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Below are important safety warnings and precautions for the use of Pirfenidone (Esbriet). Please review these details carefully and consult your healthcare provider with any questions or concerns:

• Liver Injury: Pirfenidone (Esbriet) has the potential to cause significant liver issues, which can be severe or even life-threatening. Your healthcare provider will conduct liver enzyme tests prior to starting treatment, followed by monthly tests for the first six months, and then every three months thereafter, or as deemed necessary. If you experience symptoms such as severe nausea, vomiting, pain in the upper right abdomen, fatigue, loss of appetite, or yellowing of the skin or eyes, seek medical attention immediately as these may indicate liver problems. Liver enzyme levels typically normalize upon discontinuation or dose adjustment of the medication.

• Sunlight Sensitivity: This medication increases the sensitivity of your skin to sunlight and ultraviolet light, making sunburns more likely. This sensitivity can occur even in winter or on cloudy days. To minimize risks, apply sunscreen with an SPF of 50 or higher when outdoors and wear protective clothing. It is advisable to limit sun exposure and avoid tanning lamps, especially if you are taking other medications that increase sun sensitivity.

• Severe Skin Reactions: Although rare, serious skin reactions like Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. If you notice skin changes such as rash, blisters, redness, peeling, or if you experience fever and swollen lymph nodes, discontinue use immediately and seek medical help. If diagnosed with one of these conditions, you will need to stop taking Pirfenidone (Esbriet) permanently.

• Stomach-related Side Effects: Commonly, Pirfenidone (Esbriet) may cause gastrointestinal issues such as nausea, stomach pain, diarrhea, and indigestion, particularly during the first three months of treatment. These side effects usually resolve over time. If they persist, consult your healthcare provider.

There are no contraindications available for this medication. Always communicate with your healthcare provider regarding any pre-existing conditions or current medications to ensure safe use of Pirfenidone (Esbriet).

When taking this medication, some common side effects may occur, such as nausea, rash, stomach pain or discomfort, upper respiratory tract infections, diarrhea, tiredness, headache, reduced appetite, indigestion, dizziness, and vomiting. These effects are generally mild and often subside over time. However, if they persist or worsen, it is advisable to consult a healthcare provider.

Other reported side effects include heartburn, sinus inflammation, sleep difficulties, weight loss, joint pain, general weakness, skin sensitivity, itchiness, changes in taste, and non-heart-related chest pain. While these are less common, they should still be monitored, and if they become concerning, seek medical advice.

In rare instances, serious side effects may occur, requiring immediate medical attention. These include signs of liver damage, such as persistent nausea or vomiting, loss of appetite, abdominal pain, yellowing of the eyes or skin, and dark urine. Additionally, severe skin reactions like hives, blisters, skin reddening or peeling, and mouth sores should be urgently addressed. It is crucial to be aware of these potential side effects to ensure timely management and care.