Pharmacologic class (EPC) · 7 drug pages

Aminosalicylate: adverse event reports filed with FDA

59,220 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.

59,220
reports across the class: 0.3% of all reports; 3,834
reports, 12 months to June 2026: 5,416 in the 12 months before; 86.5%
marked serious by the reporter: 57.4% across all reports; 7
drugs with a page: brand and generic names counted separately

Aminosalicylate is a pharmacologic class (an FDA Established Pharmacologic Class) with 7 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 59,220 adverse event reports received by FDA, 0.3% of the database, from January 2004 to June 2026.

3,834 reports arrived in the 12 months to June 2026, down 29% from 5,416 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 86.5% of the class's reports are marked serious, 11.3% record death among the outcomes and 28.9% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (44.6%), rheumatoid arthritis (26.8%) and pain (21.8%). 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
Sulfasalazine	generic	40,741	2,020	89.9%	Drug ineffective
Mesalamine	generic	8,961	1,401	92%	Drug ineffective
LialdaMesalamine	brand	3,749	165	56.4%	Drug ineffective
PentasaMesalamine	brand	3,082	141	80.1%	Drug ineffective
AzulfidineSulfasalazine	brand	1,332	91	68.5%	Drug ineffective
AprisoMesalamine	brand	836	2	42%	Diarrhoea
Azulfidine En-TabsSulfasalazine	brand	519	14	97.5%	Pyrexia

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 expected44.6%26,412
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease26.8%15,882
Painpain, site not specified21.8%12,938
Drug intolerancethe medicine was not tolerated20.9%12,405
Fatiguetiredness18.5%10,978
Joint swellinga swollen joint17.6%10,417
Off label useused for a purpose or in a way not on the label17%10,052
Rashskin rash16.9%9,997
Arthralgiajoint pain16.2%9,577
Abdominal discomfortstomach discomfort15.9%9,391
Contraindicated product administered15.5%9,191
Alopeciahair loss15%8,877
Condition aggravatedthe condition being treated got worse14.9%8,816
Systemic lupus erythematosuslupus, an autoimmune disease14.5%8,559
Synovitis14%8,266
Arthropathy13.8%8,161
Treatment failurethe treatment did not work13.7%8,129
Drug hypersensitivityan allergic-type reaction to a medicine13.4%7,913
Swellingswelling13.1%7,785
Pemphigus13.1%7,745
Glossodynia12.8%7,561
Nauseafeeling sick12%7,113
Hand deformity12%7,109
Hypersensitivityan allergic-type reaction11.8%6,976
Infusion related reactiona reaction during or soon after an infusion11.6%6,879

Solid bar: share of all class reports. Hollow bar: the median share across the 7 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death11.3%6,700

Life-threatening11.8%6,985

Hospitalisation (initial or prolonged)28.9%17,138

Disability14.9%8,836

Congenital anomaly5.1%2,993

Other serious74.8%44,287

Not serious13.5%8,007

Patient age

Under 20.2%97

2 to 110.8%486

12 to 171.4%828

18 to 4420.8%12,300

45 to 6422.3%13,235

65 to 748.8%5,205

75 and over4.9%2,888

Age not given40.8%24,181

Who reported

Physician26.4%15,646

Pharmacist2.4%1,438

Other health professional45.5%26,952

Lawyer0%21

Consumer or non-health professional24.3%14,400

Not given1.3%763

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 Aminosalicylate reports

Which drugs are in the Aminosalicylate class on this site?

Sulfasalazine, Mesalamine, Lialda, Pentasa, Azulfidine and Apriso and 1 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

59,220 reports through June 2026, 3,834 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 (44.6%), rheumatoid arthritis (26.8%), pain (21.8%), drug intolerance (20.9%) and fatigue (18.5%).

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.