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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Pirfenidone
Generic Name
Pirfenidone
Active Ingredient
PirfenidoneCategory
Pyridone [EPC]
Variants
55
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 801 mg/1 | TABLET, COATED | ORAL | 76282-716 |
| 801 mg/1 | TABLET | ORAL | 60505-4682 |
| 801 mg/1 | TABLET, COATED | ORAL | 62332-480 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Pirfenidone, you must consult a qualified healthcare professional.
| 801 mg/1 | TABLET, FILM COATED | ORAL | 0480-3611 |
| 267 mg/1 | TABLET, FILM COATED | ORAL | 72603-258 |
| 267 mg/1 | TABLET, FILM COATED | ORAL | 0781-8085 |
| 267 mg/1 | TABLET, FILM COATED | ORAL | 42571-335 |
| 801 mg/1 | TABLET | ORAL | 51407-914 |
| 801 mg/1 | TABLET, FILM COATED | ORAL | 69238-1641 |
| 267 mg/1 | TABLET, COATED | ORAL | 71335-2944 |
| 801 mg/1 | TABLET, COATED | ORAL | 72162-2466 |
| 267 mg/1 | TABLET, FILM COATED | ORAL | 42291-491 |
+ 38 more variants
Detailed information about Pirfenidone
Pirfenidone is an orally active pyridone anti-fibrotic agent primarily used to treat idiopathic pulmonary fibrosis (IPF) by reducing lung tissue scarring and slowing disease progression.
The administration of pirfenidone follows a strict titration (gradual increase) schedule. This is designed to help the body adjust to the medication and minimize gastrointestinal side effects. According to the standard clinical protocol, the dosage is increased over a 21-day period until the full maintenance dose is reached.
The maximum recommended daily dose of pirfenidone is 2403 mg per day. Doses should be taken at the same times each day (e.g., breakfast, lunch, and dinner).
The safety and effectiveness of pirfenidone in pediatric patients (under the age of 18) have not been established. Idiopathic Pulmonary Fibrosis is a disease that almost exclusively affects older adults; therefore, pirfenidone is not approved for use in children or adolescents.
Pirfenidone should be used with caution in patients with mild to moderate renal impairment. However, it is not recommended for use in patients with severe renal impairment (CrCl less than 30 mL/min) or end-stage renal disease (ESRD) requiring dialysis, as the drug's metabolites may accumulate to unsafe levels.
Since pirfenidone is primarily metabolized by the liver, hepatic function must be assessed before and during treatment. It should be used with caution in patients with mild to moderate hepatic impairment (Child-Pugh Class A or B). Pirfenidone is strictly contraindicated in patients with severe hepatic impairment (Child-Pugh Class C).
No specific dosage adjustments are generally required for elderly patients based solely on age. However, since older adults are more likely to have decreased renal or hepatic function, healthcare providers often monitor this population more closely.
If you miss a dose of pirfenidone, take it as soon as you remember, provided it is taken with food. However, if it is almost time for your next scheduled dose, skip the missed dose and resume your regular schedule. Never take two doses at once to make up for a missed one. If you miss doses for 14 consecutive days or more, you should contact your doctor, as you may need to restart the 21-day titration schedule from the beginning to avoid side effects.
There is limited experience with pirfenidone overdose. Signs of an overdose may include exaggerated side effects, such as severe nausea, vomiting, dizziness, or extreme fatigue. In the event of a suspected overdose, contact your local poison control center or seek emergency medical attention immediately. Treatment is generally supportive, focusing on maintaining vital functions.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking the medication without medical guidance, as this could lead to a rapid decline in lung function.
Pirfenidone is associated with several common side effects, many of which are manageable with proper administration techniques. The most frequently reported issues include:
Pirfenidone is a potent medication that requires diligent adherence to safety protocols. Patients must be aware that while the drug helps manage IPF, it carries risks that necessitate regular medical supervision. The most critical safety measures involve protecting the liver and the skin.
No FDA black box warnings for Pirfenidone. However, the absence of a black box warning does not mean the drug is without risk; it simply means the risks are currently managed through standard precautions and monitoring.
Certain drugs can dangerously increase the levels of pirfenidone in the body by inhibiting the enzymes responsible for its breakdown.
There are specific circumstances where pirfenidone must NEVER be used because the risks far outweigh any potential benefits:
Pirfenidone is classified as Pregnancy Category C (based on older FDA systems). There are no adequate and well-controlled studies of pirfenidone in pregnant women. Animal studies have shown that pirfenidone can cross the placental barrier and may cause decreased fetal body weight or increased prolongation of gestation at very high doses. Because the effects on a human fetus are unknown, pirfenidone should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Women of childbearing potential should discuss effective contraception with their doctor.
It is not known whether pirfenidone or its metabolites are excreted in human milk. However, many drugs are excreted in breast milk, and animal studies have detected pirfenidone in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pirfenidone is not approved for use in patients under 18 years of age. The safety and efficacy in this population have not been studied. Since IPF is a disease of aging, there is no clinical data to support its use in children.
Pirfenidone is a small molecule that exerts anti-fibrotic, anti-inflammatory, and antioxidant effects. Its primary molecular target is the suppression of Transforming Growth Factor-beta (TGF-β) synthesis. TGF-β is a potent cytokine that stimulates the transformation of fibroblasts into myofibroblasts and triggers the production of collagen and fibronectin. By inhibiting this pathway, pirfenidone slows the formation of the extracellular matrix that constitutes a lung scar. Additionally, it reduces the production of Tumor Necrosis Factor-alpha (TNF-α), thereby dampening the inflammatory response that often precedes and accompanies fibrosis.
The pharmacodynamic effect of pirfenidone is primarily observed through the stabilization of lung function. There is a clear dose-response relationship; clinical trials showed that the 2403 mg/day dose was significantly more effective than lower doses. The onset of action is gradual, with the clinical benefits (slowing of FVC decline) typically becoming statistically significant after 6 to 12 months of continuous therapy. There is no evidence of the development of tolerance to the drug's anti-fibrotic effects over time.
Common questions about Pirfenidone
Pirfenidone is primarily used to treat a specific lung disease called Idiopathic Pulmonary Fibrosis (IPF). In patients with IPF, the lungs become scarred and stiff over time, making it difficult to breathe and get enough oxygen into the blood. Pirfenidone works as an anti-fibrotic agent, meaning it helps to slow down the formation of new scar tissue in the lungs. While it cannot cure the disease or reverse existing scars, it is effective at preserving lung function and slowing the progression of the condition. It is typically prescribed to adults who have been diagnosed through clinical imaging or lung biopsy. Your doctor will monitor your breathing through regular pulmonary function tests to see how well the medication is working for you.
The most common side effects of Pirfenidone include nausea, skin rash, and stomach upset. Many patients also report feeling very tired (fatigue), experiencing a loss of appetite, or having diarrhea. Because the drug makes your skin much more sensitive to sunlight, sunburns can occur very easily even with brief exposure. To manage these issues, it is essential to take the medication with a full meal and to use high-SPF sunscreen daily. Most of these side effects are most intense during the first few weeks of treatment and may improve as your body adjusts to the dose. If the side effects become severe, your doctor may suggest a temporary dose reduction.
It is generally advised to limit or avoid alcohol consumption while taking Pirfenidone. Both alcohol and Pirfenidone are processed by the liver, and combining them can increase the risk of liver strain or damage. Since Pirfenidone is already known to cause elevations in liver enzymes in some patients, adding alcohol to the mix could potentially lead to more serious hepatotoxicity. If you do choose to drink, it should be in very small amounts and only after discussing it with your healthcare provider. Your doctor will be monitoring your liver function through regular blood tests, and any signs of liver stress would require you to stop drinking alcohol entirely. Always prioritize your liver health while on this long-term therapy.
The safety of Pirfenidone during pregnancy has not been clearly established in human studies. Animal research has suggested that the drug can reach the fetus and may cause lower birth weights at high doses, but there is no definitive data on how it affects human pregnancy. Because of these unknowns, Pirfenidone is usually only prescribed to pregnant women if the benefit to the mother's lung health clearly outweighs the potential risks to the baby. If you are planning to become pregnant or find out you are pregnant while taking this drug, you must notify your doctor immediately. Most women of childbearing age are advised to use effective birth control while on this medication. Breastfeeding is also generally discouraged while taking Pirfenidone.
Pirfenidone does not provide immediate relief from symptoms like shortness of breath or coughing. Instead, it works slowly over months to protect your lung tissue from further damage. In clinical trials, the benefits of the medication—specifically the slowing of the decline in lung function—were usually measured over a 6-month to 12-month period. You may not 'feel' the drug working on a daily basis, but its effect is being exerted at the cellular level to prevent scarring. It is vital to continue taking the medication exactly as prescribed, even if you do not notice an immediate improvement in your breathing. Consistency is the key to achieving the long-term goal of preserving your lung capacity.
You should not stop taking Pirfenidone suddenly without first consulting your healthcare provider. If you stop the medication, the protective effect it has on your lungs will cease, and the rate of scarring may increase again. Furthermore, if you stop taking the drug for more than 14 days, you cannot simply resume your full dose. Your body will lose its tolerance to the medication, and you will likely need to restart the 21-day titration process, beginning with the lowest dose, to avoid severe nausea and vomiting. If you are experiencing side effects that make you want to quit, talk to your doctor about a dose adjustment instead of stopping abruptly. They can help you manage the transition safely.
If you miss a dose of Pirfenidone, you should take it as soon as you remember, as long as you take it with food. However, if it is almost time for your next scheduled dose, you should skip the missed dose entirely and return to your normal schedule. You should never take two doses at the same time to 'catch up,' as this significantly increases the risk of severe nausea and dizziness. Maintaining a consistent level of the drug in your system is important, so try to use a pillbox or a phone alarm to help you remember your three daily doses. If you miss more than a few days of treatment, contact your doctor's office for specific instructions on how to resume.
Actually, Pirfenidone is much more likely to cause weight loss than weight gain. Many patients experience a decrease in appetite (anorexia) and gastrointestinal side effects like nausea or stomach pain, which can lead to eating less. In clinical studies, a significant number of patients lost a small amount of weight during the first year of treatment. If you notice a significant or rapid drop in your weight, it is important to discuss this with your doctor or a nutritionist. They may recommend eating smaller, more frequent, high-calorie meals or taking the medication in the middle of a large meal to help maintain your weight while your body adjusts to the drug.
Pirfenidone can interact with several other medications, some of which can be dangerous. It is especially important to avoid the antidepressant fluvoxamine, as it can cause Pirfenidone levels to rise to toxic levels in your blood. Other drugs, like the antibiotic ciprofloxacin, can also increase Pirfenidone levels and may require a dose adjustment. Conversely, some substances like tobacco smoke can make Pirfenidone much less effective. You must provide your doctor with a complete list of all prescription drugs, over-the-counter medicines, vitamins, and herbal supplements you are taking. This allows your healthcare team to check for any potential 'drug-drug interactions' that could affect your safety or the drug's efficacy.
Yes, Pirfenidone is available as a generic medication in many countries, including the United States. The FDA approved the first generic versions of Pirfenidone tablets and capsules in 2022. Generic versions contain the same active ingredient and are required to meet the same strict standards for safety, strength, and quality as the original brand-name drug (Esbriet). Using the generic version can significantly reduce the cost of treatment for patients and insurance providers. If you are concerned about the cost of your medication, ask your doctor or pharmacist if a generic version is available and appropriate for you. Regardless of whether you take the brand or the generic, the dosing and monitoring requirements remain the same.
Other drugs with the same active ingredient (Pirfenidone)
While most side effects are mild to moderate, some require urgent medical intervention. Stop taking Pirfenidone and call your doctor immediately if you experience:
> Warning: Stop taking Pirfenidone and call your doctor immediately if you experience any of these serious symptoms. Early detection of liver issues is critical for preventing permanent damage.
Long-term use of pirfenidone (over several years) requires ongoing monitoring of liver function and nutritional status. Some patients may experience chronic fatigue or persistent gastrointestinal sensitivity. However, for many, the benefit of slowing the progression of lung scarring outweighs these long-term management challenges. There is currently no evidence that pirfenidone causes cumulative organ toxicity outside of the liver and skin risks already identified.
As of 2026, there are no FDA black box warnings for pirfenidone. However, the FDA does require prominent warnings regarding liver enzyme elevations and photosensitivity reactions in the prescribing information. The risk of drug-induced liver injury (DILI) is the most significant safety concern associated with this medication.
Report any unusual symptoms or changes in your health to your healthcare provider promptly. Keeping a daily log of symptoms during the first few months of treatment can help your doctor adjust your care plan effectively.
To ensure the safe use of pirfenidone, the following monitoring schedule is typically required:
Pirfenidone may cause dizziness or fatigue in some patients. You should observe how the medication affects you before driving a vehicle or operating heavy machinery. If you feel lightheaded or excessively tired, avoid these activities and consult your doctor.
Alcohol should be consumed with extreme caution, if at all, while taking pirfenidone. Both alcohol and pirfenidone are processed by the liver. Concurrent use can increase the strain on the liver and heighten the risk of hepatotoxicity. Discuss your alcohol consumption habits honestly with your healthcare provider.
Do not stop taking pirfenidone abruptly unless directed by a doctor (e.g., in the case of a severe allergic reaction). If treatment is interrupted for more than 14 days, the medication must be restarted using the initial 21-day titration schedule to minimize side effects.
> Important: Discuss all your medical conditions, especially any history of liver or kidney disease, with your healthcare provider before starting Pirfenidone.
Pirfenidone is not known to interfere significantly with common laboratory tests, other than the expected changes in liver function tests (ALT/AST). It does not typically affect glucose, electrolytes, or blood counts, though regular monitoring of all health markers is standard for IPF patients.
For each major interaction, the management strategy involves:
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter pain relievers and cold medicines.
These are conditions where the doctor must carefully weigh the risks versus the benefits:
There is no known cross-sensitivity between pirfenidone and other common anti-fibrotic drugs like nintedanib. However, patients who have had skin reactions to other photosensitizing medications (like tetracycline antibiotics or thiazide diuretics) should be monitored closely, as they may be more prone to pirfenidone-induced rashes.
> Important: Your healthcare provider will evaluate your complete medical history, including your liver and kidney function, before prescribing Pirfenidone.
In clinical trials, a large percentage of the participants were 65 years of age and older. No overall differences in safety or effectiveness were observed between these patients and younger adult patients. However, geriatric patients are more likely to have age-related declines in liver or kidney function and may be taking multiple other medications (polypharmacy), which increases the risk of drug interactions. Close monitoring is recommended.
> Important: Special populations require individualized medical assessment and more frequent clinical follow-ups.
|---|---|
| Bioavailability | High (exact % not defined, but well-absorbed) |
| Protein Binding | 50% to 58% (primarily Albumin) |
| Half-life | ~3 hours |
| Tmax | 0.5 hours (fasted) to 3 hours (with food) |
| Metabolism | Hepatic (CYP1A2 70-80%, others 20-30%) |
| Excretion | Renal (~80% as metabolites) |
Pirfenidone belongs to the Pyridone class of anti-fibrotic agents. It is distinct from other treatments like Nintedanib, which is a tyrosine kinase inhibitor. Within the therapeutic area of respiratory medicine, it is classified as a disease-modifying agent for Interstitial Lung Disease (ILD).