Drug · FAERS side-effect profile with label screen
Hydrocortisone Cream side effects: what 66,971 FDA adverse event reports show
Who reports
66,971 reports · 83% serious · 9,817 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.
FDA label, Indications and Usage
What it is
Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol.
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
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). 1,201 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 | 463.9 346.5–621.1ROR 464.6 · calibrated p 4e-13 ✓ | 180.0 EB05 153.9 · 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%) | not reported in cached trials |
| Lymphoid tissue hypoplasia | 68 | 265.0 191.6–366.5ROR 265.3 · calibrated p 9e-11 ✓ | 137.4 EB05 112.1 · 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 | not reported in cached trials |
| Vaginal flatulence | 138 | 259.1 206.6–324.8ROR 259.6 · calibrated p 6e-11 ✓ | 138.5 EB05 120.1 · 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%) | not reported in cached trials |
| Thymus hypoplasia | 73 | 231.7 171.0–313.9ROR 232.0 · calibrated p 3e-10 ✓ | 128.3 EB05 105.4 · 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 | not reported in cached trials |
| C-reactive protein | 343 | 191.0 166.9–218.5ROR 191.9 · calibrated p 7e-10 ✓ | 117.5 EB05 107.4 · 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 | not reported in cached trials |
| Grip strength | 87 | 188.6 144.5–246.3ROR 188.9 · calibrated p 1e-9 ✓ | 114.5 EB05 95.7 · 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 | not reported in cached trials |
| Topical steroid withdrawal reaction | 143 | 186.6 151.6–229.6ROR 186.9 · calibrated p 1e-9 ✓ | 114.8 EB05 99.8 · 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 | not reported in cached trials |
| Deep vein thrombosis postoperative | 723 | 183.5 167.4–201.1ROR 185.5 · calibrated p 8e-10 ✓ | 115.0 EB05 108.1 · 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 | not reported in cached trials |
| Lupus vulgaris | 430 | 177.7 157.8–200.0ROR 178.8 · calibrated p 1e-9 ✓ | 112.5 EB05 103.8 · 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 | not reported in cached trials |
| Rheumatic fever | 1,490 | 162.6 152.7–173.0ROR 166.2 · calibrated p 2e-9 ✓ | 106.6 EB05 102.1 · 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 | not reported in cached trials |
| Swollen joint count increased | 1,048 | 158.9 147.5–171.1ROR 161.4 · calibrated p 3e-9 ✓ | 104.9 EB05 99.7 · 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 | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 221 | 155.3 132.2–182.6ROR 155.9 · calibrated p 4e-9 ✓ | 102.7 EB05 91.8 · 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 | not reported in cached trials |
| Facet joint syndrome | 1,018 | 149.7 138.9–161.3ROR 152.0 · calibrated p 4e-9 ✓ | 100.9 EB05 95.8 · 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 | not reported in cached trials |
| Cystitis bacterial | 96 | 123.1 97.2–156.0ROR 123.3 · calibrated p 3e-8 ✓ | 86.8 EB05 73.2 · 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 | not reported in cached trials |
| Adjustment disorder with depressed mood | 558 | 120.0 108.8–132.3ROR 121.0 · calibrated p 3e-8 ✓ | 86.4 EB05 80.5 · 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 | not reported in cached trials |
| Swollen joint count | 68 | 119.6 90.4–158.3ROR 119.8 · calibrated p 5e-8 ✓ | 84.4 EB05 68.9 · 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 | not reported in cached trials |
| Norovirus test positive | 88 | 116.8 91.4–149.2ROR 116.9 · calibrated p 5e-8 ✓ | 83.5 EB05 69.8 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 8.5 (6.8–10.6) | Lab value / disease marker | serious n=88 | not reported in cached trials |
| X-ray abnormal | 441 | 102.8 92.3–114.4ROR 103.5 · calibrated p 9e-8 ✓ | 77.1 EB05 71.2 · 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 | not reported in cached trials |
| Dislocation of vertebra | 548 | 102.4 93.0–112.7ROR 103.2 · calibrated p 9e-8 ✓ | 76.9 EB05 71.6 · 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 | not reported in cached trials |
| Steroid dependence | 209 | 102.1 87.4–119.4ROR 102.5 · calibrated p 1e-7 ✓ | 76.4 EB05 68.1 · 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%) | not reported in cached trials |
| Subcutaneous drug absorption impaired | 134 | 102.1 84.0–124.1ROR 102.3 · calibrated p 1e-7 ✓ | 76.1 EB05 65.9 · 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 | not reported in cached trials |
| Duodenal ulcer perforation | 1,804 | 102.1 96.8–107.6ROR 104.9 · calibrated p 8e-8 ✓ | 76.8 EB05 73.9 · 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 53.4 · ♀ 100% (drug 58%) · 93% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 1,732 | 100.9 95.7–106.5ROR 103.6 · calibrated p 9e-8 ✓ | 76.2 EB05 73.2 · IC025 +6.1 3/3 methods agree vs other Corticosteroids: PRR 3.8 (3.7–4.0) | Lab value / disease marker | serious PRR 53.2 · ♀ 100% (drug 58%) · 93% clinician | not reported in cached trials |
| Rheumatoid factor positive | 1,359 | 96.5 90.8–102.5ROR 98.5 · calibrated p 1e-7 ✓ | 73.6 EB05 70.4 · 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 | not reported in cached trials |
| Steroid withdrawal syndrome | 238 | 95.5 82.6–110.5ROR 95.9 · 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=238 · ♀ 82% (drug 58%) | not reported in cached trials |
| Craniopharyngioma | 74 | 88.0 67.9–113.9ROR 88.1 · calibrated p 4e-7 ✓ | 67.5 EB05 55.5 · IC025 +5.2 3/3 methods agree vs other Corticosteroids: PRR 8.3 (6.5–10.5) | No label text to screen label has no adverse-reaction text | serious n=73 · 100% clinician | not reported in cached trials |
| Adrenocortical insufficiency acute | 414 | 86.2 77.3–96.1ROR 86.7 · calibrated p 3e-7 ✓ | 67.3 EB05 62.1 · 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 | not reported in cached trials |
| Retinitis | 345 | 81.5 72.4–91.8ROR 81.9 · calibrated p 5e-7 ✓ | 64.4 EB05 58.9 · 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 | not reported in cached trials |
| Mycobacterium chelonae infection | 152 | 81.4 68.1–97.3ROR 81.6 · calibrated p 6e-7 ✓ | 64.1 EB05 56.0 · 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 | not reported in cached trials |
| Appendicolith | 75 | 77.0 59.8–99.1ROR 77.1 · calibrated p 1e-6 ✓ | 60.9 EB05 50.2 · 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 | not reported in cached trials |
| Peripheral venous disease | 760 | 73.5 68.0–79.6ROR 74.4 · calibrated p 1e-6 ✓ | 59.5 EB05 56.0 · 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 | not reported in cached trials |
| Analgesic therapy | 58 | 72.9 54.7–97.0ROR 72.9 · calibrated p 2e-6 ✓ | 58.1 EB05 46.6 · 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 | not reported in cached trials |
| Hypocholesterolaemia | 58 | 72.6 54.5–96.6ROR 72.7 · calibrated p 2e-6 ✓ | 57.9 EB05 46.4 · 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 | not reported in cached trials |
| Secondary immunodeficiency | 222 | 71.4 61.7–82.6ROR 71.7 · calibrated p 1e-6 ✓ | 57.9 EB05 51.8 · 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%) | not reported in cached trials |
| Catarrh | 162 | 69.7 58.7–82.6ROR 69.8 · calibrated p 2e-6 ✓ | 56.6 EB05 49.7 · 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%) | not reported in cached trials |
| Abscess bacterial | 63 | 66.9 50.9–87.8ROR 66.9 · calibrated p 3e-6 ✓ | 54.3 EB05 43.9 · 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 | not reported in cached trials |
| Helicobacter infection | 1,788 | 66.5 63.3–70.0ROR 68.3 · calibrated p 2e-6 ✓ | 54.9 EB05 52.8 · 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 40.3 · ♀ 100% (drug 58%) · 94% clinician | not reported in cached trials |
| Adrenal suppression | 147 | 66.0 55.2–78.8ROR 66.1 · calibrated p 3e-6 ✓ | 54.1 EB05 47.2 · 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 | not reported in cached trials |
| Pemphigus | 1,984 | 59.4 56.6–62.3ROR 61.2 · calibrated p 4e-6 ✓ | 49.9 EB05 48.1 · 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 34.8 · ♀ 100% (drug 58%) · 93% clinician | not reported in cached trials |
| C-reactive protein abnormal | 1,003 | 58.0 54.3–62.1ROR 58.9 · calibrated p 5e-6 ✓ | 48.9 EB05 46.5 · 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 | not reported in cached trials |
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 | 3,988 | 4.24.1–4.3 | signal |
| Interstitial lung disease | 1,253 | 4.13.9–4.4 | signal |
| Hyponatraemia | 1,003 | 3.93.7–4.2 | signal |
| Neutropenia / agranulocytosis | 2,498 | 3.23.1–3.3 | signal |
| Serious infection | 7,233 | 2.92.9–3.0 | signal |
| Pancreatitis | 716 | 2.82.6–3.0 | signal |
| Hyperglycaemia / diabetes | 3,004 | 2.72.6–2.8 | signal |
| Anaphylaxis / angioedema | 1,035 | 2.62.4–2.8 | signal |
| Severe cutaneous reaction | 614 | 2.62.4–2.8 | signal |
| Opportunistic infection | 1,079 | 2.52.3–2.6 | signal |
| Gi bleeding | 1,395 | 2.42.3–2.5 | signal |
| Depression | 1,969 | 2.22.1–2.3 | signal |
| Rhabdomyolysis / myopathy | 558 | 2.22.0–2.3 | raised |
| Anaemia | 2,034 | 2.12.0–2.2 | signal |
| Thrombocytopenia | 1,374 | 2.01.9–2.1 | raised |
| Venous thromboembolism | 1,327 | 1.91.8–2.0 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Hydrocortisone Cream as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT03539601 — A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-mod (N=237, PHASE4; 6 AE terms posted; arms: Vehicle; Crisaborole Ointment 2% BID; Hydrocortisone Butyrate Cream 0.1% BID; Pimecrolimus Cream 1% BID)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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) | 9,452 | 3.4 3.4–3.5ROR 3.8 · calibrated p 0.409 | 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 | not reported in cached trials |
| Drug ineffective (drug did not work) | 7,487 | 1.8 1.7–1.8ROR 1.9 · calibrated p 0.878 | 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 | not reported in cached trials |
| Fatigue (tiredness) | 5,934 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.797 | 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 | not reported in cached trials |
| Condition aggravated | 5,459 | 5.7 5.6–5.9ROR 6.2 · calibrated p 0.140 | 5.7 EB05 5.5 · 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 | not reported in cached trials |
| Nausea | 5,026 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.988 | 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 | not reported in cached trials |
| Rash | 4,942 | 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 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 | not reported in cached trials |
| Diarrhoea (diarrhea) | 4,469 | 2.2 2.1–2.2ROR 2.3 · calibrated p 0.918 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree vs other Corticosteroids: PRR 2.7 (2.6–2.8) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.1 · serious PRR 2.3 | not reported in cached trials |
| Headache | 4,434 | 2.2 2.2–2.3ROR 2.3 · calibrated p 0.897 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Corticosteroids: PRR 3.0 (3.0–3.1) | No label text to screen label has no adverse-reaction text | age-adj. PRR 1.9 · serious PRR 2.8 · ♀ 80% (drug 58%) | NCT03539601: 2/71 (2.8%) on Hydrocortisone Cream |
| Pain | 4,434 | 2.3 2.2–2.3ROR 2.4 · calibrated p 0.878 | 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%) | NCT03539601: 1/59 (1.7%) on Hydrocortisone Cream |
| Dyspnoea (shortness of breath) | 4,298 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.820 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Corticosteroids: PRR 2.5 (2.4–2.6) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.2 · serious PRR 2.2 | not reported in cached trials |
| Arthralgia (joint pain) | 4,298 | 3.3 3.2–3.4ROR 3.4 · calibrated p 0.503 | 3.2 EB05 3.2 · IC025 +1.6 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%) | not reported in cached trials |
| Pyrexia (fever) | 3,979 | 3.6 3.5–3.7ROR 3.8 · calibrated p 0.418 | 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 | not reported in cached trials |
| Vomiting | 3,925 | 2.6 2.6–2.7ROR 2.7 · calibrated p 0.719 | 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 | not reported in cached trials |
| Pruritus (itching) | 3,731 | 3.1 3.0–3.2ROR 3.2 · calibrated p 0.555 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Corticosteroids: PRR 3.7 (3.6–3.8) | No label text to screen label has no adverse-reaction text | age-adj. PRR 2.5 · serious PRR 4.0 | not reported in cached trials |
| Malaise (feeling unwell) | 3,618 | 2.6 2.5–2.7ROR 2.7 · calibrated p 0.740 | 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 2.5 · serious PRR 2.8 · ♀ 79% (drug 58%) | not reported in cached trials |
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 Cream?
In FDA FAERS, the most frequently co-reported reaction terms for Hydrocortisone Cream 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 Cream have an FDA boxed warning?
No. The FDA label retrieved for Hydrocortisone Cream has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Hydrocortisone Cream 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 19b09776-165a-9579-e063-6294a90a9d39, effective 20260305; matched on
openfda.generic_name.exact:"HYDROCORTISONE CREAM" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 1,241 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 CREAM, 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.