The U.S. Food and Drug Administration (FDA) announced on Nov. 7 that it is proposing to remove oral phenylephrine, a widely used active ingredient in over-the-counter (OTC) cold medications, from the market.
After an extensive review of scientific data, the FDA concluded that oral phenylephrine is ineffective for relieving nasal congestion.
Oral phenylephrine is present in numerous OTC products, both as a standalone ingredient and in combination with others like acetaminophen or dextromethorphan.
Several over-the-counter medications contain oral phenylephrine as a nasal decongestant, including brands such as Sudafed PE, Vicks DayQuil, Tylenol Sinus Congestion & Pain, and Robitussin Peak Cold Nasal Relief.
The FDA emphasized that the ineffectiveness of phenylephrine does not impact the efficacy of these other ingredients in treating symptoms such as pain or cough.
“It is the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”
Until a final order is issued, manufacturers can continue to market OTC products containing oral phenylephrine.
The FDA is seeking public comments on the proposal, which focuses on effectiveness concerns rather than safety issues. If finalized, companies will be given time to reformulate their products or remove them from shelves, the agency said.
Consumers are advised that alternative treatments for nasal congestion are available. These include medications containing other decongestants like pseudoephedrine and nasal sprays with decongestant properties.
Non-pharmacological options such as saline nasal sprays and humidifiers can also provide relief, especially for children, the agency said.
Theresa Michele, M.D., director of the FDA’s office of nonprescription drug products, noted, “Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold.”
The FDA’s proposal does not affect phenylephrine used in nasal sprays or in topical products for hemorrhoid treatment, where it remains effective. The action is limited to orally administered phenylephrine found in tablets, capsules, and liquid medicine.
Phenylephrine has been a common ingredient in cold remedies for decades, intended to relieve nasal stuffiness by constricting blood vessels in the nasal passages. The recent studies have questioned its efficacy when consumed orally, prompting the FDA’s comprehensive review.
Since 2004, phenylephrine has been increasingly marketed as a substitute for pseudoephedrine, a common decongestant. Over concerns about pseudoephedrine’s use in making methamphetamine, restrictions were placed on the sale of pseudoephedrine in 2005.
Phenylephrine is currently available in the cough-and-cold aisle without restriction, while limited quantities of pseudoephedrine may be purchased at a pharmacy with a government-issued ID.
In September 2023, the FDA’s nonprescription drug advisory committee unanimously concluded that current scientific data do not support the effectiveness of orally administered phenylephrine as a nasal decongestant.
Consumers are encouraged to read the drug facts label on OTC medications to identify active ingredients and understand usage directions and warnings. The FDA also recommends consulting a healthcare professional if nasal congestion persists beyond seven days or is accompanied by a fever.
