Codeine in Pregnancy
Quick answer: Use cautiously short-term. Avoid near delivery (neonatal withdrawal/respiratory depression risk).
FDA pregnancy category
FDA category meanings
- A: Adequate human studies show no fetal risk
- B: Animal studies show no risk; human studies inadequate or animal risk not confirmed in humans
- C: Animal studies show risk; human data inadequate. Use only if benefit justifies risk
- D: Evidence of human fetal risk; benefits may outweigh risks in serious situations
- X: Risks clearly outweigh benefits — contraindicated in pregnancy
Note: The FDA replaced the letter category system with the Pregnancy and Lactation Labeling Rule (PLLR) in 2015 for new drug labels, providing more detailed narrative information. Letter categories remain useful as a quick reference.
Important context for Codeine
Use cautiously short-term. Avoid near delivery (neonatal withdrawal/respiratory depression risk). Always discuss any medication during pregnancy with your obstetric care provider — risk-benefit assessment depends on the specific clinical situation, gestational age, dose, duration, and available alternatives.
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Frequently asked questions
Is Codeine safe during pregnancy?
Use cautiously short-term. Avoid near delivery (neonatal withdrawal/respiratory depression risk). The FDA category for Codeine is C. This is general information — discuss your specific situation with your obstetric provider.
What does FDA pregnancy category mean?
Categories A through X classify medications by available evidence of fetal risk. A = safest with adequate human data; X = contraindicated. The categorization depends on animal studies, human data, and risk-benefit balance. Categories were replaced by narrative labeling in 2015 but remain a useful quick reference.
Should I stop my medication if I become pregnant?
Never stop chronic medications without consulting your doctor — abrupt discontinuation of some drugs (antiepileptics, antidepressants, blood pressure medications) can be more harmful than continuation. Plan medication changes before conception when possible.
Last reviewed: by iMedic Medical Editorial Team. Our editorial process.