Medical Editor: John P. Cunha, DO, FACOEP
What Is Fetzima?
Fetzima (levomilnacipran) extended-release is a type of antidepressant called a serotonin and norepinephrine reuptake inhibitor (SNRI) used to treat Major Depressive Disorder (MDD).
What Are Side Effects of Fetzima?
Fetzima may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- difficulty urinating,
- fast, pounding, or irregular heartbeats,
- anxiety,
- arm, back or jaw pain,
- loss of balance or coordination,
- muscle stiffness, trembling or jerking,
- nausea,
- blurred vision,
- painful urinating,
- numbness or tingling,
- painful urination,
- pounding in the ears,
- chest pain or pressure,
- rapid or irregular heartbeat,
- restlessness,
- cloudy urine,
- confusion,
- tremors,
- little or no urination,
- difficulty passing urination (dribbling),
- slow heartbeat,
- difficulty speaking,
- sweating,
- dizziness,
- lightheadedness,
- drooling,
- trouble sleeping (insomnia),
- weakness,
- unusual tiredness,
- uncontrolled muscle movements, especially of the face, neck and back,
- dry mouth,
- fainting, and
- irritability
Get medical help right away if you have any of the symptoms listed above.
Common side effects of Fetzima include:
- nausea,
- vomiting,
- constipation,
- sweating,
- increased heart rate,
- slowed heart rate,
- heart palpitations,
- erectile dysfunction,
- rash,
- decreased appetite,
- hot flashes,
- testicular pain,
- problems ejaculating,
- urinary hesitation,
- increased sweating,
- high or low blood pressure, or
- decreased appetite.
Antidepressants such as Fetzima 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 while taking Fetzima.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Fetzima
The recommended dose range for Fetzima is 40 mg to 120 mg once daily, with or without food.
What Drugs, Substances, or Supplements Interact with Fetzima?
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.
Fetzima During Pregnancy and Breastfeeding
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.
Additional Information
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.
QUESTION
Depression is a(n) __________ . See AnswerGet emergency medical help if you have signs of an allergic reaction: skin rash or hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
- blurred vision, tunnel vision, eye pain or swelling, eye redness;
- painful or difficult urination;
- easy bruising, unusual bleeding, purple or red spots under your skin;
- pounding heartbeats or fluttering in your chest;
- seizure (convulsions);
- manic episodes--racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative; or
- low sodium level--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.
Serious side effects may be more likely in older adults.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Common side effects may include:
- nausea, vomiting, constipation;
- irregular heartbeats;
- sweating; or
- decreased sex drive, impotence, or difficulty having an orgasm.
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.
SLIDESHOW
Learn to Spot Depression: Symptoms, Warning Signs, Medication See SlideshowSIDE 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]
- Increased Risk of 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]
- Sexual Dysfunction [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.
Patient Exposure
The safety of FETZIMA was evaluated in 3,317 patients (18-78 years of age) diagnosed with MDD who participated in clinical studies, representing 1,186 patient-years of exposure. Among the 3,317 FETZIMA-treated patients, 1,583 were exposed to FETZIMA in short-term, placebo-controlled studies. There were 825 patients who continued from short-term studies into a one-year, open-label extension study.
Of the 3,317 patients exposed to at least one dose of FETZIMA, 895 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 short-term 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 placebo-controlled 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 Patients
| System Organ Class Preferred Term |
Placebo (N =1040) % |
FETZIMA 40-120 mg/d (N = 1583) % |
| Gastrointestinal disorders | ||
| Nausea | 6 | 17 |
| Constipation | 3 | 9 |
| Vomiting | 1 | 5 |
| Cardiac disorders | ||
| Tachycardiaa | 2 | 6 |
| Palpitations | 1 | 5 |
| Repro ductive system and breast disordersb | ||
| Erectile dysfunctionc | 1 | 6 |
| Testicular paind | <1 | 4 |
| Ej a culation disordere | <1 | 5 |
| Investigations | ||
| Heart rate increasedf | 1 | 6 |
| Blood pressure increasedg | 1 | 3 |
| Renal and urinary disorders | ||
| Urinary hesitation | 0 | 4 |
| Skin and subcutaneous tissue disorders | ||
| Hyperhidrosis | 2 | 9 |
| Rashh | 0 | 2 |
| Vascular disorders | ||
| Hot flush | 1 | 3 |
| Hypotensioni | 1 | 3 |
| Hypertensionj | 1 | 3 |
| Metabolism and nutrition disorders | ||
| Decrea sed appetite | 1 | 3 |
| 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 dose-related 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) % |
FETZIMA | ||
| 40 mg/d (N = 366) % |
80 mg/d (N = 367) % |
120 mg/d (N = 180) % |
||
| Urinary hesitation | 0 | 4 | 5 | 6 |
| Erectile dysfunctiona | 2 | 6 | 8 | 10 |
| a Percentage is relative to the number of male patients. 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:
Cardiac disorders: Angina pectoris; Supraventricular and Ventricular extrasystoles
Eye disorders: Dry eye; Vision blurred; Conjunctival hemorrhage
General disorders: Chest pain; Thirst
Gastrointestinal disorders: Abdominal pain; Flatulence
Investigations disorders: Blood cholesterol increased; Liver function test abnormal
Nervous System disorders: Migraine; Paraesthesia; Syncope; Extrapyramidal disorder
Psychiatric disorders: Agitation; Anger; Bruxism; Panic attack; Tension; Aggression
Renal and Urinary disorder: Pollakiuria; Hematuria; Proteinuria
Respiratory, thoracic and mediastinal disorders: Yawning
Skin and subcutaneous tissue disorders: Dry skin; Pruritus; Urticaria
Postmarketing Experience
The following adverse reaction has been identified during post-approval use of FETZIMA or other selective serotonin and norepinephrine reuptake inhibitors. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac disorders: Takotsubo cardiomyopathy
DRUG INTERACTIONS
Drugs Having Clinically Important Interactions with FETZIMA
Table 5 includes clinically important drug interactions with FETZIMA.
Table 5: Clinically Important Drug Interactions with FETZIMA
| Monoamine Oxidase Inhibitors (MAOIs) | |
| Clinical Impact: | Concomitant use of SSRIs and SNRIs including FETZIMA with MAOIs increases the risk of serotonin syndrome. |
| Intervention: |
Concomitant use of FETZIMA is contraindicated:
|
| Examples: | selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Other Serotonergic Drugs | |
| Clinical Impact: | Concomitant use of FETZIMA with other serotonergic drugs increases the risk of serotonin syndrome. |
| Intervention: | Monitor for symptoms of serotonin syndrome when FETZIMA is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, immediately discontinue FETZIMA and/or concomitant serotonergic drugs [see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS AND PRECAUTIONS]. |
| Examples: | other SNRIs, SSRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, amphetamines, tryptophan, and St. John's Wort |
| Drugs that Interfere with Hemostasis | |
| Clinical Impact: | Concomitant use of FETZIMA with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding. This may be due to the effect of FETZIMA on the release of serotonin by platelets. |
| Intervention: | Closely monitor for bleeding for patients receiving an antiplatelet or anticoagulant drug when FETZIMA is initiated or discontinued [see WARNINGS AND PRECAUTIONS]. |
| Examples: | NSAIDs, aspirin, and warfarin |
| Strong CYP3A4 Inhibitors | |
| Clinical Impact: | Concomitant use of FETZIMA with strong CYP3A4 inhibitors increases levomilnacipran exposure [see Pharmacokinetics]. |
| Intervention: | The dose of FETZIMA should not exceed 80 mg once daily when used with strong CYP3A4 inhibitors [see DOSAGE AND ADMINISTRATION.] |
| Examples: | Ketoconazole, itraconazole, clarithromycin |
| Alcohol | |
| Clinical Impact: | Concomitant use of FETZIMA and alcohol may result in accelerated release of levomilnacipran. |
| Intervention: | Avoid concomitant use of FETZIMA and alcohol [see CLINICAL PHARMACOLOGY]. |
Read the entire FDA prescribing information for Fetzima (Levomilnacipran) Extended-release Capsules)
© Fetzima Patient Information is supplied by Cerner Multum, Inc. and Fetzima Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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