Ritalin: adverse event reports filed with FDA

6,147

reports as suspect product

0% of all reports · about 273 a year

175

reports, 12 months to June 2026

312 in the 12 months before

75.2%

marked serious by the reporter

45% across the class

3.5%

record death among outcomes, as reported

216 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 Ritalin reports recording the termmedian drug in central nervous system stimulant

1. Drug ineffectivethe medicine did not work as expected14.5%889
2. Anxietyanxiety7.4%455
3. Depressionlow mood6.2%383
4. Headachehead pain6.1%374
5. Fatiguetiredness5.4%332
6. Aggressionaggressive behaviour4.9%299
7. Feeling abnormalfeeling odd or not right4.9%299
8. Disturbance in attentiondifficulty concentrating4.8%296
9. Insomniadifficulty sleeping4.8%293
10. Somnolencedrowsiness4.5%275
11. Agitationrestlessness4.1%254
12. Nauseafeeling sick4.1%253
13. Drug dependencedependence on a medicine4%245
14. Decreased appetitereduced appetite3.9%241
15. Weight decreasedweight loss3.5%217
16. Suicidal ideationthoughts of suicide3.3%205
17. Malaisegeneral feeling of being unwell3.3%203
18. Abnormal behaviourunusual behaviour3.1%191
19. Tremorshaking3%182
20. Drug abusemisuse of a medicine2.9%177
21. Dizzinesslight-headedness or unsteadiness2.8%174
22. Irritabilityirritability2.6%159
23. Vomitingbeing sick2.3%143
24. Palpitationsawareness of the heartbeat2.3%140
25. Drug interactionan interaction between medicines2.2%134
26. Overdosea dose above the recommended amount2.1%132
27. Dyspnoeashortness of breath2.1%131
28. Off label useused for a purpose or in a way not on the label2.1%130
29. Tachycardiafast heart rate2.1%128
30. Painpain, site not specified2%126

Top 30 of 928 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. 40% 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 6,147 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ritalin 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 Ritalin as a suspect or interacting product; reports listing it only as a concomitant medication (13,384) 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.