Drug · FAERS side-effect profile with label screen
Docosanol side effects: what 14,560 FDA adverse event reports show
Drug class
Not stated in label
Who reports
14,560 reports · 2% serious · 9 with death outcome · 75% female
openFDA FAERS counts, all years, deduplication not applied
Used for
treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching
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 6No label text to screen 34
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. 382 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 |
|---|---|---|---|---|---|---|
| Application site bleeding | 45 | 314.6 227.8–434.3ROR 315.5 · χ² 11,258 / p <1e-300 | 232.3 EB05 180.7 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Oral herpes | 2,456 | 208.3 200.3–216.6ROR 250.3 · χ² 441,973 / p <1e-300 | 181.5 EB05 175.5 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 140.4 · 99% consumer | no trial data cached |
| Herpes simplex | 706 | 176.0 163.0–190.0ROR 184.9 · χ² 109,175 / p <1e-300 | 156.0 EB05 146.6 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 100% consumer | no trial data cached |
| Application site hypoaesthesia | 19 | 127.2 79.6–203.3ROR 127.3 · χ² 2,069 / p <1e-300 | 104.8 EB05 70.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Application site scar | 101 | 126.1 102.9–154.4ROR 126.9 · χ² 11,394 / p <1e-300 | 113.4 EB05 96.0 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 100% consumer | no trial data cached |
| Application site scab | 165 | 118.1 100.9–138.4ROR 119.5 · χ² 17,584 / p <1e-300 | 107.8 EB05 94.7 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 99% consumer | no trial data cached |
| Lip haemorrhage | 87 | 105.5 84.9–131.1ROR 106.1 · χ² 8,287 / p <1e-300 | 96.3 EB05 80.4 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 100% consumer | no trial data cached |
| Application site paraesthesia | 87 | 102.4 82.4–127.2ROR 103.0 · χ² 8,051 / p <1e-300 | 93.6 EB05 78.3 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 100% consumer | no trial data cached |
| Application site infection | 33 | 99.0 69.6–140.8ROR 99.2 · χ² 2,902 / p <1e-300 | 88.0 EB05 65.6 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 · 100% consumer | no trial data cached |
| Drug administration error | 1,779 | 87.2 83.4–91.3ROR 99.2 · χ² 143,009 / p <1e-300 | 82.2 EB05 79.0 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious PRR 44.8 · 99% consumer | no trial data cached |
| Lip infection | 12 | 86.0 48.0–154.0ROR 86.1 · χ² 872 / p 6e-192 | 72.2 EB05 44.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Lip pain | 151 | 80.0 68.0–94.2ROR 80.9 · χ² 11,084 / p <1e-300 | 75.1 EB05 65.6 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 99% consumer | no trial data cached |
| Application site swelling | 208 | 62.5 54.5–71.8ROR 63.4 · χ² 12,002 / p <1e-300 | 59.6 EB05 53.1 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 100% consumer | no trial data cached |
| Lip exfoliation | 50 | 56.6 42.7–75.0ROR 56.8 · χ² 2,572 / p <1e-300 | 53.4 EB05 42.1 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 100% consumer | no trial data cached |
| Lip erythema | 28 | 54.1 37.1–78.8ROR 54.2 · χ² 1,354 / p 1e-296 | 50.4 EB05 36.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Lip blister | 91 | 49.6 40.3–61.1ROR 49.9 · χ² 4,143 / p <1e-300 | 47.5 EB05 39.9 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 98% consumer | no trial data cached |
| Application site haemorrhage | 89 | 47.9 38.8–59.1ROR 48.2 · χ² 3,910 / p <1e-300 | 46.0 EB05 38.5 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Incorrect product administration duration | 639 | 46.8 43.3–50.5ROR 48.9 · χ² 27,690 / p <1e-300 | 45.3 EB05 42.4 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious n=2 · 100% consumer | no trial data cached |
| Lip disorder | 59 | 46.0 35.5–59.6ROR 46.2 · χ² 2,471 / p <1e-300 | 44.0 EB05 35.3 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 · 98% consumer | no trial data cached |
| Inadequate aseptic technique in use of product | 11 | 45.9 25.2–83.7ROR 45.9 · χ² 426 / p 7e-95 | 41.5 EB05 24.7 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Lip discolouration | 38 | 44.8 32.5–61.9ROR 44.9 · χ² 1,536 / p <1e-300 | 42.6 EB05 32.4 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 97% consumer | no trial data cached |
| Incorrect drug administration duration | 803 | 41.7 38.9–44.6ROR 44.0 · χ² 30,961 / p <1e-300 | 40.5 EB05 38.2 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Cheilitis (inflamed lips) | 145 | 39.6 33.6–46.7ROR 40.0 · χ² 5,277 / p <1e-300 | 38.4 EB05 33.4 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 99% consumer | no trial data cached |
| Lip pruritus | 21 | 36.9 24.0–56.9ROR 37.0 · χ² 681 / p 2e-150 | 35.0 EB05 24.1 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Chapped lips | 104 | 35.3 29.0–42.8ROR 35.5 · χ² 3,346 / p <1e-300 | 34.2 EB05 29.1 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 100% consumer | no trial data cached |
| Application site pain | 445 | 29.7 27.0–32.5ROR 30.6 · χ² 12,060 / p <1e-300 | 29.1 EB05 26.9 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 100% consumer | no trial data cached |
| Application site dryness | 68 | 29.2 23.0–37.1ROR 29.4 · χ² 1,789 / p <1e-300 | 28.5 EB05 23.2 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Application site discolouration | 81 | 29.2 23.4–36.3ROR 29.3 · χ² 2,133 / p <1e-300 | 28.5 EB05 23.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 99% consumer | no trial data cached |
| Product package associated injury | 43 | 28.4 21.0–38.5ROR 28.5 · χ² 1,090 / p 3e-239 | 27.6 EB05 21.3 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=1 · 100% consumer | no trial data cached |
| Application site irritation | 231 | 27.2 23.9–31.0ROR 27.6 · χ² 5,698 / p <1e-300 | 26.7 EB05 23.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 100% consumer | no trial data cached |
| Application site discharge | 21 | 26.5 17.2–40.8ROR 26.6 · χ² 482 / p 4e-107 | 25.5 EB05 17.6 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Application site reaction | 123 | 25.4 21.2–30.3ROR 25.6 · χ² 2,806 / p <1e-300 | 24.9 EB05 21.4 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 100% consumer | no trial data cached |
| Lip swelling | 559 | 24.6 22.7–26.7ROR 25.5 · χ² 12,441 / p <1e-300 | 24.2 EB05 22.6 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.2 · 99% consumer | no trial data cached |
| Product complaint | 374 | 21.9 19.8–24.2ROR 22.4 · χ² 7,327 / p <1e-300 | 21.5 EB05 19.8 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=1 · 100% consumer | no trial data cached |
| Lip dry | 126 | 20.5 17.2–24.4ROR 20.7 · χ² 2,287 / p <1e-300 | 20.2 EB05 17.4 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial data cached |
| Application site inflammation | 19 | 20.2 12.8–31.8ROR 20.2 · χ² 323 / p 1e-72 | 19.5 EB05 13.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 | no trial data cached |
| Application site vesicles | 87 | 19.5 15.8–24.0ROR 19.6 · χ² 1,485 / p <1e-300 | 19.1 EB05 16.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 100% consumer | no trial data cached |
| Therapeutic product effect delayed | 58 | 18.7 14.5–24.3ROR 18.8 · χ² 944 / p 1e-207 | 18.4 EB05 14.7 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=2 · 100% consumer | no trial data cached |
| Application site papules | 13 | 17.9 10.4–31.0ROR 18.0 · χ² 189 / p 3e-43 | 16.9 EB05 9.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Oral discomfort | 164 | 17.1 14.7–20.0ROR 17.3 · χ² 2,450 / p <1e-300 | 16.9 EB05 14.9 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1 · 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 7,060 | 7.8 7.6–7.9ROR 14.1 · χ² 44,060 / p <1e-300 | 7.7 EB05 7.6 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 1.7 · 100% consumer | no trial data cached |
| Oral herpes | 2,456 | 208.3 200.3–216.6ROR 250.3 · χ² 441,973 / p <1e-300 | 181.5 EB05 175.5 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 140.4 · 99% consumer | no trial data cached |
| Condition aggravated | 1,965 | 9.4 9.0–9.8ROR 10.7 · χ² 14,897 / p <1e-300 | 9.4 EB05 9.0 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.2 · 99% consumer | no trial data cached |
| Drug administration error | 1,779 | 87.2 83.4–91.3ROR 99.2 · χ² 143,009 / p <1e-300 | 82.2 EB05 79.0 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious PRR 44.8 · 99% consumer | no trial data cached |
| Incorrect drug administration duration | 803 | 41.7 38.9–44.6ROR 44.0 · χ² 30,961 / p <1e-300 | 40.5 EB05 38.2 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | 100% consumer | no trial data cached |
| Herpes simplex | 706 | 176.0 163.0–190.0ROR 184.9 · χ² 109,175 / p <1e-300 | 156.0 EB05 146.6 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · 100% consumer | no trial data cached |
| Incorrect product administration duration | 639 | 46.8 43.3–50.5ROR 48.9 · χ² 27,690 / p <1e-300 | 45.3 EB05 42.4 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious n=2 · 100% consumer | no trial data cached |
| Lip swelling | 559 | 24.6 22.7–26.7ROR 25.5 · χ² 12,441 / p <1e-300 | 24.2 EB05 22.6 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.2 · 99% consumer | no trial data cached |
| Wrong technique in product usage process | 552 | 3.9 3.6–4.3ROR 4.1 · χ² 1,217 / p 7e-267 | 3.9 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 100% consumer | no trial data cached |
| Product quality issue | 539 | 5.8 5.3–6.3ROR 6.0 · χ² 2,127 / p <1e-300 | 5.7 EB05 5.3 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 · 99% consumer | no trial data cached |
| Inappropriate schedule of drug administration | 493 | 9.9 9.1–10.8ROR 10.2 · χ² 3,918 / p <1e-300 | 9.8 EB05 9.1 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 · 99% consumer | no trial data cached |
| Application site pain | 445 | 29.7 27.0–32.5ROR 30.6 · χ² 12,060 / p <1e-300 | 29.1 EB05 26.9 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · 100% consumer | no trial data cached |
| Inappropriate schedule of product administration | 402 | 3.3 3.0–3.6ROR 3.3 · χ² 638 / p 5e-141 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · 100% consumer | no trial data cached |
| Product complaint | 374 | 21.9 19.8–24.2ROR 22.4 · χ² 7,327 / p <1e-300 | 21.5 EB05 19.8 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=1 · 100% consumer | no trial data cached |
| Hypersensitivity (allergic reaction) | 318 | 2.5 2.2–2.8ROR 2.5 · χ² 279 / p 6e-63 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 · 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 Docosanol?
In FDA FAERS, the most frequently co-reported reaction terms for Docosanol are oral herpes, herpes simplex, lip swelling, application site pain, hypersensitivity. 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 Docosanol have an FDA boxed warning?
No. The FDA label retrieved for Docosanol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Docosanol 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 15c51055-2a07-4a0f-b140-89af34aa90db, effective 20230606; matched on
openfda.generic_name.exact:"DOCOSANOL") - 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, 422 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.