Drug · FAERS side-effect profile with label screen
Coal Tar side effects: what 784 FDA adverse event reports show
Drug class
Not stated in label
Who reports
784 reports · 91% serious · 14 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
controls the symptom of: dandruff seborrheic dermatitis psoriasis
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 1No label text to screen 39
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. 42 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 |
|---|---|---|---|---|---|---|
| Affect lability | 193 | 544.8 481.2–616.8ROR 722.4 · χ² 102,155 / p <1e-300 | 506.8 EB05 449.6 · IC025 +7.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 470.9 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
| Motor dysfunction | 192 | 517.5 456.9–586.1ROR 685.0 · χ² 96,615 / p <1e-300 | 483.0 EB05 428.3 · IC025 +7.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 404.0 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
| Muscle spasticity | 192 | 420.6 371.5–476.2ROR 556.7 · χ² 78,745 / p <1e-300 | 397.6 EB05 352.6 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 374.3 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
| Sinus congestion | 209 | 419.6 373.1–471.9ROR 571.8 · χ² 85,557 / p <1e-300 | 398.0 EB05 354.7 · IC025 +7.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=209 · ♀ 100% (drug 63%) · 93% clinician | no trial data cached |
| Skin haemorrhage | 214 | 402.7 358.8–451.9ROR 553.5 · χ² 84,115 / p <1e-300 | 383.0 EB05 341.8 · IC025 +7.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=213 · ♀ 98% (drug 63%) · 92% clinician | no trial data cached |
| Coordination abnormal | 193 | 372.6 329.3–421.6ROR 494.0 · χ² 70,211 / p <1e-300 | 354.5 EB05 314.5 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 322.2 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
| Respiratory tract congestion | 199 | 338.9 300.2–382.5ROR 453.8 · χ² 65,905 / p <1e-300 | 324.1 EB05 288.1 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 489.1 · ♀ 100% (drug 63%) · 92% clinician | no trial data cached |
| Hemiparesis | 191 | 303.1 267.7–343.2ROR 400.4 · χ² 56,604 / p <1e-300 | 290.9 EB05 257.9 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 204.9 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
| Sinus disorder | 211 | 287.6 256.1–323.1ROR 393.2 · χ² 59,393 / p <1e-300 | 277.4 EB05 247.4 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 386.0 · ♀ 99% (drug 63%) · 92% clinician | no trial data cached |
| Sneezing | 211 | 254.8 226.8–286.1ROR 348.2 · χ² 52,629 / p <1e-300 | 246.7 EB05 220.0 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 396.9 · ♀ 99% (drug 63%) · 92% clinician | no trial data cached |
| Eating disorder | 189 | 238.6 210.6–270.4ROR 314.1 · χ² 44,128 / p <1e-300 | 231.0 EB05 204.6 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 208.4 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
| Angina pectoris | 186 | 173.6 153.0–196.9ROR 227.2 · χ² 31,577 / p <1e-300 | 169.5 EB05 150.0 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 112.7 · ♀ 100% (drug 63%) · 91% clinician | no trial data cached |
| Aphasia (loss of speech) | 193 | 171.5 151.7–194.0ROR 227.2 · χ² 32,389 / p <1e-300 | 167.6 EB05 148.7 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 128.2 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
| Cystitis | 202 | 170.1 151.0–191.7ROR 228.8 · χ² 33,625 / p <1e-300 | 166.4 EB05 148.0 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 145.8 · ♀ 100% (drug 63%) · 92% clinician | no trial data cached |
| Dysarthria (slurred speech) | 193 | 137.9 122.0–156.0ROR 182.6 · χ² 26,007 / p <1e-300 | 135.4 EB05 120.1 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 102.5 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
| Rhinorrhoea (runny nose) | 223 | 92.9 83.1–103.8ROR 129.4 · χ² 20,164 / p <1e-300 | 91.8 EB05 82.2 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 140.9 · ♀ 94% (drug 63%) · 91% clinician | no trial data cached |
| Psoriasis | 425 | 87.2 81.8–93.0ROR 189.3 · χ² 36,247 / p <1e-300 | 86.6 EB05 79.9 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 143.6 | no trial data cached |
| Cataract | 178 | 80.5 70.7–91.6ROR 103.9 · χ² 13,895 / p <1e-300 | 79.6 EB05 70.3 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.1 · ♀ 100% (drug 63%) · 93% clinician | no trial data cached |
| Secretion discharge | 36 | 78.1 56.8–107.6ROR 81.9 · χ² 2,659 / p <1e-300 | 74.9 EB05 56.6 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 80.9 | no trial data cached |
| Skin exfoliation | 227 | 73.3 65.6–81.8ROR 102.7 · χ² 16,126 / p <1e-300 | 72.6 EB05 65.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 136.3 · ♀ 97% (drug 63%) · 91% clinician | no trial data cached |
| Pulmonary congestion | 34 | 68.9 49.5–95.7ROR 71.9 · χ² 2,202 / p <1e-300 | 66.2 EB05 49.6 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.6 | no trial data cached |
| Influenza like illness (flu-like illness) | 200 | 64.9 57.6–73.1ROR 86.8 · χ² 12,535 / p <1e-300 | 64.3 EB05 57.2 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 89.1 · ♀ 100% (drug 63%) · 92% clinician | no trial data cached |
| Arthritis | 182 | 61.9 54.5–70.3ROR 80.3 · χ² 10,864 / p <1e-300 | 61.4 EB05 54.3 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.8 · ♀ 99% (drug 63%) · 92% clinician | no trial data cached |
| Pulmonary mass | 32 | 57.7 41.1–81.0ROR 60.1 · χ² 1,723 / p <1e-300 | 55.7 EB05 41.3 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.7 | no trial data cached |
| Dysphagia (difficulty swallowing) | 201 | 56.9 50.5–64.1ROR 76.2 · χ² 11,012 / p <1e-300 | 56.5 EB05 50.2 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.3 · ♀ 100% (drug 63%) · 91% clinician | no trial data cached |
| Influenza | 216 | 51.8 46.2–58.0ROR 71.1 · χ² 10,738 / p <1e-300 | 51.4 EB05 45.9 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 54.6 · ♀ 98% (drug 63%) | no trial data cached |
| Gastrointestinal disorder | 169 | 51.2 44.8–58.6ROR 65.0 · χ² 8,292 / p <1e-300 | 50.9 EB05 44.7 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.1 · ♀ 99% (drug 63%) · 92% clinician | no trial data cached |
| Psoriatic arthropathy | 74 | 49.3 39.7–61.3ROR 54.3 · χ² 3,454 / p <1e-300 | 48.6 EB05 40.0 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.7 | no trial data cached |
| Sinusitis | 189 | 49.3 43.5–55.8ROR 64.6 · χ² 8,917 / p <1e-300 | 49.0 EB05 43.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.2 · ♀ 100% (drug 63%) · 93% clinician | no trial data cached |
| Chest discomfort | 187 | 49.1 43.3–55.7ROR 64.2 · χ² 8,796 / p <1e-300 | 48.8 EB05 43.2 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.3 · ♀ 97% (drug 63%) · 93% clinician | no trial data cached |
| Muscular weakness | 191 | 45.0 39.8–50.9ROR 59.2 · χ² 8,209 / p <1e-300 | 44.8 EB05 39.7 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.6 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
| Rheumatoid arthritis | 188 | 44.5 39.3–50.5ROR 58.3 · χ² 7,988 / p <1e-300 | 44.3 EB05 39.2 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.4 · ♀ 100% (drug 63%) · 93% clinician | no trial data cached |
| Movement disorder | 51 | 42.3 32.5–55.2ROR 45.2 · χ² 2,017 / p <1e-300 | 41.7 EB05 32.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.2 | no trial data cached |
| Palpitations (pounding heartbeat) | 180 | 41.2 36.2–46.9ROR 53.2 · χ² 7,050 / p <1e-300 | 41.0 EB05 36.2 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.3 · ♀ 99% (drug 63%) · 93% clinician | no trial data cached |
| Blood pressure increased | 215 | 37.6 33.5–42.1ROR 51.4 · χ² 7,665 / p <1e-300 | 37.4 EB05 33.4 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious PRR 34.5 · ♀ 91% (drug 63%) | no trial data cached |
| Panic attack | 48 | 35.2 26.8–46.4ROR 37.5 · χ² 1,563 / p <1e-300 | 34.7 EB05 27.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.2 | no trial data cached |
| Nasopharyngitis (common cold) | 237 | 34.4 30.9–38.2ROR 48.8 · χ² 7,700 / p <1e-300 | 34.2 EB05 30.7 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.2 · ♀ 92% (drug 63%) | no trial data cached |
| Poor quality product administered | 13 | 34.1 19.9–58.4ROR 34.6 · χ² 384 / p 7e-86 | 32.5 EB05 20.2 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Skin fissures | 24 | 34.0 22.9–50.5ROR 35.1 · χ² 737 / p 2e-162 | 33.2 EB05 23.5 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 · ♀ 100% (drug 63%) | no trial data cached |
| Pharyngitis streptococcal | 13 | 32.2 18.7–55.1ROR 32.7 · χ² 362 / p 6e-81 | 30.8 EB05 19.1 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | 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 |
|---|---|---|---|---|---|---|
| Psoriasis | 425 | 87.2 81.8–93.0ROR 189.3 · χ² 36,247 / p <1e-300 | 86.6 EB05 79.9 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 143.6 | no trial data cached |
| Malaise (feeling unwell) | 300 | 18.3 16.7–20.0ROR 29.0 · χ² 4,980 / p <1e-300 | 18.2 EB05 16.6 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.4 | no trial data cached |
| Nasopharyngitis (common cold) | 237 | 34.4 30.9–38.2ROR 48.8 · χ² 7,700 / p <1e-300 | 34.2 EB05 30.7 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.2 · ♀ 92% (drug 63%) | no trial data cached |
| Skin exfoliation | 227 | 73.3 65.6–81.8ROR 102.7 · χ² 16,126 / p <1e-300 | 72.6 EB05 65.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 136.3 · ♀ 97% (drug 63%) · 91% clinician | no trial data cached |
| Fall | 223 | 18.0 16.1–20.1ROR 24.7 · χ² 3,608 / p <1e-300 | 17.9 EB05 16.0 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.6 · ♀ 100% (drug 63%) | no trial data cached |
| Rhinorrhoea (runny nose) | 223 | 92.9 83.1–103.8ROR 129.4 · χ² 20,164 / p <1e-300 | 91.8 EB05 82.2 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 140.9 · ♀ 94% (drug 63%) · 91% clinician | no trial data cached |
| Pyrexia (fever) | 222 | 17.2 15.4–19.2ROR 23.5 · χ² 3,417 / p <1e-300 | 17.1 EB05 15.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.6 · ♀ 99% (drug 63%) | no trial data cached |
| Cough | 221 | 21.1 18.9–23.6ROR 29.0 · χ² 4,274 / p <1e-300 | 21.1 EB05 18.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.6 · ♀ 93% (drug 63%) | no trial data cached |
| Anxiety | 219 | 20.5 18.4–23.0ROR 28.1 · χ² 4,106 / p <1e-300 | 20.5 EB05 18.3 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.9 · ♀ 90% (drug 63%) · 91% clinician | no trial data cached |
| Influenza | 216 | 51.8 46.2–58.0ROR 71.1 · χ² 10,738 / p <1e-300 | 51.4 EB05 45.9 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 54.6 · ♀ 98% (drug 63%) | no trial data cached |
| Blood pressure increased | 215 | 37.6 33.5–42.1ROR 51.4 · χ² 7,665 / p <1e-300 | 37.4 EB05 33.4 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious PRR 34.5 · ♀ 91% (drug 63%) | no trial data cached |
| Pneumonia (lung infection) | 214 | 17.7 15.8–19.9ROR 24.0 · χ² 3,410 / p <1e-300 | 17.7 EB05 15.8 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.6 · ♀ 98% (drug 63%) | no trial data cached |
| Skin haemorrhage | 214 | 402.7 358.8–451.9ROR 553.5 · χ² 84,115 / p <1e-300 | 383.0 EB05 341.8 · IC025 +7.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=213 · ♀ 98% (drug 63%) · 92% clinician | no trial data cached |
| Sneezing | 211 | 254.8 226.8–286.1ROR 348.2 · χ² 52,629 / p <1e-300 | 246.7 EB05 220.0 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 396.9 · ♀ 99% (drug 63%) · 92% clinician | no trial data cached |
| Sinus disorder | 211 | 287.6 256.1–323.1ROR 393.2 · χ² 59,393 / p <1e-300 | 277.4 EB05 247.4 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 386.0 · ♀ 99% (drug 63%) · 92% clinician | 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 Coal Tar?
In FDA FAERS, the most frequently co-reported reaction terms for Coal Tar are psoriasis, malaise, nasopharyngitis, skin exfoliation, fall, rhinorrhoea. 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 Coal Tar have an FDA boxed warning?
No. The FDA label retrieved for Coal Tar has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Coal Tar 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 1c18fde9-d39b-4339-8f62-3f352d450291, effective 20240528; matched on
openfda.generic_name.exact:"COAL TAR") - 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, 82 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.