Advil® and Motrin® are the trade names of ibuprofen. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat fever, inflammation, and a variety of mild to moderate pain conditions. Frequent indications of ibuprofen are common conditions like menstrual cramps, toothaches, backaches, and sports-related injuries. Ibuprofen is also an ingredient in many over-the-counter combination products.
Advantages of ibuprofen
The main advantage of ibuprofen is that, in general, it is safe to use, cheap, and available over-the-counter. It also causes less stomach problems than its alternatives and it comes in different flavored liquid forms, making it easier for some people, including children, to take.
Disadvantages of ibuprofen
The main disadvantage of ibuprofen is that it doesn’t last as long as other NSAIDs, so you need to take it a few times a day to get relief of your symptoms. Also, it needs to be taken with food or milk to avoid getting an upset stomach. And, like all NSAIDs, ibuprofen can raise your risk of getting blood clots, a heart attack, or stroke.
Medical studies on ibuprofen use during pregnancy
Use of ibuprofen has been reported in a large number of human pregnancies without evidence of a syndrome of congenital anomalies. The frequency of congenital anomalies was no greater than expected among 51 infants whose mothers took ibuprofen during the first trimester of pregnancy in the Boston Collaborative Drug Surveillance Program (Aselton et al. 1985). Major congenital anomalies were reported in 143 (4.5%) of 3,178 infants of women who had received prescriptions for ibuprofen during the first trimester of pregnancy in a study of Michigan Medicaid recipients. The expected rate was 4.1%. No association was found for any particular subgroup of anomalies, including heart defects.
In a cohort study of Norwegian women and singleton child pairs, no effect on rate of infant survival, congenital malformations or structural heart defects were found with ibuprofen use during pregnancy (Nezvalová-Henriksen et al. 2013).
Among 2,557 pregnancies where ibuprofen or another NSAID medication was taken, the rate of major birth defects was not increased (Ericson and Källén 2017). However, the incidence of congenital heart defects was higher than expected. In data from the Baltimore-Washington Infant Study (Wilson et al. 1998) an increased risk was found for a heart problem at birth called ventricular septal defect. This finding was confirmed by Ofori and colleagues (2006), who used data from the Province of Quebec between 1997-2003.
Oligohydraminios, a condition characterized by a deficiency of amniotic fluid, was present in 8 of 30 women treated with ibuprofen to prevent preterm delivery (Hendricks et al. 1990).
Aselton et al. (1985) found one child with a congenital defect among 51 exposed during the first trimester of pregnancy. A borderline association between maternal use of ibuprofen and gastroschisis (a birth defect of the abdominal wall) was observed by Torfs et al. (1996) in a case-control study that included 110 infants. However, this was not confirmed by Werler et al. (1992) in in another case-control study of 206 infants with gastroschisis. A 2009 analysis of data in the National Birth Defects Prevention Study found an elevated risk of gastroschisis in pregnancies that included first trimester use of ibuprofen (Mac Bird et al. 2009).
The risk of miscarriage was 40-80% higher than expected among women who took NSAIDs early in pregnancy in three epidemiological studies (Li et al. 2003; Nielsen et al. 2001, 2004), but the temporal relationship between miscarriage and treatment differed between the studies. These investigations did not assess the effects of ibuprofen separately from other drugs of this class. A 2014 historical cohort study in Israel found no increased risk of miscarriage with use of ibuprofen (Daniel et al. 2014).
Bottom line: An increased risk of miscarriage was associated with use of ibuprofen, particularly near the time of conception, but a re-analysis of the data weakened the association. Some, though not all, epidemiology studies have suggested that use of NSAIDs, including ibuprofen, during pregnancy might increase the risk of cardiac defects and gastroschisis. Use during the third trimester of pregnancy is not recommended and should be avoided (if possible) due to concerns about premature ductal (heart valve) closure in the developing baby.
Medical studies of ibuprofen during breastfeeding
Ibuprofen was not transferred to human milk in significant quantities (Rigourd et al. 2014). One group of investigators reported a milk:plasma ratio of 1:126 and the weight-adjusted dose to the nursing infant as 0.0008% of the maternal dose (Walter and Dilger 1997). One week after delivery, a milk sample was received from 13 women 1.5 to 8 hours after their third dose of ibuprofen. The infant dose was highest in the colostral phase when the milk protein content was the highest. The American Academy of Pediatrics classified ibuprofen as compatible with breastfeeding (American Academy of Pediatrics Committee on Drugs 2001).
Bottom line: Because of its extremely low levels in breastmilk, short half-life and safe use in infants in doses much higher than those excreted in breastmilk, ibuprofen is a preferred choice as an analgesic or anti-inflammatory agent in nursing mothers.
- American Academy of Pediatrics Committee on Drugs. 2001. Transfer of Drugs and Other Chemicals into Human Milk.
- Aselton P, Jick H, Milunsky A, Hunter JR, Stergachis A. 1985. First-Trimester Drug Use and Congenital Disorders.
- Bird T, Robbins JM, Druschel C et al. 2009. Demographic and Environmental Risk Factors for Gastroschisis and Omphalocele in the National Birth Defects Prevention Study. Journal of Pediatric Surgery 44 (8): 1546–51.
- Daniel S, Koren G, Lunenfeld E et al. 2014. Fetal Exposure to Nonsteroidal Anti-Inflammatory Drugs and Spontaneous Abortions. CMAJ : Canadian Medical Association Journal 186 (5): E177-82.
- Ericson A, Källén BA. 2017. Nonsteroidal Anti-Inflammatory Drugs in Early Pregnancy.
- Hendricks SK, Smith JR, Moore DE, Brown ZA. 1990. Oligohydramnios Associated with Prostaglandin Synthetase Inhibitors in Preterm Labour.
- Li DK, Liu L, Odouli R. 2003. Exposure to Non-Steroidal Anti-Inflammatory Drugs during Pregnancy and Risk of Miscarriage: Population Based Cohort Study. BMJ (Clinical Research Ed.) 327 (7411): 368.
- Nezvalová-Henriksen K, Spigset O, Nordeng H. 2013. Effects of Ibuprofen, Diclofenac, Naproxen, and Piroxicam on the Course of Pregnancy and Pregnancy Outcome: A Prospective Cohort Study. BJOG : An International Journal of Obstetrics and Gynaecology 120 (8): 948–59.
- Nielsen GL, Sørensen HT, Larsen H, Pedersen L. 2001. Risk of Adverse Birth Outcome and Miscarriage in Pregnant Users of Non-Steroidal Anti-Inflammatory Drugs: Population Based Observational Study and Case-Control Study.
- Nielsen GL, Skriver MV, Pedersen L et al. 2004. Danish Group Reanalyses Miscarriage in NSAID Users. BMJ (Clinical Research Ed.) 328 (7431): 109.
- Ofori B, Oraichi D, Blais L et al. 2006. Risk of Congenital Anomalies in Pregnant Users of Non-Steroidal Anti-Inflammatory Drugs: A Nested Case-Control Study. Birth Defects Research Part B: Developmental and Reproductive Toxicology 77 (4): 268–79.
- Rigourd V, de Villepin B, Amirouche A, et al. 2014. Ibuprofen Concentrations in Human Mature Milk–First Data about Pharmacokinetics Study in Breast Milk with AOR-10127 Study. Therapeutic Drug Monitoring 36 (5): 590–96.
- Torfs CP, Katz EA, Bateson TF, Lam PK et al. 1996. Maternal Medications and Environmental Exposures as Risk Factors for Gastroschisis. Teratology 54 (2): 84–92.
- Walter K, Dilger C. 1997. Ibuprofen in Human Milk.
- Werler MM, Mitchell AA, Shapiro S. 1992. First Trimester Maternal Medication Use in Relation to Gastroschisis. Teratology 45 (4): 361–67.
- Wilson PD, Loffredo CA, Correa-Villaseñor A, Ferencz C. 1998. Attributable Fraction for Cardiac Malformations.