mesalazine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
phenylazosalicylic acid derivatives antibacterial 1710 89-57-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • 5-ASA
  • mesalamine
  • 2-Hydroxy-5-aminobenzoic acid
  • 3-Carboxy-4-hydroxyaniline
  • 5-Amino-2-hydroxybenzoic acid
  • 5-Aminosalicylic acid
  • claversal
  • mesacol
  • mesalazine
  • mesalsal
  • mesasal
  • m-Aminosalicylic acid
  • mesalamine hydrochloride
  • mesalamine HCl
An anti-inflammatory agent, structurally related to the SALICYLATES, which is active in INFLAMMATORY BOWEL DISEASE. It is considered to be the active moiety of SULPHASALAZINE. (From Martindale, The Extra Pharmacopoeia, 30th ed)
  • Molecular weight: 153.14
  • Formula: C7H7NO3
  • CLOGP: 1.06
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 3
  • TPSA: 83.55
  • ALOGS: -1.10
  • ROTB: 1

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
1.50 g O
1.50 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.84 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 7 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 447.77 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.33 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.39 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.61 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 24, 1987 FDA MEDA PHARMS

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
Colitis ulcerative 2650.88 10.71 1041 74686 25050 63388245
Haematochezia 1157.05 10.71 747 74980 52797 63360498
Frequent bowel movements 927.87 10.71 482 75245 22540 63390755
Off label use 918.53 10.71 2284 73443 672178 62741117
Condition aggravated 504.56 10.71 1324 74403 400893 63012402
Rectal haemorrhage 459.51 10.71 416 75311 48614 63364681
Macular degeneration 446.18 10.71 307 75420 24069 63389226
Inappropriate schedule of product administration 415.60 10.71 564 75163 103401 63309894
Faecal calprotectin increased 375.34 10.71 142 75585 3061 63410234
Abdominal pain 369.25 10.71 968 74759 292488 63120807
Mucous stools 343.18 10.71 144 75583 4104 63409191
Diarrhoea haemorrhagic 332.02 10.71 178 75549 8864 63404431
Lupus-like syndrome 283.08 10.71 194 75533 15101 63398194
Crohn's disease 281.99 10.71 131 75596 4782 63408513
Intentional product use issue 260.15 10.71 511 75216 127381 63285914
Therapeutic reaction time decreased 224.34 10.71 90 75637 2280 63411015
Drug level below therapeutic 222.44 10.71 111 75616 4755 63408540
Proctitis 213.57 10.71 112 75615 5329 63407966
Colitis 194.79 10.71 264 75463 48264 63365031
Clostridium difficile infection 192.76 10.71 207 75520 29715 63383580
Death 188.88 10.71 106 75621 374275 63039020
Toxicity to various agents 179.48 10.71 38 75689 247212 63166083
Retinitis 173.18 10.71 102 75625 6094 63407201
Defaecation urgency 169.76 10.71 88 75639 4087 63409208
Drug ineffective 156.96 10.71 1915 73812 1042850 62370445
Product use issue 156.93 10.71 598 75129 219922 63193373
Completed suicide 147.74 10.71 6 75721 145667 63267628
Product residue present 139.56 10.71 76 75651 3903 63409392
Therapeutic response shortened 125.51 10.71 108 75619 11780 63401515
Fistula 119.14 10.71 99 75628 10294 63403001
Blood pressure fluctuation 117.89 10.71 204 75523 46113 63367182
Intestinal stenosis 117.86 10.71 61 75666 2823 63410472
Exostosis 117.55 10.71 125 75602 17737 63395558
Female genital tract fistula 114.76 10.71 85 75642 7474 63405821
Inflammatory bowel disease 112.60 10.71 66 75661 3907 63409388
Rectal tenesmus 110.60 10.71 41 75686 833 63412462
Premature labour 109.08 10.71 102 75625 12402 63400893
Fall 108.12 10.71 189 75538 392145 63021150
Drug specific antibody present 105.79 10.71 65 75662 4194 63409101
Bone erosion 102.72 10.71 116 75611 17601 63395694
Exposure during pregnancy 102.57 10.71 412 75315 155135 63258160
Joint dislocation 102.10 10.71 119 75608 18681 63394614
Laryngitis 101.64 10.71 113 75614 16854 63396441
Weight decreased 101.41 10.71 620 75107 276178 63137117
Pregnancy 101.36 10.71 168 75559 36668 63376627
Poor venous access 98.23 10.71 104 75623 14681 63398614
Drug level decreased 96.15 10.71 78 75649 7841 63405454
Incorrect dose administered 92.18 10.71 214 75513 59754 63353541
Vaginal flatulence 91.47 10.71 54 75673 3239 63410056
Pancreatitis 88.90 10.71 187 75540 48868 63364427
Large intestinal stenosis 87.43 10.71 44 75683 1919 63411376
Arthropathy 85.87 10.71 92 75635 234700 63178595
Hepatic cirrhosis 82.17 10.71 123 75604 24611 63388684
C-reactive protein increased 81.92 10.71 274 75453 94433 63318862
Acute kidney injury 80.89 10.71 118 75609 263297 63149998
Therapeutic product effect incomplete 79.04 10.71 327 75400 124729 63288566
Erythema nodosum 78.94 10.71 57 75670 4818 63408477
Gastrointestinal inflammation 78.30 10.71 60 75667 5552 63407743
Drug level above therapeutic 77.40 10.71 56 75671 4749 63408546
Anal fistula 75.22 10.71 49 75678 3502 63409793
Chronic sinusitis 74.30 10.71 84 75643 12759 63400536
Loss of therapeutic response 73.67 10.71 28 75699 611 63412684
Dyspnoea 72.01 10.71 478 75249 660835 62752460
Febrile neutropenia 69.69 10.71 27 75700 118422 63294873
Flatulence 68.43 10.71 137 75590 34565 63378730
Steroid dependence 68.34 10.71 36 75691 1728 63411567
Drug interaction 67.09 10.71 106 75621 229025 63184270
Segmental diverticular colitis 67.03 10.71 19 75708 155 63413140
Cytomegalovirus colitis 66.16 10.71 39 75688 2333 63410962
Intestinal obstruction 65.80 10.71 126 75601 30773 63382522
Foot deformity 62.31 10.71 116 75611 27737 63385558
Pedal pulse abnormal 61.74 10.71 18 75709 164 63413131
Red blood cell sedimentation rate increased 61.17 10.71 151 75576 43831 63369464
Neutropenia 60.22 10.71 72 75655 174933 63238362
Anal abscess 59.16 10.71 47 75680 4585 63408710
Malignant neoplasm progression 58.74 10.71 13 75714 82108 63331187
Ear infection 58.31 10.71 136 75591 38077 63375218
Stomatitis 58.15 10.71 48 75679 138677 63274618
Peripheral swelling 58.11 10.71 146 75581 265796 63147499
Contraindicated product administered 57.92 10.71 107 75620 217541 63195754
Tubulointerstitial nephritis 57.76 10.71 93 75634 19810 63393485
Proctalgia 57.48 10.71 52 75675 6058 63407237
Joint stiffness 57.44 10.71 143 75584 41726 63371569
Vaginal discharge 56.37 10.71 62 75665 9136 63404159
Diarrhoea 56.21 10.71 1179 74548 714187 62699108
Platelet count decreased 55.43 10.71 35 75692 116087 63297208
Intentional overdose 54.56 10.71 11 75716 74141 63339154
Anal fissure 54.44 10.71 44 75683 4399 63408896
Organising pneumonia 54.03 10.71 49 75678 5727 63407568
Malaise 54.01 10.71 744 74983 415210 62998085
Confusional state 53.82 10.71 127 75600 236253 63177042
Infusion related reaction 53.79 10.71 487 75240 245034 63168261
Swelling 53.57 10.71 160 75567 275218 63138077
Radiculopathy 52.69 10.71 58 75669 8553 63404742
Calcium ionised decreased 52.36 10.71 18 75709 291 63413004
Stress 50.86 10.71 186 75541 66981 63346314
Abdominal distension 50.46 10.71 221 75506 86394 63326901
Arthritis 50.43 10.71 272 75455 115649 63297646
White blood cell count decreased 50.27 10.71 55 75672 139049 63274246
Insomnia 49.52 10.71 115 75612 215137 63198158
Paraesthesia oral 49.22 10.71 85 75642 19171 63394124
Blood creatinine increased 48.49 10.71 22 75705 87822 63325473
Eosinophilic pneumonia 48.04 10.71 31 75696 2180 63411115
Overdose 48.00 10.71 40 75687 115038 63298257
Atrial fibrillation 46.88 10.71 42 75685 116594 63296701
Pyoderma gangrenosum 46.76 10.71 37 75690 3588 63409707
Cardiac failure congestive 46.74 10.71 26 75701 92407 63320888
Abnormal faeces 46.45 10.71 44 75683 5436 63407859
Coma 46.42 10.71 10 75717 64354 63348941
Drug specific antibody 46.25 10.71 31 75696 2324 63410971
Procedural pain 45.98 10.71 88 75639 21481 63391814
Cryopyrin associated periodic syndrome 45.97 10.71 17 75710 343 63412952
Large intestinal ulcer 44.10 10.71 35 75692 3409 63409886
Endometriosis 43.73 10.71 42 75685 5278 63408017
Oral allergy syndrome 43.58 10.71 11 75716 54 63413241
COVID-19 43.00 10.71 256 75471 112847 63300448
Hypotension 41.89 10.71 175 75552 272429 63140866
Heart rate irregular 41.22 10.71 86 75641 22335 63390960
Neuropathy peripheral 41.00 10.71 45 75682 113622 63299673
Rectal abscess 40.86 10.71 23 75704 1260 63412035
Abscess 40.56 10.71 72 75655 16596 63396699
Abortion spontaneous 40.30 10.71 136 75591 47059 63366236
Cytomegalovirus infection 39.26 10.71 81 75646 20871 63392424
Anal stenosis 38.75 10.71 16 75711 437 63412858
Thrombocytopenia 38.71 10.71 76 75651 151081 63262214
Joint swelling 38.53 10.71 231 75496 327435 63085860
Osteoporosis 37.83 10.71 152 75575 57186 63356109
Faeces soft 37.74 10.71 40 75687 5652 63407643
Bacillus infection 37.64 10.71 19 75708 834 63412461
Cardiac arrest 37.58 10.71 33 75694 92512 63320783
Depressed level of consciousness 36.75 10.71 14 75713 62064 63351231
Myocarditis 36.68 10.71 53 75674 10272 63403023
Colectomy total 36.56 10.71 12 75715 167 63413128
Intestinal fistula 36.51 10.71 19 75708 889 63412406
Feeding intolerance 36.39 10.71 18 75709 756 63412539
Anorectal discomfort 36.35 10.71 28 75699 2611 63410684
Electrocardiogram QT prolonged 35.96 10.71 13 75714 59517 63353778
Cardiac failure 35.94 10.71 32 75695 89110 63324185
Anal cancer 35.93 10.71 16 75711 528 63412767
Hyponatraemia 35.42 10.71 49 75678 111851 63301444
Heart rate decreased 35.19 10.71 127 75600 45433 63367862
Pemphigus 34.80 10.71 108 75619 183618 63229677
Ileal stenosis 34.73 10.71 23 75704 1690 63411605
Cardio-respiratory arrest 34.71 10.71 14 75713 59945 63353350
Seizure 34.56 10.71 66 75661 132568 63280727
Small intestinal obstruction 34.49 10.71 71 75656 18266 63395029
Balance disorder 34.40 10.71 30 75697 84392 63328903
Wheezing 34.31 10.71 38 75689 95557 63317738
Impaired quality of life 34.13 10.71 60 75667 13723 63399572
Lipase increased 33.98 10.71 50 75677 9850 63403445
Abdominal pain lower 33.44 10.71 86 75641 25592 63387703
Acute febrile neutrophilic dermatosis 33.40 10.71 28 75699 2946 63410349
Ill-defined disorder 33.38 10.71 29 75698 81726 63331569
Product administered to patient of inappropriate age 33.10 10.71 29 75698 3239 63410056
Sedation 32.51 10.71 4 75723 38805 63374490
Colectomy 32.34 10.71 26 75701 2580 63410715
Delirium 32.34 10.71 10 75717 50531 63362764
Anal incontinence 32.21 10.71 58 75669 13518 63399777
Muscle injury 32.15 10.71 19 75708 65326 63347969
Anorectal disorder 31.92 10.71 22 75705 1727 63411568
Catarrh 31.89 10.71 21 75706 1528 63411767
Subcutaneous abscess 31.35 10.71 36 75691 5560 63407735
Hypoaesthesia 30.46 10.71 321 75406 168072 63245223
Oral candidiasis 30.36 10.71 77 75650 22721 63390574
Intestinal resection 30.32 10.71 26 75701 2822 63410473
Multiple sclerosis relapse 30.29 10.71 10 75717 48468 63364827
Bacterial vulvovaginitis 30.14 10.71 16 75711 780 63412515
Infrequent bowel movements 30.14 10.71 19 75708 1283 63412012
Burns second degree 29.48 10.71 22 75705 1956 63411339
Drug abuse 29.27 10.71 26 75701 72492 63340803
Glossodynia 29.24 10.71 112 75615 178764 63234531
Sleep disorder due to general medical condition, insomnia type 28.93 10.71 13 75714 52204 63361091
Hepatitis infectious mononucleosis 28.64 10.71 9 75718 108 63413187
Lower respiratory tract infection 28.58 10.71 73 75654 132234 63281061
Hypoxia 28.55 10.71 18 75709 59774 63353521
Device expulsion 28.29 10.71 4 75723 34918 63378377
Iron deficiency anaemia 28.22 10.71 69 75658 19900 63393395
Ileostomy 27.89 10.71 19 75708 1463 63411832
Lupus vulgaris 27.75 10.71 35 75692 5959 63407336
Neoplasm progression 27.65 10.71 5 75722 36423 63376872
Proctitis ulcerative 27.40 10.71 11 75716 279 63413016
Femur fracture 27.19 10.71 8 75719 41748 63371547
Disseminated cytomegaloviral infection 26.76 10.71 10 75717 208 63413087
Haemorrhoids 26.62 10.71 72 75655 22078 63391217
Intestinal ulcer 26.34 10.71 18 75709 1393 63411902
Hypoglycaemia 26.14 10.71 20 75707 60045 63353250
Epistaxis 25.99 10.71 29 75698 72696 63340599
Vein rupture 25.95 10.71 17 75710 1226 63412069
Pyrexia 25.53 10.71 738 74989 469740 62943555
Iron deficiency 25.52 10.71 37 75690 7193 63406102
Intestinal anastomosis 25.50 10.71 12 75715 451 63412844
Arthralgia 25.50 10.71 873 74854 568837 62844458
Skin warm 25.39 10.71 32 75695 5444 63407851
Oropharyngeal pain 25.21 10.71 196 75531 94291 63319004
Listeriosis 25.12 10.71 18 75709 1503 63411792
Synovitis 25.11 10.71 126 75601 186792 63226503
Hyperkalaemia 24.96 10.71 17 75710 54186 63359109
Disease progression 24.80 10.71 70 75657 122688 63290607
Bowel movement irregularity 24.78 10.71 31 75696 5233 63408062
Gastric disorder 24.62 10.71 7 75720 37362 63375933
Papilloma viral infection 24.61 10.71 18 75709 1552 63411743
Intentional product misuse 24.39 10.71 22 75705 60895 63352400
Pulmonary hypertension 24.38 10.71 7 75720 37116 63376179
Folliculitis 24.09 10.71 29 75698 70288 63343007
Lactic acidosis 23.74 10.71 8 75719 38279 63375016
Herpes simplex hepatitis 23.53 10.71 11 75716 407 63412888
Tremor 23.46 10.71 80 75647 132159 63281136
Agitation 23.43 10.71 22 75705 59735 63353560
Blood glucose increased 23.31 10.71 40 75687 83716 63329579
Renal failure 23.10 10.71 68 75659 117584 63295711
Small intestinal stenosis 22.91 10.71 12 75715 569 63412726
Unresponsive to stimuli 22.91 10.71 6 75721 33810 63379485
Rash 22.73 10.71 503 75224 560368 62852927
Gastrointestinal sounds abnormal 22.59 10.71 26 75701 4025 63409270
Body temperature fluctuation 22.59 10.71 20 75707 2265 63411030
Rheumatoid arthritis 22.49 10.71 194 75533 253625 63159670
Chronic obstructive pulmonary disease 22.40 10.71 25 75702 62661 63350634
Metabolic acidosis 22.31 10.71 13 75714 45056 63368239
Hyperglycaemia 22.31 10.71 11 75716 41856 63371439
Abscess intestinal 21.96 10.71 17 75710 1597 63411698
Enterocutaneous fistula 21.86 10.71 16 75711 1381 63411914
Injection site papule 21.83 10.71 13 75714 792 63412503
Pyoderma 21.83 10.71 10 75717 353 63412942
Respiratory arrest 21.72 10.71 6 75721 32639 63380656
Pus in stool 21.61 10.71 6 75721 45 63413250
Intestinal mucosal hypertrophy 21.56 10.71 9 75718 253 63413042
Central obesity 21.44 10.71 15 75712 1206 63412089
Hypercholesterolaemia 21.42 10.71 65 75662 21269 63392026
Eosinophilic pleural effusion 21.38 10.71 6 75721 47 63413248
Impaired healing 21.06 10.71 58 75669 102484 63310811
Blood iron decreased 20.95 10.71 51 75676 14670 63398625
Obesity 20.90 10.71 5 75722 29947 63383348
Myocardial infarction 20.89 10.71 56 75671 99837 63313458
Sleep disorder 20.88 10.71 41 75686 81525 63331770
Full blood count abnormal 20.79 10.71 6 75721 31711 63381584
Osteoarthritis 20.77 10.71 189 75538 95154 63318141
Bladder trabeculation 20.65 10.71 6 75721 54 63413241
Aphthous ulcer 20.60 10.71 49 75678 13889 63399406
Arthritis enteropathic 20.41 10.71 9 75718 290 63413005
Type IV hypersensitivity reaction 20.35 10.71 21 75706 2877 63410418
Sinusitis 20.18 10.71 173 75554 226480 63186815
Caesarean section 20.10 10.71 55 75672 16977 63396318
Target skin lesion 20.04 10.71 7 75720 119 63413176
Hand deformity 20.00 10.71 110 75617 159347 63253948
Self-injurious ideation 20.00 10.71 20 75707 2639 63410656
Rhabdomyolysis 19.95 10.71 14 75713 43937 63369358
Muscular weakness 19.74 10.71 77 75650 122276 63291019
Duodenal ulcer perforation 19.70 10.71 47 75680 87162 63326133
Vaginal abscess 19.68 10.71 10 75717 445 63412850
Pain 19.58 10.71 705 75022 739923 62673372
Rectal stenosis 19.57 10.71 8 75719 213 63413082
Parosmia 19.39 10.71 30 75697 6176 63407119
Bursitis 19.33 10.71 10 75717 37031 63376264
Hypervolaemia 19.33 10.71 5 75722 28408 63384887
Infusion site thrombosis 19.27 10.71 7 75720 134 63413161
Hypercalcaemia 19.23 10.71 5 75722 28317 63384978
Lupus hepatitis 19.11 10.71 5 75722 29 63413266
Nephritis bacterial 18.97 10.71 5 75722 30 63413265
Intestinal dilatation 18.90 10.71 16 75711 1706 63411589
Rectal ulcer 18.90 10.71 14 75713 1231 63412064
Abdominal abscess 18.72 10.71 25 75702 4501 63408794
Urticaria chronic 18.72 10.71 11 75716 654 63412641
Neutrophil count decreased 18.55 10.71 24 75703 56382 63356913
Respiratory failure 18.49 10.71 61 75666 101797 63311498
Cardiac disorder 18.45 10.71 20 75707 50796 63362499
Uveitis 18.41 10.71 44 75683 12509 63400786
Accidental exposure to product 18.31 10.71 5 75722 27400 63385895
Hepatocellular injury 18.28 10.71 5 75722 27376 63385919
Drug withdrawal syndrome 18.09 10.71 5 75722 27189 63386106
Fear of disease 18.04 10.71 14 75713 1320 63411975
Faecal calprotectin abnormal 17.87 10.71 6 75721 90 63413205
Memory impairment 17.87 10.71 64 75663 104194 63309101
Autoimmune pancreatitis 17.80 10.71 8 75719 270 63413025
Acute myocardial infarction 17.79 10.71 8 75719 32116 63381179
Chromaturia 17.79 10.71 52 75675 16665 63396630
Foetal death 17.76 10.71 40 75687 10940 63402355
Listeria sepsis 17.70 10.71 11 75716 724 63412571
Alanine aminotransferase increased 17.58 10.71 64 75663 103706 63309589
Hypopnoea 17.26 10.71 22 75705 3784 63409511
Infectious mononucleosis 17.26 10.71 16 75711 1923 63411372
Nephrolithiasis 17.22 10.71 97 75630 41887 63371408
Cognitive disorder 17.10 10.71 25 75702 55790 63357505
Diabetes mellitus 17.10 10.71 25 75702 55785 63357510
Respiratory disorder 17.02 10.71 13 75714 39069 63374226
Abdominal tenderness 17.01 10.71 33 75694 8133 63405162
Eosinophilic pneumonia chronic 16.96 10.71 7 75720 191 63413104
Clostridium test positive 16.94 10.71 20 75707 3181 63410114
Full blood count decreased 16.92 10.71 5 75722 26019 63387276
Erythema 16.86 10.71 299 75428 175452 63237843
Adverse drug reaction 16.85 10.71 157 75570 79557 63333738
Appendicitis 16.83 10.71 33 75694 8196 63405099
Cerebrovascular accident 16.78 10.71 69 75658 107955 63305340
Oral administration complication 16.71 10.71 6 75721 111 63413184
Visual impairment 16.70 10.71 164 75563 84282 63329013
Gastrointestinal oedema 16.63 10.71 13 75714 1239 63412056
Encephalopathy 16.63 10.71 13 75714 38607 63374688
Psychotic disorder 16.60 10.71 5 75722 25707 63387588
Device dislocation 16.60 10.71 5 75722 25700 63387595
Drug-induced liver injury 16.55 10.71 93 75634 40129 63373166
Idiosyncratic drug reaction 16.50 10.71 11 75716 817 63412478
Headache 16.37 10.71 917 74810 632324 62780971
Plasmablastic lymphoma 16.22 10.71 7 75720 214 63413081
Mediastinal effusion 16.14 10.71 5 75722 57 63413238
Oxygen saturation decreased 16.11 10.71 53 75674 88532 63324763
C-reactive protein abnormal 15.80 10.71 19 75708 46077 63367218
Anal skin tags 15.65 10.71 9 75718 514 63412781
Neonatal gastrointestinal haemorrhage 15.63 10.71 4 75723 21 63413274
Gastrooesophageal reflux disease 15.54 10.71 60 75667 95579 63317716
Enteritis 15.48 10.71 32 75695 8254 63405041
Mucosal inflammation 15.40 10.71 20 75707 46908 63366387
Bradycardia 15.35 10.71 41 75686 73186 63340109
Central nervous system necrosis 15.22 10.71 6 75721 145 63413150
Rectal spasm 15.21 10.71 5 75722 70 63413225
Signet-ring cell carcinoma 15.12 10.71 3 75724 3 63413292
Mental status changes 15.03 10.71 15 75712 39584 63373711
Contusion 14.98 10.71 111 75616 149933 63263362
Blood pressure increased 14.94 10.71 274 75453 161788 63251507
Musculoskeletal pain 14.93 10.71 58 75669 92219 63321076
Osteonecrosis of jaw 14.90 10.71 12 75715 35111 63378184
Exposure to SARS-CoV-2 14.73 10.71 14 75713 1737 63411558
Haemoptysis 14.63 10.71 8 75719 28718 63384577
Suicidal ideation 14.61 10.71 33 75694 62388 63350907
Thyroiditis subacute 14.61 10.71 7 75720 274 63413021
Aspartate aminotransferase increased 14.44 10.71 57 75670 90220 63323075
Aggression 14.41 10.71 5 75722 23493 63389802
Pneumonia aspiration 14.40 10.71 12 75715 34528 63378767
Pulmonary tuberculosis 14.34 10.71 22 75705 4495 63408800
Plasma cell myeloma 14.33 10.71 13 75714 35892 63377403
Anal squamous cell carcinoma 14.30 10.71 8 75719 433 63412862
Epstein-Barr virus test positive 14.17 10.71 9 75718 616 63412679
Prescribed underdose 14.09 10.71 9 75718 29680 63383615
Pancreatitis acute 14.08 10.71 67 75660 27099 63386196
Drug specific antibody absent 14.05 10.71 5 75722 90 63413205
Gingival graft 13.97 10.71 4 75723 34 63413261
Palmar-plantar erythrodysaesthesia syndrome 13.94 10.71 5 75722 23010 63390285
Electrocardiogram ST-T segment abnormal 13.93 10.71 7 75720 304 63412991
Campylobacter infection 13.92 10.71 11 75716 1065 63412230
Somnolence 13.91 10.71 141 75586 178544 63234751
Haemorrhage 13.82 10.71 122 75605 60900 63352395
Abdominal adhesions 13.82 10.71 18 75709 3164 63410131
Coronary artery disease 13.81 10.71 11 75716 32366 63380929
Cryptosporidiosis infection 13.77 10.71 7 75720 312 63412983
Purulent discharge 13.67 10.71 22 75705 4684 63408611
Syncope 13.63 10.71 83 75644 117302 63295993
Suicide attempt 13.62 10.71 33 75694 60885 63352410
Malignant splenic neoplasm 13.60 10.71 3 75724 7 63413288
Blood pressure diastolic increased 13.52 10.71 34 75693 9976 63403319
Dyskinesia 13.49 10.71 11 75716 31991 63381304
Cytomegalovirus enterocolitis 13.46 10.71 9 75718 672 63412623
Upper gastrointestinal haemorrhage 13.45 10.71 3 75724 18849 63394446
Urinary retention 13.30 10.71 10 75717 30291 63383004
Multiple organ dysfunction syndrome 13.29 10.71 30 75697 56722 63356573
Pouchitis 13.26 10.71 8 75719 499 63412796
Diabetic ketoacidosis 13.22 10.71 4 75723 20501 63392794
Dysarthria 13.21 10.71 19 75708 42692 63370603
Pharyngeal paraesthesia 13.11 10.71 14 75713 1995 63411300
Vitamin D increased 13.10 10.71 9 75718 703 63412592
Multisystem inflammatory syndrome in children 13.05 10.71 3 75724 9 63413286
Porphyria acute 13.05 10.71 11 75716 1166 63412129
Glutamate dehydrogenase level abnormal 13.05 10.71 3 75724 9 63413286
Haemorrhage foetal 13.05 10.71 3 75724 9 63413286
Infusion site streaking 13.01 10.71 8 75719 517 63412778
Loss of consciousness 12.96 10.71 85 75642 118036 63295259
Asthma 12.90 10.71 94 75633 127467 63285828
Rhinitis 12.72 10.71 36 75691 11330 63401965
Eczema infected 12.65 10.71 4 75723 49 63413246
Product dose omission issue 12.60 10.71 200 75527 234113 63179182
Blood calcium decreased 12.58 10.71 8 75719 26443 63386852
Encephalitis cytomegalovirus 12.52 10.71 8 75719 553 63412742
Dyspnoea exertional 12.46 10.71 34 75693 60268 63353027
Muscle twitching 12.39 10.71 4 75723 19664 63393631
Bone disorder 12.31 10.71 5 75722 21321 63391974
Abortion 12.23 10.71 15 75712 2481 63410814
International normalised ratio increased 12.17 10.71 23 75704 46402 63366893
Faecal volume increased 12.16 10.71 5 75722 135 63413160
Dysstasia 12.15 10.71 5 75722 21161 63392134
Gait disturbance 12.10 10.71 150 75577 183028 63230267
Lymphocyte count decreased 12.02 10.71 11 75716 30246 63383049
Gastrointestinal infection 12.00 10.71 31 75696 9250 63404045
Irritable bowel syndrome 11.96 10.71 54 75673 82358 63330937
Pruritus 11.93 10.71 334 75393 361119 63052176
Intentional self-injury 11.90 10.71 8 75719 25679 63387616
Eosinophilic pneumonia acute 11.87 10.71 7 75720 419 63412876
Disturbance in attention 11.80 10.71 17 75710 38172 63375123
Dry eye 11.77 10.71 19 75708 40742 63372553
Pneumonia 11.75 10.71 436 75291 456331 62956964
Vaginal infection 11.73 10.71 27 75700 7491 63405804
Gastrointestinal obstruction 11.73 10.71 10 75717 1077 63412218
Cholangitis sclerosing 11.72 10.71 12 75715 1629 63411666
Antineutrophil cytoplasmic antibody positive 11.67 10.71 8 75719 622 63412673
Knee arthroplasty 11.63 10.71 30 75697 54176 63359119
Toxic epidermal necrolysis 11.59 10.71 8 75719 25326 63387969
Eye pain 11.55 10.71 14 75713 33840 63379455
Therapy interrupted 11.53 10.71 13 75714 32442 63380853
Joint range of motion decreased 11.51 10.71 13 75714 32415 63380880
Pseudopolyp 11.51 10.71 6 75721 282 63413013
Colonic fistula 11.47 10.71 6 75721 284 63413011
Ileal perforation 11.46 10.71 7 75720 447 63412848
Portal fibrosis 11.41 10.71 6 75721 287 63413008
Cytomegalovirus mucocutaneous ulcer 11.38 10.71 3 75724 18 63413277
Fluid retention 11.35 10.71 35 75692 59651 63353644
Chills 11.26 10.71 194 75533 113184 63300111
Haematoma 11.26 10.71 15 75712 34805 63378490
Abortion missed 11.25 10.71 12 75715 1707 63411588
Renal cell carcinoma stage IV 11.24 10.71 3 75724 19 63413276
Maternal exposure during breast feeding 11.20 10.71 19 75708 4222 63409073
Small intestine carcinoma 11.14 10.71 7 75720 470 63412825
Gastrointestinal fistula 11.14 10.71 7 75720 470 63412825
Blister 11.14 10.71 100 75627 129714 63283581
Tuberculosis 11.10 10.71 34 75693 11177 63402118
Acute respiratory failure 11.01 10.71 15 75712 34470 63378825
Generalised tonic-clonic seizure 11.00 10.71 11 75716 29005 63384290
Eczema 10.95 10.71 71 75656 32220 63381075
Dyspepsia 10.93 10.71 177 75550 102019 63311276
Pleurisy 10.93 10.71 28 75699 8312 63404983
Oedema 10.83 10.71 70 75657 97552 63315743
Depression 10.80 10.71 167 75560 196325 63216970

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
Colitis ulcerative 2432.52 12.46 918 51394 15602 34889017
Off label use 986.15 12.46 2019 50293 417505 34487114
Frequent bowel movements 944.65 12.46 435 51877 12352 34892267
Haematochezia 919.97 12.46 670 51642 45864 34858755
Condition aggravated 647.98 12.46 1084 51228 191112 34713507
Inappropriate schedule of product administration 546.58 12.46 564 51748 61732 34842887
Intentional product use issue 440.91 12.46 494 51818 59322 34845297
Colitis 440.57 12.46 400 51912 37350 34867269
Blood pressure fluctuation 293.37 12.46 267 52045 24982 34879637
Product use issue 291.25 12.46 413 51899 62803 34841816
Death 272.96 12.46 128 52184 397921 34506698
Weight decreased 248.71 12.46 700 51612 175601 34729018
Rectal haemorrhage 247.30 12.46 303 52009 39946 34864673
Faecal calprotectin increased 243.89 12.46 104 52208 2440 34902179
Drug ineffective 234.19 12.46 1317 50995 455434 34449185
Abdominal pain 220.31 12.46 639 51673 162979 34741640
Clostridium difficile infection 217.84 12.46 199 52113 18699 34885920
Drug level below therapeutic 210.26 12.46 121 52191 5494 34899125
Defaecation urgency 203.35 12.46 92 52220 2497 34902122
Crohn's disease 202.12 12.46 97 52215 3020 34901599
Anal abscess 191.81 12.46 120 52192 6353 34898266
Drug specific antibody present 182.49 12.46 92 52220 3193 34901426
Mucous stools 178.13 12.46 75 52237 1703 34902916
Drug level decreased 170.78 12.46 120 52192 7726 34896893
Therapeutic reaction time decreased 163.35 12.46 64 52248 1199 34903420
Diarrhoea haemorrhagic 162.65 12.46 110 52202 6654 34897965
Myocarditis 159.47 12.46 145 52167 13537 34891082
Toxicity to various agents 155.58 12.46 53 52259 200309 34704310
Impaired quality of life 150.46 12.46 99 52213 5719 34898900
Therapeutic response shortened 140.05 12.46 104 52208 7300 34897319
Weight increased 135.33 12.46 374 51938 92659 34811960
Steroid dependence 132.26 12.46 58 52254 1459 34903160
Cytomegalovirus colitis 131.71 12.46 70 52242 2714 34901905
Night sweats 127.06 12.46 143 52169 17209 34887410
Bronchiectasis 126.39 12.46 110 52202 9691 34894928
Heart rate decreased 115.56 12.46 186 52126 31559 34873060
Inflammatory bowel disease 112.19 12.46 64 52248 2856 34901763
Fistula 109.47 12.46 87 52225 6753 34897866
Product residue present 107.70 12.46 61 52251 2685 34901934
Infusion related reaction 105.13 12.46 240 52072 52817 34851802
Blood pressure increased 104.99 12.46 330 51982 87772 34816847
Acute kidney injury 104.15 12.46 186 52126 304802 34599817
Gastrointestinal inflammation 103.79 12.46 65 52247 3446 34901173
Hypotension 101.87 12.46 109 52203 221540 34683079
Loss of therapeutic response 100.67 12.46 37 52275 577 34904042
Completed suicide 100.16 12.46 14 52298 98154 34806465
Drug abuse 99.10 12.46 15 52297 99081 34805538
Cholangitis sclerosing 97.56 12.46 46 52266 1375 34903244
Therapeutic product effect decreased 95.69 12.46 180 52132 34563 34870056
Anal fistula 93.61 12.46 72 52240 5327 34899292
Febrile neutropenia 93.38 12.46 44 52268 136805 34767814
Large intestinal stenosis 93.28 12.46 46 52266 1521 34903098
Fall 91.84 12.46 101 52211 202784 34701835
Incorrect dose administered 87.82 12.46 190 52122 40325 34864294
Platelet count decreased 83.99 12.46 37 52275 119680 34784939
Hepatosplenic T-cell lymphoma 79.57 12.46 29 52283 441 34904178
Congenital hiatus hernia 79.23 12.46 34 52278 810 34903809
Neutropenia 79.01 12.46 71 52241 156707 34747912
Drug level above therapeutic 76.46 12.46 58 52254 4203 34900416
Pulmonary tuberculosis 75.08 12.46 60 52252 4694 34899925
Proctitis 74.06 12.46 46 52266 2403 34902216
Renal failure 73.42 12.46 53 52259 130504 34774115
Diarrhoea 73.18 12.46 897 51415 389015 34515604
Small intestinal stenosis 72.39 12.46 28 52284 506 34904113
Malignant neoplasm progression 72.31 12.46 21 52291 88025 34816594
Tubulointerstitial nephritis 69.52 12.46 118 52194 20906 34883713
Ileal stenosis 68.95 12.46 36 52276 1345 34903274
Drug interaction 68.19 12.46 148 52164 225798 34678821
Anal fissure 67.44 12.46 54 52258 4236 34900383
Rectal tenesmus 66.03 12.46 30 52282 822 34903797
Confusional state 66.03 12.46 71 52241 144089 34760530
Intestinal stenosis 65.95 12.46 41 52271 2145 34902474
Cardiac failure congestive 64.56 12.46 22 52290 83248 34821371
Myocardial infarction 63.20 12.46 53 52259 121032 34783587
Cardiac arrest 62.42 12.46 33 52279 96126 34808493
Heart rate irregular 62.18 12.46 96 52216 15711 34888908
Disseminated tuberculosis 60.63 12.46 39 52273 2166 34902453
Hyperkalaemia 57.99 12.46 16 52296 69373 34835246
Proctalgia 57.74 12.46 56 52256 5667 34898952
Flatulence 57.32 12.46 109 52203 21089 34883530
Poor venous access 56.63 12.46 53 52259 5130 34899489
Disease progression 55.55 12.46 48 52264 108029 34796590
Loss of personal independence in daily activities 53.82 12.46 139 52173 33040 34871579
Drug specific antibody 53.77 12.46 20 52292 323 34904296
Faeces soft 52.69 12.46 43 52269 3465 34901154
Abdominal abscess 52.10 12.46 46 52266 4129 34900490
Pyrexia 51.48 12.46 740 51572 332273 34572346
Intestinal obstruction 50.55 12.46 108 52204 22714 34881905
Pericarditis 50.47 12.46 74 52238 11571 34893048
Therapeutic product effect incomplete 50.08 12.46 178 52134 50363 34854256
Somnolence 49.45 12.46 56 52256 111060 34793559
Colectomy 49.03 12.46 32 52280 1822 34902797
Acne 48.94 12.46 71 52241 10995 34893624
Eosinophilic pneumonia 48.61 12.46 41 52271 3460 34901159
Cardio-respiratory arrest 47.60 12.46 12 52300 55261 34849358
Vitamin D deficiency 47.58 12.46 54 52258 6554 34898065
Abnormal faeces 46.29 12.46 39 52273 3286 34901333
Philadelphia positive chronic myeloid leukaemia 45.75 12.46 14 52298 119 34904500
Coma 45.44 12.46 7 52305 45671 34858948
Hypoglycaemia 44.91 12.46 13 52299 54627 34849992
Intestinal fistula 43.99 12.46 24 52288 981 34903638
Pouchitis 43.27 12.46 21 52291 670 34903949
Intentional overdose 42.75 12.46 7 52305 43667 34860952
Thrombocytopenia 42.55 12.46 108 52204 156139 34748480
Arthralgia 41.72 12.46 413 51899 169628 34734991
Mucosal inflammation 40.59 12.46 5 52307 38617 34866002
C-reactive protein decreased 39.83 12.46 29 52283 1973 34902646
Cytomegalovirus enteritis 39.76 12.46 18 52294 489 34904130
Cardiac failure 39.50 12.46 47 52265 91201 34813418
Small intestinal obstruction 38.42 12.46 75 52237 14791 34889828
Stress 38.24 12.46 116 52196 30231 34874388
Oedema peripheral 38.17 12.46 76 52236 119736 34784883
Cytomegalovirus infection 37.85 12.46 105 52207 26030 34878589
Pancreatitis 37.69 12.46 136 52176 38755 34865864
Pneumonia 37.35 12.46 355 51957 362272 34542347
Intestinal perforation 37.00 12.46 56 52256 9004 34895615
Rectal abscess 36.81 12.46 24 52288 1364 34903255
Abdominal distension 36.67 12.46 179 52133 58313 34846306
Chronic gastrointestinal bleeding 36.53 12.46 15 52297 319 34904300
Aggression 36.50 12.46 7 52305 38957 34865662
International normalised ratio increased 35.82 12.46 13 52299 47314 34857305
Neutrophil count decreased 35.48 12.46 16 52296 51088 34853531
Dyschezia 35.44 12.46 24 52288 1454 34903165
Body temperature fluctuation 35.12 12.46 25 52287 1642 34902977
Weight fluctuation 35.02 12.46 41 52271 5144 34899475
COVID-19 34.96 12.46 217 52095 77333 34827286
Treatment failure 34.52 12.46 150 52162 46547 34858072
Impaired work ability 34.41 12.46 47 52265 6883 34897736
Tuberculous pleurisy 34.36 12.46 15 52297 373 34904246
Pseudopolyp 34.28 12.46 13 52299 222 34904397
Rhabdomyolysis 34.13 12.46 31 52281 68132 34836487
Dyspnoea 33.82 12.46 381 51931 376401 34528218
Atrial fibrillation 33.77 12.46 84 52228 122309 34782310
Delirium 33.43 12.46 12 52300 43979 34860640
Clostridium difficile colitis 33.18 12.46 73 52239 15657 34888962
Hallucination 32.92 12.46 18 52294 51480 34853139
Overdose 32.35 12.46 54 52258 91005 34813614
Seizure 32.13 12.46 68 52244 104789 34799830
Depressed level of consciousness 32.03 12.46 12 52300 42829 34861790
Mental status changes 31.40 12.46 9 52303 38074 34866545
Pancreatitis acute 31.27 12.46 103 52209 28038 34876581
Lactic acidosis 31.01 12.46 7 52305 34765 34869854
Haemophagocytic lymphohistiocytosis 30.59 12.46 63 52249 12910 34891709
Proctocolectomy 30.30 12.46 10 52302 111 34904508
Histoplasmosis 30.23 12.46 22 52290 1496 34903123
Pancreatic toxicity 30.11 12.46 8 52304 38 34904581
Pulmonary oedema 29.82 12.46 17 52295 47512 34857107
Erythema nodosum 29.58 12.46 21 52291 1373 34903246
Hyponatraemia 29.41 12.46 49 52263 82642 34821977
Anorectal discomfort 29.34 12.46 24 52288 1940 34902679
Gastrointestinal anastomotic leak 29.34 12.46 14 52298 430 34904189
Large intestinal ulcer 29.29 12.46 24 52288 1945 34902674
Enterovesical fistula 29.09 12.46 17 52295 794 34903825
Enteritis 28.65 12.46 47 52265 8095 34896524
Abscess 28.59 12.46 58 52254 11759 34892860
Respiratory arrest 28.58 12.46 4 52308 28039 34876580
Cytomegalovirus enterocolitis 28.37 12.46 18 52294 976 34903643
Blood creatine phosphokinase increased 28.21 12.46 16 52296 44841 34859778
Neuropathy peripheral 28.10 12.46 51 52261 83212 34821407
Encephalopathy 27.94 12.46 9 52303 35310 34869309
Plasma cell myeloma 27.89 12.46 14 52298 42023 34862596
Lupus-like syndrome 27.86 12.46 27 52285 2729 34901890
Malignant melanoma in situ 27.69 12.46 22 52290 1706 34902913
Agitation 27.68 12.46 27 52285 57372 34847247
Hypoxia 27.65 12.46 25 52287 55070 34849549
Gastrointestinal disorder 27.38 12.46 112 52200 33836 34870783
Job dissatisfaction 27.38 12.46 10 52302 153 34904466
Periumbilical abscess 27.38 12.46 8 52304 57 34904562
Blood urea increased 27.31 12.46 6 52306 30358 34874261
Blood creatinine increased 27.13 12.46 64 52248 94912 34809707
Abdominal pain lower 26.91 12.46 53 52259 10518 34894101
Pyoderma gangrenosum 26.83 12.46 20 52292 1411 34903208
Respiratory failure 26.58 12.46 79 52233 108493 34796126
Acute myocardial infarction 26.22 12.46 25 52287 53694 34850925
Systemic lupus erythematosus 26.08 12.46 30 52282 3694 34900925
Drug intolerance 25.79 12.46 165 52147 59405 34845214
Short-bowel syndrome 25.63 12.46 11 52301 262 34904357
Plasmablastic lymphoma 25.56 12.46 12 52300 355 34904264
Proctitis ulcerative 25.54 12.46 8 52304 74 34904545
Angioedema 25.48 12.46 12 52300 37362 34867257
Hyperglycaemia 24.94 12.46 14 52298 39466 34865153
Narcotic bowel syndrome 24.87 12.46 9 52303 134 34904485
Gastrointestinal mucosa hyperaemia 24.81 12.46 11 52301 284 34904335
Flushing 24.61 12.46 105 52207 32315 34872304
Campylobacter infection 24.48 12.46 16 52296 913 34903706
C-reactive protein increased 24.13 12.46 151 52161 53947 34850672
Asthenia 23.96 12.46 243 52069 245008 34659611
Eosinophilic colitis 23.75 12.46 10 52302 227 34904392
Enteritis infectious 23.58 12.46 18 52294 1316 34903303
Ileostomy 23.51 12.46 14 52298 677 34903942
Suicide attempt 23.13 12.46 15 52297 39101 34865518
Alanine aminotransferase increased 22.64 12.46 55 52257 80760 34823859
Anastomotic infection 22.49 12.46 8 52304 113 34904506
Aspartate aminotransferase increased 22.44 12.46 42 52270 67741 34836878
Rectal stenosis 22.38 12.46 9 52303 181 34904438
Pneumonia aspiration 22.26 12.46 18 52294 41885 34862734
Ileal ulcer 22.06 12.46 13 52299 617 34904002
Perirectal abscess 21.77 12.46 19 52293 1679 34902940
Stomatitis 21.68 12.46 19 52293 42495 34862124
Anorectal disorder 21.62 12.46 16 52296 1116 34903503
Multiple organ dysfunction syndrome 21.54 12.46 52 52260 76514 34828105
Pulmonary hypertension 21.28 12.46 3 52309 20921 34883698
Intestinal resection 21.28 12.46 19 52293 1730 34902889
Epistaxis 21.19 12.46 34 52278 58217 34846402
Dyskinesia 21.04 12.46 4 52308 22409 34882210
White blood cell count decreased 20.88 12.46 73 52239 95372 34809247
Iron deficiency anaemia 20.73 12.46 47 52265 10282 34894337
Listeriosis 20.57 12.46 15 52297 1023 34903596
Organising pneumonia 20.34 12.46 34 52278 5945 34898674
Loss of consciousness 20.33 12.46 60 52252 82607 34822012
Faecal calprotectin abnormal 20.28 12.46 9 52303 233 34904386
Abscess intestinal 20.27 12.46 18 52294 1628 34902991
Intestinal diaphragm disease 20.03 12.46 9 52303 240 34904379
Gastroenteritis clostridial 19.70 12.46 10 52302 352 34904267
Infection reactivation 19.69 12.46 17 52295 1481 34903138
Blood bilirubin increased 19.67 12.46 17 52295 38279 34866340
Body temperature decreased 19.50 12.46 53 52259 12981 34891638
Breath sounds abnormal 19.36 12.46 36 52276 6845 34897774
Fluid retention 19.32 12.46 8 52304 26879 34877740
Bowel movement irregularity 19.04 12.46 23 52289 2982 34901637
Ventricular tachycardia 18.95 12.46 8 52304 26571 34878048
T-cell lymphoma 18.79 12.46 14 52298 987 34903632
Gait disturbance 18.70 12.46 65 52247 85075 34819544
Unresponsive to stimuli 18.56 12.46 9 52303 27560 34877059
Overgrowth bacterial 18.44 12.46 7 52305 120 34904499
Acute haemorrhagic ulcerative colitis 18.37 12.46 4 52308 6 34904613
Sleep apnoea syndrome 18.30 12.46 4 52308 20317 34884302
Henoch-Schonlein purpura 18.17 12.46 17 52295 1645 34902974
Intentional product misuse 18.16 12.46 25 52287 45586 34859033
Campylobacter gastroenteritis 18.07 12.46 13 52299 868 34903751
Chronic kidney disease 18.06 12.46 21 52291 41189 34863430
Gastrointestinal tract irritation 17.94 12.46 9 52303 309 34904310
Subileus 17.87 12.46 23 52289 3180 34901439
B-cell lymphoma 17.86 12.46 27 52285 4336 34900283
Cytokine release syndrome 17.79 12.46 6 52306 22871 34881748
General physical health deterioration 17.58 12.46 116 52196 128153 34776466
Rectal cancer 17.55 12.46 19 52293 2188 34902431
Hypervolaemia 17.51 12.46 4 52308 19705 34884914
Insomnia 17.44 12.46 88 52224 103819 34800800
Syncope 17.39 12.46 74 52238 91377 34813242
Anal cancer 17.39 12.46 10 52302 453 34904166
Appendicectomy 17.37 12.46 14 52298 1108 34903511
Urinary tract infection 17.27 12.46 66 52246 84015 34820604
Calcinosis 17.26 12.46 12 52300 759 34903860
Intestinal anastomosis complication 17.13 12.46 7 52305 147 34904472
Abnormal behaviour 17.04 12.46 8 52304 24961 34879658
Dysphagia 17.04 12.46 43 52269 62338 34842281
Cognitive disorder 16.97 12.46 11 52301 28682 34875937
Bradycardia 16.95 12.46 57 52255 75361 34829258
Anaemia 16.77 12.46 247 52065 233088 34671531
Blood glucose increased 16.71 12.46 48 52264 66670 34837949
Sepsis 16.67 12.46 164 52148 166397 34738222
Cardiac perforation 16.54 12.46 6 52306 90 34904529
Malaise 16.53 12.46 379 51933 185446 34719173
Peritonitis 16.51 12.46 58 52254 16307 34888312
Renal impairment 16.46 12.46 79 52233 94434 34810185
Aphthous ulcer 16.46 12.46 28 52284 4967 34899652
Colectomy total 15.85 12.46 7 52305 179 34904440
Muscular weakness 15.77 12.46 56 52256 72841 34831778
Psoriatic arthropathy 15.74 12.46 5 52307 19793 34884826
Abdominal adhesions 15.63 12.46 15 52297 1498 34903121
Rectal lesion 15.62 12.46 5 52307 50 34904569
Irritable bowel syndrome 15.57 12.46 23 52289 3620 34900999
Adenocarcinoma of colon 15.35 12.46 22 52290 3369 34901250
Ascites 15.28 12.46 29 52283 46542 34858077
Hypokalaemia 15.24 12.46 41 52271 58173 34846446
Large intestine perforation 15.22 12.46 37 52275 8466 34896153
Memory impairment 15.09 12.46 26 52286 43292 34861327
Blood pressure diastolic increased 15.04 12.46 27 52285 4998 34899621
Latent tuberculosis 15.01 12.46 14 52298 1349 34903270
Psychotic disorder 14.98 12.46 9 52303 24443 34880176
Cardiac disorder 14.91 12.46 26 52286 43100 34861519
Gastrointestinal stenosis 14.90 12.46 6 52306 121 34904498
Procedural intestinal perforation 14.89 12.46 4 52308 20 34904599
Abdominal pain upper 14.84 12.46 168 52144 71322 34833297
Subdural haematoma 14.80 12.46 6 52306 20415 34884204
Dry mouth 14.76 12.46 14 52298 30151 34874468
Calcium deficiency 14.70 12.46 7 52305 214 34904405
Autoimmune pancreatitis 14.66 12.46 8 52304 327 34904292
Aphasia 14.45 12.46 7 52305 21447 34883172
Rectal ulcer 14.44 12.46 12 52300 992 34903627
Acute respiratory failure 14.39 12.46 15 52297 30913 34873706
Hepatic function abnormal 14.23 12.46 28 52284 44335 34860284
Diffuse large B-cell lymphoma 14.20 12.46 33 52279 7337 34897282
Anastomotic ulcer 14.17 12.46 8 52304 350 34904269
Intestinal mucosal hypertrophy 14.16 12.46 5 52307 69 34904550
Fluctuance 14.14 12.46 4 52308 25 34904594
Meningitis listeria 14.10 12.46 9 52303 493 34904126
Gastrooesophageal sphincter insufficiency 14.10 12.46 5 52307 70 34904549
Epstein-Barr virus associated lymphoma 14.03 12.46 10 52302 658 34903961
Hypercalcaemia 14.02 12.46 3 52309 15465 34889154
COVID-19 pneumonia 14.00 12.46 4 52308 16963 34887656
Sedation 13.93 12.46 7 52305 20999 34883620
Nasopharyngitis 13.88 12.46 163 52149 69805 34834814
Haemorrhoidal haemorrhage 13.84 12.46 22 52290 3689 34900930
Speech disorder 13.68 12.46 11 52301 25675 34878944
Small intestine adenocarcinoma 13.68 12.46 6 52306 151 34904468
Sudden death 13.67 12.46 3 52309 15198 34889421
Blood pressure diastolic decreased 13.62 12.46 37 52275 9057 34895562
Acute febrile neutrophilic dermatosis 13.61 12.46 13 52299 1290 34903329
Exposure to SARS-CoV-2 13.59 12.46 9 52303 525 34904094
Acrochordon 13.57 12.46 8 52304 380 34904239
Cardiogenic shock 13.44 12.46 12 52300 26606 34878013
Micturition urgency 13.44 12.46 30 52282 6495 34898124
Intestinal haemorrhage 13.42 12.46 21 52291 3475 34901144
Megacolon 13.38 12.46 15 52297 1795 34902824
Urinary retention 13.36 12.46 21 52291 36267 34868352
Ophthalmic migraine 13.32 12.46 5 52307 83 34904536
Subcutaneous abscess 13.27 12.46 22 52290 3821 34900798
Inflammation 13.26 12.46 80 52232 28215 34876404
Astrovirus test positive 13.23 12.46 3 52309 6 34904613
Burns second degree 13.22 12.46 12 52300 1117 34903502
Gastrointestinal pain 13.21 12.46 21 52291 3521 34901098
Unemployment 13.18 12.46 4 52308 33 34904586
Drug hypersensitivity 13.17 12.46 181 52131 80348 34824271
Haemoptysis 13.14 12.46 20 52292 34986 34869633
Dental caries 13.09 12.46 24 52288 4515 34900104
Cerebral haemorrhage 13.07 12.46 20 52292 34917 34869702
Cheilitis 13.07 12.46 17 52295 2374 34902245
Arthritis 13.05 12.46 86 52226 31260 34873359
Pelvic abscess 13.04 12.46 11 52301 928 34903691
Cerebrovascular accident 13.02 12.46 74 52238 84737 34819882
Tuberculosis 12.95 12.46 35 52277 8542 34896077
Anti-platelet antibody 12.92 12.46 3 52309 7 34904612
Peripheral circulatory failure 12.89 12.46 6 52306 174 34904445
Listeria sepsis 12.89 12.46 6 52306 174 34904445
Illness 12.84 12.46 47 52265 13482 34891137
Small intestinal perforation 12.76 12.46 16 52296 2155 34902464
Short stature 12.74 12.46 5 52307 94 34904525
Clostridium test positive 12.72 12.46 20 52292 3322 34901297
Haemorrhage intracranial 12.72 12.46 4 52308 15942 34888677
Anastomotic stenosis 12.72 12.46 7 52305 291 34904328
Orthostatic hypotension 12.72 12.46 12 52300 25907 34878712
Decreased appetite 12.69 12.46 174 52138 166218 34738401
Therapy non-responder 12.61 12.46 101 52211 39045 34865574
PIK3CA-activated mutation 12.60 12.46 5 52307 97 34904522
Oral viral infection 12.58 12.46 4 52308 39 34904580
Viral infection 12.55 12.46 56 52256 17567 34887052

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
Colitis ulcerative 4168.22 10.70 1618 106130 33124 79603516
Off label use 2012.43 10.70 4016 103732 903199 78733441
Haematochezia 1775.36 10.70 1231 106517 86414 79550226
Frequent bowel movements 1460.04 10.70 739 107009 28800 79607840
Condition aggravated 1081.64 10.70 2201 105547 498923 79137717
Inappropriate schedule of product administration 964.98 10.70 1040 106708 132588 79504052
Intentional product use issue 727.88 10.70 960 106788 151152 79485488
Faecal calprotectin increased 575.75 10.70 233 107515 5308 79631332
Rectal haemorrhage 503.67 10.70 567 107181 75733 79560907
Abdominal pain 440.64 10.70 1339 106409 388230 79248410
Drug level below therapeutic 437.85 10.70 229 107519 9541 79627099
Colitis 437.16 10.70 517 107231 72790 79563850
Mucous stools 422.02 10.70 183 107565 4979 79631661
Blood pressure fluctuation 386.29 10.70 465 107283 66680 79569960
Product use issue 382.75 10.70 863 106885 208959 79427681
Clostridium difficile infection 377.71 10.70 371 107377 42314 79594326
Diarrhoea haemorrhagic 367.94 10.70 227 107521 13007 79623633
Therapeutic reaction time decreased 359.54 10.70 146 107602 3355 79633285
Weight decreased 344.05 10.70 1158 106590 354040 79282600
Death 329.42 10.70 178 107570 566336 79070304
Toxicity to various agents 325.89 10.70 84 107664 421456 79215184
Defaecation urgency 311.96 10.70 154 107594 5670 79630970
Therapeutic response shortened 277.23 10.70 204 107544 15659 79620981
Completed suicide 274.22 10.70 14 107734 245753 79390887
Drug specific antibody present 258.98 10.70 142 107606 6510 79630130
Drug level decreased 258.00 10.70 188 107560 14214 79622426
Drug ineffective 253.20 10.70 2393 105355 1078520 78558120
Lupus-like syndrome 234.97 10.70 175 107573 13682 79622958
Anal abscess 209.38 10.70 140 107608 9215 79627425
Proctitis 190.75 10.70 115 107633 6317 79630323
Incorrect dose administered 188.73 10.70 357 107391 76273 79560367
Fistula 185.68 10.70 148 107600 12792 79623848
Fall 179.35 10.70 238 107510 487391 79149249
Acute kidney injury 178.63 10.70 266 107482 519138 79117502
Myocarditis 174.03 10.70 179 107569 21554 79615086
Cytomegalovirus colitis 168.68 10.70 95 107653 4590 79632050
Inflammatory bowel disease 162.34 10.70 99 107649 5552 79631088
Poor venous access 157.25 10.70 156 107592 17993 79618647
Drug level above therapeutic 154.27 10.70 113 107635 8610 79628030
Febrile neutropenia 153.47 10.70 60 107688 230939 79405701
Heart rate decreased 150.65 10.70 309 107439 70007 79566633
Steroid dependence 148.20 10.70 72 107676 2558 79634082
Rectal tenesmus 145.52 10.70 62 107686 1613 79635027
Anal fistula 139.00 10.70 97 107651 6847 79629793
Retinitis 134.90 10.70 88 107660 5555 79631085
Hypotension 132.26 10.70 246 107502 440071 79196569
Platelet count decreased 131.90 10.70 49 107699 194615 79442025
Therapeutic product effect incomplete 130.74 10.70 455 107293 141190 79495450
Neutropenia 130.40 10.70 118 107630 287592 79349048
Loss of therapeutic response 126.81 10.70 47 107701 837 79635803
Product residue present 125.41 10.70 71 107677 3465 79633175
Large intestinal stenosis 125.27 10.70 66 107682 2790 79633850
Drug interaction 124.64 10.70 232 107516 414951 79221689
Gastrointestinal inflammation 120.63 10.70 92 107656 7452 79629188
Anal fissure 118.93 10.70 92 107656 7611 79629029
Diarrhoea 118.89 10.70 1756 105992 878733 78757907
Tubulointerstitial nephritis 117.10 10.70 196 107552 38039 79598601
Drug abuse 117.05 10.70 37 107711 162654 79473986
Weight increased 113.84 10.70 702 107046 276684 79359956
Impaired quality of life 112.49 10.70 117 107631 14269 79622371
Dyspnoea 109.17 10.70 695 107053 856330 78780310
Heart rate irregular 106.12 10.70 172 107576 32507 79604133
Blood pressure increased 103.72 10.70 561 107187 210799 79425841
Crohn's disease 103.03 10.70 52 107696 2008 79634632
Flatulence 102.63 10.70 197 107551 42527 79594113
Intentional overdose 101.50 10.70 12 107736 105948 79530692
Intestinal stenosis 100.81 10.70 63 107685 3691 79632949
Cardiac failure congestive 99.60 10.70 34 107714 142368 79494272
Cardiac arrest 98.38 10.70 55 107693 172041 79464599
Malignant neoplasm progression 97.69 10.70 31 107717 135959 79500681
Confusional state 95.10 10.70 178 107570 317819 79318821
Eosinophilic pneumonia 94.38 10.70 69 107679 5241 79631399
COVID-19 90.96 10.70 438 107310 157236 79479404
Cardio-respiratory arrest 90.94 10.70 18 107730 108492 79528148
Stress 88.95 10.70 273 107475 79339 79557301
Coma 87.99 10.70 15 107733 100634 79536006
Exostosis 86.03 10.70 110 107638 16748 79619892
C-reactive protein increased 85.22 10.70 373 107375 128654 79507986
Infusion related reaction 84.75 10.70 567 107181 229670 79406970
Faeces soft 84.33 10.70 78 107670 8245 79628395
Overdose 82.87 10.70 76 107672 184130 79452510
Joint dislocation 82.49 10.70 108 107640 16831 79619809
Hyperkalaemia 80.54 10.70 27 107721 114371 79522269
Congenital hiatus hernia 79.96 10.70 33 107715 791 79635849
Drug specific antibody 77.96 10.70 47 107701 2581 79634059
Proctalgia 77.59 10.70 81 107667 9920 79626720
Laryngitis 76.15 10.70 101 107647 15938 79620702
Cholangitis sclerosing 75.24 10.70 46 107702 2591 79634049
Depressed level of consciousness 75.03 10.70 19 107729 96633 79540007
Renal failure 74.83 10.70 97 107651 200871 79435769
Malaise 73.01 10.70 995 106753 488874 79147766
Abnormal faeces 72.95 10.70 69 107679 7502 79629138
Macular degeneration 72.84 10.70 83 107665 11213 79625427
Erythema nodosum 72.43 10.70 59 107689 5258 79631382
Thrombocytopenia 72.01 10.70 157 107591 265102 79371538
Exposure during pregnancy 71.12 10.70 298 107450 100834 79535806
Bone erosion 70.69 10.70 103 107645 17744 79618896
Stomatitis 70.32 10.70 57 107691 146700 79489940
Atrial fibrillation 70.15 10.70 99 107649 197787 79438853
Ileal stenosis 68.85 10.70 42 107706 2356 79634284
Cardiac failure 68.33 10.70 65 107683 154777 79481863
Abdominal distension 67.99 10.70 331 107417 119319 79517321
White blood cell count decreased 67.94 10.70 93 107655 188195 79448445
Pregnancy 65.95 10.70 125 107623 26726 79609914
Rectal abscess 65.28 10.70 39 107709 2106 79634534
Segmental diverticular colitis 64.69 10.70 19 107729 155 79636485
Hyponatraemia 64.01 10.70 88 107660 177760 79458880
Hypoxia 63.45 10.70 30 107718 103213 79533427
Small intestinal stenosis 63.06 10.70 28 107720 807 79635833
Hepatosplenic T-cell lymphoma 61.71 10.70 28 107720 850 79635790
Large intestinal ulcer 60.70 10.70 51 107697 4746 79631894
Colectomy 60.32 10.70 44 107704 3330 79633310
Chronic sinusitis 60.27 10.70 81 107667 12945 79623695
Hypoglycaemia 60.20 10.70 31 107717 101563 79535077
Cytomegalovirus infection 60.06 10.70 159 107589 42485 79594155
Bronchiectasis 59.73 10.70 108 107640 22278 79614362
Blood creatinine increased 59.63 10.70 73 107675 154984 79481656
Arthralgia 59.26 10.70 1093 106655 570710 79065930
Intestinal obstruction 59.17 10.70 159 107589 42861 79593779
Respiratory arrest 59.06 10.70 5 107743 57545 79579095
Pedal pulse abnormal 58.39 10.70 18 107730 176 79636464
Disease progression 57.03 10.70 101 107647 184261 79452379
Pulmonary tuberculosis 56.24 10.70 61 107687 7804 79628836
Delirium 56.13 10.70 22 107726 84605 79552035
Myocardial infarction 55.94 10.70 102 107646 184027 79452613
Organising pneumonia 55.22 10.70 71 107677 10868 79625772
Procedural pain 53.67 10.70 105 107643 22979 79613661
Body temperature fluctuation 53.46 10.70 43 107705 3764 79632876
Arthritis 53.00 10.70 300 107448 114580 79522060
Female genital tract fistula 52.94 10.70 52 107696 5923 79630717
Lactic acidosis 52.40 10.70 15 107733 70344 79566296
Ear infection 52.21 10.70 132 107616 34300 79602340
Pyoderma gangrenosum 52.19 10.70 44 107704 4114 79632526
Arthropathy 52.14 10.70 100 107648 177011 79459629
Pyrexia 51.96 10.70 1241 106507 677468 78959172
Night sweats 51.22 10.70 171 107577 51924 79584716
Rhabdomyolysis 50.73 10.70 39 107709 103092 79533548
Abscess 50.48 10.70 102 107646 22849 79613791
Abdominal abscess 50.48 10.70 55 107693 7072 79629568
Red blood cell sedimentation rate increased 48.95 10.70 155 107593 45787 79590853
Paraesthesia oral 48.67 10.70 94 107654 20377 79616263
Seizure 48.59 10.70 115 107633 188719 79447921
Foot deformity 48.27 10.70 103 107645 23971 79612669
Neutrophil count decreased 48.20 10.70 34 107714 93925 79542715
Disseminated tuberculosis 47.90 10.70 42 107706 4141 79632499
Joint stiffness 47.46 10.70 142 107606 40688 79595952
Weight fluctuation 47.14 10.70 68 107680 11607 79625033
Hepatic cirrhosis 46.99 10.70 128 107620 34778 79601862
Anorectal discomfort 46.95 10.70 39 107709 3572 79633068
Neuropathy peripheral 46.85 10.70 74 107674 141231 79495409
Swelling 46.72 10.70 144 107604 216567 79420073
Pouchitis 46.65 10.70 24 107724 965 79635675
Orthostatic hypotension 45.64 10.70 10 107738 56154 79580486
Insomnia 45.35 10.70 174 107574 244996 79391644
Bowel movement irregularity 45.07 10.70 49 107699 6285 79630355
Mucosal inflammation 44.87 10.70 23 107725 75557 79561083
Acne 44.15 10.70 107 107641 27083 79609557
Respiratory failure 43.56 10.70 114 107634 180797 79455843
Epistaxis 43.40 10.70 52 107696 111463 79525177
Intestinal fistula 43.39 10.70 26 107722 1412 79635228
Abdominal pain lower 43.24 10.70 117 107631 31665 79604975
Sedation 42.66 10.70 9 107739 51886 79584754
Endometriosis 42.34 10.70 37 107711 3631 79633009
Cryopyrin associated periodic syndrome 42.21 10.70 17 107731 382 79636258
International normalised ratio increased 41.72 10.70 32 107716 84689 79551951
Haemorrhoids 41.42 10.70 109 107639 29019 79607621
Pancreatitis 41.33 10.70 193 107555 68382 79568258
Plasmablastic lymphoma 40.85 10.70 18 107730 509 79636131
Encephalopathy 40.77 10.70 20 107728 67377 79569263
Acute myocardial infarction 40.68 10.70 27 107721 77009 79559631
Acute febrile neutrophilic dermatosis 40.62 10.70 37 107711 3835 79632805
Multiple sclerosis relapse 40.52 10.70 7 107741 46526 79590114
Agitation 40.42 10.70 45 107703 99670 79536970
Cytomegalovirus enterocolitis 40.03 10.70 26 107722 1629 79635011
Pseudopolyp 39.91 10.70 17 107731 442 79636198
Somnolence 39.59 10.70 177 107571 238804 79397836
Aggression 39.58 10.70 10 107738 50948 79585692
Iron deficiency anaemia 39.53 10.70 99 107649 25573 79611067
Listeriosis 39.45 10.70 29 107719 2221 79634419
C-reactive protein decreased 39.31 10.70 31 107717 2637 79634003
Subcutaneous abscess 39.20 10.70 51 107697 7898 79628742
Ileostomy 39.11 10.70 26 107722 1694 79634946
Philadelphia positive chronic myeloid leukaemia 39.04 10.70 13 107735 166 79636474
Calcium ionised decreased 38.99 10.70 18 107730 569 79636071
Pulmonary oedema 38.98 10.70 37 107711 88217 79548423
Anorectal disorder 38.96 10.70 29 107719 2264 79634376
Small intestinal obstruction 38.72 10.70 102 107646 27170 79609470
Pancreatitis acute 38.70 10.70 151 107597 49453 79587187
Pulmonary hypertension 38.19 10.70 9 107739 48071 79588569
Hyperglycaemia 38.03 10.70 24 107724 70311 79566329
Multiple organ dysfunction syndrome 37.97 10.70 65 107683 120181 79516459
Alanine aminotransferase increased 37.96 10.70 104 107644 162466 79474174
Product administered to patient of inappropriate age 37.85 10.70 42 107706 5511 79631129
Unresponsive to stimuli 37.83 10.70 14 107734 55774 79580866
Muscular weakness 37.40 10.70 103 107645 160626 79476014
Mental status changes 37.39 10.70 22 107726 66937 79569703
Faecal calprotectin abnormal 37.37 10.70 13 107735 191 79636449
Abortion spontaneous 36.57 10.70 105 107643 29402 79607238
Colectomy total 36.48 10.70 15 107733 356 79636284
Intentional product misuse 36.37 10.70 45 107703 95120 79541520
Chronic gastrointestinal bleeding 35.84 10.70 16 107732 467 79636173
Proctocolectomy 35.56 10.70 12 107736 160 79636480
Blood creatine phosphokinase increased 35.12 10.70 23 107725 66067 79570573
Balance disorder 34.47 10.70 50 107698 98807 79537833
Wheezing 34.21 10.70 66 107682 116598 79520042
Hypervolaemia 33.89 10.70 8 107740 42682 79593958
Vaginal flatulence 33.87 10.70 28 107720 2547 79634093
Intestinal resection 33.85 10.70 33 107715 3724 79632916
Aspartate aminotransferase increased 33.65 10.70 87 107661 138554 79498086
Catarrh 33.59 10.70 26 107722 2152 79634488
Oral allergy syndrome 33.58 10.70 10 107738 86 79636554
Obesity 33.57 10.70 4 107744 35121 79601519
Pneumonia aspiration 33.35 10.70 25 107723 66942 79569698
Feeding intolerance 32.49 10.70 18 107730 842 79635798
Abscess intestinal 32.26 10.70 28 107720 2723 79633917
Bradycardia 32.19 10.70 86 107662 135471 79501169
Peripheral swelling 31.94 10.70 223 107525 269394 79367246
Skin warm 31.85 10.70 42 107706 6590 79630050
Blood urea increased 31.83 10.70 13 107735 48777 79587863
Neoplasm progression 31.78 10.70 15 107733 51667 79584973
Tuberculous pleurisy 31.39 10.70 16 107732 631 79636009
Burns second degree 31.33 10.70 27 107721 2601 79634039
Treatment failure 31.17 10.70 360 107388 170126 79466514
Femur fracture 31.17 10.70 7 107741 38645 79597995
Loss of consciousness 31.16 10.70 119 107629 167824 79468816
Enteritis 31.11 10.70 64 107684 14519 79622121
Hypercalcaemia 30.91 10.70 7 107741 38423 79598217
Syncope 30.87 10.70 131 107617 179318 79457322
Cerebrovascular accident 30.82 10.70 107 107641 155185 79481455
Anal cancer 30.79 10.70 17 107731 790 79635850
Nephritis bacterial 30.75 10.70 8 107740 39 79636601
Cytomegalovirus enteritis 30.65 10.70 17 107731 797 79635843
Intestinal anastomosis 30.53 10.70 16 107732 669 79635971
Dyschezia 30.27 10.70 28 107720 2960 79633680
Aphthous ulcer 30.18 10.70 69 107679 16820 79619820
Cytokine release syndrome 30.09 10.70 6 107742 35992 79600648
Diabetic ketoacidosis 30.01 10.70 5 107743 34117 79602523
Rectal stenosis 29.99 10.70 13 107735 353 79636287
Disseminated cytomegaloviral infection 29.80 10.70 14 107734 461 79636179
Premature labour 29.77 10.70 46 107702 8344 79628296
Cardiac disorder 29.71 10.70 27 107721 65730 79570910
Anal stenosis 29.47 10.70 14 107734 473 79636167
Pneumonia 29.37 10.70 674 107074 659572 78977068
Eosinophilic colitis 29.28 10.70 14 107734 480 79636160
Osteonecrosis of jaw 29.05 10.70 11 107737 43215 79593425
Hepatocellular injury 28.97 10.70 14 107734 47579 79589061
Cognitive disorder 28.95 10.70 31 107717 69895 79566745
Accidental exposure to product 28.89 10.70 4 107744 31318 79605322
Suicide attempt 28.86 10.70 42 107706 82890 79553750
Osteoporosis 28.81 10.70 147 107601 53965 79582675
Oropharyngeal pain 28.76 10.70 249 107499 109104 79527536
Hepatitis infectious mononucleosis 28.68 10.70 10 107738 148 79636492
Acute respiratory failure 28.67 10.70 23 107725 59518 79577122
Intestinal ulcer 28.57 10.70 23 107725 2015 79634625
Exposure to SARS-CoV-2 28.52 10.70 23 107725 2021 79634619
Proctitis ulcerative 28.28 10.70 12 107736 309 79636331
Blood glucose increased 28.01 10.70 72 107676 114903 79521737
Gastric disorder 27.83 10.70 8 107740 37425 79599215
Enterocutaneous fistula 27.22 10.70 22 107726 1939 79634701
Intestinal mucosal hypertrophy 27.18 10.70 12 107736 341 79636299
Psychotic disorder 27.06 10.70 11 107737 41391 79595249
Periumbilical abscess 26.95 10.70 8 107740 68 79636572
Bacterial vulvovaginitis 26.59 10.70 14 107734 591 79636049
Haemoptysis 26.50 10.70 22 107726 55977 79580663
Gastrointestinal mucosa hyperaemia 26.50 10.70 13 107735 472 79636168
Hallucination 26.47 10.70 47 107701 85698 79550942
Vitamin D deficiency 26.25 10.70 59 107689 14220 79622420
Sleep disorder due to general medical condition, insomnia type 26.23 10.70 13 107735 43543 79593097
Hypokalaemia 26.12 10.70 103 107645 143937 79492703
Listeria sepsis 26.03 10.70 15 107733 757 79635883
Intestinal perforation 25.58 10.70 66 107682 17360 79619280
Blood pressure diastolic increased 25.53 10.70 59 107689 14483 79622157
Sepsis 25.40 10.70 237 107511 269191 79367449
Blood iron decreased 25.34 10.70 61 107687 15373 79621267
Bacillus infection 25.16 10.70 17 107731 1138 79635502
Plasma cell myeloma 25.11 10.70 21 107727 53238 79583402
Malignant melanoma in situ 24.88 10.70 23 107725 2429 79634211
Enterovesical fistula 24.80 10.70 17 107731 1165 79635475
Dyskinesia 24.59 10.70 15 107733 44758 79591882
Device expulsion 24.58 10.70 3 107745 25858 79610782
Renal impairment 24.27 10.70 120 107628 157663 79478977
Pyoderma 24 10.70 12 107736 454 79636186
Uveitis 23.95 10.70 63 107685 16767 79619873
Rectal ulcer 23.84 10.70 21 107727 2083 79634557
Nephrolithiasis 23.80 10.70 138 107610 53153 79583487
Clostridium test positive 23.77 10.70 36 107712 6418 79630222
Fluid retention 23.66 10.70 36 107712 69773 79566867
Pancreatic toxicity 23.63 10.70 7 107741 59 79636581
Memory impairment 23.53 10.70 75 107673 111659 79524981
Sleep apnoea syndrome 23.34 10.70 10 107738 36468 79600172
Ventricular tachycardia 23.10 10.70 14 107734 41921 79594719
Drug withdrawal syndrome 23.06 10.70 9 107739 34709 79601931
Epstein-Barr virus test positive 23.00 10.70 16 107732 1123 79635517
Contraindicated product administered 22.99 10.70 122 107626 157416 79479224
Parosmia 22.88 10.70 37 107711 6977 79629663
Depression 22.50 10.70 186 107562 216604 79420036
Electrocardiogram QT prolonged 22.48 10.70 56 107692 90330 79546310
Ill-defined disorder 22.30 10.70 34 107714 65841 79570799
Herpes simplex hepatitis 22.23 10.70 12 107736 533 79636107
Intentional self-injury 22.21 10.70 8 107740 32411 79604229
Anastomotic infection 21.93 10.70 8 107740 136 79636504
Campylobacter infection 21.92 10.70 19 107729 1844 79634796
Intestinal anastomosis complication 21.87 10.70 10 107738 309 79636331
Muscle injury 21.86 10.70 20 107728 48541 79588099
Clostridium difficile colitis 21.80 10.70 94 107654 32189 79604451
Gastrointestinal oedema 21.75 10.70 22 107726 2596 79634044
Oxygen saturation decreased 21.70 10.70 95 107653 128952 79507688
Right ventricular failure 21.68 10.70 3 107745 23494 79613146
Poisoning 21.57 10.70 4 107744 25268 79611372
Aphasia 21.33 10.70 19 107729 46713 79589927
Pleurisy 21.21 10.70 45 107703 10430 79626210
Henoch-Schonlein purpura 21.11 10.70 22 107726 2688 79633952
Haemorrhoidal haemorrhage 21.02 10.70 35 107713 6760 79629880
Gastrointestinal sounds abnormal 20.99 10.70 31 107717 5404 79631236
Inappropriate antidiuretic hormone secretion 20.75 10.70 5 107743 26308 79610332
Tuberculosis 20.72 10.70 56 107692 15142 79621498
Disorientation 20.68 10.70 33 107715 62743 79573897
Extrapyramidal disorder 20.68 10.70 3 107745 22676 79613964
Lupus vulgaris 20.59 10.70 24 107724 3322 79633318
Body temperature decreased 20.50 10.70 92 107656 32053 79604587
Sudden death 20.47 10.70 3 107745 22508 79614132
Vein rupture 20.47 10.70 19 107729 2017 79634623
Perirectal abscess 20.43 10.70 19 107729 2022 79634618
Joint swelling 20.42 10.70 271 107477 288375 79348265
Cardiogenic shock 20.42 10.70 16 107732 41898 79594742
Dysplasia 20.20 10.70 16 107732 1370 79635270
Dysarthria 20.04 10.70 38 107710 67584 79569056
Hypopnoea 20.02 10.70 30 107718 5299 79631341
Tremor 19.97 10.70 141 107607 169942 79466698
Autoimmune pancreatitis 19.92 10.70 12 107736 658 79635982
Narcotic bowel syndrome 19.90 10.70 9 107739 271 79636369
Upper gastrointestinal haemorrhage 19.90 10.70 16 107732 41364 79595276
Histoplasmosis 19.88 10.70 20 107728 2345 79634295
Blood bilirubin increased 19.82 10.70 37 107711 66195 79570445
Pseudomembranous colitis 19.82 10.70 30 107718 5344 79631296
Megacolon 19.74 10.70 24 107724 3471 79633169
Urinary tract infection 19.68 10.70 257 107491 274255 79362385
Haematoma 19.61 10.70 25 107723 52170 79584470
Bladder trabeculation 19.53 10.70 6 107742 58 79636582
Speech disorder 19.51 10.70 27 107721 54418 79582222
Infrequent bowel movements 19.51 10.70 17 107731 1662 79634978
Lower respiratory tract infection 19.46 10.70 99 107649 129121 79507519
Urinary retention 19.39 10.70 29 107719 56601 79580039
Muscle twitching 18.96 10.70 5 107743 24759 79611881
Impaired work ability 18.81 10.70 64 107684 19617 79617023
Synovitis 18.67 10.70 123 107625 150611 79486029
Hypothermia 18.58 10.70 4 107744 22742 79613898
Device dislocation 18.50 10.70 6 107742 25964 79610676
Suicidal ideation 18.44 10.70 48 107700 76292 79560348
Colon dysplasia 18.43 10.70 8 107740 218 79636422
Urticaria chronic 18.40 10.70 11 107737 595 79636045
Bursitis 18.34 10.70 13 107735 35831 79600809
Impaired healing 18.34 10.70 59 107689 87596 79549044
Palmar-plantar erythrodysaesthesia syndrome 18.34 10.70 11 107737 33123 79603517
Large intestine perforation 18.21 10.70 52 107696 14515 79622125
Anal skin tags 18.06 10.70 10 107738 467 79636173
Subdural haematoma 18.02 10.70 10 107738 31424 79605216
Tumour lysis syndrome 18.01 10.70 5 107743 23934 79612706
Target skin lesion 18.00 10.70 7 107741 143 79636497
Rash maculo-papular 17.99 10.70 30 107718 56048 79580592
Therapy interrupted 17.92 10.70 10 107738 31331 79605309
Caesarean section 17.91 10.70 47 107701 12488 79624152
B-cell lymphoma 17.89 10.70 31 107717 6184 79630456
Full blood count decreased 17.73 10.70 7 107741 26812 79609828
Foetal anaemia 17.73 10.70 4 107744 9 79636631
Thrombotic microangiopathy 17.64 10.70 3 107745 20166 79616474
Small intestinal perforation 17.59 10.70 22 107726 3275 79633365
Coronary artery disease 17.53 10.70 39 107709 65435 79571205
Disturbance in attention 17.41 10.70 26 107722 50775 79585865
Enteritis infectious 17.38 10.70 22 107726 3316 79633324
Iron deficiency 17.37 10.70 42 107706 10612 79626028
Gait disturbance 17.27 10.70 188 107560 207318 79429322
Atrial flutter 17.27 10.70 4 107744 21621 79615019
Dry mouth 17.22 10.70 61 107687 87958 79548682
Gastrointestinal tract irritation 17.14 10.70 11 107737 675 79635965
Urinary incontinence 17.09 10.70 18 107730 40891 79595749
Haemorrhage intracranial 17.05 10.70 7 107741 26186 79610454
Blood calcium decreased 17.00 10.70 11 107737 31808 79604832
Injection site reaction 16.94 10.70 30 107718 54755 79581885
Therapy non-responder 16.89 10.70 195 107553 92110 79544530
Fear of disease 16.89 10.70 14 107734 1278 79635362
Central obesity 16.87 10.70 16 107732 1745 79634895
Sopor 16.85 10.70 12 107736 32998 79603642
T-cell lymphoma 16.79 10.70 14 107734 1289 79635351
Infectious mononucleosis 16.67 10.70 17 107731 2025 79634615
Glomerular filtration rate decreased 16.61 10.70 5 107743 22697 79613943
Gastrointestinal haemorrhage 16.60 10.70 124 107624 147595 79489045
Anal incontinence 16.42 10.70 58 107690 18110 79618530
Adenocarcinoma of colon 16.42 10.70 28 107720 5513 79631127
Anastomotic ulcer 16.42 10.70 11 107737 726 79635914
Histoplasmosis disseminated 16.39 10.70 18 107730 2335 79634305
Small intestine adenocarcinoma 16.29 10.70 7 107741 186 79636454
Injection site papule 16.24 10.70 12 107736 926 79635714
Irritability 16.20 10.70 19 107729 41125 79595515
Anaemia 16.09 10.70 468 107280 444547 79192093
Toxic epidermal necrolysis 16.08 10.70 22 107726 44559 79592081
Abdominal pain upper 16.05 10.70 406 107342 223413 79413227
Prescribed underdose 16.05 10.70 10 107738 29504 79607136
Pelvic abscess 15.95 10.70 17 107731 2132 79634508
Overgrowth bacterial 15.85 10.70 7 107741 199 79636441
Rash 15.84 10.70 630 107118 577728 79058912
Abortion 15.83 10.70 14 107734 1396 79635244
Rhinitis 15.81 10.70 50 107698 14757 79621883
Ischaemic stroke 15.70 10.70 13 107735 33118 79603522
Carbohydrate antigen 19-9 increased 15.59 10.70 9 107739 456 79636184
Blood glucose decreased 15.54 10.70 8 107740 26226 79610414
Large intestine polyp 15.53 10.70 45 107703 12663 79623977
Altered state of consciousness 15.44 10.70 22 107726 43800 79592840
Mediastinal effusion 15.37 10.70 5 107743 59 79636581
Angioedema 15.34 10.70 52 107696 75983 79560657
Eosinophilic pleural effusion 15.34 10.70 8 107740 331 79636309
Respiratory disorder 15.33 10.70 23 107725 44833 79591807
Thyroiditis subacute 15.32 10.70 8 107740 332 79636308
Contusion 15.27 10.70 128 107620 148648 79487992
Dystonia 15.14 10.70 5 107743 21394 79615246
Oedema 15.10 10.70 97 107651 119483 79517157
Drug specific antibody absent 15.08 10.70 7 107741 224 79636416
Musculoskeletal pain 15.08 10.70 79 107669 102275 79534365
Drug reaction with eosinophilia and systemic symptoms 15.06 10.70 41 107707 64203 79572437
Vaginal discharge 15.04 10.70 32 107716 7431 79629209
Procedural intestinal perforation 14.94 10.70 7 107741 229 79636411
Restlessness 14.79 10.70 25 107723 46467 79590173
Therapeutic product effect decreased 14.78 10.70 307 107441 163556 79473084
Loss of personal independence in daily activities 14.65 10.70 207 107541 102373 79534267
Pus in stool 14.60 10.70 5 107743 70 79636570
Ventricular fibrillation 14.55 10.70 13 107735 31913 79604727
Generalised tonic-clonic seizure 14.54 10.70 23 107725 43887 79592753
Serum ferritin decreased 14.52 10.70 17 107731 2363 79634277
Blood pressure diastolic abnormal 14.47 10.70 4 107744 19198 79617442
Sleep disorder 14.45 10.70 63 107685 85614 79551026
Infusion site thrombosis 14.40 10.70 7 107741 249 79636391
Hepatic failure 14.40 10.70 39 107709 61173 79575467
Retinal vein occlusion 14.37 10.70 20 107728 3303 79633337
Hallucination, auditory 14.36 10.70 5 107743 20688 79615952
Status epilepticus 14.30 10.70 8 107740 25033 79611607
Ataxia 14.30 10.70 8 107740 25031 79611609
Dysstasia 14.28 10.70 10 107738 27736 79608904
Progressive multifocal leukoencephalopathy 14.25 10.70 5 107743 20595 79616045
Latent tuberculosis 14.23 10.70 20 107728 3333 79633307
Gastrointestinal pain 14.13 10.70 37 107711 9818 79626822
Neuroleptic malignant syndrome 14.09 10.70 10 107738 27549 79609091
Hepatic function abnormal 14.08 10.70 51 107697 73056 79563584
Benign prostatic hyperplasia 14.08 10.70 41 107707 11571 79625069
Blister 14.04 10.70 99 107649 119377 79517263
Faeces discoloured 14.04 10.70 77 107671 29050 79607590
Cytopenia 14.01 10.70 5 107743 20378 79616262
Blood pressure diastolic decreased 13.98 10.70 79 107669 30137 79606503
Skin ulcer 13.90 10.70 33 107715 54117 79582523
Vaginal abscess 13.88 10.70 8 107740 404 79636236
Illness 13.88 10.70 109 107639 46402 79590238
Ileocolectomy 13.80 10.70 4 107744 31 79636609
Aspiration 13.76 10.70 5 107743 20153 79616487
Large intestine erosion 13.69 10.70 4 107744 32 79636608
Ejection fraction decreased 13.58 10.70 16 107732 34561 79602079
Pleural effusion 13.58 10.70 128 107620 145134 79491506
Haemophagocytic lymphohistiocytosis 13.55 10.70 62 107686 21775 79614865
Astrovirus test positive 13.54 10.70 3 107745 6 79636634
Acute haemorrhagic ulcerative colitis 13.54 10.70 3 107745 6 79636634
Hypertrophic anal papilla 13.54 10.70 3 107745 6 79636634
Stevens-Johnson syndrome 13.46 10.70 20 107728 39146 79597494
Gastrointestinal infection 13.45 10.70 40 107708 11421 79625219
Myocardial ischaemia 13.40 10.70 9 107739 25510 79611130
Omphalitis 13.34 10.70 5 107743 92 79636548
Sinusitis 13.29 10.70 185 107563 195316 79441324
Vitamin D increased 13.25 10.70 9 107739 608 79636032
Blood potassium increased 13.25 10.70 12 107736 29263 79607377
Rectal discharge 13.24 10.70 10 107738 798 79635842
Emotional distress 13.17 10.70 21 107727 39948 79596692
Arthritis enteropathic 13.15 10.70 7 107741 302 79636338
Metabolic acidosis 13.13 10.70 62 107686 82467 79554173
Respiratory distress 13.11 10.70 38 107710 58301 79578339
Ascites 13.09 10.70 55 107693 75507 79561133
Ophthalmic migraine 13.05 10.70 6 107742 188 79636452
Infection reactivation 13.03 10.70 17 107731 2640 79634000
Gastrointestinal wall thickening 13.03 10.70 17 107731 2640 79634000
Dysphagia 13.03 10.70 104 107644 122032 79514608
Herpes zoster reactivation 12.99 10.70 6 107742 190 79636450
Self-injurious ideation 12.98 10.70 20 107728 3618 79633022
Abortion missed 12.95 10.70 12 107736 1271 79635369
Porphyria acute 12.94 10.70 13 107735 1522 79635118
Drug effect less than expected 12.91 10.70 15 107733 2069 79634571
Duodenal ulcer perforation 12.87 10.70 46 107702 66165 79570475
Drug eruption 12.75 10.70 25 107723 43910 79592730
Enterocolitis bacterial 12.71 10.70 9 107739 650 79635990
Peripheral nerve transposition 12.68 10.70 3 107745 9 79636631
Haemorrhage foetal 12.68 10.70 3 107745 9 79636631
Haematuria 12.62 10.70 49 107699 68787 79567853
Hypothyroidism 12.61 10.70 33 107715 52359 79584281
Epstein-Barr virus associated lymphoma 12.60 10.70 11 107737 1078 79635562
Furuncle 12.55 10.70 30 107718 7524 79629116
Infusion site extravasation 12.55 10.70 36 107712 10072 79626568
Myelosuppression 12.52 10.70 22 107726 40274 79596366
Antibody test abnormal 12.50 10.70 9 107739 667 79635973
Folliculitis 12.50 10.70 36 107712 55344 79581296
Septic shock 12.44 10.70 106 107642 122695 79513945
Hepatic cytolysis 12.44 10.70 11 107737 27140 79609500
Cholestasis 12.41 10.70 33 107715 52076 79584564
Cerebral infarction 12.40 10.70 27 107721 45649 79590991
Idiosyncratic drug reaction 12.38 10.70 12 107736 1345 79635295
Intestinal diaphragm disease 12.34 10.70 7 107741 343 79636297
Campylobacter gastroenteritis 12.32 10.70 12 107736 1353 79635287
Ileal ulcer 12.25 10.70 11 107737 1119 79635521
Unemployment 12.24 10.70 4 107744 48 79636592
Rectal lesion 12.23 10.70 5 107743 117 79636523
Defaecation disorder 12.21 10.70 9 107739 692 79635948
Eosinophilic pneumonia chronic 12.19 10.70 8 107740 510 79636130
Ureterolithiasis 12.15 10.70 20 107728 3828 79632812
Amnesia 12.13 10.70 44 107704 63013 79573627
Large intestine infection 12.13 10.70 18 107730 3151 79633489
Drug level abnormal 12.08 10.70 7 107741 357 79636283
Anastomotic stenosis 12.08 10.70 8 107740 518 79636122
Hepatic encephalopathy 12.06 10.70 9 107739 24157 79612483
Infusion site streaking 12.05 10.70 8 107740 520 79636120
Gastroenteritis clostridial 12.02 10.70 10 107738 918 79635722
Anti-platelet antibody 12.01 10.70 3 107745 12 79636628
Stricturoplasty 12.01 10.70 3 107745 12 79636628
Asthenia 12.00 10.70 567 107181 511122 79125518
Cerebral haemorrhage 11.94 10.70 39 107709 57634 79579006
Transfusion 11.92 10.70 7 107741 21323 79615317
Helicobacter infection 11.91 10.70 51 107697 69653 79566987
Pneumocystis jirovecii infection 11.89 10.70 17 107731 2877 79633763
Migraine 11.88 10.70 175 107573 87318 79549322
Abdominal adhesions 11.86 10.70 19 107729 3554 79633086
Neurotoxicity 11.78 10.70 16 107732 32502 79604138
Hypercholesterolaemia 11.78 10.70 62 107686 23033 79613607
Cerebral venous sinus thrombosis 11.77 10.70 15 107733 2276 79634364
Gastrointestinal bacterial infection 11.77 10.70 10 107738 945 79635695
Selective abortion 11.74 10.70 4 107744 55 79636585
Antinuclear antibody increased 11.71 10.70 11 107737 1186 79635454
Arrhythmia 11.63 10.70 43 107705 61229 79575411
Posterior reversible encephalopathy syndrome 11.62 10.70 11 107737 26270 79610370
Graft versus host disease 11.57 10.70 3 107745 15023 79621617
Polyuria 11.55 10.70 3 107745 15011 79621629
Atrioventricular block complete 11.55 10.70 4 107744 16606 79620034
Red blood cell sedimentation rate abnormal 11.54 10.70 7 107741 20956 79615684
Radiculopathy 11.52 10.70 32 107716 8792 79627848
Skin necrosis 11.51 10.70 5 107743 18082 79618558
IgA nephropathy 11.41 10.70 13 107735 1755 79634885
Gait inability 11.41 10.70 41 107707 58876 79577764
Maternal exposure during pregnancy 11.41 10.70 253 107495 136285 79500355
Transplant rejection 11.41 10.70 6 107742 19431 79617209
Angina pectoris 11.40 10.70 34 107714 51698 79584942
Paranoia 11.40 10.70 6 107742 19426 79617214
Inflammation 11.38 10.70 184 107564 93569 79543071
Intestinal dilatation 11.30 10.70 16 107732 2684 79633956
Type IV hypersensitivity reaction 11.28 10.70 20 107728 4061 79632579
Anal squamous cell carcinoma 11.22 10.70 8 107740 584 79636056
Pharyngeal paraesthesia 11.21 10.70 16 107732 2705 79633935
Product administration error 11.20 10.70 16 107732 31830 79604810
Diffuse large B-cell lymphoma 11.17 10.70 39 107709 12110 79624530
Heart rate increased 11.16 10.70 227 107521 120497 79516143
Gingival pain 11.13 10.70 32 107716 8966 79627674
Aspergillus infection 11.12 10.70 6 107742 19155 79617485
Jaundice 11.09 10.70 36 107712 53313 79583327
Psoriatic arthropathy 11.05 10.70 61 107687 77938 79558702
Mydriasis 11.03 10.70 5 107743 17638 79619002
Mental impairment 10.99 10.70 6 107742 19030 79617610
Intestinal adenocarcinoma 10.96 10.70 6 107742 274 79636366
Product prescribing error 10.96 10.70 28 107720 44785 79591855
Placental transfusion syndrome 10.91 10.70 4 107744 69 79636571
Antineutrophil cytoplasmic antibody positive 10.90 10.70 11 107737 1295 79635345
Mycobacterium tuberculosis complex test positive 10.89 10.70 16 107732 2776 79633864
Headache 10.89 10.70 1025 106723 652747 78983893
Large intestine operation 10.87 10.70 3 107745 19 79636621
Dysuria 10.86 10.70 34 107714 50917 79585723
Shock 10.81 10.70 27 107721 43521 79593119
Cardiac perforation 10.80 10.70 5 107743 159 79636481
Meningitis listeria 10.79 10.70 10 107738 1059 79635581
Second primary malignancy 10.79 10.70 3 107745 14347 79622293
Haemodynamic instability 10.75 10.70 5 107743 17377 79619263
Sleep disorder due to a general medical condition 10.71 10.70 3 107745 14274 79622366
Central nervous system necrosis 10.71 10.70 6 107742 287 79636353
Enterocolitis haemorrhagic 10.70 10.70 14 107734 2180 79634460

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A07EC02 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
INTESTINAL ANTIINFLAMMATORY AGENTS
Aminosalicylic acid and similar agents
FDA CS M0000971 Aminosalicylic Acids
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
FDA EPC N0000175781 Aminosalicylate
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents

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

DiseaseRelationSNOMED_IDDOID
Chronic ulcerative proctitis indication 52231000
Chronic ulcerative rectosigmoiditis indication 52506002
Ulcerative colitis indication 64766004 DOID:8577
Ulcerative colitis in remission indication 697969008
Crohn's disease off-label use 34000006
Interstitial nephritis contraindication 28689008 DOID:1063
Minimal change disease contraindication 44785005 DOID:10966
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409
Pyloric obstruction contraindication 244815007
Anemia contraindication 271737000 DOID:2355
Neutropenic disorder contraindication 303011007 DOID:1227




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 2.74 acidic
pKa2 13.47 acidic
pKa3 5.86 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
375MG APRISO VALEANT PHARMS INTL N022301 Oct. 31, 2008 RX CAPSULE, EXTENDED RELEASE ORAL 8865688 May 1, 2030 FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1.2GM LIALDA TAKEDA PHARMS USA N022000 Jan. 16, 2007 RX TABLET, DELAYED RELEASE ORAL June 26, 2023 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 5.12 CHEMBL CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR WOMBAT-PK CHEMBL
Arachidonate 5-lipoxygenase Enzyme INHIBITOR CHEMBL CHEMBL
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor AGONIST UNKNOWN IUPHAR
Tumor necrosis factor Cytokine IC50 4.70 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 5.11 CHEMBL
Hydroxyacid oxidase 1 Enzyme IC50 5.11 CHEMBL

External reference:

IDSource
4019494 VUID
N0000147614 NUI
D00377 KEGG_DRUG
4019494 VANDF
C0127615 UMLSCUI
CHEBI:6775 CHEBI
CHEMBL704 ChEMBL_ID
DB00244 DRUGBANK_ID
2700 IUPHAR_LIGAND_ID
6291-36-7 SECONDARY_CAS_RN
4075 PUBCHEM_CID
52582 RXNORM
37855 MMSL
37856 MMSL
5056 MMSL
d01031 MMSL
001600 NDDF
387501005 SNOMEDCT_US
86977007 SNOMEDCT_US
D019804 MESH_DESCRIPTOR_UI
5444 INN_ID
4Q81I59GXC UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Delzicol HUMAN PRESCRIPTION DRUG LABEL 1 0023-5853 CAPSULE, DELAYED RELEASE 400 mg ORAL NDA 31 sections
Delzicol HUMAN PRESCRIPTION DRUG LABEL 1 0023-5853 CAPSULE, DELAYED RELEASE 400 mg ORAL NDA 31 sections
Asacol HD HUMAN PRESCRIPTION DRUG LABEL 1 0023-5901 TABLET, DELAYED RELEASE 800 mg ORAL NDA 31 sections
Asacol HD HUMAN PRESCRIPTION DRUG LABEL 1 0023-5901 TABLET, DELAYED RELEASE 800 mg ORAL NDA 31 sections
Asacol HD HUMAN PRESCRIPTION DRUG LABEL 1 0023-5901 TABLET, DELAYED RELEASE 800 mg ORAL NDA 31 sections
sfRowasaSulfite-Free Formulation HUMAN PRESCRIPTION DRUG LABEL 1 0037-0022 SUSPENSION 4 g RECTAL NDA 20 sections
sfRowasaSulfite-Free Formulation HUMAN PRESCRIPTION DRUG LABEL 1 0037-0022 SUSPENSION 4 g RECTAL NDA 20 sections
sfRowasaSulfite-Free Formulation HUMAN PRESCRIPTION DRUG LABEL 1 0037-0022 SUSPENSION 4 g RECTAL NDA 20 sections
Rowasa HUMAN PRESCRIPTION DRUG LABEL 1 0037-0066 SUSPENSION 4 g RECTAL NDA 22 sections
Rowasa HUMAN PRESCRIPTION DRUG LABEL 1 0037-0066 SUSPENSION 4 g RECTAL NDA 22 sections
Rowasa HUMAN PRESCRIPTION DRUG LABEL 1 0037-0066 SUSPENSION 4 g RECTAL NDA 22 sections
Rowasa HUMAN PRESCRIPTION DRUG LABEL 1 0037-0066 SUSPENSION 4 g RECTAL NDA 22 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-5907 CAPSULE, DELAYED RELEASE 400 mg ORAL ANDA 26 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-5907 CAPSULE, DELAYED RELEASE 400 mg ORAL ANDA 26 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-5907 CAPSULE, DELAYED RELEASE 400 mg ORAL ANDA 26 sections
mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-9224 CAPSULE, EXTENDED RELEASE 375 mg ORAL NDA authorized generic 26 sections
mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-9224 CAPSULE, EXTENDED RELEASE 375 mg ORAL NDA authorized generic 26 sections
mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-9224 CAPSULE, EXTENDED RELEASE 375 mg ORAL NDA authorized generic 26 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0378-1375 CAPSULE, EXTENDED RELEASE 0.38 g ORAL ANDA 27 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0378-1375 CAPSULE, EXTENDED RELEASE 0.38 g ORAL ANDA 27 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0378-9230 SUPPOSITORY 1000 mg RECTAL ANDA 28 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0378-9230 SUPPOSITORY 1000 mg RECTAL ANDA 28 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0472-1915 SUPPOSITORY 1000 mg RECTAL ANDA 27 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0472-1915 SUPPOSITORY 1000 mg RECTAL ANDA 27 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0472-1915 SUPPOSITORY 1000 mg RECTAL ANDA 27 sections
MESALAMINE HUMAN PRESCRIPTION DRUG LABEL 1 0527-3012 TABLET, DELAYED RELEASE 1.20 g ORAL ANDA 29 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0591-2245 TABLET, DELAYED RELEASE 1.20 g ORAL ANDA 25 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0591-2245 TABLET, DELAYED RELEASE 1.20 g ORAL ANDA 25 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0591-2245 TABLET, DELAYED RELEASE 1.20 g ORAL ANDA 25 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0781-7088 SUPPOSITORY 1000 mg RECTAL ANDA 26 sections