Reported Reactions

Adverse event reports that FDA received

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Status epilepticus adverse event reports that record this term

Kind of term
MedDRA preferred term

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.

Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

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.

Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .

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

Reports on file

From January 2004 to June 2026, FDA received 11,139 adverse event reports that record the MedDRA preferred term Status epilepticus. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 717 reports in the 12 months to June 2026 and 707 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 783 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 717 (0.1%) record this term. Reports for patients aged 18 to 44 were 25.8% of the reports that record this term and 12.3% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 83 drug pages with 50 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

FDA says:

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.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

Drugs that the reports with the term Status epilepticus name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen63
AlprazolamBenzodiazepine69
Baclofengamma-Aminobutyric acid-ergic agonist173
Brivaracetam105
Briviact74
BupropionAminoketone312
Bupropion hydrochlorideAminoketone145
CarbamazepineMood stabilizer371
CefepimeCephalosporin antibacterial132
CeftriaxoneCephalosporin antibacterial72
ClobazamBenzodiazepine357
ClonazepamBenzodiazepine252
CyclophosphamideAlkylating drug107
CyclosporineCalcineurin inhibitor immunosuppressant53
CytarabineNucleoside metabolic inhibitor61
DalfampridinePotassium channel blocker50
Depakene59
DexamethasoneCorticosteroid146
DiazepamBenzodiazepine235
E Keppra66
Epidiolex128
EscitalopramSerotonin reuptake inhibitor53
EthosuximideAnti-epileptic agent70
EtoposideTopoisomerase inhibitor64
FentanylOpioid agonist104
Fintepla80
FluconazoleAzole antifungal52
FluorouracilNucleoside metabolic inhibitor57
FosphenytoinAnti-epileptic agent78
FurosemideLoop diuretic57
FycompaNoncompetitive AMPA glutamate receptor antagonist78
GabapentinAnti-epileptic agent132
GilenyaSphingosine 1-phosphate receptor modulator64
IbuprofenNonsteroidal anti-inflammatory drug70
Keppra587
Ketamine68
Lacosamide692
LamictalAnti-epileptic agent108
LamotrigineAnti-epileptic agent496
LansoprazoleProton pump inhibitor59
Levetiracetam1,750
LevofloxacinFluoroquinolone antibacterial108
LidocaineAmide local anesthetic170
LorazepamBenzodiazepine282
Magnesium sulfateCalculi dissolution agent51
MethotrexateFolate analog metabolic inhibitor138
MethylprednisoloneCorticosteroid157
MidazolamBenzodiazepine376
Mirtazapine115
Mycophenolate mofetilAntimetabolite immunosuppressant114
OxaliplatinPlatinum-based drug81
OxcarbazepineAnti-epileptic agent141
Pentobarbital65
PerampanelNoncompetitive AMPA glutamate receptor antagonist164
Phenobarbital361
PhenytoinAnti-epileptic agent565
Phenytoin sodiumAnti-epileptic agent81
PrednisoloneCorticosteroid85
PrednisoneCorticosteroid136
PropofolGeneral anesthetic318
QuetiapineAtypical antipsychotic180
Quetiapine fumarateAtypical antipsychotic55
RisperidoneAtypical antipsychotic65
RituximabCD20-directed cytolytic antibody101
SabrilAnti-epileptic agent125
Sodium valproate61
TacrolimusCalcineurin inhibitor immunosuppressant173
TegretolMood stabilizer101
TheophyllineMethylxanthine96
Thiopental51
Topamax54
Topiramate387
Tramadol98
Tranexamic acid83
TysabriIntegrin receptor antagonist89
Valproate191
Valproate sodiumAnti-epileptic agent187
Valproic acidAnti-epileptic agent492
VenlafaxineSerotonin and norepinephrine reuptake inhibitor120
VigabatrinAnti-epileptic agent116
Vimpat406
Vincristine66
ZonisamideAnti-epileptic agent136

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 46 pharmacologic classes with 50 or more reports that record this term. The rows are in order of name.

FDA says:

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.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

Pharmacologic classes of the drugs that the reports with the term Status epilepticus name, in order of name
ClassReports with this term
Alkylating drug192
Amide local anesthetic233
Aminoketone492
Anthracycline topoisomerase inhibitor53
Anti-epileptic agent2,967
Antimetabolite immunosuppressant143
Atypical antipsychotic537
Azole antifungal74
Benzodiazepine1,727
beta-Adrenergic blocker91
Biguanide70
Calcineurin inhibitor immunosuppressant271
Calculi dissolution agent51
CD20-directed cytolytic antibody128
Central nervous system stimulant85
Cephalosporin antibacterial319
Corticosteroid600
Factor Xa inhibitor68
Fluoroquinolone antibacterial165
Folate analog metabolic inhibitor168
gamma-Aminobutyric acid-ergic agonist186
General anesthetic413
Herpes simplex virus nucleoside analog DNA polymerase inhibitor59
HMG-CoA reductase inhibitor52
Human immunoglobulin G52
Integrin receptor antagonist99
Kinase inhibitor118
Loop diuretic79
Methylxanthine96
Mood stabilizer536
Noncompetitive AMPA glutamate receptor antagonist242
Nonsteroidal anti-inflammatory drug134
Nucleoside metabolic inhibitor213
Opioid agonist262
Penem antibacterial112
Penicillin-class antibacterial85
Platinum-based drug157
Potassium channel blocker62
Programmed death Receptor-1 blocking antibody55
Proton pump inhibitor152
Serotonin and norepinephrine reuptake inhibitor176
Serotonin reuptake inhibitor315
Sphingosine 1-phosphate receptor modulator82
Topoisomerase inhibitor69
Tumor necrosis factor blocker54
Vascular endothelial growth factor inhibitor54

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Status epilepticus, by month, five years to June 2026
010020020222023202420252026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Patients in these reports

Age of the patient in the reports that record Status epilepticus
AgeReportsShareShare as a bar
Under 24083.7%
2 to 111,0639.5%
12 to 175484.9%
18 to 442,87525.8%
45 to 641,94917.5%
65 to 741,0599.5%
75 and over8777.9%
Age not given2,36021.2%
Sex of the patient in the reports that record Status epilepticus
SexReportsShareShare as a bar
Female5,37948.3%
Male4,44039.9%
Unknown or not given1,32011.9%

Age and sex are as the report gives them. 31.8% of these reports give the United States as the country.

Terms near this one

Official pages

The site checked these addresses on . The links open in a new tab.

Cite this page

Reported Reactions. Status epilepticus: adverse event reports that record this term. https://reportedreactions.com/reaction/status-epilepticus/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

The count has the reports with each spelling of one MedDRA preferred term. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

What does Status epilepticus mean in an adverse event report?

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.

Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on .