Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Mesalamine
Drug ID BADD_D01397
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 approved
ATC Code A07EC02
DrugBank ID DB00244
KEGG ID D00377
MeSH ID D019804
PubChem ID 4075
TTD Drug ID D0C4YC
NDC Product Code 0023-5854; 49452-0450; 21922-045; 59762-0117; 62332-724; 68382-452; 68682-113; 54127-0945; 62331-064; 58914-501; 60687-650; 0037-0066; 67877-717; 68382-435; 0023-5801; 11014-0129; 0904-6832; 51927-1078; 57297-192; 57451-1141; 54092-100; 54092-189; 59651-397; 0037-0022; 60687-397; 63304-175; 0378-1375; 69918-560; 0781-7088; 12598-9155; 24528-0003; 49957-511; 59285-037; 63552-042; 42291-563; 51407-274; 63629-2397; 65649-103; 70710-1302; 42419-024; 49706-0882; 70966-0035; 45802-098; 50268-577; 63629-8678; 0527-3012; 70771-1513; 0591-2245; 12598-9151; 12598-9554; 47621-059; 54127-0947; 70600-006; 45802-929; 46708-724; 0023-5901; 54092-476; 60687-556; 62559-420; 63629-8679; 63629-8827; 64980-282; 68382-711; 70518-3239; 70710-1543; 70771-1110; 49964-0015; 54127-0950; 62350-0076; 62756-115; 63552-043; 16714-245; 42291-564; 50090-3002; 0023-5853; 0472-1915; 70771-1353; 70771-1625; 12598-5158; 12598-9553; 12651-582; 62331-060; 62512-0072; 31722-005; 45802-923; 54092-191; 59762-0118; 60687-408; 63304-089; 70748-214; 12598-9154; 59651-396; 62991-2705; 67454-001; 68743-476; 16714-830; 0093-5907; 43353-884; 60687-703; 70771-1071; 12598-5163; 49706-8821; 54127-0943; 0093-9224
UNII 4Q81I59GXC
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.005361%Not Available
Abdominal distension07.01.04.0010.006568%
Abdominal pain07.01.05.0020.012570%
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.0030.005727%
Abdominal tenderness07.01.05.0040.000366%Not Available
Abnormal dreams17.15.02.001; 19.02.03.001--Not Available
Abnormal faeces07.01.03.0010.001866%Not Available
Abortion18.01.01.0010.000183%Not Available
Abortion spontaneous18.01.04.0010.000640%Not Available
Acne23.02.01.0010.002324%Not Available
Acute febrile neutrophilic dermatosis23.03.03.033; 01.02.01.0060.000457%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.0010.000274%Not Available
Acute respiratory failure22.02.06.001; 14.01.04.0040.000183%Not Available
Administration site reaction12.07.04.011; 08.02.04.011--Not Available
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase increased13.03.04.005--
Albuminuria20.02.01.001--Not Available
Alopecia23.02.02.0010.006825%
Alveolitis22.01.01.001--Not Available
Amblyopia06.02.01.001--Not Available
Amenorrhoea21.01.02.001; 05.05.01.002--
Amylase increased13.05.01.009--
Anaemia01.03.02.001--
Anal fissure07.03.01.0020.000183%
Anal fistula07.11.05.0020.000183%
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Angina pectoris02.02.02.002; 24.04.04.0020.000183%
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anorectal disorder07.03.01.001--Not Available
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