A significant new analysis published in a leading medical journal has cast serious doubt on the effectiveness and safety of tramadol, a widely prescribed opioid painkiller. The research, published in BMJ Evidence-Based Medicine in October 2025, concludes that the drug's potential harms likely outweigh its limited benefits for chronic pain management.
What is Tramadol and Why Was It Studied?
Tramadol is a dual-action opioid, often perceived as a "safer" option, prescribed globally for moderate to severe acute and chronic pain, such as post-surgical or injury-related pain. According to the NHS UK, it is a strong opiate-based painkiller that doesn't stop pain completely but reduces its sensation. It is sold under numerous brand names including Maxitram, Zydol, Zamadol, and Tradorec, and is available only by prescription in tablet, capsule, liquid, or injectable forms.
The study was prompted by tramadol's rise as one of the most commonly prescribed opioids, partly due to beliefs about its lower risk profile and reduced addictiveness compared to other short-acting opioids. Researchers identified a lack of comprehensive assessment of its efficacy and safety across chronic pain conditions, leading to this new investigation.
Key Findings: Modest Relief and Heightened Risks
The researchers analysed 19 randomised clinical trials involving 6506 participants with chronic pain, including conditions like osteoarthritis, neuropathic pain, chronic low back pain, and fibromyalgia. The average participant age was 58.
The findings were stark. Tramadol was found to have only a slight effect on reducing chronic pain, with a "low certainty of evidence." The level of pain relief was so modest that it fell below the threshold considered "clinically effective" for many patients.
More alarmingly, the analysis showed a likely increase in the risk of serious adverse events. The data indicated a doubling in the risk of harms, primarily driven by cardiac events such as chest pain, coronary artery disease, and congestive heart failure. The study also noted a heightened, though questionable due to short follow-up, association with some cancers.
Common non-serious side effects were also prevalent, including:
- Nausea
- Dizziness
- Constipation
- Sleepiness
Implications and Calls for Caution
Based on their analysis, the researchers issued a clear conclusion: "The potential harms of tramadol probably outweigh its benefits." They recommended that the use of tramadol should be minimised. This echoes earlier advice in the BMJ suggesting regulatory bodies consider reclassifying tramadol and that prescribers exercise as much caution with it as with other short-acting opioids.
The study's authors acknowledged a "high risk of bias" in the included trials, but noted this likely means the findings overestimate tramadol's benefits and underestimate its harms. The treatment duration in the trials ranged from 2 to 16 weeks.
This research adds to global concerns about opioid use. The study notes that approximately 60 million people worldwide experience opioid addiction, with opioids linked to nearly 80% of the roughly 600,000 drug-related deaths in 2019.
For patients in India and worldwide who rely on or are prescribed tramadol, this study underscores the critical importance of consulting healthcare providers to understand the risks and explore all available pain management options.
