The Bottom Line

Very few medications have been adequately studied during pregnancy, leaving women and their health care providers (HCP) to make decisions on whether to recommend/use a medication based on little to no data. (Women should read Research and Pregnant Women to better understand how medications are studied in pregnancy.)

This leaves some women feeling incredibly guilty and anxious throughout their pregnancy. Further, some women may choose to avoid taking a necessary medication out of fear it could cause harm to their baby, which could result in harm to the woman.

Women can mitigate this by having open, detailed risks and benefits conversations with their HCPs regarding their own, individualized pregnancies. Women need to talk to their HCP, ask questions, and ask them for the information/reasoning or experience behind their decisions.

Women should always talk to their HCP before taking any medications while pregnant, including those available over-the-counter. 

Jump to:
Share on:

Background

This page serves as an introduction to categories of medications, most of which have their own page. Like all other pages on this site, this page is updated frequently and will include other types of medications in the near future.

There is an overwhelming lack of information regarding most medications during pregnancy due to well-known research hurdles.

Most of the information available today is in the form of case reports, drug registry data, and/or retrospective cohort trials (comparing pregnant woman exposed to agent X, with pregnant women not exposed to agent X), which forms the basis for current recommendations.

Additionally, most of this available data is the result of “opportunistic studies” performed when pregnant women are already taking a specific medication.

There are also significant limitations to the above: study sizes are small, study populations do not represent pregnant women as a whole, and accurate reporting of dosing and exposure to medications is very inaccurate.

Due to this, HCPs and pregnant women have vastly incomplete or misleading data to work with when attempting to make a medical decision during pregnancy.

Photo by Karolina Grabowska from Pexels

Therefore, most safety-related concerns regarding medication use requires a risks and benefits discussion with an HCP because there just is not enough data.

It is recommended that as soon as women find out they are pregnant, they should call their HCP to discuss their current medications – even if they will not physically be seen in the office until 6 or 8 weeks of pregnancy. Some medications may need to be stopped or changed either before pregnancy or immediately upon pregnancy.

Acetaminophen

Acetaminophen (Tylenol®/Paracetamol®) is the most common pain-relieving medication used during pregnancy, with an estimated 65% to 75% of pregnant women in the United States using the medication, throughout all trimesters.

Due to its widespread use during pregnancy, more data is available for acetaminophen that many other medications, and it is considered to have the best safety profile compared to other pharmaceutical options. However, caution is warranted regarding its indiscriminate use during pregnancy and current recommendations indicate using the medication only when necessary at the lowest dose for the shortest time possible.

Read Acetaminophen.

One of the largest studies to assess non-prescription pain killers and pregnancy outcomes published in July 2021:

The study showed an association between increased health risks when pregnancies (n=151,141) were exposed to at least one of five analgesics (pain relievers): paracetamol/acetaminophen, aspirin, and non-steroidal anti-inflammatory drugs (NSAIDs) diclofenac, naproxen, and ibuprofen.

The authors found a 1.5 increased risk (but overall risk was LOW) of: neural tube defects, admission to a neonatal unit, neonatal death, premature delivery before 37 weeks, baby’s condition at birth based on APGAR score of less than 7 at 5 minutes, stillbirth, birthweight under 2.5 kg (5.5 lbs), hypospadias (a birth defect affecting the penis), baby’s condition at birth based on APGAR score of less than 7 at 1 minute, and birth weight over 4 kg (8.8 lbs).

However, and of note, details on the timing, dosage, product type (single-ingredient vs combination) and administration were not available. Therefore, more research is necessary, as these outcomes may be different based on specific analgesic. For example, associations of paracetamol/acetaminophen use alone with high birth weight, neural tube defects and hypospadias were not significant. Further, diclofenac consumption was associated with significantly decreased odds of stillbirth (Zafeiri et al. 2021).

Read more information on Acetaminophen to learn why studying analgesic safety in pregnancy is difficult.

ACE Inhibitors

Study published in March 2021 indicated that women exposed to angiotensin-converting-enzyme inhibitors or angiotensin receptor blockers (medications) during early pregnancy had higher risk of adverse fetal outcomes, including malformations and stillbirths, than non-exposed controls. This increased risk was independent of underlying maternal hypertension, as those exposed to other anti-hypertensives did not exhibit a higher risk than healthy controls.

Acne

There is currently no data indicating popular topical over-the-counter (OTC) medications such as azelaic acid or benzoyl peroxide are harmful, while some minor considerations should be considered with salicylic acid.

Photo by Ketut Subiyanto from Pexels

Note: There are certain medications used to treat acne in the general population that should be completely avoided during pregnancy (oral and topical retinoids), and even months before pregnancy.  

Any woman who is pregnant or believes she may be pregnant and is currently using any topical or oral retinoid medication for acne or psoriasis needs to call her HCP, who will likely advise she stop taking the medication immediately. Women should also tell their HCP if they have taken any of these medications within the last two years.

Read more detailed information regarding OTC and prescription acne medications here.

Antacids

Antacids containing aluminum and calcium are considered safe during pregnancy and are first-line treatments for heartburn and acid reflux when taken in appropriate doses, and according to an HCP’s instructions.

Although concerns regarding aluminum consumption are common in the scientific community, there is no consistent evidence that aluminum exposure due to antacid use is harmful during pregnancy when taken as directed.  However, women have other options as well.

Women can read more detailed information regarding heartburn/acid reflux medications here.

Antibiotics

Antibiotics are used to fight or prevent bacterial infections (not viruses). Their use is common during pregnancy for both obstetric and non-obstetric reasons. Antibiotic choice depends on the type of infection and woman’s medical history.

As a general rule due to a lack of data, it is recommended that antibiotics should be prescribed for pregnant women only for appropriate indications and for the shortest effective duration.

In a February 2021 nationwide cohort study, the use of macrolide antibiotics in pregnancy was not associated with an increased risk of major birth defects, to include after use in the first trimester. According to the study, macrolide antibiotics are used for the treatment of common bacterial infections, such as upper and lower respiratory infections and sexually transmitted diseases, and are frequently used as alternatives for patients allergic to penicillin.

Antibiotics can be used during pregnancy for:

Common side effects of antibiotics in general include:

  • Rash

  • Nausea

  • Diarrhea

  • Yeast infections

Women should talk to their HCP about any concerns they have regarding antibiotic use during pregnancy. Some antibiotics may be necessary; women should ask as many questions as they need to feel comfortable with their decision.

new

Antidepressants

In an October 2022 cohort study that included 145,702 antidepressant-exposed pregnancies, antidepressant exposure during pregnancy was not associated with autism spectrum disorder, attention-deficit/hyperactivity disorder, specific learning disorders, developmental speech/language disorders, developmental coordination disorders, intellectual disabilities, or behavioral disorders. Results were generally consistent across antidepressant medication classes, commonly used individual drugs, and gestational exposure windows.

Antihistamines

Antihistamines are commonly used during pregnancy for conditions such as asthma, seasonal allergies, respiratory infections, dermatological conditions, acid reflux, and nausea and vomiting of pregnancy (NVP). For NVP, they are considered first-line medications after ginger and vitamin B6 due to their positive safety profile.

Antihistamines are commonly prescribed during pregnancy. As of 2014, it was estimated that about 10% to 15% of pregnant women took an antihistamine for NVP, indigestion, allergies, or asthma.

Women who suffer from allergies and wish to take an over-the-counter antihistamine (or for any reason) should talk to their HCP first.

Reviews of dozens of studies have demonstrated a lack of association between antihistamine exposure during pregnancy and birth defects or adverse pregnancy outcomes and antihistamines not assessed to be teratogenic. However, antihistamines need to be further assessed individually for more optimal data.

Common antihistamines include:

  • Brompheniramine (Dimetapp®)

  • Cetirizine (Zyrtec®)

  • Chlorpheniramine (ChlorTrimeton®)

  • Dimenhydrinate (Dramamine®)

  • Diphenhydramine (Benadryl®)

  • Doxylamine (Unisom®)

  • Hydroxyzine (Atarax®)

  • Loratadine (Claritin®)

  • Promethazine (Phenergan®)

  • Triprolidine (Actifed® Cold and Allergy)

Read more information about antihistamine use and NVP.

Anti-Psychotics

Study published in June 2021 indicated use of second-generation antipsychotics (S-GA) during early pregnancy was not associated with an increased risk of overall major congenital malformations (birth defects) compared to unexposed or to first-generation use. However, olanzapine use was associated with an increased risk of major birth defects, specifically, musculoskeletal malformations when compared to unexposed.

Antiseizure Medications

Use of antiseizure medications has become more common, despite exposure to some of these medications being associated with a two-to fivefold increased risk of major congenital malformations. This risk appears to be highest with valproate (5%–15%); other antiseizure medications vary in risk.

It is critical that women who take antiseizure medication call their health care provider as soon as they learn they are pregnant. Women should continue their regimen until they speak with their provider, as stopping medication may also cause harm.

Laxatives

Different types of laxatives include bulk-forming agents, stool softeners, osmotic laxatives, and stimulant laxatives. Although very few laxatives have been studied in pregnancy, short-term use is not expected to cause fetal abnormalities or pregnancy-related concerns due to low absorption.

However, some laxatives should be avoided during pregnancy due to potential side effects for the mother such as electrolyte imbalances, abdominal cramps, and dehydration. Further, certain laxatives are not meant for long-term use.

Women can read more detailed information regarding laxative safety here.

Nausea and Vomiting

Women have numerous options available to help them manage their Nausea and Vomiting (NVP) symptoms if diet and lifestyle modifications fail to provide relief. Suffering is no longer necessary, and women should call their HCP to discuss their options.

HCPs prefer to use a "ladder" approach, that starts with the medications that have the most data, and then gradually progressing "up the ladder" if symptoms do not improve. The earlier a woman involves her HCP, the lower on the ladder she can start, and the more likely she and her HCP can find something that will work.

These include:

  • Multivitamin variations

  • Antacids/proton pump inhibitors (Pepcid®)

  • Vitamin supplementation (B6)

  • Ginger capsules

  • Antihistamines (Unisom®, Dramamine®, Phenergen®, Tigan®)

  • Phenothiazines/Dopamine antagonists (Reglan®, Phenergen®, Compazine®, Thorazine®)

  • Serotonin 5-HT3 antagonists (Zofran®)

  • Intravenous fluids/electrolytes

  • Intravenous antiemetics

  • Intravenous nutrition

  • Corticosteroids

Women can read more detailed information regarding these medications under NVP Medication Introduction and NVP Medication – Detailed.

NSAIDs

Nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, and naproxen are used in the general population to treat or prevent inflammation and pain. Their use during pregnancy is controversial due to the potential risk risk of bleeding or other complications, as these drugs do cross the placenta.

Photo by Caleb Oquendo from Pexels

See side box under "Acetaminophen" for a study presented in July 2021 regarding the overall safety of non-prescription pain relievers in pregnancy, that included NSAIDs.

A study published in May 2021 on naproxen in pregnancy indicated that of 121 exposed pregnancies recorded by two German teratology information services, naproxen does not appear to have a significant teratogenic effect. However, the authors noted that due to the limited cohort size and lack of comparable reference group results should be interpreted with caution and better studied NSAIDs such as ibuprofen should be preferred in the first and second trimester of pregnancy.

A study published in April 2021 attempted to determine if there was an association between Attention-Deficit/Hyperactivity Disorder (ADHD) in children in preschool and primary school and prenatal exposure to NSAIDs), based on timing and duration.

The analyses on ADHD diagnosis and ADHD symptoms included 56, 340 and 34,961 children respectively. Children exposed to NSAIDs prenatally had no increased risk of ADHD diagnosis or ADHD symptoms. Further, there was no duration-response relationship for either outcome.

On October 15, 2020, the U.S. Food and Drug Administration (FDA) released a letter requiring labeling changes on both prescription and OTC NSAIDs, indicating their use after 20 weeks of pregnancy could result in complications.

These changes are required to explain that if women take the medications around 20 weeks or later in their pregnancy, the drugs can (but not always) cause rare but serious kidney problems in the unborn baby, which can lead to low levels of amniotic fluid and the potential for pregnancy-related complications (some of these complications reversed when women stopped NSAID use).

Information regarding the minimum safe dose, or the average exposure in which these complications may start to appear was not included in the alert.

FDA indicated HCPs are likely already aware of these concerns and the publication of the letter was to more broadly inform women of these same concerns.

Note: Low-dose aspirin (80 to 150 mg) is commonly used for the prevention of preeclampsia and intrauterine growth restriction, is currently assessed to be safe, and was not included in the alert. Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of an HCP.

All questions related to NSAID use during pregnancy should be referred to a health care provider.

Opioids

In this April 2021 cohort study of 12,424 pregnancies, 891 women were dispensed prescription opioids. Opioid exposure in the first trimester was not associated with major birth defects, but women dispensed opioids in the third trimester had higher risks of offspring with minor birth defects in the musculoskeletal system.

OTC Cold Medications

Current available evidence suggests most OTC cold medications are likely safe with proper and limited short-term use.

Before using any OTC medication, it is very important pregnant women talk to their HCP and read the label carefully for active ingredients, side effects, appropriate dosing, and warnings.

Common cold medication ingredients include:

  • Vitamin C

  • Zinc

  • Dextromethorphan (Suppressant)

  • Guaifenesin (Expectorant)

  • Pseudoephedrine/Phenylephrine (Oral Decongestants)

  • Diphenhydramine/Chlorpheniramine (Antihistamines)

  • Acetaminophen (Analgesic)

  • Oxymetazoline/Xylometazoline (Inhaled Decongestant)

Women can read detailed information regarding these medications during pregnancy here.

Action

Before using any OTC medication, it is very important pregnant women talk to their HCP and read the label carefully for active ingredients, side effects, appropriate dosing, and warnings.

Women should try to have open, detailed risks and benefits conversations regarding any medication that may be necessary during their pregnancy, or any medication they wish to take.

Women need to talk to their HCP, ask questions, and ask them for the information/reasoning or experience behind their decisions. This can help women feel more confident in their own decisions; they can also understand that in choosing to take medication during their pregnancy, they may have in fact made the best decision – not the worst.

References

Drugs and Lactation Database (LactMed)

Treating for Two: Medicines and Pregnancy (U.S. Centers for Disease Control and Prevention)

Medicine and Pregnancy (U.S. Food and Drug Administration)

FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy (U.S. Food and Drug Administration)

Sulfonamides, Nitrofurantoin, and Risk of Birth Defects (American College of Obstetricians and Gynecologists)

Antibiotic Treatments for Urinary Tract Infections Are Commonly Prescribed To Pregnant Women (U.S. Centers for Disease Control and Prevention)

References

Test ToolTip

    Sign up to read 3 pages for free or subscribe now for full site access.