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
S (Water solubility) 68 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Bocci G, Oprea TI, Benet LZ

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 760.70 11.24 325 54680 13497 63420520
Orthostatic hypotension 747.51 11.24 437 54568 35723 63398294
Creatinine renal clearance decreased 718.52 11.24 328 54677 15980 63418037
Sedation 635.30 11.24 404 54601 38405 63395612
Cognitive disorder 621.59 11.24 458 54547 55357 63378660
Blood calcium decreased 590.06 11.24 336 54669 26115 63407902
Balance disorder 490.19 11.24 476 54529 83946 63350071
Depressed level of consciousness 475.70 11.24 409 54596 61669 63372348
Drug ineffective 372.62 11.24 224 54781 1044541 62389476
Hepatic encephalopathy 322.68 11.24 169 54836 11113 63422904
Constipation 295.24 11.24 621 54384 224322 63209695
Fall 280.69 11.24 860 54145 391474 63042543
Hypotension 239.71 11.24 644 54361 271960 63162057
Jaundice cholestatic 227.54 11.24 116 54889 7208 63426809
Hypomania 213.50 11.24 106 54899 6224 63427793
Mobility decreased 204.29 11.24 372 54633 120787 63313230
Schizophrenia 196.85 11.24 117 54888 9835 63424182
Blood bilirubin increased 176.25 11.24 188 54817 36952 63397065
Ammonia increased 175.13 11.24 84 54921 4572 63429445
Drug intolerance 151.89 11.24 40 54965 308621 63125396
Arthropathy 149.63 11.24 15 54990 234777 63199240
Drug hypersensitivity 147.77 11.24 43 54962 310644 63123373
Psychotic disorder 143.44 11.24 142 54863 25570 63408447
Synovitis 143.36 11.24 4 55001 186914 63247103
Treatment failure 140.13 11.24 8 54997 199035 63234982
Systemic lupus erythematosus 139.46 11.24 11 54994 208907 63225110
Hyponatraemia 135.08 11.24 299 54706 111601 63322416
Faecaloma 128.14 11.24 82 54923 7859 63426158
Glossodynia 123.46 11.24 8 54997 178868 63255149
Contraindicated product administered 121.73 11.24 21 54984 217627 63216390
Swelling 120.54 11.24 44 54961 275334 63158683
Hand deformity 120.15 11.24 4 55001 159453 63274564
Maternal exposure during pregnancy 119.27 11.24 23 54982 220039 63213978
Rheumatoid arthritis 119.06 11.24 36 54969 253783 63180234
Toxicity to various agents 115.71 11.24 472 54533 246778 63187239
Inability to afford medication 115.38 11.24 51 54954 2296 63431721
Joint swelling 112.15 11.24 73 54932 327593 63106424
Cholelithiasis 105.11 11.24 158 54847 43767 63390250
Infusion related reaction 101.23 11.24 43 54962 245478 63188539
Therapeutic product effect decreased 98.91 11.24 23 54982 193164 63240853
Sinusitis 97.84 11.24 37 54968 226616 63207401
Discomfort 91.72 11.24 17 54988 167357 63266660
Ascites 89.71 11.24 141 54864 40587 63393430
Alopecia 88.74 11.24 97 54908 337439 63096578
Completed suicide 86.09 11.24 12 54993 145661 63288356
Hepatic cirrhosis 84.96 11.24 106 54899 24628 63409389
Hyperkalaemia 80.77 11.24 158 54847 54045 63379972
Asthma-chronic obstructive pulmonary disease overlap syndrome 80.00 11.24 38 54967 2023 63431994
Haematemesis 79.41 11.24 114 54891 30298 63403719
Wound 76.80 11.24 23 54982 163240 63270777
Total lung capacity increased 75.88 11.24 38 54967 2272 63431745
Product use issue 74.21 11.24 50 54955 220470 63213547
Neutropenic sepsis 74.08 11.24 81 54924 16357 63417660
Arthralgia 74.07 11.24 250 54755 569460 62864557
Injection site pain 73.70 11.24 12 54993 129788 63304229
Hepatotoxicity 73.09 11.24 122 54883 36919 63397098
Skin candida 71.94 11.24 33 54972 1622 63432395
Abdominal discomfort 70.07 11.24 106 54899 320779 63113238
Therapeutic product effect incomplete 63.77 11.24 15 54990 125041 63308976
Hypersensitivity 62.63 11.24 98 54907 292587 63141430
Musculoskeletal stiffness 61.91 11.24 42 54963 184576 63249441
Heart sounds 60.03 11.24 25 54980 971 63433046
Dehydration 58.66 11.24 301 54704 173053 63260964
Prolonged expiration 57.72 11.24 25 54980 1071 63432946
Confusional state 57.52 11.24 376 54629 236004 63198013
Pericarditis 55.88 11.24 22 54983 131557 63302460
Nasopharyngitis 55.47 11.24 84 54921 254173 63179844
Lymphatic fistula 55.14 11.24 22 54983 764 63433253
General physical health deterioration 55.00 11.24 330 54675 201072 63232945
Vomiting 54.96 11.24 732 54273 558885 62875132
Femoral hernia incarcerated 53.70 11.24 22 54983 819 63433198
Wound infection pseudomonas 53.12 11.24 25 54980 1303 63432714
Psoriatic arthropathy 52.99 11.24 8 54997 91512 63342505
Intestinal pseudo-obstruction 51.98 11.24 22 54983 890 63433127
Rash 51.41 11.24 281 54724 560590 62873427
Fatigue 49.88 11.24 511 54494 887517 62546500
Pancreatic steatosis 49.69 11.24 22 54983 994 63433023
Helicobacter infection 49.59 11.24 10 54995 92775 63341242
Off label use 49.45 11.24 362 54643 674100 62759917
Jaundice 49.44 11.24 90 54915 29161 63404856
Urinary retention 48.41 11.24 91 54914 30210 63403807
Hypokalaemia 48.30 11.24 198 54807 103606 63330411
Abdominal pain 46.85 11.24 423 54582 293033 63140984
Hepatic failure 46.07 11.24 98 54907 35558 63398459
Multiple drug therapy 45.26 11.24 32 54973 3614 63430403
Sarcoidosis 44.74 11.24 42 54963 7080 63426937
Varices oesophageal 44.67 11.24 30 54975 3118 63430899
Nasal polyps 44.58 11.24 39 54966 6000 63428017
Haemarthrosis 44.56 11.24 30 54975 3131 63430886
Urticaria 44.22 11.24 47 54958 165755 63268262
Exposure during pregnancy 43.88 11.24 42 54963 155505 63278512
Irritable bowel syndrome 43.80 11.24 9 54996 82403 63351614
Neutrophil count increased 43.21 11.24 62 54943 16465 63417552
Blood cholesterol increased 42.85 11.24 14 54991 94018 63339999
Injection site erythema 42.35 11.24 10 54995 83164 63350853
Arterial haemorrhage 41.47 11.24 23 54982 1694 63432323
Hepatocellular carcinoma 41.32 11.24 25 54980 2169 63431848
Ill-defined disorder 41.29 11.24 10 54995 81745 63352272
Acute kidney injury 41.16 11.24 378 54627 263037 63170980
Weight increased 39.85 11.24 106 54899 260686 63173331
Encephalopathy 39.74 11.24 97 54908 38523 63395494
Chronic hepatic failure 39.59 11.24 16 54989 575 63433442
Seroma 39.41 11.24 24 54981 2107 63431910
Urinary tract infection 36.99 11.24 371 54634 264313 63169704
Arthritis 36.72 11.24 28 54977 115893 63318124
Ileus 36.69 11.24 54 54951 14671 63419346
Aortic arteriosclerosis 35.94 11.24 35 54970 6174 63427843
Dementia 35.87 11.24 61 54944 18733 63415284
Diverticulum intestinal 35.45 11.24 36 54969 6677 63427340
Anaemia 34.36 11.24 397 54608 293033 63140984
Therapeutic response decreased 34.22 11.24 6 54999 61519 63372498
Cardiac murmur 32.90 11.24 51 54954 14501 63419516
Infection 32.88 11.24 96 54909 229077 63204940
Urinary incontinence 32.51 11.24 80 54925 31934 63402083
Aortic valve stenosis 32.08 11.24 25 54980 3274 63430743
Gastrointestinal disorder 31.96 11.24 40 54965 131199 63302818
Type 2 diabetes mellitus 31.88 11.24 8 54997 63860 63370157
Psoriasis 31.60 11.24 18 54987 86939 63347078
Abdominal tenderness 31.30 11.24 37 54968 8129 63425888
Peritonitis bacterial 31.08 11.24 29 54976 4850 63429167
Intentional overdose 30.50 11.24 13 54992 74139 63359878
Headache 30.46 11.24 377 54628 632864 62801153
Hip arthroplasty 30.43 11.24 3 55002 47643 63386374
White blood cell count increased 29.55 11.24 101 54904 48460 63385557
Duodenal ulcer 29.49 11.24 35 54970 7721 63426296
Depressive symptom 29.30 11.24 26 54979 4076 63429941
Wound dehiscence 29.06 11.24 28 54977 4875 63429142
Cirrhosis alcoholic 28.86 11.24 10 54995 232 63433785
Oesophageal varices haemorrhage 28.36 11.24 16 54989 1218 63432799
Alkalosis hypochloraemic 28.32 11.24 9 54996 158 63433859
Product dose omission issue 28.21 11.24 106 54899 234207 63199810
Delirium 28.07 11.24 102 54903 50439 63383578
Nail dystrophy 28.05 11.24 15 54990 1028 63432989
Hepatic cyst 27.88 11.24 28 54977 5126 63428891
Melaena 27.83 11.24 73 54932 30292 63403725
Mucosal inflammation 27.17 11.24 96 54909 46832 63387185
Portal hypertension 26.87 11.24 24 54981 3795 63430222
Hypertriglyceridaemia 26.75 11.24 30 54975 6229 63427788
C-reactive protein abnormal 26.74 11.24 4 55001 46092 63387925
Disturbance in attention 26.45 11.24 83 54922 38106 63395911
Seizure 26.37 11.24 201 54804 132433 63301584
Injection site reaction 26.16 11.24 9 54996 58515 63375502
Respiration abnormal 26.14 11.24 30 54975 6387 63427630
Cholestasis of pregnancy 25.79 11.24 15 54990 1210 63432807
Thrombocytopenia 25.68 11.24 221 54784 150936 63283081
Abdominal distension 25.60 11.24 145 54860 86470 63347547
Tachyarrhythmia 25.60 11.24 25 54980 4425 63429592
Sepsis 25.56 11.24 223 54782 152900 63281117
Dermatitis bullous 25.36 11.24 34 54971 8474 63425543
Hyperammonaemic encephalopathy 24.88 11.24 19 54986 2415 63431602
Disorientation 24.84 11.24 83 54922 39369 63394648
Pneumonia 24.72 11.24 543 54462 456224 62977793
Cardiospasm 24.28 11.24 17 54988 1890 63432127
Lung neoplasm malignant 24.26 11.24 53 54952 19580 63414437
Intestinal obstruction 24.07 11.24 70 54935 30829 63403188
Hyperammonaemia 23.95 11.24 26 54979 5206 63428811
Haemoglobin decreased 23.82 11.24 211 54794 145274 63288743
Injection site pruritus 23.82 11.24 5 55000 45111 63388906
Superinfection 23.73 11.24 19 54986 2588 63431429
Rhinitis allergic 23.63 11.24 39 54966 11688 63422329
Hypernatraemia 23.59 11.24 31 54974 7578 63426439
Palmoplantar keratoderma 23.50 11.24 17 54988 1990 63432027
Intestinal dilatation 23.46 11.24 16 54989 1706 63432311
Pruritus genital 23.43 11.24 19 54986 2635 63431382
Abortion spontaneous 23.39 11.24 6 54999 47189 63386828
Oedema peripheral 23.33 11.24 259 54746 189252 63244765
Peripheral swelling 23.32 11.24 135 54870 265807 63168210
Mouth ulceration 23.13 11.24 72 54933 32912 63401105
Adverse event 23.13 11.24 15 54990 67544 63366473
Hypoaesthesia 23.10 11.24 72 54933 168321 63265696
Hiatus hernia 23.03 11.24 55 54950 21539 63412478
Portal hypertensive gastropathy 23.03 11.24 12 54993 780 63433237
Suicide attempt 23.02 11.24 12 54993 60906 63373111
Left ventricular dysfunction 22.99 11.24 39 54966 11949 63422068
Body mass index decreased 22.75 11.24 10 54995 444 63433573
Blood pressure increased 22.43 11.24 69 54936 161993 63272024
Inflammation 22.29 11.24 23 54982 82250 63351767
Insurance issue 22.25 11.24 27 54978 6094 63427923
Depressed mood 22.22 11.24 81 54924 40110 63393907
Gastrointestinal haemorrhage 22.11 11.24 133 54872 81043 63352974
Therapy non-responder 21.97 11.24 20 54985 75881 63358136
Lip swelling 21.96 11.24 68 54937 30995 63403022
Product prescribing error 21.88 11.24 61 54944 26228 63407789
Appetite disorder 21.43 11.24 29 54976 7292 63426725
Axillary pain 21.42 11.24 16 54989 1967 63432050
Injection site bruising 21.41 11.24 5 55000 41905 63392112
Upper gastrointestinal haemorrhage 21.18 11.24 49 54956 18803 63415214
Blood albumin abnormal 21.11 11.24 10 54995 529 63433488
Pain in extremity 20.92 11.24 185 54820 331301 63102716
Monocyte count increased 20.90 11.24 29 54976 7464 63426553
Femoral neck fracture 20.86 11.24 31 54974 8492 63425525
Mouth swelling 20.74 11.24 23 54982 4717 63429300
Hepatitis C 20.38 11.24 24 54981 5250 63428767
Device expulsion 20.33 11.24 3 55002 34919 63399098
Spinal cord paralysis 20.28 11.24 5 55000 32 63433985
Death 20.21 11.24 445 54560 373936 63060081
Inappropriate schedule of product administration 20.18 11.24 37 54968 103928 63330089
Flail chest 20.14 11.24 6 54999 84 63433933
Fibromyalgia 20.11 11.24 24 54981 80396 63353621
Eructation 19.96 11.24 30 54975 8303 63425714
Product monitoring error 19.91 11.24 22 54983 4494 63429523
Pancytopenia 19.88 11.24 148 54857 96785 63337232
Vascular encephalopathy 19.82 11.24 9 54996 432 63433585
Hallucination 19.79 11.24 97 54908 54720 63379297
Lung perforation 19.63 11.24 6 54999 92 63433925
Intentional product use issue 19.50 11.24 52 54953 127840 63306177
Toxic epidermal necrolysis 19.36 11.24 57 54948 25277 63408740
Pruritus 19.34 11.24 210 54795 361243 63072774
Bradycardia 19.32 11.24 119 54886 73108 63360909
Bronchiectasis 19.29 11.24 43 54962 16099 63417918
Drug interaction 19.28 11.24 292 54713 228839 63205178
Herpes zoster 19.18 11.24 26 54979 82436 63351581
Sleep terror 19.17 11.24 17 54988 2663 63431354
Abdominal rigidity 18.95 11.24 15 54990 2009 63432008
Pulmonary vein occlusion 18.90 11.24 6 54999 105 63433912
Pneumatosis intestinalis 18.66 11.24 16 54989 2397 63431620
Anuria 17.98 11.24 36 54969 12515 63421502
Ejection fraction decreased 17.79 11.24 51 54954 22281 63411736
Muscle twitching 17.73 11.24 47 54958 19621 63414396
Cholestasis 17.71 11.24 61 54944 29373 63404644
Hypomagnesaemia 17.68 11.24 60 54945 28677 63405340
Hiccups 17.67 11.24 15 54990 2216 63431801
Red blood cell sedimentation rate increased 17.63 11.24 8 54997 43974 63390043
Prescribed overdose 17.59 11.24 4 55001 34149 63399868
Hallucination, visual 17.28 11.24 46 54959 19252 63414765
Salivary gland enlargement 17.22 11.24 8 54997 405 63433612
Therapeutic drug monitoring analysis not performed 17.09 11.24 12 54993 1340 63432677
Osteoarthritis 16.72 11.24 36 54969 95307 63338710
Bronchitis 16.72 11.24 54 54951 124881 63309136
Chronic obstructive pulmonary disease 16.62 11.24 102 54903 62584 63371433
Syncope 16.58 11.24 165 54840 117220 63316797
Hyperglycaemia 16.50 11.24 76 54929 41791 63392226
Liver function test abnormal 16.50 11.24 84 54921 48097 63385920
Postoperative wound infection 16.45 11.24 32 54973 10893 63423124
Escherichia infection 16.41 11.24 35 54970 12719 63421298
Thoracic operation 16.32 11.24 6 54999 166 63433851
Blister 16.09 11.24 58 54947 129756 63304261
Nervous system disorder 16.07 11.24 44 54961 18722 63415295
Lethargy 16.04 11.24 93 54912 55914 63378103
Tension headache 15.88 11.24 21 54984 5165 63428852
Cardiovascular disorder 15.88 11.24 33 54972 11779 63422238
Hypertension 15.85 11.24 160 54845 279143 63154874
Functional gastrointestinal disorder 15.83 11.24 19 54986 4240 63429777
Aplastic anaemia 15.61 11.24 29 54976 9540 63424477
Blood alkaline phosphatase increased 15.48 11.24 76 54929 42891 63391126
Electrocardiogram T wave inversion 15.42 11.24 17 54988 3464 63430553
Rales 15.37 11.24 34 54971 12663 63421354
Hepatorenal syndrome 15.32 11.24 13 54992 1919 63432098
Stevens-Johnson syndrome 15.27 11.24 52 54953 24898 63409119
Oral contusion 15.27 11.24 5 55000 97 63433920
Stomatitis 15.26 11.24 65 54940 138660 63295357
Haematocrit increased 15.15 11.24 14 54991 2312 63431705
Frostbite 14.99 11.24 5 55000 103 63433914
Tumour hyperprogression 14.94 11.24 5 55000 104 63433913
Alkalosis 14.89 11.24 7 54998 364 63433653
Plasma cell myeloma 14.77 11.24 66 54939 35839 63398178
Circulatory collapse 14.57 11.24 47 54958 21891 63412126
Asterixis 14.47 11.24 11 54994 1388 63432629
Neutropenia 14.31 11.24 222 54783 174783 63259234
Aspiration 14.22 11.24 30 54975 10821 63423196
Joint injury 14.20 11.24 4 55001 29568 63404449
Nail infection 14.19 11.24 14 54991 2509 63431508
Febrile neutropenia 14.16 11.24 161 54844 118288 63315729
Cardiac ventricular thrombosis 14.16 11.24 8 54997 611 63433406
Liver injury 14.16 11.24 19 54986 60501 63373516
Foetal exposure during pregnancy 14.14 11.24 5 55000 31957 63402060
Inflammatory marker increased 14.12 11.24 23 54982 6816 63427201
Activated partial thromboplastin time abnormal 14.08 11.24 5 55000 125 63433892
Adverse drug reaction 14.06 11.24 30 54975 79684 63354333
Thrombocytosis 14.01 11.24 21 54984 5797 63428220
Vascular parkinsonism 14.00 11.24 5 55000 127 63433890
Cardiomyopathy acute 13.85 11.24 6 54999 257 63433760
Spinal cord infarction 13.83 11.24 6 54999 258 63433759
Ear infection 13.75 11.24 8 54997 38205 63395812
Immunisation 13.73 11.24 10 54995 1183 63432834
Physical assault 13.59 11.24 9 54996 914 63433103
Portopulmonary hypertension 13.58 11.24 5 55000 139 63433878
Gamma-glutamyltransferase increased 13.58 11.24 62 54943 33969 63400048
Colitis ulcerative 13.55 11.24 3 55002 26088 63407929
Spinal subdural haematoma 13.48 11.24 5 55000 142 63433875
Salivary hypersecretion 13.48 11.24 24 54981 7642 63426375
Impaired healing 13.25 11.24 45 54960 102497 63331520
Tricuspid valve incompetence 13.24 11.24 35 54970 14586 63419431
Neutrophil count decreased 13.24 11.24 89 54916 56317 63377700
Mechanical urticaria 13.24 11.24 7 54998 469 63433548
Subileus 13.18 11.24 15 54990 3164 63430853
Haemoglobin increased 13.12 11.24 16 54989 3630 63430387
Blood pressure systolic increased 13.12 11.24 13 54992 47384 63386633
Blood albumin decreased 13.02 11.24 35 54970 14731 63419286
Mutism 12.99 11.24 11 54994 1619 63432398
Pregnancy 12.85 11.24 8 54997 36828 63397189
Atrial tachycardia 12.72 11.24 17 54988 4223 63429794
Contusion 12.70 11.24 77 54928 149967 63284050
Pustule 12.60 11.24 11 54994 1688 63432329
Oropharyngeal pain 12.53 11.24 41 54964 94446 63339571
Appendicitis 12.26 11.24 24 54981 8205 63425812
Product administration error 12.26 11.24 45 54960 22352 63411665
Antipsychotic drug level increased 12.24 11.24 15 54990 3420 63430597
Sinus arrhythmia 11.86 11.24 10 54995 1463 63432554
Pickwickian syndrome 11.85 11.24 6 54999 367 63433650
Cardiac disorder 11.84 11.24 16 54989 50800 63383217
Chronotropic incompetence 11.83 11.24 4 55001 86 63433931
Multiple organ dysfunction syndrome 11.83 11.24 87 54918 56665 63377352
Dyskinesia 11.81 11.24 57 54948 31945 63402072
Gastrointestinal sounds abnormal 11.78 11.24 16 54989 4035 63429982
Jugular vein thrombosis 11.74 11.24 14 54991 3104 63430913
Vascular device infection 11.73 11.24 22 54983 7290 63426727
Flank pain 11.67 11.24 36 54969 16374 63417643
Mental status changes 11.50 11.24 66 54939 39533 63394484
Product selection error 11.50 11.24 4 55001 94 63433923
Hepatic hydrothorax 11.48 11.24 3 55002 25 63433992
Road traffic accident 11.40 11.24 9 54996 36623 63397394
Premature delivery 11.39 11.24 6 54999 30275 63403742
Carotid artery occlusion 11.39 11.24 17 54988 4677 63429340
Skin abrasion 11.32 11.24 25 54980 9304 63424713
Anticonvulsant drug level below therapeutic 11.31 11.24 7 54998 632 63433385
Fracture 11.28 11.24 40 54965 19544 63414473
Sciatica 11.24 11.24 8 54997 34316 63399701

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 688.55 11.03 352 45867 14333 34896379
Hepatic cirrhosis 182.04 11.03 164 46055 17150 34893562
Confusional state 158.57 11.03 484 45735 143676 34767036
Hepatic failure 147.31 11.03 204 46015 34327 34876385
Inability to afford medication 140.94 11.03 58 46161 1412 34909300
Ammonia increased 136.09 11.03 80 46139 4289 34906423
Ascites 132.35 11.03 228 45991 46343 34864369
Drug ineffective 121.05 11.03 266 45953 456485 34454227
Constipation 83.89 11.03 381 45838 136601 34774111
Hepatorenal syndrome 78.29 11.03 47 46172 2619 34908093
Varices oesophageal 77.49 11.03 53 46166 3702 34907010
Drug abuse 77.43 11.03 18 46201 99078 34811634
Completed suicide 74.42 11.03 19 46200 98149 34812563
Toxic epidermal necrolysis 73.65 11.03 115 46104 21531 34889181
Hepatocellular carcinoma 68.99 11.03 66 46153 7443 34903269
General physical health deterioration 68.50 11.03 343 45876 127926 34782786
Off label use 62.65 11.03 314 45905 419210 34491502
Faecaloma 62.62 11.03 54 46165 5323 34905389
Encephalopathy 57.24 11.03 137 46082 35182 34875530
Pneumatosis intestinalis 53.15 11.03 43 46176 3880 34906832
Peritonitis bacterial 52.93 11.03 52 46167 6058 34904654
Oesophageal varices haemorrhage 52.46 11.03 39 46180 3107 34907605
Blood bilirubin increased 52.09 11.03 139 46080 38157 34872555
Hyperammonaemia 51.12 11.03 52 46167 6315 34904397
Abdominal pain 49.01 11.03 377 45842 163241 34747471
Arthralgia 46.46 11.03 97 46122 169944 34740768
Gastric varices 46.26 11.03 20 46199 552 34910160
Insurance issue 44.99 11.03 30 46189 2009 34908703
Chronic hepatic failure 44.97 11.03 19 46200 495 34910217
Hyponatraemia 44.71 11.03 222 45997 82469 34828243
Abdominal distension 44.53 11.03 174 46045 58318 34852394
Haematemesis 43.30 11.03 106 46113 27605 34883107
Portal hypertension 41.73 11.03 38 46181 4024 34906688
Jaundice 41.63 11.03 114 46105 31768 34878944
Alveolar lung disease 39.64 11.03 16 46203 370 34910342
Hepatitis C 35.93 11.03 54 46165 9776 34900936
Pulmonary interstitial emphysema syndrome 34.93 11.03 16 46203 508 34910204
Antipsychotic drug level increased 33.67 11.03 33 46186 3832 34906880
Cirrhosis alcoholic 33.21 11.03 18 46201 824 34909888
Liver transplant 32.70 11.03 27 46192 2507 34908205
Pyramidal tract syndrome 32.41 11.03 12 46207 218 34910494
Toxicity to various agents 32.08 11.03 146 46073 200216 34710496
Rash 31.82 11.03 169 46050 222583 34688129
Injection site pain 30.61 11.03 7 46212 38998 34871714
High-grade B-cell lymphoma 30.44 11.03 10 46209 125 34910587
Stoma site erythema 30.25 11.03 17 46202 836 34909876
Periarthritis calcarea 29.96 11.03 9 46210 82 34910630
Benign gastrointestinal neoplasm 29.74 11.03 10 46209 135 34910577
Articular calcification 29.67 11.03 9 46210 85 34910627
Stoma site discharge 29.58 11.03 19 46200 1194 34909518
On and off phenomenon 28.92 11.03 25 46194 2472 34908240
Systemic infection 28.78 11.03 35 46184 5177 34905535
Product use in unapproved indication 28.06 11.03 72 46147 117427 34793285
Ileus 27.80 11.03 65 46154 16434 34894278
Neutrophil count increased 27.22 11.03 66 46153 17080 34893632
Portal hypertensive gastropathy 26.40 11.03 14 46205 613 34910099
Immature granulocyte count increased 26.14 11.03 9 46210 131 34910581
Acute kidney injury 26.10 11.03 556 45663 304432 34606280
Rheumatoid arthritis 26.04 11.03 9 46210 38229 34872483
Fall 25.89 11.03 394 45825 202491 34708221
Product dose omission issue 25.87 11.03 77 46142 119634 34791078
Pneumonia 25.47 11.03 643 45576 361984 34548728
Myocardial infarction 25.37 11.03 79 46140 121006 34789706
Adrenal cyst 24.80 11.03 9 46210 154 34910558
Conjunctival irritation 24.28 11.03 8 46211 101 34910611
Hypermagnesaemia 24.27 11.03 10 46209 244 34910468
Joint swelling 24.26 11.03 26 46193 59864 34850848
Foetal exposure during pregnancy 24.22 11.03 10 46209 38091 34872621
Inappropriate schedule of product administration 24.19 11.03 28 46191 62268 34848444
Therapeutic product effect incomplete 23.95 11.03 19 46200 50522 34860190
Myalgia 23.77 11.03 47 46172 84063 34826649
Hypernatraemia 23.35 11.03 41 46178 8449 34902263
Intentional product use issue 23.10 11.03 27 46192 59789 34850923
Treatment failure 22.84 11.03 17 46202 46680 34864032
Atrial fibrillation 22.81 11.03 84 46135 122309 34788403
Nasopharyngitis 22.57 11.03 36 46183 69932 34840780
Cardiac failure congestive 22.29 11.03 48 46171 83222 34827490
Asterixis 22.17 11.03 16 46203 1217 34909495
Urinary tract infection 22.01 11.03 188 46031 83893 34826819
Polypectomy 21.97 11.03 12 46207 558 34910154
White blood cell count increased 21.88 11.03 110 46109 41041 34869671
Neutropenic sepsis 21.86 11.03 53 46166 13714 34896998
Mesothelioma 21.80 11.03 11 46208 434 34910278
Drug resistance 21.70 11.03 4 46215 25923 34884789
Acute abdomen 21.49 11.03 19 46200 1936 34908776
Mental status changes 21.10 11.03 103 46116 37980 34872732
Haemoglobin decreased 20.95 11.03 248 45971 120524 34790188
Pneumonia aspiration 20.88 11.03 110 46109 41793 34868919
Lower respiratory tract infection 20.81 11.03 90 46129 31547 34879165
Activated partial thromboplastin time shortened 20.74 11.03 11 46208 482 34910230
Hepatitis C RNA positive 20.45 11.03 8 46211 170 34910542
Metamyelocyte count increased 20.26 11.03 10 46209 376 34910336
Wrong patient received product 20.09 11.03 21 46198 2633 34908079
Vomiting 19.43 11.03 446 45773 247175 34663537
Urinary retention 19.29 11.03 97 46122 36191 34874521
Spleen congestion 19.08 11.03 9 46210 306 34910406
Freezing phenomenon 19.06 11.03 16 46203 1520 34909192
Asthma 19.03 11.03 17 46202 42639 34868073
Delirium 18.93 11.03 111 46108 43880 34866832
Epilepsy 18.90 11.03 67 46152 21428 34889284
Blood pressure increased 18.79 11.03 57 46162 88045 34822667
Hypophagia 18.71 11.03 72 46147 23950 34886762
Liver function test abnormal 18.64 11.03 86 46133 30988 34879724
Hepatic calcification 18.25 11.03 9 46210 338 34910374
Hypersensitivity 18.21 11.03 33 46186 61002 34849710
Adrenal adenoma 18.05 11.03 10 46209 478 34910234
Dehydration 17.96 11.03 256 45963 129713 34780999
Therapeutic product effect decreased 17.84 11.03 12 46207 34731 34875981
Myelocyte count increased 17.77 11.03 9 46210 358 34910354
Adrenomegaly 17.72 11.03 9 46210 360 34910352
Costal cartilage fracture 17.70 11.03 8 46211 246 34910466
Ureaplasma infection 17.68 11.03 9 46210 362 34910350
Dysphagia 17.66 11.03 142 46077 62239 34848473
Rectal haemorrhage 17.60 11.03 102 46117 40147 34870565
Genital erythema 17.29 11.03 8 46211 260 34910452
Arthritis 17.24 11.03 10 46209 31336 34879376
Intentional product misuse 17.17 11.03 21 46198 45590 34865122
Interstitial lung disease 17.16 11.03 38 46181 65244 34845468
Portal vein thrombosis 17.07 11.03 23 46196 3765 34906947
Therapy interrupted 16.91 11.03 48 46171 13649 34897063
Psoriatic arthropathy 16.68 11.03 3 46216 19795 34890917
Coronary artery disease 16.39 11.03 24 46195 48281 34862431
Upper gastrointestinal haemorrhage 16.33 11.03 72 46147 25446 34885266
Colitis ischaemic 16.19 11.03 30 46189 6445 34904267
COVID-19 15.95 11.03 51 46168 77499 34833213
Orthostatic hypotension 15.74 11.03 72 46147 25847 34884865
Differential white blood cell count abnormal 15.68 11.03 14 46205 1445 34909267
Portal shunt procedure 15.55 11.03 4 46215 19 34910693
Activated partial thromboplastin time prolonged 15.47 11.03 35 46184 8660 34902052
Nephrocalcinosis 15.43 11.03 10 46209 638 34910074
Eosinophilic pneumonia 15.39 11.03 21 46198 3480 34907232
Venous thrombosis limb 15.32 11.03 16 46203 2003 34908709
Diffuse alveolar damage 15.22 11.03 17 46202 2297 34908415
Blast cells present 15.11 11.03 9 46210 494 34910218
Disorientation 15.10 11.03 85 46134 33103 34877609
Peripheral artery stenosis 14.97 11.03 11 46208 861 34909851
Ischaemic hepatitis 14.80 11.03 15 46204 1813 34908899
Lethargy 14.72 11.03 99 46120 41023 34869689
Sepsis 14.63 11.03 305 45914 166256 34744456
Abdominal tenderness 14.44 11.03 22 46197 4029 34906683
Melaena 14.41 11.03 88 46131 35292 34875420
Hepatic cancer 14.38 11.03 33 46186 8242 34902470
Peritonitis 14.37 11.03 51 46168 16314 34894398
Weight 14.36 11.03 4 46215 27 34910685
Portal tract inflammation 14.33 11.03 5 46214 76 34910636
Platelet count decreased 14.29 11.03 230 45989 119487 34791225
Hypertension 14.13 11.03 114 46105 136329 34774383
Hyperkalaemia 14.08 11.03 147 46072 69242 34841470
Headache 14.03 11.03 184 46035 200451 34710261
Arteriosclerosis coronary artery 13.74 11.03 42 46177 12443 34898269
Salivary gland disorder 13.73 11.03 6 46213 170 34910542
Monocyte count decreased 13.65 11.03 12 46207 1214 34909498
Paracentesis 13.55 11.03 8 46211 432 34910280
Vascular purpura 13.33 11.03 14 46205 1764 34908948
Wrong technique in product usage process 13.09 11.03 17 46202 35969 34874743
Spinal cord injury thoracic 13.06 11.03 5 46214 100 34910612
Myoclonus 13.03 11.03 46 46173 14679 34896033
Anaemia 13.01 11.03 402 45817 232933 34677779
Coma hepatic 12.99 11.03 8 46211 467 34910245
Portal shunt 12.98 11.03 4 46215 40 34910672
Influenza 12.98 11.03 29 46190 49637 34861075
Arthropathy 12.89 11.03 10 46209 26897 34883815
Gastrointestinal tract mucosal pigmentation 12.76 11.03 8 46211 482 34910230
Rash vesicular 12.73 11.03 17 46202 2760 34907952
Adrenocortical insufficiency acute 12.72 11.03 13 46206 1587 34909125
Hyperbilirubinaemia 12.72 11.03 50 46169 16793 34893919
Osteochondrosis 12.63 11.03 11 46208 1099 34909613
Hypercreatininaemia 12.59 11.03 8 46211 493 34910219
Anti-erythropoietin antibody negative 12.53 11.03 6 46213 211 34910501
Hypoalbuminaemia 12.51 11.03 40 46179 12134 34898578
Volvulus 12.51 11.03 13 46206 1619 34909093
Sexually inappropriate behaviour 12.43 11.03 8 46211 504 34910208
Platelet count increased 12.36 11.03 34 46185 9492 34901220
Bacterial translocation 12.29 11.03 7 46212 353 34910359
Bloody discharge 12.24 11.03 8 46211 518 34910194
Communication disorder 12.17 11.03 16 46203 2558 34908154
Cytomegalovirus infection 12.16 11.03 10 46209 26125 34884587
Drug hypersensitivity 12.08 11.03 60 46159 80469 34830243
Erosive duodenitis 11.91 11.03 13 46206 1711 34909001
Application site hypersensitivity 11.91 11.03 5 46214 128 34910584
Cerebral arteriovenous malformation haemorrhagic 11.89 11.03 4 46215 54 34910658
Vision blurred 11.88 11.03 27 46192 45936 34864776
Erythema 11.75 11.03 69 46150 88711 34822001
Otorrhoea 11.45 11.03 8 46211 578 34910134
Diplopia 11.41 11.03 4 46215 16839 34893873
Stress 11.39 11.03 14 46205 30333 34880379
Abdominal cavity drainage 11.37 11.03 7 46212 408 34910304
Dyskinesia 11.27 11.03 59 46160 22354 34888358
Small intestinal obstruction 11.12 11.03 44 46175 14822 34895890
Adrenoleukodystrophy 11.05 11.03 4 46215 68 34910644

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 905.66 10.34 472 88806 23694 79631416
Sedation complication 688.97 10.34 341 88937 15328 79639782
Creatinine renal clearance decreased 618.60 10.34 338 88940 18664 79636446
Orthostatic hypotension 611.07 10.34 505 88773 55659 79599451
Blood calcium decreased 506.62 10.34 359 88919 31460 79623650
Cognitive disorder 478.75 10.34 485 88793 69441 79585669
Sedation 475.60 10.34 423 88855 51472 79603638
Balance disorder 413.36 10.34 531 88747 98326 79556784
Drug ineffective 377.79 10.34 394 88884 1080519 78574591
Depressed level of consciousness 344.06 10.34 480 88798 96172 79558938
Constipation 316.15 10.34 859 88419 282191 79372919
Inability to afford medication 260.85 10.34 103 89175 2670 79652440
Fall 259.30 10.34 1156 88122 486473 79168637
Ammonia increased 254.50 10.34 138 89140 7497 79647613
Ascites 213.76 10.34 337 88941 75225 79579885
Hepatic cirrhosis 204.64 10.34 223 89055 34683 79620427
Confusional state 201.59 10.34 796 88482 317201 79337909
Blood bilirubin increased 197.96 10.34 303 88975 65929 79589181
Mobility decreased 192.94 10.34 424 88854 121751 79533359
Hypotension 184.23 10.34 975 88303 439342 79215768
Completed suicide 179.00 10.34 30 89248 245737 79409373
Hypomania 173.19 10.34 107 89171 7437 79647673
Jaundice cholestatic 171.91 10.34 124 89154 11160 79643950
Hepatic failure 166.23 10.34 268 89010 60944 79594166
Faecaloma 164.68 10.34 122 89156 11442 79643668
Schizophrenia 159.84 10.34 135 89143 15305 79639805
Hyponatraemia 143.69 10.34 482 88796 177366 79477744
Arthropathy 132.58 10.34 20 89258 177091 79478019
Rheumatoid arthritis 132.21 10.34 35 89243 208435 79446675
Drug hypersensitivity 130.79 10.34 87 89191 298829 79356281
Joint swelling 123.63 10.34 86 89192 288560 79366550
Arthralgia 121.22 10.34 290 88988 571513 79083597
Treatment failure 119.36 10.34 23 89255 170463 79484647
Drug intolerance 118.08 10.34 75 89203 264044 79391066
Haematemesis 115.72 10.34 209 89069 52055 79603055
Therapeutic product effect decreased 112.84 10.34 23 89255 163840 79491270
Hepatocellular carcinoma 108.33 10.34 86 89192 8935 79646175
Off label use 107.87 10.34 587 88691 906628 78748482
General physical health deterioration 107.11 10.34 598 88680 274640 79380470
Varices oesophageal 105.62 10.34 72 89206 5919 79649191
Sinusitis 104.46 10.34 44 89234 195457 79459653
Injection site pain 101.07 10.34 13 89265 129825 79525285
Systemic lupus erythematosus 99.65 10.34 10 89268 121139 79533971
Hand deformity 98.93 10.34 4 89274 103915 79551195
Infusion related reaction 98.03 10.34 69 89209 230168 79424942
Psychotic disorder 96.06 10.34 169 89109 41233 79613877
Swelling 93.51 10.34 64 89214 216647 79438463
Therapeutic product effect incomplete 87.50 10.34 25 89253 141620 79513490
Maternal exposure during pregnancy 86.39 10.34 23 89255 136515 79518595
Encephalopathy 85.69 10.34 215 89063 67182 79587928
Nasopharyngitis 85.32 10.34 95 89183 253786 79401324
Toxic epidermal necrolysis 84.68 10.34 167 89111 44414 79610696
Cholelithiasis 82.19 10.34 182 89096 52482 79602628
Hepatorenal syndrome 81.96 10.34 54 89224 4195 79650915
Hypersensitivity 80.83 10.34 105 89173 262134 79392976
Contraindicated product administered 80.15 10.34 38 89240 157500 79497610
Glossodynia 78.87 10.34 11 89267 103326 79551784
Neutropenic sepsis 78.28 10.34 122 89156 26942 79628168
Jaundice 76.18 10.34 178 89100 53171 79601939
Abdominal pain 76.01 10.34 717 88561 388852 79266258
Pneumatosis intestinalis 74.71 10.34 60 89218 6337 79648773
Drug abuse 72.94 10.34 46 89232 162645 79492465
Insurance issue 71.74 10.34 56 89222 5677 79649433
Oesophageal varices haemorrhage 70.18 10.34 49 89229 4187 79650923
Hyperkalaemia 68.79 10.34 282 88996 114116 79540994
Acute kidney injury 68.28 10.34 884 88394 518520 79136590
Rash 67.00 10.34 377 88901 577981 79077129
Hyperammonaemia 66.97 10.34 72 89206 11021 79644089
Total lung capacity increased 66.90 10.34 38 89240 2260 79652850
Peritonitis bacterial 66.57 10.34 67 89211 9500 79645610
Chronic hepatic failure 65.98 10.34 29 89249 990 79654120
Discomfort 64.35 10.34 30 89248 125587 79529523
Musculoskeletal stiffness 63.85 10.34 61 89217 174947 79480163
Alopecia 62.10 10.34 102 89176 231253 79423857
Portal hypertension 61.24 10.34 56 89222 7052 79648058
Dehydration 59.94 10.34 479 88799 247708 79407402
Abdominal distension 59.78 10.34 279 88999 119371 79535739
Hepatitis C 59.35 10.34 70 89208 11855 79643255
Urinary retention 59.18 10.34 168 89110 56462 79598648
Psoriatic arthropathy 57.91 10.34 9 89269 77990 79577120
Product use issue 57.73 10.34 91 89187 209731 79445379
Skin candida 56.72 10.34 33 89245 2054 79653056
Ileus 55.70 10.34 103 89175 26108 79629002
Asthma-chronic obstructive pulmonary disease overlap syndrome 55.10 10.34 38 89240 3183 79651927
Heart sounds 51.48 10.34 24 89254 942 79654168
Folliculitis 49.94 10.34 3 89275 55377 79599733
Hepatotoxicity 49.48 10.34 148 89130 51204 79603906
Arthritis 49.43 10.34 34 89244 114846 79540264
Lymphatic fistula 49.25 10.34 22 89256 781 79654329
Abdominal discomfort 49.23 10.34 132 89146 250595 79404515
Weight increased 48.67 10.34 154 89124 277232 79377878
Headache 48.51 10.34 483 88795 653289 79001821
Femoral hernia incarcerated 48.25 10.34 22 89256 820 79654290
Inappropriate schedule of product administration 48.24 10.34 47 89231 133581 79521529
Prolonged expiration 48.08 10.34 25 89253 1246 79653864
Pneumonia 47.76 10.34 1019 88259 659227 78995883
Gastric varices 47.69 10.34 21 89257 720 79654390
Injection site erythema 46.11 10.34 15 89263 78182 79576928
Pericarditis 45.99 10.34 30 89248 104206 79550904
Blood pressure increased 45.60 10.34 106 89172 211254 79443856
Aortic arteriosclerosis 45.47 10.34 53 89225 8865 79646245
Vomiting 45.41 10.34 1019 88259 664809 78990301
Neutrophil count increased 45.19 10.34 101 89177 29295 79625815
Urinary tract infection 45.16 10.34 488 88790 274024 79381086
Wound infection pseudomonas 45.03 10.34 26 89252 1595 79653515
Hypernatraemia 44.40 10.34 67 89211 14384 79640726
Abdominal tenderness 44.35 10.34 57 89221 10537 79644573
Intentional product use issue 43.73 10.34 64 89214 152048 79503062
Helicobacter infection 43.59 10.34 12 89266 69692 79585418
Muscle injury 42.69 10.34 3 89275 48558 79606552
Anaemia 42.14 10.34 716 88562 444299 79210811
Pancreatic steatosis 41.82 10.34 22 89256 1123 79653987
Sepsis 41.59 10.34 473 88805 268955 79386155
Therapeutic response decreased 40.90 10.34 12 89266 66841 79588269
Wound 40.64 10.34 42 89236 116137 79538973
Portal hypertensive gastropathy 40.14 10.34 23 89255 1391 79653719
Urticaria 39.85 10.34 93 89185 185108 79470002
Hypokalaemia 39.79 10.34 287 88991 143753 79511357
Alveolar lung disease 39.24 10.34 17 89261 560 79654550
Delirium 39.12 10.34 193 89085 84434 79570676
Melaena 38.90 10.34 153 89125 60737 79594373
Liver function test abnormal 38.79 10.34 159 89119 64316 79590794
Irritable bowel syndrome 38.40 10.34 11 89267 62230 79592880
Exposure during pregnancy 38.36 10.34 34 89244 101098 79554012
Ill-defined disorder 38.21 10.34 13 89265 65862 79589248
Cirrhosis alcoholic 37.70 10.34 20 89258 1039 79654071
Pulmonary interstitial emphysema syndrome 37.51 10.34 16 89262 507 79654603
Injection site reaction 37.06 10.34 8 89270 54777 79600333
Psoriasis 36.60 10.34 28 89250 89559 79565551
Haemoglobin decreased 35.65 10.34 393 88885 221726 79433384
Multiple drug therapy 34.88 10.34 32 89246 4046 79651064
Product dose omission issue 34.53 10.34 151 89127 247386 79407724
White blood cell count increased 34.35 10.34 170 89108 74463 79580647
Arterial haemorrhage 34.19 10.34 26 89252 2535 79652575
Disorientation 34.04 10.34 150 89128 62626 79592484
Systemic infection 34.00 10.34 48 89230 9704 79645406
Hypertension 33.93 10.34 224 89054 330768 79324342
Fatigue 33.92 10.34 788 88490 928939 78726171
Intestinal pseudo-obstruction 33.77 10.34 26 89252 2583 79652527
Injection site swelling 33.73 10.34 6 89272 47126 79607984
Mental status changes 33.33 10.34 156 89122 66803 79588307
Blood cholesterol increased 33.15 10.34 27 89251 83693 79571417
Asterixis 32.92 10.34 26 89252 2681 79652429
C-reactive protein abnormal 32.84 10.34 7 89271 48360 79606750
Liver transplant 32.67 10.34 32 89246 4391 79650719
Gastrointestinal disorder 32.65 10.34 54 89224 122151 79532959
Injection site bruising 32.15 10.34 4 89274 40998 79614112
Sarcoidosis 32.03 10.34 43 89235 8292 79646818
Gastrointestinal haemorrhage 31.84 10.34 278 89000 147441 79507669
Nasal polyps 31.58 10.34 40 89238 7287 79647823
High-grade B-cell lymphoma 31.58 10.34 10 89268 132 79654978
Injection site pruritus 31.11 10.34 5 89273 42278 79612832
Benign gastrointestinal neoplasm 31.10 10.34 10 89268 139 79654971
Periarthritis calcarea 31.05 10.34 9 89269 86 79655024
Peripheral swelling 30.46 10.34 177 89101 269440 79385670
Hypoaesthesia 30.45 10.34 101 89177 179251 79475859
Seroma 29.94 10.34 23 89255 2277 79652833
Hypermagnesaemia 29.46 10.34 18 89260 1226 79653884
Therapy non-responder 29.40 10.34 36 89242 92269 79562841
Hip arthroplasty 29.27 10.34 3 89275 35753 79619357
Drug resistance 28.89 10.34 6 89272 42207 79612903
Intentional overdose 28.14 10.34 47 89231 105913 79549197
Antipsychotic drug level increased 28.06 10.34 34 89244 5923 79649187
Dementia 27.58 10.34 75 89203 24584 79630526
Lethargy 27.27 10.34 170 89108 81122 79573988
Therapy interrupted 27.10 10.34 87 89191 31254 79623856
Pain in extremity 27.10 10.34 269 89009 364269 79290841
Osteoarthritis 26.82 10.34 35 89243 87274 79567836
Wrong technique in product usage process 26.64 10.34 26 89252 73849 79581261
Erythema 26.62 10.34 144 89134 223146 79431964
Diverticulum intestinal 26.58 10.34 40 89238 8565 79646545
COVID-19 25.94 10.34 90 89188 157584 79497526
Herpes zoster 25.93 10.34 40 89238 93043 79562067
Adrenal cyst 25.85 10.34 9 89269 162 79654948
Upper gastrointestinal haemorrhage 25.64 10.34 103 89175 41277 79613833
Seizure 24.96 10.34 322 88956 188512 79466598
Nail dystrophy 24.87 10.34 15 89263 998 79654112
Suicide attempt 24.71 10.34 34 89244 82898 79572212
Hallucination 24.34 10.34 172 89106 85573 79569537
Hepatic cyst 24.30 10.34 32 89246 6057 79649053
Pruritus 24.27 10.34 304 88974 394344 79260766
Conjunctival irritation 23.85 10.34 8 89270 128 79654982
Blood pressure fluctuation 23.79 10.34 24 89254 67121 79587989
Articular calcification 23.63 10.34 9 89269 211 79654899
Oedema peripheral 23.49 10.34 405 88873 251883 79403227
Red blood cell sedimentation rate increased 23.48 10.34 11 89267 45931 79609179
Femoral neck fracture 23.47 10.34 41 89237 9943 79645167
Pyramidal tract syndrome 23.32 10.34 12 89266 585 79654525
Spinal cord paralysis 23.29 10.34 8 89270 138 79654972
Urinary incontinence 23.13 10.34 99 89179 40810 79614300
Wrong patient received product 22.80 10.34 27 89251 4591 79650519
Fibromyalgia 22.79 10.34 23 89255 64317 79590793
Dyskinesia 22.78 10.34 105 89173 44668 79610442
Cholestasis of pregnancy 22.58 10.34 14 89264 979 79654131
Blood pressure systolic increased 22.55 10.34 25 89253 66961 79588149
Product use in unapproved indication 22.45 10.34 176 89102 250183 79404927
Joint injury 22.40 10.34 4 89274 31331 79623779
Hypophagia 22.06 10.34 105 89173 45262 79609848
Hyperammonaemic encephalopathy 22.04 10.34 27 89251 4755 79650355
Cardiac murmur 21.72 10.34 52 89226 15772 79639338
Product prescribing error 21.27 10.34 103 89175 44710 79610400
Intestinal obstruction 21.24 10.34 100 89178 42920 79612190
Adverse drug reaction 21.03 10.34 26 89252 66366 79588744
Myalgia 20.88 10.34 122 89156 185519 79469591
Death 20.85 10.34 803 88475 565711 79089399
Haemarthrosis 20.85 10.34 29 89249 5783 79649327
Intestinal dilatation 20.82 10.34 20 89258 2680 79652430
Disturbance in attention 20.79 10.34 112 89166 50689 79604421
Migraine 20.40 10.34 42 89236 87451 79567659
Freezing phenomenon 20.35 10.34 17 89261 1897 79653213
Obesity 20.25 10.34 7 89271 35118 79619992
Colitis ulcerative 19.90 10.34 7 89271 34735 79620375
Arteriosclerosis coronary artery 19.73 10.34 54 89224 17762 79637348
Functional gastrointestinal disorder 19.57 10.34 26 89252 4964 79650146
Hiccups 19.56 10.34 38 89240 9993 79645117
On and off phenomenon 19.51 10.34 21 89257 3219 79651891
Ureaplasma infection 19.42 10.34 13 89265 1037 79654073
Portal vein thrombosis 19.32 10.34 28 89250 5799 79649311
Peritonitis 19.18 10.34 72 89206 27964 79627146
Hepatic calcification 19.08 10.34 9 89269 363 79654747
Hepatitis C RNA positive 19.01 10.34 8 89270 245 79654865
Oropharyngeal pain 18.95 10.34 61 89217 109292 79545818
Heart rate decreased 18.85 10.34 31 89247 70285 79584825
Bradycardia 18.69 10.34 233 89045 135324 79519786
Dermatitis bullous 18.68 10.34 46 89232 14199 79640911
Inflammation 18.65 10.34 49 89229 93704 79561406
Axillary pain 18.65 10.34 17 89261 2132 79652978
Abortion spontaneous 18.60 10.34 5 89273 29502 79625608
Costal cartilage fracture 18.54 10.34 8 89270 261 79654849
Accidental exposure to product 18.48 10.34 6 89272 31316 79623794
Aspiration 18.39 10.34 57 89221 20101 79635009
Escherichia infection 18.38 10.34 53 89225 17964 79637146
Aortic valve stenosis 18.37 10.34 26 89252 5268 79649842
Hallucination, visual 18.34 10.34 79 89199 32650 79622460
Acute abdomen 18.30 10.34 20 89258 3117 79651993
Platelet count decreased 18.29 10.34 313 88965 194351 79460759
Stoma site discharge 18.25 10.34 17 89261 2192 79652918
Adrenomegaly 18.22 10.34 9 89269 402 79654708
Wound dehiscence 18.06 10.34 29 89249 6566 79648544
Epilepsy 18.04 10.34 92 89186 40768 79614342
Asthma 17.87 10.34 84 89194 135011 79520099
Flail chest 17.71 10.34 6 89272 99 79655011
Adverse event 17.62 10.34 25 89253 60189 79594921
Hypervolaemia 17.39 10.34 94 89184 42596 79612514
Spleen congestion 17.37 10.34 9 89269 445 79654665
Lung perforation 17.28 10.34 6 89272 107 79655003
Differential white blood cell count abnormal 17.19 10.34 16 89262 2061 79653049
Appetite disorder 17.19 10.34 31 89247 7708 79647402
Genital erythema 17.11 10.34 8 89270 316 79654794
Pneumonia aspiration 17.10 10.34 131 89147 66836 79588274
Metamyelocyte count increased 17.08 10.34 10 89268 630 79654480
Thrombocytopenia 17.07 10.34 403 88875 264856 79390254
Night sweats 16.93 10.34 20 89258 52075 79603035
Erosive duodenitis 16.93 10.34 16 89262 2101 79653009
Body mass index decreased 16.75 10.34 10 89268 653 79654457
Impaired healing 16.55 10.34 47 89231 87608 79567502
Alkalosis hypochloraemic 16.49 10.34 9 89269 495 79654615
Throat irritation 16.46 10.34 13 89265 40933 79614177
Ear infection 16.46 10.34 9 89269 34423 79620687
Infection 16.46 10.34 182 89096 241530 79413580
Abnormal faeces 16.40 10.34 30 89248 7541 79647569
Plasma cell myeloma 16.39 10.34 109 89169 53150 79601960
Feeling hot 16.32 10.34 26 89252 59708 79595402
Activated partial thromboplastin time shortened 16.31 10.34 11 89267 888 79654222
Bronchitis 16.26 10.34 83 89195 130561 79524549
Intentional self-injury 16.20 10.34 8 89270 32411 79622699
Blood albumin abnormal 16.20 10.34 10 89268 694 79654416
Rectal haemorrhage 16.12 10.34 143 89135 76157 79578953
Toxicity to various agents 16.08 10.34 600 88678 420940 79234170
Depressed mood 16.01 10.34 101 89177 48379 79606731
Hyperbilirubinaemia 15.97 10.34 62 89216 24456 79630654
Blood alkaline phosphatase increased 15.95 10.34 124 89154 63540 79591570
Depressive symptom 15.92 10.34 27 89251 6396 79648714
Respiration abnormal 15.79 10.34 30 89248 7758 79647352
Portal shunt procedure 15.72 10.34 4 89274 22 79655088
Inguinal hernia 15.72 10.34 27 89251 6461 79648649
Subileus 15.67 10.34 25 89253 5629 79649481
Pulmonary vein occlusion 15.66 10.34 6 89272 143 79654967
Splenomegaly 15.63 10.34 55 89223 20699 79634411
Portal shunt 15.45 10.34 5 89273 71 79655039
Blister 15.39 10.34 75 89203 119401 79535709
Nephrocalcinosis 15.27 10.34 13 89265 1489 79653621
Dysphagia 15.19 10.34 206 89072 121930 79533180
Stomatitis 15.17 10.34 99 89179 146658 79508452
Abdominal rigidity 15.16 10.34 18 89260 3070 79652040
Salivary gland enlargement 15.04 10.34 8 89270 418 79654692
Eye pain 15.02 10.34 12 89266 37566 79617544
Bleeding time prolonged 14.93 10.34 12 89266 1269 79653841
Hepatic cancer 14.88 10.34 35 89243 10494 79644616
Immature granulocyte count increased 14.81 10.34 9 89269 607 79654503
Oral contusion 14.79 10.34 5 89273 82 79655028
Blood sodium decreased 14.77 10.34 75 89203 33180 79621930
Vascular encephalopathy 14.72 10.34 9 89269 614 79654496
Monocyte count increased 14.59 10.34 35 89243 10626 79644484
Intentional product misuse 14.54 10.34 56 89222 95109 79560001
Pleural effusion 14.54 10.34 236 89042 145026 79510084
Hiatus hernia 14.42 10.34 58 89220 23254 79631856
Mouth swelling 14.42 10.34 25 89253 6026 79649084
Paracentesis 14.41 10.34 12 89266 1333 79653777
Rhinitis allergic 14.41 10.34 38 89240 12231 79642879
Nodule 14.30 10.34 4 89274 22990 79632120
Drug ineffective for unapproved indication 14.29 10.34 22 89256 51216 79603894
Feeling abnormal 14.22 10.34 112 89166 159087 79496023
Unresponsive to stimuli 14.17 10.34 109 89169 55679 79599431
Cardiac disorder 14.15 10.34 33 89245 65724 79589386
Prescribed overdose 14.05 10.34 13 89265 37870 79617240
Salivary gland disorder 13.98 10.34 7 89271 322 79654788
Road traffic accident 13.93 10.34 17 89261 43647 79611463
Lactic acidosis 13.92 10.34 130 89148 70229 79584881
Injection site haemorrhage 13.74 10.34 7 89271 27863 79627247
Full blood count abnormal 13.74 10.34 15 89263 40459 79614651
Activated partial thromboplastin time abnormal 13.65 10.34 7 89271 339 79654771
Incoherent 13.63 10.34 28 89250 7664 79647446
Blast cells present 13.60 10.34 10 89268 927 79654183
Weight 13.55 10.34 4 89274 41 79655069
Stoma site erythema 13.54 10.34 13 89265 1740 79653370
Nail infection 13.49 10.34 15 89263 2384 79652726
Circulatory collapse 13.40 10.34 80 89198 37588 79617522
Megacolon 13.38 10.34 18 89260 3477 79651633
Neutropenia 13.35 10.34 419 88859 287291 79367819
Anxiety 13.25 10.34 197 89081 248315 79406795
Grip strength decreased 13.24 10.34 4 89274 21865 79633245
Thoracic operation 13.22 10.34 6 89272 221 79654889
Tachyarrhythmia 13.12 10.34 26 89252 6936 79648174
Diabetic gastropathy 13 10.34 3 89275 10 79655100
Toxic encephalopathy 13.00 10.34 35 89243 11405 79643705
Myelocyte count increased 12.98 10.34 9 89269 760 79654350
Premature delivery 12.98 10.34 5 89273 23462 79631648
Illness 12.94 10.34 20 89258 46491 79608619
Spinal cord injury thoracic 12.91 10.34 5 89273 123 79654987
Bladder cancer 12.90 10.34 3 89275 19523 79635587
Groin pain 12.88 10.34 38 89240 13042 79642068
Vascular parkinsonism 12.87 10.34 5 89273 124 79654986
Pregnancy 12.86 10.34 7 89271 26844 79628266
Portal tract inflammation 12.79 10.34 5 89273 126 79654984
Peripheral artery stenosis 12.62 10.34 11 89267 1300 79653810
Anaphylactic shock 12.60 10.34 13 89265 35983 79619127
Gastrointestinal tract mucosal pigmentation 12.59 10.34 10 89268 1040 79654070
Electrolyte imbalance 12.58 10.34 68 89210 30813 79624297
Fungal infection 12.55 10.34 17 89261 41731 79613379
Blood albumin decreased 12.44 10.34 57 89221 24186 79630924
Throat tightness 12.35 10.34 8 89270 27899 79627211
Nervous system disorder 12.23 10.34 61 89217 26795 79628315
Flushing 12.20 10.34 54 89224 88214 79566896
Dry eye 12.19 10.34 14 89264 36917 79618193
Influenza 12.13 10.34 90 89188 129516 79525594
Coma hepatic 12.07 10.34 10 89268 1103 79654007
Stress 12.06 10.34 47 89231 79565 79575545
Acute hepatic failure 12.06 10.34 66 89212 30047 79625063
Incontinence 11.96 10.34 39 89239 14125 79640985
Vascular purpura 11.93 10.34 16 89262 3082 79652028
Muscle twitching 11.81 10.34 57 89221 24707 79630403
Contusion 11.79 10.34 108 89170 148668 79506442
Bronchiectasis 11.76 10.34 53 89225 22333 79632777
Small intestinal obstruction 11.76 10.34 61 89217 27211 79627899
Adrenoleukodystrophy 11.70 10.34 4 89274 68 79655042
Anal injury 11.59 10.34 5 89273 163 79654947
Poisoning 11.52 10.34 7 89271 25265 79629845
Diffuse alveolar damage 11.49 10.34 17 89261 3587 79651523
Portopulmonary hypertension 11.45 10.34 5 89273 168 79654942
Duodenal ulcer haemorrhage 11.45 10.34 25 89253 7138 79647972
Polypectomy 11.39 10.34 10 89268 1194 79653916
Superinfection 11.35 10.34 20 89258 4882 79650228
Hydronephrosis 11.26 10.34 44 89234 17410 79637700
Cytomegalovirus infection 11.24 10.34 19 89259 42625 79612485
Cataract 11.22 10.34 34 89244 62086 79593024
Cardiomyopathy acute 11.22 10.34 6 89272 317 79654793
Heart rate irregular 11.21 10.34 12 89266 32667 79622443
Colon cancer metastatic 11.18 10.34 13 89265 2168 79652942
Vision blurred 11.17 10.34 71 89207 105827 79549283
Duodenal ulcer 11.16 10.34 42 89236 16327 79638783
Interstitial lung disease 11.12 10.34 77 89201 112523 79542587
Gastrointestinal sounds abnormal 11.10 10.34 21 89257 5414 79649696
Anti-erythropoietin antibody negative 11.08 10.34 6 89272 325 79654785
Hyperglycaemia 11.06 10.34 124 89154 70211 79584899
Product quality issue 11.06 10.34 13 89265 33927 79621183
Left ventricular dysfunction 11.06 10.34 47 89231 19314 79635796
Cardiac failure congestive 11.02 10.34 104 89174 142298 79512812
Lip swelling 10.99 10.34 81 89197 40830 79614280
Rash vesicular 10.96 10.34 22 89256 5923 79649187
Adrenal adenoma 10.95 10.34 10 89268 1257 79653853
Alpha 1 foetoprotein decreased 10.94 10.34 3 89275 23 79655087
Hypoalbuminaemia 10.87 10.34 50 89228 21247 79633863
Bilirubin conjugated increased 10.82 10.34 21 89257 5518 79649592
Body temperature decreased 10.81 10.34 12 89266 32133 79622977
Heart rate increased 10.75 10.34 85 89193 120639 79534471
Hepatitis acute 10.70 10.34 40 89238 15502 79639608
Sexually inappropriate behaviour 10.69 10.34 7 89271 538 79654572
Hypertriglyceridaemia 10.68 10.34 35 89243 12705 79642405
Cytokine release syndrome 10.68 10.34 73 89205 35925 79619185
Tumour hyperprogression 10.61 10.34 5 89273 201 79654909
Lung neoplasm malignant 10.52 10.34 60 89218 27732 79627378
Food refusal 10.52 10.34 7 89271 553 79654557
Neck pain 10.51 10.34 46 89232 75371 79579739
Poisoning deliberate 10.43 10.34 4 89274 18824 79636286
Chronotropic incompetence 10.42 10.34 4 89274 96 79655014
Bursitis 10.37 10.34 15 89263 35829 79619281
Alkalosis 10.36 10.34 7 89271 567 79654543
Injury 10.36 10.34 48 89230 77448 79577662
Failure to thrive 10.35 10.34 33 89245 11811 79643299

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 0116-4005 SOLUTION 10 g ORAL ANDA 20 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 0116-4005 SOLUTION 10 g ORAL ANDA 20 sections
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 0121-0577 SOLUTION 10 g ORAL ANDA 22 sections
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 0121-0577 SOLUTION 10 g ORAL ANDA 22 sections
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 0121-0873 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 0121-1154 SOLUTION 20 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 0121-1746 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 0121-4577 SOLUTION 10 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 0527-5120 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 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
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
Constulose HUMAN PRESCRIPTION DRUG LABEL 1 45963-439 SOLUTION 10 g ORAL ANDA 19 sections