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What’s New in the
Patient Safety World
November 2025
Tramadol – Not
Worth the Risks?
When their patient’s pain is not responding to aspirin, acetaminophen, or an NSAID, many clinicians choose tramadol as the next option. It is widely perceived by many clinicians as safer than other opioids. In fact, many clinicians don’t even realize it is an opioid and don’t think it might lead to addiction.
But a recent systematic review with meta-analysis has questioned whether the benefits of tramadol outweigh the potential risks. Barakji et al. (Barakji 2025) reviewed 19 randomized placebo-controlled clinical trials looking at tramadol vs. placebo for chronic pain. They note that all outcome results were at high risk of bias. The meta-analysis did show evidence of a beneficial effect of tramadol on chronic pain (mean difference numerical rating scale -0.93 points). But the effect size was below their predefined minimal important difference of 1.0 point on the numerical rating scale and there was a low certainty of evidence. The analysis also found evidence of a harmful effect of tramadol on serious adverse events (OR 2.13; p=0.001; moderate certainty of evidence), mainly driven by a higher proportion of cardiac events and neoplasms. The authors conclude that the potential harms associated with tramadol use for pain management likely outweigh its limited benefits.
It will be interesting to see whether prescribing patterns change as a result of this meta-analysis. Our other column today “Gabapentin Prescribing Continues to Increase” shows that prescribing of that drug has continued to increase despite data you would expect to have diminished its use.
References:
Barakji JA, Maagaard M, Petersen JJ, et al. Tramadol versus placebo for chronic pain: a systematic review with meta-analysis and trial sequential analysis. BMJ Evidence-Based Medicine 2025; Published Online First: 07 October 2025
https://ebm.bmj.com/content/early/2025/09/26/bmjebm-2025-114101
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