loperamide ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
1599 53179-11-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • loperamide
  • loperamide hydrochloride
  • imodium
  • loperamide HCl
One of the long-acting synthetic ANTIDIARRHEALS; it is not significantly absorbed from the gut, and has no effect on the adrenergic system or central nervous system, but may antagonize histamine and interfere with acetylcholine release locally.
  • Molecular weight: 477.05
  • Formula: C29H33ClN2O2
  • CLOGP: 4.66
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 43.78
  • ALOGS: -5.74
  • ROTB: 7
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 0.01 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.48 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 40 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.348 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 4.305 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 12.331 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 21.281 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 6.090 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 15.820 % High 1
herg hERG pIC50 5.844 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 9.727 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 47.315 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 6.350 % High 1
kinase-safety-class ACVR2B,AKT1,AKT2,AKT3,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,JAK3,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPKAPK2,MET,NTRK2,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKDC,SIK2,SIK3,STK33,TEK,TGFBR1,TTK 42
kinase-selectivity-class AKT3,AXL,EIF2AK3,GRK2,PDK4,SIK2 6
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 19.724 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 5.140 High 1
mh-clint Mouse hepatocyte intrinsic clearance 71.779 High 1
mppb Mouse plasma protein binding (% unbound) 4.620 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 18.113 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 10.620 % High 1
rat-kpuu-brain Rat brain Kpuu 0.010 % High 1
rh-clint Rat hepatocyte intrinsic clearance 100.925 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 18.050 % High 1
rppb Rat plasma protein binding (% unbound) 5.200 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 107.399 uM High 1

Approvals:

DateAgencyCompanyOrphan
Dec. 28, 1976 FDA MCNEIL CONS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Diarrhoea 1330.42 11.01 3409 114541 935781 89574716
Dehydration 527.62 11.01 924 117026 193523 90316974
Colitis 424.81 11.01 489 117461 69453 90441044
Systemic lupus erythematosus 379.40 11.01 23 117927 361873 90148624
Nausea 361.97 11.01 2573 115377 1107743 89402754
Maternal exposure during pregnancy 359.74 11.01 29 117921 360034 90150463
Hand deformity 347.31 11.01 8 117942 296354 90214143
Schizophrenia 341.01 11.01 223 117727 14691 90495806
Pericarditis 302.98 11.01 11 117939 270140 90240357
Hypokalaemia 299.73 11.01 579 117371 130537 90379960
Anti-cyclic citrullinated peptide antibody positive 291.21 11.01 3 117947 236430 90274067
Constipation 290.47 11.01 913 117037 279482 90231015
Glossodynia 290.21 11.01 38 117912 321741 90188756
Hypomania 266.59 11.01 158 117792 8739 90501758
Helicobacter infection 258.72 11.01 8 117942 226842 90283655
Jaundice cholestatic 256.44 11.01 161 117789 9882 90500615
Abdominal pain 250.46 11.01 1099 116851 394622 90115875
Wound 247.86 11.01 47 117903 302933 90207564
Weight decreased 245.69 11.01 1062 116888 378848 90131649
Vomiting 245.57 11.01 1809 116141 786484 89724013
Arthropathy 238.94 11.01 89 117861 366153 90144344
Contraindicated product administered 237.07 11.01 62 117888 320077 90190420
Proctitis 225.78 11.01 175 117775 15084 90495413
Macular degeneration 221.31 11.01 260 117690 37710 90472787
Psoriatic arthropathy 220.85 11.01 21 117929 228314 90282183
Folliculitis 208.10 11.01 15 117935 204338 90306159
Chronic sinusitis 207.85 11.01 202 117748 23600 90486897
Type 2 diabetes mellitus 206.73 11.01 15 117935 203229 90307268
Total lung capacity increased 198.72 11.01 107 117843 4914 90505583
Vaginal flatulence 195.88 11.01 149 117801 12489 90498008
Cholelithiasis 193.40 11.01 287 117663 52219 90458278
Impaired healing 190.08 11.01 37 117913 234162 90276335
Female genital tract fistula 189.54 11.01 169 117781 17699 90492798
Synovitis 186.90 11.01 98 117852 329654 90180843
Discomfort 186.86 11.01 62 117888 274273 90236224
Febrile neutropenia 180.97 11.01 534 117416 157815 90352682
Vaginal discharge 177.15 11.01 169 117781 19295 90491202
Hypomagnesaemia 173.93 11.01 223 117727 35365 90475132
Anaemia 173.20 11.01 911 117039 351891 90158606
Pneumonia viral 173.13 11.01 120 117830 8703 90501794
Pneumonia aspiration 168.65 11.01 236 117714 40704 90469793
Torsade de pointes 167.83 11.01 147 117803 15035 90495462
Therapeutic product effect decreased 167.12 11.01 76 117874 277495 90233002
Paraesthesia oral 163.64 11.01 204 117746 31455 90479042
Ventricular tachycardia 162.27 11.01 180 117770 24528 90485969
Drug intolerance 161.95 11.01 207 117743 447384 90063113
Blood bilirubin increased 160.65 11.01 238 117712 43232 90467265
Radiculopathy 159.62 11.01 156 117794 18349 90492148
Swelling 158.77 11.01 187 117763 418871 90091626
Frequent bowel movements 155.97 11.01 272 117678 56663 90453834
Rheumatoid arthritis 153.92 11.01 147 117803 362467 90148030
Coma 152.90 11.01 310 117640 72322 90438175
Oral candidiasis 151.46 11.01 208 117742 35247 90475250
Drug abuse 147.40 11.01 329 117621 82018 90428479
Asthma-chronic obstructive pulmonary disease overlap syndrome 146.77 11.01 87 117863 4812 90505685
Treatment failure 146.41 11.01 109 117841 303819 90206678
Exposure during pregnancy 145.51 11.01 64 117886 238346 90272151
Neuropathy peripheral 143.42 11.01 448 117502 136522 90373975
Decreased appetite 132.40 11.01 891 117059 375649 90134848
Haematochezia 132.20 11.01 288 117662 70625 90439872
Joint range of motion decreased 127.17 11.01 14 117936 135629 90374868
Electrocardiogram QT prolonged 126.89 11.01 287 117663 72169 90438328
Joint swelling 126.87 11.01 293 117657 503007 90007490
Procedural pain 126.66 11.01 185 117765 33175 90477322
Soft tissue disorder 125.43 11.01 75 117875 4215 90506282
Hypersensitivity 123.41 11.01 254 117696 454423 90056074
Rectal haemorrhage 121.42 11.01 306 117644 82438 90428059
Colitis microscopic 121.25 11.01 107 117843 11052 90499445
Gastrooesophageal reflux disease 119.79 11.01 481 117469 165856 90344641
Drug hypersensitivity 115.93 11.01 271 117679 463338 90047159
Irritable bowel syndrome 115.49 11.01 63 117887 207385 90303112
Drug ineffective 114.72 11.01 1202 116748 1383096 89127401
Injury 112.71 11.01 58 117892 197291 90313206
Oral pain 112.32 11.01 173 117777 32510 90477987
Intestinal obstruction 111.75 11.01 185 117765 36946 90473551
Vascular device infection 111.09 11.01 105 117845 11847 90498650
Urticaria 110.59 11.01 147 117803 312587 90197910
Sinusitis 108.85 11.01 174 117776 342914 90167583
Acute kidney injury 107.15 11.01 749 117201 319638 90190859
Mobility decreased 107.09 11.01 101 117849 250633 90259864
Liver injury 106.91 11.01 44 117906 170523 90339974
Obesity 106.64 11.01 8 117942 105499 90404998
Bursitis 106.36 11.01 21 117929 131633 90378864
Small intestinal obstruction 103.66 11.01 133 117817 21101 90489396
Psychotic disorder 101.33 11.01 161 117789 31069 90479428
Musculoskeletal stiffness 101.21 11.01 143 117807 296389 90214108
Abdominal discomfort 101.12 11.01 303 117647 477025 90033472
Ill-defined disorder 100.25 11.01 58 117892 184833 90325664
Gastrointestinal stoma complication 99.80 11.01 53 117897 2366 90508131
Mucosal inflammation 98.39 11.01 226 117724 57399 90453098
Lip dry 98.33 11.01 9 117941 100946 90409551
Sarcoidosis 97.75 11.01 93 117857 10580 90499917
Flatulence 96.04 11.01 184 117766 41183 90469314
Colitis ulcerative 92.76 11.01 227 117723 60039 90450458
Nasal polyps 92.49 11.01 91 117859 10789 90499708
C-reactive protein abnormal 89.92 11.01 27 117923 127402 90383095
Appetite disorder 88.28 11.01 82 117868 9051 90501446
Knee arthroplasty 87.93 11.01 5 117945 83177 90427320
Somnolence 87.83 11.01 518 117432 208566 90301931
Weight increased 86.55 11.01 268 117682 417659 90092838
Hypercholesterolaemia 86.03 11.01 14 117936 100878 90409619
Live birth 86.01 11.01 4 117946 79103 90431394
Malignant neoplasm progression 85.86 11.01 320 117630 106550 90403947
Hip arthroplasty 85.73 11.01 3 117947 76205 90434292
Alopecia 82.33 11.01 348 117602 494723 90015774
Road traffic accident 81.20 11.01 20 117930 107606 90402891
Gait inability 80.74 11.01 45 117905 146411 90364086
Blister 80.21 11.01 130 117820 254868 90255629
Pneumonia 78.83 11.01 1216 116734 636843 89873654
Syncope 78.07 11.01 361 117589 132302 90378195
Blood magnesium decreased 77.71 11.01 99 117851 15594 90494903
Pulmonary fibrosis 77.27 11.01 22 117928 107481 90403016
Inflammation 76.16 11.01 72 117878 178520 90331977
Urinary tract infection 75.86 11.01 667 117283 304965 90205532
Gastrointestinal procedural complication 75.21 11.01 27 117923 455 90510042
Hepatotoxicity 75.20 11.01 177 117773 45665 90464832
Blood creatinine increased 74.41 11.01 295 117655 101091 90409406
Neutropenia 74.07 11.01 524 117426 224380 90286117
Lethargy 73.08 11.01 214 117736 62925 90447572
Cardiac murmur 72.13 11.01 103 117847 18091 90492406
Arthralgia 70.41 11.01 661 117289 777861 89732636
Presbyacusis 68.35 11.01 45 117905 2997 90507500
Brain stem glioma 68.01 11.01 20 117930 171 90510326
Rhinitis allergic 67.98 11.01 96 117854 16689 90493808
Pain 67.61 11.01 903 117047 995438 89515059
Wound infection 67.39 11.01 27 117923 106375 90404122
Hepatic enzyme increased 66.67 11.01 243 117707 360493 90150004
Neutropenic sepsis 66.59 11.01 99 117851 18031 90492466
Prescribed overdose 66.52 11.01 22 117928 97603 90412894
Infusion related reaction 65.59 11.01 299 117651 416481 90094016
Psoriasis 64.86 11.01 58 117892 147696 90362801
Pyrexia 63.83 11.01 1210 116740 659275 89851222
Blood magnesium increased 63.71 11.01 45 117905 3363 90507134
Autoimmune disorder 62.48 11.01 12 117938 76732 90433765
Pleural fibrosis 61.54 11.01 45 117905 3551 90506946
Enterocolitis 61.39 11.01 72 117878 10418 90500079
Segmental diverticular colitis 60.99 11.01 18 117932 156 90510341
Intentional product use issue 60.60 11.01 119 117831 216773 90293724
Clostridium difficile infection 60.60 11.01 141 117809 36104 90474393
Intentional overdose 60.20 11.01 262 117688 93572 90416925
Completed suicide 60.08 11.01 60 117890 144998 90365499
Lower limb fracture 59.99 11.01 18 117932 84995 90425502
Musculoskeletal pain 59.98 11.01 81 117869 171170 90339327
Blepharospasm 59.64 11.01 3 117947 55442 90455055
Respiration abnormal 59.28 11.01 62 117888 7901 90502596
Pleural thickening 58.67 11.01 42 117908 3206 90507291
Gastrointestinal stoma output increased 58.65 11.01 24 117926 585 90509912
Fibromyalgia 57.78 11.01 113 117837 206156 90304341
Pedal pulse abnormal 56.51 11.01 18 117932 206 90510291
Blood potassium decreased 56.41 11.01 163 117787 47564 90462933
Rash 55.95 11.01 716 117234 795384 89715113
Heart sounds 55.65 11.01 28 117922 1116 90509381
Product quality issue 55.61 11.01 17 117933 79308 90431189
Sepsis 55.19 11.01 412 117538 179402 90331095
Calcium ionised decreased 55.12 11.01 20 117930 348 90510149
Cardiac arrest 54.84 11.01 276 117674 104659 90405838
Prescribed underdose 54.57 11.01 15 117935 75004 90435493
Hypophosphataemia 54.40 11.01 81 117869 14773 90495724
Injection site reaction 54.15 11.01 26 117924 92054 90418443
Prolonged expiration 53.16 11.01 28 117922 1229 90509268
Nail dystrophy 51.91 11.01 28 117922 1290 90509207
Migraine 51.87 11.01 106 117844 190286 90320211
Anal incontinence 51.72 11.01 83 117867 16147 90494350
Product use issue 51.69 11.01 237 117713 329682 90180815
Pneumonitis 51.39 11.01 150 117800 44020 90466477
Ear infection 50.66 11.01 14 117936 69761 90440736
Sciatica 50.54 11.01 35 117915 101347 90409150
Adverse event 50.45 11.01 47 117903 117371 90393126
Gastroenteritis radiation 49.70 11.01 21 117929 556 90509941
Product use in unapproved indication 49.49 11.01 247 117703 335989 90174508
Ejection fraction decreased 49.34 11.01 107 117843 26146 90484351
Dry skin 49.12 11.01 236 117714 87837 90422660
Therapeutic response decreased 48.83 11.01 28 117922 89701 90420796
Deafness neurosensory 48.68 11.01 52 117898 6789 90503708
Platelet count decreased 48.54 11.01 325 117625 136644 90373853
Lupus-like syndrome 48.52 11.01 4 117946 48842 90461655
Device related infection 48.35 11.01 105 117845 25681 90484816
Ventricular arrhythmia 48.08 11.01 42 117908 4279 90506218
Lung neoplasm malignant 48 11.01 101 117849 24172 90486325
Enteritis 47.81 11.01 63 117887 10258 90500239
Bronchiectasis 47.79 11.01 96 117854 22234 90488263
Rhinorrhoea 47.35 11.01 234 117716 88082 90422415
Lower respiratory tract infection 46.84 11.01 168 117782 250491 90260006
Hypocalcaemia 45.62 11.01 140 117810 42228 90468269
Mydriasis 45.44 11.01 75 117875 14937 90495560
Foot deformity 45.16 11.01 11 117939 59640 90450857
Gallbladder polyp 45.00 11.01 23 117927 948 90509549
Disease progression 44.79 11.01 353 117597 156262 90354235
Grip strength decreased 44.78 11.01 33 117917 92543 90417954
Stoma complication 44.65 11.01 20 117930 612 90509885
Condition aggravated 44.27 11.01 529 117421 595016 89915481
Lung disorder 43.82 11.01 80 117870 149803 90360694
Brugada syndrome 43.30 11.01 18 117932 457 90510040
Pulmonary embolism 42.57 11.01 304 117646 130516 90379981
Blood cholesterol increased 42.57 11.01 134 117816 207878 90302619
Electrocardiogram QRS complex prolonged 42.28 11.01 50 117900 7298 90503199
Unresponsive to stimuli 42.01 11.01 127 117823 37994 90472503
Therapeutic reaction time decreased 41.60 11.01 36 117914 3622 90506875
White blood cell count decreased 41.56 11.01 365 117585 166744 90343753
Hypoaesthesia 41.16 11.01 240 117710 313970 90196527
Epigastric discomfort 41.09 11.01 50 117900 7518 90502979
Pruritus 41.01 11.01 479 117471 541046 89969451
Liver function test abnormal 40.61 11.01 152 117798 50693 90459804
Long QT syndrome 40.48 11.01 37 117913 4000 90506497
Palmar-plantar erythrodysaesthesia syndrome 40.43 11.01 103 117847 27920 90482577
Brain injury 40.20 11.01 50 117900 7688 90502809
Defaecation urgency 40.16 11.01 45 117905 6197 90504300
Intentional self-injury 39.43 11.01 105 117845 29229 90481268
Fatigue 39.34 11.01 1856 116094 1152167 89358330
Corneal reflex decreased 39.13 11.01 15 117935 306 90510191
Device expulsion 38.87 11.01 4 117946 40882 90469615
Pregnancy 38.87 11.01 16 117934 62031 90448466
Dry mouth 38.77 11.01 117 117833 183942 90326555
Coeliac disease 38.45 11.01 6 117944 44604 90465893
Ventricular fibrillation 38.32 11.01 67 117883 13977 90496520
Osteoarthritis 38.03 11.01 129 117821 195601 90314896
Neutrophil count decreased 37.26 11.01 188 117762 71344 90439153
Hypophagia 37.07 11.01 117 117833 35820 90474677
Premature delivery 36.32 11.01 4 117946 38758 90471739
Disability 36.23 11.01 5 117945 40740 90469757
Rales 35.02 11.01 69 117881 15758 90494739
Hypertension 34.90 11.01 404 117546 457128 90053369
Asthenia 34.78 11.01 925 117025 532826 89977671
Back injury 34.51 11.01 9 117941 46613 90463884
Dyspepsia 34.43 11.01 402 117548 197758 90312739
Herpes zoster 34.39 11.01 226 117724 94418 90416079
Injection site pain 34.07 11.01 114 117836 173585 90336912
Hyperglycaemia 33.97 11.01 144 117806 50826 90459671
Electrolyte imbalance 33.97 11.01 87 117863 23658 90486839
Chronic obstructive pulmonary disease 33.64 11.01 187 117763 73642 90436855
Arteriovenous fistula occlusion 33.62 11.01 14 117936 357 90510140
Drug interaction 33.16 11.01 217 117733 276236 90234261
Feeding intolerance 33.00 11.01 19 117931 995 90509502
Abdominal distension 32.85 11.01 286 117664 130315 90380182
Leukopenia 32.74 11.01 234 117716 100476 90410021
Nasopharyngitis 32.41 11.01 356 117594 406748 90103749
Accidental overdose 31.92 11.01 95 117855 28178 90482319
Immune-mediated enterocolitis 31.82 11.01 35 117915 4722 90505775
Dihydropyrimidine dehydrogenase deficiency 31.43 11.01 10 117940 114 90510383
Large intestine perforation 31.40 11.01 50 117900 9662 90500835
Dermatitis acneiform 31.33 11.01 40 117910 6314 90504183
Abnormal faeces 31.28 11.01 41 117909 6641 90503856
Tumour pain 30.91 11.01 23 117927 1864 90508633
Osteoporosis 30.52 11.01 49 117901 96482 90414015
Blue toe syndrome 29.99 11.01 14 117936 472 90510025
Muscle spasticity 29.89 11.01 5 117945 35317 90475180
Clostridium difficile colitis 29.45 11.01 89 117861 26617 90483880
Finger deformity 29.34 11.01 4 117946 32893 90477604
Pulmonary thrombosis 28.44 11.01 48 117902 9734 90500763
Pouchitis 28.40 11.01 15 117935 662 90509835
Anal abscess 28.25 11.01 36 117914 5672 90504825
Conduction disorder 28.09 11.01 21 117929 1714 90508783
Accidental exposure to product 28.07 11.01 10 117940 42356 90468141
Walking aid user 27.97 11.01 6 117944 35500 90474997
Gastrointestinal sounds abnormal 27.95 11.01 32 117918 4511 90505986
Contusion 27.75 11.01 202 117748 251014 90259483
Asthma 27.58 11.01 193 117757 241967 90268530
Drug-induced liver injury 27.48 11.01 47 117903 90271 90420226
Hypovolaemia 27.27 11.01 54 117896 12377 90498120
Pleural effusion 27.00 11.01 243 117707 111748 90398749
Plasma cell myeloma 26.94 11.01 115 117835 40713 90469784
Hyponatraemia 26.90 11.01 279 117671 133259 90377238
Post procedural diarrhoea 26.85 11.01 12 117938 365 90510132
Hemianopia 26.78 11.01 22 117928 2060 90508437
Oedema 26.74 11.01 152 117798 200143 90310354
Bacterial disease carrier 26.73 11.01 21 117929 1845 90508652
Injection site erythema 26.68 11.01 55 117895 98447 90412050
Blood potassium increased 26.61 11.01 73 117877 20676 90489821
Skin fissures 26.48 11.01 73 117877 20736 90489761
Gastroenteritis 26.42 11.01 91 117859 29138 90481359
Paraesthesia 26.35 11.01 204 117746 250122 90260375
Drug tolerance decreased 26.20 11.01 5 117945 32125 90478372
Liver function test increased 25.96 11.01 44 117906 84811 90425686
Confusional state 25.70 11.01 351 117599 385854 90124643
Genitourinary tract neoplasm 25.68 11.01 7 117943 44 90510453
Urosepsis 25.56 11.01 73 117877 21159 90489338
Cardiogenic shock 25.55 11.01 80 117870 24388 90486109
Ascites 25.23 11.01 126 117824 47614 90462883
Retching 25.16 11.01 68 117882 19091 90491406
Reflux gastritis 25.00 11.01 18 117932 1386 90509111
Injection site pruritus 25.00 11.01 20 117930 53814 90456683
No adverse event 24.98 11.01 31 117919 67951 90442546
Multiple sclerosis relapse 24.84 11.01 19 117931 52286 90458211
Large intestine polyp 24.61 11.01 44 117906 9342 90501155
Malnutrition 24.51 11.01 66 117884 18492 90492005
Joint stiffness 24.31 11.01 40 117910 78002 90432495
Drug resistance 24.28 11.01 5 117945 30444 90480053
Loss of personal independence in daily activities 24.25 11.01 93 117857 136012 90374485
Bacterial translocation 24.16 11.01 14 117936 742 90509755
Gastritis 24.09 11.01 113 117837 41640 90468857
Cellulitis 24.01 11.01 202 117748 91135 90419362
Ulcer haemorrhage 23.95 11.01 3 117947 26318 90484179
Thrombocytopenia 23.85 11.01 393 117557 208332 90302165
Megacolon 23.59 11.01 21 117929 2193 90508304
Amnesia 23.55 11.01 68 117882 108437 90402060
Bezoar 23.48 11.01 23 117927 2711 90507786
Therapy non-responder 23.34 11.01 95 117855 136609 90373888
Small intestine ulcer 23.24 11.01 11 117939 383 90510114
Cardiotoxicity 23.23 11.01 48 117902 11341 90499156
Hepatitis 23.23 11.01 35 117915 70704 90439793
Biliary sepsis 23.16 11.01 15 117935 971 90509526
Ileus 23.02 11.01 60 117890 16486 90494011
Cough 23.02 11.01 636 117314 368326 90142171
Delirium 22.94 11.01 65 117885 104294 90406203
Short-bowel syndrome 22.85 11.01 13 117937 665 90509832
Pancreatitis chronic 22.73 11.01 23 117927 2820 90507677
Oedema peripheral 22.62 11.01 466 117484 257449 90253048
Dysgeusia 22.54 11.01 131 117819 52429 90458068
Gastroenteritis bacterial 22.49 11.01 11 117939 412 90510085
Renal pain 22.46 11.01 38 117912 7721 90502776
Blood sodium decreased 22.42 11.01 83 117867 27530 90482967
Fistula 22.40 11.01 49 117901 12040 90498457
Bronchial wall thickening 22.29 11.01 20 117930 2111 90508386
Injection site swelling 22.29 11.01 27 117923 59812 90450685
Laryngitis 22.17 11.01 20 117930 50733 90459764
Flashback 22.00 11.01 10 117940 317 90510180
Muscular weakness 21.95 11.01 168 117782 206498 90303999
Thymus disorder 21.91 11.01 10 117940 320 90510177
Inflammatory bowel disease 21.57 11.01 30 117920 5141 90505356
Anxiety 21.52 11.01 279 117671 309493 90201004
Overdose 21.50 11.01 306 117644 157403 90353094
Joint dislocation 21.42 11.01 16 117934 44566 90465931
Pancytopenia 21.33 11.01 245 117705 120018 90390479
Onychomycosis 21.30 11.01 11 117939 37365 90473132
Bone hypertrophy 21.24 11.01 11 117939 466 90510031
Tenderness 21.18 11.01 80 117870 26788 90483709
Atrioventricular block first degree 21.17 11.01 39 117911 8472 90502025
Malaise 21.04 11.01 948 117002 585038 89925459
Sedation 21.02 11.01 19 117931 48152 90462345
Stomatitis haemorrhagic 20.69 11.01 7 117943 98 90510399
Dyspnoea exertional 20.69 11.01 163 117787 72125 90438372
Bone cyst 20.42 11.01 20 117930 2358 90508139
Dysuria 20.13 11.01 103 117847 39298 90471199
Injection site bruising 20.13 11.01 23 117927 52284 90458213
Palmar erythema 20.12 11.01 18 117932 1893 90508604
Productive cough 20.02 11.01 170 117780 76893 90433604
Cyst 19.99 11.01 57 117893 16504 90493993
Foetal exposure during pregnancy 19.91 11.01 16 117934 42959 90467538
Exostosis 19.76 11.01 24 117926 53110 90457387
Memory impairment 19.71 11.01 163 117787 197081 90313416
Catheter site haemorrhage 19.53 11.01 24 117926 3644 90506853
Maternal exposure timing unspecified 19.43 11.01 3 117947 22480 90488017
Osteopenia 19.40 11.01 70 117880 22932 90487565
Epistaxis 19.15 11.01 182 117768 84943 90425554
General physical health deterioration 19.11 11.01 336 117614 354779 90155718
Nail infection 19.10 11.01 20 117930 2552 90507945
Plantar erythema 19.03 11.01 8 117942 209 90510288
Liver disorder 19.03 11.01 87 117863 121182 90389315
Presyncope 19.03 11.01 87 117863 31718 90478779
Intestinal perforation 18.97 11.01 50 117900 13831 90496666
Sleep disorder 18.74 11.01 166 117784 197864 90312633
Abdominal mass 18.69 11.01 23 117927 3498 90506999
Intestinal fibrosis 18.45 11.01 8 117942 226 90510271
Paralysis recurrent laryngeal nerve 18.43 11.01 6 117944 74 90510423
Pancreatic disorder 18.40 11.01 21 117929 2950 90507547
Sinus arrest 18.33 11.01 18 117932 2128 90508369
Rhinovirus infection 18.33 11.01 30 117920 5933 90504564
Hepatic pain 18.31 11.01 23 117927 3572 90506925
Iron deficiency anaemia 18.28 11.01 70 117880 23592 90486905
Electrocardiogram abnormal 18.25 11.01 41 117909 10257 90500240
Drug ineffective for unapproved indication 18.22 11.01 37 117913 66607 90443890
Large intestinal obstruction 18.21 11.01 20 117930 2694 90507803
Depressive symptom 18.19 11.01 28 117922 5257 90505240
Gait disturbance 17.95 11.01 235 117715 260261 90250236
Lip erosion 17.88 11.01 14 117936 1224 90509273
Laryngitis viral 17.80 11.01 6 117944 83 90510414
Neck pain 17.74 11.01 82 117868 113881 90396616
Food interaction 17.62 11.01 14 117936 1250 90509247
Rectal abscess 17.54 11.01 15 117935 1485 90509012
Haemorrhoids 17.45 11.01 75 117875 26627 90483870
Depression 17.29 11.01 281 117669 300320 90210177
Hip fracture 17.27 11.01 87 117863 32990 90477507
Skin lesion 17.26 11.01 95 117855 37270 90473227
Proctalgia 17.25 11.01 35 117915 8163 90502334
Protein total decreased 17.03 11.01 32 117918 7057 90503440
Respiratory disorder 16.87 11.01 37 117913 64779 90445718
Metastases to spinal cord 16.78 11.01 8 117942 283 90510214
Stoma site ulcer 16.70 11.01 8 117942 286 90510211
Onychalgia 16.56 11.01 13 117937 1141 90509356
Hepatic cirrhosis 16.56 11.01 36 117914 63217 90447280
Glaucoma 16.53 11.01 62 117888 20693 90489804
Gastrointestinal disorder 16.45 11.01 235 117715 256452 90254045
Hydronephrosis 16.27 11.01 44 117906 12358 90498139
Cor pulmonale acute 16.23 11.01 9 117941 438 90510059
Hypervitaminosis B12 16.17 11.01 4 117946 16 90510481
Metastases to abdominal cavity 16.13 11.01 10 117940 600 90509897
Arrhythmia 15.93 11.01 102 117848 42230 90468267
Anal haemorrhage 15.90 11.01 18 117932 2506 90507991
Gamma-glutamyltransferase increased 15.89 11.01 94 117856 37858 90472639
Stevens-Johnson syndrome 15.86 11.01 78 117872 29298 90481199
Peripheral pulse decreased 15.79 11.01 5 117945 56 90510441
Pleural calcification 15.79 11.01 5 117945 56 90510441
Drug use disorder 15.67 11.01 34 117916 8309 90502188
Hypermagnesaemia 15.66 11.01 13 117937 1236 90509261
Vitamin B1 deficiency 15.65 11.01 9 117941 470 90510027
Peritoneal perforation 15.49 11.01 6 117944 126 90510371
C-reactive protein increased 15.47 11.01 156 117794 181233 90329264
Device occlusion 15.39 11.01 36 117914 9246 90501251
Stoma obstruction 15.25 11.01 7 117943 227 90510270
Traumatic haematoma 15.23 11.01 15 117935 1780 90508717
Diarrhoea haemorrhagic 15.18 11.01 39 117911 10624 90499873
Oropharyngeal pain 15.10 11.01 222 117728 114965 90395532
Oesophagitis 14.98 11.01 53 117897 17196 90493301
Night sweats 14.96 11.01 102 117848 128664 90381833
Enterocutaneous fistula 14.96 11.01 14 117936 1560 90508937
Pelvic neoplasm 14.90 11.01 8 117942 365 90510132
Ureteric obstruction 14.90 11.01 16 117934 2102 90508395
Large intestine erosion 14.83 11.01 6 117944 142 90510355
Nail bed tenderness 14.80 11.01 8 117942 370 90510127
Depressed mood 14.79 11.01 114 117836 50108 90460389
Rheumatoid nodule 14.72 11.01 4 117946 20162 90490335
Congenital knee deformity 14.71 11.01 5 117945 71 90510426
Wrong technique in product usage process 14.70 11.01 46 117904 71525 90438972
Faecaloma 14.69 11.01 38 117912 10393 90500104
Dyslalia 14.64 11.01 10 117940 708 90509789
Dry eye 14.63 11.01 127 117823 57804 90452693
Ileal stenosis 14.48 11.01 17 117933 2461 90508036
Myelosuppression 14.44 11.01 30 117920 53561 90456936
Crohn's disease 14.36 11.01 24 117926 4827 90505670
Paronychia 14.33 11.01 32 117918 7974 90502523
Injection site urticaria 14.28 11.01 3 117947 18008 90492489
Hyperchlorhydria 14.25 11.01 15 117935 1926 90508571
Neoplasm progression 14.24 11.01 103 117847 44383 90466114
Joint effusion 14.22 11.01 4 117946 19706 90490791
Hepatic lesion 14.12 11.01 26 117924 5647 90504850
Infection 14.09 11.01 361 117589 361733 90148764
Overgrowth bacterial 14.06 11.01 6 117944 163 90510334
Device related bacteraemia 14.03 11.01 8 117942 411 90510086
Gastrointestinal stoma output abnormal 14.01 11.01 8 117942 412 90510085
Catheter site bruise 14.01 11.01 9 117941 575 90509922
Femur fracture 14.00 11.01 24 117926 46058 90464439
Portal tract inflammation 14.00 11.01 5 117945 83 90510414
Autoimmune nephritis 13.98 11.01 8 117942 414 90510083
Atrial fibrillation 13.96 11.01 248 117702 133363 90377134
Odynophagia 13.84 11.01 34 117916 9009 90501488
Autoimmune colitis 13.81 11.01 10 117940 777 90509720
Unmasking of previously unidentified disease 13.78 11.01 13 117937 1463 90509034
Bronchial secretion retention 13.65 11.01 20 117930 3595 90506902
Immunodeficiency 13.61 11.01 22 117928 43212 90467285
Device infusion issue 13.51 11.01 17 117933 2645 90507852
Frustration tolerance decreased 13.51 11.01 31 117919 7865 90502632
Areflexia 13.49 11.01 20 117930 3633 90506864
Abdominal pain lower 13.45 11.01 76 117874 30101 90480396
Faeces soft 13.42 11.01 30 117920 7481 90503016
Mucosal infection 13.41 11.01 6 117944 183 90510314
Hair growth abnormal 13.39 11.01 20 117930 3656 90506841
Thrombosis 13.33 11.01 150 117800 73101 90437396
Creatinine renal clearance decreased 13.33 11.01 4 117946 18895 90491602
Lacrimation increased 13.31 11.01 70 117880 26992 90483505
Stoma site extravasation 13.29 11.01 7 117943 307 90510190
Hot flush 13.29 11.01 127 117823 59361 90451136
Adverse drug reaction 13.28 11.01 93 117857 116608 90393889
Failure to thrive 13.28 11.01 32 117918 8379 90502118
Gastroenteropancreatic neuroendocrine tumour disease 13.23 11.01 4 117946 38 90510459
Malabsorption 13.22 11.01 24 117926 5154 90505343
Catheter site irritation 13.18 11.01 9 117941 637 90509860
Anastomotic leak 13.17 11.01 9 117941 638 90509859
Hypotension 13.13 11.01 533 117417 324864 90185633
Tumour inflammation 13.04 11.01 5 117945 102 90510395
Skin warm 12.95 11.01 30 117920 7657 90502840
Neutropenic colitis 12.95 11.01 21 117929 4122 90506375
Death 12.93 11.01 722 117228 455829 90054668
Catheter site erythema 12.90 11.01 23 117927 4871 90505626
Cachexia 12.88 11.01 28 117922 6850 90503647
Metastases to pancreas 12.79 11.01 7 117943 332 90510165
Systemic inflammatory response syndrome 12.75 11.01 27 117923 6489 90504008
Coronary artery disease 12.70 11.01 15 117935 33608 90476889
Cystitis noninfective 12.67 11.01 12 117938 1357 90509140
Long QT syndrome congenital 12.65 11.01 5 117945 111 90510386
Foetal arrhythmia 12.62 11.01 6 117944 211 90510286
Soft tissue swelling 12.60 11.01 12 117938 1366 90509131
Pupillary reflex impaired 12.51 11.01 16 117934 2529 90507968
Self-injurious ideation 12.50 11.01 18 117932 3185 90507312
Spleen atrophy 12.46 11.01 4 117946 47 90510450
Obstruction 12.42 11.01 20 117930 3901 90506596
Chills 12.40 11.01 241 117709 131740 90378757
Anal fistula 12.36 11.01 21 117929 4280 90506217
Extrapyramidal disorder 12.35 11.01 3 117947 16300 90494197
Functional gastrointestinal disorder 12.35 11.01 23 117927 5039 90505458
Faecalith 12.33 11.01 3 117947 11 90510486
Osteosclerosis 12.30 11.01 21 117929 4299 90506198
Rectal tenesmus 12.26 11.01 11 117939 1161 90509336
Gastrointestinal inflammation 12.25 11.01 27 117923 6669 90503828
Autonomic neuropathy 12.25 11.01 12 117938 1415 90509082
Serotonin syndrome 12.19 11.01 19 117931 37868 90472629
Onychomadesis 12.19 11.01 26 117924 45972 90464525
Lung neoplasm 12.14 11.01 27 117923 6708 90503789
Alveolar bone resorption 12.09 11.01 4 117946 52 90510445
Ataxia 12.04 11.01 51 117899 17991 90492506
Urinary tract stoma complication 12.02 11.01 4 117946 53 90510444
Cold sweat 12.00 11.01 43 117907 14038 90496459
Alcohol abuse 11.97 11.01 14 117936 2019 90508478
Blood pressure systolic increased 11.79 11.01 122 117828 58223 90452274
Cytomegalovirus colitis 11.74 11.01 18 117932 3368 90507129
Tri-iodothyronine increased 11.72 11.01 6 117944 248 90510249
Hypoparathyroidism 11.68 11.01 10 117940 991 90509506
Spinal cord compression 11.59 11.01 22 117928 4889 90505608
Suicidal ideation 11.58 11.01 53 117897 73802 90436695
Gastrointestinal stoma output decreased 11.57 11.01 5 117945 140 90510357
False positive investigation result 11.52 11.01 9 117941 784 90509713
Amputation 11.50 11.01 6 117944 258 90510239
Full blood count decreased 11.46 11.01 72 117878 29617 90480880
Hypoalbuminaemia 11.45 11.01 46 117904 15851 90494646
Injection site haemorrhage 11.39 11.01 12 117938 28306 90482191
Gluten sensitivity 11.37 11.01 9 117941 799 90509698
Transposition of the great vessels 11.32 11.01 6 117944 267 90510230
Haemoglobin increased 11.32 11.01 28 117922 7453 90503044
Forced expiratory volume decreased 11.29 11.01 24 117926 5784 90504713
Skin necrosis 11.22 11.01 4 117946 16937 90493560
Large intestinal stenosis 11.19 11.01 15 117935 2482 90508015
Food allergy 11.17 11.01 10 117940 25468 90485029
Polyarthritis 11.07 11.01 5 117945 18345 90492152
Accidental exposure to product by child 11.05 11.01 11 117939 1322 90509175
Erythema 11.04 11.01 383 117567 228863 90281634

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Diarrhoea 789.71 10.87 2032 65547 458817 42094939
Torsade de pointes 351.15 10.87 200 67379 8394 42545362
Electrocardiogram QT prolonged 261.01 10.87 350 67229 47595 42506161
Electrocardiogram QRS complex prolonged 244.58 10.87 138 67441 5685 42548071
Drug abuse 215.68 10.87 498 67081 104273 42449483
Dehydration 214.91 10.87 600 66979 141167 42412589
Ventricular tachycardia 193.64 10.87 239 67340 29921 42523835
Colitis 171.38 10.87 283 67296 46289 42507467
Intentional overdose 171.27 10.87 299 67280 51157 42502599
Drug ineffective 129.10 10.87 539 67040 629658 41924098
Abdominal pain 120.84 10.87 609 66970 189862 42363894
Decreased appetite 104.40 10.87 591 66988 192546 42361210
Vascular device infection 92.34 10.87 77 67502 6033 42547723
Intestinal obstruction 85.40 10.87 154 67425 27004 42526752
Fatigue 83.13 10.87 1054 66525 434587 42119169
Small intestinal obstruction 78.54 10.87 115 67464 16946 42536810
Blood mercury abnormal 76.05 10.87 25 67554 257 42553499
Enteritis 74.74 10.87 89 67490 10727 42543029
Electrocardiogram T wave alternans 65.48 10.87 18 67561 93 42553663
Intentional self-injury 65.01 10.87 99 67480 15103 42538653
Cardiotoxicity 64.66 10.87 69 67510 7376 42546380
Vomiting 61.64 10.87 716 66863 289007 42264749
Nausea 61.32 10.87 925 66654 395874 42157882
Brugada syndrome 61.24 10.87 31 67548 1022 42552734
Weight decreased 60.48 10.87 548 67031 207400 42346356
Overdose 60.02 10.87 327 67252 104937 42448819
Product use in unapproved indication 56.45 10.87 131 67448 184325 42369431
Conduction disorder 49.38 10.87 37 67542 2481 42551275
Colitis microscopic 48.42 10.87 40 67539 3093 42550663
Immune-mediated enterocolitis 48.22 10.87 52 67527 5625 42548131
5-hydroxyindolacetic acid in urine increased 47.21 10.87 16 67563 182 42553574
Alveolar lung disease 46.88 10.87 20 67559 442 42553314
Electrolyte imbalance 45.12 10.87 90 67489 17011 42536745
Frequent bowel movements 44.21 10.87 102 67477 21305 42532451
Foetal exposure during pregnancy 42.93 10.87 11 67568 47300 42506456
Pulmonary interstitial emphysema syndrome 40.00 10.87 19 67560 544 42553212
Treatment failure 39.86 10.87 25 67554 62599 42491157
Drug use disorder 39.61 10.87 64 67515 10269 42543487
Low density lipoprotein decreased 39.38 10.87 25 67554 1279 42552477
Cardiac arrest 39.13 10.87 302 67277 109018 42444738
Gastrointestinal stoma complication 37.75 10.87 26 67553 1527 42552229
Colitis ulcerative 35.87 10.87 107 67472 26068 42527688
Asthma 35.53 10.87 28 67551 62286 42491470
Intestinal perforation 34.61 10.87 62 67517 10812 42542944
Pancreatic enzyme abnormality 34.28 10.87 11 67568 104 42553652
Clostridium difficile colitis 34.13 10.87 92 67487 21160 42532596
Stoma complication 33.99 10.87 17 67562 546 42553210
Hepatic neoplasm 33.91 10.87 28 67551 2163 42551593
Flatulence 33.70 10.87 102 67477 25050 42528706
Wheezing 33.33 10.87 23 67556 54758 42498998
Unmasking of previously unidentified disease 33.28 10.87 22 67557 1207 42552549
Rheumatoid arthritis 32.94 10.87 13 67566 42427 42511329
Ileus 32.92 10.87 85 67494 19054 42534702
Stomatitis 32.56 10.87 162 67417 50167 42503589
Completed suicide 32.39 10.87 65 67514 96400 42457356
Enterocolitis 32.10 10.87 57 67522 9872 42543884
Abscess intestinal 32.04 10.87 25 67554 1781 42551975
Drug ineffective for unapproved indication 31.40 10.87 17 67562 46146 42507610
Ventricular arrhythmia 31.35 10.87 44 67535 6235 42547521
Intestinal intraepithelial lymphocytes increased 30.86 10.87 12 67567 207 42553549
Pouchitis 30.69 10.87 19 67560 930 42552826
5-hydroxyindolacetic acid increased 30.06 10.87 10 67569 107 42553649
Drug hypersensitivity 30.04 10.87 71 67508 99318 42454438
Sedation 29.82 10.87 6 67573 30469 42523287
Hypomagnesaemia 29.62 10.87 106 67473 28382 42525374
Drug withdrawal syndrome 29.44 10.87 88 67491 21461 42532295
Contraindicated product administered 29.31 10.87 3 67576 25269 42528487
Gastrointestinal stoma output decreased 29.25 10.87 10 67569 117 42553639
Psoriatic arthropathy 28.86 10.87 3 67576 24964 42528792
Long QT syndrome 28.65 10.87 30 67549 3137 42550619
Blood potassium decreased 28.57 10.87 84 67495 20300 42533456
Hypokalaemia 28.41 10.87 203 67376 71518 42482238
Condition aggravated 28.12 10.87 271 67308 260483 42293273
Palmar-plantar erythrodysaesthesia syndrome 28.07 10.87 84 67495 20498 42533258
Drug interaction 27.33 10.87 281 67298 266718 42287038
Syncope 27.33 10.87 259 67320 99147 42454609
Therapeutic product effect incomplete 27.22 10.87 44 67535 70895 42482861
Expired product administered 26.71 10.87 33 67546 4130 42549626
Febrile neutropenia 26.66 10.87 428 67151 185275 42368481
Psoriasis 26.28 10.87 23 67556 48581 42505175
Faecal calprotectin increased 25.68 10.87 28 67551 3066 42550690
Gastrointestinal stoma output increased 25.67 10.87 13 67566 429 42553327
Myelosuppression 24.59 10.87 17 67562 40444 42513312
Wrong technique in product usage process 24.50 10.87 19 67560 42616 42511140
Cryptitis 24.35 10.87 11 67568 280 42553476
Anal fissure 23.65 10.87 35 67544 5204 42548552
Myocardial infarction 23.38 10.87 109 67470 123900 42429856
Abdominal distension 23.37 10.87 194 67385 71541 42482215
Enterocolonic fistula 23.30 10.87 8 67571 95 42553661
Microvillous inclusion disease 22.95 10.87 10 67569 233 42553523
Autoimmune colitis 22.90 10.87 17 67562 1124 42552632
Drug resistance 22.73 10.87 13 67566 34235 42519521
Intestinal fistula 22.36 10.87 17 67562 1165 42552591
Apoptosis 22.09 10.87 13 67566 580 42553176
Diarrhoea haemorrhagic 22.08 10.87 42 67537 7665 42546091
Therapeutic product effect decreased 21.81 10.87 18 67561 39132 42514624
Rhabdomyolysis 21.80 10.87 58 67521 77961 42475795
Abnormal faeces 21.77 10.87 29 67550 3912 42549844
Gastroenteritis 21.37 10.87 66 67513 16383 42537373
Generalised oedema 21.30 10.87 63 67516 15273 42538483
Angioedema 20.75 10.87 22 67557 42455 42511301
Atrioventricular block first degree 20.64 10.87 37 67542 6454 42547302
Blood follicle stimulating hormone increased 20.45 10.87 9 67570 215 42553541
Aggression 20.34 10.87 24 67555 44139 42509617
Depression 20.34 10.87 99 67480 111264 42442492
Abdominal abscess 20.14 10.87 32 67547 5061 42548695
Hepatic haematoma 19.99 10.87 11 67568 431 42553325
Probiotic therapy 19.72 10.87 8 67571 155 42553601
Faeces soft 19.62 10.87 31 67548 4881 42548875
Accidental overdose 18.89 10.87 92 67487 28238 42525518
Arteriosclerosis 18.77 10.87 3 67576 17986 42535770
Dihydropyrimidine dehydrogenase deficiency 18.72 10.87 7 67572 108 42553648
Piloerection 18.59 10.87 9 67570 269 42553487
Colorectal cancer metastatic 18.58 10.87 14 67565 947 42552809
Blood magnesium decreased 18.42 10.87 39 67540 7687 42546069
Drug dispensed to wrong patient 18.38 10.87 11 67568 506 42553250
Intentional product misuse 18.38 10.87 164 67415 61736 42492020
Gastrointestinal obstruction 18.32 10.87 15 67564 1145 42552611
Idiopathic pulmonary fibrosis 18.31 10.87 29 67550 4575 42549181
Psychotic disorder 18.11 10.87 12 67567 29196 42524560
Blood cholesterol increased 17.96 10.87 10 67569 26731 42527025
Injection site pain 17.68 10.87 41 67538 57757 42495999
Peripheral embolism 17.47 10.87 14 67565 1037 42552719
Diffuse alveolar damage 17.37 10.87 21 67558 2571 42551185
Dysgeusia 17.34 10.87 103 67476 34086 42519670
Short-bowel syndrome 17.05 10.87 9 67570 324 42553432
Respiratory depression 16.95 10.87 67 67512 18801 42534955
Asthenia 16.67 10.87 572 67007 280221 42273535
Interstitial lung disease 16.60 10.87 66 67513 78396 42475360
Fibrous histiocytoma 16.49 10.87 9 67570 347 42553409
Pneumonitis 16.47 10.87 118 67461 41600 42512156
No adverse event 16.12 10.87 23 67556 38998 42514758
Body surface area decreased 16.03 10.87 4 67575 13 42553743
Gastroenteritis staphylococcal 15.88 10.87 8 67571 261 42553495
Basosquamous carcinoma 15.73 10.87 6 67573 98 42553658
Steatorrhoea 15.73 10.87 12 67567 827 42552929
Malignant neoplasm progression 15.59 10.87 250 67329 108150 42445606
Off label use 15.58 10.87 841 66738 637494 41916262
Dyschromatopsia 15.28 10.87 10 67569 539 42553217
Dependence 15.17 10.87 15 67564 1465 42552291
Joint swelling 15.17 10.87 56 67523 67966 42485790
Device related infection 15.09 10.87 68 67511 20211 42533545
Incorrect route of product administration 15.05 10.87 10 67569 24295 42529461
Hypovolaemia 14.84 10.87 46 67533 11439 42542317
Sepsis 14.71 10.87 417 67162 198917 42354839
Musculoskeletal stiffness 14.63 10.87 45 67534 57720 42496036
Peripheral motor neuropathy 14.61 10.87 18 67561 2246 42551510
Neuroleptic malignant syndrome 14.46 10.87 8 67571 21464 42532292
Drug delivery device placement 14.43 10.87 6 67573 124 42553632
Pyrexia 14.42 10.87 763 66816 393279 42160477
Puncture site erythema 14.27 10.87 3 67576 3 42553753
Prostate cancer 14.20 10.87 31 67548 44612 42509144
Malnutrition 14.18 10.87 53 67526 14489 42539267
Right ventricular dilatation 14.12 10.87 11 67568 782 42552974
Multiple organ dysfunction syndrome 14.07 10.87 93 67486 96942 42456814
Noninfective gingivitis 13.89 10.87 9 67570 477 42553279
Electrocardiogram PR prolongation 13.79 10.87 12 67567 996 42552760
Biliary obstruction 13.76 10.87 21 67558 3208 42550548
Subileus 13.76 10.87 22 67557 3499 42550257
Anal abscess 13.64 10.87 35 67544 7815 42545941
Overgrowth bacterial 13.61 10.87 6 67573 144 42553612
Bladder cancer 13.60 10.87 5 67574 17042 42536714
Crohn's disease 13.56 10.87 20 67559 2964 42550792
Drug reaction with eosinophilia and systemic symptoms 13.56 10.87 29 67550 42046 42511710
CSF white blood cell count decreased 13.52 10.87 4 67575 28 42553728
Pain in jaw 13.43 10.87 52 67527 14450 42539306
Oesophageal varices haemorrhage 13.36 10.87 22 67557 3585 42550171
Erythema 13.04 10.87 110 67469 108683 42445073
Stress 13.02 10.87 32 67547 44180 42509576
Neoplasm 12.97 10.87 30 67549 6275 42547481
Disturbance in attention 12.95 10.87 17 67562 29849 42523907
Mixed dementia 12.89 10.87 7 67572 267 42553489
Cardiogenic shock 12.84 10.87 23 67556 35617 42518139
Necrotising ulcerative gingivostomatitis 12.82 10.87 5 67574 87 42553669
Proctalgia 12.71 10.87 32 67547 7061 42546695
Anal fistula infection 12.64 10.87 4 67575 36 42553720
Radiation proctitis 12.62 10.87 6 67573 172 42553584
Bacterial diarrhoea 12.53 10.87 6 67573 175 42553581
Diverticulitis intestinal perforated 12.39 10.87 7 67572 289 42553467
Taste disorder 12.38 10.87 40 67539 10167 42543589
Intussusception 12.38 10.87 10 67569 749 42553007
Drug intolerance 12.21 10.87 76 67503 80348 42473408
Nephroangiosclerosis 12.07 10.87 6 67573 190 42553566
Blood creatine phosphokinase increased 11.99 10.87 38 67541 48300 42505456
Biopsy intestine abnormal 11.96 10.87 3 67576 10 42553746
Acquired haemophilia 11.93 10.87 14 67565 1661 42552095
Obstructive airways disorder 11.90 10.87 13 67566 24746 42529010
Agranulocytosis 11.72 10.87 19 67560 30593 42523163
Ejection fraction 11.60 10.87 6 67573 207 42553549
Injection site erythema 11.60 10.87 9 67570 20186 42533570
Constipation 11.55 10.87 338 67241 161953 42391803
Cytomegalovirus infection 11.51 10.87 21 67558 32285 42521471
Eye infection fungal 11.48 10.87 8 67571 479 42553277
Biopsy 11.47 10.87 7 67572 334 42553422
Acute kidney injury 11.43 10.87 701 66878 366636 42187120
Megacolon 11.39 10.87 16 67563 2269 42551487
Paranoia 11.38 10.87 4 67575 14022 42539734
Faecal volume decreased 11.37 10.87 6 67573 216 42553540
Immune-mediated hepatitis 11.35 10.87 21 67558 3753 42550003
Gastrointestinal stoma output abnormal 11.34 10.87 3 67576 13 42553743
Gastrointestinal sounds abnormal 11.34 10.87 16 67563 2278 42551478
Periodontal disease 11.33 10.87 10 67569 846 42552910
Clostridium difficile infection 11.32 10.87 68 67511 22591 42531165
Retinal ischaemia 11.30 10.87 8 67571 491 42553265
Cholangitis 11.22 10.87 40 67539 10687 42543069
Niemann-Pick disease 11.16 10.87 3 67576 14 42553742
Pancreatic failure 11.11 10.87 11 67568 1076 42552680
Loss of personal independence in daily activities 11.11 10.87 41 67538 49775 42503981
Anal fistula 11.10 10.87 28 67551 6185 42547571
Pancreatitis acute 11.05 10.87 91 67488 33473 42520283
Post procedural fistula 11.01 10.87 5 67574 129 42553627
Aplastic anaemia 11.00 10.87 3 67576 12381 42541375
Cardiac failure congestive 10.97 10.87 85 67494 85517 42468239
Creatinine renal clearance abnormal 10.96 10.87 7 67572 362 42553394
Faecaloma 10.94 10.87 28 67551 6242 42547514
Myasthenia gravis 10.89 10.87 6 67573 16131 42537625

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Diarrhoea 1534.52 10.48 4348 155991 1135157 109293803
Dehydration 589.42 10.48 1271 159068 278240 110150720
Colitis 574.66 10.48 725 159614 101598 110327362
Torsade de pointes 481.49 10.48 337 160002 22263 110406697
Electrocardiogram QT prolonged 378.16 10.48 614 159725 108346 110320614
Nausea 366.63 10.48 3045 157294 1232645 109196315
Ventricular tachycardia 352.54 10.48 398 159941 49611 110379349
Drug abuse 314.89 10.48 754 159585 176657 110252303
Abdominal pain 297.10 10.48 1499 158840 511490 109917470
Systemic lupus erythematosus 287.95 10.48 21 160318 254317 110174643
Hand deformity 287.31 10.48 6 160333 218500 110210460
Maternal exposure during pregnancy 283.05 10.48 23 160316 254860 110174100
Vomiting 258.54 10.48 2224 158115 908451 109520509
Schizophrenia 254.01 10.48 228 160111 21598 110407362
Weight decreased 253.05 10.48 1342 158997 466715 109962245
Anti-cyclic citrullinated peptide antibody positive 247.63 10.48 3 160336 181981 110246979
Duodenal ulcer perforation 241.48 10.48 3 160336 177697 110251263
Hypomania 235.72 10.48 160 160179 10050 110418910
Electrocardiogram QRS complex prolonged 229.19 10.48 173 160166 12848 110416112
Hypokalaemia 228.99 10.48 682 159657 181766 110247194
Synovitis 216.88 10.48 64 160275 274028 110154932
Pericarditis 214.80 10.48 31 160308 219083 110209877
Jaundice cholestatic 209.50 10.48 172 160167 14436 110414524
Psoriatic arthropathy 207.12 10.48 22 160317 196739 110232221
Contraindicated product administered 205.72 10.48 53 160286 248214 110180746
Arthropathy 198.65 10.48 84 160255 287438 110141522
Helicobacter infection 197.57 10.48 18 160321 181859 110247101
Proctitis 195.35 10.48 176 160163 16751 110412209
Drug ineffective 195.29 10.48 1349 158990 1519191 108909769
Constipation 191.93 10.48 1024 159315 356762 110072198
Decreased appetite 191.66 10.48 1263 159076 474583 109954377
Total lung capacity increased 191.47 10.48 109 160230 5003 110423957
Wound 188.67 10.48 53 160286 234384 110194576
Vaginal flatulence 184.74 10.48 148 160191 11996 110416964
Muscle injury 184.55 10.48 4 160335 140803 110288157
Vascular device infection 183.34 10.48 168 160171 16344 110412616
Female genital tract fistula 183.28 10.48 168 160171 16351 110412609
Type 2 diabetes mellitus 181.06 10.48 22 160317 177210 110251750
Therapeutic product effect decreased 179.28 10.48 65 160274 244251 110184709
Chronic sinusitis 177.38 10.48 200 160139 24884 110404076
Frequent bowel movements 176.46 10.48 347 159992 71043 110357917
Glossodynia 173.50 10.48 53 160286 221951 110207009
Cholelithiasis 172.42 10.48 321 160018 63101 110365859
Febrile neutropenia 171.49 10.48 909 159430 315858 110113102
Vaginal discharge 169.86 10.48 167 160172 17741 110411219
Macular degeneration 167.51 10.48 181 160158 21478 110407482
Folliculitis 163.66 10.48 24 160315 167629 110261331
Intestinal obstruction 163.34 10.48 284 160055 52943 110376017
Small intestinal obstruction 161.59 10.48 216 160123 31997 110396963
Drug intolerance 159.02 10.48 214 160125 406298 110022662
Hypomagnesaemia 155.98 10.48 299 160040 60071 110368889
Drug hypersensitivity 151.78 10.48 266 160073 453824 109975136
Treatment failure 149.67 10.48 110 160229 277124 110151836
Impaired healing 148.32 10.48 50 160289 196667 110232293
Radiculopathy 143.29 10.48 158 160181 19178 110409782
Colitis microscopic 142.36 10.48 133 160206 13261 110415699
Joint swelling 136.02 10.48 273 160066 442572 109986388
Blood bilirubin increased 135.86 10.48 324 160015 75648 110353312
Obesity 135.33 10.48 7 160332 113344 110315616
Rheumatoid arthritis 135.01 10.48 141 160198 299472 110129488
Gastrointestinal stoma complication 130.96 10.48 73 160266 3216 110425744
Exposure during pregnancy 130.75 10.48 40 160299 167384 110261576
Paraesthesia oral 129.52 10.48 199 160140 33472 110395488
Joint range of motion decreased 124.73 10.48 15 160324 121817 110307143
Swelling 123.39 10.48 199 160140 350842 110078118
Asthma-chronic obstructive pulmonary disease overlap syndrome 122.22 10.48 89 160250 6255 110422705
Bursitis 121.38 10.48 21 160318 129897 110299063
Haematochezia 118.50 10.48 403 159936 115121 110313839
Oral candidiasis 118.48 10.48 224 160115 44536 110384424
Procedural pain 116.01 10.48 195 160144 35370 110393590
Discomfort 114.82 10.48 86 160253 214621 110214339
C-reactive protein abnormal 114.72 10.48 24 160315 129671 110299289
Mobility decreased 112.38 10.48 107 160232 237315 110191645
Completed suicide 109.26 10.48 114 160225 242267 110186693
Flatulence 108.32 10.48 236 160103 51913 110377047
Colitis ulcerative 106.43 10.48 299 160040 77064 110351896
Musculoskeletal stiffness 104.68 10.48 152 160187 279670 110149290
Neuropathy peripheral 104.22 10.48 525 159814 178752 110250208
Intentional overdose 103.95 10.48 424 159915 132077 110296883
Brugada syndrome 103.15 10.48 49 160290 1539 110427421
Enteritis 103.12 10.48 133 160206 19023 110409937
Rectal haemorrhage 102.49 10.48 394 159945 119439 110309521
Anaemia 97.72 10.48 1217 159122 545869 109883091
Injury 97.38 10.48 69 160270 177196 110251764
Red blood cell sedimentation rate increased 96.18 10.48 4 160335 78298 110350662
Pneumonia 95.41 10.48 1792 158547 874922 109554038
Sinusitis 94.41 10.48 179 160160 296509 110132451
Irritable bowel syndrome 94.12 10.48 61 160278 164154 110264806
Lip dry 93.88 10.48 16 160323 100067 110328893
Ill-defined disorder 93.03 10.48 56 160283 156797 110272163
Syncope 90.89 10.48 553 159786 201983 110226977
Product use in unapproved indication 89.32 10.48 340 159999 447037 109981923
Fatigue 89.19 10.48 2349 157990 1213609 109215351
Live birth 87.23 10.48 3 160336 69481 110359479
Inflammation 86.95 10.48 91 160248 193147 110235813
Acute kidney injury 86.53 10.48 1347 158992 634083 109794877
Hypercholesterolaemia 86.36 10.48 14 160325 90823 110338137
Enterocolitis 85.89 10.48 121 160218 18828 110410132
Fibromyalgia 85.67 10.48 73 160266 170836 110258124
Pneumonia aspiration 84.72 10.48 285 160054 80948 110348012
Urticaria 84.44 10.48 213 160126 318644 110110316
Cardiac arrest 84.39 10.48 531 159808 196222 110232738
Cardiotoxicity 84.36 10.48 113 160226 16768 110412192
Malignant neoplasm progression 83.05 10.48 484 159855 174083 110254877
Weight increased 80.52 10.48 324 160015 419320 110009640
Gait inability 80.44 10.48 49 160290 136327 110292633
Gastrooesophageal reflux disease 79.86 10.48 490 159849 179486 110249474
Mucosal inflammation 79.68 10.48 313 160026 95828 110333132
Pneumonia viral 78.95 10.48 89 160250 11068 110417892
Sarcoidosis 78.40 10.48 94 160245 12485 110416475
Blood mercury abnormal 78.24 10.48 25 160314 257 110428703
Hypersensitivity 78.09 10.48 311 160028 403687 110025273
Blood magnesium decreased 78.06 10.48 119 160220 19877 110409083
Pyrexia 77.96 10.48 1776 158563 896489 109532471
Conduction disorder 76.11 10.48 56 160283 3999 110424961
Liver injury 74.47 10.48 65 160274 150348 110278612
Nasal polyps 73.18 10.48 93 160246 13107 110415853
Immune-mediated enterocolitis 71.65 10.48 81 160258 10104 110418856
Gastrointestinal stoma output increased 71.45 10.48 33 160306 971 110427989
Lethargy 70.67 10.48 296 160043 93280 110335680
Oral pain 70.53 10.48 163 160176 37281 110391679
Coma 70.48 10.48 348 159991 117521 110311439
Gastrointestinal procedural complication 69.64 10.48 26 160313 439 110428521
Appetite disorder 69.25 10.48 78 160261 9691 110419269
Pneumonitis 69.05 10.48 256 160083 76275 110352685
Knee arthroplasty 69.00 10.48 7 160332 64941 110364019
Accidental overdose 68.05 10.48 197 160142 51637 110377323
Psoriasis 67.51 10.48 62 160277 139931 110289029
Blood cholesterol increased 67.50 10.48 102 160237 184683 110244277
Overdose 67.48 10.48 574 159765 233220 110195740
Soft tissue disorder 66.89 10.48 49 160290 3475 110425485
Blepharospasm 66.71 10.48 3 160336 54848 110374112
Road traffic accident 65.58 10.48 37 160302 107361 110321599
Ventricular arrhythmia 65.54 10.48 77 160262 10010 110418950
Electrolyte imbalance 65.20 10.48 157 160182 36871 110392089
Blister 64.05 10.48 147 160192 227229 110201731
Clostridium difficile infection 62.63 10.48 192 160147 51937 110377023
Blood potassium decreased 61.95 10.48 196 160143 53918 110375042
Palmar-plantar erythrodysaesthesia syndrome 61.85 10.48 164 160175 40861 110388099
Sepsis 61.74 10.48 736 159603 326610 110102350
Electrocardiogram T wave alternans 61.36 10.48 18 160321 135 110428825
Long QT syndrome 61.30 10.48 63 160276 7055 110421905
Stoma complication 60.93 10.48 30 160309 1021 110427939
Segmental diverticular colitis 59.07 10.48 18 160321 156 110428804
Brain stem glioma 58.98 10.48 19 160320 201 110428759
Musculoskeletal pain 57.69 10.48 111 160228 182912 110246048
Product quality issue 57.63 10.48 20 160319 77279 110351681
Presbyacusis 57.63 10.48 41 160298 2778 110426182
Lower limb fracture 57.04 10.48 19 160320 75329 110353631
Injection site reaction 56.86 10.48 29 160310 89041 110339919
Rhinitis allergic 56.77 10.48 97 160242 17825 110411135
Pulmonary fibrosis 55.66 10.48 40 160299 102002 110326958
Sciatica 54.76 10.48 33 160306 92366 110336594
Abdominal discomfort 54.39 10.48 341 159998 393517 110035443
Condition aggravated 53.86 10.48 746 159593 734090 109694870
Drug use disorder 53.57 10.48 95 160244 17979 110410981
Heart sounds 52.82 10.48 28 160311 1115 110427845
Pedal pulse abnormal 52.80 10.48 18 160321 230 110428730
Blood magnesium increased 52.70 10.48 44 160295 3779 110425181
Prescribed overdose 52.30 10.48 31 160308 87550 110341410
Autoimmune disorder 52.28 10.48 15 160324 65468 110363492
Neutropenic sepsis 51.61 10.48 128 160211 30618 110398342
Arthralgia 50.74 10.48 810 159529 778822 109650138
Drug interaction 50.69 10.48 472 159867 499711 109929249
Pouchitis 50.21 10.48 29 160310 1368 110427592
Clostridium difficile colitis 49.60 10.48 158 160181 43620 110385340
Abnormal faeces 49.52 10.48 64 160275 9172 110419788
Cardiac murmur 49.49 10.48 110 160229 24518 110404442
Device related infection 48.82 10.48 147 160192 39372 110389588
Wound infection 48.58 10.48 41 160298 96424 110332536
5-hydroxyindolacetic acid in urine increased 48.46 10.48 16 160323 184 110428776
Pruritus 48.29 10.48 575 159764 580985 109847975
Nail dystrophy 48.20 10.48 27 160312 1201 110427759
Back injury 48.10 10.48 6 160333 47393 110381567
Lung disorder 47.84 10.48 120 160219 179927 110249033
Therapeutic reaction time decreased 47.79 10.48 48 160291 5231 110423729
Injection site pain 47.73 10.48 118 160221 177804 110251156
Asthma 47.49 10.48 194 160145 250097 110178863
Prolonged expiration 47.39 10.48 29 160310 1523 110427437
Dihydropyrimidine dehydrogenase deficiency 47.25 10.48 16 160323 200 110428760
Urinary tract infection 46.74 10.48 698 159641 325584 110103376
Migraine 46.71 10.48 113 160226 171539 110257421
Gastroenteritis radiation 46.65 10.48 23 160316 785 110428175
Pleural thickening 46.61 10.48 39 160300 3360 110425600
Respiration abnormal 46.49 10.48 64 160275 9745 110419215
Intestinal perforation 46.04 10.48 97 160242 20847 110408113
Hepatotoxicity 45.89 10.48 198 160141 63202 110365758
Neutropenia 45.62 10.48 780 159559 373840 110055120
Sedation 45.51 10.48 22 160317 69661 110359299
Coeliac disease 44.99 10.48 5 160334 43182 110385778
Psychotic disorder 44.79 10.48 169 160170 50768 110378192
Calcium ionised decreased 44.64 10.48 21 160318 645 110428315
Blood creatinine increased 44.59 10.48 433 159906 182456 110246504
Ileus 44.46 10.48 121 160218 30608 110398352
Unmasking of previously unidentified disease 43.72 10.48 35 160304 2833 110426127
Therapeutic response decreased 42.77 10.48 46 160293 96453 110332507
Atrioventricular block first degree 42.46 10.48 75 160264 14150 110414810
Pleural fibrosis 42.40 10.48 41 160298 4267 110424693
Abdominal distension 41.92 10.48 413 159926 174690 110254270
Lupus-like syndrome 41.80 10.48 5 160334 40787 110388173
Adverse event 41.75 10.48 58 160281 108751 110320209
Grip strength decreased 41.71 10.48 33 160306 80141 110348819
Hepatic enzyme increased 41.67 10.48 283 160056 320609 110108351
Osteoarthritis 41.65 10.48 131 160208 182492 110246468
Drug ineffective for unapproved indication 41.31 10.48 53 160286 102785 110326175
Pulmonary interstitial emphysema syndrome 41.24 10.48 19 160320 556 110428404
Foot deformity 40.80 10.48 10 160329 48470 110380490
Dyspepsia 40.77 10.48 440 159899 190525 110238435
Unresponsive to stimuli 40.76 10.48 192 160147 63598 110365362
Pregnancy 40.22 10.48 12 160327 51055 110377905
Hypophagia 40.14 10.48 167 160172 52459 110376501
Alveolar lung disease 40.13 10.48 20 160319 699 110428261
Defaecation urgency 39.86 10.48 56 160283 8691 110420269
Hypocalcaemia 39.78 10.48 194 160145 65172 110363788
Low density lipoprotein decreased 39.45 10.48 25 160314 1397 110427563
Myelosuppression 38.54 10.48 48 160291 94292 110334668
Anal incontinence 38.53 10.48 93 160246 21871 110407089
Osteoporosis 38.12 10.48 42 160297 87110 110341850
Dry skin 38.03 10.48 277 160062 107376 110321584
Pain 37.82 10.48 1075 159264 953880 109475080
Urosepsis 37.80 10.48 114 160225 30561 110398399
Ear infection 37.74 10.48 22 160317 62710 110366250
Lower respiratory tract infection 37.53 10.48 203 160136 242903 110186057
5-hydroxyindolacetic acid increased 37.50 10.48 12 160327 124 110428836
Alopecia 37.45 10.48 343 159996 364410 110064550
Hepatic neoplasm 36.55 10.48 36 160303 3831 110425129
Drug resistance 36.51 10.48 18 160321 56356 110372604
Somnolence 36.44 10.48 620 159719 296829 110132131
Injection site erythema 36.34 10.48 50 160289 94126 110334834
Intentional self-injury 36.12 10.48 128 160211 37301 110391659
Gastroenteritis 36.01 10.48 131 160208 38669 110390291
Nasopharyngitis 35.82 10.48 382 159957 393979 110034981
Anal abscess 35.57 10.48 62 160277 11576 110417384
Muscle spasticity 35.36 10.48 5 160334 35910 110393050
Hypophosphataemia 35.10 10.48 117 160222 33065 110395895
Intentional product use issue 35.05 10.48 213 160126 247693 110181267
Contusion 34.86 10.48 197 160142 233164 110195796
Cryptitis 34.63 10.48 15 160324 378 110428582
Tumour pain 34.53 10.48 31 160308 2936 110426024
Deafness neurosensory 34.42 10.48 55 160284 9564 110419396
Infusion related reaction 34.30 10.48 370 159969 380792 110048168
Platelet count decreased 34.16 10.48 496 159843 229947 110199013
Autoimmune colitis 34.11 10.48 26 160313 1959 110427001
Ejection fraction decreased 33.78 10.48 133 160206 40747 110388213
Hypoaesthesia 33.78 10.48 292 160047 313931 110115029
Injection site pruritus 33.76 10.48 16 160323 51242 110377718
Prescribed underdose 33.69 10.48 27 160312 65147 110363813
Device expulsion 33.68 10.48 3 160336 30888 110398072
Anal fissure 33.32 10.48 55 160284 9826 110419134
Gastrointestinal stoma output decreased 33.12 10.48 13 160326 253 110428707
Gastrointestinal sounds abnormal 32.73 10.48 42 160297 5976 110422984
Injection site swelling 32.69 10.48 25 160314 61765 110367195
Drug withdrawal syndrome 32.42 10.48 125 160214 37929 110391031
Malnutrition 32.32 10.48 100 160239 27179 110401781
Rash 32.26 10.48 925 159414 820039 109608921
Dry mouth 31.96 10.48 165 160174 199783 110229177
Lung neoplasm malignant 31.19 10.48 114 160225 33728 110395232
Premature delivery 30.79 10.48 4 160335 30628 110398332
Disease progression 30.73 10.48 511 159828 243523 110185437
Intestinal intraepithelial lymphocytes increased 30.69 10.48 12 160327 231 110428729
Dysgeusia 30.68 10.48 190 160149 69795 110359165
Asthenia 30.53 10.48 1255 159084 687744 109741216
Diarrhoea haemorrhagic 30.47 10.48 69 160270 15570 110413390
Onychomycosis 30.44 10.48 9 160330 38522 110390438
Megacolon 29.88 10.48 34 160305 4271 110424689
Joint stiffness 29.86 10.48 32 160307 67211 110361749
Mydriasis 29.84 10.48 85 160254 22072 110406888
Arteriovenous fistula occlusion 29.84 10.48 15 160324 534 110428426
Corneal reflex decreased 29.74 10.48 15 160324 538 110428422
Finger deformity 29.51 10.48 6 160333 33086 110395874
Pancreatic enzyme abnormality 29.34 10.48 11 160328 188 110428772
Gallbladder polyp 29.31 10.48 20 160319 1267 110427693
Wrong technique in product usage process 29.27 10.48 51 160288 87297 110341663
Drug tolerance decreased 29.17 10.48 3 160336 27537 110401423
Faecal calprotectin increased 29.12 10.48 42 160297 6677 110422283
Hypovolaemia 29.05 10.48 83 160256 21591 110407369
Pleural effusion 28.96 10.48 389 159950 177320 110251640
Drug-induced liver injury 28.90 10.48 84 160255 119983 110308977
Large intestine perforation 28.73 10.48 70 160269 16559 110412401
No adverse event 28.69 10.48 39 160300 73800 110355160
Feeding intolerance 28.40 10.48 19 160320 1165 110427795
Renal pain 28.33 10.48 51 160288 9766 110419194
Multiple sclerosis relapse 28.32 10.48 19 160320 50221 110378739
Arrhythmia 28.10 10.48 185 160154 69390 110359570
Pulmonary embolism 28.08 10.48 452 159887 214022 110214938
Proctalgia 27.64 10.48 60 160279 13162 110415798
Large intestine polyp 27.59 10.48 65 160274 15052 110413908
Depression 27.36 10.48 311 160028 317024 110111936
Liver disorder 27.12 10.48 110 160229 142133 110286827
Fistula 27.07 10.48 65 160274 15234 110413726
Dermatitis acneiform 26.98 10.48 58 160281 12637 110416323
Rhinorrhoea 26.47 10.48 246 160093 102420 110326540
Epigastric discomfort 26.22 10.48 47 160292 8968 110419992
Anxiety 26.05 10.48 348 159991 344730 110084230
Product use issue 25.89 10.48 308 160031 311387 110117573
Pancreatitis chronic 25.61 10.48 32 160307 4433 110424527
Therapy non-responder 25.59 10.48 129 160210 157178 110271782
Drug dispensed to wrong patient 25.47 10.48 15 160324 734 110428226
Ventricular fibrillation 25.41 10.48 123 160216 41190 110387770
Loss of personal independence in daily activities 24.99 10.48 122 160217 149898 110279062
Biliary sepsis 24.97 10.48 21 160318 1822 110427138
Skin fissures 24.78 10.48 85 160254 24373 110404587
Disability 23.98 10.48 7 160332 30216 110398744
Blue toe syndrome 23.98 10.48 14 160325 674 110428286
Faecaloma 23.91 10.48 61 160278 14847 110414113
Rhabdomyolysis 23.66 10.48 92 160247 120309 110308651
Faeces soft 23.58 10.48 51 160288 11159 110417801
Brain injury 23.57 10.48 57 160282 13419 110415541
Hyponatraemia 23.57 10.48 445 159894 217208 110211752
Neuroleptic malignant syndrome 23.42 10.48 10 160329 34049 110394911
Piloerection 23.42 10.48 15 160324 854 110428106
Injection site bruising 23.20 10.48 24 160315 51239 110377721
Probiotic therapy 23.18 10.48 9 160330 170 110428790
Accidental exposure to product 23.11 10.48 23 160316 49985 110378975
Genitourinary tract neoplasm 22.54 10.48 7 160332 65 110428895
Microvillous inclusion disease 22.48 10.48 10 160329 269 110428691
Short-bowel syndrome 22.42 10.48 14 160325 762 110428198
Pancreatitis acute 22.39 10.48 157 160182 60117 110368843
Reflux gastritis 22.26 10.48 18 160321 1478 110427482
Angioedema 22.21 10.48 71 160268 98429 110330531
Gastroenteritis bacterial 22.12 10.48 12 160327 501 110428459
Intentional product misuse 22.10 10.48 292 160047 132612 110296348
Respiratory disorder 21.87 10.48 44 160295 71338 110357622
Hypertension 21.74 10.48 568 159771 509516 109919444
Plasma cell myeloma 21.68 10.48 161 160178 62775 110366185
Ascites 21.28 10.48 217 160122 92591 110336369
Idiopathic pulmonary fibrosis 21.28 10.48 31 160308 4973 110423987
Bacterial disease carrier 21.22 10.48 21 160318 2248 110426712
Abscess intestinal 21.10 10.48 25 160314 3279 110425681
Hyperglycaemia 20.99 10.48 202 160137 84888 110344072
Oedema 20.87 10.48 199 160140 209777 110219183
Apoptosis 20.73 10.48 13 160326 713 110428247
Hot flush 20.56 10.48 165 160174 65871 110363089
Coronary artery disease 20.45 10.48 46 160293 71644 110357316
Bacterial translocation 20.21 10.48 17 160322 1475 110427485
Onychomadesis 19.97 10.48 22 160317 45641 110383319
Neoplasm progression 19.90 10.48 161 160178 64434 110364526
Adverse drug reaction 19.89 10.48 82 160257 105477 110323483
Bronchiectasis 19.88 10.48 105 160234 36388 110392572
Memory impairment 19.85 10.48 186 160153 196758 110232202
Hepatic haematoma 19.65 10.48 14 160325 951 110428009
Suicidal ideation 19.62 10.48 70 160269 93867 110335093
Rheumatoid nodule 19.58 10.48 3 160336 20293 110408667
Enterocolonic fistula 19.56 10.48 8 160331 174 110428786
Iron deficiency anaemia 19.44 10.48 94 160245 31465 110397495
Gastrointestinal disorder 19.36 10.48 241 160098 241711 110187249
Confusional state 19.15 10.48 525 159814 468155 109960805
Duodenal polyp 19.14 10.48 11 160328 514 110428446
Enterocutaneous fistula 19.00 10.48 20 160319 2303 110426657
White blood cell count decreased 18.99 10.48 451 159888 228939 110200021
Night sweats 18.99 10.48 115 160224 133868 110295092
Electrocardiogram abnormal 18.93 10.48 65 160274 18644 110410316
Hemianopia 18.81 10.48 22 160317 2846 110426114
Peripheral swelling 18.81 10.48 444 159895 403590 110025370
Gastrointestinal inflammation 18.70 10.48 42 160297 9427 110419533
Small intestine ulcer 18.57 10.48 13 160326 858 110428102
Gastritis 18.29 10.48 137 160202 53562 110375398
Myocardial infarction 18.26 10.48 184 160155 191899 110237061
Gastroenteritis staphylococcal 18.18 10.48 9 160330 310 110428650
Flashback 18.12 10.48 10 160329 432 110428528
Blood sodium decreased 18.04 10.48 106 160233 38213 110390747
Subileus 18.01 10.48 33 160306 6404 110422556
Radiation proctitis 17.99 10.48 8 160331 215 110428745
Laryngitis 17.93 10.48 21 160318 42390 110386570
Laryngitis viral 17.87 10.48 6 160333 73 110428887
Walking aid user 17.83 10.48 7 160332 25068 110403892
Paraesthesia 17.69 10.48 288 160051 276233 110152727
Blood pressure systolic increased 17.60 10.48 191 160148 82800 110346160
Puncture site erythema 17.60 10.48 5 160334 33 110428927
Transposition of the great vessels 17.58 10.48 6 160333 77 110428883
Bladder cancer 17.44 10.48 4 160335 20288 110408672
Infection 17.42 10.48 396 159943 361804 110067156
Gamma-glutamyltransferase increased 17.39 10.48 150 160189 61159 110367801
Drug reaction with eosinophilia and systemic symptoms 17.26 10.48 61 160278 82034 110346926
Failure to thrive 17.25 10.48 51 160288 13523 110415437
Niemann-Pick disease 17.22 10.48 5 160334 36 110428924
Post procedural diarrhoea 17.16 10.48 10 160329 480 110428480
Hypervitaminosis B12 17.15 10.48 4 160335 10 110428950
Tumour inflammation 17.10 10.48 6 160333 84 110428876
Metastases to spinal cord 16.97 10.48 8 160331 247 110428713
Functional gastrointestinal disorder 16.91 10.48 31 160308 6018 110422942
Sedation complication 16.89 10.48 4 160335 19851 110409109
Amnesia 16.83 10.48 87 160252 105321 110323639
Right ventricular dilatation 16.82 10.48 19 160320 2368 110426592
Tongue coated 16.72 10.48 17 160322 1879 110427081
Respiratory depression 16.70 10.48 91 160248 31910 110397050
Wheezing 16.60 10.48 265 160074 254965 110173995
Non-small cell lung cancer 16.57 10.48 36 160303 7899 110421061
Pain in jaw 16.55 10.48 129 160210 51048 110377912
Ulcer haemorrhage 16.55 10.48 6 160333 22565 110406395
Paronychia 16.40 10.48 44 160295 11037 110417923
Diversion colitis 16.38 10.48 4 160335 13 110428947
C-reactive protein increased 16.35 10.48 220 160119 217699 110211261
Bone cyst 16.32 10.48 23 160316 3580 110425380
Large intestinal obstruction 16.31 10.48 24 160315 3884 110425076
Joint effusion 16.30 10.48 5 160334 20900 110408060
Neutrophil count decreased 16.24 10.48 256 160083 120685 110308275
Nail infection 16.18 10.48 19 160320 2469 110426491
Mania 16.17 10.48 5 160334 20791 110408169
Extrapyramidal disorder 16.16 10.48 11 160328 28856 110400104
Gastrointestinal obstruction 16.07 10.48 18 160321 2222 110426738
Serotonin syndrome 16.04 10.48 39 160300 59114 110369846
Blood follicle stimulating hormone increased 16.03 10.48 9 160330 402 110428558
Chills 15.87 10.48 375 159964 190205 110238755
Dysuria 15.86 10.48 145 160194 60086 110368874
Bicuspid aortic valve 15.77 10.48 5 160334 50 110428910
Stoma site ulcer 15.73 10.48 8 160331 292 110428668
Respiratory tract congestion 15.68 10.48 13 160326 30844 110398116
Pelvic neoplasm 15.66 10.48 8 160331 295 110428665
Enterocolitis infectious 15.62 10.48 22 160317 3422 110425538
Gastrointestinal stoma output abnormal 15.61 10.48 9 160330 423 110428537
Abortion spontaneous 15.57 10.48 16 160323 34266 110394694
Thymus disorder 15.51 10.48 10 160329 576 110428384
Rales 15.47 10.48 74 160265 24665 110404295
Palmar erythema 15.44 10.48 18 160321 2320 110426640
Basosquamous carcinoma 15.42 10.48 6 160333 114 110428846
Neoplasm 15.39 10.48 43 160296 11044 110417916
Aplastic anaemia 15.38 10.48 8 160331 24300 110404660
Tubulointerstitial nephritis 15.35 10.48 35 160304 54249 110374711
Glaucoma 15.29 10.48 69 160270 22448 110406512
Incorrect route of product administration 15.28 10.48 45 160294 64016 110364944
Exostosis 15.25 10.48 27 160312 45929 110383031
Medication error 15.16 10.48 90 160249 105276 110323684
Presyncope 15.14 10.48 122 160217 48765 110380195
Duodenitis 15.13 10.48 38 160301 9158 110419802
Ileostomy 15.11 10.48 18 160321 2374 110426586
Cardiac failure congestive 15.04 10.48 143 160196 150857 110278103
Rectal abscess 14.95 10.48 19 160320 2677 110426283
Intestinal ulcer 14.90 10.48 18 160321 2409 110426551
Impaired work ability 14.88 10.48 10 160329 26409 110402551
Visual impairment 14.84 10.48 124 160215 134304 110294656
Pancreatic disorder 14.78 10.48 23 160316 3911 110425049
Liver function test increased 14.75 10.48 72 160267 88476 110340484
Cyst 14.72 10.48 55 160284 16441 110412519
Systemic inflammatory response syndrome 14.70 10.48 47 160292 12996 110415964
Body surface area decreased 14.66 10.48 5 160334 64 110428896
Oesophagitis 14.55 10.48 81 160258 28634 110400326
Injection site haemorrhage 14.35 10.48 16 160323 33012 110395948
Expired product administered 14.35 10.48 35 160304 8285 110420675
Intestinal fistula 14.31 10.48 15 160324 1718 110427242
Diffuse alveolar damage 14.29 10.48 23 160316 4024 110424936
Ureteric obstruction 14.28 10.48 20 160319 3094 110425866
Tachycardia 14.28 10.48 430 159909 226215 110202745
Bezoar 14.26 10.48 23 160316 4031 110424929
Hypoalbuminaemia 14.20 10.48 81 160258 28893 110400067
Cholangitis 14.19 10.48 54 160285 16281 110412679
Gluten sensitivity 14.18 10.48 9 160330 504 110428456
Creatinine renal clearance decreased 14.07 10.48 7 160332 21808 110407152
Drug eruption 14.06 10.48 36 160303 53623 110375337
Congenital knee deformity 14.00 10.48 4 160335 27 110428933
Metastases to abdominal cavity 14.00 10.48 11 160328 867 110428093
Prerenal failure 13.95 10.48 24 160315 4435 110424525
Gastroenteropancreatic neuroendocrine tumour disease 13.94 10.48 5 160334 75 110428885
Nail bed tenderness 13.88 10.48 8 160331 376 110428584
Sudden death 13.85 10.48 71 160268 24324 110404636
Bronchial wall thickening 13.83 10.48 20 160319 3187 110425773
Hydronephrosis 13.79 10.48 63 160276 20602 110408358
Stomatitis haemorrhagic 13.78 10.48 7 160332 255 110428705
Diabetes mellitus 13.72 10.48 86 160253 99295 110329665
Sleep disorder 13.68 10.48 204 160135 198440 110230520
Injection site urticaria 13.64 10.48 4 160335 17211 110411749
Metastases to liver 13.63 10.48 93 160246 35293 110393667
Blood creatine phosphokinase increased 13.62 10.48 57 160282 73020 110355940
Musculoskeletal disorder 13.56 10.48 8 160331 22656 110406304
Diverticulitis intestinal perforated 13.51 10.48 9 160330 548 110428412
Bone disorder 13.37 10.48 7 160332 21185 110407775
Anal haemorrhage 13.37 10.48 25 160314 4927 110424033
Delusion 13.37 10.48 9 160330 23746 110405214
Catheter site erythema 13.34 10.48 28 160311 6000 110422960
Metastases to pancreas 13.34 10.48 10 160329 735 110428225
Hair texture abnormal 13.32 10.48 22 160317 3932 110425028
Hypermagnesaemia 13.32 10.48 14 160325 1609 110427351
Product dose omission issue 13.25 10.48 360 159979 321422 110107538
Complication associated with device 13.25 10.48 61 160278 20012 110408948
Decubitus ulcer 13.23 10.48 57 160282 18179 110410781
Bone hypertrophy 13.19 10.48 10 160329 747 110428213
Arteriosclerosis 13.13 10.48 10 160329 24757 110404203
Peritoneal perforation 13.04 10.48 6 160333 175 110428785
Anal injury 13.04 10.48 6 160333 175 110428785
Mixed dementia 13.04 10.48 7 160332 286 110428674
Vitamin B1 deficiency 13.03 10.48 11 160328 959 110428001
Abdominal abscess 13.03 10.48 35 160304 8784 110420176
Therapy partial responder 13.01 10.48 21 160318 37040 110391920
Cognitive disorder 12.99 10.48 74 160265 87437 110341523
Terminal ileitis 12.89 10.48 14 160325 1670 110427290
Osteopenia 12.86 10.48 65 160274 22144 110406816
Pleural calcification 12.82 10.48 6 160333 182 110428778
Urine output decreased 12.82 10.48 60 160279 19816 110409144
Chapped lips 12.76 10.48 19 160320 3109 110425851
Haemorrhoids 12.71 10.48 92 160247 35580 110393380
Self-medication 12.71 10.48 28 160311 6204 110422756
Plantar erythema 12.67 10.48 7 160332 303 110428657
Device related bacteraemia 12.66 10.48 12 160327 1218 110427742
Gait disturbance 12.58 10.48 307 160032 277901 110151059
Rebound effect 12.56 10.48 3 160336 14803 110414157
Bulimia nervosa 12.46 10.48 7 160332 313 110428647
Pathogen resistance 12.45 10.48 5 160334 17667 110411293
Muscular weakness 12.41 10.48 270 160069 248198 110180762
Hair growth abnormal 12.35 10.48 20 160319 3517 110425443
Stoma creation 12.33 10.48 6 160333 199 110428761
Feeling cold 12.31 10.48 88 160251 33899 110395061
Fibrous histiocytoma 12.28 10.48 10 160329 829 110428131
Agranulocytosis 12.25 10.48 47 160292 61713 110367247
Drug delivery device placement 12.25 10.48 6 160333 202 110428758
Device occlusion 12.22 10.48 49 160290 15136 110413824
Drug dose omission by device 12.20 10.48 3 160336 14513 110414447
Pulmonary thrombosis 12.19 10.48 46 160293 13817 110415143
Device difficult to use 12.18 10.48 6 160333 18799 110410161
Abdominal mass 12.18 10.48 24 160315 4917 110424043
Steatorrhoea 12.18 10.48 11 160328 1050 110427910
Oesophageal varices haemorrhage 12.17 10.48 24 160315 4921 110424039
Pancreatic failure 12.13 10.48 16 160323 2338 110426622
Ileus paralytic 12.07 10.48 41 160298 11696 110417264
Fistula of small intestine 12.05 10.48 11 160328 1064 110427896
Inflammatory bowel disease 12.02 10.48 30 160309 7204 110421756
Paranoia 11.90 10.48 9 160330 22365 110406595
Anal fistula 11.90 10.48 33 160306 8440 110420520
Hepatitis 11.88 10.48 79 160260 89975 110338985
Red blood cell count decreased 11.87 10.48 147 160192 65776 110363184
Hepatic pain 11.83 10.48 23 160316 4667 110424293
Treatment noncompliance 11.79 10.48 60 160279 72930 110356030
Dependence 11.74 10.48 17 160322 2712 110426248
Injection site rash 11.73 10.48 10 160329 23409 110405551
Lip erosion 11.72 10.48 14 160325 1852 110427108
Rash erythematous 11.72 10.48 70 160269 81762 110347198
Post transplant lymphoproliferative disorder 11.71 10.48 4 160335 15609 110413351
Sopor 11.65 10.48 22 160317 36524 110392436
Acquired claw toe 11.60 10.48 4 160335 53 110428907
Hip fracture 11.59 10.48 89 160250 35062 110393898
Hyperchlorhydria 11.58 10.48 15 160324 2154 110426806
Paralysis recurrent laryngeal nerve 11.58 10.48 6 160333 228 110428732
Bacterial diarrhoea 11.52 10.48 7 160332 363 110428597
Blindness 11.49 10.48 22 160317 36337 110392623
Sleep disorder due to a general medical condition 11.44 10.48 38 160301 52074 110376886
Joint dislocation 11.42 10.48 20 160319 34170 110394790
Colon cancer metastatic 11.38 10.48 16 160323 2485 110426475
Arterial occlusive disease 11.34 10.48 4 160335 15304 110413656
Immune-mediated hepatitis 11.33 10.48 28 160311 6683 110422277
Portal tract inflammation 11.27 10.48 6 160333 241 110428719
Neck pain 11.27 10.48 119 160220 123011 110305949
Biopsy intestine abnormal 11.26 10.48 3 160336 15 110428945
Hepatic cirrhosis 11.26 10.48 55 160284 67571 110361389
Food refusal 11.20 10.48 10 160329 940 110428020
Biopsy 11.19 10.48 9 160330 733 110428227
Protein total decreased 11.17 10.48 38 160301 10852 110418108
Rectal adenocarcinoma 11.15 10.48 13 160326 1676 110427284
Pseudomembranous colitis 11.14 10.48 27 160312 6364 110422596
HER2 positive breast cancer 11.13 10.48 7 160332 386 110428574
Embolism 11.12 10.48 50 160289 16239 110412721
Hemiplegia 11.08 10.48 10 160329 22772 110406188
Malabsorption 11.05 10.48 27 160312 6398 110422562
Inferior vena cava dilatation 11.05 10.48 10 160329 957 110428003
Cor pulmonale acute 11.00 10.48 9 160330 751 110428209
Nodule 10.98 10.48 19 160320 32612 110396348
Cystitis noninfective 10.97 10.48 13 160326 1705 110427255
Peripheral pulse decreased 10.97 10.48 4 160335 63 110428897
Intestinal villi atrophy 10.90 10.48 8 160331 569 110428391
Spleen atrophy 10.80 10.48 4 160335 66 110428894
Infective pulmonary exacerbation of cystic fibrosis 10.71 10.48 4 160335 14767 110414193
Mitral valve incompetence 10.68 10.48 20 160319 33309 110395651
Sensory disturbance 10.64 10.48 6 160333 17423 110411537
Faecal volume decreased 10.63 10.48 7 160332 418 110428542
Blood alkaline phosphatase increased 10.63 10.48 153 160186 70782 110358178
Pneumoperitoneum 10.62 10.48 20 160319 3964 110424996
Hair colour changes 10.60 10.48 22 160317 4679 110424281
Administration site cellulitis 10.58 10.48 4 160335 70 110428890
Transplant rejection 10.57 10.48 12 160327 24555 110404405
Lacrimation increased 10.56 10.48 79 160260 30871 110398089
Tenderness 10.54 10.48 76 160263 29361 110399599
Lactic acidosis 10.52 10.48 85 160254 92726 110336234
Exposure via skin contact 10.52 10.48 3 160336 13144 110415816
Abdominal infection 10.50 10.48 22 160317 4709 110424251

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A07DA03 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
ANTIPROPULSIVES
Antipropulsives
ATC A07DA53 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
ANTIPROPULSIVES
Antipropulsives
FDA MoA N0000000174 Opioid Agonists
MeSH PA D000930 Antidiarrheals
MeSH PA D005765 Gastrointestinal Agents
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:55322 ฮผ-opioid receptor agonist
CHEBI has role CHEBI:55323 antidiarrhoeal drug
CHEBI has role CHEBI:149553 anticoronaviral agent
FDA EPC N0000175690 Opioid Agonist

Related Drugs by ATC class:

A07DA Antipropulsives 5 drugs
difenoxindiphenoxylateeluxadolineloperamide oxidemorphine

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

DiseaseRelationSNOMED_IDDOID
Traveler's diarrhea indication 11840006
Diarrhea indication 62315008
Diarrhea Secondary to Inflammatory Bowel Disease indication
Chemotherapy-Induced Diarrhea off-label use
Infectious diarrheal disease contraindication 19213003 DOID:13250
Paralytic ileus contraindication 55525008 DOID:8442
Hemorrhagic diarrhea contraindication 95545007
Disease of liver contraindication 235856003 DOID:409




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.78 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Mu-type opioid receptor GPCR AGONIST Ki 8.82 WOMBAT-PK CHEMBL
Sodium channel protein type 5 subunit alpha Ion channel IC50 6.62 CHEMBL
D(2) dopamine receptor GPCR Ki 5.24 CHEMBL
Glutamate receptor ionotropic, NMDA 2A Ion channel WOMBAT-PK
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 6.58 DRUG MATRIX
Sodium-dependent serotonin transporter Transporter Ki 5.93 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 5.58 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 6.34 DRUG MATRIX
Histamine H1 receptor GPCR IC50 5.70 WOMBAT-PK
Histamine H2 receptor GPCR Ki 5.52 DRUG MATRIX
Aldehyde oxidase Enzyme IC50 5 WOMBAT-PK
Voltage-dependent P/Q-type calcium channel subunit alpha-1A Ion channel WOMBAT-PK
5-hydroxytryptamine receptor 1D GPCR Ki 5.58 CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 5.85 CHEMBL
Cytochrome P450 2D6 Enzyme IC50 5.70 DRUG MATRIX
D(4) dopamine receptor GPCR Ki 5.73 CHEMBL
Alpha-1D adrenergic receptor GPCR Ki 5.60 DRUG MATRIX
Alpha-1B adrenergic receptor GPCR Ki 5.43 CHEMBL
Kappa-type opioid receptor GPCR Ki 6.81 WOMBAT-PK
Calmodulin Cytosolic other WOMBAT-PK
Delta-type opioid receptor GPCR Ki 6.91 WOMBAT-PK
Somatostatin receptor type 5 GPCR Ki 5.35 WOMBAT-PK
Glutamate receptor ionotropic, NMDA 2B Ion channel WOMBAT-PK
Glutamate receptor ionotropic, NMDA 2C Ion channel WOMBAT-PK
Glutamate receptor ionotropic, NMDA 2D Ion channel WOMBAT-PK
Angiopoietin-1 receptor Kinase Kd 5.23 CHEMBL
Solute carrier family 22 member 1 Transporter IC50 4.63 CHEMBL
Cocaine esterase Enzyme IC50 5.39 CHEMBL
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel IC50 6.57 CHEMBL
Menin Nuclear other IC50 4.16 CHEMBL
Beta-2 adrenergic receptor GPCR Ki 5.69 DRUG MATRIX
Transmembrane protein 97 Enzyme Ki 7.44 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 6.27 DRUG MATRIX
Membrane-associated progesterone receptor component 1 Membrane receptor Ki 6.07 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR IC50 5.21 CHEMBL
Mu-type opioid receptor GPCR Ki 9.80 CHEMBL
Delta-type opioid receptor GPCR Ki 7.30 CHEMBL
Calmodulin Cytosolic other Kd 5.46 CHEMBL

External reference:

IDSource
4019804 VUID
N0000147893 NUI
D00729 KEGG_DRUG
34552-83-5 SECONDARY_CAS_RN
4019178 VANDF
4019804 VANDF
C0023992 UMLSCUI
CHEBI:6532 CHEBI
CHEMBL841 ChEMBL_ID
CHEMBL1707 ChEMBL_ID
D008139 MESH_DESCRIPTOR_UI
DB00836 DRUGBANK_ID
7215 IUPHAR_LIGAND_ID
3098 INN_ID
6X9OC3H4II UNII
3955 PUBCHEM_CID
151889 RXNORM
2069 MMSL
2336 MMSL
4992 MMSL
d01025 MMSL
001154 NDDF
004545 NDDF
116726003 SNOMEDCT_US
387040009 SNOMEDCT_US
57574005 SNOMEDCT_US
A1CMV PDB_CHEM_ID
6X9OC3H4II INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Loperamide Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-0311 CAPSULE 2 mg ORAL ANDA 26 sections
good sense anti diarrheal anti gas HUMAN OTC DRUG LABEL 2 0113-0087 TABLET 2 mg ORAL ANDA 16 sections
Good Sense anti diarrheal HUMAN OTC DRUG LABEL 1 0113-0224 TABLET, FILM COATED 2 mg ORAL ANDA 16 sections
Good Sense Anti Diarrheal Anti Gas HUMAN OTC DRUG LABEL 2 0113-1087 TABLET 2 mg ORAL ANDA 16 sections
Good Sense antidiarrheal HUMAN OTC DRUG LABEL 1 0113-1645 SOLUTION 1 mg ORAL ANDA 16 sections
Good Sense antidiarrheal HUMAN OTC DRUG LABEL 1 0113-1645 SOLUTION 1 mg ORAL ANDA 16 sections
anti diarrheal HUMAN OTC DRUG LABEL 1 0113-2224 TABLET, FILM COATED 2 mg ORAL ANDA 16 sections
injoy diarrhea relief HUMAN OTC DRUG LABEL 1 0113-6004 TABLET, FILM COATED 2 mg ORAL ANDA 16 sections
Anti-Diarrheal HUMAN OTC DRUG LABEL 1 0363-0375 TABLET 2 mg ORAL ANDA 16 sections
anti diarrheal HUMAN OTC DRUG LABEL 1 0363-1010 TABLET, FILM COATED 2 mg ORAL ANDA 16 sections
Anti-Diarrheal HUMAN OTC DRUG LABEL 1 0363-1176 CAPSULE, LIQUID FILLED 2 mg ORAL NDA 17 sections
anti diarrheal and anti gas HUMAN OTC DRUG LABEL 2 0363-1830 TABLET 2 mg ORAL ANDA 16 sections
Anti Diarrheal HUMAN OTC DRUG LABEL 1 0363-2022 SOLUTION 1 mg ORAL ANDA 16 sections
Loperamide Hydrochloride and Simethicone Human OTC Drug Label 2 0363-9606 TABLET 2 mg ORAL ANDA 16 sections
Loperamide Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-2100 CAPSULE 2 mg ORAL ANDA 29 sections
Loperamide Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8497 CAPSULE 2 mg ORAL ANDA 18 sections
loperamide hydrochloride HUMAN OTC DRUG LABEL 1 0904-6836 SOLUTION 1 mg ORAL ANDA 16 sections
LOPERAMIDE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0904-7472 CAPSULE 2 mg ORAL ANDA 23 sections
anti diarrheal HUMAN OTC DRUG LABEL 1 0904-7725 TABLET, FILM COATED 2 mg ORAL ANDA 16 sections
anti diarrheal HUMAN OTC DRUG LABEL 1 0904-7725 TABLET, FILM COATED 2 mg ORAL ANDA 16 sections
Anti-Diarrheal HUMAN OTC DRUG LABEL 1 11673-177 CAPSULE, LIQUID FILLED 2 mg ORAL NDA 17 sections
Up and Up anti diarrheal HUMAN OTC DRUG LABEL 1 11673-224 TABLET, FILM COATED 2 mg ORAL ANDA 16 sections
up and up anti diarrheal anti gas HUMAN OTC DRUG LABEL 2 11673-646 TABLET 2 mg ORAL ANDA 16 sections
Up and Up anti diarrheal HUMAN OTC DRUG LABEL 1 11673-900 SUSPENSION 1 mg ORAL ANDA 16 sections
Anti-Diarrheal HUMAN OTC DRUG LABEL 1 11822-0375 TABLET 2 mg ORAL ANDA 16 sections
anti diarrheal anti gas HUMAN OTC DRUG LABEL 2 11822-1003 TABLET 2 mg ORAL ANDA 16 sections
loperamide hydrochloride HUMAN OTC DRUG LABEL 1 11822-1645 SUSPENSION 1 mg ORAL ANDA 16 sections
loperamide hydrochloride HUMAN OTC DRUG LABEL 1 11822-5519 SOLUTION 1 mg ORAL ANDA 16 sections
Anti-Diarrheal HUMAN OTC DRUG LABEL 1 11822-7834 CAPSULE, LIQUID FILLED 2 mg ORAL NDA 17 sections
Loperamide Hydrochloride HUMAN OTC DRUG LABEL 1 11822-9590 CAPSULE, LIQUID FILLED 2 mg ORAL ANDA 16 sections