Daytrana (methylphenidate) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Daytrana
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Methylphenidate
Class: Central nervous system stimulant
Also reported as: Daytrana Patch

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From July 2006 to June 2026, FDA received 13,703 adverse event reports that name Daytrana. In these reports the drug is a suspect or interacting product.

In the same period, 288 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 54 reports in the 12 months to June 2026 and 136 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 54 (under 0.1%) name Daytrana. Reports from consumers or other non-health professionals were 85.7% of the reports that name Daytrana and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Daytrana is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 43 reports that name Daytrana.
In January to March 2026, FDA received 4.
In April to June 2025, FDA received 95.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 241 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 13,701 of the 13,703 reports (99.9%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 241 terms.

Reaction terms in the reports that name Daytrana, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 13,703 reports
No adverse eventno adverse event was reported	6,789	49.5%
Product quality issuea problem with the product itself	5,129	37.4%
Off label useused for a purpose or in a way not on the label	5,086	37.1%
Drug administration errora mistake in giving the medicine	1,890	13.8%
Wrong technique in drug usage processthe medicine was used in the wrong way	1,766	12.9%
Application site erythemaredness where the product was applied	1,654	12.1%
Drug ineffectivethe medicine did not work as expected	1,451	10.6%
Drug dose omissiona dose was missed	1,402	10.2%
Incorrect drug administration duration	1,191	8.7%
Drug prescribing errora prescribing mistake	1,075	7.8%
Wrong technique in product usage processthe product was used in the wrong way	962	7%
Product adhesion issue	804	5.9%
Application site pruritusitching where the product was applied	798	5.8%
Drug administered at inappropriate site	677	4.9%
Disturbance in attentiondifficulty concentrating	671	4.9%
Application site irritation	635	4.6%
Decreased appetitereduced appetite	495	3.6%
Disturbance in social behaviour	444	3.2%
Application site pain	438	3.2%
Psychomotor hyperactivity	411	3%
Device difficult to usethe device was hard to use	389	2.8%
Product administration errora mistake in giving the product	381	2.8%
Application site rash	325	2.4%
Device adhesion issue	294	2.1%
Abnormal behaviourunusual behaviour	283	2.1%
Aggressionaggressive behaviour	255	1.9%
Insomniadifficulty sleeping	237	1.7%
Device breakagethe device broke	218	1.6%
Prescribed overdose	199	1.5%
Therapy cessation	194	1.4%
Drug effect decreasedthe medicine had less effect	176	1.3%
Accidental exposure to product	164	1.2%
Application site swelling	163	1.2%
Device issuea problem with the device	160	1.2%
Headachehead pain	160	1.2%
Overdosea dose above the recommended amount	148	1.1%
Product administered at inappropriate site	148	1.1%
Educational problem	146	1.1%
Weight decreasedweight loss	138	1%
Application site urticaria	136	1%
Anxiety	135	1%
Adhesive tape use	122	0.9%
Therapeutic product ineffective	119	0.9%
Incorrect storage of drug	117	0.9%
Drug effect delayed	112	0.8%
Tic	109	0.8%
Application site discolouration	106	0.8%
Agitationrestlessness	103	0.8%
Irritability	100	0.7%
Application site vesicles	97	0.7%

Download all 241 terms of Daytrana (CSV)

The counts add to more than 13,703 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Methylphenidate with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Methylphenidate	Generic name	6,483
Methylphenidate hydrochloride	Generic name	5,916
Concerta	Brand name	10,834
Daytrana (this page)	Brand name	13,703
Jornay Pm	Brand name	496
Methylin	Brand name	355
QuilliChew ER	Brand name	439
Quillivant	Brand name	2,010
Ritalin	Brand name	6,147

Sum of the separately reported names: 46,383. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Daytrana, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2006	46	40	2	0	4	0	0	35	6
2007	84	67	0	0	14	2	0	51	17
2008	45	35	0	1	8	2	1	26	10
2009	43	35	0	0	11	5	0	22	8
2010	1,064	30	0	1	13	2	0	16	1,034
2011	1,931	10	0	0	3	0	0	7	1,921
2012	485	11	0	1	6	1	0	8	474
2013	1,644	24	0	2	6	5	0	18	1,620
2014	1,467	13	1	0	2	1	0	10	1,454
2015	1,144	32	0	1	6	7	0	25	1,112
2016	906	23	0	0	4	1	0	18	883
2017	2,511	33	0	0	5	0	0	30	2,478
2018	655	7	0	1	2	2	0	6	648
2019	330	5	0	0	0	1	0	5	325
2020	229	11	0	1	1	1	0	11	218
2021	184	170	0	1	1	0	0	169	14
2022	304	141	0	0	2	0	0	140	163
2023	212	66	0	0	3	0	0	63	146
2024	226	6	0	0	2	0	0	5	220
2025	141	13	0	0	4	0	0	11	128
2026	52	0	0	0	0	0	0	0	52

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Daytrana, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Daytrana, by the year in which FDA received them
Year	Reports
2006	40
2007	87
2008	45
2009	43
2010	33
2011	1,646
2012	1,830
2013	1,656
2014	1,500
2015	1,182
2016	1,015
2017	2,393
2018	613
2019	289
2020	215
2021	369
2022	260
2023	197
2024	111
2025	132
2026	47

Reports that name Daytrana, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Daytrana
Age	Reports	Share
Under 2	5	under 0.1%
2 to 11	2,903	21.2%
12 to 17	976	7.1%
18 to 44	452	3.3%
45 to 64	153	1.1%
65 to 74	18	0.1%
75 and over	7	0.1%
Age not given	9,189	67.1%

Sex of the patient in the reports that name Daytrana
Sex	Reports	Share
Female	2,722	19.9%
Male	6,109	44.6%
Unknown or not given	4,872	35.6%

Type of reporter in the reports that name Daytrana
Reporter	Reports	Share
Physician	651	4.8%
Pharmacist	723	5.3%
Other health professional	452	3.3%
Lawyer	10	0.1%
Consumer or non-health professional	11,749	85.7%
Not given	118	0.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 99.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Daytrana record
Indication as recorded (MedDRA)	Reports	Share
Attention deficit/hyperactivity disorder	7,335	53.5%
Attention deficit hyperactivity disorder	987	7.2%
Disturbance in attention	54	0.4%
Autism	48	0.4%
Narcolepsy	40	0.3%
Autism spectrum disorder	28	0.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 13,703 reports.

Drugs in the same reports

Other drugs that the reports of Daytrana name, in any role, in order of name
Drug	Reports that name the two
Abilify	125
Adderall	131
Clonidine	292
Intuniv	226
Melatonin	147
Methylphenidate	137
Ritalin	240
Singulair	133
Zoloft	137
Zyrtec	121

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Methylphenidate same ingredient
Methylphenidate hydrochloride same ingredient
Concerta same ingredient
Jornay Pm same ingredient
Methylin same ingredient
QuilliChew ER same ingredient
Dexmethylphenidate hydrochloride same class
Caffeine citrate same class
Dextroamphetamine same class
Caffeine same class
Dextroamphetamine sulfate same class
Daypro next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for DaytranaThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Daytrana: adverse event reports that FDA received. https://reportedreactions.com/drug/daytrana/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Daytrana as a suspect or interacting product. The 288 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Daytrana was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Daytrana?

No. It is a count of what people reported to FDA: 13,703 reports from July 2006 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (85.7%), pharmacist (5.3%) and physician (4.8%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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