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Febuxostat

فبوکسوستات

⚠ Unverified

🦴 Musculo-Skeletal SystemXanthine oxidase inhibitor

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Safety not established 👴 Older adults:No specific problem stated 🇮🇷 Registered in Iran ⛔ 1 contraindications ⚠️ 1 interactions 🇺🇸 FDA approved generic (ANDA) ANDA213069 ATC M04AA03

Market / country: 🇺🇸 USA

Uloric (US)

🧮 Dose calculator

Disease / regimen

Gout · Regimen source: FDA Febuxostat · 2.1

• If uric acid is not <6 after 2 weeks, 80 mg. Severe renal impairment: max 40 mg. Flare prophylaxis (NSAID or colchicine) when starting. FDA Febuxostat · 2

Formulation

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🛡️ Safety & information

Contraindications

⛔ Concomitant azathioprine or mercaptopurine. FDA Febuxostat · 4

Warnings

• Boxed warning: higher cardiovascular death than allopurinol in gout patients with CV disease; use only when allopurinol fails or is not tolerated. FDA Febuxostat · Boxed Warning

Important interactions

• Azathioprine and mercaptopurine — contraindicated (raised levels and toxicity). FDA Febuxostat · 4

Formulations

40 mg tablet — tablet 🇺🇸 USA FDA Febuxostat · 3
80 mg tablet — tablet 🇺🇸 USA FDA Febuxostat · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Febuxostat · 8.1
“Risk Summary Limited available data with febuxostat tablets use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Febuxostat · 8.2
“Risk Summary There are no data on the presence of febuxostat in human milk, the effects on the breastfed infant, or the effects on milk production.”
👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Febuxostat · 8.4
“Safety and effectiveness of febuxostat tablets in pediatric patients have not been established.”
👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Febuxostat · 8.5
“No dose adjustment is necessary in elderly patients.”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)ANDA213069
DailyMed (FDA label)FDA Febuxostat
MedlinePlus (NIH)Febuxostat
WHO ATC/DDDM04AA03
Darooyab (Iran)Febuxostat

🇮🇷 Registered in Iran Darooyab · G-4752/Febuxostat

Dosage forms with Iranian generic codes, per Darooyab.

16693 · FEBUXOSTAT 40MG TAB · قرص فبوکسوستات ۴۰ میلی‌گرم
19835 · FEBUXOSTAT 80MG TAB · قرص فبوکسوستات ۸۰ میلی‌گرم
25137 · FEBUXOSTAT 120 mg TABLET · قرص فبوکسوستات ۱۲۰ میلی‌گرم

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Febuxostat · 3 FDA Febuxostat · 2.1 FDA Febuxostat · 2 FDA Febuxostat · 4 FDA Febuxostat · Boxed Warning FDA Febuxostat · SPL approval / marketing category FDA Febuxostat · 8.1 FDA Febuxostat · 8.2 FDA Febuxostat · 8.4 FDA Febuxostat · 8.5
UK SmPC (eMC / MHRA)❌ Not present
Published guideline❌ Not present
Licensed reference (medical school)❌ Not present
Iranian leaflet (IFDA)❌ Not present
Pharmacy website (secondary, unreliable)✅ Present
Darooyab · G-4752/Febuxostat
Clinical review⚠ Unverified