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U.S. Department of Health and Human Services


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Aralen (Chloroquine Phosphate) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)


November 2013

Summary View


  • Retinopathy/maculopathy, as well as macular degeneration have been reported and irreversible retinal damage has been observed in some patients who had received long-term or high-dosage 4-aminoquinoline therapy. Retinopathy has been reported to be dose related. Risk factors for the development of retinopathy include age, duration of treatment, high daily and/or cumulated doses.


Special Senses – Ocular
  • Maculopathy and macular degeneration have been reported and may be irreversible…