Is Zantac (Ranitidine) safe during pregnancy

Zantac (generic name ranitidine), an oral medication in the group of histamine-2 blockers, is usually considered safe during pregnancy [1] for treating problems like acid reflux, nausea, indigestion and heartburn [2]. It has also been safely used for preventing Mendelson’s syndrome [3]. However, it is always recommended to consult your doctor to discuss any potential risks, whether you are considering the prescription or over-the-counter dosages [4].

Zantac FDA pregnancy category

Category B – Studies have shown ranitidine to cross the placenta, but there is no evidence of any serious harm to the baby [1].

How much Zantac can you take while pregnant

The dosage varies from one individual to another, depending on the purpose of use, severity of the symptoms and the medical history of the mother. The regular recommended adult dosage of 300mg per day [5] is usually considered safe for pregnant women. Smaller dosages of 75mg and 150mg are also available [6]. Make sure to talk to your physician before starting on any specific dose.

Are there any risks of taking Zantac while pregnant

A 1996 study compared 178 women who were exposed to histamine-2 receptor antagonists with another group of 178 women with no such exposure. Both groups had similar gestational age, alcohol and smoking history. In the exposure group, 71% of the women took ranitidine with the rest having other forms of H2RAs. There was no exceptional difference between the two groups in terms of elective or spontaneous abortions, preterm birth, congenital malformations and birth weight [7].

One study showed its maternal serum-umbilical cord concentration ratio to be 0.9 in average after an intravenous administration of ranitidine for preventing Mendelson’s syndrome in 20 women in the 38th week of their pregnancy. The ratio averaged around 0.38 when a 150mg dosage was given to 80 women, 1 to 8 hours prior to a scheduled c-section at the 37th week [1].

Another study was done where 909 women in labor were given a 150mg oral dosage of ranitidine every 6 hours for preventing Mendelson’s syndrome. The results were compared with those of a control group consisting of 378 women who received conventional alkali therapy. There was no evidence of a higher incidence of any surgical intervention or placental/post-partum hemorrhage in the ranitidine group. The study showed similar outcomes for neonatal health between the two groups as well [1].

Animal studies have shown no evidence of fetal harm even after administration of dosages 160 times higher than that recommended for humans [8].

Most studies have been performed to determine the safety of ranitidine (Zantac) during the later stages of pregnancy, specifically the third trimester; however, no adverse outcomes have been reported due to its use in the first and second trimesters. A study carried out between 1985 and 1992, showed no association between any birth defects and the use of ranitidine in the first trimester [7].

Zantac and breastfeeding

It is secreted into breast milk in small amounts and should be used with caution by nursing mothers. However, studies have failed to show any serious adverse effects [9]. It is strongly advised to talk to your doctor before using it [8].

[ref]

  1. http://www.drugs.com/pregnancy/ranitidine.html
  2. http://www.ncbi.nlm.nih.gov/pubmed/9207819
  3. http://patient.info/doctor/mendelsons-syndrome
  4. http://www.webmd.com/drugs/2/drug-4090-7033/zantac-oral/ranitidinetablet-oral/details#precautions
  5. http://www.drugs.com/dosage/zantac.html
  6. http://www.womenshealthcare.org/patient/info-for-pregnancy
  7. http://www.medscape.com/viewarticle/515100_5
  8. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Zantac_Oral/pdf/ZANTAC-ORAL.PDF
  9. http://www.medscape.com/viewarticle/515100_6 [/ref]