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Ondansetron

اندانسترون

⚠ Unverified

🍽️ Alimentary Tract And Metabolism5-HT3 receptor antagonist

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution 🇮🇷 Registered in Iran ⛔ 2 contraindications 🇺🇸 FDA approved generic (ANDA) ANDA078539 ATC A04AA01

Market / country: 🇺🇸 USA

Zofran (US)

🧮 Dose calculator

Disease / regimen

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

Formulation

Age *

Weight (kg) *

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 Ondansetron FDA Ondansetron inj.FDA Ondansetron sol.
MedlinePlus (NIH)Ondansetron Ondansetron 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)✅ Present
FDA Ondansetron · 3 FDA Ondansetron · 2.1 FDA Ondansetron sol. · How Supplied FDA Ondansetron inj. · 3 FDA Ondansetron · 1 FDA Ondansetron · 2.1, Table 2 FDA Ondansetron · 8.4 FDA Ondansetron · 2.1, Table 1 FDA Ondansetron inj. · 2.2, Table 1 FDA Ondansetron inj. · 2.2 FDA Ondansetron inj. · 2.1 FDA Ondansetron inj. · 2 FDA Ondansetron inj. · 2.3 FDA Ondansetron · 4 FDA Ondansetron · 5.2 FDA Ondansetron · 5.3 FDA Ondansetron · 5.4 FDA Ondansetron · 5.5 FDA Ondansetron · 8.1 FDA Ondansetron · 8.2 FDA Ondansetron · 8.5 FDA Ondansetron · SPL approval / marketing category
UK SmPC (eMC / MHRA)❌ Not present
Published guideline✅ Present
CPS Ondansetron 2018 · Recommendations
Licensed reference (medical school)❌ Not present
Iranian leaflet (IFDA)❌ Not present
Pharmacy website (secondary, unreliable)✅ Present
Darooyab · G-2622/Ondansetron
Clinical review⚠ Unverified

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