{
 "query": "prednisone",
 "ingredient": "prednisone",
 "slug": "prednisone",
 "rxcui": "8640",
 "brands": [
  "Rayos",
  "Deltasone"
 ],
 "names": [
  "prednisone"
 ],
 "classes": [
  {
   "id": "A07EA",
   "name": "Corticosteroids acting locally"
  },
  {
   "id": "H02AB",
   "name": "Glucocorticoids"
  }
 ],
 "alternatives": [
  "beclomethasone",
  "betamethasone",
  "budesonide",
  "cloprednol",
  "cortisone",
  "cortivazol",
  "deflazacort",
  "dexamethasone",
  "fluocortolone",
  "hydrocortisone",
  "meprednisone",
  "methylprednisolone",
  "paramethasone",
  "prednisolone",
  "prednylidene",
  "rimexolone",
  "tixocortol",
  "triamcinolone",
  "vamorolone"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 240
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE PredniSONE 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 Hypercalcemia associated with cancer Nonsuppurative thyroiditis 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 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 Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme ...",
  "contraindications": "CONTRAINDICATIONS Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation. Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insu...",
  "adverse_reactions": "ADVERSE REACTIONS (listed alphabetically, under each subsection) The following adverse reactions have been reported with prednisone or other corticosteroids: Allergic Reactions anaphylactoid or hypersensitivity reactions, anaphylaxis, angioedema. Cardiovascular System bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, ECG changes caused by potassium deficiency, edema, fat embolism, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal ), necrotizing angiitis, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic acne, acneiform eruptions, allergic dermatitis, alopecia, angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin, ecchymoses and petechiae (bruising), erythema, facial edema, hirsutism, impaired wound healing, increased sweating, Karposi\u2019s sarcoma (see PRECAUTIONS: General Precautions ), lupus erythematosus-like lesions, perineal irritation, purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions t...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise. Persons who are on 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": "Prednisone",
  "manufacturer": "Par Health USA, LLC",
  "application_number": "ANDA040584",
  "pharm_class_epc": [
   "Corticosteroid [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260731",
  "set_id": "10fe5a3b-84dc-4600-87c2-b80c97ce18cf",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 445214,
  "serious": 356271,
  "death": 44612,
  "hospitalization": 153705,
  "primary_suspect": 444019,
  "top_reactions": [
   [
    "Drug Ineffective",
    63705
   ],
   [
    "Off Label Use",
    55461
   ],
   [
    "Fatigue",
    38197
   ],
   [
    "Pain",
    35061
   ],
   [
    "Dyspnoea",
    31697
   ],
   [
    "Arthralgia",
    30600
   ],
   [
    "Condition Aggravated",
    28044
   ],
   [
    "Diarrhoea",
    26198
   ],
   [
    "Nausea",
    25566
   ],
   [
    "Headache",
    24189
   ],
   [
    "Rheumatoid Arthritis",
    24137
   ],
   [
    "Pneumonia",
    22584
   ],
   [
    "Rash",
    21491
   ],
   [
    "Malaise",
    19782
   ],
   [
    "Pyrexia",
    19156
   ]
  ],
  "by_year": {
   "2019": 42438,
   "2020": 49178,
   "2021": 43771,
   "2022": 40555,
   "2023": 39177,
   "2024": 40854,
   "2025": 38345,
   "2026": 16179
  },
  "by_year_primary": {
   "2019": 42418,
   "2020": 49148,
   "2021": 43704,
   "2022": 40307,
   "2023": 38968,
   "2024": 40608,
   "2025": 38076,
   "2026": 16115
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220719",
   "reason": "Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets",
   "firm": "Strides Pharma Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20200304",
   "reason": "Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg",
   "firm": "Par Pharmaceutical Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20161003",
   "reason": "Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.",
   "firm": "West-Ward Pharmaceutical",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20130614",
   "reason": "Labeling: Missing Label; missing label on blister card",
   "firm": "Boehringer Ingelheim Roxane Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 4,
 "drugsfda": {
  "applications": 123,
  "nda": 5,
  "anda": 73,
  "first_approval": "19550221",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 26,
  "labeling_recent": 1,
  "sponsors": [
   "ACTAVIS LABS FL INC",
   "AIPING PHARM INC",
   "AM THERAP",
   "AMNEAL",
   "AMNEAL PHARMS NY",
   "AUROBINDO PHARMA LTD",
   "BAYER PHARMS",
   "BUNDY"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/21/1955"
 },
 "trials": {
  "total": 2504,
  "completed": 1148,
  "terminated": 367,
  "with_results": 686,
  "industry": 949,
  "phase3": 629,
  "results_share": 0.5975609756097561,
  "terminated_share": 0.14656549520766773
 },
 "pubmed": {
  "rct": 843,
  "meta": 32,
  "recent_rct": 74,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "prednisone",
   "Rayos",
   "Deltasone"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 15814810,
  "beneficiaries": 7659993,
  "spend": 81469404.69,
  "by_brand": [
   {
    "brand": "Prednisone",
    "claims": 15810812,
    "per_claim": 4.1244271192,
    "is_generic": true
   },
   {
    "brand": "Rayos",
    "claims": 3238,
    "per_claim": 4967.0512971,
    "is_generic": false
   },
   {
    "brand": "Prednisone Intensol",
    "claims": 760,
    "per_claim": 230.98789474,
    "is_generic": false
   }
  ],
  "per_claim": 5.151462754848145
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "prednisone",
  "matched": "prednisone",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 94799,
  "fills": 15814810,
  "per_million": 5994.31798421859,
  "ratio": 2.1648345102734035,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 88,
   "letter": "A",
   "why": [
    "5,994 FDA reports naming it as the suspect drug per million Medicare fills, 2.2x the median drug on this site (-7)",
    "Death share in reports is near or below the FAERS average (1.1x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 74,
   "letter": "C",
   "why": [
    "843 randomized trials and 32 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)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 97,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 1 Class III across 73 generic makers (-3)"
   ],
   "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 (73 applications)",
    "19 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 89,
 "grade": "A",
 "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 beclomethasone, betamethasone, budesonide? 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.)"
 ]
}