Tadalafil in pregnancy: classified as Category B. Tadalafil pregnancy safety: Category B — Probably safe. Risk Summary Tadalafil tablets are not indicated for use in females. There are no data with the use

Pregnancy SafetyUse With CautionFDA Cat. BAI-Verified

Is Tadalafil safe during pregnancy?

Risk Summary Tadalafil tablets are not indicated for use in females. There are no data with the use of tadalafil tablets 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 ( see Data).

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 Tadalafil tablets are not indicated for use in females. There are no data with the use of tadalafil tablets 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 ( see Data).

Avoid

2nd Trimester

Weeks 13–26 · Baby growing

Risk Summary Tadalafil tablets are not indicated for use in females. There are no data with the use of tadalafil tablets 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 ( see Data).

Avoid

3rd Trimester

Weeks 27–40 · Final development

Risk Summary Tadalafil tablets are not indicated for use in females. There are no data with the use of tadalafil tablets 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 ( see Data).

B

Category B — Likely Safe

Animal studies show no risk, but limited human data available.

Brands Available in India

Tadalafil 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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