Pirfenidone (Page 2 of 7)

6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Liver Enzyme Elevations and Drug-Induced Liver Injury [see Warnings and Precautions (5.1)]
  • Photosensitivity Reaction or Rash [see Warnings and Precautions (5.2)]
  • Gastrointestinal Disorders [see Warnings and Precautions (5.3)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of pirfenidone has been evaluated in more than 1400 subjects with over 170 subjects exposed to pirfenidone for more than 5 years in clinical trials.

Pirfenidone was studied in 3 randomized, double-blind, placebo-controlled trials (Studies 1, 2, and 3) in which a total of 623 patients received 2,403 mg/day of pirfenidone and 624 patients received placebo. Subjects ages ranged from 40 to 80 years (mean age of 67 years). Most patients were male (74%) and Caucasian (95%). The mean duration of exposure to pirfenidone was 62 weeks (range: 2 to 118 weeks) in these 3 trials.

At the recommended dosage of 2,403 mg/day, 14.6% of patients on pirfenidone compared to 9.6% on placebo permanently discontinued treatment because of an adverse event. The most common (>1%) adverse reactions leading to discontinuation were rash and nausea. The most common (>3%) adverse reactions leading to dosage reduction or interruption were rash, nausea, diarrhea, and photosensitivity reaction.

The most common adverse reactions with an incidence of ≥10% and more frequent in the pirfenidone than placebo treatment group are listed in Table 2.

Table 2. Adverse Reactions Occurring in ≥10% of Pirfenidone-Treated Patients and More Commonly Than Placebo in Studies 1, 2, and 3

% of Patients (0 to 118 Weeks)

Adverse Reaction

Pirfenidone 2,403 mg/day

(N = 623)

Placebo

(N = 624)

Nausea

36%

16%

Rash

30%

10%

Abdominal Pain1

24%

15%

Upper Respiratory Tract Infection

27%

25%

Diarrhea

26%

20%

Fatigue

26%

19%

Headache

22%

19%

Decreased Appetite

21% 8%

Dyspepsia

19%

7%

Dizziness

18%

11%

Vomiting

13%

6%

Gastro-esophageal Reflux Disease

11%

7%

Sinusitis

11%

10%

Insomnia

10%

7%

Weight Decreased

10%

5%

Arthralgia

10%

7%

1 Includes abdominal pain, upper abdominal pain, abdominal distension, and stomach discomfort.

Adverse reactions occurring in ≥5 to <10% of pirfenidone-treated patients and more commonly than placebo are photosensitivity reaction (9% vs. 1%), pruritus (8% vs. 5%), asthenia (6% vs. 4%), dysgeusia (6% vs. 2%), and non-cardiac chest pain (5% vs. 4%).

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.