Medication for the treatment of fibromyalgia
The drugs amitriptyline, duloxetine, milnacipran and pregabalin can relieve fibromyalgia pain in some people. They may cause side effects such as a dry mouth or nausea. Normal painkillers like ibuprofen or acetaminophen (paracetamol) aren’t recommended for the treatment of fibromyalgia.
There is currently no approved medication that was specifically developed for the treatment of fibromyalgia. But some medications that have been approved for the treatment of other types of chronic pain or diseases can help in fibromyalgia too. Studies have shown this to be true for the following drugs:
With the exception of amitriptyline, when these drugs are used for the treatment of fibromyalgia, it is legally considered to be unapproved (off-label) use. Special regulations apply here, affecting things like whether health insurers cover the costs. This is different if someone who has fibromyalgia also has a medical condition for which the medication has been approved, such as depression. It can take several weeks for the medication to start working.
It makes sense not to rely on medication alone, but instead combine it with other treatments. For instance, gentle physical exercise can relieve the symptoms and improve your resilience. The way you manage your life with the illness is important too – things like trying to reduce stress and planning your day to avoid overdoing it can help.
How effective are medications?
In some people who have fibromyalgia, the drugs amitriptyline, duloxetine, milnacipran and pregabalin can clearly reduce the pain. Their effectiveness can be estimated based on the results of studies. This is what the studies found:
- Pain was reduced by at least half in about 25 out of 100 people who took any of these medications.
- Pain was reduced by at least half in about 15 out of 100 people who took a placebo (fake medication).
In other words, the medication clearly reduced fibromyalgia pain in about 10 out of 100 participants.
But the study participants were almost exclusively women. And most of the studies only lasted between three and six months.
How common are side effects?
The studies also looked at the side effects of the medications, and how often participants stopped their treatment due to side effects such as nausea or sleep problems in particular. The results showed the following:
- On average, 13 to 20 out of 100 people who took any of these medications stopped their treatment due to side effects – compared to
- about 8 out of 100 people who took a placebo.
In other words, 5 to 12 out of 100 people stopped taking the medication because the side effects were so strong. But the frequency of side effects will also depend on things like which drug and dose is used.
How are these medications used?
If you decide to try out treatment with one of these medications, you can’t expect immediate results. It takes two to four weeks for them to start working, if they work.
If this medication is used over a long time period, it can make sense to see whether it is still needed after a while. For instance, if someone has started doing more exercise or has learned relaxation or stress management techniques since they started taking medication, then their symptoms may have improved so much that they no longer need the medication. So people are sometimes advised to see how they feel if they stop taking medication after six months.
Amitriptyline is a type of medication known as tricyclic antidepressants. It inhibits the action of several chemical messengers (neurotransmitters), including serotonin and noradrenaline (norepinephrine). When used for the treatment of fibromyalgia, amitriptyline is prescribed in low doses. It is taken once a day in the form of a tablet, usually in the evening (dose: 10 to 50 mg).
Some people find that amitriptyline becomes less effective over time. So doctors sometimes advise people to regularly stop taking it for a while – for instance, every three months.
The possible side effects of amitriptyline include a dry mouth, nausea, sleepiness, constipation and a slight increase in weight. Sleepiness is most common in the first few weeks of treatment, while the body gets used to the medication. If side effects occur, you can talk to your doctor about perhaps reducing the dose.
Duloxetine is a type of antidepressant medication known as serotonin-noradrenaline re-uptake inhibitors (SNRIs). It has been approved for the treatment of depression, generalized anxiety disorder and pain caused by diabetes-related nerve damage. But there has also been research into its effectiveness in people who have fibromyalgia. When used in fibromyalgia, it is generally taken as a capsule in the morning (dose: 60 mg). The possible side effects of duloxetine include nausea, a dry mouth, drowsiness and sleep problems.
Pregabalin has been approved for the treatment of certain pain disorders, epilepsy and generalized anxiety disorder. Like other medications mentioned above, it also affects the action of specific chemical messengers (neurotransmitters). Pregabalin is taken in the form of capsules two to three times daily, spread out across the day (dose: 150 to 450 mg). Alternatively, it can be taken in the form of a syrup.
The possible side effects include dizziness, vision problems, sleepiness, a slight increase in weight and water retention in the legs.
Like duloxetine, milnacipran is an SNRI and has been approved for the treatment of depression. It is typically used in doses of 100 to 200 mg per day. The possible side effects of milnacipran include nausea, constipation, a red face, increased heart rate, sweating a lot, high blood pressure and drowsiness.
Avoiding side effects
In order to avoid side effects as much as possible, it’s a good idea to start treatment with the above-mentioned medications with a low dose. The dose can then be gradually increased to allow your body to slowly get used to it. If a higher dose isn’t well tolerated, the dose can gradually be reduced again. When stopping treatment, too, it is important not to stop abruptly but gradually reduce the dose instead.
Some side effects such as drowsiness mainly occur in the first few weeks of treatment and then go away again. Most people tolerate the medication well. If someone gets a headache or feels sick after taking medication, it is often assumed that these are side effects. But it could just be a coincidence. Just because two things happen at about the same time, it doesn’t necessarily mean that there is a link.
In order to assess the risk of possible interactions with other drugs, it’s important to let your doctor know about any other medication you are taking. This includes herbal products and dietary supplements.
Why aren’t painkillers suitable for the treatment of fibromyalgia?
Painkillers such as acetylsalicylic acid (the drug in medications like Aspirin), diclofenac, ibuprofen and paracetamol (acetaminophen) aren’t recommended for the treatment of fibromyalgia. They haven’t been proven to help in fibromyalgia. But they can have various side effects.
Other painkillers such as metamizole, as well as stronger medications such as the opioid called oxycodone, aren’t considered to be suitable either. People may become dependent on opioids. And there hasn’t been enough research on the use of opioids in the treatment of fibromyalgia. But research on the use of opioids in other chronic pain disorders has shown that these medications aren’t very effective in the treatment of chronic pain. This is because the mechanisms of acute and chronic pain are quite different.
Which medications need to be studied more closely?
A lot of medications that are sometimes used to treat fibromyalgia haven’t been well studied in this area. Medical societies don’t recommend them for the treatment of fibromyalgia. These medications include:
- Sedatives and sleeping pills (also called hypnotics)
- Cannabis-based medication (cannabinoids)
- Hormones (e.g. testosterone, estrogen, growth hormones or thyroid hormones)
- Medication that relaxes your muscles (muscle relaxants)
- Medication that fights viruses (virostatics)
- Monoamine oxidase (MAO) inhibitors
- Anesthetic medication (e.g. ketamine)
- Sodium oxybate
All of these medications can have side effects. So it’s a good idea to talk to your doctor and carefully weigh the pros and cons of using them.
Cording M, Derry S, Phillips T, Moore RA, Wiffen PJ. Milnacipran for pain in fibromyalgia in adults. Cochrane Database Syst Rev 2015; (10): CD008244.
Derry S, Cording M, Wiffen PJ, Law S, Phillips T, Moore RA. Pregabalin for pain in fibromyalgia in adults. Cochrane Database Syst Rev 2016; (9): CD011790.
Deutsche Schmerzgesellschaft. Definition, Pathophysiologie, Diagnostik und Therapie des Fibromyalgiesyndroms. AWMF-Registernr.: 145-004. March 17, 2017.
Gaskell H, Moore RA, Derry S, Stannard C. Oxycodone for pain in fibromyalgia in adults. Cochrane Database Syst Rev 2016; (9): CD012329.
Lunn MP, Hughes RA, Wiffen PJ. Duloxetine for treating painful neuropathy, chronic pain or fibromyalgia. Cochrane Database Syst Rev 2014; (1): CD007115.
Moore RA, Derry S, Aldington D, Cole P, Wiffen PJ. Amitriptyline for fibromyalgia in adults. Cochrane Database Syst Rev 2015; (7): CD011824.
Walitt B, Klose P, Fitzcharles MA, Phillips T, Häuser W. Cannabinoids for fibromyalgia. Cochrane Database Syst Rev 2016; (7): CD011694.
IQWiG health information is written with the aim of helping
people understand the advantages and disadvantages of the main treatment options and health
Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.
Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.