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Guaifenesin Pregnancy and Breastfeeding Warnings

Brand names: Breonesin, Calmylin Expectorant, Diabetic Expectorant, Dristan Chesty Cough Guaiphenesin, Family Meltus Chesty Coughs, GG 200 NR, Guaiatussin, Guiatuss, Humavent LA, Humibid, Mucinex, Mucinex Children's Chest Congestion, Mucinex Maximum Strength, Muco-Fen, Mucus Relief, Mytussin, Q-Tussin, Robafen, Robitussin Chest Congestion, Robitussin Mucus + Chest Congestion, Siltussin, Sorbutuss, Strepsils Chesty Cough, Tussin, Tussin Expectorant

Medically reviewed by Drugs.com. Last updated on Dec 21, 2023.

Guaifenesin Pregnancy Warnings

The Collaborative Perinatal Project reported 197 first-trimester exposures to guaifenesin. Fourteen malformations were reported for a relative risk not significantly different from 1.0.

In a review of 229,101 deliveries to Michigan Medicaid patients, 141 first-trimester exposures to guaifenesin and 349 exposures anytime during pregnancy were recorded. A total of 9 birth defects were reported with first trimester exposure (6 expected) and included 2 cardiovascular defects. These data do not support an association between guaifenesin and birth defects. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994)

Guaifenesin has been assigned to pregnancy category C. by the FDA. There are no controlled data in human pregnancy. Guaifenesin is only recommend for use during pregnancy when benefit outweighs risk.

See references

Guaifenesin Breastfeeding Warnings

There are no data on the excretion of guaifenesin into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

  1. Heinonen O, Shapiro S; Kaufman DW ed., Slone D. Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, Inc. 1977;297.
  2. Product Information. Humibid (guaiFENesin). Medeva Pharmaceuticals. PROD.

References for breastfeeding information

  1. Covington TR, eds., Lawson LC, Young LL. Handbook of Nonprescription Drugs. Washington, DC: American Pharmaceutical Association. 1993.

Further information

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