MedDRA preferred term

Neurotoxicity: adverse event reports recording this term

17,089 reports to FDA record it, 2004–2026; 0.1% of the database.

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.

17,089
reports recording the term: 0.1% of all reports; 1,522
reports, 12 months to June 2026: 1,365 in the 12 months before; 98.7%
marked serious by the reporter: 57.4% across all reports; 10.5%
record death among outcomes, as reported: 9.1% across all reports

17,089 reports in FDA's adverse event database record the MedDRA term "Neurotoxicity": 0.1% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

1,522 reports recorded it in the 12 months to June 2026, up 12% from 1,365 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 98.7% are marked serious, 10.5% include death among the outcomes and 36.1% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Oxaliplatin, Methotrexate and Yescarta. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

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

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Oxaliplatin	Platinum-based drug	1,379	2.2%
Methotrexate	Folate analog metabolic inhibitor	1,174	0.6%
Yescarta	CD19-directed chimeric antigen receptor	1,147	16.6%
Cyclophosphamide	Alkylating drug	872	0.6%
Fluorouracil	Nucleoside metabolic inhibitor	769	1.3%
Tacrolimus	Calcineurin inhibitor immunosuppressant	767	0.8%
Paclitaxel	Microtubule inhibitor	604	0.9%
Vincristine	—	595	1%
Capecitabine	Nucleoside metabolic inhibitor	547	1.1%
Cytarabine	Nucleoside metabolic inhibitor	518	1%
Metronidazole	Nitroimidazole antimicrobial	518	2.1%
Dexamethasone	Corticosteroid	504	0.4%
Bevacizumab	Vascular endothelial growth factor inhibitor	479	0.9%
Prednisone	Corticosteroid	476	0.3%
Acyclovir	Herpes simplex virus nucleoside analog DNA polymerase inhibitor	448	4%
Rituximab	CD20-directed cytolytic antibody	419	0.3%
Carboplatin	Platinum-based drug	401	0.4%
Etoposide	Topoisomerase inhibitor	381	0.6%
Blincyto	—	377	5.8%
Kymriah	CD19-directed chimeric antigen receptor	373	10.2%
Doxorubicin	Anthracycline topoisomerase inhibitor	335	0.6%
Baclofen	gamma-Aminobutyric acid-ergic agonist	318	1.5%
Ifosfamide	Alkylating drug	308	1.7%
Cisplatin	Platinum-based drug	303	0.5%
Irinotecan	—	289	1.4%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.1% across the whole database. 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."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Nucleoside metabolic inhibitor	2,732	0.9%	0.4%
Platinum-based drug	2,083	0.9%	0.5%
CD19-directed chimeric antigen receptor	1,794	12.8%	9.3%
Alkylating drug	1,513	0.6%	0.2%
Folate analog metabolic inhibitor	1,440	0.5%	0%
Corticosteroid	1,346	0.2%	0%
Calcineurin inhibitor immunosuppressant	1,181	0.6%	0.2%
Microtubule inhibitor	997	0.7%	0.7%
Herpes simplex virus nucleoside analog DNA polymerase inhibitor	817	2.7%	2.6%
Vascular endothelial growth factor inhibitor	709	0.4%	0.1%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.8%143

2 to 114.1%704

12 to 174.1%700

18 to 4413.2%2,253

45 to 6424.5%4,195

65 to 7416%2,736

75 and over8.5%1,458

Age not given28.7%4,900

Patient sex

Female37.1%6,338

Male40.9%6,991

Not given22%3,760

Grey bar: all 20,646,523 reports in the database. 39.5% of these reports give the United States as the country.

Questions about "Neurotoxicity"

What does "Neurotoxicity" mean in an adverse event report?

It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record neurotoxicity?

17,089 reports through June 2026 (0.1% of all reports), 1,522 of them in the latest 12 months.

Which drugs appear most often in these reports?

Oxaliplatin (1,379), Methotrexate (1,174), Yescarta (1,147), Cyclophosphamide (872) and Fluorouracil (769). Drugs with many reports overall lead almost every term's list. 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."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

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. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. 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.