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Cough Update: Safety and Tolerability of Extended-Release Guaifenesin in Patients with Cough, Thickened Mucus and Chest Congestion Associated with Upper Respiratory Tract Infection

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eMediNexus    17 January 2021

An extended-release (ER) formulation of the expectorant guaifenesin has recently been launched in India for the treatment of productive cough accompanied by mucus (phlegm).

The goal of a study published in Drug, Healthcare and Patient Safety was to further elucidate the safety profile of ER guaifenesin in patients with acute upper respiratory tract infection (URTI).

This prospective, post-marketing surveillance study enrolled 552 adults with cough, thickened mucus and chest congestion due to URTI, who took ER guaifenesin 1200 mg every 12 hrs for 7 days.

Overall, 29 treatment-emergent AEs were recorded in 28/552 patients, including gastrointestinal (n = 11), nervous system (n = 8), psychiatric (n = 3), respiratory, thoracic and mediastinal (n = 2), skin and subcutaneous tissue (n = 2) and general disorders (n = 3). All AEs were mild in severity and no serious AEs or deaths occurred. The majority of both patients and investigators were either satisfied or very satisfied with improvements in treatment outcomes.

Thus, the results showed that ER guaifenesin was well tolerated and had a favorable safety profile in otherwise healthy patients suffering from symptoms of cough, thickened mucus and chest congestion associated with URTI.

Source: Drug, Healthcare and Patient Safety. 2019 Oct 10;11:87-94. doi: 10.2147/DHPS.S222109.

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