Pirfenidone

Common brands: Esbriet, Acid Reducer, Aspirin 325, Aspirin 81, Prednisone

Top reporter: Genentech, Inc.

Pyridone [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Corticosteroid [EPC]Proton Pump Inhibitor [EPC]Platelet Aggregation Inhibitor [EPC]
40,089
Total Reports
18,624
Serious Reports
9,361
Death Reports
30
Reported Reactions
Death Report Ratio: High (23.35%)

Patient Demographics

Male
24,217
Female
14,155

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Pirfenidone.

# Reaction Reports % of Total
1 DEATH 7,473
13.2%
2 NAUSEA 5,151
9.1%
3 FATIGUE 3,792
6.7%
4 DECREASED APPETITE 3,248
5.7%
5 DIARRHOEA 3,234
5.7%
6 DYSPNOEA 2,917
5.1%
7 WEIGHT DECREASED 2,214
3.9%
8 DIZZINESS 2,167
3.8%
9 RASH 2,034
3.6%
10 COUGH 2,020
3.6%
11 VOMITING 1,803
3.2%
12 PNEUMONIA 1,769
3.1%
13 ABDOMINAL DISCOMFORT 1,678
3.0%
14 ABDOMINAL PAIN UPPER 1,506
2.7%
15 HEADACHE 1,498
2.6%
16 OFF LABEL USE 1,488
2.6%
17 ASTHENIA 1,430
2.5%
18 MALAISE 1,341
2.4%
19 NO ADVERSE EVENT 1,217
2.1%
20 DYSPEPSIA 1,170
2.1%
21 PRURITUS 1,065
1.9%
22 INSOMNIA 1,025
1.8%
23 DRUG INEFFECTIVE 817
1.4%
24 CONSTIPATION 790
1.4%
25 OXYGEN SATURATION DECREASED 776
1.4%
26 PHOTOSENSITIVITY REACTION 712
1.3%
27 GASTROOESOPHAGEAL REFLUX DISEASE 625
1.1%
28 FALL 621
1.1%
29 GASTRIC DISORDER 573
1.0%
30 PRODUCTIVE COUGH 564
1.0%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.