May 22 2022

Classification of the active ingredient ranitidine


Risk level in pregnancy: This medicine is classified as Category B.

There are no adequate and controlled studies on fetal exposure to ranitidine by pregnant women, so this medication should be used only if clearly your need.

The few available data do not contradict the possible safety of the drug. A comparative study on 553 pregnancies, which included 355 patients treated with ranitidine, most of whom received the drug for at least the first quarter, showed no differences in major malformations compared to controls; although there was an increase in premature births, the authors did not specifically attributed to ranitidine [1].

Another study evaluated the prevalence of congenital malformations after exposure to cimetidine, omeprazole and ranitidine compared to unexposed controls, analyzing data from two cohorts registered in the United Kingdom General Practice Research Database and the Friuli-Venezia Giulia Health Database.

There were 20 stillbirths and 2261 live births in both cohorts combined, with 100 malformed offspring. The overall rate of malformations was 4.4%.

The relative risk of non-genetic congenital malformations associated with the use of cimetidine, omeprazole and ranitidine was 1.4 (95% CI: 0.8-2.4) compared to the unexposed group. On the other hand, found no relationship between exposure to drugs and premature delivery or growth retardation. These findings suggest that the use of acid-suppressing drugs during the first trimester of pregnancy is not associated with an increased teratogenic risk [2].

References:

1: Garbis H, Elefant E, Diav-Citrin O, Mastroiacovo P, Schaefer C, Vial T, Clementi M, Valti E, McElhatton P, Smorlesi C, Rodriguez EP, Robert-Gnansia E, Merlob P, Peiker G, Pexieder T, Schueler L, Ritvanen A, Mathieu-Nolf M. Pregnancy outcome after exposure to ranitidine and other H2-blockers. A collaborative study of the European Network of Teratology Information Services. Reprod Toxicol. 2005 Mar-Apr;19(4):453-8.
2: Ruigómez A, García Rodríguez LA, Cattaruzzi C, Troncon MG, Agostinis L, Wallander MA, Johansson S. Use of cimetidine, omeprazole, and ranitidine in pregnant women and pregnancy outcomes. Am J Epidemiol. 1999 Sep 1;150(5):476-81.

Update 18.06.2010

Meaning of category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.