Esbriet Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).


There is currently no drug history available for this drug.

Other Information

Each ESBRIET capsule contains 267 mg of pirfenidone, which belongs to the chemical class of pyridone. ESBRIET is available as a white hard gelatin capsule for oral administration.

The chemical name of pirfenidone is 5-methyl-1-phenyl-2-1(H)-pyridone. It has a molecular formula of C12H11NO and a molecular weight of 185.23. The structural formula of pirfenidone is:

Chemical Structure

Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C.

ESBRIET capsule contains pirfenidone and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, and magnesium stearate.

In addition, the capsule shell contains gelatin and titanium dioxide. The capsule brown printing ink includes shellac, iron oxide black, iron oxide red, iron oxide yellow, propylene glycol, ammonium hydroxide.

Esbriet Manufacturers

  • Intermune, Inc.
    Esbriet (Pirfenidone) Capsule [Intermune, Inc.]
  • Genentech, Inc.
    Esbriet (Pirfenidone) Capsule [Genentech, Inc.]

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