Prescription medicine
Granisetron Brand names: Sustol, Sancuso, Granisol; first approved as Kytril
Granisetron (Kytril) is a prescription medicine with an FDA approval on record since 1993. FDA's NDC Directory lists it from 8 generic labelers, and pharmacies paid $1.31 per granisetron HCl 1 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $685.85 per Sancuso 3.1 mg/24 hr patch.
- Generic listed
Check it at the source: the granisetron FDA label on DailyMed (effective August 31, 2017, Mylan Institutional LLC); the NDA 20239 record on Drugs@FDA; every granisetron label on DailyMed.
Highlights of the record
FDA label of August 31, 2017; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageGranisetron hydrochloride injection is a serotonin-3 (5-HT 3 ) receptor antagonist indicated for:
The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
Forms and strengths
- 1 mg
- 0.1 mg/ml
- 1 mg/ml
- 2 mg/10ml
- 3.1 mg/24h
- 4 mg/4ml
- 10 mg/.4ml
Injection (solution); injection; film-coated tablet; solution; tablet.
On the market
- Earliest approval on file
- December 29, 1993 Kytril, Roche; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 48 first December 31, 2007; 25 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 8 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.31 per tablet Granisetron HCl 1 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2019 0 Class I among all firms' recalls; latest June 12, 2019; 1 more by firms not listed as its makers
- FAERS reports
- 12,067 through July 30, 2026
What is granisetron used for?
From the label: indications and usageGranisetron hydrochloride injection is a serotonin-3 (5-HT 3 ) receptor antagonist indicated for:
The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
The prevention and treatment of postoperative nausea and vomiting in adults. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. […]
Conditions named in the indications of granisetron's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Serotonin-3 Receptor Antagonist.
Source: FDA drug label (Granisetron Hydrochloride), Mylan Institutional LLC, effective August 31, 2017 (SPL set 8d88adba-7f5e-4e97-84b3-6ca8ec98c023), via openFDA; the full label on DailyMed
What does the patient leaflet for granisetron say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SUSTOL?SUSTOL can cause serious side effects, including: Serious injection site reactions. Some injection site reactions may be serious or severe and require medical care. Injection site reactions may include infections, prolonged bleeding, bruising, swelling that is caused by blood that collects under the skin (hematoma), small bumps (nodules) at the injection site, pain, and tenderness. Some injection site reactions can happen up to 2 weeks or more after receiving SUSTOL. Tell your healthcare provider if you have: ο pain or tenderness that you need to take pain medicine for or if you have pain that interferes with your daily activity. ο bruising, hematoma, or a nodule at the injection site that does not go away. Your risk of severe bruising and hematomas at the injection site is increased if you take a blood thinner medicine (anticoagulant or antiplatelet medicine). […] Get emergency medical help right away if you have any signs or symptoms of a serious allergic reaction, including: ο hives ο breathing trouble ο swollen face ο chest pain […]
Source: FDA drug label (SUSTOL), Heron Therapeutics, Inc., effective April 30, 2026 (SPL set f7c7ffdd-8270-4030-bc1e-a1cb28a6de56), via openFDA; the full label on DailyMed
Is there a generic for granisetron (Kytril)?
The FDA approved the first generic granisetron on December 31, 2007. 48 generic applications are approved; 25 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists granisetron from 8 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1993 earliest approval on file
- 2007 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for granisetron (Kytril)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.31 per Granisetron HCl 1 mg tablet, down 19% from $1.62 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Granisetron HCl 1 mg tablet (generic)
- Sancuso 3.1 mg/24 hr patch (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Granisetron HCl 1 mg tablet | Generic | $1.31 per tablet | $39.15 | -19% |
| Sancuso 3.1 mg/24 hr patch | Brand | $685.85 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has granisetron been recalled?
The FDA's Enforcement Report lists 2 recalls naming granisetron since 2019: 0 Class I (the most serious), 2 Class II, 0 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of granisetron and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the granisetron label say about other medicines?
The granisetron label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name granisetron. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Fentanyl | warnings and precautions | Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake Inhibitors (SNRIs), monoamine oxidase Inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). |
| Ketoconazole | drug interactions | In in vitro human microsomal studies, ketoconazole inhibited ring oxidation of granisetron hydrochloride. |
| Lithium | warnings and precautions | Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake Inhibitors (SNRIs), monoamine oxidase Inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). |
| Methylene blue | warnings and precautions | Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake Inhibitors (SNRIs), monoamine oxidase Inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). |
| Mirtazapine | warnings and precautions | Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake Inhibitors (SNRIs), monoamine oxidase Inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). |
| Phenobarbital | drug interactions | In a human pharmacokinetic study, hepatic enzyme induction with phenobarbital resulted in a 25% increase in total plasma clearance of intravenous granisetron hydrochloride. |
| Tramadol | warnings and precautions | Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake Inhibitors (SNRIs), monoamine oxidase Inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). |
Other labels that name granisetron
Source: FDA drug label (Granisetron Hydrochloride), Mylan Institutional LLC, effective August 31, 2017 (SPL set 8d88adba-7f5e-4e97-84b3-6ca8ec98c023), via openFDA; the full label on DailyMed
What do FAERS reports show for granisetron?
The FDA Adverse Event Reporting System holds 12,067 reports that list granisetron among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,221 are coded as a death and 5,990 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as granisetron?
3 other medicines are given the same way (intravenous) and in the same FDA class as granisetron or labeled mainly for the same use (nausea and vomiting), the same class first. Nausea and vomiting lists all 16 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Palonosetron | Nausea and vomiting | 14 labelers | n/a | A presentation being discontinued |
| Aprepitant | Nausea and vomiting | none listed | n/a | A presentation being discontinued |
| Amisulpride | Nausea and vomiting | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as granisetron
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does granisetron compare with medicines for the same use?
3 side-by-side pages set granisetron beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to granisetron
- 3 medicines for the same use
- Other serotonin-3 receptor antagonists
- the pharmacologic class, with prices and generics
- Granisetron side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other