Drug · FAERS side-effect profile with label screen
Sulfur side effects: what 8,379 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Clinicians Complex
openFDA label
Who reports
8,379 reports · 2% serious · 6 with death outcome · 82% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For the treatment of acne • Dries up acne pimples • Dries and clears acne blemishes Helps keep skin clear of new acne blemishes
FDA label, Indications and Usage
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
Reporting / coding artifact 3No label text to screen 37
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 193 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 |
|---|---|---|---|---|---|---|
| Skin fragility | 162 | 177.7 151.8–208.2ROR 181.2 · χ² 26,397 / p <1e-300 | 162.7 EB05 142.7 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Acne cystic | 104 | 89.1 73.4–108.2ROR 90.2 · χ² 8,662 / p <1e-300 | 84.7 EB05 71.9 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | 98% consumer | no trial data cached |
| Acne | 2,256 | 76.4 73.7–79.2ROR 104.1 · χ² 163,291 / p <1e-300 | 74.1 EB05 71.5 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.9 · 100% consumer | no trial data cached |
| Skin burning sensation | 2,016 | 73.0 70.2–75.9ROR 95.8 · χ² 139,432 / p <1e-300 | 70.9 EB05 68.3 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.8 · 100% consumer | no trial data cached |
| Skin irritation | 1,265 | 70.9 67.4–74.7ROR 83.4 · χ² 84,898 / p <1e-300 | 68.9 EB05 65.8 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 100% consumer | no trial data cached |
| Seborrhoea | 98 | 68.3 56.0–83.4ROR 69.1 · χ² 6,263 / p <1e-300 | 65.7 EB05 55.5 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 100% consumer | no trial data cached |
| Chemical burn | 27 | 60.9 41.6–89.2ROR 61.1 · χ² 1,495 / p <1e-300 | 57.2 EB05 41.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Pain of skin | 633 | 60.1 55.7–64.8ROR 64.9 · χ² 35,882 / p <1e-300 | 58.6 EB05 54.8 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Lower respiratory tract infection viral | 11 | 56.3 31.0–102.4ROR 56.4 · χ² 532 / p 6e-118 | 50.6 EB05 30.1 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Chemical burn of skin | 54 | 54.0 41.2–70.6ROR 54.3 · χ² 2,696 / p <1e-300 | 51.9 EB05 41.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Acne pustular | 17 | 53.0 32.8–85.6ROR 53.1 · χ² 799 / p 5e-176 | 49.2 EB05 32.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Dry skin | 2,549 | 49.4 47.8–51.1ROR 70.6 · χ² 119,311 / p <1e-300 | 48.5 EB05 46.9 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.2 · 100% consumer | no trial data cached |
| Skin hyperpigmentation | 163 | 48.5 41.6–56.5ROR 49.4 · χ² 7,393 / p <1e-300 | 47.3 EB05 41.5 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 100% consumer | no trial data cached |
| Skin discomfort | 44 | 42.1 31.3–56.7ROR 42.3 · χ² 1,696 / p <1e-300 | 40.7 EB05 31.6 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | 98% consumer | no trial data cached |
| Skin hypopigmentation | 29 | 42.1 29.2–60.7ROR 42.2 · χ² 1,103 / p 4e-242 | 40.4 EB05 29.5 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Skin exfoliation | 1,152 | 35.2 33.3–37.1ROR 40.6 · χ² 37,826 / p <1e-300 | 34.7 EB05 33.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 · 99% consumer | no trial data cached |
| Rash papular | 283 | 31.9 28.4–35.8ROR 33.0 · χ² 8,347 / p <1e-300 | 31.5 EB05 28.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | 99% consumer | no trial data cached |
| Sensitive skin | 85 | 29.7 24.0–36.8ROR 30.0 · χ² 2,303 / p <1e-300 | 29.2 EB05 24.4 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | 99% consumer | no trial data cached |
| Skin swelling | 95 | 28.2 23.1–34.5ROR 28.6 · χ² 2,443 / p <1e-300 | 27.8 EB05 23.4 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 98% consumer | no trial data cached |
| Skin tightness | 50 | 27.0 20.4–35.6ROR 27.1 · χ² 1,211 / p 1e-265 | 26.4 EB05 20.8 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Erythema (skin redness) | 2,047 | 25.2 24.3–26.2ROR 33.0 · χ² 47,531 / p <1e-300 | 24.9 EB05 24.1 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 · 99% consumer | no trial data cached |
| Rash macular | 202 | 14.6 12.7–16.7ROR 14.9 · χ² 2,534 / p <1e-300 | 14.5 EB05 12.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.1 · 99% consumer | no trial data cached |
| Skin fissures | 107 | 14.3 11.8–17.2ROR 14.4 · χ² 1,299 / p 7e-285 | 14.1 EB05 12.0 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Dermatitis | 114 | 13.8 11.5–16.6ROR 14.0 · χ² 1,339 / p 2e-293 | 13.7 EB05 11.7 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Skin injury | 18 | 13.7 8.6–21.8ROR 13.7 · χ² 199 / p 2e-45 | 12.9 EB05 8.0 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Scar | 93 | 13.6 11.1–16.7ROR 13.8 · χ² 1,071 / p 3e-235 | 13.5 EB05 11.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.0 · 100% consumer | no trial data cached |
| Scab | 61 | 13.5 10.5–17.4ROR 13.6 · χ² 692 / p 8e-153 | 13.3 EB05 10.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Skin erosion | 16 | 12.6 7.7–20.6ROR 12.6 · χ² 159 / p 1e-36 | 11.4 EB05 6.9 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Skin warm | 28 | 12.1 8.3–17.5ROR 12.1 · χ² 273 / p 1e-61 | 11.5 EB05 8.0 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Skin reaction | 67 | 12.0 9.4–15.2ROR 12.1 · χ² 660 / p 8e-146 | 11.7 EB05 9.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | 99% consumer | no trial data cached |
| Inappropriate schedule of drug administration | 331 | 11.5 10.4–12.8ROR 12.0 · χ² 3,168 / p <1e-300 | 11.4 EB05 10.4 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 · 99% consumer | no trial data cached |
| Rosacea | 19 | 10.3 6.6–16.2ROR 10.3 · χ² 150 / p 1e-34 | 9.2 EB05 5.9 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Drug administered to patient of inappropriate age | 29 | 10.0 7.0–14.4ROR 10.1 · χ² 226 / p 3e-51 | 9.3 EB05 6.6 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | 93% consumer | no trial data cached |
| Skin wrinkling | 10 | 9.3 5.0–17.2ROR 9.3 · χ² 65 / p 3e-16 | 7.2 EB05 4.0 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Underdose | 267 | 9.2 8.2–10.3ROR 9.4 · χ² 1,936 / p <1e-300 | 9.1 EB05 8.2 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Skin haemorrhage | 49 | 8.5 6.4–11.3ROR 8.6 · χ² 317 / p 3e-71 | 8.1 EB05 6.3 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 100% consumer | no trial data cached |
| Sunburn | 23 | 7.7 5.1–11.7ROR 7.8 · χ² 128 / p 6e-30 | 6.9 EB05 4.8 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Skin discolouration | 129 | 7.0 5.9–8.4ROR 7.1 · χ² 662 / p 2e-146 | 6.9 EB05 5.9 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.1 · 100% consumer | no trial data cached |
| Inappropriate schedule of product administration | 455 | 6.5 5.9–7.1ROR 6.8 · χ² 2,104 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 1.7 · 99% consumer | no trial data cached |
| Rash erythematous | 115 | 6.2 5.1–7.4ROR 6.2 · χ² 491 / p 4e-109 | 6.0 EB05 5.1 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | 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 |
|---|---|---|---|---|---|---|
| Dry skin | 2,549 | 49.4 47.8–51.1ROR 70.6 · χ² 119,311 / p <1e-300 | 48.5 EB05 46.9 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.2 · 100% consumer | no trial data cached |
| Acne | 2,256 | 76.4 73.7–79.2ROR 104.1 · χ² 163,291 / p <1e-300 | 74.1 EB05 71.5 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.9 · 100% consumer | no trial data cached |
| Erythema (skin redness) | 2,047 | 25.2 24.3–26.2ROR 33.0 · χ² 47,531 / p <1e-300 | 24.9 EB05 24.1 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 · 99% consumer | no trial data cached |
| Skin burning sensation | 2,016 | 73.0 70.2–75.9ROR 95.8 · χ² 139,432 / p <1e-300 | 70.9 EB05 68.3 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.8 · 100% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 1,428 | 2.7 2.6–2.8ROR 3.1 · χ² 1,648 / p <1e-300 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 98% consumer | no trial data cached |
| Skin irritation | 1,265 | 70.9 67.4–74.7ROR 83.4 · χ² 84,898 / p <1e-300 | 68.9 EB05 65.8 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 100% consumer | no trial data cached |
| Skin exfoliation | 1,152 | 35.2 33.3–37.1ROR 40.6 · χ² 37,826 / p <1e-300 | 34.7 EB05 33.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 · 99% consumer | no trial data cached |
| Rash | 821 | 4.7 4.4–5.1ROR 5.2 · χ² 2,470 / p <1e-300 | 4.7 EB05 4.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 · 100% consumer | no trial data cached |
| Pruritus (itching) | 650 | 4.3 4.0–4.6ROR 4.6 · χ² 1,676 / p <1e-300 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 · 99% consumer | no trial data cached |
| Pain of skin | 633 | 60.1 55.7–64.8ROR 64.9 · χ² 35,882 / p <1e-300 | 58.6 EB05 54.8 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Overdose | 516 | 6.0 5.5–6.5ROR 6.3 · χ² 2,149 / p <1e-300 | 5.9 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 · 99% consumer | no trial data cached |
| Inappropriate schedule of product administration | 455 | 6.5 5.9–7.1ROR 6.8 · χ² 2,104 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 1.7 · 99% consumer | no trial data cached |
| Inappropriate schedule of drug administration | 331 | 11.5 10.4–12.8ROR 12.0 · χ² 3,168 / p <1e-300 | 11.4 EB05 10.4 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 · 99% consumer | no trial data cached |
| Hypersensitivity (allergic reaction) | 315 | 4.3 3.8–4.7ROR 4.4 · χ² 788 / p 1e-173 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.2 · 99% consumer | no trial data cached |
| Rash papular | 283 | 31.9 28.4–35.8ROR 33.0 · χ² 8,347 / p <1e-300 | 31.5 EB05 28.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | 99% consumer | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Sulfur?
In FDA FAERS, the most frequently co-reported reaction terms for Sulfur are dry skin, acne, erythema, skin burning sensation, skin irritation, skin exfoliation. 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 Sulfur have an FDA boxed warning?
No. The FDA label retrieved for Sulfur has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sulfur 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 0f13770a-774b-49ad-8417-02928371682a, effective 20251111; matched on
openfda.generic_name.exact:"SULFUR") - 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, 233 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.