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 For the treatment of active ulcerative proctitis.
Marketing Status Prescription; Discontinued
ATC Code A07EC02
DrugBank ID DB00244
KEGG ID D00377
MeSH ID D019804
PubChem ID 4075
TTD Drug ID D0C4YC
NDC Product Code 12598-5158; 68743-476; 59651-396; 12598-9554; 0023-5853; 45802-923; 68682-113; 12598-9154; 68382-452; 60687-397; 12598-9157; 0023-5901; 31722-005; 12598-5157; 0023-5801; 70771-1353; 54092-189; 62991-2705; 54127-0947; 0378-9230; 50090-4168; 49957-511; 42291-563; 49706-0882; 70748-214; 63552-042; 58914-501; 70600-006; 69238-1274; 63629-8678; 62559-420; 62756-115; 49706-8821; 12598-9155; 70710-1543; 54092-191; 54092-476; 16714-245; 16714-830; 63629-2397; 0093-5907; 42291-564; 67877-717; 57297-192; 49964-0015; 47621-059; 0093-9224; 63552-043; 63304-175; 59762-0118; 60687-556; 70771-1110; 51407-274; 54127-0945; 0781-7088; 70771-1071; 50090-3497; 0037-0022; 54127-0950; 45802-929; 70771-1513; 62512-0072; 42419-024; 0472-1915; 49452-0450; 0023-5854; 0378-1375; 43353-884; 70710-1302; 54092-100; 12651-582; 59285-037; 54127-0943; 62350-0076; 69918-560; 0591-2245; 24528-0003; 60687-408; 63629-8679; 12598-9553; 0904-6832; 62331-060; 12598-5163; 64980-282; 70771-1625; 68382-435; 57451-1141; 11014-0129; 67454-001; 51927-1078; 0037-0066; 70518-3239; 63629-8827; 59762-0117; 12598-9151; 45802-098; 68382-711; 65649-103; 50090-3002
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)
Lacrimal disorder06.08.02.005--Not Available
Blood disorder01.05.01.004--Not Available
Hepatobiliary disease09.01.08.003--Not Available
Urine analysis abnormal13.13.02.008--Not Available
Renal impairment20.01.03.010--Not Available
Hepatic enzyme abnormal13.03.01.020--Not Available
Cystitis noninfective20.03.02.001--
Lichenoid keratosis23.01.01.004--Not Available
Chronic kidney disease20.01.03.017--
Vulvovaginal mycotic infection21.14.02.004; 11.03.05.004--Not Available
Bone marrow failure01.03.03.005--
Acute interstitial pneumonitis22.01.02.016--Not Available
Liver injury12.01.02.003; 09.01.07.022--Not Available
Anal pruritus07.03.03.002--Not Available
Anorectal discomfort07.03.03.003--Not Available
Oropharyngeal discomfort22.02.05.027; 07.05.05.008--Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.004--
Acute kidney injury20.01.03.016--
Sperm concentration decreased13.20.01.008--Not Available
Lacrimal structural disorder06.06.04.013--Not Available
Medication residue present13.15.01.032--Not Available
Candida infection11.03.03.021--
Anal incontinence07.01.06.029; 17.05.01.021--
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