Is tramadol (ultram) safe to use during pregnancy?

Tramadol Use During Pregnancy

Tramadol should be avoided during pregnancy due to risks of embryotoxicity, fetotoxicity, and neonatal withdrawal syndrome. 1

Safety Classification and Risks

Tramadol is classified as FDA Pregnancy Category C, indicating that:

• It has been shown to be embryotoxic and fetotoxic in animal studies 1
• There are no adequate and well-controlled studies in pregnant women 1
• The drug should only be used if potential benefits justify potential risks to the fetus 1

Documented Risks

The FDA drug label specifically notes several concerning findings:

• Animal studies show embryotoxicity and fetotoxicity at maternally toxic doses 1
• Tramadol crosses the placenta with a mean umbilical vein to maternal vein ratio of 0.83 1
• Post-marketing reports include cases of:
  • Neonatal seizures
  • Neonatal withdrawal syndrome
  • Fetal death
  • Stillbirth 1

Clinical Considerations

Timing Considerations

Tramadol should particularly be avoided:

• In the first trimester when risk of congenital malformations is greatest 2
• Prior to or during labor unless potential benefits outweigh risks 1
• Chronic use during pregnancy may lead to physical dependence and post-partum withdrawal symptoms in the newborn 1, 3

Neonatal Withdrawal Syndrome

Case reports document neonatal abstinence syndrome after maternal tramadol use:

• Symptoms typically develop within 36 hours after delivery 3
• Treatment with phenobarbital may be required 3
• Hospital observation of the neonate for at least 3 days is recommended if the mother used tramadol during pregnancy 3

Alternative Pain Management Options

For pregnant patients requiring pain management, consider these alternatives with better safety profiles:

• First-line agents with established safety records:

  • Acetaminophen 4
  • Certain antacids 4

• For moderate to severe pain requiring opioid therapy:

  • Consult with obstetrics and pain management specialists
  • Consider short-term use of better-studied opioids if absolutely necessary

Breastfeeding Considerations

Tramadol is also problematic during breastfeeding:

• It is excreted in breast milk 1
• The FDA issued a warning against taking tramadol while breastfeeding 2
• Safety in infants and newborns has not been studied 1
• Following a single IV 100 mg dose, 0.1% of the maternal dose is excreted in breast milk within 16 hours 1

Key Takeaways

1. Tramadol should be avoided during pregnancy unless absolutely necessary
2. The risks include embryotoxicity, fetotoxicity, neonatal withdrawal syndrome, and potential fetal death
3. If used during pregnancy, plan for hospital delivery and extended neonatal observation
4. Alternative pain management options with better safety profiles should be considered
5. Tramadol is also not recommended during breastfeeding