Frequently Asked Questions

Get answers to common questions about Savella and fibromyalgia.

ABOUT SAVELLA:

What is Savella?
What are some of the benefits of Savella?
What else can I do to manage my symptoms while taking Savella?
What should I tell my healthcare provider before taking Savella?

TAKING SAVELLA:

How should I take Savella?
What should I do if I need to stop taking Savella?
What are the most common side effects of Savella?

FIBROMYALGIA INFORMATION:

What is fibromyalgia?
What causes fibromyalgia?
Who does fibromyalgia affect?

What is Savella?

Savella is a proven effective medication for the management of fibromyalgia. In clinical studies that compared Savella to placebo, patients who took Savella said:

They felt less pain and
their fibromyalgia overall was improved and
their physical function was improved

Savella is a medication approved for the management of fibromyalgia shown to help people feel these benefits at the same time. Learn more about Savella.

What are some of the benefits of Savella?

Savella's efficacy was tested in four studies. Nearly 4,000 adult patients participated in the studies; all of them met the American College of Rheumatology criteria for fibromyalgia. These criteria include having a history of widespread pain for at least 3 months and having pain present at 11 or more of 18 specific tender points. Learn more about the benefits of Savella.

What else can I do to manage my symptoms while taking Savella?

Among the more effective ways to relieve symptoms of fibromyalgia is to get regular exercise. Some other ways to minimize symptoms include eating a healthy, balanced diet, and getting enough sleep. Learn more about managing fibromyalgia.

What should I tell my healthcare provider before taking Savella?

Before starting Savella, tell your healthcare provider about all your medical conditions, including if you have:

Hypertension (high blood pressure), heart rhythm problems, fast heart rate, or other heart diseases
Liver problems or a history of substantial alcohol use
Kidney problems or difficulty passing urine, including painful urination
Current or past manic episodes or seizure disorders
Bleeding disorders
Glaucoma

Also, to avoid a potentially serious or life-threatening condition, tell your healthcare provider if you are taking, or are planning to take, any prescription or over-the-counter medications, including:

Medication prescribed for a psychiatric or neurological condition including other selective serotonin and norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), certain migraine or headache medications (triptans), or tryptophan
NSAID pain relievers (such as ibuprofen or naproxen), aspirin, warfarin, or other blood thinners
Diuretics

Tell your healthcare provider if you are pregnant, planning to become pregnant during therapy, or breastfeeding. Learn more about taking Savella

How should I take Savella?

Always take Savella as prescribed by your doctor. Your healthcare provider may increase your dose gradually during the first week until you reach the recommended 100 mg/day dose. You should take Savella by mouth twice daily, with or without food. Keep in mind that you may find taking Savella more tolerable if you take it with a meal. Learn more about taking Savella

What should I do if I need to stop taking Savella?

To avoid potential withdrawal symptoms, never reduce your dose or stop taking Savella on your own. Always talk to your healthcare professional first.

As with other medications in its class (SNRIs and SSRIs), stopping Savella too quickly could result in withdrawal symptoms.
Rather than stopping abruptly, your healthcare professional will help you reduce your dose gradually.
Savella is not a narcotic medication and does not cause addiction. Additionally, studies have shown that Savella has a very low potential for abuse.

Learn more about taking Savella

What are the most common side effects of Savella?

The most common side effect associated with Savella treatment is nausea. In clinical trials, patients experiencing nausea described it as mild to moderate. Approximately 6% of those taking Savella discontinued due to nausea vs 0.6% for those taking a sugar pill (placebo).

Other common side effects of Savella were headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis (excessive sweating), vomiting, palpitations, increased heart rate, dry mouth, and hypertension. This is not a complete list of side effects. Please ask your healthcare provider about possible risks and side effects and see the Important Risk Information about Savella.

In clinical trials, Savella was not shown to be associated with weight gain or weight loss. Patients in clinical trials who took Savella had an average weight loss of 1.76 lbs compared to patients in the placebo group who lost an average of .44 lbs.

What is fibromyalgia?

Fibromyalgia is a common, chronic medical condition that affects an estimated 6-12 million people in the United States. Despite its prevalence, nearly 70% of all fibromyalgia cases remain undiagnosed. Although fibromyalgia affects both men and women of all ages, it is most common among women (80-90% of cases) between the ages of 20 and 55. There are a range of symptoms associated with fibromyalgia, including chronic, widespread pain and tenderness lasting more than three months. These symptoms typically have a significant impact on patients’ daily activities.
Learn more about fibromyalgia

What causes fibromyalgia?

The cause of fibromyalgia is unknown. Existing evidence shows that fibromyalgia is not caused by muscle inflammation. Many experts believe that fibromyalgia is associated with changes in the processing of pain signals in the brain and spinal cord. So for someone living with fibromyalgia, sensitivity to pain is heightened due to this change in pain processing. Learn more about the causes of fibromyalgia.

Who does fibromyalgia affect?

Fibromyalgia affects 6-12 million people in the United States alone. And although fibromyalgia affects both men and women of all ages, it is most common among women (80-90% of cases) between the ages of 20 and 55. Learn more about fibromyalgia.

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Learn about treatments used to manage fibromyalgia.

SAVELLA (milnacipran HCl) is indicated for the management of fibromyalgia in adults. SAVELLA is not approved for use in pediatric patients. SAVELLA is available by prescription only.

Important Risk Information About SAVELLA

SAVELLA is not used to treat depression, but it acts like medicines that are used to treat depression (antidepressants) and other psychiatric disorders.
Antidepressants may increase suicidal thoughts or actions in some children, teenagers, and young adults.
Call your doctor right away or seek emergency help if you have new or worsening additional symptoms, unusual changes in behavior, mood, thoughts or feelings, thoughts of suicide, anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity.
Call your healthcare provider right away if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly. Be especially observant within the first few months of treatment or after a change in the dose.
SAVELLA is approved only for adults aged 18 and older.
For more information about this risk, please read the SAVELLA Patient Medication Guide in the Full Prescribing Information.

SAVELLA may be associated with serious side effects. Call your healthcare provider right away or seek emergency help if you experience any of the following symptoms:

Agitation, hallucinations, muscle twitching, sweating or fever, stiff muscles, dizziness, or diarrhea; these may be signs of serotonin syndrome, a potentially life-threatening condition.
Increase in blood pressure or heart rate. Your healthcare provider should check your blood pressure and heart rate before starting and throughout SAVELLA treatment. Before starting SAVELLA, tell your doctor if you have high blood pressure or problems with your heart or blood vessels (cardiovascular disease).
Seizures or convulsions.
Itching, right upper-belly pain, dark urine, yellow skin or eyes, or unexplained flu-like symptoms, which may be signs of life-threatening liver problems.
Headache, weakness, confusion, problems concentrating or memory problems may be signs of low salt levels in the blood. Elderly people may be at greater risk.
Abnormal bleeding, especially if SAVELLA is taken with other medicines such as the blood thinner warfarin, NSAID pain relievers (ibuprofen or naproxen), or aspirin.
Manic episodes, which may include greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior, unusually grand ideas, excess happiness or irritability, and talking more or faster.
Problems with urination, which may include decreased urine flow or inability to pass urine.
Visual problems: Eye pain; changes in vision; swelling or redness in or around the eye. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

Do not stop SAVELLA without first talking to your healthcare provider. Stopping SAVELLA too quickly may cause serious symptoms, including:

anxiety, irritability, or confusion
feeling tired or problems sleeping
headache, dizziness, seizures
electric shock-like sensations, ringing in ears

SAVELLA is not for everyone. Do not take SAVELLA if you:

Take a Monoamine Oxidase Inhibitor (MAOI), including the antibiotic linezolid. Taking SAVELLA close in time to these medications can cause serious or even life-threatening side effects.

Before starting SAVELLA, tell your healthcare provider:

About all your prescriptions and over-the-counter medicines and supplements you take or plan to take including:

Medicines for migraines, mood, or psychotic disorders to avoid a potentially life-threatening condition
Aspirin, NSAID pain relievers, or blood thinners, because they may increase the risk for bleeding

About how often and how much alcohol you drink.
If you are pregnant or plan to become pregnant during therapy or breast-feeding.

Other Safety Information related to SAVELLA:

SAVELLA may cause sleepiness and dizziness. Until you know how SAVELLA affects you, you shouldn't drive a car or operate hazardous machinery.

Most common side effects of SAVELLA:

Nausea, headache, constipation, dizziness, insomnia, hot flush, excessive sweating, vomiting, palpitations, increased heart rate, dry mouth, and increased blood pressure. This is not a complete list.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/Safety/Medwatch, or call 1-800-FDA-1088.

The information provided in this site is intended for US residents only. The products described on this site may have different product labeling in countries outside of the United States.