Important Risk Information
- 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.
- 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.
- anxiety, irritability, or confusion
- feeling tired or problems sleeping
- headache, dizziness, seizures
- electric shock-like sensations, ringing in ears
- 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.
The information provided in this site is intended for U.S. residents only. The products described on this site may have different product labeling in countries outside of the United States.