Key points
- Major depressive disorder in adults is the one FDA-approved use.
- The label says it is not approved for fibromyalgia, and that its safety and effectiveness for fibromyalgia have not been established.
- It has specific warnings about raised heart rate and blood pressure, plus trouble starting to urinate.
- The boxed warning covers suicidal thoughts and behaviors in children, teens and young adults, and it is not approved for anyone under 18.
- It should not be stopped suddenly: talk with your prescriber first.
What levomilnacipran is
Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor (SNRI). The brand name is Fetzima, an extended-release capsule. It is related to milnacipran, a separate medicine, and the label says people allergic to levomilnacipran or milnacipran should not take it.
MedlinePlus lists milnacipran as its own medicine, and the Fetzima label speaks directly to fibromyalgia, as described below.
What it is approved for
The Food and Drug Administration (FDA) label lists one use: major depressive disorder in adults. It adds a limit in plain terms: Fetzima is not approved for managing fibromyalgia, and its safety and effectiveness for fibromyalgia have not been established.
It is not approved for children. The label reports that two studies in children and teens with depression did not show it worked better than placebo.
How it is thought to work
The label says the exact way levomilnacipran works against depression is unknown. It is thought to raise the activity of serotonin and norepinephrine, two brain chemicals, by blocking the transporters that clear them away. The norepinephrine effect is also why the label discusses urinary symptoms.
What taking levomilnacipran can be like
MedlinePlus says it may take several weeks or longer to feel the full benefit. The National Institute of Mental Health (NIMH) notes that people respond differently and that finding the right medicine can take several tries.
The label says the capsule is swallowed whole, not opened, chewed or crushed, and can be taken with or without food. It also limits use in people with kidney disease and says it is not recommended in end-stage kidney disease, so tell your prescriber about any kidney problems.
Notice your heartbeat and how you feel when you need to urinate, and report changes. A fast or pounding heartbeat and trouble urinating are both on the MedlinePlus list of problems to call about.
Do not stop levomilnacipran suddenly or without talking to your prescriber. The label says stopping, particularly abruptly, has been linked to irritability, agitation, dizziness, electric shock sensations, anxiety, confusion, headache and trouble sleeping, and that the dose should be reduced gradually whenever possible.
Side effects and warnings
Boxed warning: antidepressants increased the risk of suicidal thoughts and behaviors in children, teens and young adults in short-term studies. Everyone taking an antidepressant should be watched closely for worsening and for new suicidal thoughts. MedlinePlus says the risk may be more likely in the first few months and when a dose goes up. If you are in crisis, call or text 988 or call 911. Locascio Wellness does not provide emergency services, and our crisis resources page lists other options.
Dangerous combinations: the label does not allow levomilnacipran together with monoamine oxidase inhibitors (MAOIs) used for psychiatric conditions. It sets a gap of at least 7 days after levomilnacipran before an MAOI and at least 14 days after an MAOI before levomilnacipran, because of serotonin syndrome. It also should not be begun in someone being treated with linezolid or intravenous methylene blue. Other medicines raise serotonin syndrome risk too, including triptans, tramadol and St. John's wort.
The most commonly reported side effects on the label are nausea, constipation, sweating, increased heart rate, erection problems, ejaculation problems, fast heartbeat, vomiting and palpitations.
- Heart rate: the label says it should be measured before and during treatment, and existing fast heart rhythms and other heart disease should be treated first.
- Blood pressure: measure before and during treatment, and control existing high blood pressure first.
- Urinary hesitation or retention: the label advises caution in people prone to urinary blockage, so tell your prescriber about these symptoms.
- Bleeding: the risk may increase, especially with aspirin, anti-inflammatory pain relievers or warfarin.
- Also on the label: angle-closure glaucoma, mania or hypomania, seizures and low sodium.
Can levomilnacipran be managed online in Pennsylvania and New York
The label says Fetzima is not a controlled substance, and it describes no certified setting or restricted program. A video visit can cover symptoms and side effects, but heart rate and blood pressure need a real measurement, so ask how those checks would happen.
A licensed psychiatrist on our team, a Doctor of Osteopathic Medicine (DO), treats depression online by secure video, for people physically located in Pennsylvania or New York during each visit. Whether it is an option for you is a decision for you and your prescriber. Ask us whether our psychiatrist can help. Our guide to SSRIs and SNRIs for depression gives more background.
Our therapists do not prescribe. They see clients in Pennsylvania, West Virginia, Arizona, Colorado and Florida, not New York, so a New York reader can get psychiatry here but not therapy here. Ask us about fees and coverage.
Common questions
Is levomilnacipran used for fibromyalgia?
The label says no: Fetzima is not approved for managing fibromyalgia, and its safety and effectiveness for it have not been established. Milnacipran is a separate medicine with its own label. If fibromyalgia is part of your health picture, bring it up with your prescriber so that your treatment plan reflects all your conditions and medicines.
Why does my heart rate matter on levomilnacipran?
SNRIs, including Fetzima, have been linked to increased heart rate, and increased heart rate, fast heartbeat and palpitations are among its most commonly reported side effects. The label says heart rate should be measured before and during treatment. Tell your prescriber about any heart problems, and report a racing or pounding heartbeat right away.
Should I tell my prescriber if I am pregnant or breastfeeding?
Yes. Tell your prescriber if you are pregnant, planning a pregnancy or breastfeeding, and do not stop levomilnacipran on your own because of it. Your prescriber can go over what the label says about your situation. Share every medicine and supplement you take too, since some can interact with it.
Sources
Published by Locascio Wellness. Published November 5, 2026. Clinically reviewed by Kenneth M. Levy, DO, Psychiatrist (Pennsylvania license OS007464L). This page is general information, not medical advice or a diagnosis.