mesalazine 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) 1 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 7 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 447.77 ┬ÁM/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 3253.76 10.69 1079 49654 19982 53278351
Haematochezia 649.06 10.69 438 50295 41920 53256413
Crohn's disease 628.84 10.69 238 50495 6512 53291821
Off label use 522.05 10.69 1285 49448 470927 52827406
Frequent bowel movements 516.51 10.69 259 50474 14153 53284180
Diarrhoea haemorrhagic 281.90 10.69 144 50589 8176 53290157
Abdominal pain 273.39 10.69 689 50044 255214 53043119
Rectal haemorrhage 257.08 10.69 253 50480 41228 53257105
Product use issue 243.01 10.69 458 50275 139126 53159207
Condition aggravated 238.86 10.69 721 50012 296413 53001920
Faecal calprotectin increased 220.68 10.69 81 50652 2027 53296306
Colitis 213.24 10.69 229 50504 41323 53257010
Inappropriate schedule of product administration 201.74 10.69 299 50434 74579 53223754
Mucous stools 188.94 10.69 80 50653 2946 53295387
Clostridium difficile infection 172.54 10.69 170 50563 27723 53270610
Lupus-like syndrome 164.64 10.69 105 50628 9107 53289226
Macular degeneration 150.08 10.69 111 50622 12250 53286083
Therapeutic reaction time decreased 149.34 10.69 54 50679 1293 53297040
Product residue present 146.81 10.69 74 50659 4082 53294251
Intestinal stenosis 141.19 10.69 63 50670 2638 53295695
Exposure during pregnancy 141.16 10.69 344 50389 124516 53173817
Drug level below therapeutic 136.37 10.69 68 50665 3665 53294668
Inflammatory bowel disease 132.74 10.69 67 50666 3706 53294627
Death 128.14 10.69 92 50641 357140 52941193
Fistula 122.18 10.69 86 50647 8784 53289549
Toxicity to various agents 113.42 10.69 34 50699 219564 53078769
Completed suicide 107.06 10.69 6 50727 138195 53160138
Defaecation urgency 105.54 10.69 54 50679 3074 53295259
Premature labour 102.98 10.69 89 50644 12273 53286060
Blood pressure fluctuation 101.77 10.69 146 50587 35324 53263009
Large intestinal stenosis 100.02 10.69 44 50689 1780 53296553
Drug ineffective 99.38 10.69 1198 49535 816047 52482286
Rheumatoid arthritis 99.06 10.69 92 50641 314439 52983894
Proctitis 95.62 10.69 44 50689 1981 53296352
Intentional product use issue 91.94 10.69 209 50524 72285 53226048
Pancreatitis 84.61 10.69 155 50578 45987 53252346
Pregnancy 82.37 10.69 124 50609 31317 53267016
Intestinal obstruction 79.09 10.69 116 50617 28625 53269708
Anal fistula 78.01 10.69 43 50690 2848 53295485
Therapeutic response shortened 76.13 10.69 59 50674 6980 53291353
Erythema nodosum 75.94 10.69 48 50685 4097 53294236
Gastrointestinal inflammation 72.77 10.69 49 50684 4657 53293676
Diarrhoea 69.29 10.69 902 49831 624644 52673689
Anal abscess 68.27 10.69 44 50689 3884 53294449
Rectal tenesmus 66.79 10.69 23 50710 475 53297858
Organising pneumonia 66.09 10.69 48 50685 5148 53293185
Female genital tract fistula 64.54 10.69 43 50690 4015 53294318
Incorrect dose administered 63.41 10.69 146 50587 50899 53247434
Fall 61.71 10.69 158 50575 358282 52940051
Contraindicated product administered 61.44 10.69 26 50707 135603 53162730
Drug level decreased 58.92 10.69 50 50683 6724 53291609
Drug specific antibody present 58.70 10.69 38 50695 3380 53294953
Poor venous access 54.72 10.69 57 50676 9918 53288415
Segmental diverticular colitis 54.68 10.69 15 50718 138 53298195
Loss of therapeutic response 53.38 10.69 15 50718 152 53298181
Ileal stenosis 53.22 10.69 27 50706 1509 53296824
Pyoderma gangrenosum 52.11 10.69 34 50699 3065 53295268
Pemphigus 52.06 10.69 17 50716 104014 53194319
Cytomegalovirus colitis 51.78 10.69 29 50704 1981 53296352
Small intestinal obstruction 51.27 10.69 72 50661 17075 53281258
Infusion related reaction 50.97 10.69 287 50446 155670 53142663
Myocarditis 49.37 10.69 50 50683 8418 53289915
Pedal pulse abnormal 49.12 10.69 14 50719 150 53298183
Drug interaction 47.43 10.69 85 50648 219244 53079089
Arthropathy 47.32 10.69 39 50694 141414 53156919
Anal cancer 45.06 10.69 17 50716 460 53297873
Eosinophilic pneumonia 43.91 10.69 27 50706 2195 53296138
Acute kidney injury 43.57 10.69 112 50621 253756 53044577
Abortion spontaneous 42.86 10.69 119 50614 46516 53251817
Cytomegalovirus infection 42.79 10.69 71 50662 19468 53278865
Synovitis 42.36 10.69 25 50708 107868 53190465
Calcium ionised decreased 41.79 10.69 14 50719 265 53298068
Swelling 41.36 10.69 74 50659 191031 53107302
Malignant neoplasm progression 40.86 10.69 9 50724 71532 53226801
Abnormal faeces 40.53 10.69 34 50699 4500 53293833
Febrile neutropenia 40.24 10.69 25 50708 104911 53193422
Glossodynia 39.71 10.69 23 50710 100268 53198065
Anal stenosis 39.45 10.69 14 50719 317 53298016
Colectomy total 38.41 10.69 11 50722 120 53298213
Anal fissure 38.34 10.69 28 50705 3028 53295305
Product administered to patient of inappropriate age 37.90 10.69 27 50706 2809 53295524
Proctalgia 37.90 10.69 35 50698 5261 53293072
Colectomy 37.10 10.69 24 50709 2132 53296201
Confusional state 37.04 10.69 81 50652 194140 53104193
Ileostomy 36.14 10.69 19 50714 1144 53297189
Neutropenia 35.94 10.69 60 50673 159125 53139208
Abscess 35.80 10.69 57 50676 15099 53283234
Hand deformity 35.72 10.69 18 50715 84831 53213502
Acute febrile neutrophilic dermatosis 35.09 10.69 26 50707 2875 53295458
Heart rate irregular 34.27 10.69 66 50667 20318 53278015
Rectal abscess 34.20 10.69 18 50715 1086 53297247
Subcutaneous abscess 34.20 10.69 33 50700 5241 53293092
Blood creatinine increased 34.11 10.69 18 50715 82644 53215689
Weight decreased 33.91 10.69 357 50376 234591 53063742
Flatulence 33.61 10.69 85 50648 31432 53266901
Intentional overdose 33.58 10.69 11 50722 67194 53231139
Steroid dependence 33.31 10.69 12 50721 284 53298049
Small intestinal stenosis 32.94 10.69 14 50719 520 53297813
Feeding intolerance 32.77 10.69 14 50719 527 53297806
Drug level above therapeutic 31.80 10.69 28 50705 3956 53294377
Stomatitis 31.67 10.69 28 50705 98130 53200203
Atrial fibrillation 31.29 10.69 36 50697 111616 53186717
Cardiac arrest 31.10 10.69 26 50707 93641 53204692
Coma 31.07 10.69 10 50723 61773 53236560
Abdominal pain lower 30.98 10.69 69 50664 23524 53274809
Proctitis ulcerative 30.87 10.69 11 50722 252 53298081
Pyrexia 30.69 10.69 546 50187 402647 52895686
Papilloma viral infection 30.67 10.69 18 50715 1344 53296989
Foetal death 30.58 10.69 41 50692 9306 53289027
Intestinal fistula 30.50 10.69 15 50718 784 53297549
Intestinal resection 30.40 10.69 22 50711 2346 53295987
Retinitis 29.89 10.69 17 50716 1196 53297137
Listeriosis 29.89 10.69 18 50715 1409 53296924
Iron deficiency anaemia 29.82 10.69 59 50674 18521 53279812
Hypotension 29.33 10.69 133 50600 253943 53044390
Cardiac failure congestive 29.28 10.69 27 50706 92730 53205603
Abdominal distension 28.85 10.69 151 50582 79639 53218694
C-reactive protein increased 28.46 10.69 134 50599 67752 53230581
Rectal stenosis 27.60 10.69 9 50724 156 53298177
Joint swelling 27.58 10.69 122 50611 234516 53063817
Drug abuse 27.43 10.69 14 50719 65512 53232821
Dyspnoea 27.35 10.69 393 50340 585839 52712494
Hypoglycaemia 27.21 10.69 11 50722 59002 53239331
Platelet count decreased 27.02 10.69 38 50695 108061 53190272
Abscess intestinal 26.87 10.69 17 50716 1453 53296880
Overdose 26.81 10.69 38 50695 107698 53190635
Rectal ulcer 26.55 10.69 16 50717 1254 53297079
Enteritis 26.43 10.69 34 50699 7412 53290921
Delirium 26.26 10.69 4 50729 41425 53256908
Pain 26.22 10.69 398 50335 588000 52710333
Large intestinal ulcer 26.20 10.69 23 50710 3236 53295097
Lipase increased 26.01 10.69 38 50695 9340 53288993
Anorectal discomfort 25.96 10.69 20 50713 2345 53295988
Intestinal anastomosis 25.69 10.69 10 50723 295 53298038
Intestinal mucosal hypertrophy 25.11 10.69 9 50724 210 53298123
Cardiac failure 24.79 10.69 27 50706 85817 53212516
Cerebrovascular accident 24.32 10.69 39 50694 105135 53193198
Caesarean section 24.27 10.69 52 50681 17268 53281065
Abdominal abscess 24.02 10.69 25 50708 4345 53293988
Insomnia 24.00 10.69 94 50639 186978 53111355
Cardio-respiratory arrest 23.94 10.69 13 50720 58745 53239588
Skin warm 23.88 10.69 27 50706 5150 53293183
Appendicitis 23.87 10.69 31 50702 6823 53291510
Pyoderma 23.84 10.69 9 50724 244 53298089
Somnolence 23.68 10.69 81 50652 167653 53130680
Type IV hypersensitivity reaction 23.68 10.69 20 50713 2672 53295661
Enterocutaneous fistula 23.64 10.69 15 50718 1289 53297044
Hyperkalaemia 23.61 10.69 11 50722 54245 53244088
Impaired quality of life 23.49 10.69 26 50707 4845 53293488
Vaginal flatulence 23.24 10.69 9 50724 262 53298071
Neuropathy peripheral 23.18 10.69 39 50694 103148 53195185
Peripheral swelling 23.12 10.69 109 50624 205999 53092334
Eosinophilic pleural effusion 23.08 10.69 6 50727 44 53298289
Intestinal dilatation 22.83 10.69 16 50717 1622 53296711
Hepatitis infectious mononucleosis 22.79 10.69 7 50726 99 53298234
Tubulointerstitial nephritis 22.49 10.69 49 50684 16455 53281878
Target skin lesion 22.47 10.69 7 50726 104 53298229
Thrombocytopenia 22.41 10.69 63 50670 138664 53159669
Electrocardiogram QT prolonged 22.23 10.69 13 50720 56390 53241943
Infrequent bowel movements 22.16 10.69 14 50719 1194 53297139
Intestinal ulcer 21.87 10.69 14 50719 1221 53297112
Neonatal gastrointestinal haemorrhage 21.60 10.69 4 50729 3 53298330
Signet-ring cell carcinoma 21.60 10.69 4 50729 3 53298330
Bladder trabeculation 21.52 10.69 6 50727 59 53298274
Vein rupture 21.36 10.69 12 50721 825 53297508
White blood cell count decreased 21.25 10.69 55 50678 124420 53173913
Herpes simplex hepatitis 21.16 10.69 9 50724 335 53297998
Drug specific antibody 20.96 10.69 15 50718 1572 53296761
Gastrointestinal sounds abnormal 20.96 10.69 22 50711 3862 53294471
Hyponatraemia 20.93 10.69 45 50688 108562 53189771
Femur fracture 20.64 10.69 6 50727 39579 53258754
Nephritis bacterial 20.54 10.69 5 50728 27 53298306
Oropharyngeal pain 20.51 10.69 140 50593 81128 53217205
Abdominal tenderness 20.44 10.69 31 50702 7876 53290457
Plasma cell myeloma 20.38 10.69 10 50723 47864 53250469
Helicobacter infection 20.22 10.69 6 50727 39063 53259270
Arthralgia 20.17 10.69 554 50179 439229 52859104
Faeces soft 20.15 10.69 22 50711 4037 53294296
Pulmonary tuberculosis 20.08 10.69 24 50709 4857 53293476
Clostridium test positive 19.76 10.69 17 50716 2329 53296004
Injection site papule 19.67 10.69 11 50722 749 53297584
Eosinophilic pneumonia chronic 19.66 10.69 7 50726 160 53298173
Bacillus infection 19.61 10.69 10 50723 565 53297768
Body temperature fluctuation 19.56 10.69 16 50717 2045 53296288
Lupus hepatitis 19.56 10.69 5 50728 34 53298299
Campylobacter infection 19.49 10.69 11 50722 763 53297570
Pus in stool 19.43 10.69 5 50728 35 53298298
Cryptosporidiosis infection 19.14 10.69 8 50725 285 53298048
Anal incontinence 18.91 10.69 39 50694 12608 53285725
Listeria sepsis 18.68 10.69 10 50723 625 53297708
Seizure 18.64 10.69 62 50671 129447 53168886
Pouchitis 18.49 10.69 9 50724 460 53297873
Haemorrhage 18.44 10.69 106 50627 57881 53240452
Multiple sclerosis relapse 18.16 10.69 10 50723 44843 53253490
Asthma 17.96 10.69 49 50684 108923 53189410
Drug intolerance 17.95 10.69 118 50615 205375 53092958
Infectious mononucleosis 17.89 10.69 14 50719 1679 53296654
Multisystem inflammatory syndrome in children 17.88 10.69 3 50730 0 53298333
Hypoxia 17.82 10.69 16 50717 55664 53242669
Knee arthroplasty 17.66 10.69 5 50728 33564 53264769
Respiratory arrest 17.64 10.69 5 50728 33535 53264798
Anti-cyclic citrullinated peptide antibody positive 17.62 10.69 17 50716 57155 53241178
Takayasu's arteritis 17.62 10.69 4 50729 15 53298318
Self-injurious ideation 17.47 10.69 16 50717 2380 53295953
Perirectal abscess 17.34 10.69 11 50722 945 53297388
Arthritis enteropathic 17.28 10.69 7 50726 230 53298103
Pulmonary hypertension 17.10 10.69 7 50726 37263 53261070
Lactic acidosis 17.08 10.69 7 50726 37246 53261087
Depressed level of consciousness 16.99 10.69 16 50717 54412 53243921
Hepatocellular injury 16.67 10.69 4 50729 29982 53268351
Anal squamous cell carcinoma 16.58 10.69 8 50725 401 53297932
Muscle injury 16.49 10.69 4 50729 29762 53268571
Central nervous system necrosis 16.42 10.69 6 50727 148 53298185
Sedation 16.41 10.69 4 50729 29671 53268662
Oral administration complication 16.27 10.69 6 50727 152 53298181
Epstein-Barr virus test positive 16.24 10.69 9 50724 602 53297731
Type 2 diabetes mellitus 16.15 10.69 5 50728 31665 53266668
Balance disorder 16.13 10.69 28 50705 73179 53225154
Ill-defined disorder 16.07 10.69 14 50719 49430 53248903
Gastrointestinal stoma complication 16.02 10.69 13 50720 1643 53296690
Chromaturia 15.95 10.69 42 50691 15908 53282425
Ileocolectomy 15.80 10.69 4 50729 26 53298307
Unresponsive to stimuli 15.79 10.69 6 50727 33420 53264913
Diabetes mellitus 15.51 10.69 17 50716 53882 53244451
Malignant splenic neoplasm 15.34 10.69 3 50730 4 53298329
Tuberculosis 15.23 10.69 33 50700 11038 53287295
Drug withdrawal syndrome 15.07 10.69 4 50729 28018 53270315
Nephrolithiasis 15.01 10.69 72 50661 36675 53261658
Tremor 14.98 10.69 65 50668 125671 53172662
Pneumonia 14.97 10.69 285 50448 406884 52891449
Fluid overload 14.91 10.69 4 50729 27827 53270506
Vaginal abscess 14.89 10.69 7 50726 331 53298002
Intentional product misuse 14.86 10.69 15 50718 49377 53248956
Hyperglycaemia 14.75 10.69 10 50723 40074 53258259
Chronic obstructive pulmonary disease 14.74 10.69 22 50711 61051 53237282
Colon dysplasia 14.56 10.69 4 50729 37 53298296
Anorectal disorder 14.39 10.69 12 50721 1575 53296758
Gastrointestinal obstruction 14.37 10.69 10 50723 1002 53297331
Small intestine carcinoma 14.32 10.69 7 50726 361 53297972
Faecal calprotectin abnormal 14.28 10.69 4 50729 40 53298293
Abdominal discomfort 14.19 10.69 138 50595 220924 53077409
Megacolon 14.08 10.69 13 50720 1953 53296380
Abdominal adhesions 14.06 10.69 16 50717 3074 53295259
Endometriosis 14.04 10.69 19 50714 4350 53293983
Encephalitis cytomegalovirus 14.03 10.69 8 50725 566 53297767
Glutamate dehydrogenase level abnormal 13.73 10.69 3 50730 9 53298324
Small intestinal resection 13.72 10.69 7 50726 396 53297937
Epistaxis 13.63 10.69 28 50705 68682 53229651
Pancreatitis acute 13.58 10.69 55 50678 26054 53272279
Abortion missed 13.43 10.69 12 50721 1729 53296604
Device dislocation 13.41 10.69 3 50730 23594 53274739
Heart rate decreased 13.40 10.69 70 50663 36877 53261456
Plasmablastic lymphoma 13.36 10.69 6 50727 255 53298078
Pseudopolyp 13.34 10.69 6 50727 256 53298077
Agitation 13.31 10.69 22 50711 58604 53239729
Rectal spasm 13.19 10.69 4 50729 54 53298279
Neoplasm progression 13.12 10.69 6 50727 29913 53268420
Blood iron decreased 13.05 10.69 33 50700 12195 53286138
Hypoaesthesia 13.04 10.69 188 50545 132807 53165526
Cytomegalovirus enterocolitis 13.02 10.69 8 50725 649 53297684
Thyroiditis subacute 12.92 10.69 6 50727 276 53298057
Cholangitis sclerosing 12.91 10.69 10 50723 1181 53297152
Retroperitoneal abscess 12.86 10.69 5 50728 147 53298186
Portal fibrosis 12.72 10.69 6 50727 286 53298047
Chills 12.68 10.69 154 50579 104694 53193639
Myocardial infarction 12.68 10.69 50 50683 99304 53199029
Pelvic abscess 12.67 10.69 11 50722 1525 53296808
Bacterial vulvovaginitis 12.63 10.69 8 50725 685 53297648
Acute myocardial infarction 12.62 10.69 8 50725 33227 53265106
Iron deficiency 12.61 10.69 22 50711 6278 53292055
Systemic lupus erythematosus 12.53 10.69 69 50664 125345 53172988
Meningitis listeria 12.34 10.69 7 50726 490 53297843
Fistula discharge 12.21 10.69 9 50724 987 53297346
Hypercalcaemia 12.13 10.69 4 50729 24344 53273989
Large intestinal obstruction 12.09 10.69 12 50721 1971 53296362
Purulent discharge 12.05 10.69 19 50714 4991 53293342
Hypertension 11.96 10.69 147 50586 225284 53073049
Renal failure 11.93 10.69 65 50668 118387 53179946
Mental status changes 11.92 10.69 12 50721 39559 53258774
Depression 11.86 10.69 114 50619 182938 53115395
Antineutrophil cytoplasmic antibody positive 11.84 10.69 7 50726 530 53297803
Abdominal pain upper 11.83 10.69 223 50510 166068 53132265
Gastric disorder 11.82 10.69 7 50726 30158 53268175
Loss of personal independence in daily activities 11.80 10.69 31 50702 69784 53228549
Disseminated cytomegaloviral infection 11.78 10.69 5 50728 185 53298148
Speech disorder 11.67 10.69 12 50721 39169 53259164
Dyskinesia 11.63 10.69 8 50725 31825 53266508
Hip arthroplasty 11.59 10.69 6 50727 27856 53270477
Antinuclear antibody positive 11.58 10.69 22 50711 6703 53291630
Retinal vein occlusion 11.57 10.69 12 50721 2076 53296257
Pneumoretroperitoneum 11.54 10.69 3 50730 22 53298311
Lower respiratory tract infection 11.48 10.69 46 50687 90935 53207398
Red blood cell sedimentation rate increased 11.48 10.69 55 50678 28002 53270331
Metabolic acidosis 11.42 10.69 14 50719 42228 53256105
Enterocolitis bacterial 11.42 10.69 5 50728 200 53298133
Small intestinal perforation 11.34 10.69 10 50723 1415 53296918
Malignant anorectal neoplasm 11.31 10.69 3 50730 24 53298309
White blood cell count increased 11.27 10.69 79 50654 46166 53252167
Blood glucose increased 11.15 10.69 37 50696 77324 53221009
Gastrointestinal oedema 11.13 10.69 9 50724 1131 53297202
Pleurisy 11.12 10.69 24 50709 8007 53290326
Psoriatic arthropathy 11.01 10.69 18 50715 48172 53250161
Clostridial infection 11.01 10.69 17 50716 4385 53293948
Antinuclear antibody increased 10.98 10.69 9 50724 1153 53297180
Lymphocyte stimulation test positive 10.90 10.69 7 50726 614 53297719
Sleep disorder 10.84 10.69 25 50708 58845 53239488
Gastrointestinal scarring 10.83 10.69 5 50728 227 53298106
Pneumonia aspiration 10.80 10.69 10 50723 34291 53264042
Haemorrhagic diathesis 10.79 10.69 17 50716 4461 53293872
Ileal perforation 10.75 10.69 6 50727 407 53297926

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 3001.02 11.74 1033 39965 16018 32456510
Frequent bowel movements 638.90 11.74 287 40711 9165 32463363
Off label use 547.85 11.74 1194 39804 305126 32167402
Haematochezia 544.81 11.74 427 40571 38781 32433747
Crohn's disease 461.43 11.74 182 40816 4163 32468365
Colitis 439.95 11.74 355 40643 33596 32438932
Condition aggravated 296.25 11.74 624 40374 155037 32317491
Product use issue 295.20 11.74 348 40650 52429 32420099
Blood pressure fluctuation 253.16 11.74 207 40791 19928 32452600
Inappropriate schedule of product administration 231.43 11.74 287 40711 45538 32426990
Death 212.94 11.74 109 40889 382408 32090120
Drug ineffective 191.04 11.74 969 40029 382508 32090020
Clostridium difficile infection 182.90 11.74 163 40835 17633 32454895
Abdominal pain 180.32 11.74 503 40495 149026 32323502
Myocarditis 166.71 11.74 129 40869 11461 32461067
Faecal calprotectin increased 163.50 11.74 63 40935 1349 32471179
Infusion related reaction 159.41 11.74 239 40759 45360 32427168
Drug level below therapeutic 145.38 11.74 81 40917 4114 32468414
Anal abscess 141.28 11.74 88 40910 5502 32467026
Intentional product use issue 140.11 11.74 216 40782 41995 32430533
Rectal haemorrhage 139.21 11.74 202 40796 37221 32435307
Cytomegalovirus colitis 137.47 11.74 67 40931 2575 32469953
Diarrhoea haemorrhagic 137.34 11.74 90 40908 6145 32466383
Defaecation urgency 131.37 11.74 57 40941 1668 32470860
Weight decreased 128.85 11.74 478 40520 164340 32308188
Inflammatory bowel disease 128.45 11.74 63 40935 2455 32470073
Mucous stools 128.08 11.74 50 40948 1110 32471418
Drug specific antibody present 117.63 11.74 59 40939 2414 32470114
Product residue present 107.56 11.74 58 40940 2760 32469768
Anal fistula 105.35 11.74 67 40931 4344 32468184
Cholangitis sclerosing 104.38 11.74 42 40956 1012 32471516
Large intestinal stenosis 102.39 11.74 45 40953 1359 32471169
Intestinal stenosis 96.08 11.74 48 40950 1947 32470581
Impaired quality of life 94.08 11.74 50 40948 2310 32470218
Toxicity to various agents 93.91 11.74 54 40944 177987 32294541
Ileal stenosis 93.88 11.74 41 40957 1219 32471309
Therapeutic reaction time decreased 85.81 11.74 32 40966 624 32471904
Gastrointestinal inflammation 85.23 11.74 52 40946 3132 32469396
Night sweats 84.72 11.74 103 40895 15985 32456543
Drug level decreased 84.62 11.74 68 40930 6378 32466150
Pulmonary tuberculosis 81.64 11.74 60 40938 4929 32467599
Small intestinal stenosis 81.14 11.74 28 40970 432 32472096
Fall 77.43 11.74 80 40918 196121 32276407
Completed suicide 75.27 11.74 13 40985 92504 32380024
Acute kidney injury 71.49 11.74 166 40832 293302 32179226
Hypotension 70.63 11.74 102 40896 216008 32256520
Blood pressure increased 69.39 11.74 239 40759 79115 32393413
Hepatosplenic T-cell lymphoma 68.44 11.74 25 40973 459 32472069
Fistula 68.12 11.74 56 40942 5423 32467105
Disseminated tuberculosis 66.65 11.74 39 40959 2175 32470353
Steroid dependence 66.21 11.74 19 40979 153 32472375
Pericarditis 64.60 11.74 69 40929 9304 32463224
Loss of therapeutic response 63.25 11.74 20 40978 231 32472297
Proctalgia 63.20 11.74 50 40948 4584 32467944
Therapeutic product effect decreased 62.97 11.74 128 40870 30889 32441639
Therapeutic response shortened 62.39 11.74 50 40948 4670 32467858
Eosinophilic pneumonia 61.58 11.74 42 40956 3064 32469464
Intestinal fistula 59.89 11.74 27 40971 867 32471661
Rectal tenesmus 58.42 11.74 24 40974 611 32471917
Myocardial infarction 58.25 11.74 44 40954 125632 32346896
Tubulointerstitial nephritis 57.77 11.74 95 40903 19482 32453046
Platelet count decreased 57.23 11.74 37 40961 114554 32357974
Intestinal obstruction 56.16 11.74 97 40901 20701 32451827
Vitamin D deficiency 55.87 11.74 52 40946 5942 32466586
Confusional state 55.68 11.74 59 40939 143056 32329472
Febrile neutropenia 55.23 11.74 42 40956 119524 32353004
Proctitis 54.01 11.74 35 40963 2343 32470185
Heart rate irregular 53.78 11.74 77 40921 14001 32458527
Pyrexia 53.50 11.74 627 40371 319341 32153187
Small intestinal obstruction 53.28 11.74 77 40921 14119 32458409
Somnolence 52.53 11.74 33 40965 103764 32368764
Incorrect dose administered 52.45 11.74 128 40870 34900 32437628
Drug abuse 52.19 11.74 18 40980 80225 32392303
Intestinal perforation 51.97 11.74 60 40938 8815 32463713
Renal failure 51.69 11.74 56 40942 134422 32338106
Cardiac arrest 51.46 11.74 29 40969 96747 32375781
Diarrhoea 50.43 11.74 690 40308 364112 32108416
Malignant neoplasm progression 50.38 11.74 18 40980 78478 32394050
Abdominal abscess 50.10 11.74 42 40956 4179 32468349
Cardiac failure congestive 48.72 11.74 23 40975 84829 32387699
Hyperkalaemia 48.29 11.74 14 40984 69736 32402792
Colectomy 48.02 11.74 28 40970 1551 32470977
Bronchiectasis 45.61 11.74 50 40948 6942 32465586
Neutropenia 45.51 11.74 68 40930 142107 32330421
Heart rate decreased 44.20 11.74 98 40900 25102 32447426
Pouchitis 43.66 11.74 20 40978 667 32471861
C-reactive protein decreased 43.61 11.74 27 40971 1669 32470859
Drug interaction 43.54 11.74 136 40862 218049 32254479
Cytomegalovirus infection 43.51 11.74 98 40900 25366 32447162
Haemophagocytic lymphohistiocytosis 43.30 11.74 62 40936 11273 32461255
Drug specific antibody 42.57 11.74 15 40983 247 32472281
Weight increased 41.59 11.74 212 40786 83451 32389077
Pancreatitis 41.59 11.74 124 40874 38027 32434501
Pseudopolyp 37.77 11.74 13 40985 199 32472329
Drug level above therapeutic 37.64 11.74 32 40966 3246 32469282
Perirectal abscess 37.33 11.74 24 40974 1585 32470943
Rectal abscess 36.32 11.74 20 40978 992 32471536
Histoplasmosis 36.19 11.74 22 40976 1316 32471212
Hypoglycaemia 35.70 11.74 12 40986 54370 32418158
Lupus-like syndrome 35.66 11.74 27 40971 2320 32470208
Cardio-respiratory arrest 35.64 11.74 13 40985 55976 32416552
Plasma cell myeloma 35.64 11.74 14 40984 57600 32414928
Clostridium difficile colitis 35.03 11.74 64 40934 14267 32458261
Chronic gastrointestinal bleeding 33.92 11.74 13 40985 274 32472254
Gastrointestinal anastomotic leak 33.87 11.74 14 40984 362 32472166
Erythema nodosum 33.19 11.74 19 40979 1016 32471512
Enteritis 32.68 11.74 43 40955 7218 32465310
Coma 32.49 11.74 7 40991 42605 32429923
Cardiac failure 31.14 11.74 42 40956 91631 32380897
Cytomegalovirus enteritis 31.13 11.74 14 40984 447 32472081
Aggression 31.01 11.74 6 40992 39383 32433145
Organising pneumonia 30.93 11.74 37 40961 5644 32466884
Arthralgia 30.77 11.74 304 40694 148144 32324384
Anal fissure 30.57 11.74 27 40971 2882 32469646
B-cell lymphoma 30.07 11.74 33 40965 4586 32467942
Therapeutic product effect incomplete 29.77 11.74 117 40881 41224 32431304
Campylobacter infection 29.75 11.74 16 40982 757 32471771
Gastrointestinal disorder 29.51 11.74 96 40902 30835 32441693
Intentional overdose 29.44 11.74 8 40990 41593 32430935
Disease progression 29.30 11.74 40 40958 86822 32385706
Oedema peripheral 28.92 11.74 63 40935 114028 32358500
Periumbilical abscess 28.73 11.74 8 40990 57 32472471
Dyschezia 28.62 11.74 19 40979 1325 32471203
Abdominal adhesions 28.38 11.74 19 40979 1344 32471184
Pancreatitis acute 28.05 11.74 87 40911 27248 32445280
Proctitis ulcerative 28.03 11.74 8 40990 63 32472465
Pyoderma gangrenosum 27.84 11.74 18 40980 1200 32471328
Short-bowel syndrome 27.69 11.74 11 40987 256 32472272
Poor venous access 27.42 11.74 26 40972 3040 32469488
Listeriosis 26.63 11.74 16 40982 937 32471591
Mucosal inflammation 26.52 11.74 5 40993 33429 32439099
Narcotic bowel syndrome 26.50 11.74 9 40989 132 32472396
Eosinophilic colitis 26.31 11.74 10 40988 206 32472322
Tuberculous pleurisy 26.28 11.74 12 40986 397 32472131
Drug intolerance 26.15 11.74 129 40869 50106 32422422
Ileostomy 26.05 11.74 13 40985 526 32472002
Iron deficiency anaemia 25.86 11.74 45 40953 9656 32462872
Philadelphia positive chronic myeloid leukaemia 25.65 11.74 8 40990 88 32472440
Abnormal faeces 25.44 11.74 25 40973 3055 32469473
C-reactive protein increased 25.38 11.74 124 40874 47978 32424550
Acne 25.36 11.74 46 40952 10196 32462332
Agitation 25.28 11.74 21 40977 57215 32415313
Hallucination 24.90 11.74 18 40980 52601 32419927
Ileal ulcer 24.87 11.74 13 40985 580 32471948
Rhabdomyolysis 24.73 11.74 29 40969 67236 32405292
Gastrointestinal mucosa hyperaemia 24.58 11.74 10 40988 248 32472280
Intestinal diaphragm disease 24.25 11.74 10 40988 257 32472271
Mental status changes 24.23 11.74 9 40989 38328 32434200
International normalised ratio increased 24.23 11.74 16 40982 49019 32423509
Flatulence 24.09 11.74 66 40932 19289 32453239
Urinary tract infection 23.98 11.74 40 40958 80031 32392497
Thrombocytopenia 23.88 11.74 101 40897 148198 32324330
Neutrophil count decreased 23.81 11.74 15 40983 47124 32425404
Infection reactivation 23.78 11.74 16 40982 1141 32471387
Delirium 23.68 11.74 13 40985 44033 32428495
Congenital hiatus hernia 23.65 11.74 10 40988 274 32472254
Respiratory arrest 23.63 11.74 4 40994 28904 32443624
Dyspnoea 23.41 11.74 319 40679 361726 32110802
Large intestinal ulcer 23.30 11.74 19 40979 1819 32470709
Gastroenteritis clostridial 23.22 11.74 10 40988 287 32472241
Blood urea increased 23.22 11.74 6 40992 32267 32440261
Abscess 22.86 11.74 45 40953 10605 32461923
Meningitis listeria 22.83 11.74 11 40987 412 32472116
Irritable bowel syndrome 22.73 11.74 24 40974 3193 32469335
Abscess intestinal 22.40 11.74 17 40981 1466 32471062
Flushing 22.33 11.74 88 40910 31039 32441489
Pneumonia 22.26 11.74 315 40683 354937 32117591
Depressed level of consciousness 22.04 11.74 12 40986 40835 32431693
Pulmonary oedema 21.66 11.74 16 40982 46251 32426277
Hyperglycaemia 21.13 11.74 11 40987 38380 32434148
Acute myocardial infarction 21.12 11.74 23 40975 55126 32417402
Coronary artery disease 21.02 11.74 19 40979 49687 32422841
Lactic acidosis 20.98 11.74 8 40990 33528 32439000
Pelvic abscess 20.94 11.74 14 40984 988 32471540
Enteritis infectious 20.90 11.74 16 40982 1397 32471131
Rectal stenosis 20.81 11.74 8 40990 170 32472358
T-cell lymphoma 20.69 11.74 14 40984 1008 32471520
Subileus 20.67 11.74 23 40975 3245 32469283
Campylobacter gastroenteritis 20.50 11.74 13 40985 838 32471690
Atrial fibrillation 20.35 11.74 77 40921 116627 32355901
Intestinal ulcer 20.25 11.74 13 40985 856 32471672
Epstein-Barr virus test positive 20.25 11.74 11 40987 531 32471997
Body temperature fluctuation 20.12 11.74 16 40982 1478 32471050
Dyskinesia 19.89 11.74 3 40995 23600 32448928
Overgrowth bacterial 19.77 11.74 7 40991 117 32472411
Small intestine adenocarcinoma 19.50 11.74 7 40991 122 32472406
Calcinosis 19.38 11.74 12 40986 742 32471786
Drug hypersensitivity 19.11 11.74 158 40840 73242 32399286
Angioedema 19.09 11.74 11 40987 36278 32436250
Intestinal anastomosis complication 18.94 11.74 7 40991 133 32472395
Abdominal distension 18.88 11.74 120 40878 51175 32421353
Anorectal discomfort 18.86 11.74 17 40981 1863 32470665
Encephalopathy 18.58 11.74 10 40988 34247 32438281
Gastrooesophageal sphincter insufficiency 18.54 11.74 6 40992 75 32472453
Intestinal mucosal hypertrophy 18.54 11.74 6 40992 75 32472453
Blood creatine phosphokinase increased 18.51 11.74 18 40980 45458 32427070
Large intestine perforation 18.24 11.74 35 40963 8095 32464433
Enterocutaneous fistula 18.14 11.74 12 40986 832 32471696
Intestinal resection 17.94 11.74 15 40983 1487 32471041
Seizure 17.79 11.74 69 40929 103785 32368743
Calcium deficiency 17.70 11.74 7 40991 161 32472367
Cardiac perforation 17.42 11.74 6 40992 92 32472436
Respiratory failure 17.24 11.74 73 40925 107109 32365419
Fluid retention 17.17 11.74 6 40992 26544 32445984
Cerebrovascular accident 17.03 11.74 54 40944 86266 32386262
Viral infection 16.93 11.74 52 40946 16198 32456330
Dysplasia 16.83 11.74 11 40987 747 32471781
Nodular regenerative hyperplasia 16.66 11.74 11 40987 760 32471768
Epistaxis 16.63 11.74 28 40970 55827 32416701
Anastomotic ulcer 16.59 11.74 8 40990 300 32472228
Anastomotic stenosis 16.59 11.74 8 40990 300 32472228
Demyelination 16.54 11.74 19 40979 2775 32469753
Henoch-Schonlein purpura 16.44 11.74 15 40983 1670 32470858
Insomnia 16.35 11.74 68 40930 100280 32372248
Anal cancer 16.31 11.74 9 40989 448 32472080
Pyloric stenosis 16.23 11.74 11 40987 794 32471734
Overdose 16.13 11.74 56 40942 87021 32385507
Neuropathy peripheral 16.01 11.74 47 40951 76935 32395593
Pneumocystis jirovecii infection 15.85 11.74 14 40984 1494 32471034
Anorectal disorder 15.74 11.74 12 40986 1042 32471486
Hypoxia 15.64 11.74 26 40972 52106 32420422
Acute febrile neutrophilic dermatosis 15.64 11.74 13 40985 1278 32471250
Anal stenosis 15.63 11.74 6 40992 127 32472401
Anal ulcer 15.59 11.74 10 40988 658 32471870
Proctocolectomy 15.49 11.74 5 40993 62 32472466
Enterovesical fistula 15.45 11.74 10 40988 668 32471860
Fluid overload 15.42 11.74 3 40995 19618 32452910
Latent tuberculosis 15.37 11.74 12 40986 1079 32471449
Acrochordon 15.28 11.74 8 40990 358 32472170
Stomatitis 15.16 11.74 17 40981 40212 32432316
Astrovirus test positive 14.96 11.74 3 40995 3 32472525
Diffuse large B-cell lymphoma 14.94 11.74 33 40965 8429 32464099
Pneumonia aspiration 14.85 11.74 18 40980 41138 32431390
Loss of consciousness 14.78 11.74 54 40944 82653 32389875
Colitis microscopic 14.70 11.74 15 40983 1917 32470611
Suicide attempt 14.58 11.74 16 40982 38228 32434300
Pulmonary hypertension 14.39 11.74 4 40994 20490 32452038
Dental caries 14.33 11.74 23 40975 4621 32467907
Aspartate aminotransferase increased 14.22 11.74 40 40958 66389 32406139
Blood glucose increased 14.18 11.74 39 40959 65202 32407326
White blood cell count decreased 14.12 11.74 63 40935 91135 32381393
Oedema 14.03 11.74 22 40976 45125 32427403
Abdominal pain upper 13.97 11.74 138 40860 67200 32405328
Haemoptysis 13.95 11.74 13 40985 33512 32439016
Abnormal behaviour 13.95 11.74 8 40990 26458 32446070
Blood creatinine increased 13.94 11.74 68 40930 96064 32376464
Listeria sepsis 13.91 11.74 6 40992 173 32472355
Megacolon 13.76 11.74 14 40984 1784 32470744
Breast haematoma 13.74 11.74 3 40995 6 32472522
Ankylosing spondylitis 13.74 11.74 24 40974 5166 32467362
Rectal cancer 13.69 11.74 16 40982 2381 32470147
Aphthous ulcer 13.67 11.74 22 40976 4429 32468099
Traumatic lung injury 13.64 11.74 12 40986 1274 32471254
Urinary retention 13.54 11.74 15 40983 35682 32436846
PIK3CA-activated mutation 13.53 11.74 5 40993 95 32472433
Pseudomembranous colitis 13.53 11.74 18 40980 3054 32469474
Psoriatic arthropathy 13.48 11.74 3 40995 17857 32454671
Epstein-Barr virus associated lymphoma 13.45 11.74 9 40989 636 32471892
Blastocystis infection 13.43 11.74 3 40995 7 32472521
Cardiac disorder 13.39 11.74 20 40978 41846 32430682
Herpes zoster 13.38 11.74 78 40920 32263 32440265
Depression 13.31 11.74 70 40928 96990 32375538
Unemployment 13.26 11.74 4 40994 39 32472489
Product administered to patient of inappropriate age 13.22 11.74 17 40981 2789 32469739
Pseudopolyposis 13.17 11.74 4 40994 40 32472488
Tuberculosis 13.16 11.74 32 40966 8697 32463831
Cytomegalovirus enterocolitis 13.13 11.74 10 40988 867 32471661
Subcutaneous abscess 13.10 11.74 20 40978 3850 32468678
Vena cava thrombosis 13.01 11.74 11 40987 1107 32471421
Syncope 12.93 11.74 64 40934 90060 32382468
Histoplasmosis disseminated 12.91 11.74 11 40987 1119 32471409
Chronic kidney disease 12.88 11.74 19 40979 39956 32432572
Peripheral circulatory failure 12.77 11.74 6 40992 212 32472316
Pulmonary granuloma 12.74 11.74 12 40986 1391 32471137
Gastrointestinal oedema 12.71 11.74 12 40986 1396 32471132
Systemic lupus erythematosus 12.66 11.74 17 40981 2909 32469619
Sleep apnoea syndrome 12.61 11.74 4 40994 18810 32453718
Faeces soft 12.61 11.74 16 40982 2592 32469936
Listeria encephalitis 12.59 11.74 4 40994 47 32472481
Colectomy total 12.56 11.74 5 40993 117 32472411
Haemorrhoids 12.35 11.74 40 40958 12813 32459715
Carbohydrate antigen 19-9 increased 12.32 11.74 6 40992 230 32472298
Alanine aminotransferase increased 12.27 11.74 54 40944 78425 32394103
Gastrointestinal sounds abnormal 12.27 11.74 14 40984 2031 32470497
Body temperature decreased 12.18 11.74 36 40962 10978 32461550
Asthenia 12.12 11.74 217 40781 235727 32236801
Glossitis 12.09 11.74 11 40987 1221 32471307
Proctectomy 12.08 11.74 4 40994 54 32472474
Cholesteatoma 12.03 11.74 3 40995 13 32472515
Hodgkin's disease nodular sclerosis 12.03 11.74 3 40995 13 32472515
Ileal perforation 12.02 11.74 9 40989 760 32471768
Blood bilirubin increased 11.95 11.74 19 40979 38765 32433763
Chorioretinopathy 11.88 11.74 12 40986 1515 32471013
Epstein-Barr virus infection 11.79 11.74 27 40971 7063 32465465
Ventricular tachycardia 11.75 11.74 9 40989 25547 32446981

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 drugs
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 (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

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
6291-36-7 SECONDARY_CAS_RN
4019494 VANDF
C0127615 UMLSCUI
CHEBI:6775 CHEBI
CHEMBL704 ChEMBL_ID
DB00244 DRUGBANK_ID
2700 IUPHAR_LIGAND_ID
5444 INN_ID
4Q81I59GXC UNII
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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Delzicol HUMAN PRESCRIPTION DRUG LABEL 1 0023-5853 CAPSULE, DELAYED RELEASE 400 mg ORAL NDA 30 sections
Asacol HD HUMAN PRESCRIPTION DRUG LABEL 1 0023-5901 TABLET, DELAYED RELEASE 800 mg ORAL NDA 30 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
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 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 0472-1915 SUPPOSITORY 1000 mg RECTAL ANDA 27 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
mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 0904-6832 TABLET, DELAYED RELEASE 1.20 g ORAL ANDA 26 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 16714-245 SUPPOSITORY 1000 mg RECTAL ANDA 24 sections
mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 16714-830 TABLET, DELAYED RELEASE 1.20 g ORAL ANDA 25 sections
Mesalamine Human Prescription Drug Label 1 31722-005 SUPPOSITORY 1000 mg RECTAL ANDA 25 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 42291-563 CAPSULE, DELAYED RELEASE 400 mg ORAL ANDA 26 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 42291-564 TABLET, DELAYED RELEASE 1.20 g ORAL ANDA 25 sections
APRISO HUMAN PRESCRIPTION DRUG LABEL 1 43353-884 CAPSULE, EXTENDED RELEASE 375 mg ORAL NDA 26 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 45802-098 ENEMA 4 g RECTAL ANDA 21 sections
Delzicol HUMAN PRESCRIPTION DRUG LABEL 1 50090-3002 CAPSULE, DELAYED RELEASE 400 mg ORAL NDA 28 sections
Delzicol HUMAN PRESCRIPTION DRUG LABEL 1 50090-3002 CAPSULE, DELAYED RELEASE 400 mg ORAL NDA 28 sections
mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 50090-3497 TABLET, DELAYED RELEASE 800 mg ORAL NDA authorized generic 24 sections
mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 50090-4168 TABLET, DELAYED RELEASE 1.20 g ORAL ANDA 25 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 51407-274 TABLET, DELAYED RELEASE 1.20 g ORAL ANDA 26 sections
Asacol HUMAN PRESCRIPTION DRUG LABEL 1 53808-0205 TABLET, DELAYED RELEASE 400 mg ORAL NDA 24 sections
ASACOL HUMAN PRESCRIPTION DRUG LABEL 1 53808-0823 TABLET, DELAYED RELEASE 400 mg ORAL NDA 24 sections
Mesalamine HUMAN PRESCRIPTION DRUG LABEL 1 54092-100 TABLET, DELAYED RELEASE 1.20 g ORAL NDA authorized generic 30 sections
Pentasa HUMAN PRESCRIPTION DRUG LABEL 1 54092-189 CAPSULE 250 mg ORAL NDA 22 sections
Pentasa HUMAN PRESCRIPTION DRUG LABEL 1 54092-191 CAPSULE 500 mg ORAL NDA 22 sections
Lialda HUMAN PRESCRIPTION DRUG LABEL 1 54092-476 TABLET, DELAYED RELEASE 1.20 g ORAL NDA 30 sections