Pseudoephedrine During Pregnancy – Safety, Dosage and Side Effects

Is It Safe To Take Pseudoephedrine During Pregnancy?

The American College of Obstetricians and Gynecologists (ACOG) and the American College of Allergy, Asthma, and Immunology (ACAAI) recommend using pseudoephedrine during pregnancy. (2). Most of the studies infer that pseudoephedrine can be recommended to pregnant women in the second and third trimesters in appropriate doses. However, there are many safety concerns about the use of pseudoephedrine in the first trimester (2). No studies have been done so far to infer that pseudoephedrine can increase miscarriages, preterm deliveries, and low birth weight (1).

What Are The Possible Risks Of Taking Pseudoephedrine During Pregnancy?

Pseudoephedrine falls under pregnancy category C in all three trimesters of pregnancy. The use is warranted against potential benefits involving few risks. Few studies report that pseudoephedrine in the first trimester may cause birth defects in the fetus. Three malformations have been detected in the fetus.

1. Gastroschisis, which is an opening in the abdominal wall  
2. Small interstitial atresia means a part of the intestine is not fully developed. and   
3. Hemifacial microsomia: a part of the face is smaller than usual.

However, the same studies also infer that the increase in risk is very small(3). Pseudoephedrine can constrict the blood vessels and may cause maternal hypertension (BP), which may lead to less blood supply to the fetus and may have an effect on fetal growth in the first trimester (2a). As pseudoephedrine might cause an increase in blood pressure, it may pose a risk to mothers with a history of cardiac diseases along with uncontrolled hypertension, diabetes mellitus, and hyperthyroidism (2b).

What Is the Recommended Dosage Of Pseudoephedrine During Pregnancy?

Pseudoephedrine is available in 30 mg to 120 mg doses on the market in different dosage forms, like tablets, capsules, granules, powders, liquids, plain, or coated with slow-release or extended-release forms. It is often combined with other cold  or cough preparations along with fever medication (4). Pseudoephedrine can be taken 30 mg to 60 mg every four to six hours, as needed. For extended-release forms, every 120 mg for 12 hours. The maximum dose is 240 mg/day. Take the minimum effective dose for the shortest duration. Immediate-release dosage forms will decrease the risk of exposure to the fetus. (2c) It is available in different brand names, such as Sudafed, Nexafed, Zephrex-D, and Sucor syrup.

What Are The Side Effects Of Pseudoephedrine During  Pregnancy?

Nasal Decongestants Mucus in the lungs secretes it, just like pseudoephedrine does. Though considered safe, many side effects have been reported due to its action on the central nervous system and other related systems. The common side effects of pseudoephedrine includes (5) :- 

• Vomitings
• Sleeplessness
• Dizziness
• Elevated blood pressure
• Restlessness
• Anxiety
• Hallucinations
• Seizure
• Headaches
• Urinary dysfunction
• Cardiac and stroke-related disturbances.

Most of the side effects are well tolerated and the serious effects are almost rare.

What Are the Alternatives to Pseudoephedrine?

Antihistamine medicines like Cetirizine, Loratadine, etc. are considered better alternatives to Pseudoephedrine as they clear the stuffy nose and have no potential cardiac effects, and the risk to the fetus is considered less. Trying natural decongestants such as steam inhalation, hot towels wrapped around the face, increasing fluid intake, drinking hot beverages, and normal saline nasal sprays can also relieve symptoms of a stuffy nose and can also relieve mild to moderate congestion.  It’s always better to take a doctor’s recommendation if symptoms persist for more than 2 days.

Pseudoephedrine is available as an OTC medication. The use of it in pregnancy comes with potential risks during the first trimester. Pseudoephedrine, along with relieving nasal congestion, may cause a narrowing of blood vessels in the uterus, which affects the blood flow to the fetus. Although considered safe to use in the second and third trimesters, potential malformations in the fetus are observed in first-trimester usage in a few studies. Severe cardiac effects are observed in pregnant women with known hypertension and past cardiac issues. Pregnant women need to consult their physician before taking pseudoephedrine, and the use should be for a short duration to avoid fetal risk and other adverse cardiac effects.

FAQ’s

1. Is Pseudoephedrine Better Than Phenylephrine When Pregnant?

Both come under the class of decongestants and both can affect the pregnancy, especially during the first trimester, by narrowing the blood vessels in the uterus and thereby reducing the blood flow to the fetus.

References

1. Pseudoephedrine – https://www.ncbi.nlm.nih.gov/books/NBK582924/
2. Pregnancy and OTC Cough, Cold, and Analgesic Preparations – https://www.uspharmacist.com/article/pregnancy-and-otc-cough-cold-and-analgesic-preparations
3. Teratogen update: Pseudoephedrine – https://onlinelibrary.wiley.com/doi/full/10.1002/bdra.20255
4. Pseudoephedrine—Benefits and Risks – https://www.mdpi.com/1422-0067/22/10/5146
5. Review: Side Effects of Some Commonly Used Allergy Medications (Decongestants, Anti-Leukotriene Agents, Antihistamines, Steroids, and Zinc) and Their Safety in Pregnancy – https://clinmedjournals.org/articles/ijam/international-journal-of-allergy-medications-ijam-3-024.pdf