Chlorpheniramine / hydrocodone Pregnancy and Breastfeeding Warnings

Brand names: HyTan, Hydrocodone GF, Novasus, S-T Forte 2, TussiCaps, Tussionex Pennkinetic, Vituz

Medically reviewed by Drugs.com. Last updated on Jul 21, 2025.

Chlorpheniramine / hydrocodone Pregnancy Warnings

Use is not recommended.

US FDA pregnancy category: Not assigned.

Risk summary: Prolonged use of opioids during pregnancy can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome (NOWS).

Comments:
-This drug is not recommended for use immediately prior to and during labor, as respiratory depression has been reported with codeine use during labor and delivery.
-Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; patients should be advised of the risk of NOWS and ensure that appropriate treatment will be available.

Animal studies have not been conducted with this combination product. Hydrocodone has shown teratogenicity in hamsters when given in doses 37 times the maximum recommended human dose. Babies born to mothers regularly taking opioids during pregnancy may become physically dependent. Opioids given to mothers shortly before delivery may produce some degree of respiratory depression in the newborn, especially if high doses are used. A statistically significant association between maternal use of chlorpheniramine and inguinal hernia and eye or ear anomalies was found in a small, retrospective study. Other studies have shown not shown this association. There are no adequate and well-controlled studies in pregnant women.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Chlorpheniramine / hydrocodone Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, considering the importance of the drug to the mother

Excreted into human milk: Yes (chlorpheniramine); Yes (hydrocodone)

Comments: Breastfed infants should be closely monitored for increased sedation, difficulty breastfeeding, breathing difficulties, or limpness; mothers should be counseled to seek medical assistance promptly if these develop.

Maternal use of narcotics during breastfeeding can cause infant drowsiness, CNS system depression, and even death; newborn infants are particularly sensitive. Withdrawal symptoms can occur in infants if hydrocodone is discontinued after a prolonged period (i.e., if the mother stops the drug or stops breastfeeding). Occasional, small doses of chlorpheniramine (2 to 4 mg) appear to be acceptable; however, larger doses or prolonged use may cause effects in the infant or decrease milk supply; non-sedating antihistamines are generally preferred.

See references

Further information

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

Medical Disclaimer