Ibuprofen / pseudoephedrine Pregnancy and Breastfeeding Warnings
Ibuprofen / pseudoephedrine is also known as: Advil Children's Cold, Advil Cold and Sinus, Advil Cold and Sinus Liqui-Gels, Dristan Sinus, Motrin Childrens Cold, Motrin Cold and Flu, Motrin IB Sinus, Motrin Sinus Headache, Sine-Aid IB
Medically reviewed by Drugs.com. Last updated on Jun 14, 2021.
Ibuprofen / pseudoephedrine Pregnancy Warnings
Contraindicated last trimester of pregnancy
NSAIDs should be avoided at 20 weeks gestation and later
AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned
Risk Summary: Nonsteroidal anti-inflammatory drugs (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.
-NSAID use in pregnancy prior to 20 weeks gestation should be based on a benefit-risk assessment; some authorities recommend avoiding NSAIDs throughout pregnancy whenever possible.
-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.
-NSAID use is not recommended in women attempting to conceive as it may impair female fertility.
-Pseudoephedrine use during the first trimester may be associated with gastroschisis and small intestinal atresia (SIA); data is limited and unconfirmed, risk appears to be low (only identifiable by case-control studies), and may only occur in combination products, but avoidance during the first trimester is nonetheless recommended.
Animal studies have not been performed with the combination product. There are no controlled data in human pregnancy.
Ibuprofen: Prostaglandin synthesis inhibitors may cause constriction of the ductus arteriosus in utero, and use may cause persistent pulmonary hypertension of the newborn when given during the third trimester close to delivery. They are known to inhibit labor and prolong pregnancy in humans. Animal models indicate these drugs block blastocyte implantation - do not use ibuprofen in patients trying to conceive. Non-steroidal anti-inflammatory drugs (NSAIDs) are associated with a small risk of spontaneous abortion, cardiac defects, oral clefts, and gastroschisis.
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.
Pseudoephedrine: A monitoring study of 50, 282 mother/child pairs (3082 first trimester sympathomimetic drug exposures, 9719 any time pregnancy exposures) suggested a link to categories of minor malformations (non-life-threatening, no major cosmetic defects) including inguinal hernia and clubfoot. Pseudoephedrine may be associated with gastroschisis, but this may also be caused by maternal health factors. First trimester oral decongestant exposure or maternal smoking may increase the risk of gastroschisis, small intestinal atresia (SIA), and hemifacial microsomia.
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.
Ibuprofen / pseudoephedrine Breastfeeding Warnings
Use should be avoided.
Excreted into human milk: Yes (ibuprofen and pseudoephedrine)
-The small amounts of pseudoephedrine (about 4.3 to 5.5% of maternal dose) may cause occasional irritability.
-A single pseudoephedrine dose acutely decreases milk production (average 24%); repeated use interferes with lactation.
-Do not use pseudoephedrine in patients with insufficient milk production or in those just establishing lactation.
-Ibuprofen has very low breastmilk levels, a short half-life, and is used at higher doses in infants, making it a preferred analgesic and anti-inflammatory for nursing.
References for pregnancy information
- TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ():
- 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]):
- Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
- "Product Information. Advil Cold and Sinus Liqui-Gel (ibuprofen-pseudoephedrine)." Wyeth Consumer Healthcare, Madison, NJ.
References for breastfeeding information
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
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