{
 "query": "methylprednisolone",
 "ingredient": "methylprednisolone",
 "slug": "methylprednisolone",
 "rxcui": "6902",
 "brands": [
  "Depo-Medrol",
  "Medrol",
  "HybriSil",
  "Solu-Medrol"
 ],
 "names": [
  "methylprednisolone",
  "methylprednisolone aceponate",
  "methylprednisolone acetate",
  "methylprednisolone sodium phosphate",
  "methylprednisolone sodium succinate"
 ],
 "classes": [
  {
   "id": "D07AA",
   "name": "Corticosteroids, weak (group I)"
  },
  {
   "id": "H02AB",
   "name": "Glucocorticoids"
  }
 ],
 "alternatives": [
  "betamethasone",
  "cloprednol",
  "cortisone",
  "cortivazol",
  "deflazacort",
  "dexamethasone",
  "fluocortolone",
  "hydrocortisone",
  "meprednisone",
  "paramethasone",
  "prednisolone",
  "prednisone",
  "prednylidene",
  "rimexolone",
  "triamcinolone",
  "vamorolone"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "INTRAMUSCULAR": 49,
   "ORAL": 36,
   "INTRAVENOUS": 29,
   "INTRALESIONAL": 21,
   "SOFT TISSUE": 21,
   "INTRA-ARTICULAR": 17,
   "INTRASYNOVIAL": 11,
   "INTRAVASCULAR": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "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": "CONTRAINDICATIONS Systemic fungal infections and known hypersensitivity to components.",
  "warnings_and_cautions": "",
  "warnings": "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: \u2022 Reduce resistance to new infections \u2022 Exacerbate existing infections \u2022 Increase the risk of disseminated infections \u2022 Increase the risk of reactivation or exacerbation of latent infections \u2022 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": "ADVERSE REACTIONS Fluid and Electrolyte Disturbances \u2022 Sodium retention \u2022 Congestive heart failure in susceptible patients \u2022 Hypertension \u2022 Fluid retention \u2022 Potassium loss \u2022 Hypokalemic alkalosis Musculoskeletal \u2022 Muscle weakness \u2022 Loss of muscle mass \u2022 Steroid myopathy \u2022 Osteoporosis \u2022 Tendon rupture, particularly of the Achilles tendon \u2022 Vertebral compression fractures \u2022 Aseptic necrosis of femoral and humeral heads \u2022 Pathologic fracture of long bones Gastrointestinal \u2022 Peptic ulcer with possible perforation and hemorrhage \u2022 Pancreatitis \u2022 Abdominal distention \u2022 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 \u2022 Impaired wound healing \u2022 Petechiae and ecchymoses \u2022 May suppress reactions to skin tests \u2022 Thin fragile skin \u2022 Facial erythema \u2022 Increased sweating Neurological \u2022 Increased intracranial pressure with papilledema (pseudo-tumor cerebri), usually after treatment \u2022 Convulsions \u2022 Vertigo \u2022 Headache Endocrine \u2022 Develop...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for the Patient Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Methylprednisolone",
  "manufacturer": "Mylan Pharmaceuticals Inc.",
  "application_number": "NDA011153",
  "pharm_class_epc": [
   "Corticosteroid [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260622",
  "set_id": "22dd75d6-f89a-44f7-8ca6-b64c4e9806dd",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 154859,
  "serious": 136228,
  "death": 23760,
  "hospitalization": 61751,
  "primary_suspect": 154362,
  "top_reactions": [
   [
    "Off Label Use",
    26122
   ],
   [
    "Drug Ineffective",
    18351
   ],
   [
    "Fatigue",
    10196
   ],
   [
    "Pain",
    9188
   ],
   [
    "Headache",
    8944
   ],
   [
    "Nausea",
    8883
   ],
   [
    "Pyrexia",
    7985
   ],
   [
    "Arthralgia",
    7949
   ],
   [
    "Dyspnoea",
    7819
   ],
   [
    "Pneumonia",
    7698
   ],
   [
    "Diarrhoea",
    7650
   ],
   [
    "Condition Aggravated",
    7435
   ],
   [
    "Infusion Related Reaction",
    7118
   ],
   [
    "Rash",
    6897
   ],
   [
    "Product Use In Unapproved Indication",
    6451
   ]
  ],
  "by_year": {
   "2019": 14254,
   "2020": 18081,
   "2021": 16870,
   "2022": 15576,
   "2023": 14139,
   "2024": 14853,
   "2025": 14684,
   "2026": 6011
  },
  "by_year_primary": {
   "2019": 14248,
   "2020": 18074,
   "2021": 16838,
   "2022": 15490,
   "2023": 14040,
   "2024": 14734,
   "2025": 14605,
   "2026": 5962
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260115",
   "reason": "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.",
   "firm": "Greenstone Llc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240425",
   "reason": "Presence of Particulate Matter: Potential for black particulates in the drug product.",
   "firm": "Sagent Pharmaceuticals",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240220",
   "reason": "Failed Dissolution Specifications",
   "firm": "Eugia US LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20200114",
   "reason": "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.",
   "firm": "Hikma Pharmaceuticals USA Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190506",
   "reason": "CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190506",
   "reason": "CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190506",
   "reason": "CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190506",
   "reason": "CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190506",
   "reason": "CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20141010",
   "reason": "Subpotent; 6 month stability time point",
   "firm": "American Health Packaging",
   "status": "Terminated"
  }
 ],
 "recall_total": 14,
 "drugsfda": {
  "applications": 96,
  "nda": 5,
  "anda": 69,
  "first_approval": "19571024",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 45,
  "labeling_recent": 12,
  "sponsors": [
   "ABBOTT",
   "ABRAXIS PHARM",
   "AMNEAL",
   "BEDFORD LABS",
   "BEL MAR",
   "CAPLIN",
   "CHARTWELL RX",
   "DURAMED PHARMS BARR"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/24/1957"
 },
 "trials": {
  "total": 2344,
  "completed": 1153,
  "terminated": 303,
  "with_results": 454,
  "industry": 635,
  "phase3": 587,
  "results_share": 0.39375542064180397,
  "terminated_share": 0.12926621160409557
 },
 "pubmed": {
  "rct": 687,
  "meta": 45,
  "recent_rct": 92,
  "cochrane": [
   {
    "pmid": "23450535",
    "title": "Cyclophosphamide versus methylprednisolone for treating neuropsychiatric involvement in systemic lupus erythematosus",
    "year": "2013"
   },
   {
    "pmid": "16625558",
    "title": "Cyclophosphamide versus methylprednisolone for treating neuropsychiatric involvement in systemic lupus erythematosus",
    "year": "2006"
   },
   {
    "pmid": "10908541",
    "title": "Cyclophosphamide versus methylprednisolone for the treatment of neuropsychiatric involvement in systemic lupus erythematosus",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "methylprednisolone",
   "Depo-Medrol",
   "Medrol",
   "HybriSil",
   "Solu-Medrol"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 5869265,
  "beneficiaries": 4490769,
  "spend": 42065644.58,
  "by_brand": [
   {
    "brand": "Methylprednisolone",
    "claims": 5855933,
    "per_claim": 7.1398287908,
    "is_generic": true
   },
   {
    "brand": "Methylprednisolone Acetate",
    "claims": 11520,
    "per_claim": 19.136951389,
    "is_generic": true
   },
   {
    "brand": "Depo-Medrol",
    "claims": 914,
    "per_claim": 27.500021882,
    "is_generic": false
   },
   {
    "brand": "Medrol",
    "claims": 898,
    "per_claim": 10.793819599,
    "is_generic": false
   }
  ],
  "per_claim": 7.167106031164038
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "methylprednisolone",
  "matched": "methylprednisolone",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 35301,
  "fills": 5869265,
  "per_million": 6014.552077645156,
  "ratio": 2.172142007781752,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 86,
   "letter": "B",
   "why": [
    "6,015 FDA reports naming it as the suspect drug per million Medicare fills, 2.2x the median drug on this site (-7)",
    "Death appears in 1.7x the share of reports seen across all of FAERS (-2)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 76,
   "letter": "B",
   "why": [
    "687 randomized trials and 45 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "3 independent Cochrane review(s) exist",
    "Only 39% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 86,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 10 Class II, 1 Class III across 69 generic makers (-6)",
    "12 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (69 applications)",
    "16 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 87,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, pain. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over betamethasone, cloprednol, cortisone? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}