Drug · FAERS side-effect profile with label screen
Hydrocortisone Butyrate side effects: what 1,910 FDA adverse event reports show
Drug class
Corticosteroid
FDA label, Indications wording
Brand names
Evesse
openFDA label
Who reports
1,910 reports · 94% serious · 975 with death outcome · 82% female
openFDA FAERS counts, all years, deduplication not applied
Used for
EVESSE™ (hydrocortisone butyrate) Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. EVESSE™ (hydrocortisone butyrate) Lotion is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. ( 1 )
FDA label, Indications and Usage
What it is
EVESSE™ (hydrocortisone butyrate) Lotion, 0.1% contains hydrocortisone butyrate, a non-fluorinated hydrocortisone ester, for topical use. Hydrocortisone butyrate is a corticosteroid.
FDA label, Description section
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
Labeled adverse reaction 2Labeled (related wording) 1Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 33
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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.
- 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.
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. 166 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 | 459 | 517.8 476.9–562.1ROR 681.3 · χ² 225,563 / p <1e-300 | 484.2 EB05 448.1 · IC025 +8.2 3/3 methods agree | Not in label — unassessed | serious PRR 321.0 · 95% clinician | no trial data cached |
| Folliculitis | 461 | 513.0 472.7–556.9ROR 675.9 · χ² 224,560 / p <1e-300 | 480.1 EB05 444.4 · IC025 +8.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 353.9 · 95% clinician | no trial data cached |
| Hand deformity | 498 | 434.5 402.1–469.6ROR 587.4 · χ² 206,809 / p <1e-300 | 411.2 EB05 381.8 · IC025 +8.1 3/3 methods agree | Not in label — unassessed | serious PRR 279.3 · 94% clinician | no trial data cached |
| Pemphigus | 418 | 382.1 350.4–416.6ROR 488.8 · χ² 153,176 / p <1e-300 | 362.9 EB05 334.7 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious PRR 227.5 · 92% clinician | no trial data cached |
| Joint range of motion decreased | 356 | 300.4 273.1–330.5ROR 369.0 · χ² 103,155 / p <1e-300 | 287.8 EB05 263.6 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious PRR 229.1 · 96% clinician | no trial data cached |
| Synovitis | 459 | 286.5 264.2–310.7ROR 376.9 · χ² 127,070 / p <1e-300 | 276.0 EB05 255.4 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious PRR 179.7 · 94% clinician | no trial data cached |
| Bursitis | 306 | 285.7 257.4–317.1ROR 340.0 · χ² 84,358 / p <1e-300 | 273.6 EB05 248.9 · IC025 +7.4 3/3 methods agree | Not in label — unassessed | serious PRR 201.4 · 95% clinician | no trial data cached |
| Hypercholesterolaemia | 240 | 282.5 250.5–318.5ROR 323.0 · χ² 65,367 / p <1e-300 | 269.4 EB05 242.0 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious PRR 179.9 · 95% clinician | no trial data cached |
| Pericarditis | 408 | 275.6 252.5–300.7ROR 350.1 · χ² 108,666 / p <1e-300 | 265.4 EB05 244.5 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious PRR 166.5 · 92% clinician | no trial data cached |
| Wound infection | 257 | 265.9 236.9–298.4ROR 307.1 · χ² 65,976 / p <1e-300 | 254.7 EB05 229.6 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious PRR 171.1 · 93% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 510 | 256.3 237.7–276.4ROR 349.3 · χ² 126,594 / p <1e-300 | 248.1 EB05 230.5 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious PRR 222.9 · 94% clinician | no trial data cached |
| Autoimmune disorder | 199 | 233.1 204.1–266.3ROR 260.1 · χ² 44,815 / p <1e-300 | 223.3 EB05 198.5 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 150.0 · 92% clinician | no trial data cached |
| Irritable bowel syndrome | 431 | 226.0 207.8–245.9ROR 291.6 · χ² 94,463 / p <1e-300 | 219.3 EB05 202.5 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 172.8 · 96% clinician | no trial data cached |
| Fibromyalgia | 432 | 198.8 182.8–216.2ROR 256.6 · χ² 83,401 / p <1e-300 | 193.6 EB05 178.8 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious PRR 157.9 · 94% clinician | no trial data cached |
| Sciatica | 278 | 195.9 175.5–218.6ROR 229.1 · χ² 52,789 / p <1e-300 | 189.9 EB05 171.9 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious PRR 159.0 · 93% clinician | no trial data cached |
| Wound | 474 | 190.4 176.0–206.1ROR 252.9 · χ² 87,703 / p <1e-300 | 185.8 EB05 172.1 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious PRR 136.7 · 93% clinician | no trial data cached |
| Obesity | 269 | 188.3 168.3–210.6ROR 219.0 · χ² 49,106 / p <1e-300 | 182.7 EB05 165.1 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 132.1 · 96% clinician | no trial data cached |
| Liver injury | 357 | 164.5 149.7–180.8ROR 202.1 · χ² 57,056 / p <1e-300 | 160.7 EB05 147.2 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 103.3 · 94% clinician | no trial data cached |
| Systemic lupus erythematosus | 506 | 159.3 147.7–171.8ROR 216.4 · χ² 78,428 / p <1e-300 | 156.1 EB05 145.0 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 99.0 · 93% clinician | no trial data cached |
| Impaired healing | 446 | 151.2 139.3–164.1ROR 196.9 · χ² 65,571 / p <1e-300 | 148.2 EB05 137.0 · IC025 +6.8 3/3 methods agree | Reporting / coding artifact | serious PRR 110.8 · 96% clinician | no trial data cached |
| Type 2 diabetes mellitus | 432 | 142.2 130.8–154.7ROR 183.5 · χ² 59,762 / p <1e-300 | 139.6 EB05 128.9 · IC025 +6.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 91.0 · 94% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 131 | 131.2 111.1–155.0ROR 140.8 · χ² 16,606 / p <1e-300 | 127.3 EB05 110.0 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious PRR 90.4 · 95% clinician | no trial data cached |
| Psoriatic arthropathy | 440 | 121.4 111.8–131.9ROR 157.5 · χ² 51,955 / p <1e-300 | 119.5 EB05 110.4 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 93.0 · 94% clinician | no trial data cached |
| Lower limb fracture | 194 | 112.7 98.5–128.8ROR 125.3 · χ² 21,160 / p <1e-300 | 110.3 EB05 97.9 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 75.3 | no trial data cached |
| Laryngitis | 108 | 110.3 91.7–132.6ROR 116.9 · χ² 11,477 / p <1e-300 | 107.2 EB05 91.3 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=108 · 96% clinician | no trial data cached |
| Night sweats | 300 | 103.2 93.0–114.6ROR 122.3 · χ² 30,036 / p <1e-300 | 101.6 EB05 92.3 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 108.0 · 95% clinician | no trial data cached |
| Taste disorder | 175 | 96.7 83.9–111.5ROR 106.4 · χ² 16,351 / p <1e-300 | 94.9 EB05 83.7 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 118.4 · 94% clinician | no trial data cached |
| Pulmonary fibrosis | 166 | 96.2 83.1–111.3ROR 105.2 · χ² 15,419 / p <1e-300 | 94.3 EB05 82.9 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 59.2 · 93% clinician | no trial data cached |
| Lower respiratory tract infection | 391 | 95.5 87.4–104.4ROR 119.9 · χ² 36,245 / p <1e-300 | 94.3 EB05 86.7 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 61.6 · 94% clinician | no trial data cached |
| Contraindicated product administered | 247 | 90.6 80.6–101.9ROR 104.0 · χ² 21,657 / p <1e-300 | 89.3 EB05 80.3 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious PRR 68.8 · 93% clinician | no trial data cached |
| Joint dislocation | 85 | 89.3 72.5–110.1ROR 93.5 · χ² 7,280 / p <1e-300 | 86.9 EB05 72.5 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 61.3 · 94% clinician | no trial data cached |
| Coeliac disease | 78 | 87.9 70.7–109.4ROR 91.6 · χ² 6,566 / p <1e-300 | 85.5 EB05 70.7 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 66.8 · 94% clinician | no trial data cached |
| Back injury | 86 | 87.9 71.4–108.1ROR 92.0 · χ² 7,246 / p <1e-300 | 85.6 EB05 71.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 71.0 · 98% clinician | no trial data cached |
| Foot deformity | 88 | 87.7 71.5–107.7ROR 91.9 · χ² 7,404 / p <1e-300 | 85.5 EB05 71.5 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 62.2 · 94% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 523 | 87.6 81.4–94.3ROR 120.3 · χ² 44,479 / p <1e-300 | 86.7 EB05 80.6 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 67.3 · 93% clinician | no trial data cached |
| Stomatitis (mouth sores) | 466 | 85.0 78.5–92.0ROR 112.1 · χ² 38,401 / p <1e-300 | 84.0 EB05 77.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 77.7 · 95% clinician | no trial data cached |
| Arthropathy | 425 | 84.3 77.5–91.7ROR 108.1 · χ² 34,714 / p <1e-300 | 83.3 EB05 76.9 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 62.7 · 93% clinician | no trial data cached |
| Gait inability | 252 | 84.2 75.0–94.5ROR 96.9 · χ² 20,512 / p <1e-300 | 83.1 EB05 74.8 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 63.9 · 92% clinician | no trial data cached |
| Inflammation | 381 | 82.1 75.0–89.8ROR 102.3 · χ² 30,283 / p <1e-300 | 81.2 EB05 74.5 · IC025 +6.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 66.7 · 96% clinician | no trial data cached |
| Blood cholesterol increased | 340 | 80.6 73.2–88.8ROR 97.9 · χ² 26,517 / p <1e-300 | 79.7 EB05 72.8 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious PRR 74.6 · 93% clinician | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 591 | 7.5 7.0–8.0ROR 10.4 · χ² 3,452 / p <1e-300 | 7.4 EB05 7.0 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 · 92% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 537 | 4.5 4.2–4.8ROR 5.8 · χ² 1,544 / p <1e-300 | 4.5 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.6 · 91% clinician | no trial data cached |
| Rash | 527 | 13.4 12.4–14.4ROR 18.1 · χ² 6,133 / p <1e-300 | 13.3 EB05 12.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 17.9 · 93% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 523 | 87.6 81.4–94.3ROR 120.3 · χ² 44,479 / p <1e-300 | 86.7 EB05 80.6 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 67.3 · 93% clinician | no trial data cached |
| Fatigue (tiredness) | 519 | 7.3 6.8–7.9ROR 9.7 · χ² 2,942 / p <1e-300 | 7.3 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 510 | 256.3 237.7–276.4ROR 349.3 · χ² 126,594 / p <1e-300 | 248.1 EB05 230.5 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious PRR 222.9 · 94% clinician | no trial data cached |
| Systemic lupus erythematosus | 506 | 159.3 147.7–171.8ROR 216.4 · χ² 78,428 / p <1e-300 | 156.1 EB05 145.0 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 99.0 · 93% clinician | no trial data cached |
| Hand deformity | 498 | 434.5 402.1–469.6ROR 587.4 · χ² 206,809 / p <1e-300 | 411.2 EB05 381.8 · IC025 +8.1 3/3 methods agree | Not in label — unassessed | serious PRR 279.3 · 94% clinician | no trial data cached |
| Rheumatoid arthritis | 493 | 48.1 44.5–51.9ROR 64.5 · χ² 22,700 / p <1e-300 | 47.8 EB05 44.3 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 36.0 · 94% clinician | no trial data cached |
| Swelling | 483 | 57.1 52.8–61.7ROR 76.1 · χ² 26,533 / p <1e-300 | 56.7 EB05 52.5 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 56.6 · 93% clinician | no trial data cached |
| Joint swelling | 479 | 43.8 40.5–47.4ROR 58.2 · χ² 20,036 / p <1e-300 | 43.6 EB05 40.4 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 46.2 · 93% clinician | no trial data cached |
| Wound | 474 | 190.4 176.0–206.1ROR 252.9 · χ² 87,703 / p <1e-300 | 185.8 EB05 172.1 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious PRR 136.7 · 93% clinician | no trial data cached |
| Hepatic enzyme increased | 471 | 76.6 70.8–82.9ROR 101.4 · χ² 34,942 / p <1e-300 | 75.9 EB05 70.3 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious PRR 67.7 · 94% clinician | no trial data cached |
| General physical health deterioration | 468 | 44.9 41.5–48.6ROR 59.2 · χ² 20,073 / p <1e-300 | 44.6 EB05 41.4 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 32.1 · 94% clinician | no trial data cached |
| Drug intolerance | 466 | 53.4 49.3–57.8ROR 70.3 · χ² 23,906 / p <1e-300 | 53.0 EB05 49.1 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 53.2 · 93% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Helicobacter infection — n=459, PRR 517.8
- Hand deformity — n=498, PRR 434.5
- Pemphigus — n=418, PRR 382.1
- Joint range of motion decreased — n=356, PRR 300.4
- Synovitis — n=459, PRR 286.5
- Bursitis — n=306, PRR 285.7
- Hypercholesterolaemia — n=240, PRR 282.5
- Pericarditis — n=408, PRR 275.6
- Wound infection — n=257, PRR 265.9
- Glossodynia — n=510, PRR 256.3
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 Hydrocortisone Butyrate?
In FDA FAERS, the most frequently co-reported reaction terms for Hydrocortisone Butyrate are rash, infusion related reaction, fatigue, glossodynia, systemic lupus erythematosus, hand deformity. 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 Hydrocortisone Butyrate have an FDA boxed warning?
No. The FDA label retrieved for Hydrocortisone Butyrate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Hydrocortisone Butyrate 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 988b5524-2947-4862-9d5b-e8b7fec5fd9a, effective 20260514; matched on
openfda.generic_name.exact:"HYDROCORTISONE BUTYRATE") - 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, 206 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.