Pirfenidone Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 10, 2024.

Applies to pirfenidone: oral capsule, oral tablet.

Serious side effects of pirfenidone

Along with its needed effects, pirfenidone 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 side effects

• 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 pirfenidone

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 side effects

• 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 adverse events

• 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]

Frequently asked questions

• Can Ofev and Esbriet be given together?

Further information

Pirfenidone side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer