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)
Eosinophilia01.02.04.0010.000850%
Eosinophilic pneumonia22.01.01.004; 01.02.04.0030.002549%Not Available
Eructation07.01.02.0030.000850%
Erythema23.03.06.0010.004249%Not Available
Erythema nodosum23.07.02.001; 10.02.01.0200.002124%Not Available
Eye swelling06.08.03.0030.000850%Not Available
Face oedema08.01.07.003; 23.04.01.004; 10.01.05.0020.001275%
Facial paralysis17.04.03.0080.000850%Not Available
Faeces discoloured07.01.03.0020.000850%Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Feeling cold08.01.09.0080.000850%Not Available
Feeling hot08.01.09.0090.001275%Not Available
Fistula15.03.02.0010.001275%Not Available
Flatulence07.01.04.0020.005948%
Frequent bowel movements07.02.04.0020.008498%Not Available
Gait disturbance08.01.02.002; 17.02.05.016--
Gamma-glutamyltransferase increased13.03.01.0110.000850%
Gastric ulcer07.04.03.0020.001700%
Gastrointestinal disorder07.11.01.0010.003824%Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal infection11.01.07.012; 07.19.02.0050.001275%Not Available
Goitre05.02.01.001; 14.11.01.0080.000850%Not Available
Haematemesis07.12.02.002; 24.07.02.0110.000850%Not Available
Haematochezia24.07.02.012; 07.12.02.0030.030591%Not Available
Haematuria24.07.01.047; 20.02.01.006--
Haemoglobin decreased13.01.05.0030.004249%Not Available
Haemorrhoids07.15.03.001; 24.10.02.0020.001275%
Headache17.14.01.001--
Heart rate increased13.14.04.0020.001700%Not Available
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