192857 50365432
Wound 43.13 10.82 22 46813 105772 50452517
Haemarthrosis 42.64 10.82 29 46806 2879 50555410
Injection site erythema 42.01 10.82 9 46826 74927 50483362
Jaundice 41.69 10.82 82 46753 26347 50531942
Heart sounds 40.92 10.82 17 46818 613 50557676
Fatigue 40.00 10.82 441 46394 707160 49851129
Urinary retention 39.80 10.82 80 46755 26110 50532179
Dehydration 39.56 10.82 259 46576 152190 50406099
Arterial haemorrhage 39.41 10.82 22 46813 1535 50556754
Varices oesophageal 38.97 10.82 27 46808 2762 50555527
Prolonged expiration 38.71 10.82 17 46818 704 50557585
Seroma 38.57 10.82 23 46812 1818 50556471
Hypersensitivity 36.21 10.82 92 46743 215069 50343220
Acute kidney injury 35.78 10.82 345 46490 227713 50330576
Urinary tract infection 35.69 10.82 340 46495 223680 50334609
Encephalopathy 35.53 10.82 89 46746 33622 50524667
Musculoskeletal stiffness 35.40 10.82 40 46795 128441 50429848
Chronic hepatic failure 34.72 10.82 14 46821 467 50557822
Aortic arteriosclerosis 34.39 10.82 33 46802 5349 50552940
Hepatocellular carcinoma 34.32 10.82 22 46813 1977 50556312
Hypokalaemia 33.73 10.82 166 46669 87826 50470463
Diverticulum intestinal 33.49 10.82 34 46801 5899 50552390
Delirium 33.32 10.82 94 46741 38098 50520191
Abdominal tenderness 32.77 10.82 37 46798 7243 50551046
Dementia 32.00 10.82 55 46780 15942 50542347
Duodenal ulcer 31.46 10.82 35 46800 6740 50551549
Urticaria 30.87 10.82 45 46790 129516 50428773
Aortic valve stenosis 30.72 10.82 24 46811 2951 50555338
Peritonitis bacterial 30.58 10.82 29 46806 4632 50553657
Psoriasis 30.20 10.82 13 46822 68987 50489302
Oesophageal varices haemorrhage 30.08 10.82 16 46819 1014 50557275
Drug abuse 30.06 10.82 9 46826 59837 50498452
Suicide attempt 29.44 10.82 6 46829 51726 50506563
Alkalosis hypochloraemic 29.11 10.82 9 46826 134 50558155
Exposure during pregnancy 28.86 10.82 42 46793 120973 50437316
Neutrophil count increased 28.65 10.82 49 46786 14146 50544143
Wound dehiscence 28.52 10.82 27 46808 4303 50553986
Ileus 28.48 10.82 47 46788 13182 50545107
Weight increased 28.36 10.82 94 46741 201797 50356492
Hypertriglyceridaemia 28.35 10.82 30 46805 5461 50552828
Haemoglobin decreased 28.19 10.82 208 46627 127008 50431281
Product monitoring error 27.90 10.82 22 46813 2742 50555547
Insurance issue 27.28 10.82 21 46814 2527 50555762
Intentional overdose 27.00 10.82 12 46823 62492 50495797
Superinfection 26.63 10.82 19 46816 2037 50556252
Melaena 26.32 10.82 69 46766 26795 50531494
Arthritis 26.13 10.82 25 46810 86696 50471593
Product prescribing error 26.04 10.82 59 46776 20902 50537387
Cholestasis of pregnancy 25.98 10.82 15 46820 1116 50557173
Hepatic cyst 25.82 10.82 26 46809 4467 50553822
Therapeutic response decreased 25.81 10.82 6 46829 47225 50511064
Irritable bowel syndrome 25.36 10.82 8 46827 51433 50506856
Anaemia 25.24 10.82 350 46485 252106 50306183
Dermatitis bullous 24.98 10.82 32 46803 7141 50551148
Intestinal dilatation 24.82 10.82 16 46819 1452 50556837
Headache 24.59 10.82 326 46509 506209 50052080
Ill-defined disorder 24.39 10.82 10 46825 54644 50503645
Tachyarrhythmia 24.04 10.82 24 46811 4081 50554208
Body mass index decreased 23.83 10.82 10 46825 370 50557919
Psoriatic arthropathy 23.75 10.82 7 46828 47025 50511264
Abortion spontaneous 23.45 10.82 5 46830 41767 50516522
Urinary incontinence 23.22 10.82 68 46767 28140 50530149
Hiatus hernia 23.20 10.82 52 46783 18292 50539997
Hyperammonaemia 22.97 10.82 25 46810 4699 50553590
Infection 22.62 10.82 83 46752 172871 50385418
Injection site reaction 22.58 10.82 9 46826 50023 50508266
White blood cell count increased 22.52 10.82 88 46747 42152 50516137
Injection site pruritus 22.35 10.82 5 46830 40406 50517883
Intestinal obstruction 22.10 10.82 64 46771 26319 50531970
Portal hypertension 22.05 10.82 21 46814 3371 50554918
Nail dystrophy 22.01 10.82 12 46823 799 50557490
Mucosal inflammation 21.70 10.82 84 46751 40058 50518231
Cirrhosis alcoholic 21.50 10.82 8 46827 214 50558075
Disorientation 21.48 10.82 77 46758 35407 50522882
Abdominal distension 21.47 10.82 128 46707 72775 50485514
Peripheral swelling 21.32 10.82 108 46727 205828 50352461
Sepsis 21.26 10.82 202 46633 132723 50425566
Pneumonia 21.08 10.82 478 46357 377923 50180366
Blood pressure increased 20.81 10.82 59 46776 133073 50425216
Helicobacter infection 20.75 10.82 10 46825 49692 50508597
Mouth ulceration 20.67 10.82 65 46770 27959 50530330
Eructation 20.56 10.82 29 46806 7092 50551197
Hepatitis C 20.46 10.82 24 46811 4893 50553396
Abdominal rigidity 20.37 10.82 15 46820 1689 50556600
Blood cholesterol increased 20.32 10.82 13 46822 55202 50503087
Vascular encephalopathy 20.31 10.82 9 46826 381 50557908
Bradycardia 20.20 10.82 115 46720 64311 50493978
Spinal cord paralysis 19.95 10.82 5 46830 32 50558257
Product dose omission issue 19.84 10.82 95 46740 183743 50374546
Pneumatosis intestinalis 19.66 10.82 16 46819 2087 50556202
Left ventricular dysfunction 19.56 10.82 35 46800 10471 50547818
Injection site bruising 19.45 10.82 5 46830 36763 50521526
Seizure 19.28 10.82 180 46655 117694 50440595
Gastrointestinal haemorrhage 19.26 10.82 125 46710 73196 50485093
Blood albumin abnormal 18.94 10.82 9 46826 448 50557841
Thrombocytopenia 18.94 10.82 191 46644 127482 50430807
Hallucination, visual 18.77 10.82 45 46790 16537 50541752
Syncope 18.75 10.82 161 46674 102841 50455448
Gastrointestinal disorder 18.63 10.82 37 46798 94419 50463870
Portal hypertensive gastropathy 18.57 10.82 10 46825 650 50557639
Pulmonary vein occlusion 18.51 10.82 6 46829 105 50558184
Hip arthroplasty 18.45 10.82 3 46832 30426 50527863
Femoral neck fracture 18.03 10.82 28 46807 7462 50550827
Cholestasis 17.90 10.82 58 46777 25343 50532946
Anuria 17.87 10.82 35 46800 11209 50547080
Mouth swelling 17.79 10.82 20 46815 3896 50554393
Upper gastrointestinal haemorrhage 17.59 10.82 43 46792 15992 50542297
Salivary gland enlargement 17.57 10.82 8 46827 361 50557928
Ejection fraction decreased 17.56 10.82 47 46788 18473 50539816
Depressive symptom 17.45 10.82 18 46817 3182 50555107
Device expulsion 17.13 10.82 3 46832 28819 50529470
Oral contusion 16.87 10.82 5 46830 64 50558225
Axillary pain 16.84 10.82 13 46822 1571 50556718
Postoperative wound infection 16.77 10.82 29 46806 8446 50549843
Blood alkaline phosphatase increased 16.72 10.82 74 46761 37452 50520837
Lethargy 16.67 10.82 90 46745 49342 50508947
Respiration abnormal 16.58 10.82 22 46813 5080 50553209
Liver function test abnormal 16.52 10.82 83 46752 44256 50514033
Inflammation 16.46 10.82 17 46818 56895 50501394
Alkalosis 16.21 10.82 7 46828 278 50558011
Escherichia infection 16.12 10.82 33 46802 10908 50547381
Feeling abnormal 15.90 10.82 61 46774 125431 50432858
Hepatorenal syndrome 15.74 10.82 13 46822 1730 50556559
Plasma cell myeloma 15.69 10.82 64 46771 31258 50527031
Pancytopenia 15.64 10.82 132 46703 83898 50474391
Pustule 15.52 10.82 11 46824 1167 50557122
Herpes zoster 15.50 10.82 26 46809 70760 50487529
Cardiac ventricular thrombosis 15.48 10.82 8 46827 478 50557811
Electrocardiogram T wave inversion 15.41 10.82 17 46818 3244 50555045
Pain in extremity 15.33 10.82 170 46665 272695 50285594
Tumour hyperprogression 15.24 10.82 5 46830 91 50558198
Inappropriate schedule of product administration 15.17 10.82 27 46808 71804 50486485
Death 15.09 10.82 401 46434 324978 50233311
Cardiomyopathy acute 15.03 10.82 6 46829 195 50558094
Aspiration 14.92 10.82 29 46806 9235 50549054
Inflammatory marker increased 14.89 10.82 22 46813 5612 50552677
Cardiovascular disorder 14.78 10.82 31 46804 10423 50547866
Aplastic anaemia 14.78 10.82 26 46809 7677 50550612
Hypomagnesaemia 14.66 10.82 51 46784 23105 50535184
Vascular parkinsonism 14.53 10.82 5 46830 106 50558183
Circulatory collapse 14.39 10.82 46 46789 19954 50538335
Haematocrit increased 14.34 10.82 13 46822 1961 50556328
Portopulmonary hypertension 14.31 10.82 5 46830 111 50558178
Haemoglobin increased 14.31 10.82 16 46819 3099 50555190
C-reactive protein abnormal 14.30 10.82 4 46831 27805 50530484
Pruritus 14.27 10.82 181 46654 283387 50274902
Type 2 diabetes mellitus 14.22 10.82 7 46828 34368 50523921
Activated partial thromboplastin time abnormal 14.15 10.82 5 46830 115 50558174
Visual impairment 14.12 10.82 26 46809 68249 50490040
Blood albumin decreased 14.00 10.82 35 46800 13201 50545088
Mechanical urticaria 14.00 10.82 7 46828 390 50557899
Mutism 13.96 10.82 11 46824 1370 50556919
Thrombocytosis 13.92 10.82 20 46815 4976 50553313
Product administration error 13.90 10.82 45 46790 19654 50538635
Spinal cord infarction 13.79 10.82 6 46829 243 50558046
Spinal subdural haematoma 13.72 10.82 5 46830 126 50558163
Hiccups 13.72 10.82 12 46823 1727 50556562
Depressed mood 13.61 10.82 65 46770 33958 50524331
Migraine 13.58 10.82 31 46804 75249 50483040
Oropharyngeal pain 13.27 10.82 33 46802 77768 50480521
Physical assault 13.18 10.82 9 46826 899 50557390
Asterixis 13.16 10.82 10 46825 1181 50557108
Flail chest 13.04 10.82 4 46831 58 50558231
Bronchitis 12.95 10.82 51 46784 104108 50454181
Gamma-glutamyltransferase increased 12.89 10.82 58 46777 29565 50528724
Therapy non-responder 12.86 10.82 17 46818 51005 50507284
Decreased appetite 12.83 10.82 259 46576 200664 50357625
Systemic infection 12.73 10.82 13 46822 2270 50556019
Tricuspid valve incompetence 12.71 10.82 33 46802 12737 50545552
Jugular vein thrombosis 12.64 10.82 14 46821 2682 50555607
Lung perforation 12.56 10.82 4 46831 66 50558223
Hypoaesthesia 12.45 10.82 68 46767 127189 50431100
Hepatic hydrothorax 12.44 10.82 3 46832 16 50558273
Subileus 12.38 10.82 14 46821 2745 50555544
Fracture 12.37 10.82 39 46796 16794 50541495
Gastrointestinal sounds abnormal 12.32 10.82 16 46819 3618 50554671
Blood creatinine increased 12.30 10.82 116 46719 76044 50482245
Foetal exposure during pregnancy 12.21 10.82 5 46830 27354 50530935
Mental status changes 12.20 10.82 66 46769 36206 50522083
False positive investigation result 12.16 10.82 7 46828 518 50557771
Disease progression 12.15 10.82 139 46696 95727 50462562
Febrile neutropenia 12.11 10.82 141 46694 97526 50460763
Hyperglycaemia 12.08 10.82 66 46769 36339 50521950
Intentional product use issue 12.08 10.82 34 46801 76884 50481405
Product selection error 12.03 10.82 4 46831 76 50558213
Chronotropic incompetence 11.94 10.82 4 46831 78 50558211
Sinus arrhythmia 11.93 10.82 10 46825 1359 50556930
Dyskinesia 11.71 10.82 54 46781 27807 50530482
Ballismus 11.66 10.82 4 46831 84 50558205
Adverse event 11.64 10.82 14 46821 43749 50514540
Change of bowel habit 11.51 10.82 11 46824 1773 50556516
Joint injury 11.45 10.82 3 46832 21786 50536503
Adverse drug reaction 11.44 10.82 21 46814 55201 50503088
Toxic epidermal necrolysis 11.40 10.82 44 46791 20948 50537341
Joint dislocation 11.39 10.82 31 46804 12302 50545987
Skin abrasion 11.33 10.82 24 46811 8126 50550163
COVID-19 11.31 10.82 16 46819 46646 50511643
Anticonvulsant drug level below therapeutic 11.31 10.82 7 46828 592 50557697
Coma hepatic 11.13 10.82 7 46828 609 50557680
Toxic encephalopathy 11.08 10.82 19 46816 5496 50552793
Antipsychotic drug level increased 11.03 10.82 14 46821 3095 50555194
Hypermagnesaemia 10.98 10.82 8 46827 886 50557403
No adverse event 10.93 10.82 9 46826 33569 50524720
Appetite disorder 10.91 10.82 20 46815 6094 50552195
Pregnancy 10.83 10.82 7 46828 29570 50528719

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
Hepatic encephalopathy 620.50 10.84 323 41630 12712 29519862
Hepatic cirrhosis 169.30 10.84 150 41803 14294 29518280
Confusional state 142.94 10.84 452 41501 127425 29405149
Ascites 138.41 10.84 212 41741 36407 29496167
Hepatic failure 134.26 10.84 193 41760 31319 29501255
Ammonia increased 121.24 10.84 74 41879 3957 29528617
Inability to afford medication 105.47 10.84 43 41910 949 29531625
Drug ineffective 103.14 10.84 227 41726 362943 29169631
Hepatorenal syndrome 81.55 10.84 47 41906 2259 29530315
Completed suicide 74.85 10.84 18 41935 90228 29442346
Drug abuse 68.10 10.84 15 41938 79868 29452706
Varices oesophageal 65.80 10.84 46 41907 3100 29529474
Constipation 64.35 10.84 326 41627 113834 29418740
Toxic epidermal necrolysis 60.13 10.84 99 41854 18054 29514520
Hepatocellular carcinoma 57.62 10.84 60 41893 6978 29525596
Pneumatosis intestinalis 56.37 10.84 42 41911 3127 29529447
Encephalopathy 52.70 10.84 128 41825 30915 29501659
Faecaloma 51.95 10.84 45 41908 4157 29528417
Hyperammonaemia 51.32 10.84 51 41902 5612 29526962
Peritonitis bacterial 50.62 10.84 51 41902 5705 29526869
Off label use 46.73 10.84 244 41709 300556 29232018
Oesophageal varices haemorrhage 46.26 10.84 35 41918 2667 29529907
Chronic hepatic failure 45.75 10.84 19 41934 440 29532134
Blood bilirubin increased 44.51 10.84 127 41826 33766 29498808
Abdominal distension 43.76 10.84 154 41799 45757 29486817
Hyponatraemia 42.99 10.84 200 41753 67433 29465141
Portal hypertension 42.42 10.84 37 41916 3449 29529125
General physical health deterioration 41.65 10.84 269 41684 102588 29429986
Arthralgia 41.31 10.84 85 41868 139532 29393042
Abdominal pain 40.40 10.84 329 41624 135028 29397546
Haematemesis 40.16 10.84 100 41853 24526 29508048
Alveolar lung disease 39.25 10.84 16 41937 353 29532221
Insurance issue 38.13 10.84 21 41932 924 29531650
Pulmonary interstitial emphysema syndrome 35.65 10.84 16 41937 450 29532124
Gastric varices 35.13 10.84 15 41938 373 29532201
Pyramidal tract syndrome 33.34 10.84 12 41941 186 29532388
Liver transplant 33.16 10.84 27 41926 2289 29530285
Jaundice 33.00 10.84 104 41849 29192 29503382
Antipsychotic drug level increased 32.75 10.84 31 41922 3212 29529362
Hepatitis C 31.42 10.84 50 41903 8860 29523714
High-grade B-cell lymphoma 30.93 10.84 9 41944 67 29532507
Cirrhosis alcoholic 30.91 10.84 17 41936 746 29531828
Benign gastrointestinal neoplasm 29.05 10.84 10 41943 135 29532439
Ileus 28.40 10.84 63 41890 14339 29518235
Stoma site discharge 28.00 10.84 17 41936 900 29531674
Neutrophil count increased 27.41 10.84 63 41890 14679 29517895
Product use in unapproved indication 26.43 10.84 52 41901 86823 29445751
Injection site pain 25.86 10.84 7 41946 32439 29500135
Toxicity to various agents 25.70 10.84 143 41810 173518 29359056
Hypermagnesaemia 25.53 10.84 10 41943 198 29532376
Therapy interrupted 25.46 10.84 44 41909 8342 29524232
Myocardial infarction 24.94 10.84 77 41876 110219 29422355
Rash 24.58 10.84 163 41790 189656 29342918
Foetal exposure during pregnancy 23.99 10.84 9 41944 33858 29498716
Conjunctival irritation 23.73 10.84 8 41945 101 29532473
Rheumatoid arthritis 23.70 10.84 8 41945 32144 29500430
Fall 23.43 10.84 367 41586 176811 29355763
Cardiac failure congestive 23.15 10.84 46 41907 76535 29456039
Joint swelling 22.84 10.84 22 41931 49608 29482966
Hypernatraemia 22.75 10.84 39 41914 7347 29525227
Stoma site erythema 22.62 10.84 13 41940 621 29531953
On and off phenomenon 22.53 10.84 20 41933 1908 29530666
Therapeutic product effect incomplete 22.43 10.84 14 41939 39291 29493283
Atrial fibrillation 22.33 10.84 76 41877 105570 29427004
Portal hypertensive gastropathy 22.32 10.84 12 41941 503 29532071
Polypectomy 22.12 10.84 12 41941 512 29532062
Myalgia 21.91 10.84 45 41908 73974 29458600
Acute kidney injury 21.88 10.84 511 41442 264756 29267818
Mesothelioma 21.85 10.84 11 41942 402 29532172
Wrong patient received product 21.51 10.84 21 41932 2261 29530313
Treatment failure 21.30 10.84 13 41940 36926 29495648
Lower respiratory tract infection 21.15 10.84 84 41869 26418 29506156
White blood cell count increased 20.98 10.84 107 41846 37409 29495165
Hepatitis C RNA positive 20.21 10.84 8 41945 163 29532411
Vomiting 20.05 10.84 417 41536 211843 29320731
Pneumonia aspiration 20.01 10.84 104 41849 36633 29495941
Genital erythema 19.90 10.84 8 41945 170 29532404
Interstitial lung disease 19.84 10.84 32 41921 57686 29474888
Delirium 19.74 10.84 109 41844 39288 29493286
Metamyelocyte count increased 19.60 10.84 10 41943 376 29532198
Periarthritis calcarea 19.52 10.84 6 41947 55 29532519
Urinary tract infection 19.50 10.84 172 41781 72182 29460392
Epilepsy 19.45 10.84 64 41889 18368 29514206
Product dose omission issue 19.25 10.84 71 41882 96312 29436262
Articular calcification 19.24 10.84 6 41947 58 29532516
Nasopharyngitis 18.76 10.84 35 41918 59630 29472944
Spleen congestion 18.64 10.84 9 41944 300 29532274
Drug resistance 18.43 10.84 4 41949 21536 29511038
Asterixis 18.34 10.84 14 41939 1081 29531493
Acute abdomen 18.22 10.84 17 41936 1730 29530844
Blood pressure increased 17.78 10.84 50 41903 73753 29458821
Mental status changes 17.74 10.84 97 41856 34830 29497744
Hepatic calcification 17.72 10.84 9 41944 335 29532239
Immature granulocyte count increased 17.70 10.84 6 41947 77 29532497
Adrenomegaly 17.41 10.84 9 41944 348 29532226
Adrenal cyst 17.36 10.84 6 41947 82 29532492
Haemoglobin decreased 17.28 10.84 232 41721 108143 29424431
Myelocyte count increased 17.26 10.84 9 41944 354 29532220
Hepatic cancer 17.20 10.84 32 41921 6424 29526150
Costal cartilage fracture 17.19 10.84 8 41945 245 29532329
Pneumonia 16.95 10.84 583 41370 319589 29212985
Rectal haemorrhage 16.91 10.84 95 41858 34454 29498120
Orthostatic hypotension 16.69 10.84 70 41883 22559 29510015
Portal vein thrombosis 16.68 10.84 22 41931 3287 29529287
Hypophagia 16.53 10.84 66 41887 20806 29511768
Dysphagia 16.07 10.84 133 41820 54793 29477781
Diffuse alveolar damage 15.98 10.84 17 41936 2026 29530548
Coronary artery disease 15.66 10.84 24 41929 44166 29488408
Arthritis 15.58 10.84 8 41945 25011 29507563
Wrong technique in product usage process 15.57 10.84 13 41940 31415 29501159
Intentional product misuse 15.22 10.84 16 41937 34645 29497929
Bacterial translocation 15.21 10.84 7 41946 209 29532365
Hypersensitivity 14.95 10.84 33 41920 52870 29479704
Therapeutic product effect decreased 14.82 10.84 12 41941 29439 29503135
Blast cells present 14.73 10.84 9 41944 482 29532092
Product use issue 14.62 10.84 32 41921 51412 29481162
Peripheral artery stenosis 14.56 10.84 11 41942 836 29531738
Hyperkalaemia 14.55 10.84 142 41811 61250 29471324
Dehydration 14.50 10.84 236 41717 114512 29418062
Urinary retention 14.50 10.84 86 41867 31812 29500762
Neutropenic sepsis 14.48 10.84 43 41910 11684 29520890
Liver function test abnormal 14.47 10.84 80 41873 28838 29503736
Sepsis 14.34 10.84 283 41670 142399 29390175
Intentional product use issue 14.20 10.84 24 41929 42474 29490100
Erosive duodenitis 14.17 10.84 13 41940 1294 29531280
Hypertension 14.15 10.84 102 41851 116512 29416062
Gastrointestinal tract mucosal pigmentation 14.06 10.84 8 41945 375 29532199
Inappropriate schedule of product administration 14.06 10.84 26 41927 44446 29488128
Portal tract inflammation 13.98 10.84 5 41948 76 29532498
Abdominal tenderness 13.88 10.84 21 41932 3561 29529013
Bloody discharge 13.85 10.84 8 41945 386 29532188
Lethargy 13.80 10.84 96 41857 37484 29495090
Sexually inappropriate behaviour 13.70 10.84 8 41945 394 29532180
Erythema 13.63 10.84 58 41895 75548 29457026
Paracentesis 13.63 10.84 8 41945 398 29532176
Peritonitis 13.49 10.84 49 41904 14775 29517799
Salivary gland disorder 13.46 10.84 6 41947 166 29532408
Platelet count increased 13.41 10.84 34 41919 8429 29524145
Vascular purpura 13.39 10.84 13 41940 1390 29531184
Asthma 13.38 10.84 17 41936 33832 29498742
Upper gastrointestinal haemorrhage 13.32 10.84 64 41889 21850 29510724
Activated partial thromboplastin time prolonged 13.21 10.84 32 41921 7710 29524864
Arteriosclerosis coronary artery 13.20 10.84 39 41914 10566 29522008
Activated partial thromboplastin time shortened 13.18 10.84 8 41945 423 29532151
Coma hepatic 13.00 10.84 8 41945 434 29532140
Myoclonus 12.97 10.84 45 41908 13264 29519310
Contraindication to medical treatment 12.87 10.84 8 41945 442 29532132
Spinal cord injury thoracic 12.81 10.84 5 41948 98 29532476
Portal shunt 12.70 10.84 4 41949 40 29532534
Aortic arteriosclerosis 12.64 10.84 21 41932 3855 29528719
Freezing phenomenon 12.61 10.84 12 41941 1251 29531323
Differential white blood cell count abnormal 12.57 10.84 12 41941 1257 29531317
Adrenal adenoma 12.56 10.84 7 41946 315 29532259
Hypercreatininaemia 12.56 10.84 8 41945 461 29532113
Hyperbilirubinaemia 12.45 10.84 48 41905 14886 29517688
Platelet count decreased 12.39 10.84 213 41740 104459 29428115
Anti-erythropoietin antibody negative 12.29 10.84 6 41947 205 29532369
Cytomegalovirus infection 12.26 10.84 9 41944 23206 29509368
Abdominal cavity drainage 12.11 10.84 7 41946 338 29532236
Monocyte count decreased 12.06 10.84 11 41942 1087 29531487
Escherichia urinary tract infection 12.04 10.84 18 41935 3021 29529553
Psoriatic arthropathy 12.03 10.84 3 41950 14688 29517886
Hypoalbuminaemia 11.98 10.84 37 41916 10268 29522306
Application site hypersensitivity 11.87 10.84 5 41948 120 29532454
Transcription medication error 11.76 10.84 5 41948 123 29532451
Headache 11.71 10.84 175 41778 173832 29358742
Cerebral arteriovenous malformation haemorrhagic 11.62 10.84 4 41949 54 29532520
Embedded device 11.56 10.84 6 41947 234 29532340
Portal shunt procedure 11.50 10.84 3 41950 14 29532560
Eosinophilic pneumonia 11.48 10.84 17 41936 2829 29529745
Monocyte count increased 11.29 10.84 20 41933 3866 29528708
Transfusion 11.23 10.84 29 41924 7269 29525305
Melaena 11.07 10.84 79 41874 31097 29501477
Flat affect 10.85 10.84 9 41944 783 29531791

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
Hepatic encephalopathy 821.35 10.32 433 77356 20633 64400310
Sedation complication 506.04 10.32 248 77541 10106 64410837
Orthostatic hypotension 444.88 10.32 402 77387 46336 64374607
Creatinine renal clearance decreased 428.77 10.32 248 77541 14173 64406770
Sedation 337.55 10.32 327 77462 41135 64379808
Blood calcium decreased 336.34 10.32 265 77524 25289 64395654
Drug ineffective 326.47 10.32 321 77468 839926 63581017
Cognitive disorder 320.43 10.32 363 77426 54724 64366219
Balance disorder 273.83 10.32 416 77373 83510 64337433
Constipation 249.58 10.32 723 77066 228614 64192329
Ammonia increased 223.50 10.32 126 77663 6851 64414092
Depressed level of consciousness 222.10 10.32 372 77417 81064 64339879
Hepatic cirrhosis 209.47 10.32 205 77584 26093 64394850
Confusional state 208.25 10.32 740 77049 260404 64160539
Ascites 205.97 10.32 310 77479 61691 64359252
Inability to afford medication 189.48 10.32 75 77714 1811 64419132
Fall 185.16 10.32 990 76799 415836 64005107
Completed suicide 177.26 10.32 29 77760 224385 64196558
Hepatic failure 152.25 10.32 254 77535 55140 64365803
Blood bilirubin increased 150.37 10.32 258 77531 57295 64363648
Mobility decreased 148.35 10.32 323 77466 85517 64335426
Faecaloma 134.72 10.32 104 77685 9624 64411319
Hyponatraemia 132.61 10.32 437 77352 147902 64273041
Rheumatoid arthritis 115.54 10.32 28 77761 164266 64256677
Hypotension 115.28 10.32 820 76969 380154 64040789
Jaundice cholestatic 107.82 10.32 87 77702 8583 64412360
Arthralgia 107.17 10.32 234 77555 442026 63978917
Hypomania 106.91 10.32 73 77716 5581 64415362
Drug hypersensitivity 102.41 10.32 82 77707 237733 64183210
Haematemesis 100.27 10.32 193 77596 46806 64374137
Drug abuse 96.18 10.32 21 77768 132353 64288590
Schizophrenia 94.45 10.32 90 77699 11078 64409865
Injection site pain 91.10 10.32 13 77776 111395 64309548
Joint swelling 90.57 10.32 76 77713 215306 64205637
Arthropathy 90.33 10.32 18 77771 120949 64299994
Off label use 89.54 10.32 426 77363 632380 63788563
Varices oesophageal 89.41 10.32 63 77726 5067 64415876
Hepatocellular carcinoma 89.31 10.32 77 77712 8326 64412617
Hepatorenal syndrome 84.50 10.32 54 77735 3692 64417251
Treatment failure 83.92 10.32 19 77770 116797 64304146
General physical health deterioration 79.46 10.32 469 77320 203956 64216987
Drug intolerance 79.45 10.32 66 77723 187926 64233017
Pneumatosis intestinalis 79.25 10.32 59 77730 5170 64415773
Sinusitis 78.35 10.32 39 77750 145889 64275054
Encephalopathy 77.31 10.32 199 77590 58620 64362323
Therapeutic product effect decreased 76.63 10.32 22 77767 115329 64305614
Infusion related reaction 71.66 10.32 56 77733 164411 64256532
Systemic lupus erythematosus 71.17 10.32 6 77783 77606 64343337
Nasopharyngitis 69.93 10.32 80 77709 195993 64224950
Therapeutic product effect incomplete 68.26 10.32 20 77769 103462 64317481
Abdominal pain 68.00 10.32 624 77165 311751 64109192
Insurance issue 66.90 10.32 42 77747 2784 64418159
Hyperkalaemia 65.88 10.32 269 77520 100860 64320083
Hyperammonaemia 65.74 10.32 70 77719 9834 64411109
Oesophageal varices haemorrhage 64.25 10.32 45 77744 3584 64417359
Peritonitis bacterial 63.75 10.32 66 77723 8977 64411966
Swelling 63.17 10.32 60 77729 160158 64260785
Chronic hepatic failure 62.07 10.32 27 77762 832 64420111
Toxic epidermal necrolysis 62.06 10.32 138 77651 37028 64383915
Neutropenic sepsis 61.64 10.32 105 77684 23167 64397776
Jaundice 61.56 10.32 162 77627 48350 64372593
Hand deformity 59.98 10.32 4 77785 62767 64358176
Maternal exposure during pregnancy 58.87 10.32 21 77768 95863 64325080
Rash 58.87 10.32 319 77470 458230 63962713
Acute kidney injury 56.78 10.32 807 76982 448433 63972510
Portal hypertension 56.20 10.32 52 77737 6167 64414776
Abdominal distension 55.29 10.32 246 77543 95748 64325195
Hepatitis C 54.72 10.32 67 77722 10948 64409995
Psychotic disorder 53.97 10.32 125 77664 34453 64386490
Contraindicated product administered 53.24 10.32 32 77757 107797 64313146
Hypersensitivity 52.54 10.32 98 77691 196354 64224589
Ileus 49.82 10.32 95 77694 22871 64398072
Glossodynia 49.62 10.32 9 77780 64687 64356256
Product use issue 48.75 10.32 67 77722 151648 64269295
Cholelithiasis 47.92 10.32 142 77647 45364 64375579
Aortic arteriosclerosis 46.40 10.32 51 77738 7425 64413518
Injection site erythema 46.11 10.32 14 77775 70786 64350157
Delirium 45.79 10.32 185 77604 69009 64351934
Alopecia 45.78 10.32 81 77708 165609 64255334
Lymphatic fistula 45.74 10.32 21 77768 737 64420206
Femoral hernia incarcerated 45.66 10.32 21 77768 740 64420203
Neutrophil count increased 44.90 10.32 96 77693 25078 64395865
Urinary retention 44.84 10.32 146 77643 49055 64371888
Abdominal tenderness 44.77 10.32 56 77733 9349 64411594
Skin candida 44.61 10.32 27 77762 1676 64419267
Blood pressure increased 42.76 10.32 90 77699 172462 64248481
Wound infection pseudomonas 41.96 10.32 25 77764 1508 64419435
Dehydration 41.19 10.32 421 77368 216342 64204601
Urinary tract infection 40.35 10.32 442 77347 231154 64189789
Pancreatic steatosis 40.05 10.32 21 77768 987 64419956
Headache 39.21 10.32 429 77360 529038 63891905
Alveolar lung disease 39.20 10.32 17 77772 520 64420423
Vomiting 38.44 10.32 902 76887 550215 63870728
Pulmonary interstitial emphysema syndrome 38.24 10.32 16 77773 447 64420496
Discomfort 37.20 10.32 26 77763 80852 64340091
Sepsis 36.69 10.32 432 77357 229909 64191034
Haemoglobin decreased 36.64 10.32 378 77411 194685 64226258
Arthritis 35.91 10.32 29 77760 83785 64337158
Pneumonia 35.46 10.32 904 76885 558672 63862271
Injection site reaction 34.70 10.32 7 77782 46657 64374286
Pericarditis 34.62 10.32 16 77773 62500 64358443
Portal hypertensive gastropathy 34.41 10.32 20 77769 1152 64419791
Heart sounds 34.19 10.32 16 77773 587 64420356
White blood cell count increased 34.18 10.32 164 77625 65850 64355093
Weight increased 34.05 10.32 137 77652 213211 64207732
Liver function test abnormal 34.02 10.32 152 77637 59249 64361694
Abdominal discomfort 33.78 10.32 110 77679 182212 64238731
Intestinal pseudo-obstruction 33.56 10.32 24 77765 1976 64418967
Arterial haemorrhage 33.42 10.32 25 77764 2206 64418737
Musculoskeletal stiffness 33.33 10.32 61 77728 123145 64297798
Gastric varices 32.97 10.32 15 77774 515 64420428
Injection site bruising 32.83 10.32 3 77786 36370 64384573
Fatigue 32.80 10.32 672 77117 748058 63672885
Liver transplant 32.76 10.32 32 77757 4060 64416883
Cirrhosis alcoholic 32.37 10.32 18 77771 952 64419991
Prolonged expiration 32.29 10.32 17 77772 806 64420137
Therapy interrupted 31.89 10.32 73 77716 19963 64400980
Psoriasis 31.74 10.32 24 77765 71679 64349264
Inappropriate schedule of product administration 31.44 10.32 39 77750 92247 64328696
High-grade B-cell lymphoma 31.38 10.32 9 77780 76 64420867
Injection site swelling 31.18 10.32 6 77783 41347 64379596
Therapeutic response decreased 31.07 10.32 12 77777 52176 64368767
Melaena 30.65 10.32 137 77652 53411 64367532
Benign gastrointestinal neoplasm 30.37 10.32 10 77779 139 64420804
Hypokalaemia 30.34 10.32 251 77538 121652 64299291
Hypermagnesaemia 30.31 10.32 18 77771 1079 64419864
Mental status changes 30.27 10.32 150 77639 61012 64359931
Hepatotoxicity 29.82 10.32 111 77678 39851 64381092
Wrong technique in product usage process 29.73 10.32 21 77768 64953 64355990
Injection site pruritus 29.58 10.32 5 77784 37821 64383122
Seroma 28.53 10.32 22 77767 2032 64418911
Hypernatraemia 28.40 10.32 52 77737 12137 64408806
Peripheral swelling 28.16 10.32 143 77646 209010 64211933
Asterixis 27.88 10.32 23 77766 2340 64418603
Psoriatic arthropathy 27.39 10.32 9 77780 43272 64377671
Disorientation 26.97 10.32 136 77653 55692 64365251
Lethargy 26.52 10.32 164 77625 72430 64348513
Ill-defined disorder 26.44 10.32 10 77779 44042 64376901
COVID-19 26.12 10.32 24 77765 65116 64355827
Diverticulum intestinal 25.90 10.32 38 77751 7382 64413561
Urticaria 25.83 10.32 91 77698 147226 64273717
Folliculitis 25.80 10.32 3 77786 30074 64390869
Wrong patient received product 25.70 10.32 27 77762 3735 64417208
Suicide attempt 25.26 10.32 29 77760 70978 64349965
Exposure during pregnancy 25.24 10.32 34 77755 77641 64343302
Antipsychotic drug level increased 25.22 10.32 31 77758 5084 64415859
Gastrointestinal haemorrhage 24.64 10.32 256 77533 132056 64288887
Drug resistance 24.62 10.32 6 77783 35096 64385847
Anaemia 24.58 10.32 614 77175 378066 64042877
Erythema 24.01 10.32 130 77659 186940 64234003
Dementia 23.99 10.32 67 77722 20699 64400244
Intentional overdose 23.91 10.32 45 77744 89899 64331044
Pyramidal tract syndrome 23.45 10.32 12 77777 536 64420407
Herpes zoster 23.44 10.32 37 77752 79150 64341793
Intentional product use issue 23.39 10.32 50 77739 95314 64325629
Conjunctival irritation 23.26 10.32 8 77781 128 64420815
Upper gastrointestinal haemorrhage 23.16 10.32 94 77695 35126 64385817
Product prescribing error 23.09 10.32 94 77695 35175 64385768
Product use in unapproved indication 23.07 10.32 122 77667 176496 64244447
Hepatic cyst 23.05 10.32 30 77759 5210 64415733
Spinal cord paralysis 23.04 10.32 8 77781 132 64420811
Cholestasis of pregnancy 22.53 10.32 14 77775 911 64420032
Product dose omission issue 22.50 10.32 140 77649 194607 64226336
Muscle injury 21.80 10.32 3 77786 26434 64394509
Gastrointestinal disorder 21.21 10.32 48 77741 89661 64331282
Aspiration 21.02 10.32 56 77733 16829 64404114
Hypophagia 20.96 10.32 99 77690 39488 64381455
Epilepsy 20.88 10.32 88 77701 33443 64387500
Intestinal dilatation 20.59 10.32 19 77770 2245 64418698
Periarthritis calcarea 20.48 10.32 6 77783 55 64420888
Hypertension 20.37 10.32 207 77582 259054 64161889
Bradycardia 20.27 10.32 225 77564 117994 64302949
Pain in extremity 20.27 10.32 251 77538 302834 64118109
Intentional product misuse 20.26 10.32 35 77754 72260 64348683
Hepatic cancer 20.24 10.32 34 77755 7414 64413529
Femoral neck fracture 20.05 10.32 37 77752 8687 64412256
Haemarthrosis 20.05 10.32 28 77761 5201 64415742
Irritable bowel syndrome 20.02 10.32 10 77779 37359 64383584
Hypoaesthesia 19.94 10.32 93 77696 139015 64281928
Migraine 19.80 10.32 28 77761 62649 64358294
Dyskinesia 19.77 10.32 97 77692 39291 64381652
Blood pressure fluctuation 19.76 10.32 20 77769 51851 64369092
Wound 19.68 10.32 39 77750 76438 64344505
Genital erythema 19.34 10.32 8 77781 217 64420726
Feeling abnormal 19.34 10.32 89 77700 133513 64287430
Therapy non-responder 19.31 10.32 31 77758 65868 64355075
Erosive duodenitis 19.11 10.32 16 77773 1662 64419281
Oropharyngeal pain 19.08 10.32 50 77739 88817 64332126
Nail dystrophy 19.04 10.32 12 77777 801 64420142
Arteriosclerosis coronary artery 18.83 10.32 51 77738 15478 64405465
Hepatitis C RNA positive 18.72 10.32 8 77781 236 64420707
Hepatic calcification 18.62 10.32 9 77780 355 64420588
Escherichia infection 18.57 10.32 50 77739 15118 64405825
Rectal haemorrhage 18.56 10.32 133 77656 61684 64359259
Costal cartilage fracture 18.38 10.32 8 77781 247 64420696
Seizure 18.35 10.32 293 77496 166599 64254344
Adrenomegaly 18.28 10.32 9 77780 370 64420573
Aortic valve stenosis 18.27 10.32 25 77764 4555 64416388
Peritonitis 18.25 10.32 69 77720 24954 64395989
Abortion spontaneous 18.23 10.32 4 77785 25139 64395804
Dermatitis bullous 18.17 10.32 43 77746 12011 64408932
Body mass index decreased 18.16 10.32 10 77779 519 64420424
Helicobacter infection 18.08 10.32 12 77777 38350 64382593
Portal vein thrombosis 18.06 10.32 26 77763 4965 64415978
Joint injury 18.01 10.32 3 77786 22944 64397999
Adrenal cyst 17.99 10.32 6 77783 87 64420856
Adverse drug reaction 17.93 10.32 17 77772 45447 64375496
Systemic infection 17.87 10.32 24 77765 4297 64416646
Blood pressure systolic increased 17.80 10.32 20 77769 49433 64371510
Wound dehiscence 17.57 10.32 28 77761 5846 64415097
Articular calcification 17.56 10.32 6 77783 94 64420849
Hallucination, visual 17.29 10.32 73 77716 27761 64393182
Spleen congestion 16.97 10.32 9 77780 433 64420510
Myalgia 16.81 10.32 117 77672 158500 64262443
C-reactive protein abnormal 16.77 10.32 7 77782 29040 64391903
Urinary incontinence 16.72 10.32 87 77702 36064 64384879
Alkalosis hypochloraemic 16.63 10.32 9 77780 451 64420492
Osteoarthritis 16.56 10.32 32 77757 63304 64357639
Metamyelocyte count increased 16.55 10.32 10 77779 619 64420324
Pruritus 16.54 10.32 271 77518 312129 64108814
Abdominal rigidity 16.44 10.32 18 77771 2609 64418334
Anaphylactic shock 16.42 10.32 8 77781 30320 64390623
Product monitoring error 16.31 10.32 26 77763 5428 64415515
Hip arthroplasty 16.30 10.32 3 77786 21348 64399595
Hyperbilirubinaemia 15.90 10.32 59 77730 21146 64399797
Intestinal obstruction 15.87 10.32 86 77703 36200 64384743
Monocyte count increased 15.80 10.32 32 77757 8047 64412896
Accidental exposure to product 15.80 10.32 6 77783 26358 64394585
Pulmonary vein occlusion 15.72 10.32 6 77783 131 64420812
Plasma cell myeloma 15.53 10.32 102 77687 45973 64374970
Oral contusion 15.49 10.32 5 77784 65 64420878
Suicidal ideation 15.41 10.32 36 77753 66506 64354437
Acute abdomen 15.38 10.32 18 77771 2806 64418137
Salivary gland enlargement 15.28 10.32 8 77781 375 64420568
Asthma 15.27 10.32 61 77728 95164 64325779
Subileus 15.27 10.32 24 77765 4953 64415990
Pneumonia aspiration 15.25 10.32 123 77666 59148 64361795
Intentional self-injury 15.22 10.32 8 77781 29036 64391907
Splenomegaly 15.20 10.32 52 77737 17909 64403034
Activated partial thromboplastin time abnormal 15.18 10.32 7 77782 248 64420695
Portal shunt 15.15 10.32 5 77784 70 64420873
Blood sodium decreased 15.08 10.32 73 77716 29409 64391534
Stoma site discharge 15.07 10.32 14 77775 1668 64419275
Platelet count decreased 15.04 10.32 285 77504 167426 64253517
Hiccups 15.00 10.32 32 77757 8344 64412599
Bleeding time prolonged 14.96 10.32 12 77777 1174 64419769
Flushing 14.87 10.32 47 77742 78601 64342342
Bronchitis 14.82 10.32 74 77715 108669 64312274
Vascular encephalopathy 14.81 10.32 9 77780 563 64420380
Toxic encephalopathy 14.78 10.32 35 77754 9780 64411163
Axillary pain 14.72 10.32 14 77775 1718 64419225
Blood alkaline phosphatase increased 14.60 10.32 117 77672 56162 64364781
Thrombocytopenia 14.53 10.32 363 77426 223438 64197505
Blood albumin decreased 14.46 10.32 57 77732 21016 64399927
Red blood cell sedimentation rate increased 14.41 10.32 10 77779 31225 64389718
Throat irritation 14.41 10.32 11 77778 32700 64388243
Paracentesis 14.33 10.32 12 77777 1247 64419696
Heart rate decreased 14.24 10.32 28 77761 55039 64365904
Differential white blood cell count abnormal 14.20 10.32 14 77775 1796 64419147
Neutropenia 14.20 10.32 384 77405 239240 64181703
Visual impairment 14.19 10.32 44 77745 74033 64346910
Freezing phenomenon 14.11 10.32 13 77776 1533 64419410
Hallucination 14.10 10.32 142 77647 72646 64348297
Blood albumin abnormal 14.03 10.32 9 77780 619 64420324
Blast cells present 13.85 10.32 10 77779 836 64420107
Anxiety 13.85 10.32 167 77622 202482 64218461
Injection site haemorrhage 13.77 10.32 6 77783 24272 64396671
Salivary gland disorder 13.76 10.32 7 77782 309 64420634
Hiatus hernia 13.71 10.32 54 77735 19903 64401040
Superinfection 13.71 10.32 20 77769 3866 64417077
Death 13.62 10.32 712 77077 481993 63938950
Cardiac failure congestive 13.50 10.32 97 77692 130483 64290460
Pustule 13.48 10.32 12 77777 1353 64419590
Pleural effusion 13.46 10.32 221 77568 126338 64294605
Groin pain 13.40 10.32 37 77752 11356 64409587
Vascular parkinsonism 13.37 10.32 5 77784 103 64420840
Electrolyte imbalance 13.27 10.32 63 77726 25180 64395763
Unresponsive to stimuli 13.20 10.32 105 77684 50288 64370655
Tachyarrhythmia 13.16 10.32 25 77764 6001 64414942
Cardiac disorder 13.08 10.32 30 77759 55786 64365157
Inflammation 13.07 10.32 38 77751 65262 64355681
Gastrointestinal tract mucosal pigmentation 13.03 10.32 10 77779 917 64420026
Heart rate increased 12.97 10.32 68 77721 98607 64322336
Feeling hot 12.89 10.32 22 77767 45641 64375302
Diabetic gastropathy 12.78 10.32 3 77786 10 64420933
Peripheral artery stenosis 12.69 10.32 11 77778 1198 64419745
Polypectomy 12.66 10.32 10 77779 956 64419987
Myelocyte count increased 12.56 10.32 9 77780 743 64420200
Spinal cord injury thoracic 12.54 10.32 5 77784 123 64420820
Blood cholesterol increased 12.48 10.32 26 77763 50040 64370903
Hypervolaemia 12.45 10.32 84 77705 38201 64382742
Cardiomyopathy acute 12.43 10.32 6 77783 236 64420707
Portal tract inflammation 12.43 10.32 5 77784 126 64420817
Duodenal ulcer 12.40 10.32 42 77747 14393 64406550
Duodenal ulcer haemorrhage 12.31 10.32 25 77764 6300 64414643
Eye pain 12.27 10.32 12 77777 31613 64389330
Coma hepatic 12.25 10.32 10 77779 1002 64419941
Mouth swelling 12.17 10.32 22 77767 5085 64415858
Influenza 12.08 10.32 77 77712 106454 64314489
Incontinence 12.06 10.32 37 77752 12044 64408899
Inguinal hernia 11.99 10.32 23 77766 5558 64415385
On and off phenomenon 11.99 10.32 15 77774 2504 64418439
Interstitial lung disease 11.94 10.32 69 77720 97663 64323280
Diffuse alveolar damage 11.92 10.32 17 77772 3218 64417725
Drug ineffective for unapproved indication 11.86 10.32 12 77777 31121 64389822
Vascular purpura 11.82 10.32 15 77774 2541 64418402
Portopulmonary hypertension 11.81 10.32 5 77784 144 64420799
Alkalosis 11.72 10.32 7 77782 424 64420519
Infection 11.64 10.32 155 77634 184725 64236218
Tumour hyperprogression 11.56 10.32 5 77784 152 64420791
Dysphagia 11.54 10.32 187 77602 106625 64314318
Premature delivery 11.53 10.32 4 77785 18585 64402358
Portal shunt procedure 11.49 10.32 3 77786 17 64420926
Functional gastrointestinal disorder 11.42 10.32 19 77770 4112 64416831
Adrenoleukodystrophy 11.41 10.32 4 77785 68 64420875
Incoherent 11.40 10.32 26 77763 7092 64413851
Cytomegalovirus infection 11.37 10.32 17 77772 37182 64383761
Food refusal 11.37 10.32 7 77782 448 64420495
Lung perforation 11.35 10.32 4 77785 69 64420874
Anti-erythropoietin antibody negative 11.35 10.32 6 77783 287 64420656
Dry eye 11.27 10.32 11 77778 29008 64391935
Throat tightness 11.25 10.32 7 77782 23153 64397790
Sexually inappropriate behaviour 11.19 10.32 7 77782 461 64420482
Flail chest 11.15 10.32 4 77785 73 64420870
Colitis ulcerative 11.13 10.32 7 77782 23021 64397922
Megacolon 11.07 10.32 16 77773 3066 64417877
Lactic acidosis 11.04 10.32 118 77671 61292 64359651
Transfusion 11.03 10.32 47 77742 17947 64402996
Decreased appetite 11.00 10.32 429 77360 280860 64140083
Circulatory collapse 10.96 10.32 74 77715 33658 64387285
Nodule 10.89 10.32 4 77785 17943 64403000
Product quality issue 10.78 10.32 12 77777 29787 64391156
Decubitus ulcer 10.69 10.32 38 77751 13341 64407602
Myoclonus 10.63 10.32 59 77730 25059 64395884
Pregnancy 10.57 10.32 6 77783 20859 64400084
Multiple sclerosis relapse 10.56 10.32 21 77768 41114 64379829
Stoma site erythema 10.50 10.32 10 77779 1229 64419714
Depressed mood 10.49 10.32 85 77704 40927 64380016
Contraindication to medical treatment 10.47 10.32 9 77780 969 64419974
Gastrointestinal sounds abnormal 10.46 10.32 20 77769 4823 64416120
Radiation proctitis 10.45 10.32 4 77785 88 64420855
Nail infection 10.44 10.32 12 77777 1835 64419108
Ballismus 10.35 10.32 5 77784 197 64420746
Transcription medication error 10.33 10.32 6 77783 345 64420598

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A06AD11 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR CONSTIPATION
DRUGS FOR CONSTIPATION
Osmotically acting laxatives
ATC A06AD61 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR CONSTIPATION
DRUGS FOR CONSTIPATION
Osmotically acting laxatives
FDA PE N0000009871 Stimulation Large Intestine Fluid/Electrolyte Secretion
FDA MoA N0000010288 Osmotic Activity
MeSH PA D005765 Gastrointestinal Agents
CHEBI has role CHEBI:50503 laxante
CHEBI has role CHEBI:55324 gastrointestinal drugs
FDA EPC N0000175811 Osmotic Laxative
FDA MoA N0000175833 Acidifying Activity

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

DiseaseRelationSNOMED_IDDOID
Hyperammonemia indication 9360008
Hepatic encephalopathy indication 13920009 DOID:13413
Constipation indication 14760008 DOID:2089
Diabetes mellitus contraindication 73211009 DOID:9351
Appendicitis contraindication 74400008 DOID:8337
Gastrointestinal obstruction contraindication 126765001
Galactosemia contraindication 190745006 DOID:9870




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.04 acidic
pKa2 13.36 acidic
pKa3 13.8 acidic
pKa4 13.97 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
4018617 VUID
N0000146930 NUI
D00352 KEGG_DRUG
4018617 VANDF
C0022957 UMLSCUI
CHEBI:6359 CHEBI
CHEMBL1237068 ChEMBL_ID
CHEMBL296306 ChEMBL_ID
DB00581 DRUGBANK_ID
D007792 MESH_DESCRIPTOR_UI
11333 PUBCHEM_CID
2137 INN_ID
9U7D5QH5AE UNII
215949 RXNORM
117 MMSL
4512 MMSL
4955 MMSL
d01024 MMSL
001241 NDDF
111137007 SNOMEDCT_US
273945008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 0121-0577 SOLUTION 10 g ORAL ANDA 22 sections
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 0121-0873 SOLUTION 10 g ORAL ANDA 22 sections
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 0121-1154 SOLUTION 20 g ORAL ANDA 22 sections
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 0121-1746 SOLUTION 20 g ORAL ANDA 22 sections
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 0121-4577 SOLUTION 10 g ORAL ANDA 22 sections
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 0527-5120 SOLUTION 10 g ORAL ANDA 22 sections
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 0527-5125 SOLUTION 10 g ORAL ANDA 22 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 13668-574 SOLUTION 10 g ORAL ANDA 12 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 13668-574 SOLUTION 10 g ORAL ANDA 12 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 13668-580 SOLUTION 10 g ORAL ANDA 21 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 13668-580 SOLUTION 10 g ORAL ANDA 21 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 17856-1378 SOLUTION 10 g ORAL ANDA 22 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 18124-002 SOLUTION 10 g ORAL ANDA 16 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 21695-997 SOLUTION 10 g ORAL ANDA 11 sections
Enulose HUMAN PRESCRIPTION DRUG LABEL 1 45963-438 SOLUTION 10 g ORAL ANDA 17 sections
Constulose HUMAN PRESCRIPTION DRUG LABEL 1 45963-439 SOLUTION 10 g ORAL ANDA 19 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 50090-0679 SOLUTION 10 g ORAL ANDA 21 sections
Constulose HUMAN PRESCRIPTION DRUG LABEL 1 50090-3436 SOLUTION 10 g ORAL ANDA 19 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 50383-779 SOLUTION 10 g ORAL ANDA 20 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 50383-779 SOLUTION 10 g ORAL ANDA 20 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 50383-795 SOLUTION 10 g ORAL ANDA 18 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 50383-795 SOLUTION 10 g ORAL ANDA 18 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 53217-009 SOLUTION 10 g ORAL ANDA 13 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 54868-3101 SOLUTION 10 g ORAL ANDA 11 sections
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 55700-892 SOLUTION 10 g ORAL ANDA 22 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 59741-249 SOLUTION 10 g ORAL ANDA 21 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 60432-037 SOLUTION 10 g ORAL ANDA 19 sections
Generlac HUMAN PRESCRIPTION DRUG LABEL 1 60432-038 SOLUTION 10 g ORAL ANDA 18 sections
Lactulose Solution HUMAN PRESCRIPTION DRUG LABEL 1 61037-471 SOLUTION 10 g ORAL ANDA 16 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 62135-003 SOLUTION 10 g ORAL ANDA 20 sections