Leflunomide
لفلونوماید
🎗️ Antineoplastic And Immunomodulating AgentsDMARD (pyrimidine synthesis inhibitor)
Market / country: 🇺🇸 USA
Arava (US)
🧮 Dose calculator
Rheumatoid arthritis · Regimen source: FDA Leflunomide · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Pregnancy; severe hepatic impairment; hypersensitivity; concomitant teriflunomide. FDA Leflunomide · 4
Warnings
- • Boxed warning: embryo-fetal toxicity (exclude pregnancy first) and hepatotoxicity. FDA Leflunomide · Boxed Warning
Formulations
- 10 mg tablet — tablet 🇺🇸 USA FDA Leflunomide · 3
- 20 mg tablet — tablet 🇺🇸 USA FDA Leflunomide · 3
👥 Special populations
- 🤰 PregnancyContraindicated
Label: contraindicated in pregnancy. FDA Leflunomide · 4
“Leflunomide is contraindicated in: Pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Leflunomide · 8.2
“Risk Summary Clinical lactation studies have not been conducted to assess the presence of leflunomide in human milk, the effects of leflunomide on the breastfed child, or the effects of leflunomide on milk production.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Leflunomide · 8.4
“The safety and effectiveness of leflunomide in pediatric patients have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Leflunomide · 8.5
“No dosage adjustment is needed in patients over 65.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Leflunomide · 8.3
“Contraception Females Females of reproductive potential should use effective contraception while taking leflunomide.”
🔗 Reference links
- FDA (approval record)ANDA213497
- DailyMed (FDA label)FDA Leflunomide
- MedlinePlus (NIH)Leflunomide
- WHO ATC/DDDL04AK01
- Darooyab (Iran)Leflunomide
🇮🇷 Registered in Iran Darooyab · G-112/Leflunomide
Dosage forms with Iranian generic codes, per Darooyab.
- 06351 · LEFLUNOMIDE 100MG TAB · قرص لفلونوماید ۱۰۰ میلیگرم
- 10058 · LEFLUNOMIDE 10MG TAB · قرص لفلونوماید ۱۰ میلیگرم
- 05974 · LEFLUNOMIDE 20MG TAB · قرص لفلونوماید ۲۰ میلیگرم
- 15836 · LEFLUNOMIDE 5MG TAB · قرص لفلونوماید ۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Leflunomide · 3FDA Leflunomide · 2.1FDA Leflunomide · 2.2FDA Leflunomide · 4FDA Leflunomide · Boxed WarningFDA Leflunomide · SPL approval / marketing categoryFDA Leflunomide · 8.2FDA Leflunomide · 8.4FDA Leflunomide · 8.5FDA Leflunomide · 8.3
- 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)✅ PresentDarooyab · G-112/Leflunomide
- Clinical review⚠ Unverified