SUMMARY: Tramadol is an opioid receptor agonist with serotonergic and noradrenergic activity used in the management of moderate-to-severe pain.
Published data concerning gestational tramadol exposure describe the outcomes of approximately 9,200 exposed infants, with the majority of the data considering the risk of congenital malformation and miscarriage. There are limited data regarding the risk of other adverse pregnancy outcomes.
The majority of data regarding risks of congenital malformation following first trimester tramadol exposure are reassuring. A single study has identified modest increased risks of specific malformations; however, this has not been supported by the largest study to date and confounding factors may have been contributory. The available data do not currently provide convincing evidence to suggest that first trimester tramadol use is associated with an increased risk of malformation overall, or of any specific malformation. While the majority of data regarding tramadol use in the first trimester are reassuring, tramadol use in pregnancy should be reserved for cases where adequate pain management has not been achieved using alternative analgesics.
The available data regarding risk of miscarriage following gestational tramadol exposure, although conflicting, are largely reassuring. The largest and most methodologically robust study available does not indicate an increased risk of miscarriage following gestational tramadol exposure. A single cohort study found no increased risk of preterm delivery within 146 pregnancies exposed to tramadol in at least the first trimester. There are no controlled data regarding the risk of intrauterine fetal death, low birth weight, infant neurodevelopmental impairment or cancer following intrauterine tramadol exposure.
Use of tramadol near term may cause neonatal respiratory depression and long-term use may be associated with neonatal abstinence syndrome. Where exposure has occurred in the weeks preceding delivery, monitoring of the neonate in a unit with neonatal facilities is advised.
Exposure to tramadol at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.