Last update July 1, 2025

Hydroxycarbamide; Hydroxyurea

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Hydroxyurea or hydroxycarbamide is an antimetabolite that inhibits DNA synthesis and is used to treat recurrent painful crises of sickle cell anaemia or sickle cell disease in patients aged two years and older, myeloproliferative syndromes (chronic myeloid leukaemia, polycythaemia vera, primary thrombocythemia, myeloid splenomegaly) and locally advanced squamous cell carcinomas of the head and neck. Oral administration in a single daily dose. 

It is excreted in breast milk in small amounts, below 10% of the relative or theoretical dose for paediatric patients, so no side effects are expected in infants whose mothers are undergoing treatment. (Ware 2020, Marahatta 2017, Sylvester 1987)

Most of the excreted drug appears within three hours of administration (Ware 2020, Marahatta 2017). Exposure can be reduced by half, especially in infants under 3 months of age, by waiting 3 hours to breastfeed after taking the dose. (Ware 2020)

Abrupt weaning can be psychologically traumatic and harmful to the health of both the mother and the infant (Pistilli 2013), and there is no good-quality evidence to contraindicate hydroxyurea during breastfeeding. (Expert Panel 2014)

If breastfeeding continues during prolonged treatment, it may be advisable to perform periodic haematological checks on the infant.

Alternatives

We do not have alternatives for Hydroxycarbamide; Hydroxyurea.

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Hydroxycarbamide; Hydroxyurea in other languages or writings:

Groups

Hydroxycarbamide; Hydroxyurea belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Hydroxycarbamide; Hydroxyurea in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 100 %
Molecular weight 76 daltons
VD 0.5 - 1.3 l/Kg
pKa 10.14 -
Tmax 1 - 2 hours
2 - 3 hours
M/P ratio 0.8 -
Theoretical Dose 0.4 - 2.9 mg/Kg/d
Relative Dose 2.3 - 4.9 %
Ped.Relat.Dose 2 - 8.7 %

References

  1. Ware RE, Marahatta A, Ware JL, McElhinney K, Dong M, Vinks AA. Hydroxyurea Exposure in Lactation: a Pharmacokinetics Study (HELPS). J Pediatr. 2020 Jul;222:236-239. Abstract
  2. Marahatta A, Ware RE. Hydroxyurea: Analytical techniques and quantitative analysis. Blood Cells Mol Dis. 2017 Sep;67:135-142. Abstract
  3. EMA. Hidroxicarbamida. Ficha técnica. 2014 Full text (in our servers)
  4. National Institutes of Health. National Heart, Lung and Blood Institute. Evidence-based management of sickle cell disease. Expert panel report. 2014 Full text (link to original source)
  5. EMA. Hydroxyurea. Drug Summary. 2014 Full text (in our servers)
  6. Pistilli B, Bellettini G, Giovannetti E, Codacci-Pisanelli G, Azim HA Jr, Benedetti G, Sarno MA, Peccatori FA. Chemotherapy, targeted agents, antiemetics and growth-factors in human milk: how should we counsel cancer patients about breastfeeding? Cancer Treat Rev. 2013 May;39(3):207-11. Abstract
  7. Rodriguez GI, Kuhn JG, Weiss GR, Hilsenbeck SG, Eckardt JR, Thurman A, Rinaldi DA, Hodges S, Von Hoff DD, Rowinsky EK. A bioavailability and pharmacokinetic study of oral and intravenous hydroxyurea. Blood. 1998 Abstract Full text (link to original source) Full text (in our servers)
  8. Thornley S, Manoharan A. Successful treatment of essential thrombocythemia with alpha interferon during pregnancy. Eur J Haematol. 1994 Jan;52(1):63-4. No abstract available. Abstract
  9. Sylvester RK, Lobell M, Teresi ME, Brundage D, Dubowy R. Excretion of hydroxyurea into milk. Cancer. 1987 Abstract Full text (link to original source) Full text (in our servers)

Total visits

9,557

Help us improve this entry

How to cite this entry

Do you need more information or did not found what you were looking for?

   Write us at elactancia.org@gmail.com

e-lactancia is a resource recommended by Academy of Breastfeeding Medicine - 2015 of United States of America

Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM