The Food and Drug Administration (FDA) recently released a statement regarding the effectiveness of oral phenylephrine in over-the-counter (OTC) cough and cold products. Phenylephrine is often used in products for the temporary relief of congestion, both as a single ingredient product and in combination products. 

The committee's statement indicated that current scientific data suggests the recommended dosage of orally administered phenylephrine as a nasal decongestant is ineffective—but did not have any concerns on safety at the recommended dose. 

What is a decongestant? 

A decongestant is any medication that is intended to help relieve congestion or reduce mucus. Decongestants work to relieve the symptoms associated with excess mucus (think stuffy noses or phlegm-y coughs), allowing the body to rest and fight off the cold virus. Phenylephrine is one common medication used as a decongestant.

Which products contain phenylephrine? 

Phenylephrine is used on its own or in combination with other ingredients in many products that are marketed for the temporary relief of congestion symptoms due to allergies or a common cold. Phenylephrine can be found in some versions of popular products such as Tylenol, Mucinex and Benadryl. 

Before purchasing any OTC medication, be sure to read the package to determine if the product contains phenylephrine. Having phenylephrine included as part of a multi-symptom product will in no way impede the effectiveness of the other ingredients and is still considered safe to consume. 

What will work as a decongestant? 

There are still options available that are considered safe and effective decongestants. Phenylephrine in the nasal spray form was not included in the advisory committee’s discussions and as such is still considered a safe and effective decongestant. 

Oral pseudoephedrine, like phenylephrine, is available as a sole ingredient product as well as multi-symptom formulations. However, due to abuse potential, these products will have to be purchased from behind the pharmacy counter with a driver’s license. There are also quantity limits on how much can be purchased daily and monthly. 

If you choose to take oral medications with phenylephrine and aren't finding relief for your congestion, there are some at-home options to help relieve the pressure temporarily. Humid air helps to soothe inflammation and increases mucus draining, so using a humidifier in your room is great when you have a cold—be sure to only use a cool-air humidifier with children. Similarly, taking a hot shower can help to ease congestion temporarily, allowing you to rest a bit. Drinking plenty of fluids is important whenever you have a cold, so brew your favorite tea or keep a glass of water handy. 

What are the side effects of decongestants? 

Keep in mind that oral decongestants do have side effects such as: 

  • Possible restlessness 
  • Trouble sleeping 
  • Nervousness/dizziness 
  • Degree of increased blood pressure 
  • Possible fast heartbeat 

Due to potential side effects, consult with your doctor or pharmacist before using a product containing an oral decongestant if you have the following conditions: 

  • Heart disease 
  • High blood pressure 
  • Diabetes 
  • Thyroid conditions 
  • Enlarged prostate 

What happens next? 

The FDA has not yet decided on whether to pull the phenylephrine products from the market at this time as they do not pose a safety threat. The organization most likely wants to give manufacturers the chance to reformulate their cough and cold products and avoid market shortages. 

If you currently have non-expired cold and cough medications containing phenylephrine, you can continue to take them as needed and as directed on the packaging. Be sure to keep all medications safely stored away from children and dispose of expired medications safely.

Raymond Spinella, RPH

Raymond Spinella, RPH, is manager and pharmacist-in-charge of Lifespan Pharmacy at Rhode Island Hospital