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Esbriet Side Effects

Generic Name: pirfenidone

Note: This page contains information about the side effects of pirfenidone. Some of the dosage forms included on this document may not apply to the brand name Esbriet.

In Summary

Common side effects of Esbriet 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

In addition to its needed effects, some unwanted effects may be caused by pirfenidone (the active ingredient contained in Esbriet). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking pirfenidone:

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 of the side effects that can occur with pirfenidone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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.

Not all side effects for Esbriet may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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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