OTC Medication Use In Pregnancy: Wise or Worrisome?

How Should I Approach Medication Use in Pregnancy?

Always consult your doctor or healthcare specialist for medical advice in relation to drug use while pregnant or breastfeeding. Prescribing should be made on a case-by-case basis, and information found here may not be applicable to you. This information should not take the place of medical care and advice from your healthcare provider.

There will be times in your pregnancy when you simply don't feel well - you may have a headache, cold, allergy or backache - and you wonder if it's safe to take the same medications you took before you became pregnant?

It is very important to talk to your doctor before you take any medication - prescription, over-the-counter, herbal or vitamin supplement, during pregnancy.

• Plus, women who are just starting to plan a pregnancy should discuss the need for medications with their doctor beforehand.
• For women with chronic conditions such as asthma, epilepsy, diabetes or heart conditions, medication may need to be continued throughout pregnancy.
• And it's important to remember that in every pregnancy there is a 3% to 5% background chance of having a baby with a birth defect, even if you take no medications.

Overall, the best place to start is a talk with your doc. No drug can be considered 100% safe to use during pregnancy, so always get advice from your healthcare provider.

Can I Take My Regular Medications in Pregnancy?

Ask your doctor as soon as possible about your regular medications before you make any changes.

Many woman can and should continue their medications for chronic conditions during pregnancy, but each decision is made on a case-by-case basis. Your doctor can weigh the risks and benefits of continuing your medicine in pregnancy.

For some conditions, such as asthma or epilepsy, the risk of NOT taking the medicine might be more harmful to you or your baby than the risk of continuing the medication.

It's important to learn about the safety of over-the-counter (OTC) medications before you become pregnant. Research from the Centers for Disease Control and Prevention (CDC) found the most common OTC medications used in the first trimester included:

• acetaminophen
• ibuprofen
• docusate
• pseudoephedrine
• aspirin
• naproxen

How Common is Medication Use During Pregnancy?

• Statistics show that medication use during pregnancy is surprisingly common, as reported by the CDC in 2020.
• In the US, 9 out of 10 women take medicine during pregnancy, but not all medicines are safe to take during pregnancy.
• Fewer than 10% of medicines have enough information to determine the risk to the baby.
• Costs related birth defects and prematurity is $29 billion annually.

This raises concern as some medications used during organogenesis (the time period of a baby's organ development in the first 12 weeks) can be associated with developmental abnormalities. Although animal studies can provide some information about drug toxicity in pregnancy, these results cannot be safely applied to humans without further research.

That's why it is important to ask your health care provider about medication use if you are pregnant - even for over-the-counter medications, herbal products, and dietary supplements like vitamins.

FDA Pregnancy Risk Categories

In the past, the FDA had established prescription drug pregnancy risk categories as A, B, C, D or X, which helped to define if a drug could be thought of as safe to take during pregnancy.

However, in 2015 the FDA decided to replace these risk categories on prescription drug labels with new information to make them more meaningful to both patients and healthcare providers, allowing better counseling and informed decision making.

Labeling for OTC medicines will not change; OTC drug products are not affected by the new FDA pregnancy labeling.

Learn More: FDA Pregnancy Risk Category Information - An Update

Aren't All Drugs Tested for Safety in Pregnancy?

No. The safety of many drugs in pregnancy are not known because pregnant women are excluded from drug research studies due to safety concerns for the unborn baby.

• However, drug companies may be required to set up pregnancy registries that collect information about women who have used certain medications during pregnancy.
• Using this data, a research study can outline the benefit-to-risk of using the drug in pregnancy.
• Health care professionals can look at this published literature to better determine a drug's safety in pregnancy, and compendiums can be published with the available data.
• From this data, your healthcare provider can make a better informed decision about medication use - or not - during your pregnancy.

If you select an over-the-counter medication as recommended by your doctor, it's usually best to choose one that has only one active ingredient (instead of many active ingredients). Selecting a single-ingredient product with only the active ingredient you need helps to limit the exposure to medicines in your baby.

For example, if you have a cough, instead of using a liquid cough suppressant that also contains acetaminophen (Tylenol), just use a product that contains only the cough medicine. Ask your pharmacist for help with this decision, if needed.

Tylenol (acetaminophen)

Acetaminophen (Tylenol) is a common over-the-counter (OTC) pain, headache and fever treatment routinely used in pregnancy. There has been some controversy about the use of this common painkiller during pregnancy.

Most health care providers consider acetaminophen the pain and fever-reliever of choice during pregnancy. It is best to use only as needed and at the lowest effective dose. Your doctor may have a recommendation of how much they want you to take. The maximum daily dose of extra strength acetaminophen is 3,000 mg per day (and no more than 325 mg to 1,000 mg per single dose). Always follow the specific directions on each OTC package.

Studies have linked acetaminophen use in pregnancy with various risks in children, including attention deficit hyperactivity disorder (ADHD), language delays, and asthma. However, these studies have not absolutely proven these risks and study methods were often in question.

• In a 2017 study published in Pediatrics, results suggested (but did not prove) that long-term use of acetaminophen (>29 days) in pregnancy was linked with an increased risk of attention deficit hyperactivity disorder (ADHD) in offspring, but short-term use (<8 days) was negatively linked with ADHD.
• Other studies have suggested a risk of ADHD with maternal use of acetaminophen in pregnancy. However, experts and the FDA have agreed that studies are not conclusive and the association is weak.

Acetaminophen is found in many other medications, both prescription and OTC -- like cold, flu, headache and arthritis pain medications -- so be sure not to exceed recommended doses of acetaminophen per day from ALL products you take. High doses of acetaminophen can be toxic to the liver or kidney, both in you and your baby.

Learn More: Drugs.com Acetaminophen Pregnancy Warnings

Aspirin

• Aspirin should be avoided in pregnancy unless specifically recommended by your doctor.
• If you are currenty taking aspirin and just found out you are pregnant, talk with your healthcare provider as soon as possible, before making any changes to how you take this medication.
• If a medication for minor pain, headache or fever is required, short-term use of acetaminophen is a safer option than aspirin. Regular strength and high strength aspirin and other NSAIDs are NOT preferred pain relievers during pregnancy.

Studies have shown that low-dose aspirin can lower the risk for preeclampsia in women at high risk for this complication, but this should always be under the direct care of a physician. Preeclamsia can lead to dangerous high blood pressure and protein in the urine, and cause serious complications in the mother and baby.

Higher dose aspirin used in the 3rd trimester can also lead to the premature closure of a vessel in a baby's heart (ductus arteriosus) that may lead to elevated lung pressure in the newborn.

According to Mother to Baby, low dose aspirin (81 mg/day) has been well studied in pregnancy and does not appear to increase the chance of birth defects. Low dose aspirin is considered compatible in all trimesters of pregnancy when medically needed, and only if prescribed by your doctor. High dose aspirin may increase the risk for birth defects.

Bottom line: Only take aspirin during pregnancy if your healthcare provider recommends it.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Nonsteroidal antiinflammatory drugs (NSAIDs) like ibuprofen (Advil, Motrin) or naproxen (Aleve) are commonly found in over-the-counter (OTC) medications and used for pain and fever. NSAIDs come as single ingredients or combined with other medicines.

• Pregnant women should not use NSAIDs at 20 weeks or later unless specifically advised to do so by your health care professional because these medicines may cause problems in your unborn baby.
• Always talk to your doctor before stopping any prescribed or recommended medication.
• If you take an NSAID like ibuprofen or naproxen, or a prescription NSAID or aspirin, and just found out you are pregnant, talk to your doctor as soon as possible.
• Acetaminophen is usually the pain and fever reliever of choice during pregnancy. Ibuprofen should only be used under your healthcare provider’s supervision, particularly in the 2nd and 3rd trimesters. Ask your doctor for advice.

In October 2020, the U.S. Food and Drug Administration (FDA) made a recommendation to avoid the use of NSAIDs at 20 weeks of pregnancy and later due to rare but serious kidney problems in an unborn baby. NSAID use during this time frame may result in low amniotic fluid. Follow your doctor's recommendation.

NSAIDs should NOT be used in the third trimester of pregnancy unless specifically prescribed and managed by your doctor. NSAIDs can cause a problem that may result in heart issues in the unborn baby. NSAIDs may interfere with the closure of the ductus arteriosus in the baby's heart.

Administration during labor and delivery is not recommended because the onset of labor may be delayed and the duration of labor increased. NSAIDs during labor and delivery may cause a greater bleeding risk in the mother and child.

NSAID use is not recommended in women attempting to conceive as use may impair female fertility. Infertility due to frequent use of NSAIDs appears to be a result of a blockage of the rupture of the luteinized follicle. This occurs when the organ where the egg grows (known as the follicle) fails to release an egg during ovulation.

Pseudoephedrine

Pseudoephedrine (Sudafed) is an over-the-counter (OTC) medicine used to relieve nasal congestion ("stuffy nose") caused by colds and hay fever. It is also frequently found in combination pills with OTC cold, allergy or pain medications. In most states, pseudoephedrine is kept behind the pharmacy counter due to concerns with abuse.

• Oral pseudoephedrine is NOT the preferred treatment for congestion in pregnancy and should not be used in the first trimester due to a possible risk of rare birth defects (gastroschisis, small intestinal atresia, and hemifacial microsomia).
• In addition, as noted by experts, phenylephrine (most commonly found in OTC decongestants in the US) should be avoided in pregnancy because of uncertain effectiveness and questionable safety.
• Saline nasal sprays are the first-line recommendation for congestion in pregnant women. Nasal saline solutions (Ayr) are safer options than oral decongestants. A warm air humidifier may also aid in clearing congestion.
• Decongestants can also cause blood vessel narrowing and elevate blood pressure in the woman. Do not use these medications if you have high blood pressure.
• Talk with your doctor first about use of any decongestant during your pregnancy.

Some clinical experts recommend avoiding phenylephrine at all stages of pregnancy due to lack of efficacy.

There are no studies looking at whether pseudoephedrine or phenylephrine could make it harder to get pregnant, based on data from Mother to Baby.

Dextromethorphan for Cough

Pregnant women may be more prone to colds and flu because their illness-fighting ability is slightly weakened in pregnancy. Cough is a common symptom of these illnesses. You may have some dextromethorphan (brand example: Delsym) cough suppressant in your cabinet - but should you take it?

First, check labels. Any OTC cough or cold product containing alcohol should be avoided. Be aware that dextromethorphan is often combined with other cough and cold medicines found on pharmacy shelves, which could be problematic.

• Dextromethorphan should only be given if the benefit to the mother justifies the potential risk to the fetus as determined by your doctor. Some medical experts do not recommend the use of dextromethorphan for cough in pregnant women because it has limited effectiveness, in general.
• According to Cleveland Clinic, dextromethorphan used at standard OTC doses is generally considered acceptable, but some sources recommend use be reserved for significant maternal need.
• Ask your doctor the best way to treat your cough. A soothing drink of honey, lemon and warm water can be a natural help for a cough.

Studies have not been done to see if dextromethorphan could make it harder for a woman to get pregnant.

Caffeine Use

If you consume caffeine during pregnancy, the American College of Obstretrics and Gynecology (ACOG) states that low caffeine consumption is key. This means less than 200 milligrams (mg) of caffeine per day (1 to 2 eight ounce cups of coffee). Remember to add up all of your sources caffeine throughout the day. Caffeine is also found in tea, energy drinks, some soft drinks, chocolate, and some herbs.

• Most coffees purchased today in the U.S. exceed an eight ounce cup; for example, a "Grande" coffee is 16 ounces with 165 mg of caffeine; a "Venti" has 235 mg.
• An 8 ounce cup of regular black tea contains roughly 40 to 120 mg of caffeine. A Red Bull energy drink has 80 mg. One 60-mL 5-Hour Energy can exceed 200 mg of caffeine.
• Be sure to stay well-hydrated. Don't replace drinking water with caffeinated beverages during the day.

Learn More: Caffeine Content of Various Beverages

It's important to remember that caffeine will also cross the placenta and stimulate a baby the same way it does an adult. It can cause changes in heart rate, shaking, a fast breathing rate, and difficulty sleeping following birth.

There have been reports of an increased risk of miscarriage and possibly infertility with higher caffeine doses or when combined with cigarettes or alcohol (both of which increase the risk independently).

Herbals with stimulant properties

• Guarana is a caffeine-containing herbal supplement often found in energy drinks and other products. Guarana has been reported to lead to low birthweight, birth defects, and premature birth. Guarana should not be used during pregnancy.
• Another herbal product with stimulant properties known as ephedra should also be avoided. Reports link it to increased blood pressure, heart rate, stimulation of the nervous system and the uterine muscle.

Dietary Supplements

• In general, it is best to avoid over-the-counter (OTC) herbal and certain dietary supplements in pregnancy. These products are not regulated by the FDA and may have variable quality, be contaminated, or contain undeclared prescription medicines.
• Over-the-counter "natural" dietary supplements may contain unknown substances and few studies describing their use in pregnancy are available. "Natural" does not mean safe.
• However, prenatal vitamins that contain iron, calcium and folic acid are important in pregnancy, so don't skip those supplements; take them as recommended by your doctor. Ask your pharmacist to help you select a product, if needed.
• Regular OTC supplements may not have the right dose of vitamins or minerals that you need, so ask your doctor if you need a prescription for prenatal vitamins.

Vaccines

Certain vaccines are highly recommended for use in pregnant woman. Vaccines that are inactivated (non-live vaccines) may be given during pregnancy, if needed. Vaccines that contain live viruses are not generally recommended due to the small possibility that a live vaccine might cause the disease itself.

Suggested vaccines in pregnancy include:

• Inactivated influenza virus vaccine (shot) in early fall (family members should also get a flu vaccine). Pregnant women can develop serious complications from the flu. The flu shot can be given at any time during pregnancy if you do not get it in the fall.
• Tdap vaccine (tetanus toxoid, diphtheria toxoid and acellular pertussis), ideally, given between 27 and 36 weeks of pregnancy, preferably in the earlier part of this time frame, per the CDC.
• COVID-19 vaccination is recommended for all people 12 years and older, including people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future, per the CDC.
• The need for other vaccines during pregnancy will vary, talk to your doctor.

Live vaccines, if needed, should be given before attempting to get pregnant. You may need to wait several months to become pregnant after receiving a live vaccine; ask your doctor.

• The FluMist nasal vaccine is not systemically absorbed following maternal nasal administration, based on the product label, and is not expected to result in exposure to the fetus. However, information related to the use of influenza virus vaccine (live/attenuated) in pregnancy is limited. The Advisory Committee on Immunization Practices (ACIP) states that live attenuated influenza vaccine should not be used during pregnancy.

If you're planning a pregnancy, talk to your health care provider beforehand about any vaccines you may need. Also, contact your doctor for recommendations if you plan on traveling abroad during your pregnancy, especailly with recommendations towards Zika virus.

Alcohol Use

There is no established safe level of alcohol (wine, beer, or liquor) you can drink during any trimester in pregnancy. Alcohol is also referred to as ethanol or ethyl alcohol.

Alcohol easily crosses the placenta. Studies have found higher rates of miscarriage, stillbirth, and birth defects with alcohol use during pregnancy.

Regular use or large amounts of alcohol during pregnancy can lead to Fetal Alcohol Syndrome, which can result in birth defects and behavioral or learning problems.

Also, be sure to check over-the-counter and prescription medication bottles for the presence of alcohol.

If you are concerned that you cannot avoid alcohol intake and stop drinking during your pregnancy, speak with a health care provider as soon as possible.

Allergy (Allergic Rhinitis) Treatment

Allergic rhinitis can be a new condition in pregnancy or one that the woman has suffered from for years. Nasal saline spray or properly performed saline irrigation is the best - and safest - option to try first, but is not always effective for allergy symptoms. Talk to your doc about your allergies if you are planning a pregnancy.

When possible, try to avoid what causes your allergies to lower your need for medicines. But this may not always possible. Before using an OTC product for allergies in pregnancy, ALWAYS get an OK from your doctor. Use the lowest dose possible. Over-the-counter options may include certain nasal sprays or oral antihistamine tablets.

1. For mild allergic rhinitis, over-the-counter (OTC) cromolyn sodium nasal spray (Nasalcrom), a mast cell stabilizer, may be considered. This medicine is minimally absorbed by the nasal mucosa.

2. OTC corticosteroid nasal sprays include budesonide (Rhinocort Allergy) or fluticasone intranasal (Flonase, Flonase Sensimist), which your doctor may OK for more moderate-to-severe allergy symptoms. There is a concern with triamcinolone intranasal spray (Nasacort Allergy 24HR) in the 1st trimester due to the possibility of respiratory system malformations. Do not use triamcinolone nasal spray unless your doctor has okayed it's use during your pregnancy. For more serious allergies, your doctor may need to prescribe you a prescription product.

3. Loratadine (Claritin 24 Hour, Alavert) is a non-sedating antihistamine also used to relieve the symptoms of seasonal allergies like sneezing, runny nose, and watery eyes. It is also used for chronic itchy hives or rash (urticaria). Clinical data shows that loratadine has a low risk for birth defects, adequate safety data, and may be a preferred choice over a 1st generation antihistamine like Benadryl for allergies. The online reference Mother to Baby also states that loratadine is usually safe in pregnancy. Your doctor may also recommended use of cetirizine (Zyrtec) but be aware it can cause drowsiness and you may want to take it at bedtime.

As always, check with your doctor first before you use ANY medicine during pregnancy.

OTC Topical Acne Medication

Over-the-counter (OTC) topical acne treatments are medications applied directly to the skin. See your dermatologist and OB-GYN to discuss your options for control of acne during pregnancy.

• When approved by your doctor, benzoyl peroxide, a common ingredient found in OTC acne medications, can be used during pregnancy. There are no studies looking at women who use topical benzoyl peroxide during pregnancy, but only about 5% of the amount applied on the skin is absorbed into your body. This small amount is not likely to increase the change for birth defects or cause problems for the baby.
• The American College of Obstetricians and Gynecologists (ACOG) recommends topical benzoyl peroxide, topical salicylic acid and glycolic acid, all OTC products, for treatment of acne in pregnancy. Azelaic acid (Azelex, Finacea) are prescription products they recommend. Some OTC products also contain botanicals with azelaic acid.
• If you want to use an OTC acne product that contains an ingredient not on this list, contact your health care professional. There are also many prescription medicines that should not be used during pregnancy to fight acne, so be sure to ask.

Differin gel (adapalene) is now available OTC without a prescription for acne treatment. Adapalene is a vitamin A retinoid in the same group of medications as tretinoin and isotretinoin. According to Mother to Baby, only small numbers of pregnancies have been evaluated with the use of this topical drug, and because there are safer and better studied options for acne, other options are preferred. ACOG does also not recommend topical retinoids in pregnancy.

Stomach Symptoms

Stomach complaints, such as heartburn, gas, and constipation are some of the most common issues in pregnancy. Speak with your doctor before self-treating for these issues; not all OTC medications are safe for use during pregnancy.

Heartburn

Heartburn is experienced by more than 50% of women in pregnancy. Lifestyle changes for heartburn should be tried first:

• avoid coffee
• avoid spicy or other aggravating foods. Foods that commonly make heartburn worse are coffee, cola, tea, citrus foods, chocolate, and fatty foods.
• don't lie down or go to bed within 3 hours after eating
• elevating the head of your bed by 6 to 8 inches.

If you still need help for acid reflux after trying these suggestions, check in with your doctor for advice.

Calcium-based antacids (examples: Tums, Caltrate, Titralac) can be used. If you are pregnant, do not take antacids that contain sodium bicarbonate and magnesium trisilicate.

If lifestyle and calcium-based antacids do not help, ask your doctor about the OTC acid blockers (H2 blockers) famotidine (Pepcid, Zantac 360) or cimetidine (Tagamet HB). Use is recommended only if clearly needed and the benefit outweighs the risk, so your physician can make the best call here.

In April 2020, all ranitidine (brand name: Zantac) products were removed from the US market due to presence of a possible cancer-causing agent. If you have this product at home, you should dispose of it. Zantac 360 has now returned the US market but contains the active ingredient famotidine, which does not have the same cancer-causing by-product or risk as ranitidine.

Gas

Simethicone (Gas-X, Mylanta Gas), an anti-flatulent for gas that is not absorbed into the bloodstream and is usually considered compatible with pregnancy. An infant product for gas containing simethicone (Infant's Mylicon) is also available.

Constipation

Constipation is another frequent complaint in pregnancy. Pressure on the bowels, hormonal changes, and the constipating-effects from iron and prenatal vitamins can lead to constipation. Some laxatives may alter nutrients in your body, especially if used in higher doses.

Adequate fluids (6 to 8 glasses of water per day), more fiber in your diet (such as whole grains and fresh fruits and vegetables like apples, bananas, lentils, raspberries, split peas, whole-wheat pasta) should be tried first. ACOG recommends 25 grams of fiber per day. Also, regular exercise, as recommended by your doctor, should be added to help avoid constipation.

Fiber supplements, such as psyllium (Metamucil, FiberAll) or methylcellulose (Citrucel) can help with constipation in pregnancy. These bulk-forming laxatives are not absorbed into the blood stream and pregnancy exposure is unlikely.

Milk of magnesia and polyethylene glycol (Miralax) are osmotic laxatives and not well absorbed into the intestine, so exposure in pregnancy should be small. Check with your doctor about use of these agents.

Insect Repellents

If possible, avoid mosquitoes and ticks while you are pregnant. However, if needed, insect repellents are important to help avoid serious diseases such as malaria, West Nile Virus, or Lyme Disease which may be dangerous to both the mother and baby.

When used as directed, EPA-registered insect repellents are proven safe and effective, even for pregnant and breastfeeding women, as reported by the CDC.

• DEET
• Picaridin (known as KBR 3023 and icaridin outside the US)
• IR3535
• Oil of lemon eucalyptus (OLE)
• Para-menthane-diol (PMD)
• 2-undecanone

To minimize exposure, use the lowest concentration of DEET to provide protection only for the time spent outdoors. Cover up if you prefer - wear long pants and sleeves. Just be sure not to apply under your clothes as too much may be absorbed. Also, be aware that DEET may ruin polyester or nylon gear or clothes.

All pregnant women should review the latest recommendations about Zika virus and other insect-borne diseases before travel. To help prevent contracting Zika virus, follow the latest CDC guidelines on pregnancy, travel and Zika Virus.

Learn More: Safe Use of Insecticides