levomilnacipran Side Effects
Also known as: Fetzima
Analysis of 1,858 adverse event reports submitted to the FDA from 2013 to 2025.
Total Reports
1,858
Death-Related
154
8.3% of reports
Hospitalizations
283
15.2% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 154 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| OFF LABEL USE | 95 |
| MATERNAL EXPOSURE DURING PREGNANCY | 91 |
| CONDITION AGGRAVATED | 89 |
| OVERLAP SYNDROME | 73 |
| DRUG INEFFECTIVE | 30 |
| HYPOAESTHESIA | 29 |
| VOMITING | 29 |
| ABDOMINAL PAIN UPPER | 27 |
| DRUG INTOLERANCE | 27 |
| DEATH | 26 |
| MEMORY IMPAIRMENT | 26 |
| PARAESTHESIA | 26 |
| RHEUMATOID ARTHRITIS | 26 |
| STOMATITIS | 26 |
| EPILEPSY | 25 |
| GASTROOESOPHAGEAL REFLUX DISEASE | 25 |
| MIGRAINE | 25 |
| PAIN | 25 |
| PRODUCT USE IN UNAPPROVED INDICATION | 25 |
| RHEUMATOID FACTOR POSITIVE | 25 |
Reactions in Hospitalization Reports
Top reactions in 283 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INEFFECTIVE | 54 |
| VOMITING | 43 |
| OFF LABEL USE | 42 |
| PAIN | 39 |
| HYPOAESTHESIA | 38 |
| MEMORY IMPAIRMENT | 35 |
| CONDITION AGGRAVATED | 34 |
| HYPERTENSION | 33 |
| PARAESTHESIA | 33 |
| ABDOMINAL PAIN UPPER | 32 |
| CHEST PAIN | 32 |
| GASTROOESOPHAGEAL REFLUX DISEASE | 32 |
| DEPRESSION | 31 |
| DYSPNOEA | 31 |
| RASH | 31 |
| RHEUMATOID ARTHRITIS | 31 |
| DRUG INTOLERANCE | 30 |
| MIGRAINE | 30 |
| STOMATITIS | 30 |
| TASTE DISORDER | 30 |
Nearby — Related Medications
What the FAERS Data Reveals About levomilnacipran Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 1,858 voluntary reports linked to levomilnacipran and its brand equivalents (Fetzima), spanning 2013 through 2025. Of those, 154 (8.3%) listed death as an outcome and 283 (15.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 76% were female and 24% male; age distribution skews toward 18-44, with 469 reports in that bracket. The single most reported reaction is off label use with 327 submissions, followed by drug ineffective and pain.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.