A recent analysis published in BMJ Evidence Based Medicine raises concerns about the safety and efficacy of tramadol, a widely prescribed opioid painkiller. Although it is often viewed as a “safer” alternative to other opioids, the findings suggest that tramadol may not deliver significant pain relief while increasing the risk of serious side effects.
The comprehensive review examined data from 19 clinical trials involving over 6,500 participants. Researchers found that while tramadol can reduce chronic pain, the relief is minimal and often below the threshold considered clinically important. In addition to modest pain reduction, tramadol was associated with a markedly higher risk of adverse effects, particularly those related to heart health, such as chest pain and heart failure.
Understanding the Risks of Tramadol
Tramadol is a dual-action opioid commonly prescribed for moderate to severe acute and chronic pain. Its prescription rates have surged in recent years, making it one of the most frequently used opioids in the United States. The perception that tramadol is safer and less addictive than other opioids has contributed to its popularity among healthcare providers.
Despite its widespread use, the current analysis identifies significant gaps in previous research. Prior studies did not provide a thorough evaluation of tramadol’s effectiveness and safety across various types of chronic pain. To fill this void, researchers meticulously searched databases for randomized clinical trials published up to February 2025.
The trials included in the analysis covered diverse types of chronic pain, including neuropathic pain, osteoarthritis, chronic low back pain, and fibromyalgia. Most participants were middle-aged, with an average age of 58, and treatment durations ranged from 2 to 16 weeks.
Minimal Relief, Significant Risks
When aggregating the data, the analysis revealed that tramadol provided only slight pain relief. The eight studies tracking serious side effects indicated that tramadol users faced nearly double the risk of harm compared to those receiving a placebo. This increase in risk was largely attributed to a higher incidence of “cardiac events,” which included chest pain and coronary artery disease. Additionally, tramadol was linked to an elevated risk of certain cancers, though researchers cautioned that the short follow-up periods made this conclusion uncertain.
Participants reported common side effects, such as nausea, dizziness, constipation, and sleepiness. The authors of the study pointed out that many outcomes were susceptible to bias, suggesting that the perceived benefits of tramadol may be overstated while its risks might be understated.
The analysis also highlights the broader implications of opioid use. According to the researchers, approximately 60 million individuals around the world experience the addictive effects of opioids. In 2019, drug use accounted for around 600,000 deaths, with opioids responsible for nearly 80% of these fatalities. The number of opioid-related overdose deaths in the United States rose from 49,860 in 2019 to 81,806 in 2022.
Given these alarming statistics and the findings of this new study, the researchers strongly advise minimizing the use of tramadol and other opioids whenever possible. They conclude that while tramadol may provide slight relief for chronic pain, the associated risks likely outweigh its limited benefits.