MedDRA preferred term

Nystagmus: adverse event reports recording this term

5,195 reports to FDA record it, 2004–2026; 0% 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.

5,195
reports recording the term: 0% of all reports; 216
reports, 12 months to June 2026: 192 in the 12 months before; 91.6%
marked serious by the reporter: 57.4% across all reports; 3.9%
record death among outcomes, as reported: 9.1% across all reports

"Nystagmus" is a MedDRA preferred term recorded in 5,195 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

216 reports recorded it in the 12 months to June 2026, up 13% from 192 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, 91.6% are marked serious, 3.9% include death among the outcomes and 54.7% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Phenytoin, Lamotrigine and Diazepam. 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
Phenytoin	Anti-epileptic agent	346	2.7%
Lamotrigine	Anti-epileptic agent	269	0.6%
Diazepam	Benzodiazepine	184	0.5%
Carbamazepine	Mood stabilizer	146	0.7%
Gilenya	Sphingosine 1-phosphate receptor modulator	127	0.2%
Metronidazole	Nitroimidazole antimicrobial	103	0.4%
Tegretol	Mood stabilizer	84	0.5%
Valproic acid	Anti-epileptic agent	80	0.4%
Sertraline	Serotonin reuptake inhibitor	77	0.2%
Gabapentin	Anti-epileptic agent	72	0.1%
Tysabri	Integrin receptor antagonist	71	0%
Fluoxetine	Serotonin reuptake inhibitor	68	0.2%
Quetiapine	Atypical antipsychotic	66	0.1%
Lamictal	Anti-epileptic agent	65	0.2%
Methadone hcl	—	64	1.5%
Omeprazole	Proton pump inhibitor	62	0.1%
Methadone	Opioid agonist	60	0.2%
Topiramate	—	59	0.2%
Phenytoin sodium	Anti-epileptic agent	57	1.9%
Fentanyl	Opioid agonist	55	0.1%
Levetiracetam	—	54	0.1%
Clonazepam	Benzodiazepine	53	0.1%
Oxcarbazepine	Anti-epileptic agent	53	0.7%
Venlafaxine	Serotonin and norepinephrine reuptake inhibitor	53	0.2%
Dilantin	Anti-epileptic agent	52	0.6%

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% 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
Anti-epileptic agent	1,102	0.4%	0.2%
Benzodiazepine	390	0.2%	0.1%
Serotonin reuptake inhibitor	302	0.1%	0.1%
Mood stabilizer	268	0.5%	0.4%
Atypical antipsychotic	253	0%	0%
Opioid agonist	216	0%	0%
Serotonin and norepinephrine reuptake inhibitor	144	0.1%	0.1%
Corticosteroid	132	0%	0%
Sphingosine 1-phosphate receptor modulator	132	0.1%	0%
Nitroimidazole antimicrobial	105	0.3%	0%

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 24.2%219

2 to 115%262

12 to 173.3%174

18 to 4427.1%1,407

45 to 6425.5%1,327

65 to 748%416

75 and over4.5%233

Age not given22.3%1,157

Patient sex

Female51.7%2,684

Male36.3%1,888

Not given12%623

Grey bar: all 20,646,523 reports in the database. 37.2% of these reports give the United States as the country.

Questions about "Nystagmus"

What does "Nystagmus" 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 nystagmus?

5,195 reports through June 2026 (0% of all reports), 216 of them in the latest 12 months.

Which drugs appear most often in these reports?

Phenytoin (346), Lamotrigine (269), Diazepam (184), Carbamazepine (146) and Gilenya (127). 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.