Dabigatran and Darunavir and cobicistat interaction

Dabigatran and Darunavir and cobicistat: both prescribing labels flag this combination with the strongest language, such as a contraindication, a boxed warning, or an instruction to avoid it.

Major

Do not combine without a prescriber's guidance. The label language below is the strongest FDA uses.

What the FDA labels say

From the Dabigatran (Pradaxa) label · effective 2025-06-25

Major

Avoid use of PRADAXA Capsules and P-gp inhibitors in patients with severe renal impairment (CrCl 15-30 mL/min) [see Drug Interactions (7.1) and Use in Specific Populations (8.6) ] .

Warnings and precautionsby drug classView label on DailyMed
Major

Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients Avoid use of PRADAXA Capsules and concomitant P-gp inhibitors in patients with CrCl < 50 mL/min [see Drug Interactions (7.2) and Use in Specific Populations (8.6) ] .

Warnings and precautionsby drug classView label on DailyMed
Major

Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism in Adult Patients Following Hip Replacement Surgery Avoid use of PRADAXA Capsules and concomitant P-gp inhibitors in patients with CrCl < 50 mL/min [see Drug Interactions (7.3) and Use in Specific Populations (8.6) ] .

Warnings and precautionsby drug classView label on DailyMed
Major

P-gp inhibitors in adult patients with CrCl 30-50 mL/min: Reduce dosage or avoid ( 7 )

Drug interactionsby drug classView label on DailyMed
Major

P-gp inhibitors in adult patients with CrCl < 30 mL/min: Not recommended ( 7 )

Drug interactionsby drug classView label on DailyMed

From the Darunavir and cobicistat (PREZCOBIX) label · effective 2026-02-01

Major

…apixaban prescribing information. rivaroxaban ↑ rivaroxaban Co-administration of rivaroxaban with PREZCOBIX or PREZCOBIX PED is not recommended because it may lead to an increased bleeding risk. dabigatran etexilate edoxaban ↑ dabigatran ↑ edoxaban Refer to the dabigatran etexilate or edoxaban prescribing information for recommendations regarding co-administration.

Drug interactionsnames DabigatranView label on DailyMed
Moderate

Clinical monitoring is recommended when a DOAC not affected by CYP3A4 but transported by P-gp, including dabigatran etexilate and edoxaban, is co-administered with PREZCOBIX or PREZCOBIX PED.

Drug interactionsnames DabigatranView label on DailyMed
Moderate

Anticoagulants: Direct Oral Anticoagulants (DOACs) apixaban ↑ apixaban Due to potentially increased bleeding risk, dosing recommendations for co-administration of apixaban with PREZCOBIX or PREZCOBIX PED depend on the apixaban dose.

Drug interactionsby drug classView label on DailyMed
Moderate

Other Anticoagulants: warfarin warfarin: effect unknown Monitor the international normalized ratio (INR) when co-administering with warfarin.

Drug interactionsby drug classView label on DailyMed
Minor

The specific recommendations are based on indication, renal function, and effect of the co-administered P-gp inhibitors on the concentration of dabigatran or edoxaban.

Drug interactionsnames DabigatranView label on DailyMed

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Not medical advice. Interaction Checker quotes FDA label text and NIH fact sheets. Whether an interaction matters for you depends on doses, timing, kidney and liver function, and other conditions. Confirm with a pharmacist or prescriber.