# Ondansetron

Ondansetron, sold as Zofran, is FDA-approved to prevent nausea and vomiting from cancer treatment and surgery. For that use the evidence grade is strong-human. Its use for nausea in pregnancy is not approved. It can upset the heart's rhythm.

Status checked: 2026-10-26. Last verified: 2026-10-26. Primary source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020103

This page has not been individually reviewed by a clinician.

Information, not medical advice.

| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | Zofran, Zofran ODT, ondansetron hydrochloride | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039,020605s023,020781s023lbl.pdf) |
| Class | non-peptide | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039,020605s023,020781s023lbl.pdf) |
| Regulatory status | fda-approved | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020103) |
| Status source read | 2026-10-26 | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020103) |
| Evidence grade | strong-human | our assessment | 2026-10-26 | [source](https://peptideindex.ai/methodology#evidence-grade) |
| Label dosing | From the Zofran labels. By mouth, adults take a single 24 mg dose 30 minutes before highly nausea-causing chemotherapy. Before other chemotherapy, adults take 8 mg 30 minutes before it and 8 mg 8 hours later. Then they take 8 mg every 12 hours for 1 to 2 days after it ends. Before surgery, adults take 16 mg an hour before anesthesia. By vein before chemotherapy, the dose is 0.15 mg per kilogram, up to 16 mg, given three times. People with severe liver disease take no more than 8 mg a day. The prescriber sets the dose. | primary | 2026-10-26 | [source](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039,020605s023,020781s023lbl.pdf) |

## Name

Ondansetron

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039,020605s023,020781s023lbl.pdf

## Summary

A prescription drug that prevents nausea and vomiting from cancer treatment and surgery. Zofran is its brand name.

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039,020605s023,020781s023lbl.pdf

## Short answer

Ondansetron, sold as Zofran, is FDA-approved to prevent nausea and vomiting from cancer treatment and surgery. For that use the evidence grade is strong-human. Its use for nausea in pregnancy is not approved. It can upset the heart's rhythm.

Source: https://peptideindex.ai/methodology#short-answer

## Known risks

- It can change the heart's electrical rhythm, called QT prolongation. Rare cases of a deadly rhythm, torsade de pointes, have been reported [^1] [^2].
- FDA found that a 32 mg single dose into a vein was pulled from sale for reasons of safety. That dose raised the heart rhythm risk [^6].
- Serotonin syndrome has been reported, mostly in people who also took some antidepressants or opioids. Some cases were fatal [^1].
- Taken with apomorphine, it can cause a big drop in blood pressure and passing out. The label says not to combine them [^1].
- Some people have had bad allergic reactions. A few had trouble breathing [^1].
- Reduced blood flow to the heart has been reported, mostly when it was given into a vein [^1].
- After belly surgery or cancer drugs, it can hide a blocked bowel [^1].
- In the label's studies, the most common problems were headache and feeling tired. Others were constipation and diarrhea [^1].
- A 2018 US study of 1.8 million pregnancies found a small rise in oral clefts, a split lip or palate, with use in the first three months [^9].

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039,020605s023,020781s023lbl.pdf

## What nobody knows yet

- Nobody knows for sure if it harms a baby in early pregnancy. The label says studies have found mixed results [^1] [^9] [^10].
- A 2016 review of nausea in pregnancy found the evidence was of low quality [^14].
- The 2014 trial in pregnant women was small. Only 36 women took part [^15].
- After surgery, a 2020 review found only low or very low certainty about serious harms. It called for more studies of harms [^13].

Source: https://pubmed.ncbi.nlm.nih.gov/27701665/

## What it is

Ondansetron is a drug that prevents nausea and vomiting [^1]. It blocks one kind of serotonin receptor, called 5-HT3 [^1]. It is not a peptide.

It comes as a tablet, a tablet that melts on the tongue, a liquid to swallow and a shot [^1] [^2]. Zofran is the brand name [^1]. FDA first approved it in 1991 [^1].

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039,020605s023,020781s023lbl.pdf

## Where it stands legally

Ondansetron is FDA-approved: Drugs@FDA lists Zofran tablets, Zofran shots and Zofran tablets that melt on the tongue as approved drugs [^3] [^4] [^5]. The approval covers nausea and vomiting from cancer drugs, radiation and surgery [^1] [^2]. It does not cover nausea in pregnancy, which is an off-label use [^17] [^18]. Checked 26 October 2026.

Drugs@FDA lists the Zofran brand products as no longer sold. A Federal Register notice says they were not pulled for safety reasons [^3] [^4] [^5]. One high dose was different. In 2015, FDA found that a 32 mg single dose into a vein was pulled from sale for reasons of safety [^6].

In 2023, a federal appeals court upheld the dismissal of hundreds of birth defect lawsuits [^17] [^18]. It found FDA would have rejected the pregnancy warning the families wanted [^18].

Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug [^7]. Ondansetron is not on FDA's 503A category list [^8].

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020103

## What the evidence shows

The evidence grade is strong-human for stopping vomiting after surgery and from a stomach bug in children [^11] [^13]. A 2020 review pooled 585 studies of drugs used during surgery [^13]. It found high-certainty evidence that ondansetron cuts vomiting in the first day [^13].

In a 2006 trial, 215 children with a stomach bug got one dose or a dummy pill [^11]. Of those on the drug, 14% vomited, against 35% on the dummy pill [^11]. A 2011 review of seven trials found it cut the need for a drip and a hospital stay [^12].

For nausea in pregnancy, a 2016 review linked it to fewer symptoms [^14]. The review rated the evidence as low quality [^14]. In a 2014 trial of 36 women, it eased nausea more than doxylamine and pyridoxine [^15].

On safety in pregnancy, studies disagree. A 2013 study of pregnancies in Denmark found no rise in birth defects or miscarriage [^10]. A 2018 US study found a small rise in oral clefts [^9]. A 2023 study in rats found no birth defects in the pups [^16].

Source: https://pubmed.ncbi.nlm.nih.gov/33075160/

## Legitimate ways to get it

The legal way to get ondansetron is a prescription [^1] [^2]. Its labels cover nausea and vomiting from cancer drugs, radiation and surgery [^1] [^2]. The Zofran brand products are listed as no longer sold [^3] [^4] [^5].

Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug [^7].

US trials that use ondansetron are open, such as one comparing it with fosaprepitant for nausea [^19]. The trials block on this page lists open trials with their dates.

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039,020605s023,020781s023lbl.pdf

## Access routes

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020103

### Approved product

Detail: Approved by FDA as a prescription drug. Drugs@FDA lists the Zofran brand products as no longer sold.

Brand names: Zofran, Zofran ODT

Manufacturer: Sandoz

Indication: Prevention of nausea and vomiting from cancer chemotherapy, radiotherapy and surgery.

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020103

### Lawful compounding

Detail: Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug.

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

## Recruiting trials

Snapshot date: 2026-10-26.

A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.

- nct NCT05784350, url https://clinicaltrials.gov/study/NCT05784350, phase Not applicable, title Preoperative Point of Care Ultrasound Guided Fluid Optimization and Intravenous Ondansetron to Prevent General Anesthesia-Induced Hypotension, status not-yet-recruiting, sponsor Meir Medical Center, countries Israel, us states none listed
- nct NCT07891312, url https://clinicaltrials.gov/study/NCT07891312, phase Not applicable, title Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery, status not-yet-recruiting, sponsor Qianfoshan Hospital, countries none listed, us states none listed
- nct NCT07795060, url https://clinicaltrials.gov/study/NCT07795060, phase Phase 2, title Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera, status not-yet-recruiting, sponsor Public Interest Science Center, countries Republic of the Congo, us states none listed
- nct NCT07588217, url https://clinicaltrials.gov/study/NCT07588217, phase Phase 2/Phase 3, title Ondansetron for the Prevention of Patient Self-Inflicted Lung Injury in Patients With ARDS - Pilot RCT, status not-yet-recruiting, sponsor Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal, countries Canada, us states none listed
- nct NCT07848984, url https://clinicaltrials.gov/study/NCT07848984, phase Phase 2, title Chinese Herbal Acupoint Application Combined With Triple Antiemetic Therapy for Prevention of Chemotherapy-Induced Nausea and Vomiting in Breast Cancer, status not-yet-recruiting, sponsor Second Affiliated Hospital, Zhejiang University, School of Medicine, countries China, us states none listed
- nct NCT07793760, url https://clinicaltrials.gov/study/NCT07793760, phase Phase 4, title Dexamethasone Versus Ondansetron for Preventing Post-Spinal Hypotension in Preeclampsia, status not-yet-recruiting, sponsor Assiut University, countries none listed, us states none listed
- nct NCT07858149, url https://clinicaltrials.gov/study/NCT07858149, phase Phase 4, title Effects of Ondansetron Timing During Spinal Anesthesia for Urologic Surgery, status not-yet-recruiting, sponsor Istanbul University, countries Turkey (Türkiye), us states none listed
- nct NCT07868861, url https://clinicaltrials.gov/study/NCT07868861, phase Phase 1, title A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults, status recruiting, sponsor Nasus Pharma, countries Israel, us states none listed
- nct NCT07813975, url https://clinicaltrials.gov/study/NCT07813975, phase Not applicable, title Evaluating the Impact of Vitamin D Supplementation on Healing Bed Sores in ICU., status recruiting, sponsor Maha Salah, countries Egypt, us states none listed
- nct NCT07681076, url https://clinicaltrials.gov/study/NCT07681076, phase Phase 4, title Study to Assess Safety and Tolerability of KarXT With Administration of Antiemetics in Healthy Volunteers, status recruiting, sponsor Karuna Therapeutics, Inc., a Bristol Myers Squibb company, countries United States, us states California, Florida, Georgia
- nct NCT07761312, url https://clinicaltrials.gov/study/NCT07761312, phase Phase 4, title Afentanil and Remifentanil for Anesthesia Quality and Recovery, status not-yet-recruiting, sponsor Qianfoshan Hospital, countries none listed, us states none listed
- nct NCT07638527, url https://clinicaltrials.gov/study/NCT07638527, phase Phase 4, title Time to First Rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy, status recruiting, sponsor Faisalabad Medical University, countries Pakistan, us states none listed
- nct NCT07777276, url https://clinicaltrials.gov/study/NCT07777276, phase Phase 4, title Sleep Quality - Comparing the Effect of Ondansetron or Dexamethasone Given as Routine Prophylaxis Intraoperatively to Prevent Post Operative Nausea and Vomiting (SCORPION), status not-yet-recruiting, sponsor Telethon Kids Institute, countries Australia, Brazil, us states none listed
- nct NCT07662200, url https://clinicaltrials.gov/study/NCT07662200, phase Early phase 1, title A Simplified Regimen to Prevent Nausea and Vomiting Using Netupitant/Palonosetron in Germ Cell Cancer Patients Receiving Chemotherapy, status not-yet-recruiting, sponsor Ottawa Hospital Research Institute, countries Canada, us states none listed
- nct NCT07740577, url https://clinicaltrials.gov/study/NCT07740577, phase Phase 4, title Routine Antiemetic Prophylaxis for Nonfasted Parturients Undergoing Cesarean Sections Under Spinal Anesthesia, status recruiting, sponsor Sanliurfa Education and Research Hospital, countries Turkey (Türkiye), us states none listed
- nct NCT07697625, url https://clinicaltrials.gov/study/NCT07697625, phase Phase 1, title A Clinical Trial of MK-4082 in Healthy Participants (MK-4082-005), status recruiting, sponsor Merck Sharp & Dohme LLC, countries United States, us states California
- nct NCT07768124, url https://clinicaltrials.gov/study/NCT07768124, phase Not applicable, title Acupoint Application for Chemotherapy-Induced Nausea and Vomiting in Lung Cancer, status recruiting, sponsor Xiu Huang, countries China, us states none listed
- nct NCT07639723, url https://clinicaltrials.gov/study/NCT07639723, phase Phase 4, title Aprepitant to Improve Same Day Discharge for TKA, status not-yet-recruiting, sponsor Endeavor Health, countries United States, us states Illinois
- nct NCT07643285, url https://clinicaltrials.gov/study/NCT07643285, phase Not applicable, title Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy, status recruiting, sponsor Ahmet Burak Doğan, MD, countries Turkey (Türkiye), us states none listed
- nct NCT07632144, url https://clinicaltrials.gov/study/NCT07632144, phase Not applicable, title Ondansetron Versus Lidocaine for Preventing Pain on Propofol Injection., status not-yet-recruiting, sponsor Mongi Slim Hospital, countries Tunisia, us states none listed
- nct NCT07706348, url https://clinicaltrials.gov/study/NCT07706348, phase Phase 1/Phase 2, title Intraperitoneal Irrigation of Ondansteron in Combination With Lidocaine in Acute Postoperative Pain, status recruiting, sponsor Assiut University, countries Egypt, us states none listed
- nct NCT07558226, url https://clinicaltrials.gov/study/NCT07558226, phase Not applicable, title Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy, status recruiting, sponsor Fundacio Puigvert, countries Spain, us states none listed
- nct NCT07603596, url https://clinicaltrials.gov/study/NCT07603596, phase Phase 1, title Opioid-free Anesthesia and Postoperative Delirium, status not-yet-recruiting, sponsor Qianfoshan Hospital, countries none listed, us states none listed
- nct NCT07381634, url https://clinicaltrials.gov/study/NCT07381634, phase Phase 2, title The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities, status recruiting, sponsor First Affiliated Hospital of Wenzhou Medical University, countries China, us states none listed
- nct NCT07511491, url https://clinicaltrials.gov/study/NCT07511491, phase Not applicable, title Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section, status recruiting, sponsor Tanta University, countries Egypt, us states none listed
- nct NCT07455955, url https://clinicaltrials.gov/study/NCT07455955, phase Phase 2, title Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile, status recruiting, sponsor Chinese University of Hong Kong, countries Hong Kong, us states none listed
- nct NCT07489742, url https://clinicaltrials.gov/study/NCT07489742, phase Not applicable, title Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Tonsillectomy, status recruiting, sponsor Tanta University, countries Egypt, us states none listed
- nct NCT07458295, url https://clinicaltrials.gov/study/NCT07458295, phase Not applicable, title The Efficacy and Safety of Liposomal Bupivacaine for Transversus Abdominis Plane Block in Relieving Postoperative Pain After Laparoscopic Surgery in Gynecologic Oncology, status recruiting, sponsor Beijing Tiantan Hospital, countries China, us states none listed
- nct NCT07458282, url https://clinicaltrials.gov/study/NCT07458282, phase Not applicable, title The Efficacy and Safety of Liposomal Bupivacaine for Transversus Abdominis Plane Block in Relieving Postoperative Pain After Laparoscopic Surgery, status recruiting, sponsor Beijing Tiantan Hospital, countries China, us states none listed
- nct NCT07458256, url https://clinicaltrials.gov/study/NCT07458256, phase Not applicable, title The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Laparoscopic Surgery, status recruiting, sponsor Beijing Tiantan Hospital, countries China, us states none listed
- nct NCT07442539, url https://clinicaltrials.gov/study/NCT07442539, phase Not applicable, title The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Hemorrhoid Surgery, status recruiting, sponsor Beijing Tiantan Hospital, countries China, us states none listed
- nct NCT07432711, url https://clinicaltrials.gov/study/NCT07432711, phase Not applicable, title The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Video-assisted Thoracoscopic Surgery, status recruiting, sponsor Beijing Tiantan Hospital, countries China, us states none listed
- nct NCT07441902, url https://clinicaltrials.gov/study/NCT07441902, phase Not applicable, title The Efficacy and Safety of Liposomal Bupivacaine for Rhomboid Intercostal Nerve Block in Relieving Postoperative Pain After Video-assisted Thoracoscopic Surgery, status recruiting, sponsor Beijing Tiantan Hospital, countries China, us states none listed
- nct NCT07330999, url https://clinicaltrials.gov/study/NCT07330999, phase Not applicable, title Three Variants of the PENG Block With and Without Perineural Adjuvants in Older Adults, status recruiting, sponsor Poznan University of Medical Sciences, countries Poland, us states none listed
- nct NCT07699276, url https://clinicaltrials.gov/study/NCT07699276, phase Phase 2, title Steroid Sparing Regimen With Olanzapine and Palonosetron for Emetic Prevention for High Dose Cisplatin, status recruiting, sponsor Mahidol University, countries Thailand, us states none listed
- nct NCT07377903, url https://clinicaltrials.gov/study/NCT07377903, phase Not applicable, title Post Operative Shivering Following Anesthesia, status not-yet-recruiting, sponsor Sohag University, countries none listed, us states none listed
- nct NCT07607990, url https://clinicaltrials.gov/study/NCT07607990, phase Not applicable, title Effects of Rectal Indomethacin Suppository on Postoperative CRBD in Patients Undergoing LRP, status recruiting, sponsor Zhejiang University, countries China, us states none listed
- nct NCT07361822, url https://clinicaltrials.gov/study/NCT07361822, phase Not applicable, title Comparison of Cumulative Opioid Consumption Between Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes of Intravenous PCA Following Mixed Surgery, status recruiting, sponsor Beijing Tiantan Hospital, countries China, us states none listed
- nct NCT07375121, url https://clinicaltrials.gov/study/NCT07375121, phase Not applicable, title Comparison of the Efficacy and Safety of Fixed-rate Basal Infusion Mode and Time-programmed Decremental Background Infusion Mode of Intravenous PCA Following Mixed Surgery, status recruiting, sponsor Beijing Tiantan Hospital, countries China, us states none listed
- nct NCT07246070, url https://clinicaltrials.gov/study/NCT07246070, phase Phase 2, title Nano-crystalline Megestrol Acetate for Chemotherapy-induced Nausea and Vomiting, status not-yet-recruiting, sponsor AIPING ZHOU, countries none listed, us states none listed
- nct NCT06869967, url https://clinicaltrials.gov/study/NCT06869967, phase Not applicable, title Evaluation of Postoperative Pain Control in Ear Surgery, status recruiting, sponsor Kocaeli University, countries Turkey (Türkiye), us states none listed
- nct NCT06953570, url https://clinicaltrials.gov/study/NCT06953570, phase Not stated, title Impact of Frailty on Nalbuphine Dose for Postoperative Analgesia in Elderly Patients Undergoing Laparoscopic GI Surgery, status not-yet-recruiting, sponsor Yongtao Sun, countries none listed, us states none listed
- nct NCT07164677, url https://clinicaltrials.gov/study/NCT07164677, phase Not applicable, title Serratus Posterior Superior Plane Block for Postoperative Pain in Cardiac Surgery, status recruiting, sponsor Ondokuz Mayıs University, countries Turkey (Türkiye), us states none listed
- nct NCT06952920, url https://clinicaltrials.gov/study/NCT06952920, phase Phase 3, title Electroacupuncture for Chemotherapy-Induced GI Symptom Clusters in Breast Cancer, status recruiting, sponsor Jiuda Zhao, countries China, us states none listed
- nct NCT07124195, url https://clinicaltrials.gov/study/NCT07124195, phase Phase 3, title Nanocrystalline Megestrol for Managing Chemotherapy-Induced Nausea and Vomiting, status not-yet-recruiting, sponsor The First Affiliated Hospital of Xinxiang Medical College, countries China, us states none listed
- nct NCT07088601, url https://clinicaltrials.gov/study/NCT07088601, phase Phase 4, title Efficacy of Oral Ondansetron Strips on Prevention of Post-Spinal Shivering, status not-yet-recruiting, sponsor Cairo University, countries none listed, us states none listed
- nct NCT06530563, url https://clinicaltrials.gov/study/NCT06530563, phase Phase 4, title the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery, status not-yet-recruiting, sponsor Xiangya Hospital of Central South University, countries China, us states none listed
- nct NCT07084753, url https://clinicaltrials.gov/study/NCT07084753, phase Not applicable, title Non-opioid Anesthesia Based on Thoracic Paravertebral Block During Laparoscopic Sleeve Gastrectomy, status not-yet-recruiting, sponsor IVO JURISIC, countries Croatia, us states none listed
- nct NCT06938581, url https://clinicaltrials.gov/study/NCT06938581, phase Not applicable, title ERAS Protocols in Breast Conserving Surgery, status recruiting, sponsor University of Nebraska, countries United States, us states Nebraska
- nct NCT06904235, url https://clinicaltrials.gov/study/NCT06904235, phase Phase 2, title Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC), status recruiting, sponsor Helsinn Healthcare SA, countries Greece, Poland, Romania, Turkey (Türkiye), us states none listed

Source: https://clinicaltrials.gov/api/v2/studies?query.intr=ondansetron&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState

## Sources

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039,020605s023,020781s023lbl.pdf

### 1. Zofran tablets, orally disintegrating tablets and oral solution label, revised February 2025

Type: label

Tier: primary

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039,020605s023,020781s023lbl.pdf

### 2. Zofran injection label, revised February 2025

Type: label

Tier: primary

Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020007s050lbl.pdf

### 3. Drugs@FDA: Zofran (ondansetron hydrochloride) tablets, application 020103

Type: regulatory

Tier: primary

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020103

### 4. Drugs@FDA: Zofran (ondansetron hydrochloride) injection, application 020007

Type: regulatory

Tier: primary

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020007

### 5. Drugs@FDA: Zofran ODT (ondansetron) orally disintegrating tablets, application 020781

Type: regulatory

Tier: primary

Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020781

### 6. Federal Register: 32 mg single-dose ondansetron injection withdrawn from sale for reasons of safety, 10 June 2015

Type: regulatory

Tier: primary

Source: https://www.federalregister.gov/documents/2015/06/10/2015-14145/determination-that-ondansetron-ondansetron-hydrochloride-injection-usp-in-pl-2408-plastic-container

### 7. FDA: bulk drug substances used in compounding under section 503A

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

### 8. FDA: 503A bulk drug substances category list, updated May 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/94155/download

### 9. Cohort study: first-trimester ondansetron, heart defects and oral clefts in US Medicaid pregnancies, 2018

Type: human-trial

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/30561479/

### 10. Cohort study: ondansetron in pregnancy and fetal outcomes in Denmark, 2013

Type: human-trial

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/23445092/

### 11. Randomized trial: oral ondansetron for gastroenteritis in a pediatric emergency department, 2006

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/16625009/

### 12. Cochrane review: antiemetics for vomiting from gastroenteritis in children, 2011

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/21901699/

### 13. Cochrane network meta-analysis: drugs to prevent nausea and vomiting after surgery, 2020

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/33075160/

### 14. Systematic review: treatments for nausea and vomiting in pregnancy, 2016

Type: systematic-review

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/27701665/

### 15. Randomized trial: ondansetron against doxylamine and pyridoxine for nausea in pregnancy, 2014

Type: rct

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/25198265/

### 16. Rat study: embryo-fetal safety of ondansetron, 2023

Type: animal

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/36737400/

### 17. Drug and Device Law: appeals court upholds preemption in the Zofran cases, January 2023

Type: legal-analysis

Tier: legal-analysis

Source: https://www.druganddevicelawblog.com/2023/01/mdl-wide-preemption-win-in-zofran-affirmed.html

### 18. Bloomberg Law: Zofran birth injury lawsuits preempted by federal law, January 2023

Type: reference

Tier: established-news

Source: https://news.bloomberglaw.com/litigation/gsk-zofran-birth-injury-lawsuits-preempted-by-federal-law

### 19. ClinicalTrials.gov NCT06382012: fosaprepitant against ondansetron for nausea and vomiting

Type: reference

Tier: primary

Source: https://clinicaltrials.gov/study/NCT06382012

Last verified: 2026-10-26.

Sources:

- https://clinicaltrials.gov/api/v2/studies?query.intr=ondansetron&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState
- https://peptideindex.ai/methodology#evidence-grade
- https://peptideindex.ai/methodology#short-answer
- https://pubmed.ncbi.nlm.nih.gov/27701665/
- https://pubmed.ncbi.nlm.nih.gov/33075160/
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039,020605s023,020781s023lbl.pdf
- https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020103

[^1]: Zofran tablets, orally disintegrating tablets and oral solution label, revised February 2025 https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039,020605s023,020781s023lbl.pdf
[^2]: Zofran injection label, revised February 2025 https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020007s050lbl.pdf
[^3]: Drugs@FDA: Zofran (ondansetron hydrochloride) tablets, application 020103 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020103
[^4]: Drugs@FDA: Zofran (ondansetron hydrochloride) injection, application 020007 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020007
[^5]: Drugs@FDA: Zofran ODT (ondansetron) orally disintegrating tablets, application 020781 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020781
[^6]: Federal Register: 32 mg single-dose ondansetron injection withdrawn from sale for reasons of safety, 10 June 2015 https://www.federalregister.gov/documents/2015/06/10/2015-14145/determination-that-ondansetron-ondansetron-hydrochloride-injection-usp-in-pl-2408-plastic-container
[^7]: FDA: bulk drug substances used in compounding under section 503A https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
[^8]: FDA: 503A bulk drug substances category list, updated May 2026 https://www.fda.gov/media/94155/download
[^9]: Cohort study: first-trimester ondansetron, heart defects and oral clefts in US Medicaid pregnancies, 2018 https://pubmed.ncbi.nlm.nih.gov/30561479/
[^10]: Cohort study: ondansetron in pregnancy and fetal outcomes in Denmark, 2013 https://pubmed.ncbi.nlm.nih.gov/23445092/
[^11]: Randomized trial: oral ondansetron for gastroenteritis in a pediatric emergency department, 2006 https://pubmed.ncbi.nlm.nih.gov/16625009/
[^12]: Cochrane review: antiemetics for vomiting from gastroenteritis in children, 2011 https://pubmed.ncbi.nlm.nih.gov/21901699/
[^13]: Cochrane network meta-analysis: drugs to prevent nausea and vomiting after surgery, 2020 https://pubmed.ncbi.nlm.nih.gov/33075160/
[^14]: Systematic review: treatments for nausea and vomiting in pregnancy, 2016 https://pubmed.ncbi.nlm.nih.gov/27701665/
[^15]: Randomized trial: ondansetron against doxylamine and pyridoxine for nausea in pregnancy, 2014 https://pubmed.ncbi.nlm.nih.gov/25198265/
[^16]: Rat study: embryo-fetal safety of ondansetron, 2023 https://pubmed.ncbi.nlm.nih.gov/36737400/
[^17]: Drug and Device Law: appeals court upholds preemption in the Zofran cases, January 2023 https://www.druganddevicelawblog.com/2023/01/mdl-wide-preemption-win-in-zofran-affirmed.html
[^18]: Bloomberg Law: Zofran birth injury lawsuits preempted by federal law, January 2023 https://news.bloomberglaw.com/litigation/gsk-zofran-birth-injury-lawsuits-preempted-by-federal-law
[^19]: ClinicalTrials.gov NCT06382012: fosaprepitant against ondansetron for nausea and vomiting https://clinicaltrials.gov/study/NCT06382012