Pirfenidone (Esbriet) Uses, Side Effects & Dosage

What is pirfenidone (Esbriet)? What is pirfenidone used for?

Pirfenidone (Esbriet) is a prescription medicine used to prevent and improve lung function in idiopathic pulmonary fibrosis, a type of serious lung disease in which the lung progressively develops scar tissue.

The mechanism of action of pirfenidone is not understood. Scientists believe that pirfenidone prevents lung damage by inhibiting the production of tissue-destructive chemicals such as reactive oxygen species, inflammatory chemicals like tumor necrosis factor-alpha (TNF-alpha), and pro-inflammatory growth factor-beta (TGF-beta).

In clinical studies pirfenidone was better than placebo in improving lung function; however, it did not improve survival in people with idiopathic pulmonary fibrosis. Pirfenidone was approved by tche FDA in October, 2014.

What brand names are available for pirfenidone (Esbriet)?


Is pirfenidone esbriet available as a generic drug?


Do I need a prescription for pirfenidone (Esbriet)?


What are the side effects of pirfenidone (Esbriet)?

Common side effects of pirfenidone include:

Pirfenidone may cause liver
problems and sensitivity to sunlight.

What is the dosage for pirfenidone (Esbriet)?

Liver tests are required before starting treatment with pirfenidone
because of the potential for liver damage.

The recommended dose of pirfenidone in patients with idiopathic pulmonary
fibrosis is 801 mg (three 276 mg capsules) three times a day with food for a
total daily dose of 2,403 mg. Patients should take pirfenidone with food to help
decrease nausea and dizziness. Pirfenidone may make the skin more sensitive to
the sun, light from sunlamps, and tanning beds. To avoid serious sunburns or
related injury, patients are advised to use sunscreen (SPF 50) and wear
protective clothing.

When starting treatment, patients are started at a low dose followed by
gradual increase to the recommended daily dose. The recommended initiation of
treatment with pirfenidone is 1 capsule three times a day with food on days 1-7,
then 2 capsules by mouth three times a day with food on days 8-14, then 3
capsules by mouth three times a day with food thereafter.

Patients restarting treatment after taking a break of 14 days or more should
re-initiate treatment by following the recommended regimen.

The dose of pirfenidone may need to be lowered or treatment may need to be
temporarily or permanently stopped if abnormally high levels of liver enzymes or
bilirubin occur. Significant increases in liver enzymes or bilirubin may
indicate serious liver damage. Patients experiencing unexplained symptoms
including jaundice (yellowing of the skin or the white part of the eyes), dark
or brown colored urine, pain on the upper right side the stomach, bleeding more
easily than normal, or feeling unusually tired should contact their doctor right
away as these may be signs and symptoms of serious liver damage.

Pirfenidone should be used cautiously in patients with mild (Child-Pugh Class
A) to moderate (Child-Pugh Class B) liver disease. Use of pirfenidone should be
avoided in patients with severe liver disease (Child-Pugh Class C).

Smoking may decrease blood levels of pirfenidone. Since reduced blood levels
of pirfenidone may decrease the effectiveness of treatment, smoking should be
avoided when using pirfenidone.

The safety and effectiveness of pirfenidone has not been established in
pediatric patients.

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Which drugs or supplements interact with pirfenidone (Esbriet)?

Pirfenidone is extensively metabolized or broken down by
the CYP1A2 type liver enzymes.

Administration of pirfenidone with strong CYP1A2 enzyme inhibitors is not
recommended because they may cause significant increases in blood levels of
pirfenidone. If pirfenidone must be taken with strong CYP1A2 inhibitors such as
fluvoxamine (Luvox) or enoxacin (Penetrex), doses of pirfenidone should be
reduced to one capsule three times daily. The dose should be reduced to two
capsules three times daily if used with ciprofloxacin (Cipro) 750 mg, a moderate
CYP1A2 inhibitor.

Similarly, use of pirfenidone should be avoided with strong CYP1A2 inducers.
Strong CYP1A2 inducers may decrease blood levels of pirfenidone and consequently
decrease the effectiveness of treatment.


COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma.
See Answer

Is pirfenidone (Esbriet) safe to take if I’m pregnant or breastfeeding?

Pirfenidone is classified as FDA pregnancy risk category C, a
designation which indicates harm is shown in animal studies, but no adequate
studies in pregnant women exist. Due to the lack of conclusive safety
data, pirfenidone should be used in pregnancy only if the potential benefit
justifies the potential risk to the fetus.

It is not known if pirfenidone is excreted in human milk. As
many drugs can enter breast milk and have the potential of causing harm to the
nursing infant, pirfenidone should be used cautiously in nursing mothers.

What else should I know about pirfenidone (Esbriet)?

What preparations of pirfenidone (Esbriet) are available?

Oral capsules: 267 mg.

How should I keep pirfenidone (Esbriet) stored?

Capsules should be stored at room temperature, between 15 C to 30 C
(59 F to 86 F).

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