An advisory committee to the FDA has agreed that there is not enough evidence to support the use of oral phenylephrine (PE) as a decongestant. PE is an ingredient in over-the-counter decongestants, and there is limited and conflicting evidence on how well it works when taken orally. Nasal sprays with PE are still effective. Neither the FDA nor the committee have concerns about the safety of this decongestant, only its effectiveness when taken orally.

An advisory committee to the FDA unanimously agreed that phenylephrine (PE) is not an effective decongestant when taken orally given current scientific evidence. This decision is based on limitations to older studies that originally suggested it was effective, including a 2015 study that found it to be no more effective than a placebo when taken by mouth.

This decision is the opinion of the advisory committee and is not the FDA’s current position. The FDA will take the committee’s decision under advisement, review the available evidence, and be the ones to decide if further action needs to be taken.

Nasal sprays containing PE are still effective. Other medications that are taken by mouth and have PE still have other ingredients that may work.

PE is still safe to use at recommended doses according to both the FDA and the advisory committee what is being called into question is just how well it works.

 The FDA has not yet decided how to proceed after the advisory committee’s decision. Further information on what the next steps would look like can be found here.

More research may be needed to clarify the effectiveness of oral PE as a decongestant.