Is amlodipine (calcium channel blocker) safe during pregnancy?

From the Guidelines

Amlodipine is not recommended as a first-line treatment during pregnancy due to limited human data and potential effects on fetal development, and alternative antihypertensive medications such as labetalol, nifedipine, or methyldopa should be considered first. The most recent and highest quality study, published in 2025 1, suggests that antihypertensive drugs known to be effective and safe in pregnancy include methyldopa and nifedipine, but does not mention amlodipine as a recommended option.

Key Considerations

• Amlodipine is classified as FDA pregnancy category C, meaning animal studies have shown adverse effects on the fetus, but there are insufficient well-controlled studies in humans 1.
• Alternative antihypertensive medications with better safety profiles during pregnancy should be considered first, such as labetalol, nifedipine, or methyldopa 1.
• If you are currently taking amlodipine and discover you are pregnant, do not stop taking it suddenly but consult your healthcare provider immediately to discuss whether a medication change is appropriate.
• The concern with amlodipine in pregnancy relates to limited human data and some animal studies suggesting potential effects on fetal development 1.

Management of Hypertension in Pregnancy

• The American College of Obstetricians and Gynecologists recommends that postpartum patients with gestational hypertension, preeclampsia, and superimposed preeclampsia have their blood pressures observed for 72 h in the hospital and for 7–10 days postpartum 1.
• Long-term follow-up is recommended for these women as they have increased lifetime cardiovascular risk 1.
• A blood pressure goal of 110–135/85 mmHg is suggested in the interest of reducing the risk for accelerated maternal hypertension and minimizing impaired fetal growth 1.

From the FDA Drug Label

The limited available data based on post-marketing reports with amlodipine use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20-times the maximum recommended human dose (MRHD), respectively However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold). Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose

The use of amlodipine during pregnancy is not entirely clear due to limited available data. However, it is known that:

• Poorly controlled hypertension in pregnancy poses risks to both the mother and fetus.
• Animal studies did not show adverse developmental effects at doses up to 10 and 20 times the maximum recommended human dose.
• Rats showed decreased litter size and increased intrauterine deaths at high doses.
• Amlodipine may prolong gestation and labor in rats. Given the unclear evidence, a conservative clinical decision would be to exercise caution when using amlodipine during pregnancy, considering the potential risks and benefits, and carefully monitoring and managing the patient accordingly 2.

From the Research

Safety of Amlodipine During Pregnancy

• The safety of amlodipine, a calcium channel blocker, during pregnancy has been evaluated in several studies 3, 4, 5, 6, 7.
• A systematic review and meta-analysis found that amlodipine can be effectively and safely used for hypertension during pregnancy, with a decreased risk for maternal side effects compared to nifedipine 3.
• Another study suggested that the use of nifedipine-XL or amlodipine can be considered for non-severe hypertension during pregnancy, although with a lower level of evidence of safety 4.
• Amlodipine was found to have a better control on systolic and diastolic blood pressure compared to intermediate-/long-acting nifedipine, with no difference in pregnancy outcomes 3.
• However, it is essential to note that the evidence is not entirely consistent, and some studies suggest that amlodipine should be used with caution during pregnancy, especially in the absence of sufficient data on its safety and efficacy 5, 6, 7.

Comparison with Other Antihypertensive Medications

• Amlodipine has been compared to other antihypertensive medications, such as nifedipine, hydralazine, and labetalol, in terms of its safety and efficacy during pregnancy 3, 5, 6.
• Nifedipine was found to be superior to hydralazine and labetalol in treating severe hypertension during pregnancy, but amlodipine was not directly compared to these medications in all studies 5, 6.
• Methyldopa and other beta-blockers have been used extensively during pregnancy, but their safety and efficacy profiles differ from those of amlodipine 7.

Clinical Implications

• The use of amlodipine during pregnancy should be carefully considered, taking into account the potential benefits and risks, as well as the availability of alternative antihypertensive medications 3, 4, 5, 6, 7.
• Healthcare providers should be aware of the latest evidence and guidelines when making decisions about the management of hypertension during pregnancy, including the use of amlodipine 3, 4, 5, 6, 7.