Ondansetron | Oral Disintegrating Tablets
Important Safety Information: Ondansetron | Oral Disintegrating Tablets
What is this?
This Important Safety Information summarizes key warnings and precautions for ondansetron orally disintegrating tablets, a prescription 5-HT3 receptor antagonist used for the prevention of nausea and vomiting associated with chemotherapy, radiation therapy, and postoperative recovery. This summary is based on the FDA-approved prescribing information . It does not include all available information. Always read your medication label and follow your healthcare provider’s instructions.
Most Serious Warnings
Ondansetron can cause:
Severe allergic reactions, including anaphylaxis and bronchospasm
QT interval prolongation and serious heart rhythm changes, including Torsade de Pointes
Serotonin syndrome, especially when used with certain antidepressants or other serotonergic medications
Myocardial ischemia, including chest pain or coronary artery spasm
Masking of bowel obstruction after abdominal surgery or chemotherapy
Who Should NOT Take Ondansetron
Do not take this medication if you:
Have a known hypersensitivity or prior serious allergic reaction to ondansetron or any component of the formulation
Are taking apomorphine
Before Taking Ondansetron, Tell Your Healthcare Provider if You:
Have congenital long QT syndrome
Have heart failure, arrhythmias, or electrolyte imbalances such as low potassium or magnesium
Take medications that prolong the QT interval
Take antidepressants, migraine medications, opioids, or other serotonergic drugs
Have liver disease, especially severe hepatic impairment
Have phenylketonuria (PKU), as orally disintegrating tablets contain phenylalanine
Are pregnant, planning to become pregnant, or breastfeeding
Possible Side Effects
Common:
Headache
Constipation
Diarrhea
Fatigue or malaise
Serious (seek medical care immediately):
Rash, hives, swelling of the face or throat, difficulty breathing
Irregular heartbeat, fainting, or severe dizziness
Agitation, hallucinations, rapid heart rate, muscle stiffness, tremor, or confusion
Chest pain or chest tightness
Severe abdominal swelling or lack of bowel movement
While Taking Ondansetron
Contact your healthcare provider right away if you:
Feel your heart racing or skipping beats
Experience lightheadedness or fainting
Develop symptoms of serotonin syndrome
Notice severe constipation or abdominal distension
Dosage Considerations
In patients with severe hepatic impairment, the total daily dose should not exceed 8 mg . Use exactly as prescribed. Do not change your dose without medical guidance.
Pregnancy and Breastfeeding
Available data have not established a clear drug-associated risk of miscarriage or major birth defects, but findings are inconsistent. Discuss risks and benefits with your healthcare provider if you are pregnant. Ondansetron is present in human milk at low levels. Consult your provider before breastfeeding .
Overdose
There is no specific antidote for overdose. Symptoms may include severe constipation, low blood pressure, fainting, vision changes, or heart rhythm disturbances. Seek emergency medical attention or contact Poison Control immediately if overdose is suspected .
Storage
Store at room temperature as directed on your pharmacy label. Keep in original packaging until use. Keep out of reach of children.
Medication Disposal
Dispose of unused medication according to local regulations or medication take-back programs. Do not flush unless instructed.
Telemedicine Disclosure
If this prescription was issued via telemedicine, contact your prescribing clinician for any concerning symptoms. Seek emergency care for severe reactions.
Disclaimer
This summary does not include all information about ondansetron and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.
