72/100 · Elevated
Manufactured by Genentech, Inc.
High Serious Event Rate for PIRFENIDONE
77,209 FDA adverse event reports analyzed
Last updated: 2026-05-12
PIRFENIDONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. Based on analysis of 77,209 FDA adverse event reports, PIRFENIDONE has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for PIRFENIDONE include DEATH, NAUSEA, FATIGUE, DECREASED APPETITE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PIRFENIDONE.
Pirfenidone has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 77,209 adverse event reports for this medication, which is primarily manufactured by Genentech, Inc..
The most commonly reported adverse events include Death, Nausea, Fatigue. Of classified reports, 55.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common serious adverse events include death, pneumonia, and respiratory failure.
Nausea, fatigue, and decreased appetite are the most frequently reported non-serious adverse events. The drug is most commonly reported in patients aged 70 and above.
Patients taking Pirfenidone should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Pirfenidone is associated with serious respiratory events, and patients should be monitored for signs of pneumonia and respiratory failure. Drug interactions, particularly with drugs that affect respiratory function, should be considered. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Pirfenidone received a safety concern score of 72/100 (elevated concern). This is based on a 55.0% serious event ratio across 39,835 classified reports. The score accounts for 77,209 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Male: 24,077, Female: 14,087, Unknown: 4. The most frequently reported age groups are age 74 (922 reports), age 76 (903 reports), age 77 (891 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 39,835 classified reports for PIRFENIDONE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Pirfenidone is associated with serious respiratory events, and patients should be monitored for signs of pneumonia and respiratory failure. Drug interactions, particularly with drugs that affect respiratory function, should be considered.
If you are taking Pirfenidone, here are important things to know. The most commonly reported side effects include death, nausea, fatigue, decreased appetite, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any signs of respiratory distress or severe side effects to their healthcare provider immediately. Regular monitoring of liver enzymes and blood pressure is recommended due to the potential for these adverse effects. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA has not issued any specific warnings regarding the use of Pirfenidone, but healthcare providers should be vigilant about monitoring patients for serious adverse events, especially respiratory issues.
The FDA has received approximately 77,209 adverse event reports associated with Pirfenidone. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Pirfenidone include Death, Nausea, Fatigue, Decreased Appetite, Diarrhoea. By volume, the top reported reactions are: Death (7,433 reports), Nausea (5,132 reports), Fatigue (3,773 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Pirfenidone.
Out of 39,835 classified reports, 21,890 (55.0%) were classified as serious and 17,945 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Pirfenidone break down by patient sex as follows: Male: 24,077, Female: 14,087, Unknown: 4. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Pirfenidone adverse events are: age 74: 922 reports, age 76: 903 reports, age 77: 891 reports, age 78: 844 reports, age 79: 843 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Pirfenidone adverse event reports is Genentech, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Pirfenidone include: Dyspnoea, Weight Decreased, Dizziness, Rash, Cough. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Pirfenidone to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Pirfenidone has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The most common serious adverse events include death, pneumonia, and respiratory failure.
Key safety signals identified in Pirfenidone's adverse event data include: Death is the most serious adverse event with 7433 reports.. Pneumonia and respiratory failure are also significant serious adverse events.. Nausea, fatigue, and decreased appetite are the most common non-serious adverse events.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Pirfenidone is associated with serious respiratory events, and patients should be monitored for signs of pneumonia and respiratory failure. Drug interactions, particularly with drugs that affect respiratory function, should be considered. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Pirfenidone.
Patients should report any signs of respiratory distress or severe side effects to their healthcare provider immediately. Regular monitoring of liver enzymes and blood pressure is recommended due to the potential for these adverse effects.
Pirfenidone has 77,209 adverse event reports on file with the FDA. Nausea, fatigue, and decreased appetite are the most frequently reported non-serious adverse events. The volume of reports for Pirfenidone reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has not issued any specific warnings regarding the use of Pirfenidone, but healthcare providers should be vigilant about monitoring patients for serious adverse events, especially respiratory issues. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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