What are the risks and recommendations for using tramadol (ultram) in a pregnant woman?

Tramadol Use in Pregnancy: Avoid Unless Absolutely Necessary

Tramadol should be strongly avoided during pregnancy due to documented risks of congenital malformations, neonatal withdrawal syndrome, and lack of established safety, with alternative analgesics being the preferred approach. 1, 2

FDA Classification and Safety Profile

• The FDA classifies tramadol as Pregnancy Category C, indicating embryotoxic and fetotoxic effects demonstrated in animal studies at maternally toxic doses 2
• The FDA label explicitly states that "safe use in pregnancy has not been established" and should only be used "if the potential benefit justifies the potential risk to the fetus" 2
• Post-marketing surveillance has documented neonatal seizures, neonatal withdrawal syndrome, fetal death, and stillbirth 2

Documented Teratogenic Risks

• A large Swedish registry study (n=1,682,846 women) found tramadol use in early pregnancy associated with a 33% increased risk of relatively severe congenital malformations (adjusted OR 1.33,95% CI 1.05-1.70) 3
• Cardiovascular defects showed a 56% increased risk (OR 1.56,95% CI 1.04-2.29) 3
• Pes equinovarus (clubfoot) demonstrated a striking 263% increased risk (OR 3.63,95% CI 1.61-6.89) 3

Neonatal Withdrawal Syndrome

• Tramadol freely crosses the placenta with umbilical vein to maternal vein ratios of 0.83, resulting in substantial fetal exposure 2, 4
• Chronic use during pregnancy leads to physical dependence and post-partum withdrawal symptoms in newborns 2
• Neonatal abstinence syndrome typically manifests 36 hours after delivery and requires pharmacological treatment with phenobarbital 5
• Delivery must occur at a facility prepared to monitor, evaluate, and treat neonatal opioid withdrawal syndrome with observation for at least 3 days 1, 5

Clinical Management Algorithm

If Tramadol Has NOT Been Started:

• Prioritize alternative analgesics over tramadol for any indication during pregnancy 1
• Consider non-opioid options first, reserving opioids only when benefits clearly outweigh risks 6

If Tramadol Is Already Being Used Chronically:

• Do NOT abruptly discontinue due to risk of maternal and fetal withdrawal 1
• Access appropriate expertise (maternal-fetal medicine, addiction medicine) for supervised tapering 6, 1
• The CDC guideline emphasizes that clinicians should "access appropriate expertise if considering tapering opioids during pregnancy because of possible risk to the pregnant patient and to the fetus if the patient goes into withdrawal" 6
• Arrange delivery at a facility equipped for neonatal intensive care 1

Labor and Delivery Considerations:

• The FDA explicitly states tramadol "should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks" 2
• Historical use for labor analgesia (100mg doses) showed similar efficacy to pethidine but this practice predates current safety data 4

Breastfeeding Concerns

• Tramadol use during lactation is not licensed by the manufacturer due to safety concerns 2, 7
• Breast milk concentrations can reach significant levels (up to 1,254 ng/mL for tramadol itself), with calculated absolute infant doses of 10-294 μg/kg/day 8
• If tramadol must be used during breastfeeding, close infant monitoring is mandatory for drowsiness, respiratory depression, decreased alertness, difficulty breathing, and feeding problems 1, 8
• Tramadol carries similar concerns to codeine, which is contraindicated in breastfeeding 1

Critical Pitfalls to Avoid

• Never initiate tramadol during pregnancy when safer alternatives exist 1
• Never abruptly discontinue chronic tramadol use without specialist consultation 6, 1
• Never deliver at a facility unprepared for neonatal withdrawal management 1
• Do not assume tramadol is "safer" than other opioids—it lacks the decades of safety data that some other medications possess 1

Risk-Benefit Context

• The CDC guideline emphasizes that during pregnancy, clinicians and patients must "carefully weigh risks and benefits when making decisions about whether to initiate opioid therapy" 6
• Unlike medications with established pregnancy safety profiles, tramadol's risk profile includes both structural malformations and neonatal complications 1, 3
• The moderate but statistically significant increase in congenital malformations, combined with guaranteed neonatal withdrawal risk with chronic use, tips the risk-benefit balance strongly against tramadol use 3, 5