Omeprazole(40mg) in pregnancy: classified as Category C. Omeprazole(40mg) pregnancy safety: Category C — Use with caution. Risk Summary There are no adequate and well-controlled studies with Omeprazole Delayed-Release Capsu

Pregnancy SafetyUse With CautionFDA Cat. CAI-Verified

Is Omeprazole(40mg) safe during pregnancy?

Risk Summary There are no adequate and well-controlled studies with Omeprazole Delayed-Release Capsules in pregnant women. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.

SAFECAUTIONAVOID

Overall verdict

Use With Caution

Trimester-by-Trimester Guide

40 weeks · 3 stages · different risks

AVOID
AVOID
AVOID
Week 1
Week 13
Week 27Week 40
Avoid

1st Trimester

Weeks 1–12 · Organs forming

Risk Summary There are no adequate and well-controlled studies with Omeprazole Delayed-Release Capsules in pregnant women. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.

Avoid

2nd Trimester

Weeks 13–26 · Baby growing

Risk Summary There are no adequate and well-controlled studies with Omeprazole Delayed-Release Capsules in pregnant women. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.

Avoid

3rd Trimester

Weeks 27–40 · Final development

Risk Summary There are no adequate and well-controlled studies with Omeprazole Delayed-Release Capsules in pregnant women. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.

C

Category C — Use Cautiously

Animal studies show adverse effects; weigh benefits vs. risks.

Brands Available in India

Omeprazole(40mg) is sold under these common brand names. All contain the same active ingredient, so safety during pregnancy is identical. Tap any brand for detailed info.

AI-Verified · Based on FDA classifications + peer-reviewed sources

Not medical advice

Every pregnancy is different. Always consult your obstetrician before taking any medicine. Drug safety classifications can change — verify current guidelines with your doctor. For emergencies, call 112.

Frequently Asked Questions

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