What is PIRFENIDONE used for?

PIRFENIDONE (brand name Pirfenidone) is a Other indicated for See full prescribing information.

What are the most common side effects of PIRFENIDONE?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for PIRFENIDONE. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is PIRFENIDONE the same as Pirfenidone?

Pirfenidone is a brand name for PIRFENIDONE. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

PIRFENIDONE

Q: How does PIRFENIDONE work?

PIRFENIDONE works through the following mechanism: 12.1 Mechanism of Action The mechanism of action of pirfenidone in the treatment of IPF has not been established..

Other

Brand names: Pirfenidone

Oral

Mechanism of Action

12.1 Mechanism of Action The mechanism of action of pirfenidone in the treatment of IPF has not been established.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS None. None

FDA Warnings

5 WARNINGS AND PRECAUTIONS Elevated liver enzymes and drug-induced liver injury: ALT, AST, and bilirubin elevations have occurred with pirfenidone including cases of drug-induced liver injury
In the post-marketing setting, non-serious and serious cases of drug-induced liver injury, including severe liver injury with fatal outcomes, have been reported
In the post-marketing period, non-serious and serious cases of DILI, including severe liver injury with fatal outcome, have been reported

Known Side Effects

11 documented side effects by frequency

Nausea

>10%

Fatigue

1-10%

Decreased Appetite

1-10%

Diarrhea

1-10%

Shortness of Breath

1-10%

Weight Loss

1-10%

Dizziness

1-10%

Rash

0.1-1%

Cough

0.1-1%

Vomiting

0.1-1%

Headache

0.1-1%

Community Discussions

No community discussions found for PIRFENIDONE yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → PIRFENIDONE openFDA label JSON → PIRFENIDONE FAERS adverse-event reports → PIRFENIDONE ClinicalTrials.gov → completed Phase 2+ trials of PIRFENIDONE

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Formulations

Dosage Forms

Tablet

Route

Oral