A slightly increased number of basophilic hepatic foci were observed in chronic rat studies with budesonide, and in carcinogenicity studies there was an increased incidence of primary hepatocellular neoplasms, astrocytomas (in male rats) and mammary tumours (female rats) observed. These tumours are probably due to the specific steroid receptor action, increased metabolic burden on the liver and anabolic effects, effects which are also known from other glucocorticosteroids in rat studies and therefore represent a class effect. No similar effects have ever been observed in man for budesonide, neither in clinical trials nor from spontaneous reports.
Desonate was approved by the FDA following two major clinical trials in 2006. Each randomized, double-blind, placebo-controlled study enrolled 582 pediatric patients (between the ages of 3 months and 18 years).  The patient was topically administered the drug or placebo two times a day for four weeks. Using the Investigator’s Global Severity Score (IGSS), the treatment was considered successful if at Week 4 there was at least a two (2) point decrease from the patient’s baseline IGSS. In clinical trial 1, 44% of patients succeeded successful treatment of Desonate versus 14% treated with the placebo. In clinical trial 2, 28% of patients succeeded successful treatment of Desonate versus 6% treated with the placebo.