loperamide ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1.40 mg/mL Benet LZ, Broccatelli F, Oprea TI
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

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 888.79 10.71 2423 75127 586053 49941521
Dehydration 277.13 10.71 676 76874 151773 50375801
Pneumonia viral 180.76 10.71 119 77431 6715 50520859
Maternal exposure during pregnancy 177.61 10.71 19 77531 159759 50367815
Systemic lupus erythematosus 155.58 10.71 17 77533 140605 50386969
Pneumonia aspiration 154.25 10.71 213 77337 30791 50496783
Drug ineffective 152.19 10.71 694 76856 818639 49708935
Vomiting 146.78 10.71 1205 76345 459553 50068021
Hypokalaemia 127.70 10.71 359 77191 87633 50439941
Coma 120.39 10.71 268 77282 56611 50470963
Decreased appetite 120.39 10.71 617 76933 200306 50327268
Gastrooesophageal reflux disease 120.03 10.71 321 77229 76107 50451467
Ventricular tachycardia 116.01 10.71 132 77418 15689 50511885
Soft tissue disorder 115.40 10.71 75 77475 4139 50523435
Drug abuse 112.38 10.71 269 77281 59577 50467997
Torsade de pointes 111.92 10.71 113 77437 11722 50515852
Nausea 109.36 10.71 1598 75952 703800 49823774
Hypomania 106.10 10.71 73 77477 4432 50523142
Glossodynia 105.29 10.71 24 77526 115545 50412029
Pain 103.16 10.71 497 77053 578406 49949168
Colitis 101.96 10.71 199 77351 38330 50489244
Jaundice cholestatic 100.05 10.71 74 77476 5037 50522537
Electrocardiogram QT prolonged 99.33 10.71 235 77315 51651 50475923
Contraindicated product administered 98.08 10.71 53 77497 148905 50378669
Pericarditis 96.67 10.71 6 77544 78683 50448891
Abdominal pain 92.41 10.71 649 76901 235579 50291995
Oral pain 91.62 10.71 149 77401 24884 50502690
Hypomagnesaemia 90.47 10.71 142 77408 23014 50504560
Schizophrenia 87.69 10.71 80 77470 7317 50520257
Completed suicide 85.26 10.71 48 77502 131841 50395733
Rheumatoid arthritis 83.47 10.71 113 77437 202437 50325137
Gastrointestinal stoma complication 82.07 10.71 42 77508 1468 50526106
Arthropathy 80.49 10.71 74 77476 157832 50369742
Neuropathy peripheral 80.10 10.71 327 77223 96430 50431144
Drug intolerance 78.94 10.71 134 77416 218970 50308604
Discomfort 70.68 10.71 39 77511 108341 50419233
Wound 70.56 10.71 37 77513 105757 50421817
Weight decreased 69.21 10.71 577 76973 220668 50306906
Small intestinal obstruction 69.06 10.71 103 77447 15965 50511609
Infusion related reaction 68.42 10.71 96 77454 169461 50358113
Somnolence 66.00 10.71 435 77115 154550 50373024
Constipation 64.98 10.71 497 77053 185211 50342363
Therapeutic product effect decreased 64.43 10.71 68 77482 135982 50391592
Exposure during pregnancy 62.50 10.71 56 77494 120959 50406615
Intestinal obstruction 61.15 10.71 129 77421 26254 50501320
Presbyacusis 60.74 10.71 43 77507 2733 50524841
Mucosal inflammation 60.37 10.71 166 77384 39976 50487598
Blood magnesium increased 59.31 10.71 43 77507 2837 50524737
Brain stem glioma 57.19 10.71 17 77533 126 50527448
Pleural thickening 56.27 10.71 40 77510 2559 50525015
Drug hypersensitivity 55.40 10.71 198 77352 250812 50276762
Swelling 55.37 10.71 143 77407 200729 50326845
Lethargy 55.12 10.71 184 77366 49248 50478326
Helicobacter infection 54.95 10.71 6 77544 49696 50477878
Deafness neurosensory 53.98 10.71 49 77501 4452 50523122
Pleural fibrosis 53.15 10.71 43 77507 3341 50524233
Intentional overdose 53.10 10.71 213 77337 62291 50465283
Febrile neutropenia 50.96 10.71 289 77261 97378 50430196
Respiration abnormal 48.76 10.71 49 77501 5053 50522521
Nail dystrophy 48.30 10.71 24 77526 787 50526787
Flatulence 45.47 10.71 123 77427 29335 50498239
Segmental diverticular colitis 44.81 10.71 14 77536 125 50527449
Psoriatic arthropathy 44.38 10.71 9 77541 47023 50480551
Pedal pulse abnormal 44.04 10.71 14 77536 133 50527441
Knee arthroplasty 43.23 10.71 3 77547 35843 50491731
Blood magnesium decreased 42.98 10.71 68 77482 11092 50516482
Calcium ionised decreased 42.95 10.71 16 77534 253 50527321
Treatment failure 42.68 10.71 92 77458 137545 50390029
Injection site pruritus 41.94 10.71 6 77544 40405 50487169
Total lung capacity increased 41.78 10.71 21 77529 706 50526868
Injection site pain 41.71 10.71 66 77484 110958 50416616
Arthralgia 41.16 10.71 452 77098 438250 50089324
Long QT syndrome 40.99 10.71 35 77515 2932 50524642
Injection site erythema 40.73 10.71 33 77517 74903 50452671
Clostridium difficile infection 40.05 10.71 107 77443 25332 50502242
Blood bilirubin increased 40.02 10.71 124 77426 31914 50495660
Electrocardiogram QRS complex prolonged 39.87 10.71 45 77505 5299 50522275
Malignant neoplasm progression 39.16 10.71 207 77343 67917 50459657
Hypersensitivity 39.12 10.71 183 77367 214978 50312596
Joint swelling 38.20 10.71 220 77330 245066 50282508
Epigastric discomfort 38.07 10.71 46 77504 5824 50521750
Drug interaction 37.95 10.71 167 77383 199454 50328120
Pneumonia 36.98 10.71 798 76752 377603 50149971
Accidental overdose 36.85 10.71 88 77462 19445 50508129
Appetite disorder 36.57 10.71 46 77504 6068 50521506
Impaired healing 36.37 10.71 32 77518 69754 50457820
Brugada syndrome 36.36 10.71 15 77535 315 50527259
Gallbladder polyp 36.16 10.71 19 77531 702 50526872
Neutropenic sepsis 36.12 10.71 72 77478 14075 50513499
Sinusitis 35.98 10.71 137 77413 170421 50357153
Herpes zoster 35.95 10.71 208 77342 70578 50456996
Injection site reaction 35.62 10.71 16 77534 50016 50477558
Blood potassium decreased 34.71 10.71 130 77420 36815 50490759
Folliculitis 34.04 10.71 9 77541 39216 50488358
Red blood cell sedimentation rate increased 33.96 10.71 3 77547 29413 50498161
Frequent bowel movements 33.35 10.71 69 77481 13849 50513725
Disease progression 33.16 10.71 256 77294 95610 50431964
Device expulsion 33.11 10.71 3 77547 28819 50498755
Hip arthroplasty 32.82 10.71 4 77546 30425 50497149
Heart sounds 32.73 10.71 17 77533 613 50526961
Cholelithiasis 32.72 10.71 130 77420 37843 50489731
Device related infection 32.42 10.71 87 77463 20648 50506926
Dry skin 31.86 10.71 141 77409 43050 50484524
Stoma complication 31.82 10.71 13 77537 266 50527308
Arteriovenous fistula occlusion 31.14 10.71 14 77536 365 50527209
Headache 31.11 10.71 568 76982 505967 50021607
Pulmonary embolism 31.06 10.71 264 77286 101440 50426134
Post procedural diarrhoea 30.89 10.71 11 77539 152 50527422
Liver function test abnormal 30.65 10.71 142 77408 44197 50483377
Prolonged expiration 30.58 10.71 17 77533 704 50526870
Conduction disorder 30.34 10.71 21 77529 1287 50526287
Abdominal discomfort 30.33 10.71 219 77331 231422 50296152
Blue toe syndrome 30.21 10.71 14 77536 392 50527182
Ventricular arrhythmia 30.20 10.71 31 77519 3278 50524296
Pouchitis 29.48 10.71 14 77536 415 50527159
Gastroenteritis radiation 29.08 10.71 14 77536 428 50527146
Weight increased 28.84 10.71 186 77364 201705 50325869
Rhinorrhoea 28.46 10.71 155 77395 51428 50476146
Intentional self-injury 28.44 10.71 89 77461 23023 50504551
Drug use disorder 28.44 10.71 29 77521 3043 50524531
Synovitis 28.43 10.71 96 77454 123769 50403805
Anal abscess 28.41 10.71 32 77518 3759 50523815
Colitis microscopic 28.31 10.71 42 77508 6478 50521096
Therapeutic response decreased 27.99 10.71 19 77531 47212 50480362
Brain injury 27.94 10.71 40 77510 5974 50521600
Syncope 27.67 10.71 260 77290 102742 50424832
Therapeutic reaction time decreased 27.42 10.71 20 77530 1332 50526242
Injection site bruising 27.39 10.71 11 77539 36757 50490817
Multiple sclerosis relapse 27.22 10.71 16 77534 42948 50484626
Wrong technique in product usage process 27.10 10.71 27 77523 55483 50472091
Anaemia 27.10 10.71 540 77010 251916 50275658
Feeding intolerance 26.95 10.71 14 77536 505 50527069
Unresponsive to stimuli 26.54 10.71 105 77445 30504 50497070
Ill-defined disorder 26.21 10.71 27 77523 54627 50472947
Pneumonitis 26.21 10.71 102 77448 29408 50498166
Type 2 diabetes mellitus 26.07 10.71 10 77540 34365 50493209
Psoriasis 25.92 10.71 41 77509 68959 50458615
Mydriasis 25.84 10.71 53 77497 10574 50517000
Premature delivery 25.79 10.71 3 77547 23660 50503914
Urinary tract infection 25.33 10.71 483 77067 223537 50304037
Musculoskeletal stiffness 25.31 10.71 106 77444 128375 50399199
Pulmonary thrombosis 25.06 10.71 43 77507 7498 50520076
Gastrointestinal stoma output increased 24.87 10.71 10 77540 196 50527378
Acute kidney injury 24.87 10.71 489 77061 227569 50300005
Reflux gastritis 24.71 10.71 16 77534 877 50526697
Vascular device infection 24.67 10.71 32 77518 4352 50523222
Ejection fraction decreased 24.36 10.71 73 77477 18447 50509127
Fatigue 24.29 10.71 1320 76230 706281 49821293
Blood creatinine increased 23.94 10.71 199 77351 75961 50451613
Enterocolitis 23.90 10.71 39 77511 6528 50521046
Thymus disorder 23.89 10.71 10 77540 218 50527356
Overdose 23.51 10.71 245 77305 99482 50428092
Injection site swelling 23.19 10.71 18 77532 41755 50485819
Pyrexia 22.71 10.71 752 76798 379451 50148123
Palmar-plantar erythrodysaesthesia syndrome 22.56 10.71 75 77475 20023 50507551
Hepatotoxicity 22.49 10.71 92 77458 27134 50500440
Alopecia 22.31 10.71 254 77296 244793 50282781
Leukopenia 21.52 10.71 177 77373 67351 50460223
Sedation 21.46 10.71 10 77540 30600 50496974
Urticaria 21.34 10.71 114 77436 129447 50398127
Dyspepsia 20.88 10.71 189 77361 73908 50453666
Large intestine polyp 20.77 10.71 39 77511 7293 50520281
Cardiotoxicity 20.69 10.71 38 77512 6989 50520585
No adverse event 20.58 10.71 13 77537 33565 50494009
Coronary artery disease 20.40 10.71 10 77540 29716 50497858
Dermatitis acneiform 20.36 10.71 28 77522 4029 50523545
Rash 20.02 10.71 514 77036 436957 50090617
Hepatic enzyme increased 19.89 10.71 126 77424 137254 50390320
Clostridium difficile colitis 19.73 10.71 66 77484 17676 50509898
Nail disorder 19.69 10.71 45 77505 9663 50517911
Skin fissures 19.64 10.71 42 77508 8626 50518948
Enteritis 19.56 10.71 37 77513 6958 50520616
Dry eye 19.46 10.71 99 77451 31996 50495578
Hypophagia 19.31 10.71 89 77461 27639 50499935
Bone hypertrophy 19.24 10.71 10 77540 361 50527213
Loss of personal independence in daily activities 19.17 10.71 50 77500 70000 50457574
Psychotic disorder 19.05 10.71 75 77475 21737 50505837
Ear infection 18.97 10.71 8 77542 25962 50501612
Food interaction 18.76 10.71 12 77538 644 50526930
Pregnancy 18.76 10.71 11 77539 29566 50498008
Accidental exposure to product 18.70 10.71 6 77544 23051 50504523
Femur fracture 18.54 10.71 18 77532 37446 50490128
Sepsis 18.37 10.71 296 77254 132629 50394945
Asthenia 18.26 10.71 628 76922 318414 50209160
Paronychia 17.84 10.71 28 77522 4536 50523038
Anal incontinence 17.75 10.71 48 77502 11442 50516132
Hypermagnesaemia 17.62 10.71 13 77537 881 50526693
Ileal stenosis 17.60 10.71 16 77534 1456 50526118
Inflammatory bowel disease 17.60 10.71 24 77526 3426 50524148
Plantar erythema 17.57 10.71 8 77542 215 50527359
Product quality issue 17.51 10.71 13 77537 30845 50496729
Autoimmune nephritis 17.47 10.71 9 77541 319 50527255
Intestinal fibrosis 17.47 10.71 7 77543 136 50527438
Cor pulmonale acute 17.42 10.71 9 77541 321 50527253
Adverse event 17.41 10.71 25 77525 43738 50483836
Drug resistance 17.17 10.71 4 77546 18985 50508589
Tenderness 17.16 10.71 65 77485 18500 50509074
Pancreatitis chronic 17.09 10.71 19 77531 2201 50525373
Peripheral pulse decreased 16.95 10.71 5 77545 36 50527538
Osteopenia 16.92 10.71 61 77489 16957 50510617
Palmar erythema 16.78 10.71 16 77534 1547 50526027
Bone cyst 16.76 10.71 18 77532 2006 50525568
Stomatitis 16.46 10.71 232 77318 101112 50426462
Fracture pain 16.45 10.71 9 77541 361 50527213
Intestinal perforation 16.41 10.71 44 77506 10435 50517139
Hepatic lesion 16.24 10.71 25 77525 3983 50523591
Foetal exposure during pregnancy 16.21 10.71 11 77539 27348 50500226
Long QT syndrome congenital 16.17 10.71 5 77545 43 50527531
Stoma site ulcer 16.08 10.71 8 77542 263 50527311
Cyst 15.99 10.71 48 77502 12139 50515435
Biliary sepsis 15.95 10.71 12 77538 838 50526736
Rectal abscess 15.86 10.71 13 77537 1029 50526545
Condition aggravated 15.79 10.71 341 77209 296717 50230857
Dysgeusia 15.79 10.71 108 77442 38808 50488766
Influenza like illness 15.73 10.71 41 77509 57418 50470156
Proctitis 15.70 10.71 17 77533 1911 50525663
Off label use 15.68 10.71 582 76968 473844 50053730
Short-bowel syndrome 15.67 10.71 9 77541 397 50527177
Sinus arrest 15.66 10.71 16 77534 1682 50525892
Blood potassium increased 15.65 10.71 58 77492 16340 50511234
Ileus 15.42 10.71 50 77500 13179 50514395
Paralysis recurrent laryngeal nerve 15.15 10.71 5 77545 54 50527520
Hypovolaemia 15.09 10.71 40 77510 9425 50518149
Gastroenteritis 14.95 10.71 73 77477 23208 50504366
Hypophosphataemia 14.90 10.71 37 77513 8377 50519197
Neutrophil count decreased 14.86 10.71 121 77429 45905 50481669
Peritoneal perforation 14.81 10.71 6 77544 120 50527454
Food refusal 14.78 10.71 8 77542 314 50527260
Product use issue 14.76 10.71 152 77398 149323 50378251
Neutropenia 14.70 10.71 313 77237 147652 50379922
Catheter site bruise 14.69 10.71 8 77542 318 50527256
Drug eruption 14.66 10.71 9 77541 23597 50503977
Unmasking of previously unidentified disease 14.64 10.71 11 77539 767 50526807
Malnutrition 14.61 10.71 49 77501 13140 50514434
Cardiac arrest 14.60 10.71 194 77356 83457 50444117
Plasma cell myeloma 14.59 10.71 90 77460 31232 50496342
Foetal arrhythmia 14.45 10.71 6 77544 128 50527446
Small intestine ulcer 14.44 10.71 8 77542 329 50527245
Onychalgia 14.42 10.71 11 77539 784 50526790
Ureteric obstruction 14.40 10.71 15 77535 1613 50525961
Product dose omission issue 14.30 10.71 197 77353 183641 50343933
Periventricular leukomalacia 14.25 10.71 5 77545 66 50527508
Ventricular fibrillation 14.25 10.71 42 77508 10517 50517057
Productive cough 14.13 10.71 133 77417 52561 50475013
Amputation 14.08 10.71 6 77544 137 50527437
Gluten sensitivity 13.94 10.71 9 77541 491 50527083
Congenital knee deformity 13.92 10.71 5 77545 71 50527503
Rectal haemorrhage 13.90 10.71 104 77446 38454 50489120
Defaecation urgency 13.84 10.71 20 77530 3013 50524561
Macular degeneration 13.82 10.71 51 77499 14337 50513237
Gastrointestinal sounds abnormal 13.80 10.71 22 77528 3612 50523962
Gastroenteropancreatic neuroendocrine tumour disease 13.78 10.71 4 77546 27 50527547
Tachycardia 13.72 10.71 222 77328 99541 50428033
Stoma site extravasation 13.56 10.71 7 77543 249 50527325
Catheter site haemorrhage 13.51 10.71 19 77531 2791 50524783
Arthritis 13.47 10.71 197 77353 86524 50441050
Pleural effusion 13.44 10.71 187 77363 81267 50446307
Tumour inflammation 13.42 10.71 4 77546 30 50527544
Hyperchlorhydria 13.38 10.71 14 77536 1514 50526060
Mobility decreased 13.35 10.71 70 77480 79878 50447696
Forced expiratory volume decreased 13.24 10.71 24 77526 4370 50523204
Therapeutic product effect incomplete 13.21 10.71 84 77466 91431 50436143
Hypocalcaemia 13.09 10.71 78 77472 26738 50500836
Intentional product use issue 13.04 10.71 67 77483 76851 50450723
Rales 12.81 10.71 39 77511 9939 50517635
Cardiorenal syndrome 12.74 10.71 9 77541 570 50527004
Product use in unapproved indication 12.61 10.71 115 77435 115704 50411870
Soft tissue swelling 12.45 10.71 11 77539 965 50526609
Anaemia of malignant disease 12.43 10.71 8 77542 434 50527140
Accidental poisoning 12.42 10.71 9 77541 593 50526981
Irritable bowel syndrome 12.40 10.71 39 77511 51402 50476172
Peritoneal disorder 12.33 10.71 8 77542 440 50527134
Faecaloma 12.32 10.71 31 77519 7077 50520497
Cerebral haemorrhage 12.26 10.71 14 77536 27038 50500536
Autoimmune colitis 12.23 10.71 8 77542 446 50527128
Motion sickness 12.17 10.71 10 77540 794 50526780
Glaucoma 12.17 10.71 52 77498 15634 50511940
Megacolon 12.11 10.71 14 77536 1692 50525882
Autonomic neuropathy 12.09 10.71 11 77539 1002 50526572
Cystitis noninfective 12.06 10.71 10 77540 804 50526770
Abortion spontaneous 12.06 10.71 29 77521 41743 50485831
Nail infection 12 10.71 15 77535 1966 50525608
Piloerection 11.98 10.71 7 77543 319 50527255
Crohn's disease 11.97 10.71 24 77526 4709 50522865
Lip erosion 11.96 10.71 10 77540 814 50526760
Intestinal anastomosis 11.92 10.71 7 77543 322 50527252
Nail bed tenderness 11.92 10.71 7 77543 322 50527252
Device issue 11.88 10.71 8 77542 19964 50507610
Cellulitis 11.86 10.71 163 77387 70635 50456939
Accidental exposure to product by child 11.84 10.71 11 77539 1029 50526545
Pharyngo-oesophageal diverticulum 11.84 10.71 3 77547 11 50527563
Osteosclerosis 11.83 10.71 20 77530 3447 50524127
Injection site rash 11.79 10.71 5 77545 16172 50511402
Road traffic accident 11.71 10.71 12 77538 24340 50503234
Immune-mediated enterocolitis 11.67 10.71 11 77539 1049 50526525
Rhinovirus infection 11.55 10.71 20 77530 3514 50524060
Alveolar bone resorption 11.52 10.71 4 77546 51 50527523
Abdominal distension 11.47 10.71 166 77384 72737 50454837
Miosis 11.44 10.71 28 77522 6282 50521292
Eye irritation 11.41 10.71 6 77544 17134 50510440
Moraxella infection 11.41 10.71 7 77543 349 50527225
Protein total decreased 11.37 10.71 25 77525 5231 50522343
Gastritis 11.35 10.71 88 77462 32895 50494679
Renal pain 11.35 10.71 26 77524 5593 50521981
Joint effusion 11.27 10.71 3 77547 13018 50514556
False positive investigation result 11.18 10.71 8 77542 517 50527057
Hip fracture 11.14 10.71 73 77477 25858 50501716
Abdominal pain upper 11.04 10.71 321 77229 158988 50368586
Serotonin syndrome 10.98 10.71 13 77537 24700 50502874
Dysuria 10.91 10.71 78 77472 28426 50499148
Injection site haemorrhage 10.86 10.71 10 77540 21336 50506238
Odynophagia 10.81 10.71 28 77522 6504 50521070

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 567.43 10.95 1494 46934 331204 29194895
Torsade de pointes 256.92 10.95 151 48277 6510 29519589
Drug abuse 232.90 10.95 446 47982 79437 29446662
Electrocardiogram QRS complex prolonged 201.38 10.95 109 48319 4001 29522098
Electrocardiogram QT prolonged 191.91 10.95 265 48163 35872 29490227
Dehydration 179.25 10.95 501 47927 114247 29411852
Intentional overdose 163.23 10.95 254 48174 38274 29487825
Colitis 122.67 10.95 199 48229 31049 29495050
Ventricular tachycardia 121.98 10.95 167 48261 22407 29503692
Abdominal pain 103.30 10.95 467 47961 134890 29391209
Drug ineffective 64.15 10.95 342 48086 362828 29163271
Intentional self-injury 64.02 10.95 90 48338 12371 29513728
Brugada syndrome 62.60 10.95 28 48400 673 29525426
Small intestinal obstruction 62.21 10.95 91 48337 12970 29513129
Intestinal obstruction 58.95 10.95 110 48318 19167 29506932
Conduction disorder 58.82 10.95 37 48391 1803 29524296
Decreased appetite 58.63 10.95 423 48005 144919 29381180
Blood mercury abnormal 57.84 10.95 19 48409 188 29525911
5-hydroxyindolacetic acid in urine increased 55.72 10.95 19 48409 213 29525886
Completed suicide 55.62 10.95 40 48388 90206 29435893
Overdose 49.00 10.95 259 48169 79560 29446539
Vomiting 48.13 10.95 545 47883 211715 29314384
Fatigue 44.67 10.95 747 47681 316074 29210025
Drug use disorder 44.24 10.95 40 48388 3382 29522717
Alveolar lung disease 43.70 10.95 18 48410 351 29525748
Electrolyte imbalance 37.85 10.95 67 48361 11207 29514892
Pulmonary interstitial emphysema syndrome 36.53 10.95 17 48411 449 29525650
Foetal exposure during pregnancy 36.14 10.95 6 48422 33861 29492238
Nausea 35.37 10.95 667 47761 288588 29237511
Pouchitis 34.97 10.95 18 48410 595 29525504
Abscess intestinal 31.84 10.95 23 48405 1411 29524688
Rheumatoid arthritis 31.55 10.95 7 48421 32145 29493954
Respiratory depression 29.34 10.95 67 48361 13456 29512643
Enteritis 29.04 10.95 45 48383 6746 29519353
Low density lipoprotein decreased 28.87 10.95 19 48409 1001 29525098
Drug hypersensitivity 28.87 10.95 42 48386 68364 29457735
Cardiotoxicity 28.53 10.95 37 48391 4707 29521392
Accidental overdose 28.53 10.95 78 48350 17515 29508584
Cardiac arrest 28.28 10.95 238 48190 85353 29440746
Weight decreased 27.45 10.95 372 48056 150533 29375566
Colitis ulcerative 27.41 10.95 63 48365 12706 29513393
Product use in unapproved indication 27.20 10.95 64 48364 86811 29439288
Ventricular arrhythmia 26.28 10.95 35 48393 4569 29521530
Abdominal distension 26.14 10.95 146 48282 45765 29480334
Treatment failure 26.02 10.95 14 48414 36925 29489174
Myocardial infarction 25.30 10.95 94 48334 110202 29415897
Hepatic neoplasm 24.80 10.95 22 48406 1814 29524285
Stomatitis 24.53 10.95 123 48305 36990 29489109
Gastrointestinal stoma complication 24.22 10.95 18 48410 1154 29524945
Hypomagnesaemia 24.02 10.95 73 48355 17395 29508704
Clostridium difficile colitis 23.88 10.95 61 48367 13151 29512948
Frequent bowel movements 23.73 10.95 49 48379 9190 29516909
Enterocolonic fistula 22.97 10.95 8 48420 96 29526003
Blood potassium decreased 22.81 10.95 67 48361 15667 29510432
Immune-mediated enterocolitis 22.71 10.95 20 48408 1633 29524466
Colitis microscopic 21.60 10.95 20 48408 1743 29524356
Ileus 21.53 10.95 62 48366 14340 29511759
Hepatic haematoma 20.82 10.95 11 48417 384 29525715
Enterocolitis 20.32 10.95 38 48390 6628 29519471
Expired product administered 20.24 10.95 24 48404 2787 29523312
Dysgeusia 20.12 10.95 82 48346 22592 29503507
Miosis 20.01 10.95 42 48386 7967 29518132
Dyschromatopsia 19.81 10.95 10 48418 317 29525782
Colorectal cancer metastatic 19.76 10.95 12 48416 549 29525550
Asthma 19.56 10.95 16 48412 33833 29492266
Flatulence 18.97 10.95 68 48360 17641 29508458
Drug resistance 18.65 10.95 6 48422 21534 29504565
Anal fissure 18.63 10.95 23 48405 2785 29523314
Atrioventricular block first degree 18.36 10.95 32 48396 5287 29520812
Peripheral embolism 17.76 10.95 14 48414 980 29525119
Generalised oedema 17.60 10.95 49 48379 11116 29514983
Device related infection 17.57 10.95 61 48367 15575 29510524
Diffuse alveolar damage 17.35 10.95 19 48409 2024 29524075
Electrocardiogram T wave alternans 17.28 10.95 4 48424 8 29526091
Abdominal abscess 17.28 10.95 26 48402 3798 29522301
Gastrointestinal obstruction 17.27 10.95 12 48416 692 29525407
Palmar-plantar erythrodysaesthesia syndrome 16.95 10.95 58 48370 14701 29511398
Therapeutic product effect decreased 16.92 10.95 14 48414 29437 29496662
Autoimmune colitis 16.87 10.95 13 48415 880 29525219
Electrocardiogram PR prolongation 16.86 10.95 12 48416 719 29525380
Wrong technique in product usage process 16.78 10.95 16 48412 31412 29494687
Right ventricular dilatation 16.72 10.95 11 48417 579 29525520
Basosquamous carcinoma 16.72 10.95 6 48422 79 29526020
Sedation 16.65 10.95 4 48424 17401 29508698
Wheezing 16.53 10.95 18 48410 33222 29492877
Pneumonitis 16.50 10.95 90 48338 27954 29498145
Intestinal perforation 16.38 10.95 39 48389 8047 29518052
Drug interaction 16.10 10.95 227 48201 197158 29328941
Gastrointestinal inflammation 15.85 10.95 22 48406 2986 29523113
Vascular device infection 15.79 10.95 20 48408 2485 29523614
Anal fistula infection 15.46 10.95 4 48424 15 29526084
Bacterial diarrhoea 15.36 10.95 5 48423 48 29526051
Proctalgia 15.25 10.95 26 48402 4219 29521880
Joint swelling 15.18 10.95 37 48391 49593 29476506
Angioedema 15.09 10.95 18 48410 31897 29494202
Unmasking of previously unidentified disease 14.71 10.95 11 48417 712 29525387
Non-small cell lung cancer 14.53 10.95 21 48407 2960 29523139
Immune-mediated hepatitis 14.38 10.95 15 48413 1512 29524587
Psoriasis 14.37 10.95 19 48409 32208 29493891
Eye infection fungal 14.21 10.95 8 48420 317 29525782
Faecaloma 14.14 10.95 25 48403 4177 29521922
Drug delivery device placement 14.11 10.95 6 48422 127 29525972
Intentional product misuse 13.99 10.95 101 48327 34560 29491539
Retinal ischaemia 13.97 10.95 8 48420 328 29525771
Aggression 13.86 10.95 23 48405 35518 29490581
Pyomyositis 13.86 10.95 6 48422 133 29525966
Subileus 13.77 10.95 20 48408 2830 29523269
Diarrhoea haemorrhagic 13.75 10.95 30 48398 5844 29520255
Necrotising ulcerative gingivostomatitis 13.66 10.95 5 48423 70 29526029
Gastrointestinal sounds abnormal 13.62 10.95 16 48412 1840 29524259
Medication error 13.59 10.95 9 48419 21202 29504897
Coronary artery disease 13.47 10.95 33 48395 44157 29481942
Gastroenteritis staphylococcal 13.44 10.95 7 48421 237 29525862
CSF white blood cell count decreased 13.39 10.95 4 48424 28 29526071
Interstitial lung disease 13.35 10.95 49 48379 57669 29468430
Pancreatic enzyme abnormality 13.15 10.95 4 48424 30 29526069
Gastroenteritis 13.13 10.95 48 48380 12568 29513531
Gastrointestinal stoma output increased 13.04 10.95 4 48424 31 29526068
Neoplasm 13.04 10.95 24 48404 4137 29521962
Musculoskeletal stiffness 13.04 10.95 26 48402 37432 29488667
Crohn's disease 12.95 10.95 20 48408 2989 29523110
Intestinal fistula 12.87 10.95 11 48417 863 29525236
Mixed dementia 12.61 10.95 7 48421 270 29525829
Malignant neoplasm progression 12.55 10.95 180 48248 73679 29452420
Prostate cancer 12.49 10.95 14 48414 25513 29500586
Nephroangiosclerosis 12.41 10.95 6 48422 173 29525926
Hypokalaemia 12.27 10.95 131 48297 50072 29476027
Lethargy 12.13 10.95 104 48324 37476 29488623
Rhabdomyolysis 11.95 10.95 55 48373 60753 29465346
Proctitis 11.93 10.95 16 48412 2103 29523996
Blood creatine phosphokinase increased 11.88 10.95 31 48397 40613 29485486
Biopsy intestine abnormal 11.87 10.95 3 48425 10 29526089
Biliary obstruction 11.75 10.95 17 48411 2397 29523702
Dermatitis acneiform 11.68 10.95 27 48401 5464 29520635
Plasma cell myeloma 11.61 10.95 102 48326 37013 29489086
Mucosal inflammation 11.58 10.95 90 48338 31505 29494594
Drug withdrawal syndrome 11.46 10.95 59 48369 17925 29508174
Cardiac failure congestive 11.37 10.95 76 48352 76505 29449594
Psychotic disorder 11.30 10.95 10 48418 20344 29505755
CSF white blood cell count increased 11.26 10.95 4 48424 51 29526048
Dry skin 11.25 10.95 71 48357 23236 29502863
Creatinine renal clearance abnormal 11.21 10.95 6 48422 215 29525884
Short-bowel syndrome 11.21 10.95 6 48422 215 29525884
Intracranial mass 11.08 10.95 11 48417 1045 29525054
Cytomegalovirus infection 11.07 10.95 13 48415 23202 29502897
Transcription medication error 11.07 10.95 5 48423 123 29525976
Niemann-Pick disease 11.07 10.95 3 48425 14 29526085
Asthenia 11.06 10.95 444 47984 214806 29311293
Pain in jaw 11.05 10.95 43 48385 11598 29514501
Eosinophilic pneumonia 10.99 10.95 18 48410 2828 29523271
Depression 10.96 10.95 88 48340 85059 29441040
Inferior vena cava dilatation 10.96 10.95 9 48419 668 29525431

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 950.07 10.42 2952 102358 719752 63673670
Dehydration 355.63 10.42 962 104348 215801 64177621
Torsade de pointes 329.35 10.42 253 105057 17110 64376312
Drug abuse 282.73 10.42 650 104660 131724 64261698
Electrocardiogram QT prolonged 270.51 10.42 474 104836 78974 64314448
Ventricular tachycardia 246.70 10.42 292 105018 33973 64359449
Colitis 219.38 10.42 365 104945 58309 64335113
Electrocardiogram QRS complex prolonged 191.48 10.42 142 105168 9102 64384320
Completed suicide 172.85 10.42 75 105235 224339 64169083
Vomiting 171.19 10.42 1506 103804 549611 63843811
Drug ineffective 170.85 10.42 750 104560 839497 63553925
Decreased appetite 142.04 10.42 864 104446 280425 64112997
Abdominal pain 141.36 10.42 933 104377 311442 64081980
Nausea 133.67 10.42 1907 103403 783893 63609529
Small intestinal obstruction 112.28 10.42 164 105146 23409 64370013
Maternal exposure during pregnancy 104.16 10.42 16 105294 95868 64297554
Gastrointestinal stoma complication 98.08 10.42 55 105255 2171 64391251
Brugada syndrome 96.19 10.42 43 105267 1035 64392387
Pneumonia viral 94.65 10.42 88 105222 7734 64385688
Hypomania 87.20 10.42 73 105237 5581 64387841
Intentional overdose 86.65 10.42 333 104977 89611 64303811
Intestinal obstruction 86.12 10.42 186 105124 36100 64357322
Conduction disorder 85.90 10.42 56 105254 2912 64390510
Accidental overdose 83.08 10.42 175 105135 33382 64360040
Gastrooesophageal reflux disease 82.71 10.42 311 104999 82832 64310590
Systemic lupus erythematosus 81.94 10.42 14 105296 77598 64315824
Pneumonia aspiration 81.32 10.42 247 105063 59024 64334398
Hypomagnesaemia 81.28 10.42 185 105125 37191 64356231
Hypokalaemia 80.53 10.42 403 104907 121500 64271922
Weight decreased 74.89 10.42 754 104556 284985 64108437
Jaundice cholestatic 69.29 10.42 78 105232 8592 64384830
Drug use disorder 69.21 10.42 66 105244 5988 64387434
Drug hypersensitivity 68.58 10.42 182 105128 237633 64155789
Soft tissue disorder 67.12 10.42 50 105260 3226 64390196
Contraindicated product administered 67.07 10.42 47 105263 107782 64285640
Therapeutic product effect decreased 66.97 10.42 54 105256 115297 64278125
Lethargy 66.84 10.42 265 105045 72329 64321093
Rheumatoid arthritis 64.89 10.42 105 105205 164189 64229233
Arthropathy 63.76 10.42 62 105248 120905 64272517
Coma 62.40 10.42 296 105014 87319 64306103
Drug intolerance 62.02 10.42 134 105176 187858 64205564
Schizophrenia 59.53 10.42 82 105228 11086 64382336
Overdose 59.41 10.42 455 104855 159111 64234311
Mucosal inflammation 58.86 10.42 230 105080 62354 64331068
Flatulence 57.99 10.42 158 105152 35508 64357914
Blood mercury abnormal 57.90 10.42 19 105291 188 64393234
5-hydroxyindolacetic acid in urine increased 55.61 10.42 19 105291 215 64393207
Brain stem glioma 54.67 10.42 17 105293 139 64393283
Oral pain 54.23 10.42 131 105179 27362 64366060
Malignant neoplasm progression 53.25 10.42 341 104969 112530 64280892
Fatigue 52.94 10.42 1597 103713 747133 63646289
Cardiotoxicity 52.62 10.42 74 105236 10200 64383222
Presbyacusis 52.08 10.42 39 105271 2536 64390886
Pneumonia 50.74 10.42 1233 104077 558343 63835079
Blood magnesium increased 50.42 10.42 42 105268 3189 64390233
Frequent bowel movements 49.48 10.42 99 105211 18206 64375216
Exposure during pregnancy 49.44 10.42 33 105277 77642 64315780
Pouchitis 49.40 10.42 25 105285 799 64392623
Ventricular arrhythmia 48.15 10.42 60 105250 7355 64386067
Injection site erythema 47.93 10.42 28 105282 70772 64322650
Pericarditis 47.90 10.42 21 105289 62495 64330927
Drug interaction 47.09 10.42 372 104938 361711 64031711
Injection site pain 47.05 10.42 68 105242 111340 64282082
Pneumonitis 46.47 10.42 184 105126 50181 64343241
Joint swelling 46.06 10.42 188 105122 215194 64178228
Pleural thickening 46.01 10.42 37 105273 2673 64390749
Segmental diverticular colitis 43.94 10.42 14 105296 125 64393297
Nail dystrophy 43.93 10.42 23 105287 790 64392632
Somnolence 43.87 10.42 517 104793 203128 64190294
Blood magnesium decreased 43.48 10.42 80 105230 13825 64379597
Stomatitis 43.29 10.42 317 104993 109288 64284134
Pain 43.23 10.42 640 104670 552871 63840551
Clostridium difficile infection 42.57 10.42 143 105167 36020 64357402
Pedal pulse abnormal 42.09 10.42 14 105296 145 64393277
Colitis microscopic 41.78 10.42 56 105254 7376 64386046
Psoriatic arthropathy 41.13 10.42 10 105300 43271 64350151
Total lung capacity increased 41.05 10.42 21 105289 687 64392735
Device related infection 40.48 10.42 126 105184 30500 64362922
Vascular device infection 40.12 10.42 50 105260 6130 64387292
Enteritis 39.69 10.42 71 105239 12006 64381416
Injection site pruritus 39.53 10.42 7 105303 37819 64355603
Red blood cell sedimentation rate increased 39.51 10.42 3 105307 31232 64362190
Synovitis 39.42 10.42 63 105247 99027 64294395
Infusion related reaction 39.42 10.42 137 105173 164330 64229092
Respiration abnormal 39.26 10.42 50 105260 6265 64387157
Weight increased 39.17 10.42 197 105113 213151 64180271
Wound 38.24 10.42 41 105269 76436 64316986
Helicobacter infection 38.19 10.42 8 105302 38354 64355068
Neuropathy peripheral 37.69 10.42 324 104986 117201 64276221
Blood potassium decreased 37.60 10.42 148 105162 40251 64353171
Alveolar lung disease 37.27 10.42 18 105292 519 64392903
Cardiac arrest 37.19 10.42 400 104910 153664 64239758
Wrong technique in product usage process 36.98 10.42 31 105279 64943 64328479
Pleural fibrosis 36.83 10.42 39 105271 4011 64389411
Sedation 36.72 10.42 11 105299 41451 64351971
Coronary artery disease 36.71 10.42 27 105283 60406 64333016
Pulmonary interstitial emphysema syndrome 36.68 10.42 17 105293 446 64392976
Enterocolitis 36.15 10.42 68 105242 11950 64381472
Constipation 35.67 10.42 549 104761 228788 64164634
Arthralgia 35.66 10.42 508 104802 441752 63951670
Discomfort 35.51 10.42 48 105262 80830 64312592
Treatment failure 35.49 10.42 87 105223 116729 64276693
Product use in unapproved indication 35.39 10.42 158 105152 176460 64216962
Palmar-plantar erythrodysaesthesia syndrome 34.84 10.42 115 105195 28704 64364718
Febrile neutropenia 33.84 10.42 461 104849 187196 64206226
Deafness neurosensory 32.78 10.42 46 105264 6328 64387094
Abdominal distension 32.56 10.42 268 105042 95726 64297696
Long QT syndrome 32.44 10.42 41 105269 5098 64388324
Dry skin 32.26 10.42 167 105143 50994 64342428
Injection site reaction 32.24 10.42 18 105292 46646 64346776
Muscle injury 32.17 10.42 3 105307 26434 64366988
Musculoskeletal stiffness 32.02 10.42 99 105211 123107 64270315
Therapeutic reaction time decreased 32.00 10.42 26 105284 1906 64391516
Electrolyte imbalance 31.66 10.42 102 105208 25141 64368281
Calcium ionised decreased 31.32 10.42 16 105294 522 64392900
Pulmonary embolism 31.25 10.42 371 104939 145985 64247437
Disease progression 31.07 10.42 361 104949 141319 64252103
Psoriasis 31.03 10.42 43 105267 71660 64321762
Appetite disorder 30.83 10.42 45 105265 6416 64387006
Myocardial infarction 30.49 10.42 153 105157 165668 64227754
Immune-mediated enterocolitis 30.45 10.42 29 105281 2627 64390795
Drug resistance 29.86 10.42 10 105300 35092 64358330
Injection site bruising 29.85 10.42 11 105299 36362 64357060
Glossodynia 29.84 10.42 37 105273 64659 64328763
Anal abscess 29.78 10.42 48 105262 7460 64385962
Gastrointestinal stoma output increased 29.75 10.42 12 105298 222 64393200
Clostridium difficile colitis 29.73 10.42 105 105205 27118 64366304
Heart sounds 29.60 10.42 16 105294 587 64392835
Syncope 29.55 10.42 390 104920 157245 64236177
Product dose omission issue 28.19 10.42 194 105116 194553 64198869
Arteriovenous fistula occlusion 28.16 10.42 15 105295 534 64392888
Intestinal perforation 28.12 10.42 71 105239 15242 64378180
Gastroenteritis radiation 28.11 10.42 16 105294 650 64392772
Sinusitis 27.77 10.42 133 105177 145795 64247627
Low density lipoprotein decreased 27.77 10.42 19 105291 1071 64392351
Atrioventricular block first degree 27.76 10.42 57 105253 10677 64382745
Prolonged expiration 27.49 10.42 17 105293 806 64392616
Unresponsive to stimuli 27.40 10.42 158 105152 50235 64343187
Blood bilirubin increased 27.20 10.42 174 105136 57379 64336043
Pyrexia 27.05 10.42 1142 104168 557502 63835920
Unmasking of previously unidentified disease 26.93 10.42 22 105288 1625 64391797
Multiple sclerosis relapse 26.82 10.42 17 105293 41118 64352304
Sepsis 26.66 10.42 526 104784 229815 64163607
Epigastric discomfort 26.28 10.42 43 105267 6768 64386654
Cardiac failure congestive 26.04 10.42 117 105193 130463 64262959
Dysgeusia 25.90 10.42 148 105162 46899 64346523
Gallbladder polyp 25.89 10.42 17 105293 895 64392527
Autoimmune colitis 25.78 10.42 20 105290 1371 64392051
Injection site swelling 25.73 10.42 18 105292 41335 64352087
Ileus 25.44 10.42 89 105221 22877 64370545
Impaired healing 25.44 10.42 37 105273 60436 64332986
Type 2 diabetes mellitus 25.17 10.42 12 105298 34008 64359414
Feeding intolerance 24.84 10.42 14 105296 558 64392864
Blue toe syndrome 24.70 10.42 14 105296 564 64392858
Skin fissures 24.64 10.42 53 105257 10253 64383169
Stoma complication 24.55 10.42 13 105297 457 64392965
Hip arthroplasty 24.51 10.42 3 105307 21348 64372074
Respiratory depression 24.39 10.42 89 105221 23354 64370068
Device expulsion 24.19 10.42 3 105307 21133 64372289
Headache 24.17 10.42 669 104641 528798 63864624
Swelling 23.98 10.42 158 105152 160060 64233362
Neutropenic sepsis 23.91 10.42 88 105222 23184 64370238
Hypophosphataemia 23.71 10.42 65 105245 14655 64378767
Brain injury 23.54 10.42 51 105259 9914 64383508
Gastrointestinal sounds abnormal 23.50 10.42 34 105276 4809 64388613
Hypophagia 23.43 10.42 127 105183 39460 64353962
Hepatic neoplasm 23.43 10.42 27 105283 3050 64390372
Accidental exposure to product 23.34 10.42 7 105303 26357 64367065
Thymus disorder 23.24 10.42 10 105300 219 64393203
Intentional self-injury 22.80 10.42 101 105209 28943 64364479
Reflux gastritis 22.15 10.42 16 105294 984 64392438
Faecaloma 22.09 10.42 49 105261 9679 64383743
Therapeutic response decreased 21.88 10.42 32 105278 52156 64341266
Cholelithiasis 21.76 10.42 138 105172 45368 64348054
Anal fissure 21.58 10.42 33 105277 4903 64388519
Acute kidney injury 20.96 10.42 915 104395 448325 63945097
Cytomegalovirus infection 20.85 10.42 18 105292 37181 64356241
Pleural effusion 20.83 10.42 306 105004 126253 64267169
Hypersensitivity 20.61 10.42 213 105097 196239 64197183
Proctalgia 20.57 10.42 41 105269 7518 64385904
Ill-defined disorder 20.52 10.42 25 105285 44027 64349395
Enterocolonic fistula 20.51 10.42 8 105302 135 64393287
Premature delivery 20.41 10.42 3 105307 18586 64374836
Abscess intestinal 20.18 10.42 22 105288 2338 64391084
Rectal haemorrhage 20.11 10.42 171 105139 61646 64331776
Tachycardia 19.86 10.42 349 104961 149230 64244192
Paronychia 19.86 10.42 37 105273 6455 64386967
Cerebral haemorrhage 19.83 10.42 33 105277 51057 64342365
Gastrointestinal inflammation 19.82 10.42 36 105274 6159 64387263
Dermatitis acneiform 19.71 10.42 43 105267 8400 64385022
Bone cyst 19.70 10.42 21 105289 2176 64391246
Sopor 19.69 10.42 12 105298 29649 64363773
Biliary sepsis 19.11 10.42 17 105293 1411 64392011
Non-small cell lung cancer 19.04 10.42 31 105279 4859 64388563
Mobility decreased 18.91 10.42 74 105236 85766 64307656
Gastroenteritis 18.74 10.42 97 105213 29614 64363808
Malnutrition 18.56 10.42 71 105239 19054 64374368
Tumour inflammation 18.35 10.42 5 105305 24 64393398
Neuroleptic malignant syndrome 18.21 10.42 9 105301 24987 64368435
Dyspepsia 18.21 10.42 206 105104 80106 64313316
Therapeutic product effect incomplete 18.15 10.42 97 105213 103385 64290037
Intentional product misuse 18.03 10.42 189 105121 72106 64321316
Nail disorder 17.99 10.42 42 105268 8582 64384840
Hepatic haematoma 17.78 10.42 13 105297 815 64392607
Pregnancy 17.65 10.42 6 105304 20859 64372563
Mydriasis 17.53 10.42 60 105250 15252 64378170
Diarrhoea haemorrhagic 17.51 10.42 49 105261 11178 64382244
Osteoporosis 17.45 10.42 26 105284 42054 64351368
Femur fracture 17.40 10.42 18 105292 34117 64359305
Injection site haemorrhage 17.30 10.42 9 105301 24269 64369153
Angioedema 17.27 10.42 48 105262 61773 64331649
Colitis ulcerative 17.26 10.42 79 105231 22949 64370473
Ventricular fibrillation 17.26 10.42 81 105229 23779 64369643
Asthenia 17.20 10.42 859 104451 427185 63966237
Post procedural diarrhoea 17.08 10.42 8 105302 215 64393207
Mania 17.05 10.42 3 105307 16283 64377139
Right ventricular dilatation 16.99 10.42 16 105294 1429 64391993
Bone hypertrophy 16.98 10.42 9 105301 317 64393105
Off label use 16.88 10.42 853 104457 631953 63761469
Food refusal 16.74 10.42 10 105300 445 64392977
Basosquamous carcinoma 16.60 10.42 6 105304 81 64393341
Hypermagnesaemia 16.58 10.42 14 105296 1083 64392339
Serotonin syndrome 16.55 10.42 24 105286 39258 64354164
Erythema 16.43 10.42 211 105099 186859 64206563
Gluten sensitivity 16.36 10.42 9 105301 342 64393080
Drug withdrawal syndrome 16.29 10.42 97 105213 31194 64362228
Niemann-Pick disease 16.29 10.42 5 105305 39 64393383
Suicidal ideation 16.22 10.42 55 105255 66487 64326935
Lactic acidosis 16.20 10.42 49 105261 61361 64332061
Rhabdomyolysis 16.08 10.42 86 105224 91640 64301782
Fracture pain 16.05 10.42 9 105301 355 64393067
Hypocalcaemia 16.04 10.42 120 105190 41633 64351789
Rectal abscess 15.98 10.42 16 105294 1541 64391881
Stoma site ulcer 15.97 10.42 8 105302 250 64393172
Immune-mediated hepatitis 15.94 10.42 20 105290 2469 64390953
No adverse event 15.79 10.42 14 105296 28547 64364875
Pancreatitis chronic 15.72 10.42 24 105286 3562 64389860
Large intestine polyp 15.65 10.42 46 105264 10791 64382631
Obesity 15.60 10.42 7 105303 20555 64372867
Ejection fraction decreased 15.60 10.42 90 105220 28617 64364805
Hypovolaemia 15.44 10.42 58 105252 15428 64377994
Ascites 15.42 10.42 162 105148 61839 64331583
Gastroenteritis staphylococcal 15.36 10.42 8 105302 272 64393150
Condition aggravated 15.35 10.42 477 104833 371949 64021473
Inflammatory bowel disease 15.33 10.42 27 105283 4511 64388911
Long QT syndrome congenital 15.28 10.42 5 105305 49 64393373
Blood creatine phosphokinase increased 15.25 10.42 47 105263 58511 64334911
Anal incontinence 15.23 10.42 57 105253 15139 64378283
Small intestine ulcer 15.22 10.42 11 105299 677 64392745
Drug ineffective for unapproved indication 15.22 10.42 17 105293 31116 64362306
Proctitis 15.07 10.42 22 105288 3137 64390285
Accidental poisoning 15.04 10.42 15 105295 1438 64391984
Palmar erythema 14.73 10.42 16 105294 1694 64391728
Short-bowel syndrome 14.70 10.42 9 105301 419 64393003
Rhinorrhoea 14.59 10.42 156 105154 59813 64333609
Haematoma 14.39 10.42 34 105276 46216 64347206
Loss of personal independence in daily activities 14.39 10.42 65 105245 72389 64321033
Congenital knee deformity 14.38 10.42 4 105306 21 64393401
Drug eruption 14.34 10.42 23 105287 36113 64357309
Abortion spontaneous 14.30 10.42 12 105298 25131 64368291
Blood pressure systolic increased 14.13 10.42 133 105177 49320 64344102
Folliculitis 14.08 10.42 17 105293 30060 64363362
Colorectal cancer metastatic 13.99 10.42 12 105298 948 64392474
Device issue 13.90 10.42 10 105300 22638 64370784
Product quality issue 13.78 10.42 17 105293 29782 64363640
Therapy non-responder 13.77 10.42 58 105252 65841 64327581
Musculoskeletal disorder 13.74 10.42 6 105304 17900 64375522
Osteopenia 13.71 10.42 56 105254 15484 64377938
Glaucoma 13.71 10.42 58 105252 16290 64377132
Cyst 13.66 10.42 47 105263 11980 64381442
Pulmonary thrombosis 13.64 10.42 43 105267 10475 64382947
Subileus 13.55 10.42 27 105283 4950 64388472
Arrhythmia 13.48 10.42 139 105171 52805 64340617
Fistula of small intestine 13.42 10.42 10 105300 645 64392777
Joint stiffness 13.39 10.42 18 105292 30386 64363036
Ileostomy 13.34 10.42 13 105297 1211 64392211
Neoplasm 13.33 10.42 33 105277 6998 64386424
Intestinal ulcer 13.30 10.42 15 105295 1656 64391766
Diffuse alveolar damage 13.27 10.42 21 105289 3214 64390208
Dry eye 13.26 10.42 87 105223 28932 64364490
Gastroenteropancreatic neuroendocrine tumour disease 13.17 10.42 4 105306 30 64393392
Bicuspid aortic valve 13.05 10.42 4 105306 31 64393391
Gait disturbance 13.05 10.42 200 105110 171955 64221467
Electrocardiogram abnormal 13.04 10.42 50 105260 13431 64379991
Joint effusion 13.02 10.42 3 105307 13470 64379952
Dyschromatopsia 12.76 10.42 10 105300 696 64392726
Status epilepticus 12.74 10.42 10 105300 21653 64371769
Inflammation 12.72 10.42 59 105251 65241 64328181
Autoimmune nephritis 12.69 10.42 9 105301 538 64392884
Sensory disturbance 12.65 10.42 3 105307 13205 64380217
Megacolon 12.63 10.42 20 105290 3062 64390360
Peritoneal perforation 12.52 10.42 6 105304 170 64393252
Injection site rash 12.52 10.42 5 105305 15737 64377685
Gait inability 12.51 10.42 32 105278 42336 64351086
Injury 12.51 10.42 48 105262 55944 64337478
Urinary tract infection 12.44 10.42 479 104831 231117 64162305
Delusion 12.37 10.42 7 105303 18007 64375415
Pemphigoid 12.34 10.42 3 105307 12983 64380439
Mixed dementia 12.33 10.42 7 105303 283 64393139
Urticaria 12.26 10.42 168 105142 147149 64246273
Bone disorder 12.26 10.42 6 105304 16753 64376669
Peripheral pulse decreased 12.24 10.42 4 105306 39 64393383
Plasma cell myeloma 12.23 10.42 122 105188 45953 64347469
Plantar erythema 12.22 10.42 7 105303 288 64393134
Haematotoxicity 12.21 10.42 3 105307 12893 64380529
Inferior vena cava dilatation 12.18 10.42 10 105300 744 64392678
Drug delivery device placement 11.94 10.42 6 105304 189 64393233
Signet-ring cell carcinoma 11.88 10.42 3 105307 10 64393412
Eye infection fungal 11.82 10.42 8 105302 443 64392979
Drug reaction with eosinophilia and systemic symptoms 11.78 10.42 47 105263 54170 64339252
Hepatic lesion 11.75 10.42 28 105282 5796 64387626
Ureteric obstruction 11.75 10.42 17 105293 2405 64391017
Cor pulmonale acute 11.65 10.42 9 105301 613 64392809
Anhedonia 11.49 10.42 4 105306 13702 64379720
Terminal ileitis 11.42 10.42 9 105301 631 64392791
Nail bed tenderness 11.41 10.42 7 105303 327 64393095
Abdominal abscess 11.33 10.42 29 105281 6275 64387147
Defaecation urgency 11.29 10.42 22 105288 3967 64389455
Diabetes mellitus 11.28 10.42 63 105247 66411 64327011
Ear infection 11.20 10.42 13 105297 23391 64370031
Cognitive disorder 11.19 10.42 49 105261 55038 64338384
Hepatotoxicity 11.18 10.42 107 105203 39855 64353567
Cardiovascular disorder 11.15 10.42 6 105304 15875 64377547
Neutropenia 11.13 10.42 488 104822 239136 64154286
Paralysis recurrent laryngeal nerve 11.08 10.42 5 105305 123 64393299
Bacterial diarrhoea 11.08 10.42 5 105305 123 64393299
Carpal tunnel syndrome 11.08 10.42 6 105304 15822 64377600
Biopsy intestine abnormal 11.08 10.42 3 105307 14 64393408
Miosis 11.07 10.42 47 105263 13219 64380203
Hepatitis acute 11.07 10.42 4 105306 13385 64380037
Electrocardiogram T wave alternans 11.07 10.42 4 105306 54 64393368
Fear 11.02 10.42 10 105300 20161 64373261
Product storage error 10.97 10.42 4 105306 13314 64380108
Acute hepatic failure 10.96 10.42 16 105294 26096 64367326
Feeling abnormal 10.89 10.42 153 105157 133449 64259973
Emotional distress 10.81 10.42 27 105283 36011 64357411
Hyperchlorhydria 10.80 10.42 14 105296 1785 64391637
Adverse event 10.78 10.42 31 105279 39458 64353964
Influenza like illness 10.73 10.42 58 105252 61644 64331778
Bulimia nervosa 10.72 10.42 6 105304 236 64393186
Burn oral cavity 10.62 10.42 4 105306 61 64393361
Intestinal villi atrophy 10.62 10.42 7 105303 371 64393051
Abdominal infection 10.59 10.42 18 105292 2922 64390500
Hypercholesterolaemia 10.52 10.42 6 105304 15367 64378055
Nail infection 10.51 10.42 14 105296 1833 64391589
Prostatic obstruction 10.51 10.42 4 105306 63 64393359
Blood chromogranin A increased 10.50 10.42 7 105303 378 64393044
Retinal ischaemia 10.50 10.42 9 105301 711 64392711
Hip fracture 10.47 10.42 78 105232 27021 64366401

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:55322 mu-opioid agonists
CHEBI has role CHEBI:55323 antidiarrheal drug
CHEBI has role CHEBI:149553 anticoronaviral drug
FDA EPC N0000175690 Opioid Agonist

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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
2MG LOPERAMIDE HYDROCHLORIDE STRIDES PHARMA A213070 Aug. 11, 2021 OTC CAPSULE ORAL April 20, 2022 COMPETITIVE GENERIC THERAPY

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
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
Cytochrome P450 2D6 Enzyme IC50 5.70 DRUG MATRIX
Alpha-1D adrenergic receptor GPCR Ki 5.60 DRUG MATRIX
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 Unclassified IC50 4.16 CHEMBL
Beta-2 adrenergic receptor GPCR Ki 5.69 DRUG MATRIX
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

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
anti diarrheal HUMAN OTC DRUG LABEL 1 0113-2224 TABLET, FILM COATED 2 mg ORAL ANDA 16 sections
basic care loperamide hydrochloride and simethicone HUMAN OTC DRUG LABEL 2 0113-7119 TABLET 2 mg ORAL ANDA 16 sections
Basic Care loperamide hydrochloride HUMAN OTC DRUG LABEL 1 0113-7224 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
loperamide hydrochloride HUMAN OTC DRUG LABEL 1 0363-0645 SUSPENSION 1 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 0363-1010 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 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 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 HUMAN PRESCRIPTION DRUG LABEL 1 0378-2100 CAPSULE 2 mg ORAL ANDA 29 sections
Loperamide Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-2100 CAPSULE 2 mg ORAL ANDA 29 sections
Antidiarrheal Relief HUMAN OTC DRUG LABEL 1 0498-1071 TABLET 2 mg ORAL ANDA 16 sections
Loperamide Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-0362 CAPSULE 2 mg ORAL ANDA 25 sections
Loperamide Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8087 CAPSULE 2 mg ORAL ANDA 29 sections
loperamide hydrochloride HUMAN OTC DRUG LABEL 1 0904-6836 SOLUTION 1 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 HUMAN OTC DRUG LABEL 1 11822-0375 TABLET 2 mg ORAL ANDA 16 sections