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Azathioprine

آزاتیوپرین

⚠ Unverified

🎗️ Antineoplastic And Immunomodulating AgentsImmunosuppressant (antimetabolite)

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Safety not established 🇮🇷 Registered in Iran ⛔ 1 contraindications ⚠️ 1 interactions 🇺🇸 FDA approved generic (ANDA) ANDA075252 ATC L04AX01

Market / country: 🇺🇸 USA

Imuran (US)

🧮 Dose calculator

Disease / regimen

Rheumatoid arthritis · Regimen source: FDA Azathioprine · Dosage and Administration — Rheumatoid Arthritis

• Single or twice-daily. From week 6–8 increase 0.5 mg/kg every 4 weeks up to 2.5 mg/kg. Test TPMT and NUDT15 before starting (deficiency → major dose reduction). FDA Azathioprine · Dosage and Administration — Rheumatoid Arthritis FDA Azathioprine · Dosage and Administration

Formulation

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🛡️ Safety & information

Contraindications

⛔ Hypersensitivity; rheumatoid arthritis in pregnancy; RA previously treated with alkylating agents (malignancy risk). FDA Azathioprine · Contraindications

Warnings

• Boxed warning: malignancy (lymphoma and skin cancer) with chronic immunosuppression. FDA Azathioprine · Boxed Warning

Important interactions

• Allopurinol and febuxostat: markedly increased toxicity (febuxostat contraindicated). FDA Azathioprine · Drug Interactions

Formulations

50 mg tablet (scored) — tablet 🇺🇸 USA FDA Azathioprine · How Supplied

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Azathioprine · Precautions/Warnings – Pregnancy
“Teratogenic Effects : See WARNINGS section.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Azathioprine · Precautions/Warnings – Nursing Mothers
“The use of Azathioprine Tablets in nursing mothers is not recommended.”
👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Azathioprine · Precautions/Warnings – Pediatric Use
“Safety and efficacy of azathioprine in pediatric patients have not been established.”
👴 Older adultsNo data
The source for this drug has no section for this group.
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)ANDA075252
DailyMed (FDA label)FDA Azathioprine
MedlinePlus (NIH)Azathioprine
WHO ATC/DDDL04AX01
Darooyab (Iran)Azathioprine

🇮🇷 Registered in Iran Darooyab · G-2730/Azathioprine

Dosage forms with Iranian generic codes, per Darooyab.

20225 · AZATHIOPRINE 100MG TAB · قرص آزاتیوپرین ۱۰۰ میلی‌گرم
17665 · AZATHIOPRINE 25MG TAB · قرص آزاتیوپرین ۲۵ میلی‌گرم
00122 · AZATHIOPRINE 50MG TAB · قرص آزاتیوپرین ۵۰ میلی‌گرم
01399 · AZATHIOPRINE SODIUM 50MG AMP · آمپول آزاتیوپرین سدیم ۵۰ میلی‌گرم

📚 Reference status for this drug

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

FDA label (DailyMed)✅ Present
FDA Azathioprine · How Supplied FDA Azathioprine · Dosage and Administration — Rheumatoid Arthritis FDA Azathioprine · Dosage and Administration FDA Azathioprine · Contraindications FDA Azathioprine · Boxed Warning FDA Azathioprine · Drug Interactions FDA Azathioprine · SPL approval / marketing category FDA Azathioprine · Precautions/Warnings – Pregnancy FDA Azathioprine · Precautions/Warnings – Nursing Mothers FDA Azathioprine · Precautions/Warnings – Pediatric Use
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-2730/Azathioprine
Clinical review⚠ Unverified