Drug · FAERS side-effect profile with label screen
Astringent side effects: what 1,853 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Salicylic Acid
openFDA label
Who reports
1,853 reports · 88% serious · 611 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
for the treatment of acne
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 1Lab value / disease marker 1No label text to screen 38
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.
- 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.
- 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. 162 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 |
|---|---|---|---|---|---|---|
| Joint dislocation | 151 | 164.6 141.1–192.0ROR 179.1 · χ² 24,041 / p <1e-300 | 158.9 EB05 138.8 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 119.9 · ♀ 100% (drug 63%) · 99% clinician | no trial data cached |
| Wound infection | 145 | 152.9 130.6–179.0ROR 165.8 · χ² 21,450 / p <1e-300 | 148.0 EB05 128.8 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 106.3 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Hypercholesterolaemia | 127 | 152.1 128.5–180.2ROR 163.3 · χ² 18,672 / p <1e-300 | 146.8 EB05 126.6 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 104.8 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Joint range of motion decreased | 152 | 130.1 111.6–151.6ROR 141.6 · χ² 19,131 / p <1e-300 | 126.6 EB05 110.6 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 107.7 · ♀ 100% (drug 63%) · 99% clinician | no trial data cached |
| Helicobacter infection | 109 | 122.2 101.8–146.8ROR 129.8 · χ² 12,849 / p <1e-300 | 118.4 EB05 100.9 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 83.9 · ♀ 100% (drug 63%) · 96% clinician | no trial data cached |
| Pemphigus | 124 | 113.9 96.0–135.2ROR 122.0 · χ² 13,637 / p <1e-300 | 110.9 EB05 95.5 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 74.3 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Laryngitis | 98 | 103.0 84.9–125.0ROR 108.7 · χ² 9,714 / p <1e-300 | 100.1 EB05 84.6 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=98 · ♀ 100% (drug 63%) · 99% clinician | no trial data cached |
| Pericarditis | 143 | 97.9 83.6–114.7ROR 106.0 · χ² 13,508 / p <1e-300 | 95.8 EB05 83.4 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 64.3 · ♀ 99% (drug 63%) | no trial data cached |
| Folliculitis | 83 | 91.6 74.2–113.1ROR 95.8 · χ² 7,291 / p <1e-300 | 89.1 EB05 74.1 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 70.2 · ♀ 100% (drug 63%) · 96% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 87 | 89.4 72.8–109.9ROR 93.8 · χ² 7,462 / p <1e-300 | 87.1 EB05 72.8 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious PRR 66.1 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Sciatica | 124 | 89.1 75.1–105.7ROR 95.4 · χ² 10,639 / p <1e-300 | 87.3 EB05 75.1 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 78.1 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| Irritable bowel syndrome | 160 | 85.3 73.5–99.0ROR 93.3 · χ² 13,163 / p <1e-300 | 83.9 EB05 73.5 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 70.6 · ♀ 98% (drug 63%) · 96% clinician | no trial data cached |
| Prescribed underdose | 147 | 84.0 71.9–98.1ROR 91.1 · χ² 11,890 / p <1e-300 | 82.5 EB05 71.9 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 93.6 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Autoimmune disorder | 68 | 80.9 64.0–102.3ROR 84.0 · χ² 5,252 / p <1e-300 | 78.6 EB05 64.2 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 56.4 · ♀ 100% (drug 63%) · 99% clinician | no trial data cached |
| Hip arthroplasty | 96 | 71.9 59.2–87.5ROR 75.8 · χ² 6,608 / p <1e-300 | 70.5 EB05 59.5 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.4 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Foot deformity | 70 | 71.8 57.0–90.4ROR 74.6 · χ² 4,787 / p <1e-300 | 70.0 EB05 57.3 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 54.5 · ♀ 100% (drug 63%) · 99% clinician | no trial data cached |
| Joint stiffness | 155 | 67.2 57.8–78.2ROR 73.2 · χ² 9,994 / p <1e-300 | 66.3 EB05 58.0 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 79.8 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| Hand deformity | 76 | 66.1 53.0–82.4ROR 68.9 · χ² 4,780 / p <1e-300 | 64.7 EB05 53.4 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.9 · ♀ 100% (drug 63%) · 99% clinician | no trial data cached |
| Wound | 156 | 63.8 54.9–74.2ROR 69.6 · χ² 9,541 / p <1e-300 | 63.0 EB05 55.1 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.3 · ♀ 99% (drug 63%) · 95% clinician | no trial data cached |
| Synovitis | 101 | 63.6 52.6–77.0ROR 67.3 · χ² 6,135 / p <1e-300 | 62.6 EB05 53.0 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.5 · ♀ 100% (drug 63%) · 99% clinician | no trial data cached |
| Pulmonary fibrosis | 101 | 60.1 49.7–72.7ROR 63.5 · χ² 5,783 / p <1e-300 | 59.1 EB05 50.1 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.7 · ♀ 97% (drug 63%) · 97% clinician | no trial data cached |
| Type 2 diabetes mellitus | 178 | 59.9 52.1–68.9ROR 66.2 · χ² 10,215 / p <1e-300 | 59.2 EB05 52.3 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.3 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| Prescribed overdose | 101 | 59.3 49.1–71.8ROR 62.7 · χ² 5,709 / p <1e-300 | 58.4 EB05 49.5 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.1 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| Lower limb fracture | 94 | 55.9 45.9–68.2ROR 58.9 · χ² 4,997 / p <1e-300 | 55.1 EB05 46.4 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.2 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| Knee arthroplasty | 97 | 52.9 43.5–64.2ROR 55.7 · χ² 4,865 / p <1e-300 | 52.1 EB05 44.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.0 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Liver function test increased | 99 | 52.7 43.5–63.9ROR 55.7 · χ² 4,955 / p <1e-300 | 52.0 EB05 44.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.8 · ♀ 100% (drug 63%) · 99% clinician | no trial data cached |
| Fibromyalgia | 108 | 50.5 42.0–60.7ROR 53.6 · χ² 5,175 / p <1e-300 | 49.9 EB05 42.5 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.5 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Liver injury | 104 | 48.8 40.5–58.9ROR 51.7 · χ² 4,811 / p <1e-300 | 48.2 EB05 40.9 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.1 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| Hepatic cirrhosis | 74 | 45.0 35.9–56.2ROR 46.8 · χ² 3,127 / p <1e-300 | 44.3 EB05 36.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.8 · ♀ 100% (drug 63%) · 99% clinician | no trial data cached |
| Impaired healing | 129 | 44.6 37.7–52.7ROR 47.9 · χ² 5,442 / p <1e-300 | 44.2 EB05 38.1 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 35.0 · ♀ 98% (drug 63%) · 98% clinician | no trial data cached |
| Osteoarthritis | 154 | 41.2 35.4–47.9ROR 44.8 · χ² 5,983 / p <1e-300 | 40.8 EB05 35.7 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.2 · ♀ 95% (drug 63%) · 95% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 78 | 39.6 31.9–49.2ROR 41.3 · χ² 2,889 / p <1e-300 | 39.1 EB05 32.4 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.0 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| Gait inability | 115 | 39.4 33.0–47.1ROR 42.0 · χ² 4,260 / p <1e-300 | 39.1 EB05 33.4 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.1 · ♀ 100% (drug 63%) | no trial data cached |
| Psoriatic arthropathy | 136 | 38.4 32.6–45.1ROR 41.3 · χ² 4,905 / p <1e-300 | 38.1 EB05 33.0 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.6 · ♀ 92% (drug 63%) · 90% clinician | no trial data cached |
| Osteoporosis | 136 | 37.5 31.9–44.1ROR 40.4 · χ² 4,785 / p <1e-300 | 37.2 EB05 32.2 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.2 · ♀ 99% (drug 63%) · 94% clinician | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 146 | 35.9 30.7–41.9ROR 38.9 · χ² 4,912 / p <1e-300 | 35.6 EB05 31.0 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.0 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| Road traffic accident | 129 | 35.0 29.6–41.3ROR 37.5 · χ² 4,217 / p <1e-300 | 34.7 EB05 30.0 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.5 · ♀ 100% (drug 63%) · 95% clinician | no trial data cached |
| Systemic lupus erythematosus | 109 | 35.0 29.1–41.9ROR 37.1 · χ² 3,556 / p <1e-300 | 34.7 EB05 29.5 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.5 · ♀ 100% (drug 63%) · 96% clinician | no trial data cached |
| Disability | 59 | 33.8 26.3–43.5ROR 34.9 · χ² 1,843 / p <1e-300 | 33.4 EB05 26.8 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.8 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| Wheezing | 158 | 30.3 26.1–35.2ROR 33.0 · χ² 4,445 / p <1e-300 | 30.1 EB05 26.4 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.2 · ♀ 90% (drug 63%) · 94% clinician | 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 |
|---|---|---|---|---|---|---|
| Pruritus (itching) | 205 | 6.1 5.4–7.0ROR 6.8 · χ² 892 / p 3e-196 | 6.1 EB05 5.4 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.4 | no trial data cached |
| Weight decreased (weight loss) | 188 | 7.6 6.7–8.7ROR 8.4 · χ² 1,089 / p 3e-239 | 7.5 EB05 6.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · ♀ 93% (drug 63%) | no trial data cached |
| Condition aggravated | 184 | 6.9 6.0–7.9ROR 7.5 · χ² 934 / p 2e-205 | 6.8 EB05 6.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 · 91% clinician | no trial data cached |
| Urticaria (hives) | 184 | 12.5 10.9–14.4ROR 13.8 · χ² 1,952 / p <1e-300 | 12.4 EB05 11.0 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.4 · ♀ 97% (drug 63%) · 97% clinician | no trial data cached |
| Weight increased (weight gain) | 183 | 9.3 8.1–10.7ROR 10.2 · χ² 1,360 / p 5e-298 | 9.2 EB05 8.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.4 · ♀ 99% (drug 63%) · 96% clinician | no trial data cached |
| Hypertension (high blood pressure) | 181 | 9.7 8.4–11.1ROR 10.6 · χ² 1,410 / p <1e-300 | 9.5 EB05 8.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.9 · ♀ 92% (drug 63%) · 93% clinician | no trial data cached |
| Infection | 178 | 14.0 12.2–16.1ROR 15.4 · χ² 2,144 / p <1e-300 | 13.9 EB05 12.3 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.4 · ♀ 89% (drug 63%) | no trial data cached |
| Type 2 diabetes mellitus | 178 | 59.9 52.1–68.9ROR 66.2 · χ² 10,215 / p <1e-300 | 59.2 EB05 52.3 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.3 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| Psoriasis | 174 | 15.1 13.1–17.4ROR 16.5 · χ² 2,283 / p <1e-300 | 15.0 EB05 13.2 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.0 | no trial data cached |
| Pain in extremity | 169 | 6.5 5.6–7.5ROR 7.0 · χ² 788 / p 1e-173 | 6.4 EB05 5.6 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · ♀ 95% (drug 63%) | no trial data cached |
| Hypoaesthesia (numbness) | 165 | 12.5 10.8–14.4ROR 13.6 · χ² 1,739 / p <1e-300 | 12.4 EB05 10.9 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.1 · ♀ 98% (drug 63%) · 97% clinician | no trial data cached |
| Toxicity to various agents | 162 | 10.9 9.4–12.7ROR 11.9 · χ² 1,461 / p <1e-300 | 10.8 EB05 9.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 | no trial data cached |
| Irritable bowel syndrome | 160 | 85.3 73.5–99.0ROR 93.3 · χ² 13,163 / p <1e-300 | 83.9 EB05 73.5 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 70.6 · ♀ 98% (drug 63%) · 96% clinician | no trial data cached |
| Wheezing | 158 | 30.3 26.1–35.2ROR 33.0 · χ² 4,445 / p <1e-300 | 30.1 EB05 26.4 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.2 · ♀ 90% (drug 63%) · 94% clinician | no trial data cached |
| Peripheral swelling | 156 | 11.5 9.9–13.4ROR 12.5 · χ² 1,496 / p <1e-300 | 11.4 EB05 10.0 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.9 · ♀ 99% (drug 63%) | 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 Astringent?
In FDA FAERS, the most frequently co-reported reaction terms for Astringent are pruritus, weight decreased, urticaria, weight increased, hypertension, infection. 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 Astringent have an FDA boxed warning?
No. The FDA label retrieved for Astringent has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Astringent 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 7d15560f-d8d1-4dfe-8eca-b16bb529ad87, effective 20260213; matched on
openfda.generic_name.exact:"ASTRINGENT") - 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, 202 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.