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Is it safe? · Pregnancy Smart

Is Pregabalin (Lyrica) Safe During Pregnancy?

Assigned clinical reviewerMatt Stahl· PharmDDraft · pending clinical reviewUpdated

What does the evidence say about pregabalin during pregnancy?

  1. The 2025 FDA label says observational studies suggest a possible small increase in overall major birth differences without a consistent pattern, while available information is insufficient to identify pregabalin-related miscarriage or long-term developmental risk; the label also directs clinicians to encourage pregnancy-registry enrollment. 1
  2. A prospective multicenter cohort compared 164 pregabalin-exposed pregnancies with 656 matched controls and found major birth differences in 7 of 116 first-trimester exposures versus 12 of 580 controls, but spontaneous abortion was not significantly higher; small numbers, different maternal conditions, and concomitant medicines limit causal interpretation. 2
  3. A US Medicaid cohort of 1,323,432 livebirth pregnancies included 477 first-trimester pregabalin exposures: the crude major-malformation rate was 5.9% versus 3.3%, but the adjusted relative risk was 1.16 with a confidence interval crossing 1, and the monotherapy estimate was 0.87; replication and pooled adjusted estimates were also nonsignificant. 3
  4. A four-country Nordic registry study included about 2,850 pregabalin-exposed births and found no clear association with low birth weight, preterm birth, small size for gestational age, low Apgar score, microcephaly, autism, or intellectual disability; major-malformation and stillbirth estimates were imprecise or attenuated with alternative analyses. 4
  5. A 2025 meta-analysis of seven cohort studies found no statistically significant association between first-trimester pregabalin monotherapy and major congenital malformations among 701 exposed pregnancies, but its pooled odds ratio was 1.79 with a wide 95% confidence interval of 0.80 to 3.99, moderate heterogeneity, and critical risk of bias. 5

Is pregabalin safe in each trimester?

  • First trimester. First-trimester data are the main concern because this is when major structural development occurs. An early small cohort reported a birth-difference signal, but larger adjusted cohorts and a 2025 meta-analysis did not find a statistically significant association. Wide confidence intervals and bias still leave uncertainty, so contact the prescriber rather than stopping abruptly.
  • Second trimester. Pregabalin decisions in the second trimester still depend on why it is used. The large Nordic cohort did not find clear associations with preterm birth, low birth weight, or low Apgar score after adjusted and active-comparator analyses, but prescription records cannot confirm every dose taken and residual confounding remains possible.
  • Third trimester. Late-pregnancy human information is less complete than first-trimester malformation data. The Nordic study did not find clear associations with preterm birth or low Apgar score, while FDA says postmarketing evidence is insufficient for several fetal and long-term outcomes. Review the delivery medication plan and any dose change with the prescribing and obstetric teams.

Frequently asked questions

Is Lyrica safe to take during pregnancy?

Lyrica cannot be labeled risk-free during pregnancy. The current FDA label describes a possible small increase in overall major birth differences without a consistent pattern, while larger adjusted studies and a 2025 meta-analysis did not find statistically significant associations. The reason for use and the consequences of changing it are part of the decision.

Does pregabalin increase the risk of miscarriage?

A prospective cohort did not find a statistically significant increase in spontaneous abortion after pregabalin exposure. FDA says the overall postmarketing information remains insufficient to identify a miscarriage risk. These findings do not prove zero risk, but they also do not support telling someone that pregabalin caused a miscarriage.

Does pregabalin cause birth defects?

The evidence is unsettled. A small early cohort reported 7 major birth differences among 116 first-trimester exposures versus 12 among 580 controls. Larger adjusted analyses did not confirm a statistically significant increase, and a 2025 meta-analysis was also nonsignificant but too imprecise and biased to exclude a meaningful increase.

Should I stop pregabalin after a positive pregnancy test?

Contact the pregabalin prescriber promptly, but do not stop suddenly on your own. FDA advises gradual withdrawal because abrupt or rapid discontinuation can cause insomnia, nausea, headache, anxiety, sweating, and diarrhea, and can increase seizure frequency in people with seizure disorders. The prescriber can weigh a gradual change against the reason pregabalin was prescribed.

Is gabapentin safer than pregabalin during pregnancy?

No head-to-head pregnancy evidence proves that gabapentin is safer overall than pregabalin. A large Nordic fetal-growth cohort found no small-for-gestational-age association for gabapentin, while a pregabalin association appeared in the full population but not among mothers with epilepsy. That single outcome cannot rank the medicines for birth differences, seizures, pain control, or newborn effects.

Do you need high-dose folic acid if you take pregabalin?

High-dose folic acid is not automatically established for every person taking pregabalin. For people with epilepsy taking any antiseizure medicine, the 2024 AAN, AES, and SMFM guideline recommends at least 0.4 mg daily before conception and during pregnancy. Your neurology and obstetric teams should choose the amount based on your indication, prenatal vitamin, and individual risks.

Does pregabalin raise the chance of preterm birth or poor fetal growth?

The four-country Nordic study did not find a clear pregabalin association with preterm birth, low birth weight, or small size for gestational age after adjusted and active-comparator analyses. A separate fetal-growth cohort found a small association in the overall population but not among mothers with epilepsy, which points to possible confounding rather than a settled causal effect.

What pregnancy registry is available for Lyrica exposure?

The North American Antiepileptic Drug Pregnancy Registry collects outcomes after exposure to medicines such as Lyrica. The current FDA label encourages pregnant patients taking pregabalin to enroll. Registration adds data for future guidance, but it does not replace medication review or provide an immediate prediction for an individual pregnancy.

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References

  1. LYRICA (pregabalin) capsules and oral solution

    FDA · https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021446s046%2C022488s022lbl.pdf

  3. Pregabalin use early in pregnancy and the risk of major congenital malformations

    PMC · https://pmc.ncbi.nlm.nih.gov/articles/PMC5440246/

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.