Last reviewed 2026-04-20 · How we verify

Fetzima (LEVOMILNACIPRAN)

Fetzima works by blocking the reabsorption of serotonin and norepinephrine in the brain, allowing more of these neurotransmitters to be available for communication between brain cells.

LEVOMILNACIPRAN (Fetzima), marketed by AbbVie, is a serotonin-norepinephrine reuptake inhibitor (SNRI) primarily indicated for major depressive disorder. A key strength of Fetzima is its mechanism of action, which effectively increases the availability of serotonin and norepinephrine, potentially offering distinct therapeutic benefits over other SNRIs. The primary risk is the upcoming key patent expiry in 2028, which could lead to increased competition from generics and impact revenue.

At a glance

Mechanism of action

The exact mechanism of the antidepressant action of levomilnacipran is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of reuptake at serotonin and norepinephrine transporters. Non-clinical studies have shown that levomilnacipran is potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI).

Approved indications

• Major depressive disorder

Boxed warnings

• WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 ) ] . FETZIMA is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 ) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ) . FETZIMA is not approved for use in pediatric patients ( 8.4 ).

Common side effects

• Nausea
• Constipation
• Hyperhidrosis
• Tachycardia
• Vomiting
• Palpitations
• Erectile dysfunction
• Heart rate increased
• Urinary hesitation
• Rash
• Hot flush
• Hypotension

Key clinical trials

• Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease (PHASE2,PHASE3)
• Efficacy and Safety Study of Levomilnacipran Hydrochloride Extended-Release Capsules in Major Depressive Disorder (PHASE3)
• Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression (PHASE2)
• A Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy (PHASE2)
• Neural Mechanisms of Monoaminergic Engagement in Late-life Depression Treatment Response (NEMO) (PHASE4)
• Effect of Peanut Ball Use ın Prımarıes on Labor Paın, Duratıon of Labor Anxıety and (NA)
• Effect of Foot Massage Performed to the Mother After Bırth on Breastfeedıng Success, Sleep Qualıty and Newborn Stress (NA)
• The Savella Pregnancy Registry

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Fetzima CI brief — competitive landscape report
• Fetzima updates RSS · CI watch RSS
• AbbVie portfolio CI