Skip to content
Clinical Trials – home

ONDANSETRON HYDROCHLORIDE DIHYDRATE: A Comprehensive Guide for Patients

1 / 4
trials open to patients / all trials
10+
Countries

In short

This article discusses clinical trials investigating the use of Ondansetron Hydrochloride Dihydrate, a medication commonly used to prevent nausea and vomiting. The trials explore its potential applications in different medical conditions, including colorectal cancer, gastroenteropancreatic neuroendocrine tumors, and opioid-induced respiratory depression. These studies aim to evaluate the drug's efficacy, safety, and potential new uses in combination with other treatments.

What is Ondansetron Hydrochloride Dihydrate?

Ondansetron Hydrochloride Dihydrate is the active ingredient in several medications used to prevent nausea and vomiting. It belongs to a class of drugs called serotonin 5-HT3 receptor antagonists. These medications work by blocking the action of serotonin, a natural substance in the body that can cause nausea and vomiting.

What is it used for?

Ondansetron is primarily used to prevent and treat nausea and vomiting associated with various conditions and treatments, including:

  • Chemotherapy-induced nausea and vomiting
  • Radiation therapy-induced nausea and vomiting
  • Post-operative nausea and vomiting
  • In some cases, severe nausea and vomiting during pregnancy (although this use is off-label and should only be under strict medical supervision)

It's important to note that ondansetron is often used as an auxiliary medication in various medical procedures and treatments to improve patient comfort and treatment adherence.

How is it administered?

Ondansetron Hydrochloride Dihydrate can be administered in several forms:

  • Oral tablets (e.g., Ondansetron Bluefish 8 mg tablets, filmdrasjerte)
  • Intravenous (IV) injection (e.g., Zofran 4 Injectie)
  • Film-coated tablets (e.g., ZOPHREN 8 mg, comprimé pelliculé)

The method of administration depends on the specific medical situation and the patient's condition. For instance, IV administration might be preferred in hospital settings or for patients undergoing chemotherapy, while oral tablets are more common for outpatient use.

Dosage Information

The dosage of ondansetron varies depending on the specific product, the condition being treated, and individual patient factors. However, some general guidelines based on the available information include:

  • For oral tablets: The maximum daily dose is typically 8 mg, with a total treatment amount of up to 960 mg over a 30-day period.
  • For intravenous use: The maximum daily dose is usually 8 mg, with a total treatment amount of up to 32 mg over a 4-day period.
  • For film-coated tablets: The maximum daily dose is 8 mg, with a total treatment amount of up to 40 mg over a 5-day period.

It's crucial to follow the dosage instructions provided by your healthcare provider, as they will consider your specific medical needs and condition.

Potential Side Effects

While ondansetron is generally well-tolerated, like all medications, it can cause side effects. Common side effects may include:

  • Headache
  • Constipation
  • Dizziness
  • Fatigue

More serious side effects, though rare, can occur. These may include allergic reactions, changes in heart rhythm, or serotonin syndrome (when used with other medications that increase serotonin levels). Always inform your healthcare provider of any side effects you experience.

Precautions and Considerations

Before using ondansetron, inform your healthcare provider if you:

  • Have any allergies, especially to ondansetron or other medications
  • Have a history of heart problems, particularly relating to heart rhythm
  • Are pregnant or breastfeeding
  • Have liver problems
  • Are taking other medications, including over-the-counter drugs and supplements

Your healthcare provider will consider these factors when determining if ondansetron is appropriate for you and in deciding the correct dosage.

Ongoing Research

Ondansetron continues to be studied in various clinical settings. Current research includes its use in:

  • Treatment of opioid-induced respiratory depression: A study is investigating the use of ondansetron alongside other medications to reverse respiratory depression caused by opioids.
  • Management of nausea and vomiting in patients with neuroendocrine tumors: Ondansetron is being used as an auxiliary medication in studies involving patients with gastroenteropancreatic neuroendocrine tumors.

These ongoing studies may provide new insights into additional uses and benefits of ondansetron in the future.

Questions people often ask

Conditions where Ondansetron Hydrochloride Dihydrate is being studied

Each condition opens its own overview and trial list

Trials with Ondansetron Hydrochloride Dihydrate

Recruiting trials first

See all 4 →
Quick filters
  • Participants:Adults
  • Participants:Adults · Healthy volunteers
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).