Skip to Content

Hydrocodone / ibuprofen Pregnancy and Breastfeeding Warnings

Hydrocodone / ibuprofen is also known as: Ibudone, Reprexain, Vicoprofen, Xylon 10

Medically reviewed by Drugs.com. Last updated on Nov 20, 2019.

Hydrocodone / ibuprofen Pregnancy Warnings

Not recommended during last trimester of pregnancy
NSAIDs should be avoided at 20 weeks gestation and later

US FDA pregnancy category: Not assigned

Risk Summary: Opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are both associated with risks during pregnancy. NSAIDs use in pregnant women at 30 weeks gestation and later may cause premature closure of the fetal ductus arteriosus; NSAID use at 20 weeks gestation or later may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

Comments:
-Avoid use during third trimester as NSAID use may cause premature closure of the ductus arteriosus.
-If NSAID use is necessary between 20- and 30-weeks' gestation, limit use to the lowest effective dose for the shortest duration possible; ultrasound monitoring of amniotic fluid should be considered if NSAID use extends beyond 48 hours; if oligohydramnios occurs, discontinue NSAID and treat appropriately.
-Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.

Animal studies have revealed evidence of increased risk of miscarriage, cardiac malformation, and gastroschisis following use of prostaglandin synthesis inhibitors in early pregnancy. Administration of nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen during the third trimester of pregnancy may cause significant adverse effects, including premature closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, pulmonary hypertension, and prolongation of bleeding time. Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. There are no controlled data in human pregnancy.

US FDA Drug Safety Communication (10-2020): The FDA is requiring a new warning be added to NSAID labeling describing the risk of fetal kidney problems that may result in low amniotic fluid. The FDA is recommending pregnant women avoid NSAID use at 20 weeks gestation or later. Through 2017, the FDA has received 35 reports of low amniotic fluid levels or kidney problems in mothers who took NSAIDs while pregnant. Five newborns died; 2 had kidney failure and confirmed low amniotic fluid, 3 had kidney failure without confirmed low amniotic fluid. The low amniotic fluid started as early as 20 weeks of pregnancy. There were 11 reports of low amniotic fluid levels during pregnancy and the fluid volume returned to normal after the NSAID was stopped. The medical literature has reported low amniotic fluid levels with use of NSAIDs for varying amounts of time, ranging from 48 hours to multiple weeks. Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. In other cases, the condition was reversible within 3 to 6 days of stopping the NSAID and in these cases reappeared when the same NSAID was restarted.

NSAIDs may impair female fertility as animal studies have shown a reversible decrease in ovulation. Chronic opioid use may cause reduced fertility in males and females; it is unknown whether these effects on fertility are reversible.

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

Hydrocodone / ibuprofen Breastfeeding Warnings

Maternal use of narcotics during breastfeeding can cause infant drowsiness, CNS system depression, and even death; newborn infants are particularly sensitive. Withdrawal symptoms can occur in infants if hydrocodone is discontinued after a prolonged period (i.e., if the mother stops the drug or stops breastfeeding). Ibuprofen is excreted in low levels in the breastmilk and its use is generally considered acceptable.

Benefit should outweigh risk

Excreted into human milk: Yes (hydrocodone); Yes (ibuprofen)

Comments:
-Once a mother's milk is in, it is best to provide pain control with nonnarcotic analgesics; if hydrocodone is used, consider limiting maternal intake to a few days with a maximum dose of 30 mg/day.
-Breastfed infants should be closely monitored for increased sedation, difficulty breastfeeding, breathing difficulties, or limpness; mothers should be counseled to seek medical assistance promptly if these develop.

See references

References for pregnancy information

  1. US Food and Drug Administration "FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid. Available from: URL: https://www.fda.gov/media/142967/download." ([2020, Oct 15]):
  2. "Product Information. Hydrocodone-Ibuprofen (hydrocodone-ibuprofen)." Par Pharmaceutical Inc (formerly Qualitest Pharmaceuticals Inc), Huntsville, AL.

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. Hydrocodone-Ibuprofen (hydrocodone-ibuprofen)." Par Pharmaceutical Inc (formerly Qualitest Pharmaceuticals Inc), Huntsville, AL.

Further information

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