Daytrana: adverse event reports filed with FDA

13,703

reports as suspect product

0.1% of all reports · about 685 a year

54

reports, 12 months to June 2026

136 in the 12 months before

5.6%

marked serious by the reporter

45% across the class

0%

record death among outcomes, as reported

3 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 Daytrana reports recording the termmedian drug in central nervous system stimulant

1. No adverse eventno adverse event was reported49.5%6,789
2. Product quality issuea problem with the product itself37.4%5,129
3. Off label useused for a purpose or in a way not on the label37.1%5,086
4. Drug administration errora mistake in giving the medicine13.8%1,890
5. Wrong technique in drug usage processthe medicine was used in the wrong way12.9%1,766
6. Application site erythemaredness where the product was applied12.1%1,654
7. Drug ineffectivethe medicine did not work as expected10.6%1,451
8. Drug dose omissiona dose was missed10.2%1,402
9. Incorrect drug administration duration8.7%1,191
10. Drug prescribing errora prescribing mistake7.8%1,075
11. Wrong technique in product usage processthe product was used in the wrong way7%962
12. Product adhesion issue5.9%804
13. Application site pruritusitching where the product was applied5.8%798
14. Drug administered at inappropriate site4.9%677
15. Disturbance in attentiondifficulty concentrating4.9%671
16. Application site irritation4.6%635
17. Decreased appetitereduced appetite3.6%495
18. Disturbance in social behaviour3.2%444
19. Application site pain3.2%438
20. Psychomotor hyperactivity3%411
21. Device difficult to usethe device was hard to use2.8%389
22. Product administration errora mistake in giving the product2.8%381
23. Application site rash2.4%325
24. Device adhesion issue2.1%294
25. Abnormal behaviourunusual behaviour2.1%283
26. Aggressionaggressive behaviour1.9%255
27. Insomniadifficulty sleeping1.7%237
28. Device breakagethe device broke1.6%218
29. Prescribed overdose1.5%199
30. Therapy cessation1.4%194

Top 30 of 375 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 26 drugs in the central nervous system stimulant 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 109,804 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. 99.9% 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 13,703 reports.

Drugs most often listed in the same reports

Other products listed in reports where Daytrana 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 central nervous system stimulant 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 Daytrana as a suspect or interacting product; reports listing it only as a concomitant medication (288) 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.