A panel of experts from the U.S. Food and Drug Administration (FDA) concluded, based on a review of scientific studies, that oral phenylephrine-based medications do not relieve nasal congestion. The statement was published on the website fda.
FDA experts identified three large clinical trials testing oral phenylephrine in recent years. It was no more effective than a placebo and did not work at any dose. The drug is safe to take by mouth, but most of it is destroyed before it enters the bloodstream.
It is not yet known how the FDA will respond to the panel’s findings. Because phenylephrine decongestants are still considered safe for human consumption and can treat other cold and allergy symptoms, they may be allowed to remain on store shelves.
Eye drops and nasal sprays that deliver phenylephrine directly into the bloodstream are still considered effective decongestants.
Sales of oral phenylephrine products in the United States exceed $1.76 billion in 2022, the authors note. By comparison, pseudoephedrine products, which actually help relieve nasal congestion, earned manufacturers just $542 million in 2022.
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