Optic neuritis 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 January 2004 to June 2026, FDA received 8,978 adverse event reports that record the MedDRA preferred term Optic neuritis. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 428 reports in the 12 months to June 2026 and 395 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 1,062 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, 428 (under 0.1%) record this term. Reports for patients aged 18 to 44 were 29.1% 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 139 drug pages with 10 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 Optic neuritis name as a suspect product, in order of name
Drug	Class	Reports with this term
Acetaminophen		20
Actemra	Interleukin-6 receptor antagonist	51
Acyclovir	Herpes simplex virus nucleoside analog DNA polymerase inhibitor	14
Adalimumab	Tumor necrosis factor blocker	65
Alemtuzumab	CD52-directed cytolytic antibody	48
Amiodarone		16
Amlodipine besylate	Dihydropyridine calcium channel blocker	11
Amoxicillin	Penicillin-class antibacterial	15
Ampyra	Potassium channel blocker	86
Anastrozole	Aromatase inhibitor	12
Atezolizumab	Programmed death Receptor-1 blocking antibody	17
Ativan	Benzodiazepine	12
Aubagio	Pyrimidine synthesis inhibitor	191
Avastin	Vascular endothelial growth factor inhibitor	19
Avonex	Interferon beta	858
Avonex Pen	Interferon beta	26
Azathioprine	Purine antimetabolite	59
Azithromycin	Macrolide antimicrobial	24
Baclofen	gamma-Aminobutyric acid-ergic agonist	15
Bedaquiline		34
Betaferon		51
Betaseron		71
Carbamazepine	Mood stabilizer	15
Carboplatin	Platinum-based drug	21
Cimzia	Tumor necrosis factor blocker	42
Ciprofloxacin	Fluoroquinolone antibacterial	23
Ciprofloxacin Lactate		10
Cisplatin	Platinum-based drug	19
Citalopram	Serotonin reuptake inhibitor	11
Clofazimine	Antimycobacterial	41
Comirnaty		25
Copaxone		207
Corticotropin		11
Cosentyx	Interleukin-17A antagonist	25
Cyclophosphamide	Alkylating drug	42
Cycloserine		27
Cyclosporine	Calcineurin inhibitor immunosuppressant	32
Cymbalta		11
Cytarabine	Nucleoside metabolic inhibitor	10
Delamanid		23
Dexamethasone	Corticosteroid	23
Dilaudid	Opioid agonist	14
Doxycycline	Tetracycline-class drug	11
Dupixent	Interleukin-4 receptor alpha antagonist	32
Enbrel	Tumor necrosis factor blocker	297
Enspryng		17
Etanercept	Tumor necrosis factor blocker	20
Ethambutol		88
Ethambutol hydrochloride	Antimycobacterial	33
Ethionamide		10
Extavia		41
Fingolimod	Sphingosine 1-phosphate receptor modulator	31
Fingolimod hydrochloride	Sphingosine 1-phosphate receptor modulator	12
Fluorouracil	Nucleoside metabolic inhibitor	18
Folic acid		16
Gemcitabine	Nucleoside metabolic inhibitor	14
Gilenya	Sphingosine 1-phosphate receptor modulator	698
Glatiramer acetate		10
Humira		296
Hydromorphone hydrochloride	Opioid agonist	11
Hydroxychloroquine	Antimalarial	14
Ibuprofen	Nonsteroidal anti-inflammatory drug	29
Imatinib	Kinase inhibitor	18
Infliximab	Tumor necrosis factor blocker	51
Interferon beta-1b		18
Ipilimumab	CTLA-4-directed blocking antibody	48
Isoniazid	Antimycobacterial	52
Kardegic		10
Kesimpta	CD20-directed cytolytic antibody	197
Keytruda	Programmed death Receptor-1 blocking antibody	74
Lamictal	Anti-epileptic agent	10
Lemtrada	CD52-directed cytolytic antibody	29
Levofloxacin	Fluoroquinolone antibacterial	36
Linezolid	Oxazolidinone antibacterial	158
Liptruzet		11
Lyrica		36
Mabthera		20
Mavenclad	Purine antimetabolite	31
Mayzent	Sphingosine 1-phosphate receptor modulator	42
Metformin	Biguanide	15
Methotrexate	Folate analog metabolic inhibitor	119
Methotrexate sodium	Folate analog metabolic inhibitor	24
Methylprednisolone	Corticosteroid	59
Methylprednisolone sodium succinate	Corticosteroid	25
Metronidazole	Nitroimidazole antimicrobial	22
Mirena	Progestin	12
Mounjaro	GLP-1 receptor agonist	30
Moxifloxacin	Fluoroquinolone antibacterial	36
Myambutol		11
Mycophenolate mofetil	Antimetabolite immunosuppressant	71
Nivolumab	Programmed death Receptor-1 blocking antibody	64
Ocrelizumab	CD20-directed cytolytic antibody	31
Ocrevus	CD20-directed cytolytic antibody	223
Omeprazole	Proton pump inhibitor	14
Opdivo	Programmed death Receptor-1 blocking antibody	26
Orencia	Selective T cell costimulation modulator	25
Oxaliplatin	Platinum-based drug	25
Ozempic	GLP-1 receptor agonist	51
Pegasys	Interferon alpha	12
Pembrolizumab	Programmed death Receptor-1 blocking antibody	27
Plegridy	Interferon beta	44
Prednisolone	Corticosteroid	59
Prednisone	Corticosteroid	167
Pregabalin		14
Pretomanid	Antimycobacterial	11
Propofol	General anesthetic	11
Pyrazinamide	Antimycobacterial	36
Quetiapine	Atypical antipsychotic	11
Rebetol		20
Rebif	Interferon beta	670
Remicade	Tumor necrosis factor blocker	126
Ribavirin	Nucleoside analog antiviral	10
Rifampicin		15
Rifampin	Rifamycin antibacterial	43
Rituxan	CD20-directed cytolytic antibody	24
Rituximab	CD20-directed cytolytic antibody	134
Satralizumab		17
Simponi	Tumor necrosis factor blocker	24
Sirturo		26
Solu-medrol	Corticosteroid	20
Stelara	Interleukin-12 antagonist	18
Sulfasalazine	Aminosalicylate	15
Tacrolimus	Calcineurin inhibitor immunosuppressant	47
Tamoxifen		10
Tecfidera		435
Teriflunomide	Pyrimidine synthesis inhibitor	47
Tramadol hydrochloride	Opioid agonist	11
Tysabri	Integrin receptor antagonist	748
Ultiva	Opioid agonist	11
Ultomiris	Complement inhibitor	11
Viagra	Phosphodiesterase 5 inhibitor	22
Vumerity		31
Wegovy	GLP-1 receptor agonist	15
Xeljanz	Janus kinase inhibitor	27
Xolair	Anti-IgE	22
Yervoy	CTLA-4-directed blocking antibody	11
Zeposia	Sphingosine 1-phosphate receptor modulator	19
Zoledronic acid	Bisphosphonate	28
Zyvox	Oxazolidinone antibacterial	11

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 39 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 Optic neuritis name, in order of name
Class	Reports with this term
Alkylating drug	54
Anti-IgE	29
Antimalarial	33
Antimetabolite immunosuppressant	80
Antimycobacterial	175
Bisphosphonate	42
Calcineurin inhibitor immunosuppressant	83
CD20-directed cytolytic antibody	629
CD52-directed cytolytic antibody	77
Corticosteroid	377
CTLA-4-directed blocking antibody	59
Fluoroquinolone antibacterial	95
Folate analog metabolic inhibitor	151
GLP-1 receptor agonist	114
Integrin receptor antagonist	773
Interferon beta	1,601
Interleukin-17A antagonist	28
Interleukin-4 receptor alpha antagonist	38
Interleukin-6 receptor antagonist	59
Janus kinase inhibitor	30
Kinase inhibitor	59
Macrolide antimicrobial	27
Nonsteroidal anti-inflammatory drug	53
Nucleoside metabolic inhibitor	59
Opioid agonist	47
Oxazolidinone antibacterial	171
Phosphodiesterase 5 inhibitor	40
Platinum-based drug	65
Potassium channel blocker	94
Programmed death Receptor-1 blocking antibody	212
Proton pump inhibitor	28
Purine antimetabolite	90
Pyrimidine synthesis inhibitor	238
Rifamycin antibacterial	43
Selective T cell costimulation modulator	30
Serotonin reuptake inhibitor	34
Sphingosine 1-phosphate receptor modulator	796
Tumor necrosis factor blocker	654
Vascular endothelial growth factor inhibitor	34

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

Reports by month

Reports that record Optic neuritis, 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 Optic neuritis
Age	Reports	Share
Under 2	4	under 0.1%
2 to 11	116	1.3%
12 to 17	130	1.4%
18 to 44	2,617	29.1%
45 to 64	2,106	23.5%
65 to 74	501	5.6%
75 and over	202	2.2%
Age not given	3,302	36.8%

Sex of the patient in the reports that record Optic neuritis
Sex	Reports	Share
Female	6,135	68.3%
Male	2,202	24.5%
Unknown or not given	641	7.1%

Age and sex are as the report gives them. 53.5% 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. Optic neuritis: adverse event reports that record this term. https://reportedreactions.com/reaction/optic-neuritis/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 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 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 Optic neuritis 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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