Levetiracetam
MedicationAntiseizure medication
Research strength: 4 / 5
FDA labeling says that human reports have not established a link between levetiracetam and major birth defects or miscarriage, but they cannot rule out all risk. The North American registry reported major birth defects in 26 of 1,283 first-trimester levetiracetam-only pregnancies (2.0%), and EURAP reported 33 of 1,325 exposed pregnancies (2.5%); these are observed registry rates, not proof that risk is absent. The AAN, AES, and SMFM guideline includes levetiracetam among medicines clinicians may consider when it fits the epilepsy type and the chance of seizure control. FDA labeling says levels can decline during pregnancy, and FDA warns that sudden stopping may lead to uncontrolled seizures. Ask your provider about your situation.
Last reviewed: 2026-10-14
Sources
- DailyMed: Levetiracetam tabletsDrug company label
- Hernandez-Diaz et al., North American Antiepileptic Drug Pregnancy Registry study
- Battino et al., EURAP major-malformation cohortUS government
- AAN, AES, and SMFM practice guidelineUS government
- FDA DRESS Drug Safety CommunicationUS government
Research strength: 4 / 5
FDA labeling says the human literature has not established a link with major birth defects or miscarriage, but the available studies cannot rule out all risk. The pregnancy registries report overall rates, not a separate second-trimester risk estimate. The AAN, AES, and SMFM guideline includes levetiracetam among options clinicians may consider when appropriate for a person's epilepsy and chance of seizure control. FDA labeling says blood levels may fall during pregnancy, with a larger decline reported in the third trimester; FDA also warns that stopping suddenly can lead to uncontrolled seizures. Ask your provider about your situation.
Last reviewed: 2026-10-14
Sources
- DailyMed: Levetiracetam tabletsDrug company label
- AAN, AES, and SMFM practice guidelineUS government
- Battino et al., EURAP major-malformation cohortUS government
- Hernandez-Diaz et al., North American Antiepileptic Drug Pregnancy Registry study
- FDA DRESS Drug Safety CommunicationUS government
Research strength: 4 / 5
FDA labeling says human studies have not established a link to major birth defects or miscarriage, but cannot prove that no risk exists. A 2026 US cohort with 5,261 levetiracetam-exposed pregnancies found no increase across its studied child-development outcomes, while a separate 2026 study reported an autism signal based on 15 exposed cases; both studies were observational, so the findings remain uncertain. EMA updated product information in 2025 based on newer observational data and said the medicine's benefit-risk balance was unchanged. FDA labeling says levels may decline more in the third trimester and recommends monitoring through postpartum; FDA also warns that sudden stopping can lead to uncontrolled seizures. Ask your provider about your situation.
Last reviewed: 2026-10-14
Sources
- DailyMed: Levetiracetam tabletsDrug company label
- Straub et al., BMJ prenatal antiseizure-drug neurodevelopment cohortUS government
- Sheehy et al., Annals of Neurology multi-cohort study
- EMA Keppra scientific conclusionEU agencyEuropean guidance
- FDA DRESS Drug Safety CommunicationUS government
Levetiracetam — Breastfeeding
Research strength: 3 / 5
LactMed reports that milk levels can be high for some mothers and may sometimes cause drowsiness or other effects in babies; it says the medicine does not automatically mean breastfeeding must stop. In one study of 20 mothers and 21 babies, three fully breastfed babies were reported as drowsy; drowsiness improved after partial breastfeeding, and all 21 gained weight for age. NHS says levetiracetam is not usually used while breastfeeding, which is more cautious than LactMed's wording. FDA labeling says the drug enters milk but notes no infant or milk-supply data, although small studies have measured milk levels and infant outcomes. FDA warns that sudden stopping may lead to uncontrolled seizures, and LactMed advises monitoring for sleepiness and weight gain. Ask your provider about your situation.
Last reviewed: 2026-10-14
Sources
- LactMed: LevetiracetamUS government
- Dinavitser et al., Levetiracetam in lactation
- NHS: LevetiracetamUK government
- DailyMed: Levetiracetam tabletsDrug company label
- FDA DRESS Drug Safety CommunicationUS government
Pregnancy
Human pregnancy evidence is observational. In the EURAP registry, 33 of 1,325 levetiracetam monotherapy pregnancies had a major congenital malformation (2.5%; 95% CI 1.8% to 3.5%). The 2025 North American Antiepileptic Drug Pregnancy Registry study reported 26 of 1,283 first-trimester levetiracetam monotherapy exposures with a major malformation (2.0%). In a first-trimester cohort, Hoeltzenbein et al. found no significant increase in major birth defects or spontaneous abortion with levetiracetam monotherapy (n=221); the higher spontaneous-abortion estimate was in the separate levetiracetam-plus-lamotrigine group, not levetiracetam alone. A 2026 Scotland population cohort included 1,086 levetiracetam monotherapy pregnancies; its authors said the findings support levetiracetam during pregnancy, while noting that pregnancy-loss outcomes include both spontaneous loss and termination and that subgroup estimates are limited. For child development, a 2026 BMJ cohort found no increase in any studied neurodevelopmental outcome among 5,261 levetiracetam-exposed pregnancies, while a 2026 five-cohort analysis reported an elevated autism estimate (p-aHR 3.62, 95% CI 1.84 to 7.11) based on 15 cases; the latter did not find a significant increase in combined neurodevelopmental disorders. These studies use different exposure windows, comparison groups, and outcome definitions, so the findings remain mixed. A 2026 Korean cohort did not report an overall anomaly increase for levetiracetam, but named hypospadias as a specific signal and called for confirmation because case numbers were limited. A 2026 EURAP fetal-growth study found a lower birthweight-centile estimate for levetiracetam monotherapy than lamotrigine (adjusted coefficient -2.51, 95% CI -4.38 to -0.63; n=1,809); this active-medication comparison does not show a difference from no medication. The AAN, AES, and SMFM guideline says levetiracetam concentrations may decrease at any point in pregnancy; DailyMed says the decrease is more pronounced during the third trimester.
Breastfeeding
LactMed reports that milk concentrations can be high in some mothers and that infants may sometimes be sleepy or have other effects. Dinavitser et al. studied 20 mothers and 21 infants (16 fully and 5 partially breastfed). The relative infant dose averaged 13.8% with full breastfeeding and 6.9% with partial breastfeeding; 3 fully breastfed infants had drowsiness that resolved after a change to partial breastfeeding, and all 21 infants gained weight for age. The study was small and does not establish the frequency of rare or long-term effects. LactMed says levetiracetam does not necessarily require stopping breastfeeding, while the NHS says it is not usually used during breastfeeding. The DailyMed label says the medicine enters milk and states that it has no data on infant effects or milk production; the small published studies described by LactMed provide some exposure and infant observations, but do not settle the difference in guidance.
A listed U.S. levetiracetam tablet label contains levetiracetam as the active ingredient. For that tablet product, listed inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide, and triacetin. This ingredient list is product-specific.
What was tested
The pregnancy registries and cohorts used medication records and pregnancy or child outcomes; they were observational rather than randomized trials. Outcomes included major congenital malformations, pregnancy loss, fetal growth, and child-development diagnoses or concerns. The 2026 US cohort defined exposure by a filled prescription during the second half of pregnancy and followed children for recorded diagnoses. The breastfeeding study measured maternal blood and milk concentrations and recorded infant feeding, drowsiness, and weight gain in 21 infants. Small samples, prescription records that do not confirm ingestion, different comparison groups, and limited follow-up affect how precisely these studies can estimate uncommon or long-term outcomes.
Breastfeeding guidance
- Source A says
- LactMed says that if levetiracetam is needed by the mother, it is not necessarily a reason to discontinue breastfeeding, with infant monitoring. (LactMed: Levetiracetam)
- Source B says
- The NHS says levetiracetam is not usually used while breastfeeding because it can pass into breast milk. (NHS: Levetiracetam)
- Why they differ
- The sources use different levels of caution. LactMed reviews milk and infant observations, while the NHS page gives brief public guidance. The available primary evidence is small and does not settle whether exposure causes adverse outcomes.
- What the evidence shows overall
- Show both positions and the limited human data without choosing one as a universal conclusion. Keep the guidance rating and describe monitoring in the breastfeeding summary.
Child neurodevelopment after pregnancy exposure
- Source A says
- The Annals of Neurology 2026 study reported a higher autism estimate for levetiracetam exposure (p-aHR 3.62, 95% CI 1.84 to 7.11), based on 15 exposed cases. (Sheehy et al., Annals of Neurology multi-cohort study)
- Source B says
- The BMJ 2026 cohort found no increased risk of any studied neurodevelopmental outcome among 5,261 levetiracetam-exposed pregnancies. (Straub et al., BMJ prenatal antiseizure-drug neurodevelopment cohort)
- Why they differ
- The studies used different exposure windows, comparison groups, and outcome definitions. The Annals estimate is based on 15 cases, while the BMJ analysis used a larger levetiracetam cohort and a different follow-up and case definition.
- Other sources
- EMA's 2025 review required product-information changes based on newer observational data but stated that the benefit-risk balance was unchanged. (EMA Keppra scientific conclusion, PRAC/CHMP)
- What the evidence shows overall
- The autism estimate is a signal that needs follow-up, not proof of a cause. The larger BMJ analysis found no increase, and EMA's action did not state that harm was established. Keep the rating and stars, and make the mixed evidence visible.
- The AAN, AES, and SMFM guideline says clinicians should select an antiseizure medicine and dose that support both seizure control and fetal outcomes, and lists levetiracetam among options when appropriate for the person's epilepsy syndrome and health context. (AAN, AES, and SMFM practice guideline)
- DailyMed labeling recommends careful monitoring during pregnancy and continued monitoring postpartum, especially if the dose changed during pregnancy. (DailyMed: Levetiracetam tablets)
- LactMed says breastfed infants should be monitored for drowsiness, adequate weight gain, and developmental milestones, with added attention for younger exclusively breastfed infants and when other antiseizure medicines are used. (LactMed: Levetiracetam)
General research, not specific to pregnancy.
FDA warns that levetiracetam can rarely cause DRESS, a serious reaction that can involve fever, rash, swollen lymph nodes, and injury to internal organs. FDA required a DRESS warning in prescribing information and patient Medication Guides. FDA also warns that suddenly stopping levetiracetam can lead to uncontrolled seizures.
- FDA's 2023 communication describes DRESS as a rare, potentially life-threatening reaction and required warnings in prescribing information and Medication Guides. FDA's reported cases do not provide an incidence estimate. (FDA Drug Safety Communication: DRESS with levetiracetam and clobazam, DailyMed: Levetiracetam tablets, DRESS warning)
- FDA warns that suddenly stopping levetiracetam can lead to uncontrolled seizures. (FDA Drug Safety Communication, sudden stopping warning)
- DailyMed: Levetiracetam tablets, Cardinal Health 107Drug company labelTertiaryPage dated 2025-04-01Independent check
- LactMed: LevetiracetamUS governmentSecondaryPage dated 2025-11-15Independent check
- AAN, AES, and SMFM practice guidelineUS governmentSecondaryPage dated 2024-05-15Independent check
- EMA Keppra scientific conclusion, PRAC/CHMPEU agencySecondaryPage dated 2025-07-24Independent checkEuropean guidance
- FDA Drug Safety Communication: DRESS with levetiracetam and clobazamUS governmentSecondaryPage dated 2023-11-28Independent check
- NHS: LevetiracetamUK governmentSecondaryIndependent check
- MHRA: Antiepileptic drugs in pregnancy, updated adviceUK governmentSecondaryPage dated 2021-01-07Independent check
- Battino et al., EURAP major-malformation cohortUS governmentPrimaryPage dated 2024-03-18
- Hernandez-Diaz et al., North American Antiepileptic Drug Pregnancy Registry studyPrimaryPage dated 2025-07-16
- Hoeltzenbein et al., Epilepsia observational cohortPrimaryPage dated 2023-11-28Independent check
- Moore et al., Scotland antiseizure medication pregnancy cohortUS governmentPrimaryIndependent check
- Straub et al., BMJ prenatal antiseizure-drug neurodevelopment cohortUS governmentPrimaryIndependent check
- Sheehy et al., Annals of Neurology multi-cohort studyPrimaryPage dated 2025-11-28
- Kim et al., Korean nationwide congenital-anomaly cohortPrimaryPage dated 2025-12-10
- Perucca et al., EURAP fetal-growth cohortPrimary
- Dinavitser et al., British Journal of Clinical Pharmacology lactation studyPrimaryIndependent check
Last reviewed 2026-10-14
Independent check 2026-10-14
Not yet clinician-reviewed
Ask your provider about your situation.
Similar medications
- Lamotrigine
- Carbamazepine
- Phenytoin
- Valproic Acid