Pharmacologic class (EPC) · 23 drug pages

Anti-epileptic agent: adverse event reports filed with FDA

269,757 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

269,757
reports across the class: 1.3% of all reports; 13,248
reports, 12 months to June 2026: 15,510 in the 12 months before; 78.1%
marked serious by the reporter: 57.4% across all reports; 23
drugs with a page: brand and generic names counted separately

Anti-epileptic agent is a pharmacologic class (an FDA Established Pharmacologic Class) with 23 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 269,757 adverse event reports received by FDA, 1.3% of the database, from January 2004 to June 2026.

13,248 reports arrived in the 12 months to June 2026, down 15% from 15,510 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 78.1% of the class's reports are marked serious, 12.6% record death among the outcomes and 31.4% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (11.9%), off label use (5.7%) and toxicity to various agents (5.4%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Gabapentin	generic	74,316	4,447	68.7%	Drug ineffective
Lamotrigine	generic	44,520	2,806	88%	Drug ineffective
LamictalLamotrigine	brand	32,368	996	65.4%	Rash
Valproic acid	generic	21,177	1,031	96.7%	Drug interaction
DepakoteDivalproex sodium	brand	14,219	297	65.4%	Seizure
Phenytoin	generic	12,618	464	92.9%	Drug ineffective
Valproate sodium	generic	11,588	708	97.5%	Foetal exposure during pregnancy
SabrilVigabatrin	brand	10,909	139	63.5%	Seizure
Oxcarbazepine	generic	8,078	715	87.7%	Drug ineffective
DilantinExtended phenytoin sodium	brand	8,011	78	71.7%	Convulsion
TrileptalOxcarbazepine	brand	7,664	157	85.7%	Seizure
Zonisamide	generic	4,885	363	87.3%	Drug ineffective
Divalproex sodium	generic	4,071	399	82.4%	Drug interaction
Vigabatrin	generic	3,664	263	80.6%	Seizure
Phenytoin sodium	generic	2,974	68	84.4%	Drug ineffective
Primidone	generic	1,769	104	77.3%	Drug interaction
ZonegranZonisamide	brand	1,458	11	82%	Convulsion
Dilantin-125Phenytoin	brand	1,344	0	72%	Stevens-Johnson syndrome
Ethosuximide	generic	1,197	90	87.5%	Drug ineffective
FosphenytoinFosphenytoin sodium	brand	947	64	91.1%	Drug ineffective
Oxtellar XrOxcarbazepine	brand	813	4	65.2%	Focal dyscognitive seizures
Fosphenytoin sodium	generic	664	20	86.9%	Drug ineffective
Divalproex sodium er	generic	503	24	85.1%	Drug interaction

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected11.9%32,160
Off label useused for a purpose or in a way not on the label5.7%15,357
Toxicity to various agentspoisoning or toxic effect of one or more substances5.4%14,685
Drug interactionan interaction between medicines5.3%14,225
Seizurea fit or convulsion5%13,527
Rashskin rash4.3%11,677
Somnolencedrowsiness4.2%11,196
Completed suicidedeath by suicide4.1%11,042
Dizzinesslight-headedness or unsteadiness4%10,661
Fatiguetiredness3.5%9,528
Nauseafeeling sick3.5%9,466
Drug hypersensitivityan allergic-type reaction to a medicine3.4%9,039
Convulsion3.3%8,860
Headachehead pain3.1%8,476
Vomitingbeing sick3%7,972
Condition aggravatedthe condition being treated got worse2.9%7,858
Foetal exposure during pregnancythe unborn baby was exposed to the medicine2.8%7,615
Painpain, site not specified2.8%7,467
Product use in unapproved indicationused for a purpose not on the label2.7%7,339
Depressionlow mood2.6%7,145
Pyrexiafever2.6%7,114
Confusional stateconfusion2.5%6,706
Falla fall2.5%6,617
Tremorshaking2.3%6,187
Anxietyanxiety2.2%6,043

Solid bar: share of all class reports. Hollow bar: the median share across the 23 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death12.6%34,099

Life-threatening6.3%17,025

Hospitalisation (initial or prolonged)31.4%84,765

Disability3.4%9,100

Congenital anomaly3.8%10,261

Other serious52.7%142,158

Not serious21.9%59,132

Patient age

Under 22.6%6,882

2 to 114.8%12,913

12 to 173.3%8,852

18 to 4422.2%59,973

45 to 6419.8%53,501

65 to 746.9%18,678

75 and over5.2%14,152

Age not given35.1%94,806

Who reported

Physician26.9%72,621

Pharmacist7.1%19,022

Other health professional31.4%84,698

Lawyer0.8%2,067

Consumer or non-health professional30.1%81,104

Not given3.8%10,245

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Anti-epileptic agent reports

Which drugs are in the Anti-epileptic agent class on this site?

Gabapentin, Lamotrigine, Lamictal, Valproic acid, Depakote and Phenytoin and 17 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

269,757 reports through June 2026, 13,248 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (11.9%), off label use (5.7%), toxicity to various agents (5.4%), drug interaction (5.3%) and seizure (5%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.