Ibuprofen
1. Pregnancy Evidence & Regulatory Labeling
FDA Pregnancy and Lactation Labeling Rule (PLLR 8.1) & EMA SmPC Section 4.6
Clinical Risk Summary
FDA Boxed Warning & Contraindication at ≥20 weeks gestation. Administration of NSAIDs at 20 weeks or later can cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. At ≥30 weeks gestation, NSAIDs cause premature closure of the fetal ductus arteriosus and pulmonary hypertension.
Human Pregnancy Experience & Clinical Studies
Post-marketing surveillance and prospective studies show oligohydramnios within days to weeks of regular NSAID therapy at ≥20 weeks gestation, and constriction of ductus arteriosus at ≥30 weeks.
Animal Reproductive & Developmental Toxicity Data
Animal studies demonstrated increased pre- and post-implantation loss and delayed parturition.
Clinical Considerations for Prescribers
Avoid throughout pregnancy, particularly from 20 weeks gestation onward. If NSAID therapy is deemed unavoidable between 20-30 weeks, limit to the lowest effective dose for <48 hours with ultrasound monitoring of amniotic fluid.
Placental Transfer
Crosses the placental barrier into fetal circulation.
Regulatory Warnings & Contraindications
FDA Boxed Warning: This medication carries an official Boxed Warning regarding embryo-fetal toxicity or pregnancy-related adverse outcomes.
Contraindicated in pregnancy at 20 weeks gestation and later due to risk of oligohydramnios, fetal renal dysfunction, and premature closure of ductus arteriosus.
2. Lactation & Breastfeeding Safety
NIH / NLM LactMed® Database & FDA Labeling Section 8.2
Summary of Use during Lactation
Ibuprofen is considered the preferred NSAID of choice during breastfeeding by NIH LactMed and the AAP. It is highly protein-bound (~99%), and extremely low levels appear in breast milk (Relative Infant Dose <1%).
Drug Levels in Breast Milk & Relative Infant Dose
Concentrations in breast milk are undetectable (<0.5 to 1 mg/L) with standard maternal doses.
Effects in Breastfed Infants & Monitored Signs
No adverse events observed in breastfed infants; safe for postpartum analgesia.
Effects on Lactation & Milk Production
No impact on milk supply.
Alternate Medications with Established Lactation Data
4. Regulatory Source Provenance & Comparison
Direct attribution to official regulatory documents without synthesized consensus
| Regulatory Organization | Jurisdiction | Document / Framework | Effective Date | Official Source Link |
|---|---|---|---|---|
|
U.S. Food and Drug Administration (FDA)
FDA Prescribing Information (PLLR)
|
United States | regulatory_label | 2026-07-01 | Official Record |
|
National Institutes of Health (NIH) / NLM
LactMed® Database (Drugs and Lactation)
|
United States / Global | evidence_monograph | 2026-08-01 | Official Record |