Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Esbriet (Pirfenidone). If you are concerned about side effects, discuss the risks and benefits of Esbriet (Pirfenidone) with your doctor.

The following side effects have been reported by at least 1% of people taking Esbriet (Pirfenidone). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• bloating
• Constipation
• decreased appetite
• Diarrhea
• difficulty sleeping
• headache
• indigestion, heartburn, or acid reflux
• itchy, dry, or red skin
• muscle or joint aches or pains
• nausea
• rash
• sun sensitivity (e.g., Sunburn, skin rash, blistering or peeling skin)
• tiredness or weakness
• vomiting
• weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• dizziness
• fast, slow, or irregular heart beat
• symptoms of infection (Fever, cough, sinus congestion or pain, difficult or painful urination)
• symptoms of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools, itching)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• chest pain
• signs of a serious allergic reaction (e.g., Hives; difficulty breathing or swallowing; or swelling of the face, lips, tongue, or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Esbriet (Pirfenidone).

Capsule

Each hard gelatin two-piece capsule, with a white opaque body and white opaque cap imprinted with "PFD 267 mg" in brown ink and containing a white-to-pale-yellow powder, contains 267 mg of Esbriet (Pirfenidone). Nonmedicinal ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone; capsule: gelatin and titanium dioxide; imprinting ink: brown S-1-16530 or 03A2 inks containing: ammonium hydroxide, iron oxide black, iron oxide red, iron oxide yellow, propylene glycol, and shellac.

Tablet

267 mg
Each yellow, oval, biconvex, film-coated tablet, debossed with "PFD", contains 267 mg of Esbriet (Pirfenidone). Nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, iron oxide, macrogol (polyethylene glycol), magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, povidone, talc, and titanium dioxide.

801 mg
Each brown, oval, biconvex, film-coated tablet, debossed with "PFD", contains 801 mg of Esbriet (Pirfenidone). Nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, iron oxide, macrogol (polyethylene glycol), magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, povidone, talc, and titanium dioxide.

Do not take Esbriet (Pirfenidone) if you:

• are allergic to Esbriet (Pirfenidone) or any ingredients of the medication
• have a history of angioedema after taking Esbriet (Pirfenidone)
• are taking the medication Fluvoxamine
• have severe kidney problems or are on dialysis
• have severe liver problems

There may be an interaction between Esbriet (Pirfenidone) and any of the following:

• Abiraterone
• Amiodarone
• birth control pills
• Bupropion
• cannabis
• Carbamazepine
• Cinacalcet
• Cyproterone
• Deferasirox
• Duloxetine
• Esomeprazole
• fluconazole
• Fluoxetine
• fluvoxamine
• grapefruit juice
• Leflunomide
• methoxsalen
• Mexiletine
• Moclobemide
• Omeprazole
• Paroxetine
• Phenytoin
• Porfimer
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• rifampin
• terbinafine
• Teriflunomide
• tobacco (smoked)
• Voriconazole

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Esbriet (Pirfenidone). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Esbriet (Pirfenidone).

Fatigue and dizziness: Esbriet (Pirfenidone) can cause fatigue and dizziness. Do not drive or operate machinery until you know that Esbriet (Pirfenidone) does not affect your ability to perform these activities safely. To reduce dizziness, take Esbriet (Pirfenidone) with food.

Kidney function: If you have Kidney Disease, discuss with your doctor how Esbriet (Pirfenidone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Esbriet (Pirfenidone), and whether any special monitoring is needed. If you have severely reduced kidney function or are receiving dialysis treatment, you should not take Esbriet (Pirfenidone).

Liver function: Liver disease or reduced liver function may cause Esbriet (Pirfenidone) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Esbriet (Pirfenidone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Esbriet (Pirfenidone), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Esbriet (Pirfenidone).

If you experience symptoms of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools, itching) while taking Esbriet (Pirfenidone), contact your doctor.

If you have severe liver disease, you should not take Esbriet (Pirfenidone).

Sun sensitivity: Esbriet (Pirfenidone) may increase the sensitivity of your skin to the sun. Avoid exposure to direct and indirect sunlight (including sunlamps and window light), use an effective sunblock daily (at least SPF 50 for UVA and UVB), and wear clothing that protects you from the sun (e.g., hat, long-sleeves) while taking Esbriet (Pirfenidone). If you get a skin reaction (e.g., rash, sunburn, blistering, peeling) from the sun, contact your doctor.

Weight loss: Esbriet (Pirfenidone) may cause loss of appetite and weight loss. Your doctor will monitor your weight while you are taking Esbriet (Pirfenidone).

Pregnancy: Esbriet (Pirfenidone) should not be used during pregnancy. If you become pregnant while taking Esbriet (Pirfenidone), contact your doctor immediately.

Breast-feeding: It is not known if Esbriet (Pirfenidone) passes into breast milk. If you are a breast-feeding mother and are taking Esbriet (Pirfenidone), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Esbriet (Pirfenidone) have not been established for anyone under the age of 18.