Cortef Side Effects

Generic Name: hydrocortisone,hydrocortisone buteprate

Please note - some side effects for Cortef may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Cortef - for the Consumer

Cortef

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 Cortef:

Difficulty sleeping; dizziness or lightheadedness; headache; increased appetite; increased sweating; indigestion; nervousness.

Seek medical attention right away if any of these SEVERE side effects occur when using Cortef:

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 menstrual periods; chest pain; eye pain or increased pressure in the eye; fever, chills, or sore throat; joint or bone pain; mood or mental changes (eg, depression); muscle pain or weakness; seizures; severe or persistent nausea or vomiting; stomach pain or bloating; swelling of feet or legs; unusual weight gain or loss; vision changes; vomiting material that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Cortef Side Effects - for the Professional

Cortef

Fluid and Electrolyte Disturbances

Sodium retention
Fluid retention
Congestive heart failure in susceptible patients
Potassium loss
Hypokalemic alkalosis
Hypertension

Musculoskeletal

Muscle weakness
Steroid myopathy
Loss of muscle mass
Osteoporosis
Tendon rupture, particularly of the Achilles tendon
Vertebral compression fractures
Aseptic necrosis of femoral and humeral heads
Pathologic fracture of long bones

Gastrointestinal

Peptic ulcer with possible perforation and hemorrhage
Pancreatitis
Abdominal distention
Ulcerative esophagitis
Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT) and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.

Dermatologic

Impaired wound healing
Thin fragile skin
Petechiae and ecchymoses
Facial erythema
Increased sweating
May suppress reactions to skin tests

Neurological

Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment
Convulsions
Vertigo
Headache

Endocrine

Development of Cushingoid state
Suppression of growth in children
Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness
Menstrual irregularities
Decreased carbohydrate tolerance
Manifestations of latent diabetes mellitus
Increased requirements for insulin or oral hypoglycemic agents in diabetics

Ophthalmic

Posterior subcapsular cataracts
Increased intraocular pressure
Glaucoma
Exophthalmos

Metabolic

Negative nitrogen balance due to protein catabolism

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Side Effects by Body System - for Healthcare Professionals

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 hypothalamus-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 hypothalamus-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 effects such as hypertension and congestive heart failure due to long-term fluid retention as well as direct vascular effects have occurred during corticosteroid therapy.

Endocrine

Endocrine effects such as decreased glucose tolerance and hyperglycemia resulting in diabetes-like symptoms have occurred. Hypothalamus-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 effects of corticosteroid therapy have included gastrointestinal upset, nausea, vomiting, and peptic ulcer disease. Pancreatitis, ulcerative esophagitis, gastrointestinal perforation and hemorrhage have also been reported.

Gastrointestinal effects most commonly occurring during corticosteroid therapy 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.

Metabolic

Metabolic adverse effects including hypernatremia (rare), hypokalemia, fluid retention, negative nitrogen balance and increased blood urea nitrogen concentration have occurred during corticosteroid therapy. Glucocorticoids have been reported to decrease the secretion of thyrotropin (TSH).

Musculoskeletal

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

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 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.

Immunologic

Immunologic effects of corticosteroid therapy have included impairment in cell-mediated immunity and increased susceptibility to bacterial, viral, fungal and parasitic infections. Immune response to skin tests may be suppressed.

Hepatic

Hepatic effects such as reversible increases in serum transaminase and alkaline phosphatase concentrations have occurred during corticosteroid therapy.

Hematologic

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

Dermatologic

Dermatologic effects occurring during corticosteroid therapy have included increased ease in bruising, ecchymosis, petechiae striae, delayed wound healing, and acne.

Ocular

Ocular changes with corticosteroid therapy have included increased intraocular pressure, glaucoma, and posterior subcapsular cataracts.

Psychiatric

Psychiatric effects including psychoses, personality or behavioral changes, and pseudotumor cerebri have occurred/been exacerbated during corticosteroid therapy.

Hypersensitivity

Bronchospasm after intravenous hydrocortisone has been reported in some patients with aspirin-sensitive respiratory disease. A challenge study with oral aspirin followed with 100 mg hydrocortisone (IV) resulted in respiratory reactions to aspirin in 45 of 53 patients. These 45 patients then received a hydrocortisone challenge. No naso-ocular, dermal, or respiratory reactions were noted in 44 of 45 patients administered hydrocortisone. One aspirin-sensitive patient experienced bronchospasm and naso-ocular reactions to hydrocortisone and naso-ocular with minimal bronchospasm with methylprednisolone. Following aspirin desensitization and while on maintenance aspirin therapy, this patient again reacted with similar symptoms to hydrocortisone.

Case reports of hypersensitivity reactions to corticosteroids have been relatively uncommon. Side effects have included bronchospasm, shock, urticaria, and angioedema. Cross-reactivity between aspirin and hydrocortisone in patients with aspirin-sensitive respiratory disease has been suggested as the mechanism in patients with asthma, however data are controversial. Anaphylaxis has been most frequently associated with rapid injection or infusion of a high dose of corticosteroid. Reactions may be mediated by an immune or nonimmune mechanism.

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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