Pharmacologic class (EPC) · 2 drug pages

Sulfone: adverse event reports filed with FDA

4,070 reports list a drug in this class as a suspect or interacting product, 2004–2026.

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.

4,070
reports across the class: 0% of all reports; 467
reports, 12 months to June 2026: 446 in the 12 months before; 75.7%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Sulfone is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 4,070 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026.

467 reports arrived in the 12 months to June 2026, close to the 446 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 75.7% of the class's reports are marked serious, 5.5% record death among the outcomes and 29.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (18.7%), off label use (13.5%) and methaemoglobinaemia (11.1%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Dapsone	generic	3,515	465	86.3%	Drug ineffective
AczoneDapsone	brand	555	2	8.6%	Drug ineffective

Ordered by report count for navigation only. 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."

Reports by month, five years

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

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected18.7%763
Off label useused for a purpose or in a way not on the label13.5%548
Methaemoglobinaemia11.1%452
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement8.6%352
Treatment failurethe treatment did not work7.1%290
Product use in unapproved indicationused for a purpose not on the label4.6%189
Condition aggravatedthe condition being treated got worse4.3%177
Pyrexiafever4.1%166
Drug ineffective for unapproved indication3.6%147
Haemolytic anaemia3.6%146
Anaemialow red blood cells3.6%145
Rashskin rash2.9%119
Drug interactionan interaction between medicines2.7%110
Dyspnoeashortness of breath2.6%105
Nauseafeeling sick2.5%103
Drug hypersensitivityan allergic-type reaction to a medicine2.3%92
Erythemaskin redness2.3%92
Therapy non-responderthe treatment did not work2.2%91
Acute kidney injurysudden loss of kidney function2.1%84
Drug-induced liver injury1.9%78
Painpain, site not specified1.9%78
Pruritusitching1.9%78
Hypoxialow oxygen1.8%75
Fatiguetiredness1.8%73
Hypertensionhigh blood pressure1.7%70

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death5.5%225

Life-threatening8.9%363

Hospitalisation (initial or prolonged)29.1%1,184

Disability1%39

Congenital anomaly0.5%22

Other serious55.8%2,270

Not serious24.3%988

Patient age

Under 20.5%22

2 to 112.4%98

12 to 174.8%194

18 to 4426.7%1,086

45 to 6423.3%950

65 to 749%367

75 and over4.7%193

Age not given28.5%1,160

Who reported

Physician26.9%1,093

Pharmacist6.8%278

Other health professional44.6%1,814

Lawyer0%2

Consumer or non-health professional18.1%738

Not given3.6%145

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Sulfone reports

Which drugs are in the Sulfone class on this site?

Dapsone and Aczone. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

4,070 reports through June 2026, 467 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (18.7%), off label use (13.5%), methaemoglobinaemia (11.1%), drug reaction with eosinophilia and systemic symptoms (8.6%) and treatment failure (7.1%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.