";s:4:"text";s:5208:" taken, how much, and when it happened. For more information, ask your healthcare provider or pharmacist.Call your doctor for medical advice about side effects. In the long-term clinical trials, the following adverse reactions occurred in greater than or equal to 5% and are not listed in Table 1: diarrhea (10%); sinusitis (8%); infection viral (6%); and arthralgia (5%).Signs/symptoms of hypercorticism reported by active questioning of patients in the long-term maintenance clinical trials are displayed in Table 3.The incidence of signs/symptoms of hypercorticism as described above in long-term maintenance clinical trials was similar to that seen in the short-term treatment clinical trials.Less common adverse reactions (less than 5%), occurring in adult patients treated with Entocort EC 9 mg (total daily dose) in short-term treatment clinical studies and/or Entocort EC 6 mg (total daily dose) in long-term maintenance clinical trials, with an incidence are listed below by system organ class:A randomized, open, parallel-group multicenter safety clinical trial specifically compared the effect of Entocort EC (less than 9 mg per day) and prednisolone (less than 40 mg per day) on bone mineral density over 2 years when used at doses adjusted to disease severity. Intake of grapefruit juice which inhibits CYP3A4 activity with budesonide can increase the systemic exposure for budesonide Limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. If you have questions about side effects, call your doctor. Drug information provided by: IBM Micromedex Along with its needed effects, a medicine may cause some unwanted effects. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. However, it caused a statistically significant increase in the incidence of hepatocellular tumors at an oral dose of 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis).