Atomoxetine: adverse event reports filed with FDA

2,334

reports as suspect product

0% of all reports · about 107 a year

373

reports, 12 months to June 2026

597 in the 12 months before

81.4%

marked serious by the reporter

43.9% across the class

34.9%

record death among outcomes, as reported

814 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Atomoxetine reports recording the termmedian drug in norepinephrine reuptake inhibitor

1. Off label useused for a purpose or in a way not on the label22.6%527
2. Drug ineffectivethe medicine did not work as expected22%514
3. Drug intolerancethe medicine was not tolerated16.3%381
4. Hypertensionhigh blood pressure15.8%368
5. Condition aggravatedthe condition being treated got worse15.3%358
6. Maternal exposure during pregnancythe mother took the medicine during pregnancy15%349
7. Insomniadifficulty sleeping14.9%348
8. Headachehead pain14.6%341
9. Arthralgiajoint pain14.5%339
10. Nauseafeeling sick14.5%339
11. Abdominal discomfortstomach discomfort14.2%332
12. Hypoaesthesianumbness14.2%332
13. General physical health deteriorationgeneral decline in health14.1%329
14. Hepatic enzyme increasedraised liver enzymes14.1%329
15. Vomitingbeing sick14.1%329
16. Abdominal pain upperupper stomach pain14%327
17. Fatiguetiredness14%327
18. Glossodynia14%327
19. Alopeciahair loss13.8%322
20. Painpain, site not specified13.8%321
21. Anti-cyclic citrullinated peptide antibody positive13.7%320
22. Blood cholesterol increasedraised cholesterol13.7%320
23. Joint swellinga swollen joint13.6%318
24. Arthropathy13.5%316
25. Hand deformity13.5%316
26. Paraesthesiatingling or pins and needles13.3%310
27. Treatment failurethe treatment did not work13.2%309
28. Blepharospasm13.2%308
29. Nail disorder13.2%308
30. Epilepsy13%303

Top 30 of 601 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the norepinephrine reuptake inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 21,234 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 41.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 2,334 reports.

Drugs most often listed in the same reports

Other products listed in reports where Atomoxetine is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the norepinephrine reuptake inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Atomoxetine as a suspect or interacting product; reports listing it only as a concomitant medication (1,287) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.