Prescription medicine
Levomilnacipran Brand names: Fetzima
Levomilnacipran (Fetzima) is a prescription medicine with an FDA approval on record since 2013. No generic is listed; pharmacies paid $17.61 per unit (Fetzima 20-40 mg titration pak) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the levomilnacipran FDA label on DailyMed (effective April 30, 2024, Allergan, Inc.); the NDA 204168 record on Drugs@FDA; every levomilnacipran label on DailyMed.
Highlights of the record
FDA label of April 30, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 ).
Used for
From the label: indications and usageFETZIMA ® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )].
Forms and strengths
- 20 mg
- 40 mg
- 80 mg
- 120 mg
Extended-release capsule; kit.
On the market
- Earliest approval on file
- July 25, 2013 Fetzima, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first February 4, 2019; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 23, 2032 Fetzima capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $17.61 per unit Fetzima 20-40 mg titration pak
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,905 through July 30, 2026
What is levomilnacipran used for?
From the label: indications and usageFETZIMA ® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )]. 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 ( 1 ). 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 ( 1 ).
Conditions named in the indications of levomilnacipran's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Serotonin and Norepinephrine Reuptake Inhibitor.
Source: FDA drug label (Fetzima), NDA204168 (Abbvie), as published by Allergan, Inc., effective April 30, 2024 (SPL set f371258d-91b3-4b6a-ac99-434a1964c3af), via openFDA; the full label on DailyMed
What does the patient leaflet for levomilnacipran say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about FETZIMA?FETZIMA may cause serious side effects, including: Increased risk of suicidal thoughts and actions. FETZIMA and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years and younger, especially within the first few months of treatment or when the dose is changed. FETZ IMA is not for use in children. Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider or get emergency medical help right away if you or your family member have any of the following symptoms, especially if the y are new, worse, or worry you: ● attempts to commit suicide ● acting on dangerous impulses ● acting aggressive, being angry or violent ● thoughts about suicide or dying ● new or worse depression ● new or worsening anxiety ● panic attacks ● feeling very agitated or restless ● new or worse irritability ● trouble sleeping ● an extreme increase in activity or talking (mania) ● other unusual changes in behavior or mood
From the patient leaflet: What should I avoid while taking FETZIMA?Do not drive, operate heavy machinery, or do other dangerous activities until you know how FETZIMA affects you. FETZIMA can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. Avoid drinking alcohol during treatment with FETZIMA.
From the patient leaflet: How should I store FETZIMA?Store FETZIMA at room temperature between 68°F to 77°F (20°C to 25°C). Keep FETZIMA and all medicines out of the reach of children.
Source: FDA drug label (Fetzima), NDA204168 (Abbvie), as published by Allergan, Inc., effective April 30, 2024 (SPL set f371258d-91b3-4b6a-ac99-434a1964c3af), via openFDA; the full label on DailyMed
Is there a generic for levomilnacipran (Fetzima)?
The FDA approved the first generic levomilnacipran on February 4, 2019. 4 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 3 patents for Fetzima capsules: the compound patent runs to May 23, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2019 first generic approved
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for levomilnacipran (Fetzima)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $17.61 per unit (Fetzima 20-40 mg titration pak), up 5% from $16.76 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Fetzima ER 120 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fetzima 20-40 mg titration pak | Brand | $17.61 per unit | n/a | +5% |
| Fetzima ER 120 mg capsule | Brand | $17.59 per capsule | $527.61 | +5% |
| Fetzima ER 20 mg capsule | Brand | $17.60 per capsule | $527.92 | +5% |
| Fetzima ER 40 mg capsule | Brand | $17.61 per capsule | $528.34 | +5% |
| Fetzima ER 80 mg capsule | Brand | $17.59 per capsule | $527.62 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the levomilnacipran label say about other medicines?
The levomilnacipran label names 18 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | drug interactions | 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. … initiated or discontinued [see Warnings and Precautions ( 5.5 )]. NSAIDs, aspirin, and warfarin Strong CYP3A4 Inhibitors |
| Buspirone | drug interactions | Clinical Impact: Concomitant use of FETZIMA with other serotonergic drugs increases the risk of serotonin syndrome. … other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort Drugs that Interfere with Hemostasis |
| Clarithromycin | drug interactions | Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of FETZIMA with strong CYP3A4 inhibitors increases levomilnacipran exposure. 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 |
| Fentanyl | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, and St. … |
| Isocarboxazid | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: Concomitant use of SSRIs and SNRIs including FETZIMA with MAOIs increases the risk of serotonin syndrome. … and Warnings and Precautions ()]. Examples: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Itraconazole | drug interactions | Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of FETZIMA with strong CYP3A4 inhibitors increases levomilnacipran exposure. 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 |
| Ketoconazole | drug interactions | Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of FETZIMA with strong CYP3A4 inhibitors increases levomilnacipran exposure. 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 |
| Linezolid | contraindications | 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 [see Dosage and Administration ( 2.6 ) and Warnings and Precautions ( 5.2 )]. |
| Lithium | drug interactions | Clinical Impact: Concomitant use of FETZIMA with other serotonergic drugs increases the risk of serotonin syndrome. … Examples: other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort Drugs that Interfere with Hemostasis |
| Meperidine | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, and St. … |
| Methadone | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, and St. … |
| Methylene blue | contraindications | 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 [see Dosage and Administration ( 2.6 ) and Warnings and Precautions ( 5.2 )]. |
| Milnacipran | contraindications | CONTRAINDICATIONS 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 … |
| Phenelzine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: Concomitant use of SSRIs and SNRIs including FETZIMA with MAOIs increases the risk of serotonin syndrome. … and Precautions ()]. Examples: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
Every other medicine the levomilnacipran label names
| Medicine named | Section | What the label says |
|---|---|---|
| Selegiline | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: Concomitant use of SSRIs and SNRIs including FETZIMA with MAOIs increases the risk of serotonin syndrome. … Administration (,), Contraindications (), and Warnings and Precautions ()]. Examples: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Tramadol | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone … |
| Tranylcypromine | drug interactions | Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: Concomitant use of SSRIs and SNRIs including FETZIMA with MAOIs increases the risk of serotonin syndrome. … Contraindications (), and Warnings and Precautions ()]. Examples: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Warfarin | drug interactions | 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. … discontinued [see Warnings and Precautions ( 5.5 )]. NSAIDs, aspirin, and warfarin Strong CYP3A4 Inhibitors |
Source: FDA drug label (Fetzima), NDA204168 (Abbvie), as published by Allergan, Inc., effective April 30, 2024 (SPL set f371258d-91b3-4b6a-ac99-434a1964c3af), via openFDA; the full label on DailyMed
What do FAERS reports show for levomilnacipran?
The FDA Adverse Event Reporting System holds 1,905 reports that list levomilnacipran among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 168 are coded as a death and 306 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as levomilnacipran?
30 other medicines are given the same way (oral) and in the same FDA class as levomilnacipran or labeled mainly for the same use (depression), the same class first. Depression lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Venlafaxine | Depression | 62 labelers | $0.0799 per capsule 75 mg capsule | No current entry |
| Duloxetine | Depression | 45 labelers | $0.102 per capsule 30 mg capsule | No current entry |
| Desvenlafaxine | Depression | 21 labelers | $0.396 per unit 50 mg | No current entry |
| Bupropion | Depression | 73 labelers | $0.0785 per tablet 150 mg tablet | No current entry |
| Aripiprazole | Depression | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Fluoxetine | Depression | 59 labelers | $0.0519 per capsule 40 mg capsule | No current entry |
| Sertraline | Depression | 48 labelers | $0.0507 per tablet 100 mg tablet | No current entry |
| Amitriptyline | Depression | 36 labelers | $0.03 per tablet 10 mg tablet | No current entry |
Every medicine labeled for the same conditions as levomilnacipran
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to levomilnacipran
- 30 medicines for the same use
- Other SNRIs
- the pharmacologic class, with prices and generics
- Levomilnacipran side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other