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Hydroxychloroquine

Hyplaxy · ATC code P01BA02

Also known as: Hydroxychloroquin, Hidroksiklorokin, Idrossiclorochina, Hidroxicloroquina · Brand names: Plaquenil, Sovuna, Hydroxychloroquin Heumann, Hydroxychloroquin Ipca, Hydroxychloroquin Ratiopharm, Hydroxychloroquinsulfat Dr. Eberth, Quensyl, Hyplaxy, Kinovir, Korokin, Neuquin, Ovipla

Key facts
Active substance
Hydroxychloroquine
Drug class
Aminoquinoline
ATC code
P01BA02
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Key facts

Hydroxychloroquine is a 4-aminoquinoline antimalarial. Per the US label it is used for malaria and for rheumatoid arthritis, systemic lupus erythematosus and chronic discoid lupus erythematosus.

What it is used for

  • Treatment of uncomplicated malaria (P. falciparum, malariae, vivax, ovale) and malaria prophylaxis where chloroquine resistance is not reported (adults and children)
  • Acute and chronic rheumatoid arthritis in adults
  • Systemic lupus erythematosus and chronic discoid lupus erythematosus in adults
  • Not recommended for complicated malaria or resistant strains

Dosing

  • Take with food or milk; do not crush or divide; not recommended in children under 31 kg
  • Malaria prophylaxis: adults 400 mg once a week, from 2 weeks before travel until 4 weeks after leaving; children 31 kg or more 6.5 mg/kg (up to 400 mg) weekly
  • Malaria treatment, adults: 800 mg initially, then 400 mg at 6, 24 and 48 hours
  • Rheumatoid arthritis: initially 400 mg to 600 mg daily, chronic 200 mg to 400 mg daily
  • Lupus (systemic and discoid): 200 mg once daily, or 400 mg once daily or in two divided doses

Contraindications

  • Known hypersensitivity to 4-aminoquinoline compounds

Important warnings

  • Cardiomyopathy and ventricular arrhythmias, including fatal cases; QT prolongation, do not exceed the recommended dose
  • Irreversible retinal damage related to cumulative dosage and duration; baseline eye exam within the first year
  • Serious skin reactions, worsening of psoriasis, hematologic toxicity, hemolytic anemia with G6PD deficiency
  • Hypoglycemia, myopathy/neuropathy and neuropsychiatric reactions including suicidality

Side effects

  • Serious: cardiomyopathy, arrhythmias, retinopathy, serious skin reactions, bone marrow depression, hypoglycemia
  • Post-approval reports include anemia, agranulocytosis, leukopenia and thrombocytopenia

Interactions

  • QT-prolonging or arrhythmogenic drugs: not recommended together
  • Insulin and other antidiabetic drugs: enhanced effect, dose reduction may be needed
  • Drugs that lower the seizure threshold: caution

Pregnancy and breastfeeding

  • Decades of experience have not identified a drug-associated risk of major birth defects or miscarriage; untreated disease carries risks
  • Present in human milk at low levels; no adverse reactions reported in breastfed infants

Summary of the official product information, written with AI on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

USA

  • PlaquenilAdvanz Pharma (US) Corp. · 3 register entries
  • SovunaANI Pharmaceuticals, Inc. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Germany

  • Hydroxychloroquin HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
  • Hydroxychloroquin IpcaIpca Productos Farmaceuticos Unipessoal Lda · 1 register entry
  • Hydroxychloroquin RatiopharmRatiopharm Gmbh · 1 register entry
  • Hydroxychloroquinsulfat Dr. EberthDr. Friedrich Eberth Arzneimittel Gmbh · 1 register entry
  • QuensylSanofi-Aventis Deutschland Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Austria

  • HyplaxyMakpharm D.O.O. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • KinovirATABAY KİMYA SAN. VE TİC. A.Ş. · 1 register entry
  • KorokinKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
  • NeuquinNEUTEC İLAÇ SAN. TİC. A.Ş · 1 register entry
  • OviplaWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • PlaquenilSANOFİ SAĞLIK ÜRÜNLERİ LTD. ŞTİ. · 3 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 26 more European countries
Belgium
Plaquenil
Bulgaria
Моривид
Croatia
Hyplaxy
Czechia
Plaquenil
Denmark
Pimaxiro, Plaquenil
Estonia
Hydroxychloroquine Auxilia, Plaquenil
Finland
Oxiklorin
France
Plaquenil
Greece
Plaquenil
Hungary
Hidroxiklorokin Meditop, Plaquenil
Iceland
Plaquenil
Ireland
Plaquenil
Italy
Idrossiclorochina Aurobindo, Idrossiclorochina Doc, Plaquenil
Latvia
Plaquenil
Lithuania
Plaquenil
Luxembourg
Plaquenil
Malta
Hydroxychloroquine Sulfate Ipca Laboratories Uk, Hydroxychloroquine Sulfate Ipca Produtos Farmaceuticos Unipessoal Lda, Plaquenil
Netherlands
Hydroxychloroquine Sulfate Aurobindo, Hydroxychloroquinesulfaat Cf, Hydroxychloroquinesulfaat Doc, Hydroxychloroquinesulfaat Focus, Hydroxychloroquinesulfaat Teva, Plaquenil
Norway
Pimaxiro, Plaquenil
Poland
Autokila, Hydroquenin, Hydroxychloroquine Adamed, Hydroxychloroquine Sulfate Edest Intas Third Party Sales, Novidin
Portugal
Hidroxicloroquina Basi, Hidroxicloroquina Generis, Hidroxicloroquina Laboratorios Gebro Pharma S.A., Plaquinol
Romania
Hidroxiclorochina Atb, Plaquenil
Slovakia
Plaquenil
Slovenia
Hyplaxy
Spain
Dolquine, Duplaxil, Hidroxicloroquina Aurovitas, Hidroxicloroquina Rubió, Hidroxicloroquina Sulfato Uxa, Hidroxicloroquina Teva-Ratiopharm
Sweden
Pimaxiro, Plaquenil

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. HYDROXYCHLOROQUINE SULFATE (Dr. Reddy's Laboratories Inc.) – Prescribing Information, 2025-12-05. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=452092b4-7a8f-4d19-8113-f1c2a948d3d8
  2. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  5. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  6. Wikidata (CC0): ATC P01BA.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.