atomoxetine Side Effects
Also known as: Strattera
Analysis of 3,228 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
3,228
Death-Related
879
27.2% of reports
Hospitalizations
1,203
37.3% 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 879 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| OFF LABEL USE | 398 |
| ARTHRALGIA | 327 |
| GLOSSODYNIA | 325 |
| HYPERTENSION | 325 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 324 |
| HEPATIC ENZYME INCREASED | 324 |
| ABDOMINAL DISCOMFORT | 319 |
| ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE | 317 |
| BLOOD CHOLESTEROL INCREASED | 317 |
| DRUG INTOLERANCE | 317 |
| ALOPECIA | 314 |
| ARTHROPATHY | 314 |
| HAND DEFORMITY | 313 |
| JOINT SWELLING | 312 |
| NAIL DISORDER | 308 |
| CONDITION AGGRAVATED | 293 |
| MATERNAL EXPOSURE DURING PREGNANCY | 290 |
| NAUSEA | 271 |
| PEMPHIGUS | 271 |
| INFUSION RELATED REACTION | 270 |
Reactions in Hospitalization Reports
Top reactions in 1,203 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| OFF LABEL USE | 450 |
| CONDITION AGGRAVATED | 317 |
| HYPERTENSION | 311 |
| HEPATIC ENZYME INCREASED | 308 |
| HEADACHE | 303 |
| ARTHRALGIA | 300 |
| BLOOD CHOLESTEROL INCREASED | 299 |
| ABDOMINAL DISCOMFORT | 298 |
| DRUG INTOLERANCE | 298 |
| ALOPECIA | 295 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 295 |
| GLOSSODYNIA | 294 |
| ARTHROPATHY | 293 |
| DRUG INEFFECTIVE | 293 |
| FATIGUE | 293 |
| INSOMNIA | 293 |
| JOINT SWELLING | 293 |
| GASTROINTESTINAL DISORDER | 292 |
| HAND DEFORMITY | 292 |
| ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE | 288 |
Nearby — Related Medications
What the FAERS Data Reveals About atomoxetine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 3,228 voluntary reports linked to atomoxetine and its brand equivalents (Strattera), spanning 2004 through 2025. Of those, 879 (27.2%) listed death as an outcome and 1,203 (37.3%) 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, 57% were female and 39% male; age distribution skews toward 18-44, with 1,400 reports in that bracket. The single most reported reaction is drug ineffective with 606 submissions, followed by off label use and nausea.
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.