Pirfenidone Side Effects

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

Applies to pirfenidone: oral capsule, oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may make your skin more sensitive to sunlight. Use sunscreen or sunblock lotions with a sun protection factor (SPF) 50 or higher on a regular basis when you are outdoors. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Check with your doctor right away if you have diarrhea, nausea, vomiting, heartburn, stomach pain or upset while using this medicine.

Stop smoking before treatment with Esbriet® and avoid smoking while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

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]

See also:

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