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Is pirfenidone FDA approved?

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Quick Answer

The U.S. Food and Drug Administration approved pirfenidone, under the brand name Esbriet, for the treatment of idiopathic pulmonary fibrosis in October 2014, according to an FDA news release. IPF patients can take Esbriet as an alternative treatment to having oxygen therapy, pulmonary rehabilitation and lung transplant.

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Full Answer

While pirfenidone has been found safe and effective to use, it is not for IPF patients who are suffering from severe liver disease or kidney failure or those who are having dialysis, states the FDA. It may also cause some side effects including nausea, upper respiratory tract infection, rash, abdominal pain, loss of appetite and arthralgia. Patients who take this oral medicine also become prone to sunburn more easily, so they should avoid exposure to sunlight.

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