Codeine
MedicationAscomp with Codeine, Codar, Guaiatussin AC, Tylenol with Codeine
Opioid analgesic
Research strength: 3 / 5
MotherToBaby reports mixed findings on codeine and some birth defects, with no clear pattern and, if an increase exists, likely a small one. A Norwegian cohort found similar overall birth-defect rates in exposed and unexposed pregnancies, while an Ontario cohort found links with some groups of first-trimester birth defects; neither study shows that codeine caused an outcome. Most Norwegian participants used codeine with paracetamol, and cohort enrollment began around gestational weeks 17 or 18, so early losses are not well represented. MotherToBaby says the miscarriage chance with codeine is unknown, and the current U.S. label says there are not enough human data to assess it. Ask your provider about your situation.
Last reviewed: 2026-10-14
Research strength: 3 / 5
MotherToBaby and the available cohort data do not identify a codeine-specific second-trimester effect. The Norwegian cohort included codeine use in weeks 13 to 28, but most exposed participants also used paracetamol, and the study did not separate a causal effect for this trimester. MotherToBaby says human data are limited and does not give a prescribed-codeine risk estimate for this period. Ask your provider about your situation.
Last reviewed: 2026-10-14
Research strength: 3 / 5
MotherToBaby reports that one study linked third-trimester codeine use with more postpartum bleeding and emergency cesarean births, but the chance with prescribed use is unknown. The Norwegian cohort found these associations, but nearly all exposed participants took codeine with paracetamol and other causes could not be ruled out. MotherToBaby says opioid use near delivery can lead to withdrawal symptoms in a newborn, and ACOG says infants exposed to opioids during pregnancy should be monitored by a pediatric care provider. In a 2022 cohort of pregnancies with at least two opioid prescriptions in the last 90 days, codeine had a lower adjusted risk of newborn withdrawal than hydrocodone, but that relative comparison is not an absolute codeine risk. Ask your provider about your situation.
Last reviewed: 2026-10-14
Sources
- MotherToBaby: CodeineTeratology service
- Norwegian Mother and Child Cohort Study: Codeine use during pregnancyUS government
- Esposito et al., JAMA Network Open 2022: Prescription opioids and neonatal opioid withdrawal syndromeUS government
- ACOG Committee Opinion No. 711: Opioid Use and Opioid Use Disorder in PregnancyProfessional society
- DailyMed: Codeine Sulfate Tablets, LannettDrug company label
Codeine — Breastfeeding
Research strength: 3 / 5
The U.S. FDA recommends against codeine during breastfeeding, and U.S. labels say breastfeeding is not recommended. EMA product information lists breastfeeding as a contraindication, and NHS Specialist Pharmacy Service says codeine should not be used. LactMed and ACOG are more qualified: they prefer other pain medicines and describe short use with close infant monitoring if codeine is selected. A 2012 Ontario cohort found no increase in 30-day infant readmission after maternal codeine prescriptions, but it did not verify whether infants were breastfed. A 2026 model predicted low infant morphine levels but did not measure clinical outcomes; the 2006 case report remains under an Expression of Concern, not a retraction. Ask your provider about your situation.
Last reviewed: 2026-10-14
Sources
- FDA Drug Safety Communication: Codeine and breastfeeding
- DailyMed: TYLENOL with Codeine tabletsDrug company label
- European Medicines Agency: Codeine Article 31 referral, Annex III product informationEU agencyEuropean guidance
- NHS Specialist Pharmacy Service: Using codeine, dihydrocodeine or tramadol during breastfeedingUK government
- LactMed: CodeineUS government
- ACOG Clinical Consensus No. 1: Pharmacologic Stepwise Multimodal Approach for Postpartum Pain Management
- Juurlink et al., Clinical Toxicology 2012: Postpartum maternal codeine therapy and neonatal outcomesUS government
- The Lancet Editors: Expression of Concern about the 2006 codeine case reportUS government
- Anderson and Hannam, Paediatric Anaesthesia 2026: Codeine and metabolite concentrations in the breastfed neonateUS government
Pregnancy
Human pregnancy evidence is observational. A Norwegian cohort (2011) included 2,666 codeine-exposed pregnancies, but only 45 participants used codeine alone; 2,621 used codeine with paracetamol. Overall malformations were reported in 4.9% of exposed and 5.0% of unexposed pregnancies (adjusted OR 0.9, 95% CI 0.8-1.1). MoBa's first questionnaire was completed around gestational weeks 17 or 18, limiting assessment of earlier pregnancy losses. An Ontario cohort (2022) included 599,579 pregnancies and reported associations between first-trimester codeine prescriptions and gastrointestinal anomalies (RR 1.53, 95% CI 1.12-2.09) and ankyloglossia (RR 2.14, 95% CI 1.35-3.40); observational findings do not prove causation. A 2022 cohort of 48,202 pregnancies with at least two opioid prescriptions in the final 90 days found a lower adjusted NOWS risk for codeine than hydrocodone (RR 0.57, 95% CI 0.46-0.70), a relative comparison rather than an absolute codeine risk. In 2026, an Australian cohort reported an adjusted score difference of -0.04 for reading and numeracy in the study's codeine exposure group, below the authors' threshold for a small effect; that group included codeine combination products. A 2026 Manitoba study found developmental vulnerability in 51% of the mixed opioid exposure group and 32% of matched controls (AOR 1.46, 95% CI 1.23-1.71), but sibling comparison results were 44% versus 48% (AOR 0.92, 95% CI 0.58-1.46); codeine exposures overlapped with other opioids. A 2026 periconceptional study reported an association involving acetaminophen-codeine combinations in one severity category, not codeine alone. The U.S. codeine sulfate label says human data are insufficient to assess major birth defects or miscarriage and reports animal developmental findings.
Breastfeeding
The U.S. FDA's 2017 Drug Safety Communication recommended against codeine during breastfeeding. Current U.S. labels say breastfeeding is not recommended, while EMA product information lists breastfeeding as a contraindication. LactMed recommends an alternative analgesic after milk comes in and limits oral codeine to 2-3 days at a low dose with close infant monitoring if codeine is used. ACOG lists acetaminophen and ibuprofen as first-line postpartum analgesics for people providing breast milk and says to review duration and newborn toxicity signs if codeine is selected. A 2012 Ontario retrospective cohort compared 7,804 mothers who filled postpartum codeine prescriptions with 7,804 controls; infant 30-day readmission did not increase (HR 0.95, 95% CI 0.81-1.11), but breastfeeding was not verified. The PubMed record for the 2006 case report has no abstract, and the original report has an Expression of Concern from 2026. A 2026 pharmacokinetic compartment model predicted neonatal morphine concentrations below 1 μg/L regardless of genotype, but it did not measure clinical outcomes. Published case reports and guidance remain divided, and the infant risk cannot be quantified from these data.
Codeine is an opioid analgesic used for pain and sometimes cough. It may be prescribed alone or in combination products, including products with acetaminophen or paracetamol. Tylenol with Codeine contains both acetaminophen and codeine.
What was tested
Pregnancy research includes prospective and retrospective population cohorts, self-reported use, and prescription records. Most studies are observational and some include combination products or broad opioid exposure. Breastfeeding evidence includes case reports, small milk and infant concentration studies, a postpartum prescription cohort that did not verify infant feeding, and pharmacokinetic modeling. This audit did not identify a randomized trial of codeine-specific infant outcomes through breast milk.
Whether codeine should be used during breastfeeding
- Source A says
- The FDA's 2017 communication recommends against codeine in breastfeeding mothers, current U.S. labels say breastfeeding is not recommended, EMA product information lists breastfeeding as a contraindication, and NHS SPS says codeine should not be used. (FDA Drug Safety Communication: Codeine and breastfeeding, DailyMed: TYLENOL with Codeine tablets, European Medicines Agency: Codeine Article 31 referral, Annex III product information, NHS Specialist Pharmacy Service: Using codeine, dihydrocodeine or tramadol during breastfeeding)
- Source B says
- LactMed allows a short, low-dose course with close infant monitoring if codeine is needed, while ACOG says to review duration and newborn toxicity signs if a codeine-containing medicine is selected. A 2026 pharmacokinetic model predicts low neonatal morphine concentrations but does not report observed clinical outcomes. (LactMed: Codeine, ACOG Clinical Consensus No. 1: Pharmacologic Stepwise Multimodal Approach for Postpartum Pain Management, Anderson and Hannam, Paediatric Anaesthesia 2026: Codeine and metabolite concentrations in the breastfed neonate)
- Why they differ
- The sources use different caution thresholds when infant outcome data are limited and the 2006 case report is disputed. U.S. guidance says not recommended, while EMA product information lists breastfeeding as a contraindication. LactMed interprets limited population and pharmacokinetic evidence as supporting a narrowly qualified option; ACOG provides postpartum pain guidance rather than a blanket endorsement of codeine. The 2026 model is not a clinical outcome study.
- Other sources
- A 2012 Ontario cohort did not find higher 30-day infant readmission after maternal postpartum codeine prescriptions, but infant feeding status was not verified. The 2006 Lancet report is listed as under an Expression of Concern in the journal record, not as retracted. (Juurlink et al., Clinical Toxicology 2012: Postpartum maternal codeine therapy and neonatal outcomes, Koren et al., Lancet 2006: Pharmacogenetics of morphine poisoning in a breastfed neonate of a codeine-prescribed mother, The Lancet Editors: Expression of Concern about the 2006 codeine case report)
- What the evidence shows overall
- Evidence on infant outcomes through milk is limited. The 2012 cohort did not verify breastfeeding, and the 2026 model did not observe clinical outcomes. The 2006 case report remains under an Expression of Concern, so neither the report nor the model settles causation. Most regulatory and public-health sources take a no-use position, while LactMed and ACOG give qualified guidance. The rating remains avoid with 3 stars because recommendations conflict and human outcome evidence is limited.
- ACOG lists acetaminophen and ibuprofen as first-line postpartum analgesics for people intending to provide breast milk. If a codeine-containing medicine is selected, ACOG says to review treatment duration and newborn signs of toxicity with the family. (ACOG)
- MotherToBaby says people who take codeine regularly, have dependence, or have opioid use disorder should talk with a healthcare provider before stopping, because sudden stopping can cause withdrawal; any dose reduction is described as gradual and provider-directed. (MotherToBaby)
General research, not specific to pregnancy.
Codeine labels and regulator actions also address dependence, breathing suppression, interactions, and accidental exposure outside pregnancy.
- The TYLENOL with Codeine label warns about addiction, abuse, and misuse, and about life-threatening respiratory depression. (DailyMed: TYLENOL with Codeine tablets)
- EMA's 2025 variation adds product-information warnings about opioid use disorder and dependence, central sleep apnoea, hyperalgesia, gabapentinoid interactions, and pancreatitis or sphincter of Oddi dysfunction. (European Medicines Agency: Codeine PSUSA 2025 variation)
- In 2024, the UK MHRA made codeine linctus and codeine oral solutions prescription-only because of dependence, addiction, and overdose risks. This action applies to those oral solutions, not all codeine medicines. (MHRA Drug Safety Update: Codeine linctus and codeine oral solutions)
- MotherToBaby: CodeineTeratology serviceSecondaryPage dated 2025-03-01
- LactMed: CodeineUS governmentSecondaryPage dated 2026-09-15
- DailyMed: Codeine Sulfate Tablets, LannettDrug company labelTertiary
- DailyMed: TYLENOL with Codeine tabletsDrug company labelTertiary
- FDA Drug Safety Communication: Codeine and breastfeedingSecondaryPage dated 2017-04-20
- Nezvalová-Henriksen et al., BJOG 2011: Codeine use during pregnancy and pregnancy outcomesUS governmentPrimaryIndependent check
- Bowie et al., CMAJ 2022: Prescribed opioid analgesics in early pregnancy and congenital anomaliesUS governmentPrimaryIndependent check
- Esposito et al., JAMA Network Open 2022: Prescription opioids and neonatal opioid withdrawal syndromeUS governmentPrimaryIndependent check
- Juurlink et al., Clinical Toxicology 2012: Postpartum maternal codeine therapy and neonatal outcomesUS governmentPrimaryIndependent check
- Koren et al., Lancet 2006: Pharmacogenetics of morphine poisoning in a breastfed neonate of a codeine-prescribed motherUS governmentPrimary
- The Lancet Editors: Expression of Concern about the 2006 codeine case reportUS governmentPrimaryPage dated 2026-02-03Independent check
- ACOG Committee Opinion No. 711: Opioid Use and Opioid Use Disorder in PregnancyProfessional societySecondaryIndependent check
- ACOG Clinical Consensus No. 1: Pharmacologic Stepwise Multimodal Approach for Postpartum Pain ManagementSecondaryIndependent check
- European Medicines Agency: Codeine Article 31 referral, Annex III product informationEU agencySecondaryPage dated 2013-08-02Independent checkEuropean guidance
- NHS Specialist Pharmacy Service: Using codeine, dihydrocodeine or tramadol during breastfeedingUK governmentSecondaryPage dated 2026-03-04Independent check
- Varney et al., 2026: Prenatal prescription opioid exposure and third-grade academic performanceUS governmentPrimaryIndependent check
- Teacher-reported kindergarten development among children exposed to prescription opioids during pregnancyUS governmentPrimaryIndependent check
- Ekenze et al., Clinical Pharmacology and Therapeutics 2026: Periconceptional use of analgesics and severity of structural birth defectsUS governmentPrimaryIndependent check
- Anderson and Hannam, Paediatric Anaesthesia 2026: Codeine and metabolite concentrations in the breastfed neonateUS governmentPrimaryIndependent check
- European Medicines Agency: Codeine PSUSA 2025 variationEU agencySecondaryPage dated 2025-11-27Independent checkEuropean guidance
- MHRA Drug Safety Update: Codeine linctus and codeine oral solutionsUK governmentSecondaryPage dated 2024-02-20Independent check
Last reviewed 2026-10-14
Independent check 2026-10-14
Not yet clinician-reviewed
Ask your provider about your situation.