Tapentadol withdrawal symptoms, dependence and how to stop safely

Tapentadol withdrawal symptoms can include restlessness, sweating, chills, a runny nose, yawning, aches, anxiety, poor sleep, stomach cramps, sickness and diarrhoea. They are most likely if you stop suddenly after taking it for some time. Tapentadol is an opioid that can cause dependence and addiction, so never stop or cut down on your own: agree a slow plan with your prescriber.

Most pages about tapentadol addiction are written for the United States. This guide uses UK sources instead: the official Palexia leaflets, MHRA safety advice and NICE guidance on medicines that cause dependence. For a general overview of the medicine, read our complete guide to tapentadol.

Is tapentadol addictive?

Yes, it can be. The Palexia SR patient leaflet says plainly that tapentadol is an opioid and “can cause dependence and/or addiction”. It adds that repeated use can lead to dependence, abuse and addiction, which may result in a life-threatening overdose.

The risk is not limited to people who misuse the medicine. In 2020 the MHRA warned that prolonged use of opioids may lead to dependence and addiction “even at therapeutic doses”. It also said that using an opioid for non-cancer pain for longer than 3 months carries a higher risk.

After that review, the Commission on Human Medicines recommended that the packaging of all opioid medicines in the UK carries the warnings “Can cause addiction” and “Contains opioid”.

Tolerance, dependence and addiction: what is the difference?

These three words are often used as if they mean the same thing. They do not, and the difference matters when you talk to your doctor.

• Tolerance means the medicine works less well over time. The leaflet describes this as becoming “accustomed to it”. You may feel you need more to get the same pain relief.
• Physical dependence means your body has adapted to the medicine. If you stop suddenly, you may get withdrawal symptoms. NICE guidance on medicines associated with dependence says dependence is an expected effect of these medicines and is not, by itself, a reason to avoid them.
• Addiction (the SmPC calls it opioid use disorder) is different. It involves craving, losing control over use and carrying on despite harm.

So feeling unwell when you miss doses does not automatically mean you are addicted. But it does mean you should never stop without a plan.

Who is at higher risk?

The Palexia SR summary of product characteristics (SmPC) says a higher dose and longer treatment can increase the risk of opioid use disorder. It lists these extra risk factors:

• a personal or family history (parents or siblings) of problems with alcohol, prescription medicines or illegal drugs
• currently smoking
• a personal history of mental health conditions, such as depression, anxiety or a personality disorder

Tell your prescriber if any of these apply to you. It does not always mean you cannot have tapentadol, but it may change how closely you are reviewed.

Taking tapentadol with other sedating medicines, such as benzodiazepines or Z-drugs like zopiclone, adds a separate danger. The SmPC warns the combination may cause sedation, slowed breathing, coma and death.

Signs you may be becoming dependent or addicted

The Palexia SR leaflet lists warning signs. Speak to your doctor if you notice that you:

• need to take the medicine for longer than your doctor advised
• need to take more than the recommended dose
• feel you must keep taking it even when it does not help your pain
• use it for reasons other than pain, for example “to stay calm” or “help you sleep”
• have tried to cut down or stop several times without success
• feel unwell when you stop, and better once you take it again

The MHRA’s patient guidance on opioid addiction also lists craving for the medicine as a sign. If you notice any of these, the MHRA says to talk to your doctor or a pharmacist.

Tapentadol withdrawal symptoms

Withdrawal symptoms happen when your body has adapted to an opioid and the dose drops too quickly. The table below compares the symptoms listed in the Palexia SR leaflet with those in MHRA guidance for all opioids.

Source	Withdrawal symptoms listed
Palexia SR patient leaflet	Restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle pain, dilated pupils, irritability, anxiety, backache, joint pain, weakness, stomach cramps, difficulty sleeping, feeling sick, loss of appetite, being sick, diarrhoea, and increases in blood pressure, breathing rate or heart rate
MHRA guidance (all opioids)	Shivers, diarrhoea, difficulty sleeping, sweating, body aches, widespread or increased pain, irritability and agitation, feeling sick and being sick

Your original pain may also come back. The leaflet notes that if you stop treatment too soon, your pain is likely to return. That is not withdrawal, but it can feel similar, so mention it to your prescriber.

Do not try to treat withdrawal symptoms yourself with other medicines. The MHRA advises patients not to self-medicate to overcome withdrawal effects. NICE also says withdrawal symptoms should not be treated with another medicine that can cause dependence.

How common is withdrawal, and how long does it last?

In the Palexia SR leaflet, drug withdrawal syndrome is listed as uncommon, affecting up to 1 in 100 people. Drug dependence is listed as rare, up to 1 in 1,000. The leaflet says there are generally no after-effects when treatment stops. But on uncommon occasions, people who have taken it for some time may feel unwell if they stop abruptly.

The SmPCs add some detail from clinical trials. Trials of immediate-release Palexia lasted up to 90 days, and trials of Palexia SR up to 1 year. Both showed little evidence of withdrawal after abrupt stopping, and symptoms were generally mild when they occurred. These were controlled trials, so your own experience may differ.

No UK source gives a fixed timeline for tapentadol withdrawal, and how long it lasts varies from person to person. What the MHRA does say is that safely coming off opioids “can take a long time”, and that reducing from a high dose may take weeks or months.

How to stop tapentadol safely

The leaflet is clear: do not suddenly stop taking tapentadol unless your doctor tells you to, and tell your doctor before stopping. Stopping safely is something you plan together. There is no single schedule that suits everyone, so this guide does not give one.

Agree a plan before you start

The SmPC says treatment goals, the length of treatment and a plan for ending it should be agreed with you before tapentadol is started. It also says tapentadol should not be used longer than necessary. If you were never given a plan, ask for a review.

What a good reduction plan looks like

NICE guideline NG215 sets out principles that prescribers in England should follow:

• The decision to reduce is made with you, using shared decision-making.
• The medicine is not stopped abruptly unless there are exceptional medical circumstances.
• The reduction is slow and stepwise, with steps that get smaller as the dose gets lower.
• The pace must be acceptable to you. It can be paused if withdrawal symptoms become hard to cope with.
• Support should be available throughout, and withdrawal may take several months or more.

Only your prescriber can set your doses. Do not change your dose, or how you take your tablets, without their advice.

Managing pain while you reduce

The NHS says painkillers are generally not considered a primary way to manage long-term pain. If pain is hard to manage, you can ask your GP about a referral to a specialist pain clinic or a pain management programme. Our chronic pain hub explains the other options in plain words.

Tapentadol abuse and UK law

Tapentadol was added to Class A of the Misuse of Drugs Act 1971 by SI 2011/744, made in March 2011. It was placed in Schedule 2 of the Misuse of Drugs Regulations 2001 by SI 2011/448, in force from 28 March 2011. Our guide to controlled drugs in the UK explains what these classes and schedules mean.

You may see claims online that tapentadol is “less addictive” than other opioids. One US study of people entering addiction treatment did find lower reported abuse of extended-release tapentadol than of comparison opioids. But the authors said the small number of tapentadol cases limited firm conclusions. The UK leaflets make no such claim and give the same addiction warnings as other opioids.

The SmPC warns that abuse or deliberate misuse of opioids may result in overdose and death. Only take tapentadol that has been prescribed for you, and never share it. If you are unsure whether an online seller is legitimate, see how to check a UK online pharmacy.

Pregnancy and withdrawal in newborn babies

The Palexia SR leaflet says not to take tapentadol in pregnancy unless your doctor has told you to. If it is used over long periods in pregnancy, the newborn baby may have withdrawal symptoms, which might be life-threatening if not recognised and treated. If you are pregnant or planning a pregnancy, do not stop suddenly: speak to your doctor straight away.

Getting support in the UK

• Your prescriber or GP is the first step for a review or a reduction plan.
• Your pharmacist can talk through side effects, withdrawal symptoms and other medicines you take.
• Local drug services can help with any kind of dependence. The NHS says a GP may be a good place to start, but you can also contact a local drug treatment service yourself.
• FRANK runs a drugs helpline on 0300 123 6600 if you are not sure where to turn.

The NHS describes addiction as a treatable condition. Asking for help is a normal part of good pain care, not a failure.

This article is for information only and does not replace advice from your doctor or pharmacist. Read our medical disclaimer.