Drug · FAERS side-effect profile with label screen
Hydrocortisone Sodium Succinate side effects: what 9,343 FDA adverse event reports show
Who reports
9,343 reports · 91% serious · 2,383 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
DESCRIPTION Hydrocortisone Tablets, USP contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.
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
Labeled (related wording) 3Likely indication confounding 4Reporting / coding artifact 1Lab value / disease marker 7Not in label — unassessed 25
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). 1,080 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 |
|---|---|---|---|---|---|---|
| Grip strength | 51 | 634.1 464.8–865.1ROR 637.6 · calibrated p 2e-14 ✓ | 415.9 EB05 328.6 · IC025 +5.9 3/3 methods agree vs other Corticosteroids: PRR 3.7 (2.8–4.9) | Not in label — unassessed | serious n=51 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 130 | 543.9 449.4–658.2ROR 551.5 · calibrated p 3e-14 ✓ | 410.3 EB05 354.4 · IC025 +7.1 3/3 methods agree vs other Corticosteroids: PRR 2.2 (1.9–2.6) | Lab value / disease marker | serious n=130 · ♀ 100% (drug 59%) · 97% clinician | not reported in cached trials |
| Lupus vulgaris | 221 | 512.7 443.5–592.6ROR 525.1 · calibrated p 4e-14 ✓ | 401.9 EB05 359.4 · IC025 +7.5 3/3 methods agree vs other Corticosteroids: PRR 2.2 (1.9–2.5) | Not in label — unassessed | serious n=221 · ♀ 100% (drug 59%) · 96% clinician | not reported in cached trials |
| Mechanical ventilation complication | 27 | 493.8 325.5–749.1ROR 495.3 · calibrated p 6e-13 ✓ | 314.0 EB05 226.6 · IC025 +5.0 3/3 methods agree vs other Corticosteroids: only this drug | Reporting / coding artifact | serious n=27 · ♀ 0% (drug 59%) · 100% clinician | not reported in cached trials |
| Swollen joint count | 40 | 436.1 310.9–611.7ROR 437.9 · calibrated p 9e-13 ✓ | 310.3 EB05 237.7 · IC025 +5.5 3/3 methods agree vs other Corticosteroids: PRR 3.1 (2.3–4.3) | Not in label — unassessed | serious n=40 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| C-reactive protein | 147 | 434.3 364.4–517.7ROR 441.3 · calibrated p 3e-13 ✓ | 346.8 EB05 302.3 · IC025 +7.1 3/3 methods agree vs other Corticosteroids: PRR 1.9 (1.6–2.2) | Lab value / disease marker | serious n=147 · ♀ 100% (drug 59%) · 98% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 294 | 396.2 350.6–447.9ROR 409.1 · calibrated p 5e-13 ✓ | 329.0 EB05 298.6 · IC025 +7.6 3/3 methods agree vs other Corticosteroids: PRR 1.7 (1.5–1.9) | Not in label — unassessed | serious n=294 · ♀ 100% (drug 59%) · 96% clinician | not reported in cached trials |
| Retinitis | 243 | 382.8 334.5–437.9ROR 392.9 · calibrated p 8e-13 ✓ | 318.3 EB05 286.1 · IC025 +7.4 3/3 methods agree vs other Corticosteroids: PRR 2.8 (2.5–3.2) | Likely indication confounding term in indications | serious n=243 · ♀ 100% (drug 59%) · 97% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 291 | 379.0 335.3–428.5ROR 391.2 · calibrated p 8e-13 ✓ | 317.0 EB05 287.6 · IC025 +7.5 3/3 methods agree vs other Corticosteroids: PRR 2.2 (2.0–2.5) | Not in label — unassessed | serious n=291 · ♀ 100% (drug 59%) · 97% clinician | not reported in cached trials |
| Acquired porphyria | 10 | 368.8 188.9–720.2ROR 369.2 · calibrated p 1e-10 ✓ | 197.6 EB05 114.7 · IC025 +3.2 3/3 methods agree vs other Corticosteroids: PRR 64.3 (27.8–148.9) | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Dislocation of vertebra | 313 | 367.9 327.0–413.9ROR 380.6 · calibrated p 1e-12 ✓ | 309.6 EB05 281.9 · IC025 +7.5 3/3 methods agree vs other Corticosteroids: PRR 2.4 (2.1–2.6) | Not in label — unassessed | serious n=313 · ♀ 100% (drug 59%) · 95% clinician | not reported in cached trials |
| X-ray abnormal | 243 | 354.0 309.7–404.8ROR 363.5 · calibrated p 2e-12 ✓ | 298.2 EB05 268.0 · IC025 +7.3 3/3 methods agree vs other Corticosteroids: PRR 2.3 (2.0–2.6) | Lab value / disease marker | serious n=243 · ♀ 100% (drug 59%) · 96% clinician | not reported in cached trials |
| Swollen joint count increased | 411 | 340.9 307.9–377.5ROR 356.6 · calibrated p 2e-12 ✓ | 291.5 EB05 268.6 · IC025 +7.6 3/3 methods agree vs other Corticosteroids: PRR 1.6 (1.5–1.8) | Lab value / disease marker | serious n=411 · ♀ 100% (drug 59%) · 97% clinician | not reported in cached trials |
| Seronegative arthritis | 137 | 312.2 261.4–373.0ROR 316.9 · calibrated p 8e-12 ✓ | 263.7 EB05 228.7 · IC025 +6.8 3/3 methods agree vs other Corticosteroids: PRR 4.7 (4.0–5.6) | Likely indication confounding shares a disease stem with the indications wording | serious n=137 · ♀ 100% (drug 59%) · 98% clinician | not reported in cached trials |
| Rheumatic fever | 533 | 312.1 285.7–341.0ROR 331.0 · calibrated p 4e-12 ✓ | 271.0 EB05 252.2 · IC025 +7.6 3/3 methods agree vs other Corticosteroids: PRR 1.5 (1.4–1.6) | Likely indication confounding shares a disease stem with the indications wording | serious n=533 · ♀ 100% (drug 59%) · 97% clinician | not reported in cached trials |
| Facet joint syndrome | 367 | 295.9 265.8–329.3ROR 307.9 · calibrated p 8e-12 ✓ | 257.6 EB05 236.2 · IC025 +7.4 3/3 methods agree vs other Corticosteroids: PRR 1.6 (1.4–1.7) | Not in label — unassessed | serious n=367 · ♀ 100% (drug 59%) · 95% clinician | not reported in cached trials |
| Porphyria acute | 159 | 292.3 248.0–344.4ROR 297.3 · calibrated p 1e-11 ✓ | 250.5 EB05 219.5 · IC025 +6.9 3/3 methods agree vs other Corticosteroids: PRR 3.9 (3.4–4.6) | Not in label — unassessed | serious n=159 · ♀ 100% (drug 59%) · 96% clinician | not reported in cached trials |
| Nipple swelling | 29 | 289.1 196.4–425.5ROR 290.0 · calibrated p 6e-11 ✓ | 219.0 EB05 159.9 · IC025 +5.0 3/3 methods agree vs other Corticosteroids: only this drug | Not in label — unassessed | serious n=29 · ♀ 0% (drug 59%) | not reported in cached trials |
| Inspiratory capacity decreased | 25 | 224.0 148.5–337.8ROR 224.6 · calibrated p 7e-10 ✓ | 176.3 EB05 125.6 · IC025 +4.7 3/3 methods agree vs other Corticosteroids: only this drug | Not in label — unassessed | serious n=25 · ♀ 0% (drug 59%) · 100% clinician | not reported in cached trials |
| Hepatic enzyme | 12 | 210.8 116.6–380.9ROR 211.0 · calibrated p 5e-9 ✓ | 147.8 EB05 90.1 · IC025 +3.5 3/3 methods agree vs other Corticosteroids: PRR 4.0 (2.2–7.1) | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Subcutaneous drug absorption impaired | 45 | 202.0 149.0–273.9ROR 203.0 · calibrated p 8e-10 ✓ | 171.8 EB05 133.6 · IC025 +5.4 3/3 methods agree vs other Corticosteroids: PRR 1.7 (1.3–2.3) | Not in label — unassessed | serious n=45 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Rheumatoid factor positive | 446 | 188.0 171.1–206.7ROR 197.4 · calibrated p 5e-10 ✓ | 172.1 EB05 159.1 · IC025 +7.0 3/3 methods agree vs other Corticosteroids: PRR 1.3 (1.2–1.4) | Lab value / disease marker | serious n=446 · ♀ 100% (drug 59%) · 96% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 507 | 166.5 152.5–181.8ROR 176.0 · calibrated p 1e-9 ✓ | 154.0 EB05 143.1 · IC025 +6.9 3/3 methods agree vs other Corticosteroids: PRR 1.1 (1.0–1.2) | Labeled (related wording) related wording | serious PRR 98.1 · ♀ 100% (drug 59%) · 95% clinician | not reported in cached trials |
| Hypocholesterolaemia | 20 | 155.8 99.1–245.2ROR 156.2 · calibrated p 2e-8 ✓ | 128.1 EB05 87.6 · IC025 +4.3 3/3 methods agree vs other Corticosteroids: PRR 1.9 (1.2–3.0) | Not in label — unassessed | serious n=20 · 100% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 382 | 141.5 127.9–156.6ROR 147.5 · calibrated p 6e-9 ✓ | 132.2 EB05 121.5 · IC025 +6.7 3/3 methods agree vs other Corticosteroids: PRR 1.6 (1.4–1.7) | Not in label — unassessed | serious n=382 · ♀ 100% (drug 59%) · 97% clinician | not reported in cached trials |
| Helicobacter infection | 577 | 134.6 124.1–146.1ROR 143.4 · calibrated p 7e-9 ✓ | 126.4 EB05 118.0 · IC025 +6.7 3/3 methods agree vs other Corticosteroids: PRR 1.2 (1.1–1.3) | Not in label — unassessed | serious PRR 85.1 · ♀ 100% (drug 59%) · 97% clinician | not reported in cached trials |
| Peripheral venous disease | 219 | 130.2 113.8–149.0ROR 133.3 · calibrated p 1e-8 ✓ | 121.7 EB05 108.8 · IC025 +6.4 3/3 methods agree vs other Corticosteroids: PRR 1.2 (1.0–1.4) | Not in label — unassessed | serious n=219 · ♀ 100% (drug 59%) · 94% clinician | not reported in cached trials |
| Bone erosion | 189 | 126.4 109.4–146.2ROR 129.0 · calibrated p 2e-8 ✓ | 118.3 EB05 104.8 · IC025 +6.3 3/3 methods agree vs other Corticosteroids: PRR 2.1 (1.8–2.5) | Not in label — unassessed | serious n=189 · ♀ 100% (drug 59%) · 98% clinician | not reported in cached trials |
| C-reactive protein abnormal | 333 | 123.0 110.4–137.1ROR 127.5 · calibrated p 2e-8 ✓ | 115.8 EB05 105.8 · IC025 +6.5 3/3 methods agree vs other Corticosteroids: PRR 1.3 (1.1–1.4) | Lab value / disease marker | serious n=333 · ♀ 100% (drug 59%) · 97% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 364 | 121.1 109.2–134.3ROR 126.0 · calibrated p 2e-8 ✓ | 114.2 EB05 104.7 · IC025 +6.5 3/3 methods agree vs other Corticosteroids: PRR 0.8 (0.7–0.9) | Lab value / disease marker | serious PRR 73.1 · ♀ 100% (drug 59%) · 96% clinician | not reported in cached trials |
| Muscle injury | 417 | 120.1 109.1–132.3ROR 125.7 · calibrated p 2e-8 ✓ | 113.4 EB05 104.5 · IC025 +6.5 3/3 methods agree vs other Corticosteroids: PRR 1.2 (1.1–1.4) | Not in label — unassessed | serious PRR 78.3 · ♀ 100% (drug 59%) · 98% clinician | not reported in cached trials |
| Folliculitis | 492 | 112.2 102.7–122.6ROR 118.4 · calibrated p 3e-8 ✓ | 106.4 EB05 98.8 · IC025 +6.4 3/3 methods agree vs other Corticosteroids: PRR 1.2 (1.1–1.3) | Not in label — unassessed | serious PRR 79.6 · ♀ 100% (drug 59%) · 97% clinician | not reported in cached trials |
| Mycobacterium chelonae infection | 35 | 111.9 79.8–157.1ROR 112.3 · calibrated p 1e-7 ✓ | 100.9 EB05 75.8 · IC025 +4.9 3/3 methods agree vs other Corticosteroids: PRR 1.1 (0.8–1.5) | Not in label — unassessed | serious n=35 | not reported in cached trials |
| Hand deformity | 605 | 108.8 100.5–117.7ROR 116.2 · calibrated p 4e-8 ✓ | 103.4 EB05 96.7 · IC025 +6.4 3/3 methods agree vs other Corticosteroids: PRR 1.1 (1.0–1.2) | Not in label — unassessed | serious PRR 71.5 · ♀ 100% (drug 59%) · 97% clinician | not reported in cached trials |
| Pemphigus | 511 | 96.2 88.2–104.8ROR 101.7 · calibrated p 1e-7 ✓ | 91.9 EB05 85.4 · IC025 +6.3 3/3 methods agree vs other Corticosteroids: PRR 0.8 (0.8–0.9) | Likely indication confounding term in indications | serious PRR 58.6 · ♀ 100% (drug 59%) · 96% clinician | not reported in cached trials |
| Wound infection | 422 | 90.6 82.4–99.7ROR 94.9 · calibrated p 2e-7 ✓ | 86.8 EB05 80.0 · IC025 +6.1 3/3 methods agree vs other Corticosteroids: PRR 1.7 (1.6–1.9) | Labeled (related wording) related wording | serious PRR 59.2 · ♀ 100% (drug 59%) · 94% clinician | not reported in cached trials |
| Lip dry | 340 | 88.5 79.5–98.4ROR 91.8 · calibrated p 2e-7 ✓ | 84.7 EB05 77.4 · IC025 +6.1 3/3 methods agree vs other Corticosteroids: PRR 1.4 (1.3–1.6) | Not in label — unassessed | serious n=340 · ♀ 100% (drug 59%) · 96% clinician | not reported in cached trials |
| Drug tolerance decreased | 106 | 88.3 72.8–107.1ROR 89.3 · calibrated p 3e-7 ✓ | 83.7 EB05 71.1 · IC025 +5.6 3/3 methods agree vs other Corticosteroids: PRR 1.6 (1.3–1.9) | Labeled (related wording) related wording | serious n=106 · ♀ 100% (drug 59%) · 97% clinician | not reported in cached trials |
| Breast cancer stage iii | 239 | 86.5 76.2–98.3ROR 88.8 · calibrated p 3e-7 ✓ | 82.8 EB05 74.3 · IC025 +5.9 3/3 methods agree vs other Corticosteroids: PRR 1.3 (1.1–1.5) | Not in label — unassessed | serious n=239 · ♀ 100% (drug 59%) · 95% clinician | not reported in cached trials |
| Joint range of motion decreased | 496 | 86.5 79.2–94.4ROR 91.2 · calibrated p 2e-7 ✓ | 83.0 EB05 77.0 · IC025 +6.1 3/3 methods agree vs other Corticosteroids: PRR 1.6 (1.5–1.7) | Not in label — unassessed | serious PRR 67.3 · ♀ 100% (drug 59%) · 97% clinician | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Hydrocortisone Sodium Succinate 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) | 1,647 | 4.3 4.1–4.5ROR 5.0 · calibrated p 0.239 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree vs other Corticosteroids: PRR 0.5 (0.4–0.5) | Reporting / coding artifact | serious PRR 4.9 | not reported in cached trials |
| Infusion related reaction (reaction during infusion) | 1,243 | 43.0 40.8–45.3ROR 49.5 · calibrated p 1e-5 ✓ | 42.2 EB05 40.3 · IC025 +5.3 3/3 methods agree vs other Corticosteroids: PRR 1.3 (1.2–1.3) | Not in label — unassessed | serious PRR 32.8 · 93% clinician | not reported in cached trials |
| Pyrexia (fever) | 1,107 | 7.2 6.8–7.6ROR 8.0 · calibrated p 0.066 | 7.2 EB05 6.8 · IC025 +2.7 3/3 methods agree vs other Corticosteroids: PRR 0.7 (0.7–0.8) | Not in label — unassessed | serious PRR 5.6 · 90% clinician | NCT00691002: 3/362 (0.8%) on Hydrocortisone Sodium Succinate |
| Fatigue (tiredness) | 1,098 | 3.2 3.0–3.4ROR 3.5 · calibrated p 0.494 | 3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Corticosteroids: PRR 0.5 (0.5–0.5) | Not in label — unassessed | serious PRR 3.6 · ♀ 80% (drug 59%) | not reported in cached trials |
| Dyspnoea (shortness of breath) | 996 | 4.0 3.7–4.2ROR 4.3 · calibrated p 0.325 | 3.9 EB05 3.7 · IC025 +1.9 3/3 methods agree vs other Corticosteroids: PRR 0.6 (0.5–0.6) | Not in label — unassessed | serious PRR 3.4 | not reported in cached trials |
| Nausea | 982 | 2.8 2.6–3.0ROR 3.0 · calibrated p 0.625 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Corticosteroids: PRR 0.6 (0.5–0.6) | Not in label — unassessed | serious PRR 3.2 · ♀ 79% (drug 59%) | NCT00691002: 1/453 (0.2%) on Hydrocortisone Sodium Succinate (serious AE) |
| Rash | 949 | 4.9 4.6–5.2ROR 5.4 · calibrated p 0.199 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree vs other Corticosteroids: PRR 0.6 (0.6–0.7) | Not in label — unassessed | serious PRR 6.7 · ♀ 83% (drug 59%) · 91% clinician | not reported in cached trials |
| Headache | 930 | 3.3 3.1–3.5ROR 3.6 · calibrated p 0.462 | 3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree vs other Corticosteroids: PRR 0.6 (0.6–0.7) | Labeled adverse reaction exact term | serious PRR 4.1 · ♀ 85% (drug 59%) | NCT00691002: 8/362 (2.2%) on Hydrocortisone Sodium Succinate |
| Pain | 930 | 3.4 3.2–3.6ROR 3.7 · calibrated p 0.448 | 3.4 EB05 3.2 · IC025 +1.7 3/3 methods agree vs other Corticosteroids: PRR 0.5 (0.5–0.6) | Not in label — unassessed | serious PRR 3.3 · ♀ 84% (drug 59%) | NCT00691002: 1/362 (0.3%) on Hydrocortisone Sodium Succinate (serious AE) |
| Diarrhoea (diarrhea) | 912 | 3.2 3.0–3.4ROR 3.4 · calibrated p 0.505 | 3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Corticosteroids: PRR 0.5 (0.5–0.6) | Labeled adverse reaction exact term | serious PRR 3.4 | NCT00691002: 4/351 (1.1%) on Hydrocortisone Sodium Succinate |
| Vomiting | 904 | 4.3 4.1–4.6ROR 4.7 · calibrated p 0.271 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree vs other Corticosteroids: PRR 0.7 (0.7–0.7) | Not in label — unassessed | serious PRR 4.0 · ♀ 81% (drug 59%) · 91% clinician | not reported in cached trials |
| Condition aggravated | 902 | 6.7 6.3–7.2ROR 7.3 · calibrated p 0.087 | 6.7 EB05 6.3 · IC025 +2.6 3/3 methods agree vs other Corticosteroids: PRR 0.5 (0.5–0.6) | Reporting / coding artifact | serious PRR 6.4 | not reported in cached trials |
| Hypertension (high blood pressure) | 843 | 9.0 8.4–9.5ROR 9.7 · calibrated p 0.035 ✓ | 8.9 EB05 8.4 · IC025 +3.0 3/3 methods agree vs other Corticosteroids: PRR 0.9 (0.8–0.9) | Labeled adverse reaction exact term | serious PRR 7.1 · ♀ 85% (drug 59%) · 93% clinician | NCT00691002: 7/453 (1.5%) on Hydrocortisone Sodium Succinate |
| Drug ineffective (drug did not work) | 829 | 1.4 1.3–1.5ROR 1.5 · calibrated p 0.611 | 1.4 EB05 1.3 · IC025 +0.4 vs other Corticosteroids: PRR 0.3 (0.2–0.3) | Reporting / coding artifact | serious PRR 2.4 | not reported in cached trials |
| Pruritus (itching) | 821 | 4.9 4.6–5.2ROR 5.3 · calibrated p 0.209 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree vs other Corticosteroids: PRR 0.8 (0.7–0.8) | Not in label — unassessed | serious PRR 7.2 · ♀ 88% (drug 59%) | NCT00691002: 2/351 (0.6%) on Hydrocortisone Sodium Succinate |
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.
- Grip strength — n=51, PRR 634.1
- Lupus vulgaris — n=221, PRR 512.7
- Swollen joint count — n=40, PRR 436.1
- Deep vein thrombosis postoperative — n=294, PRR 396.2
- Adjustment disorder with depressed mood — n=291, PRR 379.0
- Dislocation of vertebra — n=313, PRR 367.9
- Facet joint syndrome — n=367, PRR 295.9
- Porphyria acute — n=159, PRR 292.3
- Nipple swelling — n=29, PRR 289.1
- Inspiratory capacity decreased — n=25, PRR 224.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Methotrexate Sodium ↔ Rheumatoid Arthritis.
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 Sodium Succinate?
In FDA FAERS, the most frequently co-reported reaction terms for Hydrocortisone Sodium Succinate are infusion related reaction, pyrexia, fatigue, dyspnoea, nausea, 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 Sodium Succinate have an FDA boxed warning?
No. The FDA label retrieved for Hydrocortisone Sodium Succinate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Hydrocortisone Sodium Succinate 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") - 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, 1,120 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)
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