Caldecort

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blistering, burning, crusting, dryness, or flaking of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)
• thinning, weakness, or wasting away of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Applies to hydrocortisone topical: compounding powder, rectal cream with applicator, rectal foam, rectal ointment, rectal solution, rectal suppository, topical cream, topical gel, topical kit, topical lotion, topical ointment, topical pad, topical paste, topical solution, topical spray, topical stick

General

The most commonly reported side effects were burning, itching, irritation, dryness, and folliculitis.[Ref]

Cardiovascular

Frequency not reported: 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, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis[Ref]

Endocrine

Frequency not reported: HPA axis suppression, decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients[Ref]

Immunologic

Frequency not reported: Decreased resistance to infection, concomitant skin infections[Ref]

Ocular

Frequency not reported: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections[Ref]

Psychiatric

Frequency not reported: Depression, emotional instability, euphoria, insomnia, mood swings, personality changes, psychic disorders[Ref]

Local

Frequency not reported: Burning, itching, irritation, dryness, folliculitis[Ref]

Gastrointestinal

Frequency not reported: Abdominal distention, 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[Ref]

Musculoskeletal

Frequency not reported: Aseptic necrosis of femoral and humeral heads, Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures[Ref]

Hypersensitivity

Frequency not reported: Anaphylactoid reaction, anaphylaxis, angioedema[Ref]

Respiratory

Frequency not reported: Pulmonary edema

Dermatologic

Frequency not reported: 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, miliaria, telangiectasia[Ref]

Metabolic

Frequency not reported: Fluid retention, hypokalemic alkalosis, potassium loss, sodium retention, negative nitrogen balance due to protein catabolism, increased appetite, weight gain[Ref]

Hepatic

Frequency not reported: Elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly[Ref]

Nervous system

Frequency not reported: Convulsions, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, neuritis, neuropathy, vertigo[Ref]

Other

Frequency not reported: Abnormal fat deposits, hiccups, increased or decreased motility and number of spermatozoa, malaise[Ref]

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