Rhinocort Aqua Adverse Reactions

Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with budesonide are listed below by System Organ Class (SOC). The frequencies are defined in accordance with current guidance, as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10 000 and <1/1000), very rare (<1/10 000) and not known (cannot be estimated from the available data).
ADRs are presented by frequency category based on incidence in adequately designed clinical trials or epidemiology studies, if available or when incidence is unavailable, frequency category is listed as Not known. (See Table 2.)

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In rare cases, signs or symptoms of systemic glucocorticosteroid side effects such as Cushing's syndrome, Cushingoid features, psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children), may occur with intranasal glucocorticosteroids, probably depending on dose, exposure time, concomitant and previous corticosteroid exposure, and individual sensitivity (see Precautions).
Paediatric population: Growth retardation has been reported in children receiving intranasal steroids.