Yes, Ondem-MD 4 (Ondansetron) is generally not recommended during the first trimester of pregnancy, as some studies have suggested a small increased risk of orofacial birth defects such as cleft lip or cleft palate when used early in pregnancy. This precaution is mentioned in official sources such as the FDA label, UK EMC, and MedlinePlus. However, in certain situations, especially in women with severe nausea and vomiting (hyperemesis gravidarum) who do not respond to safer first-line medicines, doctors may still prescribe Ondansetron if the potential benefits outweigh the possible risks.