Ondansetron ODT (Ondansetron)

Generic Name

Ondansetron

Brand Names

Ondansetron ODT, Sumansetron

FDA approval date: November 07, 2006

Classification: Serotonin-3 Receptor Antagonist

Form: Injection, Tablet, Kit, Solution

What is Ondansetron ODT (Ondansetron)?

Nausea and vomiting can be more than just unpleasant; they can be profoundly draining, preventing you from eating, drinking and recovering from illness or medical treatment. For patients undergoing chemotherapy, radiation or surgery, the fear of post-treatment sickness can add a heavy layer of anxiety to an already stressful situation. Fortunately, a highly effective and widely used medication called Ondansetron is available to provide powerful relief.

Ondansetron is a prescription medication that is a cornerstone in the prevention of nausea and vomiting. It belongs to a class of drugs known as serotonin 5-HT3 receptor antagonists. Unlike older anti-nausea medications that often caused significant drowsiness, Ondansetron offers a more targeted approach. As a well-established, first-line therapy, it has revolutionized the patient experience for countless individuals, allowing them to better tolerate essential medical treatments and improve their quality of life during recovery.

What does Ondansetron do?

Ondansetron is approved by the U.S. Food and Drug Administration (FDA) specifically to prevent, not treat, nausea and vomiting associated with:

Chemotherapy: It is highly effective at preventing the nausea and vomiting induced by cancer-fighting drugs.
Radiation Therapy: It helps manage the sickness that can result from radiation treatments, particularly those aimed at the abdomen.
Surgery: It is commonly given before or after surgical procedures to prevent post-operative nausea and vomiting (PONV).

The primary goal of Ondansetron is to stop nausea and vomiting before they start. By providing this preventative control, it helps patients maintain hydration and nutrition, feel more comfortable, and have a more positive outlook on their treatment and recovery process. Its effectiveness is well-documented, making it a standard of care in hospitals and cancer centers around the world.

How does Ondansetron work?

To understand how Ondansetron works, it’s helpful to know about a natural chemical messenger in your body called serotonin. While serotonin is well-known for its role in mood, it also plays a crucial part in the digestive system and the body’s vomiting reflex.

When your body undergoes treatments like chemotherapy or surgery, cells in your stomach and small intestine can be damaged, causing them to release large amounts of serotonin. This flood of serotonin then travels to and stimulates specific nerve endings in the gut, and a part of the brain called the “chemoreceptor trigger zone,” or the vomiting center. When this center is activated, it sends signals that trigger the feelings of nausea and the physical act of vomiting.

Ondansetron is a 5-HT3 receptor antagonist. This means it works by precisely targeting and blocking the 5-HT3 receptors that serotonin binds to. Think of these receptors as specific docking stations for serotonin. Ondansetron swoops in and occupies these docking stations on the nerves in both the gut and the brain’s vomiting center. By blocking these sites, it prevents excess serotonin from delivering its “nausea-inducing” message. This targeted blockade effectively interrupts the vomiting reflex at its source, providing powerful and specific relief without affecting other body systems in the way older medications did.

Ondansetron side effects

Ondansetron is generally well-tolerated, and its side effects are often mild. However, like any medication, it has potential risks.

The most common side effects include:

Headache
Constipation
Fatigue or drowsiness
Diarrhea
Dizziness

Serious side effects, though rare, include QT prolongation, a change in the heart’s electrical rhythm, which can cause a fast, irregular heartbeat. This risk increases in patients with existing heart conditions, electrolyte imbalances (low potassium or magnesium) or those on other heart rhythm-affecting medications.

Another rare but serious risk is serotonin syndrome. This can occur if Ondansetron is taken with other medications that also increase serotonin levels, such as certain antidepressants (SSRIs, SNRIs). Symptoms can include agitation, hallucinations, rapid heart rate, fever and muscle stiffness.

Contact your doctor immediately for fainting, fluttering/racing heartbeat or severe dizziness. Inform them of your full medical history, including heart/liver conditions and all medications (Mayo Clinic, 2024).

Ondansetron dosage

Ondansetron comes in various forms: oral tablets, orally disintegrating tablets (ODT), oral solution and injections (IV/IM) for rapid hospital use. Dosing and timing are crucial; it’s typically given 30 minutes before chemotherapy or just before anesthesia to prevent nausea.

Routine lab monitoring is generally not needed. However, for patients at high risk of heart rhythm issues or electrolyte imbalances (e.g., due to certain chemotherapies, severe vomiting, or diarrhea), doctors may order an ECG and blood tests to check heart rhythm, potassium, and magnesium levels (National Institutes of Health, 2016).

Does Ondansetron have a generic version?

Yes, Ondansetron is widely available as a generic medication. The most common brand name is Zofran (and Zofran ODT for the disintegrating tablet), but the generic is used extensively. The U.S. Food and Drug Administration holds generic drugs to the same high standards of quality, safety and effectiveness as the brand-name product (FDA, 2021). The availability of a generic makes this essential medication very affordable and accessible.

Conclusion

Ondansetron is a powerful and highly effective medication that has become an indispensable tool in modern medicine for preventing nausea and vomiting. Its targeted action on serotonin receptors provides relief with fewer side effects than older alternatives, making difficult medical treatments more tolerable for millions of patients.

While it is important to be aware of the potential risks, especially concerning heart rhythm, Ondansetron is considered safe and effective when used as prescribed by a qualified healthcare provider. Open communication with your doctor about your health history and any symptoms you experience is the best way to ensure this medication works safely for you, allowing you to focus on your recovery.

References

Food and Drug Administration (FDA). (2021). Generic Drug Facts. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drug-facts
Mayo Clinic. (2024). Ondansetron (Oral Route, Oromucosal Route). Retrieved from https://www.mayoclinic.org/drugs-supplements/ondansetron-oral-route-oromucosal-route/side-effects/drg-20070572
National Institutes of Health. (2016). Ondansetron. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a601209.html

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Brand Information

Ondansetron (Ondansetron)

1Indications and Usage Section

1 INDICATIONS AND USAGE

Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with:

highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2

Ondansetron orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting.

2Dosage and Administration Section

2 DOSAGE AND ADMINISTRATION

2.1 Dosage

The recommended dosage regimens for adult and pediatric patients are described in Table 1 and Table 2, respectively.

Table 1: Adult Recommended Dosage Regimen for Prevention of Nausea and Vomiting

Table 2: Pediatric Recommended Dosage Regimen for Prevention of Nausea and Vomiting

2.2 Dosage in Hepatic Impairment

In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), do not exceed a total daily dose of 8 mg [see USE IN SPECIFIC POPULATIONS (8.6), CLINICAL PHARMACOLOGY (12.3)].

2.3 Administration Instructions for Ondansetron Orally Disintegrating Tablets

Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, remove the tablet from the bottle or PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

3Dosage Forms and Strengths

Ondansetron Orally Disintegrating Tablets USP, 4 mg are white to off-white, round tablets debossed with ‘5’ on one side and ‘E’ on the other side with an embossed circular edge.

Ondansetron Orally Disintegrating Tablets USP, 8 mg are white to off-white, round tablets debossed with ‘7’ on one side and ‘E’ on the other side with an embossed circular edge.

4Contraindications

Ondansetron orally disintegrating tablets are contraindicated in patients:

known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see ADVERSE REACTIONS (6.2)]

5Warnings and Precautions

5.1 Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. If hypersensitivity reactions occur, discontinue use of ondansetron; treat promptly per standard of care and monitor until signs and symptoms resolve [see CONTRAINDICATIONS (4)].

5.2 QT Prolongation

Electrocardiogram (ECG) changes, including QT interval prolongation have been seen in patients receiving ondansetron. In addition, postmarketing cases of Torsade de Pointes have been reported in patients using ondansetron. Avoid ondansetron in patients with congenital long QT syndrome. ECG monitoring is recommended in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or patients taking other medicinal products that lead to QT prolongation [see CLINICAL PHARMACOLOGY (12.2)].

5.3 Serotonin Syndrome

The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists alone. 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). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of ondansetron alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center.

5.4 Masking of Progressive Ileus and Gastric Distension

The use of ondansetron in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distension. Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction.

5.5 Phenylketonuria

Phenylketonuric patients should be informed that ondansetron orally disintegrating tablets contain phenylalanine (a component of aspartame). Each 4 mg orally disintegrating tablet contains 1.68 mg phenylalanine and 8 mg orally disintegrating tablet contains 3.37 mg phenylalanine.

6Adverse Reactions Section

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Table 3: Most Common Adverse Reactions in Adultsa for the Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Chemotherapy [Primarily Cyclophosphamide-based Regimens]

Less Common Adverse Reactions

Table 4: Most Common Adverse Reactions in Adultsa for the Prevention of Postoperative Nausea and Vomiting

In a crossover study with 25 subjects, headache was reported in 6 subjects administered ondansetron orally disintegrating tablets with water (24%) as compared with 2 subjects administered ondansetron orally disintegrating tablets without water (8%).

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ondansetron. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

7Drug Interactions

7.1 Serotonergic Drugs

Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT3 receptor antagonists and other serotonergic drugs, including SSRIs and SNRIs. Monitor for the emergence of serotonin syndrome. If symptoms occur, discontinue ondansetron and initiate supportive treatment [see WARNINGS AND PRECAUTIONS (5.3)].

7.2 Drugs Affecting Cytochrome P-450 Enzymes

Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver [see CLINICAL PHARMACOLOGY (12.3)]. Because ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of ondansetron. 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. However, on the basis of available data, no dosage adjustment for ondansetron is recommended for patients on these drugs [see CLINICAL PHARMACOLOGY (12.3)].

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.

7.4 Chemotherapy

Carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron.

7.5 Alfentanil and Atracurium

Ondansetron does not alter the respiratory depressant effects produced by alfentanil or the degree of neuromuscular blockade produced by atracurium. Interactions with general or local anesthetics have not been studied.

8Use in Specific Populations

8.1 Pregnancy

Risk Summary

Published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy (see Data). Available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. Reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area, respectively (see Data).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, miscarriages, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Human Data

Available data on ondansetron use in pregnant women from several published epidemiological studies preclude an assessment of a drug-associated risk of adverse fetal outcomes due to important methodological limitations, including the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, recall bias, and other unadjusted confounders.

Ondansetron exposure in utero has not been associated with overall major congenital malformations in aggregate analyses. One large retrospective cohort study examined 1970 women who received a prescription for ondansetron during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage, stillbirth, preterm delivery, infants of low birth weight, or infants small for gestational age.

Two large retrospective cohort studies and one case-control study have assessed ondansetron exposure in the first trimester and risk of cardiovascular defects with inconsistent findings. Relative risks (RR) ranged from 0.97 (95% CI 0.86 to 1.10) to 1.62 (95% CI 1.04, 2.54). A subset analysis in one of the cohort studies observed that ondansetron was specifically associated with cardiac septal defects (RR 2.05, 95% CI 1.19, 3.28); however, this association was not confirmed in other studies.

Several studies have assessed ondansetron and the risk of oral clefts with inconsistent findings. A retrospective cohort study of 1.8 million pregnancies in the U.S. Medicaid Database showed an increased risk of oral clefts among 88,467 pregnancies in which oral ondansetron was prescribed in the first trimester (RR 1.24, 95% CI 1.03, 1.48), but no such association was reported with intravenous ondansetron in 23,866 pregnancies (RR 0.95, 95% CI 0.63, 1.43). In the subgroup of women who received both forms of administration, the RR was 1.07 (95% CI 0.59, 1.93). Two case-control studies, using data from birth defects surveillance programs, reported conflicting associations between maternal use of ondansetron and isolated cleft palate (OR 1.6 [95% CI 1.1, 2.3] and 0.5 [95% CI 0.3, 1.0]). It is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy).

Animal Data

In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of ondansetron up to 15 mg/kg/day and 30 mg/kg/day, respectively, during the period of organogenesis. With the exception of a slight decrease in maternal body weight gain in the rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. At doses of 15 mg/kg/day in rats and 30 mg/kg/day in rabbits, the maternal exposure margin was approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, respectively, based on body surface area.

In a pre- and postnatal developmental toxicity study, pregnant rats received oral doses of ondansetron up to 15 mg/kg/day from Day 17 of pregnancy to litter Day 21. With the exception of a slight reduction in maternal body weight gain, there were no effects upon the pregnant rats and the pre- and postnatal development of their offspring, including reproductive performance of the mated F1 generation. At a dose of 15 mg/kg/day in rats, the maternal exposure margin was approximately 6 times the maximum recommended human oral dose of 24 mg/day, based on body surface area.

8.2 Lactation

Risk Summary

8.4 Pediatric Use

The safety and effectiveness of orally administered ondansetron have been established in pediatric patients 4 years and older for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Use of ondansetron in these age-groups is supported by evidence from adequate and well- controlled studies of ondansetron in adults with additional data from 3 open-label, uncontrolled, non-U.S. trials in 182 pediatric patients aged 4 to 18 years with cancer who were given a variety of cisplatin or noncisplatin regimens [see DOSAGE AND ADMINISTRATION (2.2), CLINICAL STUDIES (14.1)].

prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy

8.5 Geriatric Use

Of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in U.S.- and foreign-controlled clinical trials, for which there were subgroup analyses, 938 (19%) were aged 65 years and older.

8.6 Hepatic Impairment

No dosage adjustment is needed in patients with mild or moderate hepatic impairment.

8.7 Renal Impairment

No dosage adjustment is recommended for patients with any degree of renal impairment (mild, moderate, or severe). There is no experience beyond first-day administration of ondansetron [see CLINICAL PHARMACOLOGY (12.3)].

9Drug Abuse and Dependence

Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

10Overdosage

There is no specific antidote for ondansetron overdose. Patients should be managed with appropriate supportive therapy.

11Description

The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula:

The molecular formula is C18H19N3O representing a molecular weight of 293.4 g/mol. Ondansetron is a white to off-white powder.

Each 4 mg ondansetron orally disintegrating tablet, USP for oral administration contains 4 mg ondansetron base. Each 8 mg ondansetron orally disintegrating tablet, USP for oral administration contains 8 mg ondansetron base. Each ondansetron orally disintegrating tablet, USP also contains the inactive ingredients mannitol, crospovidone, lactose monohydrate, microcrystalline cellulose, aspartame, strawberry guarana flavor, colloidal silicon dioxide, and magnesium stearate. The strawberry guarana flavor contains maltodextrin, propylene glycol, artificial flavors, and acetic acid. Ondansetron orally disintegrating tablets, USP are orally administered formulation of ondansetron which disintegrates on the tongue and does not require water to aid dissolution or swallowing.

Meets USP Disintegration Test 2.

12Clinical Pharmacology

12.1 Mechanism of Action

Ondansetron is a selective 5-HT3 receptor antagonist. While its mechanism of action has not been fully characterized, ondansetron is not a dopamine-receptor antagonist. Serotonin receptors of the 5-HT3 type are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. It is not certain whether ondansetron’s antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with release of serotonin from the enterochromaffin cells of the small intestine. In humans, urinary 5-hydroxyindoleacetic acid (5-HIAA) excretion increases after cisplatin administration in parallel with the onset of emesis. The released serotonin may stimulate the vagal afferents through the 5-HT3 receptors and initiate the vomiting reflex.

12.2 Pharmacodynamics

In healthy subjects, single intravenous doses of 0.15 mg/kg of ondansetron had no effect on esophageal motility, gastric motility, lower esophageal sphincter pressure, or small intestinal transit time. Multiday administration of ondansetron has been shown to slow colonic transit in healthy subjects. Ondansetron has no effect on plasma-prolactin concentrations.

12.3 Pharmacokinetics

Absorption

Table 5: Pharmacokinetics in Male and Female Healthy Subjects After a Single Dose of a Ondansetron 8 mg Tablet

Table 6: Pharmacokinetics in Male and Female Healthy Subjects After a Single Dose of a Ondansetron 24 mg Tablet

Renal Impairment: Renal impairment is not expected to significantly influence the total clearance of ondansetron as renal clearance represents only 5% of the overall clearance. However, the mean plasma clearance of ondansetron was reduced by about 50% in patients with severe renal impairment (creatinine clearance less than 30 mL/min). The reduction in clearance was variable and not consistent with an increase in half-life [see USE IN SPECIFIC POPULATIONS (8.7)].

13Non Clinical Toxicology

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenic effects were not seen in 2-year studies in rats and mice with oral ondansetron doses up to 10 mg/kg per day and 30 mg/kg per day, respectively (approximately 4 and 6 times the maximum recommended human oral dose of 24 mg per day, based on body surface area).

14Clinical Studies

14.1 Prevention of Chemotherapy-Induced Nausea and Vomiting

Highly Emetogenic Chemotherapy

Table 7: Emetic Episodes-Treatment Response in Patients Receiving Moderately Emetogenic Chemotherapy (Cyclophosphamide-based Regimen Containing Doxorubicin)

a Median undefined since at least 50% of the patients were withdrawn or had more than 2 emetic episodes.

In a double-blind, U.S. trial in 336 patients receiving a cyclophosphamide-based chemotherapy regimen containing either methotrexate or doxorubicin, ondansetron 8 mg administered twice a day, was as effective as ondansetron 8 mg administered 3 times a day in preventing nausea and vomiting. Ondansetron 8 mg three times daily is not a recommended regimen for the treatment of moderately emetogenic chemotherapy [see DOSAGE AND ADMINISTRATION (2.1)].

Table 8: Emetic Episodes-Treatment Response after Ondansetron Tablets Administered Twice a Day and Three Times a Day

a The first 8 mg dose was administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent 8 mg dose 8 hours after the first dose, followed by 8 mg administered twice a day for 2 days after the completion of chemotherapy.

Re-treatment

14.2 Radiation-Induced Nausea and Vomiting

Total Body Irradiation

14.3 Postoperative Nausea and Vomiting

In 2 placebo-controlled, double-blind trials (one conducted in the U.S. and the other outside the U.S.) in 865 females undergoing inpatient surgical procedures, ondansetron 16 mg as a single dose or placebo was administered one hour before the induction of general balanced anesthesia (barbiturate, opioid, nitrous oxide, neuromuscular blockade, and supplemental isoflurane or enflurane), ondansetron was significantly more effective than placebo in preventing postoperative nausea and vomiting.

No trials have been performed in males.

15How Supplied/Storage and Handling

Ondansetron Orally Disintegrating Tablets USP, 4 mg are white to off-white, round tablets debossed with ‘5’ on one side and ‘E’ on the other side with an embossed circular edge.

Bottles of 20 Tablets NDC 80425-0073-01

Bottles of 30 Tablets NDC 80425-0073-02

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

16Patient Counseling Information

QT Prolongation

Instruct the patient to report the use of all medications, especially apomorphine, to their healthcare provider. Concomitant use of apomorphine and ondansetron may cause a significant drop in blood pressure and loss of consciousness.

Administration of Ondansetron Orally Disintegrating Tablets

Do not attempt to push ondansetron orally disintegrating tablets through the foil backing.

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