Brand name · Sulfasalazine
Azulfidine: adverse event reports filed with FDA
1,332 reports list it as a suspect or interacting product, 2004–2026. Class: Aminosalicylate.
- 1,332
- reports as suspect product
- 0% of all reports · about 59 a year
- 91
- reports, 12 months to June 2026
- 107 in the 12 months before
- 68.5%
- marked serious by the reporter
- 86.5% across the class
- 16.7%
- record death among outcomes, as reported
- 222 reports · not verified by FDA
1,332 adverse event reports received by FDA list the brand name Azulfidine (sulfasalazine) as a suspect or interacting product, from January 2004 to June 2026. A further 2,076 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 91 reports listed it, down 15% from 107 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 59 reports a year and 0% of the 20,646,523 reports in the database, and 2.2% of the reports for the aminosalicylate class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are drug ineffective (19.6%), drug hypersensitivity (18.5%) and diarrhoea (11.8%). A report can list several reactions, so shares add to more than 100%; 461 different terms appear across these reports. Drug ineffective is recorded in 19.6% of these reports, about the same share as in the median aminosalicylate drug (19.6%).
68.5% of the reports are marked serious by the reporter (86.5% across the class); 16.7% record death among the outcomes and 37.7% record hospitalisation, as reported. 42% of the reports came from physicians, and the largest patient age group is 45 to 64 (25.2%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Azulfidine reports recording the termmedian drug in aminosalicylate
- Drug ineffectivethe medicine did not work as expected19.6%261
- Drug hypersensitivityan allergic-type reaction to a medicine18.5%246
- Diarrhoealoose or frequent stools11.8%157
- Rashskin rash11.3%151
- Headachehead pain10.7%142
- Pyrexiafever10.7%142
- Arthralgiajoint pain10.2%136
- Dizzinesslight-headedness or unsteadiness10.1%135
- Painpain, site not specified9.5%127
- Astheniaweakness or lack of energy9.5%126
- Decreased appetitereduced appetite9.5%126
- Night sweatssweating at night9.5%126
- Abdominal pain upperupper stomach pain9.4%125
- Joint range of motion decreasedreduced movement of a joint9.4%125
- Off label useused for a purpose or in a way not on the label9.3%124
- Frequent bowel movements9.2%123
- Bursitis9.1%121
- Joint swellinga swollen joint9%120
- Muscle spasmsmuscle cramps9%120
- Lung disordera lung problem, type not specified8.9%119
- Psoriatic arthropathy8.9%119
- Hepatic enzyme increasedraised liver enzymes8.9%118
- Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease8.9%118
- Depressionlow mood8.8%117
- Peripheral swellingswelling of the arms or legs8.8%117
- Liver disorder8.6%115
- Musculoskeletal painpain in muscles or bones8.6%115
- Abdominal discomfortstomach discomfort8.5%113
- Feeling hotfeeling hot8.5%113
Top 30 of 461 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 7 drugs in the aminosalicylate class; it describes the reports, not the patients. 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."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 59,220 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 43.5% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Rheumatoid arthritis | 461 | 34.6% |
| Colitis ulcerative | 48 | 3.6% |
| Arthritis | 8 | 0.6% |
| Crohn's disease | 8 | 0.6% |
| Psoriatic arthropathy | 8 | 0.6% |
| Crohn's disease | 7 | 0.5% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,332 reports.
In context
| Measure | Azulfidine | Aminosalicylate | All reports |
|---|---|---|---|
| Reports as suspect product | 1,332 | 59,220 | 20,646,523 |
| Share of that pool | — | 2.2% | 0% |
| Reports, latest 12 months | 91 | — | 1,332,454 |
| Marked serious | 68.5% | 86.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 167 | 113 | 91 |
| Hospitalisation recorded, per 1,000 reports | 377 | 289 | 213 |
| Consumer-filed share | 19.4% | 24.3% | 45.8% |
| Top term, share of reports | Drug ineffective 19.6% | median 19.6% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."
Other drugs in the aminosalicylate class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Sulfasalazine | generic | 40,741 | 2,020 | 89.9% |
| Mesalamine | generic | 8,961 | 1,401 | 92% |
| Lialda | brand | 3,749 | 165 | 56.4% |
| Pentasa | brand | 3,082 | 141 | 80.1% |
| Apriso | brand | 836 | 2 | 42% |
| Azulfidine En-Tabs | brand | 519 | 14 | 97.5% |
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." A brand and its generic are separate rows because reporters name them separately.
Questions about Azulfidine reports
How many adverse event reports has FDA received for Azulfidine?
1,332 reports list Azulfidine as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 91 of them arrived in the latest 12 months. Another 2,076 list it only as a concomitant medication.
What reactions are recorded in Azulfidine reports?
drug ineffective (19.6%), drug hypersensitivity (18.5%), diarrhoea (11.8%), rash (11.3%) and headache (10.7%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Azulfidine was responsible.
How serious are the reports?
68.5% are marked serious by the reporter. Among the outcomes recorded, 16.7% of reports include death and 37.7% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (42%), other health professional (28.3%) and consumer or non-health professional (19.4%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Azulfidine rising?
91 reports in the 12 months to June 2026, down 15% from 107 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Azulfidine was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Azulfidine?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Azulfidine as a suspect or interacting product; reports listing it only as a concomitant medication (2,076) are excluded. 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.