Celestone Side Effects

Generic name: betamethasone

Note: This document contains side effect information about betamethasone. Some of the dosage forms listed on this page may not apply to the brand name Celestone.

Some side effects of Celestone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to betamethasone: oral syrup, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking betamethasone (the active ingredient contained in Celestone) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• problems with your vision;

• swelling, rapid weight gain, feeling short of breath;

• severe depression, unusual thoughts or behavior, seizure (convulsions);

• bloody or tarry stools, coughing up blood;

• pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects of betamethasone may include:

• sleep problems (insomnia), mood changes;

• acne, dry skin, thinning skin, bruising or discoloration;

• slow wound healing;

• increased sweating;

• headache, dizziness, spinning sensation;

• nausea, stomach pain, bloating; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to betamethasone: compounding powder, injectable solution, injectable suspension, oral syrup, oral tablet

General

Corticosteroid complications are primarily dose and duration of therapy dependent. Adverse effects have occurred less frequently at physiologic or lower pharmacologic dosages.

Adverse effects associated with duration of corticosteroid therapy include those occurring during short-term therapy (up to three weeks) or those occurring during long-term therapy (greater than 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 axis, and mood changes including mild euphoria and insomnia, nervousness, restlessness, mania, catatonia, depression, delusions, hallucinations, and violent behavior.

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

Cardiovascular

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

Endocrine

Endocrine side effects have included decreased glucose tolerance and hyperglycemia resulting in diabetes-like symptoms. Hypothalamic-pituitary-adrenal activity has been suppressed up to 12 months following long-term corticosteroid administration. Cushingoid appearance commonly has occurred with chronic therapy. Hirsutism or virilism, impotence, and menstrual irregularities may occur.

Corticosteroid therapy may induce glucose intolerance by reducing the utilization of glucose in tissues and increasing hepatic glucose output. Diabetes mellitus requiring diet modifications and hypoglycemic agents has developed in some patients.

Adrenal suppression can persist for up to twelve months after long-term corticosteroid therapy. Giving corticosteroids once a day or once every other day may reduce adrenal suppression. After corticosteroid therapy has been tapered, supplemental corticosteroid therapy during times of physical stress may be required.

Gastrointestinal

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

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

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).

Musculoskeletal

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

Corticosteroids inhibit intestinal absorption and increase urinary excretion of calcium leading to bone resorption and bone loss. Postmenopausal females are at risk of loss of bone density. Sixteen percent of elderly patients treated with corticosteroids for 5 years may experience vertebral compression fractures.

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

Immunologic

Immunologic side effects have included impairment in cell-mediated immunity and increased susceptibility to bacterial, viral, fungal and parasitic infections. Immune response to skin tests has been suppressed. Rare cases of anaphylaxis have been reported in patients receiving parenteral corticosteroids.

Ocular

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

One study reviewing the use of intranasal steroids in 286,078 patients found no increased risk of cataracts.

Dermatologic

Dermatologic side effects have included an increased ease in bruising, ecchymosis, petechiae striae, delayed wound healing, and acne.

Psychiatric

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

Hematologic

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

Other

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

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