Pharmacologic class (EPC) · 2 drug pages
Pyridone: adverse event reports filed with FDA
38,749 reports list a drug in this class as a suspect or interacting product, 2009–2026.
- 38,749
- reports across the class
- 0.2% of all reports
- 918
- reports, 12 months to June 2026
- 1,120 in the 12 months before
- 55%
- marked serious by the reporter
- 57.4% across all reports
- 2
- drugs with a page
- brand and generic names counted separately
Pyridone is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 38,749 adverse event reports received by FDA, 0.2% of the database, from April 2009 to June 2026.
918 reports arrived in the 12 months to June 2026, down 18% from 1,120 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 55% of the class's reports are marked serious, 23.5% record death among the outcomes and 18.7% record hospitalisation, as reported.
Across the class the reactions recorded most often are death (19%), nausea (13%) and fatigue (9.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.
The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Drugs in the class
| Drug | Name type | Reports | Latest 12 months | Marked serious | Top term recorded |
|---|---|---|---|---|---|
| EsbrietPirfenidone | brand | 35,230 | 209 | 51.9% | Death |
| Pirfenidone | generic | 3,519 | 709 | 86.2% | Death |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Reports by month, five years
FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
Reactions recorded across the class
share of class reports recording the termmedian drug in the class
- Deaththe patient died; cause not stated by this term19%7,358
- Nauseafeeling sick13%5,028
- Fatiguetiredness9.5%3,674
- Decreased appetitereduced appetite8.2%3,186
- Diarrhoealoose or frequent stools8%3,113
- Dyspnoeashortness of breath6.7%2,610
- Weight decreasedweight loss5.6%2,175
- Dizzinesslight-headedness or unsteadiness5.4%2,074
- Rashskin rash5.2%2,022
- Coughcough4.5%1,732
- Vomitingbeing sick4.5%1,732
- Pneumonialung infection4.4%1,699
- Abdominal discomfortstomach discomfort4.3%1,653
- Abdominal pain upperupper stomach pain3.8%1,480
- Off label useused for a purpose or in a way not on the label3.6%1,384
- Headachehead pain3.5%1,374
- Astheniaweakness or lack of energy3.5%1,367
- Malaisegeneral feeling of being unwell3.3%1,285
- No adverse eventno adverse event was reported3.1%1,213
- Dyspepsiaindigestion3%1,165
- Pruritusitching2.7%1,062
- Insomniadifficulty sleeping2.6%1,000
- Constipationconstipation2%763
- Drug ineffectivethe medicine did not work as expected2%763
- Photosensitivity reactionskin reaction to sunlight1.9%722
Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.
Outcomes, patients and reporters
Outcomes recorded
Patient age
Who reported
Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.
Questions about Pyridone reports
Which drugs are in the Pyridone class on this site?
Esbriet and Pirfenidone. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.
How many reports does the class have?
38,749 reports through June 2026, 918 of them in the latest 12 months. A report listing two drugs of the class counts once for each.
What reactions are recorded most often?
death (19%), nausea (13%), fatigue (9.5%), decreased appetite (8.2%) and diarrhoea (8%).
Can the members table be used to rank the drugs?
No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.
How do I report an adverse event?
Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.