Drug · FAERS side-effect profile with label screen
Prednisone side effects: what 499,794 FDA adverse event reports show
Who reports
499,794 reports · 79% serious · 52,153 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
PredniSONE 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 .
FDA label, Indications and Usage
What it is
Prednisone is a synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system.
PubChem CID 5865 (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) 4Likely indication confounding 8Lab value / disease marker 11Not in label — unassessed 17
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). 1,179 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 |
|---|---|---|---|---|---|---|
| Anti-cyclic citrullinated peptide antibody positive | 5,618 | 162.4 153.2–172.2ROR 164.3 · calibrated p 2e-9 ✓ | 33.1 EB05 32.4 · IC025 +5.0 3/3 methods agree vs other Corticosteroids: PRR 14.0 (13.7–14.4) | Lab value / disease marker | serious PRR 24.4 · ♀ 100% (drug 60%) · 93% clinician | no trial arm names this drug |
| Swollen joint count increased | 2,341 | 128.1 118.0–139.2ROR 128.7 · calibrated p 2e-8 ✓ | 31.5 EB05 30.4 · IC025 +4.9 3/3 methods agree vs other Corticosteroids: PRR 10.4 (10.0–10.8) | Lab value / disease marker | serious n=2,335 · ♀ 100% (drug 60%) · 95% clinician | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody | 495 | 121.9 102.2–145.5ROR 122.0 · calibrated p 3e-8 ✓ | 31.1 EB05 28.8 · IC025 +4.8 3/3 methods agree vs other Corticosteroids: PRR 9.1 (8.3–10.0) | Lab value / disease marker | serious n=493 · ♀ 100% (drug 60%) · 100% clinician | no trial arm names this drug |
| Pemphigus | 9,174 | 119.7 114.9–124.6ROR 121.9 · calibrated p 2e-8 ✓ | 30.9 EB05 30.4 · IC025 +4.9 3/3 methods agree vs other Corticosteroids: PRR 18.6 (18.2–18.9) | Likely indication confounding term in indications | serious PRR 22.7 · ♀ 100% (drug 60%) | no trial arm names this drug |
| Rheumatic fever | 3,108 | 104.3 97.6–111.4ROR 104.9 · calibrated p 8e-8 ✓ | 29.8 EB05 29.0 · IC025 +4.8 3/3 methods agree vs other Corticosteroids: PRR 9.7 (9.4–10.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=3,106 · ♀ 100% (drug 60%) · 94% clinician | no trial arm names this drug |
| Lupus vulgaris | 814 | 91.1 80.5–103.1ROR 91.2 · calibrated p 2e-7 ✓ | 28.7 EB05 27.0 · IC025 +4.7 3/3 methods agree vs other Corticosteroids: PRR 8.8 (8.2–9.4) | Not in label — unassessed | serious n=814 · ♀ 100% (drug 60%) · 100% clinician | no trial arm names this drug |
| Rheumatoid factor positive | 3,930 | 89.9 85.0–95.1ROR 90.6 · calibrated p 2e-7 ✓ | 28.6 EB05 27.8 · IC025 +4.8 3/3 methods agree vs other Corticosteroids: PRR 13.0 (12.6–13.4) | Lab value / disease marker | serious n=3,927 · ♀ 100% (drug 60%) · 93% clinician | no trial arm names this drug |
| Duodenal ulcer perforation | 4,860 | 82.3 78.3–86.4ROR 83.1 · calibrated p 4e-7 ✓ | 27.8 EB05 27.1 · IC025 +4.7 3/3 methods agree vs other Corticosteroids: PRR 11.9 (11.5–12.2) | Labeled (related wording) related wording | serious PRR 20.3 · ♀ 100% (drug 60%) · 94% clinician | no trial arm names this drug |
| Deep vein thrombosis postoperative | 1,287 | 80.1 72.9–88.0ROR 80.3 · calibrated p 6e-7 ✓ | 27.5 EB05 26.3 · IC025 +4.7 3/3 methods agree vs other Corticosteroids: PRR 8.0 (7.6–8.5) | Not in label — unassessed | serious n=1,287 · ♀ 100% (drug 60%) · 100% clinician | no trial arm names this drug |
| C-reactive protein | 574 | 72.0 62.8–82.5ROR 72.1 · calibrated p 1e-6 ✓ | 26.5 EB05 24.7 · IC025 +4.6 3/3 methods agree vs other Corticosteroids: PRR 7.8 (7.1–8.5) | Lab value / disease marker | serious n=574 · ♀ 100% (drug 60%) · 100% clinician | no trial arm names this drug |
| Hand deformity | 7,949 | 64.7 62.4–67.0ROR 65.7 · calibrated p 2e-6 ✓ | 25.5 EB05 25.0 · IC025 +4.6 3/3 methods agree vs other Corticosteroids: PRR 16.9 (16.6–17.3) | Not in label — unassessed | serious PRR 20.2 · ♀ 98% (drug 60%) | no trial arm names this drug |
| Steroid dependence | 506 | 61.4 53.4–70.5ROR 61.4 · calibrated p 4e-6 ✓ | 24.9 EB05 23.2 · IC025 +4.5 3/3 methods agree vs other Corticosteroids: PRR 15.9 (14.5–17.5) | Not in label — unassessed | serious n=501 · ♀ 0% (drug 60%) · 100% clinician | no trial arm names this drug |
| Granuloma skin | 482 | 57.9 50.4–66.6ROR 58.0 · calibrated p 6e-6 ✓ | 24.4 EB05 22.6 · IC025 +4.4 3/3 methods agree vs other Corticosteroids: PRR 302.5 (248.2–368.6) | Not in label — unassessed | serious n=479 · ♀ 100% (drug 60%) | no trial arm names this drug |
| Facet joint syndrome | 1,801 | 55.5 51.7–59.6ROR 55.7 · calibrated p 7e-6 ✓ | 23.9 EB05 23.0 · IC025 +4.5 3/3 methods agree vs other Corticosteroids: PRR 8.3 (7.9–8.7) | Not in label — unassessed | serious n=1,800 · ♀ 100% (drug 60%) · 93% clinician | no trial arm names this drug |
| Blood pressure diastolic abnormal | 1,433 | 52.4 48.5–56.7ROR 52.6 · calibrated p 1e-5 ✓ | 23.4 EB05 22.4 · IC025 +4.4 3/3 methods agree vs other Corticosteroids: PRR 43.4 (40.7–46.2) | Lab value / disease marker | serious n=1,373 · ♀ 81% (drug 60%) | no trial arm names this drug |
| Adjustment disorder with depressed mood | 1,072 | 47.2 43.2–51.5ROR 47.3 · calibrated p 2e-5 ✓ | 22.3 EB05 21.2 · IC025 +4.4 3/3 methods agree vs other Corticosteroids: PRR 8.8 (8.2–9.3) | Not in label — unassessed | serious n=1,072 · ♀ 100% (drug 60%) · 100% clinician | no trial arm names this drug |
| Blood pressure systolic abnormal | 1,297 | 45.1 41.7–48.8ROR 45.2 · calibrated p 3e-5 ✓ | 21.8 EB05 20.9 · IC025 +4.3 3/3 methods agree vs other Corticosteroids: PRR 43.4 (40.6–46.4) | Lab value / disease marker | serious n=1,244 · ♀ 81% (drug 60%) | no trial arm names this drug |
| C-reactive protein abnormal | 3,242 | 42.5 40.4–44.6ROR 42.8 · calibrated p 4e-5 ✓ | 21.2 EB05 20.6 · IC025 +4.3 3/3 methods agree vs other Corticosteroids: PRR 14.3 (13.8–14.8) | Lab value / disease marker | serious n=3,231 · ♀ 91% (drug 60%) | no trial arm names this drug |
| X-ray abnormal | 892 | 41.4 37.7–45.5ROR 41.5 · calibrated p 4e-5 ✓ | 20.9 EB05 19.8 · IC025 +4.3 3/3 methods agree vs other Corticosteroids: PRR 9.0 (8.4–9.7) | Lab value / disease marker | serious n=891 · ♀ 100% (drug 60%) · 100% clinician | no trial arm names this drug |
| Dust allergy | 480 | 41.1 36.2–46.6ROR 41.1 · calibrated p 5e-5 ✓ | 20.9 EB05 19.3 · IC025 +4.2 3/3 methods agree vs other Corticosteroids: PRR 115.4 (100.3–132.9) | Likely indication confounding shares a disease stem with the indications wording | serious n=478 · ♀ 0% (drug 60%) | no trial arm names this drug |
| Helicobacter infection | 5,030 | 40.4 38.8–42.0ROR 40.8 · calibrated p 5e-5 ✓ | 20.7 EB05 20.2 · IC025 +4.3 3/3 methods agree vs other Corticosteroids: PRR 12.2 (11.8–12.5) | Not in label — unassessed | serious PRR 16.0 · ♀ 100% (drug 60%) · 92% clinician | no trial arm names this drug |
| Synovitis | 8,900 | 40.3 39.2–41.5ROR 41.0 · calibrated p 4e-5 ✓ | 20.7 EB05 20.3 · IC025 +4.3 3/3 methods agree vs other Corticosteroids: PRR 17.9 (17.6–18.3) | Likely indication confounding term in indications | serious PRR 15.8 · ♀ 94% (drug 60%) | no trial arm names this drug |
| Muscle injury | 4,043 | 40.2 38.5–42.0ROR 40.6 · calibrated p 5e-5 ✓ | 20.7 EB05 20.1 · IC025 +4.3 3/3 methods agree vs other Corticosteroids: PRR 13.8 (13.4–14.3) | Not in label — unassessed | serious PRR 16.3 · ♀ 100% (drug 60%) · 92% clinician | no trial arm names this drug |
| Dislocation of vertebra | 1,083 | 39.3 36.1–42.7ROR 39.4 · calibrated p 6e-5 ✓ | 20.4 EB05 19.4 · IC025 +4.2 3/3 methods agree vs other Corticosteroids: PRR 8.8 (8.3–9.4) | Not in label — unassessed | serious n=1,083 · ♀ 100% (drug 60%) · 100% clinician | no trial arm names this drug |
| Sleep disorder due to general medical condition, insomnia type | 3,038 | 37.0 35.2–38.9ROR 37.2 · calibrated p 8e-5 ✓ | 19.8 EB05 19.2 · IC025 +4.2 3/3 methods agree vs other Corticosteroids: PRR 14.5 (14.0–15.0) | Not in label — unassessed | serious n=3,022 · ♀ 100% (drug 60%) · 93% clinician | no trial arm names this drug |
| Diffuse large b-cell lymphoma recurrent | 957 | 33.2 30.5–36.2ROR 33.3 · calibrated p 2e-4 ✓ | 18.7 EB05 17.7 · IC025 +4.1 3/3 methods agree vs other Corticosteroids: PRR 49.6 (45.8–53.8) | Likely indication confounding shares a disease stem with the indications wording | serious n=953 | no trial arm names this drug |
| Folliculitis | 4,563 | 32.7 31.5–34.0ROR 33.0 · calibrated p 2e-4 ✓ | 18.5 EB05 18.1 · IC025 +4.2 3/3 methods agree vs other Corticosteroids: PRR 13.0 (12.6–13.4) | Not in label — unassessed | serious PRR 15.9 · ♀ 97% (drug 60%) · 93% clinician | no trial arm names this drug |
| Red blood cell sedimentation rate abnormal | 1,022 | 32.4 29.8–35.2ROR 32.4 · calibrated p 2e-4 ✓ | 18.4 EB05 17.5 · IC025 +4.1 3/3 methods agree vs other Corticosteroids: PRR 148.0 (133.4–164.2) | Lab value / disease marker | serious n=1,016 · ♀ 85% (drug 60%) | no trial arm names this drug |
| Retinitis | 721 | 31.4 28.5–34.6ROR 31.5 · calibrated p 2e-4 ✓ | 18.1 EB05 17.0 · IC025 +4.0 3/3 methods agree vs other Corticosteroids: PRR 8.9 (8.3–9.6) | Likely indication confounding term in indications | serious n=720 · ♀ 100% (drug 60%) · 100% clinician | no trial arm names this drug |
| Pericarditis | 6,736 | 28.0 27.2–28.9ROR 28.4 · calibrated p 3e-4 ✓ | 17.0 EB05 16.6 · IC025 +4.0 3/3 methods agree vs other Corticosteroids: PRR 14.4 (14.1–14.7) | Not in label — unassessed | serious PRR 12.5 · ♀ 96% (drug 60%) · 92% clinician | no trial arm names this drug |
| Blood parathyroid hormone decreased | 583 | 26.5 23.9–29.4ROR 26.5 · calibrated p 5e-4 ✓ | 16.4 EB05 15.3 · IC025 +3.9 3/3 methods agree vs other Corticosteroids: PRR 354.3 (292.6–429.1) | Lab value / disease marker | serious n=582 · ♀ 100% (drug 60%) | no trial arm names this drug |
| Histoplasmosis disseminated | 607 | 26.3 23.8–29.2ROR 26.4 · calibrated p 5e-4 ✓ | 16.3 EB05 15.3 · IC025 +3.9 3/3 methods agree vs other Corticosteroids: only this drug | Not in label — unassessed | serious n=606 · 100% clinician | no trial arm names this drug |
| Glossodynia (burning tongue/mouth pain) | 8,626 | 25.9 25.2–26.6ROR 26.4 · calibrated p 5e-4 ✓ | 16.2 EB05 15.9 · IC025 +4.0 3/3 methods agree vs other Corticosteroids: PRR 17.3 (17.0–17.7) | Not in label — unassessed | serious PRR 16.8 · ♀ 100% (drug 60%) | no trial arm names this drug |
| Peripheral venous disease | 1,457 | 23.7 22.2–25.3ROR 23.7 · calibrated p 9e-4 ✓ | 15.3 EB05 14.6 · IC025 +3.8 3/3 methods agree vs other Corticosteroids: PRR 8.6 (8.2–9.1) | Not in label — unassessed | serious n=1,447 · ♀ 100% (drug 60%) · 92% clinician | no trial arm names this drug |
| Secondary immunodeficiency | 420 | 22.4 19.8–25.2ROR 22.4 · calibrated p 0.001 ✓ | 14.7 EB05 13.6 · IC025 +3.7 3/3 methods agree vs other Corticosteroids: PRR 9.8 (8.8–10.8) | Labeled (related wording) related wording | serious n=419 · 100% clinician | no trial arm names this drug |
| Polyomavirus-associated nephropathy | 808 | 21.9 20.1–23.9ROR 22.0 · calibrated p 0.001 ✓ | 14.6 EB05 13.7 · IC025 +3.7 3/3 methods agree vs other Corticosteroids: PRR 29.3 (27.0–31.7) | Likely indication confounding shares a disease stem with the indications wording | serious n=808 · ♀ 33% (drug 60%) · 100% clinician | no trial arm names this drug |
| Nocardiosis | 888 | 21.9 20.1–23.7ROR 21.9 · calibrated p 0.001 ✓ | 14.5 EB05 13.7 · IC025 +3.7 3/3 methods agree vs other Corticosteroids: PRR 31.9 (29.5–34.4) | Labeled (related wording) related wording | serious n=885 · ♀ 33% (drug 60%) · 100% clinician | no trial arm names this drug |
| Steroid diabetes | 492 | 21.0 18.8–23.4ROR 21.0 · calibrated p 0.002 ✓ | 14.1 EB05 13.1 · IC025 +3.7 3/3 methods agree vs other Corticosteroids: PRR 21.0 (19.0–23.2) | Labeled (related wording) related wording | serious n=492 · ♀ 0% (drug 60%) · 100% clinician | no trial arm names this drug |
| Post transplant lymphoproliferative disorder | 1,691 | 20.9 19.7–22.2ROR 21.0 · calibrated p 0.002 ✓ | 14.1 EB05 13.6 · IC025 +3.7 3/3 methods agree vs other Corticosteroids: PRR 34.2 (32.3–36.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=1,689 · 100% clinician | no trial arm names this drug |
| Bone erosion | 1,189 | 20.8 19.4–22.3ROR 20.9 · calibrated p 0.002 ✓ | 14.1 EB05 13.4 · IC025 +3.7 3/3 methods agree vs other Corticosteroids: PRR 15.7 (14.8–16.7) | Not in label — unassessed | serious n=1,182 · ♀ 100% (drug 60%) | no trial arm names this drug |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Opportunistic infection | 12,957 | 4.34.2–4.4 | signal |
| Interstitial lung disease | 8,962 | 4.24.1–4.3 | signal |
| Serious infection | 55,017 | 3.13.1–3.2 | signal |
| Liver injury | 20,088 | 2.92.9–3.0 | signal |
| Tendon disorder | 2,193 | 2.52.4–2.6 | signal |
| Neutropenia / agranulocytosis | 13,607 | 2.42.3–2.4 | signal |
| Anaemia | 15,075 | 2.22.1–2.2 | signal |
| Venous thromboembolism | 9,787 | 1.91.9–2.0 | raised |
| Hyperglycaemia / diabetes | 15,428 | 1.91.9–1.9 | raised |
| Thrombocytopenia | 9,688 | 1.91.8–1.9 | raised |
| Kidney injury | 19,922 | 1.91.8–1.9 | raised |
| Gi bleeding | 7,426 | 1.71.7–1.8 | raised |
| Osteonecrosis | 2,230 | 1.61.6–1.7 | raised |
| Fall / fracture | 14,103 | 1.61.6–1.6 | raised |
| Pancreatitis | 2,977 | 1.61.5–1.6 | raised |
| Depression | 9,693 | 1.51.4–1.5 | raised |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Prednisone only as a background or rescue medication (NCT01471340, NCT02883049); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 66,433 | 2.2 2.2–2.2ROR 2.4 · calibrated p 0.876 | 2.1 EB05 2.1 · IC025 +1.1 3/3 methods agree vs other Corticosteroids: PRR 28.5 (28.5–28.5) | Reporting / coding artifact | age-adj. PRR 2.5 · serious PRR 3.6 | no trial arm names this drug |
| Off label use (used outside approved label) | 55,472 | 2.8 2.8–2.8ROR 3.0 · calibrated p 0.619 | 2.7 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Corticosteroids: PRR 19.6 (19.6–19.6) | Reporting / coding artifact | age-adj. PRR 2.6 · serious PRR 3.3 | no trial arm names this drug |
| Fatigue (tiredness) | 40,816 | 2.3 2.2–2.3ROR 2.4 · calibrated p 0.864 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Corticosteroids: PRR 24.8 (24.8–24.8) | Labeled (related wording) related wording | age-adj. PRR 1.9 · serious PRR 2.5 | no trial arm names this drug |
| Pain | 37,879 | 2.7 2.7–2.7ROR 2.8 · calibrated p 0.685 | 2.6 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Corticosteroids: PRR 30.8 (30.8–30.8) | Labeled adverse reaction exact term | age-adj. PRR 2.6 · serious PRR 2.6 · ♀ 80% (drug 60%) | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 34,942 | 2.7 2.7–2.7ROR 2.8 · calibrated p 0.686 | 2.6 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Corticosteroids: PRR 26.2 (26.2–26.2) | Not in label — unassessed | age-adj. PRR 2.4 · serious PRR 2.3 | no trial arm names this drug |
| Arthralgia (joint pain) | 33,217 | 3.6 3.5–3.6ROR 3.8 · calibrated p 0.426 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other Corticosteroids: PRR 30.0 (30.0–30.1) | Labeled adverse reaction exact term | age-adj. PRR 3.1 · serious PRR 3.8 | no trial arm names this drug |
| Condition aggravated | 28,620 | 4.3 4.2–4.3ROR 4.5 · calibrated p 0.297 | 4.0 EB05 3.9 · IC025 +2.0 3/3 methods agree vs other Corticosteroids: PRR 22.1 (22.0–22.2) | Reporting / coding artifact | age-adj. PRR 3.7 · serious PRR 4.1 | no trial arm names this drug |
| Nausea | 28,567 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.688 | 1.5 EB05 1.5 · IC025 +0.6 vs other Corticosteroids: PRR 20.8 (20.7–20.9) | Labeled adverse reaction exact term | age-adj. PRR 1.4 · serious PRR 1.7 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 28,440 | 1.9 1.9–1.9ROR 1.9 · calibrated p 0.916 | 1.9 EB05 1.8 · IC025 +0.9 vs other Corticosteroids: PRR 21.0 (20.9–21.1) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.0 | no trial arm names this drug |
| Headache | 26,618 | 1.8 1.8–1.8ROR 1.9 · calibrated p 0.868 | 1.8 EB05 1.8 · IC025 +0.8 vs other Corticosteroids: PRR 22.7 (22.6–22.8) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.1 | no trial arm names this drug |
| Pneumonia (lung infection) | 25,118 | 3.5 3.4–3.5ROR 3.6 · calibrated p 0.465 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree vs other Corticosteroids: PRR 23.2 (23.0–23.3) | Labeled (related wording) related wording | age-adj. PRR 3.1 · serious PRR 2.4 | no trial arm names this drug |
| Rheumatoid arthritis | 24,918 | 11.6 11.5–11.8ROR 12.2 · calibrated p 0.016 ✓ | 9.2 EB05 9.1 · IC025 +3.2 3/3 methods agree vs other Corticosteroids: PRR 35.6 (35.3–35.9) | Likely indication confounding term in indications | age-adj. PRR 9.6 · serious PRR 7.8 · ♀ 88% (drug 60%) | no trial arm names this drug |
| Rash | 22,930 | 2.3 2.3–2.3ROR 2.3 · calibrated p 0.880 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Corticosteroids: PRR 18.3 (18.2–18.5) | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 2.9 · ♀ 80% (drug 60%) | no trial arm names this drug |
| Pyrexia (fever) | 21,743 | 2.7 2.7–2.8ROR 2.8 · calibrated p 0.686 | 2.6 EB05 2.6 · IC025 +1.4 3/3 methods agree vs other Corticosteroids: PRR 16.8 (16.7–17.0) | Labeled adverse reaction exact term | age-adj. PRR 2.3 · serious PRR 2.2 | no trial arm names this drug |
| Malaise (feeling unwell) | 20,933 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.994 | 2.0 EB05 2.0 · IC025 +1.0 vs other Corticosteroids: PRR 22.4 (22.2–22.6) | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 2.2 | no trial arm names this drug |
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.
- Lupus vulgaris — n=814, PRR 91.1
- Deep vein thrombosis postoperative — n=1,287, PRR 80.1
- Hand deformity — n=7,949, PRR 64.7
- Steroid dependence — n=506, PRR 61.4
- Granuloma skin — n=482, PRR 57.9
- Facet joint syndrome — n=1,801, PRR 55.5
- Adjustment disorder with depressed mood — n=1,072, PRR 47.2
- Helicobacter infection — n=5,030, PRR 40.4
- Muscle injury — n=4,043, PRR 40.2
- Dislocation of vertebra — n=1,083, PRR 39.3
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 Prednisone?
In FDA FAERS, the most frequently co-reported reaction terms for Prednisone are fatigue, pain, dyspnoea, arthralgia, nausea, 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 Prednisone have an FDA boxed warning?
No. The FDA label retrieved for Prednisone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Prednisone 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 0062fcc7-aa08-4990-9d33-d798725907f1, effective 20260908; matched on
openfda.generic_name.exact:"PREDNISONE") - PubChem CID 5865 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, 1,219 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
PREDNISONE, 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.