Drug · FAERS side-effect profile with label screen
Hydrocortisone side effects: what 88,710 FDA adverse event reports show
Who reports
88,710 reports · 82% serious · 11,614 with death outcome · 61% 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) 5Likely indication confounding 5Lab value / disease marker 8Not in label — unassessed 22
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.
- 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). 1,172 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 |
|---|---|---|---|---|---|---|
| Vaginal flatulence | 191 | 399.5 316.2–504.8ROR 400.4 · calibrated p 1e-12 ✓ | 145.4 EB05 128.9 · IC025 +6.5 3/3 methods agree vs other Corticosteroids: PRR 8.0 (6.9–9.3) | Not in label — unassessed | serious n=191 · ♀ 100% (drug 61%) | not reported in cached trials |
| Human bocavirus infection | 114 | 357.7 267.0–479.2ROR 358.2 · calibrated p 5e-12 ✓ | 138.2 EB05 118.2 · IC025 +6.1 3/3 methods agree vs other Corticosteroids: PRR 8.1 (6.7–9.9) | Not in label — unassessed | serious n=114 | not reported in cached trials |
| Deep vein thrombosis postoperative | 947 | 222.3 203.4–243.0ROR 224.7 · calibrated p 1e-10 ✓ | 113.8 EB05 107.9 · IC025 +6.6 3/3 methods agree vs other Corticosteroids: PRR 5.7 (5.4–6.1) | Not in label — unassessed | serious n=947 · ♀ 100% (drug 61%) · 93% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 314 | 211.3 181.4–246.2ROR 212.1 · calibrated p 3e-10 ✓ | 110.4 EB05 100.5 · IC025 +6.4 3/3 methods agree vs other Corticosteroids: PRR 5.6 (5.0–6.2) | Lab value / disease marker | serious n=314 · ♀ 100% (drug 61%) · 100% clinician | not reported in cached trials |
| Lupus vulgaris | 553 | 206.4 184.1–231.4ROR 207.7 · calibrated p 3e-10 ✓ | 109.3 EB05 101.9 · IC025 +6.5 3/3 methods agree vs other Corticosteroids: PRR 5.8 (5.3–6.3) | Not in label — unassessed | serious n=553 · ♀ 100% (drug 61%) · 100% clinician | not reported in cached trials |
| C-reactive protein | 416 | 201.2 176.5–229.4ROR 202.2 · calibrated p 4e-10 ✓ | 107.7 EB05 99.3 · IC025 +6.4 3/3 methods agree vs other Corticosteroids: PRR 5.5 (5.0–6.0) | Lab value / disease marker | serious n=416 · ♀ 100% (drug 61%) · 100% clinician | not reported in cached trials |
| Swollen joint count increased | 1,385 | 189.8 176.9–203.7ROR 192.8 · calibrated p 6e-10 ✓ | 104.7 EB05 100.2 · IC025 +6.6 3/3 methods agree vs other Corticosteroids: PRR 5.8 (5.5–6.1) | Lab value / disease marker | serious n=1,385 · ♀ 100% (drug 61%) · 96% clinician | not reported in cached trials |
| Rheumatic fever | 1,890 | 181.2 170.7–192.3ROR 185.1 · calibrated p 8e-10 ✓ | 102.1 EB05 98.3 · IC025 +6.6 3/3 methods agree vs other Corticosteroids: PRR 5.6 (5.4–5.9) | Likely indication confounding shares a disease stem with the indications wording | serious n=1,890 · ♀ 100% (drug 61%) · 94% clinician | not reported in cached trials |
| Grip strength | 97 | 170.6 131.3–221.7ROR 170.8 · calibrated p 3e-9 ✓ | 96.9 EB05 81.8 · IC025 +5.7 3/3 methods agree vs other Corticosteroids: PRR 7.4 (6.0–9.1) | Not in label — unassessed | serious n=97 · ♀ 100% (drug 61%) · 100% clinician | not reported in cached trials |
| Facet joint syndrome | 1,230 | 151.7 141.3–163.0ROR 153.9 · calibrated p 4e-9 ✓ | 92.0 EB05 87.8 · IC025 +6.4 3/3 methods agree vs other Corticosteroids: PRR 5.5 (5.2–5.8) | Not in label — unassessed | serious n=1,230 · ♀ 100% (drug 61%) · 93% clinician | not reported in cached trials |
| Topical steroid withdrawal reaction | 146 | 145.5 118.3–178.9ROR 145.7 · calibrated p 8e-9 ✓ | 88.8 EB05 77.4 · IC025 +5.8 3/3 methods agree vs other Corticosteroids: PRR 8.5 (7.2–10.1) | Labeled (related wording) related wording | serious n=142 · 100% consumer | not reported in cached trials |
| Adjustment disorder with depressed mood | 757 | 142.6 130.2–156.0ROR 143.8 · calibrated p 7e-9 ✓ | 88.5 EB05 83.3 · IC025 +6.3 3/3 methods agree vs other Corticosteroids: PRR 6.0 (5.6–6.4) | Not in label — unassessed | serious n=757 · ♀ 100% (drug 61%) · 95% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 187 | 123.7 103.6–147.7ROR 124.0 · calibrated p 3e-8 ✓ | 80.4 EB05 71.2 · IC025 +5.8 3/3 methods agree vs other Corticosteroids: PRR 7.6 (6.5–8.8) | Not in label — unassessed | serious n=186 · ♀ 100% (drug 61%) · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 2,421 | 122.4 116.5–128.5ROR 125.8 · calibrated p 2e-8 ✓ | 80.4 EB05 77.8 · IC025 +6.2 3/3 methods agree vs other Corticosteroids: PRR 5.5 (5.3–5.7) | Lab value / disease marker | serious PRR 56.6 · ♀ 100% (drug 61%) · 93% clinician | not reported in cached trials |
| Swollen joint count | 83 | 120.4 92.4–157.0ROR 120.6 · calibrated p 4e-8 ✓ | 78.3 EB05 65.1 · IC025 +5.4 3/3 methods agree vs other Corticosteroids: PRR 6.8 (5.5–8.5) | Not in label — unassessed | serious n=83 · ♀ 100% (drug 61%) · 100% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 2,466 | 119.8 114.2–125.7ROR 123.2 · calibrated p 2e-8 ✓ | 79.3 EB05 76.7 · IC025 +6.2 3/3 methods agree vs other Corticosteroids: PRR 5.6 (5.4–5.8) | Labeled (related wording) related wording | serious PRR 55.6 · ♀ 100% (drug 61%) · 94% clinician | not reported in cached trials |
| Dislocation of vertebra | 728 | 115.1 105.4–125.8ROR 116.1 · calibrated p 4e-8 ✓ | 77.2 EB05 72.6 · IC025 +6.1 3/3 methods agree vs other Corticosteroids: PRR 5.7 (5.3–6.2) | Not in label — unassessed | serious n=728 · ♀ 100% (drug 61%) · 94% clinician | not reported in cached trials |
| Rheumatoid factor positive | 1,822 | 109.2 103.4–115.4ROR 111.5 · calibrated p 5e-8 ✓ | 74.5 EB05 71.7 · IC025 +6.1 3/3 methods agree vs other Corticosteroids: PRR 5.5 (5.3–5.8) | Lab value / disease marker | serious n=1,822 · ♀ 100% (drug 61%) · 94% clinician | not reported in cached trials |
| X-ray abnormal | 563 | 109.0 98.7–120.5ROR 109.7 · calibrated p 6e-8 ✓ | 74.3 EB05 69.3 · IC025 +6.0 3/3 methods agree vs other Corticosteroids: PRR 5.5 (5.0–5.9) | Lab value / disease marker | serious n=563 · ♀ 100% (drug 61%) · 95% clinician | not reported in cached trials |
| Cystitis bacterial | 97 | 94.2 74.4–119.3ROR 94.3 · calibrated p 3e-7 ✓ | 66.5 EB05 56.1 · IC025 +5.3 3/3 methods agree vs other Corticosteroids: PRR 8.6 (7.0–10.6) | Not in label — unassessed | serious n=97 | not reported in cached trials |
| Norovirus test positive | 90 | 90.9 71.2–115.9ROR 90.9 · calibrated p 3e-7 ✓ | 64.7 EB05 54.3 · IC025 +5.2 3/3 methods agree vs other Corticosteroids: PRR 8.7 (7.0–10.8) | Lab value / disease marker | serious n=90 · 100% clinician | not reported in cached trials |
| Craniopharyngioma | 93 | 90.0 70.8–114.3ROR 90.1 · calibrated p 4e-7 ✓ | 64.3 EB05 54.1 · IC025 +5.3 3/3 methods agree vs other Corticosteroids: PRR 10.7 (8.6–13.3) | Not in label — unassessed | serious n=91 · ♀ 0% (drug 61%) · 100% clinician | not reported in cached trials |
| Steroid dependence | 219 | 82.0 70.3–95.7ROR 82.2 · calibrated p 5e-7 ✓ | 60.6 EB05 54.1 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 6.2 (5.4–7.1) | Not in label — unassessed | serious n=216 · ♀ 27% (drug 61%) | not reported in cached trials |
| Adrenocortical insufficiency acute | 492 | 81.5 73.6–90.3ROR 82.0 · calibrated p 5e-7 ✓ | 60.5 EB05 56.1 · IC025 +5.7 3/3 methods agree vs other Corticosteroids: PRR 10.0 (9.1–11.0) | Likely indication confounding term in indications | serious n=487 | not reported in cached trials |
| Retinitis | 427 | 81.2 72.7–90.6ROR 81.6 · calibrated p 5e-7 ✓ | 60.3 EB05 55.6 · IC025 +5.7 3/3 methods agree vs other Corticosteroids: PRR 5.0 (4.6–5.6) | Likely indication confounding term in indications | serious n=427 · ♀ 100% (drug 61%) · 100% clinician | not reported in cached trials |
| Appendicolith | 96 | 79.9 63.4–100.7ROR 80.0 · calibrated p 8e-7 ✓ | 59.0 EB05 49.8 · IC025 +5.2 3/3 methods agree vs other Corticosteroids: PRR 10.6 (8.6–13.2) | Not in label — unassessed | serious n=96 · ♀ 0% (drug 61%) · 100% clinician | not reported in cached trials |
| Steroid withdrawal syndrome | 250 | 76.9 66.6–88.7ROR 77.1 · calibrated p 8e-7 ✓ | 57.8 EB05 52.0 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 7.6 (6.7–8.6) | Labeled (related wording) related wording | serious n=250 · ♀ 82% (drug 61%) | not reported in cached trials |
| Helicobacter infection | 2,454 | 74.9 71.6–78.3ROR 77.0 · calibrated p 8e-7 ✓ | 56.8 EB05 55.0 · IC025 +5.7 3/3 methods agree vs other Corticosteroids: PRR 5.5 (5.3–5.7) | Not in label — unassessed | serious PRR 42.1 · ♀ 100% (drug 61%) · 94% clinician | not reported in cached trials |
| Peripheral venous disease | 895 | 68.2 63.3–73.5ROR 68.9 · calibrated p 2e-6 ✓ | 52.9 EB05 50.0 · IC025 +5.6 3/3 methods agree vs other Corticosteroids: PRR 5.1 (4.8–5.4) | Not in label — unassessed | serious n=892 · ♀ 100% (drug 61%) · 92% clinician | not reported in cached trials |
| Pemphigus | 2,770 | 67.7 64.9–70.6ROR 69.8 · calibrated p 1e-6 ✓ | 52.6 EB05 51.0 · IC025 +5.6 3/3 methods agree vs other Corticosteroids: PRR 4.8 (4.6–5.0) | Likely indication confounding term in indications | serious PRR 37.0 · ♀ 100% (drug 61%) · 93% clinician | not reported in cached trials |
| Muscle injury | 1,781 | 65.4 62.1–68.9ROR 66.8 · calibrated p 2e-6 ✓ | 51.2 EB05 49.3 · IC025 +5.6 3/3 methods agree vs other Corticosteroids: PRR 5.5 (5.3–5.8) | Not in label — unassessed | serious PRR 38.9 · ♀ 100% (drug 61%) · 94% clinician | not reported in cached trials |
| Mycobacterium chelonae infection | 154 | 62.4 52.2–74.5ROR 62.5 · calibrated p 4e-6 ✓ | 49.1 EB05 42.9 · IC025 +5.1 3/3 methods agree vs other Corticosteroids: PRR 5.1 (4.3–6.0) | Not in label — unassessed | serious n=154 | not reported in cached trials |
| Hand deformity | 2,709 | 61.6 59.1–64.3ROR 63.6 · calibrated p 3e-6 ✓ | 48.9 EB05 47.4 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 5.0 (4.9–5.2) | Not in label — unassessed | serious PRR 37.3 · ♀ 100% (drug 61%) · 93% clinician | not reported in cached trials |
| C-reactive protein abnormal | 1,313 | 60.8 57.3–64.6ROR 61.7 · calibrated p 3e-6 ✓ | 48.4 EB05 46.2 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 5.2 (4.9–5.5) | Lab value / disease marker | serious n=1,313 · ♀ 100% (drug 61%) · 91% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 1,305 | 60.0 56.5–63.7ROR 60.9 · calibrated p 4e-6 ✓ | 47.9 EB05 45.7 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 5.6 (5.3–5.9) | Not in label — unassessed | serious n=1,297 · ♀ 100% (drug 61%) · 96% clinician | not reported in cached trials |
| Folliculitis | 2,092 | 59.9 57.2–62.9ROR 61.4 · calibrated p 4e-6 ✓ | 47.8 EB05 46.1 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 5.5 (5.2–5.7) | Not in label — unassessed | serious PRR 39.3 · ♀ 98% (drug 61%) · 95% clinician | not reported in cached trials |
| Catarrh | 169 | 55.3 46.8–65.4ROR 55.4 · calibrated p 8e-6 ✓ | 44.7 EB05 39.3 · IC025 +5.1 3/3 methods agree vs other Corticosteroids: PRR 7.5 (6.4–8.7) | Not in label — unassessed | serious n=169 · ♀ 0% (drug 61%) | not reported in cached trials |
| Secondary immunodeficiency | 223 | 54.2 46.8–62.6ROR 54.3 · calibrated p 9e-6 ✓ | 44.0 EB05 39.3 · IC025 +5.1 3/3 methods agree vs other Corticosteroids: PRR 4.9 (4.3–5.6) | Labeled (related wording) related wording | serious n=222 | not reported in cached trials |
| Adrenal suppression | 148 | 50.2 42.0–59.9ROR 50.2 · calibrated p 2e-5 ✓ | 41.2 EB05 35.9 · IC025 +4.9 3/3 methods agree vs other Corticosteroids: PRR 8.0 (6.7–9.4) | Labeled (related wording) related wording | serious n=148 | not reported in cached trials |
| Seronegative arthritis | 194 | 49.3 42.2–57.5ROR 49.4 · calibrated p 2e-5 ✓ | 40.7 EB05 36.1 · IC025 +5.0 3/3 methods agree vs other Corticosteroids: PRR 6.8 (5.9–7.9) | Likely indication confounding shares a disease stem with the indications wording | serious n=194 · ♀ 100% (drug 61%) · 100% 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 | 5,296 | 4.24.1–4.3 | signal |
| Interstitial lung disease | 1,610 | 4.03.8–4.2 | signal |
| Hyponatraemia | 1,129 | 3.33.2–3.5 | signal |
| Serious infection | 10,034 | 3.13.0–3.2 | signal |
| Hyperglycaemia / diabetes | 4,324 | 3.02.9–3.1 | signal |
| Opportunistic infection | 1,522 | 2.72.5–2.8 | signal |
| Pancreatitis | 879 | 2.62.4–2.8 | signal |
| Tendon disorder | 412 | 2.62.3–2.8 | signal |
| Neutropenia / agranulocytosis | 2,674 | 2.62.5–2.7 | signal |
| Anaphylaxis / angioedema | 1,290 | 2.42.3–2.6 | signal |
| Depression | 2,855 | 2.42.3–2.5 | signal |
| Gi bleeding | 1,754 | 2.32.2–2.4 | signal |
| Severe cutaneous reaction | 691 | 2.22.0–2.4 | signal |
| Anaemia | 2,716 | 2.22.1–2.2 | signal |
| Rhabdomyolysis / myopathy | 671 | 2.01.8–2.1 | raised |
| Venous thromboembolism | 1,738 | 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 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) | 11,939 | 3.3 3.2–3.3ROR 3.6 · calibrated p 0.452 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree vs other Corticosteroids: PRR 3.5 (3.5–3.6) | Reporting / coding artifact | age-adj. PRR 2.7 · serious PRR 3.9 | not reported in cached trials |
| Drug ineffective (drug did not work) | 10,822 | 2.0 1.9–2.0ROR 2.1 · calibrated p 0.988 | 1.9 EB05 1.9 · IC025 +0.9 vs other Corticosteroids: PRR 3.6 (3.5–3.6) | Reporting / coding artifact | age-adj. PRR 2.2 · serious PRR 3.2 | not reported in cached trials |
| Fatigue (tiredness) | 9,280 | 2.8 2.8–2.9ROR 3.1 · calibrated p 0.607 | 2.8 EB05 2.8 · IC025 +1.5 3/3 methods agree vs other Corticosteroids: PRR 4.5 (4.4–4.6) | Not in label — unassessed | age-adj. PRR 2.6 · serious PRR 3.3 | not reported in cached trials |
| Pain | 7,397 | 2.9 2.8–2.9ROR 3.0 · calibrated p 0.616 | 2.8 EB05 2.8 · IC025 +1.5 3/3 methods agree vs other Corticosteroids: PRR 4.5 (4.5–4.6) | Not in label — unassessed | age-adj. PRR 2.9 · serious PRR 2.9 | NCT00691002: 1/362 (0.3%) on Hydrocortisone (serious AE) |
| Nausea | 7,058 | 2.1 2.1–2.2ROR 2.2 · calibrated p 0.941 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Corticosteroids: PRR 4.3 (4.2–4.4) | Not in label — unassessed | age-adj. PRR 1.9 · serious PRR 2.5 | NCT00691002: 1/453 (0.2%) on Hydrocortisone (serious AE) |
| Condition aggravated | 6,987 | 5.6 5.4–5.7ROR 6.0 · calibrated p 0.152 | 5.5 EB05 5.4 · IC025 +2.4 3/3 methods agree vs other Corticosteroids: PRR 4.4 (4.3–4.5) | Reporting / coding artifact | age-adj. PRR 4.2 · serious PRR 5.6 | not reported in cached trials |
| Arthralgia (joint pain) | 6,980 | 4.0 3.9–4.1ROR 4.3 · calibrated p 0.328 | 4.0 EB05 3.9 · IC025 +2.0 3/3 methods agree vs other Corticosteroids: PRR 4.8 (4.7–4.9) | Not in label — unassessed | age-adj. PRR 3.4 · serious PRR 4.6 | NCT00691002: 12/453 (2.6%) on Hydrocortisone |
| Headache | 6,516 | 2.5 2.4–2.5ROR 2.6 · calibrated p 0.775 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree vs other Corticosteroids: PRR 4.5 (4.4–4.6) | Labeled adverse reaction exact term | age-adj. PRR 2.1 · serious PRR 3.1 | NCT00691002: 8/362 (2.2%) on Hydrocortisone |
| Rash | 6,481 | 3.6 3.5–3.7ROR 3.8 · calibrated p 0.422 | 3.5 EB05 3.5 · IC025 +1.8 3/3 methods agree vs other Corticosteroids: PRR 4.4 (4.3–4.5) | Not in label — unassessed | age-adj. PRR 3.2 · serious PRR 4.6 | not reported in cached trials |
| Diarrhoea (diarrhea) | 6,390 | 2.4 2.3–2.4ROR 2.5 · calibrated p 0.827 | 2.3 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Corticosteroids: PRR 3.9 (3.8–4.0) | Labeled adverse reaction exact term | age-adj. PRR 2.2 · serious PRR 2.6 | NCT00691002: 4/351 (1.1%) on Hydrocortisone |
| Dyspnoea (shortness of breath) | 6,172 | 2.6 2.5–2.7ROR 2.7 · calibrated p 0.726 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Corticosteroids: PRR 3.6 (3.5–3.7) | Not in label — unassessed | age-adj. PRR 2.4 · serious PRR 2.4 | not reported in cached trials |
| Pyrexia (fever) | 5,505 | 3.8 3.7–3.9ROR 4.0 · calibrated p 0.380 | 3.8 EB05 3.7 · IC025 +1.9 3/3 methods agree vs other Corticosteroids: PRR 3.7 (3.6–3.8) | Not in label — unassessed | age-adj. PRR 2.9 · serious PRR 3.2 | NCT00691002: 3/362 (0.8%) on Hydrocortisone |
| Vomiting | 5,307 | 2.7 2.6–2.8ROR 2.8 · calibrated p 0.694 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Corticosteroids: PRR 4.3 (4.2–4.4) | Not in label — unassessed | age-adj. PRR 2.2 · serious PRR 2.6 | not reported in cached trials |
| Malaise (feeling unwell) | 5,092 | 2.8 2.7–2.8ROR 2.9 · calibrated p 0.672 | 2.7 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Corticosteroids: PRR 4.5 (4.4–4.6) | Not in label — unassessed | age-adj. PRR 2.7 · serious PRR 3.0 | not reported in cached trials |
| Pruritus (itching) | 5,081 | 3.2 3.1–3.3ROR 3.3 · calibrated p 0.525 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree vs other Corticosteroids: PRR 5.1 (5.0–5.2) | Not in label — unassessed | age-adj. PRR 2.7 · serious PRR 4.3 | NCT00691002: 2/351 (0.6%) on Hydrocortisone |
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.
- Vaginal flatulence — n=191, PRR 399.5
- Human bocavirus infection — n=114, PRR 357.7
- Deep vein thrombosis postoperative — n=947, PRR 222.3
- Lupus vulgaris — n=553, PRR 206.4
- Grip strength — n=97, PRR 170.6
- Facet joint syndrome — n=1,230, PRR 151.7
- Adjustment disorder with depressed mood — n=757, PRR 142.6
- Subcutaneous drug absorption impaired — n=187, PRR 123.7
- Swollen joint count — n=83, PRR 120.4
- Dislocation of vertebra — n=728, PRR 115.1
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?
In FDA FAERS, the most frequently co-reported reaction terms for Hydrocortisone are fatigue, pain, nausea, arthralgia, headache, rash. 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 have an FDA boxed warning?
No. The FDA label retrieved for Hydrocortisone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Hydrocortisone 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, 1,212 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.