Drugs › Central nervous system stimulant
Brand name · Methylphenidate hydrochloride
Concerta: adverse event reports filed with FDA
10,834 reports list it as a suspect or interacting product, 2004–2026. Class: Central nervous system stimulant. Also reported as Concerta Xl, Concerta 36mg.
- 10,834
- reports as suspect product
- 0.1% of all reports · about 482 a year
- 281
- reports, 12 months to June 2026
- 617 in the 12 months before
- 65.2%
- marked serious by the reporter
- 45% across the class
- 2.4%
- record death among outcomes, as reported
- 261 reports · not verified by FDA
10,834 adverse event reports received by FDA list the brand name Concerta (methylphenidate hydrochloride) as a suspect or interacting product, from January 2004 to June 2026. A further 6,928 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 281 reports listed it, down 54% from 617 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 482 reports a year and 0.1% of the 20,646,523 reports in the database, and 9.9% of the reports for the central nervous system stimulant class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are drug ineffective (10.9%), off label use (4.7%) and headache (3.9%). A report can list several reactions, so shares add to more than 100%; 963 different terms appear across these reports. Drug ineffective is recorded in 10.9% of these reports, a smaller share than in the median central nervous system stimulant drug (17.8%).
65.2% of the reports are marked serious by the reporter (45% across the class); 2.4% record death among the outcomes and 19.8% record hospitalisation, as reported. 42.2% of the reports came from consumers, and the largest patient age group is 18 to 44 (15.5%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Concerta reports recording the termmedian drug in central nervous system stimulant
- Drug ineffectivethe medicine did not work as expected10.9%1,180
- Off label useused for a purpose or in a way not on the label4.7%505
- Headachehead pain3.9%421
- Insomniadifficulty sleeping3.9%421
- Anxietyanxiety3.7%406
- Product dose omission issuea dose was missed3.6%391
- Aggressionaggressive behaviour3.6%390
- Suicidal ideationthoughts of suicide3.6%389
- Decreased appetitereduced appetite3.6%386
- Depressionlow mood3%328
- Hospitalisationadmission to hospital2.9%317
- Product availability issuethe product was not available2.9%315
- Disturbance in attentiondifficulty concentrating2.9%313
- Drug dose omissiona dose was missed2.7%297
- Abnormal behaviourunusual behaviour2.6%283
- Nauseafeeling sick2.5%270
- Fatiguetiredness2.5%269
- Feeling abnormalfeeling odd or not right2.4%264
- Weight decreasedweight loss2.3%253
- Suicide attempta suicide attempt2.3%244
- Agitationrestlessness2.2%239
- Adverse eventan unwanted medical event, type not specified2.2%233
- Overdosea dose above the recommended amount2.2%233
- Intentional overdosea deliberate overdose2%217
- Somnolencedrowsiness1.9%211
- Tachycardiafast heart rate1.9%211
- Irritabilityirritability1.9%208
- Product substitution issuea problem after switching products1.9%202
- Palpitationsawareness of the heartbeat1.8%190
- Tic1.8%190
Top 30 of 963 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 50.4% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Attention deficit/hyperactivity disorder | 3,402 | 31.4% |
| Attention deficit hyperactivity disorder | 1,298 | 12% |
| Disturbance in attention | 100 | 0.9% |
| Narcolepsy | 53 | 0.5% |
| Psychomotor hyperactivity | 51 | 0.5% |
| Ill-defined disorder | 40 | 0.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 10,834 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Concerta reports |
|---|---|---|
| Ritalin | 494 | 4.6% |
| Risperdal | 320 | 3% |
| Methylphenidate hydrochloride | 290 | 2.7% |
| Adderall | 210 | 1.9% |
| Methylphenidate | 209 | 1.9% |
| Abilify | 176 | 1.6% |
| Strattera | 164 | 1.5% |
| Vyvanse | 138 | 1.3% |
| Risperidone | 134 | 1.2% |
| Clonidine | 120 | 1.1% |
Other products listed in reports where Concerta 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
| Measure | Concerta | Central nervous system stimulant | All reports |
|---|---|---|---|
| Reports as suspect product | 10,834 | 109,804 | 20,646,523 |
| Share of that pool | — | 9.9% | 0.1% |
| Reports, latest 12 months | 281 | — | 1,332,454 |
| Marked serious | 65.2% | 45% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 24 | 79 | 91 |
| Hospitalisation recorded, per 1,000 reports | 198 | 129 | 213 |
| Consumer-filed share | 42.2% | 57.1% | 45.8% |
| Top term, share of reports | Drug ineffective 10.9% | median 17.8% | 6.3% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Vyvanse | brand | 17,546 | 627 | 25.7% |
| Daytrana | brand | 13,703 | 54 | 5.6% |
| Adderall | brand | 10,074 | 622 | 38% |
| Methylphenidate | generic | 6,483 | 738 | 74.2% |
| Ritalin | brand | 6,147 | 175 | 75.2% |
| Methylphenidate hydrochloride | generic | 5,916 | 703 | 57.7% |
| Excedrin | brand | 5,530 | 47 | 27.5% |
| Excedrin Migraine | brand | 4,662 | 97 | 12.1% |
| Amphetamine | generic | 4,388 | 486 | 96.1% |
| Lisdexamfetamine dimesylate | generic | 4,300 | 713 | 73.1% |
| Caffeine | generic | 3,721 | 348 | 92.8% |
| Excedrin Extra Strength | brand | 3,242 | 53 | 30.1% |
| Quillivant | brand | 2,010 | 92 | 11.1% |
| Focalin | brand | 1,832 | 80 | 39.1% |
| Amphetamine sulfate | generic | 1,474 | 89 | 93.7% |
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.
Questions about Concerta reports
How many adverse event reports has FDA received for Concerta?
10,834 reports list Concerta as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 281 of them arrived in the latest 12 months. Another 6,928 list it only as a concomitant medication.
What reactions are recorded in Concerta reports?
drug ineffective (10.9%), off label use (4.7%), headache (3.9%), insomnia (3.9%) and anxiety (3.7%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Concerta was responsible.
How serious are the reports?
65.2% are marked serious by the reporter. Among the outcomes recorded, 2.4% of reports include death and 19.8% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (42.2%), physician (27.4%) and other health professional (14%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Concerta rising?
281 reports in the 12 months to June 2026, down 54% from 617 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Concerta was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Concerta?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 Concerta as a suspect or interacting product; reports listing it only as a concomitant medication (6,928) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.