Skip to Content

Chloroquine Pregnancy and Breastfeeding Warnings

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

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. "Recommendations for the prevention of malaria among travelers." MMWR Morb Mortal Wkly Rep 39 (1990): 1-10
  5. Ramharter M, Grobusch MP, Kiessling G, et al. "Clinical and Parasitological Characteristics of Puerperal Malaria." J Infect Dis 191 (2005): 1005-1009
  6. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  7. 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
  8. 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
  9. Freedman DO "Clinical practice. Malaria prevention in short-term travelers." N Engl J Med 359 (2008): 603-12

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. 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
  4. 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
  5. Ogunbona FA, Onyeji CO, Bolaji OO, Torimiro SE "Excretion of chloroquine and desethylchloroquine in human milk." Br J Clin Pharmacol 23 (1987): 473-6
  6. Akintonwa A, Gbajumo SA, Mabadeje AF "Placental and milk transfer of chloroquine in humans." Ther Drug Monit 10 (1988): 147-9
  7. "American Academy of Pediatrics. Committee on Drugs. The transfer of drugs and other chemicals into human milk." Pediatrics 108 (2001): 776-89
  8. "Product Information. Aralen (chloroquine)." Sanofi Winthrop Pharmaceuticals, New York, NY.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.