Safety of OTC Medications in Pregnant Women

OTC GuideJune 2008
Volume 12
Issue 1

Ms. Weaver is a pharmacy student and Dr. Howell is an assistant professor of pharmacy practice at Lake Erie College of Osteopathic Medicine School of Pharmacy, Erie, Pennsylvania.

More than 80% of women use medications during pregnancy, most of which are sold OTC.1,2 Medical and pharmacyrecords often lack documentation of nonprescription medication use, which makes it more difficult to detect an association between OTC medications and specific birth defects.3

Because the teratogenic effects of most medications are unknown, many health care professionals refrain from prescribing or recommending medications for pregnant women.4 This practice could be dangerous and lead to inappropriate use of self-administered OTC medications.2

The objective of this review is to provide pharmacists with the most current information on the effects of OTC medications on pregnant women and the fetus, in order to be able to advise pregnant patients on how to safely alleviate specific symptoms. Table 1 highlights treatment for specific symptoms in pregnant women.

Table 1


The OTC medication most commonly used by pregnant women is acetaminophen.3 Studies have not shown an increase in birth defects associated with occasional use of acetaminophen at any time during pregnancy; however, it is important to caution all patients about using the appropriate dose only when needed, because of hepatotoxicity and, rarely, nephrotoxicity associated with overuse in the general public.2

Most nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, are not recommended unless pain is intolerable and cannot be relieved with acetaminophen.2 NSAIDs can potentially cause premature closure of the fetal ductus arteriosus and should be avoided in the third trimester.5

Cold Medications

Cold relief products often contain several different types of medications and do not actually shorten the length of the cold; therefore, it is recommended that they are used only for serious discomfort.2 Nonpharmacologic remedies that can relieve symptoms include increasing fluid intake, using a humidifier, resting for an adequate time, and elevating the head while sleeping.6

If the patient is still severely congested, pseudoephedrine is the oral decongestant drug of choice or pregnant women.2,6 Short-acting formulations and low doses should be recommended.2

Oxymetazoline, a nasal decongestant spray, also may be recommended for up to 3 days for symptomatic congestion. It should not be used beyond the recommended period because of rebound congestion, which could lead to overuse of the medication and previously unseen teratogenic effects.2,7

For cough and sore throat, pregnant patients may be advised to gargle with saltwater and use nonmenthol cough drops.8 If these methods do not provide adequate relief of symptoms, guaifenesin, an expectorant, and dextromethorphan, a cough suppressant, are recommended alone or in combination in the case of severe maternal discomfort.2

Allergy Medications

The antihistamines chlorpheniramine and diphenhydramine are most often used for allergies in pregnant patients.2

Loratadine is a newer nonsedating antihistamine that has recently switched to OTC.2 Based on evidence regarding its use as a prescription medication, it is classified as pregnancy risk category B (Table 2).7 It is recommended that it be used only when allergy symptoms cannot be relieved by first- and second-line alternatives.2

Table 2


Nonpharmacologic remedies are of particular importance when considering afflictions of the gastrointestinal tract. Lifestyle and dietary changes are often effective without medications. Pregnant women suffering from gastroesophagealreflux disease should eat small, frequent meals; avoid caffeine and spicy foods; avoid any food before bedtime; and elevate the head while sleeping.4 These alternatives may provide sufficient relief alone.

If medication is necessary for the relief of symptoms, aluminum, calcium, and magnesium preparations are generally recommended.4 Sodium bicarbonate is not recommended as an antacid because of sodium?s potential to cause fluid and electrolyte imbalances in both the mother and the fetus.4

Antiflatulents, Laxatives, and Antidiarrheals

Constipation is common during pregnancy and may be corrected without medication through increased intake of dietary fiber and fluids and physical exercise.4 Some health care professionals believe medications for constipation and diarrhea are often futile, and, in some cases, may actually aggravate the condition.2

Like NSAIDs, bismuth subsalicylate may cause premature closure of the fetal ductus arteriosus and may lead to subsequent persistent pulmonary hypertension of the newborn.2,5

Nausea/Motion Sickness Medications

The results of several studies suggest that the antihistamines meclizine and dimenhydrinate can be used by pregnant women for the prevention or treatment of nausea or motion sickness with minimal risk to the fetus.

Topical Medications

The imidazole agents, including clotrimazole, butoconazole, miconazole, and tioconazole, are the most commonly used OTC antifungal treatments.1 Both topical and vaginal formulations have low systemic absorption and are considered safe for use by pregnant women.2 Trials have not shown an association between birth defects and the use of these medications at any time during pregnancy.1

Like the opical antifungal treatments, most other topical medications are poorly absorbed through the skin and pose little danger to the fetus. Examples of topical drugs that are considered safe for use by pregnant women include: benzoyl peroxide for acne, zinc pyrithione for dandruff, hydrocortisone for inflammation, and bacitracin and benzocaine often used in combination as an antiseptic and anesthetic.2

Smoking Cessation Products

Patient education and the development of an individualized plan are the preferred methods for smoking cessation in pregnant women. When this approach is not successful, nicotine replacement therapy should be considered as an alternative to continued smoking. Despite the risk of nicotine-induced fetal abnormalities, cigarette smoke contains >3000 chemicals, many of which are more harmful to the fetus than nicotine alone.1

When recommending nicotine replacement therapy to pregnant women, immediate-release products, such as gum, spray, or inhalers, are preferred to patches, which are continuous-release. The amount of nicotine should be limited to what is absolutely necessary to stop smoking.

General Factors to Consider

When recommending OTC products, pharmacists should always take certain factors into consideration, including stage of pregnancy and embryologic development, safety of the ingredients, route of administration, dose, and any other medicationsthat the patient may be taking. Products with the fewest number of safe ingredients should be chosen and administered in the lowest dose possible. It also is important to educate the patient to follow directions carefully and to use the product for the shortest duration necessary.

If possible, nonpharmacologic therapy should be the first recommendation made by a pharmacist. If symptoms can be adequately relieved, then the risk associated with medication use may be avoided.


  • Black RA, Hill DA. Over-the-counter medications in pregnancy. Am Fam Physician. 2003;67:2517-2524.
  • Conover EA. Over-the-counter products: nonprescription medications, nutraceuticals, and herbal agents. Clin Obstet Gynecol. 2002;45:89-98.
  • Werler MM, Mitchell AA, Hernandez-Diaz S, Honein MA. Use of over-the-counter medications during pregnancy. Am J Obstet Gynecol. 2005;193:771-777.
  • DiPiro JT, Posey LM, Talbert RL, Yee GC, Matzke GR, Wells BG. Pharmacotherapy: A Pathophysiologic Approach. 6th ed. New York, NY: Mcgraw-Hill; 2005.
  • Alano MA, Ngougmna E, Ostrea EM, Konduri GG. Analysis of nonsteroidal antiinflammatory drugs in meconium and its relation to persistent pulmonary hypertension of the newborn. Pediatrics. 2001;107:519-523.
  • Rodriguez L, Greenfield M. Coughs and Colds in Pregnancy. Dr. Spock Web site. 2004 [cited 2007 August].,1510,5985,00.html.
  • Lexi-comp Database. Lexi-Comp. Online: 2007 August.
  • Health Pregnancy Guide. Information for Patients: Medications and Pregnancy. Pittsburgh, PA: University of Pittsburgh Medical Center; 2003.

Related Videos
Practice Pearl #1 Active Surveillance vs Treatment in Patients with NETs
© 2024 MJH Life Sciences

All rights reserved.