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OTC Medication Use In Pregnancy: Wise or Worrisome?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Aug 10, 2020.

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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. Remember, 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 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.

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.

Overall, the best place to start is a talk with your doc. No drug can be considered 100% safe to use during pregnancy.

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 in 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.

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 drugs with new information to make them more meaningful to both patients and healthcare providers, allowing better counseling and informed decision making.

The new sections include:

  • Pregnancy (includes Labor and Delivery)
  • Lactation (includes Nursing Mothers)
  • Females and Males of Reproductive Potential

Prescription drugs submitted for approval after June 30, 2015 will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.

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 specific pregnancy

Is Tylenol (acetaminophen) Safe in Pregnancy?

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.

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.

Most health care providers consider acetaminophen the pain and fever-reliever of choice during pregnancy; there are few other options.

  • Studies have shown acetaminophen to be safe in pregnancy at recommended doses and for short-term use -- no more than 325 to 1,000 mg per single dose and 3,000 to 4,000 mg for a total daily dose. An increased risk of birth defects, miscarriage, or still birth has not been seen following use of normal acetaminophen doses.
  • Plus, it is important to bring down a fever in the mother since a high temperature can be dangerous for the fetus. Aspirin and NSAIDs (examples are ibuprofen and naproxen) should NOT be used in pregnancy in most cases.

Follow dosing directions and your doctors advice about all medications closely. It is reasonable to avoid long-term use of acetaminophen in pregnancy, when possible, until more robust studies are available. High doses of acetaminophen can be toxic to the liver or kidney, both in you and your baby. 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.

Learn More: Drugs.com Acetaminophen Pregnancy Warnings

Beware with Aspirin Use

If a medication for minor pain, headache or fever is required, short-term use of acetaminophen is a safer option than aspirin.

  • Aspirin should be avoided in pregnancy unless specifically recommended by your doctor. It does cross the placenta.
  • Aspirin can interfere with blood clotting and can contribute to bleeding for both the mother and the baby, especially later in pregnancy or during birth.
  • 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.

In some pregnant women low-dose aspirin may be used to lessen the risk for preeclampsia after 12 weeks of pregnancy, 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 complciations in the mother and baby.

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, but only if prescribed by your doctor. High dose aspirin may increase the risk for birth defects.

NSAID Safety in Pregnancy

Ask your doctor about NSAID use in pregnancy before you become pregnant. Always talk to your doctor before stopping any prescribed or recommended medication. If you take an OTC NSAID like ibuprofen or naproxen each day and just found out you are pregnant, be sure to discuss this with your doctor as soon as possible.

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. The benefit of NSAID use should always outweigh the risk in pregnancy. Acetaminophen is usually the pain and fever reliever of choice in pregnancy.

NSAIDs should NOT be used in the third trimester of pregnancy unless specifically prescribed and managed by your doctor.

  • Like aspirin, NSAIDs like ibuprofen and others may interfere with the closure of the ductus arteriosus in the baby's heart.
  • Prior to 30 weeks gestation, studies are inconclusive regarding potential embryofetal risks, but effects may begin as early as 24 weeks.

According to Mother To Baby (Feb. 2019), most studies have not found an overall increased chance for birth defects, low birth weight, or preterm labor with the use of NSAIDs in the first or second trimester of pregnancy. Risk of NSAID use during the first trimester cannot be excluded but appears low as reported by Up to Date (July 2020). A low risk for some birth defects as well as an elevated risk for miscarriage cannot be ruled out.

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.

The Stuffy Nose and Pregnancy: What to Do?

Pseudoephedrine and phenylephrine (Sudafed, Sudafed PE) are over-the-counter (OTC) medicines used to relieve nasal congestion caused by colds and hay fever. They are frequently found in combination pills with OTC cold or allergy medications. In most states, pseudoephedrine is kept behind the pharmacy counter.

  • Products like oral pseudoephedrine or phenylephrine are not the preferred treatment for congestion in pregnancy and should not be used in the first trimester due to a possible risk of some birth defects.
  • Saline nasal irrigation is the first-line recommendation for congestion in pregnant women.
  • Although additional data are needed, it is best to avoid decongestants like pseudoephedrine in pregnancy. Some case studies suggest malformations (gastroschisis, small intestinal atresia, and hemifacial microsomia) may occur with first trimester use of pseudoephedrine. An elevated heart rate in the fetus was reported in one case study.
  • Decongestants can also cause blood vessel narrowing and elevate blood pressure. Do not use these medications if you have high blood pressure.

Alternatives to oral decongestants, like nasal saline solutions (Ayr or Ocean Nasal Spray) are safer options than oral decongestants.

There are no studies looking at whether pseudoephedrine could make it harder to get pregnant, based on data from Mother to Baby (July 2020).

Drug Use in Pregnancy: Cough Agents

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 and you may have some guaifenesin expectorant or dextromethorphan cough suppressant in your cabinet - should you take it?

First, check labels. Any OTC cough or cold product containing alcohol should be avoided.

  • Dextromethorphan should only be given if the benefit to the mother justifies the potential risk to the fetus as determined by your doctor. The available human data have not found an association between dextromethorphan (examples: Delsym, Vicks Formula 44) and an increased risk of birth defects in humans, and it's use has been noted as compatible with both pregnancy and breastfeeding. 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.
  • Guaifenesin (Robitussin, Mucinex, Tussin) is used to thin and loosen mucus from the throat and lungs. Most studies suggest that guaifenesin is not associated with an increase in birth defects.
  • Be sure to use products that have only the one ingredient you want; many OTC cough and cold medicines are combinations of several drugs, including decongestants like pseudoephedrine or phenylephrine that you want to avoid.
  • Cough suppressants containing ethanol (alcohol) should be avoided.

Other options? Cough lozenges are safe, or a soothing drink of honey, lemon and warm water can be a natural help for a cough.

Caffeine: Can I Still Have My Latte?

  • Caffeine has not been linked to birth defects, but most health experts agree that low to moderate caffeine consumption in pregnancy is key, meaning less than 200 to 300 milligrams (mg) of caffeine per day (1-2 eight ounce cups of coffee). Remember to add up all of your sources caffeine throughout the day.
  • 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 30 to 45 mg of caffeine. A Red Bull energy drink has 67 mg.
  • 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 increased heart rate, shaking, increased breathing rate, and difficulty sleeping following birth.

Learn More: Caffeine Content of Various Beverages

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). No reports have found an association between caffeine and birth defects.

Guarana is a caffeine-containing herbal supplement often found in energy drinks, and some medications may contain caffeine, too. Guarana has been reported to lead to low birthweight, birth defects, and premature birth. Experts recommend guarana not be used in pregnancy. Another herbal product with stimulant properties known as ephedra should also be avoided.

Use of Dietary Supplements in Pregnancy

  • In general, it is best to avoid OTC herbal and certain dietary supplements in pregnancy. These products are not regulated by the FDA and may have variable quality or be contaminated.
  • Over-the-counter "natural" dietary supplements may contain unknown substances and few studies describing their use in pregnancy are available.
  • 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.
  • Regular over-the-counter supplements may not have the right dose of vitamins that you need, so ask your doctor if you need a prescription for prenatal vitamins.

It's Flu Season - Should I Get a Shot?

Certain vaccines are highly recommended for 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.
  • These vaccines have been shown to be safe and necessary in pregnancy.
  • 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. It may be required that you wait several months to become pregnant after a live vaccine; ask your dcotor.

  • The FluMist nasal vaccine contains a live virus and should NOT be used in pregnant women.
  • Other live vaccines to avoid include the chickenpox (varicella) vaccine, measles-mumps-rubella (MMR) vaccine, and shingles (varicella-zoster) vaccine such as Zostavax.

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.

Is Any Amount of Alcohol Okay in Pregnancy?

  • No, 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.

Pregnancy During Allergy Season

  • Allergic rhinitis can be a new condition in pregnancy or one that the woman has suffered from for years.
  • Nasal saline spray is the best - and safest - option to try first, but is not always effective for allergy symptoms.
  • When possible, it is best to avoid the allergen to lessen the need for allergy medication during pregnancy. But this is not always possible.
  • Before using an OTC product for allergies in pregnancy, ALWAYS get an OK from your doctor. Use the lowest dose possible.

For mild allergic rhinitis, cromolyn sodium nasal spray (Nasalcrom), a mast cell stabilizer, may be considered.

For moderate-to-severe nasal allergies, glucocorticoid sprays are often the treatment of choice during pregnancy, with the exception of triamcinolone (for example: Nasacort Allergy 24HR) in the 1st trimester.

OTC corticosteroid nasal sprays include budesonide (Rhinocort Allergy) or fluticasone intranasal (Flonase, Flonase Sensimist). There is a concern with triamcinolone intranasal spray (Nasacort Allergy 24HR) in the 1st trimester due to the possibility of respiratory system malformations.

Mometasone (Nasonex) spray is another nasal glucocorticoid option for allergic rhinitis in pregnancy but requires a prescription from your doctor.

Intranasal glucocorticoid sprays work better than oral antihistamine tablets for seasonal allergies or hay fever. However, if tablets are used, non-sedating antihistamines are usually preferred over sedating, first generation antihistamines like diphenhydramine.

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. 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. The respected online reference Mother to Baby also states that loratadine is usually safe in pregnancy.

Other non-sedating antihistamines noted with a lower risk in pregnancy may include:

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

Can I Use My Acne Medication?

Over-the-counter (OTC) topical acne treatments are medications applied directly to the skin.

  • Benzoyl peroxide, a common ingredient found in OTC acne medications, can be used during pregnancy. OTC topical acne products do not appear to increase the risk for birth defects in pregnancy as so little of the medication (5% to 10%) gets through the skin.
  • The American College of Obstetricians and Gynecologists (ACOG) recommends topical benzoyl peroxide, azelaic acid, topical salicylic acid and glycolic acid for treatment of acne in pregnancy.
  • See your dermatologist to discuss your options for control of acne during pregnancy.

Differin (adalapene) 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, these other options are preferred.

The prescription oral drug isotretinoin (Accutane) for acne should NOT be used in pregnancy due to the high risk of birth defects. In fact, just one dose of isotretinoin can cause severe birth defects or death of a baby. NEVER use this medicine if you are pregnant or may become pregnant. Topical tretinoin (Retin A), also a prescription drug, is also NOT recommended because other, safer options are available.

Stomach Symptoms in Pregnancy

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 if you are pregnant; not all OTC medications are safe for use.

Heartburn

Heartburn is experienced by more than 50% of women in pregnancy. Lifestyle changes for heartburn should be tried first: avoid coffee, spicy or other aggravating foods, don't lie down after eating, and lying on your left side or using a pillow to prop up during sleep are the best first choices. If you still need help for acid reflux, check in with your doctor for suggestions.

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.

Ask your doctor about the OTC acid blockers (H2 blockers) famotidine (Pepcid 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. H2 blockers do appear to cross the placenta. Nizatidine (Axid AR) should be used with caution in pregnancy. In April 2020, all ranitidine (Zantac, others) products were removed from the US market.

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, and adequate exercise should be tried first (and used regularly) to help avoid constipation.

Fiber supplements, such as psyllium (Metamucil, FiberAll) or methylcellulose (Citrucel) can help with constipation in pregnancy and generally are not absorbed into the blood stream; 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.

In the Outdoors: How to Stay Bug-Free.

If possible, avoid mosquitoes and ticks while you are pregnant. 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, especially if any travel is planned. To help prevent contracting Zika virus, follow the latest CDC guidelines on pregnancy, travel and Zika Virus.

Learn More Here: Safe Use of Insecticides

Finished: OTC Medication Use In Pregnancy: Wise or Worrisome?

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.