Stevens-Johnson syndrome adverse event reports that record this term

Kind of term: MedDRA preferred term
Plain meaning: a severe skin and mucous-membrane reaction

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 21,832 adverse event reports that record the MedDRA preferred term Stevens-Johnson syndrome. In plain words, the term means: a severe skin and mucous-membrane reaction. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 966 reports in the 12 months to June 2026 and 994 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 629 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, 966 (0.1%) record this term. Reports for patients aged 18 to 44 were 19% 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.

Plain meaning

A severe skin and mucous-membrane reaction. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 138 drug pages with 50 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 Stevens-Johnson syndrome name as a suspect product, in order of name
Drug	Class	Reports with this term
Abilify	Atypical antipsychotic	53
Acetaminophen		443
Acetylcysteine		106
Acetylsalicylic Acid		67
Allopurinol	Xanthine oxidase inhibitor	919
Amlodipine	Calcium channel blocker	118
Amoxicillin	Penicillin-class antibacterial	350
Amoxicillin Clavulanic Acid		58
Aspirin	Nonsteroidal anti-inflammatory drug	196
Atezolizumab	Programmed death Receptor-1 blocking antibody	57
Atorvastatin		51
Augmentin	Penicillin-class antibacterial	53
Augmentin '125		61
Avelox		88
Azithromycin	Macrolide antimicrobial	160
Azithromycin Anhydrous		85
Bactrim	Dihydrofolate reductase inhibitor antibacterial	339
Bextra		1,428
Capecitabine	Nucleoside metabolic inhibitor	52
Carbamazepine	Mood stabilizer	506
Carboplatin	Platinum-based drug	159
Cefepime	Cephalosporin antibacterial	56
Ceftriaxone	Cephalosporin antibacterial	206
Cefuroxime	Cephalosporin antibacterial	50
Celebrex	Nonsteroidal anti-inflammatory drug	177
Cephalexin	Cephalosporin antibacterial	58
Ciprofloxacin	Fluoroquinolone antibacterial	378
Cisplatin	Platinum-based drug	76
Clarithromycin	Macrolide antimicrobial	190
Clexane		58
Clindamycin	Lincosamide antibacterial	91
Clobazam	Benzodiazepine	50
Clonazepam	Benzodiazepine	90
Cotrimoxazole		80
Cyclophosphamide	Alkylating drug	88
Cyclosporine	Calcineurin inhibitor immunosuppressant	63
Cymbalta		90
Cytarabine	Nucleoside metabolic inhibitor	50
Dexamethasone	Corticosteroid	138
Diazepam	Benzodiazepine	105
Diclofenac	Nonsteroidal anti-inflammatory drug	129
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	107
Diflucan	Azole antifungal	79
Dilantin	Anti-epileptic agent	429
Dilantin-125	Anti-epileptic agent	362
Docetaxel	Microtubule inhibitor	60
Doxycycline	Tetracycline-class drug	141
Enbrel	Tumor necrosis factor blocker	68
Enfortumab vedotin		201
Erythromycin		65
Excegran		55
Fluconazole	Azole antifungal	217
Fluorouracil	Nucleoside metabolic inhibitor	52
Furosemide	Loop diuretic	175
Gabapentin	Anti-epileptic agent	74
Heparin		73
Heparin sodium	Anti-coagulant	58
Humira		111
Hydrochlorothiazide	Thiazide diuretic	54
Hydroxychloroquine	Antimalarial	50
Ibuprofen	Nonsteroidal anti-inflammatory drug	841
Incivek		54
Indapamide	Thiazide-like diuretic	53
Isoniazid	Antimycobacterial	66
Januvia	Dipeptidyl peptidase 4 inhibitor	56
Keppra		157
Keytruda	Programmed death Receptor-1 blocking antibody	307
Lamictal	Anti-epileptic agent	1,292
Lamivudine	Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	96
Lamotrigine	Anti-epileptic agent	1,281
Lansoprazole	Proton pump inhibitor	77
Lasix	Loop diuretic	172
Lenalidomide	Thalidomide analog	53
Levaquin		164
Levetiracetam		295
Levofloxacin	Fluoroquinolone antibacterial	144
Lyrica		103
Meropenem	Penem antibacterial	141
Metamizole		61
Methotrexate	Folate analog metabolic inhibitor	192
Methylprednisolone	Corticosteroid	135
Metoclopramide	Dopamine-2 receptor antagonist	73
Metronidazole	Nitroimidazole antimicrobial	116
Mirtazapine		66
Naproxen	Nonsteroidal anti-inflammatory drug	99
Nevirapine	Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor	193
Nexium	Proton pump inhibitor	89
Nivolumab	Programmed death Receptor-1 blocking antibody	119
Norvasc	Calcium channel blocker	57
Novalgin		101
Omeprazole	Proton pump inhibitor	209
Opdivo	Programmed death Receptor-1 blocking antibody	196
Oxaliplatin	Platinum-based drug	56
Oxcarbazepine	Anti-epileptic agent	78
Paclitaxel	Microtubule inhibitor	98
Pantoprazole	Proton pump inhibitor	114
Pantoprazole sodium	Proton pump inhibitor	56
Pantozol		90
Paracetamol		273
Pembrolizumab	Programmed death Receptor-1 blocking antibody	162
Pemetrexed	Folate analog metabolic inhibitor	52
Phenobarbital		64
Phenytoin	Anti-epileptic agent	353
Phenytoin sodium	Anti-epileptic agent	110
Piperacillin and tazobactam	Penicillin-class antibacterial	140
Piperacillin sodium,tazobactam sodium		76
Plavix	P2Y12 platelet inhibitor	52
Prednisolone	Corticosteroid	142
Prednisone	Corticosteroid	144
Propofol	General anesthetic	77
Ramipril	Angiotensin converting enzyme inhibitor	79
Ranitidine	Histamine-2 receptor antagonist	54
Revlimid	Thalidomide analog	194
Ribavirin	Nucleoside analog antiviral	77
Rifampicin		54
Rituximab	CD20-directed cytolytic antibody	116
Rocephin		80
Sertraline	Serotonin reuptake inhibitor	50
Spironolactone	Aldosterone antagonist	63
Sulfamethoxazole and trimethoprim	Dihydrofolate reductase inhibitor antibacterial	202
Sulfamethoxazole, trimethoprim	Dihydrofolate reductase inhibitor antibacterial	128
Sulfasalazine	Aminosalicylate	101
Tamiflu	Neuraminidase inhibitor	58
Tegretol	Mood stabilizer	298
Topiramate		50
Tramadol		66
Trileptal	Anti-epileptic agent	105
Valproate sodium	Anti-epileptic agent	87
Valproic acid	Anti-epileptic agent	162
Vancomycin	Glycopeptide antibacterial	348
Vancomycin hydrochloride	Glycopeptide antibacterial	53
Viramune		101
Xarelto	Factor Xa inhibitor	50
Yervoy	CTLA-4-directed blocking antibody	90
Zithromax	Macrolide antimicrobial	94
Zonisamide	Anti-epileptic agent	88
Zovirax	Herpes simplex virus nucleoside analog DNA polymerase inhibitor	51
Zyloric		52

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 48 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 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 Stevens-Johnson syndrome name, in order of name
Class	Reports with this term
Aldosterone antagonist	107
Alkylating drug	222
Aminosalicylate	113
Angiotensin 2 receptor blocker	107
Angiotensin converting enzyme inhibitor	145
Anti-epileptic agent	4,526
Antimalarial	126
Atypical antipsychotic	332
Azole antifungal	363
Benzodiazepine	442
beta-Adrenergic blocker	114
Calcium channel blocker	193
CD20-directed cytolytic antibody	157
Cephalosporin antibacterial	604
Corticosteroid	779
CTLA-4-directed blocking antibody	146
Dihydrofolate reductase inhibitor antibacterial	761
Dopamine-2 receptor antagonist	100
Factor Xa inhibitor	133
Fluoroquinolone antibacterial	610
Folate analog metabolic inhibitor	323
Glycopeptide antibacterial	401
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	164
Herpes simplex virus nucleoside analog DNA polymerase inhibitor	154
Histamine-2 receptor antagonist	121
HMG-CoA reductase inhibitor	141
Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor	252
Kinase inhibitor	495
Lincosamide antibacterial	128
Loop diuretic	376
Macrolide antimicrobial	446
Microtubule inhibitor	172
Mood stabilizer	831
Nitroimidazole antimicrobial	145
Nonsteroidal anti-inflammatory drug	1,829
Nucleoside metabolic inhibitor	276
Opioid agonist	235
Osmotic laxative	124
Penem antibacterial	180
Penicillin-class antibacterial	650
Platinum-based drug	291
Programmed death Receptor-1 blocking antibody	892
Proton pump inhibitor	599
Serotonin reuptake inhibitor	232
Tetracycline-class drug	183
Thalidomide analog	249
Tumor necrosis factor blocker	170
Xanthine oxidase inhibitor	955

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

Reports by month

Reports that record Stevens-Johnson syndrome, 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 Stevens-Johnson syndrome
Age	Reports	Share
Under 2	92	0.4%
2 to 11	1,114	5.1%
12 to 17	842	3.9%
18 to 44	4,145	19%
45 to 64	4,272	19.6%
65 to 74	2,342	10.7%
75 and over	2,232	10.2%
Age not given	6,793	31.1%

Sex of the patient in the reports that record Stevens-Johnson syndrome
Sex	Reports	Share
Female	11,145	51%
Male	8,198	37.6%
Unknown or not given	2,489	11.4%

Age and sex are as the report gives them. 42.8% 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.

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Reported Reactions. Stevens-Johnson syndrome: adverse event reports that record this term. https://reportedreactions.com/reaction/stevens-johnson-syndrome/ 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 Stevens-Johnson syndrome mean in an adverse event report?

In plain words: a severe skin and mucous-membrane reaction. 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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