Study Finds Tramadol Not That Effective for Chronic Pain

By Pat Anson

One of the most widely prescribed opioid painkillers in the world is not that effective at relieving chronic pain and increases the risk of serious side effects such as heart disease, according to a new study.

Tramadol is a synthetic opioid used to treat moderate to severe pain. It is widely perceived as a weaker and “safer” opioid, but the new research found otherwise.

“Tramadol may have a slight effect on reducing chronic pain, while likely increasing the risk of both serious and non-serious adverse events,” wrote lead author Jehad Barakji, MD, a researcher at the Copenhagen Trial Unit at the Centre for Clinical Intervention Research in Denmark.

“The potential harms associated with tramadol use for pain management likely outweigh its limited benefits.”

Barakji and his colleagues analyzed findings from 19 clinical trials of tramadol involving over 6,500 pain patients, making it the first study to assess tramadol’s efficacy and safety across a range of chronic pain conditions.

Five of the studies looked at the impact of tramadol on neuropathic pain; nine focused on osteoarthritis; four looked at chronic lower back pain; and one focused on fibromyalgia.

The findings, published in BMJ Evidence Based Medicine, show that while tramadol eased pain, the effect was small and below what would be considered clinically effective. Tramadol also appeared to increase the risk of cardiac events, such as chest pain, coronary artery disease, and congestive heart failure. 

Use of tramadol was also associated with a higher risk of neoplasms, an excessive growth of tissue that could be an early sign of cancer. However, researchers say the evidence of a tramadol-cancer connection was “questionable” because the studies analyzed were not long enough.

Non-serious side effects caused by tramadol include nausea, dizziness, constipation and somnolence.

Tramadol is considered a weak opioid because it does not bind directly to opioid receptors in the brain like other opioids do. Many patients say tramadol gives them little or no pain relief, but it’s often the only opioid their doctor is willing to prescribe.

In 2023, over 16 million prescriptions were written for tramadol in the United States, down from 25 million prescriptions a decade earlier. Tramadol is classified as a Schedule IV controlled substance in the U.S., indicating it has a low potential for abuse and addiction compared to other opioids.

The consumer watchdog group Public Citizen unsuccessfully petitioned the FDA and DEA in 2019 to upschedule tramadol to a more restrictive Schedule II substance, saying tramadol was “an increasingly overprescribed, addictive, potentially deadly narcotic.”

Tramadol is widely abused by youths in Asia and Africa, where it is often mixed with soft drinks, energy drinks and alcohol to induce euphoria.