Duloxetine
MedicationCymbalta, Irenka
SNRI antidepressant
Research strength: 3 / 5
MotherToBaby says duloxetine is not expected to increase birth defects. A large US cohort found no clear overall increase in major birth defects, although it could not rule out a small increase in heart defects; a Nordic cohort found no increase in major or minor malformations. In a Danish duloxetine study, miscarriage risk was not higher than for nonusers, venlafaxine users, or people who stopped before pregnancy, but one comparison with SSRI users showed a small signal that the authors said may reflect other differences between groups. An earlier Danish study found no antidepressant-related increase among women with a depression diagnosis, but had few duloxetine pregnancies. Ask your provider about your situation.
Last reviewed: 2026-10-14
Sources
- MotherToBaby fact sheet: DuloxetineTeratology service
- DailyMed label for Cymbalta (duloxetine)Drug company label
- Huybrechts et al., BMJ 2020US government
- Ankarfeldt et al., PLoS Medicine 2021US government
- Ankarfeldt et al., Drugs Real World Outcomes 2021US government
- Kjaersgaard et al., PLoS One 2013US government
Research strength: 3 / 5
MotherToBaby says it remains unclear whether duloxetine increases preterm delivery or low birth weight. A large US cohort found no increase in preterm birth with early exposure but a small increase with late exposure. A Danish-Swedish cohort found mixed preterm results across comparison groups and said an increase could not be ruled out, while finding no increase in babies born small for gestational age. Ankarfeldt et al. measured small-for-gestational-age, not low birth weight, so that finding does not directly settle the low-birth-weight question. Ask your provider about your situation.
Last reviewed: 2026-10-14
Research strength: 3 / 5
MotherToBaby reports temporary newborn symptoms after exposure, including breathing, sleep, feeding, movement, or temperature problems; most are mild and improve, though some babies need special care. The US Cymbalta label says late-third-trimester exposure has been linked with newborn complications that can require longer hospital care, breathing support, or tube feeding. A US hospital cohort of women prescribed antidepressants found higher observed NICU and adaptation-syndrome rates among duloxetine-exposed infants than for other studied medicines, but its selected group does not estimate population risk. The Cymbalta label and a large US cohort also report a higher chance of postpartum bleeding after duloxetine use in the month before delivery. Ask your provider about your situation.
Last reviewed: 2026-10-14
Duloxetine — Breastfeeding
Research strength: 2 / 5
LactMed says published breastfeeding data are limited, but measured milk doses and infant blood levels were low in small studies. The US Cymbalta label advises monitoring exposed infants for sedation, poor feeding, and poor weight gain. LactMed describes one possible drowsiness case in a baby whose mother also took agomelatine; the mother thought agomelatine might be responsible. MotherToBaby and the 2023 NHS SPS page reported no infant side effects, while EMA product information says breastfeeding is not recommended because infant safety is unknown. Ask your provider about your situation.
Last reviewed: 2026-10-14
Sources
- LactMed (NIH): DuloxetineUS government
- DailyMed label for Cymbalta (duloxetine)Drug company label
- MotherToBaby fact sheet: DuloxetineTeratology service
- NHS Specialist Pharmacy Service: Using certain antidepressants during breastfeedingUK government
- EMA Cymbalta product informationEU agencyEuropean guidance
- Lobo et al., Clinical Pharmacokinetics 2008US government
- Kwok et al., Neurotoxicology and Teratology 2023
Pregnancy
Huybrechts et al. (2020), a large US Medicaid cohort, reported adjusted relative risks of 1.11 (95% CI 0.93 to 1.33) for major congenital malformations overall and 1.29 (0.99 to 1.68) for cardiac malformations. It found preterm birth relative risks of 1.01 (0.92 to 1.10) with early exposure and 1.19 (1.04 to 1.37) with late exposure; the postpartum hemorrhage relative risk was 1.53 (1.08 to 2.18). Its preeclampsia estimates were 1.12 (0.96 to 1.31) with early exposure and 1.04 (0.80 to 1.35) with late exposure, so it did not demonstrate a clear increase. Ankarfeldt et al. (2021) found no increase in major or minor malformations or stillbirth in more than two million Nordic births, including 1,512 duloxetine-exposed pregnancies. In the Danish miscarriage cohort (1,019,957 pregnancies, 1,212 exposed), risk was not increased versus nonusers, venlafaxine users, or duloxetine discontinuers; one comparison with SSRI users showed a borderline estimate of 1.25 (95% CI 1.00 to 1.57), which the authors said may reflect confounding. Kjaersgaard et al. (2013) found no antidepressant-associated miscarriage increase among women diagnosed with depression, but duloxetine-specific analyses had few pregnancies and lacked disease-severity adjustment. Ankarfeldt et al. (2023; 2,083,467 pregnancies) found no increase in small-for-gestational-age births; preterm results varied by comparator, and the authors said an increase could not be ruled out. Marks et al. (2021) reported the highest observed NICU and adaptation-syndrome rates among duloxetine-exposed infants in a selected hospital cohort of 3,694 women prescribed antidepressants: 39.6% for NICU admission and 15.1% for adaptation syndrome. These cohort rates are not general-population risk estimates.
Breastfeeding
Lobo et al. (2008) studied six lactating women who stopped nursing during the study; estimated infant exposure was 0.14% of the maternal weight-adjusted dose, but infant outcomes were not assessed. Boyce et al. (2009) reported one exclusively breastfed infant with no observed toxicity through day 32. Boyce et al. (2011) reported low milk transfer and no observed infant adverse events in one mother-infant pair. Collin-Lévesque et al. (2018) described two nonexclusive breastfeeding cases with low measured milk levels; one newborn had a congenital pulmonary airway malformation after in-utero co-exposure to duloxetine and methylphenidate, which cannot be attributed to breast milk. LactMed reports low or undetectable plasma levels in two breastfed infants and one possible drowsiness case in an infant whose mother also took agomelatine and duloxetine; the mother thought agomelatine might be responsible. A 2023 MotherSafe observational cohort followed 14 breastfeeding women and about 16 infants exposed to agomelatine; the publisher preview is incomplete and does not expose the case details. The current US Cymbalta label reports sedation, poor feeding, and poor weight gain in infants exposed through milk and advises monitoring; the specific poor-feeding and poor-weight-gain reports were not traced to a named primary case in the label text.
Duloxetine is an SNRI antidepressant sold under brand names including Cymbalta and Irenka. MotherToBaby says it is used for depression, anxiety, and chronic pain.
What was tested
Pregnancy evidence mainly comes from observational cohorts that compare prescription records with birth, miscarriage, and newborn records. These studies can identify associations but cannot establish that duloxetine caused an outcome. Breastfeeding evidence includes small studies measuring drug in milk or infant blood, case reports, and one small observational cohort focused on agomelatine. Infant outcome follow-up for duloxetine remains limited.
EMA precaution about neonatal PPHN and the scope of other pulmonary-hypertension reviews
- Source A says
- EMA product information says no studies have investigated PPHN with SNRI treatment, but the possible risk cannot be ruled out with duloxetine because of a related mechanism. (EMA Cymbalta product information)
- Source B says
- The US Cymbalta label does not mention PPHN. EMA's 2022 PRAC review found insufficient evidence of a causal link between SSRIs or SNRIs and new pulmonary hypertension or worsening disease in patients with existing pulmonary hypertension. (DailyMed label for Cymbalta (duloxetine), Eli Lilly, EMA PRAC minutes: pulmonary hypertension signal follow-up, September 2022)
- Why they differ
- The EMA pregnancy text extrapolates from SSRI data to neonatal PPHN, while the 2022 PRAC review concerned pulmonary hypertension more generally and existing disease. The outcomes and populations are not identical.
- Other sources
- The MHRA's 2021 class-level notice also discusses PPHN with SSRIs and SNRIs, but its product-information update list for postpartum bleeding did not include duloxetine. That notice is outside the audit's five-year window. (MHRA Drug Safety Update: SSRI/SNRI postpartum haemorrhage)
- What the evidence shows overall
- No duloxetine-specific PPHN study or risk estimate was identified. Keep the EMA wording as a mechanism-based precaution, not an established duloxetine effect. No rating change is proposed.
What the July 2025 FDA SSRI panel means for duloxetine
- Source A says
- The FDA page documents a July 21, 2025 panel about SSRIs and pregnancy; it does not state an FDA conclusion or discuss duloxetine. (FDA Expert Panel on SSRIs and Pregnancy, event page)
- Source B says
- ACOG and SMFM challenged claims made by several panelists and supported SSRI treatment during pregnancy when indicated. Their statements were about SSRIs, not duloxetine. (ACOG statement on SSRIs during pregnancy, SMFM statement on SSRIs and pregnancy)
- Why they differ
- The FDA page is an event record rather than a formal agency decision. The professional statements responded to panelists and address SSRIs, so their conclusions should not be carried over to duloxetine.
- What the evidence shows overall
- No FDA safety communication or label change specific to duloxetine was identified from this panel. It does not change the duloxetine-specific evidence or ratings.
Breastfeeding recommendations and reported infant effects
- Source A says
- EMA product information says use while breastfeeding is not recommended because infant safety is unknown. The US Cymbalta label advises monitoring infants for sedation, poor feeding, and poor weight gain. (EMA Cymbalta product information, DailyMed label for Cymbalta (duloxetine), Eli Lilly)
- Source B says
- LactMed says that if the mother requires duloxetine, it is not a reason to discontinue breastfeeding. NHS SPS says duloxetine can be used with caution, although better-studied SSRIs or TCAs are preferred. MotherToBaby and the 2023 NHS SPS page report no infant side effects. (LactMed (NIH): Duloxetine, NHS Specialist Pharmacy Service: Using certain antidepressants during breastfeeding, MotherToBaby fact sheet: Duloxetine)
- Why they differ
- Published lactation data are sparse and mostly measure drug levels. The US label does not identify the specific reports of poor feeding or poor weight gain in its text; LactMed describes one possible drowsiness case with agomelatine co-exposure.
- What the evidence shows overall
- Low milk transfer does not establish that no infant effects occur. Keep the guidance rating and show both the label's monitoring instruction and the limits of the small infant follow-up data.
- MotherToBaby says it is important to discuss treatment changes with healthcare providers; stopping suddenly can cause withdrawal symptoms. (MotherToBaby)
- The Cymbalta label notes that women who discontinue antidepressants during pregnancy were more likely to relapse than women who continued in a prospective study. The study involved people with a history of major depression and was not specific to duloxetine. (DailyMed Cymbalta label and Cohen et al., JAMA 2006)
- NHS SPS says duloxetine can be used with caution during breastfeeding, while better-studied SSRIs or tricyclic antidepressants are preferred and infant monitoring is advised. (NHS Specialist Pharmacy Service)
General research, not specific to pregnancy.
The Cymbalta label carries a boxed warning about suicidal thoughts and behavior with antidepressants in children, adolescents, and young adults in short-term studies. The label calls for close monitoring of everyone starting antidepressant therapy. In 2024, EMA recommended warnings for neuroleptic malignant syndrome and stress cardiomyopathy; it said the overall benefit-risk balance was unchanged.
- The boxed warning states: "Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber." (DailyMed label for Cymbalta (duloxetine), Eli Lilly)
- The 2024 EMA review found a reasonable possibility of a causal relationship between duloxetine and neuroleptic malignant syndrome and stress cardiomyopathy, and recommended updating product information. EMA said the overall benefit-risk balance was unchanged. (EMA PRAC 2024 duloxetine PSUSA conclusions)
- MotherToBaby fact sheet: DuloxetineTeratology serviceSecondary
- DailyMed label for Cymbalta (duloxetine), Eli LillyDrug company labelTertiaryPage dated 2025-07-21
- LactMed (NIH): DuloxetineUS governmentSecondaryPage dated 2024-01-15Independent check
- EMA Cymbalta product informationEU agencySecondaryIndependent checkEuropean guidance
- MHRA Drug Safety Update: SSRI/SNRI postpartum haemorrhageUK governmentSecondaryPage dated 2021-01-07Independent check
- NHS Specialist Pharmacy Service: Using certain antidepressants during breastfeedingUK governmentSecondaryPage dated 2023-11-17Independent check
- FDA Expert Panel on SSRIs and Pregnancy, event pageUS governmentSecondaryPage dated 2025-07-23
- ACOG statement on SSRIs during pregnancyProfessional societySecondaryPage dated 2025-07-21Independent check
- SMFM statement on SSRIs and pregnancyProfessional societySecondaryPage dated 2025-07-23Independent check
- Huybrechts et al., BMJ 2020US governmentPrimaryIndependent check
- Ankarfeldt et al., Danish nationwide miscarriage cohort 2021US governmentPrimaryIndependent check
- Ankarfeldt et al., Denmark and Sweden malformation cohort 2021US governmentPrimaryIndependent check
- Ankarfeldt et al., Denmark and Sweden preterm cohort 2023US governmentPrimaryIndependent check
- Kjaersgaard et al., PLoS One 2013US governmentPrimaryIndependent check
- Marks et al., Pharmacotherapy 2021US governmentPrimaryIndependent check
- Lobo et al., Clinical Pharmacokinetics 2008US governmentPrimaryIndependent check
- Briggs et al., The Annals of Pharmacotherapy 2009US governmentPrimaryIndependent check
- Boyce et al., Archives of Women's Mental Health 2011US governmentPrimaryIndependent check
- Collin-Lévesque et al., Breastfeeding Medicine 2018US governmentPrimaryIndependent check
- Kwok et al., Neurotoxicology and Teratology 2023PrimaryIndependent check
- Cohen et al., JAMA 2006US governmentPrimaryIndependent check
- EMA PRAC minutes: pulmonary hypertension signal follow-up, September 2022EU agencySecondaryEuropean guidance
- EMA PRAC 2024 duloxetine PSUSA conclusionsSecondaryPage dated 2024-07-08
Last reviewed 2026-10-14
Independent check 2026-10-14
Not yet clinician-reviewed
Ask your provider about your situation.