Summary
Commonly reported side effects of pirfenidone include: abdominal distention, abdominal pain, diarrhea, dizziness, dyspepsia, fatigue, gastroesophageal reflux disease, nausea, skin rash, upper abdominal pain, vomiting, weight loss, and anorexia. Other side effects include: pruritus, skin photosensitivity, and decreased appetite. Continue reading for a comprehensive list of adverse effects.
Applies to pirfenidone: oral capsule, oral tablet.
Serious side effects of Pirfenidone
Along with its needed effects, pirfenidone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking pirfenidone:
More common
- Diarrhea
- itching or skin rash
- nausea
- redness or other discoloration of the skin
- severe sunburn
- stomach discomfort, upset, or pain
- vomiting
Incidence not known
- Black, tarry stools
- blistering, peeling, or loosening of the skin
- chest pain
- chills
- cough or hoarseness
- fever with or without chills
- general feeling of tiredness or weakness
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lower back or side pain
- painful or difficult urination
- red irritated eyes
- red skin lesions, often with a purple center
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- unusual bleeding or bruising
- unusual tiredness or weakness
Other side effects of Pirfenidone
Some side effects of pirfenidone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Acid or sour stomach
- body aches or pain
- change in taste
- dizziness
- ear congestion
- headache
- heartburn or indigestion
- increased sensitivity of the skin to sunlight
- lack or loss of strength
- loss of appetite
- pain or tenderness around the eyes and cheekbones
- sneezing
- stuffy or runny nose
- trouble sleeping
- weight loss
For Healthcare Professionals
Applies to pirfenidone: oral capsule, oral tablet.
Hepatic
Common (1% to 10%): Increased ALT, increased AST, increased gamma glutamyl transferase
Postmarketing reports: Increased bilirubin in combination with increased ALT and AST[Ref]
Hypersensitivity
Very common (10% or more): Photosensitivity reaction (up to 12.2%)
Postmarketing reports: Angioedema[Ref]
Dermatologic
Very common (10% or more): Rash (up to 30%)
Common (1% to 10%): Pruritus, erythema, dry skin, erythemous/macular/pruritic rash, sunburn[Ref]
Gastrointestinal
Very common (10% or more): Nausea (up to 36%), diarrhea (up to 26%), abdominal pain/distension/discomfort (up to 24%), dyspepsia (up to 19%), vomiting (up to 13%), gastroesophageal reflux disease (up to 11%)
Common (1% to 10%): Gastritis, constipation, flatulence[Ref]
Nervous system
Very common (10% or more): Headache (up to 22%), dizziness (up to 18%)
Common (1% to 10%): Somnolence, dysgeusia[Ref]
Other
Very common (10% or more): Fatigue (up to 26%)
Common (1% to 10%): Asthenia, non-cardiac chest pain[Ref]
Metabolic
Very common (10% or more): Anorexia (up to 13%), decreased weight (up to 10%)
Common (1% to 10%): Decreased appetite[Ref]
Cardiovascular
Common (1% to 10%): Hot flush[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection[Ref]
Hematologic
Postmarketing reports: Agranulocytosis[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (up to 10%)
Common (1% to 10%): Myalgia[Ref]
Psychiatric
Very common (10% or more): Insomnia (up to 10%)[Ref]
Respiratory
Very common (10% or more): Upper respiratory tract infection (up to 27%), sinusitis (up to 11%)
Common (1% to 10%): Cough[Ref]
