Most Common Side Effects
Learn about 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 versus 0.6% for those taking a sugar pill (placebo). You may find taking Savella more tolerable if you take it with a meal.
Other common side effects are headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis (excessive sweating), vomiting, palpitations, increased heart rate, dry mouth, and hypertension.
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.
This is not a complete list of side effects. Please see the Important Risk Information about Savella. And ask your healthcare provider about possible risks and side effects.
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- 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.
- 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.
- anxiety, irritability, or confusion
- feeling tired or problems sleeping
- headache, dizziness, seizures
- electric shock-like sensations, ringing in ears
- Have uncontrolled narrow-angle glaucoma.
- 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.
- 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.
- SAVELLA may cause sleepiness and dizziness. Until you know how SAVELLA affects you, you shouldn't drive a car or operate hazardous machinery.
- 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.