OTC Medication Use In Pregnancy: Wise or Worrisome?
Medically reviewed on Jul 23, 2018 by L. Anderson, PharmD.
How Should I Approach Medication Use in Pregnancy?
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 3-5% 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.
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.
How Common is Medication Use During Pregnancy?
Statistics show that medication use during pregnancy is surprisingly common. Prescription drug use in the first trimester has increased by over 60 percent in the last 30 years.
In addition, use of four or more medications in the first trimester tripled. According to the FDA, there are about six million pregnancies in the U.S. each year, and 50% of pregnant women say that they take at least one medicine.
This raises concern as some medications used during organogenesis (the time period of 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 extrapolated to humans.
Roughly 10 percent of birth defects result from drug exposure in pregnancy.
FDA Pregnancy Risk Categories
In the past, FDA had established prescription drug pregnancy risk categories as A, B, C, D or X.
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.
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 Safe in Pregnancy?
Acetaminophen (Tylenol) is a common over-the-counter (OTC) pain, headache and fever treatment routinely used in pregnancy. There has been a lot of controversy about the use of this common painkiller during pregnancy lately.
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.
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.
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
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.
According to Mother to Baby, low dose aspirin (less than 81 mg/day) has been well studied in pregnancy and does not appear to increase the chance of birth defects or other pregnancy complications. In some pregnant women low-dose aspirin may be used for certain medical conditions, but typically this would be under the direct care of a physician. If a medication for minor pain, headache or fever is required, short-term use of acetaminophen is usually a safer option.
My Back Aches: NSAID Safety in Pregnancy
Nonsteroidal antiinflammatory drugs (NSAIDs) like ibuprofen (Advil, Motrin) are commonly found in OTC medications. Ask your doctor about NSAID use in pregnancy. Some birth defects as well as an elevated risk for miscarriage have been reported with NSAIDs; more study is required to definitely link these outcomes, however, caution is advised.
Infertility due to frequent use of NSAIDs has also been reported, and appears to be a result of a blockage of the rupture of the luteinized follicle. One series of case reports stated that 4 out of 5 women conceived successfully after stopping NSAIDs.
NSAIDs should NOT be used in the third trimester of pregnancy unless specifically prescribed by your doctor. Like aspirin, NSAIDs like ibuprofen may interfere with the closure of the ductus arteriosus in the baby's heart. Acetaminophen is usually the pain and fever reliever of choice in pregnancy.
Drug Use in Pregnancy: Cough Suppressants
Pregnant women may be more prone to colds and flu because their illness-fighting immune system is slightly weakened in pregnancy.
The available human data have not found an association between dextromethorphan (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 by Briggs, et al. However, dextromethorphan should only be given if the benefit to the mother justifies the potential risk to the fetus as determined by your doctor. Cough suppressants containing ethanol (alcohol) should be avoided.
Cough lozenges are safe, or a soothing drink of honey, lemon and warm water can be a natural help for a cough.
The Stuffy Nose and Pregnancy: What to Do?
Pseudoephedrine and phenylephrine (Sudafed, Sudafed PE) are OTC medicines used to relieve nasal congestion caused by colds and hay fever. Decongestants can cause blood vessel narrowing and elevate blood pressure. Products like oral pseudoephedrine or phenylephrine are not the preferred treatment for congestion in pregnancy and should not be used in the first trimester; nasal saline irrigation is the first-line recommendation.
It is best to avoid decongestants in pregnancy, some case studies as reported by Briggs and others suggest malformations (gastroschisis, small intestinal atresia, and hemifacial microsomia) may occur with first trimester use of pseudoephedrine.
Alternatives to oral decongestants, like nasal saline solutions (Ayr) or a decongestant spray (Neo-Synephrine) are safer options than oral decongestants, but limit use of decongestant sprays to no more than 3 days in a row to prevent rebound congestion.
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 (1-3 eight ounce cups of coffee). Most coffees purchased today in the U.S. exceed an eight ounce cup; for example, a "Grande" coffee at Starbucks is 16 ounces.
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. As reported by Briggs, there have been reports of an increased risk of miscarriage and possibly infertility with higher caffeine doses. 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. Ernst and colleagues suggest Guarana may 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 Vitamin and Herbal Supplements
In general, it is best to avoid OTC herbal and dietary supplements in pregnancy. These products are not regulated by the FDA and may have variable quality.
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 as recommended by your doctor.
Regular over-the-counter supplements may not have the right dose of vitamins you need, so ask your doctor if you need a prescription.
It's Flu Season - Should I Get a Shot?
Certain vaccines are actually encouraged for pregnant woman. Vaccines that are inactivated (killed vaccines) may be given during pregnancy if needed. Vaccines that contain live viruses are not generally recommended.
Suggested vaccines in pregnancy include:
- inactivated influenza shot
- Tdap vaccine (tetanus toxoid, diphtheria toxoid and acellular pertussis).
The FluMist nasal vaccine contains a live virus and should NOT be used.
If you're planning a pregnancy, talk to your health care provider beforehand about any vaccines you may need. Live vaccines should be given at least a month before attempting to get pregnant.
Is Any Amount of Alcohol Okay in Pregnancy?
There is no established safe level of alcohol (wine, beer, or liquor) you can drink during any trimester in pregnancy.
Alcohol easily crosses the placenta. Studies have found higher rates of miscarriage, stillbirth, and birth defects with alcohol use during pregnancy. Also, be sure to check over-the-counter medication bottles for the presence of alcohol.
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. If you are concerned that you cannot avoid alcohol intake during your pregnancy, speak with a health care provider as soon as possible.
Pregnancy During Allergy Season
When possible, it is best to avoid the allergen to lessen the need for allergy medication during pregnancy. But this is not always possible.
Allergic rhinitis can be a new condition in pregnancy or one that the woman has suffered from for years. For nasal allergies in pregnant women, the use of intranasal cromolyn sodium, a mast cell stabilizer, or a corticosteroid nasal spray such as budesonide (Rhinocort Allergy) or fluticasone intranasal (Flonase) is another option, with low absorption into the bloodstream.
Non-sedating antihistamines are usually preferred over sedating first generation antihistamines like diphenhydramine. Loratadine (Claritin) is a non-sedating antihistamine also used to relieve the symptoms of seasonal allergies like sneezing, runny nose, and watery eyes. Clinical data from Briggs 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 source Mother to Baby also states that loratadine is usually safe in pregnancy.
Other non-sedating antihistamines noted with a lower risk in pregnancy 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 product does not appear to increase the risk for birth defects in pregnancy as so little of the medication (5-10%) 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.
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.
Differin (adalapene) is now available OTC without a prescription for acne treatment. Adapalene is 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 may be preferred.
Stomach Symptoms in Pregnancy
Stomach complaints, such as heartburn, gas, and constipation are common in pregnancy. Heartburn is experienced by more than 50 percent of women in pregnancy.
Simethicone (Gas-X, Mylanta Gas), an anti-flatulent for gas that is not absorbed into the bloodstream, is also compatible with pregnancy.
Adequate fluids (water) and exercise is always important to combat constipation, but the stool softener docusate sodium (Colace) has been reported as compatible with pregnancy by Briggs et al.
Fiber supplements, such as Metamucil or FiberCon can help with constipation in pregnancy, too, if okayed by your doctor.
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.
According to the CDC, insect repellents registered with the EPA, such as DEET, can be used on pregnant women. 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 and apply DEET to clothes instead of skin to minimize exposure. Just be sure not to apply under your clothes as too much may be absorbed. Also, DEET may ruin polyester or nylon gear or clothes.
Recommendations change frequently and should be consulted by pregnant women before any international travel. Women of child-bearing age can protect themselves from mosquito bites by wearing long-sleeved shirts and pants, using mosquito repellent, and staying indoors when possible. Since Zika virus is sexually transmitted, women should use condoms if they live in an active Zika area.
- If the female is exposed to an active Zika area, she should wait at least 8 weeks after the last possible exposure or after symptoms start (if she developed symptoms) before trying to conceive. During this waiting period, use condoms or do not have sex.
- If the male partner was exposed to an active Zika area, he should wait at least 6 months after the last possible exposure or after symptoms start (if he developed symptoms) before trying to conceive. During this waiting period, use condoms or do not have sex.
Finished: OTC Medication Use In Pregnancy: Wise or Worrisome?
- Nisenblat V, Normal R (authors). Up To Date. The effects of caffeine on reproductive outcomes in women. June 2017. Accessed July 24, 2018 at https://www.uptodate.com/contents/the-effects-of-caffeine-on-reproductive-outcomes-in-women
- Mendonça LL, Khamashta MA, Nelson-Piercy C, et al. Non-steroidal anti-inflammatory drugs as a possible cause for reversible infertility. Rheumatology (Oxford). 2000;39(8):880. Accessed July 24, 2018 at https://www.ncbi.nlm.nih.gov/pubmed?term=10952743
- Lockwood C, Magriples U, authors. Prenatal care: Patient education, health promotion, and safety of commonly used drugs. Up To Date. Accessed July 4, 2018 at https://www.uptodate.com/contents/prenatal-care-patient-education-health-promotion-and-safety-of-commonly-used-drugs
- U.S. Food and Drug Administration (FDA). Medicine and Pregnancy. Last updated 2/16/2018. Accessed July 24, 2018 at https://www.fda.gov/forconsumers/byaudience/forwomen/ucm118567.htm
- Mitchell AA, Gilboa SM, Werler MM, Kelley KE, Louik C, Hernandez-Diaz S, and the National Birth Defects Prevention Study. Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am J Obstet Gynecol. 2011;205:51.e1-8. Accessed July 24, 2018.
- Centers for Disease Control and Prevention. Adult Vaccination. Pregnant Women. Accessed July 24, 2018 at http://www.cdc.gov/vaccines/adults/rec-vac/pregnant.html
- Briggs GG, Freeman RK, Yaffe SJ, eds. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. 8th ed. Philadelphia: Lippincott Williams and Wilkins, 2008.
- Centers for Disease Control and Prevention. Treating for Two: Medications and Pregnancy. Accessed July 24, 2018 at http://www.cdc.gov/pregnancy/meds/
- Servey J, Chang J. Over-the-counter medications in pregnancy. Am Fam Physician. 2014 Oct 15;90(8):548-555. Accessed July 24, 2018 at http://www.aafp.org/afp/2014/1015/p548.html
- Nakhai-Pour, H. et al. Use of nonaspirin nonsteroidal antiinflammatory drugs during pregnancy and the risk of spontaneous abortion. CMAJ 2011;DOI:10.1503 /cmaj.110454 Accessed July 24, 2018 at http://www.cmaj.ca/content/early/2011/09/06/cmaj.110454.full.pdf
- Cabbage LA, Neal JL. Over-the-counter medications and pregnancy: An integrative review. Nurse Practitioner: The American Journal of Primary Healthcare. June 2011;36:22-8. Accessed July 24, 2018 at http://journals.lww.com/tnpj/Fulltext/2011/06000/Over_the_counter_medications_and_pregnancy__An.8.aspx
- MotherToBaby. Organization of Teratology Information Specialists. Fact Sheets. Accessed July 24, 2018 at http://mothertobaby.org/fact-sheets-parent/
- Kar S, et al. A review of antihistamines used during pregnancy. J Pharmacol Pharmacother. 2012 Apr-Jun; 3(2): 105–108. Accessed July 24, 2018 at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3356948/
- Ernst, E. Herbal medicinal products during pregnancy: are they safe?. BJOG: An International Journal of Obstetrics and Gynaecology. 2002:109;227–35. Accessed July 24, 2018 at doi:10.1111/j.1471-0528.2002.t01-1-01009.x
- Ystrom E, Gustavson K, Brandlistuen RE, et al. Prenatal Exposure to Acetaminophen and Risk of ADHD. Pediatrics. 2017;140(5):e20163840. Accessed July 24, 2018.
- Liew Z, et al. 2014. Acetaminophen use during pregnancy, behavioral problems, and hyperkinetic disorders. JAMA Pediatr;168(4):313-20. Accessed July 24, 2018.