Summary: What the new analysis shows about tramadol and chronic pain
A recent pooled data analysis published online in BMJ Evidence Based Medicine questions the overall value of tramadol for chronic pain management. The review suggests that while tramadol can slightly reduce pain, the magnitude of relief may be below what many clinicians and patients would consider clinically meaningful. More importantly, the analysis links tramadol to a higher risk of serious adverse events, particularly cardiac problems, raising concerns about its risk-benefit balance for chronic pain conditions.
Scope and methods
Researchers conducted a comprehensive search of randomized controlled trials comparing tramadol with placebo in adults with chronic pain, including cancer-related pain. The review included trials published up to February 2025, aiming to fill gaps left by earlier, narrower assessments of tramadol’s efficacy and safety across diverse chronic pain conditions.
Who was studied and what conditions were evaluated?
The eligible trials encompassed 6,506 participants with chronic pain, with an average age around 58 years. Participants varied in diagnosis, spanning neuropathic pain, osteoarthritis, chronic low back pain, and fibromyalgia. Most studies used oral tablets; a single trial tested a topical cream. Treatment durations ranged from 2 to 16 weeks, with follow-up lasting 3 to 15 weeks.
Effect on pain: is tramadol worth it?
Across the trials, tramadol demonstrated a reduction in pain compared with placebo. However, the researchers describe the average analgesic effect as small and below established thresholds for clinical significance in chronic pain management. For many patients, the pain relief may not translate into meaningful improvement in daily functioning or quality of life.
Harms and safety signals
On safety, the pooled data show a notable increase in adverse events among tramadol users. Over follow-up periods ranging from 7 to 16 weeks, there was a doubling in the risk of harms relative to placebo. The rise was largely driven by cardiac events, including chest pain, coronary artery disease, and congestive heart failure.
There were also signals of an elevated risk for certain cancers in the short term, though the researchers caution that the short follow-up makes this finding uncertain and worth further study. In addition, tramadol users experienced more mild-to-moderate side effects such as nausea, dizziness, constipation, and sleepiness.
Bias and interpretation
The researchers acknowledge that many results carry a high risk of bias, a common challenge in trial-based evidence for analgesics. Such bias could mean the true benefits are smaller and harms larger than reported. Nevertheless, the overall pattern across multiple trials points to a limited net benefit and an amplified harm profile for tramadol in chronic pain management.
Implications for practice and policy
The findings align with a growing call to reassess the role of tramadol in treatment guidelines, especially for chronic non-cancer pain. Given the modest pain relief and the potential for serious cardiac events, clinicians may need to minimize tramadol use, favoring alternative therapies with clearer benefit-to-harm profiles. Policymakers and guideline committees should weigh these data when updating recommendations for opioid prescribing and monitoring.
Context on opioid use and public health
The study underscores broader concerns about opioid use worldwide. An estimated 60 million people experience addictive effects of opioids, and opioid-related deaths remain a global challenge. Even as perceptions of tramadol as a “safer” option persist, this analysis adds to the evidence that the risk-benefit balance for tramadol may not favor widespread use, particularly for chronic pain conditions where long-term treatment is common.
Bottom line
For chronic pain, tramadol offers limited and occasionally modest pain relief while increasing the risk of serious adverse events, especially cardiac problems. Patients and clinicians should engage in shared decision-making, consider safer alternatives, and monitor for adverse effects if tramadol is used.
