| 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 | 299.22 | 9.95 | 685 | 61313 | 185023 | 50358103 |
| Infective pulmonary exacerbation of cystic fibrosis | 201.90 | 9.95 | 124 | 61874 | 7785 | 50535341 |
| Contraindicated product administered | 156.26 | 9.95 | 6 | 61992 | 148952 | 50394174 |
| Rheumatoid arthritis | 126.65 | 9.95 | 45 | 61953 | 202505 | 50340621 |
| Synovitis | 126.54 | 9.95 | 6 | 61992 | 123859 | 50419267 |
| Drug ineffective | 116.82 | 9.95 | 563 | 61435 | 818770 | 49724356 |
| Systemic lupus erythematosus | 113.82 | 9.95 | 18 | 61980 | 140604 | 50402522 |
| Macular degeneration | 112.79 | 9.95 | 112 | 61886 | 14276 | 50528850 |
| Treatment failure | 106.16 | 9.95 | 20 | 61978 | 137617 | 50405509 |
| Drug intolerance | 106.02 | 9.95 | 69 | 61929 | 219035 | 50324091 |
| Maternal exposure during pregnancy | 106.01 | 9.95 | 32 | 61966 | 159746 | 50383380 |
| Arthropathy | 105.91 | 9.95 | 31 | 61967 | 157875 | 50385251 |
| Hand deformity | 101.87 | 9.95 | 5 | 61993 | 100194 | 50442932 |
| Completed suicide | 86.42 | 9.95 | 27 | 61971 | 131862 | 50411264 |
| Abdominal pain | 76.33 | 9.95 | 523 | 61475 | 235705 | 50307421 |
| Glossodynia | 73.35 | 9.95 | 25 | 61973 | 115544 | 50427582 |
| Pericarditis | 71.11 | 9.95 | 7 | 61991 | 78682 | 50464444 |
| Joint swelling | 68.79 | 9.95 | 122 | 61876 | 245164 | 50297962 |
| Swelling | 67.80 | 9.95 | 88 | 61910 | 200784 | 50342342 |
| Urinary tract infection | 67.68 | 9.95 | 488 | 61510 | 223532 | 50319594 |
| Therapeutic product effect decreased | 66.91 | 9.95 | 42 | 61956 | 136008 | 50407118 |
| Exposure during pregnancy | 65.79 | 9.95 | 33 | 61965 | 120982 | 50422144 |
| Dehydration | 65.24 | 9.95 | 363 | 61635 | 152086 | 50391040 |
| Febrile neutropenia | 62.37 | 9.95 | 261 | 61737 | 97406 | 50445720 |
| Drug hypersensitivity | 57.58 | 9.95 | 140 | 61858 | 250870 | 50292256 |
| Mental status changes | 56.21 | 9.95 | 132 | 61866 | 36140 | 50506986 |
| Plasma cell myeloma | 54.11 | 9.95 | 119 | 61879 | 31203 | 50511923 |
| Discomfort | 53.92 | 9.95 | 33 | 61965 | 108347 | 50434779 |
| Wound | 52.93 | 9.95 | 32 | 61966 | 105762 | 50437364 |
| Infusion related reaction | 52.49 | 9.95 | 79 | 61919 | 169478 | 50373648 |
| Alopecia | 45.63 | 9.95 | 151 | 61847 | 244896 | 50298230 |
| Lower respiratory tract infection | 43.31 | 9.95 | 32 | 61966 | 95169 | 50447957 |
| Arthralgia | 42.55 | 9.95 | 339 | 61659 | 438363 | 50104763 |
| Abdominal distension | 42.06 | 9.95 | 189 | 61809 | 72714 | 50470412 |
| Intestinal obstruction | 41.95 | 9.95 | 97 | 61901 | 26286 | 50516840 |
| Toxicity to various agents | 41.61 | 9.95 | 128 | 61870 | 212371 | 50330755 |
| Intentional overdose | 38.82 | 9.95 | 14 | 61984 | 62490 | 50480636 |
| Helicobacter infection | 38.77 | 9.95 | 7 | 61991 | 49695 | 50493431 |
| Failure to thrive | 38.26 | 9.95 | 43 | 61955 | 6315 | 50536811 |
| Drug interaction | 37.84 | 9.95 | 122 | 61876 | 199499 | 50343627 |
| Hypersensitivity | 37.07 | 9.95 | 137 | 61861 | 215024 | 50328102 |
| Small intestinal obstruction | 36.00 | 9.95 | 68 | 61930 | 16000 | 50527126 |
| Nausea | 34.86 | 9.95 | 1119 | 60879 | 704279 | 49838847 |
| Pneumonia | 34.58 | 9.95 | 653 | 61345 | 377748 | 50165378 |
| Sepsis | 33.09 | 9.95 | 277 | 61721 | 132648 | 50410478 |
| Asthenia | 31.02 | 9.95 | 556 | 61442 | 318486 | 50224640 |
| Fall | 30.59 | 9.95 | 578 | 61420 | 334354 | 50208772 |
| Aplastic anaemia | 30.15 | 9.95 | 42 | 61956 | 7661 | 50535465 |
| Nasopharyngitis | 29.95 | 9.95 | 128 | 61870 | 192799 | 50350327 |
| Acute respiratory failure | 28.69 | 9.95 | 89 | 61909 | 28693 | 50514433 |
| Eye irritation | 28.34 | 9.95 | 64 | 61934 | 17076 | 50526050 |
| Full blood count decreased | 27.98 | 9.95 | 75 | 61923 | 22271 | 50520855 |
| Vomiting | 27.88 | 9.95 | 750 | 61248 | 460008 | 50083118 |
| Hepatic enzyme increased | 26.69 | 9.95 | 83 | 61915 | 137297 | 50405829 |
| Abortion spontaneous | 26.55 | 9.95 | 9 | 61989 | 41763 | 50501363 |
| Abdominal discomfort | 26.27 | 9.95 | 171 | 61827 | 231470 | 50311656 |
| Disease progression | 25.59 | 9.95 | 203 | 61795 | 95663 | 50447463 |
| Condition aggravated | 25.41 | 9.95 | 237 | 61761 | 296821 | 50246305 |
| Off label use | 25.32 | 9.95 | 419 | 61579 | 474007 | 50069119 |
| Hospice care | 24.91 | 9.95 | 33 | 61965 | 5739 | 50537387 |
| Respiratory distress | 24.78 | 9.95 | 88 | 61910 | 30401 | 50512725 |
| Deep vein thrombosis | 24.01 | 9.95 | 163 | 61835 | 73141 | 50469985 |
| Hyponatraemia | 23.73 | 9.95 | 200 | 61798 | 95939 | 50447187 |
| Drug abuse | 23.68 | 9.95 | 23 | 61975 | 59823 | 50483303 |
| Foetal exposure during pregnancy | 23.29 | 9.95 | 3 | 61995 | 27356 | 50515770 |
| Product odour abnormal | 22.78 | 9.95 | 15 | 61983 | 1062 | 50542064 |
| Injection site pain | 22.33 | 9.95 | 66 | 61932 | 110958 | 50432168 |
| Pulmonary embolism | 22.22 | 9.95 | 206 | 61792 | 101498 | 50441628 |
| Blood potassium decreased | 22.22 | 9.95 | 97 | 61901 | 36848 | 50506278 |
| Foreign body sensation in eyes | 21.90 | 9.95 | 18 | 61980 | 1793 | 50541333 |
| White blood cell count decreased | 21.42 | 9.95 | 228 | 61770 | 116494 | 50426632 |
| Hypoxia | 21.34 | 9.95 | 121 | 61877 | 51002 | 50492124 |
| Psoriatic arthropathy | 21.13 | 9.95 | 16 | 61982 | 47016 | 50496110 |
| Blister | 20.87 | 9.95 | 46 | 61952 | 85372 | 50457754 |
| Hypophagia | 20.82 | 9.95 | 78 | 61920 | 27650 | 50515476 |
| Peritonitis bacterial | 20.66 | 9.95 | 27 | 61971 | 4634 | 50538492 |
| Death | 20.31 | 9.95 | 532 | 61466 | 324847 | 50218279 |
| Gastrointestinal motility disorder | 19.80 | 9.95 | 26 | 61972 | 4483 | 50538643 |
| Rhinovirus infection | 19.74 | 9.95 | 23 | 61975 | 3511 | 50539615 |
| C-reactive protein increased | 19.57 | 9.95 | 32 | 61966 | 66442 | 50476684 |
| Platelet count decreased | 19.54 | 9.95 | 199 | 61799 | 100527 | 50442599 |
| Ill-defined disorder | 19.40 | 9.95 | 23 | 61975 | 54631 | 50488495 |
| Colitis | 19.37 | 9.95 | 96 | 61902 | 38433 | 50504693 |
| Adenocarcinoma of colon | 19.14 | 9.95 | 18 | 61980 | 2144 | 50540982 |
| Noninfectious peritonitis | 19.04 | 9.95 | 7 | 61991 | 135 | 50542991 |
| Flatulence | 19.00 | 9.95 | 79 | 61919 | 29379 | 50513747 |
| Fumbling | 18.85 | 9.95 | 7 | 61991 | 139 | 50542987 |
| Hip fracture | 18.69 | 9.95 | 72 | 61926 | 25859 | 50517267 |
| Impaired healing | 18.38 | 9.95 | 36 | 61962 | 69750 | 50473376 |
| Instillation site pain | 18.32 | 9.95 | 12 | 61986 | 842 | 50542284 |
| Cystic fibrosis | 18.32 | 9.95 | 20 | 61978 | 2844 | 50540282 |
| Malnutrition | 18.29 | 9.95 | 46 | 61952 | 13143 | 50529983 |
| Oedema peripheral | 18.14 | 9.95 | 283 | 61715 | 157678 | 50385448 |
| Suicide attempt | 18.12 | 9.95 | 22 | 61976 | 51710 | 50491416 |
| Injection site pruritus | 17.84 | 9.95 | 14 | 61984 | 40397 | 50502729 |
| Injection site reaction | 17.81 | 9.95 | 21 | 61977 | 50011 | 50493115 |
| Musculoskeletal stiffness | 17.70 | 9.95 | 89 | 61909 | 128392 | 50414734 |
| Venous pressure jugular increased | 17.67 | 9.95 | 10 | 61988 | 539 | 50542587 |
| Rash | 17.63 | 9.95 | 405 | 61593 | 437066 | 50106060 |
| Seizure | 17.49 | 9.95 | 221 | 61777 | 117653 | 50425473 |
| Carbon dioxide decreased | 17.49 | 9.95 | 16 | 61982 | 1841 | 50541285 |
| Lethargy | 17.45 | 9.95 | 112 | 61886 | 49320 | 50493806 |
| Pseudohyponatraemia | 17.38 | 9.95 | 5 | 61993 | 42 | 50543084 |
| Device expulsion | 16.99 | 9.95 | 7 | 61991 | 28815 | 50514311 |
| Atelectasis | 16.84 | 9.95 | 55 | 61943 | 18215 | 50524911 |
| Therapeutic product effect incomplete | 16.58 | 9.95 | 57 | 61941 | 91458 | 50451668 |
| Decubitus ulcer | 16.51 | 9.95 | 36 | 61962 | 9382 | 50533744 |
| Neuropathy peripheral | 16.37 | 9.95 | 186 | 61812 | 96571 | 50446555 |
| Product taste abnormal | 16.36 | 9.95 | 15 | 61983 | 1730 | 50541396 |
| Hospitalisation | 15.54 | 9.95 | 139 | 61859 | 67798 | 50475328 |
| Blood sodium decreased | 15.47 | 9.95 | 59 | 61939 | 21088 | 50522038 |
| Neutrophil count decreased | 15.46 | 9.95 | 103 | 61895 | 45923 | 50497203 |
| Salivary gland enlargement | 15.44 | 9.95 | 8 | 61990 | 361 | 50542765 |
| Blood calcium decreased | 15.34 | 9.95 | 58 | 61940 | 20648 | 50522478 |
| Urticaria | 15.00 | 9.95 | 95 | 61903 | 129466 | 50413660 |
| Impaired gastric emptying | 14.91 | 9.95 | 33 | 61965 | 8685 | 50534441 |
| Product use issue | 14.66 | 9.95 | 115 | 61883 | 149360 | 50393766 |
| Hyponatraemic seizure | 14.54 | 9.95 | 8 | 61990 | 408 | 50542718 |
| Urinary retention | 14.43 | 9.95 | 67 | 61931 | 26123 | 50517003 |
| Pleural effusion | 14.42 | 9.95 | 158 | 61840 | 81296 | 50461830 |
| Rectal prolapse | 14.42 | 9.95 | 14 | 61984 | 1735 | 50541391 |
| Injection site swelling | 14.38 | 9.95 | 18 | 61980 | 41755 | 50501371 |
| Hepatotoxicity | 13.94 | 9.95 | 8 | 61990 | 27218 | 50515908 |
| Embolism | 13.80 | 9.95 | 28 | 61970 | 6940 | 50536186 |
| Large intestinal obstruction | 13.77 | 9.95 | 14 | 61984 | 1835 | 50541291 |
| Inflammation | 13.61 | 9.95 | 31 | 61967 | 56881 | 50486245 |
| Hepatic function abnormal | 13.59 | 9.95 | 12 | 61986 | 32669 | 50510457 |
| Encephalopathy | 13.55 | 9.95 | 79 | 61919 | 33632 | 50509494 |
| Atrial fibrillation | 13.53 | 9.95 | 187 | 61811 | 101558 | 50441568 |
| Staphylococcal infection | 13.38 | 9.95 | 82 | 61916 | 35534 | 50507592 |
| Neurogenic bladder | 13.37 | 9.95 | 17 | 61981 | 2840 | 50540286 |
| Injection site erythema | 13.36 | 9.95 | 47 | 61951 | 74889 | 50468237 |
| Liver injury | 13.12 | 9.95 | 7 | 61991 | 24799 | 50518327 |
| Infection | 13.10 | 9.95 | 142 | 61856 | 172812 | 50370314 |
| Intentional self-injury | 13.01 | 9.95 | 6 | 61992 | 23106 | 50520020 |
| Sulphaemoglobinaemia | 12.97 | 9.95 | 3 | 61995 | 9 | 50543117 |
| Kyphosis | 12.93 | 9.95 | 15 | 61983 | 2280 | 50540846 |
| Product complaint | 12.89 | 9.95 | 37 | 61961 | 11429 | 50531697 |
| Hip arthroplasty | 12.86 | 9.95 | 11 | 61987 | 30418 | 50512708 |
| Distal intestinal obstruction syndrome | 12.70 | 9.95 | 7 | 61991 | 358 | 50542768 |
| Respiratory failure | 12.70 | 9.95 | 169 | 61829 | 91012 | 50452114 |
| Streptococcal bacteraemia | 12.65 | 9.95 | 12 | 61986 | 1446 | 50541680 |
| Back pain | 12.36 | 9.95 | 355 | 61643 | 219675 | 50323451 |
| Proctalgia | 12.25 | 9.95 | 22 | 61976 | 4981 | 50538145 |
| Drug resistance | 12.23 | 9.95 | 4 | 61994 | 18985 | 50524141 |
| Calculus bladder | 12.22 | 9.95 | 8 | 61990 | 561 | 50542565 |
| Urinary tract infection enterococcal | 12.22 | 9.95 | 15 | 61983 | 2419 | 50540707 |
| Haemorrhoids | 12.21 | 9.95 | 51 | 61947 | 19002 | 50524124 |
| Unmasking of previously unidentified disease | 12.16 | 9.95 | 9 | 61989 | 769 | 50542357 |
| Pregnancy | 12.13 | 9.95 | 11 | 61987 | 29566 | 50513560 |
| Creatinine renal clearance decreased | 12.08 | 9.95 | 37 | 61961 | 11844 | 50531282 |
| Carbohydrate antigen 125 increased | 12.05 | 9.95 | 15 | 61983 | 2452 | 50540674 |
| Anxiety | 11.82 | 9.95 | 293 | 61705 | 177313 | 50365813 |
| Psoriasis | 11.82 | 9.95 | 44 | 61954 | 68956 | 50474170 |
| Orthostatic hypotension | 11.79 | 9.95 | 69 | 61929 | 29412 | 50513714 |
| Knee arthroplasty | 11.77 | 9.95 | 16 | 61982 | 35830 | 50507296 |
| Reticulocyte count increased | 11.76 | 9.95 | 9 | 61989 | 809 | 50542317 |
| Biliary dyskinesia | 11.66 | 9.95 | 15 | 61983 | 2535 | 50540591 |
| Balance disorder | 11.62 | 9.95 | 135 | 61863 | 70455 | 50472671 |
| Weight decreased | 11.62 | 9.95 | 354 | 61644 | 220891 | 50322235 |
| Hypercalcaemia | 11.61 | 9.95 | 58 | 61940 | 23294 | 50519832 |
| Incorrect product administration duration | 11.48 | 9.95 | 31 | 61967 | 9244 | 50533882 |
| Pneumonia aspiration | 11.40 | 9.95 | 71 | 61927 | 30933 | 50512193 |
| Visceral pain | 11.30 | 9.95 | 3 | 61995 | 18 | 50543108 |
| Erythema | 11.17 | 9.95 | 120 | 61878 | 146294 | 50396832 |
| Lung adenocarcinoma stage I | 11.16 | 9.95 | 3 | 61995 | 19 | 50543107 |
| Escherichia urinary tract infection | 11.16 | 9.95 | 33 | 61965 | 10362 | 50532764 |
| Faecaloma | 11.15 | 9.95 | 26 | 61972 | 7082 | 50536044 |
| Compression fracture | 11.02 | 9.95 | 23 | 61975 | 5814 | 50537312 |
| Toxic epidermal necrolysis | 10.99 | 9.95 | 6 | 61992 | 20986 | 50522140 |
| Listeraemia | 10.98 | 9.95 | 4 | 61994 | 75 | 50543051 |
| Blood cholesterol increased | 10.97 | 9.95 | 33 | 61965 | 55182 | 50487944 |
| Anal incontinence | 10.96 | 9.95 | 35 | 61963 | 11455 | 50531671 |
| Red blood cell sedimentation rate increased | 10.85 | 9.95 | 12 | 61986 | 29404 | 50513722 |
| Atrial enlargement | 10.83 | 9.95 | 6 | 61992 | 310 | 50542816 |
| Pustule | 10.80 | 9.95 | 10 | 61988 | 1168 | 50541958 |
| Fibrinolysis | 10.78 | 9.95 | 3 | 61995 | 22 | 50543104 |
| Irritable bowel syndrome | 10.76 | 9.95 | 30 | 61968 | 51411 | 50491715 |
| Diverticulum | 10.74 | 9.95 | 33 | 61965 | 10581 | 50532545 |
| Decreased appetite | 10.69 | 9.95 | 322 | 61676 | 200601 | 50342525 |
| Tremor | 10.69 | 9.95 | 199 | 61799 | 114704 | 50428422 |
| Sedation complication | 10.55 | 9.95 | 29 | 61969 | 8737 | 50534389 |
| Dysphagia | 10.52 | 9.95 | 143 | 61855 | 77375 | 50465751 |
| Enterovirus infection | 10.47 | 9.95 | 8 | 61990 | 717 | 50542409 |
| Cognitive disorder | 10.46 | 9.95 | 91 | 61907 | 44032 | 50499094 |
| Adverse event | 10.33 | 9.95 | 24 | 61974 | 43739 | 50499387 |
| Cardiomyopathy | 10.21 | 9.95 | 42 | 61956 | 15544 | 50527582 |
| Early satiety | 10.03 | 9.95 | 8 | 61990 | 764 | 50542362 |
| Pelvic fracture | 10.01 | 9.95 | 34 | 61964 | 11486 | 50531640 |
| Denture wearer | 10.00 | 9.95 | 5 | 61993 | 209 | 50542917 |
| 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 | 169.58 | 10.31 | 469 | 44825 | 113691 | 29415542 |
| Infective pulmonary exacerbation of cystic fibrosis | 114.83 | 10.31 | 87 | 45207 | 6149 | 29523084 |
| Toxicity to various agents | 108.42 | 10.31 | 66 | 45228 | 173595 | 29355638 |
| Appendicolith | 95.50 | 10.31 | 62 | 45232 | 3418 | 29525815 |
| Drug interaction | 83.56 | 10.31 | 108 | 45186 | 197277 | 29331956 |
| Urinary tract infection | 78.01 | 10.31 | 266 | 45028 | 72088 | 29457145 |
| Completed suicide | 72.34 | 10.31 | 24 | 45270 | 90222 | 29439011 |
| Abdominal distension | 70.34 | 10.31 | 191 | 45103 | 45720 | 29483513 |
| Abdominal pain | 64.78 | 10.31 | 391 | 44903 | 134966 | 29394267 |
| Plasma cell myeloma | 59.46 | 10.31 | 157 | 45137 | 36958 | 29492275 |
| Appendicitis | 58.97 | 10.31 | 70 | 45224 | 8709 | 29520524 |
| Drug ineffective | 55.56 | 10.31 | 328 | 44966 | 362842 | 29166391 |
| Febrile neutropenia | 54.80 | 10.31 | 326 | 44968 | 111914 | 29417319 |
| Sepsis | 46.31 | 10.31 | 375 | 44919 | 142307 | 29386926 |
| Dehydration | 45.96 | 10.31 | 317 | 44977 | 114431 | 29414802 |
| Ocular procedural complication | 45.42 | 10.31 | 12 | 45282 | 54 | 29529179 |
| Vomiting | 44.68 | 10.31 | 509 | 44785 | 211751 | 29317482 |
| Aplastic anaemia | 42.59 | 10.31 | 55 | 45239 | 7455 | 29521778 |
| Victim of child abuse | 41.63 | 10.31 | 22 | 45272 | 823 | 29528410 |
| Fall | 38.21 | 10.31 | 427 | 44867 | 176751 | 29352482 |
| Interstitial lung disease | 35.85 | 10.31 | 22 | 45272 | 57696 | 29471537 |
| Drug abuse | 34.45 | 10.31 | 43 | 45251 | 79840 | 29449393 |
| Hyponatraemia | 33.32 | 10.31 | 197 | 45097 | 67436 | 29461797 |
| Muscle spasticity | 32.90 | 10.31 | 39 | 45255 | 4844 | 29524389 |
| Pneumonia | 32.11 | 10.31 | 677 | 44617 | 319495 | 29209738 |
| Hospice care | 30.13 | 10.31 | 38 | 45256 | 5030 | 29524203 |
| Cerebral artery thrombosis | 30.13 | 10.31 | 17 | 45277 | 725 | 29528508 |
| Small intestinal obstruction | 29.30 | 10.31 | 63 | 45231 | 12998 | 29516235 |
| C-reactive protein increased | 28.72 | 10.31 | 16 | 45278 | 44247 | 29484986 |
| Nausea | 28.44 | 10.31 | 610 | 44684 | 288645 | 29240588 |
| Bacteraemia | 28.14 | 10.31 | 71 | 45223 | 16252 | 29512981 |
| Brain scan abnormal | 27.99 | 10.31 | 17 | 45277 | 833 | 29528400 |
| Intentional overdose | 27.92 | 10.31 | 12 | 45282 | 38516 | 29490717 |
| Stress | 27.65 | 10.31 | 84 | 45210 | 21406 | 29507827 |
| Ascites | 27.41 | 10.31 | 120 | 45174 | 36499 | 29492734 |
| Renal impairment | 27.20 | 10.31 | 52 | 45242 | 81281 | 29447952 |
| Hallucination | 26.54 | 10.31 | 137 | 45157 | 44575 | 29484658 |
| Rhabdomyolysis | 25.93 | 10.31 | 33 | 45261 | 60775 | 29468458 |
| Failure to thrive | 25.81 | 10.31 | 44 | 45250 | 7640 | 29521593 |
| Complication associated with device | 24.83 | 10.31 | 35 | 45259 | 5156 | 29524077 |
| Cardiogenic shock | 24.68 | 10.31 | 75 | 45219 | 19115 | 29510118 |
| Treatment failure | 24.48 | 10.31 | 13 | 45281 | 36926 | 29492307 |
| Pneumonia aspiration | 24.23 | 10.31 | 116 | 45178 | 36621 | 29492612 |
| Suicide attempt | 24.12 | 10.31 | 11 | 45283 | 34099 | 29495134 |
| Foetal exposure during pregnancy | 23.83 | 10.31 | 11 | 45283 | 33856 | 29495377 |
| Myocardial infarction | 23.61 | 10.31 | 88 | 45206 | 110208 | 29419025 |
| Hypophagia | 23.57 | 10.31 | 78 | 45216 | 20794 | 29508439 |
| Cystic fibrosis | 23.53 | 10.31 | 19 | 45275 | 1473 | 29527760 |
| Hip fracture | 22.84 | 10.31 | 50 | 45244 | 10442 | 29518791 |
| Rhinovirus infection | 22.19 | 10.31 | 26 | 45268 | 3190 | 29526043 |
| Deep vein thrombosis | 22.01 | 10.31 | 157 | 45137 | 57242 | 29471991 |
| Respiratory distress | 20.19 | 10.31 | 100 | 45194 | 32006 | 29497227 |
| Therapeutic product effect incomplete | 19.31 | 10.31 | 19 | 45275 | 39286 | 29489947 |
| Rheumatoid arthritis | 18.94 | 10.31 | 13 | 45281 | 32139 | 29497094 |
| Mental status changes | 18.67 | 10.31 | 104 | 45190 | 34823 | 29494410 |
| Decubitus ulcer | 18.43 | 10.31 | 37 | 45257 | 7274 | 29521959 |
| Contraindicated product administered | 18.28 | 10.31 | 3 | 45291 | 18263 | 29510970 |
| Ileus | 18.25 | 10.31 | 56 | 45238 | 14346 | 29514887 |
| Urinary incontinence | 18.08 | 10.31 | 61 | 45233 | 16420 | 29512813 |
| Back pain | 17.85 | 10.31 | 237 | 45057 | 102047 | 29427186 |
| Psoriasis | 17.73 | 10.31 | 14 | 45280 | 32213 | 29497020 |
| Implant site erosion | 17.70 | 10.31 | 6 | 45288 | 71 | 29529162 |
| Muscular weakness | 16.39 | 10.31 | 156 | 45138 | 61896 | 29467337 |
| Shunt malfunction | 16.22 | 10.31 | 7 | 45287 | 165 | 29529068 |
| Aspiration | 16.22 | 10.31 | 43 | 45251 | 10137 | 29519096 |
| Coma | 16.21 | 10.31 | 22 | 45272 | 39428 | 29489805 |
| Hypoxia | 16.13 | 10.31 | 126 | 45168 | 47253 | 29481980 |
| Acute respiratory failure | 15.73 | 10.31 | 81 | 45213 | 26321 | 29502912 |
| Areflexia | 15.35 | 10.31 | 20 | 45274 | 2734 | 29526499 |
| Product use in unapproved indication | 15.10 | 10.31 | 75 | 45219 | 86800 | 29442433 |
| Hepatic function abnormal | 15.04 | 10.31 | 23 | 45271 | 39236 | 29489997 |
| Hepatocellular injury | 14.79 | 10.31 | 7 | 45287 | 21236 | 29507997 |
| Sports injury | 14.55 | 10.31 | 6 | 45288 | 126 | 29529107 |
| Atelectasis | 14.34 | 10.31 | 54 | 45240 | 15338 | 29513895 |
| Condition aggravated | 14.33 | 10.31 | 149 | 45145 | 146146 | 29383087 |
| Hypertonia | 14.30 | 10.31 | 23 | 45271 | 3806 | 29525427 |
| Burkholderia test positive | 14.25 | 10.31 | 12 | 45282 | 987 | 29528246 |
| Malignant neoplasm progression | 14.09 | 10.31 | 174 | 45120 | 73685 | 29455548 |
| Chylothorax | 14.03 | 10.31 | 10 | 45284 | 643 | 29528590 |
| Underdose | 13.98 | 10.31 | 45 | 45249 | 11824 | 29517409 |
| Metabolic encephalopathy | 13.57 | 10.31 | 22 | 45272 | 3665 | 29525568 |
| Blood creatine phosphokinase increased | 13.56 | 10.31 | 26 | 45268 | 40618 | 29488615 |
| Unresponsive to stimuli | 13.55 | 10.31 | 75 | 45219 | 25051 | 29504182 |
| Epidural lipomatosis | 13.26 | 10.31 | 10 | 45284 | 701 | 29528532 |
| Renal failure | 13.22 | 10.31 | 117 | 45177 | 118482 | 29410751 |
| Cytokine release syndrome | 13.04 | 10.31 | 47 | 45247 | 13072 | 29516161 |
| Dysphagia | 13.01 | 10.31 | 135 | 45159 | 54791 | 29474442 |
| Liver disorder | 12.96 | 10.31 | 14 | 45280 | 27735 | 29501498 |
| Hospitalisation | 12.84 | 10.31 | 117 | 45177 | 45871 | 29483362 |
| Lower respiratory tract infection | 12.80 | 10.31 | 13 | 45281 | 26489 | 29502744 |
| Fatigue | 12.55 | 10.31 | 599 | 44695 | 316222 | 29213011 |
| Drug eruption | 12.47 | 10.31 | 5 | 45289 | 16736 | 29512497 |
| Flatulence | 12.47 | 10.31 | 57 | 45237 | 17652 | 29511581 |
| Humerus fracture | 12.09 | 10.31 | 16 | 45278 | 2220 | 29527013 |
| Encephalopathy | 11.95 | 10.31 | 85 | 45209 | 30958 | 29498275 |
| Cholestasis | 11.92 | 10.31 | 11 | 45283 | 23451 | 29505782 |
| Myalgia | 11.69 | 10.31 | 66 | 45228 | 73953 | 29455280 |
| Anal incontinence | 11.63 | 10.31 | 29 | 45265 | 6586 | 29522647 |
| Sickle cell anaemia with crisis | 11.62 | 10.31 | 17 | 45277 | 2591 | 29526642 |
| Premature baby | 11.57 | 10.31 | 6 | 45288 | 17274 | 29511959 |
| Transfusion reaction | 11.56 | 10.31 | 10 | 45284 | 853 | 29528380 |
| Faecaloma | 11.48 | 10.31 | 22 | 45272 | 4180 | 29525053 |
| Tracheostomy malfunction | 11.19 | 10.31 | 4 | 45290 | 56 | 29529177 |
| Leukopenia | 11.18 | 10.31 | 45 | 45249 | 55158 | 29474075 |
| Viral diarrhoea | 11.14 | 10.31 | 5 | 45289 | 130 | 29529103 |
| Overdose | 11.13 | 10.31 | 74 | 45220 | 79745 | 29449488 |
| Cerebral infarction | 10.93 | 10.31 | 13 | 45281 | 24662 | 29504571 |
| Facial paralysis | 10.88 | 10.31 | 36 | 45258 | 9593 | 29519640 |
| Gastric hypomotility | 10.87 | 10.31 | 4 | 45290 | 61 | 29529172 |
| Drug hypersensitivity | 10.80 | 10.31 | 61 | 45233 | 68345 | 29460888 |
| Pruritus | 10.64 | 10.31 | 121 | 45173 | 116728 | 29412505 |
| Crowned dens syndrome | 10.64 | 10.31 | 3 | 45291 | 18 | 29529215 |
| Blood pressure decreased | 10.58 | 10.31 | 35 | 45259 | 45442 | 29483791 |
| Encopresis | 10.57 | 10.31 | 5 | 45289 | 147 | 29529086 |
| Implant site swelling | 10.48 | 10.31 | 4 | 45290 | 68 | 29529165 |
| Chronic sinusitis | 10.44 | 10.31 | 13 | 45281 | 1698 | 29527535 |
| Confusional state | 10.44 | 10.31 | 263 | 45031 | 127614 | 29401619 |
| Medical device site pain | 10.37 | 10.31 | 4 | 45290 | 70 | 29529163 |
| Perirectal abscess | 10.37 | 10.31 | 12 | 45282 | 1453 | 29527780 |
| 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 | 291.25 | 9.84 | 803 | 83216 | 228534 | 64186179 |
| Infective pulmonary exacerbation of cystic fibrosis | 285.88 | 9.84 | 183 | 83836 | 11613 | 64403100 |
| Completed suicide | 154.39 | 9.84 | 50 | 83969 | 224364 | 64190349 |
| Drug ineffective | 145.88 | 9.84 | 583 | 83436 | 839664 | 63575049 |
| Febrile neutropenia | 140.19 | 9.84 | 549 | 83470 | 187108 | 64227605 |
| Toxicity to various agents | 120.91 | 9.84 | 179 | 83840 | 363334 | 64051379 |
| Synovitis | 114.89 | 9.84 | 3 | 84016 | 99087 | 64315626 |
| Contraindicated product administered | 112.58 | 9.84 | 7 | 84012 | 107822 | 64306891 |
| Rheumatoid arthritis | 112.26 | 9.84 | 37 | 83982 | 164257 | 64250456 |
| Abdominal pain | 107.74 | 9.84 | 736 | 83283 | 311639 | 64103074 |
| Appendicolith | 104.91 | 9.84 | 62 | 83957 | 3407 | 64411306 |
| Drug interaction | 103.12 | 9.84 | 197 | 83822 | 361886 | 64052827 |
| Abdominal distension | 101.29 | 9.84 | 315 | 83704 | 95679 | 64319034 |
| Urinary tract infection | 101.26 | 9.84 | 580 | 83439 | 231016 | 64183697 |
| Dehydration | 100.16 | 9.84 | 551 | 83468 | 216212 | 64198501 |
| Sepsis | 92.41 | 9.84 | 564 | 83455 | 229777 | 64184936 |
| Aplastic anaemia | 78.85 | 9.84 | 94 | 83925 | 13826 | 64400887 |
| Treatment failure | 76.86 | 9.84 | 28 | 83991 | 116788 | 64297925 |
| Plasma cell myeloma | 74.52 | 9.84 | 177 | 83842 | 45898 | 64368815 |
| Maternal exposure during pregnancy | 68.33 | 9.84 | 20 | 83999 | 95864 | 64318849 |
| Drug hypersensitivity | 67.10 | 9.84 | 130 | 83889 | 237685 | 64177028 |
| Hand deformity | 65.73 | 9.84 | 4 | 84015 | 62767 | 64351946 |
| Mental status changes | 64.76 | 9.84 | 201 | 83818 | 60961 | 64353752 |
| Hyponatraemia | 64.43 | 9.84 | 371 | 83648 | 147968 | 64266745 |
| Drug intolerance | 63.94 | 9.84 | 91 | 83928 | 187901 | 64226812 |
| Failure to thrive | 61.82 | 9.84 | 72 | 83947 | 10332 | 64404381 |
| Joint swelling | 60.52 | 9.84 | 118 | 83901 | 215264 | 64199449 |
| Systemic lupus erythematosus | 57.52 | 9.84 | 15 | 84004 | 77597 | 64337116 |
| Arthropathy | 57.52 | 9.84 | 44 | 83975 | 120923 | 64293790 |
| Appendicitis | 56.98 | 9.84 | 79 | 83940 | 13490 | 64401223 |
| Small intestinal obstruction | 56.07 | 9.84 | 106 | 83913 | 23467 | 64391246 |
| Pneumonia | 55.93 | 9.84 | 1031 | 82988 | 558545 | 63856168 |
| Vomiting | 55.64 | 9.84 | 1017 | 83002 | 550100 | 63864613 |
| Therapeutic product effect decreased | 54.79 | 9.84 | 42 | 83977 | 115309 | 64299404 |
| Exposure during pregnancy | 52.15 | 9.84 | 18 | 84001 | 77657 | 64337056 |
| Intentional overdose | 52.07 | 9.84 | 26 | 83993 | 89918 | 64324795 |
| Infusion related reaction | 51.70 | 9.84 | 84 | 83935 | 164383 | 64250330 |
| Drug abuse | 50.24 | 9.84 | 59 | 83960 | 132315 | 64282398 |
| Respiratory distress | 49.97 | 9.84 | 166 | 83853 | 52165 | 64362548 |
| Hospice care | 49.08 | 9.84 | 55 | 83964 | 7570 | 64407143 |
| Fall | 48.44 | 9.84 | 787 | 83232 | 416039 | 63998674 |
| Acute respiratory failure | 48.21 | 9.84 | 159 | 83860 | 49775 | 64364938 |
| Arthralgia | 45.71 | 9.84 | 363 | 83656 | 441897 | 63972816 |
| Victim of child abuse | 44.36 | 9.84 | 22 | 83997 | 849 | 64413864 |
| Lower respiratory tract infection | 44.24 | 9.84 | 35 | 83984 | 94579 | 64320134 |
| Rhinovirus infection | 42.38 | 9.84 | 46 | 83973 | 6110 | 64408603 |
| Nausea | 41.37 | 9.84 | 1326 | 82693 | 784474 | 63630239 |
| Deep vein thrombosis | 41.12 | 9.84 | 256 | 83763 | 104926 | 64309787 |
| Hypophagia | 39.07 | 9.84 | 127 | 83892 | 39460 | 64375253 |
| Cystic fibrosis | 37.43 | 9.84 | 33 | 83986 | 3401 | 64411312 |
| Hypoxia | 37.29 | 9.84 | 219 | 83800 | 87930 | 64326783 |
| Ocular procedural complication | 37.19 | 9.84 | 16 | 84003 | 443 | 64414270 |
| Intestinal obstruction | 36.34 | 9.84 | 117 | 83902 | 36169 | 64378544 |
| C-reactive protein increased | 36.33 | 9.84 | 42 | 83977 | 94867 | 64319846 |
| Glossodynia | 35.53 | 9.84 | 20 | 83999 | 64676 | 64350037 |
| Ascites | 35.13 | 9.84 | 167 | 83852 | 61834 | 64352879 |
| Bacteraemia | 34.79 | 9.84 | 95 | 83924 | 26816 | 64387897 |
| Pericarditis | 33.38 | 9.84 | 20 | 83999 | 62496 | 64352217 |
| Hypersensitivity | 32.77 | 9.84 | 138 | 83881 | 196314 | 64218399 |
| Drug resistance | 31.99 | 9.84 | 4 | 84015 | 35098 | 64379615 |
| Pneumonia aspiration | 30.97 | 9.84 | 156 | 83863 | 59115 | 64355598 |
| Nasopharyngitis | 30.72 | 9.84 | 141 | 83878 | 195932 | 64218781 |
| Interstitial lung disease | 30.62 | 9.84 | 50 | 83969 | 97682 | 64317031 |
| Renal impairment | 30.60 | 9.84 | 83 | 83936 | 134934 | 64279779 |
| Wound | 30.19 | 9.84 | 33 | 83986 | 76444 | 64338269 |
| Hospitalisation | 29.99 | 9.84 | 184 | 83835 | 75023 | 64339690 |
| Alopecia | 29.77 | 9.84 | 113 | 83906 | 165577 | 64249136 |
| Condition aggravated | 29.69 | 9.84 | 326 | 83693 | 372100 | 64042613 |
| Injection site pain | 29.59 | 9.84 | 63 | 83956 | 111345 | 64303368 |
| Atelectasis | 29.22 | 9.84 | 90 | 83929 | 27176 | 64387537 |
| Suicide attempt | 28.74 | 9.84 | 30 | 83989 | 70977 | 64343736 |
| Discomfort | 28.63 | 9.84 | 38 | 83981 | 80840 | 64333873 |
| Folliculitis | 28.48 | 9.84 | 3 | 84016 | 30074 | 64384639 |
| Disease progression | 26.14 | 9.84 | 291 | 83728 | 141389 | 64273324 |
| Myocardial infarction | 26.12 | 9.84 | 119 | 83900 | 165702 | 64249011 |
| Encephalopathy | 26.09 | 9.84 | 148 | 83871 | 58671 | 64356042 |
| Overdose | 26.04 | 9.84 | 113 | 83906 | 159453 | 64255260 |
| Hip fracture | 25.90 | 9.84 | 86 | 83933 | 27013 | 64387700 |
| Psoriatic arthropathy | 25.83 | 9.84 | 12 | 84007 | 43269 | 64371444 |
| Product odour abnormal | 25.75 | 9.84 | 17 | 84002 | 1136 | 64413577 |
| Brain scan abnormal | 25.55 | 9.84 | 17 | 84002 | 1151 | 64413562 |
| Off label use | 25.18 | 9.84 | 630 | 83389 | 632176 | 63782537 |
| Carbon dioxide decreased | 25.06 | 9.84 | 25 | 83994 | 3010 | 64411703 |
| Dysphagia | 24.79 | 9.84 | 230 | 83789 | 106582 | 64308131 |
| Death | 24.62 | 9.84 | 812 | 83207 | 481893 | 63932820 |
| Cerebral artery thrombosis | 24.60 | 9.84 | 16 | 84003 | 1043 | 64413670 |
| Coma | 24.58 | 9.84 | 48 | 83971 | 87567 | 64327146 |
| Seizure | 24.37 | 9.84 | 328 | 83691 | 166564 | 64248149 |
| Pleural effusion | 24.29 | 9.84 | 262 | 83757 | 126297 | 64288416 |
| Cardiogenic shock | 24.25 | 9.84 | 95 | 83924 | 32332 | 64382381 |
| Rhabdomyolysis | 24.25 | 9.84 | 52 | 83967 | 91674 | 64323039 |
| Pulmonary embolism | 24.06 | 9.84 | 294 | 83725 | 146062 | 64268651 |
| Respiratory failure | 24.04 | 9.84 | 318 | 83701 | 160865 | 64253848 |
| Hepatic function abnormal | 24.03 | 9.84 | 29 | 83990 | 64284 | 64350429 |
| Therapeutic product effect incomplete | 23.91 | 9.84 | 63 | 83956 | 103419 | 64311294 |
| Swelling | 22.90 | 9.84 | 119 | 83900 | 160099 | 64254614 |
| Asthenia | 22.84 | 9.84 | 724 | 83295 | 427320 | 63987393 |
| Lethargy | 22.57 | 9.84 | 167 | 83852 | 72427 | 64342286 |
| Helicobacter infection | 22.33 | 9.84 | 11 | 84008 | 38351 | 64376362 |
| Urinary incontinence | 21.67 | 9.84 | 99 | 83920 | 36052 | 64378661 |
| Injection site erythema | 21.45 | 9.84 | 37 | 83982 | 70763 | 64343950 |
| Pruritus | 21.24 | 9.84 | 283 | 83736 | 312117 | 64102596 |
| Liver disorder | 21.08 | 9.84 | 23 | 83996 | 53328 | 64361385 |
| Psoriasis | 20.36 | 9.84 | 39 | 83980 | 71664 | 64343049 |
| Injection site pruritus | 20.33 | 9.84 | 12 | 84007 | 37814 | 64376899 |
| Blood calcium decreased | 20.04 | 9.84 | 76 | 83943 | 25478 | 64389235 |
| Hepatic enzyme increased | 20.01 | 9.84 | 94 | 83925 | 129849 | 64284864 |
| Urinary retention | 20.00 | 9.84 | 121 | 83898 | 49080 | 64365633 |
| White blood cell count decreased | 19.77 | 9.84 | 302 | 83717 | 157535 | 64257178 |
| Product administered to patient of inappropriate age | 19.64 | 9.84 | 27 | 83992 | 4574 | 64410139 |
| Hallucination | 19.62 | 9.84 | 162 | 83857 | 72626 | 64342087 |
| Decubitus ulcer | 19.09 | 9.84 | 49 | 83970 | 13330 | 64401383 |
| Inflammation | 19.00 | 9.84 | 35 | 83984 | 65265 | 64349448 |
| Cytokine release syndrome | 18.93 | 9.84 | 65 | 83954 | 20764 | 64393949 |
| Impaired healing | 18.88 | 9.84 | 31 | 83988 | 60442 | 64354271 |
| Fumbling | 18.77 | 9.84 | 7 | 84012 | 132 | 64414581 |
| Unresponsive to stimuli | 18.66 | 9.84 | 121 | 83898 | 50272 | 64364441 |
| Eye irritation | 18.56 | 9.84 | 54 | 83965 | 15802 | 64398911 |
| Malnutrition | 18.55 | 9.84 | 61 | 83958 | 19064 | 64395649 |
| Injection site swelling | 18.45 | 9.84 | 16 | 84003 | 41337 | 64373376 |
| Peritonitis bacterial | 18.29 | 9.84 | 38 | 83981 | 9005 | 64405708 |
| Spinal cord compression | 17.93 | 9.84 | 29 | 83990 | 5674 | 64409039 |
| Ileus | 17.76 | 9.84 | 68 | 83951 | 22898 | 64391815 |
| Product use in unapproved indication | 17.72 | 9.84 | 146 | 83873 | 176472 | 64238241 |
| Medical device site pain | 17.64 | 9.84 | 8 | 84011 | 252 | 64414461 |
| Salivary gland enlargement | 17.53 | 9.84 | 9 | 84010 | 374 | 64414339 |
| Sports injury | 17.52 | 9.84 | 7 | 84012 | 160 | 64414553 |
| Blood potassium decreased | 17.48 | 9.84 | 101 | 83918 | 40298 | 64374415 |
| Injection site reaction | 17.48 | 9.84 | 21 | 83998 | 46643 | 64368070 |
| Blister | 17.43 | 9.84 | 51 | 83968 | 80916 | 64333797 |
| Atrial fibrillation | 17.26 | 9.84 | 316 | 83703 | 170773 | 64243940 |
| Hepatotoxicity | 17.19 | 9.84 | 16 | 84003 | 39946 | 64374767 |
| Infection | 17.13 | 9.84 | 156 | 83863 | 184724 | 64229989 |
| Proctalgia | 16.76 | 9.84 | 33 | 83986 | 7526 | 64407187 |
| Kyphosis | 16.68 | 9.84 | 18 | 84001 | 2375 | 64412338 |
| Neurogenic bladder | 16.61 | 9.84 | 22 | 83997 | 3597 | 64411116 |
| Lymphocyte count decreased | 16.49 | 9.84 | 100 | 83919 | 40599 | 64374114 |
| Erythema | 16.42 | 9.84 | 160 | 83859 | 186910 | 64227803 |
| Hepatocellular injury | 16.27 | 9.84 | 21 | 83998 | 45214 | 64369499 |
| Anal incontinence | 16.13 | 9.84 | 50 | 83969 | 15146 | 64399567 |
| Flatulence | 15.98 | 9.84 | 90 | 83929 | 35576 | 64379137 |
| Full blood count decreased | 15.96 | 9.84 | 65 | 83954 | 22517 | 64392196 |
| Hypertonia | 15.74 | 9.84 | 29 | 83990 | 6296 | 64408417 |
| Product taste abnormal | 15.63 | 9.84 | 16 | 84003 | 1987 | 64412726 |
| Foreign body sensation in eyes | 15.55 | 9.84 | 15 | 84004 | 1734 | 64412979 |
| Adenocarcinoma of colon | 15.49 | 9.84 | 25 | 83994 | 4883 | 64409830 |
| Liver injury | 15.39 | 9.84 | 10 | 84009 | 29922 | 64384791 |
| Pseudohyponatraemia | 15.27 | 9.84 | 6 | 84013 | 131 | 64414582 |
| Hyponatraemic seizure | 15.27 | 9.84 | 9 | 84010 | 492 | 64414221 |
| Sickle cell anaemia with crisis | 15.27 | 9.84 | 26 | 83993 | 5306 | 64409407 |
| Labelled drug-drug interaction medication error | 15.00 | 9.84 | 5 | 84014 | 22057 | 64392656 |
| Abortion spontaneous | 14.96 | 9.84 | 7 | 84012 | 25136 | 64389577 |
| Back pain | 14.89 | 9.84 | 429 | 83590 | 249742 | 64164971 |
| Anal spasm | 14.86 | 9.84 | 3 | 84016 | 3 | 64414710 |
| Noninfectious peritonitis | 14.83 | 9.84 | 7 | 84012 | 242 | 64414471 |
| Non-cardiac chest pain | 14.74 | 9.84 | 34 | 83985 | 8646 | 64406067 |
| Aspiration | 14.74 | 9.84 | 52 | 83967 | 16833 | 64397880 |
| Toxic epidermal necrolysis | 14.71 | 9.84 | 16 | 84003 | 37150 | 64377563 |
| Streptococcal bacteraemia | 14.62 | 9.84 | 19 | 84000 | 3048 | 64411665 |
| Oedema peripheral | 14.61 | 9.84 | 368 | 83651 | 209949 | 64204764 |
| Malignant neoplasm progression | 14.53 | 9.84 | 217 | 83802 | 112654 | 64302059 |
| Urticaria | 14.22 | 9.84 | 123 | 83896 | 147194 | 64267519 |
| Upper respiratory tract infection | 14.10 | 9.84 | 151 | 83868 | 72634 | 64342079 |
| Drooling | 14.01 | 9.84 | 25 | 83994 | 5294 | 64409419 |
| Confusional state | 13.97 | 9.84 | 442 | 83577 | 260702 | 64154011 |
| Rectal prolapse | 13.85 | 9.84 | 14 | 84005 | 1712 | 64413001 |
| Drug eruption | 13.81 | 9.84 | 16 | 84003 | 36120 | 64378593 |
| Cytomegalovirus infection | 13.66 | 9.84 | 17 | 84002 | 37182 | 64377531 |
| Platelet count decreased | 13.65 | 9.84 | 300 | 83719 | 167411 | 64247302 |
| Medication error | 13.48 | 9.84 | 28 | 83991 | 49938 | 64364775 |
| Muscle spasticity | 13.42 | 9.84 | 50 | 83969 | 16619 | 64398094 |
| Myalgia | 13.36 | 9.84 | 137 | 83882 | 158480 | 64256233 |
| Incorrect product administration duration | 13.16 | 9.84 | 35 | 83984 | 9723 | 64404990 |
| Escherichia urinary tract infection | 13.14 | 9.84 | 40 | 83979 | 11997 | 64402716 |
| Pulmonary function test decreased | 12.89 | 9.84 | 27 | 83992 | 6434 | 64408279 |
| Red blood cell sedimentation rate increased | 12.86 | 9.84 | 13 | 84006 | 31222 | 64383491 |
| Epidural lipomatosis | 12.84 | 9.84 | 10 | 84009 | 867 | 64413846 |
| Cellulitis | 12.82 | 9.84 | 182 | 83837 | 93475 | 64321238 |
| Sulphaemoglobinaemia | 12.79 | 9.84 | 3 | 84016 | 9 | 64414704 |
| Pyrexia | 12.67 | 9.84 | 867 | 83152 | 557777 | 63856936 |
| Rash | 12.67 | 9.84 | 479 | 83540 | 458070 | 63956643 |
| Carbohydrate antigen 125 increased | 12.57 | 9.84 | 14 | 84005 | 1914 | 64412799 |
| Ill-defined disorder | 12.47 | 9.84 | 24 | 83995 | 44028 | 64370685 |
| Faecaloma | 12.23 | 9.84 | 34 | 83985 | 9694 | 64405019 |
| Shunt malfunction | 12.18 | 9.84 | 6 | 84013 | 228 | 64414485 |
| Implant site erosion | 12.17 | 9.84 | 5 | 84014 | 123 | 64414590 |
| Joint stiffness | 12.13 | 9.84 | 13 | 84006 | 30391 | 64384322 |
| Blood albumin decreased | 12.10 | 9.84 | 57 | 83962 | 21016 | 64393697 |
| Enterovirus infection | 12.03 | 9.84 | 12 | 84007 | 1445 | 64413268 |
| Colitis | 11.97 | 9.84 | 123 | 83896 | 58551 | 64356162 |
| Large intestinal obstruction | 11.75 | 9.84 | 16 | 84003 | 2686 | 64412027 |
| Clostridium difficile infection | 11.70 | 9.84 | 84 | 83935 | 36079 | 64378634 |
| Bandaemia | 11.53 | 9.84 | 7 | 84012 | 404 | 64414309 |
| Product complaint | 11.48 | 9.84 | 38 | 83981 | 11916 | 64402797 |
| Creatinine renal clearance decreased | 11.40 | 9.84 | 43 | 83976 | 14378 | 64400335 |
| Hypotension | 11.40 | 9.84 | 606 | 83413 | 380368 | 64034345 |
| Cholestasis | 11.40 | 9.84 | 26 | 83993 | 44846 | 64369867 |
| Musculoskeletal stiffness | 11.39 | 9.84 | 104 | 83915 | 123102 | 64291611 |
| Neutrophil count decreased | 11.37 | 9.84 | 152 | 83867 | 77044 | 64337669 |
| Leukocytosis | 11.26 | 9.84 | 86 | 83933 | 37654 | 64377059 |
| Impaired work ability | 11.16 | 9.84 | 3 | 84016 | 15216 | 64399497 |
| Visceral pain | 11.12 | 9.84 | 3 | 84016 | 18 | 64414695 |
| Crowned dens syndrome | 10.98 | 9.84 | 3 | 84016 | 19 | 64414694 |
| Device expulsion | 10.95 | 9.84 | 7 | 84012 | 21129 | 64393584 |
| Distal intestinal obstruction syndrome | 10.95 | 9.84 | 8 | 84011 | 630 | 64414083 |
| Rectal stenosis | 10.85 | 9.84 | 6 | 84013 | 290 | 64414423 |
| Gastrointestinal motility disorder | 10.75 | 9.84 | 22 | 83997 | 5157 | 64409556 |
| Angina pectoris | 10.75 | 9.84 | 27 | 83992 | 45054 | 64369659 |
| Blood chloride increased | 10.69 | 9.84 | 21 | 83998 | 4782 | 64409931 |
| Scoliosis | 10.52 | 9.84 | 24 | 83995 | 6058 | 64408655 |
| Orthostatic hypotension | 10.51 | 9.84 | 100 | 83919 | 46638 | 64368075 |
| Instillation site pain | 10.50 | 9.84 | 8 | 84011 | 671 | 64414042 |
| Pneumonia respiratory syncytial viral | 10.39 | 9.84 | 11 | 84008 | 1420 | 64413293 |
| Impaired gastric emptying | 10.32 | 9.84 | 30 | 83989 | 8774 | 64405939 |
| Listeraemia | 10.19 | 9.84 | 4 | 84015 | 87 | 64414626 |
| Muscular weakness | 10.11 | 9.84 | 227 | 83792 | 127111 | 64287602 |
| Embolism | 10.10 | 9.84 | 37 | 83982 | 12198 | 64402515 |
| Torsade de pointes | 10.07 | 9.84 | 5 | 84014 | 17358 | 64397355 |
| Metabolic encephalopathy | 10.04 | 9.84 | 28 | 83991 | 7997 | 64406716 |
| Sedation complication | 10.02 | 9.84 | 33 | 83986 | 10321 | 64404392 |
| Calculus bladder | 9.98 | 9.84 | 10 | 84009 | 1210 | 64413503 |
| Haemoglobin decreased | 9.87 | 9.84 | 328 | 83691 | 194735 | 64219978 |
| Granulocytopenia | 9.86 | 9.84 | 33 | 83986 | 10407 | 64404306 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | HALFLYTELY | BRAINTREE | N021551 | July 16, 2010 | DISCN | FOR SOLUTION, TABLET, DELAYED RELEASE | ORAL | 7291324 | Oct. 22, 2022 | GASTROINTESTINAL LAVAGE INDICATED FOR CLEANSING OF THE COLON AS A 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 | 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 | 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 |
None
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 |
| 174 | PUBCHEM_CID |
| 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 |
| 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 | 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 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 |
| 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 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 |
| 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 |
| Basic Care Clearlax | HUMAN OTC DRUG LABEL | 1 | 0113-7306 | POWDER, FOR SOLUTION | 17 g | ORAL | ANDA | 16 sections |
| smooth lax | HUMAN OTC DRUG LABEL | 1 | 0363-0306 | POWDER, FOR SOLUTION | 17 g | ORAL | ANDA | 16 sections |
| Smooth LAX | HUMAN OTC DRUG LABEL | 1 | 0363-0465 | POWDER | 17 g | TOPICAL | ANDA | 16 sections |
| Smooth LAX | HUMAN OTC DRUG LABEL | 1 | 0363-0489 | POWDER, FOR SOLUTION | 17 g | ORAL | ANDA | 10 sections |
| Walgreens Multi-Symptom Relief Eye Drops | HUMAN OTC DRUG LABEL | 5 | 0363-1462 | SOLUTION/ DROPS | 1 g | OPHTHALMIC | OTC monograph final | 13 sections |
| Walgreens Sterile Advance Relief Eye Drops | HUMAN OTC DRUG LABEL | 4 | 0363-1677 | SOLUTION/ DROPS | 0.01 mg | OPHTHALMIC | OTC monograph final | 12 sections |
| Walgreens Eye Drops Advanced Relief 15mL | HUMAN OTC DRUG LABEL | 4 | 0363-4547 | LIQUID | 1 g | OPHTHALMIC | OTC monograph final | 12 sections |
| Walgreens Lubricant Eye Drops High Performance 15mL and twin pack | HUMAN OTC DRUG LABEL | 2 | 0363-4549 | LIQUID | 0.40 g | OPHTHALMIC | OTC monograph final | 14 sections |
| Walgreens Lubricant Eye Drops Dry Eye 15mL and twin pack | HUMAN OTC DRUG LABEL | 2 | 0363-4551 | LIQUID | 0.40 g | OPHTHALMIC | OTC monograph final | 13 sections |
| Lubricant Eye | HUMAN OTC DRUG LABEL | 2 | 0363-6451 | SOLUTION/ DROPS | 4 mg | OPHTHALMIC | OTC monograph final | 13 sections |
| Walgreens Lubricant Eye Drops | HUMAN OTC DRUG LABEL | 2 | 0363-7220 | SOLUTION/ DROPS | 0.40 mg | OPHTHALMIC | OTC monograph final | 11 sections |
| Walgreens Lubricant Eye | HUMAN OTC DRUG LABEL | 2 | 0363-7267 | SOLUTION/ DROPS | 4 mg | OPHTHALMIC | OTC monograph final | 12 sections |
| Eye Lubricant | HUMAN OTC DRUG LABEL | 2 | 0363-8396 | LIQUID | 4 mg | OPHTHALMIC | OTC monograph final | 12 sections |
| Industrial Strength Eye Drops | HUMAN OTC DRUG LABEL | 2 | 0498-0162 | SOLUTION/ DROPS | 1 g | OPHTHALMIC | OTC monograph final | 15 sections |
| rugby PEG 3350 | HUMAN OTC DRUG LABEL | 1 | 0536-1052 | POWDER, FOR SOLUTION | 17 g | ORAL | ANDA | 16 sections |
| Rugby Lubricating Eye Drops | HUMAN OTC DRUG LABEL | 2 | 0536-1219 | LIQUID | 0.40 g | OPHTHALMIC | OTC monograph final | 11 sections |