This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
INDICATIONS AND USAGE Methylprednisolone tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Synovitis of osteoarthritis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Psoriatic arthritis Epicondylitis Acute gouty arthritis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Bullous dermatitis herpetiformis Severe erythema multiforme ...
CONTRAINDICATIONS Systemic fungal infections and known hypersensitivity to components.
WARNINGS In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Immunosuppression and Increased Risk of Infection Corticosteroids, including methylprednisolone, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: • Reduce resistance to new infections • Exacerbate existing infections • Increase the risk of disseminated infections • Increase the risk of reactivation or exacerbation of latent infections • Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal. The rate of infectious complications increases with increasing corticosteroid dosages. Monitor for the development of infection and consider methylprednisolone withdrawal or dosage reduction as needed. Tuberculosis If methylprednisolone is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur. Closely monitor such patients for reactivation. During prolo...
ADVERSE REACTIONS Fluid and Electrolyte Disturbances • Sodium retention • Congestive heart failure in susceptible patients • Hypertension • Fluid retention • Potassium loss • Hypokalemic alkalosis Musculoskeletal • Muscle weakness • Loss of muscle mass • Steroid myopathy • Osteoporosis • Tendon rupture, particularly of the Achilles tendon • Vertebral compression fractures • Aseptic necrosis of femoral and humeral heads • Pathologic fracture of long bones Gastrointestinal • Peptic ulcer with possible perforation and hemorrhage • Pancreatitis • Abdominal distention • Ulcerative esophagitis Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome, and reversible upon discontinuation. Dermatologic • Impaired wound healing • Petechiae and ecchymoses • May suppress reactions to skin tests • Thin fragile skin • Facial erythema • Increased sweating Neurological • Increased intracranial pressure with papilledema (pseudo-tumor cerebri), usually after treatment • Convulsions • Vertigo • Headache Endocrine • Develop...
Source: FDA SPL label for Methylprednisolone (Mylan Pharmaceuticals Inc.), effective 20260622. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 14,254 | 18,081 | 16,870 | 15,576 | 14,139 | 14,853 | 14,684 | 6,011 |
6,015 reports blaming this drug for every million Medicare prescriptions filled, which is 2.2× the typical drug on this site. (35,301 reports in 2024–2026, against 5,869,265 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 01/2026 | Class II | Greenstone Llc | Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil. |
| 04/2024 | Class II | Sagent Pharmaceuticals | Presence of Particulate Matter: Potential for black particulates in the drug product. |
| 02/2024 | Class II | Eugia US LLC | Failed Dissolution Specifications |
| 04/2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| 04/2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| 01/2020 | Class III | Hikma Pharmaceuticals USA Inc. | Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol. |
| 05/2019 | Class II | Zydus Pharmaceuticals USA Inc | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. |
| 05/2019 | Class II | Zydus Pharmaceuticals USA Inc | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. |
| 05/2019 | Class II | Zydus Pharmaceuticals USA Inc | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. |
| 05/2019 | Class II | Zydus Pharmaceuticals USA Inc | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. |
| 05/2019 | Class II | Zydus Pharmaceuticals USA Inc | CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. |
| 10/2014 | Class III | American Health Packaging | Subpotent; 6 month stability time point |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Methylprednisolone | 5,855,933 | $7 |
| Methylprednisolone Acetate | 11,520 | $19 |
| Depo-Medrol | 914 | $28 |
| Medrol | 898 | $11 |
1 drug in the same class grades a letter or more higher than methylprednisolone on this site. Worth asking whether one of them would do the same job for you.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.