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Ondansetron: uses, dosing, side effects & brands

Ondansetron is a medicine sold in the U.S. under 7 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Available as
Solution · Injectable · Tablet · Tablet, orally disintegrating · Film
Sold as
7 products — Ondansetron Hydrochloride, Zofran and Dextrose in Plastic Container and Zofran, and others
Prescription?
Prescription only
Generic available?
Yes
Half-life
about 3 to 5 hours (roughly 4 hours) in healthy adults
What the pharmacy pays
about $0.15 per ml — not your price

Every ondansetron product we track (7)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Ondansetron products
#DrugRatingPharmacy pays
172/100$0View →
272/100$0View →
368/100$0View →
468/100$0View →
568/100$0View →
654/100$0View →
7Not yet rated$0View →

What ondansetron pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Ondansetron pill imprints
ImprintStrengthColourShape
F;928 mgyellowoval
F;928 mgyellowoval
F;914 mgwhiteoval
F;914 mgwhiteoval
F;914 mgwhiteoval
G;44 mgwhiteround
F;928 mgyellowoval

Ondansetron recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

How long ondansetron keeps

No ondansetron label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Ondansetron and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Ondansetron is frequently used for nausea during and after cesarean section, usually in doses of 4 to 8 mg intravenously. Use during and after cesarean section appears to not affect the onset of breastfeeding. No adverse infant effects have been reported in this setting or among women who received ondansetron postpartum in a pharmacokinetic study. Use of ondansetron in nursing mothers beyond the immediate postpartum setting has not been studied well, but the drug is labeled for use in infants as young as 1 month of age. A computer model demonstrated that the amounts in milk are much less than this dose. No special precautions are required.

Full LactMed record for ondansetron: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised June 15, 2025. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about ondansetron

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 136,219 reports naming ondansetron, and the FDA flagged 79% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • nausea16,071 reports
  • fatigue11,361 reports
  • diarrhoea10,605 reports
  • vomiting9,754 reports
  • dyspnoea6,599 reports
  • headache6,148 reports
  • pyrexia6,102 reports
  • constipation5,260 reports

Read these as a signal, not a rate. A report does not mean ondansetron caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.

Source: openFDA drug/event (FAERS), retrieved August 25, 2026.

How long ondansetron stays in your system

The elimination half-life of ondansetron is about 3 to 5 hours (roughly 4 hours) in healthy adults. Not a prodrug. Ondansetron has some nonconjugated metabolites with pharmacologic activity, but the label states they are not present in plasma at concentrations likely to significantly contribute to its effect, so no active metabolite meaningfully outlasts the parent. Half-life lengthens with age (increase seen in patients over 75, to roughly 5-6 hours) and especially with liver disease: mean half-life rises to about 11.6 hours in mild-to-moderate hepatic impairment and to about 20 hours in severe hepatic impairment (Child-Pugh 10+). In severe renal impairment (CrCl under 30 mL/min) mean plasma clearance falls about 50%, though the label gives no specific half-life. Rule of thumb: it takes roughly 4-5 half-lives (about a day in a healthy adult) to clear the drug from the body.

Ondansetron hydrochloride tablet, film coated — FDA label (DailyMed), Clinical Pharmacology / Pharmacokinetics

Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.

Is ondansetron safe during pregnancy?

The label says the data are limited

The label says published studies on ondansetron and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about its safety in pregnancy. It notes some studies found a possible association with cardiac septal defects or oral clefts (with oral, not IV, ondansetron) while others did not confirm this, and available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. Animal studies showed no fetal harm at exposures several times the human dose. The label does not tell patients to take or stop the drug; anyone who is or may become pregnant should discuss it with their prescriber.

This is what ondansetron’s FDA label says — not a recommendation to take or stop it. In pregnancy, that decision is your prescriber’s; do not start or stop a medicine on your own.

Ondansetron hydrochloride — DailyMed FDA label

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Frequently asked questions

Is ondansetron safe during pregnancy?

The label says published studies on ondansetron and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about its safety in pregnancy. It notes some studies found a possible association with cardiac septal defects or oral clefts (with oral, not IV, ondansetron) while others did not confirm this, and available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. Animal studies showed no fetal harm at exposures several times the human dose. The label does not tell patients to take or stop the drug; anyone who is or may become pregnant should discuss it with their prescriber. This is what ondansetron's FDA label says; whether to use it in pregnancy is your prescriber's decision.

How long does ondansetron stay in your system?

The elimination half-life of ondansetron is about 3 to 5 hours (roughly 4 hours) in healthy adults — that is how long the body takes to clear half of a dose. Not a prodrug. Ondansetron has some nonconjugated metabolites with pharmacologic activity, but the label states they are not present in plasma at concentrations likely to significantly contribute to its effect, so no active metabolite meaningfully outlasts the parent. Half-life lengthens with age (increase seen in patients over 75, to roughly 5-6 hours) and especially with liver disease: mean half-life rises to about 11.6 hours in mild-to-moderate hepatic impairment and to about 20 hours in severe hepatic impairment (Child-Pugh 10+). In severe renal impairment (CrCl under 30 mL/min) mean plasma clearance falls about 50%, though the label gives no specific half-life. Rule of thumb: it takes roughly 4-5 half-lives (about a day in a healthy adult) to clear the drug from the body. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.

Can you take ondansetron with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ondansetron against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is ondansetron sold under?

We track 7 ondansetron-containing products in the U.S.: Ondansetron Hydrochloride, Zofran and Dextrose in Plastic Container, Zofran, Zofran ODT, Zofran Preservative Free, Ondansetron and Zuplenz. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does ondansetron come in?

Across the brands we track, ondansetron is currently marketed as solution, injectable, tablet, tablet, orally disintegrating and film, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic ondansetron?

Yes. Our catalog lists 2 generic ondansetron products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.

Has ondansetron been recalled?

The FDA's Enforcement database lists 2 recall records whose product description mentions ondansetron. The most recent: Ondansetron Orally Disintegrating Tablets (Dec 30, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

What are the common side effects of ondansetron?

The most common are headache, constipation, tiredness, and dizziness. Some people notice a warm or flushed feeling. These are usually mild; constipation is worth managing with fluids and fiber, since ondansetron slows the gut and can occasionally mask a serious blockage.

Can ondansetron affect your heart rhythm?

Yes. Ondansetron can prolong the QT interval, a change in the heart's electrical timing that can rarely trigger a dangerous rhythm called Torsades de pointes. The risk is higher with larger doses, with low blood potassium or magnesium, and when combined with other QT-prolonging drugs. Because of this, a single 32 mg intravenous dose was withdrawn. Seek care for fainting, palpitations, or an irregular heartbeat.

What is serotonin syndrome and how does ondansetron relate to it?

Ondansetron affects serotonin signaling and can contribute to serotonin syndrome, especially when combined with other serotonergic drugs such as certain antidepressants (SSRIs, SNRIs) or migraine triptans. Get emergency care for agitation, confusion, fast heartbeat, fever, sweating, muscle twitching or stiffness, tremor, or loss of coordination.

Which ondansetron effects are routine versus a reason to seek help?

Headache, constipation, and mild tiredness are expected and usually manageable. Seek urgent care for fainting or an irregular or racing heartbeat, the cluster of symptoms suggesting serotonin syndrome, or signs of a serious allergic reaction such as rash, swelling of the face or throat, or trouble breathing. Also tell your doctor if severe constipation, bloating, or belly pain develops, since ondansetron can hide the symptoms of a bowel obstruction.

What is ondansetron used for?

Ondansetron (brand Zofran) is FDA-approved to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery (anesthesia). It works by blocking serotonin (5-HT3) signals that trigger the vomiting reflex. It is used to prevent nausea rather than as a general treatment for an already-upset stomach.

Is ondansetron used off-label for other kinds of nausea?

Yes. Doctors frequently prescribe ondansetron off-label for nausea and vomiting from stomach bugs (gastroenteritis) and, more controversially, for severe morning sickness in pregnancy. These are not FDA-approved uses. Pregnancy use in particular is debated and should only be done under a doctor's guidance.

Does ondansetron have serious side effects to know about?

The most important one is a heart-rhythm change called QT prolongation, especially at higher doses or in people with existing heart-rhythm problems or low potassium/magnesium. Common milder side effects include headache, constipation, and tiredness. Tell your doctor about any heart conditions before using it.

Cite this page
APA
pharmaranks. (2026, July 24). Ondansetron: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ondansetron
MLA
“Ondansetron: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ondansetron.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for ondansetron on DailyMed (NIH) ↗.