From the Guidelines
Phenylephrine-based over-the-counter medications are not recommended for treating nasal congestion due to their lack of effectiveness. Common OTC products containing phenylephrine include Sudafed PE, Advil Congestion Relief, and various store brands labeled as non-drowsy decongestants. The lack of efficacy of phenylephrine is attributed to its poor absorption and rapid metabolism when taken orally, resulting in insufficient active drug reaching nasal blood vessels to cause meaningful constriction and congestion relief 1.
Some key points to consider when evaluating the use of phenylephrine-based medications include:
- The potential for side effects such as insomnia, irritability, and palpitations, particularly in older adults and young children, or in patients with certain medical conditions such as cardiac arrhythmia, angina pectoris, cerebrovascular disease, hypertension, bladder neck obstruction, glaucoma, or hyperthyroidism 1.
- The risk of elevated blood pressure, which is generally observed in hypertensive individuals, and the need for careful consideration of the risks and benefits before using oral decongestants in children below age 6 years 1.
- The availability of alternative treatments, such as pseudoephedrine (Sudafed, kept behind pharmacy counters), which is more effective but requires ID to purchase due to its potential use in methamphetamine production, or nasal sprays like oxymetazoline (Afrin) or fluticasone (Flonase), which may provide better relief 1.
In terms of specific patient populations, it is essential to exercise caution when using oral decongestants, particularly in:
- Children under 6 years of age, due to the risk of agitated psychosis, ataxia, hallucinations, and even death 1.
- Patients with certain medical conditions, such as cerebrovascular or cardiovascular disease, hyperthyroidism, closed-angle glaucoma, and bladder neck obstruction, due to the potential for adverse effects 1.
- Pregnant women, due to the potential for fetal heart rate changes with administration during pregnancy 1.
Overall, the use of phenylephrine-based medications for treating nasal congestion is not recommended due to their lack of effectiveness and potential for side effects. Instead, alternative treatments such as pseudoephedrine or nasal sprays like oxymetazoline or fluticasone may be considered, taking into account the specific needs and medical conditions of each patient.
From the Research
Phenylephrine Based Medications Over-the-Counter (OTC)
- Phenylephrine is a common ingredient in OTC medications for nasal congestion relief, but its efficacy at certain doses has been questioned 2.
- A study published in 2015 found that phenylephrine hydrochloride (PE HCl) was not significantly better than placebo at relieving nasal congestion in adults with seasonal allergic rhinitis, even at doses of up to 40 mg every 4 hours 2.
- The Food and Drug Administration has requested further studies to assess the efficacy and safety of PE HCl, which may impact the phenylephrine section of the FDA monograph on OTC cold, cough, allergy, bronchodilator, and antiasthmatic products 2.
Alternative Treatments for Allergic Rhinitis
- Nasal saline irrigation has been shown to be a effective adjunctive therapy for allergic rhinitis, with improvements in patient-reported disease severity and quality of life 3, 4, 5, 6.
- Saline irrigation may reduce patient-reported disease severity compared to no saline irrigation at up to three months in both adults and children with allergic rhinitis, with no reported adverse effects 3.
- Hypertonic nasal saline irrigation, in particular, has been found to have superior efficacy to isotonic nasal saline irrigation for alleviating congestion and improving quality of life scores in patients with allergic rhinitis 5.
- Nasal saline irrigation appears to be safe, with minor adverse effects that can be avoided with technique modification and salinity adjustment 6.