Drug · FAERS side-effect profile with label screen
Petrolatum side effects: what 1,387 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,387 reports · 79% serious · 211 with death outcome · 50% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Uses ■ helps treat and prevent diaper rash ■ protects chafed skin due to diaper rash ■ helps seal out wetness Warnings For external use only
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 29 strongest signals
Lab value / disease marker 2No label text to screen 27
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. 24 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 |
|---|---|---|---|---|---|---|
| Skin infection | 16 | 21.7 13.3–35.3ROR 21.9 · χ² 295 / p 2e-66 | 21.1 EB05 13.6 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.8 | no trial data cached |
| Iron deficiency anaemia | 13 | 21.4 12.5–36.8ROR 21.6 · χ² 233 / p 7e-53 | 20.6 EB05 12.5 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.5 | no trial data cached |
| Bacteraemia | 14 | 18.0 10.7–30.3ROR 18.2 · χ² 208 / p 2e-47 | 17.2 EB05 10.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.3 | no trial data cached |
| Schizophrenia | 14 | 17.4 10.3–29.3ROR 17.6 · χ² 200 / p 8e-46 | 16.6 EB05 9.9 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.2 | no trial data cached |
| Disseminated intravascular coagulation | 15 | 16.1 9.7–26.6ROR 16.2 · χ² 197 / p 4e-45 | 15.3 EB05 9.2 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 | no trial data cached |
| Vitamin d deficiency | 10 | 15.5 8.4–28.8ROR 15.6 · χ² 122 / p 1e-28 | 13.9 EB05 6.9 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.6 | no trial data cached |
| Blood bilirubin increased | 26 | 14.5 9.9–21.3ROR 14.8 · χ² 314 / p 1e-70 | 14.1 EB05 9.8 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 11.7 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 13 | 13.0 7.6–22.4ROR 13.2 · χ² 133 / p 5e-31 | 11.7 EB05 6.5 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.5 | no trial data cached |
| Cellulitis (skin infection) | 43 | 12.9 9.6–17.3ROR 13.3 · χ² 461 / p 2e-102 | 12.6 EB05 9.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 | no trial data cached |
| Drug eruption | 15 | 12.9 7.8–21.3ROR 13.0 · χ² 153 / p 2e-35 | 11.7 EB05 6.9 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.8 | no trial data cached |
| Pneumonia aspiration | 21 | 12.7 8.3–19.5ROR 12.9 · χ² 216 / p 4e-49 | 12.0 EB05 7.8 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.3 · 95% clinician | no trial data cached |
| Accident | 10 | 12.7 6.9–23.6ROR 12.8 · χ² 96 / p 5e-23 | 10.7 EB05 5.4 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.0 | no trial data cached |
| Adrenal insufficiency | 10 | 12.6 6.8–23.4ROR 12.7 · χ² 96 / p 6e-23 | 10.6 EB05 5.4 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.3 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 18 | 12.2 7.7–19.3ROR 12.4 · χ² 174 / p 4e-40 | 11.2 EB05 7.0 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.0 | no trial data cached |
| Skin fissures | 13 | 10.4 6.1–17.9ROR 10.5 · χ² 101 / p 4e-24 | 8.8 EB05 5.1 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 | no trial data cached |
| Febrile neutropenia | 45 | 10.3 7.7–13.7ROR 10.6 · χ² 369 / p 2e-82 | 9.9 EB05 7.5 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · 98% clinician | no trial data cached |
| Delirium | 23 | 10.1 6.7–15.1ROR 10.2 · χ² 179 / p 4e-41 | 9.2 EB05 6.2 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · 95% clinician | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 15 | 9.7 5.9–16.0ROR 9.8 · χ² 109 / p 1e-25 | 8.3 EB05 5.1 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 | no trial data cached |
| Hepatic function abnormal | 23 | 9.4 6.3–14.1ROR 9.5 · χ² 164 / p 7e-38 | 8.5 EB05 5.7 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 · 91% clinician | no trial data cached |
| Neutrophil count decreased | 22 | 8.2 5.4–12.4ROR 8.3 · χ² 132 / p 6e-31 | 7.3 EB05 5.0 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 6.3 | no trial data cached |
| Dermatitis | 11 | 8.0 4.5–14.5ROR 8.1 · χ² 61 / p 3e-15 | 6.4 EB05 3.7 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.7 | no trial data cached |
| Dermatitis atopic | 26 | 7.9 5.4–11.5ROR 8.0 · χ² 149 / p 1e-34 | 7.1 EB05 5.0 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Application site pain | 11 | 7.6 4.2–13.6ROR 7.6 · χ² 56 / p 3e-14 | 6.0 EB05 3.5 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 | no trial data cached |
| Interstitial lung disease | 23 | 7.2 4.8–10.8ROR 7.3 · χ² 117 / p 2e-27 | 6.4 EB05 4.5 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial data cached |
| Angina pectoris | 11 | 5.8 3.2–10.4ROR 5.8 · χ² 39 / p 2e-10 | 4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 | no trial data cached |
| Eczema | 16 | 4.8 3.0–7.8ROR 4.9 · χ² 45 / p 1e-11 | 4.3 EB05 2.8 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Skin exfoliation | 26 | 4.7 3.2–6.9ROR 4.8 · χ² 73 / p 6e-18 | 4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 | no trial data cached |
| Lung neoplasm malignant | 12 | 4.4 2.5–7.7ROR 4.4 · χ² 28 / p 6e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | no trial data cached |
| Dry skin | 30 | 3.4 2.4–4.9ROR 3.5 · χ² 50 / p 8e-13 | 3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | 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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 45 | 10.3 7.7–13.7ROR 10.6 · χ² 369 / p 2e-82 | 9.9 EB05 7.5 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · 98% clinician | no trial data cached |
| Cellulitis (skin infection) | 43 | 12.9 9.6–17.3ROR 13.3 · χ² 461 / p 2e-102 | 12.6 EB05 9.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 | no trial data cached |
| Dry skin | 30 | 3.4 2.4–4.9ROR 3.5 · χ² 50 / p 8e-13 | 3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | no trial data cached |
| Skin exfoliation | 26 | 4.7 3.2–6.9ROR 4.8 · χ² 73 / p 6e-18 | 4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 | no trial data cached |
| Dermatitis atopic | 26 | 7.9 5.4–11.5ROR 8.0 · χ² 149 / p 1e-34 | 7.1 EB05 5.0 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Blood bilirubin increased | 26 | 14.5 9.9–21.3ROR 14.8 · χ² 314 / p 1e-70 | 14.1 EB05 9.8 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 11.7 | no trial data cached |
| Interstitial lung disease | 23 | 7.2 4.8–10.8ROR 7.3 · χ² 117 / p 2e-27 | 6.4 EB05 4.5 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial data cached |
| Hepatic function abnormal | 23 | 9.4 6.3–14.1ROR 9.5 · χ² 164 / p 7e-38 | 8.5 EB05 5.7 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 · 91% clinician | no trial data cached |
| Delirium | 23 | 10.1 6.7–15.1ROR 10.2 · χ² 179 / p 4e-41 | 9.2 EB05 6.2 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · 95% clinician | no trial data cached |
| Neutrophil count decreased | 22 | 8.2 5.4–12.4ROR 8.3 · χ² 132 / p 6e-31 | 7.3 EB05 5.0 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 6.3 | no trial data cached |
| Pneumonia aspiration | 21 | 12.7 8.3–19.5ROR 12.9 · χ² 216 / p 4e-49 | 12.0 EB05 7.8 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.3 · 95% clinician | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 18 | 12.2 7.7–19.3ROR 12.4 · χ² 174 / p 4e-40 | 11.2 EB05 7.0 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.0 | no trial data cached |
| Eczema | 16 | 4.8 3.0–7.8ROR 4.9 · χ² 45 / p 1e-11 | 4.3 EB05 2.8 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Skin infection | 16 | 21.7 13.3–35.3ROR 21.9 · χ² 295 / p 2e-66 | 21.1 EB05 13.6 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.8 | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 15 | 9.7 5.9–16.0ROR 9.8 · χ² 109 / p 1e-25 | 8.3 EB05 5.1 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 | 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 Petrolatum?
In FDA FAERS, the most frequently co-reported reaction terms for Petrolatum are febrile neutropenia, cellulitis, dry skin, skin exfoliation, dermatitis atopic, blood bilirubin 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 Petrolatum have an FDA boxed warning?
No. The FDA label retrieved for Petrolatum has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Petrolatum 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 0a0e6de8-b7c1-af7e-e063-6394a90a3ee2, effective 20240826; matched on
openfda.generic_name.exact:"PETROLATUM") - 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, 53 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.