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Pirfenidone Side Effects

The most commonly reported side effects of pirfenidone include death, nausea, and fatigue, based on 40,170 FDA adverse event reports from 2005 to 2025.

Pirfenidone side effects

Percentages show how often each reaction appears relative to total reports for pirfenidone.

1
Death18.5%7,435
2
Nausea12.8%5,142
3
Fatigue9.4%3,780
4
Decreased Appetite8.0%3,233
5
Diarrhoea8.0%3,220
6
Dyspnoea7.2%2,896
7
Weight Decreased5.5%2,202
8
Dizziness5.3%2,149
9
Rash5.1%2,029
10
Cough5.0%1,994
11
Vomiting4.4%1,785
12
Pneumonia4.4%1,753
13
Abdominal Discomfort4.2%1,675
14
Abdominal Pain Upper3.7%1,501
15
Off Label Use3.7%1,495

These are voluntary reports and do not establish that pirfenidone caused these reactions.

Report severity

55.3%Serious22,216 reports
19.6%Hospitalizations7,868 reports
23.2%Fatal9,331 reports

Seriousness is determined by the reporter, not by OpenClaim.

Pirfenidone drug interactions

Other drugs that appear in adverse event reports alongside pirfenidone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Treprostinil2.3%917
2
Nintedanib1.4%572
3
Mycophenolate0.3%132
4
Rituximab0.2%94
5
Ciprofloxacin0.2%93
6
Prednisone0.2%91
7
Macitentan0.2%80
8
Gabapentin0.2%79
9
Aspirin0.2%64
10
Prednisolone0.2%62
11
Metformin0.1%57
12
Ambrisentan0.1%53
13
Omeprazole0.1%51
14
Sertraline-hydrochloride0.1%50
15
Pantoprazole-sodium0.1%50

Taken alongside

1
Aspirin7.5%3,021
2
Atorvastatin-calcium6.4%2,576
3
Omeprazole5.9%2,379
4
Prednisone5.5%2,218
5
Albuterol5.4%2,161
6
Furosemide4.6%1,864
7
Levothyroxine-sodium4.3%1,733
8
Metoprolol4.0%1,595
9
Fluticasone3.9%1,582
10
Pantoprazole-sodium3.8%1,544
11
Metformin3.7%1,497
12
Amlodipine3.5%1,390
13
Ergocalciferol3.1%1,229
14
Losartan-potassium3.0%1,215
15
Acetaminophen3.0%1,187

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports pirfenidone side effects

35.5% of pirfenidone adverse event reports involve female patients and 60.3% involve male patients. The largest age group is elderly at 85%. These figures reflect who reports side effects, not underlying risk.

Sex

Female35.5%
Male60.3%
Unknown4.2%

Age group

< 2<0.1%
2–11<0.1%
12–17<0.1%
18–6414.4%
65+85.3%

What is pirfenidone used for

Conditions and purposes for which patients were taking pirfenidone when the adverse event was reported.

Abdominal HerniaAbdominal Hernia ObstructiveAbdominal PainAbdominal Pain UpperAcute Interstitial PneumonitisAcute Left Ventricular FailureAcute LeukaemiaAcute Myeloid LeukaemiaAcute Respiratory FailureAcute TonsillitisAdverse Drug ReactionAdverse EventAgranulocytosisAlbinismAlveolar Lung Disease

Showing 15 of 525 indications

Pirfenidone brand names and reporting trend

Pirfenidone is sold under the brand name Esbriet.

Brand names

Esbriet4,988

Quarterly reports (20052025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking pirfenidone with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.