Drugs › Norepinephrine reuptake inhibitor
Generic name
Atomoxetine hydrochloride: adverse event reports filed with FDA
1,939 reports list it as a suspect or interacting product, 2004–2026. Class: Norepinephrine reuptake inhibitor. Also reported as Atomoxetine Hydrochloride Capsule, Atomoxetine Hydrochloride 40mg, Atomoxetine Hcl Capsules.
- 1,939
- reports as suspect product
- 0% of all reports · about 87 a year
- 629
- reports, 12 months to June 2026
- 543 in the 12 months before
- 92%
- marked serious by the reporter
- 43.9% across the class
- 56.2%
- record death among outcomes, as reported
- 1,090 reports · not verified by FDA
Between February 2004 and June 2026, 1,939 adverse event reports received by FDA list atomoxetine hydrochloride, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (568) are left out of every figure here.
In the 12 months to June 2026, 629 reports listed it, up 16% from 543 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 87 reports a year and 0% of the 20,646,523 reports in the database, and 9.1% of the reports for the norepinephrine reuptake inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded off label use (34%), drug ineffective (29.1%) and maternal exposure during pregnancy (28.3%). A report can list several reactions, so shares add to more than 100%; 474 different terms appear across these reports. Off label use is recorded in 34% of these reports, a larger share than in the median norepinephrine reuptake inhibitor drug (12.4%).
92% of the reports are marked serious by the reporter (43.9% across the class); 56.2% record death among the outcomes and 58.6% record hospitalisation, as reported. 63.6% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (53.9%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 hydrochloride reports recording the termmedian drug in norepinephrine reuptake inhibitor
- Off label useused for a purpose or in a way not on the label34%660
- Drug ineffectivethe medicine did not work as expected29.1%565
- Maternal exposure during pregnancythe mother took the medicine during pregnancy28.3%549
- Epilepsy27.5%533
- Confusional stateconfusion26.9%522
- Painpain, site not specified26.9%522
- Hypoaesthesianumbness26.8%519
- Psoriatic arthropathy26.5%513
- Abdominal pain upperupper stomach pain26.2%508
- Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease26%505
- Swellingswelling25.6%496
- Systemic lupus erythematosuslupus, an autoimmune disease25.5%495
- Type 2 diabetes mellitustype 2 diabetes25.5%495
- Pericarditisinflammation of the sac around the heart25.3%491
- Blepharospasm25.3%490
- Condition aggravatedthe condition being treated got worse24.6%477
- Pemphigus24.4%473
- Vomitingbeing sick24.1%467
- C-reactive protein increased23.7%460
- Memory impairmentmemory problems23.7%459
- Product use in unapproved indicationused for a purpose not on the label23.6%458
- Astheniaweakness or lack of energy23.5%455
- Gastrooesophageal reflux diseaseacid reflux23.5%455
- Facet joint syndrome23.4%454
- Wound23.3%452
- Rashskin rash23.2%450
- Infusion related reactiona reaction during or soon after an infusion23.1%447
- Synovitis22.9%444
- Arthropathy22.5%437
- Duodenal ulcer perforation22.4%435
Top 30 of 474 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 12% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Migraine | 923 | 47.6% |
| Attention deficit hyperactivity disorder | 190 | 9.8% |
| Attention deficit/hyperactivity disorder | 160 | 8.3% |
| Foetal exposure during pregnancy | 41 | 2.1% |
| Rheumatoid arthritis | 23 | 1.2% |
| Product use in unapproved indication | 6 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,939 reports.
In context
| Measure | Atomoxetine hydrochloride | Norepinephrine reuptake inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 1,939 | 21,234 | 20,646,523 |
| Share of that pool | — | 9.1% | 0% |
| Reports, latest 12 months | 629 | — | 1,332,454 |
| Marked serious | 92% | 43.9% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 562 | 101 | 91 |
| Hospitalisation recorded, per 1,000 reports | 586 | 169 | 213 |
| Consumer-filed share | 21.6% | 40% | 45.8% |
| Top term, share of reports | Off label use 34% | median 12.4% | 4.1% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Strattera | brand | 15,826 | 82 | 33.5% |
| Atomoxetine | generic | 2,334 | 373 | 81.4% |
| Qelbree | brand | 1,135 | 337 | 28.6% |
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.
Questions about Atomoxetine hydrochloride reports
How many adverse event reports has FDA received for Atomoxetine hydrochloride?
1,939 reports list Atomoxetine hydrochloride as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 629 of them arrived in the latest 12 months. Another 568 list it only as a concomitant medication.
What reactions are recorded in Atomoxetine hydrochloride reports?
off label use (34%), drug ineffective (29.1%), maternal exposure during pregnancy (28.3%), epilepsy (27.5%) and confusional state (26.9%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Atomoxetine hydrochloride was responsible.
How serious are the reports?
92% are marked serious by the reporter. Among the outcomes recorded, 56.2% of reports include death and 58.6% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (63.6%), consumer or non-health professional (21.6%) and physician (11.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Atomoxetine hydrochloride rising?
629 reports in the 12 months to June 2026, up 16% from 543 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Atomoxetine hydrochloride was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Atomoxetine hydrochloride?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (568) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.