Dabigatran Etexilate with Prednisolone Interaction Details

Brand Names Associated with Dabigatran Etexilate

Brand Names Associated with Prednisolone

Medical Content Editor Dr. Brian Staiger, PharmD
Last updated Jan 08, 2024

Interaction Effect

Increased risk of gastrointestinal bleeding

Interaction Summary

Concomitant use of dabigatran with an oral glucocorticoid may increase the risk of gastrointestinal bleeding (GIB). In a cohort study, patients prescribed non-vitamin K oral anticoagulants (NOACs) concomitantly with oral glucocorticoids in the preceding 60 days experienced a higher rate of GIB compared with those who were not prescribed glucocorticoids; increased risk was noted with higher dosages of glucocorticoids and in those with increased propensity for bleeding. If coadministration is necessary, close monitoring is recommended.

Severity

Moderate

Onset

Unspecified

Evidence

Theoretical

How To Manage Interaction

Concomitant use of dabigatran with an oral glucocorticoid may increase the risk of gastrointestinal bleeding. If coadministration is necessary, close monitoring is recommended, especially at higher dosages of glucocorticoids and in those at increased risk of bleeding.

Mechanism Of Interaction

Precise mechanism unknown

Literature Reports

A) Concomitant use of non-vitamin K oral anticoagulants (NOACs) and oral glucocorticoids was associated with an increased risk of gastrointestinal bleeding (GIB) when compared with NOACs alone in a nested case-control study from a large cohort of Danish adults with atrial fibrillation (N=98,376; median age 75 years; 44% female; 16% exposed to glucocorticoids; 27% receiving dabigatran). Among those who were prescribed oral glucocorticoids at an equipotent dosage of less than 20 mg of daily predniSOLONE in the preceding 60 days (n=727), GIB occurred in 25% vs 16% in the unexposed control group (n=28,363) [HR, 1.54; 95% CI, 1.29 to 1.84]. In comparison to no exposure, this risk was further increased when an equipotent dosage of 20 mg predniSOLONE or more daily was prescribed (n=536), with 32% in this group experiencing GIB [HR, 2.19; 95% CI, 1.81 to 2.65]. The majority of glucocorticoid prescriptions were for oral predniSOLONE (84.5%), with inflammatory lung disease being the most common indication (30.8%). Other indications included rheumatic disease (8.4%) and cancer (8.1%); however, a non-specific or unknown indication for glucocorticoids was reported in 52.6% of the exposed group. Those in the exposure group had a recorded prescription for any glucocorticoid within 60 days preceding GIB, but detailed information related to duration of glucocorticoid treatment and timing of treatment relative to GIB hospitalization occurrence was not reported .

Dabigatran Etexilate Overview

• Dabigatran is used to treat deep vein thrombosis (DVT; a blood clot, usually in the leg) and pulmonary embolism (PE; a blood clot in the lung) in adults and children 3 months of age and older who have been treated with an injectable anticoagulant ('blood thinner'). It is also used to reduce the risk of a DVT and PE from happening again after initial treatment is completed in adults and children 3 months of age and older. Dabigatran is used to help prevent DVT and PE in adults who have had hip replacement surgery. Dabigatran is also used to help prevent strokes or serious blood clots in adults who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) without heart valve disease. Dabigatran is in a class of anticoagulant medications called direct thrombin inhibitors. It works by preventing blood clots from forming in the body.

Prednisolone Overview

• Prednisolone is used alone or with other medications to treat the symptoms of low corticosteroid levels (lack of certain substances that are usually produced by the body and are needed for normal body functioning). Prednisolone is also used to treat certain conditions that affect the blood, skin, eyes, central nervous system, kidneys, lungs, stomach, and intestines. It is also used to treat allergic reactions; and certain types of arthritis; multiple sclerosis (a disease in which the nerves do not function properly); and to help prevent transplant rejection (attack of the transplanted organ by the body) in certain adults who have received a transplant. Prednisolone is also sometimes used to treat symptoms from certain types of cancer. Prednisolone is in a class of medications called corticosteroids. It works by reducing swelling and redness and by changing the way the immune system works.

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Definitions

Severity Categories

Contraindicated

These drugs, generally, should not be used together simultaneously due to the high risk of severe adverse effects. Combining these medications can lead to dangerous health outcomes and should be strictly avoided unless otherwise instructed by your provider.

Major

This interaction could result in very serious and potentially life-threatening consequences. If you are taking this drug combination, it is very important to be under close medical supervision to minimize severe side effects and ensure your safety. It may be necessary to change a medication or dosage to prevent harm.

Moderate

This interaction has the potential to worsen your medical condition or alter the effectiveness of your treatment. It's important that you are monitored closely and you potentially may need to make adjustments in your treatment plan or drug dosage to maintain optimal health.

Minor

While this interaction is unlikely to cause significant problems, it could intensify side effects or reduce the effectiveness of one or both medications. Monitoring for changes in symptoms and your condition is recommended, and adjustments may be made if needed to manage any increased or more pronounced side effects.

Onset

Rapid: Onset of drug interaction typically occurs within 24 hours of co-administration.

Delayed: Onset of drug interaction typically occurs more than 24 hours after co-administration.

Evidence

Level of documentation of the interaction.

Established: The interaction is documented and substantiated in peer-reviewed medical literature.

Theoretical: This interaction is not fully supported by current medical evidence or well-documented sources, but it is based on known drug mechanisms, drug effects, and other relevant information.

How To Manage The Interaction

Provides a detailed discussion on how patients and clinicians can approach the identified drug interaction as well as offers guidance on what to expect and strategies to potentially mitigate the effects of the interaction. This may include recommendations on adjusting medication dosages, altering the timing of drug administration, or closely monitoring for specific symptoms.

It's important to note that all medical situations are unique, and management approaches should be tailored to individual circumstances. Patients should always consult their healthcare provider for personalized advice and guidance on managing drug interactions effectively.

Mechanism Of Interaction

The theorized or clinically determined reason (i.e., mechanism) why the drug-drug interaction occurs.

Disclaimer: The information provided on this page is for informational purposes only and should not be considered medical advice. Always consult with a qualified healthcare professional regarding your specific circumstances and medical conditions.

Where Does Our Information Come From?

Information for our drug interactions is compiled from several drug compendia, including:

• Gold Standard Drug Database
• Micromedex
• Lexicomp
• DrugBank

The prescribing information for each drug, as published on DailyMED, is also used. 

Individual drug-drug interaction detail pages contain references specific to that interaction. You can click on the reference number within brackets '[]' to see what reference was utilized.

The information posted is fact-checked by HelloPharmacist clinicians and reviewed quarterly.