Note: This document contains side effect information about pirfenidone. Some dosage forms listed on this page may not apply to the brand name Esbriet.

Summary

Common side effects of Esbriet include: abdominal distention, abdominal pain, diarrhea, dizziness, dyspepsia, fatigue, gastroesophageal reflux disease, nausea, skin rash, upper abdominal pain, vomiting, weight loss, and anorexia. Other side effects include: pruritus, skin photosensitivity, and decreased appetite. Continue reading for a comprehensive list of adverse effects.

Applies to pirfenidone: oral capsule, oral tablet.

Serious side effects of Esbriet

Along with its needed effects, pirfenidone (the active ingredient contained in Esbriet) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pirfenidone:

More common

• Diarrhea
• itching or skin rash
• nausea
• redness or other discoloration of the skin
• severe sunburn
• stomach discomfort, upset, or pain
• vomiting

Incidence not known

• Black, tarry stools
• blistering, peeling, or loosening of the skin
• chest pain
• chills
• cough or hoarseness
• fever with or without chills
• general feeling of tiredness or weakness
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lower back or side pain
• painful or difficult urination
• red irritated eyes
• red skin lesions, often with a purple center
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness

Other side effects of Esbriet

Some side effects of pirfenidone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• body aches or pain
• change in taste
• dizziness
• ear congestion
• headache
• heartburn or indigestion
• increased sensitivity of the skin to sunlight
• lack or loss of strength
• loss of appetite
• pain or tenderness around the eyes and cheekbones
• sneezing
• stuffy or runny nose
• trouble sleeping
• weight loss

For Healthcare Professionals

Applies to pirfenidone: oral capsule, oral tablet.

Hepatic

Common (1% to 10%): Increased ALT, increased AST, increased gamma glutamyl transferase

Postmarketing reports: Increased bilirubin in combination with increased ALT and AST^[Ref]

Hypersensitivity

Very common (10% or more): Photosensitivity reaction (up to 12.2%)

Postmarketing reports: Angioedema^[Ref]

Dermatologic

Very common (10% or more): Rash (up to 30%)

Common (1% to 10%): Pruritus, erythema, dry skin, erythemous/macular/pruritic rash, sunburn^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 36%), diarrhea (up to 26%), abdominal pain/distension/discomfort (up to 24%), dyspepsia (up to 19%), vomiting (up to 13%), gastroesophageal reflux disease (up to 11%)

Common (1% to 10%): Gastritis, constipation, flatulence^[Ref]

Nervous system

Very common (10% or more): Headache (up to 22%), dizziness (up to 18%)

Common (1% to 10%): Somnolence, dysgeusia^[Ref]

Other

Very common (10% or more): Fatigue (up to 26%)

Common (1% to 10%): Asthenia, non-cardiac chest pain^[Ref]

Metabolic

Very common (10% or more): Anorexia (up to 13%), decreased weight (up to 10%)

Common (1% to 10%): Decreased appetite^[Ref]

Cardiovascular

Common (1% to 10%): Hot flush^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection^[Ref]

Hematologic

Postmarketing reports: Agranulocytosis^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 10%)

Common (1% to 10%): Myalgia^[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 10%)^[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 27%), sinusitis (up to 11%)

Common (1% to 10%): Cough^[Ref]