Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.
From the official U.S. FDA label for ondansetron (ondansetron hydrochloride dihydrate), the active ingredient registered with NAFDAC.
Ondansetron is indicated for the prevention of nausea and vomiting associated with: • highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 • initial and repeat courses of moderately emetogenic cancer chemotherapy • radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen Ondansetron is also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron is a 5-HT 3 receptor antagonist indicated for the prevention of: • nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 . …
The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • QT Prolongation [see Warnings and Precautions ( 5.2 )] • Serotonin Syndrome [see Warnings and Precautions ( 5.3 )] • Myocardial Ischemia [see Warnings and Precautions ( 5.4 )] • Masking of Progressive Ileus and Gastric Distension [see Warnings and Precautions ( 5.5 )] The most common adverse reactions in adults for the: • prevention of chemotherapy-induced (≥5%) are: headache, malaise/fatigue, constipation, diarrhea. ( 6.1 ) • prevention of radiation-induced nausea and vomiting (≥2%) are: headache, constipation, and diarrhea. …
Ondansetron is 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 )] • receiving concomitant apomorphine due to the risk of profound hypotension and loss of consciousness Patients known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any components of the formulation. ( 4 ) • Concomitant use of apomorphine. ( 4 )
• Hypersensitivity Reactions Including Anaphylaxis and Bronchospasm : Discontinue ondansetron if suspected. Monitor and treat promptly per standard of care until signs and symptoms resolve. ( 5.1 ) • QT Interval Prolongation and Torsade de Pointes : Avoid in patients with congenital long QT syndrome; monitor with electrocardiograms (ECGs) if concomitant electrolyte abnormalities, cardiac failure or arrhythmias, or use of other QT prolonging drugs. ( 5.2 ) • Serotonin Syndrome : Reported with 5-HT 3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. If such symptoms occur, discontinue ondansetron and initiate supportive treatment. …
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. …
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Zofdan Tablets 4 mg contains Ondansetron (Ondansetron Hydrochloride Dihydrate) (4 mg), as tablet, according to its NAFDAC registration record.
Yes. Zofdan Tablets 4 mg is listed on the NAFDAC register under registration number A4-101296, and its registration is active as of 5 November 2026.
No WHO falsified or substandard medical product alert currently matches Zofdan Tablets 4 mg in our automatically synced alert list.
Run a free authenticity scan with the NAFDAC number A4-101296, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.
Ondansetron is indicated for the prevention of nausea and vomiting associated with: • highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 • initial and repeat courses of moderately emetogenic cancer chemotherapy • radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen On (Summarised from the official U.S. FDA label for ondansetron (ondansetron hydrochloride dihydrate). Always follow your doctor or pharmacist.)
Reviews are personal experiences from RxVerify users, not medical advice. Report side effects to your doctor and to NAFDAC.