Reported Reactions

Adverse event reports that FDA received

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Nervous system disorder 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 30,802 adverse event reports that record the MedDRA preferred term Nervous system disorder. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 1,126 reports in the 12 months to June 2026 and 1,114 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 563 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, 1,126 (0.1%) record this term. Reports for patients 75 and over were 5.2% of the reports that record this term and 9.5% 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 70 drug pages with 100 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 Nervous system disorder name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen134
AlprazolamBenzodiazepine174
AmlodipineCalcium channel blocker107
AspirinNonsteroidal anti-inflammatory drug127
Avelox211
AvonexInterferon beta189
BevacizumabVascular endothelial growth factor inhibitor148
Blincyto100
CarboplatinPlatinum-based drug185
ChantixPartial cholinergic nicotinic agonist115
CiproCorticosteroid165
CiprofloxacinFluoroquinolone antibacterial315
CisplatinPlatinum-based drug115
ClonazepamBenzodiazepine123
CosentyxInterleukin-17A antagonist144
CyclophosphamideAlkylating drug423
Cymbalta171
CytarabineNucleoside metabolic inhibitor251
Darvocet1,245
Darvon1,263
DexamethasoneCorticosteroid402
DoxorubicinAnthracycline topoisomerase inhibitor156
Doxorubicin hydrochlorideAnthracycline topoisomerase inhibitor112
EfavirenzHuman immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor116
EffexorSerotonin and norepinephrine reuptake inhibitor114
EnbrelTumor necrosis factor blocker464
EtoposideTopoisomerase inhibitor237
FentanylOpioid agonist139
ForteoParathyroid hormone analog104
GabapentinAnti-epileptic agent210
GilenyaSphingosine 1-phosphate receptor modulator135
Humira756
Hydrocodone bitartrate and acetaminophenOpioid agonist102
Levaquin218
LevofloxacinFluoroquinolone antibacterial203
LipitorHMG-CoA reductase inhibitor115
Lyrica406
MethotrexateFolate analog metabolic inhibitor503
MethylprednisoloneCorticosteroid162
MetoclopramideDopamine-2 receptor antagonist7,093
Metoclopramide hydrochlorideDopamine-2 receptor antagonist442
MetronidazoleNitroimidazole antimicrobial154
Morphine sulfateOpioid agonist159
Mycophenolate mofetilAntimetabolite immunosuppressant175
Neurontin141
NexiumProton pump inhibitor109
OrenciaSelective T cell costimulation modulator118
Oxycodone hydrochlorideOpioid agonist176
OxyContinOpioid agonist161
PrednisoloneCorticosteroid157
PrednisoneCorticosteroid403
Pregabalin113
Propoxyphene Napsylate and Acetaminophen1,268
QuetiapineAtypical antipsychotic112
ReglanDopamine-2 receptor antagonist342
RemicadeTumor necrosis factor blocker184
RevlimidThalidomide analog199
RituximabCD20-directed cytolytic antibody380
SeroquelAtypical antipsychotic167
TacrolimusCalcineurin inhibitor immunosuppressant174
Tramadol125
Tramadol hydrochlorideOpioid agonist117
TysabriIntegrin receptor antagonist220
ValtrexHerpes simplex virus nucleoside analog DNA polymerase inhibitor156
VancomycinGlycopeptide antibacterial102
VenlafaxineSerotonin and norepinephrine reuptake inhibitor107
Venlafaxine hydrochlorideSerotonin and norepinephrine reuptake inhibitor103
Vincristine240
Vioxx185
XeljanzJanus kinase inhibitor110

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 58 pharmacologic classes with 100 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 Nervous system disorder name, in order of name
ClassReports with this term
Alkylating drug670
Angiotensin 2 receptor blocker139
Anthracycline topoisomerase inhibitor282
Anti-epileptic agent688
Antimetabolite immunosuppressant222
Atypical antipsychotic939
Azole antifungal258
Benzodiazepine772
beta-Adrenergic blocker184
Biguanide125
Calcineurin inhibitor immunosuppressant348
Calcium channel blocker133
CD19-directed chimeric antigen receptor105
CD20-directed cytolytic antibody524
Central nervous system depressant124
Corticosteroid1,537
Cytochrome P450 3A inhibitor116
Dopamine-2 receptor antagonist7,879
Factor Xa inhibitor165
Fluoroquinolone antibacterial550
Folate analog metabolic inhibitor619
GLP-1 receptor agonist116
Glycopeptide antibacterial102
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor173
HER2/neu receptor antagonist117
Herpes simplex virus nucleoside analog DNA polymerase inhibitor294
HMG-CoA reductase inhibitor246
Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor184
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor179
Insulin analog177
Integrin receptor antagonist266
Interferon beta238
Interleukin-17A antagonist163
Interleukin-6 receptor antagonist120
Janus kinase inhibitor226
Kinase inhibitor814
Microtubule inhibitor154
Mood stabilizer226
Nitroimidazole antimicrobial173
Nonsteroidal anti-inflammatory drug406
Nucleoside metabolic inhibitor587
Opioid agonist1,454
Osmotic laxative153
P2Y12 platelet inhibitor141
Parathyroid hormone analog106
Partial cholinergic nicotinic agonist117
Platinum-based drug376
Programmed death Receptor-1 blocking antibody363
Proteasome inhibitor196
Proton pump inhibitor312
Selective T cell costimulation modulator159
Serotonin and norepinephrine reuptake inhibitor417
Serotonin reuptake inhibitor627
Sphingosine 1-phosphate receptor modulator157
Thalidomide analog331
Topoisomerase inhibitor250
Tumor necrosis factor blocker972
Vascular endothelial growth factor inhibitor251

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

Reports by month

Reports that record Nervous system disorder, 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 Nervous system disorder
AgeReportsShareShare as a bar
Under 22150.7%
2 to 114201.4%
12 to 174001.3%
18 to 443,45911.2%
45 to 645,07616.5%
65 to 742,3537.6%
75 and over1,6105.2%
Age not given17,26956.1%
Sex of the patient in the reports that record Nervous system disorder
SexReportsShareShare as a bar
Female17,27156.1%
Male10,51234.1%
Unknown or not given3,0199.8%

Age and sex are as the report gives them. 65.2% of these reports give the United States as the country.

Terms near this one

Official pages

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Reported Reactions. Nervous system disorder: adverse event reports that record this term. https://reportedreactions.com/reaction/nervous-system-disorder/ 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 Nervous system disorder 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 .