Drug · FAERS side-effect profile with label screen
Prednisolone Sodium Phosphate side effects: what 2,446 FDA adverse event reports show
Who reports
2,446 reports · 87% serious · 461 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Prednisolone Oral Solution USP is 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 mineralocorticoids where applicable: in infancy mineralocorticoid supplementation is of particular importance).
FDA label, Indications and Usage
What it is
DESCRIPTION Prednisolone Oral Solution USP contains prednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone is a white to practically white, odorless, crystalline powder.
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 adverse reaction 2Labeled (related wording) 2Likely indication confounding 6Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 27
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 121 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 |
|---|---|---|---|---|---|---|
| Acute hepatic failure | 75 | 47.5 38.0–59.4ROR 49.0 · χ² 3,354 / p <1e-300 | 46.8 EB05 38.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 31.2 · ♀ 92% (drug 56%) · 91% clinician | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 69 | 46.3 36.7–58.5ROR 47.6 · χ² 2,999 / p <1e-300 | 45.5 EB05 37.2 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious PRR 43.6 · ♀ 10% (drug 56%) | no trial data cached |
| Coeliac disease | 44 | 38.6 28.8–51.8ROR 39.3 · χ² 1,567 / p <1e-300 | 37.8 EB05 29.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 31.5 · ♀ 100% (drug 56%) · 98% clinician | no trial data cached |
| Uveitis | 60 | 38.2 29.8–49.1ROR 39.2 · χ² 2,131 / p <1e-300 | 37.7 EB05 30.3 · IC025 +4.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 26.7 · ♀ 5% (drug 56%) | no trial data cached |
| Bursitis | 53 | 37.8 29.0–49.4ROR 38.6 · χ² 1,856 / p <1e-300 | 37.2 EB05 29.5 · IC025 +4.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 29.2 · ♀ 98% (drug 56%) · 96% clinician | no trial data cached |
| Affect lability | 32 | 28.5 20.2–40.2ROR 28.8 · χ² 818 / p 3e-180 | 28.0 EB05 20.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 · ♀ 93% (drug 56%) | no trial data cached |
| Immunodeficiency | 48 | 28.0 21.2–37.1ROR 28.6 · χ² 1,221 / p 9e-268 | 27.7 EB05 21.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 20.0 · ♀ 93% (drug 56%) · 94% clinician | no trial data cached |
| Motor dysfunction | 31 | 26.3 18.6–37.4ROR 26.7 · χ² 729 / p 8e-161 | 25.9 EB05 19.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 21.8 · ♀ 100% (drug 56%) | no trial data cached |
| Muscle spasticity | 35 | 24.3 17.4–33.7ROR 24.6 · χ² 756 / p 1e-166 | 23.9 EB05 18.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 22.8 · ♀ 100% (drug 56%) | no trial data cached |
| Lower limb fracture | 52 | 23.4 17.9–30.6ROR 23.9 · χ² 1,091 / p 2e-239 | 23.2 EB05 18.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 · ♀ 98% (drug 56%) | no trial data cached |
| Prescribed overdose | 52 | 23.1 17.6–30.2ROR 23.6 · χ² 1,075 / p 4e-236 | 22.9 EB05 18.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 25.9 · ♀ 100% (drug 56%) · 96% clinician | no trial data cached |
| Bedridden | 33 | 21.6 15.4–30.3ROR 21.9 · χ² 627 / p 1e-138 | 21.3 EB05 15.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 17.3 · ♀ 100% (drug 56%) | no trial data cached |
| Contraindicated product administered | 74 | 21.1 16.8–26.4ROR 21.7 · χ² 1,394 / p <1e-300 | 20.9 EB05 17.2 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 17.0 · ♀ 94% (drug 56%) · 92% clinician | no trial data cached |
| Sinus congestion | 31 | 19.7 13.9–27.9ROR 19.9 · χ² 530 / p 1e-117 | 19.4 EB05 14.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 100% (drug 56%) | no trial data cached |
| Coordination abnormal | 32 | 19.6 13.9–27.6ROR 19.8 · χ² 545 / p 1e-120 | 19.3 EB05 14.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 17.3 · ♀ 94% (drug 56%) | no trial data cached |
| Skin haemorrhage | 30 | 17.9 12.5–25.5ROR 18.1 · χ² 460 / p 2e-102 | 17.6 EB05 12.8 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=30 · ♀ 100% (drug 56%) | no trial data cached |
| Visual acuity reduced | 69 | 17.7 14.0–22.3ROR 18.2 · χ² 1,070 / p 6e-235 | 17.6 EB05 14.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.7 · ♀ 13% (drug 56%) | no trial data cached |
| Hemiparesis | 33 | 16.6 11.8–23.3ROR 16.8 · χ² 469 / p 3e-104 | 16.4 EB05 12.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · ♀ 100% (drug 56%) | no trial data cached |
| Respiratory tract congestion | 30 | 16.2 11.3–23.1ROR 16.4 · χ² 412 / p 6e-92 | 15.9 EB05 11.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 24.6 · ♀ 100% (drug 56%) | no trial data cached |
| Treatment failure | 154 | 16.1 13.8–18.8ROR 17.1 · χ² 2,172 / p <1e-300 | 16.0 EB05 14.0 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 10.1 · ♀ 78% (drug 56%) | no trial data cached |
| Angina pectoris | 51 | 15.2 11.6–19.9ROR 15.5 · χ² 661 / p 4e-146 | 15.0 EB05 11.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 · ♀ 89% (drug 56%) | no trial data cached |
| Cytomegalovirus infection | 29 | 15.0 10.4–21.5ROR 15.1 · χ² 364 / p 2e-81 | 14.6 EB05 10.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · 100% clinician | no trial data cached |
| Foot fracture | 33 | 14.9 10.6–20.9ROR 15.1 · χ² 414 / p 3e-92 | 14.6 EB05 10.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · ♀ 100% (drug 56%) | no trial data cached |
| Sleep disorder due to a general medical condition | 27 | 14.3 9.8–20.9ROR 14.5 · χ² 321 / p 4e-72 | 13.9 EB05 9.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.7 | no trial data cached |
| Wheezing | 97 | 14.1 11.6–17.1ROR 14.6 · χ² 1,167 / p 5e-256 | 14.0 EB05 11.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 · ♀ 86% (drug 56%) | no trial data cached |
| Flank pain | 15 | 13.8 8.3–22.8ROR 13.8 · χ² 165 / p 5e-38 | 12.7 EB05 7.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 | no trial data cached |
| Pneumocystis jirovecii pneumonia | 16 | 13.7 8.4–22.4ROR 13.8 · χ² 176 / p 2e-40 | 12.8 EB05 7.7 · IC025 +2.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.1 | no trial data cached |
| Sinus disorder | 31 | 13.4 9.5–19.0ROR 13.6 · χ² 344 / p 5e-77 | 13.0 EB05 9.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.4 · ♀ 100% (drug 56%) | no trial data cached |
| Joint range of motion decreased | 20 | 12.8 8.3–19.9ROR 12.9 · χ² 207 / p 4e-47 | 12.1 EB05 7.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 · 95% clinician | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 66 | 12.3 9.7–15.6ROR 12.6 · χ² 673 / p 1e-148 | 12.1 EB05 9.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 · ♀ 97% (drug 56%) | no trial data cached |
| Pemphigus | 17 | 11.7 7.3–18.9ROR 11.8 · χ² 156 / p 4e-36 | 10.6 EB05 6.5 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications | serious PRR 7.7 | no trial data cached |
| Eating disorder | 29 | 11.6 8.1–16.7ROR 11.8 · χ² 272 / p 3e-61 | 11.1 EB05 7.8 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.7 · ♀ 100% (drug 56%) | no trial data cached |
| Sneezing | 30 | 11.5 8.1–16.4ROR 11.6 · χ² 278 / p 1e-62 | 10.9 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 · ♀ 100% (drug 56%) | no trial data cached |
| Oedema | 69 | 10.9 8.7–13.8ROR 11.2 · χ² 614 / p 7e-136 | 10.7 EB05 8.6 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.9 · ♀ 95% (drug 56%) · 97% clinician | no trial data cached |
| Eye pain | 70 | 10.9 8.6–13.7ROR 11.2 · χ² 619 / p 6e-137 | 10.6 EB05 8.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 · ♀ 12% (drug 56%) | no trial data cached |
| Loss of personal independence in daily activities | 59 | 10.6 8.3–13.7ROR 10.9 · χ² 507 / p 2e-112 | 10.3 EB05 8.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · ♀ 84% (drug 56%) | no trial data cached |
| Asthma | 133 | 10.2 8.6–12.0ROR 10.7 · χ² 1,097 / p 9e-241 | 10.0 EB05 8.7 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 9.1 · ♀ 91% (drug 56%) | no trial data cached |
| Helicobacter infection | 12 | 10.1 5.7–17.8ROR 10.1 · χ² 89 / p 2e-21 | 8.3 EB05 4.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Osteoporosis | 48 | 10.0 7.6–13.2ROR 10.2 · χ² 380 / p 6e-85 | 9.6 EB05 7.4 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 · ♀ 94% (drug 56%) | no trial data cached |
| Fracture | 22 | 10.0 6.6–15.1ROR 10.1 · χ² 169 / p 7e-39 | 9.0 EB05 6.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 · ♀ 100% (drug 56%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Treatment failure | 154 | 16.1 13.8–18.8ROR 17.1 · χ² 2,172 / p <1e-300 | 16.0 EB05 14.0 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 10.1 · ♀ 78% (drug 56%) | no trial data cached |
| Asthma | 133 | 10.2 8.6–12.0ROR 10.7 · χ² 1,097 / p 9e-241 | 10.0 EB05 8.7 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 9.1 · ♀ 91% (drug 56%) | no trial data cached |
| Hypersensitivity (allergic reaction) | 128 | 5.9 5.0–7.0ROR 6.2 · χ² 523 / p 4e-116 | 5.8 EB05 5.0 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 7.0 | no trial data cached |
| Rheumatoid arthritis | 126 | 9.6 8.1–11.3ROR 10.0 · χ² 962 / p 2e-211 | 9.4 EB05 8.1 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 7.7 · ♀ 98% (drug 56%) · 90% clinician | no trial data cached |
| Drug hypersensitivity | 109 | 4.8 4.0–5.8ROR 5.0 · χ² 328 / p 1e-73 | 4.7 EB05 4.0 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 8.5 · ♀ 99% (drug 56%) · 92% clinician | no trial data cached |
| Product use issue | 101 | 4.6 3.8–5.6ROR 4.8 · χ² 287 / p 1e-64 | 4.5 EB05 3.8 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 · 92% clinician | no trial data cached |
| Wheezing | 97 | 14.1 11.6–17.1ROR 14.6 · χ² 1,167 / p 5e-256 | 14.0 EB05 11.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 · ♀ 86% (drug 56%) | no trial data cached |
| Acute hepatic failure | 75 | 47.5 38.0–59.4ROR 49.0 · χ² 3,354 / p <1e-300 | 46.8 EB05 38.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 31.2 · ♀ 92% (drug 56%) · 91% clinician | no trial data cached |
| Nasopharyngitis (common cold) | 74 | 3.4 2.7–4.3ROR 3.5 · χ² 126 / p 1e-29 | 3.4 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · ♀ 91% (drug 56%) | no trial data cached |
| Psoriasis | 74 | 4.9 3.9–6.1ROR 5.0 · χ² 224 / p 6e-51 | 4.7 EB05 3.9 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 8.6 · ♀ 100% (drug 56%) · 93% clinician | no trial data cached |
| Contraindicated product administered | 74 | 21.1 16.8–26.4ROR 21.7 · χ² 1,394 / p <1e-300 | 20.9 EB05 17.2 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 17.0 · ♀ 94% (drug 56%) · 92% clinician | no trial data cached |
| Drug intolerance | 70 | 6.2 5.0–7.9ROR 6.4 · χ² 304 / p 2e-68 | 6.0 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 · ♀ 100% (drug 56%) | no trial data cached |
| Eye pain | 70 | 10.9 8.6–13.7ROR 11.2 · χ² 619 / p 6e-137 | 10.6 EB05 8.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 · ♀ 12% (drug 56%) | no trial data cached |
| Oedema | 69 | 10.9 8.7–13.8ROR 11.2 · χ² 614 / p 7e-136 | 10.7 EB05 8.6 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.9 · ♀ 95% (drug 56%) · 97% clinician | no trial data cached |
| Visual acuity reduced | 69 | 17.7 14.0–22.3ROR 18.2 · χ² 1,070 / p 6e-235 | 17.6 EB05 14.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.7 · ♀ 13% (drug 56%) | no trial data cached |
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.
- Acute hepatic failure — n=75, PRR 47.5
- Coeliac disease — n=44, PRR 38.6
- Affect lability — n=32, PRR 28.5
- Immunodeficiency — n=48, PRR 28.0
- Motor dysfunction — n=31, PRR 26.3
- Muscle spasticity — n=35, PRR 24.3
- Lower limb fracture — n=52, PRR 23.4
- Prescribed overdose — n=52, PRR 23.1
- Bedridden — n=33, PRR 21.6
- Sinus congestion — n=31, PRR 19.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Corticosteroids (prednisolone) ↔ Avascular necrosis of bone.
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 Prednisolone?
In FDA FAERS, the most frequently co-reported reaction terms for Prednisolone are asthma, hypersensitivity, rheumatoid arthritis, drug hypersensitivity, wheezing, acute hepatic failure. 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 Prednisolone have an FDA boxed warning?
No. The FDA label retrieved for Prednisolone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Prednisolone 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 35f0b197-c3ae-445a-8da7-9ffcd4472e05, effective 20260123; matched on
openfda.generic_name.exact:"PREDNISOLONE") - 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, 161 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
Page generated 2026-10-08. 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.