Rhinocort Aqua Adverse Reactions

Clinical Trial Data: The safety of budesonide from clinical trial data is based on data from 15 placebo-controlled randomized studies in the treatment of allergic rhinitis.
The Tables 2 to 3 include adverse events that occurred where greater than one event was reported, and the incidence was greater than placebo and in 1% of patients or more. (See Table 2 and Table 3.)

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Post Marketing Data: Adverse drug reactions (ADRs) identified during Post-marketing experience with budesonide are included in Table 4.
The frequencies are provided according to the following convention: Very common ≥1/10; Common ≥1/100 and < 1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000; Not known (cannot be estimated from the available data).
In Table 4, ADRs identified are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available or 2) when incidence is unavailable, frequency category is listed as Not known. (See Table 4.)

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