Drug · FAERS side-effect profile with label screen
Hydrocortisone Valerate side effects: what 609 FDA adverse event reports show
Drug class
Not stated in label
Who reports
609 reports · 71% serious · 28 with death outcome · 61% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Hydrocortisone valerate cream, 0.2% and hydrocortisone valerate ointment, 0.2% are medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.
FDA label, Indications and Usage
What it is
DESCRIPTION Hydrocortisone valerate cream USP, 0.2% and hydrocortisone valerate ointment USP, 0.2%, contain hydrocortisone valerate, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)-pregn-4-ene-3,20-dione, a synthetic corticosteroid for topical dermatologic use.
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 39 strongest signals
Labeled adverse reaction 1Labeled (related wording) 3Reporting / coding artifact 3Lab value / disease marker 10Not in label — unassessed 22
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. 21 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 |
|---|---|---|---|---|---|---|
| Vitamin d deficiency | 27 | 95.6 66.1–138.3ROR 100.0 · χ² 2,429 / p <1e-300 | 89.5 EB05 64.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 93.8 · ♀ 100% (drug 61%) · 100% clinician | no trial data cached |
| Temperature intolerance | 27 | 91.3 63.1–132.1ROR 95.5 · χ² 2,316 / p <1e-300 | 85.7 EB05 61.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 100% (drug 61%) · 93% clinician | no trial data cached |
| Spinal disorder | 25 | 90.9 61.9–133.6ROR 94.8 · χ² 2,130 / p <1e-300 | 85.0 EB05 60.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 85.9 · ♀ 100% (drug 61%) · 100% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 26 | 80.9 55.5–117.9ROR 84.5 · χ² 1,969 / p <1e-300 | 76.3 EB05 54.8 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious PRR 74.6 · ♀ 100% (drug 61%) · 100% clinician | no trial data cached |
| Neutrophil count increased | 24 | 80.6 54.4–119.3ROR 83.8 · χ² 1,804 / p <1e-300 | 75.7 EB05 53.6 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 72.1 · ♀ 100% (drug 61%) · 100% clinician | no trial data cached |
| Adrenal insufficiency | 25 | 72.0 49.1–105.8ROR 75.1 · χ² 1,679 / p <1e-300 | 68.3 EB05 48.7 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 59.3 · ♀ 100% (drug 61%) · 100% clinician | no trial data cached |
| Coordination abnormal | 26 | 63.8 43.8–93.0ROR 66.6 · χ² 1,544 / p <1e-300 | 61.0 EB05 43.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 72.1 · ♀ 100% (drug 61%) · 96% clinician | no trial data cached |
| Blood test abnormal | 25 | 61.4 41.8–90.2ROR 64.0 · χ² 1,424 / p <1e-300 | 58.7 EB05 41.8 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 76.5 · ♀ 100% (drug 61%) · 100% clinician | no trial data cached |
| Ulcer | 26 | 56.3 38.6–82.0ROR 58.7 · χ² 1,356 / p 5e-297 | 54.1 EB05 38.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 57.8 · ♀ 100% (drug 61%) · 96% clinician | no trial data cached |
| Blood urea increased | 25 | 51.2 34.9–75.2ROR 53.4 · χ² 1,180 / p 7e-259 | 49.3 EB05 35.1 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious PRR 46.2 · ♀ 100% (drug 61%) · 100% clinician | no trial data cached |
| Carpal tunnel syndrome | 20 | 49.1 31.9–75.6ROR 50.7 · χ² 894 / p 8e-197 | 47.0 EB05 32.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 49.4 | no trial data cached |
| Autoimmune disorder | 12 | 43.2 24.7–75.7ROR 44.1 · χ² 453 / p 7e-101 | 40.6 EB05 24.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 37.6 | no trial data cached |
| Osteomyelitis | 22 | 41.9 27.8–63.2ROR 43.4 · χ² 838 / p 2e-184 | 40.5 EB05 28.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 34.7 · 91% clinician | no trial data cached |
| Blood pressure fluctuation | 26 | 37.2 25.6–54.2ROR 38.8 · χ² 881 / p 7e-194 | 36.3 EB05 26.0 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious PRR 36.9 · ♀ 91% (drug 61%) · 92% clinician | no trial data cached |
| Blood alkaline phosphatase increased | 26 | 36.0 24.7–52.5ROR 37.6 · χ² 851 / p 3e-187 | 35.1 EB05 25.2 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious PRR 33.8 · ♀ 100% (drug 61%) · 100% clinician | no trial data cached |
| Glycosylated haemoglobin increased | 24 | 32.8 22.2–48.6ROR 34.1 · χ² 709 / p 1e-156 | 32.1 EB05 22.7 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious PRR 60.7 · ♀ 100% (drug 61%) · 100% clinician | no trial data cached |
| Dermatitis | 19 | 31.6 20.3–49.2ROR 32.6 · χ² 533 / p 3e-118 | 30.7 EB05 20.8 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 49.6 | no trial data cached |
| Red blood cell count decreased | 25 | 30.1 20.5–44.2ROR 31.3 · χ² 675 / p 5e-149 | 29.5 EB05 21.0 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious PRR 32.3 · ♀ 100% (drug 61%) · 100% clinician | no trial data cached |
| Type 2 diabetes mellitus | 27 | 27.5 19.0–39.8ROR 28.8 · χ² 665 / p 6e-147 | 27.1 EB05 19.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 23.7 · ♀ 100% (drug 61%) · 96% clinician | no trial data cached |
| C-reactive protein increased | 25 | 23.7 16.1–34.8ROR 24.7 · χ² 521 / p 1e-115 | 23.3 EB05 16.6 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 20.1 · ♀ 95% (drug 61%) · 100% clinician | no trial data cached |
| White blood cell count increased | 25 | 22.4 15.2–32.8ROR 23.3 · χ² 490 / p 8e-109 | 22.0 EB05 15.6 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 21.9 · ♀ 100% (drug 61%) · 100% clinician | no trial data cached |
| Nasal congestion (stuffy nose) | 36 | 21.2 15.4–29.1ROR 22.5 · χ² 674 / p 7e-149 | 21.0 EB05 15.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 35.7 · ♀ 84% (drug 61%) | no trial data cached |
| Throat irritation | 25 | 19.3 13.1–28.3ROR 20.0 · χ² 415 / p 1e-92 | 19.0 EB05 13.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 36.4 · ♀ 100% (drug 61%) · 100% clinician | no trial data cached |
| Cognitive disorder | 26 | 19.3 13.2–28.0ROR 20.1 · χ² 433 / p 2e-96 | 19.0 EB05 13.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 21.1 · ♀ 100% (drug 61%) · 96% clinician | no trial data cached |
| Psoriatic arthropathy | 22 | 18.8 12.5–28.4ROR 19.5 · χ² 355 / p 2e-79 | 18.5 EB05 12.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 19.3 · ♀ 90% (drug 61%) | no trial data cached |
| Multiple sclerosis | 26 | 18.6 12.8–27.1ROR 19.4 · χ² 417 / p 5e-93 | 18.3 EB05 13.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 22.7 · ♀ 100% (drug 61%) · 96% clinician | no trial data cached |
| Dry eye | 26 | 18.5 12.7–26.9ROR 19.3 · χ² 413 / p 3e-92 | 18.2 EB05 12.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 39.5 · ♀ 95% (drug 61%) · 100% clinician | no trial data cached |
| Ear infection | 14 | 18.2 10.8–30.5ROR 18.6 · χ² 210 / p 5e-48 | 17.4 EB05 10.5 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.0 | no trial data cached |
| Blood glucose decreased | 25 | 17.9 12.2–26.2ROR 18.6 · χ² 382 / p 2e-85 | 17.6 EB05 12.3 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 30.0 · ♀ 100% (drug 61%) · 100% clinician | no trial data cached |
| Depressed mood | 27 | 17.7 12.2–25.6ROR 18.4 · χ² 409 / p 3e-91 | 17.4 EB05 12.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 21.3 · ♀ 95% (drug 61%) · 93% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 26 | 16.3 11.2–23.8ROR 17.0 · χ² 359 / p 2e-80 | 16.0 EB05 11.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · ♀ 100% (drug 61%) · 96% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 31 | 16.2 11.5–22.8ROR 17.0 · χ² 427 / p 3e-95 | 15.9 EB05 11.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.6 · ♀ 89% (drug 61%) · 90% clinician | no trial data cached |
| Rheumatoid arthritis | 50 | 15.2 11.7–19.9ROR 16.5 · χ² 654 / p 2e-144 | 15.1 EB05 11.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 · ♀ 98% (drug 61%) · 92% clinician | no trial data cached |
| Therapeutic response decreased | 26 | 14.9 10.2–21.6ROR 15.5 · χ² 323 / p 2e-72 | 14.5 EB05 10.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 30.9 · ♀ 95% (drug 61%) · 100% clinician | no trial data cached |
| Psoriasis | 55 | 14.5 11.3–18.6ROR 15.8 · χ² 681 / p 2e-150 | 14.3 EB05 11.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 27.0 | no trial data cached |
| Contraindicated product administered | 12 | 13.7 7.8–24.0ROR 14.0 · χ² 129 / p 3e-30 | 12.3 EB05 6.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 12.8 | no trial data cached |
| Dermatitis atopic | 18 | 12.4 7.9–19.6ROR 12.8 · χ² 178 / p 7e-41 | 11.5 EB05 7.2 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious n=7 | no trial data cached |
| Femur fracture | 10 | 11.1 6.0–20.5ROR 11.3 · χ² 82 / p 6e-20 | 9.0 EB05 4.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Colitis ulcerative | 12 | 9.3 5.3–16.2ROR 9.4 · χ² 81 / p 1e-19 | 7.6 EB05 4.4 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | 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 |
|---|---|---|---|---|---|---|
| Psoriasis | 55 | 14.5 11.3–18.6ROR 15.8 · χ² 681 / p 2e-150 | 14.3 EB05 11.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 27.0 | no trial data cached |
| Rheumatoid arthritis | 50 | 15.2 11.7–19.9ROR 16.5 · χ² 654 / p 2e-144 | 15.1 EB05 11.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 · ♀ 98% (drug 61%) · 92% clinician | no trial data cached |
| Nasal congestion (stuffy nose) | 36 | 21.2 15.4–29.1ROR 22.5 · χ² 674 / p 7e-149 | 21.0 EB05 15.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 35.7 · ♀ 84% (drug 61%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 31 | 16.2 11.5–22.8ROR 17.0 · χ² 427 / p 3e-95 | 15.9 EB05 11.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.6 · ♀ 89% (drug 61%) · 90% clinician | no trial data cached |
| Depressed mood | 27 | 17.7 12.2–25.6ROR 18.4 · χ² 409 / p 3e-91 | 17.4 EB05 12.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 21.3 · ♀ 95% (drug 61%) · 93% clinician | no trial data cached |
| Type 2 diabetes mellitus | 27 | 27.5 19.0–39.8ROR 28.8 · χ² 665 / p 6e-147 | 27.1 EB05 19.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 23.7 · ♀ 100% (drug 61%) · 96% clinician | no trial data cached |
| Temperature intolerance | 27 | 91.3 63.1–132.1ROR 95.5 · χ² 2,316 / p <1e-300 | 85.7 EB05 61.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 100% (drug 61%) · 93% clinician | no trial data cached |
| Vitamin d deficiency | 27 | 95.6 66.1–138.3ROR 100.0 · χ² 2,429 / p <1e-300 | 89.5 EB05 64.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 93.8 · ♀ 100% (drug 61%) · 100% clinician | no trial data cached |
| Therapeutic response decreased | 26 | 14.9 10.2–21.6ROR 15.5 · χ² 323 / p 2e-72 | 14.5 EB05 10.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 30.9 · ♀ 95% (drug 61%) · 100% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 26 | 16.3 11.2–23.8ROR 17.0 · χ² 359 / p 2e-80 | 16.0 EB05 11.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · ♀ 100% (drug 61%) · 96% clinician | no trial data cached |
| Dry eye | 26 | 18.5 12.7–26.9ROR 19.3 · χ² 413 / p 3e-92 | 18.2 EB05 12.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 39.5 · ♀ 95% (drug 61%) · 100% clinician | no trial data cached |
| Multiple sclerosis | 26 | 18.6 12.8–27.1ROR 19.4 · χ² 417 / p 5e-93 | 18.3 EB05 13.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 22.7 · ♀ 100% (drug 61%) · 96% clinician | no trial data cached |
| Cognitive disorder | 26 | 19.3 13.2–28.0ROR 20.1 · χ² 433 / p 2e-96 | 19.0 EB05 13.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 21.1 · ♀ 100% (drug 61%) · 96% clinician | no trial data cached |
| Blood alkaline phosphatase increased | 26 | 36.0 24.7–52.5ROR 37.6 · χ² 851 / p 3e-187 | 35.1 EB05 25.2 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious PRR 33.8 · ♀ 100% (drug 61%) · 100% clinician | no trial data cached |
| Blood pressure fluctuation | 26 | 37.2 25.6–54.2ROR 38.8 · χ² 881 / p 7e-194 | 36.3 EB05 26.0 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious PRR 36.9 · ♀ 91% (drug 61%) · 92% 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.
- Vitamin d deficiency — n=27, PRR 95.6
- Temperature intolerance — n=27, PRR 91.3
- Spinal disorder — n=25, PRR 90.9
- Coordination abnormal — n=26, PRR 63.8
- Ulcer — n=26, PRR 56.3
- Carpal tunnel syndrome — n=20, PRR 49.1
- Osteomyelitis — n=22, PRR 41.9
- Type 2 diabetes mellitus — n=27, PRR 27.5
- Nasal congestion — n=36, PRR 21.2
- Throat irritation — n=25, PRR 19.3
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 Valerate?
In FDA FAERS, the most frequently co-reported reaction terms for Hydrocortisone Valerate are psoriasis, rheumatoid arthritis, nasal congestion, infusion related reaction, depressed mood, type 2 diabetes mellitus. 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 Valerate have an FDA boxed warning?
No. The FDA label retrieved for Hydrocortisone Valerate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Hydrocortisone Valerate 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 a9011d6f-6808-48a7-ab6b-df8d40540570, effective 20250707; matched on
openfda.generic_name.exact:"HYDROCORTISONE VALERATE") - 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, 60 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.