Lisdexamfetamine
MedicationVyvanse
CNS stimulant
Research strength: 3 / 5
MotherToBaby explains that lisdexamfetamine breaks down into dextroamphetamine, so its pregnancy evidence is indirect; Huybrechts et al. found no increased overall or heart-malformation risk in a large cohort of amphetamine-exposed pregnancies, but the results do not isolate lisdexamfetamine. A Norwegian register study reported higher miscarriage odds with lisdexamfetamine prescription fills (aOR 1.81, 95% CI 1.06-3.10); fills do not show actual use. The current FDA label says human data are insufficient to inform risks for major birth defects and miscarriage and warns that lisdexamfetamine may cause fetal harm. The FDA boxed warning states: 'Lisdexamfetamine dimesylate capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including lisdexamfetamine dimesylate capsules, can result in overdose and death.' Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- MotherToBaby: Dextroamphetamine (Adderall) Fact SheetTeratology service
- Huybrechts et al., JAMA Psychiatry 2018US government
- Srinivas et al., Attention-deficit hyperactivity disorder medication use in pregnancy and risk of miscarriageUS government
- DailyMed: Lisdexamfetamine dimesylate capsule labelDrug company label
- FDA: Prescription stimulant boxed-warning updateUS government
Research strength: 3 / 5
MotherToBaby says pregnancy evidence is indirect and findings for preterm birth and high blood pressure conditions are mixed; Cohen et al. found a small association with preeclampsia for early stimulant exposure and higher preterm-birth risk among those continuing after 20 weeks, but the study did not isolate lisdexamfetamine. Recent Norwegian, US, and Australian cohorts also report associations with some outcomes across ADHD medicines; these studies are observational and do not establish a lisdexamfetamine-specific effect. The FDA label says human data are insufficient to inform risks for major birth defects and miscarriage and warns that lisdexamfetamine may cause fetal harm. The FDA boxed warning states: 'Lisdexamfetamine dimesylate capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including lisdexamfetamine dimesylate capsules, can result in overdose and death.' Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- MotherToBaby: Dextroamphetamine (Adderall) Fact SheetTeratology service
- Cohen et al., Placental Complications Associated With Psychostimulant Use in PregnancyUS government
- Srinivas et al., ADHD Medication Use in Pregnancy and Risk of Preterm BirthUS government
- Hasan et al., Prescription Stimulant Continuation in Pregnancy and Birth OutcomesUS government
- Sit et al., ADHD Medication Use During Pregnancy and Cardiometabolic ConditionsUS government
- DailyMed: Lisdexamfetamine dimesylate capsule labelDrug company label
- FDA: Prescription stimulant boxed-warning updateUS government
Research strength: 3 / 5
MotherToBaby says withdrawal has not been reported in newborns when dextroamphetamine was taken as prescribed, while higher-dose or nonprescribed amphetamine use may cause temporary jitteriness, sleepiness, or trouble breathing around birth. The FDA label says human data cannot determine the risks of major birth defects or miscarriage and includes a warning that lisdexamfetamine may cause fetal harm. An Australian cohort of women prescribed dexamphetamine or lisdexamfetamine found no statistically significant difference in newborn abstinence diagnoses between continuers and those who stopped, but it cannot rule out uncommon outcomes. The FDA boxed warning states: 'Lisdexamfetamine dimesylate capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including lisdexamfetamine dimesylate capsules, can result in overdose and death.' Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- MotherToBaby: Dextroamphetamine (Adderall) Fact SheetTeratology service
- Russell et al., Neurodevelopmental outcomes of children exposed to dexamphetamine during pregnancyUS government
- DailyMed: Lisdexamfetamine dimesylate capsule labelDrug company label
- FDA: Prescription stimulant boxed-warning updateUS government
Lisdexamfetamine — Breastfeeding
Research strength: 2 / 5
DailyMed says breastfeeding is not recommended during lisdexamfetamine treatment because potential serious infant reactions include cardiovascular effects, increased blood pressure and heart rate, suppressed growth, and peripheral vasculopathy; LactMed notes that some experts allow therapeutic amphetamine use with monitoring for infant irritability, insomnia, and feeding difficulty, while long-term development data remain limited. A small prospective study followed 13 infants exposed to lisdexamfetamine or mixed amphetamine salts; possible symptoms were reported in some infants, while developmental scores were normal, so the study cannot resolve the risk. The FDA boxed warning states: 'Lisdexamfetamine dimesylate capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including lisdexamfetamine dimesylate capsules, can result in overdose and death.' Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
Pregnancy
Huybrechts et al. (2018) pooled large US and Nordic pregnancy cohorts and found no increased risk of any malformations with amphetamine exposure (RR 1.05, 95% CI 0.93-1.19) or cardiac malformations (RR 0.96, 95% CI 0.78-1.19). The evidence concerns amphetamines overall, not lisdexamfetamine alone. A Norwegian register study of 13,298 pregnancies reported an association between lisdexamfetamine prescription fills and miscarriage (aOR 1.81, 95% CI 1.06-3.10); the authors caution that filled prescriptions may not reflect actual use. In a large US cohort, early stimulant exposure was associated with preeclampsia (aRR 1.29, 95% CI 1.11-1.49), while continuation after 20 weeks was associated with preterm birth (aRR 1.30, 95% CI 1.10-1.55). A 2025 Nordic cohort of 11,075 pregnancies found higher preterm-birth risk with at least two early ADHD-medication fills (aRR 1.29, 95% CI 1.08-1.53); any late use was not statistically significant, though risk estimates rose with each 30 days of late exposure. More recent US and Australian studies also report associations between continued stimulant or ADHD-medication exposure and some obstetric outcomes, but they combine drug classes and are observational. In the NSW cohort, only 27 participants were identified as exposed to lisdexamfetamine, so pooled class results provide little LDX-specific precision.
Breastfeeding
LactMed describes a prospective follow-up of 13 breastfed infants whose mothers took lisdexamfetamine (6) or mixed amphetamine salts (7). Five infants had possible amphetamine-related symptoms, including sleepiness, crying or restlessness, colic, or constipation; all had normal Denver developmental and pediatric quality-of-life scores. The primary pilot abstract also reports normal neurodevelopment and no significant adverse effects, while stressing that larger studies are needed. This sample is too small to rule out uncommon effects or establish long-term outcomes. LactMed also notes that long-term neurodevelopmental effects of dextroamphetamine in milk have not been well studied and that high doses might affect milk production, especially before lactation is established. DailyMed says breastfeeding is not recommended during treatment because of potential serious infant reactions, including cardiovascular effects, increased blood pressure and heart rate, growth suppression, and peripheral vasculopathy.
Lisdexamfetamine is a prodrug that the body converts to dextroamphetamine. It is a central nervous system stimulant prescribed for ADHD and, in adults, binge-eating disorder. The current label carries a boxed warning for abuse, misuse, and addiction, including the risk of overdose and death from misuse or abuse.
What was tested
Pregnancy evidence includes observational registry, claims, and cohort studies, a pooled malformation analysis, and a perinatal ADHD guideline review. Most studies rely on prescription fills or dispensing records rather than confirmed use; several combine lisdexamfetamine with other stimulants or ADHD medicines. The Norwegian miscarriage study reports an LDX-specific association, but cannot show that filled prescriptions were taken or establish causation. Breastfeeding evidence includes small human follow-up studies and a 13-infant pilot; it is not large enough to assess uncommon infant reactions or long-term development. No randomized trial testing pregnancy or breastfeeding outcomes was identified.
Miscarriage risk with prescribed amphetamines
- Source A says
- MotherToBaby says studies of prescribed amphetamines as a group have not shown a consistent increase in miscarriage. (MotherToBaby: Dextroamphetamine (Adderall) Fact Sheet)
- Source B says
- A Norwegian register study found higher miscarriage odds associated with lisdexamfetamine prescription fills (aOR 1.81, 95% CI 1.06-3.10). (Srinivas et al., British Journal of Psychiatry: ADHD medication use in pregnancy and risk of miscarriage)
- Why they differ
- The MotherToBaby statement summarizes earlier evidence across prescribed amphetamines, while the newer study reports an LDX-specific association. Prescription fills may not represent actual use, and observational data cannot establish that the medicine caused the outcome.
- Other sources
- The current FDA label says the available human data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. (DailyMed: Lisdexamfetamine dimesylate capsule label)
- What the evidence shows overall
- The newer association is important and should be disclosed, but uncertainty about actual exposure and confounding means it does not establish causation. Earlier mixed evidence and the label's data limitation should remain visible alongside it.
Preeclampsia, hypertension, and preterm birth with ADHD medication
- Source A says
- MotherToBaby describes mixed findings across studies of prescribed amphetamines, including studies with and without associations for preterm birth and high blood pressure conditions. (MotherToBaby: Dextroamphetamine (Adderall) Fact Sheet)
- Source B says
- Cohen, Srinivas, Hasan, and Sit report associations with some obstetric outcomes in observational cohorts, especially with continued or more frequent exposure; these studies generally combine medication classes. (Cohen et al., Obstetrics & Gynecology 2017: Placental Complications Associated With Psychostimulant Use in Pregnancy, Srinivas et al., Paediatric and Perinatal Epidemiology: ADHD medication use in pregnancy and risk of preterm birth, Hasan et al., Journal of Attention Disorders: Prescription Stimulant Continuation in Pregnancy and Birth Outcomes, Sit et al., 2026: ADHD medication use during pregnancy and cardiometabolic conditions)
- Why they differ
- The studies use different populations, exposure windows, comparator groups, and definitions. ADHD severity, treatment selection, and other health factors can confound associations, and most estimates are not specific to lisdexamfetamine.
- What the evidence shows overall
- The evidence supports reporting possible associations and uncertainty, not presenting class-level observational estimates as LDX-specific effects.
Lisdexamfetamine use while breastfeeding
- Source A says
- The manufacturer label says breastfeeding is not recommended during treatment because of potential serious infant reactions, including cardiovascular effects, blood-pressure and heart-rate increases, growth suppression, and peripheral vasculopathy. (DailyMed: Lisdexamfetamine dimesylate capsule label)
- Source B says
- LactMed notes that some experts allow therapeutic amphetamine doses with monitoring for irritability, insomnia, and feeding difficulty. A small pilot followed 13 infants and found normal developmental measures, but possible symptoms were reported. (LactMed: Lisdexamfetamine, Benassayag Kaduri et al., Psychiatry Research 2024: Amphetamine use for ADHD during breastfeeding and children's neurodevelopmental outcomes)
- Why they differ
- The label uses a precautionary threshold because of potential serious reactions and limited data. LactMed weighs small human studies and expert practice, while acknowledging that long-term developmental evidence is sparse.
- What the evidence shows overall
- The sources differ in how they act under uncertainty, not in evidence of an established serious infant-harm signal. The limited evidence does not resolve the risk, and the label's breastfeeding-not-recommended statement should remain explicit.
- Scoten et al. describe individualized perinatal planning, including weighing medication considerations against the effects of inadequately managed ADHD and working collaboratively with the patient and support network. (Scoten et al., perinatal ADHD guideline review)
- The FDA label directs prescribers to assess each patient's risk for abuse, misuse, and addiction before prescribing, educate patients and families about risks and storage, and reassess and monitor during treatment. (DailyMed: Lisdexamfetamine dimesylate capsule label)
- LactMed reports that some experts allow therapeutic amphetamine doses during nursing with infant monitoring for irritability, insomnia, and feeding difficulty; the manufacturer label says breastfeeding is not recommended during lisdexamfetamine treatment. (LactMed: Lisdexamfetamine)
General research, not specific to pregnancy.
The current label's boxed warning applies to lisdexamfetamine use generally, not only pregnancy or breastfeeding.
- Lisdexamfetamine dimesylate capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including lisdexamfetamine dimesylate capsules, can result in overdose and death. (DailyMed: Lisdexamfetamine dimesylate capsule label)
- The label directs prescribers to assess risk before prescribing and to reassess and monitor for signs and symptoms of abuse, misuse, and addiction during treatment. (DailyMed: Lisdexamfetamine dimesylate capsule label)
- MotherToBaby: Dextroamphetamine (Adderall) Fact SheetTeratology serviceSecondary
- LactMed: LisdexamfetamineUS governmentSecondaryPage dated 2026-04-15
- DailyMed: Lisdexamfetamine dimesylate capsule labelDrug company labelTertiaryPage dated 2026-09-16
- FDA: Prescription stimulant boxed-warning updateUS governmentSecondaryPage dated 2026-04-03
- Huybrechts et al., JAMA Psychiatry 2018: Association Between Methylphenidate and Amphetamine Use in Pregnancy and Risk of Congenital MalformationsUS governmentPrimaryIndependent check
- Cohen et al., Obstetrics & Gynecology 2017: Placental Complications Associated With Psychostimulant Use in PregnancyUS governmentPrimaryIndependent check
- Srinivas et al., British Journal of Psychiatry: ADHD medication use in pregnancy and risk of miscarriageUS governmentPrimaryIndependent check
- Srinivas et al., Paediatric and Perinatal Epidemiology: ADHD medication use in pregnancy and risk of preterm birthUS governmentPrimaryIndependent check
- Russell et al., 2024: Neurodevelopmental outcomes of children exposed to dexamphetamine during pregnancyUS governmentPrimaryIndependent check
- Benassayag Kaduri et al., Psychiatry Research 2024: Amphetamine use for ADHD during breastfeeding and children's neurodevelopmental outcomesUS governmentPrimaryIndependent check
- Hasan et al., Journal of Attention Disorders: Prescription Stimulant Continuation in Pregnancy and Birth OutcomesUS governmentPrimaryIndependent check
- Babinski and Tuan, Journal of Clinical Psychiatry 2026: Obstetric Risk Associated With Stimulant Versus Nonstimulant Treatment During PregnancyUS governmentPrimaryIndependent check
- Sit et al., 2026: ADHD medication use during pregnancy and cardiometabolic conditionsUS governmentPrimaryIndependent check
- Scoten et al., American Journal of Obstetrics and Gynecology 2024: ADHD in pregnancy and the postpartum periodUS governmentPrimary
- CDC: Medicine and Pregnancy, An OverviewUS governmentSecondaryPage dated 2026-09-17
Last reviewed 2026-10-16
Independent check 2026-10-16
Not yet clinician-reviewed
Ask your provider about your situation.
Similar medications
- Dextroamphetamine
- Amphetamine