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: D

Comments:
-Patients should attempt to achieve smoking cessation through behavioral interventions first; patients who are unlikely to/cannot quit without pharmacological support may use nicotine replacement therapy (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; however, spontaneous abortions have been reported in patients using NRT.

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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

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.

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.

See references