Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Linaclotide
Drug ID BADD_D01291
Description Linaclotide is an orally administered, peptide agonist of guanylate cyclase 2C for the treatment of irritable bowel syndrome. Chemically, it is a heterodetic cyclic peptide and consists of fourteen amino acids. The protein sequence is as follows: Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr. There are three disulfide bonds which are located between Cys1 and Cys6; between Cys2 and Cys10; and between Cys5 and Cys13. FDA approved on August 30, 2012.
Indications and Usage Treatment of irritable bowel syndrome (IBS) with constipation and chronic idiopathic constipation.
Marketing Status approved
ATC Code A06AX04
DrugBank ID DB08890
KEGG ID D09355
MeSH ID C523483
PubChem ID 16158208
TTD Drug ID D00GNJ
NDC Product Code 59651-011; 0456-1204; 0456-1203; 14403-0014; 0456-1202; 69766-007; 0456-1206; 12869-110; 63557-0014; 0456-1205; 68625-121; 68625-122; 0456-1201; 32861-0010
UNII N0TXR0XR5X
Synonyms linaclotide | ASP-0456 | ASP0456 | Linzess | MD-1100 | Linaclotide Acetate | MD-1100 acetate
Chemical Information
Molecular Formula C59H79N15O21S6
CAS Registry Number 851199-59-2
SMILES CC1C(=O)NC2CSSCC3C(=O)NC(C(=O)NC(C(=O)NC(CSSCC(NC(=O)CNC(=O)C(NC2=O)C(C)O)C(=O)N C(CC4=CC=C(C=C4)O)C(=O)O)C(=O)NC(CSSCC(C(=O)N3)N)C(=O)NC(C(=O)N5CCCC5C(=O)N1)CC( =O)N)CC6=CC=C(C=C6)O)CCC(=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 distension07.01.04.001--
Abdominal pain07.01.05.002--
Asthenia08.01.01.001--Not Available
Blood bicarbonate decreased13.02.01.035--
Defaecation urgency07.02.04.001--Not Available
Dehydration14.05.05.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.11.04.006--
Dyspepsia07.01.02.001--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Gastrooesophageal reflux disease07.02.02.003--
Gastroenteritis viral11.05.04.005; 07.19.03.005--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Hypokalaemia14.05.03.002--
Infection11.01.08.002--Not Available
Melaena24.07.02.013; 07.12.02.004--Not Available
Nervous system disorder17.02.10.001--Not Available
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Rash23.03.13.001--Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Sinusitis22.07.03.007; 11.01.13.005--
Skin disorder23.03.03.007--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urticaria23.04.02.001; 10.01.06.001--
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