From the FDA Drug Label
Pirfenidone may cause serious side effects, including: ... bleeding or bruising more easily than normal
The bleeding risk associated with Esbriet (Pirfenidone) includes bleeding or bruising more easily than normal. 1
From the Research
Esbriet (pirfenidone) carries a low risk of bleeding, and significant bleeding events are not typically associated with this medication. While not specifically known as a medication that increases bleeding risk, patients taking Esbriet should be aware of potential interactions with other medications that affect blood clotting 2. Esbriet is primarily used to treat idiopathic pulmonary fibrosis (IPF) and works by reducing lung tissue scarring through anti-inflammatory and antifibrotic effects. The most common side effects include gastrointestinal issues, skin reactions, and liver enzyme elevations, but significant bleeding events are not typically associated with this medication. However, patients who are already on anticoagulants or antiplatelet medications should inform their healthcare provider about Esbriet use to monitor for any potential additive effects. If unusual bleeding occurs while taking Esbriet, such as easy bruising, nosebleeds, or blood in urine or stool, patients should seek medical attention promptly. Regular monitoring of liver function is recommended during Esbriet treatment, as liver impairment could theoretically affect clotting factor production, though this is not a direct bleeding risk of the medication itself 3.
Some key points to consider when evaluating the bleeding risk of Esbriet include:
- The medication's mechanism of action, which does not directly affect blood clotting
- The potential for interactions with other medications that may increase bleeding risk
- The importance of monitoring liver function, as liver impairment could theoretically affect clotting factor production
- The need for patients to inform their healthcare provider about any unusual bleeding events while taking Esbriet
It's worth noting that the most recent and highest quality study on the topic, published in 2020, found that pirfenidone was effective for long-term control of IPF and had a favorable safety profile, with gastrointestinal disorders, fatigue, and photosensitivity being the most common adverse events 2. Overall, the available evidence suggests that Esbriet carries a low risk of bleeding, and patients can be reassured about the safety of this medication when used as directed.