Drug · FAERS side-effect profile with label screen
Silver Sulfadiazine side effects: what 2,276 FDA adverse event reports show
Drug class
Sulfonamide Antibacterial
FDA label (Established Pharmacologic Class)
Who reports
2,276 reports · 65% serious · 291 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Silver sulfadiazine cream, USP 1% is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns.
FDA label, Indications and Usage
What it is
DESCRIPTION Silver sulfadiazine cream, USP 1% is a soft, white, water dispersible cream containing the antimicrobial agent silver sulfadiazine in micronized form for topical application. Each gram of silver sulfadiazine cream contains 10mg of micronized silver sulfadiazine.
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) 2Likely indication confounding 1Reporting / coding artifact 6Lab value / disease marker 2Not in label — unassessed 27
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 95 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 |
|---|---|---|---|---|---|---|
| Toxic epidermal necrolysis (severe skin peeling reaction) | 39 | 23.9 17.5–32.6ROR 24.3 · χ² 831 / p 5e-183 | 23.6 EB05 18.0 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.1 · ♀ 14% (drug 58%) · 91% clinician | no trial data cached |
| End stage renal disease | 39 | 19.5 14.3–26.7ROR 19.9 · χ² 667 / p 2e-147 | 19.3 EB05 14.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.2 | no trial data cached |
| Skin ulcer | 51 | 18.2 13.9–23.9ROR 18.6 · χ² 813 / p 4e-179 | 18.1 EB05 14.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 | no trial data cached |
| Economic problem | 24 | 14.4 9.6–21.4ROR 14.5 · χ² 285 / p 3e-64 | 13.9 EB05 9.5 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 13.9 | no trial data cached |
| Malnutrition | 17 | 14.1 8.8–22.7ROR 14.2 · χ² 194 / p 2e-44 | 13.3 EB05 8.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 | no trial data cached |
| Chronic kidney disease | 109 | 13.1 10.9–15.8ROR 13.7 · χ² 1,211 / p 1e-265 | 13.0 EB05 11.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
| Hyperlipidaemia | 17 | 13.1 8.1–21.0ROR 13.2 · χ² 178 / p 8e-41 | 12.1 EB05 7.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 | no trial data cached |
| Cellulitis (skin infection) | 66 | 12.1 9.5–15.3ROR 12.4 · χ² 660 / p 9e-146 | 11.9 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Anhedonia | 32 | 11.1 7.9–15.7ROR 11.3 · χ² 285 / p 3e-64 | 10.6 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Renal tubular necrosis | 11 | 10.3 5.7–18.6ROR 10.4 · χ² 83 / p 3e-20 | 8.4 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Skin infection | 12 | 9.9 5.6–17.4ROR 10.0 · χ² 87 / p 4e-21 | 8.2 EB05 4.6 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.1 | no trial data cached |
| Skin discolouration | 49 | 9.8 7.5–13.0ROR 10.0 · χ² 380 / p 5e-85 | 9.4 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 73% consumer | no trial data cached |
| Skin lesion | 29 | 9.8 6.8–14.1ROR 9.9 · χ² 221 / p 3e-50 | 9.1 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
| Blister | 54 | 8.9 6.8–11.6ROR 9.1 · χ² 371 / p 6e-83 | 8.5 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Application site pain | 21 | 8.8 5.7–13.5ROR 8.9 · χ² 137 / p 5e-32 | 7.8 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=7 · 75% consumer | no trial data cached |
| Scab | 10 | 8.1 4.4–15.1ROR 8.2 · χ² 56 / p 4e-14 | 6.3 EB05 3.6 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Tooth loss | 17 | 7.5 4.7–12.1ROR 7.6 · χ² 89 / p 2e-21 | 6.4 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Tubulointerstitial nephritis | 15 | 7.4 4.5–12.2ROR 7.4 · χ² 77 / p 1e-18 | 6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Oral candidiasis (oral thrush) | 10 | 7.1 3.8–13.2ROR 7.1 · χ² 46 / p 5e-12 | 5.6 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Impaired healing | 25 | 7.0 4.8–10.4ROR 7.1 · χ² 123 / p 6e-29 | 6.3 EB05 4.5 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | no trial data cached |
| Wound | 21 | 7.0 4.5–10.7ROR 7.0 · χ² 101 / p 4e-24 | 6.2 EB05 4.2 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 3.8 | no trial data cached |
| Renal injury | 22 | 6.8 4.5–10.2ROR 6.8 · χ² 102 / p 2e-24 | 6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Sleep apnoea syndrome | 14 | 6.7 4.0–11.4ROR 6.8 · χ² 63 / p 1e-15 | 5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Blood pressure systolic increased | 14 | 6.6 3.9–11.1ROR 6.6 · χ² 61 / p 3e-15 | 5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 6.4 | no trial data cached |
| Product prescribing issue | 14 | 6.3 3.8–10.7ROR 6.4 · χ² 58 / p 1e-14 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Cardiomyopathy | 10 | 6.2 3.4–11.6ROR 6.3 · χ² 39 / p 2e-10 | 5.0 EB05 2.9 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Pulmonary hypertension | 14 | 6.2 3.7–10.4ROR 6.2 · χ² 56 / p 4e-14 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Therapy partial responder | 10 | 6.1 3.3–11.4ROR 6.1 · χ² 38 / p 4e-10 | 4.9 EB05 2.8 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.6 | no trial data cached |
| Osteomyelitis | 12 | 6.1 3.5–10.8ROR 6.1 · χ² 46 / p 5e-12 | 5.1 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Osteopenia | 10 | 6.0 3.3–11.2ROR 6.1 · χ² 37 / p 5e-10 | 4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Blood urea increased | 11 | 6.0 3.3–10.9ROR 6.0 · χ² 41 / p 7e-11 | 4.9 EB05 2.9 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 5.9 | no trial data cached |
| Device related infection | 10 | 6.0 3.2–11.1ROR 6.0 · χ² 37 / p 7e-10 | 4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 | no trial data cached |
| Renal failure acute | 27 | 5.8 4.0–8.4ROR 5.8 · χ² 102 / p 3e-24 | 5.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Bone disorder | 11 | 5.5 3.1–10.0ROR 5.5 · χ² 36 / p 8e-10 | 4.6 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Renal failure (kidney failure) | 80 | 5.5 4.4–6.8ROR 5.7 · χ² 293 / p 6e-66 | 5.3 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 90 | 5.4 4.4–6.7ROR 5.6 · χ² 324 / p 8e-73 | 5.3 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Rib fracture | 12 | 5.4 3.1–9.5ROR 5.4 · χ² 39 / p 3e-10 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 13 | 5.4 3.1–9.2ROR 5.4 · χ² 42 / p 4e-11 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Product use in unapproved indication | 142 | 5.4 4.6–6.3ROR 5.6 · χ² 505 / p 5e-112 | 5.3 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 | no trial data cached |
| Localised infection | 14 | 5.3 3.2–9.0ROR 5.4 · χ² 45 / p 1e-11 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.1 | 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 |
|---|---|---|---|---|---|---|
| Product use in unapproved indication | 142 | 5.4 4.6–6.3ROR 5.6 · χ² 505 / p 5e-112 | 5.3 EB05 4.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 | no trial data cached |
| Chronic kidney disease | 109 | 13.1 10.9–15.8ROR 13.7 · χ² 1,211 / p 1e-265 | 13.0 EB05 11.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 90 | 5.4 4.4–6.7ROR 5.6 · χ² 324 / p 8e-73 | 5.3 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Drug hypersensitivity | 83 | 3.9 3.2–4.9ROR 4.0 · χ² 181 / p 2e-41 | 3.9 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Renal failure (kidney failure) | 80 | 5.5 4.4–6.8ROR 5.7 · χ² 293 / p 6e-66 | 5.3 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Cellulitis (skin infection) | 66 | 12.1 9.5–15.3ROR 12.4 · χ² 660 / p 9e-146 | 11.9 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Blister | 54 | 8.9 6.8–11.6ROR 9.1 · χ² 371 / p 6e-83 | 8.5 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Skin ulcer | 51 | 18.2 13.9–23.9ROR 18.6 · χ² 813 / p 4e-179 | 18.1 EB05 14.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 | no trial data cached |
| Emotional distress | 50 | 3.8 2.9–5.0ROR 3.9 · χ² 101 / p 6e-24 | 3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Skin discolouration | 49 | 9.8 7.5–13.0ROR 10.0 · χ² 380 / p 5e-85 | 9.4 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 73% consumer | no trial data cached |
| Cardiac failure congestive | 41 | 4.7 3.4–6.3ROR 4.7 · χ² 115 / p 5e-27 | 4.4 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · ♀ 37% (drug 58%) | no trial data cached |
| End stage renal disease | 39 | 19.5 14.3–26.7ROR 19.9 · χ² 667 / p 2e-147 | 19.3 EB05 14.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.2 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 39 | 23.9 17.5–32.6ROR 24.3 · χ² 831 / p 5e-183 | 23.6 EB05 18.0 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.1 · ♀ 14% (drug 58%) · 91% clinician | no trial data cached |
| Anhedonia | 32 | 11.1 7.9–15.7ROR 11.3 · χ² 285 / p 3e-64 | 10.6 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Skin lesion | 29 | 9.8 6.8–14.1ROR 9.9 · χ² 221 / p 3e-50 | 9.1 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | 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.
- End stage renal disease — n=39, PRR 19.5
- Skin ulcer — n=51, PRR 18.2
- Chronic kidney disease — n=109, PRR 13.1
- Cellulitis — n=66, PRR 12.1
- Anhedonia — n=32, PRR 11.1
- Skin discolouration — n=49, PRR 9.8
- Skin lesion — n=29, PRR 9.8
- Blister — n=54, PRR 8.9
- Application site pain — n=21, PRR 8.8
- Renal injury — n=22, PRR 6.8
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 Silver Sulfadiazine?
In FDA FAERS, the most frequently co-reported reaction terms for Silver Sulfadiazine are chronic kidney disease, acute kidney injury, drug hypersensitivity, renal failure, cellulitis, blister. 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 Silver Sulfadiazine have an FDA boxed warning?
No. The FDA label retrieved for Silver Sulfadiazine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Silver 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 067895f9-a797-4cbd-a3d2-d611d512fe5b, effective 20250617; matched on
openfda.generic_name.exact:"SILVER 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, 135 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.