Pharmacologic class (EPC) · 2 drug pages

Antirheumatic agent: adverse event reports filed with FDA

71,196 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.

71,196
reports across the class: 0.3% of all reports; 3,992
reports, 12 months to June 2026: 5,195 in the 12 months before; 92.1%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Antirheumatic agent 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 71,196 adverse event reports received by FDA, 0.3% of the database, from January 2004 to June 2026.

3,992 reports arrived in the 12 months to June 2026, down 23% from 5,195 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 92.1% of the class's reports are marked serious, 14.3% record death among the outcomes and 30.8% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (51.5%), rheumatoid arthritis (37.5%) and pain (30%). 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
Leflunomide	generic	36,993	2,568	94.2%	Drug ineffective
AravaLeflunomide	brand	34,203	1,424	89.8%	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 expected51.5%36,660
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease37.5%26,709
Painpain, site not specified30%21,330
Drug intolerancethe medicine was not tolerated27%19,188
Joint swellinga swollen joint26.1%18,584
Fatiguetiredness24.5%17,419
Rashskin rash23.5%16,702
Arthralgiajoint pain23.3%16,608
Contraindicated product administered22.4%15,927
Abdominal discomfortstomach discomfort21.2%15,104
Alopeciahair loss21.1%15,016
Arthropathy19.8%14,086
Off label useused for a purpose or in a way not on the label19.4%13,830
Synovitis19.3%13,750
Swellingswelling19.1%13,623
Systemic lupus erythematosuslupus, an autoimmune disease19%13,560
Pemphigus18.3%13,049
Condition aggravatedthe condition being treated got worse17.5%12,493
Hypersensitivityan allergic-type reaction17.5%12,459
Glossodynia17.2%12,239
Treatment failurethe treatment did not work16.8%11,982
Hand deformity16.7%11,906
Hepatic enzyme increasedraised liver enzymes16.5%11,782
Drug hypersensitivityan allergic-type reaction to a medicine15.6%11,109
Peripheral swellingswelling of the arms or legs15.2%10,799

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

Death14.3%10,216

Life-threatening15.9%11,291

Hospitalisation (initial or prolonged)30.8%21,907

Disability21.2%15,087

Congenital anomaly7.7%5,472

Other serious81.4%57,928

Not serious7.9%5,637

Patient age

Under 20.1%63

2 to 110.2%174

12 to 170.3%237

18 to 4421.1%14,998

45 to 6424.6%17,492

65 to 748.6%6,145

75 and over4.1%2,913

Age not given41%29,174

Who reported

Physician25.6%18,205

Pharmacist1.2%854

Other health professional52.6%37,460

Lawyer0.1%36

Consumer or non-health professional19.4%13,797

Not given1.2%844

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 Antirheumatic agent reports

Which drugs are in the Antirheumatic agent class on this site?

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

How many reports does the class have?

71,196 reports through June 2026, 3,992 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 (51.5%), rheumatoid arthritis (37.5%), pain (30%), drug intolerance (27%) and joint swelling (26.1%).

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.