"The U.S. Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.
Major depressive disorder (MDD), commonly referred to as depression, is a mental disorder characterized by mo"...
Fetzima Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Fetzima (levomilnacipran) extended-release is a type of antidepressant called a serotonin and norepinephrine reuptake inhibitor (SNRI) used to treat Major Depressive Disorder (MDD). Common side effects include nausea or vomiting, constipation, sweating, and erectile dysfunction. Antidepressants may increase suicidal thoughts in some children, teenagers, or young adults, particularly in the first few months of treatment. Tell your doctor if you have thoughts of suicide.
The recommended dose range for Fetzima is 40 mg to 120 mg once daily, with or without food. Fetzima may interact with medicines used to treat mood, anxiety, psychotic or thought disorders; migraine headache medicines (triptans); other antidepressants, antipsychotics, sibutramine, tramadol, tryptophan, St. John's Wort, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, warfarin, or diuretics. Tell your doctor all medications and supplements you use. During pregnancy, Fetzima should be used only if the potential benefit justifies the potential risk to the fetus. It is unknown if Fetzima passes into breast milk. Consult your doctor before breastfeeding.
Our Fetzima (levomilnacipran) extended-release Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Fetzima FDA Prescribing Information: Side Effects
The following adverse reactions are discussed in greater detail in other sections of the label.
- Hypersensitivity [see CONTRAINDICATIONS]
- Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see WARNINGS AND PRECAUTIONS]
- Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
- Elevated Blood Pressure [see WARNINGS AND PRECAUTIONS]
- Elevated Heart Rate [see WARNINGS AND PRECAUTIONS]
- Abnormal Bleeding [see WARNINGS AND PRECAUTIONS]
- Angle Closure Glaucoma [see WARNINGS AND PRECAUTIONS]
- Urinary Hesitation or Retention [see WARNINGS AND PRECAUTIONS]
- Activation of Mania/Hypomania [see WARNINGS AND PRECAUTIONS]
- Seizure [see WARNINGS AND PRECAUTIONS]
- Discontinuation Syndrome [see WARNINGS AND PRECAUTIONS]
- Hyponatremia [see WARNINGS AND PRECAUTIONS]
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
The safety of FETZIMA was evaluated in 2,673 patients (18-78 years of age) diagnosed with MDD who participated in clinical studies, representing 942 patient-years of exposure. Among the 2,673 FETZIMA-treated patients, 1,583 were exposed to FETZIMA in short-term, placebocontrolled studies. There were 825 patients who continued from short-term studies into a oneyear, open-label extension study.
Of the 2,673 patients exposed to at least one dose of FETZIMA, 737 patients were exposed to FETZIMA for at least 6 months and 367 were exposed for one year. In these studies FETZIMA was given at doses ranging from 40-120 mg once daily and was given without regard to food.
Adverse Reactions Reported As Reasons For Discontinuation Of Treatment
In the short-term placebo-controlled pre-marketing studies for MDD, 9% of the 1,583 patients who received FETZIMA (40-120 mg) discontinued treatment due to an adverse event, compared with 3% of the 1,040 placebo-treated patients in those studies. The most common adverse reaction leading to discontinuation in at least 1% of the FETZIMA-treated patients in the shortterm placebo-controlled studies was nausea (1.5%).
Common Adverse Reactions In Placebo-Controlled MDD Studies
The most commonly observed adverse events in FETZIMA-treated MDD patients in placebocontrolled studies (incidence ≥ 5% and at least twice the rate of placebo) were: nausea, constipation, hyperhidrosis, heart rate increased, erectile dysfunction, tachycardia, vomiting, and palpitations.
Table 3 shows the incidence of adverse reactions that occurred in ≥ 2% of FETZIMA-treated MDD patients and at least twice the rate of placebo in the placebo-controlled studies.
Table 3 : Adverse Reactions Occurring in ≥ 2% of
FETZIMA-treated Patients and at Least Twice the rate of Placebo-treated
|System Organ Class
(N =1040) %
|FETZIMA 40-120 mg/d
(N = 1583) %
|Reproductive system and breast disordersb|
|Testicular paind||< 1||4|
|Ejaculation disordere||< 1||5|
|Heart rate increasedf||1||6|
|Blood pressure increasedg||1||3|
|Renal and urinary disorders|
|Skin and subcutaneous tissue disorders|
|Metabolism and nutrition disorders|
|a Tachycardia also includes: sinus tachycardia
and postural orthostatic tachycardia syndrome
b Percentage is relative to the number of patients in the associated demographic sex category. Fewer than 2% of FETZIMA-treated MDD female patients in placebo-controlled clinical studies reported adverse events related to sexual function.
c erectile dysfunction includes: erectile dysfunction, organic erectile dysfunction and psychogenic erectile dysfunction
d testicular pain includes: testicular pain, epididymitis, and seminal vesiculitis
e ejaculation disorder includes: ejaculation disorder, ejaculation delayed, ejaculation failure, and premature ejaculation
f Heart rate increased also includes: orthostatic heart rate response increased
g Blood pressure increased also includes: blood pressure systolic increased, blood pressure diastolic increased and blood pressure orthostatic increased
h Rash also includes: rash generalized, rash maculo-papular, rash erythematous and rash macular
i Hypotension also includes: orthostatic hypotension and dizziness postural
j Hypertension also includes: labile hypertension
N = number of patients in the Safety Population
Dose-related Adverse Reactions
In pooled data from the short-term placebo-controlled fixed-dose studies, there were no doserelated adverse reactions (greater than 2% overall incidence) in patients treated with FETZIMA across the dose range 40-120 mg once daily, with the exception of erectile dysfunction and urinary hesitation (see Table 4).
Table 4 : Dose-Related Adverse Reactions
|System Organ Class Preferred Term||Placebo
(N = 362) %
(N = 366) %
(N = 367) %
(N = 180) %
|a Percentage is relative to the number of male
N = number of patients in the Safety Population
Other Adverse Reactions Observed In Clinical Studies
Other infrequent adverse reactions, not described elsewhere in the label, occurring at an incidence of < 2% in MDD patients treated with FETZIMA were:
General disorders: Chest pain; Thirst
Gastrointestinal disorders: Abdominal pain; Flatulence
Investigations disorders: Blood cholesterol increased; Liver function test abnormal
Respiratory, thoracic and mediastinal disorders: Yawning
Read the entire FDA prescribing information for Fetzima (Levomilnacipran) Extended-release Capsules)
Additional Fetzima Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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