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ondansetron

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Brand names: Zofran

5-HT3 Receptor Antagonist (Antiemetic) Rx

Ondansetron is a medicine that helps prevent nausea and vomiting. It is often used during cancer treatment or after surgery.

Drug Pricing (NADAC)

Generic Price

$0.31/unit

Generic Available

Yes (34 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

This medicine is used to prevent nausea and vomiting.

Common side effects

Headache, Feeling tired, Constipation

Key warnings

Ondansetron can cause heart problems like a prolonged QT interval.

How It Works

Ondansetron blocks a natural substance in your body called serotonin. Serotonin can cause nausea and vomiting. By blocking serotonin, ondansetron reduces these side effects.

How to Take It

Take ondansetron exactly as your doctor tells you. The dose depends on your treatment. For chemotherapy, you may take it 30 minutes before treatment. For surgery, you may take it 1 hour before.

Pregnancy & Breastfeeding

Talk to your doctor if you are pregnant or breastfeeding. It is not known if ondansetron will harm your unborn baby. Studies on the risk of birth defects are inconsistent.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store ondansetron tablets at room temperature (68°-77°F) in a closed container.

Side Effects (from patient reports)

Based on 64,495 FDA adverse event reports.

Feeling sick to your stomach
11,557
Feeling tired
8,201
Loose, watery stools
7,793
Throwing up
7,326
Using the medicine for something it is not approved for
6,386
Death
4,874
Fever
4,791
Difficulty breathing
4,708
Fever with low white blood cell count
4,495
Pain
4,364

FDA Adverse Event Report Analysis

Detailed analysis of 103,354 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.

Total Reports

103,354

Death-Related Reports

13,423

Hospitalization Reports

47,077

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 57,269 (61%)
Male 37,164 (39%)

Age Distribution

0–17 6,388
18–44 12,839
45–64 26,693
65–74 18,143
75+ 11,629

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 NAUSEA 11,554
2 FATIGUE 8,199
3 DIARRHOEA 7,791
4 VOMITING 7,326
5 OFF LABEL USE 6,386
6 DEATH 4,872
7 PYREXIA 4,788
8 DYSPNOEA 4,707
9 FEBRILE NEUTROPENIA 4,495
10 PAIN 4,367
11 HEADACHE 4,223
12 CONSTIPATION 3,884
13 ASTHENIA 3,662
14 DRUG INEFFECTIVE 3,594
15 PNEUMONIA 3,446

Reactions in Death Reports

DEATH 4,848
NAUSEA 1,078
OFF LABEL USE 1,056
VOMITING 969
SEPSIS 864
PNEUMONIA 818
DIARRHOEA 761
DYSPNOEA 706
FATIGUE 680
CARDIAC ARREST 630

Reactions in Hospitalization Reports

NAUSEA 4,892
VOMITING 4,248
FEBRILE NEUTROPENIA 3,885
DIARRHOEA 3,779
PYREXIA 3,440
FATIGUE 2,922
PNEUMONIA 2,832
DYSPNOEA 2,676
OFF LABEL USE 2,455
ACUTE KIDNEY INJURY 2,139

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Ondansetron can cause heart problems like a prolonged QT interval. If you have congenital long QT syndrome, you should not take this medicine. Ondansetron can also cause Serotonin Syndrome, especially if you are taking other medicines for depression or pain. Seek immediate medical attention if you experience chest pain.

Known Drug Interactions

7.3 Tramadol Although no pharmacokinetic drug interaction between ondansetron and tramadol has been observed, data from 2 small trials indicate that when used together, ondansetron may increase patient-controlled administration of tramadol. Monitor patients to ensure adequate pain control when ondansetron is administered with tramadol.

Mechanism: Using these drugs together might make the pain reliever less effective, leading patients to need more of it to feel relief.

What to do: Watch your pain levels closely and tell your doctor if your pain medication does not seem to be working as well as it should.

In a crossover trial in 76 pediatric patients, intravenous ondansetron did not increase systemic concentrations of high-dose methotrexate.

Mechanism: These two drugs do not seem to change how much medicine stays in your system when used together.

What to do: No special changes are usually needed, but always follow your doctor's specific instructions when taking these medications.

In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased.

Mechanism: Carbamazepine makes your liver work faster to get rid of ondansetron, which lowers the amount of medicine in your body.

What to do: Your doctor may need to increase your dose of ondansetron to make sure it still works to prevent nausea.

In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased.

Mechanism: Rifampin speeds up the breakdown of ondansetron, which can make the medicine less effective.

What to do: Talk to your doctor about adjusting your dose, as the ondansetron may not work as well while taking rifampin.

In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased.

Mechanism: Phenytoin causes your body to process and remove ondansetron more quickly than usual.

What to do: Your healthcare provider might need to change your dose to ensure the medicine still works to stop nausea.

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Common Questions

Can I take ondansetron for morning sickness?
Talk to your doctor before using ondansetron for morning sickness.
Does ondansetron make you sleepy?
Ondansetron can cause fatigue in some people.
Can I drink alcohol while taking ondansetron?
Ask your doctor if it is safe to drink alcohol while taking ondansetron.
What should I do if ondansetron doesn't work?
Talk to your doctor if ondansetron is not helping your nausea.
Can I take ondansetron with other medicines?
Tell your doctor about all the medicines you take, including over-the-counter drugs.
Is ondansetron addictive?
Ondansetron is not addictive.
How long does ondansetron take to work?
Ondansetron usually starts working within 30 minutes to 1 hour.
Can children take ondansetron?
Yes, children can take ondansetron. The dose depends on the child's age and weight.
Does food affect how ondansetron works?
Food does not usually affect how ondansetron works.
Can I drive while taking ondansetron?
Ondansetron can cause dizziness. Be careful driving or operating machinery.
What are the common side effects of ondansetron?
The most commonly reported side effects of ondansetron include Headache, Feeling tired, Constipation, Diarrhea. Based on 64,495 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does ondansetron interact with other medications?
Yes, ondansetron has 6 known drug interactions. Notable interactions include tramadol, methotrexate, carbamazepine. Always inform your doctor about all medications you are taking.
What drug class is ondansetron?
ondansetron belongs to the 5-HT3 Receptor Antagonist (Antiemetic) drug class. It requires a prescription (Rx). This medicine is used to prevent nausea and vomiting.
Is ondansetron safe during pregnancy?
Talk to your doctor if you are pregnant or breastfeeding. It is not known if ondansetron will harm your unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has ondansetron been recalled?
There are 2 recalls associated with ondansetron products. Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Check the recalls section below for full details and affected products.

Active Recalls

Class II December 30, 2025

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

Glenmark Pharmaceuticals Inc., USA

Class II November 17, 2025

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

Preferred Pharmaceuticals, Inc.

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Medication Guides

Related Health & Safety Data

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What the FDA Data Shows for ondansetron

The FDA label for ondansetron (sold under brand names such as Zofran) classifies it as a prescription-only medication in the 5-HT3 Receptor Antagonist (Antiemetic) class. This medicine is used to prevent nausea and vomiting. Official labeling lists 4 commonly reported side effects, including Headache, Feeling tired, Constipation.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 64,495 voluntary reports. The database also lists 6 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.31.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 2 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: April 24, 2024

All federal data sources used on this page