Are over-the-counter phenylephrine products safe and effective?

What is phenylephrine?

Phenylephrine is an over-the-counter decongestant that has been on the market for decades. Like other decongestants, it was thought to work by causing constriction of blood vessels in the nose to allow clogged nasal passages to drain. It is one of the most common ingredients in over-the-counter cold products, such as Sudafed PE. It is available alone and in many combination products. The FDA categorizes phenylephrine as Generally Recognized as Safe and Effective (GRASE).

Why did the FDA meet to discuss phenylephrine?

Phenylephrine is a common over-the-counter product. Americans spent an estimated $1.8 billion on phenylephrine products last year. Buying it may be an unnecessary expense if it does not work. Just as bad, all medicines have risks, and if they don’t also have benefits, we shouldn’t take them. Because phenylephrine was approved many years ago, the studies used to determine whether it was safe and effective were not conducted as well as clinical studies are conducted today. More recent information suggested that oral phenylephrine was no more effective than placebo for the treatment of nasal congestion. Based on this new information, the FDA convened a panel of experts to reexamine all of the information regarding the efficacy of oral phenylephrine.

What did the FDA phenylephrine panel find?

After reviewing the initial approval studies and more current information, the panel unanimously voted that oral phenylephrine was no more effective than placebo in treating nasal congestion, even at higher doses than what is available over-the-counter now. It is important to note that the review of the studies discovered no safety concerns.

Will phenylephrine be taken off the market?

As of September 13, 2023, whether phenylephrine will be taken off the market is unclear. The FDA considers expert panel recommendations in addition to pharmaceutical companies' and the general public's comments. These comments and legal challenges may delay an ultimate decision.

What do I do if I have a phenylephrine product at home?

There are currently no safety concerns about oral phenylephrine. Patients can continue to take the product if needed for nasal decongestion if it works for them. Do not take more of the product than recommended if it is not working. High doses of phenylephrine are associated with increased blood pressure. Phenylephrine is also available in combination with other over-the-counter medications, such as acetaminophen, dextromethorphan, and antihistamines, which can be toxic if taken in large doses.

What can I take for nasal congestion if phenylephrine does not work or is no longer available?

There are several alternative medications available over-the-counter to treat nasal congestion. Oral pseudoephedrine is available behind the pharmacy counter but without a prescription. There are also decongestant nasal sprays containing phenylephrine or other ingredients such as oxymetazoline (Afrin) for short term relief of nasal congestion due to colds. In cases of congestion due to allergic rhinitis, there are antihistamines and nasal steroids in addition to oral and nasal decongestants. Non-medicated nasal saline sprays can also help.

Does phenylephrine nasal spray work?

The FDA panel did not evaluate the phenylephrine nasal spray. It will likely remain available for the foreseeable future.

What should I do if I took too much phenylephrine?

If you or someone else takes too much phenylephrine, takes it by mistake, or you have questions, help from experts is available through the webPOISONCONTROL online tool at www.poison.org and by phone at 1-800-222-1222. Poison Control guidance is always free, confidential, and available 24 hours a day online or by phone.

Maryann Amirshahi, PharmD, MD, MPH, PhD
Medical Toxicologist