Lisdexamfetamine dimesylate: adverse event reports filed with FDA

4,300

reports as suspect product

0% of all reports · about 229 a year

713

reports, 12 months to June 2026

1,080 in the 12 months before

73.1%

marked serious by the reporter

45% across the class

1.3%

record death among outcomes, as reported

56 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 Lisdexamfetamine dimesylate reports recording the termmedian drug in central nervous system stimulant

1. Intentional overdosea deliberate overdose24%1,034
2. Intentional self-injury23.1%995
3. Drug ineffectivethe medicine did not work as expected17.5%751
4. Product availability issuethe product was not available11.1%476
5. Inability to afford medication9%386
6. Product substitution issuea problem after switching products7.7%332
7. Fatiguetiredness7.5%324
8. Headachehead pain7%302
9. Anxietyanxiety5.9%252
10. Depressionlow mood5.8%250
11. Insurance issue5.7%247
12. Off label useused for a purpose or in a way not on the label5.2%224
13. Product use issuea problem in how the product was used5.1%219
14. Condition aggravatedthe condition being treated got worse4.9%211
15. Palpitationsawareness of the heartbeat4.7%201
16. Inappropriate schedule of product administrationthe product was taken at the wrong times4.4%189
17. Somnolencedrowsiness4.3%187
18. Disturbance in attentiondifficulty concentrating4.2%179
19. Loss of personal independence in daily activities4.1%176
20. Feeling abnormalfeeling odd or not right4%172
21. Insomniadifficulty sleeping3.9%167
22. Suicidal ideationthoughts of suicide3.7%160
23. Confusional stateconfusion3.5%152
24. Weight decreasedweight loss3.5%150
25. Irritabilityirritability3.3%141
26. Product use in unapproved indicationused for a purpose not on the label3%131
27. Stressstress3%130
28. Migrainemigraine2.9%125
29. Nauseafeeling sick2.9%125
30. Pyrexiafever2.9%124

Top 30 of 740 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. 34% 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 4,300 reports.

Drugs most often listed in the same reports

Other products listed in reports where Lisdexamfetamine dimesylate 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 Lisdexamfetamine dimesylate as a suspect or interacting product; reports listing it only as a concomitant medication (580) 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.