A panel of experts from the U.S. Food and Drug Administration reviewed multiple scientific studies and concluded that oral phenylephrine-based medications do not relieve nasal congestion. The assessment was published on the FDA website and reflects a significant re-evaluation of commonly used cold and allergy remedies.
The FDA group identified three large clinical trials conducted in recent years that tested oral phenylephrine. In these trials, the medicine did not outperform a placebo at any dose, indicating a lack of meaningful symptom relief for nasal blockage. The panel noted that while the drug is considered safe to take by mouth, most of the active ingredient is destroyed before it can reach the bloodstream, which appears to limit its effectiveness as a decongestant.
What remains uncertain is how the FDA will respond to these findings in terms of the regulatory status of oral phenylephrine products. Since phenylephrine decongestants are still deemed safe for human consumption and can address other cold and allergy symptoms, they may still be permitted on store shelves while the agency reviews potential changes to labeling or approvals.
By contrast, eye drops and nasal sprays that deliver phenylephrine directly to the site of action in the nose or eye continue to be regarded as effective decongestants. Targeted delivery appears to bypass the systemic absorption issues that limit oral phenylephrine, providing relief more reliably for sufferers of congestion and related symptoms.
Market data from 2022 show that sales of oral phenylephrine products in the United States surpassed 1.76 billion dollars. In the same period, pseudoephedrine products, which have demonstrated clearer efficacy in relieving nasal congestion, generated about 542 million dollars for manufacturers. This discrepancy underscores ongoing consumer reliance on decongestants, even as scientific consensus questions the value of oral phenylephrine for nasal blockage. [Source attribution: FDA panel report and market analysis]
In clinical discussions, medical professionals emphasize the importance of choosing decongestants based on proven efficacy. For individuals seeking relief from congestion, alternatives such as pseudoephedrine or nasal sprays with proven effectiveness may be more reliable options, depending on personal medical history and regulatory guidance. Consumers are advised to consult a healthcare professional to determine the most suitable treatment approach for their symptoms. [Source attribution: FDA clinical findings and prescribing guidance]