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2002 for the treatment of irritable bowel syndrome with constipation (IBS-C).[L5918,F4229] It was, however, voluntarily withdrawn from widespread use in the US market in 2007 after concerns arose over the possibility that tegaserod could potentially cause dangerous cardiovascular events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)
Intestinal ischaemia24.04.08.001; 07.15.02.001--Not Available
Laryngeal pain22.02.05.036--
Loss of consciousness17.02.04.004--Not Available
Menorrhagia21.01.03.002--
Mental disability26.01.01.001--Not Available
Mental impairment17.03.03.002; 19.21.02.003--Not Available
Mesenteric vascular insufficiency24.04.08.011; 07.15.02.010--Not Available
Migraine24.03.05.003; 17.14.02.001--Not Available
Mood swings19.04.03.001--Not Available
Muscle spasms15.05.03.004--
Myalgia15.05.02.001--
Nausea07.01.07.001--
Neoplasm16.16.02.001--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Osteoarthritis15.01.04.001--Not Available
Ovarian cyst21.11.01.002; 16.04.03.001--Not Available
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Polyuria20.02.03.002--Not Available
Proctalgia07.03.02.001--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Renal pain20.02.03.003--Not Available
Shock24.06.02.002--Not Available
Sinus congestion22.04.06.001--Not Available
Sinusitis11.01.13.005; 22.07.03.007--
Skin disorder23.03.03.007--Not Available
Sleep disorder19.02.04.001--Not Available
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