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Chloroquine Pregnancy and Breastfeeding Warnings

Chloroquine is also known as: Aralen, Aralen Hydrochloride, Aralen Phosphate

Medically reviewed by Last updated on Dec 5, 2017.

Chloroquine Pregnancy Warnings

Chloroquine has not been formally assigned to a pregnancy category by the FDA. There are no controlled data in human pregnancies. Congenital anomalies were reported in the offspring of one woman being treated with chloroquine 250 to 500 mg daily during pregnancy for SLE; however, chloroquine has been used in the prophylaxis and treatment of malaria during pregnancy without evidence of fetal harm. Chloroquine is the drug of choice for the prophylaxis and treatment of sensitive malaria species during pregnancy. Chloroquine should only be given during pregnancy when need has been clearly established.

See references

Chloroquine Breastfeeding Warnings

Chloroquine is excreted into human milk. Chloroquine is considered compatible with breast-feeding by the American Academy of Pediatrics. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

The excretion of chloroquine and the major metabolite, desethylchloroquine, in breast milk was investigated in 11 lactating mothers after a single oral dose of chloroquine (600 mg base). The maximum daily dose of the drug that the infant can receive from breastfeeding was about 0.7% of the maternal start dose of the drug in malaria chemotherapy; therefore, separate chemoprophylaxis is required for the infant.

See references

References for pregnancy information

  1. CDC. Centers for Disease Control and Prevention "Treatment of malaria (guidelines for clinicians). Available from: URL: Malaria _ CDC_2004clinicalguidance.pdf." ([2004 Jun 16]):
  2. "Product Information. Aralen (chloroquine)." Sanofi Winthrop Pharmaceuticals, New York, NY.
  3. Arguin PM, Mali S, CDC. Centers for Disease Control and Prevention "Infectious diseases related to travel. Malaria. Available from: URL:" ([2011 Nov 08]):
  4. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  5. Klinger G, Morad Y, Westall CA, et al. "Ocular toxicity and antenatal exposure to chloroquine or hydroxychloroquine for rheumatic diseases." Lancet 358 (2001): 813-4
  6. "Recommendations for the prevention of malaria among travelers." MMWR Morb Mortal Wkly Rep 39 (1990): 1-10
  7. Freedman DO "Clinical practice. Malaria prevention in short-term travelers." N Engl J Med 359 (2008): 603-12
  8. Ramharter M, Grobusch MP, Kiessling G, et al. "Clinical and Parasitological Characteristics of Puerperal Malaria." J Infect Dis 191 (2005): 1005-1009
  9. Schultz LJ, Steketee RW, Macheso A, Kazembe P, Chitsulo L, Wirima JJ "The efficacy of antimalarial regimens containing sulfadoxine-pyrimethamine and/or chloroquine in preventing peripheral and placental plasmodium falciparum infection among pregnant women in malawi." Am J Trop Med Hyg 51 (1994): 515-22

References for breastfeeding information

  1. Arguin PM, Mali S, CDC. Centers for Disease Control and Prevention "Infectious diseases related to travel. Malaria. Available from: URL:" ([2011 Nov 08]):
  2. Ette EI, Essien EE, Ogonor JI, Brown-Awala EA "Chloroquine in human milk." J Clin Pharmacol 27 (1987): 499-502
  3. Ogunbona FA, Onyeji CO, Bolaji OO, Torimiro SE "Excretion of chloroquine and desethylchloroquine in human milk." Br J Clin Pharmacol 23 (1987): 473-6
  4. "American Academy of Pediatrics. Committee on Drugs. The transfer of drugs and other chemicals into human milk." Pediatrics 108 (2001): 776-89
  5. "Product Information. Aralen (chloroquine)." Sanofi Winthrop Pharmaceuticals, New York, NY.
  6. Boelaert JR, Yaro S, Augustijns P, et al. "Chloroquine accumulates in breast-milk cells: potential impact in the prophylaxis of postnatal mother-to-child transmission of HIV-1." AIDS 15 (2001): 2205-7
  7. Edstein MD, Veenendaal JR, Newman K, Hyslop R "Excretion of chloroquine, dapsone and pyrimethamine in human milk." Br J Clin Pharmacol 22 (1986): 733-5
  8. Akintonwa A, Gbajumo SA, Mabadeje AF "Placental and milk transfer of chloroquine in humans." Ther Drug Monit 10 (1988): 147-9

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.