A major scientific review has found that one of the world’s most widely used opioid painkillers provides only minimal pain relief while significantly increasing the risk of serious, and potentially fatal health complications, including heart related events.
Tramadol is a prescription opioid that has been used for decades to treat chronic pain. It has long been viewed as a safer alternative to stronger opioid drugs such as oxycodone or fentanyl, as well as to some non-steroidal anti-inflammatory drugs (NSAIDs) and other analgesics.
The medication was patented in 1972 and introduced commercially in 1977 under the brand name Tramal by the German pharmaceutical company Grünenthal. It later gained approval in both the UK and the United States during the mid-1990s.
Now researchers have said the drug’s risks may outweigh its benefits.
A new study led by researchers in Denmark and published in BMJ Evidence Based Medicine examined data from 19 randomised placebo-controlled clinical trials involving 6,506 participants with chronic pain. Participants received either tramadol or a placebo.
The findings showed that while tramadol slightly reduced pain scores, the improvement was so small that it failed to meet the threshold typically considered meaningful for patients.
At the same time, people taking tramadol were more than twice as likely to experience a serious adverse event compared with those given a placebo.
The increase in serious complications was largely linked to cardiovascular problems, including conditions such as chest pain, coronary artery disease and congestive heart failure.
Researchers also noted a higher occurrence of certain cancers among tramadol users. It stated: “Beta binomial regression showed evidence of a harmful effect of tramadol on serious adverse events (OR 2.13; 97.5% CI 1.29 to 3.51; p=0.001; moderate certainty of evidence), mainly driven by a higher proportion of cardiac events and neoplasms.”
The review found tramadol lowered pain scores by less than one point on a standard 10-point scale, a reduction considered clinically insignificant. Non-serious side effects were common, including nausea, dizziness, constipation, and somnolence.
The team of researchers concluded: “Tramadol may have a slight effect on reducing chronic pain levels (low certainty of evidence) while likely increasing the risk of both serious (moderate certainty of evidence) and non-serious adverse events (very low certainty of evidence).
“The potential harms associated with tramadol use for pain management likely outweigh its limited benefits.”