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Ibuprofen Pregnancy and Breastfeeding Warnings

Ibuprofen is also known as: A-G Profen, Advil, Advil Children's, Advil Liqui-Gels, Advil Migraine, Children's Motrin, Childrens Ibuprofen Berry, Genpril, Haltran, IBU, IBU-200, Ibu-Tab, Ibuprofen PMR, Menadol, Midol IB, Motrin, Motrin Childrens, Motrin IB, Proprinal, Q-Profen, Rufen, Saleto-200, Saleto-400, Saleto-600, Saleto-800

Medically reviewed by Drugs.com. Last updated on Jan 13, 2020.

Ibuprofen Pregnancy Warnings

Starting at 30 weeks gestation: Not recommended
Prior to 30 weeks gestation: Benefit should outweigh risk

AU TGA pregnancy category: C
US FDA pregnancy category: C

Risk Summary: Nonsteroidal anti-inflammatory drug (NSAID) use during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus and therefore should be avoided; prior to 30 weeks gestation, studies are inconclusive regarding potential embryofetal risks.

Comments:
-Avoid use starting at 30 weeks gestation (third trimester).
-Not recommended in women attempting to conceive as use may impair female fertility.

Published reports have not shown clear developmental effects in animal studies with dosing up to 0.4 (rabbits) and 0.5 (rats) times the maximum recommended human dose (MRHD) throughout gestation. In rats, dosed at 0.8 times the MRHD on gestation days 9 and 10, an increase in membranous ventricular septal defects was reported; maternal toxicity was also reported. Animal data has shown that prostaglandins play an important role in endometrial vascular permeability, blastocyst implantation, and decidualization; administration of prostaglandin synthesis inhibitors such as this drug, has been shown to result in increased pre-and post-implantation loss. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. 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.

NSAIDs may impair female fertility; withdrawal of NSAID therapy should be considered in women with difficulties conceiving or who are undergoing investigation of infertility.

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Ibuprofen Breastfeeding Warnings

This drug is a preferred choice as an analgesic/anti-inflammatory agent in nursing mothers because of the very low levels in breastmilk and demonstrated safety with therapeutic administration to infants at doses much higher than those excreted in breast milk. Limited published reports indicate that following oral administration, this drug is present in human milk at relative infant doses of 0.06% to 0.6% of the maternal weight-adjusted daily dose. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

Benefit should outweigh risk

Excreted into human milk: Yes (small amounts)

Comments: Adverse effects on the breastfed infant and effects on milk production have not been reported.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. NeoProfen (ibuprofen)." Ovation Pharmaceuticals Inc, Deerfield, IL.
  3. "Product Information. Ibuprofen (ibuprofen)." Par Pharmaceutical Inc, Spring Valley, NY.
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Motrin (ibuprofen)." Pharmacia and Upjohn, Kalamazoo, MI.
  6. "Product Information. Caldolor (ibuprofen)." Cumberland Pharmaceuticals Inc, Nashville, TN.

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. "Product Information. Motrin (ibuprofen)." Pharmacia and Upjohn, Kalamazoo, MI.
  3. "Product Information. NeoProfen (ibuprofen)." Ovation Pharmaceuticals Inc, Deerfield, IL.
  4. "Product Information. Caldolor (ibuprofen)." Cumberland Pharmaceuticals Inc, Nashville, TN.
  5. "Product Information. Ibuprofen (ibuprofen)." Par Pharmaceutical Inc, Spring Valley, NY.
  6. Cerner Multum, Inc. "Australian Product Information." O 0
  7. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.