Methylphenidate adverse event reports that FDA received

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

Name type: Generic name
Class: Central nervous system stimulant
Also reported as: Methylphenidate Sr, Methylphenidate Er, Methylphenidate Er 36mg

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 April 2004 to June 2026, FDA received 6,483 adverse event reports that name Methylphenidate. In these reports the drug is a suspect or interacting product.

In the same period, 9,090 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 738 reports in the 12 months to June 2026 and 822 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, 738 (0.1%) name Methylphenidate. Reports from consumers or other non-health professionals were 27.8% of the reports that name Methylphenidate 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 Methylphenidate 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 264 reports that name Methylphenidate.
In January to March 2026, FDA received 164.
In April to June 2025, FDA received 288.

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 534 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 6,342 of the 6,483 reports (97.8%).

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 534 terms.

Reaction terms in the reports that name Methylphenidate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 6,483 reports
Drug ineffectivethe medicine did not work as expected	1,003	15.5%
Product substitution issuea problem after switching products	597	9.2%
Toxicity to various agentspoisoning or toxic effect of one or more substances	567	8.7%
Off label useused for a purpose or in a way not on the label	362	5.6%
Drug abusemisuse of a medicine	357	5.5%
Anxiety	321	5%
Drug interactionan interaction between medicines	284	4.4%
Agitationrestlessness	272	4.2%
Headachehead pain	271	4.2%
Aggressionaggressive behaviour	268	4.1%
Completed suicidedeath by suicide	264	4.1%
Tachycardiafast heart rate	247	3.8%
Insomniadifficulty sleeping	222	3.4%
Disturbance in attentiondifficulty concentrating	211	3.3%
Somnolencedrowsiness	211	3.3%
Irritability	209	3.2%
Overdosea dose above the recommended amount	209	3.2%
Condition aggravatedthe condition being treated got worse	194	3%
Hypertensionhigh blood pressure	193	3%
Suicidal ideationthoughts of suicide	188	2.9%
Nauseafeeling sick	187	2.9%
Fatiguetiredness	169	2.6%
Intentional overdosea deliberate overdose	163	2.5%
Depressionlow mood	159	2.5%
Decreased appetitereduced appetite	155	2.4%
Abnormal behaviourunusual behaviour	135	2.1%
Drug dependencedependence on a medicine	133	2.1%
Vomitingbeing sick	133	2.1%
Product quality issuea problem with the product itself	121	1.9%
Suicide attempta suicide attempt	120	1.9%
Feeling abnormalfeeling odd or not right	119	1.8%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	114	1.8%
Dizzinesslight-headedness or unsteadiness	113	1.7%
Confusional stateconfusion	109	1.7%
Tremorshaking	107	1.7%
Cardio-respiratory arrestthe heart and breathing stopped	101	1.6%
Hallucinationseeing or hearing things that are not there	100	1.5%
Intentional product misusedeliberate use not as intended	98	1.5%
Treatment failurethe treatment did not work	96	1.5%
Depressed moodlow mood	95	1.5%
Anger	89	1.4%
Deaththe patient died; cause not stated by this term	86	1.3%
Palpitationsawareness of the heartbeat	86	1.3%
Psychomotor hyperactivity	86	1.3%
Dyskinesiainvoluntary movements	85	1.3%
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor	85	1.3%
Weight decreasedweight loss	85	1.3%
Poisoning	84	1.3%
Product adhesion issue	84	1.3%
Drug effect decreasedthe medicine had less effect	83	1.3%

Download all 534 terms of Methylphenidate (CSV)

The counts add to more than 6,483 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 (this page)	Generic name	6,483
Methylphenidate hydrochloride	Generic name	5,916
Concerta	Brand name	10,834
Daytrana	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 Methylphenidate, 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
2004	4	4	3	1	1	0	0	0	0
2005	15	15	2	0	6	0	0	12	0
2006	5	4	0	0	3	0	0	1	1
2007	3	2	0	0	1	0	0	1	1
2008	5	3	0	0	1	0	0	2	2
2009	6	5	2	0	0	0	0	3	1
2010	93	90	43	4	25	1	0	33	3
2011	120	107	37	4	21	2	0	55	13
2012	127	107	19	8	25	2	0	72	20
2013	298	218	60	8	27	17	4	146	80
2014	288	217	36	12	37	21	0	151	71
2015	224	141	32	12	41	4	0	78	83
2016	166	107	21	7	35	4	1	66	59
2017	521	443	78	12	256	16	2	190	78
2018	366	244	29	5	70	16	5	166	122
2019	326	258	31	16	111	10	11	173	68
2020	312	244	40	10	101	4	15	148	68
2021	357	297	42	20	116	11	15	215	60
2022	476	379	36	31	138	10	14	283	97
2023	693	476	63	36	121	33	5	373	217
2024	721	537	92	48	183	21	8	392	184
2025	867	546	71	34	221	11	21	422	321
2026	490	364	32	46	82	16	12	307	126

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 Methylphenidate, 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 Methylphenidate, by the year in which FDA received them
Year	Reports
2004	4
2005	16
2006	6
2007	4
2008	5
2009	8
2010	88
2011	118
2012	153
2013	297
2014	284
2015	247
2016	182
2017	515
2018	376
2019	349
2020	323
2021	369
2022	516
2023	703
2024	695
2025	797
2026	428

Reports that name Methylphenidate, 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 Methylphenidate
Age	Reports	Share
Under 2	63	1%
2 to 11	1,049	16.2%
12 to 17	939	14.5%
18 to 44	1,915	29.5%
45 to 64	586	9%
65 to 74	89	1.4%
75 and over	55	0.8%
Age not given	1,787	27.6%

Sex of the patient in the reports that name Methylphenidate
Sex	Reports	Share
Female	2,385	36.8%
Male	3,280	50.6%
Unknown or not given	818	12.6%

Type of reporter in the reports that name Methylphenidate
Reporter	Reports	Share
Physician	1,682	25.9%
Pharmacist	380	5.9%
Other health professional	2,212	34.1%
Lawyer	19	0.3%
Consumer or non-health professional	1,804	27.8%
Not given	386	6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 51.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Methylphenidate record
Indication as recorded (MedDRA)	Reports	Share
Attention deficit hyperactivity disorder	1,514	23.4%
Attention deficit/hyperactivity disorder	972	15%
Narcolepsy	84	1.3%
Autism spectrum disorder	63	1%
Depression	56	0.9%
Disturbance in attention	35	0.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 6,483 reports.

Drugs in the same reports

Other drugs that the reports of Methylphenidate name, in any role, in order of name
Drug	Reports that name the two
Aripiprazole	397
Clonazepam	347
Concerta	203
Diazepam	211
Fluoxetine	245
Olanzapine	199
Pregabalin	264
Quetiapine	370
Risperidone	399
Sertraline	293

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 hydrochloride same ingredient
Concerta same ingredient
Daytrana same ingredient
Jornay Pm same ingredient
Methylin same ingredient
QuilliChew ER same ingredient
Methylphenidate hcl same class
Lisdexamfetamine dimesylate same class
Lisdexamfetamine same class
Midol same class
Methylenedioxymethamphetamine next in the A to Z list
Methylene blue 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 MethylphenidateThe 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.

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Reported Reactions. Methylphenidate: adverse event reports that FDA received. https://reportedreactions.com/drug/methylphenidate/ 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 Methylphenidate as a suspect or interacting product. The 9,090 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 Methylphenidate 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 Methylphenidate?

No. It is a count of what people reported to FDA: 6,483 reports from April 2004 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?

Other health professional (34.1%), consumer or non-health professional (27.8%) and physician (25.9%). 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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