700 Children's® – A Blog by Pediatric Experts

Oral Phenylephrine Doesn’t Work and the FDA Finally Recognized It

Sep 15, 2023
Pill bottle dumped out

We’ve all seen the over-the-counter oral cough & cold and allergy medicines that contain phenylephrine. This ingredient is in many of these medications have been around since the early 1970s and has been touted to be effective at helping our stuffy noses when we get sick with a cold. But the scientific data hasn’t quite held up.

In study after study over the years, the drug has proven to be ineffective at helping with the one thing it’s supposed to be helping with – nasal congestion. It turns out, not that much actually reaches your nose. What’s even more astounding is that there really isn’t that much difference in nasal congestion if you don’t take these oral medicines to begin with.

Earlier this week, a 16-member panel from the US Food and Drug Administration all agreed that the current dose of oral phenylephrine is not effective as a nasal decongestant. (It won’t be studied at higher doses due to safety concerns.)

To be clear, there are nasal sprays that contain phenylephrine. The FDA did not rule on these and they will continue to be available over the counter.

So why are the oral medications containing phenylephrine still on the shelves?

This is a complicated question, but the reality is that medications containing phenylephrine are a massive industry and generate a whole lot of money for some big companies. These medications containing phenylephrine became even more prevalent in the mid-2000s after access to another decongestant, pseudoephedrine, was restricted. (Medications containing pseudoephedrine are the ones behind the pharmacy counter that you need to present valid identification to purchase.)

We’ve known about this for quite some time.

Phenylephrine helps decrease the swelling of blood vessels in your nose which should then help reduce the congestion. However, studies have shown that in the oral form in these medications, not enough of the phenylephrine ends up getting into your nasal passages (by way of being broken down in the gut and liver and ending up in your blood stream to get to your nose).

The role of phenylephrine was challenged even back in 2007, however the FDA committee at the time said that phenylephrine “may be effective” and so these medications stayed on the shelves.

What’s next?

The FDA usually follows the recommendations from its committees, and if it follows this decision, it could begin a process that would take phenylephrine containing medications off the shelves. This would be quite disruptive for the companies that would be forced to reformulate existing medications, so it’ll be interesting to see how this plays out. The bottom line is that if medications aren’t effective, they shouldn’t be sold on our grocery store shelves.

If you have specific questions about medications you’ve been using to help with your nasal symptoms, please speak with your doctor.

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Farah Khan
Farah Khan, MD

Farah Khan is on the Allergy and Immunology Physician Team at Nationwide Children's Hospital.

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Pediatric News You Can Use From America’s Largest Pediatric Hospital and Research Center

700 Children’s® features the most current pediatric health care information and research from our pediatric experts – physicians and specialists who have seen it all. Many of them are parents and bring a special understanding to what our patients and families experience. If you have a child – or care for a child – 700 Children’s was created especially for you.