Dymista Adverse Reactions

In the 4 placebo-controlled studies (MP4001, MP4002, MP4004 and MP4006), 1006 patients were treated with DYMISTA, 1012 with placebo, 851 with azelastine (AZE) in DYMISTA vehicle, 846 with fluticasone propionate (FLU) in DYMISTA vehicle, 152 with Astelin Nasal Spray (marketed AZE), and 153 with fluticasone propionate from Roxanne Laboratories Inc. (marketed FLU). The mean duration of exposure to each of these products was about 14 days. There were no relevant differences between the treatment groups in the overall rate of premature discontinuations and also the primary reason for discontinuation.
Across all treatment groups, the percentage of subjects with any AEs was low and majority of AEs were mild in nature. The most frequently reported adverse events (AEs) were dysgeusia, epistaxis and headache. However, headache and especially epistaxis were also frequently reported under placebo. Treatment-emergent adverse events reported with an incidence of ≥ 1% in the DYMISTA treated group, in the 4 pivotal studies, are shown in Table 2. (See Table 2.)

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Table 3 listed possible adverse reactions for DYMISTA, with frequencies corresponding to: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data). (See Table 3.)

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