Aripiprazole

Pregnancy

MotherToBaby says studies have not found a higher chance of birth defects, but the human evidence is limited. Freeman et al. (2021) included 158 first trimester exposed mothers and 690 controls; among 163 exposed infants, 7 (4.29%) had a major malformation, compared with 14 of 690 controls (1.99%). The adjusted odds ratio was 1.35 (95% CI 0.43 to 4.20), not statistically significant, and the authors noted the small sample. Bellet et al. (2015) included 86 exposed and 172 comparison patients; the odds ratio for miscarriage was 1.66 (95% CI 0.63 to 4.38), not statistically significant. Sakai et al. (2017) found a miscarriage reporting signal in Japan's spontaneous adverse-event database (reporting odds ratio 2.76, 95% CI 1.62 to 4.69; 18 reports). This database has no pregnancy denominator and cannot estimate a person's chance of miscarriage or show that the medicine caused it. The 2026 correction to Wang et al.'s network meta-analysis removed overlapping study data. It reports 21 included studies and 1,701,089 pregnancies overall, with 15 studies and 1,698,670 participants reporting the main malformation outcome; its corrected estimate for aripiprazole was OR 1.29 (95% CrI 1.001 to 1.93), described as a slight increase. The correction says these pooled estimates were unadjusted and contrasts them with Huybrechts et al. (2023), whose large Nordic and US cohort found that in utero antipsychotic exposure generally was not meaningfully associated with increased malformation risk after adjusted analyses; that study's conclusion is class-wide, not an aripiprazole-specific null result. Bellet et al. reported higher rates of prematurity (OR 2.57, 95% CI 1.06 to 6.27) and fetal growth restriction (OR 2.97, 95% CI 1.23 to 7.16), but said short maternal exposure made these findings difficult to interpret. Galbally et al. (2018) reported lower birth weight, shorter gestation, more pregnancy hypertension, and more neonatal admissions in a preliminary study of 26 patients, and called for larger studies because confounding could explain the findings. Quinn et al. (2026) reviewed 12 class-wide studies covering more than 10 million pregnancies; it found no association for second generation antipsychotics as a group with malformations (OR 1.16, 95% CI 0.78 to 1.72) and an association between antipsychotic exposure overall and preterm birth (OR 1.35, 95% CI 1.13 to 1.62), with substantial heterogeneity. These results do not isolate aripiprazole. Obara et al. (2026) found no adjusted association between first trimester exposure to any antipsychotic and overall major malformations in a Japanese claims cohort; only 317 patients with psychiatric disorders were exposed to any antipsychotic, and results were not separated for aripiprazole. Rath et al. (2026) found reduced viability in a placental cell model at aripiprazole concentrations of at least 10 micromolar; this laboratory result does not establish a human pregnancy outcome. FDA labeling says available epidemiologic studies have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. EMA product information says pregnancy use should occur only if the expected benefit clearly justifies the potential risk because human information is insufficient and animal studies raised concerns. The FDA class warning, added to labeling in 2011 and retained in current labeling, says third trimester exposure to antipsychotics can be followed by newborn movement or withdrawal symptoms.

Breastfeeding

LactMed reports that maternal doses up to 15 mg daily produce low milk levels, but aripiprazole can lower prolactin and reports include poor milk supply, lactation cessation, and infant weight loss or poor weight gain. The source advises watching for dehydration and lack of appropriate weight gain, and says another drug may be preferred, especially for a newborn or preterm infant. NHS SPS estimates variable, small milk amounts of 0.7% to 8.3% of the weight adjusted maternal dose, allows oral use with caution and infant monitoring, and prefers other antipsychotics. Nanjundaswamy et al. (2025) reviewed 35 postpartum patients who continued aripiprazole; 26 (74%) had complete lactation failure and 4 (11%) had insufficient milk production. Spann et al. (2025) identified 34 breastfeeding cases at multiple sites; 23 (73.5%) stopped breastfeeding by the last midwife visit, 8 (23.5%) supplemented with formula, and one exclusively breastfed. Both series measured feeding or milk production in selected retrospective samples, without a comparison group, and do not establish the rate of problems among all users or prove direct infant effects from medicine in milk. The direct infant data are sparse. FDA labeling says to monitor breastfed infants for dehydration and lack of appropriate weight gain. EMA product information says the decision about breastfeeding should weigh benefits to the child against benefits of treatment for the mother.

What was tested

Pregnancy evidence includes observational cohorts, a prospective pregnancy registry, a spontaneous adverse-event reporting analysis, and reviews of observational studies; randomized pregnancy trials were not identified. The 2026 corrected network meta-analysis used pooled unadjusted estimates, while the largest cohort comparison used adjusted analyses. Newborn movement or withdrawal concerns come mainly from antipsychotic class labeling and small observational reports. Breastfeeding evidence includes small milk-level reports, case reports, and two retrospective chart studies that measured milk supply and breastfeeding outcomes rather than direct infant drug effects. The 2026 placental study used a cell model, not pregnant people.