Dabigatran
دابیگاتران
🩸 Blood And Blood Forming OrgansDirect thrombin inhibitor
Market / country: 🇺🇸 USA
Pradaxa (US)
🧮 Dose calculator
Atrial fibrillation / anticoagulation · Regimen source: FDA Dabigatran · 2.2
- • CrCl 15–30: 75 mg twice daily; <15 or dialysis: no recommendation. Do not open or chew capsules. FDA Dabigatran · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Active bleeding; mechanical prosthetic heart valve; serious hypersensitivity. FDA Dabigatran · 4
Warnings
- • Boxed warning: premature discontinuation increases thrombotic events; spinal/epidural haematoma. FDA Dabigatran · Boxed Warning
Formulations
- 75 mg capsule — capsule 🇺🇸 USA FDA Dabigatran · 3
- 110 mg capsule — capsule 🇺🇸 USA FDA Dabigatran · 3
- 150 mg capsule — capsule 🇺🇸 USA FDA Dabigatran · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Dabigatran · 8.1
“Risk Summary The limited available data on Dabigatran Etexilate Capsules use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Dabigatran · 8.2
“Breastfeeding is not recommended during treatment with Dabigatran Etexilate Capsules.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Dabigatran · 8.4
“The safety and effectiveness of Dabigatran Etexilate Capsules for the treatment and the reduction in risk of recurrence of venous thromboembolism have been established in pediatric patients 8 to less than 18 years of age.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Dabigatran · 8.5
“The risk of stroke and bleeding increases with age, but the risk-benefit profile is favorable in all age groups [see Warnings and Precautions (5), Adverse Reactions (6.1), and Clinical Studies (14.1)] .”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Dabigatran · 8.3
“Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician.”
🔗 Reference links
- FDA (approval record)ANDA208040
- DailyMed (FDA label)FDA Dabigatran
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDB01AE07
- Darooyab (Iran)Dabigatran
🇮🇷 Registered in Iran Darooyab · G-4711/Dabigatran
Dosage forms with Iranian generic codes, per Darooyab.
- 13583 · DABIGATRAN 110MG CAP · کپسول دابیگاتران ۱۱۰ میلیگرم
- 19438 · DABIGATRAN 150MG CAP · کپسول دابیگاتران ۱۵۰ میلیگرم
- 13584 · DABIGATRAN 75MG CAP · کپسول دابیگاتران ۷۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Dabigatran · 3FDA Dabigatran · 2.2FDA Dabigatran · 2.3, Table 1FDA Dabigatran · 4FDA Dabigatran · Boxed WarningFDA Dabigatran · 8.1FDA Dabigatran · 8.2FDA Dabigatran · 8.4FDA Dabigatran · 8.5FDA Dabigatran · 8.3FDA Dabigatran · SPL approval / marketing category
- 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-4711/Dabigatran
- Clinical review⚠ Unverified