Levomilnacipran: uses, dosing, side effects & brands
Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor sold in the U.S. under 2 brand and generic names, for major depressive disorder. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Serotonin and Norepinephrine Reuptake Inhibitor
- Treats (across its forms)
- Major Depressive Disorder
- Available as
- Capsule, extended release · Kit
- Sold as
- 2 products — Fetzima and Levomilnacipran Hydrochloride
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 12 hours
- Boxed warning
- Boxed warning
How levomilnacipran is dosed
From the FDA label for Fetzima (application NDA204168). Other levomilnacipran products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended dosage: 40 mg to 120 mg once daily with or without food ( 2.1 ). Initial dosage is 20 mg once daily for 2 days and then increase to 40 mg once daily ( 2.1 ). Based on clinical response and tolerability, increase dose in increments of 40 mg at intervals of 2 or more days ( 2.1 ). The maximum recommended dosage is 120 mg once daily ( 2.1 ). Take capsules whole; do not open, chew or crush ( 2.1 ) Renal impairment ( 2.3 ) : ○ 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 ( 2.4 ) 2.1 Recommended Dosage The recommended dosage range for FETZIMA is 40 mg to 120 mg once daily, with or without food. FETZIMA should be initiated at 20 mg once daily for 2 days and then increased to 40 mg once daily. Based on clinical response and tolerability, FETZIMA may be increased in increments of 40 mg at intervals of 2 or more days. The maximum recommended dosage is 120 mg once daily. Take FETZIMA at approximately the same time each day. Swallow FETZIMA whole; do not open, chew, or crush the capsule. 2.2 Screen for Bipolar Disorder Prior to Starting FETZIMA Prior to initiating treatment with FETZIMA or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings…
Levomilnacipran side effects
The following adverse reactions are discussed in greater detail in other sections of the label. Hypersensitivity [see Contraindications ( 4 )] Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] Elevated Blood Pressure [see Warnings and Precautions ( 5.3 )] Elevated Heart Rate [see Warnings and Precautions ( 5.4 )] Increased Risk of Bleeding [see Warnings and Precautions ( 5.5 )] Angle Closure Glaucoma [see Warnings and Precautions ( 5.6 )] Urinary Hesitation or Retention [see Warnings and Precautions ( 5.7 )] Activation of Mania/Hypomania [see Warnings and Precautions ( 5.8 )] Seizure [see Warnings and Precautions ( 5.9 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.10 )] Hyponatremia [see Warnings and Precautions ( 5.11 )] Sexual Dysfunction [see Warnings and Precautions ( 5.12 )] 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 ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse…
Who shouldn’t take levomilnacipran
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 [see Dosage and Administration ( 2.5 ) and Warnings and Precautions ( 5.2 )] . 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 )] . Hypersensitivity to levomilnacipran, milnacipran HCl, or any excipient in the FETZIMA formulation ( 4 ). Do not use MAOIs intended to treat psychiatric disorders with FETZIMA or within 7 days of stopping treatment with FETZIMA. Do not use FETZIMA within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start FETZIMA in a patient who is being treated with linezolid or intravenous methylene blue ( 4 ).
Levomilnacipran drug interactions
Strong CYP3A4 inhibitors : Maximum recommended dosage is 80 mg once daily ( 7 ). 7.1 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 [see Dosage and Administration ( 2.5 , 2.6 ), Contraindications ( 4 ), and Warnings and Precautions ( 5.2 )] . Examples: selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact: Concomitant use of FETZIMA with other serotonergic drugs increases the risk of serotonin syndrome. Intervention: Monitor for symptoms of serotonin syndrome when FETZIMA is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, immediately discontinue FETZIMA and/or concomitant serotonergic drugs [ see Dosage and Administration ( 2.5 , 2.6 ) , Contraindications ( 4 ) , and Warnings and Precautions ( 5.2 ) ] . Examples: other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort Drugs that Interfere with Hemostasis 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. Intervention: Closely monitor for bleeding for patients receiving an antiplatelet or anticoagulant drug when FETZIMA is initiated or discontinued [see Warnings and Precautions ( 5.5 )] . Examples: NSAIDs, aspirin, and warfarin Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of FETZIMA with strong CYP3A4 inhibitors increases levomilnacipran exposure [see Pharmacokinetics ( 12.3 )] . Intervention: The dose of FETZIMA should not exceed 80 mg once daily when used with strong CYP3A4 inhibitors [see Dosage and Administration ( 2.6 ). Examples: Ketoconazole, itraconazole, clarithromycin Alcohol Clinical Impact: Concomitant use of FETZIMA and alcohol may result in accelerated release of levomilnacipran. Intervention: Avoid concomitant use of FETZIMA and alcohol [see Clinical Pharmacology ( 12.3 )] .
Every levomilnacipran product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Capsule | No data | — | View → | |
| 2 | 72/100 | Prescription | Capsule | No data | — | View → |
What levomilnacipran pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Levomilnacipran and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for levomilnacipran: levels in milk, effects in breastfed infants, and the drugs it would consider insteadLevomilnacipran has not been studied in nursing mothers. However, the racemic form of milnacipran has low levels in breastmilk and would not be expected to cause any adverse effects in breastfed infants. Until more data become available, levomilnacipran should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Monitor breastfed infants for agitation, irritability, poor feeding and poor weight gain.
National Institute of Child Health and Human Development, record revised January 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about levomilnacipran
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 8 reports naming levomilnacipran, and the FDA flagged 75% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- fall2 reports
- alopecia1 reports
- amenorrhoea1 reports
- complication of device removal1 reports
- device issue1 reports
- encephalopathy1 reports
- foetal exposure during pregnancy1 reports
- hospitalisation1 reports
Read these as a signal, not a rate. A report does not mean levomilnacipran caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
How long levomilnacipran stays in your system
The elimination half-life of levomilnacipran is about 12 hours. This is the apparent terminal elimination half-life of the parent drug; the label reports no separate distribution/terminal split. Levomilnacipran (the active enantiomer of milnacipran, marketed as Fetzima extended-release) is metabolized to desethyl levomilnacipran and p-hydroxy levomilnacipran, but the label states these metabolites are INACTIVE, so no active metabolite outlasts the parent. Populations: the label recommends NO dose adjustment based on age (older adults) and NO dose adjustment for mild, moderate, or severe HEPATIC impairment, implying no clinically meaningful change in half-life there. RENAL function is the key factor — renal excretion predominates (about 58% excreted unchanged in urine), so exposure rises with declining kidney function: the maximum dose is capped at 80 mg/day in moderate and 40 mg/day in severe renal impairment, and the drug is not recommended in end-stage renal disease. The label does not give explicit per-population half-life numbers.
Fetzima (levomilnacipran) FDA label — DailyMed, §12.3 Pharmacokinetics ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is levomilnacipran?
Fetzima (Levomilnacipran Hydrochloride) is a serotonin and norepinephrine reuptake inhibitor used to treat Major Depressive Disorder.
What kind of drug is levomilnacipran?
The FDA classifies levomilnacipran as a serotonin and norepinephrine reuptake inhibitor. SNRIs slow the reabsorption of two brain chemicals, serotonin and norepinephrine, back into nerve cells. This leaves more of both available in the gaps between neurons to keep signaling, which can improve mood, anxiety, and certain types of chronic pain. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does levomilnacipran stay in your system?
The elimination half-life of levomilnacipran is about 12 hours — that is how long the body takes to clear half of a dose. This is the apparent terminal elimination half-life of the parent drug; the label reports no separate distribution/terminal split. Levomilnacipran (the active enantiomer of milnacipran, marketed as Fetzima extended-release) is metabolized to desethyl levomilnacipran and p-hydroxy levomilnacipran, but the label states these metabolites are INACTIVE, so no active metabolite outlasts the parent. Populations: the label recommends NO dose adjustment based on age (older adults) and NO dose adjustment for mild, moderate, or severe HEPATIC impairment, implying no clinically meaningful change in half-life there. RENAL function is the key factor — renal excretion predominates (about 58% excreted unchanged in urine), so exposure rises with declining kidney function: the maximum dose is capped at 80 mg/day in moderate and 40 mg/day in severe renal impairment, and the drug is not recommended in end-stage renal disease. The label does not give explicit per-population half-life numbers. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take levomilnacipran with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run levomilnacipran against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is levomilnacipran sold under?
We track 2 levomilnacipran-containing products in the U.S.: Fetzima and Levomilnacipran Hydrochloride. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does levomilnacipran come in?
Across the brands we track, levomilnacipran is currently marketed as capsule, extended release and kit, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic levomilnacipran?
Yes. Our catalog lists 1 generic levomilnacipran product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Levomilnacipran: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/levomilnacipran
- MLA
- “Levomilnacipran: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/levomilnacipran.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for levomilnacipran on DailyMed (NIH) ↗ — including its boxed warning in full.