Ibuprofen

 Risk Factor: BM*
 Class: CENTRAL NERVOUS SYSTEM DRUGS / Nonsteroidal Anti-inflammatory Drugs

Contents of this page:

Fetal Risk Summary
Breast Feeding Summary
References
Questions and Answers

Fetal Risk Summary

Ibuprofen is a nonsteroidal antiinflammatory drug (NSAID) indicated for the reduction of fever and mild to moderate pain. It is in the same subclass (propionic acids) as five other NSAIDs (fenoprofen, flurbiprofen, ketoprofen, naproxen, and oxaprozin). No evidence of developmental abnormalities was observed in reproduction studies in rats and rabbits at doses slightly less then the maximum human clinical dose (1).

No published reports linking the use of ibuprofen with congenital defects have been located. The manufacturer has received information by a voluntary reporting system on the use of ibuprofen in 50 pregnancies (2). Seven of these cases were reported retrospectively and 43 prospectively. The results of the retrospective cases included one fetal death (cause of death unknown, no abnormalities observed) after 3rd trimester exposure, and one spontaneous abortion without abnormality. Five infants with defects were observed, including an anencephalic infant exposed during the 1st trimester to ibuprofen and Bendectin (doxylamine succinate and pyridoxine hydrochloride), petit mal seizures progressing to grand mal convulsions, cerebral palsy (the fetus had also been exposed to other drugs), a hearsay report of microphthalmia with nasal cleft and mildly rotated palate, and tooth staining (2) (M.M. Westland, personal communication, The Upjohn Company, 1981). A cause and effect relationship between the drug and these defects is doubtful.

Prospectively, 23 of the exposed pregnancies ended in normal outcomes, 1 infant was stillborn, and 1 ended in spontaneous abortion, both without apparent abnormality (2). Seven of the pregnancies were electively terminated, 3 had unknown outcomes, and 8 of the pregnancies were still progressing at the time of the report.

In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 3,178 newborns had been exposed to ibuprofen during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of 143 (4.5%) major birth defects were observed (129 expected). Specific data were available for six defect categories, including (observed/expected) 33/30 cardiovascular defects, 7/5 oral clefts, 3/2 spina bifida, 11/9 polydactyly, 5/5 limb reduction defects, and 4/8 hypospadias. These data do not support an association between the drug and congenital defects.

A combined 2001 population-based observational cohort study and a case-control study estimated the risk of adverse pregnancy outcome from the use of NSAIDs (3). The studies were based on data from the Danish birth registry and the North Jutland county's hospital discharge registry collected between 1991 and 1998. Only those women who had received a prescription for a NSAID at doses equivalent to 400 mg or 600 mg of ibuprofen were classified as exposed (NSAID doses equivalent to 200 mg of ibuprofen are over-the-counter in Denmark). The cohort involved 1,462 pregnant women who had received a NSAID prescription in the interval from 30 days before conception to birth and a Reference group of 17,259 pregnant women who had not been prescribed any drugs during pregnancy. In both groups, only pregnancies lasting longer than 28 weeks' were included. There were 1,106 women (76%) who had received a NSAID prescription between 30 days before conception and the end of the 1st trimester. The prevalences of congenital malformations in infants of these women and the Reference group were(N=46, 4.2%, 95% confidence interval [CI] 3.0%5.3% vs. (N=564, 3.3%, 95% CI 3.0%3.5%), respectively; adjusted odds ratio (OR) 1.27 (95% CI 0.931.75). A total of 997 women received a NSAID prescription in the 2nd and/or 3rd trimesters. In this group, the OR for preterm delivery was 1.05 (95% CI 0.801.39) and for low birth weight (excluding preterm infants) 0.79 95% CI (0.451.38). Adjusting the data for the use of indomethacin (the tocolytic of choice in Denmark) did not affect the results. There was no evidence of a specific grouping of defects or of a dose-response relationship for adverse birth outcome. Based on the analysis, the authors concluded that NSAIDs were not associated with adverse birth outcome (3).

In the case-control portion of the above study, cases were defined as first recorded SAB in women who had received a prescription for NSAIDs in the 12 weeks before the date of discharge from the hospital after the SAB (63 of 4,268 women who had SABs) (3). The controls were 29,750 primiparous women who had live births, 318 of whom had received a prescription for NSAIDs in the 1st trimester. The data was analyzed for the time from receiving a NSAID prescription in the weeks before the SAB (or missed abortion), adjusted for maternal age. The OR (95% CI) for 1 week, 23 weeks, 46 weeks, 79 weeks, and 1012 weeks before the SAB were 6.99 (2.7517.74), 3.00 (1.217.44), 4.38 (2.667.20), 2.69 (1.814.00), and 1.26 (0.851.87), respectively. The results indicated that NSAIDs were associated with SAB because the OR decreased as the interval from assumed NSAID exposure to SAB increased (3).

The use of ibuprofen as a tocolytic agent has been associated with reduced amniotic fluid volume (4,5 and 6). Fourteen (82.3%) of 17 women treated with a NSAID had decreased amniotic fluid volume (4). Of the 17 women, ibuprofen, 12002400 mg/day, was used alone in 3 pregnancies and was combined with ritodrine in one. The other 13 women were treated with indomethacin (see also Indomethacin). One woman who was treated with ibuprofen for 44 days had a return to a normal amniotic fluid volume after the drug was stopped (time for reversal not specified).

Ibuprofen, 600 mg every 6 hours, was used as a tocolytic in a woman with a triplet pregnancy at approximately 26 weeks' gestation (5). Terbutaline and magnesium sulfate were combined with ibuprofen at various times for tocolysis. Oligohydramnios in each sac (pockets <1 cm) was documented by ultrasonogram on the 20th day of therapy and ibuprofen therapy was stopped. Therapy was restarted 5 days later when normal fluid volume for the three fetuses was observed but oligohydramnios was again evident after 4 days and ibuprofen was discontinued. Tocolysis was then maintained with terbutaline and normal fluid volumes were observed 5 days after the second course of ibuprofen. The triplets were eventually delivered by elective cesarean section at 35 weeks' gestation, but no details on the infants were given.

A brief 1992 abstract described the results of using ibuprofen, 12002400 mg/day, as a tocolytic agent in 52 pregnancies (61 fetuses) up to 32 weeks' gestation (6). Amniotic fluid volumes were evaluated every 12 weeks. No cases of true oligohydramnios were observed, although 3 cases of low-normal fluid occurred that resolved after discontinuation of ibuprofen. Periodic Doppler echocardiography during therapy revealed a non-dose-related mild constriction of the ductus arteriosus in 4 (6.6%) of the fetuses. Ductal constriction was observed in 3 of the fetuses within 1 week of starting ibuprofen. Normal echocardiograms were obtained in all 4 cases within 1 week of discontinuing therapy.

Constriction of the ductus arteriosus in utero is a pharmacologic consequence arising from the use of prostaglandin synthesis inhibitors during pregnancy (see also Indomethacin) (7). Persistent pulmonary hypertension of the newborn may occur if these agents are used in the 3rd trimester close to delivery (7). These drugs also have been shown to inhibit labor and prolong pregnancy, both in humans (8) and in animals (9). Women attempting to conceive should not use any prostaglandin synthesis inhibitor, including ibuprofen, because of the findings in a variety of animal models that indicate these agents block blastocyst implantation (10,11). Moreover, as noted above, NSAIDs have also been associated with spontaneous abortions.

[*Risk Factor D if used in 3rd trimester or near delivery.]

Breast Feeding Summary

Ibuprofen is excreted into human milk. Two studies were unable to detect the drug (12,13 and 14), but a third study using a more sensitive assay (lower limit 2.5 ng/mL) was able to quantify ibuprofen in milk (15). In 12 patients taking 400 mg every 6 hours for 24 hours, an assay capable of detecting 1 g/mL failed to demonstrate ibuprofen in the milk (12,13). In a second report, a woman was treated with 400 mg twice daily for 3 weeks (14). Milk levels shortly before and up to 8 hours after drug administration were all less than 0.5 g/mL.

The third study involved a lactating woman who underwent maxillary surgery (15). After surgery, she took ibuprofen 400 mg six times over a 42.5-hour interval for postoperative pain. Ten breast milk samples were collected during this same period. Ibuprofen was detected (13 ng/mL) 30 minutes after the first dose. The maximum milk concentration, 181 ng/mL, was found 20.5 hours after the first dose (about 5 hours after the third dose). Although the infant was not nursing, the infant's weight adjusted dose would have been an estimated 0.0008% of the mother's dose (15).

The American Academy of Pediatrics considers ibuprofen to be compatible with breast feeding (16).

References

1. Product information. Motrin. McNeil Consumer, 2000.
2. Barry WS, Meinzinger MM, Howse CR. Ibuprofen overdose and exposure in utero: results from a postmarketing voluntary reporting system. Am J Med 1984;77(1A):359.
3. Nielsen GL, Sorensen HT, Larsen H, Pedersen L. Risk of adverse birth outcome and miscarriage in pregnant users of non-steroidal anti-inflammatory drugs: population based observational study and case-control study. Br Med J 2001;322:26670.
4. Hickok DE, Hollenbach KA, Reilley SF, Nyberg DA. The association between decreased amniotic fluid volume and treatment with nonsteroidal anti-inflammatory agents for preterm labor. Am J Obstet Gynecol 1989;160:152531.
5. Wiggins DA, Elliott JP. Oligohydramnios in each sac of a triplet gestation caused by Motrinfulfilling Kock's postulates. Am J Obstet Gynecol 1990;162:4601.
6. Hennessy MD, Livingston EC, Papagianos J, Killam AP. The incidence of ductal constriction and oligohydramnios during tocolytic therapy with ibuprofen (abstract). Am J Obstet Gynecol 1992;166:324
7. Levin DL. Effects of inhibition of prostaglandin synthesis on fetal development, oxygenation, and the fetal circulation. Semin Perinatol 1980;4:3544.
8. Fuchs F. Prevention of prematurity. Am J Obstet Gynecol 1976;126:80920.
9. Powell JG, Cochrane RL. The effects of a number of non-steroidal anti-inflammatory compounds on parturition in the rat. Prostaglandins 1982;23:46988.
10. Matt DW, Borzelleca JF. Toxic effects on the female reproductive system during pregnancy, parturition, and lactation. In Witorsch RJ, ed. Reproductive Toxicology. 2nd ed. New York, NY:Raven Press, 1995:17593.
11. Dawood MY. Nonsteroidal antiinflammatory drugs and reproduction. Am J Obstet Gynecol 1993;169:125565.
12. Townsend RJ, Benedetti T, Erickson S, Gillespie WR, Albert KS. A study to evaluate the passage of ibuprofen into breast milk (abstract). Drug Intell Clin Pharm 1982;16:4823.
13. Townsend RJ, Benedetti TJ, Erickson S, Cengiz C, Gillespie WR, Gschwend J, Albert KS. Excretion of ibuprofen into breast milk. Am J Obstet Gynecol 1984;149:1846.
14. Weibert RT, Townsend RJ, Kaiser DG, Naylor AJ. Lack of ibuprofen secretion into human milk. Clin Pharm 1982;1:4578.
15. Walter K, Dilger C. Ibuprofen in human milk. Br J Clin Pharmacol 1997;44:20913.
16. Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:13750.
    
    

Questions and Answers

Can someone that is pregnant take ibuprofen for migranes?

My daughter nomally takes vicodin for her migranes. However she recently found out she was pregnant. Therefor she cannot take her vicodins. She is suffering right now and want to know if she Can take ibuprofen to relieve her migrane?

I don't think it is safe unless directed by a doctor to take Ibuprofen while pregnant. God knows that stuff is great!! However, I think she can take Tylenol or Acetaminophen safely.

Is it safe to take ibuprofen or acetaminophen when you pregnant?

I am having severe headaches and I've heard that they come with the lovely symptoms of pregnancy lol. But my question is, is it safe to take ibuprofen or acetaminophen while pregnant? I want the headache to stop but I want to be sure its safe for my little one. :)

Do not take Ibuprofen it may cause premature closure of a major blood vessel near the baby's heart Acetaminophen is considered safe but I would defiantly find another option like relaxing in a luke warm bath, massaging your temples, placing a cold rag over your eyes. If all else fells, take the lowest dose of tylenol possible.

Safe to take aspirin or ibuprofen while pregnant?

HI I have been TTC this month, so i really don't know yet, i've done 2 tests but it's too early to tell because my period is only due in 9-10. I've tested today and it came back negative. Problem is i have a bad cold and i'm not really sure if i can take aspirin or ibuprofen or not ( in case i am )? I've been having some symptoms, but i'm not counting on them yet! Thank you so much!

No, you should not take Ibuprofen because that could harm your baby "IF" you are expecting. The only OTC drug you are allowed to take is Tylenol. If you are unsure and still need the okay, contact your physician to get a definite answer. Good luck and baby dust to you!!! Im TTC also!

Has anyone gotten pregnant while taking Advil/ibuprofen?

We have been trying to get pregnant for 2 months now. I really want to try this month, but my sinus's are killing me and the only thing that relieves them is ibuprofen (Advil, etc.). However, I read taking this can reduce your chances by half! Has anyone been in this situation and it doesn't really matter?

take some advil

Can you take ibuprofen when your pregnant?

The doctor just gave my wife some.

you can take it but not in the 1st trimester as well as aspirin, the only thing that is really 100% safe in all parts of pregnancy is tylenol, tell her to take that, ibuprofen and aspiren can cause birth defects in the 1st trimester, so depends how far she is, i still wouldnt take it though even though chances are nothing will happen, but just to be safe i would stick with the tylenol

Can I take Ibuprofen while pregnant?

I occasionally get a pain through my leg and the only thing i have ever found to help it is 400mg of over the counter (cheap brand) ibuprofen. I was wondering if it was okay to take.. I have seen some websites say no it isn't okay. And I have seen others that say it is on the list that doctors give you of OKAY medicines....
I am at 4 weeks.

Thanks for all the help in advance!

Okay here is the deal with Ibuprofen. It is a medication that is classified as an NSAID. NSAIDs have NOT been shown to cause birth defects HOWEVER - the problem with NSAIDs is they can thin the blood and decreases clotting factors. These medications in pregnancy should ONLY be taken under the direct supervision of your doctor. In pregnancy your body is in what is called a Hypercoagulable state. What that means is that your blood clots easier then normal and there is a reason for that. There is something in pregnancy that can cause almost immediate death to both you and your baby - this is called a placental abruption. This is when the placenta separates from the uterine wall. Your body needs to immediately clot this area to stop the bleeding. Your heart on average pumps 6L of blood a minute (through your body, including the placenta) - at term in pregnancy your body is holding about 6-7L of blood...non-pregnant it's about 4-5L of blood. If your body is not able to clot and this happens you will die quickly.

You need to talk to your doctor about taking this medication while you are pregnant. Right now try taking 2 Tylenol. Might not help as much but it's safer until you have been to the doc. Congrats on your pregnancy by the way

just found out im pregnant ?i toke ibuprofen a few weeks ago as i thought it was my period starting ?

my last period was jan22 i found out i was pregnant 5 days ago and when i get af cramps i take ibuprofen .i toke about 3 pills in 5days... will my baby be ok ive been taking pre natels and staying away from those medications

You'll be fine! It doesn't sound like you took too much. Here's a website that may ease your fears.

http://www.ask.com/bar?q=ibuprofen+when+...



Here's some info from the site.

Medication is a concern to most expecting moms and for good reason. Some medications can cause serious problems to an unborn child while others have no known effects. For this reason, it is best to discuss all medications with your doctor before taking them.

Most doctors agree that acetaminophen, or Tylenol, is the best choice of pain reliever for pregnant women. While ibuprofen is not known to cause problems during the first and second trimesters, it is unsafe for women to take during the last three months of pregnancy. It has been shown to cause problems for unborn babies that late in development.

While pregnant, try to stick with Tylenol as your pain reliever. But if it doesn’t cure your aches and pains, it is probably okay to take ibuprofen as long as you are not in the third trimester of pregnancy.

Can a woman take Ibuprofen while she's pregnant?

This is for my cousin, me and her had a discussion, can a pregnant woman take Ibuprofen and drink coffee with caffeine in it, I told her no, am I right?

Motrin Tablets is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke).

Motrin Tablets may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding.


Caffeine easily passes from the mother to her unborn child through the placenta. Because the systems for breaking down and eliminating chemicals are not fully developed in the unborn child, blood levels of caffeine may remain elevated for longer periods in the unborn child compared to the mother. Higher amounts of caffeine could affect babies in the same way as it does adults.

Some reports have stated that children born to mothers who consumed more than 500mg/day were more likely to have faster heart rates, tremors, increased breathing rate and spend more time awake in the days following birth. Also, caffeine has a diuretic effect, which results in fluid and calcium being drawn out of your system. This will prevent your child from getting some of the important nutrients and fluids it requires during growth. Further, coffee and tea, especially when taken with cream and sugar, are filling and satisfying but don’t provide you with the nutrients that are required during pregnancy. Caffeine may even prevent the absorption of vital things such as iron. Though mild caffeine consumption probably does not cause any serious birth defects, it is probably best to try and limit your caffeine intake throughout your pregnancy.