FETZIMA® (levomilnacipran) extended-release capsules are a prescription medicine used to treat a certain type
of depression called Major Depressive Disorder (MDD) in adults.
It is not known if FETZIMA is safe and effective for use in children.
FETZIMA is not for use for the management of fibromyalgia, and its efficacy and safety have not been
established for that use.
IMPORTANT SAFETY INFORMATION
FETZIMA may cause serious side effects, including:
Increased risk of suicidal thoughts or actions in some children,
adolescents, and young adults. FETZIMA
and other antidepressant medicines may increase suicidal thoughts or actions in some children and young
especially within the first few months of treatment or when the dose is changed. FETZIMA is not
for use in children.
Depression or other serious mental illnesses are the most important causes of suicidal thoughts or
actions. Some people may have a higher risk of having suicidal thoughts or actions.
people who have (or have a family history of) depression or bipolar illness (also called manic-depressive
illness) or have a history of suicidal thoughts or actions.
Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if
you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or
when the dose is changed.
Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or
Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between
visits as needed, especially if you have concerns about symptoms.
Call your healthcare provider or get emergency medical help right away if you or your family member
have any of these symptoms, especially if they are new, worse, or worry you:
Attempts to commit suicide; acting on dangerous impulses; acting aggressive; being angry or violent; thoughts
about suicide or dying; new or worsening depression or anxiety; feeling very agitated or restless; panic attacks;
trouble sleeping; new or worsening irritability; an extreme increase in activity or talking (mania); or other
unusual changes in behavior or mood.
FETZIMA may cause serious side effects, including:
Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when
FETZIMA is taken with certain other medicines. Stop taking FETZIMA and call your healthcare provider or go
to the nearest hospital emergency room right away if you have any of the following signs and symptoms of
serotonin syndrome: agitation, confusion, fast heartbeat, dizziness, flushing, tremors, stiff muscles or muscle
twitching, seizures, seeing or hearing things that are not real (hallucinations), coma, blood pressure changes,
sweating, high body temperature (hyperthermia), loss of coordination, nausea, vomiting, or diarrhea.
High blood pressure (hypertension).
Your healthcare provider should check your blood pressure before you
start and during treatment with FETZIMA. If you have high blood pressure, it should be controlled before you
start treatment with FETZIMA.
Increased heart rate.
Your healthcare provider should check your heart rate before you start and during
treatment with FETZIMA. If you have heart problems or problems with an abnormal heartbeat, your problems
should be treated before you start treatment with FETZIMA.
Increased risk of bleeding.
Taking FETZIMA with aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs),
warfarin, or blood thinners may add to this risk. Tell your healthcare provider right away about any unusual
bleeding or bruising.
Eye problems (angle-closure glaucoma).
Many antidepressant medicines, including FETZIMA, may cause a
certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have changes
in your vision or eye pain.
Problems with urination.
FETZIMA may cause you to have problems with urination, including decreased
urine flow and being unable to pass any urine. Tell your healthcare provider if you develop any problems with
urine flow during treatment with FETZIMA.
Manic episodes may happen in people with bipolar disorder who take FETZIMA. Symptoms
may include greatly increased energy, racing thoughts, unusually grand ideas, talking more or faster than
usual, severe trouble sleeping, reckless behavior, or excessive happiness or irritability.
Suddenly stopping FETZIMA may cause you to have serious side effects. Your
healthcare provider may want to decrease your dose slowly. Symptoms may include changes in your mood,
irritability and agitation, dizziness, electric shock sensation (paresthesia), anxiety, confusion, headache,
tiredness, problems sleeping, hypomania, ringing in your ears (tinnitus), and seizures.
Low sodium levels in the blood (hyponatremia).
Low sodium levels in your blood may be serious and may
cause death. Elderly people may be at greater risk for this. Symptoms may include headache, difficulty
concentrating, memory changes, confusion, weakness, and unsteadiness on your feet.
In severe or more
sudden cases, signs and symptoms include
hallucinations (seeing or hearing things that are not real),
fainting, seizures, coma, respiratory arrest, and death.
Taking FETZIMA may cause sexual problems. Talk to your healthcare provider if you
develop any changes in your sexual function or if you have any questions or concerns about sexual problems
DO NOT take FETZIMA if you:
are allergic to levomilnacipran, milnacipran HCl, or any of the ingredients in FETZIMA
take a monoamine oxidase inhibitor (MAOI)
have stopped taking an MAOI within the last 14 days
are being treated with the antibiotic linezolid or intravenous methylene blue
Do not start taking an MAOI for at least 7 days after you stop treatment with FETZIMA.
Before taking FETZIMA, tell your healthcare provider if you:
have or had a family history of suicide, depression, bipolar disorder, mania, or hypomania
have high blood pressure
have or had heart problems or stroke
have or had bleeding problems
have glaucoma (high pressure in the eye)
have or had problems urinating (hesitating) or emptying your bladder (retention)
have or had seizures (convulsions)
have low sodium levels in your blood
have or had kidney problems
are pregnant or plan to become pregnant. FETZIMA may harm your unborn baby. Taking FETZIMA during
your third trimester of pregnancy may cause an increased risk of bleeding after delivery and may cause harm
to your baby. Talk to your healthcare provider about the risks to you and your baby if you take FETZIMA during
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during
treatment with FETZIMA.
There is a pregnancy registry for females who are exposed to FETZIMA during pregnancy. The purpose of the
registry is to collect information about the health of females exposed to FETZIMA and their baby. If you become
pregnant during treatment with FETZIMA, talk to your healthcare provider about registering with the National
Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at
are breastfeeding or plan to breastfeed. It is not known if FETZIMA passes into your breast milk. Talk to your
healthcare provider about the best way to feed your baby during treatment with FETZIMA.
If you breastfeed during treatment with FETZIMA, call you healthcare provider right away if your baby
develops sleepiness or fussiness, or is not feeding or gaining weight well.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
FETZIMA and other medicines may affect each other causing possible serious side effects.
FETZIMA may affect the way other medicines work and other medicines may affect the way FETZIMA works.
Especially tell your healthcare provider if you take:
medicines used to treat mood, anxiety, psychotic or thought disorders, including selective serotonin reuptake
inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs), MAOIs, medicines used to treat
migraine headache known as triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan,
buspirone, amphetamines, or St. John’s Wort
medicines that can affect blood clotting, such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) and
Do not start or stop any other medicines during treatment with FETZIMA without talking to your healthcare
provider first. Stopping FETZIMA suddenly may cause you to have serious side effects.
Avoid drinking alcohol during treatment with FETZIMA. Do not drive, operate heavy machinery, or do other
dangerous activities until you know how FETZIMA affects you. FETZIMA can cause sleepiness or may affect
your ability to make decisions, think clearly, or react quickly.
The most common side effects of FETZIMA
nausea, vomiting, constipation, sweating, abnormal heartbeat, and erectile dysfunction
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of FETZIMA. For more information, ask your healthcare provider or
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit
AbbVie.com/myAbbVieAssist to learn more.