A large evidence review has raised fresh concerns about tramadol, a popular prescription opioid often marketed as a “safer” alternative to stronger narcotic painkillers. The new study, published in BMJ Evidence‑Based Medicine, pooled data from 19 randomised clinical trials involving 6,506 adults who were treated for various forms of chronic or moderate to severe pain.
Five of the trials focused on neuropathic pain, nine examined osteoarthritis, four looked at chronic low back pain and one studied fibromyalgia, reflecting the broad range of conditions for which tramadol is commonly prescribed. The average participant age was 58 years, with most patients between 47 and 69, and treatment periods ranged from two to 16 weeks, followed by up to 15 weeks of additional monitoring.
Overall, tramadol did reduce pain compared with placebo, but the improvement was modest and fell below thresholds usually regarded as clinically meaningful. In other words, many patients may not feel enough benefit to justify routine long‑term use, especially when weighed against the drug’s safety profile.
Serious side effects and heart risks
The trials tracked serious adverse events during follow‑up, and the pattern that emerged is troubling. Participants taking tramadol experienced more serious health issues than those on placebo, including chest pain, irregular heart rhythms and congestive heart failure, suggesting tramadol may heighten cardiovascular risk, particularly in older adults with existing conditions.
Researchers also noted an increased incidence of certain cancers among tramadol users, though they cautioned that the relatively short follow‑up time makes it difficult to draw firm conclusions about cause and effect. Even so, the authors say that the overall safety signal is strong enough to label tramadol’s risk–benefit balance “questionable,” especially when numerous non‑opioid options exist for many forms of chronic pain.
Bias concerns but global opioid context
The team acknowledged that several of the included trials show a high risk of bias, often because of incomplete reporting or unclear methods. That means the true extent of both benefits and harms could be somewhat overstated or understated, but the direction of the findings still favours caution rather than liberal prescribing.
Their warning comes against the backdrop of a global opioid crisis in which millions of people live with dependence or addiction to prescription painkillers. The authors cite estimates that about 60 million individuals worldwide experience addictive effects from opioids, with roughly 600,000 deaths linked to opioid use each year, and about 80% of these fatalities involving overdose.
US overdose surge and tramadol’s role
In the United States, opioid‑related overdose deaths climbed from 49,860 in 2019 to 81,806 in 2022, highlighting the devastating toll of both illicit drugs and prescription medications. Tramadol is among the most commonly used opioids in North America and appears in multiple clinical guidelines for managing moderate to severe chronic pain, reinforcing its reputation as a routine, even relatively benign, option.
However, the BMJ authors argue that this reputation is not supported by high‑quality evidence. They emphasise that even a “mild” opioid still carries the core risks of dependence, withdrawal and overdose, particularly when used for longer than initially planned or combined with other sedating medications.
Researchers urge more cautious prescribing
Summarising the overall evidence, the researchers conclude that tramadol may provide a slight reduction in chronic pain, but at the cost of increased serious and non‑serious adverse events. Using the GRADE framework, they rate the certainty of benefit as low and the certainty of harm as very low to low, yet still sufficient to advise that routine use for long‑term pain management is likely unjustified.
They recommend that clinicians prioritise non‑opioid strategies such as physiotherapy, exercise programmes, psychological therapies and safer medicines like certain antidepressants or anti‑inflammatory drugs, depending on the underlying condition. For patients already taking tramadol, experts say any changes should be made in consultation with a doctor, as abrupt discontinuation can trigger withdrawal symptoms and a rebound in pain.
What patients should discuss with doctors
Pain specialists stress that decisions about tramadol must be individualised, taking into account a patient’s medical history, heart‑disease risk, mental‑health status and previous exposure to opioids. Patients are urged to ask their clinicians clear questions about expected benefits, duration of treatment, tapering plans and non‑opioid alternatives so they can make informed choices. For in-depth report read here.
For health systems already grappling with opioid‑related harms, the new findings strengthen calls to systematically review guidelines that position tramadol as a first‑line or long‑term solution for chronic pain. While the drug will likely remain an option in select cases, researchers say its use should be far more limited and closely monitored, with transparent conversations about both its modest benefits and its potential to cause serious health complications.
Readers who want a quick snapshot of the latest medical breakthroughs and major public‑health alerts can also explore our Health News Updates.
