MethylPREDNISolone Dose Pack Side Effects

Generic name: methylprednisolone

Note: This document contains side effect information about methylprednisolone. Some of the dosage forms listed on this page may not apply to the brand name MethylPREDNISolone Dose Pack.

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

For the Consumer

Applies to methylprednisolone: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking methylprednisolone (the active ingredient contained in MethylPREDNISolone Dose Pack) 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:

• problems with your vision;

• swelling, rapid weight gain, feeling short of breath;

• severe depression, unusual thoughts or behavior, seizure (convulsions);

• bloody or tarry stools, coughing up blood;

• pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects of methylprednisolone may include:

• sleep problems (insomnia), mood changes;

• acne, dry skin, thinning skin, bruising or discoloration;

• slow wound healing;

• increased sweating;

• headache, dizziness, spinning sensation;

• nausea, stomach pain, bloating; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to methylprednisolone: compounding powder, injectable powder for injection, injectable suspension, oral tablet

General

Adverse effects have occurred less frequently when minimum dosages have been administered.

Adverse effects of corticosteroid therapy may be subdivided into those associated with short-term therapy (to three weeks) and those of long-term therapy (> 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 (HPA) axis, and mood changes ranging from mild euphoria and insomnia to nervousness, restlessness, mania, catatonia, depression, delusions, hallucinations, and violent behavior.

Long-term effects have included HPA suppression, Cushingoid appearance, hirsutism or virilism, impotence, and 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. Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, fat embolism, myocardial rupture following recent myocardial infarction, syncope, tachycardia, thromboembolism, thrombophlebitis, and vasculitis have also been reported.

Hypertension has been associated with long-term therapy with corticosteroids and is thought to be due to fluid retention.

Endocrine

Corticosteroid therapy may induce glucose intolerance by reducing the utilization of glucose in tissues and increasing hepatic glucose output. Patients on alternate day therapy may exhibit significantly higher serum glucose on the day methylprednisolone (the active ingredient contained in MethylPREDNISolone Dose Pack) is taken. 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. Adrenal suppression may be reduced by giving corticosteroids once a day or once every other day. After corticosteroid therapy has been tapered, supplemental corticosteroid therapy during times of physical stress may be required.

Endocrine side effects have included decreased glucose tolerance and hyperglycemia resulting in diabetes-like symptoms. Hypothalamic-pituitary-adrenal activity has been suppressed 12 months or more following long-term corticosteroid administration. Cushingoid appearance commonly has occurred with chronic therapy. Hirsutism or virilism, impotence, and menstrual irregularities may occur. Glycosuria, hirsutism, and hypertrichosis have also been reported.

Gastrointestinal

Gastrointestinal side effects have included gastrointestinal upset, nausea, vomiting, and peptic ulcer disease. Pancreatitis, ulcerative esophagitis, gastrointestinal perforation and hemorrhage have also been reported. Additionally, abdominal distention, bowel/bladder dysfunction (after intrathecal administration), increased appetite, and perforation of the small and large intestine (particularly in patients with inflammatory bowel disease) have 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 side effects have included hypernatremia (rare), hypokalemia, fluid retention, negative nitrogen balance and increase in blood urea nitrogen concentration.

Musculoskeletal

Musculoskeletal side effects have included myopathy, osteoporosis, vertebral compression fractures, tendon rupture (particularly the Achilles tendon), and aseptic necrosis of bone have occurred during corticosteroid therapy. Aseptic necrosis most often has affected the femoral head. Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, and vertebral compression fractures has also been reported.

Corticosteroid myopathy presenting as weakness and wasting of the proximal limb and girdle muscles has occurred, but has generally resolved following cessation of therapy.

Corticosteroids inhibit intestinal absorption and increase urinary excretion of calcium leading to bone resorption and bone loss. Bone loss of 3% over one year has been demonstrated with prednisolone 10 mg per day. Postmenopausal females are at risk of loss of bone density. Up to 16% of elderly patients treated with corticosteroids for 5 years may experience vertebral compression fractures. One author reported measurable bone loss over two years in women on concomitant therapy with prednisone 7.5 mg per day and tamoxifen.

Hematologic

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

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 may be suppressed.

Hepatic

Hepatic side effects have included reversible increases in serum transaminase and alkaline phosphatase concentrations. Hepatomegaly has also bee reported.

Ocular

In renal transplant patients maintained on prednisone 10 mg per day, 33% developed posterior subcapsular cataracts. Mean time to cataract development was 26 months. Increased intraocular pressure has occurred in 5% of patients.

Ocular side effects have included increased intraocular pressure, glaucoma, and posterior subcapsular cataracts.

Psychiatric

Psychiatric side effects have included psychoses, personality or behavioral changes, depression, emotional instability, euphoria, mood swings, and psychic disorders.

Dermatologic

Dermatologic side effects have included bruising, ecchymosis, petechiae striae, delayed wound healing, and acne. Allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, erythema, hyperpigmentation, hypopigmentation, increase sweating, rash, sterile abscess, striae, thin fragile skin, and thinning scalp hair, and urticaria have also been reported.

Other

Other side effects have included a glucocorticoid withdrawal syndrome seen upon abrupt discontinuation of corticosteroid therapy that was not associated with adrenal suppression.

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.

Oncologic

Oncologic side effects have included Kaposi's sarcoma. Clinical remission may occur with discontinuation of therapy.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis with or without circulatory collapse, cardiac arrest, or bronchospasm with parenteral administration of methylprednisolone (the active ingredient contained in MethylPREDNISolone Dose Pack) Anaphylactoid reactions and angioedema have also been reported.

Local

Local side effects have included hyperpigmentation, hypopigmentation, subcutaneous and cutaneous atrophy, and sterile abscess at injection sites following parenteral administration.

Respiratory

Respiratory side effects have included pulmonary edema.

Nervous system

Nervous system side effects have included convulsions, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, neuritis, neuropathy, paresthesia, and vertigo.

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