Sulfasalazine side effects: what 77,779 FDA adverse event reports show

Sulfasalazine · 1,285 reaction terms · 908,319 drug–reaction co-reports · data 2026-09-14

Drug class

Aminosalicylate

FDA label (Established Pharmacologic Class)

Who reports

77,779 reports · 84% serious · 7,233 with death outcome · 77% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Sulfasalazine delayed release tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; b) for the prolongation of the remission period between acute attacks of ulcerative.

FDA label, Indications and Usage

What it is

Sulfasalazine is an azobenzene consisting of diphenyldiazene having a carboxy substituent at the 4-position, a hydroxy substituent at the 3-position and a 2-pyridylaminosulphonyl substituent at the 4'-position.

PubChem CID 5339 (ChEBI)

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 1Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 3Lab value / disease marker 11Not in label — unassessed 22

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,245 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Synovial fluid analysis	79	2,991.0 1,380.9–6,478.6ROR 2,994.0 · calibrated p 2e-18 ✓	230.8 EB05 191.1 · IC025 +6.2 3/3 methods agree	Reporting / coding artifact	serious n=79 · ♀ 100% (drug 77%) · 100% clinician	no trial arm names this drug
Human antichimeric antibody positive	304	2,598.9 1,796.1–3,760.6ROR 2,609.1 · calibrated p 3e-21 ✓	237.8 EB05 216.2 · IC025 +7.2 3/3 methods agree	Lab value / disease marker	serious n=304 · ♀ 100% (drug 77%)	no trial arm names this drug
Anti-cyclic citrullinated peptide antibody positive	5,597	1,046.1 987.3–1,108.4ROR 1,127.1 · calibrated p 6e-18 ✓	212.1 EB05 207.5 · IC025 +7.7 3/3 methods agree	Lab value / disease marker	serious PRR 146.3 · ♀ 99% (drug 77%) · 93% clinician	no trial arm names this drug
Red blood cell sedimentation rate	212	851.3 645.9–1,122.1ROR 853.6 · calibrated p 5e-16 ✓	199.2 EB05 177.7 · IC025 +6.9 3/3 methods agree	Lab value / disease marker	serious n=212	no trial arm names this drug
Swollen joint count increased	2,295	775.8 715.6–841.1ROR 799.4 · calibrated p 4e-16 ✓	198.0 EB05 191.3 · IC025 +7.5 3/3 methods agree	Lab value / disease marker	serious n=2,293 · ♀ 99% (drug 77%) · 95% clinician	no trial arm names this drug
Anti-cyclic citrullinated peptide antibody	487	750.4 630.7–892.7ROR 755.1 · calibrated p 1e-15 ✓	195.1 EB05 181.0 · IC025 +7.2 3/3 methods agree	Lab value / disease marker	serious n=487 · ♀ 100% (drug 77%) · 95% clinician	no trial arm names this drug
Rheumatoid factor positive	4,138	704.3 664.8–746.3ROR 743.9 · calibrated p 8e-16 ✓	193.1 EB05 188.2 · IC025 +7.5 3/3 methods agree	Lab value / disease marker	serious n=4,136 · ♀ 99% (drug 77%) · 93% clinician	no trial arm names this drug
Lupus vulgaris	844	675.8 595.2–767.2ROR 683.2 · calibrated p 2e-15 ✓	190.3 EB05 179.7 · IC025 +7.3 3/3 methods agree	Not in label — unassessed	serious n=844 · ♀ 100% (drug 77%) · 96% clinician	no trial arm names this drug
Rheumatic fever	3,055	644.1 603.4–687.6ROR 670.4 · calibrated p 2e-15 ✓	188.3 EB05 182.7 · IC025 +7.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=3,053 · ♀ 100% (drug 77%) · 95% clinician	no trial arm names this drug
Hepatic enzyme	93	547.7 383.7–781.8ROR 548.4 · calibrated p 1e-13 ✓	173.0 EB05 145.4 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=93 · ♀ 100% (drug 77%) · 100% clinician	no trial arm names this drug
Pemphigus	8,068	508.9 490.6–527.8ROR 567.6 · calibrated p 1e-14 ✓	174.8 EB05 171.7 · IC025 +7.4 3/3 methods agree	Not in label — unassessed	serious PRR 120.6 · ♀ 100% (drug 77%) · 91% clinician	no trial arm names this drug
Duodenal ulcer perforation	4,720	495.2 472.1–519.5ROR 527.1 · calibrated p 3e-14 ✓	173.2 EB05 169.1 · IC025 +7.4 3/3 methods agree	Not in label — unassessed	serious PRR 118.9 · ♀ 100% (drug 77%) · 94% clinician	no trial arm names this drug
Deep vein thrombosis postoperative	1,252	485.1 442.1–532.3ROR 493.0 · calibrated p 7e-14 ✓	171.6 EB05 163.8 · IC025 +7.2 3/3 methods agree	Not in label — unassessed	serious n=1,252 · ♀ 100% (drug 77%) · 94% clinician	no trial arm names this drug
C-reactive protein	558	437.5 382.3–500.7ROR 440.7 · calibrated p 3e-13 ✓	164.7 EB05 153.6 · IC025 +7.0 3/3 methods agree	Lab value / disease marker	serious n=558 · ♀ 100% (drug 77%) · 95% clinician	no trial arm names this drug
Granuloma skin	507	432.0 375.2–497.5ROR 434.9 · calibrated p 3e-13 ✓	163.9 EB05 152.2 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious n=507	no trial arm names this drug
Musculoskeletal deformity	138	385.0 296.5–499.9ROR 385.7 · calibrated p 2e-12 ✓	154.2 EB05 133.8 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=138 · ♀ 100% (drug 77%) · 100% clinician	no trial arm names this drug
Hand deformity	7,498	367.0 354.6–379.8ROR 406.0 · calibrated p 5e-13 ✓	154.4 EB05 151.5 · IC025 +7.2 3/3 methods agree	Not in label — unassessed	serious PRR 115.3 · 91% clinician	no trial arm names this drug
C-reactive protein abnormal	3,578	345.3 328.7–362.7ROR 361.9 · calibrated p 2e-12 ✓	150.4 EB05 146.3 · IC025 +7.1 3/3 methods agree	Lab value / disease marker	serious n=3,573	no trial arm names this drug
Rheumatoid factor negative	98	337.3 250.3–454.6ROR 337.7 · calibrated p 8e-12 ✓	144.8 EB05 122.3 · IC025 +6.1 3/3 methods agree	Reporting / coding artifact	serious n=98	no trial arm names this drug
Swollen joint count	135	331.3 257.2–426.6ROR 331.9 · calibrated p 7e-12 ✓	144.8 EB05 125.4 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=135 · ♀ 100% (drug 77%) · 100% clinician	no trial arm names this drug
Facet joint syndrome	1,686	313.3 292.1–336.1ROR 320.3 · calibrated p 5e-12 ✓	143.9 EB05 138.2 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious n=1,684 · ♀ 100% (drug 77%) · 95% clinician	no trial arm names this drug
Grip strength	123	307.5 237.2–398.7ROR 308.0 · calibrated p 2e-11 ✓	139.8 EB05 120.3 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=123 · ♀ 100% (drug 77%) · 100% clinician	no trial arm names this drug
Synovitis	9,222	284.5 276.5–292.8ROR 322.7 · calibrated p 5e-12 ✓	137.7 EB05 135.4 · IC025 +7.1 3/3 methods agree	Not in label — unassessed	serious PRR 98.8	no trial arm names this drug
X-ray abnormal	888	269.3 245.3–295.5ROR 272.4 · calibrated p 3e-11 ✓	133.7 EB05 126.5 · IC025 +6.9 3/3 methods agree	Lab value / disease marker	serious n=888 · 95% clinician	no trial arm names this drug
Body height below normal	315	255.3 218.7–298.0ROR 256.3 · calibrated p 5e-11 ✓	129.5 EB05 117.9 · IC025 +6.6 3/3 methods agree	Reporting / coding artifact	serious n=315 · ♀ 100% (drug 77%)	no trial arm names this drug
Dislocation of vertebra	1,073	253.2 233.0–275.2ROR 256.8 · calibrated p 4e-11 ✓	129.7 EB05 123.3 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=1,073 · ♀ 100% (drug 77%) · 94% clinician	no trial arm names this drug
Adjustment disorder with depressed mood	969	251.5 230.4–274.6ROR 254.7 · calibrated p 5e-11 ✓	129.2 EB05 122.5 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=969 · ♀ 100% (drug 77%) · 96% clinician	no trial arm names this drug
Presbyacusis	147	243.5 194.7–304.6ROR 244.0 · calibrated p 1e-10 ✓	125.3 EB05 109.2 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=147 · ♀ 100% (drug 77%)	no trial arm names this drug
Helicobacter infection	4,755	237.5 228.5–246.8ROR 252.9 · calibrated p 5e-11 ✓	125.7 EB05 122.7 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious PRR 91.3 · ♀ 100% (drug 77%) · 94% clinician	no trial arm names this drug
Red blood cell sedimentation rate abnormal	1,073	232.3 214.1–252.1ROR 235.6 · calibrated p 1e-10 ✓	124.0 EB05 117.9 · IC025 +6.8 3/3 methods agree	Lab value / disease marker	serious n=1,069	no trial arm names this drug
Retinitis	743	217.6 197.5–239.7ROR 219.7 · calibrated p 2e-10 ✓	119.6 EB05 112.5 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious n=743 · ♀ 100% (drug 77%) · 94% clinician	no trial arm names this drug
Sleep disorder due to general medical condition, insomnia type	2,798	208.5 198.5–218.9ROR 216.2 · calibrated p 2e-10 ✓	117.0 EB05 113.4 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=2,795 · ♀ 98% (drug 77%) · 94% clinician	no trial arm names this drug
Seronegative arthritis	483	204.8 181.9–230.6ROR 206.1 · calibrated p 3e-10 ✓	115.4 EB05 107.1 · IC025 +6.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=480 · 92% clinician	no trial arm names this drug
Subcutaneous drug absorption impaired	228	194.9 164.3–231.2ROR 195.5 · calibrated p 6e-10 ✓	111.7 EB05 100.1 · IC025 +6.3 3/3 methods agree	Labeled (related wording) related wording	serious n=227 · ♀ 100% (drug 77%) · 100% clinician	no trial arm names this drug
Muscle injury	3,407	192.4 184.2–200.9ROR 201.1 · calibrated p 4e-10 ✓	111.8 EB05 108.7 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 83.3 · ♀ 100% (drug 77%) · 94% clinician	no trial arm names this drug
Bone erosion	1,423	181.8 170.0–194.5ROR 185.2 · calibrated p 8e-10 ✓	108.1 EB05 103.5 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious n=1,420	no trial arm names this drug
Blood parathyroid hormone decreased	593	178.8 161.1–198.4ROR 180.2 · calibrated p 1e-9 ✓	106.8 EB05 99.8 · IC025 +6.5 3/3 methods agree	Lab value / disease marker	serious n=593	no trial arm names this drug
Hypocholesterolaemia	122	177.7 141.3–223.4ROR 177.9 · calibrated p 2e-9 ✓	105.0 EB05 90.3 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=122 · ♀ 100% (drug 77%) · 100% clinician	no trial arm names this drug
Folliculitis	3,905	164.5 158.2–171.1ROR 173.2 · calibrated p 1e-9 ✓	101.8 EB05 99.2 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious PRR 82.3 · ♀ 100% (drug 77%) · 94% clinician	no trial arm names this drug
Pericarditis	5,998	152.1 147.5–156.9ROR 164.8 · calibrated p 2e-9 ✓	97.0 EB05 94.9 · IC025 +6.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 67.2 · ♀ 99% (drug 77%) · 93% clinician	no trial arm names this drug

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Liver injury	11,564	10.710.5–10.9	signal
Interstitial lung disease	3,543	10.310.0–10.6	signal
Tendon disorder	647	4.64.3–5.0	signal
Serious infection	11,609	4.14.0–4.2	signal
Hyperglycaemia / diabetes	4,671	3.73.6–3.8	signal
Opportunistic infection	1,778	3.63.4–3.7	signal
Depression	2,808	2.72.6–2.8	signal
Anaphylaxis / angioedema	1,149	2.52.3–2.6	signal
Pancreatitis	623	2.11.9–2.3	raised
Severe cutaneous reaction	573	2.11.9–2.3	raised
Malignancy	2,681	1.91.9–2.0	raised
Venous thromboembolism	1,470	1.81.7–1.9	raised
Fall / fracture	2,408	1.71.6–1.8	raised
Gi bleeding	1,139	1.71.6–1.8	raised
Anaemia	1,510	1.41.3–1.4	raised
Rhabdomyolysis / myopathy	394	1.31.2–1.4	raised

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Sulfasalazine only as a background or rescue medication (NCT00259610, NCT00720798); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Drug ineffective (drug did not work)	29,356	6.1 6.1–6.2ROR 9.2 · calibrated p 0.042 ✓	6.0 EB05 6.0 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 6.7 · serious PRR 10.6	no trial arm names this drug
Rheumatoid arthritis	19,529	56.2 55.5–57.0ROR 74.7 · calibrated p 9e-7 ✓	46.6 EB05 46.0 · IC025 +5.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 45.2 · serious PRR 38.6	no trial arm names this drug
Pain	15,947	7.1 7.0–7.2ROR 8.7 · calibrated p 0.050	7.0 EB05 6.9 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 6.6 · serious PRR 7.3	no trial arm names this drug
Drug intolerance	13,762	44.9 44.2–45.7ROR 54.3 · calibrated p 8e-6 ✓	38.5 EB05 38.0 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 46.8 · serious PRR 42.3	no trial arm names this drug
Arthralgia (joint pain)	13,481	9.0 8.9–9.2ROR 10.7 · calibrated p 0.025 ✓	8.8 EB05 8.6 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 7.9 · serious PRR 10.5	no trial arm names this drug
Fatigue (tiredness)	13,318	4.7 4.6–4.8ROR 5.4 · calibrated p 0.191	4.6 EB05 4.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	age-adj. PRR 3.8 · serious PRR 5.8	no trial arm names this drug
Joint swelling	12,744	31.8 31.3–32.4ROR 37.9 · calibrated p 7e-5 ✓	28.5 EB05 28.1 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	age-adj. PRR 26.5 · serious PRR 33.1	no trial arm names this drug
Off label use (used outside approved label)	11,129	3.5 3.4–3.6ROR 3.9 · calibrated p 0.396	3.5 EB05 3.4 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 3.3 · serious PRR 4.3	no trial arm names this drug
Rash	10,987	7.0 6.9–7.1ROR 8.0 · calibrated p 0.067	6.8 EB05 6.7 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 6.3 · serious PRR 10.0	no trial arm names this drug
Abdominal discomfort	10,045	17.2 16.9–17.5ROR 19.6 · calibrated p 0.002 ✓	16.2 EB05 15.9 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	age-adj. PRR 14.5 · serious PRR 24.4	no trial arm names this drug
Contraindicated product administered	9,681	127.7 124.8–130.7ROR 145.7 · calibrated p 6e-9 ✓	86.5 EB05 85.1 · IC025 +6.4 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 104.7 · serious PRR 73.6	no trial arm names this drug
Condition aggravated	9,593	8.8 8.6–9.0ROR 9.9 · calibrated p 0.033 ✓	8.6 EB05 8.4 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 7.9 · serious PRR 8.7	no trial arm names this drug
Alopecia (hair loss)	9,474	13.6 13.3–13.9ROR 15.3 · calibrated p 0.006 ✓	13.0 EB05 12.8 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 10.3 · serious PRR 18.7 · ♀ 97% (drug 77%)	no trial arm names this drug
Synovitis	9,222	284.5 276.5–292.8ROR 322.7 · calibrated p 5e-12 ✓	137.7 EB05 135.4 · IC025 +7.1 3/3 methods agree	Not in label — unassessed	serious PRR 98.8	no trial arm names this drug
Arthropathy	9,216	53.3 52.2–54.4ROR 60.3 · calibrated p 4e-6 ✓	44.5 EB05 43.8 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	age-adj. PRR 45.4 · serious PRR 37.2	no trial arm names this drug

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Lupus vulgaris — n=844, PRR 675.8
Hepatic enzyme — n=93, PRR 547.7
Pemphigus — n=8,068, PRR 508.9
Duodenal ulcer perforation — n=4,720, PRR 495.2
Deep vein thrombosis postoperative — n=1,252, PRR 485.1
Granuloma skin — n=507, PRR 432.0
Musculoskeletal deformity — n=138, PRR 385.0
Hand deformity — n=7,498, PRR 367.0
Swollen joint count — n=135, PRR 331.3
Facet joint syndrome — n=1,686, PRR 313.3

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Sulfasalazine?

In FDA FAERS, the most frequently co-reported reaction terms for Sulfasalazine are rheumatoid arthritis, pain, arthralgia, fatigue, joint swelling, rash. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Sulfasalazine have an FDA boxed warning?

No. The FDA label retrieved for Sulfasalazine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Sulfasalazine causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 257cee60-b68f-4c2b-b57d-8e4d73d17e09, effective 20260825; matched on openfda.generic_name.exact:"SULFASALAZINE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
PubChem CID 5339 description (ChEBI)
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,285 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query SULFASALAZINE, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.