History of Phenylephrine in Timeline

Phenylephrine is a medication primarily used as a decongestant for nasal congestion, available as a nasal spray or oral tablet. It also serves to dilate pupils, elevate blood pressure when administered intravenously, and alleviate hemorrhoids via suppositories. Additionally, it can be applied topically to the skin. Common brand names include Neosynephrine and Sudafed PE. It is a common over-the-counter medication, but its efficacy as an oral decongestant has been debated.

1933: Phenylephrine Patented

In 1933, Phenylephrine was patented.

1938: Phenylephrine Medical Use

In 1938, Phenylephrine came into medical use.

1938: Introduction for medical use

In 1938, phenylephrine was first introduced for medical use.

2004: Phenylephrine marketed as substitute for pseudoephedrine

Since 2004, phenylephrine has been increasingly marketed as a substitute for pseudoephedrine due to restrictions on pseudoephedrine sales.

2005: Combat Methamphetamine Epidemic Act of 2005

In 2005, provisions of the Combat Methamphetamine Epidemic Act placed restrictions on pseudoephedrine sales, leading to phenylephrine being marketed as a substitute.

2007: Meta-analysis and FDA withdrawal in 2007

In 2007, a meta-analysis concluded that the evidence for phenylephrine's effectiveness is insufficient. Also in 2007, the Food and Drug Administration withdrew the indication for the temporary relief of nasal congestion associated with sinusitis.

2009: Studies on allergic rhinitis

In 2009, studies examined phenylephrine's effects on allergic rhinitis symptoms, finding it no more effective than a placebo.

September 2023: FDA advisory committee deems phenylephrine ineffective

In September 2023, an FDA advisory committee unanimously agreed that there is insufficient evidence that orally administered phenylephrine is effective as a nasal decongestant.

2023: FDA Panel Concludes Ineffectiveness

In 2023, a U.S. Food and Drug Administration (FDA) panel concluded that oral phenylephrine is ineffective as a nasal decongestant, performing no better than a placebo.

November 2024: FDA proposes removal of oral phenylephrine

In November 2024, the FDA proposed to remove oral phenylephrine as an active ingredient in over-the-counter drugs for temporary nasal congestion relief.