Tramadol Side Effects Outweigh Pain Management Benefits, Study Finds

Researchers urge health care professionals to follow recent guidelines and recommendations calling for the reduction of opioid use whenever possible.

A new study indicates that tramadol offers limited pain relief while being associated with serious side effects, including cardiovascular complications.

According to findings published in the journal BMJ Evidence-Based Medicine on October 7, people taking tramadol for chronic pain faced an increased risk of congestive heart failure, heart disease and cancer. 

Despite more than 271.1 million prescriptions for tramadol being issued in the U.S. in 2024 alone, researchers reported that they found no evidence to confirm tramadol is an effective pain treatment.

Tramadol was first approved in 1995 as a non-controlled prescription painkiller under the brand name Ultram, and later marketed in combination with acetaminophen as Ultracet. It was promoted as a safer alternative to stronger opioids, with a lower risk of addiction and abuse.

However, rising reports of dependency and misuse led federal regulators to reclassify tramadol as a Schedule IV controlled substance in 2014, placing it in the same category as drugs considered to have limited but still significant abuse potential.

In the new study, researchers from the Centre for Clinical Intervention Research at Rigshospitalet in Copenhagen, Denmark, reviewed 19 randomized clinical trials including more than 6,500 participants with chronic pain.

Led by Dr. Jehad Ahmad Barakji, the team examined the effect of tramadol on chronic pain including neuropathic pain, osteoarthritis, chronic low back pain and fibromyalgia. The data led the research team to determine tramadol failed to reach the predetermined threshold for it to be considered effective in treating pain.

However, the data also indicates using tramadol for pain relief more than doubled the risk of serious side effects when compared to patients who were given a placebo. Side effects included chest pain, coronary artery disease, congestive heart failure, prostate cancer, breast cancer and thyroid neoplasm, with heart-related problems being the most common.

Additionally, using tramadol increased a person’s risk of several non-serious side effects including nausea, constipation and excessive drowsiness, the findings suggest.

The research team noted most previous tramadol clinical trials had a high risk of bias, meaning they may have overstated tramadol’s benefits and underestimated its risks. They concluded that the current study supports recent recommendations to reduce opioid use whenever possible.

Tramadol Health Concerns

Prior studies and warnings have been issued over potential tramadol health risks throughout the last decade.

The U.S. Food and Drug Administration (FDA) issued a safety warning in 2015, indicating Tramadol may cause serious breathing problems among children, which could be life-threatening.

A separate 2021 study suggested tramadol may expose users to an increased risk of death and heart problems compared to natural opioid-containing prescriptions.

Opioids are known to account for 70% of all drug overdoses, with more than 60 million people worldwide experiencing their addictive effects.

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