Harms of tramadol ‘outweigh the benefits’ of GP prescribing

Tramadol is not very effective for chronic pain yet comes with an increased risk of serious side effects that suggest it should be avoided, researchers have concluded.

A meta-analysis combining data from 19 studies involving 6,500 patients with neuropathic pain, osteoarthritis, chronic low back pain and fibromyalgia, found that although the opioid drug did ease pain, the effect was small and below what would be considered clinically effective. 

Among the eight trials that looked at the proportion of serious side effects, the researchers found double the risk of harms associated with tramadol compared with placebo.

This increased risk was mainly driven by a higher proportion of cardiac events, including chest pain, coronary artery disease, and congestive heart failure, they reported in BMJ Evidence-Based Medicine.

The analysis of all the trial results also linked tramadol with a heightened risk of several milder side effects, including nausea, dizziness, constipation, and sleepiness.

But the level of evidence from the trials was low overall, they added.

Data from Open Prescribing shows a fairly flat level of tramadol prescribing by GPs in England in the past five years with 442,000 items prescribed in July 2025.

The researchers noted use of the drug in the US had surged in recent years possibly because of its perceived lower risk of side effects and view that it is safer and less addictive than other short-acting opioids.

But the findings led the Danish team to conclude that the potential harms of tramadol probably outweigh its benefits, and that its use should be minimised.

‘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.

‘Given these trends and the present findings, the use of tramadol and other opioids should be minimised to the greatest extent possible,’ they concluded.

UK researchers earlier this month reported that thousands of opioid deaths in England and Wales have been missed off official statistics.

The team at King’s College London scrutinised data from coroners reports between 2011 and 2022 and found 13,000 deaths that had not been recorded in official figures.