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Jasmine Uchi, PharmD

FDA Re-evaluates Popular Cold Medicine: What You Need to Know

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

 

Disclaimer: The product and/or information provided on VeganMed is of a general nature and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. We do not lab test the products to confirm that they are free from animal ingredients, and it is possible that the formulation and ingredients could have changed. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition or product. The information provided in this post is accurate and up to date as of the date it was written. However, please note that circumstances and facts may change over time, and new information may become available that could alter the accuracy or relevance of the content. We encourage readers to verify and cross-reference any information provided here with trusted sources or consult relevant professionals for the most current and accurate updates.

 

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