Drug · FAERS side-effect profile with label screen
Hydrocortisone 1% side effects: what 66,703 FDA adverse event reports show
Brand names
Hydrocortisone
openFDA label
Who reports
66,703 reports · 83% serious · 9,800 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema seborrheic dermatitis poison ivy, poison oak, and poison sumac psoriasis insect bites cosmetics jewelry detergents soaps temporarily relieves external anal and genital itching other uses of this product should be only under the advise and supervision of a doctor
FDA label, Indications and Usage
What it is
Cortisol is a 17alpha-hydroxy-C21-steroid that is pregn-4-ene substituted by oxo groups at positions 3 and 20 and hydroxy groups at positions 11, 17 and 21.
PubChem CID 5754 (ChEBI)
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 1Lab value / disease marker 8No label text to screen 31
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.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,203 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 |
|---|---|---|---|---|---|---|
| Human bocavirus infection | 113 | 465.7 347.9–623.6ROR 466.5 · calibrated p 4e-13 ✓ | 180.7 EB05 154.5 · IC025 +6.4 3/3 methods agree vs other Corticosteroids: PRR 8.1 (6.6–9.8) | No label text to screen label has no adverse-reaction text | serious n=113 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Lymphoid tissue hypoplasia | 68 | 266.1 192.4–367.9ROR 266.3 · calibrated p 9e-11 ✓ | 138.0 EB05 112.6 · IC025 +5.7 3/3 methods agree vs other Corticosteroids: PRR 7.6 (5.9–9.7) | No label text to screen label has no adverse-reaction text | serious n=68 | no trial arm names this drug |
| Vaginal flatulence | 138 | 260.1 207.4–326.2ROR 260.6 · calibrated p 6e-11 ✓ | 139.0 EB05 120.6 · IC025 +6.3 3/3 methods agree vs other Corticosteroids: PRR 5.6 (4.7–6.7) | No label text to screen label has no adverse-reaction text | serious n=138 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Thymus hypoplasia | 73 | 232.6 171.7–315.2ROR 232.9 · calibrated p 2e-10 ✓ | 128.7 EB05 105.8 · IC025 +5.7 3/3 methods agree vs other Corticosteroids: PRR 7.6 (6.0–9.7) | No label text to screen label has no adverse-reaction text | serious n=73 | no trial arm names this drug |
| C-reactive protein | 343 | 191.7 167.6–219.3ROR 192.7 · calibrated p 6e-10 ✓ | 117.9 EB05 107.8 · IC025 +6.5 3/3 methods agree vs other Corticosteroids: PRR 4.5 (4.0–5.0) | Lab value / disease marker | serious n=343 · ♀ 100% (drug 58%) · 95% clinician | no trial arm names this drug |
| Grip strength | 87 | 189.4 145.0–247.3ROR 189.6 · calibrated p 1e-9 ✓ | 114.9 EB05 96.0 · IC025 +5.8 3/3 methods agree vs other Corticosteroids: PRR 6.6 (5.3–8.2) | No label text to screen label has no adverse-reaction text | serious n=87 · ♀ 100% (drug 58%) · 100% clinician | no trial arm names this drug |
| Topical steroid withdrawal reaction | 143 | 187.3 152.2–230.5ROR 187.7 · calibrated p 1e-9 ✓ | 115.2 EB05 100.2 · IC025 +6.1 3/3 methods agree vs other Corticosteroids: PRR 8.3 (7.0–9.8) | No label text to screen label has no adverse-reaction text | serious n=139 · ♀ 79% (drug 58%) · 100% consumer | no trial arm names this drug |
| Deep vein thrombosis postoperative | 723 | 184.2 168.1–202.0ROR 186.3 · calibrated p 8e-10 ✓ | 115.5 EB05 108.6 · IC025 +6.6 3/3 methods agree vs other Corticosteroids: PRR 4.3 (4.0–4.6) | No label text to screen label has no adverse-reaction text | serious n=723 · ♀ 100% (drug 58%) · 91% clinician | no trial arm names this drug |
| Lupus vulgaris | 430 | 178.4 158.5–200.9ROR 179.6 · calibrated p 1e-9 ✓ | 112.9 EB05 104.3 · IC025 +6.5 3/3 methods agree vs other Corticosteroids: PRR 4.4 (4.0–4.8) | No label text to screen label has no adverse-reaction text | serious n=430 · ♀ 100% (drug 58%) · 95% clinician | no trial arm names this drug |
| Rheumatic fever | 1,490 | 163.2 153.4–173.7ROR 166.9 · calibrated p 2e-9 ✓ | 107.0 EB05 102.5 · IC025 +6.6 3/3 methods agree vs other Corticosteroids: PRR 4.4 (4.2–4.6) | No label text to screen label has no adverse-reaction text | serious n=1,490 · ♀ 100% (drug 58%) · 94% clinician | no trial arm names this drug |
| Swollen joint count increased | 1,048 | 159.5 148.1–171.8ROR 162.0 · calibrated p 2e-9 ✓ | 105.4 EB05 100.1 · IC025 +6.5 3/3 methods agree vs other Corticosteroids: PRR 4.3 (4.1–4.6) | Lab value / disease marker | serious n=1,048 · ♀ 100% (drug 58%) · 95% clinician | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody | 221 | 156.0 132.7–183.3ROR 156.5 · calibrated p 4e-9 ✓ | 103.1 EB05 92.2 · IC025 +6.2 3/3 methods agree vs other Corticosteroids: PRR 3.8 (3.4–4.4) | Lab value / disease marker | serious n=221 · ♀ 100% (drug 58%) · 100% clinician | no trial arm names this drug |
| Facet joint syndrome | 1,018 | 150.3 139.5–161.9ROR 152.6 · calibrated p 4e-9 ✓ | 101.3 EB05 96.1 · IC025 +6.5 3/3 methods agree vs other Corticosteroids: PRR 4.5 (4.2–4.8) | No label text to screen label has no adverse-reaction text | serious n=1,018 · ♀ 100% (drug 58%) · 94% clinician | no trial arm names this drug |
| Cystitis bacterial | 96 | 123.6 97.6–156.6ROR 123.8 · calibrated p 3e-8 ✓ | 87.1 EB05 73.4 · IC025 +5.6 3/3 methods agree vs other Corticosteroids: PRR 8.5 (6.9–10.5) | No label text to screen label has no adverse-reaction text | serious n=96 | no trial arm names this drug |
| Adjustment disorder with depressed mood | 558 | 120.5 109.3–132.8ROR 121.5 · calibrated p 3e-8 ✓ | 86.7 EB05 80.8 · IC025 +6.2 3/3 methods agree vs other Corticosteroids: PRR 4.3 (4.0–4.7) | No label text to screen label has no adverse-reaction text | serious n=558 · ♀ 100% (drug 58%) · 95% clinician | no trial arm names this drug |
| Swollen joint count | 68 | 120.1 90.8–158.9ROR 120.2 · calibrated p 5e-8 ✓ | 84.8 EB05 69.2 · IC025 +5.3 3/3 methods agree vs other Corticosteroids: PRR 5.5 (4.3–7.0) | No label text to screen label has no adverse-reaction text | serious n=68 · ♀ 100% (drug 58%) · 100% clinician | no trial arm names this drug |
| Norovirus test positive | 88 | 117.3 91.7–149.8ROR 117.4 · calibrated p 5e-8 ✓ | 83.8 EB05 70.1 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 8.5 (6.8–10.6) | Lab value / disease marker | serious n=88 | no trial arm names this drug |
| X-ray abnormal | 441 | 103.2 92.7–114.9ROR 103.9 · calibrated p 9e-8 ✓ | 77.4 EB05 71.5 · IC025 +6.0 3/3 methods agree vs other Corticosteroids: PRR 4.2 (3.8–4.6) | Lab value / disease marker | serious n=441 · ♀ 100% (drug 58%) · 95% clinician | no trial arm names this drug |
| Dislocation of vertebra | 548 | 102.8 93.3–113.2ROR 103.6 · calibrated p 9e-8 ✓ | 77.2 EB05 71.9 · IC025 +6.0 3/3 methods agree vs other Corticosteroids: PRR 4.2 (3.9–4.6) | No label text to screen label has no adverse-reaction text | serious n=548 · ♀ 100% (drug 58%) · 93% clinician | no trial arm names this drug |
| Steroid dependence | 209 | 102.5 87.7–119.9ROR 102.9 · calibrated p 1e-7 ✓ | 76.7 EB05 68.4 · IC025 +5.8 3/3 methods agree vs other Corticosteroids: PRR 5.9 (5.1–6.7) | No label text to screen label has no adverse-reaction text | serious n=208 · ♀ 27% (drug 58%) | no trial arm names this drug |
| Subcutaneous drug absorption impaired | 134 | 102.5 84.3–124.6ROR 102.7 · calibrated p 1e-7 ✓ | 76.4 EB05 66.2 · IC025 +5.6 3/3 methods agree vs other Corticosteroids: PRR 5.3 (4.4–6.3) | No label text to screen label has no adverse-reaction text | serious n=134 · ♀ 100% (drug 58%) · 100% clinician | no trial arm names this drug |
| Duodenal ulcer perforation | 1,804 | 102.5 97.2–108.0ROR 105.3 · calibrated p 8e-8 ✓ | 77.1 EB05 74.2 · IC025 +6.2 3/3 methods agree vs other Corticosteroids: PRR 4.0 (3.8–4.2) | No label text to screen label has no adverse-reaction text | serious PRR 53.5 · ♀ 100% (drug 58%) · 93% clinician | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody positive | 1,732 | 101.3 96.0–106.9ROR 104.0 · calibrated p 8e-8 ✓ | 76.5 EB05 73.5 · IC025 +6.1 3/3 methods agree vs other Corticosteroids: PRR 3.8 (3.7–4.0) | Lab value / disease marker | serious PRR 53.3 · ♀ 100% (drug 58%) · 93% clinician | no trial arm names this drug |
| Rheumatoid factor positive | 1,359 | 96.9 91.2–102.9ROR 98.9 · calibrated p 1e-7 ✓ | 73.9 EB05 70.7 · IC025 +6.1 3/3 methods agree vs other Corticosteroids: PRR 4.1 (3.8–4.3) | Lab value / disease marker | serious n=1,359 · ♀ 100% (drug 58%) · 94% clinician | no trial arm names this drug |
| Steroid withdrawal syndrome | 237 | 95.4 82.5–110.3ROR 95.7 · calibrated p 2e-7 ✓ | 72.7 EB05 65.3 · IC025 +5.8 3/3 methods agree vs other Corticosteroids: PRR 7.2 (6.3–8.2) | No label text to screen label has no adverse-reaction text | serious n=237 · ♀ 81% (drug 58%) | no trial arm names this drug |
| Craniopharyngioma | 75 | 89.9 69.5–116.2ROR 90.0 · calibrated p 4e-7 ✓ | 68.7 EB05 56.6 · IC025 +5.2 3/3 methods agree vs other Corticosteroids: PRR 8.4 (6.6–10.7) | No label text to screen label has no adverse-reaction text | serious n=74 · 100% clinician | no trial arm names this drug |
| Adrenocortical insufficiency acute | 414 | 86.5 77.6–96.5ROR 87.1 · calibrated p 3e-7 ✓ | 67.6 EB05 62.3 · IC025 +5.8 3/3 methods agree vs other Corticosteroids: PRR 8.3 (7.5–9.1) | No label text to screen label has no adverse-reaction text | serious n=409 | no trial arm names this drug |
| Retinitis | 345 | 81.8 72.7–92.1ROR 82.3 · calibrated p 5e-7 ✓ | 64.7 EB05 59.2 · IC025 +5.7 3/3 methods agree vs other Corticosteroids: PRR 4.0 (3.6–4.5) | No label text to screen label has no adverse-reaction text | serious n=345 · ♀ 100% (drug 58%) · 93% clinician | no trial arm names this drug |
| Mycobacterium chelonae infection | 152 | 81.7 68.3–97.7ROR 81.9 · calibrated p 6e-7 ✓ | 64.3 EB05 56.2 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 5.0 (4.3–5.9) | No label text to screen label has no adverse-reaction text | serious n=152 | no trial arm names this drug |
| Appendicolith | 75 | 77.3 60.0–99.5ROR 77.4 · calibrated p 1e-6 ✓ | 61.1 EB05 50.4 · IC025 +5.1 3/3 methods agree vs other Corticosteroids: PRR 8.1 (6.4–10.2) | No label text to screen label has no adverse-reaction text | serious n=75 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Peripheral venous disease | 760 | 73.8 68.2–79.9ROR 74.7 · calibrated p 1e-6 ✓ | 59.7 EB05 56.2 · IC025 +5.7 3/3 methods agree vs other Corticosteroids: PRR 4.3 (4.0–4.6) | No label text to screen label has no adverse-reaction text | serious n=757 · ♀ 100% (drug 58%) · 91% clinician | no trial arm names this drug |
| Analgesic therapy | 58 | 73.2 55.0–97.4ROR 73.2 · calibrated p 2e-6 ✓ | 58.3 EB05 46.7 · IC025 +4.9 3/3 methods agree vs other Corticosteroids: PRR 9.2 (7.0–12.0) | Reporting / coding artifact | serious n=58 · ♀ 0% (drug 58%) · 100% clinician | no trial arm names this drug |
| Hypocholesterolaemia | 58 | 72.9 54.8–97.0ROR 72.9 · calibrated p 2e-6 ✓ | 58.1 EB05 46.6 · IC025 +4.9 3/3 methods agree vs other Corticosteroids: PRR 5.9 (4.5–7.7) | No label text to screen label has no adverse-reaction text | serious n=58 · ♀ 100% (drug 58%) · 100% clinician | no trial arm names this drug |
| Secondary immunodeficiency | 222 | 71.7 62.0–83.0ROR 71.9 · calibrated p 1e-6 ✓ | 58.1 EB05 52.0 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 4.9 (4.3–5.6) | No label text to screen label has no adverse-reaction text | serious n=221 · ♀ 100% (drug 58%) | no trial arm names this drug |
| Catarrh | 162 | 69.9 59.0–82.9ROR 70.1 · calibrated p 2e-6 ✓ | 56.9 EB05 49.9 · IC025 +5.3 3/3 methods agree vs other Corticosteroids: PRR 7.1 (6.1–8.4) | No label text to screen label has no adverse-reaction text | serious n=162 · ♀ 0% (drug 58%) | no trial arm names this drug |
| Abscess bacterial | 63 | 67.2 51.1–88.2ROR 67.2 · calibrated p 3e-6 ✓ | 54.5 EB05 44.1 · IC025 +4.9 3/3 methods agree vs other Corticosteroids: PRR 9.5 (7.3–12.3) | No label text to screen label has no adverse-reaction text | serious n=63 · 100% clinician | no trial arm names this drug |
| Helicobacter infection | 1,788 | 66.8 63.5–70.3ROR 68.6 · calibrated p 2e-6 ✓ | 55.1 EB05 53.0 · IC025 +5.7 3/3 methods agree vs other Corticosteroids: PRR 3.9 (3.7–4.1) | No label text to screen label has no adverse-reaction text | serious PRR 40.4 · ♀ 100% (drug 58%) · 94% clinician | no trial arm names this drug |
| Adrenal suppression | 147 | 66.2 55.4–79.1ROR 66.4 · calibrated p 3e-6 ✓ | 54.4 EB05 47.4 · IC025 +5.3 3/3 methods agree vs other Corticosteroids: PRR 7.9 (6.7–9.4) | No label text to screen label has no adverse-reaction text | serious n=147 | no trial arm names this drug |
| Pemphigus | 1,984 | 59.6 56.9–62.5ROR 61.4 · calibrated p 4e-6 ✓ | 50.1 EB05 48.3 · IC025 +5.6 3/3 methods agree vs other Corticosteroids: PRR 3.4 (3.2–3.5) | No label text to screen label has no adverse-reaction text | serious PRR 34.9 · ♀ 100% (drug 58%) · 93% clinician | no trial arm names this drug |
| C-reactive protein abnormal | 1,003 | 58.3 54.5–62.3ROR 59.1 · calibrated p 5e-6 ✓ | 49.1 EB05 46.6 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 3.9 (3.7–4.2) | Lab value / disease marker | serious n=1,003 · ♀ 100% (drug 58%) · 94% clinician | no trial arm names this drug |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Liver injury | 3,974 | 4.24.1–4.3 | signal |
| Interstitial lung disease | 1,251 | 4.13.9–4.4 | signal |
| Hyponatraemia | 1,001 | 3.93.7–4.2 | signal |
| Neutropenia / agranulocytosis | 2,495 | 3.23.1–3.3 | signal |
| Serious infection | 7,215 | 3.02.9–3.0 | signal |
| Pancreatitis | 713 | 2.82.6–3.0 | signal |
| Hyperglycaemia / diabetes | 2,997 | 2.72.6–2.8 | signal |
| Anaphylaxis / angioedema | 1,031 | 2.62.4–2.8 | signal |
| Severe cutaneous reaction | 609 | 2.62.4–2.8 | signal |
| Opportunistic infection | 1,078 | 2.52.4–2.7 | signal |
| Gi bleeding | 1,387 | 2.42.3–2.5 | signal |
| Depression | 1,963 | 2.22.1–2.3 | signal |
| Rhabdomyolysis / myopathy | 555 | 2.22.0–2.3 | raised |
| Anaemia | 2,023 | 2.12.0–2.2 | signal |
| Thrombocytopenia | 1,371 | 2.01.9–2.1 | raised |
| Venous thromboembolism | 1,319 | 1.91.8–2.0 | raised |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Hydrocortisone 1% only as a background or rescue medication (NCT02883049, NCT02112916); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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) | 9,446 | 3.4 3.4–3.5ROR 3.9 · calibrated p 0.406 | 3.4 EB05 3.4 · IC025 +1.7 3/3 methods agree vs other Corticosteroids: PRR 2.8 (2.7–2.8) | Reporting / coding artifact | age-adj. PRR 2.8 · serious PRR 4.1 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 7,473 | 1.8 1.8–1.8ROR 1.9 · calibrated p 0.881 | 1.8 EB05 1.7 · IC025 +0.8 vs other Corticosteroids: PRR 2.4 (2.4–2.5) | Reporting / coding artifact | age-adj. PRR 2.0 · serious PRR 2.9 | no trial arm names this drug |
| Fatigue (tiredness) | 5,923 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.794 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Corticosteroids: PRR 2.8 (2.8–2.9) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.2 · serious PRR 2.7 | no trial arm names this drug |
| Condition aggravated | 5,460 | 5.8 5.6–5.9ROR 6.2 · calibrated p 0.138 | 5.7 EB05 5.6 · IC025 +2.5 3/3 methods agree vs other Corticosteroids: PRR 3.4 (3.3–3.5) | Reporting / coding artifact | age-adj. PRR 4.4 · serious PRR 5.7 | no trial arm names this drug |
| Nausea | 4,998 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.986 | 2.0 EB05 1.9 · IC025 +0.9 vs other Corticosteroids: PRR 3.0 (2.9–3.1) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.8 · serious PRR 2.3 | no trial arm names this drug |
| Rash | 4,914 | 3.6 3.5–3.7ROR 3.8 · calibrated p 0.417 | 3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree vs other Corticosteroids: PRR 3.3 (3.2–3.4) | No label text to screen label has no adverse-reaction text | age-adj. PRR 3.1 · serious PRR 4.6 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 4,455 | 2.2 2.1–2.2ROR 2.3 · calibrated p 0.917 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree vs other Corticosteroids: PRR 2.7 (2.6–2.7) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.1 · serious PRR 2.3 | no trial arm names this drug |
| Headache | 4,429 | 2.2 2.2–2.3ROR 2.3 · calibrated p 0.894 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Corticosteroids: PRR 3.0 (2.9–3.1) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.9 · serious PRR 2.8 · ♀ 80% (drug 58%) | no trial arm names this drug |
| Pain | 4,423 | 2.3 2.2–2.3ROR 2.4 · calibrated p 0.876 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Corticosteroids: PRR 2.7 (2.6–2.7) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.3 · serious PRR 2.3 · ♀ 79% (drug 58%) | no trial arm names this drug |
| Arthralgia (joint pain) | 4,295 | 3.3 3.2–3.4ROR 3.4 · calibrated p 0.500 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree vs other Corticosteroids: PRR 2.9 (2.8–3.0) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.6 · serious PRR 3.8 · ♀ 79% (drug 58%) | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 4,286 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.818 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Corticosteroids: PRR 2.5 (2.4–2.5) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.2 · serious PRR 2.2 | no trial arm names this drug |
| Pyrexia (fever) | 3,971 | 3.6 3.5–3.7ROR 3.8 · calibrated p 0.416 | 3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree vs other Corticosteroids: PRR 2.6 (2.5–2.7) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.7 · serious PRR 3.0 | no trial arm names this drug |
| Vomiting | 3,911 | 2.6 2.6–2.7ROR 2.7 · calibrated p 0.718 | 2.6 EB05 2.6 · IC025 +1.3 3/3 methods agree vs other Corticosteroids: PRR 3.1 (3.0–3.2) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.2 · serious PRR 2.6 | no trial arm names this drug |
| Pruritus (itching) | 3,698 | 3.1 3.0–3.2ROR 3.2 · calibrated p 0.559 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Corticosteroids: PRR 3.7 (3.5–3.8) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.5 · serious PRR 4.0 | no trial arm names this drug |
| Malaise (feeling unwell) | 3,613 | 2.6 2.5–2.7ROR 2.7 · calibrated p 0.737 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Corticosteroids: PRR 3.1 (3.0–3.2) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.6 · serious PRR 2.8 · ♀ 79% (drug 58%) | no trial arm names this drug |
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 Hydrocortisone 1%?
In FDA FAERS, the most frequently co-reported reaction terms for Hydrocortisone 1% are fatigue, nausea, rash, diarrhoea, headache, pain. 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 1% have an FDA boxed warning?
No. The FDA label retrieved for Hydrocortisone 1% has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Hydrocortisone 1% 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 0c5325e3-4796-856c-e063-6394a90a1f90, effective 20231212; matched on
openfda.generic_name.exact:"HYDROCORTISONE 1%") - PubChem CID 5754 description (ChEBI)
- 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, 1,243 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 - ClinicalTrials.gov API v2 (query
HYDROCORTISONE 1%, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.