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CLINICAL EVIDENCE CENTER

Pregnancy & Lactation Drug Safety

Structured, evidence-based medication safety data aggregated directly from U.S. FDA Prescribing Labels (PLLR), NIH LactMed®, and EMA Product Characteristics.

U.S. FDA (PLLR) NIH / NLM LactMed® EMA (SmPC 4.6) DailyMed (SPL)
Clinical & Educational Disclaimer: This portal provides reference safety information compiled from official regulatory labeling and clinical databases. Labeling and safety evidence vary by jurisdiction and clinical context. This tool does not constitute medical advice or replace individualized clinical evaluation by a qualified healthcare professional.
Database Coverage & Provenance
Aggregated from Authoritative Sources
5,652 Active Ingredients Indexed
6,726 Pregnancy Monograph Records
398 LactMed® Breastfeeding Records
4 Regulatory Sources Connected
Evidence Notice: Coverage varies by source and jurisdiction. In accordance with the FDA Pregnancy and Lactation Labeling Rule (PLLR), modern evaluations rely on detailed clinical risk narratives rather than artificial universal letter categories.

Key Medication Safety Profiles

Frequently referenced active ingredients across maternal-fetal medicine and lactation.

Analgesic & Antipyretic PLLR 8.1

Acetaminophen

First-Line Analgesic (Safe in All Trimesters)
Pregnancy
PLLR Indexed
Lactation RID
<2%
View Clinical Monograph
NSAID PLLR 8.1

Ibuprofen

Boxed Warning ≥20 Weeks (Oligohydramnios)
Pregnancy
PLLR Indexed
Lactation RID
<1% (Preferred in Lactation)
View Clinical Monograph
Penicillin Antibacterial PLLR 8.1

Amoxicillin

First-Line Antibacterial (Safe)
Pregnancy
PLLR Indexed
Lactation RID
<0.5%
View Clinical Monograph
ACE Inhibitor PLLR 8.1

Lisinopril

Boxed Warning: Severe Fetal Toxicity
Pregnancy
PLLR Indexed
Lactation RID
Limited Data (Monitor BP)
View Clinical Monograph
HMG-CoA Reductase Inhibitor PLLR 8.1

Atorvastatin

Contraindicated in Pregnancy
Pregnancy
PLLR Indexed
Lactation RID
Not Recommended
View Clinical Monograph
Biguanide Antidiabetic PLLR 8.1

Metformin

Gestational Diabetes Alternative (Safe)
Pregnancy
PLLR Indexed
Lactation RID
<1.1%
View Clinical Monograph
5-HT3 Antiemetic PLLR 8.1

Ondansetron

Second-Line for Hyperemesis Gravidarum
Pregnancy
PLLR Indexed
Lactation RID
<1.5%
View Clinical Monograph
SSRI Antidepressant PLLR 8.1

Sertraline

Preferred SSRI in Pregnancy & Lactation
Pregnancy
PLLR Indexed
Lactation RID
<2.2%
View Clinical Monograph
Vitamin K Antagonist PLLR 8.1

Warfarin

Boxed Warning: Fetal Warfarin Syndrome
Pregnancy
PLLR Indexed
Lactation RID
<0.1% (Safe in Lactation)
View Clinical Monograph
Systemic Retinoid PLLR 8.1

Isotretinoin

Severe Teratogen (iPLEDGE REMS)
Pregnancy
PLLR Indexed
Lactation RID
Not Recommended
View Clinical Monograph
Salicylate / Antiplatelet PLLR 8.1

Aspirin

Low-Dose: Preeclampsia Prevention (12-36w)
Pregnancy
PLLR Indexed
Lactation RID
Low-Dose Safe
View Clinical Monograph
Beta-1 Blocker PLLR 8.1

Atenolol

Avoid: Intrauterine Growth Restriction
Pregnancy
PLLR Indexed
Lactation RID
6.6% - 19% (Avoid in Lactation)
View Clinical Monograph

Clinical Evidence & Provenance Standard

FDA PLLR Labeling Rule

Integrates structured narratives from Section 8.1 (Pregnancy), 8.2 (Lactation), and 8.3 (Females and Males of Reproductive Potential) replacing legacy, non-nuanced letter categories.

NIH LactMed® Database

Quantifies maternal milk concentrations, Relative Infant Dose (RID percentages), infant serum levels, and observed adverse effects during breastfeeding.

Multi-Jurisdiction Provenance

Preserves distinct regulatory text from US FDA and European EMA Section 4.6 with exact timestamps, preventing synthetic or fabricated global consensus.

System Notice

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