Safety and tolerability of extended-release guaifenesin in patients with cough, thickened mucus, and chest congestion associated with upper respiratory tract infection

S. Tripathi, A. Nikhare, G. Sharma, T. Shea, H. Albrecht

Drug Healthc and Patient Saf. 2019; 11 87–94

Purpose:

To examine the safety profile of extended-release guaifenesin in a population of patients with acute upper respiratory tract infection (URTI)

Methods:

• Open-label, prospective, single-arm, post-marketing surveillance study conducted across nine study centers in India

• 552 adult patients aged ≥18 years were enrolled; had cough, thickened mucus, and chest congestion who were diagnosed with acute bronchitis, URTI, or sinusitis

• 1200 mg extended-release guaifenesin (two 600 mg bilayer tablets) every 12 hours for 7 days

• Primary endpoint was the number, type, and frequency of Adverse Events (AEs) as well as the proportion of patients with AEs

• AEs recorded, questionnaires administered to patients and investigators

Results:

Extended-release guaifenesin was well tolerated and had a favorable safety profile in otherwise healthy patients suffering from URTI symptoms

• A total of 29 treatment-emergent AEs were recorded in 28 of the 552 patients; all AEs were assessed as transient and mild in severity

• No serious AEs reported

• Patients and investigators were satisfied or very satisfied with improvement in treatment of chest congestion and cough

The FDA defines OTC drugs as medicines it decides are “effective for use without a doctor's prescription.”¹ This open-label, prospective post-marketing surveillance study across nine centers in India examined the safety profile of extended-release guaifenesin (the active ingredient in MUCINEX®), 1200 mg every 12 hours for 7 days, in 552 adults with URTI, acute bronchitis or sinusitis. Only 29 treatment-emergent adverse events occurred in 28 patients, all transient and mild, with no serious events, and patients and investigators were satisfied or very satisfied with the improvement.²

Source:

1 U.S. Food and Drug Administration. Over-the-Counter Medicines: What's Right for You? https://www.fda.gov/drugs/understanding-over-counter-medicines/over-counter-medicines-whats-right-you

2 Safety and tolerability of extended-release guaifenesin in patients with cough, thickened mucus, and chest congestion associated with upper respiratory tract infection. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6791405/