Sabril: adverse event reports filed with FDA

10,909

reports as suspect product

0.1% of all reports · about 485 a year

139

reports, 12 months to June 2026

154 in the 12 months before

63.5%

marked serious by the reporter

78.1% across the class

9.1%

record death among outcomes, as reported

990 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 Sabril reports recording the termmedian drug in anti-epileptic agent

1. Seizurea fit or convulsion14.2%1,548
2. Drug dose omissiona dose was missed11.4%1,239
3. Drug ineffectivethe medicine did not work as expected8.4%917
4. Convulsion6.3%684
5. Deaththe patient died; cause not stated by this term6.1%669
6. Drug withdrawal convulsions4.5%487
7. Pneumonialung infection4.1%449
8. Somnolencedrowsiness3.5%385
9. Vomitingbeing sick2.9%317
10. Product dose omission issuea dose was missed2.2%239
11. Infantile spasms2%222
12. Irritabilityirritability1.9%209
13. Pyrexiafever1.7%185
14. Visual impairmentreduced vision1.7%182
15. Insomniadifficulty sleeping1.6%177
16. Incorrect dose administeredthe wrong dose was given1.5%168
17. Malaisegeneral feeling of being unwell1.4%158
18. Visual field defect1.3%146
19. Fatiguetiredness1.3%144
20. Status epilepticus1.1%125
21. Respiratory failurethe lungs could not supply enough oxygen1.1%122
22. Condition aggravatedthe condition being treated got worse1.1%120
23. Respiratory distressdifficulty breathing1.1%118
24. Retinogram abnormal1.1%116
25. Abnormal behaviourunusual behaviour1%105
26. Aggressionaggressive behaviour0.9%103
27. Tremorshaking0.9%102
28. Agitationrestlessness0.9%100
29. Wrong technique in product usage processthe product was used in the wrong way0.9%99
30. Pneumonia aspirationlung infection from breathing in material0.9%97

Top 30 of 578 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 23 drugs in the anti-epileptic agent 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 269,757 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. 93.1% 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 10,909 reports.

Drugs most often listed in the same reports

Other products listed in reports where Sabril 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 anti-epileptic agent 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 Sabril as a suspect or interacting product; reports listing it only as a concomitant medication (712) 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.