Last update May 21, 2021


Low Risk

Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

Fat-soluble statin, which acts by reducing cholesterol synthesis.
Indicated in the treatment of hypercholesterolemia, primary, familial (hetero and homozygous) and combined familial hyperlipidaemia.
Authorized use from 10 years of age.
Oral administration in a daily dose.

At the date of the last update, the authors did not find any published data on its excretion in breast milk.

Its pharmacokinetic data (very high percentage of protein binding and moderately high molecular weight) make it highly unlikely that significant quantities will pass into breast milk.

The tiny known secretion in breast milk, of pravastatin (Pan 1988) and rosuvastatin (Lwin 2018, Schutte 2013) and presumably from the rest of statins, is very unlikely to alter the lipid composition of breast milk and decrease its cholesterol concentration.

Because of its low oral bioavailability it has difficulty passing to the infant plasma from ingested breast milk, except in premature infants and in the immediate neonatal period in which there may be greater intestinal permeability.

Mothers homozygous for familial hypercholesterolemia took statins for 18 pregnancies and 11 lactations lasting 3 to 9 months. Infants had no developmental or school learning problems (Botha 2018).

Expert authors consider the use of statins, especially rosuvastatin or pravastatin, safe or probably compatible or of minimal risk during pregnancy and/or lactation (Hale 2021, Botha 2018, Holmsen 2017, Amir 2011).

Other authors advise postponing statin treatment from 3 months before pregnancy and until breastfeeding ends or is not exclusive (Shala 2020, Lawrence 2016 p 393).
Except in severe forms of hypercholesterolemia (Moss 2018), postponing drug treatment for a few months is unlikely to alter the long-term outcome of the disease in the mother. It is advisable to follow a lipid-lowering diet.

Cholesterol levels are normally increased (40%) during pregnancy and lactation in healthy women (Lawrence 2016 p590).
The cholesterol in breast milk is synthesized in the mammary gland and its concentration in breast milk ranges from 30 mg/dL in colostrum to 10 - 20 mg/dL in mature breast milk (Lawrence 2016 p98, 105 and 767).
The cholesterol concentration is greatly increased (up to 3 times higher) in the milk of lactating mothers with homozygous familial hypercholesterolemia (Holmsen 2017, Tsang 1978). Statin treatment would, at best, reduce it to normal levels (Holmsen 2017).

Cholesterol is necessary for the development of brain tissue, myelination of nerves, and is the basis for many enzymes. Breastfed infants have higher plasma cholesterol levels than those fed artificial formulas and this will protect them against the consequences of hypercholesterolemia in adult life (Lawrence 2016 p108).

Infants fed substitute formulas “artificial milk” do not receive cholesterol in their diet, as these products do not contain cholesterol (Lawrence 2016 p 109 and 215). The amount of cholesterol in breast milk that would remain after the hypothetical reduction in cholesterol produced by statins taken by the mother, would still be much higher than that provided by artificial formulas (Holmsen 2017).


  • Colesevelam Hydrochloride ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Colestipol ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Colestyramine ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Ezetimibe (Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • Pravastatin Sodium (Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • Rosuvastatin Calcium (Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)

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

Simvastatin is also known as

Simvastatin in other languages or writings:


Simvastatin belongs to this group or family:


Main tradenames from several countries containing Simvastatin in its composition:


Variable Value Unit
Oral Bioavail. < 5 %
Molecular weight 419 daltons
Protein Binding > 95 %
pKa 14.91 -
Tmax 1 - 2 hours
1.9 - 4.8 hours


  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from Consulted on March 17, 2022 Full text (link to original source)
  2. AEMPS-CINFA. Simvastatina. Ficha técnica. 2020 Full text (in our servers)
  3. Shala-Haskaj P, Krähenmann F, Schmidt D. [CME: Familial Hypercholesterolemia - Statin Treatment during Pregnancy and Breastfeeding]. Praxis (Bern 1994). 2020 Apr;109(6):405-410. Abstract
  4. Merk. Simvastatin. Drug Summary. 2019 Full text (in our servers)
  5. Moss S, Tardo D, Doyle M, Rees D. Complex disease management of pregnant young patient with familial hypercholesterolaemia complicated by coronary artery disease and cerebrovascular disease. Cardiovasc Revasc Med. 2018 Dec;19(8S):20-22. Abstract
  6. Lwin EMP, Leggett C, Ritchie U, Gerber C, Song Y, Hague W, Turner S, Upton R, Garg S. Transfer of rosuvastatin into breast milk: liquid chromatography-mass spectrometry methodology and clinical recommendations. Drug Des Devel Ther. 2018 Oct 29;12:3645-3651. Abstract
  7. Botha TC, Pilcher GJ, Wolmarans K, Blom DJ, Raal FJ. Statins and other lipid-lowering therapy and pregnancy outcomes in homozygous familial hypercholesterolaemia: A retrospective review of 39 pregnancies. Atherosclerosis. 2018 Oct;277:502-507. Abstract
  8. Holmsen ST, Bakkebø T, Seferowicz M, Retterstøl K. Statins and breastfeeding in familial hypercholesterolaemia. Tidsskr Nor Laegeforen. 2017 May 23;137(10):686-687. Abstract
  9. Lawrence RA, Lawrence RM. Breastfeeding. A guide for the medical profession. Eighth Edition. Philadelphia: Elsevier; 2016
  10. Schutte AE, Symington EA, du Preez JL. Rosuvastatin is transferred into human breast milk: a case report. Am J Med. 2013 Sep;126(9):e7-8. Abstract Full text (link to original source) Full text (in our servers)
  11. Amir LH, Pirotta MV, Raval M. Breastfeeding--evidence based guidelines for the use of medicines. Aust Fam Physician. 2011 Sep;40(9):684-90. Review. Abstract Full text (link to original source) Full text (in our servers)
  12. Schachter M. Chemical, pharmacokinetic and pharmacodynamic properties of statins: an update. Fundam Clin Pharmacol. 2005 Abstract Full text (link to original source) Full text (in our servers)
  13. Mauro VF. Clinical pharmacokinetics and practical applications of simvastatin. Clin Pharmacokinet. 1993 Abstract
  14. Pan H, Fleiss P, Moore L, Glaess S, Ivashkiv E, Dollar D, Martynowicz H. Excretion of pravastatin, an HMG CoA reductase inhibitor, in breast milk of lactating women. In: Seventeeth Annual Meeting American College of Clinical Pharmacology, Abstracts. In: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006–. 2020 Feb 17. Abstract Full text (link to original source)
  15. Tsang RC, Glueck CJ, McLain C, Russell P, Joyce T, Bove K, Mellies M, Steiner PM. Pregnancy, parturition, and lactation in familial homozygous hypercholesterolemia. Metabolism. 1978 Jul;27(7):823-9. No abstract available. Abstract

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