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Pseudoephedrine for Adults with Sinus Congestion: A Review of the Clinical Effectiveness, Safety and Guidelines

Last updated: March 25, 2015
Project Number: RC0642-000
Product Line: Rapid Response
Research Type: Drug
Report Type: Summary with Critical Appraisal
Result type: Report

Question

  1. What is the clinical effectiveness and safety of pseudoephedrine compared to placebo for adults with sinus congestion?
  2. What is the clinical effectiveness and safety of pseudoephedrine plus acetaminophen compared to placebo for adults with sinus congestion?
  3. What is the comparative clinical effectiveness of pseudoephedrine and pseudoephedrine plus acetaminophen for adults with sinus congestion?
  4. What are the evidence-based guidelines for the use of pseudoephedrine (with or without acetaminophen) for adults with sinus congestion?

Key Message

Current evidence suggests that pseudoephedrine, in combination with acetaminophen, is effective compared to placebo in providing temporary symptom relief from nasal congestion due to upper respiratory tract infections or cold-like symptoms. No comparative evidence exists that has evaluated single-ingredient pseudoephedrine against combination therapy of pseudoephedrine and acetaminophen. The safety profile remains uncertain: adverse events appear to be minor when administered acutely with greater risk of serious adverse events over long-term use. Evidence-based guidelines generally recommend the use of decongestant, limited as adjuncts to provide temporary symptom relief, in patients with non-infectious rhinitis/ rhinosinusitis or allergic rhinitis. Several of the identified guidelines caution its use in patients with hypertension, ischemic heart disease, glaucoma, prostatic hypertrophy and/or diabetes mellitus.