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Aspirin Pregnancy and Breastfeeding Warnings

Aspirin is also known as: Acetylsalicylic Acid, Acuprin 81, Arthritis Pain, Ascriptin, Ascriptin Enteric, Aspergum, Aspir 81, Aspir-Low, Aspirin Lite Coat, Aspirin Low Strength, Aspiritab, Aspirtab, Bayer Aspirin, Bayer Children's Aspirin, Buffered Aspirin, Bufferin, Bufferin Low Dose, Easprin, Ecotrin, Ecotrin Adult Low Strength, Empirin, Fasprin, Halfprin, St. Joseph 81 mg Aspirin Enteric Safety-Coated, ZORprin

Aspirin Pregnancy Warnings

100 mg/day or less: Use with caution Greater than 100 mg/day: Contraindicated (third trimester); Use only if clearly indicated (first and second trimester) AU TGA pregnancy category: C US FDA pregnancy category: Not Assigned Comments: -Avoid use during third trimester as it may cause premature closure of the ductus arteriosus. -If used in the first and second trimester, it should be used at the lowest dose for the shortest duration possible.

In animals, use of prostaglandin synthesis inhibitors has been shown to increase pre and post-implantation loss and embryo-fetal lethality. Epidemiologic studies suggest increased risk of miscarriage, cardiac malformations, and gastroschisis when used early in pregnancy; the absolute risk of cardiovascular malformations increased from less than 1% to up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. During the third trimester of pregnancy, administration of nonsteroidal anti-inflammatory drugs (NSAIDs) pregnancy may cause premature closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, pulmonary hypertension, and prolongation of bleeding time. There are no controlled data in human pregnancy. Administration during labor and delivery is not recommended; onset of labor may be delayed and duration increased with greater bleeding tendency in mother and child. A study of the use of low-dose aspirin (60 mg per day) to prevent and treat preeclampsia in 9364 pregnant women (the Collaborative Low-dose Aspirin Study in Pregnancy--CLASP) did "not support routine prophylactic or therapeutic administration of antiplatelet therapy in pregnancy to all women at increased risk of preeclampsia or IUGR." In that study, no excess of intraventricular hemorrhage, neonatal bleeds, or mortality attributable to bleeding were observed. The investigators did identify a possible role for low-dose aspirin in the treatment of early-onset preeclampsia severe enough to need very preterm delivery. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. 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.

See references

Aspirin Breastfeeding Warnings

This drug is excreted in human milk in small amounts. Low dose aspirin (75 to 162 mg/day) is considered by many experts to be compatible with breastfeeding. Peak milk salicylate levels have been reported up to 9 hours after maternal dosing with peak levels generally occurring 2 to 6 hours after nursing. Large doses may result in rashes, platelet abnormalities, and bleeding in nursing infants. Long-term, high dose maternal use was associated with 1 case of metabolic acidosis in breastfed infant. The risk for Reye's syndrome in infants with viral infections is unknown.

Benefit should outweigh risk Excreted into human milk: Yes Comments: -This drug appears compatible with breastfeeding for occasional use and in low doses for anti-thrombosis; however, repeated use in normal doses and long-term use, especially in high doses should be avoided. -Breastfed infants should be monitored for hemolysis, prolonged bleeding time, and metabolic acidosis.

See references

References for pregnancy information

  1. US Food and Drug Administration "TITLE 21--FOOD AND DRUGS,CHAPTER I--FOOD AND DRUG ADMINISTRATION,DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER D--DRUGS FOR HUMAN USE,PART 341 COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FO. Available from: URL: https://ww" ([2016, Apr 01]):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Clasp: a randomised trial lf low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women." Lancet 343 (1994): 619-29

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. Department of Adolescent and Child Health and Development. UNICEF. World Health Organization "Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. Available from: URL: http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1" ([2003]):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. US Food and Drug Administration "TITLE 21--FOOD AND DRUGS,CHAPTER I--FOOD AND DRUG ADMINISTRATION,DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER D--DRUGS FOR HUMAN USE,PART 341 COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FO. Available from: URL: https://ww" ([2016, Apr 01]):

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