6 mins read

Pirfenidone is used to treat a serious lung condition called idiopathic pulmonary fibrosis (IPF). Common side effects of pirfenidone include nausea and vomiting, diarrhea, and stomach pain. It can also make your skin more sensitive to sunlight. Serious side effects are rare but can include severe skin reactions. If you get a rash, stop taking pirfenidone and call your health care provider right away. Pirfenidone comes as a tablet or capsule that you take by mouth.

Uses

What is pirfenidone used for?

Pirfenidone is commonly used to treat idiopathic pulmonary fibrosis (IPF). IPF is a serious lung condition where scar tissue builds up in the lungs, making it hard to breathe. IPF gets worse over time.

Pirfenidone may also be used for other conditions as determined by your health care provider.

How does pirfenidone work (mechanism of action)?

Pirfenidone may work by blocking certain processes in the lungs that can lead to scarring (fibrosis). This may help slow down the progression of IPF.

How is pirfenidone supplied (dosage forms)?

Brands and other names

  • Esbriet

Dosage forms and strengths

  • 267 mg oral capsules
  • 267 mg, 534 mg, and 801 mg oral tablets

How should I store pirfenidone?

Pirfenidone should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Keep the container tightly closed.

Side Effects

What are the most common side effects of pirfenidone?

The most common side effects of pirfenidone are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Stomach problems, including nausea and vomiting, stomach pain, diarrhea, upset stomach, and acid reflux (see below)
  • Rash or other skin reactions (see below)
  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Tiredness
  • Headache
  • Decreased appetite
  • Dizziness
  • Trouble sleeping
  • Weight loss
  • Joint pain

There may be other side effects of pirfenidone that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of pirfenidone?

While less common, the most serious side effects of pirfenidone are described below, along with what to do if they happen.

Severe Allergic Reactions. Pirfenidone may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for drug reaction with eosinophilia and systemic symptoms. It is also sometimes called multiorgan hypersensitivity. This is a reaction that can affect multiple parts of the body including your liver, kidneys, and heart. Stop taking the medicine and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Shortness of breath, trouble swallowing, or throat tightness
  • Swelling in your feet, ankles, or legs
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Dark-colored pee
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Severe Skin Reactions. Pirfenidone can cause severe skin reactions, called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), that can lead to death if not treated. If you get a rash, stop taking pirfenidone and call your health care provider right away. Get emergency help if you have any of the following symptoms of SJS or TEN.

  • Painful red or purple skin that looks burned and peels off
  • Flat red rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes
  • Flu-like symptoms, including fever, chills, and muscle aches

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking pirfenidone. Keep all appointments for blood tests before starting and during treatment with pirfenidone. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Easy bleeding or bruising

Sensitivity to Sunlight. Your skin may be very sensitive to light from the sun and devices that give off similar light, such as sunlamps and tanning beds, while you are taking certain drugs, including pirfenidone. This is called photosensitivity. Avoid sun exposure while taking pirfenidone. If you need to be in the sun, use sunscreen and wear a hat and clothes that cover your skin. Exposing your skin to this kind of light, even for a short time, can cause your skin to be severely sunburned, blistered, or swollen. Tell your health care provider right away if any of these happen.

Stomach Problems. Pirfenidone can cause stomach and digestive problems, including nausea and vomiting, diarrhea, upset stomach, stomach pain, and acid reflux. Tell your health care provider about any stomach problems you have while taking pirfenidone. Your health care provider may need to adjust your dose if you have bothersome stomach problems while taking pirfenidone.

Warnings & Precautions

Who should not use pirfenidone?

Allergies to Ingredients. People who are allergic to any of the following should not take pirfenidone.

  • Esbriet
  • Pirfenidone
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in pirfenidone.

What should I know about pirfenidone before using it?

Do not take pirfenidone unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share pirfenidone with other people, even if they have the same condition as you. It may harm them.

Keep pirfenidone out of the reach of children.

You should take pirfenidone with food. Taking it with food may help limit nausea and dizziness.

Keep all appointments, including for blood tests, before you start taking pirfenidone and during treatment. This helps your health care provider make sure it is safe for you to start and continue taking pirfenidone. 

What should I tell my health care provider before using pirfenidone?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if pirfenidone is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Liver problems
  • Kidney problems

Smoking. Tell your health care provider if you smoke. You should avoid smoking while taking pirfenidone. Pirfenidone may not work as well if you smoke.

Other Medicines and Supplements. Pirfenidone may interact with other medicines and supplements. Before taking pirfenidone, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if pirfenidone may cause harm to a fetus. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if pirfenidone passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take pirfenidone while breastfeeding.

Interactions

Does pirfenidone interact with foods or drinks?

There are no known interactions between pirfenidone and foods or drinks.

It is unknown if drinking alcohol will affect pirfenidone.

Does pirfenidone interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking pirfenidone.

  • Fluvoxamine (Luvox), which is a medicine commonly used for obsessive-compulsive disorder (OCD)
  • Ciprofloxacin, which is an antibiotic used for certain bacterial infections
  • Any other medicine that can make you sensitive to sunlight, such as certain antibiotics or water pills (diuretics)

Many other medicines may alter the blood levels of pirfenidone. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with pirfenidone. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much pirfenidone?

If you or someone else has used too much pirfenidone, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of pirfenidone?

If you miss a dose, take it as soon as you remember with food. If it is almost time for your next dose and meal, skip the missed dose and only take the next dose. Do not take double or extra doses, and do not  take more than three doses per day. 

If you miss 14 days or more of pirfenidone, call your health care provider right away for advice.