Drug · FAERS side-effect profile with label screen
Hydrocortisone Acetate side effects: what 72,236 FDA adverse event reports show
Who reports
72,236 reports · 83% serious · 10,727 with death outcome · 59% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Hydrocortisone tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorti.
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
Labeled (related wording) 3Likely indication confounding 6Reporting / coding artifact 3Lab value / disease marker 7Not in label — unassessed 21
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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, 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 | 429.9 321.1–575.6ROR 430.6 · calibrated p 8e-13 ✓ | 167.3 EB05 143.0 · IC025 +6.3 3/3 methods agree vs other Corticosteroids: PRR 8.1 (6.6–9.8) | Not in label — unassessed | serious n=113 | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 342 | 307.9 264.3–358.6ROR 309.3 · calibrated p 9e-12 ✓ | 147.4 EB05 134.7 · IC025 +6.8 3/3 methods agree vs other Corticosteroids: PRR 6.1 (5.5–6.8) | Lab value / disease marker | serious n=342 · ♀ 100% (drug 59%) · 95% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 966 | 284.2 260.0–310.6ROR 288.0 · calibrated p 1e-11 ✓ | 142.5 EB05 135.1 · IC025 +7.0 3/3 methods agree vs other Corticosteroids: PRR 5.9 (5.5–6.2) | Not in label — unassessed | serious n=966 · ♀ 100% (drug 59%) · 91% clinician | not reported in cached trials |
| Lupus vulgaris | 585 | 282.9 252.4–317.1ROR 285.2 · calibrated p 2e-11 ✓ | 141.9 EB05 132.5 · IC025 +6.9 3/3 methods agree vs other Corticosteroids: PRR 6.1 (5.6–6.6) | Not in label — unassessed | serious n=585 · ♀ 100% (drug 59%) · 95% clinician | not reported in cached trials |
| Rheumatic fever | 2,024 | 252.4 237.9–267.9ROR 259.7 · calibrated p 4e-11 ✓ | 134.2 EB05 129.4 · IC025 +7.0 3/3 methods agree vs other Corticosteroids: PRR 6.1 (5.8–6.3) | Likely indication confounding shares a disease stem with the indications wording | serious n=2,024 · ♀ 100% (drug 59%) · 94% clinician | not reported in cached trials |
| Swollen joint count increased | 1,443 | 251.7 234.6–270.1ROR 256.8 · calibrated p 4e-11 ✓ | 134.0 EB05 128.3 · IC025 +6.9 3/3 methods agree vs other Corticosteroids: PRR 6.1 (5.8–6.4) | Lab value / disease marker | serious n=1,443 · ♀ 100% (drug 59%) · 95% clinician | not reported in cached trials |
| Grip strength | 106 | 245.9 189.7–318.8ROR 246.3 · calibrated p 1e-10 ✓ | 129.5 EB05 110.1 · IC025 +6.0 3/3 methods agree vs other Corticosteroids: PRR 8.2 (6.7–10.0) | Not in label — unassessed | serious n=106 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Lymphoid tissue hypoplasia | 68 | 245.6 177.6–339.7ROR 245.9 · calibrated p 2e-10 ✓ | 127.8 EB05 104.3 · IC025 +5.7 3/3 methods agree vs other Corticosteroids: PRR 7.6 (5.9–9.7) | Likely indication confounding shares a disease stem with the indications wording | serious n=68 | not reported in cached trials |
| Vaginal flatulence | 138 | 240.1 191.5–301.1ROR 240.6 · calibrated p 1e-10 ✓ | 128.6 EB05 111.5 · IC025 +6.2 3/3 methods agree vs other Corticosteroids: PRR 5.6 (4.7–6.7) | Not in label — unassessed | serious n=138 · ♀ 100% (drug 59%) | not reported in cached trials |
| C-reactive protein | 405 | 235.4 206.4–268.4ROR 236.7 · calibrated p 1e-10 ✓ | 128.7 EB05 118.5 · IC025 +6.6 3/3 methods agree vs other Corticosteroids: PRR 5.3 (4.8–5.9) | Lab value / disease marker | serious n=405 · ♀ 100% (drug 59%) · 95% clinician | not reported in cached trials |
| Thymus hypoplasia | 73 | 214.8 158.5–290.9ROR 215.0 · calibrated p 5e-10 ✓ | 119.2 EB05 98.0 · IC025 +5.7 3/3 methods agree vs other Corticosteroids: PRR 7.6 (6.0–9.7) | Likely indication confounding shares a disease stem with the indications wording | serious n=73 | not reported in cached trials |
| Sleep disorder therapy | 77 | 205.3 153.2–275.2ROR 205.6 · calibrated p 7e-10 ✓ | 116.4 EB05 96.2 · IC025 +5.7 3/3 methods agree vs other Corticosteroids: only this drug | Reporting / coding artifact | serious n=77 · ♀ 0% (drug 59%) · 100% clinician | not reported in cached trials |
| Topical steroid withdrawal reaction | 155 | 197.5 160.9–242.3ROR 197.9 · calibrated p 6e-10 ✓ | 115.5 EB05 101.0 · IC025 +6.1 3/3 methods agree vs other Corticosteroids: PRR 9.1 (7.7–10.7) | Labeled (related wording) related wording | serious n=151 · ♀ 81% (drug 59%) · 100% consumer | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 2,775 | 186.8 178.1–195.8ROR 194.2 · calibrated p 5e-10 ✓ | 113.2 EB05 109.7 · IC025 +6.7 3/3 methods agree vs other Corticosteroids: PRR 6.3 (6.1–6.6) | Lab value / disease marker | serious PRR 78.9 · ♀ 100% (drug 59%) · 93% clinician | not reported in cached trials |
| Swollen joint count | 95 | 183.2 141.6–237.0ROR 183.4 · calibrated p 2e-9 ✓ | 109.5 EB05 92.3 · IC025 +5.8 3/3 methods agree vs other Corticosteroids: PRR 7.9 (6.4–9.8) | Not in label — unassessed | serious n=95 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 771 | 180.5 165.0–197.5ROR 182.4 · calibrated p 9e-10 ✓ | 110.6 EB05 104.2 · IC025 +6.6 3/3 methods agree vs other Corticosteroids: PRR 6.1 (5.7–6.6) | Not in label — unassessed | serious n=771 · ♀ 100% (drug 59%) · 95% clinician | not reported in cached trials |
| Facet joint syndrome | 1,205 | 180.3 167.8–193.7ROR 183.4 · calibrated p 9e-10 ✓ | 110.7 EB05 105.5 · IC025 +6.6 3/3 methods agree vs other Corticosteroids: PRR 5.4 (5.1–5.7) | Not in label — unassessed | serious n=1,205 · ♀ 100% (drug 59%) · 94% clinician | not reported in cached trials |
| Rheumatoid factor positive | 2,193 | 178.7 169.5–188.4ROR 184.3 · calibrated p 8e-10 ✓ | 110.2 EB05 106.3 · IC025 +6.7 3/3 methods agree vs other Corticosteroids: PRR 6.8 (6.5–7.1) | Lab value / disease marker | serious n=2,193 · ♀ 100% (drug 59%) · 94% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 2,719 | 171.4 163.5–179.6ROR 178.1 · calibrated p 1e-9 ✓ | 107.4 EB05 104.0 · IC025 +6.7 3/3 methods agree vs other Corticosteroids: PRR 6.2 (6.0–6.4) | Labeled (related wording) related wording | serious PRR 74.5 · ♀ 100% (drug 59%) · 93% clinician | not reported in cached trials |
| Dislocation of vertebra | 740 | 145.0 132.8–158.4ROR 146.5 · calibrated p 6e-9 ✓ | 96.3 EB05 90.6 · IC025 +6.4 3/3 methods agree vs other Corticosteroids: PRR 5.8 (5.4–6.3) | Not in label — unassessed | serious n=740 · ♀ 100% (drug 59%) · 94% clinician | not reported in cached trials |
| X-ray abnormal | 582 | 140.7 127.5–155.4ROR 141.9 · calibrated p 8e-9 ✓ | 94.3 EB05 88.0 · IC025 +6.3 3/3 methods agree vs other Corticosteroids: PRR 5.7 (5.2–6.1) | Lab value / disease marker | serious n=582 · ♀ 100% (drug 59%) · 95% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 163 | 124.0 103.2–149.1ROR 124.3 · calibrated p 3e-8 ✓ | 85.9 EB05 75.4 · IC025 +5.8 3/3 methods agree vs other Corticosteroids: PRR 6.5 (5.6–7.6) | Not in label — unassessed | serious n=163 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Cystitis bacterial | 96 | 114.1 90.1–144.6ROR 114.3 · calibrated p 6e-8 ✓ | 80.5 EB05 67.9 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 8.5 (6.9–10.5) | Not in label — unassessed | serious n=96 | not reported in cached trials |
| Norovirus test positive | 88 | 108.2 84.7–138.3ROR 108.4 · calibrated p 9e-8 ✓ | 77.5 EB05 64.8 · IC025 +5.4 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 |
| Analgesic therapy | 83 | 107.7 83.6–138.6ROR 107.8 · calibrated p 1e-7 ✓ | 77.1 EB05 64.2 · IC025 +5.4 3/3 methods agree vs other Corticosteroids: PRR 13.8 (10.9–17.4) | Reporting / coding artifact | serious n=83 · ♀ 0% (drug 59%) · 100% clinician | not reported in cached trials |
| Helicobacter infection | 2,691 | 104.2 99.7–108.8ROR 108.2 · calibrated p 6e-8 ✓ | 76.5 EB05 74.1 · IC025 +6.2 3/3 methods agree vs other Corticosteroids: PRR 6.1 (5.8–6.3) | Not in label — unassessed | serious PRR 56.1 · ♀ 100% (drug 59%) · 93% clinician | not reported in cached trials |
| Steroid dependence | 223 | 103.3 88.6–120.4ROR 103.6 · calibrated p 1e-7 ✓ | 75.6 EB05 67.7 · IC025 +5.8 3/3 methods agree vs other Corticosteroids: PRR 6.3 (5.5–7.2) | Not in label — unassessed | serious n=221 · ♀ 28% (drug 59%) | not reported in cached trials |
| Pemphigus | 3,234 | 102.1 98.2–106.2ROR 106.9 · calibrated p 7e-8 ✓ | 75.4 EB05 73.3 · IC025 +6.2 3/3 methods agree vs other Corticosteroids: PRR 5.7 (5.5–5.9) | Likely indication confounding term in indications | serious PRR 52.5 · ♀ 100% (drug 59%) · 93% clinician | not reported in cached trials |
| Retinitis | 434 | 102.0 91.4–113.8ROR 102.6 · calibrated p 1e-7 ✓ | 75.2 EB05 69.4 · IC025 +6.0 3/3 methods agree vs other Corticosteroids: PRR 5.1 (4.7–5.7) | Likely indication confounding term in indications | serious n=434 · ♀ 100% (drug 59%) · 94% clinician | not reported in cached trials |
| Appendicolith | 97 | 99.6 79.0–125.4ROR 99.7 · calibrated p 2e-7 ✓ | 73.0 EB05 61.6 · IC025 +5.4 3/3 methods agree vs other Corticosteroids: PRR 10.8 (8.7–13.3) | Not in label — unassessed | serious n=97 · ♀ 0% (drug 59%) · 100% clinician | not reported in cached trials |
| Hand deformity | 3,143 | 91.8 88.2–95.5ROR 95.9 · calibrated p 2e-7 ✓ | 69.7 EB05 67.6 · IC025 +6.0 3/3 methods agree vs other Corticosteroids: PRR 5.9 (5.7–6.1) | Not in label — unassessed | serious PRR 52.6 · ♀ 100% (drug 59%) · 93% clinician | not reported in cached trials |
| Steroid withdrawal syndrome | 240 | 89.5 77.5–103.5ROR 89.8 · calibrated p 3e-7 ✓ | 68.0 EB05 61.1 · IC025 +5.7 3/3 methods agree vs other Corticosteroids: PRR 7.3 (6.4–8.3) | Labeled (related wording) related wording | serious n=240 · ♀ 82% (drug 59%) | not reported in cached trials |
| Peripheral venous disease | 925 | 87.5 81.3–94.1ROR 88.6 · calibrated p 3e-7 ✓ | 67.1 EB05 63.6 · IC025 +5.9 3/3 methods agree vs other Corticosteroids: PRR 5.3 (4.9–5.6) | Not in label — unassessed | serious n=922 · ♀ 100% (drug 59%) · 92% clinician | not reported in cached trials |
| Craniopharyngioma | 76 | 84.4 65.3–109.0ROR 84.5 · calibrated p 6e-7 ✓ | 64.3 EB05 53.1 · IC025 +5.1 3/3 methods agree vs other Corticosteroids: PRR 8.6 (6.7–10.8) | Not in label — unassessed | serious n=75 · 100% clinician | not reported in cached trials |
| Adrenocortical insufficiency acute | 424 | 82.4 73.9–91.7ROR 82.8 · calibrated p 5e-7 ✓ | 64.0 EB05 59.0 · IC025 +5.7 3/3 methods agree vs other Corticosteroids: PRR 8.5 (7.7–9.4) | Likely indication confounding term in indications | serious n=419 | not reported in cached trials |
| Drug therapy | 70 | 81.2 62.3–105.9ROR 81.3 · calibrated p 8e-7 ✓ | 62.4 EB05 51.1 · IC025 +5.1 3/3 methods agree vs other Corticosteroids: PRR 1,801.1 (567.1–5,719.7) | Reporting / coding artifact | serious n=70 · ♀ 0% (drug 59%) · 100% clinician | not reported in cached trials |
| Muscle injury | 1,756 | 79.0 74.9–83.2ROR 80.9 · calibrated p 5e-7 ✓ | 62.0 EB05 59.6 · IC025 +5.9 3/3 methods agree vs other Corticosteroids: PRR 5.5 (5.2–5.7) | Not in label — unassessed | serious PRR 46.6 · ♀ 100% (drug 59%) · 94% clinician | not reported in cached trials |
| Hypocholesterolaemia | 65 | 77.6 59.0–102.1ROR 77.7 · calibrated p 1e-6 ✓ | 60.2 EB05 48.9 · IC025 +5.0 3/3 methods agree vs other Corticosteroids: PRR 6.7 (5.2–8.6) | Not in label — unassessed | serious n=65 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 1,351 | 77.0 72.6–81.8ROR 78.5 · calibrated p 7e-7 ✓ | 60.8 EB05 58.2 · IC025 +5.8 3/3 methods agree vs other Corticosteroids: PRR 5.8 (5.5–6.2) | Not in label — unassessed | serious n=1,347 · ♀ 100% (drug 59%) · 95% clinician | not reported in cached trials |
| Mycobacterium chelonae infection | 152 | 75.4 63.1–90.2ROR 75.6 · calibrated p 1e-6 ✓ | 59.4 EB05 51.9 · IC025 +5.4 3/3 methods agree vs other Corticosteroids: PRR 5.0 (4.3–5.9) | Not in label — unassessed | serious n=152 | 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 | 5,344 | 5.25.1–5.4 | signal |
| Interstitial lung disease | 1,470 | 4.54.3–4.7 | signal |
| Hyponatraemia | 1,061 | 3.93.6–4.1 | signal |
| Serious infection | 8,331 | 3.23.1–3.2 | signal |
| Neutropenia / agranulocytosis | 2,633 | 3.13.0–3.2 | signal |
| Hyperglycaemia / diabetes | 3,676 | 3.13.0–3.2 | signal |
| Pancreatitis | 781 | 2.82.6–3.0 | signal |
| Severe cutaneous reaction | 633 | 2.52.3–2.7 | signal |
| Anaphylaxis / angioedema | 1,058 | 2.52.3–2.6 | signal |
| Gi bleeding | 1,523 | 2.42.3–2.6 | signal |
| Opportunistic infection | 1,134 | 2.42.3–2.6 | signal |
| Depression | 2,316 | 2.42.3–2.5 | signal |
| Rhabdomyolysis / myopathy | 603 | 2.22.0–2.3 | signal |
| Anaemia | 2,170 | 2.12.0–2.2 | signal |
| Venous thromboembolism | 1,467 | 2.01.9–2.1 | raised |
| Thrombocytopenia | 1,462 | 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 Acetate 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).
- NCT00691002 — Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Fo (N=1245, PHASE3; 56 AE terms posted; arms: LEO 80190; Calcipotriol; Hydrocortisone; LEO 80190 Vehicle)
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) | 10,701 | 3.6 3.5–3.7ROR 4.1 · calibrated p 0.366 | 3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree vs other Corticosteroids: PRR 3.1 (3.1–3.2) | Reporting / coding artifact | age-adj. PRR 2.9 · serious PRR 4.3 | not reported in cached trials |
| Drug ineffective (drug did not work) | 9,134 | 2.0 2.0–2.1ROR 2.2 · calibrated p 0.968 | 2.0 EB05 2.0 · IC025 +1.0 vs other Corticosteroids: PRR 3.0 (2.9–3.0) | Reporting / coding artifact | age-adj. PRR 2.2 · serious PRR 3.3 | not reported in cached trials |
| Fatigue (tiredness) | 7,442 | 2.8 2.7–2.9ROR 3.0 · calibrated p 0.625 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Corticosteroids: PRR 3.6 (3.5–3.6) | Not in label — unassessed | age-adj. PRR 2.5 · serious PRR 3.3 | not reported in cached trials |
| Condition aggravated | 6,610 | 6.5 6.3–6.6ROR 7.0 · calibrated p 0.098 | 6.3 EB05 6.2 · IC025 +2.6 3/3 methods agree vs other Corticosteroids: PRR 4.2 (4.1–4.3) | Reporting / coding artifact | age-adj. PRR 4.8 · serious PRR 6.4 | not reported in cached trials |
| Rash | 6,281 | 4.3 4.2–4.4ROR 4.6 · calibrated p 0.288 | 4.2 EB05 4.1 · IC025 +2.0 3/3 methods agree vs other Corticosteroids: PRR 4.3 (4.2–4.4) | Not in label — unassessed | age-adj. PRR 3.6 · serious PRR 5.6 · ♀ 79% (drug 59%) | not reported in cached trials |
| Pain | 5,956 | 2.8 2.8–2.9ROR 3.0 · calibrated p 0.629 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Corticosteroids: PRR 3.6 (3.5–3.7) | Not in label — unassessed | age-adj. PRR 2.8 · serious PRR 2.9 · ♀ 83% (drug 59%) | NCT00691002: 1/362 (0.3%) on Hydrocortisone Acetate (serious AE) |
| Nausea | 5,683 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.955 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Corticosteroids: PRR 3.4 (3.3–3.5) | Not in label — unassessed | age-adj. PRR 1.8 · serious PRR 2.5 · ♀ 79% (drug 59%) | NCT00691002: 1/453 (0.2%) on Hydrocortisone Acetate (serious AE) |
| Arthralgia (joint pain) | 5,293 | 3.7 3.6–3.8ROR 4.0 · calibrated p 0.385 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree vs other Corticosteroids: PRR 3.6 (3.5–3.7) | Not in label — unassessed | age-adj. PRR 3.0 · serious PRR 4.3 · ♀ 82% (drug 59%) | NCT00691002: 12/453 (2.6%) on Hydrocortisone Acetate |
| Diarrhoea (diarrhea) | 5,269 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.814 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Corticosteroids: PRR 3.2 (3.1–3.3) | Labeled adverse reaction exact term | age-adj. PRR 2.2 · serious PRR 2.6 | NCT00691002: 4/351 (1.1%) on Hydrocortisone Acetate |
| Headache | 5,171 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.806 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Corticosteroids: PRR 3.6 (3.5–3.7) | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 3.1 · ♀ 81% (drug 59%) | NCT00691002: 8/362 (2.2%) on Hydrocortisone Acetate |
| Dyspnoea (shortness of breath) | 5,101 | 2.6 2.6–2.7ROR 2.8 · calibrated p 0.711 | 2.6 EB05 2.6 · IC025 +1.3 3/3 methods agree vs other Corticosteroids: PRR 3.0 (2.9–3.0) | Not in label — unassessed | age-adj. PRR 2.4 · serious PRR 2.4 | not reported in cached trials |
| Pyrexia (fever) | 4,645 | 3.9 3.8–4.0ROR 4.1 · calibrated p 0.353 | 3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree vs other Corticosteroids: PRR 3.1 (3.0–3.2) | Not in label — unassessed | age-adj. PRR 3.0 · serious PRR 3.3 | NCT00691002: 3/362 (0.8%) on Hydrocortisone Acetate |
| Infusion related reaction (reaction during infusion) | 4,635 | 21.8 21.2–22.5ROR 23.3 · calibrated p 1e-3 ✓ | 20.4 EB05 19.9 · IC025 +4.3 3/3 methods agree vs other Corticosteroids: PRR 4.9 (4.8–5.1) | Not in label — unassessed | age-adj. PRR 16.6 · serious PRR 17.5 · ♀ 88% (drug 59%) · 91% clinician | not reported in cached trials |
| Vomiting | 4,604 | 2.9 2.8–2.9ROR 3.0 · calibrated p 0.628 | 2.8 EB05 2.8 · IC025 +1.5 3/3 methods agree vs other Corticosteroids: PRR 3.7 (3.6–3.8) | Not in label — unassessed | age-adj. PRR 2.3 · serious PRR 2.8 | not reported in cached trials |
| Pruritus (itching) | 4,388 | 3.4 3.3–3.5ROR 3.6 · calibrated p 0.472 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other Corticosteroids: PRR 4.4 (4.3–4.5) | Not in label — unassessed | age-adj. PRR 2.8 · serious PRR 4.6 · ♀ 79% (drug 59%) | NCT00691002: 2/351 (0.6%) on Hydrocortisone Acetate |
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.
- Human bocavirus infection — n=113, PRR 429.9
- Deep vein thrombosis postoperative — n=966, PRR 284.2
- Lupus vulgaris — n=585, PRR 282.9
- Grip strength — n=106, PRR 245.9
- Vaginal flatulence — n=138, PRR 240.1
- Swollen joint count — n=95, PRR 183.2
- Adjustment disorder with depressed mood — n=771, PRR 180.5
- Facet joint syndrome — n=1,205, PRR 180.3
- Dislocation of vertebra — n=740, PRR 145.0
- Subcutaneous drug absorption impaired — n=163, PRR 124.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.
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 Acetate?
In FDA FAERS, the most frequently co-reported reaction terms for Hydrocortisone Acetate are fatigue, rash, pain, nausea, arthralgia, diarrhoea. 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 Acetate have an FDA boxed warning?
No. The FDA label retrieved for Hydrocortisone Acetate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Hydrocortisone Acetate 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 04f112e5-ec88-46c8-b675-8b4e38a86ab4, effective 20260811; matched on
openfda.generic_name.exact:"HYDROCORTISONE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 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.