Is Naproxen (Aleve) safe during pregnancy?
What the FDA-approved label for Naproxen (Aleve) actually states in its Pregnancy Risk Summary — not a secondhand verdict. The decision is one to make with your prescriber.
What the label’s pregnancy summary says
The label carries a real risk statement. It says NSAID use, including naproxen, can cause premature closure of the fetal ductus arteriosus and fetal kidney dysfunction leading to oligohydramnios (low amniotic fluid) and, in some cases, neonatal kidney impairment. Because of these risks it advises limiting use between about 20 and 30 weeks of gestation, and avoiding naproxen at about 30 weeks of gestation and later. Data on other embryofetal risks in the first and second trimesters are described as inconclusive. Anyone who is or may be pregnant should consult their prescriber rather than start or stop on their own.
Frequently asked questions
Is Naproxen safe to take during pregnancy?
The label flags a real concern for Naproxen — see the summary above. This is not a drug to start or continue in pregnancy on your own; it needs a prescriber weighing the specific risks against the reason you would take it. The one universal rule: do not start or stop a medication in pregnancy without medical advice — an untreated condition can carry its own risk to a pregnancy.
What does the FDA label say about Naproxen in pregnancy?
The summary above is transcribed from the label's Pregnancy Risk Summary (§8.1). Since 2015 FDA labels replaced the old A/B/C/D/X letter categories with a narrative that describes what human and animal data actually show, which is what you are reading here — not a single letter grade.
Is Naproxen safe while breastfeeding?
That is a separate question the label answers in a different section (§8.2, Lactation), and it does not always match the pregnancy verdict. This page covers pregnancy only. For breastfeeding, ask your prescriber or pharmacist, or check the NIH LactMed database, which summarizes the drug-in-breast-milk evidence.
The questions people actually ask about naproxen in pregnancy
Answered by MotherToBaby, the fact sheets written by the Organization of Teratology Information Specialists and published through the NIH. Quoted in full — we do not condense them.
I take naproxen. Can it make it harder for me to get pregnant?
Some studies suggest that using naproxen and other NSAIDs might make it harder to get pregnant. This may be more likely when NSAIDs are used often or over a long period of time.
Does taking naproxen increase the chance for miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. Some studies have suggested that taking naproxen may increase the chance of miscarriage. As there can be many causes of miscarriage, it is hard to know if a medication, the medical condition, or other factors are the cause of a miscarriage.
Does taking naproxen increase the chance of birth defects?
Every pregnancy starts out with a 3-5% chance of having a birth defect. This is called the background risk. Studies do not agree if naproxen does or does not increase birth defects.
Results from a few large studies on NSAIDs, including naproxen, did not show an increased chance of birth defects. Another study looking at 23 pregnancies exposed to naproxen did not find an increased chance of birth defects. However, some studies have reported a small increased chance for heart defects when both naproxen and other NSAIDS are used in early pregnancy. An association with cleft lip and palate (an opening in the lip and / or the roof of the mouth) has also been reported, but has not been proven. It is not known if naproxen was the cause of the birth defects in these studies, or if they were due to other factors such as the medical conditions being treated.
.
Does taking naproxen in pregnancy increase the chance of other pregnancy-related problems?
Naproxen should only be used under a healthcare provider’s watch, particularly in the 2 nd and 3 rd trimesters. Your healthcare providers can closely monitor your pregnancy if you need to use naproxen during your pregnancy.
One study found that using naproxen during the first trimester increases the chance of the baby being smaller than expected (small for gestational age).
Using an NSAID in the 2 nd half of pregnancy might lower the amount of amniotic fluid (liquid that surrounds the fetus in the uterus). If there is not enough amniotic fluid (called oligohydramnios) other problems could happen for the fetus, such as damage to the kidneys, poor lung development, joint contractures (joints become stiff or unable to move), or even death. In some cases, oligohydramnios requires an early delivery through labor induction (when the healthcare provider uses a medication to start labor early) or c-section.
Naproxen use later in pregnancy might also cause narrowing of blood vessels in the fetus.
Does taking naproxen in pregnancy affect future behavior or learning for the child?
This is not known for a number of reasons. It is difficult to connect later learning problems to one exposure during pregnancy. There is also no study that checks on later learning with naproxen use only in a pregnancy. Studies that have been done on this topic for NSAIDs in general do not agree if there is or is not a higher chance for learning or attention problems. Studies that have suggested a possible association have study design limitations that do not allow us to know if this finding was linked to the medication or other factors, such as the reason the parent took an NSAID.
If a male takes naproxen, could it affect fertility or increase the chance of birth defects?
It is not known if naproxen could affect male fertility (ability to get partner pregnant) or increase the chance of birth defects above the background risk. In general, exposures that fathers or sperm donors have are unlikely to increase risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/ .
Quoted from MotherToBaby Fact Sheets — Naproxen, published January 2024. MotherToBaby states its fact sheets should not take the place of medical care and advice from your healthcare providers.
Breastfeeding is a separate question — what LactMed says about naproxen
More guides for Naproxen
Source
Naproxen — DailyMed FDA label (§8.1 Pregnancy; Adverse Reactions) ↗
Other drugs: Acetaminophen · Amitriptyline · Amlodipine · Amoxicillin · Aspirin · Azithromycin · Bupropion · Cephalexin · Ciprofloxacin · Citalopram · Diphenhydramine · Doxycycline · Duloxetine · Escitalopram · all drugs.
The pregnancy information is transcribed from the drug’s FDA-approved label (§8.1) and mirrors what the label states — “insufficient data” is never rounded up to “safe.” This is general reference information, not medical advice. Whether to take any medication in pregnancy is a decision for you and your prescriber; do not start or stop a drug on your own, because an untreated condition can also carry risk.