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Pirfenidone Side Effects

In Summary

Commonly reported side effects of pirfenidone 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. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to pirfenidone: oral capsule, oral tablet

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 Incidence not known
  • Cough or hoarseness
  • fever with or without chills
  • general feeling of tiredness or weakness
  • 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
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • unusual bleeding or bruising

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
  • joint or muscle pain
  • lack or loss of strength
  • loss of appetite
  • pain or tenderness around the eyes and cheekbones
  • sneezing
  • stuffy or runny nose
  • trouble sleeping
  • unusual tiredness or weakness
  • weight loss

For Healthcare Professionals

Applies to pirfenidone: oral capsule, oral tablet


Common (1% to 10%): Increased ALT, increased AST, increased gamma glutamyl transferase
Postmarketing reports: Increased bilirubin in combination with increased ALT and AST[Ref]


Very common (10% or more): Photosensitivity reaction (up to 12.2%)
Postmarketing reports: Angioedema[Ref]


Very common (10% or more): Rash (up to 30%)
Common (1% to 10%): Pruritus, erythema, dry skin, erythemous/macular/pruritic rash, sunburn[Ref]


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]


Very common (10% or more): Fatigue (up to 26%)
Common (1% to 10%): Asthenia, non-cardiac chest pain[Ref]


Very common (10% or more): Anorexia (up to 13%), decreased weight (up to 10%)
Common (1% to 10%): Decreased appetite[Ref]


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


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


Postmarketing reports: Agranulocytosis[Ref]


Very common (10% or more): Arthralgia (up to 10%)
Common (1% to 10%): Myalgia[Ref]


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


Very common (10% or more): Upper respiratory tract infection (up to 27%), sinusitis (up to 11%)
Common (1% to 10%): Cough[Ref]


1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Esbriet (pirfenidone)." Intermune Inc, Brisbane, CA.

Some side effects of pirfenidone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.