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

Stem definitionDrug idCAS RN
4253 25322-68-3

Description:

MoleculeDescription

Synonyms:

  • polyethylene glycol
  • polyethylene glycol 3350
  • polyethylene glycol 400
  • polyethylene glycol 300
  • macrogol
  • macrogol 4000
  • Molecular weight:
  • Formula: (C2H4O)n
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
10 g O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
July 13, 1984 FDA BRAINTREE
Sept. 21, 2018 PMDA EA Pharma 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
Constipation 424.90 9.91 852 72133 224091 63191946
Macular degeneration 332.07 9.91 253 72732 24123 63391914
Contraindicated product administered 215.06 9.91 8 72977 217640 63198397
Infective pulmonary exacerbation of cystic fibrosis 211.93 9.91 130 72855 8687 63407350
Pemphigus 195.74 9.91 3 72982 183723 63232314
Synovitis 184.20 9.91 7 72978 186911 63229126
Febrile neutropenia 172.03 9.91 404 72581 118045 63297992
Systemic lupus erythematosus 170.79 9.91 20 72965 208898 63207139
Drug intolerance 162.25 9.91 76 72909 308585 63107452
Arthropathy 159.76 9.91 37 72948 234755 63181282
Hand deformity 157.01 9.91 6 72979 159451 63256586
Treatment failure 148.75 9.91 25 72960 199018 63217019
Rheumatoid arthritis 147.07 9.91 54 72931 253765 63162272
Maternal exposure during pregnancy 139.51 9.91 40 72945 220022 63196015
Glossodynia 128.17 9.91 25 72960 178851 63237186
Pericarditis 122.89 9.91 7 72978 131572 63284465
Swelling 109.99 9.91 93 72892 275285 63140752
Therapeutic product effect decreased 107.07 9.91 44 72941 193143 63222894
Joint swelling 104.59 9.91 134 72851 327532 63088505
Drug ineffective 96.46 9.91 756 72229 1044009 62372028
Wound 95.76 9.91 34 72951 163229 63252808
Abdominal pain 93.40 9.91 617 72368 292839 63123198
Completed suicide 91.32 9.91 27 72958 145646 63270391
Chronic sinusitis 87.49 9.91 90 72895 12753 63403284
Discomfort 86.64 9.91 42 72943 167332 63248705
Helicobacter infection 80.67 9.91 7 72978 92778 63323259
Urinary tract infection 80.29 9.91 550 72435 264134 63151903
Creatinine renal clearance decreased 77.96 9.91 95 72890 16213 63399824
Alopecia 76.41 9.91 172 72813 337364 63078673
Sedation complication 75.15 9.91 86 72899 13736 63402301
Exposure during pregnancy 74.66 9.91 43 72942 155504 63260533
Procedural pain 72.84 9.91 106 72879 21463 63394574
Blood calcium decreased 72.47 9.91 118 72867 26333 63389704
Dehydration 70.72 9.91 389 72596 172965 63243072
Aplastic anaemia 70.57 9.91 70 72915 9499 63406538
Drug hypersensitivity 69.75 9.91 159 72826 310528 63105509
Arthralgia 64.29 9.91 388 72597 569322 62846715
Paraesthesia oral 61.23 9.91 92 72893 19164 63396873
Mental status changes 60.63 9.91 138 72847 39461 63376576
Lower respiratory tract infection 60.11 9.91 39 72946 132268 63283769
Hypersensitivity 60.01 9.91 157 72828 292528 63123509
Orthostatic hypotension 59.85 9.91 130 72855 36030 63380007
Plasma cell myeloma 58.19 9.91 128 72857 35777 63380260
Psoriatic arthropathy 57.28 9.91 17 72968 91503 63324534
Fall 56.95 9.91 695 72290 391639 63024398
Abdominal discomfort 53.71 9.91 189 72796 320696 63095341
Colitis 53.23 9.91 149 72836 48379 63367658
Nausea 51.66 9.91 1315 71670 853156 62562881
Hepatic enzyme increased 50.01 9.91 98 72887 202230 63213807
Vaginal flatulence 46.64 9.91 35 72950 3258 63412779
Intestinal obstruction 45.45 9.91 106 72879 30793 63385244
Balance disorder 45.43 9.91 205 72780 84217 63331820
Sedation 45.38 9.91 122 72863 38687 63377350
Cognitive disorder 45.05 9.91 154 72831 55661 63360376
Liver injury 44.30 9.91 8 72977 60512 63355525
Abdominal distension 44.14 9.91 207 72778 86408 63329629
Sepsis 42.73 9.91 312 72673 152811 63263226
Intentional overdose 42.51 9.91 16 72969 74136 63341901
Blister 42.47 9.91 52 72933 129762 63286275
Proctitis 42.35 9.91 41 72944 5400 63410637
Musculoskeletal stiffness 40.16 9.91 96 72889 184522 63231515
Failure to thrive 39.49 9.91 45 72940 7153 63408884
Condition aggravated 38.72 9.91 287 72698 401930 63014107
Female genital tract fistula 37.70 9.91 45 72940 7514 63408523
Small intestinal obstruction 37.54 9.91 72 72913 18265 63397772
Impaired healing 36.90 9.91 38 72947 102504 63313533
Nasopharyngitis 36.60 9.91 159 72826 254098 63161939
Hospice care 35.96 9.91 45 72940 7887 63408150
Acute respiratory failure 35.02 9.91 103 72882 34382 63381655
Weight decreased 34.89 9.91 478 72507 276320 63139717
Pneumonia 34.58 9.91 726 72259 456041 62959996
Hypoxia 34.29 9.91 148 72837 59644 63356393
Asthenia 34.18 9.91 625 72360 382979 63033058
Product use issue 34.17 9.91 134 72851 220386 63195651
Vaginal discharge 33.70 9.91 47 72938 9151 63406886
Rash 31.05 9.91 456 72529 560415 62855622
Ill-defined disorder 30.91 9.91 29 72956 81726 63334311
Drug interaction 30.76 9.91 147 72838 228984 63187053
Hyponatraemia 30.63 9.91 227 72758 111673 63304364
Blood cholesterol increased 30.40 9.91 38 72947 93994 63322043
Radiculopathy 30.06 9.91 43 72942 8568 63407469
Death 29.60 9.91 599 72386 373782 63042255
Respiratory distress 29.46 9.91 96 72889 33855 63382182
White blood cell count decreased 28.84 9.91 265 72720 138839 63277198
C-reactive protein increased 27.86 9.91 41 72944 94666 63321371
Full blood count decreased 27.65 9.91 79 72906 25945 63390092
Infusion related reaction 27.17 9.91 168 72817 245353 63170684
Vomiting 27.13 9.91 838 72147 558779 62857258
Inflammation 26.86 9.91 33 72952 82240 63333797
Pulmonary embolism 26.62 9.91 227 72758 116457 63299580
Lethargy 26.47 9.91 131 72854 55876 63360161
Foetal exposure during pregnancy 26.23 9.91 3 72982 31959 63384078
Platelet count decreased 26.01 9.91 225 72760 115897 63300140
General physical health deterioration 25.99 9.91 131 72854 201271 63214766
Abortion spontaneous 25.71 9.91 11 72974 47184 63368853
Seizure 25.66 9.91 249 72736 132385 63283652
Eye irritation 25.62 9.91 69 72916 21902 63394135
Malnutrition 25.31 9.91 55 72930 15243 63400794
Deep vein thrombosis 25.25 9.91 174 72811 83626 63332411
Gastrointestinal motility disorder 24.75 9.91 30 72955 5089 63410948
Infection 24.75 9.91 158 72827 229015 63187022
Hypotension 24.19 9.91 444 72541 272160 63143877
Hospitalisation 24.08 9.91 174 72811 84907 63331130
Blood potassium decreased 24.07 9.91 104 72881 41922 63374115
Hypophagia 23.28 9.91 84 72901 31175 63384862
Depressed level of consciousness 23.10 9.91 136 72849 61942 63354095
Hip arthroplasty 23.09 9.91 13 72972 47633 63368404
Irritable bowel syndrome 22.97 9.91 37 72948 82375 63333662
Rhinovirus infection 22.65 9.91 27 72958 4502 63411535
Type 2 diabetes mellitus 22.60 9.91 24 72961 63844 63352193
Dyspepsia 22.36 9.91 197 72788 101999 63314038
Anaemia 22.02 9.91 466 72519 292964 63123073
Pyrexia 21.84 9.91 701 72284 469777 62946260
Foreign body sensation in eyes 21.59 9.91 19 72966 2215 63413822
Red blood cell sedimentation rate increased 21.31 9.91 12 72973 43970 63372067
Hepatotoxicity 21.21 9.91 8 72977 37033 63379004
Faecaloma 21.17 9.91 35 72950 7906 63408131
Product odour abnormal 21.13 9.91 15 72970 1281 63414756
Peritonitis bacterial 21.04 9.91 27 72958 4852 63411185
Urinary retention 20.54 9.91 79 72906 30222 63385815
Neuropathy peripheral 20.35 9.91 210 72775 113457 63302580
Suicide attempt 20.34 9.91 24 72961 60894 63355143
Therapy non-responder 20.30 9.91 35 72950 75866 63340171
Urticaria 20.18 9.91 110 72875 165692 63250345
Flatulence 19.97 9.91 86 72899 34616 63381421
Disease progression 19.75 9.91 222 72763 122536 63293501
Knee arthroplasty 19.60 9.91 20 72965 54186 63361851
Noninfectious peritonitis 19.47 9.91 7 72978 135 63415902
Hip fracture 19.29 9.91 76 72909 29398 63386639
Device expulsion 19.25 9.91 8 72977 34914 63381123
Fumbling 19.10 9.91 7 72978 143 63415894
Large intestinal obstruction 19.05 9.91 18 72967 2301 63413736
Drug abuse 18.89 9.91 34 72951 72484 63343553
Injection site pain 18.76 9.91 81 72904 129719 63286318
Cystic fibrosis 18.75 9.91 21 72964 3275 63412762
Injection site reaction 18.55 9.91 24 72961 58500 63357537
Carbon dioxide decreased 18.45 9.91 17 72968 2104 63413933
Instillation site pain 18.40 9.91 12 72973 892 63415145
Blood sodium decreased 17.91 9.91 65 72920 24187 63391850
Adenocarcinoma of colon 17.88 9.91 18 72967 2486 63413551
Venous pressure jugular increased 17.80 9.91 10 72975 567 63415470
Pseudohyponatraemia 17.69 9.91 5 72980 42 63415995
Neutrophil count decreased 17.51 9.91 118 72867 56288 63359749
Encephalopathy 17.31 9.91 89 72896 38531 63377506
Enterovirus infection 17.15 9.91 12 72973 1002 63415035
Pleural effusion 17.06 9.91 173 72812 93037 63323000
Impaired gastric emptying 16.92 9.91 37 72948 10295 63405742
Product taste abnormal 16.89 9.91 16 72969 2051 63413986
Pregnancy 16.53 9.91 11 72974 36825 63379212
Psoriasis 16.05 9.91 49 72936 86908 63329129
Transfusion 15.97 9.91 46 72939 15171 63400866
Bacteraemia 15.91 9.91 50 72935 17298 63398739
Adverse event 15.59 9.91 34 72951 67525 63348512
Oedema peripheral 15.53 9.91 305 72680 189206 63226831
Neurogenic bladder 15.48 9.91 19 72966 3266 63412771
Atelectasis 15.38 9.91 57 72928 21426 63394611
Decubitus ulcer 15.37 9.91 36 72949 10484 63405553
Salivary gland enlargement 15.07 9.91 8 72977 405 63415632
Medication error 15.02 9.91 23 72962 52261 63363776
Streptococcal bacteraemia 14.99 9.91 14 72971 1763 63414274
Distal intestinal obstruction syndrome 14.98 9.91 8 72977 410 63415627
Atrial fibrillation 14.90 9.91 202 72783 116434 63299603
Drug resistance 14.82 9.91 4 72981 22929 63393108
Injection site pruritus 14.82 9.91 18 72967 45098 63370939
Hyponatraemic seizure 14.54 9.91 8 72977 435 63415602
Toxicity to various agents 14.34 9.91 199 72786 247051 63168986
Joint range of motion decreased 14.13 9.91 10 72975 32418 63383619
Respiratory failure 14.09 9.91 179 72806 101679 63314358
Intentional self-injury 13.97 9.91 6 72979 25681 63390356
Embolism 13.74 9.91 29 72956 7877 63408160
Rectal prolapse 13.69 9.91 14 72971 1969 63414068
Back pain 13.67 9.91 399 72586 263746 63152291
Escherichia urinary tract infection 13.38 9.91 37 72948 11925 63404112
Tremor 13.37 9.91 220 72765 132019 63284018
Frequent bowel movements 13.20 9.91 57 72928 22965 63393072
Peripheral swelling 13.05 9.91 221 72764 265721 63150316
Unmasking of previously unidentified disease 13.00 9.91 10 72975 966 63415071
Urinary tract infection staphylococcal 12.96 9.91 7 72978 367 63415670
Haemorrhoids 12.83 9.91 55 72930 22095 63393942
Oral candidiasis 12.73 9.91 56 72929 22742 63393295
Staphylococcal infection 12.62 9.91 86 72899 41170 63374867
Kyphosis 12.47 9.91 15 72970 2525 63413512
Multiple drug therapy 12.43 9.91 18 72967 3628 63412409
Product administered to patient of inappropriate age 12.42 9.91 17 72968 3251 63412786
Hyponatraemic encephalopathy 12.38 9.91 6 72979 250 63415787
Fibromyalgia 12.36 9.91 49 72936 80371 63335666
Anal incontinence 12.33 9.91 39 72946 13537 63402500
Toxic epidermal necrolysis 12.15 9.91 7 72978 25327 63390710
Loss of personal independence in daily activities 12.13 9.91 64 72921 97226 63318811
Gastrostomy tube site complication 12.06 9.91 4 72981 60 63415977
Cardiomyopathy 12.04 9.91 46 72939 17538 63398499
Rectal haemorrhage 12.04 9.91 97 72888 48933 63367104
Hepatic function abnormal 12.01 9.91 15 72970 37127 63378910
Pubic pain 12.01 9.91 5 72980 145 63415892
Calculus bladder 11.98 9.91 8 72977 619 63415418
Dysphagia 11.97 9.91 155 72830 88430 63327607
Product complaint 11.82 9.91 37 72948 12772 63403265
Pneumonia aspiration 11.78 9.91 74 72911 34466 63381571
Off label use 11.75 9.91 645 72340 673817 62742220
Urinary tract infection enterococcal 11.68 9.91 15 72970 2698 63413339
Sulphaemoglobinaemia 11.64 9.91 3 72982 17 63416020
Biliary dyskinesia 11.61 9.91 15 72970 2714 63413323
Liver disorder 11.60 9.91 28 72957 53659 63362378
Visceral pain 11.49 9.91 3 72982 18 63416019
Pruritus 11.48 9.91 322 72663 361131 63054906
Anxiety 11.36 9.91 329 72656 217212 63198825
Cardiac failure congestive 11.36 9.91 159 72826 92274 63323763
Carbohydrate antigen 125 increased 11.24 9.91 15 72970 2801 63413236
Listeraemia 11.23 9.91 4 72981 75 63415962
Cytokine release syndrome 11.11 9.91 39 72946 14275 63401762
Renal impairment 11.09 9.91 58 72927 88297 63327740
Lymphocyte count decreased 11.07 9.91 66 72919 30191 63385846
Live birth 11.04 9.91 8 72977 25622 63390415
Blood sodium abnormal 11.01 9.91 8 72977 709 63415328
Intentional product use issue 11.00 9.91 94 72891 127798 63288239
Reticulocyte count increased 10.91 9.91 9 72976 961 63415076
Lung adenocarcinoma stage I 10.86 9.91 3 72982 23 63416014
Optic atrophy 10.65 9.91 10 72975 1268 63414769
Fibrinolysis 10.64 9.91 3 72982 25 63416012
Atrial enlargement 10.54 9.91 6 72979 349 63415688
Diverticulum 10.48 9.91 34 72951 11957 63404080
Compression fracture 10.46 9.91 23 72962 6425 63409612
Musculoskeletal chest pain 10.45 9.91 50 72935 21033 63395004
Proctalgia 10.14 9.91 22 72963 6088 63409949
Contusion 10.09 9.91 117 72868 149927 63266110
Haematochezia 10.09 9.91 100 72885 53444 63362593
Denture wearer 10.09 9.91 5 72980 219 63415818
Hepatitis 10.05 9.91 19 72966 39769 63376268
Pelvic fracture 10.05 9.91 36 72949 13312 63402725
Abdominal pain lower 10.03 9.91 57 72928 25621 63390416
Pulmonary function test decreased 9.99 9.91 17 72968 3930 63412107
Pustule 9.97 9.91 11 72974 1688 63414349
Feeling abnormal 9.95 9.91 232 72753 148160 63267877
Urinary incontinence 9.95 9.91 67 72918 31947 63384090

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
Appendicolith 172.60 10.45 126 53044 8475 34895286
Constipation 162.11 10.45 517 52653 136465 34767296
Appendicitis 129.40 10.45 135 53035 14672 34889089
Toxicity to various agents 126.51 10.45 74 53096 200288 34703473
Infective pulmonary exacerbation of cystic fibrosis 117.28 10.45 91 53079 6710 34897051
Febrile neutropenia 115.92 10.45 463 52707 136386 34767375
Abdominal distension 114.59 10.45 266 52904 58226 34845535
Drug interaction 92.70 10.45 125 53045 225821 34677940
Urinary tract infection 87.41 10.45 304 52866 83777 34819984
Drug ineffective 87.01 10.45 379 52791 456372 34447389
Abdominal pain 86.66 10.45 483 52687 163135 34740626
Completed suicide 79.78 10.45 25 53145 98143 34805618
Stress 77.82 10.45 154 53016 30193 34873568
Blood phosphorus increased 77.71 10.45 76 53094 7645 34896116
Ascites 77.55 10.45 199 52971 46372 34857389
Cardiogenic shock 76.77 10.45 142 53028 26476 34877285
Hyponatraemia 74.97 10.45 286 52884 82405 34821356
Sepsis 74.87 10.45 471 52699 166090 34737671
Aplastic anaemia 71.63 10.45 81 53089 9635 34894126
Vomiting 61.77 10.45 611 52559 247010 34656751
Ventricular fibrillation 50.06 10.45 109 53061 22845 34880916
Plasma cell myeloma 49.87 10.45 159 53011 41878 34861883
Victim of child abuse 45.44 10.45 24 53146 903 34902858
Ocular procedural complication 45.33 10.45 12 53158 55 34903706
Drug abuse 44.55 10.45 51 53119 99045 34804716
Interstitial lung disease 41.27 10.45 24 53146 65258 34838503
Dehydration 41.17 10.45 338 52832 129631 34774130
Nausea 39.98 10.45 732 52438 339176 34564585
Hospice care 39.90 10.45 51 53119 6889 34896872
Fall 33.25 10.45 462 52708 202423 34701338
Bacteraemia 32.53 10.45 84 53086 19633 34884128
Renal impairment 32.28 10.45 59 53111 94454 34809307
Intentional overdose 32.25 10.45 13 53157 43661 34860100
Small intestinal obstruction 31.74 10.45 70 53100 14796 34888965
Pneumonia 30.89 10.45 745 52425 361882 34541879
Myasthenia gravis 30.82 10.45 45 53125 6895 34896866
Rhabdomyolysis 30.71 10.45 35 53135 68128 34835633
Dry mouth 30.37 10.45 108 53062 30057 34873704
Suicide attempt 29.95 10.45 11 53159 39105 34864656
Hypophagia 29.52 10.45 92 53078 23930 34879831
Cerebral artery thrombosis 29.45 10.45 17 53153 763 34902998
Muscle spasticity 28.83 10.45 40 53130 5848 34897913
Cytokine release syndrome 28.47 10.45 88 53082 22789 34880972
Treatment failure 28.35 10.45 18 53152 46679 34857082
Pneumonia aspiration 27.88 10.45 132 53038 41771 34861990
Brain scan abnormal 27.55 10.45 17 53153 863 34902898
Foetal exposure during pregnancy 27.08 10.45 12 53158 38089 34865672
C-reactive protein increased 26.36 10.45 26 53144 54072 34849689
Therapeutic product effect incomplete 26.15 10.45 23 53147 50518 34853243
Cystic fibrosis 26.04 10.45 21 53149 1637 34902124
Rhinovirus infection 25.36 10.45 32 53138 4267 34899494
Myocardial infarction 25.05 10.45 97 53073 120988 34782773
Failure to thrive 24.93 10.45 46 53124 8555 34895206
Hyperphosphataemia 24.56 10.45 32 53138 4405 34899356
Rheumatoid arthritis 24.24 10.45 14 53156 38224 34865537
Complication associated with device 23.90 10.45 37 53133 5969 34897792
Psoriasis 23.50 10.45 15 53155 38797 34864964
Hip fracture 23.06 10.45 54 53116 11871 34891890
Respiratory distress 22.75 10.45 111 53059 35554 34868207
Contraindicated product administered 22.52 10.45 3 53167 21478 34882283
Blood uric acid increased 22.47 10.45 47 53123 9577 34894184
Hallucination 22.05 10.45 144 53026 51354 34852407
Deep vein thrombosis 21.88 10.45 172 52998 65076 34838685
Drug therapy 21.28 10.45 16 53154 1125 34902636
Mental status changes 21.14 10.45 114 53056 37969 34865792
Analgesic therapy 20.88 10.45 15 53155 983 34902778
Psoriatic arthropathy 20.20 10.45 3 53167 19795 34883966
Decubitus ulcer 20.17 10.45 43 53127 8878 34894883
Aspiration 20.17 10.45 52 53118 12142 34891619
Epidural lipomatosis 20.15 10.45 15 53155 1039 34902722
Iron deficiency 19.82 10.45 32 53138 5349 34898412
Atelectasis 19.17 10.45 65 53105 17662 34886099
Hypoxia 18.89 10.45 146 53024 54949 34848812
Shunt malfunction 18.70 10.45 8 53162 186 34903575
Hepatic function abnormal 18.69 10.45 24 53146 44339 34859422
Clostridium test positive 18.34 10.45 24 53146 3318 34900443
Sleep disorder therapy 18.32 10.45 14 53156 1009 34902752
Implant site erosion 17.16 10.45 6 53164 79 34903682
Encephalopathy 17.14 10.45 102 53068 35217 34868544
Multiple organ dysfunction syndrome 17.13 10.45 185 52985 76381 34827380
Liver disorder 17.08 10.45 15 53155 32982 34870779
Coma 16.98 10.45 27 53143 45651 34858110
Injection related reaction 16.89 10.45 9 53161 345 34903416
Product use in unapproved indication 16.88 10.45 107 53063 117392 34786369
Ileus 16.54 10.45 59 53111 16440 34887321
Hospitalisation 16.41 10.45 145 53025 56757 34847004
Urinary tract infection pseudomonal 16.40 10.45 13 53157 988 34902773
Renal failure 16.24 10.45 124 53046 130433 34773328
Hepatocellular injury 15.77 10.45 7 53163 22204 34881557
Overdose 15.75 10.45 78 53092 90981 34812780
Acute respiratory failure 15.45 10.45 90 53080 30838 34872923
Muscular weakness 15.33 10.45 174 52996 72723 34831038
Intestinal pseudo-obstruction 15.32 10.45 16 53154 1740 34902021
Child abuse 15.31 10.45 9 53161 418 34903343
Drug eruption 14.56 10.45 6 53164 19892 34883869
Dysphagia 14.54 10.45 152 53018 62229 34841532
Volvulus 14.47 10.45 15 53155 1617 34902144
Urinary incontinence 14.46 10.45 62 53108 18812 34884949
Blood creatine phosphokinase increased 14.43 10.45 29 53141 44828 34858933
Sports injury 14.37 10.45 6 53164 131 34903630
Neuralgia 14.27 10.45 53 53117 15060 34888701
Burkholderia test positive 14.07 10.45 12 53158 1011 34902750
Incorrect route of product administration 13.97 10.45 52 53118 14793 34888968
Areflexia 13.96 10.45 20 53150 3011 34900750
Somnolence 13.93 10.45 242 52928 110874 34792887
Cardiac failure 13.67 10.45 82 53088 91166 34812595
Gastrostomy tube site complication 13.58 10.45 5 53165 77 34903684
Platelet transfusion 13.48 10.45 14 53156 1512 34902249
Suicidal ideation 13.09 10.45 26 53144 40362 34863399
Anaphylactic shock 13.04 10.45 4 53166 15937 34887824
Medication error 12.78 10.45 12 53158 25553 34878208
Blood calcium decreased 12.74 10.45 39 53131 10045 34893716
Viral diarrhoea 12.73 10.45 6 53164 176 34903585
Premature baby 12.71 10.45 7 53163 19626 34884135
Hypertonia 12.67 10.45 23 53147 4223 34899538
Juvenile idiopathic arthritis 12.61 10.45 15 53155 1882 34901879
Metabolic encephalopathy 12.50 10.45 23 53147 4269 34899492
Chylothorax 12.49 10.45 10 53160 771 34902990
Hypophosphataemia 12.43 10.45 41 53129 10985 34892776
Otitis media acute 12.31 10.45 9 53161 606 34903155
Myelosuppression 12.29 10.45 7 53163 19258 34884503
Faecaloma 12.25 10.45 26 53144 5351 34898410
Immune effector cell-associated neurotoxicity syndrome 12.23 10.45 21 53149 3692 34900069
Gastric hypomotility 12.02 10.45 5 53165 108 34903653
Cholestasis 11.96 10.45 14 53156 26934 34876827
Chronic sinusitis 11.94 10.45 16 53154 2263 34901498
Underdose 11.92 10.45 47 53123 13733 34890028
Humerus fracture 11.83 10.45 17 53153 2566 34901195
Thrombosis 11.78 10.45 123 53047 50335 34853426
Bladder cancer 11.76 10.45 5 53165 16273 34887488
Unresponsive to stimuli 11.74 10.45 77 53093 27492 34876269
Malignant neoplasm progression 11.49 10.45 193 52977 87853 34815908
Blood pressure decreased 11.47 10.45 40 53130 51475 34852286
Back pain 11.47 10.45 254 52916 121535 34782226
Fatigue 11.36 10.45 680 52490 369973 34533788
Off label use 11.20 10.45 523 52647 419001 34484760
Haematochezia 11.14 10.45 35 53135 46499 34857262
Transfusion reaction 11.14 10.45 10 53160 902 34902859
Palpitations 11.11 10.45 28 53142 39958 34863803
Growth hormone-producing pituitary tumour 11.02 10.45 4 53166 59 34903702
White blood cell count decreased 10.95 10.45 205 52965 95240 34808521
Tracheostomy malfunction 10.78 10.45 4 53166 63 34903698
Neurotoxicity 10.74 10.45 55 53115 17955 34885806
Malnutrition 10.72 10.45 43 53127 12666 34891095
Crowned dens syndrome 10.66 10.45 3 53167 18 34903743
Urosepsis 10.55 10.45 43 53127 12756 34891005

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
Constipation 392.62 10.04 1001 99192 282049 79362146
Febrile neutropenia 327.49 10.04 824 99369 230175 79414020
Infective pulmonary exacerbation of cystic fibrosis 287.33 10.04 187 100006 12664 79631531
Appendicolith 192.56 10.04 125 100068 8426 79635769
Synovitis 174.12 10.04 3 100190 150731 79493464
Drug ineffective 171.32 10.04 739 99454 1080174 78564021
Completed suicide 166.28 10.04 51 100142 245716 79398479
Contraindicated product administered 164.45 10.04 8 100185 157530 79486665
Aplastic anaemia 153.39 10.04 148 100045 17757 79626438
Abdominal pain 144.67 10.04 910 99283 388659 79255536
Rheumatoid arthritis 143.29 10.04 42 100151 208428 79435767
Abdominal distension 143.07 10.04 401 99792 119249 79524946
Sepsis 139.78 10.04 689 99504 268739 79375456
Appendicitis 127.99 10.04 144 100049 20650 79623545
Treatment failure 114.16 10.04 36 100157 170450 79473745
Urinary tract infection 113.72 10.04 660 99533 273852 79370343
Hand deformity 112.70 10.04 4 100189 103915 79540280
Pemphigus 111 10.04 3 100190 99579 79544616
Hyponatraemia 110.78 10.04 480 99713 177368 79466827
Dehydration 100.37 10.04 593 99600 247594 79396601
Systemic lupus erythematosus 100.26 10.04 16 100177 121133 79523062
Drug interaction 98.87 10.04 236 99957 414947 79229248
Maternal exposure during pregnancy 98.51 10.04 25 100168 136513 79507682
Joint swelling 96.51 10.04 133 100060 288513 79355682
Arthropathy 95.08 10.04 52 100141 177059 79467136
Therapeutic product effect decreased 91.07 10.04 46 100147 163817 79480378
Toxicity to various agents 89.36 10.04 254 99939 421286 79222909
Chronic sinusitis 88.47 10.04 95 100098 12931 79631264
Drug intolerance 86.99 10.04 123 100070 263996 79380199
Ascites 83.27 10.04 246 99947 75316 79568879
Macular degeneration 79.58 10.04 84 100109 11212 79632983
Blood phosphorus increased 78.39 10.04 80 100113 10267 79633928
Blood calcium decreased 78.01 10.04 142 100051 31677 79612518
Arthralgia 75.05 10.04 417 99776 571386 79072809
Creatinine renal clearance decreased 72.95 10.04 104 100089 18898 79625297
Cardiogenic shock 71.64 10.04 161 100032 41753 79602442
Plasma cell myeloma 71.14 10.04 186 100007 53073 79591122
Glossodynia 70.64 10.04 21 100172 103316 79540879
Fall 70.06 10.04 927 99266 486702 79157493
Mental status changes 70.01 10.04 214 99979 66745 79577450
Pericarditis 69.78 10.04 22 100171 104214 79539981
Sedation complication 68.03 10.04 91 100102 15578 79628617
Vomiting 65.85 10.04 1188 99005 664640 78979555
Procedural pain 65.67 10.04 110 100083 22974 79621221
Hospice care 64.39 10.04 72 100121 10252 79633943
Drug hypersensitivity 64.11 10.04 179 100014 298737 79345458
Nausea 63.14 10.04 1610 98583 955586 78688609
Exposure during pregnancy 63.12 10.04 24 100169 101108 79543087
Intentional overdose 63.11 10.04 27 100166 105933 79538262
Failure to thrive 62.83 10.04 76 100117 11768 79632427
Small intestinal obstruction 59.76 10.04 116 100077 27156 79617039
Wound 58.25 10.04 37 100156 116142 79528053
Folliculitis 57.17 10.04 3 100190 55377 79588818
Hypersensitivity 57.00 10.04 156 100037 262083 79382112
Psoriatic arthropathy 56.79 10.04 14 100179 77985 79566210
Ventricular fibrillation 56.09 10.04 124 100069 31802 79612393
Pneumonia 55.37 10.04 1149 99044 659097 78985098
Acute respiratory failure 54.68 10.04 182 100011 59359 79584836
Respiratory distress 54.17 10.04 179 100014 58160 79586035
Discomfort 53.96 10.04 47 100146 125570 79518625
Lower respiratory tract infection 52.36 10.04 51 100142 129169 79515026
Drug abuse 52.31 10.04 77 100116 162614 79481581
Helicobacter infection 51.76 10.04 12 100181 69692 79574503
Orthostatic hypotension 50.09 10.04 170 100023 55994 79588201
Alopecia 49.99 10.04 138 100055 231217 79412978
Paraesthesia oral 49.73 10.04 91 100102 20380 79623815
Vaginal flatulence 49.22 10.04 34 100159 2541 79641654
Victim of child abuse 49.15 10.04 24 100169 929 79643266
Hypoxia 48.51 10.04 257 99936 102986 79541209
Bacteraemia 48.37 10.04 119 100074 32705 79611490
Proctitis 47.40 10.04 49 100144 6383 79637812
Hypophagia 46.49 10.04 144 100049 45223 79598972
Rhinovirus infection 45.43 10.04 53 100140 7900 79636295
Nasopharyngitis 44.68 10.04 166 100027 253715 79390480
Cytokine release syndrome 44.32 10.04 122 100071 35876 79608319
C-reactive protein increased 43.53 10.04 59 100134 128968 79515227
Deep vein thrombosis 42.59 10.04 279 99914 120640 79523555
Cystic fibrosis 40.86 10.04 36 100157 3844 79640351
Intestinal obstruction 39.94 10.04 132 100061 42888 79601307
Liver injury 39.62 10.04 11 100182 56603 79587592
Drug resistance 38.71 10.04 4 100189 42209 79601986
Inflammation 37.98 10.04 37 100156 93716 79550479
Impaired healing 37.39 10.04 33 100160 87622 79556573
Ocular procedural complication 37.03 10.04 16 100177 465 79643730
Hospitalisation 36.64 10.04 223 99970 94013 79550182
Interstitial lung disease 36.48 10.04 53 100140 112547 79531648
Hepatic enzyme increased 36.47 10.04 113 100080 182497 79461698
Death 36.32 10.04 950 99243 565564 79078631
Colitis 36.17 10.04 185 100008 73122 79571073
Blister 36.06 10.04 59 100134 119417 79524778
Suicide attempt 35.64 10.04 31 100162 82901 79561294
Encephalopathy 35.31 10.04 173 100020 67224 79576971
Pulmonary embolism 35.22 10.04 350 99843 171304 79472891
Renal impairment 34.91 10.04 93 100100 157690 79486505
Female genital tract fistula 34.43 10.04 40 100153 5935 79638260
Vaginal discharge 33.41 10.04 44 100149 7419 79636776
Swelling 32.93 10.04 150 100043 216561 79427634
Clostridium test positive 31.95 10.04 40 100153 6414 79637781
Pneumonia aspiration 31.66 10.04 167 100026 66800 79577395
Liver disorder 31.21 10.04 27 100166 72390 79571805
Atelectasis 30.86 10.04 100 100093 32157 79612038
Musculoskeletal stiffness 30.40 10.04 115 100078 174893 79469302
Lethargy 30.11 10.04 190 100003 81102 79563093
Cognitive disorder 30.11 10.04 170 100023 69756 79574439
Condition aggravated 30.01 10.04 446 99747 500678 79143517
Pleural effusion 29.22 10.04 295 99898 144967 79499228
White blood cell count decreased 29.07 10.04 363 99830 187925 79456270
Stress 28.82 10.04 185 100008 79427 79564768
Injection site pain 28.36 10.04 77 100116 129761 79514434
Seizure 28.28 10.04 362 99831 188472 79455723
Radiculopathy 27.74 10.04 44 100149 8780 79635415
Sedation 27.04 10.04 133 100060 51762 79592433
Infection 26.57 10.04 186 100007 241526 79402669
Psoriasis 26.33 10.04 45 100148 89542 79554653
Dysphagia 26.01 10.04 251 99942 121885 79522310
Overdose 25.94 10.04 131 100062 184075 79460120
Hip fracture 25.59 10.04 91 100102 30670 79613525
Malnutrition 25.49 10.04 74 100119 22428 79621767
Brain scan abnormal 25.40 10.04 17 100176 1206 79642989
Pruritus 25.10 10.04 347 99846 394301 79249894
Hepatic function abnormal 25.09 10.04 33 100160 73074 79571121
Respiratory failure 25.09 10.04 342 99851 180569 79463626
Rash 25.05 10.04 545 99648 577813 79066382
Hypotension 24.97 10.04 727 99466 439590 79204605
Myocardial infarction 24.77 10.04 133 100060 183996 79460199
Hyperphosphataemia 24.62 10.04 35 100158 6341 79637854
Medication error 24.58 10.04 30 100163 68612 79575583
Cerebral artery thrombosis 24.42 10.04 16 100177 1095 79643100
Rhabdomyolysis 24.18 10.04 59 100134 103072 79541123
Product odour abnormal 23.95 10.04 17 100176 1327 79642868
Red blood cell sedimentation rate increased 23.90 10.04 14 100179 45928 79598267
Faecaloma 23.90 10.04 48 100145 11516 79632679
Abdominal discomfort 23.77 10.04 201 99992 250526 79393669
Myasthenia gravis 23.72 10.04 45 100148 10354 79633841
Blood uric acid increased 23.59 10.04 52 100141 13308 79630887
Infusion related reaction 23.47 10.04 181 100012 230056 79414139
Ill-defined disorder 23.37 10.04 29 100164 65846 79578349
Analgesic therapy 23.33 10.04 15 100178 994 79643201
Drug therapy 23.29 10.04 16 100177 1185 79643010
Gastrostomy tube site complication 23.16 10.04 9 100184 198 79643997
Asthenia 22.82 10.04 821 99372 510868 79133327
Pyrexia 22.71 10.04 1056 99137 677653 78966542
Carbon dioxide decreased 22.68 10.04 25 100168 3503 79640692
Urinary retention 22.63 10.04 135 100058 56495 79587700
Coma 22.50 10.04 59 100134 100590 79543605
Balance disorder 22.46 10.04 206 99987 98651 79545544
Product administered to patient of inappropriate age 22.21 10.04 31 100162 5522 79638673
Urinary tract infection pseudomonal 21.62 10.04 18 100175 1780 79642415
Urinary incontinence 21.42 10.04 105 100088 40804 79603391
Ileus 21.34 10.04 77 100116 26134 79618061
Intestinal pseudo-obstruction 21.28 10.04 21 100172 2588 79641607
Hallucination 21.19 10.04 182 100011 85563 79558632
Decubitus ulcer 21.16 10.04 55 100138 15632 79628563
Fibromyalgia 21.11 10.04 30 100163 64310 79579885
Sleep disorder therapy 20.71 10.04 14 100179 1010 79643185
Neurogenic bladder 20.68 10.04 26 100167 4186 79640009
Epidural lipomatosis 20.66 10.04 15 100178 1213 79642982
Iron deficiency 20.57 10.04 43 100150 10611 79633584
Streptococcal bacteraemia 20.55 10.04 24 100169 3582 79640613
Irritable bowel syndrome 20.45 10.04 29 100164 62212 79581983
Hepatotoxicity 19.96 10.04 21 100172 51331 79592864
Aspiration 19.74 10.04 63 100130 20095 79624100
Injection site reaction 19.56 10.04 24 100169 54761 79589434
Platelet transfusion 19.38 10.04 19 100174 2323 79641872
Hypophosphataemia 19.29 10.04 62 100131 19851 79624344
Injection site pruritus 19.16 10.04 15 100178 42268 79601927
Platelet count decreased 19.01 10.04 347 99846 194317 79449878
Peritonitis bacterial 18.93 10.04 39 100154 9528 79634667
Fumbling 18.82 10.04 7 100186 136 79644059
Toxic epidermal necrolysis 18.75 10.04 17 100176 44564 79599631
Urticaria 18.21 10.04 147 100046 185054 79459141
Injection site erythema 18.13 10.04 45 100148 78152 79566043
Unresponsive to stimuli 18.00 10.04 126 100067 55662 79588533
Intentional product use issue 17.73 10.04 115 100078 151997 79492198
Knee arthroplasty 17.59 10.04 17 100176 43231 79600964
Sports injury 17.41 10.04 7 100186 169 79644026
Blood potassium decreased 17.40 10.04 109 100084 46403 79597792
Lymphocyte count decreased 17.18 10.04 110 100083 47179 79597016
Anaemia 16.97 10.04 702 99491 444313 79199882
Salivary gland enlargement 16.94 10.04 9 100184 417 79643778
Child abuse 16.88 10.04 9 100184 420 79643775
Abortion spontaneous 16.81 10.04 8 100185 29499 79614696
Product use in unapproved indication 16.67 10.04 218 99975 250141 79394054
Multiple drug therapy 16.66 10.04 23 100170 4055 79640140
Enterovirus infection 16.50 10.04 16 100177 1931 79642264
Spinal cord compression 16.32 10.04 29 100164 6348 79637847
Medical device site pain 16.26 10.04 8 100185 315 79643880
Product taste abnormal 16.20 10.04 17 100176 2254 79641941
Off label use 16.04 10.04 955 99238 906260 78737935
Drug eruption 15.94 10.04 19 100174 43916 79600279
Hepatocellular injury 15.81 10.04 22 100171 47571 79596624
Therapy non-responder 15.80 10.04 61 100132 92244 79551951
Large intestinal obstruction 15.62 10.04 20 100173 3279 79640916
Full blood count decreased 15.62 10.04 71 100122 26748 79617447
Weight decreased 15.59 10.04 569 99624 354629 79289566
Immune effector cell-associated neurotoxicity syndrome 15.49 10.04 27 100166 5821 79638374
Kyphosis 15.48 10.04 18 100175 2673 79641522
Pseudohyponatraemia 15.48 10.04 6 100187 131 79644064
Anal incontinence 15.33 10.04 54 100139 18114 79626081
Escherichia urinary tract infection 15.21 10.04 45 100148 13780 79630415
Transfusion 15.16 10.04 60 100133 21270 79622925
Foreign body sensation in eyes 15.12 10.04 16 100177 2141 79642054
Atrial fibrillation 15.09 10.04 340 99853 197546 79446649
Labelled drug-drug interaction medication error 15.00 10.04 8 100185 27642 79616553
Hypertonia 14.92 10.04 30 100163 7202 79636993
Noninfectious peritonitis 14.86 10.04 7 100186 250 79643945
Hyponatraemic seizure 14.72 10.04 9 100184 546 79643649
Flatulence 14.68 10.04 98 100095 42626 79601569
Eye irritation 14.56 10.04 58 100135 20623 79623572
Non-cardiac chest pain 14.53 10.04 35 100158 9489 79634706
Weight increased 14.53 10.04 253 99940 277133 79367062
Shunt malfunction 14.50 10.04 7 100186 264 79643931
Sickle cell anaemia with crisis 14.17 10.04 31 100162 7891 79636304
Myalgia 14.13 10.04 157 100036 185484 79458711
Myelosuppression 14.02 10.04 18 100175 40278 79603917
Drooling 13.94 10.04 26 100167 5908 79638287
Adenocarcinoma of colon 13.92 10.04 25 100168 5516 79638679
Arthritis 13.82 10.04 86 100107 114794 79529401
Pulmonary function test decreased 13.80 10.04 30 100163 7607 79636588
Anal spasm 13.75 10.04 3 100190 6 79644189
Cholestasis 13.70 10.04 28 100165 52081 79592114
Bursitis 13.55 10.04 15 100178 35829 79608366
Osteoarthritis 13.51 10.04 60 100133 87249 79556946
Hip arthroplasty 13.48 10.04 15 100178 35741 79608454
Impaired work ability 13.44 10.04 4 100189 19677 79624518
Angina pectoris 13.42 10.04 28 100165 51704 79592491
Eczema 13.42 10.04 19 100174 40799 79603396
Bone erosion 13.39 10.04 3 100190 17844 79626351
Gastrointestinal motility disorder 13.36 10.04 26 100167 6096 79638099
Device expulsion 13.28 10.04 8 100185 25853 79618342
Blood albumin decreased 13.25 10.04 63 100130 24180 79620015
Disease progression 13.20 10.04 314 99879 184048 79460147
Type 2 diabetes mellitus 13.14 10.04 33 100160 57089 79587106
Embolism 13.06 10.04 43 100150 13939 79630256
Hyponatraemic encephalopathy 13.00 10.04 7 100186 333 79643862
Pregnancy 12.85 10.04 9 100184 26842 79617353
Urinary tract infection staphylococcal 12.78 10.04 10 100183 905 79643290
Malignant neoplasm progression 12.78 10.04 241 99952 135749 79508446
Cellulitis 12.68 10.04 200 99993 108860 79535335
Injection site swelling 12.67 10.04 25 100168 47107 79597088
Impaired gastric emptying 12.65 10.04 35 100158 10318 79633877
Disability 12.60 10.04 3 100190 17117 79627078
Upper respiratory tract infection 12.48 10.04 172 100021 90996 79553199
Proctalgia 12.41 10.04 34 100159 9967 79634228
Crystal nephropathy 12.41 10.04 12 100181 1443 79642752
Sinusitis 12.37 10.04 172 100021 195329 79448866
Neutrophil count decreased 12.36 10.04 176 100017 93783 79550412
Incorrect product administration duration 12.17 10.04 38 100155 11984 79632211
Dry mouth 12.03 10.04 166 100027 87853 79556342
Peripheral swelling 11.94 10.04 253 99940 269364 79374831
Paraesthesia 11.93 10.04 153 100040 176170 79468025
Distal intestinal obstruction syndrome 11.87 10.04 9 100184 778 79643417
Blood sodium decreased 11.86 10.04 77 100116 33178 79611017
Clostridium difficile infection 11.83 10.04 93 100100 42592 79601603
Palpitations 11.76 10.04 102 100091 126508 79517687
Leukocytosis 11.68 10.04 94 100099 43361 79600834
Bandaemia 11.67 10.04 7 100186 410 79643785
Thrombosis 11.65 10.04 159 100034 83941 79560254
Rectal prolapse 11.59 10.04 14 100179 2164 79642031
Carbohydrate antigen 125 increased 11.56 10.04 14 100179 2170 79642025
Growth hormone-producing pituitary tumour 11.41 10.04 4 100189 65 79644130
Back pain 11.39 10.04 479 99714 303701 79340494
Otitis media acute 11.35 10.04 11 100182 1326 79642869
Vasculitis 11.26 10.04 9 100184 25093 79619102
Metabolic encephalopathy 11.26 10.04 31 100162 9116 79635079
Crowned dens syndrome 11.09 10.04 3 100190 19 79644176
Premature delivery 11.05 10.04 8 100185 23459 79620736
Multiple organ dysfunction syndrome 10.92 10.04 212 99981 120034 79524161
Blood phosphorus decreased 10.71 10.04 25 100168 6643 79637552
Product complaint 10.69 10.04 39 100154 13310 79630885
Respiratory arrest 10.52 10.04 37 100156 57513 79586682
Implant site erosion 10.50 10.04 5 100188 183 79644012
Drug-induced liver injury 10.49 10.04 45 100148 66072 79578123
Pubic pain 10.47 10.04 5 100188 184 79644011
Gastric hypomotility 10.40 10.04 5 100188 187 79644008
Listeraemia 10.33 10.04 4 100189 87 79644108
Instillation site pain 10.31 10.04 8 100185 715 79643480
Upper gastrointestinal haemorrhage 10.31 10.04 88 100105 41292 79602903
Oedema peripheral 10.30 10.04 401 99792 251887 79392308
Hypoglycaemia 10.28 10.04 80 100113 101514 79542681
Blood chloride increased 10.18 10.04 21 100172 5135 79639060
Pancreatitis 10.06 10.04 131 100062 68444 79575751

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A06AD15 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR CONSTIPATION
DRUGS FOR CONSTIPATION
Osmotically acting laxatives
ATC A06AD65 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR CONSTIPATION
DRUGS FOR CONSTIPATION
Osmotically acting laxatives
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D054368 Laxatives
FDA PE N0000009871 Stimulation Large Intestine Fluid/Electrolyte Secretion
FDA MoA N0000010288 Osmotic Activity
FDA EPC N0000175811 Osmotic Laxative

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

DiseaseRelationSNOMED_IDDOID
Constipation indication 14760008 DOID:2089
Tear film insufficiency indication 46152009
Red eye indication 75705005
Incomplete passage of stool indication 249515001
Keratoconjunctivitis sicca off-label use 302896008 DOID:12895
Anuria contraindication 2472002 DOID:2983
Hypocalcemia contraindication 5291005
Hyperkalemia contraindication 14140009
Severe chronic ulcerative colitis contraindication 14311001
Acute vomiting contraindication 23971007
Complete atrioventricular block contraindication 27885002
Toxic megacolon contraindication 28536002 DOID:1770
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Toxic colitis contraindication 42359007
Hypokalemia contraindication 43339004
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Gastrointestinal perforation contraindication 51875005
Paralytic ileus contraindication 55525008 DOID:8442
Perforation of intestine contraindication 56905009 DOID:2074
Congenital myotonia, autosomal dominant form contraindication 57938005
Acute nephropathy contraindication 58574008
Incontinence of feces contraindication 72042002
Diabetes mellitus contraindication 73211009 DOID:9351
Appendicitis contraindication 74400008 DOID:8337
Hyperchloremia contraindication 74450001
Third degree burn injury contraindication 80247002
Hyperglycemia contraindication 80394007 DOID:4195
Intestinal obstruction contraindication 81060008 DOID:8437
Oliguria contraindication 83128009
Hyponatremia contraindication 89627008
Kidney disease contraindication 90708001 DOID:557
Gastrointestinal obstruction contraindication 126765001
Eye infection contraindication 128351009
Seizure disorder contraindication 128613002
Gastroparesis contraindication 235675006
Hyporeninemic hypoaldosteronism contraindication 236464008
Pyloric obstruction contraindication 244815007
Edema contraindication 267038008
Injury of eye region contraindication 282752000
Familial hyperkalemic periodic paralysis contraindication 304737009 DOID:14451
Gastric retention contraindication 307227006
At risk for aspiration contraindication 371736008
Angle-closure glaucoma contraindication 392291006 DOID:13550
Unconscious contraindication 418107008
Severe dehydration contraindication 450316000
Predisposition to Nausea and Vomiting contraindication
Suppression of the Gag Reflex contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 10792306 March 9, 2032 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 11529368 March 9, 2032 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 9592252 Aug. 11, 2032 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 10918723 Sept. 10, 2033 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 9326969 Sept. 10, 2033 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT SUFLAVE BRAINTREE LABS N215344 June 15, 2023 RX FOR SOLUTION ORAL June 15, 2026 NEW PRODUCT

Bioactivity Summary:

None

External reference:

IDSource
4020355 VUID
N0000148185 NUI
D03370 KEGG_DRUG
4010510 VANDF
4010512 VANDF
4017885 VANDF
4018073 VANDF
4018836 VANDF
4019294 VANDF
4020355 VANDF
4020744 VANDF
4024435 VANDF
4024437 VANDF
CHEBI:46793 CHEBI
P4K PDB_CHEM_ID
CHEMBL1201478 ChEMBL_ID
CHEMBL457299 ChEMBL_ID
CHEMBL1201479 ChEMBL_ID
C000595212 MESH_SUPPLEMENTAL_RECORD_UI
C000595213 MESH_SUPPLEMENTAL_RECORD_UI
C000595211 MESH_SUPPLEMENTAL_RECORD_UI
DB09287 DRUGBANK_ID
DB11077 DRUGBANK_ID
DB11161 DRUGBANK_ID
1310594 RXNORM
170507 MMSL
5316 MMSL
64169 MMSL
NOCODE MMSL
d05350 MMSL
002459 NDDF
002470 NDDF
006552 NDDF
007839 NDDF
009223 NDDF
009954 NDDF
010266 NDDF
356076006 SNOMEDCT_US
421083001 SNOMEDCT_US
424535007 SNOMEDCT_US
712566007 SNOMEDCT_US
712567003 SNOMEDCT_US
712568008 SNOMEDCT_US
713360008 SNOMEDCT_US
8030004 SNOMEDCT_US
C0032483 UMLSCUI
CHEMBL2108780 ChEMBL_ID
174 PUBCHEM_CID
G2M7P15E5P UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Systane Lubricant HUMAN OTC DRUG LABEL 2 0065-0429 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 13 sections
Systane Lubricant HUMAN OTC DRUG LABEL 2 0065-0429 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 13 sections
Systane HUMAN OTC DRUG LABEL 2 0065-0431 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 13 sections
Systane HUMAN OTC DRUG LABEL 2 0065-0431 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 13 sections
Systane HUMAN OTC DRUG LABEL 2 0065-0454 GEL 4 mg OPHTHALMIC OTC monograph final 13 sections
Systane HUMAN OTC DRUG LABEL 2 0065-0454 GEL 4 mg OPHTHALMIC OTC monograph final 13 sections
Systane Ultra HUMAN OTC DRUG LABEL 2 0065-1431 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 13 sections
Systane Ultra HUMAN OTC DRUG LABEL 2 0065-1431 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 13 sections
Systane Ultra HUMAN OTC DRUG LABEL 2 0065-1431 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 13 sections
Systane Ultra HUMAN OTC DRUG LABEL 2 0065-1431 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 13 sections
SystaneULTRA HUMAN OTC DRUG LABEL 2 0065-1432 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 12 sections
SystaneULTRA HUMAN OTC DRUG LABEL 2 0065-1432 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 12 sections
SYSTANE HYDRATION PF PRESERVATIVE FREE HUMAN OTC DRUG LABEL 2 0065-1437 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 13 sections
SYSTANE HYDRATION PF PRESERVATIVE FREE HUMAN OTC DRUG LABEL 2 0065-1437 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 13 sections
Systane Ultra Preservative Free HUMAN OTC DRUG LABEL 2 0065-1507 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 12 sections
Systane Ultra Preservative Free HUMAN OTC DRUG LABEL 2 0065-1507 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 12 sections
SYSTANE HYDRATION PF PRESERVATIVE FREE HUMAN OTC DRUG LABEL 2 0065-1510 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 13 sections
SYSTANE HYDRATION PF PRESERVATIVE FREE HUMAN OTC DRUG LABEL 2 0065-1510 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 13 sections
SYSTANE HYDRATION PF PRESERVATIVE FREE HUMAN OTC DRUG LABEL 2 0065-1510 SOLUTION/ DROPS 4 mg OPHTHALMIC OTC monograph final 13 sections
GenTeal Tears Gel Drops HUMAN OTC DRUG LABEL 2 0065-8067 GEL 4 mg OPHTHALMIC OTC monograph final 13 sections
GenTeal Tears Gel Drops HUMAN OTC DRUG LABEL 2 0065-8067 GEL 4 mg OPHTHALMIC OTC monograph final 13 sections
Good Sense Clear Lax HUMAN OTC DRUG LABEL 1 0113-0306 POWDER, FOR SOLUTION 17 g ORAL ANDA 16 sections
Good Sense Clear Lax HUMAN OTC DRUG LABEL 1 0113-0306 POWDER, FOR SOLUTION 17 g ORAL ANDA 16 sections
Good Sense Lubricant Eye HUMAN OTC DRUG LABEL 2 0113-0896 SOLUTION/ DROPS 0.40 g OPHTHALMIC OTC monograph final 13 sections
Good Sense Lubricant Eye HUMAN OTC DRUG LABEL 2 0113-0896 SOLUTION/ DROPS 0.40 g OPHTHALMIC OTC monograph final 13 sections
good sense clearlax HUMAN OTC DRUG LABEL 1 0113-1023 POWDER, FOR SOLUTION 17 g ORAL ANDA 16 sections
injoy constipation relief HUMAN OTC DRUG LABEL 1 0113-6900 POWDER, FOR SOLUTION 17 g ORAL ANDA 16 sections
Basic Care Clearlax HUMAN OTC DRUG LABEL 1 0113-7306 POWDER, FOR SOLUTION 17 g ORAL ANDA 16 sections
Glitch Advanced Relief Eye Drops HUMAN OTC DRUG LABEL 2 0276-0801 SOLUTION/ DROPS 1 g OPHTHALMIC OTC monograph final 14 sections
smooth lax HUMAN OTC DRUG LABEL 1 0363-0306 POWDER, FOR SOLUTION 17 g ORAL ANDA 16 sections