Lisdexamfetamine: adverse event reports filed with FDA

1,233

reports as suspect product

0% of all reports · about 84 a year

446

reports, 12 months to June 2026

232 in the 12 months before

57.8%

marked serious by the reporter

45% across the class

13.2%

record death among outcomes, as reported

163 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 reports recording the termmedian drug in central nervous system stimulant

1. Drug ineffectivethe medicine did not work as expected20.7%255
2. Recalled product administered8.9%110
3. Anxietyanxiety8.5%105
4. Product substitution issuea problem after switching products8.4%104
5. Completed suicidedeath by suicide7.5%92
6. Toxicity to various agentspoisoning or toxic effect of one or more substances5.9%73
7. Drug interactionan interaction between medicines5.8%71
8. Fatiguetiredness5.8%71
9. Headachehead pain5.4%66
10. Insomniadifficulty sleeping5.4%66
11. Irritabilityirritability5.4%66
12. Condition aggravatedthe condition being treated got worse4.1%50
13. Suicidal ideationthoughts of suicide3.9%48
14. Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor3.6%44
15. Nauseafeeling sick3.5%43
16. Depressionlow mood3.1%38
17. Therapeutic response changed3.1%38
18. Disturbance in attentiondifficulty concentrating3%37
19. Feeling abnormalfeeling odd or not right2.9%36
20. Sleep disordera sleep problem2.9%36
21. Speech disordera speech problem2.9%36
22. Aggressionaggressive behaviour2.8%35
23. Depressed moodlow mood2.8%35
24. Product physical issuea physical defect in the product2.8%35
25. Therapeutic response decreasedthe medicine worked less well2.8%35
26. Product dose omission issuea dose was missed2.8%34
27. Treatment failurethe treatment did not work2.8%34
28. Choreoathetosis2.7%33
29. Cardio-respiratory arrestthe heart and breathing stopped2.6%32
30. Off label useused for a purpose or in a way not on the label2.6%32

Top 30 of 333 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. 80.9% 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 1,233 reports.

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 as a suspect or interacting product; reports listing it only as a concomitant medication (602) 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.