Drugs › Central nervous system stimulant
Generic name
Methylphenidate hcl: adverse event reports filed with FDA
846 reports list it as a suspect or interacting product, 2004–2017. Class: Central nervous system stimulant.
- 846
- reports as suspect product
- 0% of all reports · about 38 a year
- 0
- reports, 12 months to June 2026
- 0 in the 12 months before
- 76.2%
- marked serious by the reporter
- 45% across the class
- 9.5%
- record death among outcomes, as reported
- 80 reports · not verified by FDA
846 adverse event reports received by FDA list methylphenidate hcl, a generic name as a suspect or interacting product, from January 2004 to September 2017. A further 554 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, 0 reports listed it, and none 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 38 reports a year and 0% of the 20,646,523 reports in the database, and 0.8% 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 reactions recorded most often are drug ineffective (10.2%), completed suicide (4.5%) and tic (4.5%). A report can list several reactions, so shares add to more than 100%; 262 different terms appear across these reports. Drug ineffective is recorded in 10.2% of these reports, a smaller share than in the median central nervous system stimulant drug (17.8%).
76.2% of the reports are marked serious by the reporter (45% across the class); 9.5% record death among the outcomes and 20.1% record hospitalisation, as reported. 28.8% of the reports came from other health professionals, and the largest patient age group is 2 to 11 (23.2%). 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
No report listing Methylphenidate hcl was received in the five years to June 2026; the latest was received in September 2017.
By year received
Reactions recorded in the reports
share of Methylphenidate hcl reports recording the termmedian drug in central nervous system stimulant
- Drug ineffectivethe medicine did not work as expected10.2%86
- Completed suicidedeath by suicide4.5%38
- Tic4.5%38
- Anxietyanxiety4.4%37
- Aggressionaggressive behaviour4.3%36
- Abnormal behaviourunusual behaviour4%34
- Headachehead pain4%34
- Insomniadifficulty sleeping3.9%33
- Agitationrestlessness3.5%30
- Drug effect decreasedthe medicine had less effect3.4%29
- Drug interactionan interaction between medicines3.4%29
- Cardiac arrestthe heart stopped3.2%27
- Intentional overdosea deliberate overdose3.2%27
- Fatiguetiredness3.1%26
- Vomitingbeing sick3%25
- Disturbance in attentiondifficulty concentrating2.8%24
- Irritabilityirritability2.6%22
- Suicide attempta suicide attempt2.6%22
- Hyperhidrosisexcessive sweating2.5%21
- Product substitution issuea problem after switching products2.5%21
- Decreased appetitereduced appetite2.4%20
- Dizzinesslight-headedness or unsteadiness2.4%20
- Palpitationsawareness of the heartbeat2.2%19
- Incorrect dose administeredthe wrong dose was given2.1%18
- Nauseafeeling sick2.1%18
- Heart rate increaseda fast heart rate reading2%17
- Suicidal ideationthoughts of suicide2%17
- Therapeutic response unexpected with drug substitution2%17
- Hypotensionlow blood pressure1.9%16
Top 30 of 262 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. 48.8% 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 | 390 | 46.1% |
| Ill-defined disorder | 24 | 2.8% |
| Depression | 11 | 1.3% |
| Psychomotor hyperactivity | 7 | 0.8% |
| Disturbance in attention | 4 | 0.5% |
| Major depression | 4 | 0.5% |
The indication field is filled in by the reporter and is often blank; shares are of all 846 reports.
In context
| Measure | Methylphenidate hcl | Central nervous system stimulant | All reports |
|---|---|---|---|
| Reports as suspect product | 846 | 109,804 | 20,646,523 |
| Share of that pool | — | 0.8% | 0% |
| Reports, latest 12 months | 0 | — | 1,332,454 |
| Marked serious | 76.2% | 45% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 95 | 79 | 91 |
| Hospitalisation recorded, per 1,000 reports | 201 | 129 | 213 |
| Consumer-filed share | 23.5% | 57.1% | 45.8% |
| Top term, share of reports | Drug ineffective 10.2% | 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% |
| Concerta | brand | 10,834 | 281 | 65.2% |
| 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% |
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 Methylphenidate hcl reports
How many adverse event reports has FDA received for Methylphenidate hcl?
846 reports list Methylphenidate hcl as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 554 list it only as a concomitant medication.
What reactions are recorded in Methylphenidate hcl reports?
drug ineffective (10.2%), completed suicide (4.5%), tic (4.5%), anxiety (4.4%) and aggression (4.3%). 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 Methylphenidate hcl was responsible.
How serious are the reports?
76.2% are marked serious by the reporter. Among the outcomes recorded, 9.5% of reports include death and 20.1% 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?
other health professional (28.8%), physician (23.5%) and consumer or non-health professional (23.5%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Methylphenidate hcl rising?
0 reports in the 12 months to June 2026, and none 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 Methylphenidate hcl 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 Methylphenidate hcl?
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 Methylphenidate hcl as a suspect or interacting product; reports listing it only as a concomitant medication (554) 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.