Strattera: adverse event reports filed with FDA

15,826

reports as suspect product

0.1% of all reports · about 704 a year

82

reports, 12 months to June 2026

137 in the 12 months before

33.5%

marked serious by the reporter

43.9% across the class

1.5%

record death among outcomes, as reported

238 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 Strattera reports recording the termmedian drug in norepinephrine reuptake inhibitor

1. Drug ineffectivethe medicine did not work as expected8.4%1,324
2. Nauseafeeling sick6.6%1,039
3. Fatiguetiredness6.3%994
4. Somnolencedrowsiness6%955
5. Feeling abnormalfeeling odd or not right5.6%879
6. Suicidal ideationthoughts of suicide5.1%812
7. Headachehead pain4.9%772
8. Prescribed overdose4.9%770
9. Vomitingbeing sick4.8%763
10. Insomniadifficulty sleeping4.8%758
11. Aggressionaggressive behaviour4.7%748
12. Dizzinesslight-headedness or unsteadiness4.6%724
13. Abnormal behaviourunusual behaviour4.4%698
14. Anxietyanxiety4%636
15. Decreased appetitereduced appetite3.6%567
16. Depressionlow mood3.2%513
17. Disturbance in attentiondifficulty concentrating3.2%508
18. Irritabilityirritability3.1%496
19. Abdominal pain upperupper stomach pain3.1%494
20. Anger2.9%459
21. Weight decreasedweight loss2.9%456
22. Agitationrestlessness2.8%451
23. Cryingcrying2.5%400
24. Mood swingsmood swings2.4%378
25. Heart rate increaseda fast heart rate reading2.3%371
26. Psychomotor hyperactivity2.2%352
27. Weight increasedweight gain2.1%338
28. Off label useused for a purpose or in a way not on the label2.1%332
29. Dry mouthdry mouth2.1%326
30. Hyperhidrosisexcessive sweating2%314

Top 30 of 1,260 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. 51.3% 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 15,826 reports.

Drugs most often listed in the same reports

Other products listed in reports where Strattera 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 Strattera as a suspect or interacting product; reports listing it only as a concomitant medication (3,658) 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.