What do medical sources say about Tramadol (Conzip, Ryzolt, Ultram, Ultracet) during pregnancy?

1st Trimester: MotherToBaby says it is not known whether tramadol increases the chance of birth defects or miscarriage. A Swedish registry study found a modest increase in some malformations after early exposure, including heart defects and clubfoot, while a Danish study found no clear increase in major defects or miscarriage. A 2025 French study found no clear increase in major birth defects but did find an association between tramadol prescriptions and spontaneous pregnancy loss; its authors said other factors related to the reason for treatment could explain the association. NHS Specialist Pharmacy Service says earlier evidence is reassuring, so the miscarriage findings remain mixed. These studies use prescription and registry data and cannot establish that tramadol caused the outcomes. Ask your provider about your situation. 2nd Trimester: MotherToBaby says it is not known whether tramadol increases the chance of early birth or low birth weight. A Swedish registry analysis of later-pregnancy opioid prescriptions found an association with birth before 37 weeks; the tramadol estimate was higher, but it was not specific to second-trimester exposure, and the paper did not report tramadol-specific estimates for birth before 32 weeks or low birth weight. The authors cautioned that the tramadol estimate may share a comparison group with other opioid estimates, and the study cannot show cause. The FDA label says human data are insufficient to assess miscarriage or major birth defects, and animal findings do not establish a risk in people. MotherToBaby advises talking with a provider before changing regular use because sudden withdrawal may affect pregnancy in unknown ways. Ask your provider about your situation. 3rd Trimester: MotherToBaby reports newborn withdrawal after tramadol use during pregnancy and says not every exposed baby develops it. A 2013 case report describes a newborn whose mother used 100 mg three times daily for chronic headache and migraine; withdrawal began 36 hours after birth and was treated with phenobarbital, but one case cannot estimate how often this occurs. The FDA label warns that extended opioid use during pregnancy can cause withdrawal that may be life-threatening if not recognized and treated, and calls for neonatal monitoring and expert care at delivery. The label also says tramadol is not recommended during or immediately before labor when other pain-control methods are more appropriate. These warnings concern prolonged or near-delivery exposure, not a precise risk for every course. Ask your provider about your situation.

What do medical sources say about Tramadol (Conzip, Ryzolt, Ultram, Ultracet) while breastfeeding?

MotherToBaby says tramadol passes into milk and relays FDA advice against breastfeeding because some infants could become very sleepy, feed poorly, or have serious breathing problems. LactMed also reports FDA and manufacturer advice against use, but describes conditional use for 2 to 3 days at a low dose with close infant monitoring if a mother of a newborn needs tramadol. NHS Specialist Pharmacy Service says short-term use may be considered only for full-term, healthy infants; regular use beyond 3 days needs close medical supervision. A study of 75 postpartum mothers estimated combined infant exposure at 2.88% of the maternal dose and found similar behavioral scores, but its short duration and size do not rule out rare effects. These sources disagree, and the NHS advice does not cover premature or medically fragile babies. Ask your provider about your situation.

Where do sources disagree on Tramadol (Conzip, Ryzolt, Ultram, Ultracet) in pregnancy or breastfeeding?

Do early-pregnancy tramadol prescriptions increase miscarriage or other pregnancy-loss risk? Ferrer et al. (2025) found an association between tramadol exposure and spontaneous pregnancy termination compared with unexposed pregnancies, but explicitly said possible indication bias means the study cannot establish a causal link. Sørensen et al. (2022) found no clear increase in spontaneous abortion, and NHS SPS says most earlier tramadol data do not indicate an association with miscarriage. MotherToBaby says prior prescription-based studies had conflicting results. The studies used different populations, comparison groups, exposure records, and outcome definitions. Prescription records do not establish that tramadol was taken, and pain or other conditions may affect pregnancy outcomes. The later French association is important to report, but it does not show that tramadol caused a loss. Keep miscarriage and malformation evidence uncertain, describe the 2025 association with its causal limitation, and do not state that tramadol caused a pregnancy loss or a birth defect.

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Tramadol

Medication

Conzip, Ryzolt, Ultram, Ultracet

Opioid analgesic

Pregnancy

Early pregnancy studies are observational and disagree. Källén and Reis (2015) identified 1,751 pregnancies exposed to tramadol in early pregnancy and reported adjusted odds ratios of 1.33 (95% CI 1.05-1.70) for relatively severe malformations, 1.56 (1.04-2.29) for cardiovascular defects, and 3.63 (1.61-6.89) for clubfoot. Sørensen et al. (2022) included 7,310 exposed pregnancies in its miscarriage analysis and 3,796 in the major-malformation analysis; estimates were HR 1.06 (0.99-1.14) for spontaneous abortion and RR 1.04 (0.87-1.24) for major malformations, without a clear increase. Ferrer et al. (2025) studied 1,602 tramadol-exposed pregnancies in the French EFEMERIS database. The study found an association with spontaneous pregnancy termination compared with unexposed pregnancies (adjusted HR 1.86, 95% CI 1.46-2.37), but the authors said possible indication bias prevents a causal conclusion; it did not find an increased rate of major congenital anomalies. Källén and Reis (2013) reported an association between second- or third-trimester opioid prescriptions and preterm birth before 37 weeks; the tramadol estimate was OR 1.30 (1.04-1.62), but the authors cautioned that drug-specific estimates may share a common comparison estimate. It did not report tramadol-specific estimates for very preterm birth or low birth weight; the overall opioid group showed no increase for those outcomes. A 2026 population cohort found lower third-grade reading and numeracy scores among children exposed to tramadol during pregnancy; the authors said unmeasured confounding could explain the association. The 2026 result is a new signal, not evidence of a causal effect or a trimester-specific risk. The product label says available human data are insufficient to inform risk of major birth defects or miscarriage; animal studies reported decreased fetal weight and reduced bone formation (ossification) at maternally toxic doses, which do not estimate effects in people.

Breastfeeding

Ilett et al. (2008) studied 75 breastfeeding mothers using tramadol 100 mg every six hours on postpartum days 2 to 4 after caesarean delivery. The estimated combined relative infant dose of tramadol and O-desmethyltramadol was 2.88% at steady state; exposed infants and controls had similar behavioral assessments. This small, short-term study cannot rule out rare effects or establish results for premature or medically fragile infants. Gesseck et al. (2021) documented tramadol and metabolites in milk and infant oral fluid in one case. The term newborn was growth-restricted and had prenatal exposure to methadone and other prescribed and reported substances; methadone treatment for neonatal withdrawal started on day 4. The case establishes that postnatal exposure can occur, but it cannot identify whether milk-borne tramadol caused symptoms. LactMed summarizes low milk transfer and limits its conditional advice for a mother of a newborn to 2 to 3 days at a low dose with close infant monitoring; the FDA and manufacturer advise against breastfeeding during tramadol treatment. NHS SPS permits only short-term use advice for full-term, healthy infants and emphasizes the lowest effective dose and shortest duration.

Do early-pregnancy tramadol prescriptions increase miscarriage or other pregnancy-loss risk?

Source A says: Ferrer et al. (2025) found an association between tramadol exposure and spontaneous pregnancy termination compared with unexposed pregnancies, but explicitly said possible indication bias means the study cannot establish a causal link. (Ferrer et al.: Tramadol during pregnancy, EFEMERIS database study)
Source B says: Sørensen et al. (2022) found no clear increase in spontaneous abortion, and NHS SPS says most earlier tramadol data do not indicate an association with miscarriage. MotherToBaby says prior prescription-based studies had conflicting results. (Sørensen et al.: Tramadol exposure during early pregnancy and spontaneous abortion or major malformations, NHS Specialist Pharmacy Service: Pain treatment during pregnancy, MotherToBaby: Tramadol fact sheet)
Why they differ: The studies used different populations, comparison groups, exposure records, and outcome definitions. Prescription records do not establish that tramadol was taken, and pain or other conditions may affect pregnancy outcomes. The later French association is important to report, but it does not show that tramadol caused a loss.
Other sources: The Swedish 2015 registry reported modest malformation signals, while the Danish 2022 study and French 2025 study did not find a clear increase in major malformations. These studies do not resolve causation. (Källén and Reis: Use of tramadol in early pregnancy and congenital malformation risk, Sørensen et al.: Tramadol exposure during early pregnancy and spontaneous abortion or major malformations, Ferrer et al.: Tramadol during pregnancy, EFEMERIS database study)
What the evidence shows overall: Keep miscarriage and malformation evidence uncertain, describe the 2025 association with its causal limitation, and do not state that tramadol caused a pregnancy loss or a birth defect.

Should tramadol be avoided during breastfeeding?

Source A says: MotherToBaby relays the FDA recommendation against breastfeeding during tramadol use, and the FDA-approved product label warns that a breastfed infant could be exposed to high M1 levels and serious respiratory effects. (MotherToBaby: Tramadol fact sheet, DailyMed: Tramadol hydrochloride tablets label, Amneal/Unit Dose Solutions, DailyMed: Conzip extended-release tramadol label)
Source B says: LactMed describes low milk transfer and conditional use for 2 to 3 days at a low dose with close monitoring if a mother of a newborn needs tramadol. NHS SPS says short-term use can be considered for full-term, healthy infants with dose and duration limits. (LactMed: Tramadol, NHS Specialist Pharmacy Service: Codeine, dihydrocodeine or tramadol during breastfeeding)
Why they differ: The FDA label emphasizes a potential severe outcome in infants of mothers with unusually high M1 production; LactMed and NHS SPS weigh measured low transfer and limited short-term clinical data, while still restricting duration and infant population. The available studies are too small to rule out rare serious effects or settle risk in all newborns.
Other sources: Ilett et al. found low estimated infant exposure and similar behavioral scores in a small postpartum study. A 2021 case recorded tramadol in breast milk and infant specimens, but the infant had prenatal and other exposures, so it does not show that breast-milk tramadol caused the clinical course. (Ilett et al.: Transfer of tramadol and its O-desmethyl metabolite into transitional breast milk, Gesseck et al.: Neonatal exposure to tramadol through mother's breast milk)
What the evidence shows overall: Show both the FDA and manufacturer recommendation against breastfeeding and the narrower LactMed and NHS SPS short-term guidance. Propose guidance rather than avoid for Charlie's decision; do not describe the disputed risk as settled.

General research, not specific to pregnancy.

Tramadol has opioid-related risks outside pregnancy, including long-term use, interactions, and dependence. The FDA required updated opioid labeling in 2025; EMA's 2024 tramadol review added dependence and interaction warnings, and the UK MHRA warned of bleeding risk with warfarin. A 2026 Pennsylvania Medicaid study found an association between childbirth-period tramadol exposure and persistent postpartum opioid use compared with oxycodone, but the observational result does not establish causation. OUD treatment guidance is separate from tramadol use for pain: CDC recommends methadone or buprenorphine for pregnant people with OUD, and ACOG stresses distinguishing medical opioid use, misuse, and untreated OUD.

The Conzip extended-release label's boxed warning says: "Because the use of CONZIP exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions." It also says: "Serious, life-threatening, or fatal respiratory depression may occur with use of CONZIP, especially during initiation or following a dosage increase." The label states: "Accidental ingestion of even one dose of CONZIP, especially by children, can result in a fatal overdose of tramadol." It also warns: "Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death." For extended use during pregnancy, the label states: "Use of CONZIP for an extended period of time during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts." (DailyMed: Conzip extended-release tramadol label)
The July 2025 FDA action required labeling changes for opioid pain medicines, including clearer long-term risks and a reminder not to stop suddenly when physical dependence may be present. (FDA: Major changes to opioid pain medication labeling to emphasize risks)
EMA's 2024 tramadol review added warnings about tolerance, physical and psychological dependence, opioid use disorder, secure storage, and respiratory depression with gabapentin or pregabalin. (EMA/CMDh: Tramadol PSUSA scientific conclusions and product-information changes)
The UK MHRA warned that combining tramadol with warfarin can raise INR and lead to serious bruising or bleeding. (UK MHRA: Warfarin interaction with tramadol)
A 2026 Pennsylvania Medicaid cohort found persistent postpartum opioid use in 30.9% of people exposed to tramadol during childbirth compared with 7.3% after oxycodone; the adjusted odds ratio was 4.58 (95% CI 3.87-5.43). This observational association does not establish that tramadol caused persistent use. (Postpartum persistent opioid use after opioid exposure for childbirth)
CDC's 2026 guidance recommends methadone or buprenorphine as medications for pregnant people with OUD. ACOG says medical opioid use, opioid misuse, and untreated OUD should be distinguished; this guidance concerns OUD treatment, not tramadol pregnancy-risk estimates. (CDC: Treatment of opioid use disorder before, during, and after pregnancy, ACOG Committee Opinion No. 711: Opioid use and opioid use disorder in pregnancy)

Last reviewed 2026-10-14

Independent check 2026-10-14

Not yet clinician-reviewed

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Tramadol

Tramadol — Breastfeeding

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