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2002 for the treatment of irritable bowel syndrome with constipation (IBS-C).[L5918,F4229] It was, however, voluntarily withdrawn from widespread use in the US market in 2007 after concerns arose over the possibility that tegaserod could potentially cause dangerous cardiovascular events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)
Dyspepsia07.01.02.001--
Dyspnoea22.02.01.004; 02.01.03.002--
Ear disorder04.03.01.001--Not Available
Eosinophil count increased13.01.06.004--Not Available
Eosinophilia01.02.04.001--
Eructation07.01.02.003--
Eye disorder06.08.03.001--Not Available
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.003--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Fungal infection11.03.05.001--Not Available
Gastritis07.08.02.001--
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Haemorrhoids24.10.02.002; 07.15.03.001--
Headache17.14.01.001--
Hepatitis09.01.07.004--Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.003--Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003--
Hypokalaemia14.05.03.002--
Hypotension24.06.03.002--
Hypovolaemia14.05.05.002--Not Available
Immune system disorder10.02.01.001--Not Available
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Infection11.01.08.002--Not Available
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
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