Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Mesalazine
Drug ID BADD_D02414
Description An anti-inflammatory agent, structurally related to the salicylates and non-steroidal anti-inflammatory drugs like acetylsalicylic acid, which is active in inflammatory bowel disease [A174022]. It is considered to be the active moiety of sulphasalazine. (From Martindale, The Extra Pharmacopoeia, 30th ed) Although demonstrably effective in treating and maintaining remission for ulcerative colitis, mesalazine has historically faced a number of issues regarding its lack of stability as a pharmaceutical agent [A174019]. Throughout the late seventies and the eighties, important research initiatives developed stable mesalazine formulations like the eudragit-S coating of Asacol brand mesalazine and the Pentasa brand's encapsulation of mesalazine within microgranules [A174019]. In the present day, contemporary research regarding novel methods to stabilize mesalazine continues and interest in the agent's capacity to decrease inflammatory activity and subsequently potentially reduce the risk of colorectal cancer in conditions like ulcerative colitis is maintained.[A174019,A174022]
Indications and Usage Mesalazine is indicated for the induction of remission in patients with active or mild to moderate acute exacerbations of ulcerative colitis and for the maintenance of remission of ulcerative colitis [FDA Label], [L5101]. Prescribing information for mesalazine in the UK also indicates the medication for the maintenance of remission of Crohn's ileo-colitis [L5101].
Marketing Status Not Available
ATC Code A07EC02
DrugBank ID DB00244
KEGG ID D00377
MeSH ID D019804
PubChem ID 4075
TTD Drug ID D0C4YC
NDC Product Code 12598-5152; 12598-5154; 12598-5156; 12598-6305; 12598-5151; 12598-5155
Synonyms Mesalamine | Mesalazine | m-Aminosalicylic Acid | m Aminosalicylic Acid | 5-Aminosalicylic Acid | 5 Aminosalicylic Acid | meta-Aminosalicylic Acid | meta Aminosalicylic Acid | Asacol | Asacolon | Ascolitin | Canasa | Claversal | Fivasa | Salofalk | Lixacol | Mesalamine Hydrochloride | Hydrochloride, Mesalamine | Mesalamine Monosodium Salt | Monosodium Salt, Mesalamine | Mesasal | Novo-5 ASA | Novo 5 ASA | Pentasa | Rowasa | 5-Aminosalicylate | 5 Aminosalicylate
Chemical Information
Molecular Formula C7H7NO3
CAS Registry Number 89-57-6
SMILES C1=CC(=C(C=C1N)C(=O)O)O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Cough22.02.03.0010.005948%
Crohn's disease10.02.01.005; 07.08.01.0150.028042%Not Available
Cytomegalovirus infection11.05.01.0020.000222%
Death08.04.01.001--
Defaecation urgency07.02.04.0010.001275%Not Available
Dehydration14.05.05.0010.004674%
Depressed mood19.15.02.0010.001700%Not Available
Depression19.15.01.001--
Dermatitis allergic10.01.03.014; 23.03.04.0030.000850%Not Available
Dermatitis contact23.03.04.004; 12.03.01.040; 10.01.01.0030.000850%Not Available
Diarrhoea07.02.01.0010.034415%
Diarrhoea haemorrhagic24.07.02.004; 07.02.01.0020.003399%Not Available
Discomfort08.01.08.0030.000850%Not Available
Disorientation19.13.01.002; 17.02.05.015--Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Drug hypersensitivity10.01.01.001--Not Available
Dry eye06.08.02.0010.000850%
Dry skin23.03.03.0010.002974%
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.0010.003399%
Dysphagia07.01.06.0030.003399%
Dyspnoea02.01.03.002; 22.02.01.004--
Dysuria20.02.02.0020.000850%
Eating disorder19.09.01.008; 14.03.01.0080.000850%Not Available
Electrocardiogram QT prolonged13.14.05.004--
Electrocardiogram T wave inversion13.14.05.0070.000850%Not Available
Emotional disorder19.04.02.0050.000850%Not Available
Enteritis07.08.03.0020.000850%
Enterocolitis07.08.03.0030.001700%
Eosinophil count increased13.01.06.0040.000850%Not Available
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