Quick answers
- What is Levomilnacipran hydrochloride used for?
- The FDA-approved label (Fetzima, Allergan, Inc., April 30, 2024) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Levomilnacipran hydrochloride have a boxed warning?
- Yes. The FDA label for Fetzima has a boxed warning (“WARNING: SUICIDAL THOUGHTS AND BEHAVIORS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Levomilnacipran hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Levomilnacipran hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Levomilnacipran hydrochloride?
- 1 company lists prescription products of Levomilnacipran hydrochloride in the FDA NDC Directory, including Allergan, Inc..
What Levomilnacipran hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Fetzima, Allergan, Inc., effective April 30, 2024. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
. Read it on the full label →
Forms and how it is given
| Dosage forms | Capsule, extended release |
|---|---|
| Route | Oral |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Fetzima |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| levomilnacipran hydrochloride 120 mg capsule, extended release | Brand: Fetzima | $17.59 per capsule |
| levomilnacipran hydrochloride 20 mg capsule, extended release | Brand: Fetzima | $17.60 per capsule |
| levomilnacipran hydrochloride 40 mg capsule, extended release | Brand: Fetzima | $17.60 per capsule |
| levomilnacipran hydrochloride 80 mg capsule, extended release | Brand: Fetzima | $17.59 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Allergan, Inc.4 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA204168 FETZIMA | Abbvie | July 25, 2013 | 10, latest April 19, 2024 2024: Labeling · 2023: Labeling · 2023: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fetzima, Allergan, Inc., effective April 30, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →