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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

As well as its needed effects, pirfenidone may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking pirfenidone, check with your doctor immediately:

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:
  • 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

Minor Side Effects

Some pirfenidone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

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]

References

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

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

It is possible that some side effects of pirfenidone may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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. Drugs.com 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.

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