Pradaxa (Dabigatran Etexilate)
Also sold as: Pradaxa, Dabigat, Dabiga, Pradax, Dabixa
Pregnancy
Cat X
Lactation
Avoid
Schedule
H
Forms
Capsule 75mg, 110mg, 150mg
Indications
- Non-valvular AF — stroke prevention
- DVT and PE treatment
- VTE prevention after hip/knee replacement surgery
Adult Dosing
AF (stroke prevention)
150 mg PO BD (standard). Reduce to 110 mg BD if: age ≥80, or age 75-80 + high bleeding risk, or CrCl 30-50 + amiodarone use
Take with or without food. Swallow capsule whole — do not open.
DVT/PE treatment
150 mg PO BD (after 5-10 days of parenteral anticoagulation)
Start after initial heparin/LMWH — unlike rivaroxaban/apixaban (direct oral initiation)
Post-surgical VTE prophylaxis
220 mg OD (or 150 mg OD if CrCl 30-50 / concomitant amiodarone or verapamil)
10 days (knee); 28-35 days (hip). Start 1-4 hours post-surgery.
Pediatric Dosing
No paediatric indication approved
Renal Dose Adjustment
| CrCl / eGFR | Dose Adjustment |
|---|---|
| CrCl > 50 mL/min | Standard dosing |
| CrCl 30-50 mL/min | 110 mg BD (AF); 150 mg BD with caution (DVT); reduce as above |
| CrCl 15-30 mL/min | Not approved for most indications; extreme caution. AF: 75 mg BD (US label only) |
| CrCl < 15 mL/min | CONTRAINDICATED |
Hepatic Adjustment
Avoid in severe hepatic impairment
Pregnancy & Lactation
Pregnancy: Category X
CONTRAINDICATED — use LMWH in pregnancy.
Lactation: Avoid
Unknown breast milk excretion. Avoid.
Top Drug Interactions
| Interacting Drug | Effect | Severity |
|---|---|---|
| P-gp inhibitors (amiodarone, verapamil, dronedarone, clarithromycin, ketoconazole) | Increase dabigatran levels — reduce dose (110 mg BD) or AVOID | Major |
| P-gp inducers (rifampicin, carbamazepine, phenytoin, St John's Wort) | Reduce dabigatran levels — AVOID | Major |
| PPIs (omeprazole, pantoprazole) | Reduce dabigatran absorption by 10-30% — clinically insignificant but be aware | Minor |
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Side Effects
Common
- Bleeding
- GI symptoms: dyspepsia, nausea, abdominal pain (acid released from capsule)
- Gastritis-like symptoms
Serious / Discontinue If
- Major bleeding
- GI bleeding (higher than other DOACs)
- Antidote available: Idarucizumab (Praxbind) — available in major Indian centres
Contraindications
- CrCl < 15 mL/min
- Active major bleeding
- Prosthetic heart valves
- Mechanical heart valves
- Hepatic impairment with coagulopathy
Available Indian Brands
| Brand | Manufacturer | Price (approx) |
|---|---|---|
| Pradaxa 150mg | Boehringer Ingelheim | 10 cap ₹685 |
| Dabigat 150mg | Sun Pharma | 10 cap ₹385 |
| Dabiga 150mg | Cipla | 10 cap ₹365 |
| Dabixa 110mg | Mankind | 10 cap ₹295 |
Monitoring Required
- Renal function (CrCl) — every 6-12 months (more frequently if >75 years or CrCl 30-60)
- CBC
- LFTs
- Signs of GI symptoms or bleeding
- No routine anticoagulation monitoring needed (but aPTT/TT can indicate drug presence)
Patient Counseling Points
- Swallow capsule WHOLE — do not open, crush or chew (acidic beads inside)
- GI symptoms (dyspepsia) very common — take with or immediately after food, with a full glass of water
- Store in original container — moisture-sensitive
- Discard unused capsules 4 months after opening bottle
- Antidote (Idarucizumab/Praxbind) available at major hospitals for emergencies
- Do NOT stop without medical advice
Stop Googling drug references mid-consultation
EasyClinic auto-flags Pradaxa interactions, renal cutoffs, and pregnancy warnings the moment you write the prescription. Built-in safety net for every Indian doctor.
Clinically reviewed by: Dr. Priya Sharma, DM (Cardiology), Senior Cardiologist
Last reviewed: 2026-04-01
References
- BNF — Dabigatran
- RE-LY Trial
- ESC AF Guidelines 2023
- ACCP Antithrombotic Guidelines 2021