| 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2002 for the treatment of irritable bowel syndrome with constipation (IBS-C).[L5918,F4229] It was, however, voluntarily withdrawn from widespread use in the US market in 2007 after concerns arose over the possibility that tegaserod could potentially cause dangerous cardiovascular events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 |
Tegaserod is a serotonin-4 (5-HT4) receptor agonist indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C) [F4223, F4229]. The safety and effectiveness of tegaserod in men with IBS-C have not been established [F4223, F4229]. |
| Marketing Status |
approved; investigational; withdrawn |
| ATC Code |
A06AX06 |
| DrugBank ID |
DB01079
|
| KEGG ID |
D06056; D02730
|
| MeSH ID |
C105050
|
| PubChem ID |
Not Available
|
| TTD Drug ID |
D00XWD
|
| NDC Product Code |
73435-022 |
| UNII |
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 |
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| ADRs Induced by Drug |
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*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'.
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| ADR Term |
ADReCS ID |
ADR Frequency (FAERS)
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ADR Severity Grade (FAERS)
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ADR Severity Grade (CTCAE)
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| Heavy menstrual bleeding | 21.01.03.005 | - | - | - |
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