lactulose 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 µM/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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,MAP2K6,MAP3K21,MAPK10,MAPK7,NTRK1,NTRK2,PDK2,PDK4,PIK3CD,PRKDC,SIK2,STK33,TEK 26
kinase-selectivity-class ACVRL1,CHUK,MAP2K6,PDK1,PIK3CD,ZAP70 6
pfas-class PFAS structural alert (1 = True, 0 = False) 0

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
Orthostatic hypotension 902.70 11.46 492 66390 41335 90520230
Sedation complication 866.39 11.46 361 66521 16583 90544982
Creatinine renal clearance decreased 857.84 11.46 370 66512 18529 90543036
Cognitive disorder 733.42 11.46 518 66364 68889 90492676
Blood calcium decreased 715.52 11.46 378 66504 29804 90531761
Sedation 713.86 11.46 444 66438 47727 90513838
Balance disorder 587.84 11.46 522 66360 96558 90465007
Depressed level of consciousness 584.99 11.46 461 66421 72323 90489242
Schizophrenia 438.31 11.46 216 66666 14698 90546867
Hepatic encephalopathy 382.64 11.46 192 66690 13580 90547985
Fall 350.81 11.46 959 65923 480851 90080714
Jaundice cholestatic 342.21 11.46 161 66721 9882 90551683
Constipation 341.22 11.46 683 66199 279712 90281853
Hypomania 338.61 11.46 154 66728 8743 90552822
Drug ineffective 331.52 11.46 322 66560 1383976 89177589
Hypotension 308.05 11.46 716 66166 324681 90236884
Blood bilirubin increased 285.51 11.46 245 66637 43225 90518340
Cholelithiasis 272.14 11.46 259 66623 52247 90509318
Psychotic disorder 255.44 11.46 200 66682 31030 90530535
Synovitis 223.35 11.46 4 66878 329748 90231817
Systemic lupus erythematosus 218.33 11.46 12 66870 361884 90199681
Ammonia increased 204.67 11.46 91 66791 4895 90556670
Glossodynia 202.74 11.46 8 66874 321771 90239794
Arthropathy 201.31 11.46 19 66863 366223 90195342
Hyponatraemia 200.29 11.46 356 66526 133182 90428383
Hand deformity 199.05 11.46 4 66878 296358 90265207
Asthma-chronic obstructive pulmonary disease overlap syndrome 196.58 11.46 88 66794 4811 90556754
Drug hypersensitivity 194.70 11.46 51 66831 463558 90098007
Total lung capacity increased 191.34 11.46 87 66795 4934 90556631
Faecaloma 190.33 11.46 110 66772 10321 90551244
Toxicity to various agents 185.56 11.46 549 66333 287297 90274268
Drug intolerance 184.62 11.46 51 66831 447540 90114025
Infusion related reaction 172.79 11.46 47 66835 416733 90144832
Joint swelling 172.34 11.46 78 66804 503222 90058343
Swelling 170.49 11.46 49 66833 419009 90142556
Contraindicated product administered 160.02 11.46 23 66859 320116 90241449
Rheumatoid arthritis 157.79 11.46 37 66845 362577 90198988
Treatment failure 153.87 11.46 21 66861 303907 90257658
Wound 141.94 11.46 26 66856 302954 90258611
Sarcoidosis 139.60 11.46 91 66791 10582 90550983
Maternal exposure during pregnancy 139.41 11.46 46 66836 360017 90201548
Inability to afford medication 138.78 11.46 63 66819 3559 90558006
Hepatotoxicity 136.81 11.46 169 66713 45673 90515892
Sinusitis 136.07 11.46 42 66840 343046 90218519
Therapeutic product effect decreased 131.80 11.46 23 66859 277548 90284017
Nasal polyps 130.77 11.46 88 66794 10792 90550773
Psoriatic arthropathy 130.45 11.46 10 66872 228325 90333240
Helicobacter infection 129.42 11.46 10 66872 226840 90334725
Discomfort 127.51 11.46 24 66858 274311 90287254
Ascites 120.51 11.46 162 66720 47578 90513987
Alopecia 117.89 11.46 115 66767 494956 90066609
Cardiac murmur 116.29 11.46 101 66781 18093 90543472
Irritable bowel syndrome 115.96 11.46 10 66872 207438 90354127
Pericarditis 114.68 11.46 29 66853 270122 90291443
Hypersensitivity 110.12 11.46 104 66778 454573 90106992
Type 2 diabetes mellitus 107.83 11.46 12 66870 203232 90358333
Mobility decreased 106.45 11.46 416 66466 250318 90311247
Vomiting 106.24 11.46 965 65917 787328 89774237
Blood cholesterol increased 106.13 11.46 14 66868 207998 90353567
Musculoskeletal stiffness 102.89 11.46 45 66837 296487 90265078
Hyperkalaemia 100.95 11.46 176 66706 64788 90496777
Haematemesis 100.09 11.46 124 66758 33602 90527963
Rhinitis allergic 96.97 11.46 88 66794 16697 90544868
Ill-defined disorder 95.39 11.46 12 66870 184879 90376686
Creatinine renal clearance increased 94.83 11.46 47 66835 3234 90558331
Lymphatic fistula 91.38 11.46 36 66846 1425 90560140
Dehydration 88.57 11.46 330 66552 194117 90367448
Product use issue 87.70 11.46 69 66813 329850 90231715
Nasopharyngitis 87.47 11.46 103 66779 407001 90154564
Femoral hernia incarcerated 86.82 11.46 35 66847 1473 90560092
Wound infection pseudomonas 86.50 11.46 38 66844 1985 90559580
Therapeutic product effect incomplete 85.85 11.46 19 66863 193877 90367688
Urticaria 84.91 11.46 64 66818 312670 90248895
Bronchiectasis 84.46 11.46 93 66789 22237 90539328
Fibromyalgia 84.01 11.46 24 66858 206245 90355320
Pancreatic steatosis 83.94 11.46 35 66847 1607 90559958
Lung neoplasm malignant 81.45 11.46 95 66787 24178 90537387
Arthralgia 80.82 11.46 299 66583 778223 89783342
Hypokalaemia 80.47 11.46 246 66636 130870 90430695
Renal function test abnormal 78.93 11.46 55 66827 7136 90554429
Neutropenic sepsis 78.27 11.46 81 66801 18049 90543516
Abdominal discomfort 77.99 11.46 146 66736 477182 90084383
Multiple drug therapy 77.85 11.46 54 66828 6955 90554610
C-reactive protein abnormal 77.47 11.46 4 66878 127425 90434140
Arterial haemorrhage 75.48 11.46 37 66845 2486 90559079
Urinary tract infection 75.27 11.46 433 66449 305199 90256366
Haemarthrosis 75.21 11.46 43 66839 3951 90557614
Urinary retention 73.15 11.46 113 66769 37631 90523934
Skin candida 72.18 11.46 32 66850 1709 90559856
Joint range of motion decreased 71.95 11.46 8 66874 135635 90425930
Dementia 71.23 11.46 88 66794 23773 90537792
Heart sounds 70.89 11.46 28 66854 1116 90560449
Anaemia 70.70 11.46 474 66408 352328 90209237
Exposure during pregnancy 69.71 11.46 45 66837 238365 90323200
Completed suicide 68.86 11.46 12 66870 145046 90416519
Rash 68.83 11.46 328 66554 795772 89765793
Seroma 68.73 11.46 37 66845 3023 90558542
Prolonged expiration 68.34 11.46 28 66854 1229 90560336
Gastrointestinal disorder 67.80 11.46 54 66828 256633 90304932
Weight increased 67.22 11.46 129 66753 417798 90143767
Diverticulum intestinal 67.17 11.46 55 66827 9087 90552478
Varices oesophageal 66.68 11.46 39 66843 3740 90557825
Ileus 66.22 11.46 71 66811 16475 90545090
Vascular device infection 65.80 11.46 61 66821 11891 90549674
Inflammation 65.32 11.46 25 66857 178567 90382998
Acute kidney injury 63.30 11.46 429 66453 319958 90241607
Jaundice 62.53 11.46 97 66785 32420 90529145
Hepatic failure 62.19 11.46 108 66774 39620 90521945
Hypoaesthesia 61.74 11.46 85 66797 314125 90247440
Chronic obstructive pulmonary disease 60.57 11.46 154 66728 73675 90487890
Aortic arteriosclerosis 60.21 11.46 48 66834 7636 90553929
Bursitis 60.12 11.46 12 66870 131642 90429923
Facet joint syndrome 60.09 11.46 3 66879 98386 90463179
Aortic valve stenosis 60.02 11.46 38 66844 4202 90557363
Drug interaction 59.97 11.46 379 66503 276074 90285491
Stomatitis 58.42 11.46 70 66812 274628 90286937
Wound dehiscence 58.06 11.46 42 66840 5780 90555785
Abdominal tenderness 58.05 11.46 51 66831 9273 90552292
Nasal mucosal disorder 57.85 11.46 28 66854 1829 90559736
Liver injury 57.38 11.46 27 66855 170540 90391025
Osteoarthritis 57.14 11.46 37 66845 195693 90365872
Pseudomonal sepsis 57.04 11.46 37 66845 4265 90557300
Injection site pain 56.16 11.46 29 66853 173670 90387895
Nail bed inflammation 55.64 11.46 27 66855 1774 90559791
Infection 55.43 11.46 115 66767 361979 90199586
Oedema peripheral 54.34 11.46 351 66531 257564 90304001
Pneumonia 54.13 11.46 713 66169 637346 89924219
Sepsis 53.92 11.46 269 66613 179545 90382020
Prescribed overdose 53.74 11.46 5 66877 97620 90463945
Hepatic cyst 53.55 11.46 42 66840 6526 90555039
Hypercholesterolaemia 53.38 11.46 6 66876 100886 90460679
Abdominal pain 52.84 11.46 484 66398 395237 90166328
Vascular encephalopathy 51.79 11.46 20 66862 750 90560815
Obesity 51.70 11.46 8 66874 105499 90456066
Tachyarrhythmia 51.65 11.46 38 66844 5368 90556197
Aplastic anaemia 51.46 11.46 56 66826 13213 90548352
Intestinal pseudo-obstruction 50.23 11.46 22 66860 1141 90560424
Neutrophil count increased 49.23 11.46 66 66816 19324 90542241
Streptococcal sepsis 47.95 11.46 31 66851 3553 90558012
Chronic hepatic failure 47.49 11.46 18 66864 641 90560924
Impaired healing 47.36 11.46 62 66820 234137 90327428
Mucosal inflammation 47.06 11.46 120 66762 57505 90504060
Arthritis 46.99 11.46 33 66849 167282 90394283
Injury 46.70 11.46 46 66836 197303 90364262
Blister 46.16 11.46 73 66809 254925 90306640
Psoriasis 45.82 11.46 26 66856 147728 90413837
Hepatocellular carcinoma 45.34 11.46 26 66856 2402 90559163
Hip arthroplasty 44.47 11.46 3 66879 76205 90485360
Peripheral venous disease 44.37 11.46 5 66877 83916 90477649
Lip swelling 44.36 11.46 92 66790 38518 90523047
Therapy non-responder 43.93 11.46 23 66859 136681 90424884
Adverse event 43.66 11.46 16 66866 117402 90444163
Left ventricular dysfunction 43.62 11.46 54 66828 14615 90546950
Road traffic accident 42.93 11.46 13 66869 107613 90453952
Encephalopathy 42.46 11.46 101 66781 46343 90515222
Eructation 42.33 11.46 46 66836 10836 90550729
Hiatus hernia 41.07 11.46 70 66812 25291 90536274
Gait inability 40.98 11.46 29 66853 146427 90415138
Gastrointestinal haemorrhage 40.91 11.46 153 66729 90095 90471470
Night sweats 40.88 11.46 22 66860 128744 90432821
Injection site reaction 40.79 11.46 9 66873 92071 90469494
Hallucination 40.67 11.46 124 66758 65835 90495730
Wound infection 40.41 11.46 14 66868 106388 90455177
Portal hypertension 40.37 11.46 31 66851 4670 90556895
Lung disorder 40.23 11.46 31 66851 149852 90411713
Disturbance in attention 39.40 11.46 99 66783 47010 90514555
Seizure 39.34 11.46 219 66663 152410 90409155
Therapeutic response decreased 39.28 11.46 9 66873 89720 90471845
Urinary incontinence 39.11 11.46 86 66796 37480 90524085
Injection site erythema 39.10 11.46 12 66870 98490 90463075
Death 38.15 11.46 509 66373 456042 90105523
Hyperammonaemia 37.50 11.46 34 66848 6441 90555124
Sleep disorder 37.46 11.46 55 66827 197975 90363590
Neutropenia 37.37 11.46 289 66593 224615 90336950
Headache 37.06 11.46 433 66449 862313 89699252
Anuria 36.95 11.46 50 66832 14768 90546797
Insurance issue 36.95 11.46 43 66839 10915 90550650
Haemoglobin decreased 36.94 11.46 225 66657 161731 90399834
Red blood cell sedimentation rate increased 36.73 11.46 8 66874 82587 90478978
Tricuspid valve incompetence 36.57 11.46 53 66829 16678 90544887
Portal hypertensive gastropathy 36.32 11.46 17 66865 1030 90560535
Restlessness 36.31 11.46 81 66801 35639 90525926
Pulmonary fibrosis 36.18 11.46 17 66865 107486 90454079
Dry mouth 35.92 11.46 50 66832 184009 90377556
Cardiovascular disorder 35.91 11.46 47 66835 13445 90548120
Contusion 35.77 11.46 83 66799 251133 90310432
Subileus 35.68 11.46 26 66856 3618 90557947
Neutrophil count decreased 35.58 11.46 125 66757 71407 90490158
Hypertension 35.20 11.46 196 66686 457336 90104229
Gastrointestinal sounds abnormal 34.79 11.46 28 66854 4515 90557050
Intentional product use issue 34.78 11.46 67 66815 216825 90344740
Postoperative wound infection 34.54 11.46 46 66836 13380 90548185
Hepatic cirrhosis 34.50 11.46 114 66768 63139 90498426
Candida infection 34.36 11.46 77 66805 33980 90527585
Fatigue 34.28 11.46 623 66259 1153400 89408165
Escherichia infection 34.23 11.46 50 66832 15845 90545720
Musculoskeletal pain 33.94 11.46 46 66836 171205 90390360
Varicose vein 33.93 11.46 34 66848 7293 90554272
White blood cell count increased 33.87 11.46 118 66764 67123 90494442
Peritonitis bacterial 33.64 11.46 29 66853 5142 90556423
Neuroleptic malignant syndrome 33.26 11.46 48 66834 15048 90546517
Melaena 33.25 11.46 77 66805 34720 90526845
Depressive symptom 33.09 11.46 29 66853 5256 90556309
Autoimmune disorder 33.00 11.46 8 66874 76736 90484829
Thrombocytopenia 32.90 11.46 265 66617 208460 90353105
Product quality issue 32.71 11.46 9 66873 79316 90482249
Sciatica 32.65 11.46 17 66865 101365 90460200
Bladder disorder 32.59 11.46 40 66842 10732 90550833
Pleural effusion 32.47 11.46 166 66716 111825 90449740
Cardiospasm 32.42 11.46 24 66858 3422 90558143
Toxic epidermal necrolysis 32.21 11.46 73 66809 32455 90529110
Palmoplantar keratoderma 32.04 11.46 24 66858 3483 90558082
Cirrhosis alcoholic 31.94 11.46 11 66871 296 90561269
Pruritus 31.60 11.46 252 66630 541273 90020292
Respiration abnormal 31.57 11.46 34 66848 7929 90553636
Intentional overdose 31.33 11.46 15 66867 93819 90467746
Peripheral swelling 31.21 11.46 178 66704 412928 90148637
Salivary hypersecretion 31.20 11.46 36 66846 9056 90552509
Intestinal dilatation 30.95 11.46 20 66862 2290 90559275
Colitis ulcerative 30.85 11.46 4 66878 60262 90501303
Inflammatory marker increased 30.81 11.46 36 66846 9178 90552387
Abdominal distension 30.77 11.46 183 66699 130418 90431147
Live birth 30.75 11.46 10 66872 79097 90482468
Oesophageal varices haemorrhage 30.63 11.46 17 66865 1475 90560090
Febrile neutropenia 30.60 11.46 211 66671 158138 90403427
Depressed mood 30.57 11.46 94 66788 50128 90511437
Injection site swelling 30.57 11.46 4 66878 59835 90501730
Pruritus genital 30.54 11.46 26 66856 4532 90557033
Confusional state 30.37 11.46 426 66456 385779 90175786
Alkalosis hypochloraemic 30.35 11.46 10 66872 234 90561331
Hypernatraemia 30.26 11.46 36 66846 9351 90552214
Pneumatosis intestinalis 30.25 11.46 23 66859 3414 90558151
Groin pain 30.13 11.46 41 66841 12172 90549393
Disorientation 30.12 11.46 86 66796 44028 90517537
Syncope 29.43 11.46 183 66699 132480 90429085
Sleep terror 28.97 11.46 25 66857 4439 90557126
Intestinal obstruction 28.95 11.46 76 66806 37055 90524510
Nausea 28.69 11.46 1044 65838 1109272 89452293
Hypertriglyceridaemia 28.36 11.46 32 66850 7857 90553708
Duodenal ulcer 28.14 11.46 35 66847 9517 90552048
Hyperammonaemic encephalopathy 28.13 11.46 20 66862 2679 90558886
Paronychia 27.97 11.46 32 66850 7974 90553591
Upper gastrointestinal haemorrhage 27.87 11.46 56 66826 22920 90538645
Femoral neck fracture 27.78 11.46 36 66846 10197 90551368
Appetite disorder 27.77 11.46 34 66848 9099 90552466
Nail dystrophy 27.01 11.46 15 66867 1303 90560262
Product prescribing error 26.95 11.46 65 66817 30080 90531485
Ear infection 26.81 11.46 9 66873 69766 90491799
Lower limb fracture 26.29 11.46 15 66867 84998 90476567
Monocyte count increased 26.27 11.46 33 66849 9064 90552501
Pancytopenia 26.11 11.46 165 66717 120098 90441467
Body mass index decreased 26.10 11.46 11 66871 519 90561046
Ejection fraction decreased 26.09 11.46 59 66823 26194 90535371
Foot deformity 26.08 11.46 6 66876 59645 90501920
Dermatitis bullous 26.01 11.46 35 66847 10281 90551284
Gamma-glutamyltransferase increased 25.92 11.46 74 66808 37878 90523687
Superinfection 25.59 11.46 20 66862 3092 90558473
Migraine 25.44 11.46 65 66817 190327 90371238
Mouth ulceration 25.44 11.46 76 66806 39898 90521667
Stevens-Johnson syndrome 24.84 11.46 62 66820 29314 90532251
Bradycardia 24.80 11.46 125 66757 83722 90477843
Liver function test abnormal 24.55 11.46 88 66794 50757 90510808
Cholestasis of pregnancy 24.51 11.46 15 66867 1562 90560003
Brain oedema 24.31 11.46 45 66837 17340 90544225
Multiple organ dysfunction syndrome 23.94 11.46 107 66775 68229 90493336
Exostosis 23.92 11.46 5 66877 53129 90508436
Hepatitis C 23.91 11.46 25 66857 5635 90555930
General physical health deterioration 23.74 11.46 381 66501 354734 90206831
Nervous system disorder 23.12 11.46 50 66832 21543 90540022
International normalised ratio increased 22.94 11.46 82 66800 47234 90514331
Tension headache 22.90 11.46 28 66854 7481 90554084
Mitral valve incompetence 22.81 11.46 51 66831 22473 90539092
Product monitoring error 22.74 11.46 22 66860 4522 90557043
Off label use 22.70 11.46 630 66252 1101622 89459943
Pulmonary hypertension 22.62 11.46 76 66806 42447 90519118
Muscle twitching 22.52 11.46 53 66829 24149 90537416
Injection site pruritus 22.40 11.46 6 66876 53828 90507737
Product dose omission issue 22.38 11.46 125 66757 291562 90270003
Lethargy 22.22 11.46 99 66783 63040 90498525
Blood alkaline phosphatase increased 22.19 11.46 82 66800 47997 90513568
Immunisation 22.15 11.46 16 66866 2197 90559368
Mouth swelling 22.14 11.46 24 66858 5638 90555927
Cardiogenic shock 22.14 11.46 53 66829 24415 90537150
Prescribed underdose 22.13 11.46 14 66868 75005 90486560
Myelodysplastic syndrome 21.92 11.46 48 66834 20855 90540710
Inappropriate schedule of product administration 21.76 11.46 49 66833 149884 90411681
Axillary pain 21.47 11.46 16 66866 2305 90559260
Injection site bruising 21.44 11.46 6 66876 52301 90509264
Asthma 21.28 11.46 99 66783 242061 90319504
Spinal cord paralysis 21.08 11.46 5 66877 32 90561533
Atrial tachycardia 21.03 11.46 24 66858 5966 90555599
Osteopenia 21.00 11.46 50 66832 22952 90538613
Hallucination, visual 20.87 11.46 50 66832 23042 90538523
Pulmonary vein occlusion 20.71 11.46 6 66876 90 90561475
Flail chest 20.64 11.46 6 66876 91 90561474
Pregnancy 20.58 11.46 10 66872 62037 90499528
Device expulsion 20.25 11.46 3 66879 40883 90520682
Lung perforation 20.23 11.46 6 66876 98 90561467
Blood pressure increased 20.20 11.46 76 66806 197141 90364424
Electrocardiogram QT prolonged 20.03 11.46 106 66776 72350 90489215
Plasma cell myeloma 20 11.46 71 66811 40757 90520808
Carotid artery occlusion 19.92 11.46 24 66858 6318 90555247
Liver function test increased 19.81 11.46 20 66862 84835 90476730
Back injury 19.77 11.46 5 66877 46617 90514948
Adverse drug reaction 19.63 11.46 35 66847 116666 90444899
Cholestasis 19.42 11.46 65 66817 36234 90525331
Paraesthesia 19.35 11.46 107 66775 250219 90311346
Frostbite 19.27 11.46 7 66875 221 90561344
Therapeutic drug monitoring analysis not performed 19.03 11.46 12 66870 1317 90560248
Laryngitis 18.72 11.46 7 66875 50746 90510819
Hepatorenal syndrome 18.68 11.46 14 66868 2034 90559531
Metastases to lymph nodes 18.58 11.46 32 66850 11657 90549908
Salivary gland enlargement 18.58 11.46 8 66874 398 90561167
Rales 18.51 11.46 38 66844 15789 90545776
Atrioventricular block complete 18.49 11.46 29 66853 9782 90551783
Abdominal rigidity 18.22 11.46 15 66867 2497 90559068
Haematuria 18.19 11.46 62 66820 34875 90526690
Mental status changes 18.00 11.46 73 66809 44606 90516959
Hyperglycaemia 18.00 11.46 80 66802 50890 90510675
Pain in extremity 17.80 11.46 230 66652 450299 90111266
Thoracic operation 17.80 11.46 6 66876 151 90561414
Hiccups 17.74 11.46 16 66866 3010 90558555
Hypomagnesaemia 17.53 11.46 62 66820 35526 90526039
Platelet count decreased 17.46 11.46 166 66716 136803 90424762
Taste disorder 17.46 11.46 12 66870 61534 90500031
Lung neoplasm 17.21 11.46 23 66859 6712 90554853
Blood albumin decreased 16.96 11.46 38 66844 16765 90544800
Metastases to central nervous system 16.96 11.46 39 66843 17503 90544062
Electrocardiogram T wave inversion 16.89 11.46 17 66865 3666 90557899
Stoma site discharge 16.82 11.46 13 66869 1976 90559589
Flank pain 16.71 11.46 41 66841 19181 90542384
Dyskinesia 16.60 11.46 62 66820 36472 90525093
Circulatory collapse 16.47 11.46 48 66834 24856 90536709
Asterixis 16.45 11.46 12 66870 1673 90559892
Venoocclusive disease 16.44 11.46 14 66868 2441 90559124
Suicide attempt 16.24 11.46 19 66863 75380 90486185
Unresponsive to stimuli 15.93 11.46 63 66819 38058 90523507
No adverse event 15.89 11.46 16 66866 67966 90493599
Nail infection 15.87 11.46 14 66868 2558 90559007
Myocardial infarction 15.85 11.46 133 66749 105839 90455726
Dysphagia 15.79 11.46 139 66743 112139 90449426
Anosmia 15.71 11.46 27 66855 9821 90551744
Productive cough 15.66 11.46 104 66778 76959 90484606
Functional gastrointestinal disorder 15.64 11.46 19 66863 5043 90556522
Haematocrit increased 15.59 11.46 15 66867 3063 90558502
Blood albumin abnormal 15.52 11.46 10 66872 1139 90560426
Hypophagia 15.51 11.46 60 66822 35877 90525688
Calcium ionised increased 15.31 11.46 6 66876 234 90561331
Aspiration 15.29 11.46 35 66847 15658 90545907
Physical assault 15.25 11.46 9 66873 877 90560688
Palliative care 15.23 11.46 9 66873 879 90560686
Vascular parkinsonism 14.98 11.46 5 66877 122 90561443
Bronchitis 14.97 11.46 60 66822 152867 90408698
Portopulmonary hypertension 14.90 11.46 5 66877 124 90561441
Myocardial fibrosis 14.77 11.46 9 66873 930 90560635
Antipsychotic drug level increased 14.74 11.46 16 66866 3763 90557802
Abortion spontaneous 14.73 11.46 11 66871 54045 90507520
Herpes zoster 14.51 11.46 30 66852 94614 90466951
Joint stiffness 14.43 11.46 22 66860 78020 90483545
Hypervolaemia 14.39 11.46 55 66827 32702 90528863
Hepatic hydrothorax 14.19 11.46 4 66878 54 90561511
Activated partial thromboplastin time abnormal 14.16 11.46 5 66877 145 90561420
Cardiomyopathy acute 14.10 11.46 6 66876 290 90561275
Wrong patient received product 14.05 11.46 15 66867 3462 90558103
On and off phenomenon 14.04 11.46 13 66869 2530 90559035
Spinal subdural haematoma 14.03 11.46 5 66877 149 90561416
Mutism 13.75 11.46 11 66871 1758 90559807
Blindness 13.70 11.46 47 66835 26521 90535044
Nail disorder 13.70 11.46 14 66868 59053 90502512
Oedema 13.69 11.46 89 66793 200206 90361359
Jugular vein thrombosis 13.69 11.46 15 66867 3566 90557999
Chillblains 13.65 11.46 6 66876 314 90561251
Thrombocytosis 13.62 11.46 21 66861 6980 90554585
Megacolon 13.56 11.46 12 66870 2202 90559363
Tumour hyperprogression 13.52 11.46 5 66877 166 90561399
Blood creatinine increased 13.48 11.46 124 66758 101262 90460303
Sinus arrhythmia 13.43 11.46 10 66872 1439 90560126
Procedural pain 13.35 11.46 4 66878 33356 90528209
Respiratory disorder 13.25 11.46 17 66865 64799 90496766
Dyspnoea 13.25 11.46 785 66097 880170 89681395
Hepatic enzyme increased 13.22 11.46 187 66695 360549 90201016
Fracture 13.14 11.46 41 66841 22035 90539530
Sneezing 13.06 11.46 3 66879 29866 90531699
Ear pain 13.02 11.46 14 66868 57688 90503877
Ventricular tachycardia 13.00 11.46 44 66838 24664 90536901
Hepatic cancer 12.98 11.46 17 66865 4864 90556701
Adverse reaction 12.96 11.46 3 66879 29709 90531856
Alkalosis 12.95 11.46 7 66875 577 90560988
Abnormal faeces 12.94 11.46 20 66862 6662 90554903
Pneumonia escherichia 12.93 11.46 7 66875 578 90560987
Spinal cord infarction 12.91 11.46 6 66876 358 90561207
Psychiatric decompensation 12.85 11.46 11 66871 1932 90559633
Immunodeficiency 12.84 11.46 8 66874 43226 90518339
Haematoma 12.83 11.46 60 66822 38988 90522577
Mechanical urticaria 12.72 11.46 7 66875 597 90560968
Incoherent 12.72 11.46 17 66865 4960 90556605
Pustule 12.66 11.46 13 66869 2870 90558695
Drug tolerance decreased 12.60 11.46 4 66878 32126 90529439
Renal impairment 12.57 11.46 126 66756 105295 90456270
Pickwickian syndrome 12.51 11.46 6 66876 384 90561181
Hypermagnesaemia 12.43 11.46 9 66873 1240 90560325
Facial pain 12.41 11.46 29 66853 13153 90548412
Oral contusion 12.34 11.46 5 66877 213 90561352
Leukopenia 12.31 11.46 121 66761 100589 90460976
Blood pressure systolic increased 12.25 11.46 15 66867 58330 90503235
Decubitus ulcer 12.24 11.46 27 66855 11786 90549779
Electrolyte imbalance 12.24 11.46 42 66840 23703 90537862
Product administration error 12.14 11.46 45 66837 26378 90535187
Chronotropic incompetence 12.12 11.46 4 66878 94 90561471
Osteoporosis 12.10 11.46 34 66848 96497 90465068
Coma hepatic 12.09 11.46 7 66875 659 90560906
Injection site haemorrhage 12.08 11.46 3 66879 28315 90533250
Reperfusion arrhythmia 11.90 11.46 5 66877 234 90561331
Anticonvulsant drug level below therapeutic 11.80 11.46 7 66875 689 90560876
Skin fissures 11.79 11.46 38 66844 20771 90540794
Premature delivery 11.76 11.46 7 66875 38755 90522810
Illness 11.72 11.46 27 66855 81942 90479623
Catheter site haemorrhage 11.71 11.46 14 66868 3654 90557911
Postmortem blood drug level increased 11.63 11.46 7 66875 708 90560857
Polyneuropathy 11.58 11.46 36 66846 19305 90542260
Gastritis 11.48 11.46 61 66821 41692 90519873
Dreamy state 11.47 11.46 3 66879 30 90561535

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 758.75 10.93 383 52943 16059 42551950
Hepatic cirrhosis 210.76 10.93 184 53142 19518 42548491
Confusional state 171.17 10.93 529 52797 167068 42400941
Hepatic failure 164.40 10.93 220 53106 37880 42530129
Drug ineffective 156.04 10.93 350 52976 629847 41938162
Inability to afford medication 154.98 10.93 68 53258 2062 42565947
Ammonia increased 151.36 10.93 86 53240 4573 42563436
Ascites 129.95 10.93 245 53081 56433 42511576
Constipation 101.52 10.93 437 52889 161854 42406155
Varices oesophageal 99.01 10.93 64 53262 4301 42563708
Hepatorenal syndrome 82.92 10.93 49 53277 2805 42565204
Off label use 80.49 10.93 470 52856 637865 41930144
Drug abuse 73.60 10.93 20 53306 104751 42463258
Hepatocellular carcinoma 69.06 10.93 67 53259 8127 42559882
Toxic epidermal necrolysis 66.77 10.93 120 53206 26630 42541379
Faecaloma 65.90 10.93 58 53268 6212 42561797
Encephalopathy 65.86 10.93 154 53172 41179 42526830
Completed suicide 64.84 10.93 20 53306 96445 42471564
General physical health deterioration 64.30 10.93 365 52961 150881 42417128
Hyperammonaemia 63.83 10.93 63 53263 7803 42560206
Blood bilirubin increased 59.39 10.93 150 53176 42102 42525907
Peritonitis bacterial 57.26 10.93 56 53270 6859 42561150
Product use in unapproved indication 56.22 10.93 90 53236 184366 42383643
Abdominal pain 52.70 10.93 413 52913 190058 42377951
Portal hypertension 49.75 10.93 44 53282 4743 42563266
Insurance issue 49.22 10.93 41 53285 4075 42563934
Pneumatosis intestinalis 48.04 10.93 43 53283 4709 42563300
Chronic hepatic failure 47.85 10.93 21 53305 637 42567372
Jaundice 47.78 10.93 122 53204 34467 42533542
Oesophageal varices haemorrhage 47.49 10.93 38 53288 3569 42564440
Arthralgia 47.22 10.93 118 53208 205120 42362889
Gastric varices 46.89 10.93 21 53305 669 42567340
Haematemesis 46.45 10.93 111 53215 30088 42537921
Portal hypertensive gastropathy 46.39 10.93 22 53304 801 42567208
Alveolar lung disease 44.47 10.93 18 53308 444 42567565
Fall 43.26 10.93 466 52860 234054 42333955
Inappropriate schedule of product administration 43.18 10.93 34 53292 95868 42472141
Injection site pain 42.57 10.93 10 53316 57788 42510221
Hyponatraemia 41.85 10.93 243 53083 101219 42466790
Rash 40.20 10.93 194 53132 276760 42291249
Abdominal distension 40.11 10.93 187 53139 71548 42496461
Hepatitis C 39.88 10.93 56 53270 10077 42557932
Acute kidney injury 39.56 10.93 662 52664 366675 42201334
Antipsychotic drug level increased 39.03 10.93 38 53288 4628 42563381
Ileus 38.08 10.93 78 53248 19061 42548948
Pulmonary interstitial emphysema syndrome 37.83 10.93 17 53309 546 42567463
Cirrhosis alcoholic 37.44 10.93 19 53307 803 42567206
Toxicity to various agents 34.71 10.93 158 53168 228978 42339031
Liver transplant 34.68 10.93 28 53298 2663 42565346
Periarthritis calcarea 34.34 10.93 10 53316 86 42567923
On and off phenomenon 34.31 10.93 31 53295 3436 42564573
Articular calcification 33.94 10.93 10 53316 90 42567919
Asthma 33.61 10.93 18 53308 62296 42505713
Pneumonia 31.91 10.93 721 52605 421428 42146581
Stoma site erythema 31.08 10.93 18 53308 992 42567017
Benign gastrointestinal neoplasm 30.91 10.93 10 53316 126 42567883
Systemic infection 30.38 10.93 35 53291 5170 42562839
Pneumonia aspiration 29.81 10.93 133 53193 49945 42518064
Pyramidal tract syndrome 29.72 10.93 12 53314 294 42567715
Foetal exposure during pregnancy 29.70 10.93 11 53315 47300 42520709
Stoma site discharge 29.50 10.93 20 53306 1456 42566553
Product dose omission issue 29.42 10.93 97 53229 154268 42413741
Drug resistance 29.38 10.93 4 53322 34244 42533765
Intentional product use issue 29.26 10.93 28 53298 71805 42496204
Urinary tract infection 28.92 10.93 218 53108 99066 42468943
Neutrophil count increased 28.54 10.93 71 53255 19733 42548276
Therapeutic product effect incomplete 28.49 10.93 28 53298 70911 42497098
Rheumatoid arthritis 28.14 10.93 9 53317 42431 42525578
Adrenal cyst 27.33 10.93 10 53316 186 42567823
High-grade B-cell lymphoma 27.18 10.93 10 53316 189 42567820
Haemoglobin decreased 27.11 10.93 269 53057 132202 42435807
Delirium 26.53 10.93 133 53193 52386 42515623
Nasopharyngitis 26.49 10.93 40 53286 83956 42484053
Hypermagnesaemia 25.65 10.93 11 53315 315 42567694
Intentional product misuse 25.36 10.93 24 53302 61876 42506133
Conjunctival irritation 25.08 10.93 8 53318 96 42567913
Hypernatraemia 25.02 10.93 45 53281 9987 42558022
Dehydration 24.85 10.93 279 53047 141488 42426521
Hypophagia 24.60 10.93 82 53244 26874 42541135
Vomiting 24.46 10.93 503 52823 289220 42278789
Neglect of personal appearance 24.31 10.93 11 53315 359 42567650
Activated partial thromboplastin time shortened 24.26 10.93 12 53314 480 42567529
Colitis ischaemic 24.19 10.93 37 53289 7189 42560820
Ureaplasma infection 24.11 10.93 13 53313 623 42567386
Immature granulocyte count increased 24.11 10.93 10 53316 263 42567746
White blood cell count increased 24.07 10.93 116 53210 44971 42523038
Red blood cell sedimentation rate decreased 24.04 10.93 10 53316 265 42567744
Neutropenic sepsis 23.86 10.93 58 53268 15888 42552121
Treatment failure 23.70 10.93 26 53300 62598 42505411
Asterixis 23.64 10.93 17 53309 1360 42566649
Epilepsy 23.34 10.93 79 53247 26092 42541917
Freezing phenomenon 22.97 10.93 19 53307 1870 42566139
Urinary retention 22.82 10.93 109 53217 42105 42525904
Mesothelioma 22.38 10.93 11 53315 434 42567575
Myalgia 22.25 10.93 55 53271 96025 42471984
Atrial fibrillation 21.87 10.93 95 53231 139498 42428511
Acute abdomen 21.72 10.93 19 53307 2018 42565991
Arthritis 21.47 10.93 13 53313 42052 42525957
Polypectomy 21.18 10.93 12 53314 634 42567375
Hepatic cancer 21.10 10.93 38 53288 8442 42559567
Hepatitis C RNA positive 21.10 10.93 8 53318 165 42567844
Mental status changes 20.81 10.93 106 53220 42009 42526000
Liver function test abnormal 20.78 10.93 88 53238 32303 42535706
Lymphocyte count decreased 20.59 10.93 79 53247 27730 42540279
Adrenal adenoma 20.42 10.93 11 53315 526 42567483
Orthostatic hypotension 20.35 10.93 84 53242 30486 42537523
Therapeutic product effect decreased 20.12 10.93 12 53314 39138 42528871
Platelet count decreased 20.04 10.93 263 53063 138318 42429691
Joint swelling 19.93 10.93 34 53292 67988 42500021
Sepsis 19.49 10.93 354 52972 198980 42369029
Stress 19.48 10.93 16 53310 44196 42523813
Metamyelocyte count increased 18.96 10.93 10 53316 458 42567551
Therapy interrupted 18.83 10.93 66 53260 22184 42545825
Hepatic calcification 18.74 10.93 9 53317 337 42567672
Spleen congestion 18.48 10.93 9 53317 348 42567661
Myocardial infarction 18.45 10.93 86 53240 123923 42444086
Headache 18.43 10.93 201 53125 239168 42328841
Costal cartilage fracture 18.37 10.93 8 53318 238 42567771
Colitis ulcerative 18.36 10.93 5 53321 26170 42541839
Dysphagia 18.07 10.93 154 53172 72565 42495444
Differential white blood cell count abnormal 18.06 10.93 16 53310 1728 42566281
Hypertension 17.89 10.93 129 53197 167075 42400934
Drug hypersensitivity 17.88 10.93 64 53262 99325 42468684
Lethargy 17.84 10.93 110 53216 46780 42521229
Portal vein thrombosis 17.69 10.93 25 53301 4524 42563485
Disorientation 17.57 10.93 91 53235 36298 42531711
Traumatic haemothorax 17.21 10.93 9 53317 405 42567604
Lower respiratory tract infection 17.17 10.93 99 53227 41107 42526902
Myelocyte count increased 17.11 10.93 9 53317 410 42567599
Adrenomegaly 16.81 10.93 9 53317 425 42567584
Blood pressure increased 16.80 10.93 68 53258 101860 42466149
Genital erythema 16.73 10.93 8 53318 297 42567712
Abdominal tenderness 16.71 10.93 25 53301 4764 42563245
Mental impairment 16.54 10.93 43 53283 12274 42555735
Coronary artery disease 16.53 10.93 26 53300 53694 42514315
Hypotension 16.37 10.93 430 52896 257201 42310808
Nephrocalcinosis 16.33 10.93 11 53315 792 42567217
Hypersensitivity 16.30 10.93 42 53284 72328 42495681
Rectal haemorrhage 16.20 10.93 112 53214 49494 42518515
Diffuse alveolar damage 16.10 10.93 18 53308 2574 42565435
Leg amputation 15.92 10.93 18 53308 2605 42565404
Wrong patient received product 15.92 10.93 21 53305 3562 42564447
Paracentesis 15.90 10.93 9 53317 475 42567534
Interstitial lung disease 15.85 10.93 48 53278 78414 42489595
Hyperkalaemia 15.78 10.93 162 53164 80296 42487713
Portal shunt procedure 15.77 10.93 4 53322 19 42567990
Myoclonus 15.65 10.93 52 53274 17013 42550996
Upper gastrointestinal haemorrhage 15.49 10.93 77 53249 30222 42537787
Cardiac failure congestive 15.47 10.93 55 53271 85547 42482462
Spinal cord injury thoracic 15.42 10.93 6 53320 133 42567876
Blast cells present 15.41 10.93 9 53317 504 42567505
Faecal vomiting 15.33 10.93 10 53316 682 42567327
Hyperammonaemic encephalopathy 15.19 10.93 18 53308 2740 42565269
Herpes simplex reactivation 15.18 10.93 9 53317 518 42567491
Pruritus 15.13 10.93 157 53169 188614 42379395
Peripheral artery stenosis 15.12 10.93 11 53315 896 42567113
Ischaemic hepatitis 15.06 10.93 16 53310 2161 42565848
Influenza 14.85 10.93 35 53291 62140 42505869
Melaena 14.80 10.93 91 53235 38655 42529354
Unresponsive to stimuli 14.79 10.93 78 53248 31325 42536684
Dyskinesia 14.78 10.93 67 53259 25323 42542686
Wrong technique in product usage process 14.74 10.93 19 53307 42616 42525393
Erythema 14.72 10.93 78 53248 108715 42459294
Weight 14.58 10.93 4 53322 27 42567982
Antipsychotic drug level decreased 14.51 10.93 12 53314 1181 42566828
Dry skin 14.31 10.93 24 53302 48314 42519695
Anaemia 14.28 10.93 455 52871 279823 42288186
Monocyte count decreased 14.03 10.93 13 53313 1488 42566521
Venous thrombosis limb 13.94 10.93 16 53310 2353 42565656
Splenomegaly 13.94 10.93 50 53276 16997 42551012
Embedded device 13.93 10.93 8 53318 434 42567575
Coma hepatic 13.91 10.93 8 53318 435 42567574
Nasal congestion 13.86 10.93 10 53316 29491 42538518
Salivary gland disorder 13.86 10.93 6 53320 176 42567833
Psoriatic arthropathy 13.77 10.93 7 53319 24960 42543049
Flat affect 13.72 10.93 11 53315 1036 42566973
COVID-19 13.62 10.93 87 53239 115861 42452148
Drug ineffective for unapproved indication 13.59 10.93 23 53303 46140 42521869
Sinusitis 13.53 10.93 24 53302 47268 42520741
Monocyte count increased 13.51 10.93 25 53301 5669 42562340
Traumatic intracranial haematoma 13.38 10.93 4 53322 38 42567971
Hallucination 13.35 10.93 120 53206 57387 42510622
Haematocrit decreased 13.34 10.93 82 53244 34826 42533183
Communication disorder 13.24 10.93 17 53309 2808 42565201
Anti-erythropoietin antibody negative 13.23 10.93 6 53320 197 42567812
Parkinsonian rest tremor 13.21 10.93 7 53319 324 42567685
Portal shunt 13.20 10.93 4 53322 40 42567969
Hypothermia 13.18 10.93 40 53286 12475 42555534
Productive cough 13.16 10.93 28 53298 51539 42516470
Peritonitis 13.04 10.93 52 53274 18581 42549428
Blood chloride increased 13.03 10.93 19 53307 3537 42564472
Platelet count increased 13.00 10.93 36 53290 10667 42557342
Multiple drug therapy 12.99 10.93 11 53315 1118 42566891
Abnormal faeces 12.94 10.93 20 53306 3921 42564088
Mobility decreased 12.91 10.93 82 53244 35224 42532785
Therapy non-responder 12.78 10.93 30 53296 53329 42514680
Hepatitis acute 12.74 10.93 32 53294 8943 42559066
Osteochondrosis 12.71 10.93 12 53314 1406 42566603
Gastrointestinal haemorrhage 12.70 10.93 182 53144 97544 42470465
Volvulus 12.54 10.93 14 53312 1999 42566010
Starvation 12.50 10.93 8 53318 528 42567481
Spinal cord paralysis 12.48 10.93 5 53321 120 42567889
Transfusion 12.41 10.93 35 53291 10479 42557530
Anaphylactic shock 12.38 10.93 7 53319 23510 42544499
Gait inability 12.37 10.93 59 53267 22774 42545235
Eosinophilic pneumonia 12.33 10.93 22 53304 4852 42563157
Red cell distribution width increased 12.25 10.93 27 53299 6937 42561072
Small intestinal obstruction 12.25 10.93 48 53278 17013 42550996
Hypercreatininaemia 12.22 10.93 8 53318 549 42567460
Erosive duodenitis 12.11 10.93 13 53313 1776 42566233
Hypoalbuminaemia 12.10 10.93 45 53281 15565 42552444
Portal tract inflammation 12.04 10.93 5 53321 132 42567877
Duodenal ulcer haemorrhage 11.94 10.93 24 53302 5784 42562225
Gastrointestinal tract mucosal pigmentation 11.94 10.93 8 53318 571 42567438
Cerebral arteriovenous malformation haemorrhagic 11.91 10.93 4 53322 57 42567952
Drug intolerance 11.82 10.93 56 53270 80368 42487641
Angioedema 11.75 10.93 22 53304 42455 42525554
Choking 11.75 10.93 25 53301 6273 42561736
Blood alkaline phosphatase increased 11.66 10.93 77 53249 33520 42534489
Hydronephrosis 11.64 10.93 37 53289 11828 42556181
Cachexia 11.62 10.93 29 53297 8075 42559934
Nausea 11.60 10.93 607 52719 396192 42171817
Vascular purpura 11.60 10.93 14 53312 2172 42565837
Aortic arteriosclerosis 11.55 10.93 22 53304 5098 42562911
Bloody discharge 11.54 10.93 8 53318 604 42567405
Sexually inappropriate behaviour 11.41 10.93 8 53318 615 42567394
Biopsy liver 11.40 10.93 6 53320 274 42567735
Blood sodium decreased 11.38 10.93 49 53277 18113 42549896
Schizophrenia 11.37 10.93 34 53292 10516 42557493
Pyelitis 11.35 10.93 5 53321 153 42567856
Hypervolaemia 11.28 10.93 58 53268 23067 42544942
Rash vesicular 11.14 10.93 17 53309 3296 42564713
Abdominal cavity drainage 11.11 10.93 7 53319 450 42567559
Adrenoleukodystrophy 11.10 10.93 4 53322 71 42567938
Bacterial translocation 11.07 10.93 8 53318 645 42567364
Infusion related reaction 11.03 10.93 39 53287 60767 42507242

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 1050.89 10.72 524 106707 27732 110454336
Sedation complication 761.31 10.72 376 106855 19479 110462589
Orthostatic hypotension 739.77 10.72 570 106661 65679 110416389
Creatinine renal clearance decreased 733.57 10.72 378 106853 21437 110460631
Blood calcium decreased 617.52 10.72 402 106829 35443 110446625
Cognitive disorder 547.02 10.72 541 106690 86970 110395098
Sedation 509.94 10.72 470 106761 69213 110412855
Balance disorder 490.83 10.72 585 106646 115975 110366093
Depressed level of consciousness 428.10 10.72 536 106695 111742 110370326
Drug ineffective 376.20 10.72 560 106671 1519980 108962088
Constipation 367.86 10.72 962 106269 356824 110125244
Schizophrenia 356.92 10.72 237 106994 21589 110460479
Fall 336.62 10.72 1314 105917 602168 109879900
Inability to afford medication 307.32 10.72 124 107107 3952 110478116
Blood bilirubin increased 302.86 10.72 371 106860 75601 110406467
Ammonia increased 291.93 10.72 148 107083 8102 110473966
Hypomania 284.14 10.72 156 107075 10054 110472014
Jaundice cholestatic 266.74 10.72 170 107061 14438 110467630
Hypotension 262.68 10.72 1104 106127 522745 109959323
Ascites 250.58 10.72 375 106856 92433 110389635
Cholelithiasis 229.31 10.72 295 106936 63127 110418941
Faecaloma 222.53 10.72 153 107078 14755 110467313
Hyponatraemia 200.06 10.72 562 106669 217091 110264977
Hepatic failure 198.90 10.72 287 106944 68452 110413616
Systemic lupus erythematosus 198.60 10.72 12 107219 254326 110227742
Drug hypersensitivity 195.61 10.72 98 107133 453992 110028076
Hand deformity 192.19 10.72 4 107227 218502 110263566
Arthropathy 189.05 10.72 27 107204 287495 110194573
Joint swelling 185.65 10.72 99 107132 442746 110039322
Rheumatoid arthritis 179.64 10.72 36 107195 299577 110182491
Infusion related reaction 175.38 10.72 75 107156 381087 110100981
Psychotic disorder 174.90 10.72 231 107000 50706 110431362
Drug intolerance 170.20 10.72 91 107140 406421 110075647
Total lung capacity increased 170.13 10.72 88 107143 5024 110477044
Glossodynia 168.81 10.72 12 107219 221992 110260076
Confusional state 160.17 10.72 885 106346 467795 110014273
Swelling 158.44 10.72 71 107160 350970 110131098
Therapeutic product effect decreased 158.16 10.72 24 107207 244292 110237776
Sinusitis 155.80 10.72 47 107184 296641 110185427
Asthma-chronic obstructive pulmonary disease overlap syndrome 154.99 10.72 89 107142 6255 110475813
Varices oesophageal 154.65 10.72 93 107138 7122 110474946
Treatment failure 149.09 10.72 42 107189 277192 110204876
Folliculitis 147.70 10.72 3 107228 167650 110314418
Hepatic cirrhosis 146.31 10.72 247 106984 67379 110414689
Completed suicide 141.42 10.72 31 107200 242350 110239718
Haematemesis 138.78 10.72 224 107007 58884 110423184
Psoriatic arthropathy 137.78 10.72 15 107216 196746 110285322
Arthralgia 134.14 10.72 354 106877 779278 109702790
Helicobacter infection 132.23 10.72 12 107219 181865 110300203
Hypersensitivity 130.11 10.72 120 107111 403878 110078190
Maternal exposure during pregnancy 127.40 10.72 44 107187 254839 110227229
Nasopharyngitis 124.80 10.72 119 107112 394242 110087826
Muscle injury 122.16 10.72 3 107228 140804 110341264
Acute kidney injury 121.43 10.72 1040 106191 634390 109847678
Therapeutic product effect incomplete 120.14 10.72 34 107197 223771 110258297
Irritable bowel syndrome 116.30 10.72 12 107219 164203 110317865
Hepatocellular carcinoma 114.55 10.72 87 107144 9793 110472275
Pericarditis 114.49 10.72 35 107196 219079 110262989
Contraindicated product administered 113.90 10.72 49 107182 248218 110233850
Sarcoidosis 108.15 10.72 93 107138 12486 110469582
Alopecia 107.51 10.72 117 107114 364636 110117432
Musculoskeletal stiffness 106.68 10.72 70 107161 279752 110202316
Discomfort 105.69 10.72 38 107193 214669 110267399
Wound 104.82 10.72 48 107183 234389 110247679
Mobility decreased 102.47 10.72 479 106752 236943 110245125
Blood cholesterol increased 101.18 10.72 27 107204 184758 110297310
Encephalopathy 100.01 10.72 234 106997 80821 110401247
Hepatotoxicity 99.88 10.72 202 107029 63198 110418870
Injection site pain 99.33 10.72 25 107206 177897 110304171
C-reactive protein abnormal 98.60 10.72 7 107224 129688 110352380
Jaundice 98.44 10.72 193 107038 59043 110423025
Nasal polyps 98.37 10.72 90 107141 13110 110468958
Toxic epidermal necrolysis 98.14 10.72 188 107043 56539 110425529
Fibromyalgia 97.39 10.72 23 107208 170886 110311182
Insurance issue 96.44 10.72 81 107150 10531 110471537
Hyperammonaemia 95.33 10.72 90 107141 13642 110468426
Hyperkalaemia 93.34 10.72 317 106914 135479 110346589
Ileus 92.83 10.72 131 107100 30598 110451470
Dehydration 92.79 10.72 524 106707 278987 110203081
Hepatorenal syndrome 92.73 10.72 57 107174 4540 110477528
Rash 91.65 10.72 447 106784 820517 109661551
Ill-defined disorder 89.59 10.72 21 107210 156832 110325236
Urinary retention 85.78 10.72 201 107030 69482 110412586
Vomiting 85.47 10.72 1297 105934 909378 109572690
Pneumonia 84.35 10.72 1254 105977 875460 109606608
Neutropenic sepsis 84.03 10.72 125 107106 30621 110451447
Creatinine renal clearance increased 83.63 10.72 49 107182 3576 110478492
Off label use 83.53 10.72 993 106238 1499192 108982876
Weight increased 81.15 10.72 179 107052 419465 110062603
Lymphatic fistula 81.10 10.72 36 107195 1459 110480609
Abdominal pain 80.89 10.72 806 106425 512183 109969885
Portal hypertension 80.72 10.72 67 107164 8570 110473498
Urticaria 80.62 10.72 115 107116 318742 110163326
Facet joint syndrome 80.60 10.72 3 107228 96825 110385243
Urinary tract infection 80.48 10.72 567 106664 325715 110156353
Pneumatosis intestinalis 79.37 10.72 66 107165 8463 110473605
Bursitis 79.11 10.72 15 107216 129903 110352165
Gastrointestinal disorder 78.87 10.72 71 107160 241881 110240187
Femoral hernia incarcerated 77.58 10.72 35 107196 1474 110480594
Anaemia 77.48 10.72 841 106390 546245 109935823
Peritonitis bacterial 76.90 10.72 71 107160 10462 110471606
Chronic hepatic failure 76.73 10.72 33 107198 1238 110480830
Osteoarthritis 76.18 10.72 41 107190 182582 110299486
Cardiac murmur 75.89 10.72 106 107125 24522 110457546
Hypoaesthesia 75.87 10.72 117 107114 314106 110167962
Portal hypertensive gastropathy 75.70 10.72 37 107194 1871 110480197
Sepsis 75.63 10.72 560 106671 326786 110155282
Multiple drug therapy 74.55 10.72 62 107169 7952 110474116
Joint range of motion decreased 74.32 10.72 14 107217 121818 110360250
Wound infection pseudomonas 73.10 10.72 39 107192 2372 110479696
Abdominal tenderness 72.23 10.72 74 107157 12383 110469685
Rhinitis allergic 72.15 10.72 88 107143 17834 110464234
Intentional product use issue 71.39 10.72 81 107150 247825 110234243
Pancreatic steatosis 71.29 10.72 35 107196 1787 110480281
Type 2 diabetes mellitus 70.75 10.72 42 107189 177190 110304878
Exposure during pregnancy 70.70 10.72 37 107194 167387 110314681
Oesophageal varices haemorrhage 69.69 10.72 49 107182 4896 110477172
Hypokalaemia 69.31 10.72 355 106876 182093 110299975
Obesity 69.20 10.72 13 107218 113338 110368730
Abdominal discomfort 68.98 10.72 177 107054 393681 110088387
Hepatitis C 68.08 10.72 72 107159 12501 110469567
General physical health deterioration 67.38 10.72 669 106562 424626 110057442
Night sweats 67.15 10.72 23 107208 133960 110348108
Aortic arteriosclerosis 67.12 10.72 67 107164 10871 110471197
Arthritis 66.50 10.72 40 107191 167546 110314522
Product use issue 65.26 10.72 127 107104 311568 110170500
Inappropriate schedule of product administration 64.89 10.72 61 107170 203576 110278492
Headache 63.89 10.72 548 106683 881829 109600239
Inflammation 63.82 10.72 56 107175 193182 110288886
Heart sounds 63.53 10.72 28 107203 1115 110480953
Grip strength decreased 61.90 10.72 4 107227 80170 110401898
Renal function test abnormal 60.89 10.72 58 107173 8888 110473180
Hypertension 60.79 10.72 271 106960 509813 109972255
Injection site reaction 59.36 10.72 8 107223 89062 110393006
Abdominal distension 59.21 10.72 330 106901 174773 110307295
Arterial haemorrhage 58.90 10.72 40 107191 3779 110478289
Prolonged expiration 58.31 10.72 29 107202 1523 110480545
Gastrointestinal haemorrhage 58.02 10.72 315 106916 165203 110316865
Haemoglobin decreased 57.69 10.72 426 106805 248301 110233767
Asthma 56.83 10.72 97 107134 250194 110231874
Diverticulum intestinal 56.28 10.72 63 107168 11656 110470412
Skin candida 55.11 10.72 32 107199 2296 110479772
Impaired healing 54.77 10.72 66 107165 196651 110285417
Seroma 54.33 10.72 36 107195 3265 110478803
Injury 54.28 10.72 55 107176 177210 110304858
Hypernatraemia 53.83 10.72 76 107155 17757 110464311
Oedema peripheral 53.48 10.72 520 106711 328140 110153928
Peripheral venous disease 52.75 10.72 9 107222 84108 110397960
Hypercholesterolaemia 52.19 10.72 12 107219 90825 110391243
Neutrophil count increased 51.73 10.72 108 107123 34544 110447524
Therapy non-responder 51.44 10.72 46 107185 157261 110324807
Dementia 51.17 10.72 102 107129 31571 110450497
Road traffic accident 51.17 10.72 20 107211 107378 110374690
Gastric varices 50.37 10.72 22 107209 857 110481211
Nasal mucosal disorder 50.27 10.72 28 107203 1855 110480213
Lung neoplasm malignant 49.96 10.72 105 107126 33737 110448331
Stomatitis 49.20 10.72 119 107112 270123 110211945
Liver function test abnormal 49.17 10.72 163 107068 68787 110413281
Colitis ulcerative 49.13 10.72 8 107223 77355 110404713
Blister 49.02 10.72 91 107140 227285 110254783
Cirrhosis alcoholic 48.72 10.72 23 107208 1076 110480992
Nail bed inflammation 48.31 10.72 28 107203 2002 110480066
Vascular device infection 47.82 10.72 69 107162 16443 110465625
Migraine 47.35 10.72 58 107173 171594 110310474
Sleep disorder 46 10.72 76 107155 198568 110283500
Therapeutic response decreased 45.93 10.72 18 107213 96481 110385587
Melaena 45.91 10.72 159 107072 68598 110413470
Platelet count decreased 45.88 10.72 381 106850 230062 110252006
Injection site erythema 45.76 10.72 17 107214 94159 110387909
Peripheral swelling 45.54 10.72 219 107012 403815 110078253
Lung disorder 45.42 10.72 65 107166 179982 110302086
Vascular encephalopathy 45.20 10.72 20 107211 804 110481264
Toxicity to various agents 45.13 10.72 685 106546 479870 110002198
Hepatic cyst 44.70 10.72 46 107185 7737 110474331
Bronchiectasis 44.61 10.72 105 107126 36388 110445680
Liver injury 44.55 10.72 48 107183 150365 110331703
Alveolar lung disease 44.50 10.72 19 107212 700 110481368
Prescribed overdose 43.94 10.72 15 107216 87566 110394502
Red blood cell sedimentation rate increased 43.69 10.72 11 107220 78291 110403777
Pruritus 43.44 10.72 358 106873 581202 109900866
Disorientation 43.40 10.72 159 107072 70512 110411556
Hallucination 43.24 10.72 204 107027 101228 110380840
Death 42.99 10.72 932 106299 697937 109784131
Pulmonary interstitial emphysema syndrome 41.66 10.72 17 107214 558 110481510
Haemarthrosis 41.52 10.72 43 107188 7286 110474782
Systemic infection 40.81 10.72 49 107182 9770 110472298
Mental status changes 40.78 10.72 164 107067 75958 110406110
Adverse event 40.39 10.72 28 107203 108781 110373287
Live birth 40.27 10.72 9 107222 69475 110412593
Blood pressure increased 40.10 10.72 123 107108 258250 110223818
Wound infection 39.72 10.72 22 107209 96443 110385625
Seizure 39.48 10.72 357 106874 220828 110261240
Aortic valve stenosis 39.15 10.72 39 107192 6311 110475757
Lethargy 39.01 10.72 187 107044 93389 110388679
Psoriasis 38.93 10.72 47 107184 139946 110342122
Wound dehiscence 38.57 10.72 43 107188 7919 110474149
White blood cell count increased 38.56 10.72 191 107040 96651 110385417
Product quality issue 37.48 10.72 14 107217 77285 110404783
Neuroleptic malignant syndrome 37.37 10.72 94 107137 33965 110448103
Asterixis 37.03 10.72 28 107203 3130 110478938
Dry mouth 36.42 10.72 88 107143 199860 110282208
Periarthritis calcarea 36.26 10.72 10 107221 92 110481976
Musculoskeletal pain 36.22 10.72 77 107154 182946 110299122
Injection site swelling 35.82 10.72 8 107223 61782 110420286
Liver transplant 35.59 10.72 32 107199 4557 110477511
Febrile neutropenia 35.10 10.72 465 106766 316302 110165766
Pleural effusion 34.92 10.72 293 106938 177416 110304652
Hypophagia 34.52 10.72 121 107110 52505 110429563
Antipsychotic drug level increased 34.18 10.72 38 107193 6977 110475091
Intestinal pseudo-obstruction 33.39 10.72 27 107204 3329 110478739
Subileus 33.33 10.72 36 107195 6401 110475667
Infection 33.30 10.72 210 107021 361990 110120078
Intentional overdose 33.25 10.72 48 107183 132453 110349615
Autoimmune disorder 33.22 10.72 11 107220 65472 110416596
Pulmonary fibrosis 33.17 10.72 30 107201 102012 110380056
Benign gastrointestinal neoplasm 33.13 10.72 10 107221 130 110481938
Therapy interrupted 33.07 10.72 115 107116 49707 110432361
Streptococcal sepsis 32.85 10.72 32 107199 5040 110477028
Contusion 32.83 10.72 116 107115 233245 110248823
Hyperammonaemic encephalopathy 32.82 10.72 33 107198 5401 110476667
Hip arthroplasty 32.81 10.72 7 107224 55806 110426262
Erythema 32.80 10.72 158 107073 291289 110190779
Varicose vein 32.80 10.72 37 107194 6903 110475165
Upper gastrointestinal haemorrhage 32.71 10.72 115 107116 49981 110432087
Cleft palate 32.55 10.72 13 107218 403 110481665
Hypermagnesaemia 32.42 10.72 20 107211 1603 110480465
Wrong patient received product 32.26 10.72 36 107195 6638 110475430
Neutrophil count decreased 32.04 10.72 214 107017 120727 110361341
Gastrointestinal sounds abnormal 31.76 10.72 34 107197 5984 110476084
Intestinal obstruction 31.21 10.72 118 107113 53109 110428959
Injection site bruising 31.03 10.72 6 107225 51257 110430811
Ear infection 31.03 10.72 11 107220 62721 110419347
Injection site pruritus 31.03 10.72 6 107225 51252 110430816
Pseudomonal sepsis 31.00 10.72 41 107190 9005 110473063
Coeliac disease 30.97 10.72 3 107228 43184 110438884
Adverse drug reaction 30.91 10.72 34 107197 105525 110376543
Bradycardia 30.87 10.72 257 106974 155260 110326808
Tachyarrhythmia 30.75 10.72 39 107192 8222 110473846
Escherichia infection 30.73 10.72 70 107161 23746 110458322
Disturbance in attention 30.41 10.72 130 107101 61865 110420203
Urinary incontinence 30.41 10.72 110 107121 48477 110433591
Product dose omission issue 30.39 10.72 185 107046 321597 110160471
Sciatica 30.23 10.72 27 107204 92372 110389696
Dyskinesia 30.12 10.72 114 107117 51332 110430736
Femoral neck fracture 30.00 10.72 48 107183 12519 110469549
Neutropenia 29.55 10.72 519 106712 374101 110107967
Spinal cord paralysis 29.53 10.72 10 107221 192 110481876
Depressed mood 29.43 10.72 127 107104 60682 110421386
Pneumonia aspiration 29.40 10.72 156 107075 81077 110400991
Restlessness 29.17 10.72 120 107111 56139 110425929
Groin pain 29.01 10.72 53 107178 15375 110466693
Lupus-like syndrome 28.82 10.72 3 107228 40789 110441279
Pain in extremity 28.63 10.72 318 106913 486800 109995268
Prescribed underdose 28.11 10.72 14 107217 65160 110416908
Hiatus hernia 28.03 10.72 74 107157 27532 110454536
Articular calcification 27.32 10.72 10 107221 243 110481825
High-grade B-cell lymphoma 27.25 10.72 10 107221 245 110481823
Hepatic cancer 27.17 10.72 43 107188 11113 110470955
Adrenal cyst 26.95 10.72 10 107221 253 110481815
Delirium 26.72 10.72 223 107008 134802 110347266
Product use in unapproved indication 26.31 10.72 292 106939 447085 110034983
Tricuspid valve incompetence 26.31 10.72 66 107165 23807 110458261
Nausea 26.26 10.72 1456 105775 1234234 109247834
Product prescribing error 26.23 10.72 109 107122 51222 110430846
Leg amputation 26.18 10.72 26 107205 4192 110477876
Fatigue 26.10 10.72 941 106290 1215017 109267051
Eructation 26.06 10.72 48 107183 14009 110468059
Hypervolaemia 26.04 10.72 106 107125 49354 110432714
Neglect of personal appearance 25.82 10.72 11 107220 403 110481665
Back injury 25.79 10.72 7 107224 47392 110434676
Haematuria 25.79 10.72 153 107078 82852 110399216
Ureaplasma infection 25.78 10.72 17 107214 1529 110480539
Lymphocyte count decreased 25.77 10.72 117 107114 57126 110424942
Drug interaction 25.76 10.72 651 106580 499532 109982536
Appetite disorder 25.67 10.72 39 107192 9730 110472338
Intestinal dilatation 25.65 10.72 24 107207 3596 110478472
Blood alkaline phosphatase increased 25.52 10.72 136 107095 70799 110411269
Anuria 25.48 10.72 66 107165 24275 110457793
Lip swelling 25.43 10.72 107 107124 50560 110431508
Pregnancy 25.18 10.72 9 107222 51058 110431010
Left ventricular dysfunction 24.90 10.72 64 107167 23429 110458639
Mutism 24.72 10.72 22 107209 3091 110478977
Thrombocytopenia 24.60 10.72 475 106756 348410 110133658
Conjunctival irritation 24.53 10.72 8 107223 136 110481932
Aplastic anaemia 24.52 10.72 65 107166 24243 110457825
Bladder disorder 24.50 10.72 41 107190 11096 110470972
Hallucination, visual 24.22 10.72 89 107142 39516 110442552
Nail dystrophy 24.19 10.72 15 107216 1213 110480855
Chronic obstructive pulmonary disease 24.18 10.72 185 107046 108973 110373095
Lower limb fracture 23.49 10.72 23 107208 75325 110406743
Liver function test increased 23.29 10.72 31 107200 88517 110393551
Functional gastrointestinal disorder 23.22 10.72 29 107202 6020 110476048
Splenomegaly 23.19 10.72 64 107167 24434 110457634
Foot deformity 23.14 10.72 9 107222 48471 110433597
Paraesthesia 23.07 10.72 165 107066 276356 110205712
Stoma site discharge 22.69 10.72 20 107211 2775 110479293
Postoperative wound infection 22.24 10.72 48 107183 15705 110466363
Dysphagia 22.07 10.72 237 106994 153363 110328705
Laryngitis 21.73 10.72 7 107224 42404 110439664
Suicide attempt 21.73 10.72 42 107189 103352 110378716
Monocyte count increased 21.70 10.72 43 107188 13250 110468818
Abnormal faeces 21.67 10.72 35 107196 9201 110472867
On and off phenomenon 21.62 10.72 24 107207 4400 110477668
Wrong technique in product usage process 21.56 10.72 32 107199 87316 110394752
Candida infection 21.52 10.72 98 107133 47911 110434157
Taste disorder 21.52 10.72 19 107212 65368 110416700
Respiration abnormal 21.43 10.72 36 107195 9773 110472295
Unresponsive to stimuli 21.40 10.72 120 107111 63670 110418398
Acute abdomen 21.39 10.72 21 107210 3340 110478728
Cholestasis of pregnancy 21.32 10.72 14 107217 1251 110480817
Gastrointestinal tract mucosal pigmentation 21.19 10.72 14 107217 1263 110480805
Portal vein thrombosis 21.18 10.72 30 107201 7028 110475040
Herpes zoster 21.10 10.72 46 107185 108333 110373735
Pyramidal tract syndrome 21.00 10.72 12 107219 835 110481233
Duodenal ulcer haemorrhage 21.00 10.72 32 107199 8005 110474063
Faecal vomiting 20.88 10.72 15 107216 1551 110480517
Plasma cell myeloma 20.85 10.72 118 107113 62818 110419250
Peritonitis 20.55 10.72 74 107157 32533 110449535
Hepatic calcification 20.48 10.72 9 107222 356 110481712
Lactic acidosis 20.39 10.72 157 107074 92654 110389414
Anxiety 20.37 10.72 225 107006 344853 110137215
Gamma-glutamyltransferase increased 20.34 10.72 115 107116 61194 110420874
Hepatitis C RNA positive 20.15 10.72 8 107223 244 110481824
Nail disorder 20.09 10.72 16 107215 57919 110424149
Blood pressure fluctuation 19.88 10.72 26 107205 74798 110407270
Costal cartilage fracture 19.88 10.72 8 107223 253 110481815
Differential white blood cell count abnormal 19.86 10.72 17 107214 2267 110479801
Freezing phenomenon 19.85 10.72 18 107213 2591 110479477
Joint injury 19.80 10.72 7 107224 39987 110442081
Mucosal inflammation 19.67 10.72 160 107071 95981 110386087
Neck pain 19.54 10.72 58 107173 123072 110358996
Sudden death 19.51 10.72 60 107171 24335 110457733
Drug abuse 19.48 10.72 97 107134 177314 110304754
Intentional product misuse 19.40 10.72 65 107166 132839 110349229
Blood sodium decreased 19.29 10.72 81 107150 38238 110443830
Cardiovascular disorder 19.16 10.72 57 107174 22703 110459365
Feeling hot 19.15 10.72 37 107194 91069 110390999
Portal shunt 19.15 10.72 6 107225 89 110481979
Alkalosis hypochloraemic 19.01 10.72 10 107221 591 110481477
Therapeutic response shortened 18.91 10.72 3 107228 29580 110452488
Eosinophilia 18.78 10.72 108 107123 57828 110424240
Frequent bowel movements 18.77 10.72 25 107206 71365 110410703
Circulatory collapse 18.70 10.72 87 107144 42906 110439162
Flail chest 18.56 10.72 6 107225 99 110481969
Activated partial thromboplastin time shortened 18.55 10.72 12 107219 1045 110481023
Depressive symptom 18.54 10.72 31 107200 8383 110473685
Blood albumin decreased 18.50 10.72 64 107167 27588 110454480
Body mass index decreased 18.50 10.72 11 107220 825 110481243
Drug ineffective for unapproved indication 18.14 10.72 46 107185 102792 110379276
Axillary pain 18.05 10.72 17 107214 2569 110479499
Salivary hypersecretion 17.99 10.72 47 107184 17374 110464694
Heart rate decreased 17.93 10.72 33 107198 82723 110399345
Adrenomegaly 17.93 10.72 9 107222 482 110481586
Hiccups 17.93 10.72 39 107192 12830 110469238
Erosive duodenitis 17.81 10.72 16 107215 2275 110479793
Dermatitis bullous 17.81 10.72 47 107184 17482 110464586
Osteoporosis 17.80 10.72 36 107195 87116 110394952
Spleen congestion 17.79 10.72 9 107222 490 110481578
Cytokine release syndrome 17.78 10.72 123 107108 70183 110411885
Inguinal hernia 17.75 10.72 29 107202 7696 110474372
Small intestinal obstruction 17.73 10.72 70 107161 32143 110449925
Hypothermia 17.71 10.72 61 107170 26241 110455827
Decubitus ulcer 17.62 10.72 48 107183 18188 110463880
Genital erythema 17.62 10.72 8 107223 342 110481726
Illness 17.60 10.72 33 107198 82138 110399930
Arteriosclerosis coronary artery 17.56 10.72 59 107172 25059 110457009
Metamyelocyte count increased 17.50 10.72 10 107221 696 110481372
Therapy partial responder 17.49 10.72 7 107224 37054 110445014
Lung perforation 17.35 10.72 6 107225 123 110481945
Incorrect route of product administration 17.29 10.72 22 107209 64039 110418029
Metastases to central nervous system 17.22 10.72 55 107176 22762 110459306
Blood pressure systolic increased 17.19 10.72 34 107197 82957 110399111
Megacolon 17.10 10.72 21 107210 4284 110477784
Throat irritation 17.10 10.72 16 107215 53536 110428532
Transfusion 17.08 10.72 59 107172 25413 110456655
Pulmonary vein occlusion 17.04 10.72 6 107225 130 110481938
Inflammatory marker increased 17.00 10.72 41 107190 14428 110467640
Electrolyte imbalance 16.90 10.72 76 107155 36952 110445116
Ear pain 16.88 10.72 16 107215 53210 110428858
Exostosis 16.82 10.72 12 107219 45944 110436124
Nephrocalcinosis 16.80 10.72 14 107217 1800 110480268
Nervous system disorder 16.71 10.72 68 107163 31653 110450415
Traumatic haemothorax 16.67 10.72 10 107221 762 110481306
Aspiration 16.52 10.72 66 107165 30467 110451601
Full blood count abnormal 16.47 10.72 18 107213 56034 110426034
Abdominal rigidity 16.34 10.72 19 107212 3661 110478407
Dry eye 16.30 10.72 18 107213 55775 110426293
Bleeding time prolonged 16.29 10.72 12 107219 1290 110480778
Incoherent 16.08 10.72 29 107202 8329 110473739
Rhabdomyolysis 16.02 10.72 183 107048 120218 110361850
Hypoalbuminaemia 15.98 10.72 63 107168 28911 110453157
Blood albumin abnormal 15.88 10.72 10 107221 831 110481237
Anaphylactic shock 15.76 10.72 16 107215 51530 110430538
Immature granulocyte count increased 15.71 10.72 10 107221 847 110481221
Ileus paralytic 15.70 10.72 35 107196 11702 110470366
Spinal cord injury thoracic 15.70 10.72 6 107225 165 110481903
Nodule 15.67 10.72 6 107225 32625 110449443
Portal shunt procedure 15.59 10.72 4 107227 27 110482041
Drug resistance 15.59 10.72 19 107212 56355 110425713
Stevens-Johnson syndrome 15.58 10.72 88 107143 46813 110435255
Hyperbilirubinaemia 15.57 10.72 65 107166 30606 110451462
Onychomycosis 15.55 10.72 9 107222 38522 110443546
Somnolence 15.54 10.72 388 106843 297061 110185007
Paracentesis 15.51 10.72 12 107219 1388 110480680
Lung neoplasm 15.51 10.72 28 107203 8048 110474020
Colitis ischaemic 15.47 10.72 45 107186 17705 110464363
Failure to thrive 15.46 10.72 38 107193 13536 110468532
Antipsychotic drug level decreased 15.42 10.72 12 107219 1400 110480668
Salivary gland enlargement 15.39 10.72 8 107223 461 110481607
Impaired quality of life 15.30 10.72 5 107226 30012 110452056
Acute hepatic failure 15.28 10.72 73 107158 36395 110445673
Bilirubin conjugated increased 15.17 10.72 24 107207 6200 110475868
Sneezing 15.16 10.72 6 107225 31978 110450090
Muscle spasticity 15.06 10.72 8 107223 35907 110446161
Chronic sinusitis 15.05 10.72 3 107228 25081 110456987
Flank pain 15.01 10.72 53 107178 23077 110458991
Adverse reaction 14.96 10.72 5 107226 29589 110452479
Stoma site erythema 14.93 10.72 14 107217 2103 110479965
Nail infection 14.82 10.72 15 107216 2473 110479595
Eye pain 14.81 10.72 16 107215 50083 110431985
Paronychia 14.78 10.72 33 107198 11048 110471020
Mouth swelling 14.77 10.72 26 107205 7328 110474740
Intentional self-injury 14.75 10.72 9 107222 37420 110444648
Gait inability 14.72 10.72 75 107156 136301 110345767
Leukopenia 14.67 10.72 214 107017 148577 110333491
Haemorrhoids 14.66 10.72 71 107160 35601 110446467
Haematocrit decreased 14.61 10.72 112 107119 66005 110416063
Blast cells present 14.51 10.72 10 107221 968 110481100
Hyperglycaemia 14.49 10.72 136 107095 84954 110397114
International normalised ratio increased 14.43 10.72 138 107093 86634 110395434
Joint stiffness 14.40 10.72 27 107204 67216 110414852
Injection site haemorrhage 14.38 10.72 7 107224 33021 110449047
Syncope 14.34 10.72 276 106955 202260 110279808
Ischaemic hepatitis 14.31 10.72 20 107211 4628 110477440
Salivary gland disorder 14.27 10.72 7 107224 357 110481711
Electrocardiogram QT prolonged 14.23 10.72 165 107066 108795 110373273
Calcium ionised increased 14.12 10.72 7 107224 365 110481703
Poisoning deliberate 14.12 10.72 4 107227 26327 110455741
Weight 14.12 10.72 4 107227 41 110482027
Premature delivery 14.11 10.72 6 107225 30626 110451442
Starvation 14.10 10.72 10 107221 1013 110481055
Muscle twitching 14.09 10.72 62 107169 29873 110452195
Activated partial thromboplastin time abnormal 14.01 10.72 7 107224 371 110481697
Hydronephrosis 13.97 10.72 48 107183 20617 110461451
Hepatitis acute 13.95 10.72 45 107186 18721 110463347
Traumatic intracranial haematoma 13.86 10.72 4 107227 44 110482024
Vascular parkinsonism 13.76 10.72 5 107226 119 110481949
Peripheral artery stenosis 13.70 10.72 11 107220 1343 110480725
Osteopenia 13.66 10.72 50 107181 22159 110459909
Coma hepatic 13.64 10.72 10 107221 1067 110481001
Model for end stage liver disease score increased 13.47 10.72 4 107227 49 110482019
Spinal cord infarction 13.46 10.72 10 107221 1088 110480980
Diabetic gastropathy 13.43 10.72 3 107228 10 110482058
Diffuse alveolar damage 13.34 10.72 18 107213 4029 110478039
Drug tolerance decreased 13.33 10.72 5 107226 27535 110454533
Generalised oedema 13.26 10.72 62 107169 30642 110451426
COVID-19 13.21 10.72 163 107068 244897 110237171
Underdose 13.19 10.72 26 107205 63528 110418540
Fungal infection 13.15 10.72 18 107213 50788 110431280
Mental impairment 13.12 10.72 50 107181 22589 110459479
Stress 13.11 10.72 55 107176 105293 110376775
Myoclonus 13.07 10.72 65 107166 32933 110449135
Metastases to lymph nodes 12.99 10.72 38 107193 14994 110467074
Colon cancer metastatic 12.97 10.72 14 107217 2487 110479581
Hepatic enzyme increased 12.92 10.72 226 107005 320666 110161402
Red cell distribution width increased 12.89 10.72 42 107189 17560 110464508
Choking 12.87 10.72 38 107193 15072 110466996
Thoracic operation 12.87 10.72 6 107225 273 110481795
Abnormal behaviour 12.80 10.72 73 107158 38966 110443102
Adrenal adenoma 12.76 10.72 11 107220 1481 110480587
Respiratory tract congestion 12.75 10.72 7 107224 30850 110451218
Myelocyte count increased 12.75 10.72 9 107222 905 110481163
Mitral valve incompetence 12.74 10.72 65 107166 33264 110448804
Frostbite 12.72 10.72 6 107225 280 110481788
Toxic encephalopathy 12.71 10.72 38 107193 15176 110466892
Gastric antral vascular ectasia 12.70 10.72 10 107221 1187 110480881
Mouth ulceration 12.63 10.72 85 107146 48053 110434015
Alpha 1 foetoprotein decreased 12.63 10.72 3 107228 14 110482054
Portopulmonary hypertension 12.58 10.72 5 107226 153 110481915
Medication error 12.51 10.72 56 107175 105310 110376758
Abortion spontaneous 12.49 10.72 9 107222 34273 110447795
Prothrombin time prolonged 12.47 10.72 41 107190 17220 110464848
Incontinence 12.46 10.72 40 107191 16595 110465473
Gastritis 12.45 10.72 92 107139 53607 110428461
Food refusal 12.44 10.72 9 107222 941 110481127
Polypectomy 12.41 10.72 11 107220 1538 110480530
Superinfection 12.39 10.72 21 107210 5742 110476326
Oral contusion 12.26 10.72 5 107226 164 110481904
Cataract 12.21 10.72 38 107193 79447 110402621
Macular degeneration 12.17 10.72 3 107228 21656 110460412
Faeces discoloured 12.15 10.72 65 107166 33883 110448185
Blood chloride increased 12.12 10.72 22 107209 6350 110475718
Adrenoleukodystrophy 12.10 10.72 4 107227 71 110481997
Blood urea increased 12.09 10.72 93 107138 54864 110427204
Anti-erythropoietin antibody negative 12.07 10.72 6 107225 315 110481753
Depression 11.99 10.72 226 107005 317109 110164959
Renal failure 11.97 10.72 296 106935 226278 110255790
Anal injury 11.92 10.72 5 107226 176 110481892
Myelosuppression 11.90 10.72 49 107182 94291 110387777
Visual impairment 11.80 10.72 79 107152 134349 110347719
Red blood cell sedimentation rate decreased 11.75 10.72 10 107221 1324 110480744
Accidental exposure to product 11.69 10.72 19 107212 49989 110432079
Respiratory distress 11.69 10.72 110 107121 68764 110413304
Haemangioma 11.62 10.72 14 107217 2802 110479266
Septic shock 11.61 10.72 216 107015 157312 110324756
Gastrointestinal polyp haemorrhage 11.58 10.72 8 107223 777 110481291
Bronchitis 11.54 10.72 97 107134 156935 110325133
Poisoning 11.46 10.72 7 107224 29098 110452970
Hypertriglyceridaemia 11.34 10.72 38 107193 16116 110465952
Tumour hyperprogression 11.32 10.72 6 107225 360 110481708
Influenza 11.31 10.72 107 107124 168994 110313074
Immune-mediated hepatitis 11.31 10.72 22 107209 6689 110475379
Electrocardiogram T wave inversion 11.30 10.72 20 107211 5660 110476408
Psychomotor retardation 11.30 10.72 24 107207 7768 110474300
Vascular purpura 11.28 10.72 16 107215 3755 110478313
Product monitoring error 11.25 10.72 26 107205 8901 110473167
Duodenal ulcer 11.22 10.72 43 107188 19471 110462597
Product label confusion 11.17 10.72 4 107227 22673 110459395
Muscle spasms 11.17 10.72 196 107035 277961 110204107
Respiratory disorder 11.05 10.72 34 107197 71348 110410720
Bladder cancer 11.04 10.72 3 107228 20289 110461779
Delusion 11.03 10.72 49 107182 23706 110458362
Oesophageal ulcer 10.94 10.72 24 107207 7940 110474128
Disability 10.92 10.72 8 107223 30215 110451853
Pulmonary alveolar haemorrhage 10.92 10.72 3 107228 20147 110461921
Pulmonary hypertension 10.81 10.72 91 107140 55129 110426939
Brain oedema 10.76 10.72 59 107172 31039 110451029
Cardiomyopathy acute 10.74 10.72 6 107225 400 110481668

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:50177 dermatologic drug
CHEBI has role CHEBI:50503 laxative
CHEBI has role CHEBI:55324 gastrointestinal drug
CHEBI has role CHEBI:62868 hepatoprotective agent
FDA EPC N0000175811 Osmotic Laxative
FDA MoA N0000175833 Acidifying Activity

Related Drugs by ATC class:

A06AD Osmotically acting laxatives 13 drugs
lactitolmacrogolmagnesium carbonatemagnesium citratemagnesium oxidemagnesium peroxidemagnesium sulfatemannitolpentaerythritolsodium phosphatesodium sulfatesodium tartrate show all 13 →

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




🐶 Veterinary Drug Use

None

🐶 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
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 21 sections
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 0121-0577 SOLUTION 10 g ORAL ANDA 21 sections
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 0121-0873 SOLUTION 10 g ORAL ANDA 21 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 0121-0965 POWDER, FOR SOLUTION 10 g ORAL ANDA 20 sections
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 0121-1154 SOLUTION 20 g ORAL ANDA 21 sections
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 0121-1746 SOLUTION 20 g ORAL ANDA 21 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 0121-1930 POWDER, FOR SOLUTION 20 g ORAL ANDA 20 sections
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 0121-4577 SOLUTION 10 g ORAL ANDA 21 sections
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 0527-5125 SOLUTION 10 g ORAL ANDA 22 sections
LACTULOSE HUMAN PRESCRIPTION DRUG LABEL 1 17856-0874 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 50383-356 SOLUTION 10 g ORAL ANDA 20 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 50383-357 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 51672-4243 SOLUTION 10 g ORAL ANDA 22 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 55154-9448 SOLUTION 20 g ORAL ANDA 21 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 59741-249 SOLUTION 10 g ORAL ANDA 21 sections
Lactulose Solution HUMAN PRESCRIPTION DRUG LABEL 1 61037-471 SOLUTION 10 g ORAL ANDA 16 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 62135-002 SOLUTION 10 g ORAL ANDA 11 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 62135-003 SOLUTION 10 g ORAL ANDA 20 sections
Lactulose HUMAN PRESCRIPTION DRUG LABEL 1 62135-004 SOLUTION 10 g ORAL ANDA 11 sections