New Study Questions Tramadol’s Effectiveness and Safety for Chronic Pain

Tramadol, a widely prescribed synthetic opioid once believed to be a “safer” alternative for pain relief, is now under scrutiny. A new study published in BMJ Evidence-Based Medicine suggests that Tramadol’s risks may outweigh its limited benefits, particularly when used to manage long-term, chronic pain.

Researchers from the University of Southern Denmark analyzed nearly two decades of data and found little evidence that Tramadol provides meaningful pain relief—while highlighting a concerning link to serious side effects, including cardiac complications and other health risks.

“The findings indicate that the benefits of Tramadol are uncertain, and the potential for harm is real,” said Dr. Janus Jakobsen, lead author of the study and clinical professor at the University of Southern Denmark.

Minimal Benefit, Significant Risk

Tramadol was once promoted as a balanced painkiller—stronger than over-the-counter medications but supposedly less addictive than opioids like FYL. However, the study found that its effectiveness is modest at best.

Across 19 clinical trials involving more than 6,500 participants aged 47 to 69, Tramadol offered only a “slight effect” in reducing chronic pain compared to a placebo. Researchers also discovered that these small differences in pain scores often failed to reach the “minimal important difference”—a threshold used to measure meaningful improvement in a patient’s quality of life.

In other words, even when data showed minor statistical improvements, patients themselves likely felt little to no real relief.

The Hidden Dangers of Tramadol

The Danish research team found that Tramadol use was linked to a range of non-serious and serious side effects, including:

• Nausea, dizziness, and constipation

• Excessive drowsiness

• Chest pain and cardiac problems

• In rare cases, “neoplasm” events, or abnormal cell growth that could lead to tumors

Dr. Jakobsen warned that Tramadol should not be prescribed as a first-line treatment for chronic pain, especially given the growing availability of non-opioid alternatives.

“Alternative treatments should always be considered first,” Jakobsen said. “Pain management must be individualized and carefully monitored to minimize risk.”

A Global Issue

Tramadol’s popularity has soared worldwide. Between 1990 and 2009, nearly 12 million daily doses were consumed globally, according to manufacturer data. It’s often prescribed because it’s perceived as “safer” than stronger opioids.

However, as opioid addiction affects an estimated 60 million people worldwide, experts say that assumption may be dangerously misleading. Tramadol, like other opioids, can cause dependence and withdrawal symptoms, even when used as directed.

“Tramadol is not a magic bullet,” said Dr. Michael Hooten, a pain specialist at the Mayo Clinic. “It provides modest pain relief at best, and the side effects can be significant.”

Hooten added that the study confirms what many clinicians have observed firsthand: opioids are rarely effective for long-term chronic pain due to issues of tolerance, dependency, and diminishing returns over time.

Questioning the Evidence

The study authors cautioned that their findings might overestimate Tramadol’s benefits because most of the reviewed trials carried a high risk of bias. Many were short-term, lasting 12 weeks or less, and involved mixed types of chronic pain such as osteoarthritis, diabetic nerve pain, and lower back pain.

That means the long-term safety and efficacy of Tramadol remain unclear.

“Most of these trials were too brief to determine lasting benefit,” said Dr. Jason Chang, an interventional spine specialist at Columbia University, who was not involved in the research. “We also don’t know how Tramadol compares to other treatments like NSAIDs or neuropathic medications, since it was only tested against placebos.”

NSAIDs, or non-steroidal anti-inflammatory drugs, include common pain relievers like ibuprofen and aspirin. Tramadol is often prescribed when patients cannot tolerate these medications due to other health conditions—but that doesn’t make it risk-free.

Beyond Pills: Rethinking Pain Management

Experts are urging patients and providers to move away from medication-centered approaches to pain care.

“The real tragedy is that millions have been prescribed Tramadol when what they needed was a deeper look into the root cause of their pain,” said Dr. Erika Schwartz, a New York internist and author of Don’t Let Your Doctor Kill You. “We’ve traded real solutions for prescription pads.”

Dr. Sanjay Gupta, CNN’s Chief Medical Correspondent and author of It Doesn’t Have to Hurt: Your Smart Guide to a Pain-Free Life, noted that one in five adults in the U.S. lives with chronic pain, and many have become overly reliant on medications.

“We can reduce, and even eliminate, pain by activating our body’s natural ability to manage it,” Gupta said. “Meditation, yoga, physical therapy, massage, acupuncture, and anti-inflammatory diets can all help.”

Non-opioid therapies such as heat, ice, rest, exercise, and sleep optimization remain essential tools for managing long-term pain without the risks of addiction or cardiac complications.

Proceeding with Caution

While Tramadol may still have a role in short-term or carefully monitored pain management, experts agree it should be prescribed sparingly—and only when other treatments fail.

“The conversation shouldn’t be about banning Tramadol,” said Dr. Chang. “It should be about using it smarter—short courses, clear goals, and close monitoring.”

Dr. Jakobsen echoed that sentiment, emphasizing that the new findings should prompt doctors to reconsider how freely they prescribe opioids of any kind.

“Tramadol continues to be viewed as a safer opioid option,” he said, “but the evidence does not support that belief. The use of Tramadol—and opioids more broadly—should be minimized wherever possible.”

The Bottom Line

Tramadol is not the harmless painkiller it was once thought to be. Its ability to relieve chronic pain appears minimal, while its risks—addiction, cardiac complications, and other side effects—are substantial.

For those managing chronic pain, experts recommend working with a healthcare provider to explore non-opioid and holistic treatments first. And in cases of opioid overdose or accidental exposure, Naloxone remains a life-saving medication that can reverse respiratory failure when administered promptly.

The growing body of research suggests one clear takeaway: it’s time to rethink how we treat pain—and redefine what real healing looks like.

Source: CNN