FDA-filed SPL labeling · retrieved through openFDA

Dolasetron

Dolasetron is a serotonin blocker used to prevent nausea and vomiting caused by cancer chemotherapy.

Brand name Anzemet
Drug classes Serotonin 3 Receptor Antagonists
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 1 clinical label set 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 →

At a glance
Linked label effectiveDec 12, 2023
AvailabilityRx
Earliest approval/marketing year 1997
FDA-listed product records 5
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 23, 2026
Other forms & routes:
Dolasetron at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Dolasetron (Anzemet) is a well-established option for preventing chemotherapy-related nausea and vomiting in adults and children 2 and older. It carries important heart rhythm risks — especially for people with underlying heart conditions or low potassium/magnesium levels — so let your care team know your full medical history before taking it. Take it as directed by your prescriber, typically about an hour before your chemotherapy session.

📖 Dolasetron: Patient Information Guide

A plain-language walkthrough of Dolasetron — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Dolasetron is used to prevent nausea and vomiting triggered by cancer chemotherapy.

  • Anzemet Tablets are approved to prevent nausea and vomiting caused by moderately emetogenic (nausea-inducing) cancer chemotherapy in adults and in children 2 years of age and older, including both first-time and repeat treatment courses.
⚙️How it works

Dolasetron works by blocking serotonin receptors known as 5-HT3 receptors. When chemotherapy is given, it triggers the release of serotonin (a chemical messenger) in the small intestine. That serotonin activates 5-HT3 receptors on nerve pathways that send signals to the brain's vomiting center. By blocking those receptors — both in the gut and in the brain — dolasetron interrupts that chain reaction and prevents the nausea and vomiting reflex from firing.

Unlike some older anti-nausea drugs, dolasetron has very little activity at dopamine receptors and does not appear to affect mood, concentration, or colonic (large intestine) movement in humans.

💊How it's taken

Anzemet Tablets are taken by mouth roughly one hour before chemotherapy. Food does not affect how well the drug is absorbed, so you can take it with or without a meal. No dosage adjustment is needed for liver or kidney disease, but your doctor may want to monitor your heart rhythm (ECG) if you have kidney impairment or are older.

  • Take Anzemet Tablets approximately one hour before chemotherapy starts
  • Can be taken with or without food
  • Do not exceed the dose your prescriber has prescribed
  • Always follow your prescriber's specific instructions
🤒Side effects — in detail

The most commonly reported side effects with Anzemet Tablets include:

  • Headache — the most frequently reported effect
  • Fatigue
  • Diarrhea
  • Slow heartbeat (bradycardia)
  • Fast heartbeat (tachycardia)
  • Dizziness
  • Upset stomach (dyspepsia)
  • Chills or shivering

More serious reactions — including dangerous heart rhythm changes, fainting, and signs of serotonin syndrome (agitation, muscle twitching, fever, rapid heart rate) — should be treated as medical emergencies. Contact your care team or call 911 right away if these occur.

⚠️Warnings & precautions
  • Heart rhythm (QT prolongation): Dolasetron prolongs the QT interval in a dose-related way, which can trigger a dangerous arrhythmia called Torsade de Pointes. Avoid it if you have congenital long QT syndrome, or low potassium or magnesium levels — these must be corrected first.
  • PR and QRS prolongation: Dolasetron can also slow other parts of the heart's electrical system. Serious events including second- or third-degree heart block, cardiac arrest, and life-threatening arrhythmias have been reported. People with structural heart disease, sick sinus syndrome, atrial fibrillation, myocardial ischemia, or complete heart block are at highest risk.
  • ECG monitoring: Recommended for elderly patients, those with renal impairment, congestive heart failure, bradycardia, or any significant conduction abnormality.
  • Serotonin syndrome: Using dolasetron with other serotonergic drugs can cause serotonin syndrome — a potentially fatal reaction. Watch for agitation, hallucinations, fever, fast heart rate, muscle rigidity, or loss of coordination. Seek immediate care if these occur.
  • Hypersensitivity: Do not take if you have a known allergy to dolasetron.
🔀What it interacts with

Dolasetron's overall interaction risk is considered low, but some combinations require caution:

  • QT-prolonging drugs (e.g., flecainide, quinidine): combining these with dolasetron increases the risk of dangerous heart rhythm problems
  • PR-prolonging drugs (e.g., verapamil): increases risk of heart conduction slowing
  • Cimetidine (heartburn drug): raises blood levels of dolasetron's active form by about 24%
  • Rifampin (antibiotic): lowers blood levels of dolasetron's active form by about 28%, which could reduce its effectiveness
  • Serotonergic drugs (SSRIs, SNRIs, MAO inhibitors, tramadol, lithium, mirtazapine, fentanyl, intravenous methylene blue): significantly raise the risk of serotonin syndrome
  • Drugs or conditions causing low potassium or magnesium (e.g., some diuretics): worsen the heart rhythm risks associated with dolasetron

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Tell your doctor if you have any heart condition — especially long QT syndrome, heart block, sick sinus syndrome, atrial fibrillation, myocardial ischemia, or congestive heart failure
  • Tell your doctor if you have kidney impairment — ECG monitoring is recommended
  • Tell your doctor if you are elderly — QT prolongation risk is higher and ECG monitoring may be needed
  • Tell your doctor about ALL medications you take, especially antidepressants, anti-arrhythmic drugs, or any drug that affects heart rhythm
  • Low potassium or magnesium levels must be corrected before you start this medication
  • Do not take Anzemet if you have a known allergy to dolasetron
  • Anzemet Tablets have not been studied in children under 2 years of age and are not recommended for that age group
  • Tell your doctor if you have liver problems — while no dose adjustment is required, your doctor should know your full history
🚑If you take too much

There is no specific antidote for a dolasetron overdose. If an overdose is suspected, treatment is supportive — meaning doctors will manage symptoms as they appear. Heart rhythm changes (including prolonged PR, QRS, and QT intervals) are the main concern with excessive doses, and cardiac monitoring may be needed.

📡Pharmacodynamics — effects in the body

Dolasetron selectively blocks 5-HT3 serotonin receptors and has very low affinity for dopamine receptors. In clinical studies, it did not affect pupil size, EEG brain wave patterns, mood, concentration, colonic movement, or prolactin hormone levels. At higher doses, it prolongs the QT, PR, and QRS intervals on an ECG — effects that are dose-dependent and primarily linked to its active metabolite, hydrodolasetron.

🔬Pharmacokinetics — how your body processes it

After you take an Anzemet Tablet, dolasetron is rapidly and almost completely converted in the body to its active form, hydrodolasetron. This active metabolite reaches peak blood levels in about one hour and has a mean half-life of roughly 8 hours — meaning it takes about that long for half of it to leave your system. About 75% of the oral dose is effectively absorbed (bioavailability), and food does not change this. The body clears hydrodolasetron mainly through the kidneys (about two-thirds) and through the feces (about one-third).

📦How to store it

Store at 68° to 77°F (20° to 25°C) . Protect from light.

📄 Written from Dolasetron’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

169

Supplements & herbs that interact with Dolasetron

169 supplements and herbal products have documented interactions with Dolasetron in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 4
  • Moderate · 123
  • Minor · 42
Every supplement checked against Dolasetron — ranked by severity The full interaction hub: 4 major · 123 moderate · 42 minor · every one linked to its full report. Check Dolasetron against your exact supplements

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.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Dolasetron — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Anzemet for, and when do I take it?
Anzemet is used to prevent the nausea and vomiting that chemotherapy can cause — it's not a pain reliever or a treatment for the cancer itself. You take it by mouth about one hour before your chemotherapy session starts. It works best when taken before nausea begins, so timing matters. Follow your prescriber's instructions exactly, and don't skip the dose before chemo.
Can I take Anzemet with food, or does it need to be on an empty stomach?
Good news — food doesn't affect how well Anzemet is absorbed, so you can take it with or without a meal. Whatever is easiest on your stomach that day is fine. Just try to take it about an hour before your chemotherapy starts, as directed.
What side effects should I watch out for?
The most common ones are headache, fatigue, diarrhea, and dizziness — these are usually manageable. However, some people experience changes in heart rate (either too slow or too fast), so let your care team know if your heartbeat feels off, if you feel faint, or if you have chest pain. Those symptoms need prompt medical attention.
I take an antidepressant — is that a problem with Anzemet?
It can be, so it's important to tell your doctor and pharmacist about every medication you take. Some antidepressants — including SSRIs and SNRIs — can interact with Anzemet and raise the risk of a serious reaction called serotonin syndrome. Signs include agitation, muscle twitching, fever, and a racing heart. Your care team can decide whether the combination is safe and watch for any warning signs.
I have a heart condition — is Anzemet safe for me?
That depends on the specific condition, and your doctor needs to know your full heart history before you take this medication. Anzemet can affect the heart's electrical system — it can lengthen certain intervals on an ECG, which increases the risk of irregular heartbeats. People with conditions like long QT syndrome, heart block, or slow heart rate need extra caution, and some may need heart rhythm monitoring (an ECG) while taking it. Never take it without letting your cardiologist and oncologist know.
My child is having chemotherapy — can kids take Anzemet Tablets?
Yes, Anzemet Tablets are approved for children 2 years of age and older. Children under 2 haven't been studied with this medication, so it's not recommended for that age group. The dose for children is based on body weight, up to a maximum amount — your child's oncologist will calculate the right dose. Follow their instructions carefully.
Is Dolasetron available over the counter?
Dolasetron is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Dolasetron first available?
Dolasetron has been available in the United States since at least 1997, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Dolasetron?
Dolasetron is supplied by 3 manufacturers listed in the FDA NDC Directory, including USV Private Limited, Validus Pharmaceuticals LLC, Emcure Pharmaceuticals Limited.

💬 Answers drafted from Dolasetron’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Dolasetron comes

Dolasetron is available in 1 form. 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.

Tablet

By mouth
Brands Anzemet
How this form is used
What it may be used for
  • Anzemet Tablets are used to prevent nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults
  • Anzemet Tablets are used to prevent nausea and vomiting associated with moderately emetogenic cancer chemotherapy in children 2 years and older
  • Anzemet Tablets are indicated for both initial and repeat courses of chemotherapy
Important instructions
  • Anzemet Tablets should be taken by mouth about one hour before chemotherapy
  • Anzemet Tablets can be taken with or without food
  • Anzemet Tablets should not be taken in doses exceeding the recommended amount — follow your prescriber's guidance
  • Anzemet Tablets are not recommended for children under 2 years of age
Available strengths 1 strength
2 FDA-listed product records

📊 Dolasetron across the U.S. market

How Dolasetron 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.

1
Dose forms
3
Manufacturers
1
Brand names
5
FDA-listed product records
1997
First marketed

Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

USV Private Limited40%
Validus Pharmaceuticals LLC40%
Emcure Pharmaceuticals Limited20%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

🔍 Compare Dolasetron products

A representative set of FDA-listed product records for Dolasetron — 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
💊Tablet
50 mg Oral Validus Pharmaceuticals LLC × 2 listings NDA View NDC →
💊Bulk drug substance
5 kg/5 kg Emcure Pharmaceuticals Limited BULK INGREDIENT View NDC →
1 kg/kg USV Private Limited × 2 listings BULK INGREDIENT View NDC →

Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Dolasetron NDCs →

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.

Ingredient (IN) Dolasetron RxCUI 68091 1 dose form · 3 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 371951 In current FDA listings
    Clinical drug / strength (SCD) 50 MG RxCUI 310007 100 MG RxCUI 310006 200 MG RxCUI 401714

Look up RxCUI 68091 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.

🏷️ Sold under these brand names

Anzemet

🏭 Manufacturers & labelers

USV Private Limited 2 Validus Pharmaceuticals LLC 2 Emcure Pharmaceuticals Limited 1

RxNorm drug class

Dolasetron belongs to the Serotonin-3 Receptor Antagonist class.

Pharmacologic class Serotonin-3 Receptor Antagonist
Drug family (ATC) Serotonin (5HT3) antagonists
How it works Serotonin 3 Receptor Antagonists

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.

🔬 Where this comes from

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 12, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Dolasetron.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Dolasetron after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
5
Distinct labelers/manufacturers represented
3
Linked representative label
Validus Pharmaceuticals LLC
Linked label effective
Dec 12, 2023
Composite sections available
15
Linked SPL Set ID
201b0eb8-4a1e-4e22-ab4b-addb642710d6
Linked SPL Document ID
0df5b325-3209-4bbc-ab6b-a51aa6e52513
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Validus Pharmaceuticals LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.