Ferrous sulfate Pregnancy and Breastfeeding Warnings
Brand names: Chem-Sol, Fe 50, Fe Caps, Feosol Original, Fer-Gen-Sol, Fer-In-Sol, Fer-Iron, Feratab, Fero-Gradumet Filmtab, FeroSul, Ferra T.D. Caps, Ferra-TD, Ferro-Bob, Ferro-Time, Ferrospace, Ferrousal, Iron Sulfate, Lydia E. Pinkham, Mol-Iron, MyKidz Iron 10, Slow Fe, Slow Release Iron, Yieronia
Medically reviewed by Drugs.com. Last updated on Sep 20, 2023.
Ferrous sulfate Pregnancy Warnings
Use is considered acceptable.
AU TGA pregnancy category: Exempt
US FDA pregnancy category: Not assigned
Comments:
-Routine screening for anemia, including in asymptomatic patients, is generally recommended.
-Routine supplementation during pregnancy is recommended by many organizations.
Maternal anemia increases the risk of low birthweight, premature delivery, and impaired cognitive and behavioral development. Randomized trials show that supplementation can prevent iron deficiency anemia and related adverse consequences to the infant. Recent studies have linked high serum iron with an increased risk of gestational diabetes.
AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
Ferrous sulfate Breastfeeding Warnings
Use is considered acceptable.
Excreted into human milk: Yes
Comments:
-Iron in breast milk is very bioavailable, but amounts are generally not sufficient for infants older than 4 months; iron supplementation of the mother does not change this situation.
-Iron content of breast milk is not affected by the mother's nutritional status.
See also
References for pregnancy information
- World Health Organization (WHO). Iron Deficiency Anaemia. Assessment, Prevention, and Control, A guide for programme managers http://www.who.int/nutrition/publications/en/ida_assessment_prevention_control.pdf 2016.
- Cantor A, Bougatsos C, McDonagh M, et al. Routine Iron Supplementation and Screening for Iron Deficiency Anemia in Pregnant Women: A Systematic Review to Update the U.S. Preventive Services Task Force Recommendation [Internet] https://www.ncbi.nlm.nih.gov/books/NBK285987/ 2016.
- Rawal S, Hinkle SN, Bao W, et al. A longitudinal study of iron status during pregnancy and the risk of gestational diabetes: findings from a prospective, multiracial cohort. Diabetologia. 2017;60:249-57.
- Bao W, Chavarro JE, Tobias DK, et al. Long-term risk of type 2 diabetes in relation to habitual iron intake in women with a history of gestational diabetes: a prospective cohort study. Am J Clin Nutr. 2016;103:375-81.
- NIH Office of Dietary Supplements. Iron Dietary Supplement Fact Sheet. https://ods.od.nih.gov/factsheets/Iron-HealthProfessional/?print=1 2016.
- Scholl TO, Reilly T. Anemia, Iron and Pregnancy Outcome. J Nutr. 2000;130:443S-7S.
References for breastfeeding information
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Picciano MF. Pregnancy and Lactation: Physiological Adjustments, Nutritional Requirements and the Role of Dietary Supplements. J Nutr. 2003;133:1997S-2002S.
- Allen LH. Multiple micronutrients in pregnancy and lactation: an overview. Am J Clin Nutr. 2005;81(S):1206S-12S.
- NIH Office of Dietary Supplements. Iron Dietary Supplement Fact Sheet. https://ods.od.nih.gov/factsheets/Iron-HealthProfessional/?print=1 2016.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
