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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

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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