Daytranamethylphenidate
According to the FDA label: Methylphenidate transdermal system is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.
28,180 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Daytrana 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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No Adverse Event 6,874 reports
A report that was filed but did not actually describe any adverse event. This is a record-keeping category.
Full definition in the glossary →Off Label Use 5,891 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 →Product Quality Issue 5,241 reports
A report of a possible problem with the medication's quality, such as appearance, packaging, or condition. This is a quality-tracking category.
Full definition in the glossary →Drug Ineffective 2,880 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 →Drug Administration Error 1,901 reports
A report that a medication was given or taken incorrectly in some way. This is a usage category.
Full definition in the glossary →- Wrong Technique In Drug Usage Process 1,772 reports
Application Site Erythema 1,684 reports
Redness of the skin where a medication was applied, such as under a patch or cream. Erythema means skin redness.
Full definition in the glossary →Drug Dose Omission 1,478 reports
A report that a dose of medication was missed or skipped.
Full definition in the glossary →Incorrect Drug Administration Duration 1,191 reports
A report that a medication was taken for a longer or shorter time than directed. This is a usage category.
Full definition in the glossary →Wrong Technique in Product Usage Process 1,132 reports
A report that the medication was used or administered with the wrong technique, such as an incorrect injection or inhaler method. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →- Drug Prescribing Error 1,079 reports
Disturbance in Attention 908 reports
Difficulty concentrating or staying focused.
Full definition in the glossary →Product Adhesion Issue 868 reports
A report that a medication meant to stick to the skin, such as a patch, did not adhere properly. This is a product-performance category.
Full definition in the glossary →Anxiety 845 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Fatigue 838 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →
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 | 12,082 |
| Female | 9,991 |
| Unknown | 304 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 6,648 |
| 18-34 | 2,533 |
| 35-49 | 2,072 |
| 50-64 | 1,627 |
| 65-74 | 600 |
| 75+ | 303 |
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 Daytrana. 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 | 17,664 |
| Other Serious | 7,742 |
| Hospitalization | 3,585 |
| Death | 1,091 |
| Life-Threatening | 541 |
| Disability | 387 |
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 Daytrana. 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 | 10 |
| 2005 | 24 |
| 2006 | 49 |
| 2007 | 97 |
| 2008 | 54 |
| 2009 | 79 |
| 2010 | 202 |
| 2011 | 1,877 |
| 2012 | 2,128 |
| 2013 | 2,081 |
| 2014 | 1,924 |
| 2015 | 1,950 |
| 2016 | 2,578 |
| 2017 | 3,505 |
| 2018 | 1,649 |
| 2019 | 1,355 |
| 2020 | 1,138 |
| 2021 | 1,234 |
| 2022 | 1,347 |
| 2023 | 1,537 |
| 2024 | 1,482 |
| 2025 | 1,539 |
| 2026 (partial) | 341 |
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 Daytrana
In FDA adverse event reports that mention Daytrana, these medications appeared most often in the same report.
- Oxybate (2,797 reports)
- Ergocalciferol (1,627 reports)
- Gabapentin (1,403 reports)
- Omeprazole (1,338 reports)
- Clonazepam (1,172 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