Hydrocodone
MedicationLortab, Norco, Vicodin
Opioid analgesic
Research strength: 3 / 5
MotherToBaby reports that studies of hydrocodone and birth defects have produced mixed findings. Wen and colleagues studied 12,424 live-birth pregnancies and found no clear increase in major birth defects after first-trimester opioid dispensing; that result was for opioids as a group, not hydrocodone alone. Ekenze and colleagues' 2026 National Birth Defects Prevention Study analysis found an association between hydrocodone alone and a group of more severe structural defects; the study cannot establish cause or give an absolute risk. FDA labeling for HYSINGLA ER states that available human pregnancy data are insufficient to inform risk of major birth defects. Ask your provider about your situation.
Last reviewed: 2026-10-14
Research strength: 3 / 5
MotherToBaby reports that some opioid studies link pregnancy exposure with poor fetal growth and other problems; these findings are not all hydrocodone-specific. In a 2021 Rhode Island live-birth cohort, second-trimester opioid exposure was associated with minor musculoskeletal defects, and hydrocodone was associated with a combined outcome of plagiocephaly, polydactyly, and specified hip deformities. These observational results cannot establish cause, and the study included only live births. MotherToBaby notes that women in its fetal-growth study were more likely to smoke, which can also affect growth. Ask your provider about your situation.
Last reviewed: 2026-10-14
Research strength: 2 / 5
MotherToBaby says hydrocodone is likely to carry some risk of neonatal opioid withdrawal syndrome (NOWS), based on other opioids, but its relative likelihood is unknown. FDA labeling for NORCO and HYSINGLA ER says prolonged use during pregnancy can lead to NOWS, which may be life-threatening if not recognized and treated; HYSINGLA ER labeling says management by neonatology experts is required. A large Medicaid cohort found higher NOWS risk with longer and later use of prescription opioids, but did not report a hydrocodone-only risk estimate. Wen and colleagues' third-trimester malformation results were for opioids as a group, not hydrocodone alone. Ask your provider about your situation.
Last reviewed: 2026-10-14
Hydrocodone — Breastfeeding
Research strength: 4 / 5
MotherToBaby and LactMed report that hydrocodone can pass into milk and that newborns may be especially sensitive to opioids. Once milk comes in, LactMed recommends limiting maternal intake to 2 to 3 days at up to 30 mg daily, with close infant monitoring; ABM also advises caution, monitoring, and a 30 mg daily maximum. The primary milk studies involved two mothers and 30 postpartum women, and the later study measured milk levels rather than infant outcomes. The HYSINGLA ER label says breastfeeding is not recommended during use because of possible serious infant sedation and breathing problems; this product-specific restriction is distinct from short-term immediate-release guidance. Ask your provider about your situation.
Last reviewed: 2026-10-14
Sources
- MotherToBaby - HydrocodoneTeratology service
- LactMed - HydrocodoneUS government
- ABM Clinical Protocol #28 - Peripartum Analgesia and AnesthesiaProfessional society
- Sauberan et al. 2011 - Hydrocodone and hydromorphone in breast milkUS government
- DailyMed - HYSINGLA ER labelDrug company label
Pregnancy
Human evidence on hydrocodone and birth defects is mixed. The 2021 Rhode Island cohort included 12,424 live-birth pregnancies, with 891 pregnancies dispensed opioids. It found no clear class-wide increase in major birth defects after first-trimester exposure (aRR 1.40, 95% CI 0.84-2.34), while second-trimester hydrocodone was associated with a combined outcome of plagiocephaly, polydactyly, and other specified congenital hip deformities (aRR 3.01, 95% CI 1.80-5.03). The study used claims and live-birth records and cannot establish cause. Ekenze et al. (2026) used National Birth Defects Prevention Study data from 1997-2011 and compared periconception exposure, from one month before through the first three months of pregnancy, with defect groups based on average 12-month survival. The abstract reports an OR of 2.45 for hydrocodone alone in the group with less than 70% survival; it does not provide a hydrocodone-specific confidence interval, and this is not an absolute risk. MotherToBaby describes older study findings as mixed, but the identities and results of two older null studies were not independently verified. The HYSINGLA ER label says human pregnancy data are insufficient to inform a drug-associated risk for major birth defects. No absolute risk estimate is included.
Breastfeeding
Anderson et al. (2007) measured milk from two mothers taking hydrocodone-acetaminophen; the estimated relative infant doses were 3.1% and 3.7%. Sauberan et al. (2011) measured milk levels in 30 postpartum women; fully breastfed neonates received a mean hydrocodone dose equal to 1.6% of the maternal weight-adjusted dose, with a range of 0.2%-9%. These were small pharmacokinetic studies, not studies designed to measure infant adverse outcomes. The HYSINGLA ER label says its cited immediate-release milk study did not assess breastfed infants and that HYSINGLA-specific lactation studies have not been conducted. LactMed's 18-day-old infant drowsiness report is not verified against the cited Bodley and Powers abstract, which describes the infant as asymptomatic. LactMed's separate 5-week-old case involved maternal hydrocodone-acetaminophen plus methadone, so hydrocodone alone cannot be isolated. LactMed's 15 Dec 2025 summary advises limiting maternal intake to 2 to 3 days at a maximum of 30 mg daily with close infant monitoring; ABM Protocol #28 gives similar caution and a 30 mg daily maximum.
Hydrocodone is an opioid analgesic. The checked NORCO label identifies its tablet as hydrocodone bitartrate with acetaminophen. HYSINGLA ER is a separate extended-release hydrocodone product. The distinction matters because HYSINGLA ER's breastfeeding restriction is product-specific and should not be applied to every immediate-release hydrocodone product.
What was tested
Pregnancy evidence includes a population-based case-control study of early-pregnancy opioid analgesic use (Broussard et al. 2011), a Rhode Island Medicaid live-birth cohort with trimester-specific prescription claims (Wen et al. 2021), a National Birth Defects Prevention Study case-control analysis using severity groups based on average 12-month survival (Ekenze et al. 2026), a Boston Birth Cohort study of mixed opioid exposure and fetal growth restriction (Azuine et al. 2019), and a Medicaid cohort of prescription opioid exposure and neonatal abstinence syndrome (Desai et al. 2015). The studies vary in exposure timing, outcome definitions, and whether they can isolate hydrocodone; they do not provide a hydrocodone-specific absolute risk estimate. Breastfeeding evidence includes two maternal milk samples in Anderson et al. 2007 and milk pharmacokinetic measurements in 30 postpartum women in Sauberan et al. 2011. The latter did not measure infant adverse outcomes. A primary abstract conflicts with LactMed's account of the cited 18-day infant case, so that case is not presented as verified.
Mixed findings on birth defects in early pregnancy
- Source A says
- MotherToBaby reports older first-trimester hydrocodone studies with possible heart-defect signals and describes the overall evidence as mixed. (MotherToBaby - Hydrocodone fact sheet)
- Source B says
- Wen et al. found no clear class-wide increase in major defects after first-trimester opioid dispensing; Ekenze et al. reported an association between hydrocodone alone and a severity group of structural defects. (Wen et al. 2021 - Association of Gestational Opioid Exposure and Risk of Major and Minor Congenital Malformations, Ekenze et al. 2026 - Periconceptional Use of Analgesics and Severity of Structural Birth Defects)
- Why they differ
- The studies use different populations, exposure windows, and outcomes. Wen examined major defects after trimester-specific dispensing in live births; Ekenze grouped defects by average survival and defined exposure from one month before through the first three months of pregnancy. These observational results cannot establish causation.
- What the evidence shows overall
- Keep the uncertainty visible. Add the newer hydrocodone-specific finding with its severity grouping and study limits. Do not turn it into an absolute risk or claim it resolves the older signals. The two older null-study identities remain unverified.
Breastfeeding guidance differs by hydrocodone formulation
- Source A says
- LactMed and ABM describe cautious, limited short-term hydrocodone use with infant monitoring and a 30 mg daily maximum. (LactMed - Hydrocodone, Academy of Breastfeeding Medicine Protocol #28)
- Source B says
- The HYSINGLA ER label says breastfeeding is not recommended during treatment because of possible serious infant sedation and respiratory depression; it also states that HYSINGLA-specific lactation studies were not conducted. (DailyMed - HYSINGLA ER label)
- Why they differ
- The label addresses an extended-release product without product-specific lactation studies. LactMed and ABM discuss cautious short-term use and milk data from immediate-release hydrocodone. They do not cover the same product or evidence base.
- What the evidence shows overall
- State the HYSINGLA ER restriction exactly and keep it attached to that product. Present LactMed and ABM guidance separately for the limited immediate-release evidence; do not generalize either statement across formulations.
- For acute pain during pregnancy, CDC says clinicians and patients should weigh benefits and risks together. When an opioid is needed, CDC describes use of the lowest effective dose and a treatment period no longer than the expected duration of pain severe enough to require an opioid; it also lists nonpharmacologic and nonopioid treatment options. (CDC - Opioid Use and Pregnancy)
- MotherToBaby says that people taking hydrocodone regularly or with dependence or opioid use disorder should not stop suddenly; any reduction is described as gradual and under a healthcare provider's direction. (MotherToBaby - Hydrocodone)
- CDC describes methadone or buprenorphine as medication treatment for opioid use disorder during pregnancy and prefers medication treatment over withdrawal management. This guidance concerns treatment of opioid use disorder, not hydrocodone prescribed for pain. (CDC - Treatment of OUD Before, During, and After Pregnancy)
- ACOG describes opioid use disorder as a treatable condition. (ACOG - Opioid Use Disorder and Pregnancy)
General research, not specific to pregnancy.
FDA's 2025 class-wide opioid labeling action applies to hydrocodone and emphasizes increased serious-harm risks at higher doses and risks that persist during therapy. FDA says extended-release and long-acting opioids are for severe, persistent pain when alternatives are inadequate, and warns against rapid dose reduction or abrupt discontinuation in physically dependent patients.
- FDA's July 2025 communication says higher opioid doses are associated with increased risk of serious harm and that serious-harm risks persist over the course of therapy. (FDA - Long-term opioid labeling communication)
- FDA says extended-release and long-acting opioid medicines should be used only when alternatives, including immediate-release opioids, are inadequate for severe and persistent pain. (FDA - Long-term opioid labeling communication)
- FDA warns against rapid dose reduction or abrupt discontinuation in patients who may be physically dependent, citing serious withdrawal symptoms, uncontrolled pain, and suicide. (FDA - Long-term opioid labeling communication)
- MotherToBaby - Hydrocodone fact sheetTeratology serviceSecondary
- LactMed - HydrocodoneUS governmentSecondaryPage dated 2025-12-15
- DailyMed - HYSINGLA ER labelDrug company labelTertiaryIndependent check
- DailyMed - NORCO labelDrug company labelTertiaryPage dated 2025-01-23Independent check
- Wen et al. 2021 - Association of Gestational Opioid Exposure and Risk of Major and Minor Congenital MalformationsUS governmentPrimaryIndependent check
- Ekenze et al. 2026 - Periconceptional Use of Analgesics and Severity of Structural Birth DefectsUS governmentPrimaryIndependent check
- Broussard et al. 2011 - Maternal treatment with opioid analgesics and risk for birth defectsUS governmentPrimaryIndependent check
- Azuine et al. 2019 - Prenatal risk factors and outcomes associated with maternal opioid exposureUS governmentPrimaryIndependent check
- Desai et al. 2015 - Prescription opioid analgesics and neonatal abstinence syndromeUS governmentPrimaryIndependent check
- Anderson et al. 2007 - Hydrocodone excretion into breast milkUS governmentPrimaryIndependent check
- Sauberan et al. 2011 - Breast milk hydrocodone and hydromorphone levelsUS governmentPrimaryIndependent check
- Bodley and Powers 1997 - Breastfeeding mother case studyUS governmentPrimaryIndependent check
- Academy of Breastfeeding Medicine Protocol #28Professional societySecondaryIndependent check
- CDC - Opioid Use and PregnancyUS governmentSecondaryPage dated 2025-02-11Independent check
- CDC - Treatment of OUD Before, During, and After PregnancyUS governmentSecondaryPage dated 2026-05-01Independent check
- ACOG - Opioid Use Disorder and PregnancyProfessional societySecondary
- FDA - Long-term opioid labeling communicationUS governmentSecondaryPage dated 2025-07-31
Last reviewed 2026-10-14
Independent check 2026-10-14
Not yet clinician-reviewed
Ask your provider about your situation.