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 2609.76 10.80 868 41917 16864 46626413
Crohn's disease 636.79 10.80 238 42547 6533 46636744
Haematochezia 504.89 10.80 353 42432 37140 46606137
Frequent bowel movements 407.75 10.80 209 42576 12423 46630854
Off label use 372.59 10.80 966 41819 378875 46264402
Product use issue 294.73 10.80 397 42388 94247 46549030
Diarrhoea haemorrhagic 230.07 10.80 120 42665 7389 46635888
Abdominal pain 222.49 10.80 583 42202 229448 46413829
Rectal haemorrhage 188.90 10.80 203 42582 38052 46605225
Inappropriate schedule of product administration 172.87 10.80 253 42532 64760 46578517
Condition aggravated 168.46 10.80 550 42235 244502 46398775
Faecal calprotectin increased 167.97 10.80 63 42722 1743 46641534
Colitis 166.75 10.80 188 42597 37159 46606118
Clostridium difficile infection 152.56 10.80 149 42636 24954 46618323
Product residue present 142.17 10.80 70 42715 3812 46639465
Intestinal stenosis 141.03 10.80 61 42724 2460 46640817
Mucous stools 138.13 10.80 60 42725 2445 46640832
Lupus-like syndrome 129.76 10.80 84 42701 7760 46635517
Death 124.51 10.80 77 42708 335471 46307806
Inflammatory bowel disease 123.99 10.80 60 42725 3145 46640132
Exposure during pregnancy 121.86 10.80 291 42494 107921 46535356
Toxicity to various agents 116.14 10.80 26 42759 211740 46431537
Completed suicide 109.29 10.80 6 42779 145914 46497363
Fistula 109.03 10.80 76 42709 7934 46635343
Drug level below therapeutic 101.46 10.80 52 42733 3085 46640192
Infusion related reaction 99.02 10.80 258 42527 100950 46542327
Large intestinal stenosis 92.42 10.80 41 42744 1758 46641519
Therapeutic reaction time decreased 84.08 10.80 33 42752 1035 46642242
Rheumatoid arthritis 83.76 10.80 59 42726 240156 46403121
Premature labour 81.93 10.80 74 42711 11225 46632052
Intestinal obstruction 81.93 10.80 110 42675 25965 46617312
Blood pressure fluctuation 81.59 10.80 119 42666 30329 46612948
Pregnancy 78.51 10.80 110 42675 27027 46616250
Diarrhoea 75.98 10.80 814 41971 558788 46084489
Anal fistula 74.64 10.80 40 42745 2601 46640676
Gastrointestinal inflammation 73.46 10.80 47 42738 4254 46639023
Anal abscess 71.03 10.80 43 42742 3529 46639748
Incorrect dose administered 70.06 10.80 139 42646 45411 46597866
Organising pneumonia 65.52 10.80 46 42739 4856 46638421
Erythema nodosum 63.74 10.80 41 42744 3745 46639532
Defaecation urgency 63.29 10.80 36 42749 2631 46640646
Pancreatitis 62.18 10.80 129 42656 43498 46599779
Drug ineffective 58.46 10.80 907 41878 676931 45966346
Proctitis 55.16 10.80 28 42757 1627 46641650
Ileal stenosis 54.97 10.80 27 42758 1462 46641815
Therapeutic response shortened 54.19 10.80 42 42743 5157 46638120
Cytomegalovirus colitis 53.92 10.80 28 42757 1707 46641570
Intentional product use issue 53.05 10.80 136 42649 52644 46590633
Pyoderma gangrenosum 52.21 10.80 32 42753 2685 46640592
Segmental diverticular colitis 51.53 10.80 14 42771 129 46643148
Small intestinal obstruction 50.45 10.80 68 42717 16104 46627173
Contraindicated product administered 49.88 10.80 7 42778 79940 46563337
Drug specific antibody present 48.95 10.80 32 42753 3004 46640273
Fall 47.10 10.80 150 42635 328947 46314330
Pedal pulse abnormal 45.94 10.80 13 42772 141 46643136
Anal cancer 45.60 10.80 17 42768 462 46642815
Poor venous access 44.37 10.80 46 42739 8262 46635015
Myocarditis 43.42 10.80 44 42741 7695 46635582
Colectomy total 43.20 10.80 12 42773 121 46643156
Cytomegalovirus infection 43.03 10.80 67 42718 18077 46625200
Eosinophilic pneumonia 42.82 10.80 25 42760 1919 46641358
Female genital tract fistula 42.37 10.80 30 42755 3209 46640068
Abortion spontaneous 41.34 10.80 110 42675 43536 46599741
Drug interaction 41.30 10.80 77 42708 203017 46440260
Colectomy 41.26 10.80 25 42760 2055 46641222
Anal stenosis 40.68 10.80 14 42771 300 46642977
Ileostomy 40.06 10.80 20 42765 1122 46642155
Rectal tenesmus 39.82 10.80 15 42770 420 46642857
Calcium ionised decreased 39.58 10.80 13 42772 240 46643037
Rectal abscess 39.52 10.80 19 42766 981 46642296
Abscess 38.24 10.80 55 42730 13834 46629443
Product administered to patient of inappropriate age 37.67 10.80 26 42759 2670 46640607
Pyrexia 37.60 10.80 486 42299 348316 46294961
Malignant neoplasm progression 35.48 10.80 8 42777 64918 46578359
Acute febrile neutrophilic dermatosis 35.43 10.80 25 42760 2660 46640617
Heart rate irregular 35.15 10.80 62 42723 18529 46624748
Small intestinal stenosis 33.80 10.80 14 42771 506 46642771
Febrile neutropenia 33.24 10.80 23 42762 94604 46548673
Acute kidney injury 32.66 10.80 109 42676 235746 46407531
Synovitis 32.44 10.80 8 42777 61067 46582210
Intestinal resection 32.33 10.80 22 42763 2208 46641069
Blood creatinine increased 31.94 10.80 15 42770 76388 46566889
Intentional overdose 31.71 10.80 10 42775 64934 46578343
Intestinal fistula 31.71 10.80 15 42770 747 46642530
Steroid dependence 31.45 10.80 9 42776 102 46643175
Feeding intolerance 30.70 10.80 13 42772 497 46642780
Proctalgia 30.12 10.80 29 42756 4767 46638510
Foetal death 29.17 10.80 38 42747 8705 46634572
Cardiac arrest 29.15 10.80 24 42761 90375 46552902
Subcutaneous abscess 28.79 10.80 29 42756 5034 46638243
Drug level decreased 28.50 10.80 31 42754 5881 46637396
Coma 28.46 10.80 9 42776 58340 46584937
Iron deficiency anaemia 28.26 10.80 54 42731 17152 46626125
Abdominal abscess 28.06 10.80 26 42759 4073 46639204
Abdominal pain lower 27.14 10.80 60 42725 21121 46622156
Anal fissure 27.12 10.80 21 42764 2575 46640702
Neutropenia 26.77 10.80 57 42728 143147 46500130
Cardiac failure congestive 26.45 10.80 27 42758 91723 46551554
Abnormal faeces 26.41 10.80 25 42760 4024 46639253
Intestinal anastomosis 26.28 10.80 10 42775 288 46642989
Abscess intestinal 26.24 10.80 16 42769 1330 46641947
Papilloma viral infection 26.13 10.80 16 42769 1340 46641937
Atrial fibrillation 26.07 10.80 34 42751 103556 46539721
Hypotension 25.48 10.80 118 42667 232471 46410806
Intestinal mucosal hypertrophy 25.39 10.80 9 42776 211 46643066
Type IV hypersensitivity reaction 25.35 10.80 20 42765 2520 46640757
Enterocutaneous fistula 25.18 10.80 15 42770 1195 46642082
Overdose 25.12 10.80 34 42751 101945 46541332
Tubulointerstitial nephritis 25.01 10.80 47 42738 14741 46628536
Caesarean section 24.72 10.80 50 42735 16553 46626724
Cardio-respiratory arrest 24.65 10.80 12 42773 59857 46583420
Drug abuse 24.21 10.80 14 42771 63394 46579883
Target skin lesion 24.09 10.80 7 42778 84 46643193
Proctitis ulcerative 24.03 10.80 9 42776 248 46643029
Eosinophilic pleural effusion 23.79 10.80 6 42779 40 46643237
Intestinal dilatation 23.69 10.80 16 42769 1586 46641691
Abdominal distension 23.67 10.80 131 42654 73220 46570057
Cardiac failure 23.65 10.80 23 42762 79925 46563352
Enteritis 23.54 10.80 30 42755 6725 46636552
Arthralgia 23.35 10.80 466 42319 364137 46279140
Somnolence 23.29 10.80 70 42715 156451 46486826
Hepatitis infectious mononucleosis 23.24 10.80 7 42778 96 46643181
Hypoglycaemia 22.21 10.80 11 42774 54338 46588939
Platelet count decreased 22.06 10.80 36 42749 99988 46543289
Signet-ring cell carcinoma 21.75 10.80 4 42781 3 46643274
Delirium 21.55 10.80 4 42781 37224 46606053
Appendicitis 21.55 10.80 28 42757 6398 46636879
Nephritis bacterial 21.21 10.80 5 42780 24 46643253
Infrequent bowel movements 21.16 10.80 13 42772 1095 46642182
Loss of therapeutic response 21.04 10.80 5 42780 25 46643252
Cerebrovascular accident 20.79 10.80 38 42747 101001 46542276
Macular degeneration 20.52 10.80 29 42756 7176 46636101
Rectal stenosis 20.29 10.80 7 42778 151 46643126
Eosinophilic pneumonia chronic 20.07 10.80 6 42779 80 46643197
Cryptosporidiosis infection 20.06 10.80 8 42777 262 46643015
Injection site papule 20.00 10.80 11 42774 753 46642524
Flatulence 19.89 10.80 65 42720 28813 46614464
Listeria sepsis 19.83 10.80 10 42775 573 46642704
Gastrointestinal sounds abnormal 19.79 10.80 20 42765 3486 46639791
Oropharyngeal pain 19.78 10.80 126 42659 74042 46569235
Lupus hepatitis 19.74 10.80 5 42780 34 46643243
Insomnia 19.68 10.80 81 42704 164843 46478434
Glossodynia 19.67 10.80 8 42777 44365 46598912
Hyperkalaemia 19.64 10.80 11 42774 50698 46592579
Drug intolerance 19.62 10.80 69 42716 146980 46496297
Body temperature fluctuation 19.54 10.80 15 42770 1815 46641462
Confusional state 19.41 10.80 78 42707 159814 46483463
Anal incontinence 19.38 10.80 37 42748 11741 46631536
Femur fracture 19.35 10.80 5 42780 36992 46606285
Abdominal tenderness 19.29 10.80 28 42757 7100 46636177
Pouchitis 19.22 10.80 9 42776 438 46642839
Infectious mononucleosis 19.09 10.80 14 42771 1582 46641695
Clostridium test positive 19.02 10.80 15 42770 1889 46641388
Anal squamous cell carcinoma 18.94 10.80 8 42777 304 46642973
Electrocardiogram QT prolonged 18.66 10.80 12 42773 51313 46591964
Pyoderma 18.42 10.80 7 42778 201 46643076
Campylobacter infection 18.18 10.80 10 42775 685 46642592
Perirectal abscess 18.08 10.80 11 42774 911 46642366
Listeriosis 18.07 10.80 12 42773 1157 46642120
Large intestinal ulcer 17.89 10.80 18 42767 3121 46640156
Thrombocytopenia 17.84 10.80 58 42727 126523 46516754
Rectal ulcer 17.79 10.80 12 42773 1187 46642090
Takayasu's arteritis 17.77 10.80 4 42781 15 46643262
Swelling 17.58 10.80 57 42728 124454 46518823
Pain 17.47 10.80 320 42465 476628 46166649
Arthropathy 17.29 10.80 32 42753 84668 46558609
Neuropathy peripheral 17.12 10.80 36 42749 90857 46552420
Gastrointestinal stoma complication 17.12 10.80 13 42772 1548 46641729
Anorectal discomfort 17.00 10.80 15 42770 2206 46641071
Epstein-Barr virus test positive 17.00 10.80 9 42776 571 46642706
Oral administration complication 16.91 10.80 6 42779 141 46643136
Respiratory arrest 16.88 10.80 5 42780 33811 46609466
White blood cell count decreased 16.82 10.80 50 42735 112181 46531096
Intestinal ulcer 16.82 10.80 11 42774 1033 46642244
Pulmonary hypertension 16.77 10.80 6 42779 35987 46607290
Plasma cell myeloma 16.72 10.80 10 42775 44468 46598809
Tuberculosis 16.59 10.80 32 42753 10233 46633044
Self-injurious ideation 16.55 10.80 15 42770 2285 46640992
C-reactive protein increased 16.53 10.80 101 42684 58489 46584788
Multiple sclerosis relapse 16.51 10.80 9 42776 42116 46601161
Hypoxia 16.41 10.80 14 42771 51824 46591453
Pneumonia 16.22 10.80 245 42540 376075 46267202
Megacolon 16.20 10.80 13 42772 1678 46641599
Joint swelling 16.04 10.80 88 42697 165985 46477292
Ileocolectomy 15.95 10.80 4 42781 26 46643251
Herpes simplex hepatitis 15.89 10.80 7 42778 295 46642982
Asthma 15.82 10.80 38 42747 91504 46551773
Haemorrhage 15.75 10.80 95 42690 54774 46588503
Seizure 15.58 10.80 59 42726 122995 46520282
Malignant splenic neoplasm 15.45 10.80 3 42782 4 46643273
Hepatocellular injury 15.42 10.80 4 42781 29518 46613759
Weight decreased 15.35 10.80 275 42510 210574 46432703
Hyponatraemia 15.29 10.80 45 42740 101287 46541990
Diabetes mellitus 15.28 10.80 14 42771 50051 46593226
Pus in stool 15.05 10.80 3 42782 5 46643272
Abdominal adhesions 14.94 10.80 16 42769 2981 46640296
Dyspnoea 14.75 10.80 360 42425 515188 46128089
Intentional product misuse 14.59 10.80 13 42772 47115 46596162
Small intestinal resection 14.51 10.80 7 42778 364 46642913
Hyperglycaemia 14.48 10.80 7 42778 35064 46608213
Arthritis enteropathic 14.38 10.80 6 42779 221 46643056
Myocardial infarction 14.22 10.80 44 42741 97484 46545793
Disease progression 14.17 10.80 40 42745 91260 46552017
Meningitis listeria 14.08 10.80 7 42778 389 46642888
Rectal spasm 14.00 10.80 4 42781 45 46643232
Unresponsive to stimuli 13.94 10.80 6 42779 32168 46611109
Anorectal disorder 13.89 10.80 11 42774 1393 46641884
Glutamate dehydrogenase level abnormal 13.84 10.80 3 42782 9 46643268
Plasmablastic lymphoma 13.82 10.80 6 42779 244 46643033
Retroperitoneal abscess 13.80 10.80 5 42780 125 46643152
Stomatitis 13.77 10.80 26 42759 68271 46575006
Vein rupture 13.76 10.80 8 42777 609 46642668
Acute myocardial infarction 13.76 10.80 6 42779 31918 46611359
Drug withdrawal syndrome 13.76 10.80 4 42781 27380 46615897
Lactic acidosis 13.65 10.80 7 42778 33902 46609375
Fluid overload 13.60 10.80 4 42781 27181 46616096
Pelvic abscess 13.50 10.80 11 42774 1451 46641826
Thyroiditis subacute 13.49 10.80 6 42779 259 46643018
Pulmonary tuberculosis 13.41 10.80 19 42766 4712 46638565
Chronic obstructive pulmonary disease 13.41 10.80 20 42765 57613 46585664
Abdominal pain upper 13.36 10.80 197 42588 145108 46498169
Chromaturia 13.36 10.80 37 42748 14982 46628295
Antinuclear antibody positive 13.26 10.80 22 42763 6258 46637019
Pancreatitis acute 12.88 10.80 51 42734 24821 46618456
Large intestinal obstruction 12.86 10.80 12 42773 1897 46641380
Small intestinal perforation 12.83 10.80 10 42775 1238 46642039
Antineutrophil cytoplasmic antibody positive 12.78 10.80 7 42778 475 46642802
Skin warm 12.64 10.80 18 42767 4485 46638792
Hypertension 12.63 10.80 117 42668 196239 46447038
Obstruction 12.50 10.80 11 42774 1611 46641666
Agitation 12.16 10.80 20 42765 55395 46587882
Demyelination 12.13 10.80 20 42765 5660 46637617
Antinuclear antibody increased 12.05 10.80 9 42776 1046 46642231
Pneumoretroperitoneum 12.03 10.80 3 42782 19 46643258
Nephrolithiasis 12.01 10.80 61 42724 32990 46610287
Malnutrition 11.97 10.80 34 42751 13969 46629308
Tremor 11.87 10.80 60 42725 115579 46527698
Cytomegalovirus enterocolitis 11.83 10.80 7 42778 551 46642726
Enterocolitis bacterial 11.74 10.80 5 42780 194 46643083
Acute chest syndrome 11.69 10.80 7 42778 563 46642714
Ileal perforation 11.69 10.80 6 42779 357 46642920
Chills 11.67 10.80 137 42648 95895 46547382
No adverse event 11.62 10.80 62 42723 34169 46609108
Bowel movement irregularity 11.60 10.80 15 42770 3410 46639867
Clostridial infection 11.60 10.80 17 42768 4348 46638929
Depressed level of consciousness 11.57 10.80 16 42769 47553 46595724
Histoplasmosis disseminated 11.55 10.80 9 42776 1113 46642164
Faeces soft 11.52 10.80 15 42770 3433 46639844
Malignant anorectal neoplasm 11.42 10.80 3 42782 24 46643253
Device dislocation 11.30 10.80 3 42782 21799 46621478
Inflammation 11.28 10.80 80 42705 48701 46594576
pH urine increased 11.23 10.80 5 42780 216 46643061
Pharyngeal paraesthesia 11.22 10.80 9 42776 1161 46642116
Amniotic cavity infection 11.17 10.80 9 42776 1169 46642108
Clostridium colitis 11.11 10.80 11 42774 1871 46641406
Depression 11.09 10.80 101 42684 170003 46473274
Lymphocyte stimulation test positive 11.04 10.80 7 42778 623 46642654
Pseudopolyp 10.92 10.80 5 42780 231 46643046
Epistaxis 10.87 10.80 27 42758 64278 46578999
Gastrointestinal wall thickening 10.84 10.80 8 42777 912 46642365
Pseudomembranous colitis 10.84 10.80 14 42771 3181 46640096
Coronary artery disease 10.83 10.80 9 42776 33743 46609534
Fistula discharge 10.81 10.80 8 42777 917 46642360

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 2474.62 11.59 846 34930 13588 29903114
Frequent bowel movements 545.33 11.59 244 35532 8161 29908541
Crohn's disease 470.77 11.59 182 35594 4170 29912532
Haematochezia 448.12 11.59 352 35424 33870 29882832
Off label use 421.09 11.59 920 34856 248370 29668332
Colitis 399.12 11.59 315 35461 30505 29886197
Product use issue 268.36 11.59 302 35474 45714 29870988
Blood pressure fluctuation 235.28 11.59 183 35593 17320 29899382
Condition aggravated 228.34 11.59 506 35270 137360 29779342
Death 186.09 11.59 98 35678 357185 29559517
Infusion related reaction 181.85 11.59 233 35543 40331 29876371
Drug ineffective 167.85 11.59 825 34951 339562 29577140
Inappropriate schedule of product administration 166.87 11.59 221 35555 39507 29877195
Clostridium difficile infection 155.76 11.59 138 35638 15645 29901057
Myocarditis 155.16 11.59 114 35662 9897 29906805
Abdominal pain 149.79 11.59 427 35349 135227 29781475
Faecal calprotectin increased 137.37 11.59 52 35724 1121 29915581
Cytomegalovirus colitis 128.95 11.59 61 35715 2318 29914384
Anal abscess 127.49 11.59 78 35698 4991 29911711
Inflammatory bowel disease 124.91 11.59 59 35717 2234 29914468
Diarrhoea haemorrhagic 120.22 11.59 79 35697 5726 29910976
Rectal haemorrhage 114.98 11.59 173 35603 34766 29881936
Defaecation urgency 112.87 11.59 48 35728 1413 29915289
Mucous stools 103.74 11.59 40 35736 908 29915794
Large intestinal stenosis 99.66 11.59 42 35734 1208 29915494
Product residue present 99.03 11.59 53 35723 2625 29914077
Anal fistula 96.84 11.59 60 35716 3926 29912776
Drug level below therapeutic 95.16 11.59 56 35720 3336 29913366
Intestinal stenosis 94.60 11.59 46 35730 1859 29914843
Toxicity to various agents 92.79 11.59 48 35728 177135 29739567
Weight decreased 91.08 11.59 389 35387 150532 29766170
Cholangitis sclerosing 90.73 11.59 36 35740 884 29915818
Ileal stenosis 88.99 11.59 38 35738 1130 29915572
Small intestinal stenosis 83.98 11.59 28 35748 410 29916292
Completed suicide 81.82 11.59 11 35765 99481 29817221
Impaired quality of life 79.42 11.59 38 35738 1481 29915221
Pulmonary tuberculosis 79.08 11.59 57 35719 4800 29911902
Gastrointestinal inflammation 78.77 11.59 47 35729 2872 29913830
Drug specific antibody present 77.07 11.59 41 35735 2006 29914696
Disseminated tuberculosis 73.26 11.59 40 35736 2062 29914640
Hepatosplenic T-cell lymphoma 69.91 11.59 25 35751 456 29916246
Intentional product use issue 68.39 11.59 141 35635 36299 29880403
Intestinal fistula 67.58 11.59 28 35748 771 29915931
Fall 66.02 11.59 72 35704 181800 29734902
Therapeutic reaction time decreased 65.20 11.59 24 35752 477 29916225
Eosinophilic pneumonia 63.81 11.59 40 35736 2671 29914031
Fistula 63.30 11.59 51 35725 5071 29911631
Hypotension 61.77 11.59 90 35686 200475 29716227
Acute kidney injury 60.59 11.59 150 35626 273692 29643010
Intestinal obstruction 57.38 11.59 91 35685 19121 29897581
Myocardial infarction 57.34 11.59 40 35736 125585 29791117
Small intestinal obstruction 57.30 11.59 76 35700 13583 29903119
Proctalgia 57.16 11.59 45 35731 4327 29912375
Intestinal perforation 56.67 11.59 60 35716 8459 29908243
Proctitis 56.65 11.59 34 35742 2100 29914602
Vitamin D deficiency 56.63 11.59 48 35728 5122 29911580
Pericarditis 56.17 11.59 60 35716 8546 29908156
Somnolence 53.97 11.59 24 35752 96739 29819963
Tubulointerstitial nephritis 53.79 11.59 85 35691 17806 29898896
Therapeutic response shortened 53.53 11.59 40 35736 3560 29913142
Incorrect dose administered 52.98 11.59 117 35659 31569 29885133
Malignant neoplasm progression 50.74 11.59 12 35764 72275 29844427
Night sweats 50.72 11.59 74 35702 14454 29902248
Drug level decreased 49.90 11.59 47 35729 5758 29910944
Drug abuse 49.61 11.59 18 35758 82054 29834648
Cardiac arrest 48.76 11.59 25 35751 92825 29823877
Confusional state 48.20 11.59 54 35722 134780 29781922
Steroid dependence 45.95 11.59 12 35764 69 29916633
Pyrexia 45.92 11.59 545 35231 293944 29622758
Rectal tenesmus 45.69 11.59 19 35757 528 29916174
Colectomy 45.67 11.59 26 35750 1454 29915248
Abdominal abscess 45.56 11.59 38 35738 3966 29912736
Pouchitis 45.55 11.59 20 35756 637 29916065
Cardiac failure congestive 45.42 11.59 22 35754 84385 29832317
Heart rate irregular 45.07 11.59 64 35712 12195 29904507
Platelet count decreased 43.09 11.59 38 35738 106091 29810611
Renal failure 42.53 11.59 55 35721 128911 29787791
Cytomegalovirus infection 42.53 11.59 90 35686 23584 29893118
Hyperkalaemia 42.47 11.59 13 35763 65997 29850705
Febrile neutropenia 42.37 11.59 39 35737 106654 29810048
Pancreatitis 42.19 11.59 117 35659 36373 29880329
Haemophagocytic lymphohistiocytosis 41.87 11.59 55 35721 9736 29906966
C-reactive protein decreased 41.52 11.59 25 35751 1553 29915149
Diarrhoea 41.07 11.59 592 35184 333511 29583191
Blood pressure increased 39.17 11.59 180 35596 71748 29844954
Therapeutic product effect decreased 38.45 11.59 98 35678 28978 29887724
Histoplasmosis 38.42 11.59 22 35754 1244 29915458
Lupus-like syndrome 37.00 11.59 26 35750 2103 29914599
Perirectal abscess 36.82 11.59 23 35753 1526 29915176
Erythema nodosum 35.68 11.59 19 35757 931 29915771
Cardio-respiratory arrest 35.60 11.59 12 35764 57294 29859408
Drug interaction 35.52 11.59 121 35655 199447 29717255
Gastrointestinal anastomotic leak 35.27 11.59 14 35762 344 29916358
Neutropenia 33.64 11.59 64 35712 128476 29788226
Drug specific antibody 33.60 11.59 12 35764 218 29916484
Rectal abscess 33.58 11.59 18 35758 894 29915808
Hypoglycaemia 32.86 11.59 10 35766 50971 29865731
Campylobacter infection 32.62 11.59 16 35760 659 29916043
Gastrointestinal disorder 32.31 11.59 90 35686 28047 29888655
Chronic gastrointestinal bleeding 32.21 11.59 12 35764 247 29916455
Clostridium difficile colitis 32.12 11.59 56 35720 12712 29903990
Coma 32.00 11.59 5 35771 40444 29876258
Organising pneumonia 30.71 11.59 34 35742 5040 29911662
B-cell lymphoma 30.41 11.59 32 35744 4478 29912224
Cytomegalovirus enteritis 30.30 11.59 13 35763 391 29916311
Short-bowel syndrome 29.91 11.59 11 35765 218 29916484
Abdominal adhesions 29.69 11.59 19 35757 1315 29915387
Dyschezia 29.55 11.59 18 35758 1142 29915560
Proctitis ulcerative 29.41 11.59 8 35768 55 29916647
Periumbilical abscess 29.16 11.59 8 35768 57 29916645
Plasma cell myeloma 28.65 11.59 14 35762 53448 29863254
Bronchiectasis 28.32 11.59 33 35743 5171 29911531
Pyoderma gangrenosum 28.29 11.59 17 35759 1052 29915650
Coronary artery disease 28.22 11.59 12 35764 49700 29867002
Eosinophilic colitis 28.19 11.59 10 35766 178 29916524
Gastrointestinal mucosa hyperaemia 28.14 11.59 10 35766 179 29916523
Tuberculous pleurisy 27.78 11.59 12 35764 367 29916335
Ileostomy 27.60 11.59 13 35763 489 29916213
Cardiac failure 27.05 11.59 36 35740 83382 29833320
Intentional overdose 26.98 11.59 8 35768 41473 29875229
Narcotic bowel syndrome 26.98 11.59 9 35767 132 29916570
Abscess 26.39 11.59 45 35731 10033 29906669
Aggression 26.14 11.59 6 35770 36901 29879801
Ileal ulcer 25.88 11.59 13 35763 564 29916138
Loss of therapeutic response 25.68 11.59 8 35768 93 29916609
Disease progression 25.36 11.59 35 35741 79839 29836863
Intestinal diaphragm disease 25.07 11.59 10 35766 249 29916453
Pseudopolyp 24.87 11.59 9 35767 170 29916532
Gastroenteritis clostridial 24.85 11.59 10 35766 255 29916447
Meningitis listeria 24.83 11.59 11 35765 358 29916344
Arthralgia 24.55 11.59 259 35517 135532 29781170
Flatulence 23.85 11.59 61 35715 18068 29898634
Abscess intestinal 23.83 11.59 17 35759 1408 29915294
Anal fissure 23.76 11.59 21 35755 2370 29914332
Irritable bowel syndrome 23.66 11.59 23 35753 2929 29913773
Drug intolerance 23.65 11.59 112 35664 45179 29871523
Pancreatitis acute 23.63 11.59 76 35700 25619 29891083
Mucosal inflammation 23.60 11.59 4 35772 30490 29886212
Listeriosis 23.07 11.59 14 35762 882 29915820
Subileus 22.80 11.59 23 35753 3064 29913638
T-cell lymphoma 22.36 11.59 14 35762 933 29915769
Respiratory arrest 22.29 11.59 4 35772 29254 29887448
Pelvic abscess 22.29 11.59 14 35762 938 29915764
Oedema peripheral 21.76 11.59 60 35716 105772 29810930
Campylobacter gastroenteritis 21.54 11.59 13 35763 811 29915891
Rectal stenosis 21.41 11.59 8 35768 166 29916536
Large intestinal ulcer 21.28 11.59 17 35759 1669 29915033
Agitation 21.17 11.59 20 35756 54053 29862649
Thrombocytopenia 21.15 11.59 88 35688 136956 29779746
Mental status changes 20.96 11.59 9 35767 37070 29879632
C-reactive protein increased 20.90 11.59 105 35671 43368 29873334
Epstein-Barr virus test positive 20.87 11.59 11 35765 528 29916174
Overgrowth bacterial 20.72 11.59 7 35769 107 29916595
International normalised ratio increased 20.71 11.59 16 35760 47723 29868979
Iron deficiency anaemia 20.67 11.59 38 35738 8986 29907716
Hallucination 20.58 11.59 17 35759 49042 29867660
Enteritis 20.56 11.59 32 35744 6613 29910089
Blood urea increased 20.50 11.59 6 35770 31375 29885327
Enterocutaneous fistula 20.31 11.59 12 35764 720 29915982
Pyloric stenosis 20.07 11.59 11 35765 571 29916131
Neutrophil count decreased 20.03 11.59 13 35763 42441 29874261
Small intestine adenocarcinoma 19.87 11.59 7 35769 122 29916580
Delirium 19.78 11.59 12 35764 40619 29876083
Intestinal anastomosis complication 19.51 11.59 7 35769 129 29916573
Acne 19.47 11.59 38 35738 9398 29907304
Therapeutic product effect incomplete 19.39 11.59 86 35690 33748 29882954
Intestinal ulcer 19.20 11.59 12 35764 797 29915905
Acute myocardial infarction 19.11 11.59 21 35755 52918 29863784
Rhabdomyolysis 19.06 11.59 29 35747 63551 29853151
Urinary tract infection 18.97 11.59 37 35739 73622 29843080
Abdominal distension 18.96 11.59 106 35670 45603 29871099
Atrial fibrillation 18.90 11.59 66 35710 108058 29808644
Henoch-Schonlein purpura 18.87 11.59 15 35761 1462 29915240
Intestinal mucosal hypertrophy 18.86 11.59 6 35770 75 29916627
Gastrooesophageal sphincter insufficiency 18.86 11.59 6 35770 75 29916627
Body temperature fluctuation 18.64 11.59 14 35762 1255 29915447
Lactic acidosis 18.59 11.59 7 35769 31206 29885496
Large intestine perforation 18.52 11.59 33 35743 7618 29909084
Calcium deficiency 18.48 11.59 7 35769 151 29916551
Flushing 18.47 11.59 77 35699 29415 29887287
Angioedema 18.42 11.59 9 35767 34375 29882327
Cardiac perforation 18.24 11.59 6 35770 84 29916618
Anorectal discomfort 18.14 11.59 16 35760 1801 29914901
Dysplasia 18.00 11.59 11 35765 702 29916000
Pneumocystis jirovecii infection 17.92 11.59 14 35762 1331 29915371
Anastomotic ulcer 17.82 11.59 8 35768 269 29916433
Calcinosis 17.79 11.59 11 35765 717 29915985
Depressed level of consciousness 17.64 11.59 12 35764 38210 29878492
Acute febrile neutrophilic dermatosis 17.63 11.59 13 35763 1133 29915569
Nodular regenerative hyperplasia 17.43 11.59 11 35765 743 29915959
Infection reactivation 17.42 11.59 12 35764 940 29915762
Pneumonia 17.37 11.59 288 35488 334018 29582684
Anorectal disorder 17.34 11.59 12 35764 947 29915755
Respiratory failure 17.21 11.59 62 35714 100580 29816122
Ankylosing spondylitis 17.15 11.59 24 35752 4510 29912192
Anal ulcer 17.12 11.59 10 35766 587 29916115
Herpes zoster 17.07 11.59 76 35700 29867 29886835
Colitis microscopic 17.01 11.59 15 35761 1688 29915014
Cerebrovascular accident 16.66 11.59 48 35728 83429 29833273
Demyelination 16.62 11.59 18 35758 2602 29914100
Dyskinesia 16.60 11.59 3 35773 21831 29894871
Enterovesical fistula 16.49 11.59 10 35766 629 29916073
No adverse event 16.45 11.59 52 35724 17367 29899335
Pulmonary oedema 16.37 11.59 17 35759 43958 29872744
Hyperglycaemia 16.31 11.59 11 35765 35189 29881513
Insomnia 16.29 11.59 57 35719 93279 29823423
Anal stenosis 16.22 11.59 6 35770 121 29916581
Dental caries 16.09 11.59 23 35753 4408 29912294
Tuberculosis 16.02 11.59 32 35744 8045 29908657
Weight increased 16.00 11.59 148 35628 74765 29841937
Drug hypersensitivity 15.99 11.59 138 35638 68381 29848321
Fluid retention 15.93 11.59 5 35771 24993 29891709
Viral infection 15.90 11.59 47 35729 15138 29901564
Proctocolectomy 15.83 11.59 5 35771 61 29916641
Aphthous ulcer 15.78 11.59 22 35754 4119 29912583
Poor venous access 15.67 11.59 17 35759 2463 29914239
Subcutaneous abscess 15.58 11.59 20 35756 3461 29913241
Product administered to patient of inappropriate age 15.32 11.59 17 35759 2526 29914176
Blood creatine phosphokinase increased 15.17 11.59 18 35758 43830 29872872
Astrovirus test positive 15.12 11.59 3 35773 3 29916699
Abnormal faeces 15.10 11.59 17 35759 2566 29914136
Encephalopathy 15.01 11.59 10 35766 32195 29884507
Intestinal resection 14.93 11.59 13 35763 1438 29915264
Pneumonia aspiration 14.75 11.59 14 35762 37766 29878936
Seizure 14.71 11.59 64 35712 98411 29818291
Abdominal pain upper 14.60 11.59 126 35650 62425 29854277
Dyspnoea 14.53 11.59 296 35480 332999 29583703
Listeria sepsis 14.45 11.59 6 35770 166 29916536
Anal cancer 14.31 11.59 8 35768 432 29916270
Diffuse large B-cell lymphoma 14.30 11.59 30 35746 7811 29908891
Epistaxis 14.17 11.59 26 35750 52955 29863747
Hypoxia 14.17 11.59 22 35754 47832 29868870
Gastrointestinal oedema 13.91 11.59 12 35764 1311 29915391
Breast haematoma 13.91 11.59 3 35773 6 29916696
Rectal cancer 13.90 11.59 15 35761 2161 29914541
Suicide attempt 13.87 11.59 14 35762 36683 29880019
PIK3CA-activated mutation 13.79 11.59 5 35771 95 29916607
Sacroiliitis 13.79 11.59 10 35766 850 29915852
Fluid overload 13.72 11.59 3 35773 19089 29897613
Pseudomembranous colitis 13.66 11.59 17 35759 2851 29913851
Carbohydrate antigen 19-9 increased 13.64 11.59 6 35770 192 29916510
Acrochordon 13.57 11.59 7 35769 321 29916381
Systemic lupus erythematosus 13.56 11.59 16 35760 2540 29914162
Unemployment 13.47 11.59 4 35772 39 29916663
Megacolon 13.45 11.59 13 35763 1644 29915058
Drug level above therapeutic 13.33 11.59 17 35759 2922 29913780
Peripheral circulatory failure 13.25 11.59 6 35770 206 29916496
Memory impairment 13.14 11.59 15 35761 37159 29879543
Overdose 13.10 11.59 54 35722 84283 29832419
Latent tuberculosis 13.04 11.59 10 35766 925 29915777
Colectomy total 13.03 11.59 5 35771 112 29916590
Listeria encephalitis 12.96 11.59 4 35772 45 29916657
Loss of consciousness 12.84 11.59 50 35726 79325 29837377
Ileal perforation 12.80 11.59 9 35767 728 29915974
Granuloma 12.73 11.59 15 35761 2377 29914325
Blood creatinine increased 12.69 11.59 61 35715 91314 29825388
Epstein-Barr virus associated lymphoma 12.66 11.59 8 35768 542 29916160
Wheezing 12.63 11.59 11 35765 30927 29885775
Epstein-Barr virus infection 12.63 11.59 26 35750 6680 29910022
Chronic kidney disease 12.59 11.59 16 35760 37822 29878880
Oedema 12.51 11.59 20 35756 42973 29873729
Abdominal rigidity 12.49 11.59 11 35765 1235 29915467
Proctectomy 12.36 11.59 4 35772 53 29916649
Intentional product misuse 12.24 11.59 14 35762 34653 29882049
Enanthema 12.22 11.59 7 35769 396 29916306
Hodgkin's disease nodular sclerosis 12.19 11.59 3 35773 13 29916689
Cholesteatoma 12.19 11.59 3 35773 13 29916689
Chronic obstructive pulmonary disease 12.02 11.59 23 35753 46103 29870599
Procedural intestinal perforation 12.01 11.59 3 35773 14 29916688
Vena cava thrombosis 11.95 11.59 10 35766 1048 29915654
Abnormal behaviour 11.88 11.59 8 35768 25615 29891087
Cardiac flutter 11.80 11.59 12 35764 1614 29915088
Pulmonary hypertension 11.79 11.59 4 35772 19032 29897670
Cytomegalovirus enterocolitis 11.75 11.59 9 35767 831 29915871
Anastomotic stenosis 11.68 11.59 6 35770 273 29916429
Job dissatisfaction 11.67 11.59 4 35772 64 29916638
Depression 11.63 11.59 62 35714 90375 29826327

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
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
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory drugs

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)

None

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
Arachidonate 5-lipoxygenase Enzyme INHIBITOR CHEMBL CHEMBL
Prostaglandin G/H synthase 2 Enzyme INHIBITOR DRUGBANK CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR WOMBAT-PK CHEMBL
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor AGONIST UNKNOWN IUPHAR

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Delzicol HUMAN PRESCRIPTION DRUG LABEL 1 0023-5853 CAPSULE, DELAYED RELEASE 400 mg ORAL NDA 27 sections
Asacol HD HUMAN PRESCRIPTION DRUG LABEL 1 0023-5901 TABLET, DELAYED RELEASE 800 mg ORAL NDA 27 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 0378-7401 TABLET, DELAYED RELEASE 1.20 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 16714-830 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
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 29 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
Canasa HUMAN PRESCRIPTION DRUG LABEL 1 54868-6147 SUPPOSITORY 1000 mg RECTAL NDA 12 sections