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Duralone 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 Duralone.

For the Consumer

Applies to methylprednisolone: oral tablet

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

More common
  • Aggression
  • agitation
  • anxiety
  • blurred vision
  • decrease in the amount of urine
  • dizziness
  • fast, slow, pounding, or irregular heartbeat or pulse
  • headache
  • irritability
  • mental depression
  • mood changes
  • nervousness
  • noisy, rattling breathing
  • numbness or tingling in the arms or legs
  • pounding in the ears
  • shortness of breath
  • swelling of the fingers, hands, feet, or lower legs
  • trouble thinking, speaking, or walking
  • troubled breathing at rest
  • weight gain
Incidence not known
  • Abdominal cramping and/or burning (severe)
  • abdominal pain
  • backache
  • bloody, black, or tarry stools
  • cough or hoarseness
  • darkening of skin
  • decrease in height
  • decreased vision
  • diarrhea
  • dry mouth
  • eye pain
  • eye tearing
  • facial hair growth in females
  • fainting
  • fatigue
  • fever or chills
  • flushed, dry skin
  • fractures
  • fruit-like breath odor
  • full or round face, neck, or trunk
  • heartburn and/or indigestion (severe and continuous)
  • increased hunger
  • increased thirst
  • increased urination
  • loss of appetite
  • loss of sexual desire or ability
  • lower back or side pain
  • menstrual irregularities
  • muscle pain or tenderness
  • muscle wasting or weakness
  • nausea
  • pain in back, ribs, arms, or legs
  • painful or difficult urination
  • skin rash
  • sleeplessness
  • sweating
  • trouble healing
  • trouble sleeping
  • unexplained weight loss
  • unusual tiredness or weakness
  • vision changes
  • vomiting
  • vomiting of material that looks like coffee grounds

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:

More common
  • Increased appetite
Incidence not known
  • Abnormal fat deposits on the face, neck, and trunk
  • acne
  • dry scalp
  • lightening of normal skin color
  • red face
  • reddish purple lines on the arms, face, legs, trunk, or groin
  • swelling of the stomach area
  • 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]

References

1. "Product Information. Solu-Medrol (methylprednisolone)." Pharmacia & Upjohn, Kalamazoo, MI.

2. "Product Information. Solu-Medrol (methylPREDNISolone sodium succinate)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

3. "Product Information. Medrol (methylprednisolone)." Pharmacia and Upjohn, Kalamazoo, MI.

4. "Product Information. Depo-Medrol (methylPREDNISolone acetate)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

6. Cerner Multum, Inc. "Australian Product Information." O 0

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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