{
 "query": "hydroxychloroquine",
 "ingredient": "hydroxychloroquine",
 "slug": "hydroxychloroquine",
 "rxcui": "5521",
 "brands": [
  "Plaquenil",
  "Sovuna"
 ],
 "names": [
  "hydroxychloroquine",
  "hydroxychloroquine sulfate"
 ],
 "classes": [
  {
   "id": "P01BA",
   "name": "Aminoquinolines"
  }
 ],
 "alternatives": [
  "amodiaquine",
  "chloroquine",
  "primaquine",
  "tafenoquine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 50
  },
  "boxed_warning": "",
  "indications_and_usage": "Hydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. ( 1.1 ) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. ( 1.1 ) Treatment of rheumatoid arthritis in adults. ( 1.2 ) Treatment of systemic lupus erythematosus in adults. ( 1.3 ) Treatment of chronic discoid lupus erythematosus in adults. ( 1.4 ) Limitations of Use (1.1): Hydroxychloroquine sulfate Tablets is not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant ...",
  "contraindications": "Hydroxychloroquine sulfate is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds. Patients with hypersensitivity to 4-aminoquinoline compounds ( 4 )",
  "warnings_and_cautions": "Cardiomyopathy and Ventricular Arrhythmias: Fatal or life-threatening cardiomyopathy and ventricular arrhythmias were reported. ( 5.1 ) Retinal Toxicity: Irreversible retinal damage is related to cumulative dosage and treatment duration. Baseline retinal exam and exams during treatment are recommended. ( 5.2 ) Serious Skin Reactions: Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis have been reported. ( 5.3 ) Worsening of Psoriasis: Avoid in patients with psoriasis. ( 5.4 ) Risks Associated with Use in Porphyria: Avoid in patients with porphyria. Hepatotoxicity was reported in patients with porphyria cutanea tarda. ( 5.5 ) Hematologic Toxicity: Discontinue if myelosuppression occurs. ( 5.6 ) Renal Toxicity: Consider phospholipidosis as a possible cause of renal injury in patients with underlying connective tissue disorders. Discontinue hydroxychloroquine sulfate if renal toxicity is suspected or demonstrated by tissue biopsy in any organ system. ( 5.1 , 5.8 , 5.11 ) 5.1 Cardiomyopathy and Ventricular Arrhythmias Fatal and life-threatening cases of cardiotoxicity, including cardiom...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are described in greater detail in other sections: Cardiomyopathy and Ventricular Arrhythmias [see Warnings and Precautions ( 5.1 )] Retinal Toxicity [see Warnings and Precautions ( 5.2 )] Serious Skin Reactions [see Warnings and Precautions ( 5.3 )] Worsening of Psoriasis [see Warnings and Precautions ( 5.4 )] Risks Associated with Use in Porphyria [see Warnings and Precautions ( 5.5 )] Hematologic Toxicity [see Warnings and Precautions ( 5.6 )] Hemolytic Anemia Associated with G6PD [see Warnings and Precautions ( 5.7 )] Skeletal Muscle Myopathy or Neuropathy [see Warnings and Precautions ( 5.8 )] Neuropsychiatric Reactions Including Suicidality [see Warnings and Precautions ( 5.9 )] Hypoglycemia [see Warnings and Precautions ( 5.10 )] Renal Toxicity [see Warnings and Precautions ( 5.11 )] The following adverse reactions have been identified during post-approval use of 4 -aminoquinoline drugs, including hydroxychloroquine sulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: - Blood and lymphati...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "RECENT MAJOR CHANGES Warnings and Precautions, Risks Associated with Use in Porphyria ( 5.5 ) 07/2023 Warnings and Precautions, Neuropsychiatric Reactions Including Suicidality ( 5.9 ) 07/2023",
  "information_for_patients": "Important Administration Instructions Advise the patient to take hydroxychloroquine sulfate tablet with food or milk and not to crush or divide the tablet. Cardiomyopathy and Ventricular Arrhythmias Inform the patient that serious cardiac effects, life-threatening and fatal cases have been reported with use of hydroxychloroquine sulfate. Advise patients to seek medical attention immediately if they experience any symptoms of heart rhythm changes including fast or irregular heartbeat, lightheadedness, dizziness, or syncope [see Warnings and Precautions ( 5.1 )]. Retinal Toxicity Inform the patient that irreversible retinal damage has been observed in some patients with the use of hydroxychloroquine sulfate. Advise patients of the importance of the ophthalmology visits for monitoring their eyes. Instruct patients to seek medical attention promptly if they experience decreased vision or decreased dark adaptation [see Warnings and Precautions ( 5.2 )]. Serious Skin Reactions Inform the patient that severe, life-threatening skin reactions have been reported with the use of hydroxychloroquine sulfate. Advise the patient to seek medical attention immediately if experiencing any of the fol...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Hydroxychloroquine sulfate",
  "manufacturer": "Asclemed USA, Inc.",
  "application_number": "ANDA040657",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240905",
  "set_id": "19816051-c25e-44b5-a127-e846dbd0a8d8",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 138449,
  "serious": 112417,
  "death": 11052,
  "hospitalization": 35910,
  "primary_suspect": 138211,
  "top_reactions": [
   [
    "Drug Ineffective",
    41604
   ],
   [
    "Rheumatoid Arthritis",
    26403
   ],
   [
    "Off Label Use",
    22696
   ],
   [
    "Pain",
    21392
   ],
   [
    "Fatigue",
    17983
   ],
   [
    "Arthralgia",
    17925
   ],
   [
    "Drug Intolerance",
    16877
   ],
   [
    "Joint Swelling",
    15806
   ],
   [
    "Rash",
    13888
   ],
   [
    "Nausea",
    12482
   ],
   [
    "Condition Aggravated",
    12383
   ],
   [
    "Abdominal Discomfort",
    11999
   ],
   [
    "Alopecia",
    11889
   ],
   [
    "Contraindicated Product Administered",
    11817
   ],
   [
    "Systemic Lupus Erythematosus",
    11315
   ]
  ],
  "by_year": {
   "2019": 13872,
   "2020": 24176,
   "2021": 16829,
   "2022": 12879,
   "2023": 8954,
   "2024": 10349,
   "2025": 9783,
   "2026": 3832
  },
  "by_year_primary": {
   "2019": 13864,
   "2020": 24156,
   "2021": 16796,
   "2022": 12819,
   "2023": 8913,
   "2024": 10318,
   "2025": 9764,
   "2026": 3813
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 17,
  "nda": 2,
  "anda": 15,
  "first_approval": "19550418",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 18,
  "labeling_recent": 8,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ADVANZ PHARMA",
   "ALKALOIDA ZRT",
   "AMNEAL PHARMS CO",
   "APPCO",
   "AUROBINDO PHARMA USA",
   "CHARTWELL RX",
   "CREEKWOOD PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/18/1955"
 },
 "trials": {
  "total": 630,
  "completed": 246,
  "terminated": 149,
  "with_results": 112,
  "industry": 108,
  "phase3": 166,
  "results_share": 0.45528455284552843,
  "terminated_share": 0.2365079365079365
 },
 "pubmed": {
  "rct": 205,
  "meta": 133,
  "recent_rct": 90,
  "cochrane": [
   {
    "pmid": "33624299",
    "title": "Chloroquine or hydroxychloroquine for prevention and treatment of COVID-19",
    "year": "2021"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 835.4,
  "records": 46,
  "by_name": [
   [
    "Sovuna",
    835.4
   ]
  ],
  "names_checked": [
   "hydroxychloroquine",
   "Plaquenil",
   "Sovuna"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2547277,
  "beneficiaries": 628127,
  "spend": 103800444.24000001,
  "by_brand": [
   {
    "brand": "Hydroxychloroquine Sulfate",
    "claims": 2542283,
    "per_claim": 38.623054219,
    "is_generic": true
   },
   {
    "brand": "Plaquenil",
    "claims": 4964,
    "per_claim": 1125.0822039,
    "is_generic": false
   },
   {
    "brand": "Sovuna",
    "claims": 30,
    "per_claim": 826.73433333,
    "is_generic": false
   }
  ],
  "per_claim": 40.74957071413906
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20200424",
   "title": "FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems",
   "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or",
   "kind": "drug",
   "matched": "hydroxychloroquine"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "hydroxychloroquine",
  "matched": "hydroxychloroquine",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 23895,
  "fills": 2547277,
  "per_million": 9380.605250233877,
  "ratio": 3.3877845697245608,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 76,
   "letter": "B",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2020 (-8)",
    "9,381 FDA reports naming it as the suspect drug per million Medicare fills, 3.4x the median drug on this site (-11)",
    "Death share in reports is near or below the FAERS average (0.9x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 60,
   "letter": "D",
   "why": [
    "205 randomized trials and 133 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "1 independent Cochrane review(s) exist",
    "Only 46% of completed registered trials posted results (-8)",
    "24% of registered trials were terminated, withdrawn, or suspended (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 87,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "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 $835 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 (15 applications)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "In 2020 the FDA issued a safety communication about this drug (FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or ). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are rheumatoid arthritis, 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 amodiaquine, chloroquine, primaquine? 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.)"
 ]
}