Pregnancy & breastfeeding

Ibuprofen (Advil, Motrin) in pregnancy and breastfeeding

Nonsteroidal anti-inflammatory drug (NSAID) · Pain, fever and inflammation

Published FDA label of Jan 29, 2026LactMed of Aug 15, 2025

Pregnancy

Avoid from 20 weeks

Avoid from 20 weeks of pregnancy unless a clinician directs it. From about 20 weeks NSAIDs can reduce fetal kidney function and amniotic fluid, and from 30 weeks they can close the ductus arteriosus early. Earlier in pregnancy, short courses are sometimes used, but some studies link NSAIDs around conception and in early pregnancy to miscarriage, so acetaminophen is preferred.[1, 2]

Before 20 weeks
Miscarriage findings are mixed: two studies found higher risk (Quebec OR 2.43 for any NSAID; California aHR 1.59, highest around conception) and an Israeli cohort did not (HR 1.10).[3, 2, 4]
20 to 30 weeks
Limit to the lowest dose for the shortest time. If use goes beyond 48 hours, the FDA advises considering ultrasound for amniotic fluid.[1]
30 weeks on
Avoid: risk of premature closure of the fetal ductus arteriosus.[1]

Breastfeeding

Preferred during breastfeeding

A preferred pain reliever while breastfeeding: milk levels are extremely low, the half-life is short, and infants are given far higher doses directly.

Written for clinicians. If you are pregnant or breastfeeding, talk to your clinician before you start, stop or change any medicine.

Ask EvidencePulse about ibuprofen

Get a cited answer from the newest studies, for your patient's trimester or your question.

What the human data show

The second-half-of-pregnancy risks are well established and on every label. The first-trimester question, miscarriage, rests on observational studies that disagree.

  1. FDA safety communication · United States · 2020

    Review of the literature and 35 FDA adverse event cases of low amniotic fluid or fetal kidney problems with NSAIDs.

    All prescription and OTC NSAIDs should be avoided from about 20 weeks; low-dose aspirin (81 mg) for pregnancy indications is excluded.[1]

  2. Prospective cohort (Embryotox) · Germany · 2022

    1,092 pregnancies exposed in the second or third trimester vs 1,154 exposed in the first trimester only.

    A few days of use in the second trimester did not appear harmful; weeks of use in late second trimester was linked to oligohydramnios and ductus constriction.[5]

    Ductus constriction 5/1,092 vs 0/1,154. Second-trimester oligohydramnios 0.9% vs 0.2% (RR 5.1, 1.1-24.0).

  3. Nested case-control (Quebec Pregnancy Registry) · Canada · 2011

    4,705 miscarriages vs 47,050 matched controls.

    Non-aspirin NSAID use in pregnancy was associated with miscarriage, ibuprofen included.[3]

    Any NSAID OR 2.43 (2.12-2.79); ibuprofen OR 2.19 (1.61-2.96).

  4. Prospective cohort · United States (California) · 2018

    Women enrolled in early pregnancy; acetaminophen users as an indication control.

    NSAID use around conception was associated with miscarriage, with a dose-response pattern.[2]

    aHR 1.59 (1.13-2.24) vs unexposed; 1.45 (1.01-2.08) vs acetaminophen users; around conception 1.89 (1.31-2.71).

  5. Historical cohort · Israel · 2014

    65,457 pregnancies; 4,495 exposed to NSAIDs.

    No independent association with miscarriage for nonselective NSAIDs (indomethacin was the exception).[4]

    Nonselective NSAIDs aHR 1.10 (0.99-1.22).

Miscarriage studies are prone to confounding: the pain or illness that prompts an NSAID, and early bleeding mistaken for other pain, can both precede a loss.

The FDA label, summarized

Current-format NSAID labels (here, the prescription ibuprofen label) say NSAIDs can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and sometimes neonatal kidney impairment. They advise limiting dose and duration between about 20 and 30 weeks and avoiding use from about 30 weeks; data on other first- and second-trimester risks are called inconclusive.

The over-the-counter Advil label says to ask a health professional before use if pregnant or breastfeeding, and that it is especially important not to use ibuprofen at 20 weeks or later unless a doctor directs it.

Label
Caldolor (Cumberland Pharmaceuticals Inc.), effective Jan 29, 2026 · Full label on DailyMed
Former FDA letter category
C before 30 weeks; D from 30 weeks (the FDA retired letter categories in 2015; labels now describe the data instead)

LactMed: infant exposure and effects

LactMed calls ibuprofen a preferred analgesic and anti-inflammatory in nursing mothers because of extremely low milk levels, a short half-life and safe direct use in infants at much higher doses.

Effects in breastfed infants

At least 23 breastfed infants are reported without adverse effects.

Effects on milk supply

Scheduled ibuprofen with acetaminophen for 24 hours after vaginal birth was associated with more mothers breastfeeding (98% vs 88%) than on-demand dosing.

Source
LactMed® record “Ibuprofen”, revised Aug 15, 2025 · Open the record

Alternatives to consider

  • Acetaminophen

    Preferred for pain and fever throughout pregnancy.

  • Low-dose aspirin

    Not a pain reliever substitute: 81 mg for preeclampsia prevention is a separate, recommended use exempt from the NSAID warning.[1]

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Questions clinicians ask

Can I take ibuprofen in the first trimester?

Short courses are sometimes used, but some studies link NSAIDs around conception and in early pregnancy to miscarriage, so acetaminophen is preferred. Ask a clinician before using it regularly.[2, 3]

Why avoid ibuprofen after 20 weeks?

From about 20 weeks NSAIDs can reduce the baby's kidney function and the amount of amniotic fluid, sometimes within 48 hours, and from 30 weeks they can close the ductus arteriosus too early.[1]

I took ibuprofen before I knew I was pregnant. Should I worry?

A few doses are unlikely to matter, and birth defects have not been clearly linked to ibuprofen. Stop regular use and mention it at the first prenatal visit.

Is ibuprofen safe while breastfeeding?

Yes. It is a preferred pain reliever during breastfeeding because very little reaches the milk.

References

  1. U.S. 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. Drug Safety Communication, October 15, 2020. Source
  2. Li DK, Ferber JR, Odouli R, et al. Use of nonsteroidal antiinflammatory drugs during pregnancy and the risk of miscarriage. Am J Obstet Gynecol. 2018;219(3):275.e1-275.e8. PubMed · DOI
  3. Nakhai-Pour HR, Broy P, Sheehy O, et al. Use of nonaspirin nonsteroidal anti-inflammatory drugs during pregnancy and the risk of spontaneous abortion. CMAJ. 2011;183(15):1713-1720. PubMed · DOI
  4. Daniel S, Koren G, Lunenfeld E, et al. Fetal exposure to nonsteroidal anti-inflammatory drugs and spontaneous abortions. CMAJ. 2014;186(5):E177-E182. PubMed · DOI
  5. Dathe K, Frank J, Padberg S, et al. Fetal adverse effects following NSAID or metamizole exposure in the 2nd and 3rd trimester: an evaluation of the German Embryotox cohort. BMC Pregnancy Childbirth. 2022;22(1):666. PubMed · DOI

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This summary supports clinical judgment and does not replace it or the full prescribing information. Ratings are 2 Minute Medicine editorial summaries, not FDA categories.

Sources: FDA drug labels via openFDA and DailyMed; LactMed®, Drugs and Lactation Database, National Institute of Child Health and Human Development (LactMed is a registered trademark of the U.S. Department of Health and Human Services); the studies listed above. Inclusion here does not imply endorsement by any of them.