Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tegaserode
Drug ID BADD_D02140
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2002 for the treatment of irritable bowel syndrome with constipation (IBS-C).[L5918,F4229] It was, however, voluntarily withdrawn from widespread use in the US market in 2007 after concerns arose over the possibility that tegaserod could potentially cause dangerous cardiovascular events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 D06056
MeSH ID C105050
PubChem ID Not Available
TTD Drug ID D00XWD
NDC Product Code Not Available
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 Not Available
CAS Registry Number 145158-71-0
SMILES Not Available
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)
Suicide attempt19.12.01.004--
Supraventricular tachycardia02.03.03.012--
Syncope24.06.02.012; 17.02.04.008; 02.01.02.008--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Vertigo17.02.12.002; 04.04.01.003--
Visual impairment06.02.06.008--Not Available
Vomiting07.01.07.003--
Subileus07.13.01.004--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Affect lability19.04.01.001--Not Available
Transaminases increased13.03.01.015--Not Available
Rectal tenesmus15.05.03.011; 07.03.03.001--Not Available
Angiopathy24.03.02.007--Not Available
Urine output increased13.13.03.002--Not Available
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.01.01.003--Not Available
Connective tissue disorder15.06.01.006--Not Available
Infestation23.09.05.001; 11.09.01.001--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Inner ear disorder04.04.02.002--Not Available
Polyp16.02.02.005; 08.01.06.010--Not Available
Hepatobiliary disease09.01.08.003--Not Available
Sphincter of Oddi dysfunction09.02.02.004; 07.18.02.002--Not Available
Anorectal discomfort07.03.03.003--Not Available
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