Esbrietpirfenidone
According to the FDA label: ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). ESBRIET is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF). ( 1 )
40,089 adverse event reports submitted to the FDA (2009–2026)
Top Reported Adverse Events
The most frequently reported events in association with Esbriet in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Death 7,473 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Nausea 5,151 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fatigue 3,792 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Decreased Appetite 3,248 reports
Diarrhoea 3,234 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 2,917 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Weight Decreased 2,214 reports
Dizziness 2,167 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Rash 2,034 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Cough 2,020 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Vomiting 1,803 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 1,769 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Abdominal Discomfort 1,678 reports
A general unease or mild pain in the belly area.
Full definition in the glossary →Abdominal Pain Upper 1,506 reports
Pain in the upper part of the belly, above the navel.
Full definition in the glossary →Headache 1,498 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 24,217 |
| Female | 14,155 |
| Unknown | 4 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 47 |
| 18-34 | 53 |
| 35-49 | 162 |
| 50-64 | 2,194 |
| 65-74 | 6,472 |
| 75+ | 8,969 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Esbriet. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 18,012 |
| Death | 9,361 |
| Hospitalization | 7,728 |
| Other Serious | 7,345 |
| Life-Threatening | 320 |
| Disability | 145 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Esbriet. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2009 | 4 |
| 2010 | 15 |
| 2011 | 6 |
| 2012 | 13 |
| 2013 | 10 |
| 2014 | 123 |
| 2015 | 2,883 |
| 2016 | 4,177 |
| 2017 | 2,430 |
| 2018 | 4,311 |
| 2019 | 4,319 |
| 2020 | 5,096 |
| 2021 | 4,958 |
| 2022 | 4,745 |
| 2023 | 3,566 |
| 2024 | 1,930 |
| 2025 | 1,281 |
| 2026 (partial) | 222 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Esbriet
In FDA adverse event reports that mention Esbriet, these medications appeared most often in the same report.
- Omeprazole (2,252 reports)
- Aspirin (2,213 reports)
- Prednisone (2,155 reports)
- Furosemide (1,875 reports)
- Albuterol (1,560 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026