Nicotine Pregnancy and Breastfeeding Warnings

Brand names: Commit, Habitrol, Leader Nicotine Polacrilex, Nicoderm CQ, Nicorelief, Nicorette, Nicorette DS, Nicotrol Inhaler, Nicotrol NS, Nicotrol TD, ProStep

Medically reviewed by Drugs.com. Last updated on Jul 31, 2025.

Nicotine Pregnancy Warnings

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

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk summary: This drug can cause fetal harm when administered to a pregnant woman. Spontaneous abortions have been reported in patients using nicotine replacement therapy (NRT).

Comments:
-Patients should attempt to achieve smoking cessation through behavioral interventions first; patients who are unlikely to/cannot quit without pharmacological support may use NRT, with the goal of discontinuation as soon as possible.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Patients receiving NRT should begin with intermittent nicotine products (e.g., gum, lozenge, inhaler, nasal/oral spray). Patch formulations may be used by patients with significant nausea/vomiting, but should be removed before going to bed.
-Patients using nicotine bitartrate lozenges after second trimester should be supervised by a healthcare provider.

Animal studies have revealed evidence of decreased litter size with use, and skeletal abnormalities occurred at maternally toxic doses. There are no controlled data in human pregnancy.

Human studies have revealed evidence of growth retardation, premature birth, stillbirth, spontaneous abortion, and low birth weight when exposed to tobacco smoke. Male animal studies exposed to tobacco smoke have revealed evidence of decreased sperm production, increased oxidative stress, DNA damage, and lower fertilization ability.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

Nicotine Breastfeeding Warnings

Nicotine patches: Use is not recommended.
Intermittent nicotine formulations: Use is generally considered acceptable; benefit to the mother should outweigh risk to the infant.

Excreted into human milk: Yes

Comment:
-Patients should breastfeed prior to using intermittent formulations of this drug.

Use of nicotine replacement therapy (NRT) during breastfeeding produced a milk to plasma ratio of 2.9. NRT exposure was shown to be less harmful to the breastfed infant than second hand smoke exposure.

See references

Further information

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

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