Esbriet (pirfenidone) is a brand-name drug prescribed for adults with a lung condition called idiopathic pulmonary fibrosis. As with other drugs, Esbriet can cause side effects, including nausea, dizziness, and light sensitivity.
Esbriet can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are just a few of the more common side effects reported by people who took Esbriet in clinical trials:
* For more information about this side effect, see “Side effect specifics” below.
Mild side effects can occur with Esbriet use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Esbriet’s prescribing information.
Mild side effects that have been reported with Esbriet include:
- skin rash
- fatigue
- diarrhea
- upper respiratory tract infection
- insomnia
- abdominal pain
- dizziness
- stomach upset
- headache
- decreased appetite
- weight loss
- joint pain
- gastroesophageal reflux disease
- nausea*
- mild allergic reaction†
These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Esbriet and want to tell the FDA about it, visit MedWatch.
* For more information about this side effect, see “Side effect specifics” below.
† An allergic reaction is possible after taking Esbriet but it’s not clear whether this side effect occurred in clinical trials. To learn more, see “Side effect specifics” below.
Esbriet may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Esbriet’s prescribing information.
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.
Serious side effects that have been reported and their symptoms include:
- An increase in liver enzyme levels (a sign of liver injury or damage). Symptoms can include:
- fatigue
- abdominal pain
- dark-colored urine
- jaundice
- Photosensitivity (see “Side effect specifics” below).
- Severe allergic reaction.*
* An allergic reaction is possible after using Esbriet but it’s not clear whether this side effect occurred in clinical trials. To learn more, see “Side effect specifics” below.
Esbriet may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.
Can Esbreit cause long-term side effects?
Yes, Esbriet may cause long-term side effects. In the drug’s clinical trials, there were reports of liver injury, which can cause long-term liver problems. Signs and symptoms of liver injury include:
Due to this risk, your doctor will perform liver function tests before prescribing Esbriet and during treatment. If you have high liver enzyme levels, your doctor will likely lower your dose of Esbriet. In some cases, your doctor may stop Esbriet treatment. They can also advise you on a different treatment option for your condition.
How do side effects of Esbriet compare with those seen with Ofev?
Some but not all side effects of Esbriet are the same as those of Ofev (nintedanib). Ofev is a prescription drug that’s used to treat idiopathic pulmonary fibrosis (scar tissue in the lungs). Esbriet is also prescribed for this condition.
Both drugs can cause the following side effects:
- fatigue
- nausea, vomiting, and diarrhea
- decreased appetite
- headache
- liver problems
Esbriet but not Ofev can cause gastroesophageal reflux disease. And Ofev can cause some side effects that Esbriet isn’t known to cause. These include blood clots, bleeding, back pain, and hair loss.
If you’d like to know more about how Esbriet and Ofev compare, talk with your doctor. They can help determine which medication is right for you.
Learn more about some of the side effects that Esbriet may cause. To find out how often side effects occurred in clinical trials, see the drug’s prescribing information.
Nausea
Nausea was one of the most common side effects reported in clinical trials of Esbriet. It was also a common reason why people stopped taking the drug.
What you can do
If you experience mild nausea while taking Esbriet, taking your dose with food may help. This is because some medications, including Esbriet, can upset your stomach. Taking your dose with a small snack or meal can help minimize stomach upset and relieve nausea. You can also read about home remedies and other ways to reduce nausea.
If home remedies don’t help or your nausea is severe, be sure to tell your doctor. They may adjust your dosage or stop Esbriet treatment in some cases. Your doctor may be able to recommend a different treatment option that doesn’t have this side effect.
Photosensitivity reaction
In clinical trials, some people reported photosensitivity linked to taking Esbriet. This effect, also called drug-induced photosensitivity, can happen with drugs that react to UV light. With photosensitivity, exposure to the sun or other UV light sources while taking Esbriet may cause a reaction.
Symptoms of photosensitivity can include skin discoloration, inflammation, and rash on exposed areas. In some cases, Esbriet treatment was stopped due to photosensitivity reactions.
What you can do
To reduce the risk of a photosensitivity reaction while you’re taking Esbriet, avoid or minimize sun exposure (including sunlamps). Be sure to apply SPF 50 sunscreen and cover your skin and head when you’re in the sun. If you get a sunburn or notice a rash while taking Esbriet, talk with your doctor.
Your doctor may adjust your dosage or pause Esbriet treatment. They’ll determine whether you should continue taking the drug. They can also recommend treatment options for your skin symptoms.
Allergic reaction
As with most drugs, Esbriet can cause an allergic reaction in some people. It’s not clear whether this side effect occurred in clinical trials.
Symptoms can be mild or serious and can include:
Rarely, more severe, life threatening reactions have occurred with Esbriet since the drug was approved. They include Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These allergic reactions involve unusual sores, bumps, or changes in the color of the skin and mucous membranes (in the eyes and inside of the mouth, lips, and nose).
What you can do
If your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.
For mild symptoms of an allergic reaction, call your doctor right away. They can recommend ways to ease your symptoms and determine whether you should keep taking Esbriet.
If you have questions about allergic reactions with Esbriet, talk with your doctor for more information.
Be sure to talk with your doctor about your health history before you take Esbriet. Depending on your medical condition or other factors affecting your health, this drug may not be suitable for you. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:
Liver condition. Be sure to tell your doctor if you have a liver condition such as hepatitis. This is because Esbriet may cause liver injury, which can worsen your liver condition. It also isn’t known for certain whether Esbriet is a safe treatment option for people with severe liver disease.
Due to these risks, your doctor will give you liver function tests before prescribing Esbriet and during treatment. If the tests show you have a liver condition, your doctor can recommend whether Esbriet is a safe treatment option. They may give you a lower dosage of Esbriet or prescribe a different treatment instead.
Kidney condition. Before taking Esbriet, tell your doctor if you have a kidney condition. Having a kidney condition could cause Esbriet to build up in your system, raising your risk of side effects of the drug. It also isn’t known for certain whether Esbriet is a safe treatment option for people with end stage kidney disease or receiving dialysis.
Your doctor can determine whether Esbriet is a safe treatment option. If you take Esbriet and have a kidney condition, your doctor will watch closely for side effects. To reduce your risk, they may lower your dosage or temporarily stop treatment as needed.
Pregnancy or breastfeeding. If you’re pregnant or breastfeeding your child, Esbriet may not be safe to take. Please talk with your doctor before taking Esbriet.
Alcohol consumption. If you drink alcohol, Esbriet may not be safe to take. Alcohol consumption may worsen the side effects of Esbriet such as nausea and dizziness. In addition, doctors typically won’t prescribe the drug for people with liver problems caused by heavy alcohol consumption. To learn more about liver problems and Esbriet, see “Liver condition” just above.
Smoking. Cigarette smoking may negatively affect how Esbriet works. For this reason, tell your doctor if you smoke. They may advise you to stop smoking before prescribing Esbriet. They can recommend specific methods to help you quit smoking. You can also read these tips for quitting smoking.
Allergic reaction. If you’ve ever had an allergic reaction to Esbriet or any of its ingredients, your doctor will likely recommend that you avoid taking Esbriet. Ask your doctor what other medications may be better options for you.
If you’d like to learn more about Esbriet, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.
Besides talking with your doctor, you can do some research on your own. These articles might help:
- More information about Esbriet. For details about other aspects of Esbriet, refer to this article.
- Cost. If you’d like to learn about Esbriet and cost, see this article.
- A look at your condition. For information related to idiopathic pulmonary fibrosis, see our lists of respiratory system and pulmonary system articles.
Disclaimer: Medical News Today 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.