Written By | Agencies
Tramadol may have a slight effect on reducing chronic pain (low certainty of evidence) while likely increasing the risk of both serious and non-serious adverse events
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HEALTH
One of the world’s most commonly prescribed opioid painkillers has been found to offer limited pain relief while significantly increasing the risk of serious and potentially deadly cardiovascular events, according to new research.
Tramadol, the most widely used opioid globally, has been prescribed for nearly five decades to treat moderate to severe chronic pain. The drug has long been favored by doctors due to a widespread belief that it carries a lower risk of addiction compared to stronger opioids such as oxycodone and fentanyl.
However, a comprehensive analysis conducted by researchers in Denmark challenges that assumption. After reviewing data from past clinical trials, the researchers concluded that tramadol provides clinically insignificant pain relief while more than doubling the overall risk of serious adverse events.
The analysis examined 19 randomized clinical trials involving more than 6,500 participants who were given either tramadol or a placebo. Findings showed that patients taking tramadol had a 113 percent higher likelihood of experiencing a serious adverse event of any kind compared to those on placebo.
Among the most concerning outcomes were cardiovascular complications, including chest pain, coronary artery disease (CAD), congestive heart failure and heart attacks. Other reported side effects included nausea, dizziness and constipation.
The researchers noted:
“Tramadol may have a slight effect on reducing chronic pain (low certainty of evidence) while likely increasing the risk of both serious and non-serious adverse events. The potential harms associated with tramadol use for pain management likely outweigh its limited benefits.”
While stopping short of calling for regulatory withdrawal of the drug, the authors urged clinicians to reconsider its use and substitute it with safer alternatives, though specific substitutes were not outlined.
Tramadol is commonly prescribed for both hospitalised patients and outpatients managing chronic pain at home. Like all opioids, it carries a risk of dependence, but it is generally regarded as less addictive than stronger opioids.
Amid the ongoing opioid crisis, physicians face the difficult task of balancing pressure to reduce opioid prescriptions with the obligation to relieve legitimate patient suffering. Tramadol’s reputation as a “safer” opioid has contributed to its widespread use, often ranking as the second or third most prescribed opioid.
However, the latest findings suggest that its risks may substantially outweigh its benefits, particularly among older adults. The average age of participants in the analyzed trials was 58, placing them in a demographic already at elevated risk for cardiovascular disease.
Researchers noted that many participants were likely to have undiagnosed coronary artery disease or underlying cardiac vulnerability, with tramadol potentially acting as a trigger or exacerbating factor.
Of the 19 trials reviewed, five focused on nerve pain, nine on osteoarthritis, four on chronic lower back pain, and one on fibromyalgia. Serious adverse events were systematically extracted and grouped into categories, including cardiac disorders, cancers (neoplasms), and gastrointestinal complications.
The category of “cardiac events” included documented cases such as myocardial infarction (heart attack), chest pain and congestive heart failure.
Further analysis revealed that the overall increase in serious adverse events was driven primarily by cardiac complications and cancers, though the researchers did not specify the exact increase in risk for individual cardiac outcomes. Although there are no precise data tracking tramadol use specifically among heart disease patients, the demographics of the study suggest substantial overlap. Tramadol is frequently prescribed to older adults with chronic pain—the same group most likely to have cardiovascular disease.
Given this overlap, the researchers warned that many patients with heart disease may be exposed to tramadol’s risks. They recommended that clinicians prioritize safer pain management strategies, including non-opioid medications and non-drug approaches such as targeted physical therapy and cognitive behavioral therapy.
The study was published in The BMJ (British Medical Journal).
