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You are pregnant and you get a bacterial infection and your doctor prescribes you azithromycin (AZM) and you become worried. Then you start pondering, “Is azithromycin safe in pregnancy?” In this article, we will discuss in detail whether or not azithromycin is safe during pregnancy. Here you will also find the uses and possible side effects of this drug.

1. What Is Azithromycin?
2. Is Azithromycin Safe In Pregnancy?
3. Is Azithromycin Safe During Breastfeeding?
4. Azithromycin Pregnancy Category
5. Azithromycin Uses In Pregnancy
6. Side Effects Of Azithromycin
7. FAQs By Patients
8. In A Nutshell, “Is Azithromycin Safe In Pregnancy?”

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What Is Azithromycin?

Is Azithromycin Safe In Pregnancy?

Azithromycin is a commonly prescribed drug during pregnancy. The US Food and Drug Administration (FDA) considers the antibiotic azithromycin (AZM) a pregnancy risk category B drug. This means:

• Animal reproduction studies did not show any fetal risks. Or, no adequate and well-controlled studies involving a large number of pregnant women were carried out.
• It is generally considered safe for pregnant women and can be used during pregnancy only if clearly needed.

Since adequate studies on a large sample of pregnant women have not yet been conducted, the possibility of harm to the human fetus cannot be ruled out. That’s why in the US, the prescription label on the packaging of azithromycin clearly states that, “Azithromycin should be used during pregnancy only if clearly needed.”

In general, azithromycin is considered safe to be taken during pregnancy if you acquire a bacterial infection that needs treatment. However, other antibiotics may be more suitable and effective for you, depending on the type of infection you have. Let your doctor decide which antibiotic will be the best and safest for you to take during your pregnancy. You must take this drug only under the supervision of your OB-GYN. 

Azithromycin Pregnancy Category

As stated above, the FDA has assigned pregnancy risk category B to azithromycin. This means there is no proof or evidence that azithromycin can cause birth defects when taken by pregnant women. So it is safe to be taken in pregnancy, provided:

• You are not allergic to it.
• You don’t have liver diseases (hepatitis, fatty liver, cirrhosis).
• You don’t have heart disease.
• You don’t have kidney diseases.

Is Azithromycin Safe During Breastfeeding?

Although azithromycin can pass into the breastmilk in very low levels, it is generally considered safe to use while breastfeeding. There is no confirmed epidemiological evidence which indicates that azithromycin can cause adverse effects/outcomes in nursing infants. However, you must always take azithromycin with caution and under the supervision of your doctor while breastfeeding. And you must report to your doctor immediately if:

• Your baby gets gastrointestinal problems (like diarrhea, vomiting, etc.).
• Your baby gets rashes and oral thrush (a fungal infection of the mouth and throat).
• Your baby stops feeding properly.

Azithromycin Uses In Pregnancy

Your doctor may prescribe you azithromycin during pregnancy to treat various bacterial infections, such as:

• Community-acquired pneumonia caused by Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae
• Chronic obstructive pulmonary disease (COPD) complications due to Streptococcus pneumoniae or Moraxella catarrhalis
• Travellers diarrhea
• Shigellosis
• Upper respiratory tract infections
• Pharyngitis/tonsilitis caused by Streptococcus pyogens
• Otitis media (middle ear infection)
• Urogenital infections because of chlamydia and gonorrhea

Azithromycin is used in pregnancy for the treatment of bacterial infections in women with a history of penicillin allergy. Azithromycin is also used for the management of some conditions related to childbirth, like preterm pre-labor rupture of membranes, and in the adjunctive prophylaxis for cesarean delivery. 

Side Effects Of Azithromycin 

Along with their desired effects, all medicines, including azithromycin, have certain undesirable effects (side effects), but not everyone gets them. 

Consult with your doctor right away if any of the following side effects occur.

Most Common Side Effects: These are mostly related to the gastrointestinal system, and include:

• Nausea
• Vomiting
• Diarrhea/loose stools
• Pain in the abdomen
• Loss of appetite

Less Common Side Effects: These occur in 1% or less cases, and include:

• Heart palpitations, chest pain
• Dyspepsia, flatulence, melena, acid reflux, gastritis, and cholestatic jaundice. 
• Dizziness, tiredness, and vertigo (fainting)
• Changes in your sense of taste
• Headache
• Vaginitis and nephritis
• Rash, pruritus, and dry skin
• Photosensitivity (sensitivity to light, such as sunlight)

Serious Side Effects: They are rare and can include:

• Liver injuries, which are more likely in people with a history of liver problems
• Cardiovascular arrhythmia (heart rhythm changes), especially in people who are using medications for heart rhythm, elderly people, and those with low blood potassium level
• Chronic diarrhea
• Serious allergic reactions

Frequently Asked Questions By Patients:

In A Nutshell, “Is Azithromycin Safe In Pregnancy?”

Yes. Azithromycin is a pregnancy B-category drug. So it is safe to take azithromycin in pregnancy. But you must understand that unnecessary consumption of azithromycin or any other antibiotics in pregnancy is a big NO. You must consume azithromycin during pregnancy only when it’s clearly needed and explicitly advised by your doctor. If you feel you need to take azithromycin during pregnancy, talk with your OB-GYN. Also, make sure to keep the following things in your mind:

• You must tell your OB-GYN about any other medications that you are taking. This will help your doctor look for any possible risky drug interactions.
• You must take azithromycin exactly as it is prescribed and until the prescription is over. Leaving the drug early may cause bacteria to become resistant. 
• Call your OB-GYN if you don’t feel better after completing the course of azithromycin.
• Inform your doctor if you have liver, heart, and kidney diseases.
• Don’t take azithromycin if you are allergic to it or other macrolide antibiotics such as erythromycin.

If you follow these steps, then you can be sure that you keep yourself and your baby as healthy as possible.

References:

• Sarkar M, Woodland C, Koren G, Einarson AR. Pregnancy outcome following gestational exposure to azithromycin. BMC Pregnancy Childbirth. 2006 May 30;6:18. doi: 10.1186/1471-2393-6-18. PMID: 16734900; PMCID: PMC1481555. Available from: https://pubmed.ncbi.nlm.nih.gov/16734900/
• Azithromycin (marketed as Zithromax or Zmax) information. (2022). Available from: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/azithromycin-marketed-zithromax-or-zmax-information
• US Food and Drug Administration (FDA). Highlights of Prescribing Information for Zithromax (Azithromycin). (2022). Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050710s44-050711s41-050784s28lbl.pdf