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Molecule

Granisetron

Also known as granisetron hydrochloride
Available on requestCold chainGastroenterology
Presentations
7
Brands
3
Manufacturers
3
Available from stock
0

Granisetron is a serotonin-3 receptor antagonist indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration. MedsAcross supplies Granisetron for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Serotonin-3 Receptor Antagonist, Serotonin 3 Receptor Antagonists
ATC classification
A04AA02 Granisetron · Anti-nausea and anti-vomiting medicines, subgroup A04A, subgroup A04AA
US FDA first approval
29 December 1993
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous, Oral, Subcutaneous, Transdermal
Dosage forms
Injection, Tablet, Oral solution, Transdermal patch
Identifiers
UNII WZG3J2MCOLRxCUI 26237CAS 109889-09-0DrugBank DB00889Q596708

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

SANCUSO ® is indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration. SANCUSO is a serotonin-3 (5-HT 3 ) receptor antagonist indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days.

Source: US FDA prescribing information

How it works

Granisetron is a selective 5-hydroxytryptamine 3 (5-HT 3 ) receptor antagonist with little or no affinity for other serotonin receptors, including 5-HT 1, 5-HT 1A, 5-HT 1B/C, 5-HT 2, for alpha 1 -, alpha 2 -, or beta-adrenoreceptors, for dopamine-D 2, or for histamine-H 1, benzodiazepine, picrotoxin or opioid receptors. Serotonin receptors of the 5-HT 3 type are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT 3 receptors. This evokes vagal afferent discharge, inducing vomiting. Animal studies demonstrate that, in binding to 5-HT 3 receptors, granisetron blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin.

Source: US FDA prescribing information

Dosing overview

The recommended dosage is a single transdermal system applied to the upper outer arm a minimum of 24 hours, up to a maximum of 48 hours, before chemotherapy. The transdermal system should be worn at minimum, 24 hours after chemotherapy is finished. The transdermal system can be worn for up to 7 days. Application and Removal Instructions Each transdermal system releases 3.1 mg of granisetron per 24 hours for up to 7 days. Each transdermal system is packed in a pouch and should be applied directly after the pouch has been opened. Only wear one transdermal system at any time. Do not cut the transdermal system. Open the pouch and apply the transdermal system to clean, dry, nearly hairless, intact healthy skin on the upper outer arm. Do not place SANCUSO transdermal system on skin that is red, irritated, or damaged.

Source: US FDA prescribing information

Contraindications

SANCUSO is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the transdermal system. Known hypersensitivity to granisetron or to any of the components of the transdermal system

Source: US FDA prescribing information

Warnings and precautions

Progressive Ileus and Gastric Distention: Granisetron may mask a progressive ileus and/or gastric distention, consider before use in patients with abdominal surgery. Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction. Serotonin Syndrome: Serotonin syndrome has been reported with 5-HT 3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. If such symptoms occur, discontinue SANCUSO and initiate supportive treatment. If concomitant use of SANCUSO with other serotonergic drugs is clinically warranted, patients should be aware of a potential increased risk of serotonin syndrome. Skin Reactions: Mild application site reactions have occurred, remove SANCUSO transdermal system if severe reactions or a generalized skin reaction occur.

Source: US FDA prescribing information

Side effects

The following are serious or otherwise clinically significant adverse reactions reported in other sections of labeling: Progressive ileus and gastric distention Serotonin syndrome Skin reactions Increased drug exposure with use of external heat sources Phototoxicity with ultraviolet light exposure [se Warnings and Precautions ] The most common adverse reaction (≥ 3%) is constipation.

Source: US FDA prescribing information

Interactions

Serotonergic Drugs Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT 3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs). Monitor for the emergence of serotonin syndrome. If symptoms occur, discontinue SANCUSO and initiate supportive treatment.

Source: US FDA prescribing information

Storage

Store at 20°-25°C (68°-77°F), excursions permitted between 15°-30°C (59°-86°F). SANCUSO should be stored in the original packaging.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

7 presentations of Granisetron, sorted by availability.

MedicineManufacturerRegisterAvailability
Granisetron 1 mg tabletOralGeneric name—US FDAAvailable on request
Granisetron 1 mg/1 mL injectionIntravenousGeneric name—US FDAAvailable on request
Granisetron 4 mg/4 mL injectionIntravenousGeneric name—US FDAAvailable on request
Granisol 2 mg/10 mL oral solutionOralIntra-Sana LaboratoriesUS FDAAvailable on request
Sancuso 3.1 mg/24 hours transdermal patchTransdermalCumberland PharmaceuticalsUS FDAAvailable on request
Granisetron 0.1 mg/mL injectionIntravenousGeneric name—US FDAAvailable on request
Sustol 10 mg/0.4 mL injectionSubcutaneous Cold chainHeron TherapeuticsUS FDAAvailable on request

Brands by market

3 brand names across 1 markets.

Brand names by country

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 29 December 1993Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Granisetron available for export from India?

Yes, on request. MedsAcross lists 7 presentations of Granisetron and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Granisetron have?

The catalogue lists 3 brand names for Granisetron, including Granisol, Sancuso, Sustol.

Is Granisetron approved by the US FDA?

Yes. The US FDA first approved Granisetron on 29 December 1993, according to Drugs@FDA.

Is Granisetron authorised in the European Union?

Yes. Granisetron has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Granisetron need cold chain shipping?

At least one listed presentation of Granisetron must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Granisetron in?

Granisetron is classified under ATC code A04AA02 (Granisetron).

References

  1. SANCUSO prescribing information (Cumberland Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 4 November 2024
  2. Sancuso: European public assessment report (EPAR). European Medicines Agency. Retrieved 2 December 2024

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