Cold and flu season is here. But before you reach for your favorite cold medicine, are you sure it’s working? In case you missed it, this past November, the FDA issued a proposal to remove an ingredient found in many cough and cold remedies. If you’re interested, you can read more about their proposal in our newsroom. The ingredient is called phenylephrine. And according to the FDA, it may not be effective at relieving symptoms of nasal congestion as once thought. Find answers to your questions about phenylephrine here.
What is oral phenylephrine?
Oral phenylephrine (sometimes called oral PE) is a common ingredient used in various drug products sold over the counter. It’s intended to temporarily relieve symptoms of nasal congestion from the common cold or allergies.
How do I know if a drug contains it?
You can check the drug facts label on the back of any store-bought medicines. Look for phenylephrine to be listed as a nasal decongestant.
Is it safe to consume phenylephrine?
The FDA has evaluated phenylephrine to see if there are any potential safety issues. To date, they’ve identified very few serious side effects when taking it as directed.
Can I still take products that contain phenylephrine?
Yes. If your medicine has oral phenylephrine, you may continue to use it. While this ingredient has been shown to be ineffective at treating nasal congestion, it has not been proven to be unsafe. Drug products may also contain other active ingredients that do treat symptoms of colds and allergies, such as headaches or muscle aches. The presence of phenylephrine in these products does not affect how other active ingredients work to treat those symptoms. As mentioned above, always read the drug facts label on any store-bought medications before consuming.
Can I still buy products that contain phenylephrine?
Yes. At this time, the FDA hasn’t required pharmacies to stop selling products containing phenylephrine. However, some retail stores may voluntarily remove the products from their shelves prior to the FDA’s final decision.
Why is this change being proposed?
Clinical trials have shown while phenylephrine is not unsafe, it may not be effective when taken orally. It’s part of the FDA’s job to ensure consumers have access to safe and effective drugs. In September of 2023, the FDA advisory committee concluded sufficient evidence showed phenylephrine is ineffective in a typical oral dosage.
When will the FDA finalize their ruling?
Issuing a proposed order to remove oral phenylephrine from the market is one of several steps the FDA must complete before making a final decision. The proposal is out for public comment until May 7, 2025. A final decision is expected to be made sometime in 2026.
Are there alternatives?
Yes. Alternative medicines to treat nasal congestion include oral pseudoephedrine, nasal decongestant sprays, nasal corticosteroid sprays and nasal antihistamine sprays.
Other options include cool mist humidifiers, saline nose drops or sprays and nasal suctioning with a bulb syringe. These options can be good alternatives, especially for children.
You can talk to your doctor or pharmacist about the best options for you and your family.
This article is for informational purposes only and is not meant as medical advice.
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