Celestone Soluspan Side Effects

Generic Name: betamethasone

Please note - some side effects for Celestone Soluspan 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 Celestone Soluspan - for the Consumer

Celestone Soluspan

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 Celestone Soluspan:

Acne; clumsiness; dizziness; facial flushing; general body discomfort; headache; increased appetite; increased sweating; lightheadedness; nausea; nervousness; pain, swelling, or redness at the injection site; sleeplessness; upset stomach.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in body fat; changes in menstrual periods; changes in skin color; chest pain; easy bruising or bleeding; irregular heartbeat; mental or mood changes (eg, depression); muscle pain, wasting, or weakness; seizures; severe nausea or vomiting; sudden severe dizziness or headache; swelling of feet or legs; symptoms of infection (eg, chills, fever, sore throat); tendon or bone pain; thinning of the skin; unusual skin sensation; unusual weight gain; vision changes or other eye problems; vomit that looks like coffee grounds.

Celestone Soluspan Side Effects - for the Professional

Celestone Soluspan

(listed alphabetically, under each subsection)

Allergic Reactions

Anaphylactoid reaction, anaphylaxis, angioedema.

Cardiovascular

Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.

Dermatologic

Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.

Endocrine

Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients.

Fluid and Electrolyte Disturbances

Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.

Gastrointestinal

Abdominal distention, bowel/bladder dysfunction (after intrathecal administration), elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.

Metabolic

Negative nitrogen balance due to protein catabolism.

Musculoskeletal

Aseptic necrosis of femoral and humeral heads, calcinosis (following intra-articular or intralesional use), Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare (following intra-articular use), steroid myopathy, tendon rupture, vertebral compression fractures.

Neurologic/Psychiatric

Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo. Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration.

Ophthalmic

Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections.

Other

Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.

Side Effects by Body System

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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