Molecule
Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) in adults. It is available as extended-release capsules and kits for oral use. MedsAcross supplies Levomilnacipran for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
FETZIMA ® is indicated for the treatment of major depressive disorder (MDD) in adults. Limitation of Use: FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established. FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults.
Source: US FDA prescribing information
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 a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI).
Source: US FDA prescribing information
Recommended dosage: 40 mg to 120 mg once daily with or without food. Initial dosage is 20 mg once daily for 2 days and then increase to 40 mg once daily. Based on clinical response and tolerability, increase dose in increments of 40 mg at intervals of 2 or more days. The maximum recommended dosage is 120 mg once daily. Take capsules whole, do not open, chew or crush. Renal impairment: ○ Severe renal impairment: Maximum recommended dosage is 40 mg once daily. ○ Moderate renal impairment: Maximum recommended dosage is 80 mg once daily. Discontinuation: Reduce dose gradually whenever possible
Source: US FDA prescribing information
FETZIMA is contraindicated: in patients with hypersensitivity to levomilnacipran, milnacipran HCl, or to any excipient in the formulation. with the use of MAOIs intended to treat psychiatric disorders with FETZIMA or within 7 days of stopping treatment with FETZIMA is contraindicated because of an increased risk of serotonin syndrome. The use of FETZIMA within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated. Starting FETZIMA in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.
Source: US FDA prescribing information
Boxed 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. FETZIMA is not approved for use in pediatric patients. Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue FETZIMA and serotonergic agents and initiate supportive treatment. Elevated Blood Pressure and Heart Rate: Control hypertension before initiating therapy with FETZIMA. Monitor blood pressure regularly during treatment. Increased Risk of Bleeding: Concomitant use of NSAIDs, aspirin, other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in other sections of the label. Hypersensitivity Suicidal Thoughts and Behaviors in Adolescents and Young Adults Serotonin Syndrome Elevated Blood Pressure Elevated Heart Rate Increased Risk of Bleeding Angle Closure Glaucoma Urinary Hesitation or Retention Activation of Mania/Hypomania Seizure Discontinuation Syndrome Hyponatremia Sexual Dysfunction The most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) are: nausea, constipation, hyperhidrosis, heart rate increase, erectile dysfunction, ejaculation disorder, tachycardia, vomiting, and palpitations.
Source: US FDA prescribing information
Strong CYP3A4 inhibitors: Maximum recommended dosage is 80 mg once daily. 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: With an MAOI intended to treat psychiatric disorders or within 7 days of stopping treatment with FETZIMA. Within 14 days of stopping an MAOI intended to treat psychiatric disorders In a patient who is being treated with linezolid or intravenous methylene blue.
Source: US FDA prescribing information
All package configurations: Store at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
5 presentations of Levomilnacipran, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Fetzima 120 mg extended-release capsuleOral | Allergan | US FDA | Available on request |
| Fetzima 40 mg extended-release capsuleOral | Allergan | US FDA | Available on request |
| Fetzima 80 mg extended-release capsuleOral | Allergan | US FDA | Available on request |
| Fetzima kitOral | Allergan | US FDA | Available on request |
| Fetzima 20 mg extended-release capsuleOral | Allergan | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 25 July 2013 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Levomilnacipran in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 5 presentations of Levomilnacipran and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Levomilnacipran, including Fetzima.
Yes. The US FDA first approved Levomilnacipran on 25 July 2013, according to Drugs@FDA.
No listed presentation of Levomilnacipran is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.