The FDA is taking a closer look at phenylephrine, an ingredient commonly found in over-the-counter (OTC) cold medicines like syrups, tablets, and dissolvable powders. This review is focused on effectiveness, not safety, and raises questions about how well oral phenylephrine actually treats nasal congestion — a popular choice for tackling stuffy noses from colds, allergies, or sinus issues.
What did the FDA find?
After analyzing past and recent studies on oral phenylephrine, the FDA found that these studies did not consistently show that it effectively relieves congestion. Many older studies used a measure called "nasal airway resistance" (NAR) to gauge how well phenylephrine worked. But NAR isn't a reliable measure, as it varies too much from person to person and doesn’t clearly show symptom relief. Newer studies that focused on actual symptom improvement, like how congested people felt, also showed disappointing results for phenylephrine.
What is the FDA proposing?
Due to limited evidence that oral phenylephrine effectively relieves congestion, the FDA is recommending its removal from the OTC market in tablet and liquid forms. Importantly, this decision does not relate to safety — the review found no new safety concerns with oral phenylephrine. The proposal also does not affect nasal sprays or drops containing phenylephrine, which are still considered effective for congestion relief.
Alternatives to Phenylephrine
Consumers who rely on OTC cold medicines may soon find fewer products with oral phenylephrine on store shelves. However, there are several effective alternatives for congestion relief, such as:
Oral pseudoephedrine
Nasal sprays with decongestants, corticosteroids, or antihistamines
Additional options include using cool mist humidifiers, saline nose drops, rinses or sprays, and, for children, nasal suctioning with a bulb syringe. These alternatives provide a range of choices to help manage congestion effectively.
Phenylephrine vs. Pseudoephedrine
Phenylephrine and pseudoephedrine are both common ingredients in decongestants, but they have important differences in effectiveness, availability, and usage.
Feature | Phenylephrine | Pseudoephedrine |
Effectiveness | Mixed evidence on effectiveness in oral form | Generally considered effective for nasal congestion |
Availability | Available OTC without restrictions | Available behind-the-counter due to regulations |
Forms | Oral tablets, syrups, nasal sprays, eye drops | Oral tablets, syrups |
Side Effects | Fewer reports of insomnia, jitteriness | May cause increased heart rate, insomnia |
Mechanism | Acts on blood vessels in nasal passages | Constricts blood vessels throughout the body |
Animal-free Options? | Yes | Yes |
While phenylephrine is easier to access, pseudoephedrine is generally considered more effective for nasal congestion but is regulated due to potential misuse.
Conclusion
The FDA’s review of oral phenylephrine raises concerns about its effectiveness as a decongestant, though it remains safe. If removed from OTC options, consumers still have effective alternatives like pseudoephedrine, nasal sprays, and non-medication options. Knowing these choices helps consumers find reliable relief for nasal congestion.
Read the full FDA proposal and review here.
Co-authored by: Gillian Taganas
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