{
 "query": "prednisolone",
 "ingredient": "prednisolone",
 "slug": "prednisolone",
 "rxcui": "8638",
 "brands": [
  "Pred Forte",
  "Pred Mild",
  "MILLIPRED",
  "Orapred",
  "Pediapred",
  "Veripred"
 ],
 "names": [
  "prednisolone",
  "prednisolone acetate",
  "prednisolone phosphate",
  "prednisolone sodium metasulphobenzoate",
  "prednisolone sodium phosphate",
  "prednisolone sodium succinate",
  "prednisolone tebutate"
 ],
 "classes": [
  {
   "id": "A01AC",
   "name": "Corticosteroids for local oral treatment"
  },
  {
   "id": "A07EA",
   "name": "Corticosteroids acting locally"
  },
  {
   "id": "C05AA",
   "name": "Corticosteroids"
  },
  {
   "id": "D07AA",
   "name": "Corticosteroids, weak (group I)"
  },
  {
   "id": "H02AB",
   "name": "Glucocorticoids"
  },
  {
   "id": "R01AD",
   "name": "Corticosteroids"
  },
  {
   "id": "S01BA",
   "name": "Corticosteroids, plain"
  },
  {
   "id": "S02BA",
   "name": "Corticosteroids"
  },
  {
   "id": "S03BA",
   "name": "Corticosteroids"
  }
 ],
 "alternatives": [
  "alclometasone",
  "beclomethasone",
  "betamethasone",
  "budesonide",
  "ciclesonide",
  "clobetasol",
  "clobetasone",
  "cloprednol",
  "cortisone",
  "cortivazol",
  "deflazacort",
  "desonide",
  "dexamethasone",
  "difluprednate",
  "flunisolide",
  "fluocinolone acetonide",
  "fluocinonide",
  "fluocortolone",
  "fluorometholone",
  "fluticasone",
  "fluticasone furoate",
  "hydrocortisone",
  "loteprednol",
  "medrysone",
  "meprednisone",
  "methylprednisolone",
  "mometasone",
  "paramethasone",
  "prednisone",
  "prednylidene",
  "rimexolone",
  "tixocortol",
  "triamcinolone",
  "vamorolone"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 32,
   "OPHTHALMIC": 18
  },
  "boxed_warning": "",
  "indications_and_usage": "Orapred ODT (prednisolone sodium phosphate orally disintegrating tablet) is indicated in the treatment of the following diseases or conditions: Orapred ODT is a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation ( 1 ) for the treatment of certain endocrine conditions ( 1 ) for palliation of certain neoplastic conditions ( 1 ) 1.1 Allergic Conditions Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: Atopic dermatitis Drug hypersensitivity reactions Seasonal or perennial allergic rhinitis Serum sickness 1.2 Dermatologic Diseases Bullous dermatitis herpetiformis Contact dermatitis Exfoliative erythroderma Mycosis fungoides Pemphigus Severe erythema multiforme (Stevens-Johnson syndrome) 1.3 Endocrine Conditions Congenital adrenal hyperplasia Hypercalcemia of malignancy Nonsuppurative thyroiditis Primary or secondary adrenocortical insufficiency: hydrocortisone...",
  "contraindications": "Orapred ODT is contraindicated in patients who are hypersensitive to corticosteroids such as prednisolone or any components of this product. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy. Hypersensitivity to prednisolone or any components of this product. ( 4 )",
  "warnings_and_cautions": "Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome and hyperglycemia: Monitor patients for these conditions with chronic use. Taper doses gradually for withdrawal after chronic use. ( 5.1 ) Immunosuppression and Increased Risk of Infection: Increased susceptibility to new infection and increased risk of exacerbation, dissemination, or reactivation of latent infection. Signs and symptoms of infection may be masked. ( 5.2 ) Elevated blood pressure, salt and water retention and hypokalemia: Monitor blood pressure and sodium, potassium serum levels. ( 5.3 ) GI perforation: increased risk in patients with certain GI disorders. Signs and symptoms may be masked. ( 5.4 ) Behavioral and mood disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis. Existing conditions may be aggravated. ( 5.5 ) Decrease in bone density: Monitor bone density in patients receiving long term corticosteroid therapy. ( 5.6 ) Ophthalmic effects: May include cataracts, infections and glaucoma. Monitor intraocular pressure if corticosteroid therapy is continued for more than 6 weeks. ( 5.7 ) Live or live attenuated vaccines: Do not admin...",
  "warnings": "",
  "adverse_reactions": "Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain. Allergic Reactions: Anaphylactoid reaction, anaphylaxis, angioedema Cardiovascular: 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, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scalp, edema, facial erythema, hyper or hypo-pigmentation, impaired wound healing, increased sweating, petechiae and ecchymoses, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria Endocrine: Abnormal fat deposits, decreased carbohydrate tolerance, development of Cushingoid state, hirsutism, manifestations of latent diabetes mellitus and increased requirements for insulin or oral hypoglycemic agents in diabetics, menstrual irreg...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Immunosuppression and Increased Risk of Infection ( 5.2 ) 3/2024",
  "information_for_patients": "Advise patients not to discontinue the use of Orapred abruptly or without medical supervision, to advise any healthcare provider that they are taking it, and to seek medical advice at once should they develop fever or other signs of infection. Inform patients to take Orapred exactly as prescribed, follow the instructions on the prescription label, and not stop taking Orapred without first checking with their health-care providers, as there may be a need for gradual dose reduction. Patients should discuss with their physician if they have had recent or ongoing infections or if they have recently received a vaccine. Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles. Advise patients that if they are exposed, to seek medical advice without delay. There are a number of medicines that can interact with Orapred. Patients should inform their healthcare provider of all the medicines they are taking, including over-the counter and prescription medicines (such as phenytoin, diuretics, digitalis or digoxin, rifampin, amphotericin B, cyclosporine, insulin or diabetes medicines, ketoconazole, estrogens including birth control pills and...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Orapred ODT",
  "manufacturer": "Advanz Pharma (US) Corp.",
  "application_number": "NDA021959",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250603",
  "set_id": "1e379543-c4cf-4e72-953b-db15b7f0c2a1",
  "has_boxed_warning": false,
  "boxed_labels": "0 of 32",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 172009,
  "serious": 159366,
  "death": 25166,
  "hospitalization": 76207,
  "primary_suspect": 171502,
  "top_reactions": [
   [
    "Off Label Use",
    17028
   ],
   [
    "Drug Ineffective",
    13171
   ],
   [
    "Pyrexia",
    7947
   ],
   [
    "Dyspnoea",
    6887
   ],
   [
    "Diarrhoea",
    6825
   ],
   [
    "Pneumonia",
    6623
   ],
   [
    "Condition Aggravated",
    5995
   ],
   [
    "Nausea",
    5618
   ],
   [
    "Fatigue",
    5493
   ],
   [
    "Product Use In Unapproved Indication",
    5437
   ],
   [
    "Vomiting",
    5075
   ],
   [
    "Headache",
    4864
   ],
   [
    "Rash",
    4384
   ],
   [
    "Arthralgia",
    4313
   ],
   [
    "Pain",
    4230
   ]
  ],
  "by_year": {
   "2019": 16294,
   "2020": 18067,
   "2021": 15380,
   "2022": 14745,
   "2023": 14306,
   "2024": 15604,
   "2025": 14394,
   "2026": 6485
  },
  "by_year_primary": {
   "2019": 16283,
   "2020": 18048,
   "2021": 15345,
   "2022": 14645,
   "2023": 14198,
   "2024": 15511,
   "2025": 14311,
   "2026": 6443
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260604",
   "reason": "Presence of Foreign Substance",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20260518",
   "reason": "Failed Stability Specifications",
   "firm": "AbbVie Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 114,
  "nda": 15,
  "anda": 72,
  "first_approval": "19550522",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 57,
  "labeling_recent": 8,
  "sponsors": [
   "ABBVIE",
   "ADVANZ PHARMA",
   "ALCON PHARMS LTD",
   "AMNEAL",
   "AMNEAL PHARMS",
   "AUROBINDO PHARMA LTD",
   "BARR",
   "BAUSCH"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/22/1955"
 },
 "trials": {
  "total": 2344,
  "completed": 1153,
  "terminated": 303,
  "with_results": 454,
  "industry": 635,
  "phase3": 587,
  "results_share": 0.39375542064180397,
  "terminated_share": 0.12926621160409557
 },
 "pubmed": {
  "rct": 778,
  "meta": 28,
  "recent_rct": 94,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "prednisolone",
   "Pred Forte",
   "Pred Mild",
   "MILLIPRED",
   "Orapred",
   "Pediapred",
   "Veripred"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3896538,
  "beneficiaries": 2216204,
  "spend": 159653969.33999997,
  "by_brand": [
   {
    "brand": "Prednisolone Acetate",
    "claims": 3835608,
    "per_claim": 40.421580589,
    "is_generic": true
   },
   {
    "brand": "Prednisolone Sodium Phosphate",
    "claims": 33513,
    "per_claim": 27.084510488,
    "is_generic": true
   },
   {
    "brand": "Prednisolone",
    "claims": 19699,
    "per_claim": 97.427091223,
    "is_generic": true
   },
   {
    "brand": "Pred Forte",
    "claims": 3969,
    "per_claim": 241.73703452,
    "is_generic": false
   },
   {
    "brand": "Pred Mild",
    "claims": 3319,
    "per_claim": 221.41692377,
    "is_generic": false
   },
   {
    "brand": "Prednisolone Sodium Phos ODT",
    "claims": 373,
    "per_claim": 184.94670241,
    "is_generic": false
   },
   {
    "brand": "Millipred",
    "claims": 57,
    "per_claim": 393.1545614,
    "is_generic": false
   }
  ],
  "per_claim": 40.973286886975046
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "prednisolone",
  "matched": "prednisolone",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 36265,
  "fills": 3896538,
  "per_million": 9306.979682990388,
  "ratio": 3.3611948610659974,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "9,307 FDA reports naming it as the suspect drug per million Medicare fills, 3.4x the median drug on this site (-10)",
    "Death appears in 1.6x the FAERS average share of reports (within the margin this measure deserves)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 70,
   "letter": "C",
   "why": [
    "778 randomized trials and 28 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 39% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 84,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 1 Class III across 72 generic makers (-3)",
    "8 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "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 (72 applications)",
    "34 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 85,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are pyrexia, dyspnoea. 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 alclometasone, beclomethasone, betamethasone? 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.)"
 ]
}