Note: This document contains side effect information about levomilnacipran. Some dosage forms listed on this page may not apply to the brand name Fetzima.

Summary

Common side effects of Fetzima include: erectile dysfunction, nausea, and orthostatic hypotension. Other side effects include: constipation, ejaculatory disorder, epididymitis, increased heart rate, palpitations, premature ejaculation, sinus tachycardia, tachycardia, testicular pain, urinary hesitancy, vomiting, delayed ejaculation, ejaculation failure, and hyperhidrosis. Continue reading for a comprehensive list of adverse effects.

Applies to levomilnacipran: oral capsule extended release.

Serious side effects of Fetzima

Along with its needed effects, levomilnacipran (the active ingredient contained in Fetzima) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking levomilnacipran:

More common

• Decreased interest in sexual intercourse
• difficult urination
• fast, pounding, or irregular heartbeat or pulse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance

Less common

• Anxiety
• arm, back, or jaw pain
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain, discomfort, heaviness, or tightness
• cloudy urine
• confusion
• decrease in the frequency of urination
• difficulty in passing urine (dribbling)
• difficulty with speaking
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drooling
• dry mouth
• fainting
• headache
• irritability
• loss of balance control
• muscle trembling, jerking, or stiffness
• nausea
• painful urination
• pounding in the ears
• rapid or irregular heartbeat
• restlessness
• shaking
• shuffling walk
• slow heartbeat
• stiffness of the limbs
• sweating
• trouble breathing
• trouble sleeping
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back
• unusual tiredness or weakness

Incidence not known

• Delayed or inability to have an orgasm

Other side effects of Fetzima

Some side effects of levomilnacipran may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Difficulty having a bowel movement (stool)
• increased sweating
• vomiting

Less common

• Bloated or full feeling
• decreased appetite
• dry eyes
• dry skin
• feeling of warmth
• headache, severe and throbbing
• hives or welts, itching, or rash
• passing gas
• red eye
• red face, neck, arms, and occasionally, upper chest
• stomach pain
• sudden sweating
• thirst
• yawning

For Healthcare Professionals

Applies to levomilnacipran: oral capsule extended release.

General

The most commonly reported side effects included nausea, erectile dysfunction, constipation, and hyperhidrosis.^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 17%)

Common (1% to 10%): Constipation, vomiting

Frequency not reported: Abdominal pain, flatulence^[Ref]

Cardiovascular

Common (1% to 10%): Hot flush, hypertension, hypotension, increased blood pressure, increased heart rate, palpitations, tachycardia

Frequency not reported: Angina pectoris, chest pain, increased diastolic blood pressure, increased orthostatic blood pressure, increased orthostatic heart rate response, increased systolic blood pressure, labile hypertension, orthostatic hypotension, postural orthostatic tachycardia syndrome, sinus tachycardia, supraventricular extrasystoles, ventricular extrasystoles

Postmarketing reports: Takotsubo cardiomyopathy^[Ref]

Genitourinary

Erectile dysfunction and urinary hesitation occurred as dose-related events.^[Ref]

Common (1% to 10%): Ejaculation disorder, erectile dysfunction, testicular pain, urinary hesitation

Frequency not reported: Ejaculation delayed, ejaculation failure, epididymitis, hematuria, organic erectile dysfunction, pollakiuria, proteinuria, seminal vesiculitis, urinary hesitation, urinary retention^[Ref]

Dermatologic

Common (1% to 10%): Hyperhidrosis, rash

Frequency not reported: Dry skin, erythematous rash, generalized rash, macular rash, maculopapular rash, pruritus, urticaria^[Ref]

Metabolic

Common (1% to 10%): Decreased appetite

Frequency not reported: Hyponatremia, increased blood cholesterol, thirst^[Ref]

Psychiatric

Frequency not reported: Aggression, agitation, anger, bruxism, hypomania activation, mania activation, panic attack, premature ejaculation, psychogenic erectile dysfunction, suicidal behaviors, suicidal thoughts, tension^[Ref]

Suicidal thoughts and behaviors more commonly occurred in adolescent and young adults 24 years and younger.^[Ref]

Nervous system

Frequency not reported: Extrapyramidal disorder, migraine, paresthesia, postural dizziness, seizure, serotonin syndrome, syncope^[Ref]

Ocular

Frequency not reported: Angle closure glaucoma, blurred vision, conjunctival hemorrhage, dry eye^[Ref]

Other

Frequency not reported: Discontinuation syndrome^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity^[Ref]

Hematologic

Frequency not reported: Increased bleeding risk^[Ref]

Hepatic

Frequency not reported: Abnormal liver function tests^[Ref]

Respiratory

Frequency not reported: Yawning^[Ref]