Methylphenidate hydrochloride: adverse event reports filed with FDA

5,916

reports as suspect product

0% of all reports · about 305 a year

703

reports, 12 months to June 2026

524 in the 12 months before

57.7%

marked serious by the reporter

45% across the class

6.7%

record death among outcomes, as reported

395 reports · not verified by FDA

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 Methylphenidate hydrochloride reports recording the termmedian drug in central nervous system stimulant

1. Drug ineffectivethe medicine did not work as expected19.9%1,178
2. Headachehead pain5.9%347
3. Anxietyanxiety5.7%339
4. Toxicity to various agentspoisoning or toxic effect of one or more substances5.1%302
5. Product substitution issuea problem after switching products4.9%289
6. Drug abusemisuse of a medicine4.7%278
7. Disturbance in attentiondifficulty concentrating4.2%247
8. Nauseafeeling sick4%236
9. Fatiguetiredness3.9%231
10. Insomniadifficulty sleeping3.9%231
11. Off label useused for a purpose or in a way not on the label3.8%225
12. Somnolencedrowsiness3.8%223
13. Agitationrestlessness3.7%217
14. Aggressionaggressive behaviour3.3%193
15. Decreased appetitereduced appetite3.2%192
16. Suicidal ideationthoughts of suicide3.2%192
17. Feeling abnormalfeeling odd or not right3%175
18. Irritabilityirritability2.9%173
19. Drug interactionan interaction between medicines2.9%169
20. Dizzinesslight-headedness or unsteadiness2.7%157
21. Tachycardiafast heart rate2.6%156
22. Depressionlow mood2.6%154
23. Palpitationsawareness of the heartbeat2.4%141
24. Intentional product misusedeliberate use not as intended2.2%133
25. Overdosea dose above the recommended amount2.2%131
26. Completed suicidedeath by suicide2.2%130
27. Drug dependencedependence on a medicine2.2%129
28. Hospitalisationadmission to hospital2.1%125
29. Hypertensionhigh blood pressure2.1%122
30. Abnormal behaviourunusual behaviour2%121

Top 30 of 848 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 58.1% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 5,916 reports.

Drugs most often listed in the same reports

Other products listed in reports where Methylphenidate hydrochloride 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

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

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.

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 hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (1,609) 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.