What do medical sources say about Lamotrigine (Lamictal) during pregnancy?

1st Trimester: MotherToBaby reports that most studies have not found a higher chance of major birth defects with lamotrigine, but one first-trimester study suggested a small increase in oral clefts. A 2025 review found higher odds in its overall analysis, but not in its cohort-only or more-adjusted analyses, and its authors concluded there was no increased risk. The Lamictal label says pregnancy registries did not find a consistent pattern of major birth defects and notes that most pregnancy data came from people with epilepsy. The AAN, AES, and SMFM guideline cautions against replacing a medicine that controls major seizures after pregnancy begins, because seizures may harm the pregnant person and fetus. The MHRA notes that lamotrigine levels may fall during pregnancy and rise after birth, so monitoring is part of its guidance. Ask your provider about your situation. 2nd Trimester: MotherToBaby reports that lamotrigine has not been linked with preterm delivery or low birth weight; a 2026 EURAP study found lower birthweight centiles for some other medicines compared with lamotrigine, but did not compare with pregnancies without medicine, so it cannot confirm that no-link conclusion. The Lamictal label says human pregnancy registries did not detect more major birth defects or a consistent pattern, although most data came from people with epilepsy. The AAN, AES, and SMFM guideline cautions against replacing a medicine that controls major seizures after pregnancy begins. The MHRA says lamotrigine levels may fall during pregnancy, so monitoring may be part of clinical care. Ask your provider about your situation. 3rd Trimester: MotherToBaby reports that most studies found no behavior or learning differences in children exposed to lamotrigine during pregnancy. A 2026 U.S. health-record study found no meaningful link for most development outcomes but noted a possible signal for intellectual disability based on small numbers. A small 2026 Australian study found similar cognitive results in 23 lamotrigine-exposed children and 19 children not exposed to antiseizure medicines. The Lamictal label reports that lamotrigine levels may rise after birth if a pregnancy dose is not adjusted. The AAN, AES, and SMFM guideline cautions against replacing a medicine that controls major seizures after pregnancy begins. Ask your provider about your situation.

What do medical sources say about Lamotrigine (Lamictal) while breastfeeding?

According to LactMed, breastfeeding during lamotrigine treatment does not appear to affect most infants' growth or development and is not by itself a reason to stop breastfeeding, but rare reactions have been reported. A 2025 Swedish study followed 47 breastfed infants who were also exposed during pregnancy; six had infant blood levels within the adult range used for epilepsy treatment, and one had symptoms judged probably related to lamotrigine. A 2026 MONEAD study found no adverse age-6 language or adaptive-behavior outcomes in children of women with epilepsy who breastfed while using contemporary antiseizure medicines, including lamotrigine. In that cohort, breastfeeding for six months or longer was associated with higher adaptive-behavior scores than no breastfeeding. LactMed describes infant monitoring and maternal dose review after birth, when levels can rise. Ask your provider about your situation.

Where do sources disagree on Lamotrigine (Lamictal) in pregnancy or breastfeeding?

Does first-trimester lamotrigine increase oral-cleft risk? Holmes et al. reported 5 oral clefts among 684 exposed infants (7.3 per 1,000 versus 0.7 per 1,000 in the hospital reference group). The 2025 meta-analysis of 8 studies found an overall odds ratio of 1.42 (95% CI 1.05-1.92), while cohort-only and more-adjusted analyses were not statistically significant. The 2008 EUROCAT analysis found no specific increase with lamotrigine monotherapy (odds ratio 0.67, 95% CI 0.10-2.34). The 2016 EUROCAT analysis reported an adjusted odds ratio of 1.45 (95% CI 0.80-2.63) for isolated oral clefts. The Lamictal label says the signal from one U.S. registry was not seen in other large international registries. The studies used different registry populations, control groups, and study designs. The 2008 signal came from a small exposed group; EUROCAT used malformed controls, and confidence intervals were wide. The 2025 pooled result was not present in cohort-only or more-adjusted analyses. The evidence is inconsistent. The first-trimester signal should remain visible, while the overall evidence does not establish an increased risk or show that the chance is zero.

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Lamotrigine

Medication

Lamictal

Anticonvulsant and mood stabilizer

Pregnancy

Human pregnancy evidence is mainly observational and comes largely from people treated for epilepsy. In the 2008 North American AED Pregnancy Registry report, 5 of 684 exposed infants had oral clefts (7.3 per 1,000), compared with 0.7 per 1,000 in the hospital reference group. A separate 2008 EUROCAT case-control study covering 3.9 million births did not find a specific increase in orofacial clefts with lamotrigine monotherapy, but its confidence intervals were wide. The 2016 EUROCAT analysis covered 21 registries and 10.1 million births; the adjusted odds ratio for isolated oral clefts was 1.45 (95% CI 0.80-2.63). A 2025 meta-analysis of 8 observational studies found an overall odds ratio of 1.42 (95% CI 1.05-1.92), but the result was not statistically significant in cohort-only or more-adjusted analyses; the authors concluded that lamotrigine exposure did not increase oral-cleft risk. This leaves an unresolved, low-frequency signal rather than a settled increase. For major congenital malformations overall, the 2018 prospective EURAP cohort reported 74 cases among 2,514 lamotrigine monotherapy pregnancies (2.9%); the authors placed this within the range reported for pregnancies without antiseizure medicine. This broad result does not resolve the narrower cleft question. The 2026 EURAP fetal-growth study used 4,672 lamotrigine monotherapy pregnancies as its comparator; it did not compare fetal growth with untreated pregnancies. The 2015 EURAP study combined spontaneous abortion and stillbirth as intrauterine death and reported similar rates across antiseizure monotherapies, with higher rates for polytherapy. It did not compare lamotrigine with pregnancies without antiseizure medicine, so a lamotrigine-specific miscarriage risk versus the general population was not verified. A 2026 retrospective cohort reported 1 major malformation among 28 lamotrigine monotherapy pregnancies (3.6%); that estimate is too imprecise to replace larger registries. The AAN, AES, and SMFM guideline review searched evidence through August 2022, so it does not include the 2025-2026 studies summarized here.

Breastfeeding

Lamotrigine passes into milk, and infant blood concentrations can be clinically meaningful. LactMed's March 2026 review recommends monitoring for apnea, rash, drowsiness, and poor sucking, and says to consider infant serum testing when toxicity is a concern; it also notes that maternal serum levels often rise after delivery. In a 2009 case report, a 16-day-old fully breastfed infant developed severe apnea while the mother was taking 850 mg/day; the infant recovered after breastfeeding stopped, and the authors judged the association probable. A 2025 Swedish retrospective cohort included 47 breastfed infants, all with prenatal exposure; six had plasma concentrations within the adult epilepsy-treatment reference range, one had clinical symptoms judged probably related to lamotrigine, and three of 21 tested infants had elevated liver transaminases. The study cannot separate milk exposure from prenatal exposure. In the 2026 MONEAD cohort, age-6 verbal-language and adaptive-behavior outcomes did not significantly differ between children of women with epilepsy and children of healthy women; outcomes were comparable within lamotrigine regimens across breastfeeding duration. The study addresses longer-term outcomes, not rare acute infant reactions. The Mother's 2025 fact sheet also mentions anemia in a breastfeeding case report, but a primary source verifying that specific case was not located; anemia is therefore not repeated in the period summary.

Does first-trimester lamotrigine increase oral-cleft risk?

Source A says: Holmes et al. reported 5 oral clefts among 684 exposed infants (7.3 per 1,000 versus 0.7 per 1,000 in the hospital reference group). The 2025 meta-analysis of 8 studies found an overall odds ratio of 1.42 (95% CI 1.05-1.92), while cohort-only and more-adjusted analyses were not statistically significant. (Holmes et al. 2008, North American AED Pregnancy Registry, Zhao et al. 2025, oral-cleft systematic review and meta-analysis)
Source B says: The 2008 EUROCAT analysis found no specific increase with lamotrigine monotherapy (odds ratio 0.67, 95% CI 0.10-2.34). The 2016 EUROCAT analysis reported an adjusted odds ratio of 1.45 (95% CI 0.80-2.63) for isolated oral clefts. The Lamictal label says the signal from one U.S. registry was not seen in other large international registries. (Dolk et al. 2008, EUROCAT study, Dolk et al. 2016, EUROCAT congenital-anomaly registries, DailyMed: Lamictal prescribing information)
Why they differ: The studies used different registry populations, control groups, and study designs. The 2008 signal came from a small exposed group; EUROCAT used malformed controls, and confidence intervals were wide. The 2025 pooled result was not present in cohort-only or more-adjusted analyses.
What the evidence shows overall: The evidence is inconsistent. The first-trimester signal should remain visible, while the overall evidence does not establish an increased risk or show that the chance is zero.

Neurodevelopment after prenatal lamotrigine exposure

Source A says: The MHRA review and the AAN, AES, and SMFM guideline report that available data do not suggest increased neurodevelopmental risk for lamotrigine, while noting that the evidence cannot rule out an increase. The 2026 Australian cohort found comparable cognitive performance in 23 lamotrigine-exposed children and 19 children not exposed to antiseizure medicines. (MHRA: Antiepileptic drugs in pregnancy, AAN, AES, and SMFM practice guideline, Honybun et al. 2026, Australian neurocognitive cohort)
Source B says: The 2026 U.S. claims cohort found no meaningful lamotrigine association across most neurodevelopmental outcomes but reported a potential signal for intellectual disability; the authors said rare outcomes and multiple comparisons require confirmation. (Straub et al. 2026, prenatal antiseizure-drug neurodevelopment cohort)
Why they differ: The studies used different populations and outcome methods. The U.S. claims study identified diagnoses in health records after second-half pregnancy exposure and had imprecise estimates for rare intellectual disability; the Australian study was small and used direct cognitive testing in children without major congenital anomalies. The guideline's evidence search ended in August 2022.
What the evidence shows overall: No consistent association has been established. The possible intellectual-disability signal merits follow-up but does not overturn the broader monitoring-based guidance.

Folic-acid dose guidance for people with epilepsy taking antiseizure medicine

Source A says: The AAN, AES, and SMFM guideline recommends at least 0.4 mg of folic acid daily before conception and during pregnancy for people with epilepsy taking an antiseizure medicine. (AAN, AES, and SMFM practice guideline)
Source B says: The MHRA says women using antiepileptic medicines who plan pregnancy should be offered 5 mg of folic acid daily before any possibility of pregnancy. (MHRA: Antiepileptic drugs in pregnancy)
Why they differ: These are recommendations from different jurisdictions and review processes, and the optimal dose is not established by a single comparative trial in the cited guidance.
What the evidence shows overall: The guidance differs by jurisdiction. No single folic-acid dose is asserted in the period summaries.

General research, not specific to pregnancy.

The Lamictal label contains a boxed warning about serious skin rashes and contraindicates use in people with demonstrated hypersensitivity to lamotrigine or its ingredients. FDA's 2021 communication described a potential heart-rhythm risk for people with significant heart disease. EMA's 2023 product-information action added HLA-B*1502-associated SJS/TEN information, motor or phonic tics, pseudolymphoma, and overdose-treatment information.

The Lamictal boxed warning states: “LAMICTAL can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to 0.3% in adults receiving LAMICTAL. One rash-related death was reported in a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking LAMICTAL as adjunctive therapy. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate. In addition to age, factors that may increase the risk of occurrence or the severity of rash caused by LAMICTAL include (1) coadministration of LAMICTAL with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of LAMICTAL, (3) exceeding the recommended dose escalation for LAMICTAL, or (4) the presence of the HLA-B*1502 allele. However, cases have occurred in the absence of these factors. Nearly all cases of life-threatening rashes caused by LAMICTAL have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded by the first appearance of a rash. Although benign rashes are also caused by LAMICTAL, it is not possible to predict reliably which rashes will prove to be serious or life threatening. Accordingly, LAMICTAL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related. Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or disfiguring [see Warnings and Precautions (5.1)].” (DailyMed: Lamictal prescribing information)
The Lamictal label states: “LAMICTAL is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients.” (DailyMed: Lamictal prescribing information)
FDA's March 31, 2021 communication says laboratory studies suggest lamotrigine could lead to serious arrhythmias in patients with clinically important structural or functional heart disorders. The current Lamictal label also warns that serious arrhythmias or death are possible in patients with certain underlying cardiac disorders. (FDA: Lamotrigine and heart-rhythm problems, DailyMed: Lamictal prescribing information)
The EMA/CMDh 2023 action states that HLA-B*1502 in people of Asian origin, primarily Han Chinese and Thai, has been associated with SJS/TEN risk with lamotrigine and says use should be carefully considered when a patient is known to carry the allele. The action also added motor and phonic tics, pseudolymphoma, and information about intravenous lipid treatment for cardiotoxicity from overdose. (EMA/CMDh: Lamotrigine PSUSA product-information variation, DailyMed: Lamictal prescribing information)

Last reviewed 2026-10-14

Independent check 2026-10-14

Not yet clinician-reviewed

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