| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4253 | 25322-68-3 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
|
| Dose | Unit | Route |
|---|---|---|
| 10 | g | O |
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 13, 1984 | FDA | BRAINTREE | |
| Sept. 21, 2018 | PMDA | EA Pharma Co., Ltd. |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 |
None
| Source | Code | Description |
|---|---|---|
| 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 |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 |
None
None
None
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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 |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
None
| ID | Source |
|---|---|
| 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 |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |