Depo-Medrol Side Effects

Generic Name: methylprednisolone

Please note - some side effects for Depo-Medrol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Depo-Medrol - for the Consumer

Depo-Medrol Suspension

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 Depo-Medrol Suspension:

Dizziness; facial flushing; feeling of whirling motion; headache; increased sweating; pain, swelling, or redness at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, or tarry stools; changes in body fat; changes in menstrual period; chest pain; fainting; fever, chills, or sore throat; increased hunger, thirst, or urination; mental or mood changes; muscle pain, weakness, or wasting; seizures; severe nausea or vomiting; slow wound healing; stomach pain; sudden, severe dizziness or headache; swelling of the feet or legs; tendon, bone, or joint pain; thinning or discoloration of the skin; unusual bruising or bleeding; unusual skin sensation; unusual weight gain; vision changes or other eye problems; vomit that looks like coffee grounds.

Depo-Medrol Side Effects - for the Professional

Depo-Medrol

The following adverse reactions have been reported with Depo-Medrol or other corticosteroids:

Allergic reactions: Allergic or hypersensitivity reactions, anaphylactoid reaction, anaphylaxis, angioedema

Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopthy in premature infants, myocardial rupture following recent mycocardial infarction, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.

Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increase 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 enzymes levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible subsequent 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, calcinosis (following intra-articular or intra-lesional use), 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.

Ophthalmic: Exophthalmoses, glaucoma, increased intraocular pressure, posterior subcapsular cataracts.

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.

The following adverse reactions have been reported with the following routes of administration:

Intrathecal/Epidural: Arachnoiditis, bowel/bladder dysfunction, headache, meningitis, parapareisis/paraplegia, seizures, sensory disturbances.

Intranasal: Allergic reactions, rhinitis, temporary/permanent visual impairment including blindness.

Ophthalmic: Increased intraocular pressure, infection, ocular and periocular inflammation including allergic reactions, residue or slough at injection site, temporary/permanent visual impairment including blindness.

Miscellaneous injection sites: (scalp, tonsillar fauces, sphenopalatine ganglion): Blindness

Side Effects by Body System

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 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. 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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