A large review of existing research suggests that tramadol, a strong opioid commonly prescribed for chronic pain, does not provide much meaningful relief. The analysis, published online in BMJ Evidence Based Medicine, found that while tramadol can reduce pain, the improvement is modest and falls below levels typically considered clinically important.
The findings also point to a higher likelihood of serious side effects, including heart disease. Based on these results, the researchers conclude that tramadol’s risks likely outweigh its benefits and say its use should be reduced as much as possible.
Why Tramadol Is So Widely Used
Tramadol is a dual action opioid that doctors often prescribe for moderate to severe acute and chronic pain. Because of this, it appears in several clinical guidelines for pain management, according to the researchers.
Prescriptions for tramadol have risen sharply in recent years, making it one of the most frequently used opioids in the United States. This growth may be driven by the belief that tramadol carries fewer side effects and is safer and less addictive than other short acting opioids, the authors note.
Gaps in Previous Research
Although earlier systematic reviews have included tramadol, none offered a broad evaluation of both its effectiveness and safety across different types of chronic pain. The researchers say this left important questions unanswered.
To address this, they searched research databases for randomized clinical trials published up to February 2025. These studies compared tramadol with placebo (dummy treatment) in people with chronic pain, including those with cancer related pain.
What the Trials Included
The final analysis covered 19 clinical trials involving 6506 participants. Five studies examined neuropathic pain, nine focused on osteoarthritis, four looked at chronic low back pain, and one studied fibromyalgia.
Participants had an average age of 58, with ages ranging from 47 to 69. Most studies used tablets, and only one tested a topical cream. Treatment periods lasted from 2 to 16 weeks, with follow up ranging from 3 to 15 weeks.
Small Pain Relief, Higher Risk
When the results were combined, the data showed that tramadol did reduce pain, but only slightly and not enough to meet standards for clinically effective relief.
Eight trials tracked serious side effects during follow up periods of 7 to 16 weeks. Analysis of these studies showed that tramadol was linked to about double the risk of harm compared with placebo. This increase was largely due to more reported “cardiac events,” including chest pain, coronary artery disease, and congestive heart failure.
Tramadol use was also associated with a higher risk of certain cancers. However, the researchers caution that the short follow up makes this result “questionable.”
Common Side Effects and Study Limits
Across all trials, tramadol was tied to a greater risk of milder side effects such as nausea, dizziness, constipation, and sleepiness.
The authors acknowledge that many outcomes were at high risk of bias. They suggest this likely means the benefits of tramadol are overstated while its harms are understated.
Opioid Risks in a Broader Context
The researchers emphasize the wider impact of opioid use, noting: “Approximately 60 million individuals worldwide experience the addictive effects of opioids. In 2019, drug use was responsible for approximately 600,000 deaths, with nearly 80% of these fatalities associated with opioids and approximately 25% resulting from opioid overdose.
“In the United States, the number of opioid-related overdose deaths increased from 49,860 in 2019 to 81,806 in 2022. Given these trends and the present findings, the use of tramadol and other opioids should be minimized to the greatest extent possible.”
The team concludes: “Tramadol may have a slight effect on reducing chronic pain (low certainty of evidence) while likely increasing the risk of both serious (moderate certainty of evidence) and non- serious adverse events (very low certainty of evidence). The potential harms associated with tramadol use for pain management likely outweigh its limited benefits.”
