Is Concerta (methylphenidate) safe during pregnancy?

Concerta (Methylphenidate) Safety in Pregnancy

Concerta (methylphenidate) does not appear to be associated with major congenital malformations or other significant adverse obstetrical or developmental outcomes, making it a reasonable option when ADHD treatment is necessary during pregnancy. 1

Overall Safety Profile

• Methylphenidate overall does not seem to be associated with major congenital malformations or other significant adverse obstetrical or developmental outcomes. 1
• Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. 2
• The FDA label states that no effects on morphological development were observed in animal studies at doses up to 12 times the maximum recommended human dose. 2

Specific Risks to Consider

Cardiac Malformations

• There is a possible increased risk for cardiac malformations (OR 1.59; 95% CI 1.02-2.49), but this risk appears to be small with an absolute risk of only 1.7%. 1
• Other studies have not consistently found this association, and the statistical significance of this finding is questionable. 1, 3
• A 2024 meta-analysis involving over 16 million pregnant women found no significant increase in congenital anomalies (OR 1.14; 95% CI 0.83-1.55). 4

Gastroschisis

• There is a possible increased risk for gastroschisis (aOR 3.0; 95% CI 1.2-7.4), though the absolute risk remains extremely small given the population prevalence of only 0.05%. 1
• This finding comes from one study and may be confounded by indication, with other studies not replicating this association. 1

Obstetrical Complications

• Possible small increased risk for preeclampsia (aRR 1.29; 95% CI 1.11-1.49), though other studies have not consistently found this association. 1
• Possible small increased risk for preterm birth (aOR 1.3; 95% CI 1.1-1.6), but the magnitude of risk is modest. 1
• Possible increased risk for spontaneous abortion, though confounding by indication cannot be ruled out. 1
• Possible increased risk for poor neonatal adaptation (23.6% vs 13.5%; P = 0.05), though this difference was only marginally statistically significant. 1
• Possible increased risk for NICU admission (aOR 1.5; 95% CI 1.3-1.7). 1

Clinical Recommendations

When to Use

• If ADHD treatment is necessary during pregnancy, methylphenidate is the preferred stimulant because the overall safety data are more reassuring than for amphetamines, and breastfeeding is possible. 5
• The treating physician should weigh the need for treatment against the severity of ADHD symptoms and functional impairment. 1

Monitoring

• Consider fetal echocardiography given the possible (though small) increased risk of cardiac malformations. 6
• Monitor for signs of preeclampsia and preterm labor throughout pregnancy. 1
• Monitor infants for poor neonatal adaptation, including irritability, feeding difficulties, and need for NICU admission. 1

Important Caveats

• Confounding by indication is a major limitation across all observational studies—women with ADHD may have baseline increased risks independent of medication use. 1, 3
• Absence of evidence of risk is not evidence of absence of risk, as long-term neurodevelopmental outcomes have not been adequately studied. 3, 5
• CNS stimulants can cause vasoconstriction and thereby decrease placental perfusion, though no specific fetal/neonatal adverse reactions have been reported with therapeutic doses. 2
• A pregnancy exposure registry exists (National Pregnancy Registry for Psychostimulants: 1-866-961-2388) and healthcare providers are encouraged to register patients. 2