Hemril-30 cream, ointment, suppository

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of hydrocortisone rectal is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Avoid getting a vaccine during your treatment with hydrocortisone rectal. Vaccines may not work as well while you are using a steroid medicine.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• feeling short of breath, even with mild exertion;

• swelling of your ankles or feet;

• muscle weakness;

• rapid weight gain, especially in your face and midsection;

• severe rectal pain or burning;

• bleeding from your rectum;

• severe stomach pain;

• sudden and severe headache or pain behind your eyes; or

• seizure (convulsions).

Less serious side effects may include:

• mild rectal pain or burning;

• acne;

• changes in your menstrual periods;

• increased sweating; or

• increased facial or body hair growth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to hydrocortisone topical: topical application cream, topical application foam, topical application gel/jelly, topical application kit, topical application liquid, topical application lotion, topical application ointment, topical application pad, topical application paste, topical application solution, topical application spray, topical application stick

Other dosage forms:

• topical application cream, topical application lotion, topical application ointment, topical application solution
• topical application cream
• topical application cream, topical application ointment

Along with its needed effects, hydrocortisone topical (the active ingredient contained in Hemril-30) 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 while taking hydrocortisone topical:

• 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 of hydrocortisone topical 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

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 Hemril-30 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.