Sterapred Side Effects

Generic Name: prednisone

Please note - some side effects for Sterapred may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Sterapred - for the Consumer

Sterapred

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sterapred:

Difficulty sleeping; feeling of a whirling motion; increased appetite; increased sweating; indigestion; mood changes; nervousness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); appetite loss; black, tarry stools; changes in menstrual periods; convulsions; depression; diarrhea; dizziness; exaggerated sense of well-being; fever; general body discomfort; headache; increased pressure in the eye; joint or muscle pain; mood swings; muscle weakness; personality changes; prolonged sore throat, cold, or fever; puffing of the face; severe nausea or vomiting; swelling of feet or legs; unusual weight gain; vomiting material that looks like coffee grounds; weakness; weight loss.

Side Effects by Body System

General

Adverse effects have occurred less frequently when minimum dosages were employed. Dosages greater than 10 mg per day have been associated with an increased incidence of adverse events.

Adverse effects of prednisone may be subdivided into those associated with short-term therapy (to three weeks) and those of long-term therapy (> three weeks).

Short-term effects have included sodium retention-related weight gain and fluid accumulation, hyperglycemia and glucose intolerance, hypokalemia, gastrointestinal upset and ulceration, reversible depression of the hypothalamic-pituitary-adrenal (HPA) axis, and mood changes ranging from mild euphoria and insomnia to nervousness, restlessness, mania, catatonia, depression, delusions, hallucinations, and violent behavior.

Long-term effects have included HPA suppression, Cushingoid appearance, hirsutism or virilism, impotence, and menstrual irregularities, peptic ulcer disease, cataracts and increased intraocular pressure/glaucoma, myopathy, osteoporosis, and vertebral compression fractures.

Metabolic

Metabolic side effects have included hypernatremia (rare), hypokalemia, fluid retention, negative nitrogen balance and increased blood urea nitrogen concentration. Glucocorticoids have been reported to decrease the secretion of thyrotropin (TSH).

Cardiovascular

Cardiovascular side effects have included hypertension and congestive heart failure due to long-term fluid retention and other direct vascular effects.

Up to 12% of patients may develop systolic hypertension. Hypertension has been associated with long-term therapy with prednisone and is thought to be due to fluid retention. One author has associated these changes in blood pressure with advancing age.

Endocrine

Endocrine side effects have included glucose intolerance and hyperglycemia. Diabetes-like symptoms may develop in some individuals. Hypothalamic-pituitary-adrenal activity may be suppressed for up to 12 months following long-term therapy with prednisone. Cushingoid appearance commonly has occurred with chronic therapy. In addition, hirsutism or virilism, impotence, and menstrual irregularities may occur with chronic therapy.

Corticosteroid therapy may induce glucose intolerance by reducing the utilization of glucose in tissues and increasing hepatic glucose output. Patients on alternate day therapy may exhibit significantly higher serum glucose on the day prednisone is taken. Diabetes mellitus requiring therapy with diet modifications and hypoglycemic agents has developed in some patients.

Adrenal suppression may persist up to twelve months after long-term corticosteroid therapy. Adrenal suppression may be reduced by giving corticosteroids once a day or once every other day. After corticosteroid therapy has been tapered, supplemental corticosteroid therapy during times of stress (illness, surgery, trauma) may be required.

Gastrointestinal

Gastrointestinal adverse effects most commonly have included nausea, vomiting, dyspepsia, and anorexia. Peptic ulcer disease has been associated with long-term corticosteroid therapy, but is relatively uncommon. Routine prophylactic therapy is not warranted in all individuals. Aluminum/magnesium containing antacids generally have been used to manage GI complaints without significant drug interactions.

Gastrointestinal side effects have included gastrointestinal upset, nausea, vomiting, and peptic ulcer disease. Pancreatitis, gastrointestinal perforation and hemorrhage have also been reported.

Immunologic

Patients treated with an average of 10 mg per day over several months developed 50% fewer infections compared to those treated with an average of 20 mg per day. Significantly fewer episodes of aseptic necrosis and a trend toward fewer complications in general have been reported with lower dosages.

Immunologic side effects have included impairment of cell-mediated immunity with increased patient susceptibility to bacterial, viral, fungal and parasitic infections. In addition, the immune response to skin tests may be suppressed.

Musculoskeletal

Corticosteroid myopathy has presented as weakness and wasting of the proximal limb and girdle muscles and generally has been reversible following cessation of therapy.

Corticosteroids inhibit intestinal calcium absorption and increase urinary calcium excretion leading to bone resorption and bone loss. Bone loss of 3% over one year has been demonstrated with prednisolone 10 mg per day. Postmenopausal females are particularly at risk of loss of bone density. Sixteen percent of elderly patients treated with corticosteroids for 5 years may experience vertebral compression fractures. One author reported measurable bone loss over two years in women on concomitant therapy with prednisone 7.5 mg per day and tamoxifen.

Musculoskeletal side effects have included myopathy, osteoporosis, vertebral compression fractures, and aseptic necrosis of bone. Aseptic necrosis has been reported most often to affect the femoral head.

Ocular

In renal transplant patients maintained on prednisone 10 mg per day, 33% developed posterior subcapsular cataracts. Mean time to cataract development was 26 months. Increased intraocular pressure has occurred in 5% of patients.

Ocular side effects have included increased intraocular pressure, glaucoma, and posterior subcapsular cataracts.

Other

Other side effects have included a glucocorticoid withdrawal syndrome which has been associated with abrupt discontinuation of prednisone therapy and may not be associated with adrenal suppression.

Pseudorheumatism, or glucocorticoid-withdrawal syndrome, has occurred upon withdrawal of corticosteroids but was not related to adrenal insufficiency. Patients experienced anorexia, nausea, vomiting, lethargy, headache, fever, arthralgias, myalgias and postural hypotension. Symptoms resolved when corticosteroid therapy was reinstated.

Psychiatric

Psychiatric side effects have included psychoses, behavioral changes, and pseudotumor cerebri.

Hematologic

Hematologic side effects have included thrombocytopenia, lymphopenia, and, platelet alterations resulting in thrombolic events.

Dermatologic

Dermatologic side effects have included easy bruising, ecchymosis, petechiae striae, delayed wound healing, and acne.

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