Side Effects of Solu-Cortef (hydrocortisone)

Solu-Cortef (hydrocortisone) injection is a corticosteroid used to treat inflammation due to a number of diseases and conditions that cause inflammation like rheumatoid arthritis, ulcerative colitis, serious skin conditions, allergies, and asthma. 

The medicine in Solu-Cortef is similar to cortisol, a natural hormone produced by our adrenal glands. Corticosteroids have potent anti-inflammatory actions and also suppress the immune response.

Common side effects of Solu-Cortef include

• headache,
• nausea,
• vomiting,
• dizziness,
• difficulty falling asleep or staying asleep,
• restlessness,
• depression,
• anxiety,
• increased sweating,
• increased hair growth,
• moon face,
• acne,
• thinning of the skin,
• easy bruising or bleeding,
• tiny purple spots on the skin,
• irregular periods,
• eye problems,
• muscle pain or weakness,
• water retention (swollen feet, ankles, or legs),
• black or tarry stool,
• high blood pressure, and
• high blood sugar.

Serious side effects of Solu-Cortef include increased susceptibility to infections, depressed ability of body's adrenal glands to produce corticosteroids (with long-term use), osteoporosis and an increased risk of bone fractures, and rarely, destruction of large joints (aseptic necrosis).

Drug interactions of Solu-Cortef include

• aspirin and salicylates,
• nonsteroidal anti-inflammatory drugs (NSAIDs),
• blood thinners, bupropion,
• diabetes medications,
• drugs that cause potassium loss,
• birth control,
• estrogens,
• mifepristone,
• natalizumab,
• antibiotics,
• azole antifungals,
• rifamycins,
• anti-seizure medications, and
• herbal products. 

Solu-Cortef can impede the effectiveness of vaccinations. 

Solu-Cortef also can interfere with the tuberculin skin test and cause false negative results in patients with tuberculosis infection. 

Solu-Cortef injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Birth defects including cleft palate, still birth, and premature abortion have been reported in some patients taking corticosteroids. 

Solu-Cortef is excreted into breast milk and should be used with caution in nursing mothers. Consult your doctor before breastfeeding. 

Side effects of corticosteroids include:

• Headache
• Nausea
• Vomiting
• Dizziness
• Difficulty falling asleep or staying asleep
• Restlessness
• Depression
• Anxiety
• Depression
• Increased sweating
• Increased hair growth
• Moon face
• Acne
• Thinning of the skin
• Easy bruising or bleeding
• Tiny purple spots on the skin
• Irregular periods
• Eye problems
• Muscle pain or weakness
• Water retention (swollen feet, ankles, or legs)
• Black or tarry stool
• High blood pressure
• High blood sugar
• Osteoporosis
• Bone fractures

Hydrocortisone side effects depend on the dose, the duration and the frequency of administration. Short courses of hydrocortisone usually are well tolerated with few and mild side effects. Long term, high doses of hydrocortisone usually will produce predictable and potentially serious side effects. Whenever possible, the lowest effective doses of hydrocortisone should be used for the shortest possible length of time to minimize side effects.

Hydrocortisone and other corticosteroids can mask signs of infection and impair the body's natural immune response to infection. Patients on corticosteroids are more susceptible to infections, and can develop more serious infections than healthy individuals.

• For instance, chickenpox and measles viruses can produce serious and even fatal illnesses in patients on high doses of hydrocortisone.
• Live virus vaccines, such as the smallpox vaccine, should be avoided in patients taking high doses of hydrocortisone, since even vaccine viruses may cause disease in these patients.

Some infectious organisms, such as tuberculosis (TB) and malaria, can remain dormant in a patient for years. Hydrocortisone and other corticosteroids can reactivate dormant infections in these patients and cause serious illness. Patients with dormant TB may require anti-TB medications while undergoing prolonged corticosteroid treatment.

Prolonged use of hydrocortisone can depress the ability of body's adrenal glands to produce corticosteroids. Abruptly stopping hydrocortisone in these individuals can cause symptoms of corticosteroid insufficiency, with accompanying nausea, vomiting, and even shock. Therefore, withdrawal of hydrocortisone is usually is gradually tapered.

Gradually tapering hydrocortisone not only minimizes the symptoms of corticosteroid insufficiency, it also reduces the risk of an abrupt flare of the disease under treatment. The insufficient adrenal gland function may not recover fully for many months after stopping hydrocortisone.

These patients need additional hydrocortisone treatment during periods of stress, such as surgery, to avoid symptoms of corticosteroid insufficiency and shock, while the adrenal gland is not responding by producing its own corticosteroid.

Hydrocortisone impairs calcium absorption and new bone formation. Patients on prolonged treatment with hydrocortisone and other corticosteroids can develop osteoporosis and an increased risk of bone fractures. Supplemental calcium and vitamin D are encouraged to slow this process of bone thinning. More aggressive treatment may be necessary if osteoporosis occurs.

In rare individuals, destruction of large joints (aseptic necrosis) can occur while undergoing treatment with hydrocortisone or other corticosteroids. These patients experience severe pain in the joints involved, and can require joint replacements. The reason behind such destruction is not clear.

The following adverse reactions have been reported with SOLU-CORTEF or other corticosteroids:

• Allergic reactions: Allergic or hypersensitivity reactions, anaphylactoid reaction, anaphylaxis, angioedema.
• Blood and lymphatic system disorders: Leukocytosis.
• 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 (see WARNINGS), pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.
• Dermatologic: Acne, allergic dermatitis, burning or tingling (especially in the perineal area, after intravenous injection), 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, 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.
• 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, 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, epidural lipomatosis.
• Ophthalmic: Central serous chorioretinopathy, exophthalmoses, 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, injection site infections following non-sterile administration, malaise, moon face, weight gain.

• Aminoglutethimide: Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.
• Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.
• Antibiotics: Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see DRUG INTERACTIONS, Hepatic Enzyme Inhibitors).
• Anticholinesterases: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.
• Anticoagulants, oral: Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.
• Antidiabetics: Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
• Antitubercular drugs: Serum concentrations of isoniazid may be decreased. Cholestyramine: Cholestyramine may increase the clearance of corticosteroids.
• Cyclosporine: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.
• Digitalis glycosides: Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
• Estrogens, including oral contraceptives: Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.
• Hepatic Enzyme Inducers (e.g., barbiturates, phenytoin, carbamazepine, rifampin): Drugs that induce cytochrome P450 3A4 enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.
• Hepatic Enzyme Inhibitors (e.g., ketoconazole, macrolide antibiotics such as erythromycin and troleandomycin): Drugs that inhibit cytochrome P450 3A4 have the potential to result in increased plasma concentrations of corticosteroids.
• Ketoconazole: Ketoconazole has been reported to significantly decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects.
• Nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.
• Skin tests: Corticosteroids may suppress reactions to skin tests.
• Vaccines: Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible.