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

Applies to methylprednisolone: oral tablet. Other dosage forms:

• injection powder for solution, injection solution, injection suspension

Serious side effects of Medrol Dosepak

Along with its needed effects, methylprednisolone (the active ingredient contained in Medrol Dosepak) 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 methylprednisolone:

Incidence not known

• Black, tarry stools
• blindness
• bloating
• bloody vomit
• blurred vision
• bone pain
• change in vision
• chest pain
• chills
• confusion
• constipation
• cough
• dark urine
• darkening of the skin
• decrease in height
• decrease in the amount of urine
• decreased range of motion
• decreased vision
• diarrhea
• difficulty in swallowing
• dilated neck veins
• dizziness or lightheadedness
• dry mouth
• extreme tiredness or weakness
• eye pain
• eye tearing
• eyeballs bulge out of the eye sockets
• fainting
• feeling of constant movement of self or surroundings
• fever
• flushed, dry skin
• fruit-like breath odor
• full or bloated feeling
• headache
• heartburn
• hives, itching, skin rash
• impaired wound healing
• increased hunger
• increased thirst
• increased urination
• indigestion
• irregular breathing
• irregular heartbeat
• joint pain
• limp
• loss of appetite
• loss of consciousness
• lower back or side pain
• mental depression
• mood changes
• muscle pain, cramps, or weakness
• nausea
• nervousness
• noisy, rattling breathing
• numbness or tingling in the hands, feet, or lips
• pain in the back, ribs, arms, or legs
• pain or burning in the throat
• pain or swelling in the arms or legs without any injury
• painful or difficult urination
• painful, swollen joints
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pounding in the ears
• pressure in the stomach
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• sensation of spinning
• severe or continuing stomach pain
• slow growth in children
• slow or fast heartbeat
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• swelling of the face, fingers, feet, abdominal or stomach area, or lower legs
• tearing
• tightness in the chest
• troubled breathing
• troubled breathing at rest
• unexplained weight loss
• unusual tiredness or weakness
• vomiting
• vomiting of material that looks like coffee grounds
• yellow eyes or skin

Other side effects of Medrol Dosepak

Some side effects of methylprednisolone 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:

Incidence not known

• Abnormal fat deposits on the face, neck, and trunk
• acne
• bruising
• dry scalp
• increased sweating
• large, flat, blue or purplish patches in the skin
• lightening of normal skin color
• menstrual changes
• reddish purple lines on the arms, face, legs, trunk, or groin
• redness of the face
• small, red or purple spots on the skin
• swelling of the stomach area
• thin, fragile skin
• thinning of the scalp hair

For Healthcare Professionals

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

General

The most commonly occurring side effects have included fluid retention, alteration in glucose tolerance, increased blood pressure, behavioral and mood changes, increased appetite, and weight gain; the incidence generally correlates with dosage, timing of administration, and duration of treatment.^[Ref]

Hypersensitivity

Frequency not reported: Allergic or hypersensitivity reactions; anaphylactoid reaction, anaphylaxis, angioedema, bronchospasm^[Ref]

A European review describes cases of allergic reactions, including bronchospasm and anaphylaxis, in patients allergic to cows milk proteins receiving injectable methylprednisolone products containing lactose of bovine origin. In most cases, the patients were younger than 12 years old and had childhood asthma. In some cases, the reaction was mistaken as lack of efficacy, and additional doses of were give with subsequent worsening of the patients condition. The European Union has recommended lactose-containing methylprednisolone products be reformulated to remove any trace of milk proteins by 2019.^[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, edema, hypotension^[Ref]

Endocrine

Frequency not reported: Cushingoid state, hirsutism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), moon face^[Ref]

Gastrointestinal

Frequency not reported: Abdominal distention, nausea, pancreatitis, peptic ulcer, perforation of the small and large intestine, ulcerative esophagitis, gastric hemorrhage, vomiting, abdominal pain, diarrhea, dyspepsia, nausea^[Ref]

Hepatic

Reversible transaminase elevations (AST, ALT) have been observed following corticosteroid therapy. These changes have generally been small and not associated with any clinical syndrome. Toxic hepatitis has been reported with high doses of cyclically pulsed IV therapy, onset has been several weeks or longer. Resolution has been reported with discontinuation; however, recurrence has been reported with rechallenge.^[Ref]

Frequency not reported: Hepatomegaly, elevation in liver enzymes, toxic hepatitis^[Ref]

Metabolic

Frequency not reported: Decreased carbohydrate and glucose tolerance, manifestations of latent diabetes, hypokalemic alkalosis, potassium loss, sodium retention, increased appetite, negative nitrogen balance due to protein catabolism, weight gain, metabolic acidosis, dyslipidemia, lipomatosis^[Ref]

Musculoskeletal

Frequency not reported: Suppression of growth in pediatric patients, aseptic necrosis of femoral and humeral heads, calcinosis, Charcot-like atrophy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare, steroid myopathy, tendon rupture, particularly of the Achilles tendon, vertebral compression fractures, myalgia, muscle atrophy, osteonecrosis, neuropathic arthralgia, growth retardation^[Ref]

Hematologic

Frequency not reported: Leucocytosis^[Ref]

Immunologic

Frequency not reported: Opportunistic infection^[Ref]

Ocular

Frequency not reported: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, blindness, chorioretinopathy^[Ref]

Blindness has been reported with corticosteroid injection to scalp, tonsillar fauces, sphenopalatine ganglion.^[Ref]

Psychiatric

Frequency not reported: Depression, emotional instability, euphoria, insomnia, mood swings, personality changes, psychic disorders, confusional states, anxiety, abnormal behavior, irritability^[Ref]

Dermatologic

Frequency not reported: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymosis, petechiae, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria, hypertrichosis, angioedema, skin atrophy, hyperhidrosis, pruritus^[Ref]

Local

Frequency not reported: Injection site infections, injection site reactions^[Ref]

Nervous system

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

Other

Frequency not reported: Vertigo, abnormal fat deposits, malaise, sterile abscess, impaired healing, fatigue^[Ref]

Oncologic

Frequency not reported: Kaposi's sarcoma^[Ref]

Respiratory

Frequency not reported: Pulmonary edema, pulmonary embolism, hiccups^[Ref]

Genitourinary

Frequency not reported: Menstrual irregularities, increased or decreased motility and number of spermatozoa, increased urine calcium, glycosuria^[Ref]