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Phenylephrine: FDA finds decongestants in cold and flu medication do not work

You can park your cold and flu tablets this season, because as it turns out, the main ingredient in the over-the-counter variety, phenylephrine, doesn’t even work.

If you’ve ever wondered why your cold and flu tablet does zilch to relieve your ghastly symptoms, we can tell you why.

An advisory committee to America’s Food and Drug Administration (FDA) unanimously agreed that phenylephrine in tablet form is actually ineffective. In fact, they discovered after analysing five different studies that it was nothing more than a placebo.

We feel duped, but also not surprised.

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Phenylephrine is found in oral cold and allergy decongestants, and was brought in to replace pseudoephedrine, which was banned from over-the-counter purchase to minimise its use to make methamphetamine.

Most cold and flu tablets contain a mix of paracetamol and phenylephrine, and the latter is included to supposedly act as a decongestant to help with clogged-up noses and sinuses. 

We were led to believe it narrowed blood vessels in the nose to provide relief. But now, the committee is blaming „unsound“ initial studies on the ingredient’s inclusion. 

“We do believe that the original studies were methodologically unsound and do not match today’s standard. By contrast, we believe the new data are credible and do not provide evidence that oral phenylephrine is effective as a nasal decongestant,” Dr Peter Starke, an FDA official who led the review, said

Several studies found that because of the way phenylephrine is metabolised via the gut and liver, it doesn’t enter the bloodstream in large enough amounts to provide any decongestant benefit. The panel didn’t, however, dispute phenylephrine’s effectiveness as a nasal spray.

Despite its side effects like lightheadedness, dizzy spells, an upset stomach and trouble sleeping, phenylephrine doesn’t pose a safety issue.

“It’s not a safety issue. It’s an effectiveness issue,” Dr Mark Dykewicz, an allergist and immunologist at Saint Louis University School of Medicine, told The New York Times.

If you want an ingredient that will do the job orally, Dykewicz said pseudoephedrine is the pick. Just remember, it’s kept behind the counter, nowadays.

Here in Oz, the Therapeutic Goods Administration (TGA) sees things differently, and suggests it wouldn’t take phenylephrine in pill form off the market, and stood by the initial studies claiming its efficiency. The organisation claimed effectiveness simply varied between individuals.

“Its safety and efficacy are documented in standard reference texts,” a spokesperson told Body+Soul. 

“The perceived effectiveness of medications indicated to relieve symptoms such as nasal congestion can vary between individuals. Additionally, pseudoephedrine and phenylephrine have differences in the way they work which may result in some differences in their effectiveness.”

“Legislation requires that the active ingredient(s) is displayed prominently on the main label of the medicine to enable consumers to make informed choices when purchasing over-the-counter medicines.” 

Are there natural alternatives?

Now that we’ve lost a bit of hope in our phenylephrine-loaded C&F tabs, it’s understandable that you might want to look wider for other solutions.

Standing in a steaming shower or using a humidifier can do the trick. A nasal saline spray can also clear the mucus and any other irritants preventing you from breathing freely.

However, Dr Andrew Lane, director of the Johns Hopkins Sinus Centre did advise to not go overboard. “You can’t do too much saline,” Dr Lane said.

If it’s just the congestion you want to shift, and prefer medicinal relief, you could try oral antihistamines like Zyrtec, Claritin. We do suggest checking in with your GP, though, because if you’re suffering from fevers and aches, there could be more to your illness.

Always take medication as instructed by your doctor and/or pharmacist, and comply with the instructions on the packaging. For more information about cold and flu medication, visit

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