Fluvoxamine can be taken during pregnancy, and current medical guidelines support keeping it as an option when the mental health benefits outweigh the small risks involved. The FDA’s updated labeling notes that human observational studies have found no clear link between fluvoxamine use and significant birth defects or miscarriage. That said, like all SSRIs, it does cross the placenta, and there are some specific considerations for late pregnancy and the newborn period that are worth understanding.
What the Evidence Shows About Birth Defects
The concern most people have is whether fluvoxamine causes birth defects. The available data is reassuring. In a large prospective study published in JAMA, the rate of major malformations among babies exposed to SSRIs was 4.1%, compared to 3.8% in the unexposed control group. That difference is statistically insignificant, and the researchers noted that adding thousands more participants to each group would be unlikely to change the result. These rates fall well within what’s seen in the general population.
Fluvoxamine was previously classified as “Category C” by the FDA, meaning animal studies had raised some concern but human data was lacking. That old letter system was replaced in 2015, and the updated labeling now reflects the human evidence: no clear associated risk of significant congenital disability or miscarriage based on multiple observational studies.
Risks in the Second Half of Pregnancy
The timing of SSRI use during pregnancy matters. Taking any SSRI after 20 weeks of gestation has been linked to a small increase in the risk of a newborn lung condition called persistent pulmonary hypertension (PPHN). This is a serious condition where the baby’s blood vessels in the lungs don’t relax properly after birth, making it hard to breathe. It carries a fatality rate of 10% to 20% when it does occur.
The important context is how rare this actually is. The baseline risk of PPHN is about 0.1%, or 1 in 1,000 births. For women taking SSRIs in the second half of pregnancy, that rises to roughly 0.6%, or about 6 in 1,000. Put another way, there is a 99.4% chance the baby will not be affected. The study that established this link looked at SSRIs as a class (citalopram, fluoxetine, paroxetine, and sertraline were specifically named), so the exact risk for fluvoxamine alone isn’t precisely known, but it’s reasonable to assume it’s in the same range.
What Happens Around Delivery
Babies exposed to SSRIs late in pregnancy can develop something called neonatal adaptation syndrome in the hours or days after birth. This happens because the baby has been receiving the medication through the placenta and then suddenly loses that supply. Symptoms can include irritability, feeding difficulties, breathing issues, and jitteriness. These are typically mild and resolve on their own within a few days, but the delivery team should know you’re taking fluvoxamine so they can monitor the baby appropriately.
One practical challenge with fluvoxamine specifically is that blood levels of the drug drop significantly during the third trimester. Your body processes it faster as pregnancy progresses, which can mean the dose that was working well for you earlier may become less effective. If you notice your OCD or depression symptoms returning or worsening in the third trimester, that’s a recognized pattern worth discussing with your prescriber rather than something to push through on your own.
Why Stopping Isn’t Always the Safer Choice
The instinct to stop all medication during pregnancy is understandable, but untreated mental illness carries its own risks for both mother and baby. In July 2025, the American College of Obstetricians and Gynecologists released a statement affirming that “robust evidence has shown that SSRIs are safe in pregnancy” and that for pregnant people who need them, “they are life-changing and lifesaving.”
The risks of untreated OCD during pregnancy are well documented. A large study using data from Sweden and British Columbia found that mothers with OCD had a 33% to 58% higher risk of preterm birth, a 28% to 40% higher risk of low birth weight, and a 47% to 63% higher risk of neonatal respiratory distress compared to mothers without OCD. Critically, these elevated risks persisted even among women with OCD who were not taking medication, suggesting the condition itself, not just the treatment, contributes to worse outcomes. Untreated depression carries similar concerns: higher rates of preterm birth, preeclampsia, substance use, limited engagement in prenatal care, and impaired bonding with the infant.
Discontinuing an SSRI that’s been working can also trigger a relapse, which may be harder to treat during pregnancy than it would have been to maintain treatment all along. ACOG’s position is clear: the decision should involve a conversation about risks and benefits that accounts for your individual needs, not a blanket policy of stopping medication.
Early Follow-Up on Exposed Children
Data on long-term child development after in-utero fluvoxamine exposure is limited, but what exists is encouraging. In case reports following children to 36 months of age, developmental scores on the Bayley Scales (a standard measure of cognitive, language, and motor development) were within normal limits, and growth in height and weight tracked at the 50th percentile. These are small studies, not large trials, so they can’t rule out subtle effects, but they show no red flags in the children followed so far.
Fluvoxamine and Breastfeeding
If you’re also thinking ahead to breastfeeding, fluvoxamine transfers into breast milk at relatively low levels. The estimated infant dose is about 1% of the mother’s weight-adjusted dose. In studies measuring fluvoxamine in breastfed infants’ blood, levels were undetectable in most cases. Long-term follow-up of growth and development in breastfed infants has found no adverse effects.
There are a few reported cases of infants reacting to fluvoxamine through breast milk, with symptoms including diarrhea, vomiting, agitation, and decreased sleep. In the most notable case, a 5-month-old developed severe diarrhea (15 episodes daily) and agitation within two days of the mother starting fluvoxamine. Symptoms resolved within 24 hours of the mother stopping the drug and returned when she restarted it. These reactions appear uncommon, but they’re worth watching for: if your breastfed baby develops unexplained digestive symptoms, fussiness, or sleep changes after you start or increase fluvoxamine, that connection is worth investigating.