Post marketing surveillance study (PMS) to assess the safety of fixed-dose combination therapy of paracetamol, phenylephrine, and chlorpheniramine maleate for the symptomatic treatment of common cold in Indian adults

The common cold is a frequent acute infection of the upper respiratory tract, with adults typically experiencing 4 to 6 episodes annually. For symptomatic treatment of common cold fixed dose combination (FDC) of paracetamol, phenylephrine and chlorpheniramine maleate are commonly used in clinical practice since long, However, there is limited research on the safety assessment of such fixed-dose combination therapies. This study evaluates the safety and effectiveness of a FDC containing 500 mg paracetamol, 10 mg phenylephrine and 2 mg chlorpheniramine maleate tablets for the symptomatic treatment of common cold in Indian adults. A total of 200 patients aged 18 to 65 years were recruited for this study. The primary focus was on evaluating the safety of a FDC containing 500 mg of paracetamol, 10 mg of phenylephrine and 2 mg of chlorpheniramine maleate in a tablet formulation (Febrex Plus). The study spanned 5 days, with patients visiting the clinical trial site on the first day for a baseline assessment, followed by re-evaluation visits on the 2, 3, 4 and 5 day. Safety assessments were based on adverse events reported by the patients. Effectiveness was evaluated only on the basis of symptomatic relief. During the study, a total of 24 adverse events were reported, all of which were mild in intensity and completely resolved. Eleven patients (5.5%) reported mild allergic reactions, six patients (3%) reported nausea, one patient (0.5%) reported vomiting, and six patients (3%) reported sleepiness. No unexpected or serious adverse events were reported in any of the patients. Nearly all patients experienced symptomatic relief by the third day of treatment. The FDC containing 500 mg of paracetamol, 10 mg of phenylephrine and 2 mg of chlorpheniramine maleate tablets was found to be safe and effective for the symptomatic treatment of common cold in adults. CTRI/2020/06/026030.