Drug · FAERS side-effect profile with label screen
Prednisolone Acetate side effects: what 10,281 FDA adverse event reports show
Who reports
10,281 reports · 52% serious · 552 with death outcome · 61% 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 (related wording) 2Likely indication confounding 22Reporting / coding artifact 1Not in label — unassessed 15
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.
- 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. 1,034 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 |
|---|---|---|---|---|---|---|
| Npm1 gene mutation | 10 | 6,701.8 1,844.7–24,348.3ROR 6,708.3 · χ² 13,953 / p <1e-300 | 390.0 EB05 226.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Infectious crystalline keratopathy | 13 | 1,089.0 554.7–2,138.2ROR 1,090.4 · χ² 8,474 / p <1e-300 | 346.2 EB05 215.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Infective keratitis | 10 | 335.1 171.6–654.3ROR 335.4 · χ² 2,576 / p <1e-300 | 186.0 EB05 108.0 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial data cached |
| Keratitis fungal | 24 | 272.6 178.1–417.4ROR 273.3 · χ² 5,483 / p <1e-300 | 201.8 EB05 142.7 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=24 · ♀ 33% (drug 61%) · 100% clinician | no trial data cached |
| Chimerism | 10 | 257.8 133.5–497.7ROR 258.0 · χ² 2,045 / p <1e-300 | 159.6 EB05 92.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Corneal epithelium defect | 62 | 246.8 189.7–321.1ROR 248.3 · χ² 13,302 / p <1e-300 | 206.1 EB05 166.5 · IC025 +5.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=49 · 97% clinician | no trial data cached |
| Corneal graft rejection | 20 | 219.7 138.5–348.5ROR 220.2 · χ² 3,731 / p <1e-300 | 166.9 EB05 114.1 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=19 | no trial data cached |
| Choroiditis | 33 | 196.3 137.4–280.5ROR 196.9 · χ² 5,665 / p <1e-300 | 162.3 EB05 120.9 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications | serious n=33 · ♀ 0% (drug 61%) | no trial data cached |
| Keratitis bacterial | 14 | 195.5 113.0–338.2ROR 195.7 · χ² 2,295 / p <1e-300 | 143.7 EB05 91.0 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | no trial data cached |
| Corneal infiltrates | 26 | 187.4 125.4–279.9ROR 187.8 · χ² 4,240 / p <1e-300 | 152.5 EB05 109.3 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=23 · 92% clinician | no trial data cached |
| Anterior chamber fibrin | 10 | 169.0 88.6–322.0ROR 169.1 · χ² 1,389 / p <1e-300 | 120.7 EB05 70.1 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial data cached |
| Conjunctival ulcer | 10 | 160.8 84.5–306.2ROR 161.0 · χ² 1,326 / p 1e-290 | 116.5 EB05 67.6 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial data cached |
| Necrotising scleritis | 10 | 151.2 79.5–287.4ROR 151.3 · χ² 1,251 / p 2e-274 | 111.4 EB05 64.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Corneal transplant | 49 | 138.8 103.9–185.2ROR 139.4 · χ² 6,141 / p <1e-300 | 123.7 EB05 97.3 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=38 | no trial data cached |
| Rhegmatogenous retinal detachment | 13 | 134.0 76.5–234.9ROR 134.2 · χ² 1,487 / p <1e-300 | 106.5 EB05 66.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Bronchiolitis obliterans syndrome | 10 | 128.1 67.6–242.6ROR 128.2 · χ² 1,069 / p 1e-234 | 98.4 EB05 57.1 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial data cached |
| Corneal thinning | 15 | 127.8 75.9–215.3ROR 128.0 · χ² 1,657 / p <1e-300 | 104.6 EB05 67.3 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | no trial data cached |
| Toxic anterior segment syndrome | 62 | 123.1 95.3–158.9ROR 123.8 · χ² 6,959 / p <1e-300 | 112.1 EB05 90.6 · IC025 +5.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=60 · 92% clinician | no trial data cached |
| Corneal scar | 26 | 112.7 75.9–167.2ROR 112.9 · χ² 2,620 / p <1e-300 | 99.2 EB05 71.1 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | no trial data cached |
| Anterior chamber cell | 36 | 107.2 76.7–149.9ROR 107.6 · χ² 3,497 / p <1e-300 | 96.8 EB05 73.0 · IC025 +4.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=35 · 94% clinician | no trial data cached |
| Corneal opacity | 62 | 97.4 75.5–125.6ROR 98.0 · χ² 5,550 / p <1e-300 | 90.4 EB05 73.1 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=49 · 93% clinician | no trial data cached |
| Hypotony of eye | 19 | 97.0 61.2–153.6ROR 97.1 · χ² 1,631 / p <1e-300 | 84.9 EB05 57.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Corneal deposits | 33 | 95.6 67.5–135.5ROR 95.9 · χ² 2,859 / p <1e-300 | 86.9 EB05 64.7 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=23 | no trial data cached |
| Hypopyon | 35 | 89.5 63.8–125.5ROR 89.8 · χ² 2,849 / p <1e-300 | 82.0 EB05 61.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=35 · 91% clinician | no trial data cached |
| Corneal oedema | 91 | 86.1 69.9–106.2ROR 86.9 · χ² 7,262 / p <1e-300 | 81.3 EB05 68.2 · IC025 +5.5 3/3 methods agree | Likely indication confounding term in indications | serious n=72 | no trial data cached |
| Scleral disorder | 11 | 86.1 47.1–157.3ROR 86.1 · χ² 807 / p 8e-178 | 72.6 EB05 43.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Punctate keratitis | 35 | 84.2 60.1–118.0ROR 84.5 · χ² 2,682 / p <1e-300 | 77.5 EB05 58.3 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=28 · ♀ 81% (drug 61%) · 100% clinician | no trial data cached |
| Periorbital pain | 29 | 76.4 52.8–110.7ROR 76.6 · χ² 2,007 / p <1e-300 | 70.4 EB05 51.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | ♀ 90% (drug 61%) · 100% consumer | no trial data cached |
| Corneal perforation | 20 | 67.8 43.4–105.8ROR 67.9 · χ² 1,210 / p 2e-265 | 61.9 EB05 42.3 · IC025 +3.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=20 | no trial data cached |
| Cataract subcapsular | 19 | 65.6 41.6–103.6ROR 65.8 · χ² 1,109 / p 2e-243 | 60.0 EB05 40.6 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | no trial data cached |
| Fibrous histiocytoma | 11 | 65.0 35.7–118.5ROR 65.1 · χ² 611 / p 3e-135 | 57.1 EB05 34.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Hyphaema | 16 | 64.1 39.0–105.4ROR 64.2 · χ² 903 / p 1e-198 | 58.1 EB05 37.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Endophthalmitis | 181 | 63.4 54.8–73.4ROR 64.5 · χ² 10,723 / p <1e-300 | 61.1 EB05 54.0 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=179 · ♀ 38% (drug 61%) | no trial data cached |
| Corneal disorder | 65 | 62.9 49.2–80.4ROR 63.3 · χ² 3,779 / p <1e-300 | 60.0 EB05 48.7 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications | serious n=47 | no trial data cached |
| Eye infection fungal | 11 | 60.9 33.5–111.0ROR 61.0 · χ² 572 / p 8e-127 | 54.0 EB05 32.1 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Eyelid pain | 56 | 60.6 46.5–79.0ROR 60.9 · χ² 3,127 / p <1e-300 | 57.7 EB05 46.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | 100% consumer | no trial data cached |
| Iris adhesions | 14 | 58.0 34.1–98.7ROR 58.1 · χ² 708 / p 2e-156 | 52.6 EB05 33.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Injury corneal | 14 | 56.7 33.4–96.5ROR 56.8 · χ² 692 / p 7e-153 | 51.6 EB05 32.7 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=9 | no trial data cached |
| Foreign body in eye | 25 | 55.3 37.2–82.2ROR 55.4 · χ² 1,245 / p 5e-273 | 51.8 EB05 36.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Product dropper issue | 21 | 55.1 35.7–85.0ROR 55.2 · χ² 1,034 / p 4e-227 | 51.3 EB05 35.4 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | – | 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 | 1,264 | 31.9 30.3–33.6ROR 36.2 · χ² 37,323 / p <1e-300 | 31.4 EB05 30.0 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 · 73% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 932 | 1.4 1.4–1.5ROR 1.5 · χ² 135 / p 2e-31 | 1.4 EB05 1.4 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Eye pain | 722 | 27.0 25.1–29.0ROR 29.0 · χ² 17,853 / p <1e-300 | 26.6 EB05 25.0 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 22.0 | no trial data cached |
| Off label use (used outside approved label) | 689 | 1.6 1.5–1.7ROR 1.7 · χ² 169 / p 5e-39 | 1.6 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | serious PRR 2.2 | no trial data cached |
| Vision blurred (blurred vision) | 403 | 6.0 5.5–6.6ROR 6.2 · χ² 1,691 / p <1e-300 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Eye irritation | 392 | 14.4 13.1–15.9ROR 15.0 · χ² 4,864 / p <1e-300 | 14.3 EB05 13.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 15.8 | no trial data cached |
| Fatigue (tiredness) | 375 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.385 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.4 | no trial data cached |
| Headache | 363 | 1.2 1.1–1.3ROR 1.2 · χ² 10 / p 7e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Ocular hyperaemia | 301 | 13.2 11.8–14.8ROR 13.6 · χ² 3,371 / p <1e-300 | 13.1 EB05 11.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 | no trial data cached |
| Diarrhoea (diarrhea) | 295 | 0.9 0.8–1.0ROR 0.9 · χ² 1 / p 0.126 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Pain | 281 | 0.9 0.8–1.0ROR 0.9 · χ² 1 / p 0.117 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Cataract | 278 | 9.6 8.5–10.8ROR 9.8 · χ² 2,128 / p <1e-300 | 9.5 EB05 8.6 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.8 | no trial data cached |
| Condition aggravated | 274 | 1.9 1.6–2.1ROR 1.9 · χ² 108 / p 2e-25 | 1.8 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Nausea | 269 | 0.7 0.6–0.8ROR 0.7 · χ² 37 / p 6e-10 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
| Dyspnoea (shortness of breath) | 269 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.314 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.3 | 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.
- Hypopyon — n=35, PRR 89.5
- Periorbital pain — n=29, PRR 76.4
- Endophthalmitis — n=181, PRR 63.4
- Eyelid pain — n=56, PRR 60.6
- Foreign body in eye — n=25, PRR 55.3
✓ 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 eye pain, vision blurred, eye irritation, fatigue, headache, ocular hyperaemia. 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, 1,074 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.