Is Tadalafil (tadalafil) safe around pregnant women?

From the Guidelines

Tadalafil is generally considered safe around pregnant women as it is not absorbed through the skin in significant amounts when handled, and there is no conclusive evidence to suggest it poses a risk to the fetus when used by partners of pregnant women. This medication, commonly used for erectile dysfunction and pulmonary hypertension, works by inhibiting an enzyme called phosphodiesterase type 5 (PDE5), which increases blood flow to certain areas of the body. While there is limited research on its effects during pregnancy, the available evidence suggests that it can be used safely by partners of pregnant women without putting the pregnancy at risk through normal contact 1.

Some key points to consider when evaluating the safety of tadalafil around pregnant women include:

• The lack of conclusive evidence on the effects of tadalafil on the fetus when used by partners of pregnant women
• The classification of tadalafil as FDA Pregnancy Category B, meaning animal studies have not shown risk to the fetus, but adequate human studies are lacking
• The importance of washing hands after handling tadalafil tablets as a precautionary measure
• The need for pregnant women to consult their healthcare provider for personalized advice if they have concerns about exposure to tadalafil

It's also worth noting that the management of hypertension in pregnant women is a complex issue, and antihypertensive medications such as ACE inhibitors, angiotensin receptor blockers, and spironolactone are contraindicated during pregnancy due to the risk of fetal damage 1. However, this does not directly relate to the safety of tadalafil around pregnant women.

In terms of the available evidence, a study published in 2023 found that phosphodiesterase 5 inhibitors, including tadalafil, can be used to treat pulmonary hypertension, but it did not provide specific information on the safety of these medications around pregnant women 1. Another study published in 2025 discussed the management of hypertension in pregnant women, but it did not mention tadalafil specifically 1. A third study published in 2019 provided guidance on the management of cardiovascular disease in pregnant women with diabetes, but it also did not mention tadalafil 1.

Overall, the available evidence suggests that tadalafil is safe to use around pregnant women, but it's essential to follow proper precautions and consult with a healthcare provider if there are any concerns.

From the FDA Drug Label

1. 1 Pregnancy Risk Summary Tadalafil is not indicated for use in females. There are no data with the use of tadalafil in pregnant women to inform any drug-associated risks for adverse developmental outcomes In animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures up to 11 times the maximum recommended human dose (MRHD) of 20 mg/day

• Tadalafil Safety Around Pregnant Women: The FDA drug label does not provide direct information on the safety of tadalafil around pregnant women, as it is not indicated for use in females and there are no data on its use in pregnant women 2.
• Animal Studies: Although animal reproduction studies showed no adverse developmental effects, this information is not directly applicable to human pregnancy.
• Clinical Decision: Due to the lack of direct information, it is not possible to draw a conclusion about the safety of tadalafil around pregnant women.

From the Research

Tadalafil Safety Around Pregnant Women

• The safety of tadalafil around pregnant women has been evaluated in several studies 3, 4, 5, 6.
• A multicenter phase II clinical trial found that tadalafil treatment is safe for pregnant women with hypertensive disorder of pregnancy (HDP) 3.
• A safety and dose-finding trial of tadalafil administered for fetal growth restriction (FGR) showed that tadalafil had a favorable safety profile for pregnant women and fetuses with FGR 4.
• A study on the effect and mechanism of prophylactic use of tadalafil during pregnancy on l-NAME-induced preeclampsia-like rats found that prophylactic administration of tadalafil alleviated preeclampsia symptoms, promoted fetal growth, protected endothelial function, and reduced inflammation 5.
• A comparison of maternal blood concentration of tadalafil in pregnancy between pregnant and non-pregnant women found that pregnant women may tolerate tadalafil better, with a lower cumulative frequency of side effects 6.

Adverse Events

• Significant adverse events related to tadalafil did not occur in the tadalafil treatment group in a multicenter phase II clinical trial 3.
• Maternal adverse events, such as headaches, were decreased significantly in the tadalafil treatment group 3.
• A safety and dose-finding trial found that a dose of 40 mg/day increased the number of grade 1 adverse events, but the only fetal adverse event was a case of intrauterine fetal death related to the velamentous insertion of the umbilical cord 4.
• A study on the effect and mechanism of prophylactic use of tadalafil during pregnancy found that prophylactic administration of tadalafil improved maternal weight loss during pregnancy and fetal growth restriction 5.

Pharmacokinetics and Tolerance

• A comparison of maternal blood concentration of tadalafil in pregnancy between pregnant and non-pregnant women found that the mean area under the concentration-time curve and maximum blood concentration of tadalafil were not different between the two groups 6.
• The cumulative frequency of side effects was significantly lower in the pregnant group than in the non-pregnant group 6.
• Pregnant women may tolerate tadalafil better, with a lower rate of side effects 6.