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These highlights do not include all the information needed to use HYDROXYCHLOROQUINE SULFATE TABLETS safely and effectively. See full prescribing information for HYDROXYCHLOROQUINE SULFATE TABLETS.HYDROXYCHLOROQUINE SULFATE tablets, for oral use Initial U.S. Approval: 1955
Medication labelWhy this: Advisory · dailymed-prescription
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 not recommended for: Treatment of complicated malaria. Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of Plasmodium species [see Microbiology (12.4)]. 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 [see Microbiology (12.4)]. For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention 1. Hydroxychloroquine sulfate is indicated for the treatment of acute and chronic rheumatoid arthritis in adults. Hydroxychloroquine sulfate is indicated for the treatment of systemic lupus erythematosus in adults. Hydroxychloroquine sulfate is indicated for the treatment of chronic discoid lupus erythematosus in adults.
- generic_name
- hydroxychloroquine sulfate
- product_names
- Hydroxychloroquine Sulfate
- ndc
- 71335-3079, 83980-001, 71335-3079-1, 71335-3079-2, 71335-3079-3, 71335-3079-4, 71335-3079-5, 71335-3079-6, 71335-3079-7, 71335-3079-8, 71335-3079-9
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en