Drug · FAERS side-effect profile with label screen
Sulfadiazine side effects: what 1,677 FDA adverse event reports show
Drug class
Sulfonamide Antibacterial
FDA label (Established Pharmacologic Class)
Who reports
1,677 reports · 79% serious · 264 with death outcome · 52% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Sulfadiazine Tablets are indicated in the following conditions: Chancroid Trachoma Inclusion conjunctivitis Nocardiosis Urinary tract infections (primarily pyelonephritis, pyelitis and cystitis) in the absence of obstructive uropathy or foreign bodies,.
FDA label, Indications and Usage
What it is
DESCRIPTION Sulfadiazine is an oral sulfonamide antibacterial agent. Sulfadiazine Tablets, USP contains 500 mg Sulfadiazine, USP. Inactive ingredients: corn starch, colloidal silicon dioxide, croscarmellose sodium, calcium stearate, lactose monohydrate, and sucrose.
FDA label, Description section
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 2Labeled (related wording) 4Likely indication confounding 2Reporting / coding artifact 3Not in label — unassessed 29
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.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 50 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Obstructive airways disorder | 111 | 125.6 104.8–150.5ROR 134.4 · χ² 13,465 / p <1e-300 | 121.8 EB05 103.9 · IC025 +6.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 94.3 · ♀ 1% (drug 52%) | no trial data cached |
| Full blood count abnormal | 102 | 122.1 101.1–147.6ROR 130.0 · χ² 12,021 / p <1e-300 | 118.3 EB05 100.3 · IC025 +5.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 117.2 · ♀ 0% (drug 52%) | no trial data cached |
| Vasculitis | 106 | 114.7 95.3–138.1ROR 122.4 · χ² 11,734 / p <1e-300 | 111.4 EB05 94.7 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 89.3 · ♀ 0% (drug 52%) | no trial data cached |
| Arteriosclerosis | 77 | 103.0 82.7–128.2ROR 107.9 · χ² 7,613 / p <1e-300 | 99.7 EB05 82.3 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 77.0 · ♀ 3% (drug 52%) | no trial data cached |
| Sleep disorder due to a general medical condition | 107 | 83.3 69.3–100.1ROR 88.9 · χ² 8,565 / p <1e-300 | 81.6 EB05 69.4 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 118.4 · ♀ 1% (drug 52%) | no trial data cached |
| Nodule | 81 | 78.1 63.1–96.6ROR 82.0 · χ² 6,052 / p <1e-300 | 76.2 EB05 63.3 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 87.7 · ♀ 7% (drug 52%) | no trial data cached |
| Pulmonary fibrosis | 113 | 74.4 62.2–88.9ROR 79.7 · χ² 8,064 / p <1e-300 | 73.0 EB05 62.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 54.5 · ♀ 0% (drug 52%) | no trial data cached |
| Haemoptysis | 113 | 50.7 42.4–60.7ROR 54.3 · χ² 5,445 / p <1e-300 | 50.1 EB05 42.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 41.5 · ♀ 2% (drug 52%) | no trial data cached |
| Hypothyroidism | 109 | 42.9 35.8–51.5ROR 45.9 · χ² 4,415 / p <1e-300 | 42.5 EB05 36.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 34.4 · ♀ 1% (drug 52%) | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 47 | 39.1 29.5–51.8ROR 40.2 · χ² 1,702 / p <1e-300 | 38.4 EB05 30.0 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.5 · ♀ 11% (drug 52%) | no trial data cached |
| Lung disorder | 116 | 29.7 24.9–35.4ROR 31.8 · χ² 3,187 / p <1e-300 | 29.5 EB05 25.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 24.3 · ♀ 1% (drug 52%) | no trial data cached |
| Hypoxia (low oxygen) | 77 | 27.5 22.1–34.2ROR 28.8 · χ² 1,940 / p <1e-300 | 27.3 EB05 22.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 20.4 · ♀ 3% (drug 52%) | no trial data cached |
| Loss of personal independence in daily activities | 99 | 26.1 21.5–31.6ROR 27.7 · χ² 2,363 / p <1e-300 | 25.9 EB05 21.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 25.0 · ♀ 1% (drug 52%) | no trial data cached |
| Wheezing | 107 | 22.7 18.9–27.2ROR 24.1 · χ² 2,195 / p <1e-300 | 22.5 EB05 19.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 22.8 · ♀ 0% (drug 52%) | no trial data cached |
| Therapeutic product effect incomplete | 122 | 21.6 18.2–25.6ROR 23.2 · χ² 2,381 / p <1e-300 | 21.5 EB05 18.5 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 27.7 · ♀ 6% (drug 52%) | no trial data cached |
| Productive cough (cough with phlegm) | 80 | 21.2 17.1–26.2ROR 22.2 · χ² 1,518 / p <1e-300 | 21.0 EB05 17.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 22.7 · ♀ 3% (drug 52%) | no trial data cached |
| Pancytopenia (all blood cells low) | 79 | 17.7 14.3–22.0ROR 18.6 · χ² 1,233 / p 2e-270 | 17.6 EB05 14.6 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.0 · 92% clinician | no trial data cached |
| Bone marrow failure | 27 | 16.5 11.4–24.0ROR 16.8 · χ² 378 / p 2e-84 | 16.2 EB05 11.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · ♀ 88% (drug 52%) · 100% clinician | no trial data cached |
| Pneumonia aspiration | 30 | 15.1 10.6–21.5ROR 15.3 · χ² 380 / p 6e-85 | 14.7 EB05 10.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · ♀ 96% (drug 52%) | no trial data cached |
| End stage renal disease | 22 | 15.0 9.9–22.6ROR 15.1 · χ² 273 / p 2e-61 | 14.4 EB05 9.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Nephropathy | 11 | 14.7 8.1–26.4ROR 14.8 · χ² 127 / p 1e-29 | 13.2 EB05 6.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 27 | 13.2 9.1–19.2ROR 13.4 · χ² 293 / p 5e-66 | 12.7 EB05 8.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Asthma | 115 | 12.8 10.8–15.3ROR 13.7 · χ² 1,249 / p 7e-274 | 12.7 EB05 10.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · ♀ 1% (drug 52%) | no trial data cached |
| Pancreatitis (pancreas inflammation) | 54 | 12.8 9.8–16.6ROR 13.2 · χ² 575 / p 2e-127 | 12.5 EB05 9.9 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.5 · ♀ 98% (drug 52%) · 98% clinician | no trial data cached |
| Gastrointestinal pain | 11 | 12.6 7.0–22.7ROR 12.6 · χ² 106 / p 4e-25 | 10.8 EB05 5.7 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.9 | no trial data cached |
| Rash maculo-papular | 22 | 12.4 8.2–18.8ROR 12.6 · χ² 220 / p 5e-50 | 11.7 EB05 7.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Drug hypersensitivity | 190 | 12.2 10.7–14.0ROR 13.7 · χ² 1,967 / p <1e-300 | 12.2 EB05 10.8 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.6 · ♀ 77% (drug 52%) | no trial data cached |
| Pharyngitis | 12 | 12.1 6.9–21.2ROR 12.1 · χ² 111 / p 3e-26 | 10.4 EB05 5.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 21 | 11.8 7.7–18.0ROR 11.9 · χ² 197 / p 5e-45 | 10.9 EB05 7.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.7 · ♀ 14% (drug 52%) · 95% clinician | no trial data cached |
| Thrombosis | 74 | 11.5 9.2–14.3ROR 12.0 · χ² 699 / p 2e-154 | 11.3 EB05 9.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · ♀ 0% (drug 52%) | no trial data cached |
| Central nervous system lesion | 12 | 10.9 6.2–19.1ROR 10.9 · χ² 98 / p 2e-23 | 9.1 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Pulmonary embolism (lung blood clot) | 81 | 10.6 8.6–13.1ROR 11.1 · χ² 699 / p 3e-154 | 10.4 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · ♀ 4% (drug 52%) | no trial data cached |
| Incorrect route of product administration | 14 | 10.4 6.2–17.6ROR 10.5 · χ² 110 / p 5e-26 | 8.9 EB05 5.3 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 15.2 | no trial data cached |
| Chronic kidney disease | 58 | 9.5 7.4–12.2ROR 9.8 · χ² 432 / p 3e-96 | 9.1 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Adverse reaction | 10 | 9.4 5.1–17.5ROR 9.5 · χ² 67 / p 1e-16 | 7.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Eosinophilia | 13 | 9.3 5.4–16.0ROR 9.4 · χ² 88 / p 3e-21 | 7.7 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Coma | 35 | 9.2 6.6–12.8ROR 9.4 · χ² 248 / p 4e-56 | 8.6 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 94% (drug 52%) | no trial data cached |
| Coagulopathy | 12 | 9.0 5.1–15.9ROR 9.1 · χ² 78 / p 5e-19 | 7.4 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Musculoskeletal disorder | 13 | 8.5 4.9–14.6ROR 8.6 · χ² 79 / p 4e-19 | 7.0 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Candida infection (yeast infection) | 11 | 8.2 4.6–14.9ROR 8.3 · χ² 63 / p 1e-15 | 6.6 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 hypersensitivity | 190 | 12.2 10.7–14.0ROR 13.7 · χ² 1,967 / p <1e-300 | 12.2 EB05 10.8 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.6 · ♀ 77% (drug 52%) | no trial data cached |
| Condition aggravated | 163 | 6.8 5.8–7.8ROR 7.4 · χ² 804 / p 3e-177 | 6.6 EB05 5.8 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.4 · ♀ 11% (drug 52%) | no trial data cached |
| Pain in extremity | 132 | 5.6 4.7–6.6ROR 6.0 · χ² 500 / p 4e-111 | 5.5 EB05 4.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · ♀ 15% (drug 52%) | no trial data cached |
| Therapeutic product effect incomplete | 122 | 21.6 18.2–25.6ROR 23.2 · χ² 2,381 / p <1e-300 | 21.5 EB05 18.5 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 27.7 · ♀ 6% (drug 52%) | no trial data cached |
| Lung disorder | 116 | 29.7 24.9–35.4ROR 31.8 · χ² 3,187 / p <1e-300 | 29.5 EB05 25.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 24.3 · ♀ 1% (drug 52%) | no trial data cached |
| Asthma | 115 | 12.8 10.8–15.3ROR 13.7 · χ² 1,249 / p 7e-274 | 12.7 EB05 10.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · ♀ 1% (drug 52%) | no trial data cached |
| Haemoptysis | 113 | 50.7 42.4–60.7ROR 54.3 · χ² 5,445 / p <1e-300 | 50.1 EB05 42.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 41.5 · ♀ 2% (drug 52%) | no trial data cached |
| Pulmonary fibrosis | 113 | 74.4 62.2–88.9ROR 79.7 · χ² 8,064 / p <1e-300 | 73.0 EB05 62.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 54.5 · ♀ 0% (drug 52%) | no trial data cached |
| Obstructive airways disorder | 111 | 125.6 104.8–150.5ROR 134.4 · χ² 13,465 / p <1e-300 | 121.8 EB05 103.9 · IC025 +6.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 94.3 · ♀ 1% (drug 52%) | no trial data cached |
| Hypothyroidism | 109 | 42.9 35.8–51.5ROR 45.9 · χ² 4,415 / p <1e-300 | 42.5 EB05 36.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 34.4 · ♀ 1% (drug 52%) | no trial data cached |
| Wheezing | 107 | 22.7 18.9–27.2ROR 24.1 · χ² 2,195 / p <1e-300 | 22.5 EB05 19.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 22.8 · ♀ 0% (drug 52%) | no trial data cached |
| Sleep disorder due to a general medical condition | 107 | 83.3 69.3–100.1ROR 88.9 · χ² 8,565 / p <1e-300 | 81.6 EB05 69.4 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 118.4 · ♀ 1% (drug 52%) | no trial data cached |
| Vasculitis | 106 | 114.7 95.3–138.1ROR 122.4 · χ² 11,734 / p <1e-300 | 111.4 EB05 94.7 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 89.3 · ♀ 0% (drug 52%) | no trial data cached |
| Full blood count abnormal | 102 | 122.1 101.1–147.6ROR 130.0 · χ² 12,021 / p <1e-300 | 118.3 EB05 100.3 · IC025 +5.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 117.2 · ♀ 0% (drug 52%) | no trial data cached |
| Loss of personal independence in daily activities | 99 | 26.1 21.5–31.6ROR 27.7 · χ² 2,363 / p <1e-300 | 25.9 EB05 21.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 25.0 · ♀ 1% (drug 52%) | no trial data cached |
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.
- Vasculitis — n=106, PRR 114.7
- Arteriosclerosis — n=77, PRR 103.0
- Sleep disorder due to a general medical condition — n=107, PRR 83.3
- Nodule — n=81, PRR 78.1
- Pulmonary fibrosis — n=113, PRR 74.4
- Haemoptysis — n=113, PRR 50.7
- Hypothyroidism — n=109, PRR 42.9
- Lung disorder — n=116, PRR 29.7
- Hypoxia — n=77, PRR 27.5
- Loss of personal independence in daily activities — n=99, PRR 26.1
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 Sulfadiazine?
In FDA FAERS, the most frequently co-reported reaction terms for Sulfadiazine are drug hypersensitivity, pain in extremity, lung disorder, asthma, haemoptysis, pulmonary fibrosis. 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 Sulfadiazine have an FDA boxed warning?
No. The FDA label retrieved for Sulfadiazine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sulfadiazine 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 6032d6f7-cbce-4e5d-841c-a1e24b616f91, effective 20240924; matched on
openfda.generic_name.exact:"SULFADIAZINE") - 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, fieldpatient.drug.openfda.generic_name.exact, 90 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
Page generated 2026-10-08. 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.