Central nervous system lesion 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 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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 February 2004 to June 2026, FDA received 13,648 adverse event reports that record the MedDRA preferred term Central nervous system lesion. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 340 reports in the 12 months to June 2026 and 437 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 1 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 93 drug pages with 25 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports with the term Central nervous system lesion name as a suspect product, in order of name
Drug	Class	Reports with this term
Acyclovir	Herpes simplex virus nucleoside analog DNA polymerase inhibitor	39
Afinitor	Kinase inhibitor	27
Alemtuzumab	CD52-directed cytolytic antibody	62
Amlodipine	Calcium channel blocker	31
Amlodipine besylate	Dihydropyridine calcium channel blocker	55
Amphotericin b	Lipid-based polyene antifungal	46
Ampyra	Potassium channel blocker	507
Anastrozole	Aromatase inhibitor	26
Aubagio	Pyrimidine synthesis inhibitor	293
Avonex	Interferon beta	1,131
Avonex Pen	Interferon beta	33
Azathioprine	Purine antimetabolite	46
Baclofen	gamma-Aminobutyric acid-ergic agonist	122
Betaseron		62
Bevacizumab	Vascular endothelial growth factor inhibitor	25
Bisoprolol	beta-Adrenergic blocker	78
Capecitabine	Nucleoside metabolic inhibitor	57
Carbamazepine	Mood stabilizer	56
Carboplatin	Platinum-based drug	64
Ciclosporin		34
Copaxone		467
Cyclophosphamide	Alkylating drug	126
Cyclosporine	Calcineurin inhibitor immunosuppressant	66
Cymbalta	Serotonin and norepinephrine reuptake inhibitor	29
Cytarabine	Nucleoside metabolic inhibitor	85
Dalfampridine	Potassium channel blocker	71
Dexamethasone	Corticosteroid	110
Docetaxel	Microtubule inhibitor	39
Doxepin hydrochloride	Tricyclic antidepressant	76
Doxorubicin	Anthracycline topoisomerase inhibitor	40
Enbrel	Tumor necrosis factor blocker	102
Etoposide	Topoisomerase inhibitor	62
Extavia		92
Fingolimod	Sphingosine 1-phosphate receptor modulator	71
Fulvestrant	Estrogen receptor antagonist	42
Gabapentin	Anti-epileptic agent	111
Gilenya	Sphingosine 1-phosphate receptor modulator	2,801
Glatopa		30
Herceptin	HER2/neu receptor antagonist	44
Humira		266
Imbruvica	Kinase inhibitor	32
Keppra		25
Kesimpta	CD20-directed cytolytic antibody	188
Kisqali	Kinase inhibitor	42
Lamivudine	Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	53
Lamotrigine	Anti-epileptic agent	56
Lemtrada	CD52-directed cytolytic antibody	45
Letrozole	Aromatase inhibitor	44
Levetiracetam		72
Lorazepam	Benzodiazepine	101
Lyrica		47
Mayzent	Sphingosine 1-phosphate receptor modulator	99
Mekinist	Kinase inhibitor	38
Metformin	Biguanide	28
Methotrexate	Folate analog metabolic inhibitor	160
Methylprednisolone	Corticosteroid	65
Metronidazole	Nitroimidazole antimicrobial	56
Mycophenolate mofetil	Antimetabolite immunosuppressant	135
Nivolumab	Programmed death Receptor-1 blocking antibody	49
Ocrevus	CD20-directed cytolytic antibody	105
Paclitaxel	Microtubule inhibitor	71
Pertuzumab	HER2/neu receptor antagonist	39
Plegridy	Interferon beta	92
Posaconazole	Azole antifungal	28
Pramipexole	Nonergot dopamine agonist	55
Pramipexole dihydrochloride	Nonergot dopamine agonist	35
Prednisolone	Corticosteroid	101
Prednisone	Corticosteroid	161
Rabeprazole	Proton pump inhibitor	81
Rebif	Interferon beta	792
Remicade	Tumor necrosis factor blocker	48
Revlimid	Thalidomide analog	37
Rituxan	CD20-directed cytolytic antibody	28
Rituximab	CD20-directed cytolytic antibody	128
Rosuvastatin calcium	HMG-CoA reductase inhibitor	81
Soliris	Complement inhibitor	27
Tacrolimus	Calcineurin inhibitor immunosuppressant	138
Tafinlar	Kinase inhibitor	37
Tagrisso	Kinase inhibitor	34
Tamoxifen		35
Tamsulosin		73
Tecfidera		1,249
Temazepam	Benzodiazepine	27
Teriflunomide	Pyrimidine synthesis inhibitor	42
Topiramate		29
Trastuzumab	HER2/neu receptor antagonist	51
Tysabri	Integrin receptor antagonist	1,580
Vincristine		79
Voriconazole	Azole antifungal	36
Vumerity		102
Xeloda	Nucleoside metabolic inhibitor	41
Zoledronic acid	Bisphosphonate	39
Zometa		67

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 57 pharmacologic classes with 25 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Pharmacologic classes of the drugs that the reports with the term Central nervous system lesion name, in order of name
Class	Reports with this term
Alkylating drug	164
Anthracycline topoisomerase inhibitor	60
Anti-epileptic agent	220
Antimetabolite immunosuppressant	156
Antimycobacterial	29
Aromatase inhibitor	97
Atypical antipsychotic	69
Azole antifungal	89
Benzodiazepine	167
beta-Adrenergic blocker	97
Biguanide	33
Bisphosphonate	52
Calcineurin inhibitor immunosuppressant	219
Calcium channel blocker	33
CD20-directed cytolytic antibody	493
CD52-directed cytolytic antibody	111
Cephalosporin antibacterial	26
Complement inhibitor	32
Corticosteroid	499
Dihydropyridine calcium channel blocker	57
Estrogen receptor antagonist	47
Fluoroquinolone antibacterial	27
Folate analog metabolic inhibitor	176
gamma-Aminobutyric acid-ergic agonist	124
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	68
HER2/neu receptor antagonist	154
Herpes simplex virus nucleoside analog DNA polymerase inhibitor	41
HMG-CoA reductase inhibitor	103
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	58
Human immunoglobulin G	28
Integrin receptor antagonist	1,601
Interferon beta	2,054
Interleukin-6 receptor antagonist	25
Kinase inhibitor	535
Lipid-based polyene antifungal	46
Microtubule inhibitor	110
Mood stabilizer	90
Nitroimidazole antimicrobial	56
Nonergot dopamine agonist	90
Nonsteroidal anti-inflammatory drug	52
Nucleoside metabolic inhibitor	226
Opioid agonist	109
Platinum-based drug	105
Potassium channel blocker	581
Programmed death Receptor-1 blocking antibody	127
Proton pump inhibitor	116
Purine antimetabolite	64
Pyrimidine synthesis inhibitor	335
Serotonin and norepinephrine reuptake inhibitor	56
Serotonin reuptake inhibitor	31
Sphingosine 1-phosphate receptor modulator	2,999
Thalidomide analog	54
Topoisomerase inhibitor	78
Tricyclic antidepressant	91
Tumor necrosis factor blocker	217
Vascular endothelial growth factor inhibitor	49
Vinca alkaloid	29

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

Reports by month

Reports that record Central nervous system lesion, by month, five years to June 2026

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 Central nervous system lesion
Age	Reports	Share
Under 2	43	0.3%
2 to 11	114	0.8%
12 to 17	171	1.3%
18 to 44	3,423	25.1%
45 to 64	3,253	23.8%
65 to 74	625	4.6%
75 and over	237	1.7%
Age not given	5,782	42.4%

Sex of the patient in the reports that record Central nervous system lesion
Sex	Reports	Share
Female	9,208	67.5%
Male	3,750	27.5%
Unknown or not given	690	5.1%

Age and sex are as the report gives them. 66.5% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Central nervous system lesion: adverse event reports that record this term. https://reportedreactions.com/reaction/central-nervous-system-lesion/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 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 Oct 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 Central nervous system lesion 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 2 Oct 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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