Granisetron
Granisetron is an anti-nausea medication used to prevent and treat nausea and vomiting caused by chemotherapy, radiation therapy, and surgery.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 6 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Granisetron is an anti-nausea medicine that blocks a serotonin receptor (5-HT3) in the gut and the brain's vomiting center, used to prevent nausea and vomiting from chemotherapy and radiation (and, by injection, after surgery); it is a standard first choice alongside its close cousin ondansetron, on the U.S. market since at least 2005 and available generically. Most people tolerate it well, and headache and constipation are the usual complaints. Watch for serotonin syndrome (agitation, fever, a racing heart, twitching or stiff muscles), especially alongside an antidepressant, tramadol or fentanyl. It can also affect heart rhythm, so your care team needs your full medication list and any heart history.
Clinical pearls
- Tablets or oral solution are usually taken within an hour before chemotherapy or radiation, and only on treatment days.
- Put the Sancuso patch on the upper outer arm at least a day before chemotherapy, and it can stay on up to a week.
- If ondansetron or a similar anti-nausea drug ever caused an allergic reaction, say so first, since granisetron is a close relative.
- It can mask a bowel blockage, so report severe bloating or a swollen belly promptly instead of blaming constipation.
Patient information guide A plain-language walkthrough of Granisetron, written from its FDA label.
What Granisetron is used for
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Granisetron is approved across multiple products and formulations for the prevention — and in some cases treatment — of nausea and vomiting in several settings.
- Prevention of nausea and vomiting from emetogenic (nausea-causing) cancer chemotherapy, including high-dose cisplatin — supported by granisetron hydrochloride tablets, Granisol oral solution, granisetron hydrochloride intravenous injection, and Sancuso skin patch
- Prevention of nausea and vomiting from radiation therapy, including total body irradiation and fractionated abdominal radiation — supported by granisetron hydrochloride tablets and Granisol oral solution
- Prevention and treatment of postoperative nausea and vomiting in adults — supported by granisetron hydrochloride intravenous injection
- Sancuso skin patch: prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days
- Sustol subcutaneous injection: prevention of acute and delayed nausea and vomiting associated with moderately emetogenic chemotherapy or anthracycline and cyclophosphamide combination regimens in adults, used alongside other antiemetics
How Granisetron works
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Granisetron blocks a specific type of serotonin receptor called the 5-HT3 receptor. When chemotherapy or radiation damages cells in the gut lining, those cells release serotonin — a chemical messenger — which activates 5-HT3 receptors on nearby nerves and in a vomiting center in the brain called the chemoreceptor trigger zone. Granisetron selectively binds to these receptors and blocks that signal, preventing the chain reaction that leads to nausea and vomiting.
Granisetron dosage
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Granisetron comes in several forms, and the timing and frequency depend entirely on which product you've been prescribed and why. Tablets and oral solution are taken by mouth on the days chemotherapy or radiation is given — generally within an hour before treatment. The Sancuso skin patch is applied to the upper outer arm before chemotherapy begins and worn for the duration, up to 7 days. Intravenous and subcutaneous injections are given by a healthcare provider before treatment or surgery.
- Tablets and oral solution: taken only on treatment days; continued use on non-treatment days is not recommended
- Sancuso patch: applied at least 24 hours before chemotherapy; do not cut the patch or wear more than one at a time
- Sustol injection: given no more than once every 7 days (less frequently if you have kidney impairment)
Always follow your prescriber's specific instructions — do not adjust the timing or frequency on your own.
Dosing details from the FDA-approved label
From the Granisetron prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Sustol (subcutaneous): prevention of chemotherapy-induced nausea and vomiting in adults
- 10 mg administered as a single subcutaneous injection at least 30 minutes before the start of emetogenic chemotherapy on Day 1, in combination with dexamethasone
- Maximum: Not more frequently than once every 7 days
- Moderate renal impairment (CLcr 30-59 mL/min): not more frequently than once every 14 days; avoid in severe renal impairment (CLcr < 30 mL/min)
- Granisetron hydrochloride injection (intravenous): prevention of chemotherapy-induced nausea and vomiting in adults
- 10 mcg/kg administered intravenously within 30 minutes before initiation of chemotherapy, and only on the day(s) chemotherapy is given
- May be given undiluted over 30 seconds, or diluted and infused over 5 minutes
- Granisetron hydrochloride injection: pediatric patients 2 to 16 years, chemotherapy-induced nausea and vomiting
- 10 mcg/kg
- Pediatric patients under 2 years of age have not been studied
- Prevention of postoperative nausea and vomiting in adults
- 1 mg of granisetron hydrochloride injection, undiluted, administered intravenously over 30 seconds, before induction of anesthesia or immediately before reversal of anesthesia
- Treatment of postoperative nausea and/or vomiting in adults
- 1 mg of granisetron hydrochloride injection, undiluted, administered intravenously over 30 seconds
- Sancuso (transdermal): chemotherapy-induced nausea and vomiting
- A single transdermal system applied to the upper outer arm a minimum of 24 hours, up to a maximum of 48 hours, before chemotherapy
- Worn at minimum 24 hours after chemotherapy is finished
- Can be worn for up to 7 days
- Maximum: Up to 7 days of wear; only one system at any time
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Administration ( 2.1 ): For subcutaneous injection only. Intended for administration by a healthcare provider. Administer in skin of the back of the upper arm or in the skin of the abdomen at least 1 inch away from the umbilicus. Do not administer anywhere the skin is burned, hardened, inflamed, swollen, or otherwise compromised. Due to the viscosity, administration requires a slow, sustained injection over 20 to 30 seconds. Recommended Dosage ( 2.2 ): The recommended dosage in adults is 10 mg administered as a single subcutaneous injection at least 30 minutes before the start of emetogenic chemotherapy on Day 1. Do not administer SUSTOL more frequently than once every 7 days. See full prescribing information for recommended dosage of concomitant dexamethasone. Renal Impairment ( 2.3 ): In patients with moderate renal impairment (Clcr 30-59 mL/min), administer SUSTOL not more frequently than once every 14 days. Avoid SUSTOL in patients with severe renal impairment (CLcr < 30 mL/min). 2.1 Important Administration Instructions For subcutaneous injection only. SUSTOL is intended for administration by a health care provider. SUSTOL is supplied as a refrigerated kit consisting of a single-dose, pre-filled, sterile syringe, a special thin walled 18 Ga 5/8" administration needle, two syringe warming pouches, and a Point Lok ® needle protection device. See the SUSTOL Instructions for Use included in the kit for complete administration instructions with illustrations. Do not substitute non-kit components for any of the components from the kit for administration. Preparation At least 60 minutes prior to administration, remove the SUSTOL kit from refrigeration. Unpack the kit to allow the SUSTOL syringe and all other contents to warm to room temperature. Activate one of the syringe warming pouches, and wrap the SUSTOL syringe in the warming pouch for 5 to 6 minutes to warm SUSTOL to body temperature. Prior to administration, inspect the SUSTOL syringe visually for particulate matter and discoloration. Note that the syringe is amber colored glass. SUSTOL should not be administered if particulate matter or discoloration is observed, the tip cap is missing or has been tampered with, or if the Luer fitting is missing or dislodged. Administration Use standard aseptic technique when performing the injection.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Granisetron side effects
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The most common side effects reported with granisetron include:
Common side effects
- Headache
- Constipation
- Fever
- Abdominal pain
- Elevated liver enzymes (liver test abnormalities)
- Taste changes
- Skin rash
- Weakness or fatigue (asthenia)
When to get medical help
- Signs of serotonin syndrome — agitation, hallucinations, rapid heartbeat, high fever, muscle twitching or stiffness, loss of coordination — especially if you take antidepressants or other serotonin-affecting drugs
- Severe allergic reaction — sudden trouble breathing, drop in blood pressure, hives, or swelling
- Irregular heartbeat or heart rhythm problems, especially if you have a pre-existing heart condition
- Signs of a bowel blockage (ileus) — severe bloating or stomach distension — since granisetron can mask these symptoms
Serious reactions are less common but require prompt medical attention: these include signs of serotonin syndrome (confusion, rapid heartbeat, high fever, muscle stiffness), severe allergic reactions (trouble breathing, hives, sudden low blood pressure), and heart rhythm abnormalities. Contact your care team or seek emergency help right away if any of these occur.
Granisetron warnings and precautions
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- Serotonin syndrome: A potentially life-threatening build-up of serotonin activity can occur, especially when granisetron is combined with other serotonin-affecting drugs such as SSRIs, SNRIs, MAO inhibitors, fentanyl, tramadol, or lithium. Some reported cases have been fatal. Watch for agitation, hallucinations, rapid heartbeat, high fever, sweating, muscle twitching, or loss of coordination — and seek emergency care immediately.
- Heart rhythm effects (QT prolongation): Granisetron has been associated with changes in heart electrical activity. People with pre-existing arrhythmias, heart disease, abnormal electrolyte levels, or who take other QT-prolonging drugs are at greatest risk.
- Bowel masking: Granisetron does not stimulate the digestive tract. After abdominal surgery or during chemotherapy, it may hide the signs of a serious bowel blockage (ileus). It is not a substitute for nasogastric suction.
- Allergic reactions: Severe hypersensitivity reactions — including anaphylaxis — can occur, particularly in people who have previously reacted to other 5-HT3 antagonists.
Granisetron interactions
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Tell your prescriber and pharmacist about all medications you take before starting granisetron — several drug combinations carry important risks.
- Serotonergic drugs (SSRIs, SNRIs, MAO inhibitors, mirtazapine, fentanyl, lithium, tramadol, IV methylene blue): combined use raises the risk of serotonin syndrome, a potentially life-threatening reaction
- QT-prolonging drugs (some antibiotics, antifungals, antipsychotics, antiarrhythmics): using these together with granisetron may increase the risk of serious heart rhythm problems
- CYP450 enzyme inducers (such as phenobarbital): can speed up the breakdown of granisetron, reducing how long it stays in your body
- CYP450 enzyme inhibitors (such as ketoconazole): may slow granisetron's metabolism, potentially increasing its effects
Interactions listed in the FDA-approved label
From the Granisetron prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Benzodiazepines, neuroleptics and anti-ulcer medications: Granisetron hydrochloride injection has been safely administered with these drugs commonly prescribed with antiemetic treatments.
- Emetogenic cancer chemotherapies: Granisetron hydrochloride injection does not appear to interact with them.
- Inducers or inhibitors of hepatic cytochrome P-450 enzymes: They may change the clearance and, hence, the half-life of granisetron.
- Ketoconazole: In in vitro human microsomal studies, ketoconazole inhibited ring oxidation of granisetron; the clinical significance of in vivo interactions is not known.
- Phenobarbital: Hepatic enzyme induction with phenobarbital resulted in a 25% increase in total plasma clearance of intravenous granisetron; the clinical significance is not known.
- Drugs known to prolong the QT interval and/or are arrhythmogenic: Use with granisetron may result in clinical consequences; QT prolongation has been reported with granisetron.
- Serotonergic drugs, including SSRIs and SNRIs: Serotonin syndrome (altered mental status, autonomic instability, neuromuscular symptoms) has been described with concomitant use of 5-HT3 receptor antagonists and these drugs. See Warnings and Precautions (5.4)
Read the label’s full interactions text
7 DRUG INTERACTIONS Granisetron does not induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system in vitro . There have been no definitive drug-drug interaction studies to examine pharmacokinetic or pharmacodynamic interaction with other drugs; however, in humans, granisetron hydrochloride injection has been safely administered with drugs representing benzodiazepines, neuroleptics and anti-ulcer medications commonly prescribed with antiemetic treatments. Granisetron hydrochloride injection also does not appear to interact with emetogenic cancer chemotherapies. Because granisetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of granisetron. No specific interaction studies have been conducted in anesthetized patients. In addition, the activity of the cytochrome P-450 subfamily 3A4 (involved in the metabolism of some of the main narcotic analgesic agents) is not modified by granisetron hydrochloride in vitro . In in vitro human microsomal studies, ketoconazole inhibited ring oxidation of granisetron hydrochloride. However, the clinical significance of in vivo pharmacokinetic interactions with ketoconazole is not known. In a human pharmacokinetic study, hepatic enzyme induction with phenobarbital resulted in a 25% increase in total plasma clearance of intravenous granisetron hydrochloride. The clinical significance of this change is not known. QT prolongation has been reported with granisetron hydrochloride. Use of granisetron hydrochloride in patients concurrently treated with drugs known to prolong the QT interval and/or are arrhythmogenic may result in clinical consequences.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Granisetron
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- Do not take granisetron if you have a known allergy to granisetron or any other 5-HT3 receptor antagonist (such as ondansetron or dolasetron)
- Tell your doctor if you have a heart rhythm disorder, heart disease, or abnormal blood electrolyte levels (such as low potassium or magnesium)
- Tell your doctor about all prescription and over-the-counter medications, especially antidepressants, opioid pain medicines, or any drug that affects heart rhythm
- Sustol: avoid if you have severe kidney impairment; use with reduced frequency in moderate kidney impairment
- Pregnancy: limited human safety data are available; animal studies showed no harm, but discuss the risks and benefits with your doctor
- Breastfeeding: it is not known whether granisetron passes into breast milk; weigh the benefits of breastfeeding against potential risks with your doctor
- Children: Sustol is not recommended under age 18; tablets and Granisol oral solution have not been established as safe and effective in children; intravenous granisetron hydrochloride has been studied in children aged 2–16 for chemotherapy-related nausea
- Older adults: no dose adjustment is typically required, but older adults may be more sensitive; clearance may be slower with intravenous granisetron in elderly patients
Granisetron overdose
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There is no specific antidote for a granisetron overdose. If too much is taken, treatment focuses on managing any symptoms that arise. Overdoses of up to very large single intravenous doses have been reported with no symptoms or only headache, but any suspected overdose should be reported to a healthcare provider or poison control immediately.
What Granisetron does in the body
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Granisetron is highly selective — it blocks 5-HT3 serotonin receptors with little to no effect on other receptor types, including dopamine, histamine, or opioid receptors. Studies show granisetron generally has little effect on blood pressure, heart rate, or heart electrical activity (ECG) in most people, though QT prolongation has been reported. It does not stimulate movement in the stomach or intestines, and oral doses have been shown to slow movement in the colon.
How your body processes Granisetron
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Granisetron is broken down primarily by the liver, through a process involving the CYP3A enzyme family, and is cleared mainly as metabolites — about half through the urine and about a third through the feces, with only a small fraction excreted unchanged. The Sancuso patch delivers granisetron slowly through the skin over up to 7 days, reaching peak blood levels around 48 hours after application; heat applied over the patch can increase absorption. In people with liver disease, clearance is significantly reduced. People with severe kidney disease do not appear to have significantly altered clearance of granisetron itself, though Sustol has additional kidney-related cautions due to its polymer vehicle.
How to store Granisetron
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Store single-dose vials and multiple-dose vials at 20º to 25°C (68º to 77°F) . Protect from light. Do not freeze.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Granisetron
38 supplements and herbal products have documented interactions with Granisetron in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 2
- Moderate · 25
- Minor · 11
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Granisetron: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Granisetron — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is granisetron used for?
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How does the Sancuso patch work differently from the pill or injection?
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What side effects should I actually expect?
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When should I call my doctor or get help immediately?
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Can I use a heating pad while wearing the Sancuso patch?
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Is granisetron safe if I'm pregnant or breastfeeding?
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Is Granisetron available over the counter?
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When was Granisetron first available?
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Who makes Granisetron?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Granisetron on HelloPharmacist
Granisetron forms and strengths (how it comes)
Granisetron is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Granisetron inactive ingredients by manufacturer.
Injection
How this form is used
- Granisetron Hydrochloride intravenous injection: prevention of nausea and vomiting from emetogenic chemotherapy, including high-dose cisplatin
- Granisetron Hydrochloride intravenous injection: prevention and treatment of postoperative nausea and vomiting in adults
- Sustol subcutaneous injection: prevention of acute and delayed nausea and vomiting from moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens in adults, used with other antiemetics
- Granisetron Hydrochloride intravenous injection: given by a healthcare provider into a vein before chemotherapy or before/after surgery
- Sustol: given by a healthcare provider as a subcutaneous (under-the-skin) injection in the back of the upper arm or abdomen, at least 30 minutes before chemotherapy
- Sustol: administered no more than once every 7 days; in moderate kidney impairment, no more than once every 14 days
- Sustol: avoid in patients with severe kidney impairment
Tablet
How this form is used
- Granisetron hydrochloride tablets: prevention of nausea and vomiting from emetogenic chemotherapy, including high-dose cisplatin
- Granisetron hydrochloride tablets: prevention of nausea and vomiting from radiation, including total body irradiation and fractionated abdominal radiation
- Granisetron hydrochloride tablets: taken by mouth up to 1 hour before chemotherapy or within 1 hour of radiation, only on the days treatment is given
- Granisetron hydrochloride tablets: may be taken as a once-daily or twice-daily regimen for chemotherapy (follow your prescriber's instructions)
- Granisetron hydrochloride tablets: continued use on non-treatment days has not been found beneficial
Oral solution
How this form is used
- Granisol: prevention of nausea and vomiting from emetogenic chemotherapy, including high-dose cisplatin
- Granisol: prevention of nausea and vomiting from radiation, including total body irradiation and fractionated abdominal radiation
- Granisol: taken by mouth up to 1 hour before chemotherapy or radiation, only on the days treatment is given
- Granisol: may be taken once daily or in two divided doses 12 hours apart for chemotherapy (follow prescriber's instructions for your specific regimen)
- Granisol: continued use on non-treatment days has not been found beneficial
Skin patch
How this form is used
- Sancuso: prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days
- Sancuso: apply one patch to clean, dry, nearly hairless skin on the upper outer arm at least 24 hours — and up to 48 hours — before chemotherapy starts
- Sancuso: wear the patch for at least 24 hours after chemotherapy ends; the patch can be worn up to 7 days total
- Sancuso: do not cut the patch, do not apply heat pads or heat lamps over it, and cover with clothing if exposed to direct sunlight during wear and for 10 days after removal
- Sancuso: only wear one patch at a time; do not apply to red, irritated, or damaged skin
Granisetron on the U.S. market: products, makers and brands
How Granisetron appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
10 companies list 14 Granisetron product records with the FDA, mostly as injection, tablet, oral solution; the earliest marketing or approval year on record is 1993. Brand names on the directory include Kytril, Sustol, Granisol and 1 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (14) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Granisetron is used (Medicaid data)
A general measure of how commonly Granisetron is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Granisetron is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Granisetron prescribed? Of the 1,601 medications we measure, Granisetron ranks #680 by Medicaid prescriptions — more than 58% of them.
Utilization by Granisetron product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
1 ML granisetron 1 MG/ML Injection Most dispensed
Summed across the 3 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1734399
granisetron 1 MG/ML Injectable Solution
Summed across the 2 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 240912
granisetron 1 MG Oral Tablet
Summed across the 5 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310599
0.4 ML granisetron 25 MG/ML Prefilled Syringe
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1810484
168 HR granisetron 0.129 MG/HR Transdermal System
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 825003
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Granisetron, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 12 of 40 listed Granisetron NDCs with Medicaid activity.
Compare Granisetron products
A representative set of FDA-listed product records for Granisetron — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 1 mg/mL | Intravenous | Eugia US LLC | ANDA | View NDC → |
| 4 mg/4 mL | Intravenous | Eugia US LLC | ANDA | View NDC → |
| 1 mg/mL | Intravenous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 10 mg/0.4 mL | Subcutaneous | Heron Therapeutics, Inc. | NDA | View NDC → |
| 1 mg/mL | Intravenous | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 0.1 mg/mL | Intravenous | Mylan Institutional LLC | ANDA | View label ↗ |
| 1 mg/mL | Intravenous | Mylan Institutional LLC × 2 listings | ANDA | View NDC → |
| 💊Oral solution | ||||
| 2 mg/10 mL | Oral | Intra-Sana Laboratories | ANDA | View NDC → |
| 💊Skin patch | ||||
| GRANISETRON 3.1 mg/24h | Transdermal | Cumberland Pharmaceuticals Inc. | NDA | View NDC → |
| 💊Tablet | ||||
| 1 mg | Oral | Bionpharma Inc. | ANDA | View NDC → |
| 1 mg | Oral | Breckenridge Pharmaceutical, Inc. | ANDA | View NDC → |
| 1 mg | Oral | Natco Pharma Limited | ANDA | View NDC → |
Showing 14 of 14 products — FDA National Drug Code Directory. See every product, package size and price: browse all 14 Granisetron NDCs →
Granisetron side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Granisetron — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Granisetron in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Granisetron FDA approval history
How Granisetron went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Granisetron recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Granisetron recalls since July 2021.
✅No Granisetron recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 26237 6 dose forms · 8 strengths
-
Dose form (SCDF) Injectable Solution RxCUI 377124In current FDA listingsClinical drug / strength (SCD) 1 MG/MLRxCUI 240912 -
Dose form (SCDF) Injection RxCUI 1734395In current FDA listingsClinical drug / strength (SCD) 1 ML granisetron 0.1 MG/MLRxCUI 5432181 ML granisetron 1 MG/MLRxCUI 1734399 -
Dose form (SCDF) Oral Solution RxCUI 372349In current FDA listingsClinical drug / strength (SCD) 0.2 MG/MLRxCUI 251426 -
Dose form (SCDF) Oral Tablet RxCUI 372350In current FDA listings -
Dose form (SCDF) Prefilled Syringe RxCUI 1810483No current FDA listingClinical drug / strength (SCD) 0.4 ML granisetron 25 MG/MLRxCUI 1810484 -
Dose form (SCDF) Transdermal System RxCUI 1806407In current FDA listingsClinical drug / strength (SCD) 168 HR granisetron 0.129 MG/HRRxCUI 825003
Look up RxCUI 26237 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Granisetron supply and shortage status
Whether Granisetron is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Granisetron costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 1 mg | $1.31 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Granisetron brand names
Granisetron is sold under 4 brand names in the FDA directory — Kytril, Sustol, Granisol, Sancuso. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Granisetron: manufacturers and labelers
10 companies list Granisetron products with the FDA. By number of product records, the largest are Mylan Institutional LLC, Eugia US LLC, Hikma Pharmaceuticals USA Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Granisetron drug class (RxNorm)
Granisetron belongs to the Serotonin-3 Receptor Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Granisetron page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Heron Therapeutics is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →