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
- 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
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
- 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
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:
- 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.
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
or call 1-800-FDA-1088.