Dextromethorphan
MedicationCough suppressant
Research strength: 3 / 5
MotherToBaby says dextromethorphan taken as directed for cough is not expected to raise the chance of birth defects, and its sheet says a study of 128 first-trimester users did not report more miscarriages. The 2001 primary study reports 184 exposed pregnancies overall, including 128 first-trimester exposures, 10 spontaneous abortions, and one stillbirth, but its abstract does not give a separate miscarriage count for the 128-person subgroup. A 2021 case-control study found associations for hydrocephalus, atrioventricular septal defect, and transverse limb deficiency in its dextromethorphan-without-guaifenesin group, but 96.8% in that group also reported cough medicines with other active ingredients, and the authors said findings could be chance. These results differ from MotherToBaby's broad conclusion, while the single-ingredient capsule label advises a health-professional discussion before use; the label does not state that harm is established. MotherToBaby says alcohol-containing liquids are not recommended during pregnancy, and multi-symptom products and AUVELITY have separate ingredients and labeling. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- MotherToBaby: Dextromethorphan fact sheetTeratology service
- Einarson et al., 2001 controlled pregnancy studyUS government
- Martínez-Frías et al., 2001 prenatal cough-medicine studyUS government
- Cao et al., 2021 US multisite case-control studyUS government
- CDC: About Alcohol Use During PregnancyUS government
- DailyMed: Dextromethorphan Hydrobromide Capsules, 15 mg (Glenmark)Drug company label
- DailyMed: Mucinex 12HR Cold & Fever Multi-Symptom labelDrug company label
- DailyMed: AUVELITY labelDrug company label
Research strength: 3 / 5
MotherToBaby describes pregnancy-wide evidence and says use as directed for cough is not expected to raise the chance of birth defects. The 2001 study reports outcomes for pregnancies exposed at any time, but does not give a separate second-trimester result. The 2021 case-control study reported early-pregnancy associations for hydrocephalus, atrioventricular septal defect, and transverse limb deficiency in its dextromethorphan-without-guaifenesin category; most users in that group also reported other medicine ingredients, and the authors said some findings could be chance. MotherToBaby says studies have not answered whether dextromethorphan affects preterm delivery or later learning and behavior, and says alcohol-containing liquids are not recommended in pregnancy. The single-ingredient capsule label advises consultation before use; the current Mucinex 12HR Cold & Fever Multi-Symptom label warns not to use its naproxen at 20 weeks or later unless a doctor specifically directs it, because it may cause problems in the unborn child or complications during delivery. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- MotherToBaby: Dextromethorphan fact sheetTeratology service
- Einarson et al., 2001 controlled pregnancy studyUS government
- Martínez-Frías et al., 2001 prenatal cough-medicine studyUS government
- Cao et al., 2021 US multisite case-control studyUS government
- CDC: About Alcohol Use During PregnancyUS government
- DailyMed: Dextromethorphan Hydrobromide Capsules, 15 mg (Glenmark)Drug company label
- DailyMed: Mucinex 12HR Cold & Fever Multi-Symptom labelDrug company label
- DailyMed: AUVELITY labelDrug company label
Research strength: 3 / 5
MotherToBaby describes pregnancy-wide information, not a separate third-trimester estimate, and says use as directed for cough is not expected to raise birth-defect chance. The 2001 study includes pregnancies exposed at any time but reports no third-trimester-specific outcomes. The 2021 case-control study examined early pregnancy and reported associations for hydrocephalus, atrioventricular septal defect, and transverse limb deficiency; its dextromethorphan-without-guaifenesin category usually included other active ingredients, and the authors said some findings could be chance. MotherToBaby says preterm delivery and later child behavior or learning have not been studied, and says alcohol-containing liquids are not recommended in pregnancy. The single-ingredient capsule label advises consultation before use; the current Mucinex 12HR Cold & Fever Multi-Symptom label warns not to use its naproxen at 20 weeks or later unless a doctor specifically directs it, because it may cause problems in the unborn child or complications during delivery. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- MotherToBaby: Dextromethorphan fact sheetTeratology service
- Einarson et al., 2001 controlled pregnancy studyUS government
- Martínez-Frías et al., 2001 prenatal cough-medicine studyUS government
- Cao et al., 2021 US multisite case-control studyUS government
- CDC: About Alcohol Use During PregnancyUS government
- DailyMed: Dextromethorphan Hydrobromide Capsules, 15 mg (Glenmark)Drug company label
- DailyMed: Mucinex 12HR Cold & Fever Multi-Symptom labelDrug company label
- DailyMed: AUVELITY labelDrug company label
Dextromethorphan — Breastfeeding
Research strength: 3 / 5
LactMed says dextromethorphan and its active metabolite reach breast milk in very low amounts and are not expected to affect a nursing infant. Shum et al. measured milk and plasma after one 30 mg dose in 20 women at least 3 months postpartum and estimated relative infant doses below 1%. One nursing infant developed a rash during the study; the authors said the cause was unclear and more research is needed, while LactMed's 2025 page says relevant published infant-effect information was not found. MotherToBaby says short-term over-the-counter use as directed is not expected to cause problems for most breastfed infants and prefers alcohol-free cough syrups. The single-ingredient capsule label advises a health-professional discussion before use; AUVELITY is a different prescription combination whose label advises against breastfeeding during treatment and for 5 days after the final dose. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- LactMed: DextromethorphanUS government
- MotherToBaby: Dextromethorphan fact sheetTeratology service
- Shum et al., 2022 breast-milk exposure studyUS government
- DailyMed: Dextromethorphan Hydrobromide Capsules, 15 mg (Glenmark)Drug company label
- DailyMed: Mucinex 12HR Cold & Fever Multi-Symptom labelDrug company label
- DailyMed: AUVELITY labelDrug company label
Pregnancy
Birth defects: MotherToBaby says dextromethorphan taken as directed for cough is not expected to increase the chance of birth defects. The 2021 US multisite case-control study by Cao et al. examined early-pregnancy use of cough medicines containing dextromethorphan with or without guaifenesin. It reported adjusted associations for hydrocephalus, atrioventricular septal defect, and transverse limb deficiency in its dextromethorphan-without-guaifenesin category; most mothers in this group also reported other active ingredients; dose was not collected, and the authors said the signals could be chance. Miscarriage: MotherToBaby reports that a study of 128 first-trimester users did not report an increase, but the Einarson 2001 abstract reports outcomes for all 184 exposed pregnancies and does not show a separate miscarriage count for that subgroup. In the full exposed group, the abstract lists 10 spontaneous abortions and one stillbirth; controls had eight spontaneous abortions and no stillbirth. Einarson reports three major malformations among 128 first-trimester exposures and five among controls; mean birthweights were 3,381 g exposed and 3,446 g controls. It does not report low-birthweight counts or separate second- or third-trimester results. Martínez-Frías et al. 2001 found no relation between dextromethorphan-containing cough medicines and neural tube, heart, or other defects. MotherToBaby says preterm delivery and later behavior or learning have not been studied. Evidence is observational and limited; outcomes or timing that were not studied are not resolved by these findings.
Breastfeeding
LactMed describes milk amounts as very low and not expected to affect an infant, based on published milk-level studies. Shum et al. measured milk and plasma 2 hours after one 30 mg oral dose in 20 lactating women; all were at least 3 months postpartum and CYP2D6 extensive metabolizers. The authors estimated relative infant doses below 1%, including a modelled steady-state estimate. This was not a study of newborns, other CYP2D6 metabolizer groups, repeated measured doses, or infant blood levels in the main cohort. One nursing infant developed an erythematous rash the day after the study; the authors said its cause was unclear and more research was needed. MotherToBaby says short-term OTC use as directed is not expected to cause problems for most breastfed infants and says to contact the infant's clinician if symptoms such as rash occur. LactMed's September 2025 page says relevant published infant-effect information was not found, which differs from the rash observation in the 2022 study.
Dextromethorphan is an over-the-counter cough suppressant sold as pills, liquids, and cough drops. MotherToBaby notes that it can also appear in multi-symptom cold, cough, and flu products, while prescription products may combine it with other medicines. The evidence summarized here concerns cough products containing dextromethorphan and does not automatically apply to every combination. The Mucinex 12HR Cold & Fever Multi-Symptom product combines dextromethorphan with guaifenesin and naproxen; its label has a separate warning about naproxen use at 20 weeks or later. AUVELITY is a separate prescription combination of dextromethorphan and bupropion with its own pregnancy and breastfeeding label.
What was tested
Pregnancy evidence includes two 2001 observational studies and a 2021 US multisite case-control study that examined early-pregnancy exposure. Cao et al. defined DM alone as dextromethorphan without guaifenesin, not as a single-ingredient medicine; 96.8% of mothers reporting that category also reported a cough medicine with other active components. Exposure was retrospective and dose was not collected. Breastfeeding evidence includes a milk/plasma study of 20 women after a single 30 mg dose; participants were at least 3 months postpartum and all were CYP2D6 extensive metabolizers. Infant effects were not the main outcome, and the study noted one rash with unclear cause. The FDA review for a three-ingredient Mucinex combination says no human pregnancy or reproduction studies were submitted; its warning concerns naproxen, not an observed dextromethorphan effect.
How to describe the birth-defect evidence for early-pregnancy dextromethorphan cough medicines
- Source A says
- MotherToBaby says directed cough use is not expected to raise the chance of birth defects; the Einarson and Martínez-Frías studies from 2001 did not find an increase. (MotherToBaby: Dextromethorphan fact sheet, Einarson et al., Chest 2001 controlled pregnancy study, Martínez-Frías et al., Teratology 2001 case-control study)
- Source B says
- Cao et al. 2021 reported associations for hydrocephalus, atrioventricular septal defect, and transverse limb deficiency in its dextromethorphan-without-guaifenesin category. The current single-ingredient capsule label also tells pregnant users to ask a health professional before use. (Cao et al., BMJ Open 2021 US multisite case-control study, DailyMed: Dextromethorphan Hydrobromide Capsules, 15 mg (Glenmark))
- Why they differ
- The Cao study tested multiple defect pairs with small exposed proportions, did not collect dose, and found that most mothers in the dextromethorphan-without-guaifenesin category also reported other active ingredients. Its authors said findings could be chance. The product label gives a consultation caution and does not state that harm has been established. The older studies are limited and do not resolve the newer signals.
- What the evidence shows overall
- The available human studies do not establish a general causal increase across birth defects. Keep the compatible rating and 3 stars, while showing the 2021 signals, their limits, the label caution, and the distinction between cough products and combinations.
Whether low milk transfer means infant effects have not been reported
- Source A says
- LactMed says milk amounts are very low and not expected to affect an infant, and its September 2025 page says relevant published infant-effect information was not found. MotherToBaby says short-term use as directed is not expected to cause problems for most infants. (LactMed: Dextromethorphan, MotherToBaby: Dextromethorphan fact sheet)
- Source B says
- Shum et al. 2022 estimated relative infant doses below 1% but reported one infant with an erythematous rash during the study; the authors said the cause was unclear. (Shum et al., J Clin Pharmacol 2022 breast-milk exposure study)
- Why they differ
- LactMed's statement concerns published infant-effect information, while the Shum study primarily measured milk and plasma. It reports one symptom that occurred in time with the study, but does not attribute it to the medicine. The sources may apply different thresholds to a single observation with uncertain cause.
- What the evidence shows overall
- The rash is a reported observation, not a confirmed medicine effect. Keep the compatible rating and 3 stars, report the low-transfer estimate with its study limits, and disclose the rash and uncertainty. The study does not cover newborns or other metabolizer groups.
- MotherToBaby says alcohol-containing over-the-counter liquids are not recommended during pregnancy and notes that dextromethorphan also appears in multi-symptom products, so labels can contain other active ingredients. (MotherToBaby)
- MotherToBaby prefers alcohol-free cough syrups while breastfeeding. (MotherToBaby)
- LactMed says to avoid products with a high alcohol content while nursing. (LactMed)
- The current US single-ingredient capsule label says people who are pregnant or breastfeeding should ask a health professional before use. (DailyMed: Dextromethorphan Hydrobromide Capsules, 15 mg (Glenmark))
- The Mucinex 12HR Cold & Fever Multi-Symptom label lists dextromethorphan, guaifenesin, and naproxen. It says to ask a health professional if pregnant or breastfeeding and not to use its naproxen at 20 weeks or later unless a doctor specifically directs it. (DailyMed: Mucinex 12HR Cold & Fever Multi-Symptom label)
- The AUVELITY label says it is not recommended during pregnancy and that breastfeeding is not recommended during treatment and for 5 days after the final dose. This warning is for the prescription dextromethorphan-bupropion combination, not single-ingredient cough medicines. (DailyMed: AUVELITY label)
General research, not specific to pregnancy.
The current US 15 mg capsule label includes dose, overdose, monoamine oxidase inhibitor, and symptom-duration warnings for general use. Directions can differ between this capsule, liquids, and combination products.
- This capsule label says not to use the product with a prescription monoamine oxidase inhibitor or for 2 weeks after stopping one. It says to stop use and ask a doctor if a cough lasts more than 7 days, returns, or comes with fever, rash, or persistent headache. It sets a maximum of 8 capsules in 24 hours for adults and children 12 and older and says to get medical help or contact Poison Control after an overdose. (DailyMed: Dextromethorphan Hydrobromide Capsules, 15 mg (Glenmark))
- MotherToBaby: Dextromethorphan fact sheetTeratology serviceSecondary
- LactMed: DextromethorphanUS governmentSecondaryPage dated 2025-09-15Independent check
- Einarson et al., Chest 2001 controlled pregnancy studyUS governmentPrimaryIndependent check
- Martínez-Frías et al., Teratology 2001 case-control studyUS governmentPrimaryIndependent check
- Cao et al., BMJ Open 2021 US multisite case-control studyUS governmentPrimaryIndependent check
- Shum et al., J Clin Pharmacol 2022 breast-milk exposure studyUS governmentPrimaryIndependent check
- CDC: About Alcohol Use During PregnancyUS governmentSecondaryPage dated 2026-04-02Independent check
- DailyMed: Dextromethorphan Hydrobromide Capsules, 15 mg (Glenmark)Drug company labelTertiaryPage dated 2026-10-16
- DailyMed: AUVELITY labelDrug company labelTertiary
- DailyMed: Mucinex 12HR Cold & Fever Multi-Symptom labelDrug company labelTertiaryPage dated 2026-06-02
- FDA multidisciplinary review: NDA 217338, Mucinex 12HR Cold & Fever Multi-SymptomDrug company labelSecondaryPage dated 2026-01-07Independent check
Last reviewed 2026-10-16
Independent check 2026-10-16
Not yet clinician-reviewed
Ask your provider about your situation.