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Acrivastine / pseudoephedrine Pregnancy and Breastfeeding Warnings

Brand names: Semprex-D

Acrivastine / pseudoephedrine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: B

Animal studies on the individual active ingredients and the combination showed no teratogenicity at doses 5 times the recommended human dose or above; similarly, there were no effects of either drug or the combination on fertility. Acrivastine alone at 124 times the human dose showed maternal and neonatal mortality. Acrivastine at 118 times the human dose combined with pseudoephedrine at 590 times the human dose decreased neonatal survival. There are no controlled data in human pregnancy.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Acrivastine / pseudoephedrine Breastfeeding Warnings

Benefit should outweigh risk.

Excreted into human milk: Yes

-Pseudoephedrine is excreted in human milk; it is unknown if acrivastine is excreted in human milk.

See references

References for pregnancy information

  1. Product Information. Semprex-D (acrivastine-pseudoephedrine). Endo Laboratories LLC. 2001;PROD.

References for breastfeeding information

  1. Product Information. Semprex-D (acrivastine-pseudoephedrine). Endo Laboratories LLC. 2001;PROD.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.