Stratteraatomoxetine
According to the FDA label: Atomoxetine capsule is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( 1.1 ) 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsule is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
23,431 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Strattera in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 2,357 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Nausea 1,837 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fatigue 1,827 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Vomiting 1,462 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Headache 1,433 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Somnolence 1,357 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Dizziness 1,356 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Insomnia 1,242 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 1,224 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Feeling Abnormal 1,181 reports
A general report that the person did not feel like themselves, without a more specific description.
Full definition in the glossary →Depression 1,126 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →- Prescribed Overdose 1,115 reports
Abdominal Pain Upper 1,110 reports
Pain in the upper part of the belly, above the navel.
Full definition in the glossary →Anxiety 1,031 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Suicidal Ideation 1,003 reports
Thoughts of suicide. This term records that such thoughts were reported, and its presence does not establish that a medication was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 12,773 |
| Female | 9,181 |
| Unknown | 126 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 9,397 |
| 18-34 | 2,615 |
| 35-49 | 3,175 |
| 50-64 | 1,370 |
| 65-74 | 216 |
| 75+ | 86 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Strattera. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 14,292 |
| Other Serious | 7,047 |
| Hospitalization | 3,235 |
| Life-Threatening | 1,382 |
| Death | 1,367 |
| Disability | 1,259 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Strattera. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 5,235 |
| 2005 | 3,700 |
| 2006 | 579 |
| 2007 | 510 |
| 2008 | 415 |
| 2009 | 557 |
| 2010 | 398 |
| 2011 | 414 |
| 2012 | 474 |
| 2013 | 409 |
| 2014 | 534 |
| 2015 | 4,500 |
| 2016 | 808 |
| 2017 | 508 |
| 2018 | 416 |
| 2019 | 441 |
| 2020 | 355 |
| 2021 | 295 |
| 2022 | 366 |
| 2023 | 440 |
| 2024 | 724 |
| 2025 | 1,198 |
| 2026 (partial) | 155 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Strattera
In FDA adverse event reports that mention Strattera, these medications appeared most often in the same report.
- Lamotrigine (1,730 reports)
- Cetirizine (1,613 reports)
- Methylphenidate (1,576 reports)
- Acetaminophen (1,371 reports)
- Topiramate (1,330 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026