For ethical reasons, clinical trials on pregnant women are not performed. As a result, there is a lack of data on the effect of drugs on pregnancy. Drugs may pass through the placenta and cause teratogenic side effects on the embryo/fetus. Typical manifestations of teratogenesis are fetal death, growth failure, improper organ development and cancer development later in life. Since about 50% of pregnancies are unplanned, there is a great potential for fetal teratogenic exposure, especially during the first trimester. The objective of the master thesis is to analyze the reports of teratogenic effects of medicinal products on embryo/fetus from global database VigiBase and European database EudraVigilance, as well as to compare with the suspected adverse drug reactions (ADRs) reports from Croatian national database VigiFlow. A retrospective observational study of suspected ADRs reports in system organ class (SOC) Congenital, familial and genetic disorders from Croatian national database VigiFlow, received by March 2018 was performed. Data on ADRs reports were given by HALMED's pharmacovigilance department. Suspected ADRs reports were analyzed with regard to reported active substances and congenital anomalies. A special review is given on Summary of product characteristics (SmPC), additional Risk minimisation measures (RMM) and Pregnancy prevention programme (PPP). According to the number of reported teratogenic side effects, medicinal products with effect on nervous system stand out, especially antiepileptics such as phenytoin, carbamazepine, valproic acid, gabapentin, topiramate and lamotrigine. Of the anxiolytics, diazepam is noted. The most commonly reported congenital anomalies are cardiovascular anomalies. For many reported active substances, safety in pregnancy has not been adequately investigated and there are no additional warnings in SmPC and package leaflets (PL). To improve the safety of drug use in pregnancy and reduce the risk of congenital drug-induced disorders, spontaneous reporting of side effects in postmarketing phase of medicinal product and the constant work on MMRs, including the implementation of PPP, as well as education of health workers and women of reproductive age play an important role.