Do over-the-counter decongestants work?

The U.S. Food and Drug Administration (FDA) has proposed removing a common ingredient in over-the-counter (OTC) decongestants. After reviewing available data, the FDA determined that oral phenylephrine is ineffective at treating congestion symptoms caused by colds or allergies.

While you may not see changes in your local drugstore shelves yet, Sharp Rees-Stealy Santee pharmacy supervisor Seung Oh, PharmD, offers insight on what this proposal means and what you can do to find congestion relief.

What is phenylephrine?

Oral phenylephrine has been marketed as an effective ingredient in treating nasal congestion symptoms for decades. Used in cold and allergy medicines, phenylephrine is often combined with other ingredients that manage pain relief and cough suppression.

Despite being approved over three decades ago, subsequent studies have shown that oral phenylephrine was no more effective than a placebo for congestion symptom relief.

What’s the FDA’s recommendation?

“Right now, the FDA is proposing to remove oral phenylephrine as an active ingredient in those medications you find at your local pharmacy,” says Oh. “While there is no medical concern, the FDA’s data did confirm that phenylephrine is not actually effective at treating nasal congestion symptoms.”

In the proposal stage, the FDA conducts additional reviews and receives public comments before making its final decision. Meanwhile, there is plenty you can do to combat congestion symptoms.

So, what should I use instead?

"You can still treat your congestion with pseudoephedrine and oxymetazoline,” says Oh. “Those ingredients can be found in Sudafed and Afrin, or even some generic drugstore brands.”

Some options, such as Sudafed (pseudoephedrine), require you to purchase the drug from behind the pharmacy counter and present valid photo identification. Oh stresses that if you are diagnosed with any heart condition or high blood pressure, consult with your doctor or pharmacist before taking pseudoephedrine.

While over-the-counter medications with pseudoephedrine and oxymetazoline can be excellent options for treating congestion, there are other actions you can take to speed up your relief and recovery, including:

• Using saline sprays or rinses such as Ayr spray or Neil-med sinus rinses

• Utilizing a humidifier to alleviate dryness in your home or office

• Staying adequately hydrated throughout the day

Oh also emphasizes that the FDA proposal only applies to the oral applications of phenylephrine, not nasal sprays. “Nasal sprays with phenylephrine are still considered effective, so feel free to keep using them when needed.”

What happens next?

While this remains in the proposal stage, medicine with oral phenylephrine will still be available at local drugstores. The FDA is taking comments on the proposal until May 7, 2025.

“Pay attention to the active ingredients when picking out your medication,” Oh says. “You can always consult with your care team or pharmacist if you need help deciding what’s best for you.”

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