Drug · FAERS side-effect profile with label screen
Kojic Acidskin Lightening side effects: what 1,691 FDA adverse event reports show
Brand names
Glutathione
openFDA label
Who reports
1,691 reports · 80% serious · 158 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
none
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
Lab value / disease marker 15No label text to screen 25
What the badges mean
- 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. 35 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 |
|---|---|---|---|---|---|---|
| Hepatic function abnormal | 106 | 35.6 29.6–42.8ROR 37.9 · χ² 3,522 / p <1e-300 | 35.3 EB05 30.0 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.7 · 93% clinician | no trial data cached |
| Lymphocyte count decreased | 50 | 35.2 26.7–46.2ROR 36.2 · χ² 1,622 / p <1e-300 | 34.6 EB05 27.3 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious PRR 29.6 · 100% clinician | no trial data cached |
| Neutrophil count increased | 28 | 33.9 23.4–48.9ROR 34.4 · χ² 859 / p 5e-189 | 33.1 EB05 24.0 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious PRR 25.7 · ♀ 18% (drug 55%) · 96% clinician | no trial data cached |
| Drug-induced liver injury | 69 | 27.8 22.1–35.0ROR 28.9 · χ² 1,755 / p <1e-300 | 27.6 EB05 22.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.1 · 99% clinician | no trial data cached |
| Sputum discoloured | 16 | 21.0 12.9–34.2ROR 21.2 · χ² 285 / p 3e-64 | 20.4 EB05 13.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.7 | no trial data cached |
| Hypocalcaemia (low calcium) | 30 | 19.7 13.8–28.1ROR 20.1 · χ² 515 / p 3e-114 | 19.5 EB05 14.2 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.0 · 90% clinician | no trial data cached |
| Obstructive airways disorder | 17 | 18.9 11.8–30.4ROR 19.1 · χ² 270 / p 4e-61 | 18.4 EB05 11.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.1 | no trial data cached |
| Full blood count abnormal | 16 | 18.8 11.6–30.7ROR 19.0 · χ² 253 / p 4e-57 | 18.2 EB05 11.6 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 17.9 | no trial data cached |
| Myelosuppression | 50 | 18.2 13.9–24.0ROR 18.8 · χ² 798 / p 7e-176 | 18.1 EB05 14.2 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.1 · 94% clinician | no trial data cached |
| Liver injury | 35 | 18.0 12.9–25.0ROR 18.3 · χ² 544 / p 1e-120 | 17.8 EB05 13.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.4 | no trial data cached |
| Neutrophil count decreased | 55 | 16.9 13.0–21.9ROR 17.4 · χ² 805 / p 2e-177 | 16.7 EB05 13.3 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 13.3 · 95% clinician | no trial data cached |
| Blood lactate dehydrogenase increased | 21 | 16.3 10.7–25.0ROR 16.5 · χ² 287 / p 1e-64 | 15.9 EB05 10.6 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 11.9 | no trial data cached |
| Blood urea increased | 22 | 16.2 10.7–24.6ROR 16.4 · χ² 299 / p 3e-67 | 15.8 EB05 10.7 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 12.9 · ♀ 33% (drug 55%) | no trial data cached |
| Alanine aminotransferase increased | 72 | 14.5 11.6–18.2ROR 15.2 · χ² 897 / p 3e-197 | 14.4 EB05 11.8 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 10.8 · 91% clinician | no trial data cached |
| Tendonitis | 18 | 14.4 9.1–22.7ROR 14.5 · χ² 211 / p 5e-48 | 13.6 EB05 8.6 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.1 | no trial data cached |
| Aspartate aminotransferase increased | 61 | 14.3 11.1–18.2ROR 14.8 · χ² 740 / p 3e-163 | 14.1 EB05 11.3 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 10.6 · 92% clinician | no trial data cached |
| Gamma-glutamyltransferase increased | 24 | 13.4 9.0–20.0ROR 13.6 · χ² 264 / p 1e-59 | 12.9 EB05 8.7 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 9.6 | no trial data cached |
| Pulmonary mass | 16 | 13.4 8.2–21.8ROR 13.5 · χ² 171 / p 3e-39 | 12.4 EB05 7.4 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.4 | no trial data cached |
| Blood bilirubin increased | 28 | 12.8 8.9–18.5ROR 13.0 · χ² 294 / p 4e-66 | 12.3 EB05 8.6 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 9.0 | no trial data cached |
| Sleep disorder due to a general medical condition | 16 | 12.3 7.5–20.0ROR 12.4 · χ² 155 / p 8e-36 | 11.1 EB05 6.7 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.3 | no trial data cached |
| Lung infection | 15 | 11.8 7.1–19.6ROR 11.9 · χ² 138 / p 4e-32 | 10.5 EB05 6.2 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 | no trial data cached |
| Transaminases increased | 21 | 11.7 7.7–17.9ROR 11.9 · χ² 196 / p 1e-44 | 10.9 EB05 7.1 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.0 · ♀ 30% (drug 55%) · 90% clinician | no trial data cached |
| Hypomagnesaemia | 13 | 11.6 6.8–20.0ROR 11.7 · χ² 116 / p 3e-27 | 10.1 EB05 5.7 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.9 | no trial data cached |
| Hypokalaemia (low potassium) | 43 | 11.6 8.7–15.6ROR 11.9 · χ² 408 / p 6e-91 | 11.3 EB05 8.5 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.1 · 95% clinician | no trial data cached |
| Platelet count decreased | 96 | 11.2 9.2–13.6ROR 11.8 · χ² 884 / p 2e-194 | 11.0 EB05 9.2 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 9.5 · 92% clinician | no trial data cached |
| Bone marrow failure | 18 | 10.9 6.9–17.3ROR 11.0 · χ² 152 / p 3e-35 | 9.8 EB05 6.2 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.9 | no trial data cached |
| Electrolyte imbalance | 10 | 10.8 5.8–20.0ROR 10.8 · χ² 79 / p 3e-19 | 8.7 EB05 4.6 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.0 | no trial data cached |
| Hepatic failure | 24 | 9.9 6.6–14.7ROR 10.0 · χ² 182 / p 8e-42 | 9.0 EB05 6.1 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 | no trial data cached |
| White blood cell count increased | 30 | 9.7 6.8–13.8ROR 9.8 · χ² 225 / p 4e-51 | 9.0 EB05 6.4 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 8.3 · ♀ 24% (drug 55%) · 93% clinician | no trial data cached |
| White blood cell count decreased | 79 | 9.0 7.3–11.2ROR 9.4 · χ² 559 / p 7e-124 | 8.8 EB05 7.2 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 8.5 · 91% clinician | no trial data cached |
| C-reactive protein increased | 26 | 8.9 6.1–13.0ROR 9.0 · χ² 174 / p 5e-40 | 8.1 EB05 5.6 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 6.6 · 92% clinician | no trial data cached |
| Coagulopathy | 11 | 8.2 4.6–14.8ROR 8.3 · χ² 63 / p 1e-15 | 6.5 EB05 3.8 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 | no trial data cached |
| Upper gastrointestinal haemorrhage | 10 | 7.4 4.0–13.6ROR 7.4 · χ² 49 / p 1e-12 | 5.8 EB05 3.3 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial data cached |
| Lymphadenopathy | 20 | 7.0 4.5–10.8ROR 7.1 · χ² 97 / p 3e-23 | 6.2 EB05 4.2 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 | no trial data cached |
| Blood triglycerides increased | 10 | 7.0 3.8–13.0ROR 7.0 · χ² 46 / p 7e-12 | 5.5 EB05 3.2 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.1 | no trial data cached |
| Stomatitis (mouth sores) | 33 | 6.7 4.8–9.5ROR 6.9 · χ² 156 / p 4e-36 | 6.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 · ♀ 79% (drug 55%) | no trial data cached |
| Hepatotoxicity (liver damage) | 12 | 6.7 3.8–11.8ROR 6.8 · χ² 53 / p 2e-13 | 5.5 EB05 3.3 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.9 | no trial data cached |
| Oral pain | 10 | 5.5 3.0–10.2ROR 5.5 · χ² 33 / p 5e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 | no trial data cached |
| Jaundice (yellowing of skin/eyes) | 11 | 5.1 2.8–9.1ROR 5.1 · χ² 32 / p 8e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial data cached |
| Pneumonitis | 11 | 5.0 2.8–9.1ROR 5.1 · χ² 32 / p 9e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | 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 |
|---|---|---|---|---|---|---|
| Hepatic function abnormal | 106 | 35.6 29.6–42.8ROR 37.9 · χ² 3,522 / p <1e-300 | 35.3 EB05 30.0 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.7 · 93% clinician | no trial data cached |
| Platelet count decreased | 96 | 11.2 9.2–13.6ROR 11.8 · χ² 884 / p 2e-194 | 11.0 EB05 9.2 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 9.5 · 92% clinician | no trial data cached |
| White blood cell count decreased | 79 | 9.0 7.3–11.2ROR 9.4 · χ² 559 / p 7e-124 | 8.8 EB05 7.2 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 8.5 · 91% clinician | no trial data cached |
| Alanine aminotransferase increased | 72 | 14.5 11.6–18.2ROR 15.2 · χ² 897 / p 3e-197 | 14.4 EB05 11.8 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 10.8 · 91% clinician | no trial data cached |
| Drug-induced liver injury | 69 | 27.8 22.1–35.0ROR 28.9 · χ² 1,755 / p <1e-300 | 27.6 EB05 22.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.1 · 99% clinician | no trial data cached |
| Aspartate aminotransferase increased | 61 | 14.3 11.1–18.2ROR 14.8 · χ² 740 / p 3e-163 | 14.1 EB05 11.3 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 10.6 · 92% clinician | no trial data cached |
| Neutrophil count decreased | 55 | 16.9 13.0–21.9ROR 17.4 · χ² 805 / p 2e-177 | 16.7 EB05 13.3 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 13.3 · 95% clinician | no trial data cached |
| Myelosuppression | 50 | 18.2 13.9–24.0ROR 18.8 · χ² 798 / p 7e-176 | 18.1 EB05 14.2 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.1 · 94% clinician | no trial data cached |
| Lymphocyte count decreased | 50 | 35.2 26.7–46.2ROR 36.2 · χ² 1,622 / p <1e-300 | 34.6 EB05 27.3 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious PRR 29.6 · 100% clinician | no trial data cached |
| Hypokalaemia (low potassium) | 43 | 11.6 8.7–15.6ROR 11.9 · χ² 408 / p 6e-91 | 11.3 EB05 8.5 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.1 · 95% clinician | no trial data cached |
| Liver injury | 35 | 18.0 12.9–25.0ROR 18.3 · χ² 544 / p 1e-120 | 17.8 EB05 13.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.4 | no trial data cached |
| Stomatitis (mouth sores) | 33 | 6.7 4.8–9.5ROR 6.9 · χ² 156 / p 4e-36 | 6.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 · ♀ 79% (drug 55%) | no trial data cached |
| White blood cell count increased | 30 | 9.7 6.8–13.8ROR 9.8 · χ² 225 / p 4e-51 | 9.0 EB05 6.4 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 8.3 · ♀ 24% (drug 55%) · 93% clinician | no trial data cached |
| Hypocalcaemia (low calcium) | 30 | 19.7 13.8–28.1ROR 20.1 · χ² 515 / p 3e-114 | 19.5 EB05 14.2 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.0 · 90% clinician | no trial data cached |
| Blood bilirubin increased | 28 | 12.8 8.9–18.5ROR 13.0 · χ² 294 / p 4e-66 | 12.3 EB05 8.6 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 9.0 | 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 Kojic Acidskin Lightening?
In FDA FAERS, the most frequently co-reported reaction terms for Kojic Acidskin Lightening are hepatic function abnormal, platelet count decreased, white blood cell count decreased, alanine aminotransferase increased, drug-induced liver injury, aspartate aminotransferase increased. 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 Kojic Acidskin Lightening have an FDA boxed warning?
No. The FDA label retrieved for Kojic Acidskin Lightening has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Kojic Acidskin Lightening 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 2be274be-e6d0-d961-e063-6294a90a2190, effective 20251127; matched on
openfda.generic_name.exact:"KOJIC ACIDSKIN LIGHTENING") - 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, 75 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.