What the label lists and what reports show
Levomilnacipran side effects
Levomilnacipran's FDA label: “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 ).” FAERS holds 1,905 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (222 reports).
- No generic listed
- Boxed warning
Check it at the source: the levomilnacipran FDA label on DailyMed (effective April 30, 2024, Allergan, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of FETZIMA?FETZIMA may cause serious side effects, including: See “What is the most important information I should know about FETZIMA?” Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when FETZIMA is taken with certain other medicines. See “ Do not take FETZIMA if you. ” C all you r healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome: ○ agitation ○ seeing or hearing things that are not real (hallucinations) ○ confusion ○ coma ○ fast heartbeat ○ blood pressure changes ○ dizziness ○ sweating ○ flushing ○ high body temperature (hyperthermia) ○ tremors, stiff muscles, or muscle twitching ○ loss of coordination ○ seizures ○ nausea, vomiting, diarrhea High blood pressure (hypertension). […]
Source: FDA drug label, 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 label list?
From the label: adverse reactionsThe 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 ).
Table 3 Adverse Reactions Occurring in ≥ 2% of FETZIMA-treated Patients and at Least Twice the rate of Placebo-treated Patients in Pooled MDD Studies
| System Organ Class Preferred Term | Placebo (N =1040) % | FETZIMA 40 mg to 120 mg per day (N = 1583) % |
|---|---|---|
| Nausea | 6 | 17 |
| Constipation | 3 | 9 |
| Vomiting | 1 | 5 |
| Tachycardia a | 2 | 6 |
| Palpitations | 1 | 5 |
| Erectile dysfunction c | 1 | 6 |
| Testicular pain d | <1 | 4 |
| Ejaculation disorder e | <1 | 5 |
| Heart rate increased f | 1 | 6 |
| Blood pressure increased g | 1 | 3 |
| Urinary hesitation | 0 | 4 |
| Hyperhidrosis | 2 | 9 |
| Rash h | 0 | 2 |
| Hot flush | 1 | 3 |
| Hypotension i | 1 | 3 |
| Hypertension j | 1 | 3 |
| Decreased appetite | 1 | 3 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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. …
Source: FDA drug label, 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?
1,905 reports list levomilnacipran among the medicines taken, 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. Of the 19 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Levomilnacipran: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions