Ondansetron
اندانسترون
🍽️ Alimentary Tract And Metabolism5-HT3 receptor antagonist
Market / country: 🇺🇸 USA
Zofran (US)
🧮 Dose calculator
Vomiting due to acute gastroenteritis · Regimen source: CPS Ondansetron 2018 · Recommendations
- • Single dose only; no benefit from multiple doses. Start oral rehydration 15–30 min later. For mild–moderate dehydration or failed ORS; not routine when moderate–severe diarrhea predominates. CPS Ondansetron 2018 · Recommendations
- • Weight-band alternative: 8–15 kg 2 mg; 15–30 kg 4 mg; >30 kg 6–8 mg. Liquid form recommended; a 4 mg tablet cannot give doses below 4 mg. CPS Ondansetron 2018 · Recommendations
- • This use is not in the FDA label (label: chemotherapy and postoperative nausea prevention). FDA Ondansetron · 1
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity (e.g. anaphylaxis) to ondansetron. FDA Ondansetron · 4
- ⛔ Concomitant apomorphine (profound hypotension, loss of consciousness). FDA Ondansetron · 4
Warnings
- • QT prolongation FDA Ondansetron · 5.2
- • Serotonin syndrome FDA Ondansetron · 5.3
- • Myocardial ischemia FDA Ondansetron · 5.4
- • May mask progressive ileus and gastric distension FDA Ondansetron · 5.5
- • Routine ECG/electrolyte screening before a single oral dose is not supported in children without known risk factors. CPS Ondansetron 2018 · Recommendations
Formulations
- 4 mg tablet — tablet 🇺🇸 USA FDA Ondansetron · 3
- 8 mg tablet — tablet 🇺🇸 USA FDA Ondansetron · 3
- 4 mg orally disintegrating tablet — orally disintegrating tablet 🇺🇸 USA FDA Ondansetron · 2.1
- 4 mg / 5 mL oral solution — solution 🇺🇸 USA FDA Ondansetron sol. · How Supplied
- 2 mg/mL injection (2 mL vial) — injection 🇺🇸 USA FDA Ondansetron inj. · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Ondansetron · 8.1
“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) .”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Ondansetron · 8.2
“Risk Summary Ondansetron is unlikely to result in clinically relevant exposures in breastfed infants when administered intravenously at doses up to 4 mg/day to women who are breastfeeding.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Ondansetron · 8.4
“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.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Ondansetron · 8.5
“A reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see Clinical Pharmacology (12.3) ] .”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA078539
- DailyMed (FDA label)FDA OndansetronFDA Ondansetron inj.FDA Ondansetron sol.
- MedlinePlus (NIH)OndansetronOndansetron Injection
- WHO ATC/DDDA04AA01
- Darooyab (Iran)Ondansetron
🇮🇷 Registered in Iran Darooyab · G-2622/Ondansetron
Dosage forms with Iranian generic codes, per Darooyab.
- 22103 · ONDANSETRON 32MG/50ML INJ P-BOTTLE · فرآورده تزریقی اندانسترون ۳۲ میلیگرم / ۵۰ میلیلیتر
- 02093 · ONDANSETRON HCL 4MG TAB · قرص اندانسترون هیدروکلراید ۴ میلیگرم
- 02091 · ONDANSETRON HCL 4MG/2ML AMP · آمپول اندانسترون هیدروکلراید ۴ میلیگرم / ۲ میلیلیتر
- 02394 · ONDANSETRON HCL 4MG/5ML SYRUP · شربت اندانسترون هیدروکلراید ۴ میلیگرم / ۵ میلیلیتر
- 02092 · ONDANSETRON HCL 8MG/4ML AMP · آمپول اندانسترون هیدروکلراید ۸ میلیگرم / ۴ میلیلیتر
- 52024 · ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 4 mg · قرص بازشونده دهانی اندانسترون بازشونده ۴ میلیگرم
- 52025 · ONDANSETRON TABLET, ORALLY DISINTEGRATING ORAL 8 mg · قرص بازشونده دهانی اندانسترون بازشونده ۸ میلیگرم
- 52086 · ONDANSETRON TABLET ORAL 8 mg · قرص اندانسترون ۸ میلیگرم
- 53326 · ONDANSETRON 16 mg SUPPOSITORY · شیاف اندانسترون ۱۶ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Ondansetron · 3FDA Ondansetron · 2.1FDA Ondansetron sol. · How SuppliedFDA Ondansetron inj. · 3FDA Ondansetron · 1FDA Ondansetron · 2.1, Table 2FDA Ondansetron · 8.4FDA Ondansetron · 2.1, Table 1FDA Ondansetron inj. · 2.2, Table 1FDA Ondansetron inj. · 2.2FDA Ondansetron inj. · 2.1FDA Ondansetron inj. · 2FDA Ondansetron inj. · 2.3FDA Ondansetron · 4FDA Ondansetron · 5.2FDA Ondansetron · 5.3FDA Ondansetron · 5.4FDA Ondansetron · 5.5FDA Ondansetron · 8.1FDA Ondansetron · 8.2FDA Ondansetron · 8.5FDA Ondansetron · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline✅ PresentCPS Ondansetron 2018 · Recommendations
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-2622/Ondansetron
- Clinical review⚠ Unverified