FDA label
What is hydroxychloroquine used for?
The FDA-approved uses of hydroxychloroquine, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for hydroxychloroquine sulfate (tablet, film coated) lists 4 uses: Malaria; Rheumatoid Arthritis; Systemic Lupus Erythematosus; Chronic Discoid Lupus Erythematosus.
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Hydroxychloroquine Sulfate, tablet, film coated
Indications and Usage, quoted from the label by Dr. Reddy's Laboratories Inc. (ANDA210441). Cross-references to other label sections are left out.
Malaria
Hydroxychloroquine sulfate tablets are indicated in adult and pediatric patients for the:
- Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium vivax, and Plasmodium ovale.
- Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use:
Hydroxychloroquine sulfate tablets are not recommended for:
- Treatment of complicated malaria.
- Treatment of malaria by 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 therapy with an 8-aminoquinoline drug is necessary.
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention1.
Rheumatoid Arthritis
Hydroxychloroquine sulfate tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
Systemic Lupus Erythematosus
Hydroxychloroquine sulfate tablets are indicated for the treatment of systemic lupus erythematosus in adults.
Chronic Discoid Lupus Erythematosus
Hydroxychloroquine sulfate tablets are indicated for the treatment of chronic discoid lupus erythematosus in adults.
Source: DailyMed label, set id 452092b4-7a8f-4d19-8113-f1c2a948d3d8, version 17, effective December 5, 2025. NDC 43598-131, one of 37 listings for this product.
Hydroxychloroquine Sulfate, tablet
Indications and Usage, quoted from the label by Accord Healthcare, Inc., (ANDA213342). Cross-references to other label sections are left out.
Malaria
Hydroxychloroquine sulfate is indicated in adult and pediatric patients for the:
- Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium vivax,and Plasmodium ovale.
- Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use:
Hydroxychloroquine sulfate is notrecommended for:
- Treatment of complicated malaria.
- Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of Plasmodiumspecies [see Microbiology].
- Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodiumspecies has not been identified.
- Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
- Prevention of relapses of P. vivaxor P. ovalebecause it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivaxand P. ovaleinfections, concomitant therapy with an 8-aminoquinoline drug is necessary [see Microbiology].
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention 1.
Rheumatoid Arthritis
Hydroxychloroquine sulfate is indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
Systemic Lupus Erythematosus
Hydroxychloroquine sulfate is indicated for the treatment of systemic lupus erythematosus in adults.
Chronic Discoid Lupus Erythematosus
Hydroxychloroquine sulfate is indicated for the treatment of chronic discoid lupus erythematosus in adults.
Source: DailyMed label, set id 84b00366-96ef-41e1-bac6-5d24acdb9e1d, version 10, effective April 1, 2026. NDC 16729-485, one of 16 listings for this product.
Questions
What is hydroxychloroquine used for?
The FDA label for hydroxychloroquine sulfate (tablet, film coated) lists 4 uses: Malaria; Rheumatoid Arthritis; Systemic Lupus Erythematosus; Chronic Discoid Lupus Erythematosus.
What drug class is hydroxychloroquine?
FDA lists hydroxychloroquine in the Antimalarial and Antirheumatic Agent established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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