Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tegaserod maleate
Drug ID BADD_D02139
Description Novartis' brand name Zelnorm (tegaserod) had originally received approval from the US FDA in 2002 for the treatment of irritable bowel syndrome with constipation (IBS-C).[L5918,F4229] It was, however, voluntarily withdrawn from widespread use in the US market in 2007 after concerns arose over the possibility that tegaserod could potentially cause dangerous cardiovascular events in patients.[L5918,F4229] Since then, closer evaluations of the original data suggesting such cardiovascular risk have resulted in the limited reintroduction or 're-approval' of tegaserod for treatment of IBS-C specifically in female patients less than 65 years of age and whom are considered to be at a lower risk of a cardiovascular event than the broader population.[L5918,F4229] Zelnorm (tegaserod) by Sloan Pharma subsequently gained re-approval in April of 2019.[L5918] Nevertheless, tegaserod remains un-approved in certain regions.[F4226] Despite the relative complications involved in its history of regulatory approval, ever since its first introduction in 2002 tegaserod remains the only therapy for IBS-C that possesses the unique mechanism of action of acting on serotonin-4 (5-HT(4)) receptors in smooth muscle cells and in the gastrointestinal wall to facilitate actions like esophageal relaxation, peristaltic gut movement, and natural secretions in the gut, among others.[L5918,A11044,A176762,F4229,F4223]
Indications and Usage Provides relief from the symptoms of irritable bowel syndrome including chronic idiopathic constipation.
Marketing Status Discontinued
ATC Code A06AX06
DrugBank ID DB01079
KEGG ID D02730
MeSH ID C105050
PubChem ID 135413539
TTD Drug ID D00XWD
NDC Product Code 49706-1964
Synonyms tegaserod | tegaserod maleate | 5-methoxyindol-3-carboxaldehyde amino(pentylamino)methylenehydrazone hydrogen maleate | Zelnorm | Zelmac | SDZ HTF 919 | HTF 919 | SDZ HTF-919
Chemical Information
Molecular Formula C20H27N5O5
CAS Registry Number 189188-57-6
SMILES CCCCCN=C(N)NN=CC1=CNC2=C1C=C(C=C2)OC.C(=CC(=O)O)C(=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)
Haemorrhoids24.10.02.002; 07.15.03.001--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Hypotension24.06.03.002--
Hypovolaemia14.05.05.002--Not Available
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Intestinal gangrene11.02.01.010; 07.15.01.004; 24.04.08.009--Not Available
Intestinal ischaemia24.04.08.001; 07.15.02.001--Not Available
Irritable bowel syndrome19.24.01.003; 07.02.04.003--Not Available
Laryngeal pain22.02.05.036--
Menorrhagia21.01.03.002--
Migraine24.03.05.003; 17.14.02.001--Not Available
Myalgia15.05.02.001--
Nausea07.01.07.001--
Neutrophil count decreased13.01.06.010--
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Pain in extremity15.03.04.010--
Pharyngitis07.05.07.004; 22.07.03.004; 11.01.13.003--
Proctalgia07.03.02.001--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Restlessness17.02.05.021; 19.11.02.002--
Sinus congestion22.04.06.001--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Sleep disorder19.02.04.001--Not Available
Supraventricular tachycardia02.03.03.012--
Syncope17.02.04.008; 02.01.02.008; 24.06.02.012--
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