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Esbriet

Last reviewed on RxList: 9/21/2020
Esbriet Side Effects Center

What Is Esbriet?

Esbriet (pirfenidone) is an anti-inflammatory drug used to treat idiopathic pulmonary fibrosis (IPF).

What Are Side Effects of Esbriet?

Common side effects of Esbriet include:

The recommended daily maintenance dosage of Esbriet is 801 mg (three 267 mg capsules) three times a day with food for a total of 2403 mg/day. Esbriet may interact with enoxacin, ciprofloxacin, and fluvoxamine. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Esbriet. It is unknown if this drug will harm a fetus. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Esbriet (pirfenidone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See Answer
Esbriet Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe ongoing stomach pain, vomiting, diarrhea;
  • burning or pain in your esophagus or throat; or
  • liver problems--stomach pain (upper right side), easy bruising or bleeding, feeling tired, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea, vomiting, loss of appetite;
  • stomach pain, heartburn, upset stomach;
  • diarrhea;
  • headache, dizziness, tired feeling;
  • weight loss;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • joint pain; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Esbriet (Pirfenidone Capsules)

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Esbriet Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Liver Enzyme Elevations and Drug-Induced Liver Injury [see WARNINGS AND PRECAUTIONS]
  • Photosensitivity Reaction or Rash [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Disorders [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of pirfenidone has been evaluated in more than 1400 subjects with over 170 subjects exposed to pirfenidone for more than 5 years in clinical trials.

ESBRIET was studied in 3 randomized, double-blind, placebo-controlled trials (Studies 1, 2, and 3) in which a total of 623 patients received 2403 mg/day of ESBRIET and 624 patients received placebo. Subjects ages ranged from 40 to 80 years (mean age of 67 years). Most patients were male (74%) and Caucasian (95%). The mean duration of exposure to ESBRIET was 62 weeks (range: 2 to 118 weeks) in these 3 trials.

At the recommended dosage of 2403 mg/day, 14.6% of patients on ESBRIET compared to 9.6% on placebo permanently discontinued treatment because of an adverse event. The most common (>1%) adverse reactions leading to discontinuation were rash and nausea. The most common (>3%) adverse reactions leading to dosage reduction or interruption were rash, nausea, diarrhea, and photosensitivity reaction.

The most common adverse reactions with an incidence of ≥10% and more frequent in the ESBRIET than placebo treatment group are listed in Table 2.

Table 2: Adverse Reactions Occurring in ≥10% of ESBRIET-Treated Patients and More Commonly Than Placebo in Studies 1, 2, and 3

Adverse Reaction% of Patients (0 to 118 Weeks)
ESBRIET 2403 mg/day
(N = 623)
Placebo
(N = 624)
Nausea36%16%
Rash30%10%
Abdominal Pain*24%15%
Upper Respiratory Tract Infection27%25%
Diarrhea26%20%
Fatigue26%19%
Headache22%19%
Dyspepsia19%7%
Dizziness18%11%
Vomiting13%6%
Anorexia13%5%
Gastro-esophageal Reflux Disease11%7%
Sinusitis11%10%
Insomnia10%7%
Weight Decreased10%5%
Arthralgia10%7%
*Includes abdominal pain, upper abdominal pain, abdominal distension, and stomach discomfort.

Adverse reactions occurring in ≥5 to <10% of ESBRIET-treated patients and more commonly than placebo are photosensitivity reaction (9% vs. 1%), decreased appetite (8% vs. 3%), pruritus (8% vs. 5%), asthenia (6% vs. 4%), dysgeusia (6% vs. 2%), and non-cardiac chest pain (5% vs. 4%).

Postmarketing Experience

In addition to adverse reactions identified from clinical trials the following adverse reactions have been identified during post-approval use of pirfenidone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Blood And Lymphatic System Disorders

Agranulocytosis

Immune System Disorders

Angioedema

Hepatobiliary Disorders

Drug-induced liver injury [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Esbriet (Pirfenidone Capsules)

Related Resources for Esbriet

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© Esbriet Patient Information is supplied by Cerner Multum, Inc. and Esbriet Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See Answer

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