Drug · FAERS side-effect profile with label screen
Dexpanthenol side effects: what 1,087 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Babysons
openFDA label
Who reports
1,087 reports · 99% serious · 259 with death outcome · 69% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps seal out wetness
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 1No label text to screen 39
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. 120 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 |
|---|---|---|---|---|---|---|
| Helicobacter infection | 76 | 144.9 116.5–180.1ROR 155.7 · χ² 10,640 / p <1e-300 | 138.8 EB05 114.6 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 88.8 · ♀ 100% (drug 69%) · 95% clinician | no trial data cached |
| Pemphigus | 90 | 140.7 115.3–171.6ROR 153.3 · χ² 12,257 / p <1e-300 | 135.7 EB05 113.7 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 81.8 · ♀ 100% (drug 69%) · 94% clinician | no trial data cached |
| Bursitis | 84 | 135.2 110.0–166.2ROR 146.5 · χ² 10,987 / p <1e-300 | 130.4 EB05 108.6 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 92.4 · ♀ 100% (drug 69%) · 96% clinician | no trial data cached |
| Wound infection | 72 | 128.6 102.8–160.9ROR 137.7 · χ² 8,935 / p <1e-300 | 123.7 EB05 101.5 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 80.1 · ♀ 100% (drug 69%) · 93% clinician | no trial data cached |
| Hand deformity | 73 | 108.2 86.7–135.2ROR 115.9 · χ² 7,610 / p <1e-300 | 104.7 EB05 86.1 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 68.4 · ♀ 100% (drug 69%) · 99% clinician | no trial data cached |
| Pneumonia aspiration | 138 | 107.4 91.9–125.6ROR 122.9 · χ² 14,378 / p <1e-300 | 105.3 EB05 91.4 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.6 · ♀ 98% (drug 69%) | no trial data cached |
| Pericarditis | 91 | 105.9 86.9–129.0ROR 115.5 · χ² 9,308 / p <1e-300 | 103.1 EB05 86.5 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.0 · ♀ 100% (drug 69%) · 95% clinician | no trial data cached |
| Folliculitis | 52 | 97.6 74.8–127.3ROR 102.4 · χ² 4,853 / p <1e-300 | 93.8 EB05 74.3 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.7 · ♀ 98% (drug 69%) · 94% clinician | no trial data cached |
| Obesity | 73 | 88.7 71.0–110.7ROR 95.0 · χ² 6,215 / p <1e-300 | 86.3 EB05 70.9 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 59.9 · ♀ 100% (drug 69%) · 99% clinician | no trial data cached |
| Vaginal discharge | 42 | 81.0 60.2–109.0ROR 84.2 · χ² 3,226 / p <1e-300 | 77.9 EB05 60.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=42 · ♀ 100% (drug 69%) | no trial data cached |
| Macular degeneration | 44 | 71.5 53.5–95.5ROR 74.5 · χ² 2,978 / p <1e-300 | 69.2 EB05 53.7 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.9 · ♀ 100% (drug 69%) | no trial data cached |
| Appendicitis | 34 | 70.8 50.8–98.6ROR 73.1 · χ² 2,263 / p <1e-300 | 68.0 EB05 50.9 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.8 · ♀ 0% (drug 69%) · 94% clinician | no trial data cached |
| Incorrect route of product administration | 58 | 66.8 52.0–85.9ROR 70.5 · χ² 3,684 / p <1e-300 | 65.2 EB05 52.3 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 77.7 | no trial data cached |
| Fibromyalgia | 83 | 66.1 53.8–81.4ROR 71.5 · χ² 5,248 / p <1e-300 | 65.0 EB05 54.1 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.7 · ♀ 100% (drug 69%) · 95% clinician | no trial data cached |
| Oral candidiasis (oral thrush) | 44 | 65.5 49.0–87.5ROR 68.2 · χ² 2,721 / p <1e-300 | 63.5 EB05 49.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.4 · ♀ 98% (drug 69%) | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 49 | 62.9 47.8–82.7ROR 65.8 · χ² 2,915 / p <1e-300 | 61.3 EB05 48.2 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.7 · ♀ 91% (drug 69%) · 96% clinician | no trial data cached |
| Liver injury | 76 | 60.8 48.9–75.6ROR 65.3 · χ² 4,403 / p <1e-300 | 59.8 EB05 49.3 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.7 · ♀ 100% (drug 69%) · 96% clinician | no trial data cached |
| Paraesthesia oral | 45 | 60.6 45.5–80.7ROR 63.2 · χ² 2,571 / p <1e-300 | 59.0 EB05 45.9 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 63.0 · ♀ 100% (drug 69%) | no trial data cached |
| Ventricular fibrillation | 34 | 59.1 42.4–82.3ROR 60.9 · χ² 1,878 / p <1e-300 | 57.1 EB05 42.7 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.5 · ♀ 0% (drug 69%) · 94% clinician | no trial data cached |
| Coma | 137 | 55.6 47.5–65.0ROR 63.5 · χ² 7,286 / p <1e-300 | 55.0 EB05 47.7 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.4 · ♀ 99% (drug 69%) | no trial data cached |
| Synovitis | 49 | 52.5 39.9–69.1ROR 54.9 · χ² 2,420 / p <1e-300 | 51.4 EB05 40.4 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.1 · ♀ 100% (drug 69%) · 98% clinician | no trial data cached |
| Joint range of motion decreased | 36 | 52.1 37.8–71.9ROR 53.8 · χ² 1,749 / p <1e-300 | 50.6 EB05 38.2 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.7 · ♀ 100% (drug 69%) · 97% clinician | no trial data cached |
| Epilepsy | 81 | 51.3 41.6–63.3ROR 55.4 · χ² 3,943 / p <1e-300 | 50.6 EB05 42.0 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.1 · ♀ 100% (drug 69%) · 93% clinician | no trial data cached |
| Systemic lupus erythematosus | 89 | 48.7 39.9–59.4ROR 52.9 · χ² 4,103 / p <1e-300 | 48.1 EB05 40.2 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.1 · ♀ 100% (drug 69%) · 94% clinician | no trial data cached |
| Osteoarthritis | 106 | 48.3 40.3–57.8ROR 53.4 · χ² 4,856 / p <1e-300 | 47.8 EB05 40.6 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.6 · ♀ 98% (drug 69%) | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 197 | 47.5 41.9–53.9ROR 57.8 · χ² 8,934 / p <1e-300 | 47.2 EB05 41.9 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.2 · ♀ 96% (drug 69%) | no trial data cached |
| Hypercholesterolaemia | 23 | 46.5 31.0–69.7ROR 47.5 · χ² 977 / p 1e-214 | 44.8 EB05 31.4 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.8 | no trial data cached |
| Cardiogenic shock | 34 | 46.1 33.1–64.2ROR 47.5 · χ² 1,452 / p <1e-300 | 44.9 EB05 33.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.8 · ♀ 3% (drug 69%) · 94% clinician | no trial data cached |
| Lower respiratory tract infection | 106 | 45.2 37.7–54.2ROR 50.0 · χ² 4,539 / p <1e-300 | 44.8 EB05 38.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.9 · 96% clinician | no trial data cached |
| Psoriatic arthropathy | 93 | 44.7 36.8–54.3ROR 48.8 · χ² 3,929 / p <1e-300 | 44.2 EB05 37.2 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.8 · ♀ 100% (drug 69%) · 95% clinician | no trial data cached |
| Back injury | 24 | 42.8 28.8–63.7ROR 43.8 · χ² 938 / p 3e-206 | 41.5 EB05 29.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.1 · ♀ 100% (drug 69%) · 96% clinician | no trial data cached |
| Taste disorder | 44 | 42.4 31.8–56.7ROR 44.2 · χ² 1,737 / p <1e-300 | 41.6 EB05 32.3 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.7 · ♀ 97% (drug 69%) · 93% clinician | no trial data cached |
| Type 2 diabetes mellitus | 74 | 42.4 34.0–52.8ROR 45.4 · χ² 2,945 / p <1e-300 | 41.8 EB05 34.4 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.0 · ♀ 98% (drug 69%) · 93% clinician | no trial data cached |
| Frequent bowel movements | 56 | 40.2 31.2–51.9ROR 42.4 · χ² 2,102 / p <1e-300 | 39.7 EB05 31.7 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.2 · 91% clinician | no trial data cached |
| Hepatic cirrhosis | 36 | 37.2 27.0–51.3ROR 38.5 · χ² 1,232 / p 4e-270 | 36.5 EB05 27.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.0 · ♀ 91% (drug 69%) | no trial data cached |
| Stomatitis (mouth sores) | 114 | 36.3 30.5–43.2ROR 40.5 · χ² 3,884 / p <1e-300 | 36.0 EB05 30.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.8 · ♀ 90% (drug 69%) · 97% clinician | no trial data cached |
| Irritable bowel syndrome | 40 | 36.2 26.7–49.1ROR 37.5 · χ² 1,332 / p 6e-292 | 35.6 EB05 27.2 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.8 · ♀ 100% (drug 69%) · 98% clinician | no trial data cached |
| Wound | 52 | 36.1 27.7–47.1ROR 37.9 · χ² 1,741 / p <1e-300 | 35.6 EB05 28.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.1 · ♀ 98% (drug 69%) · 96% clinician | no trial data cached |
| Bacterial infection | 33 | 34.3 24.5–48.1ROR 35.4 · χ² 1,034 / p 4e-227 | 33.7 EB05 25.1 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.1 · ♀ 14% (drug 69%) | no trial data cached |
| Breast cancer metastatic | 19 | 34.2 21.9–53.5ROR 34.8 · χ² 579 / p 3e-128 | 33.1 EB05 22.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.4 | 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 |
|---|---|---|---|---|---|---|
| Gastrooesophageal reflux disease (acid reflux) | 197 | 47.5 41.9–53.9ROR 57.8 · χ² 8,934 / p <1e-300 | 47.2 EB05 41.9 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.2 · ♀ 96% (drug 69%) | no trial data cached |
| Somnolence (drowsiness) | 178 | 17.1 14.9–19.6ROR 20.2 · χ² 2,705 / p <1e-300 | 17.0 EB05 15.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.3 | no trial data cached |
| Pneumonia aspiration | 138 | 107.4 91.9–125.6ROR 122.9 · χ² 14,378 / p <1e-300 | 105.3 EB05 91.4 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.6 · ♀ 98% (drug 69%) | no trial data cached |
| Coma | 137 | 55.6 47.5–65.0ROR 63.5 · χ² 7,286 / p <1e-300 | 55.0 EB05 47.7 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.4 · ♀ 99% (drug 69%) | no trial data cached |
| Abdominal pain | 130 | 10.8 9.2–12.7ROR 12.1 · χ² 1,157 / p 5e-254 | 10.7 EB05 9.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 · 94% clinician | no trial data cached |
| General physical health deterioration | 127 | 21.3 18.1–25.1ROR 24.0 · χ² 2,453 / p <1e-300 | 21.3 EB05 18.3 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 14.6 · 94% clinician | no trial data cached |
| Swelling | 119 | 24.6 20.8–29.2ROR 27.5 · χ² 2,681 / p <1e-300 | 24.5 EB05 21.0 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.3 · 97% clinician | no trial data cached |
| Anaemia (low red blood cells) | 117 | 11.8 10.0–14.0ROR 13.1 · χ² 1,159 / p 2e-254 | 11.7 EB05 10.0 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 | no trial data cached |
| Stomatitis (mouth sores) | 114 | 36.3 30.5–43.2ROR 40.5 · χ² 3,884 / p <1e-300 | 36.0 EB05 30.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.8 · ♀ 90% (drug 69%) · 97% clinician | no trial data cached |
| Lower respiratory tract infection | 106 | 45.2 37.7–54.2ROR 50.0 · χ² 4,539 / p <1e-300 | 44.8 EB05 38.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.9 · 96% clinician | no trial data cached |
| Osteoarthritis | 106 | 48.3 40.3–57.8ROR 53.4 · χ² 4,856 / p <1e-300 | 47.8 EB05 40.6 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.6 · ♀ 98% (drug 69%) | no trial data cached |
| Drug intolerance | 104 | 20.9 17.4–25.1ROR 23.0 · χ² 1,954 / p <1e-300 | 20.8 EB05 17.6 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 19.9 · 94% clinician | no trial data cached |
| Confusional state (confusion) | 103 | 12.3 10.2–14.8ROR 13.5 · χ² 1,063 / p 1e-233 | 12.2 EB05 10.3 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 · ♀ 98% (drug 69%) · 92% clinician | no trial data cached |
| Wheezing | 97 | 31.7 26.2–38.3ROR 34.7 · χ² 2,855 / p <1e-300 | 31.5 EB05 26.5 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.5 · ♀ 98% (drug 69%) · 99% clinician | no trial data cached |
| Rheumatoid arthritis | 95 | 16.2 13.4–19.7ROR 17.7 · χ² 1,348 / p 2e-295 | 16.1 EB05 13.6 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.6 · ♀ 99% (drug 69%) · 94% 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 Dexpanthenol?
In FDA FAERS, the most frequently co-reported reaction terms for Dexpanthenol are gastrooesophageal reflux disease, somnolence, pneumonia aspiration, coma, abdominal pain, swelling. 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 Dexpanthenol have an FDA boxed warning?
No. The FDA label retrieved for Dexpanthenol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dexpanthenol 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 8a4782fc-5917-4f63-b9bf-6597be2afc6c, effective 20241031; matched on
openfda.generic_name.exact:"DEXPANTHENOL") - 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, 160 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.