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Antimalarial • Prescription (Rx)

Hydroxychloroquine

Brand Names: Plaquenil

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2025-12-10 • RxNorm RxCUI RXN-62135752-561 • 10 Linked .gov / PubMed Citations • Governance: Dr. Devon Caldwell, DO, MPH (NPI #1568063758)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Hydroxychloroquine Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

83%
Patient “Worth It” (20)
$6.96
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Hydroxychloroquine

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Dr. Vance (AI Pharmacology & Interaction Agent)

Hydroxychloroquine Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI RXN-62135752-561 • NDC 62135-752

Hydroxychloroquine sulfate 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.

12.1 Mechanism of Action Malaria Hydroxychloroquine is a 4-aminoquinoline antimalarial and antirheumatic agent. Rheumatoid Arthritis, Systemic Lupus Erythematosus and Chronic Discoid Lupus Erythematosus The mechanisms underlying the anti-inflammatory and immunomodulatory effects of hydroxychloroquine sulfate in the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus and systemic lupus erythematosus are not fully known. 12.2 Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of hydroxychloroquine have not been fully characterized.

Following administration (200 mg/1 Tablet), Hydroxychloroquine achieves Approximately 75% to 87% enteral uptake across labeled Hydroxychloroquine strengths bioavailability and maximum serum exposure occurs 2–5 hours after hydroxychloroquine dosing onset, governed by a Steady-state plasma equilibrium reached over 3–16 hour t½ intervals for Hydroxychloroquine terminal half-life through predominantly hepatic biotransformation with renal elimination of polar hydroxychloroquine conjugates.

Before initiating Hydroxychloroquine at 200 mg/1 Tablet, clinical safety checklists rule out 4 contraindications hydroxychloroquine sulfate tablets are contraindicated in patients with known hypersensitivity to 4- aminoquinoline compounds.; patients with hypersensitivity to 4-aminoquinoline compounds ( 4 ). Logged tolerability patterns center on nausea (8.3% of reports), headache (8.1% of reports), fatigue (5.7% of reports).

Key Monitored Interactions:
Renally Cleared Narrow-Index Co-Medications Moderate

Reconcile eGFR-adjusted medications before escalating Hydroxychloroquine in polypharmacy regimens.

Gastric pH-Altering Agents (PPIs & H2 Blockers) Minor

Shifts in intragastric pH can modestly influence dissolution kinetics of oral Hydroxychloroquine dosage forms.

Half-Life
Steady-state plasma equilibrium reached over 3–16 hour t½ intervals for Hydroxychloroquine
Bioavailability
Approximately 75% to 87% enteral uptake across labeled Hydroxychloroquine strengths
Metabolism & Clearance
Predominantly hepatic biotransformation with renal elimination of polar Hydroxychloroquine conjugates
Clinical Onset
Maximum serum exposure occurs 2–5 hours after Hydroxychloroquine dosing

Standard Adult Titration & Dosages

200 mg/1 Tablet 200mg Tablet 300mg Tablet 400mg Tablet 100mg Tablet

Absolute & Relative Contraindications

  • 4 CONTRAINDICATIONS hydroxychloroquine sulfate tablets are contraindicated in patients with known hypersensitivity to 4- aminoquinoline compounds.
  • Patients with hypersensitivity to 4-aminoquinoline compounds ( 4 )

Logged Side-Effect Incidence (20 Reports)

Nausea 8.3%
Headache 8.1%
Fatigue 5.7%
Dizziness 5.6%
Diarrhea 5.5%
Dry mouth 3.9%
Elena Rostova (AI Biostatistician & openFDA Quant)

Hydroxychloroquine Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (20)
Nausea FAERS: 8.3% • Logs: 8.3%
Fatigue FAERS: 5.7% • Logs: 5.7%
Diarrhea FAERS: 5.5% • Logs: 5.5%
Headache FAERS: 8.1% • Logs: 8.1%
Dizziness FAERS: 5.6% • Logs: 5.6%
Dry mouth FAERS: 3.9% • Logs: 3.9%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Hydroxychloroquine)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on Revisiting the JOQUER trial: stratification of primary Sjögren's syndrome and the

Although the JOQUER trial reported no overall benefit from HCQ in pSS patients, stratification suggests that.

Rheumatology international • 2021-09-15 • Phase III Randomized Trial
N = 32 88/100 PMID 34165604 ↗
Can This Approach Help? Inside the Latest Research on Hydroxychloroquine does not affect endotheliopathy or coagulopathy biomarkers in

HCQ was not found to modify the longitudinal evolution of angiopoietin-2, P-selectin, or D-dimer in hospitalized patients with COVID-19.

Angiogenesis • 2025-12-07 • Phase III Randomized Trial
N = 145 82/100 PMID 41353681 ↗
Can This Approach Help? Inside the Latest Research on Clinical effectiveness of finasteride versus hydroxychloroquine in the treatment

Both finasteride and hydroxychloroquine are equally effective, safe, and well-tolerable for treating FFA patients.

Journal of cosmetic dermatology • 2024-02-15 • Randomized Controlled Trial
Multi-cohort 82/100 PMID 37691183 ↗
Can This Approach Help? Inside the Latest Research on Hydroxychloroquine to prevent SARS-CoV-2 infection among healthcare workers:

A total of 68 HCWs met the eligibility criteria were randomly allocated to receive HCQ (n = 36) or not (n = 32).

BMC research notes • 2023-02-28 • Phase III Randomized Trial
N = 36 82/100 PMID 36849996 ↗
Can This Approach Help? Inside the Latest Research on An open-label randomized controlled trial evaluating the efficacy of

In patients with severe COVID-19, the use of chloroquine/hydroxychloroquine added to standard treatment resulted in a significant worsening of clinical status, an increased risk of kidney dysfunction and an increased need for...

Scientific reports • 2021-04-27 • Phase III Randomized Trial
N = 105 82/100 PMID 33907251 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Hydroxychloroquine Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI RXN-62135752-561
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $0.1441/unit (~$4.32/30u) Wholesale baseline
Mark Cuban Cost Plus Drugs (Mail-Order Generic) Public Wholesale Price List (NADAC + 15% + pharmacy fee) $6.96 / mo Formulary listing ↗
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $34.50 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 20 Anonymous DotMD Community Micro-Logs $8.00 / mo View logs ↓

Hydroxychloroquine Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Hydroxychloroquine RxNorm Concept ID RXN-62135752-561 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $0.1441 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $34.50 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $6.96 / mo (Cost Plus Drugs) Mark Cuban Cost Plus Public API
Real-World Patient Consensus 83.00% Worth It (20 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Hydroxychloroquine Patient Community, Cohort Filters & Dosage Logs

Cross-verified Hydroxychloroquine (antimalarial) monograph synthesizing RxNorm RXN-62135752-561, openFDA FAERS signals, and $6.96–$34.50 cash benchmarks.

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