Esbriet (pirfenidone) is a prescription drug used to treat idiopathic pulmonary fibrosis. Esbriet can cause side effects that range from mild to serious. Examples include nausea, skin rash, and diarrhea.

Esbriet is used in adults to treat idiopathic pulmonary fibrosis (IPF). It comes as an oral capsule and an oral film-coated tablet. It contains the active ingredient pirfenidone. (An active ingredient is what makes a drug work.)

Keep reading to learn about the common, mild, and serious side effects that Esbriet can cause. For a general overview of the drug, including details about its uses, see this article.

Some people, but not all, may experience mild to serious side effects during Esbriet treatment. Examples of the drug’s commonly reported side effects include:

* To learn more about this side effect, see the “Side effects explained” section below.

Mild side effects have been reported with Esbriet. These include:

In most cases, side effects such as headache, difficulty sleeping, heartburn, nausea, and vomiting may be easily managed with prescription or over-the-counter medications. And some side effects may go away within 1–2 weeks on their own. But if you have ongoing or bothersome symptoms, talk with your doctor or pharmacist. Do not stop taking Esbriet unless your doctor recommends it.

Esbriet may cause mild side effects other than those listed above. See the drug’s prescribing information for details.

* To learn more about this side effect, see the “Side effects explained” section below.

Serious side effects have been reported with Esbriet. These include:

If you develop serious side effects while taking Esbriet, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

* To learn more about this side effect, see the “Side effects explained” section below.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Esbriet, visit MedWatch.

Get answers to some frequently asked questions about Esbriet’s side effects.

Does Esbriet cause long-term side effects?

It’s possible. Long-term side effects include those that may start at any time during treatment with a drug, even if you’ve taken it for a long time. It also includes side effects that may not go away even after you stop taking the drug.

Liver injury, reported in Esbriet’s studies, may lead to long-term liver problems and even death. Symptoms of liver injury include:

Esbriet can cause an increase in liver enzymes, which is a sign that the medication is causing liver injury. If your doctor finds that you have increased liver enzymes early, they will likely recommend an Esbriet dose decrease or have you stop taking the medication.

Your doctor will order liver function tests before prescribing Esbriet for you. You’ll then be tested monthly for the next 6 months and every 3 months after that.

Talk with your doctor or pharmacist to learn more about possible side effects of Esbriet and how long they may last.

Is Esbriet safe for older adults?

Initial studies of Esbriet didn’t find a difference in side effects based on a person’s age. But studies done after the drug came on the market showed that people over age 75 years may have more difficulty managing certain side effects. These included nausea, vomiting, diarrhea, and acid reflux issues. These side effects often led them to stop taking Esbriet.

If you develop bothersome or ongoing digestive problems, talk with your doctor or pharmacist for tips on how to manage them. And do not stop taking Esbriet without talking with your doctor first.

Learn more about some of the side effects Esbriet may cause.

Digestive system problems

Digestive system problems were a common side effect reported in studies of Esbriet. These problems may cause symptoms such as:

Most people who had digestive issues in Esbriet studies had them early on in treatment, usually in the first 3 months. If digestive issues persist, your doctor may reduce your dose of Esbriet.

What might help

If you have digestive problems during Esbriet treatment, taking the drug with food may help decrease these side effects. Also, your doctor may be able to reduce your dose.

Since some over-the-counter acid reducers may interact with Esbriet, discuss your heartburn treatment options with your doctor or pharmacist.

Skin irritation or rash from sunlight

Skin irritation or rash from sunlight in the first 6 months of treatment was a common side effect reported in studies of Esbriet. Skin irritation or rash from sunlight may cause symptoms such as:

  • burning, itching skin
  • sunburn-like redness or skin discoloration
  • blisters
  • weeping or peeling skin

What might help

Apply sunscreen to help prevent irritation or rash from sunlight during Esbriet treatment. This type of rash can occur even with a small amount of sunlight exposure. Applying a UVA/UVB SPF 50 sunscreen daily as part of your health routine is key. And it’s best to avoid sunlamps and tanning beds while taking Esbriet.

Notify your doctor about a sunburn immediately if you develop a fever, get severe blisters on your hands or feet, or begin to feel worse.

Allergic reaction

Like most drugs, Esbriet can cause an allergic reaction in some people. Symptoms can be mild to serious and can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)
  • swelling under your skin (usually in your eyelids, lips, hands, or feet)
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

Rare reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS syndrome) can occur. Symptoms can include:

  • scalded-looking skin
  • blisters
  • peeling skin, especially on the palms of the hands and soles of the feet
  • fever
  • flu-like symptoms
  • body aches

SJS, TEN, and DRESS syndrome are life threatening allergic reactions that require immediate medical attention.

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms. Examples include:

  • an oral antihistamine, such as Benadryl (diphenhydramine)
  • a product you apply to your skin, such as hydrocortisone cream

If your doctor confirms you’ve had a mild allergic reaction to Esbriet, they’ll decide whether you should continue taking it.

If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Esbriet, they may have you switch to a different treatment.

Keeping track of side effects

During your Esbriet treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start taking a new drug or using a combination of treatments.

Your side effect notes can include things such as:

  • what dose of the drug you were taking when you had the side effect
  • how soon you had the side effect after starting that dose
  • what your symptoms were
  • how your symptoms affected your daily activities
  • what other medications you were taking
  • any other information you feel is important

Keeping notes and sharing them with your doctor will help them learn more about how Esbriet affects you. They can then use this information to adjust your treatment plan if needed.

Below is important information you should consider before taking Esbriet.

Warnings

Esbriet can sometimes cause harmful effects in people with certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Esbriet is a good treatment option for you.

Talk with your doctor about your health history before starting Esbriet. Be sure to tell them if any of the following factors apply to you:

* To learn more about this side effect, see “Allergic reaction” under the “Side effects explained” section above.

Alcohol and Esbriet

There are no known interactions between alcohol and Esbriet. But drinking alcohol may worsen the side effects of nausea, vomiting, and heartburn, which are common with Esbriet. Also, if you drink a lot of alcohol while taking Esbriet, your risk of liver damage may be higher.

If you have questions about consuming alcohol during Esbriet treatment, talk with your doctor or pharmacist.

Pregnancy and breastfeeding with Esbriet

Before starting Esbriet treatment, it’s important to talk with your doctor if you’re pregnant, breastfeeding, or planning either.

Pregnancy

It’s not known whether it’s safe to take Esbriet during pregnancy. Studies don’t provide enough information about Esbriet use in pregnant people to know whether it can cause serious harm to a fetus or increase the risk of pregnancy loss. If you’re pregnant or planning to become pregnant, talk with your doctor before starting treatment with this drug.

If you’re able to become pregnant, your doctor may recommend using a form of birth control during your Esbriet treatment. They’ll likely recommend using it before starting Esbriet and throughout your treatment. You may also need to continue using birth control for some time after your Esbriet treatment ends.

Breastfeeding

It’s not known whether Esbriet is safe to take while breastfeeding. There isn’t enough data from studies to know whether Esbriet passes into breast milk, its effects on milk production, or its potential effects on a child who is breastfed.

Talk with your doctor about the risks and benefits of breastfeeding versus taking this medication. They may be able to recommend other treatment options for your condition or healthy feeding options for your child.

Like most drugs, Esbriet can cause a number of side effects that range from mild to serious. However, most are temporary and go away after a few days to weeks. If you have questions about side effects that Esbriet can cause, talk with your doctor. Examples of questions to help get you started include:

  • What side effects of Esbriet am I most likely to experience?
  • How do I manage the side effects of this medication?
  • Will Esbriet make me tired?

To get information on different conditions and tips for improving your health, subscribe to any of Healthline’s newsletters. You may also want to check out the online communities at Bezzy. It’s a place where people with certain conditions can find support and connect with others.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.