Drug · FAERS side-effect profile with label screen

Cortisone side effects: what 12,273 FDA adverse event reports show

Cortisone Acetate · 1,006 reaction terms · 369,737 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Cortisone Acetate (Cortisone Acetate)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

12,273 reports · 96% serious · 3,750 with death outcome · 91% female

openFDA FAERS counts, all years, deduplication not applied

Used for

When oral therapy is not feasible: 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). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2.

FDA label, Indications and Usage

What it is

DESCRIPTION: Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Cortisone acetate is a white or practically white, odorless, crystalline powder. It is stable in air. It is insoluble in water.

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 1Labeled (related wording) 1Likely indication confounding 7Reporting / coding artifact 1Lab value / disease marker 7Not in label — unassessed 23

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, 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). 966 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Anti-cyclic citrullinated peptide antibody	420	2,960.9 2,528.6–3,467.1ROR 3,065.8 · calibrated p 3e-23 ✓	1,023.9 EB05 944.3 · IC025 +8.7 3/3 methods agree	Lab value / disease marker	serious n=420 · 95% clinician	no trial arm names this drug
Swollen joint count increased	1,783	2,318.0 2,162.8–2,484.4ROR 2,711.8 · calibrated p 8e-23 ✓	966.1 EB05 929.0 · IC025 +9.5 3/3 methods agree	Lab value / disease marker	serious n=1,782 · 95% clinician	no trial arm names this drug
Rheumatic fever	2,431	2,177.6 2,055.8–2,306.5ROR 2,715.1 · calibrated p 8e-23 ✓	943.3 EB05 912.3 · IC025 +9.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=2,430 · 94% clinician	no trial arm names this drug
Anti-cyclic citrullinated peptide antibody positive	3,897	2,105.9 2,015.9–2,199.8ROR 3,085.0 · calibrated p 1e-23 ✓	932.2 EB05 907.9 · IC025 +9.7 3/3 methods agree	Lab value / disease marker	serious PRR 565.6 · 92% clinician	no trial arm names this drug
Deep vein thrombosis postoperative	1,016	1,860.7 1,704.9–2,030.7ROR 2,028.5 · calibrated p 4e-21 ✓	870.1 EB05 826.1 · IC025 +9.2 3/3 methods agree	Not in label — unassessed	serious n=1,016 · 93% clinician	no trial arm names this drug
Lupus vulgaris	611	1,825.3 1,630.2–2,043.8ROR 1,920.9 · calibrated p 1e-20 ✓	853.1 EB05 797.8 · IC025 +8.9 3/3 methods agree	Not in label — unassessed	serious n=611 · 96% clinician	no trial arm names this drug
C-reactive protein	464	1,809.7 1,589.3–2,060.6ROR 1,880.8 · calibrated p 1e-20 ✓	842.5 EB05 780.1 · IC025 +8.7 3/3 methods agree	Lab value / disease marker	serious n=464 · 96% clinician	no trial arm names this drug
Pemphigus	6,161	1,699.2 1,648.0–1,752.1ROR 3,410.8 · calibrated p 3e-24 ✓	844.3 EB05 826.7 · IC025 +9.6 3/3 methods agree	Likely indication confounding term in indications	serious PRR 511.2	no trial arm names this drug
Rheumatoid factor positive	2,806	1,636.5 1,558.5–1,718.4ROR 2,121.2 · calibrated p 2e-21 ✓	825.9 EB05 800.6 · IC025 +9.4 3/3 methods agree	Lab value / disease marker	serious n=2,804 · 93% clinician	no trial arm names this drug
Duodenal ulcer perforation	3,437	1,520.3 1,457.0–1,586.5ROR 2,111.3 · calibrated p 2e-21 ✓	796.1 EB05 774.0 · IC025 +9.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 480.9 · 93% clinician	no trial arm names this drug
Facet joint syndrome	1,354	1,297.7 1,211.6–1,389.9ROR 1,458.5 · calibrated p 3e-19 ✓	725.9 EB05 694.1 · IC025 +9.1 3/3 methods agree	Not in label — unassessed	serious n=1,354 · 94% clinician	no trial arm names this drug
Hand deformity	5,139	1,113.8 1,080.4–1,148.3ROR 1,915.3 · calibrated p 8e-21 ✓	669.3 EB05 654.0 · IC025 +9.3 3/3 methods agree	Not in label — unassessed	serious PRR 439.3 · 92% clinician	no trial arm names this drug
Helicobacter infection	3,453	880.3 848.2–913.6ROR 1,224.5 · calibrated p 2e-18 ✓	576.7 EB05 560.7 · IC025 +9.0 3/3 methods agree	Not in label — unassessed	serious PRR 368.1 · 93% clinician	no trial arm names this drug
Adjustment disorder with depressed mood	635	789.6 719.8–866.2ROR 832.6 · calibrated p 2e-16 ✓	529.3 EB05 495.7 · IC025 +8.4 3/3 methods agree	Not in label — unassessed	serious n=635 · 95% clinician	no trial arm names this drug
Swollen joint count	75	752.2 573.3–986.9ROR 756.8 · calibrated p 2e-15 ✓	459.1 EB05 378.3 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious n=75 · 95% clinician	no trial arm names this drug
Retinitis	478	688.4 619.8–764.5ROR 716.2 · calibrated p 1e-15 ✓	479.6 EB05 444.5 · IC025 +8.2 3/3 methods agree	Likely indication confounding term in indications	serious n=478 · 96% clinician	no trial arm names this drug
Hepatic enzyme	40	687.7 476.3–993.0ROR 690.0 · calibrated p 1e-14 ✓	395.9 EB05 303.2 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=40 · 100% clinician	no trial arm names this drug
Dislocation of vertebra	608	645.1 588.5–707.1ROR 678.7 · calibrated p 2e-15 ✓	460.0 EB05 430.1 · IC025 +8.3 3/3 methods agree	Not in label — unassessed	serious n=608 · 94% clinician	no trial arm names this drug
Pericarditis	4,474	629.6 611.3–648.4ROR 990.2 · calibrated p 3e-17 ✓	457.7 EB05 446.6 · IC025 +8.7 3/3 methods agree	Not in label — unassessed	serious PRR 278.4 · 93% clinician	no trial arm names this drug
Muscle injury	2,148	608.0 580.6–636.6ROR 736.7 · calibrated p 8e-16 ✓	445.2 EB05 429.7 · IC025 +8.6 3/3 methods agree	Not in label — unassessed	serious PRR 291.6 · 94% clinician	no trial arm names this drug
X-ray abnormal	454	584.8 526.4–649.8ROR 607.2 · calibrated p 8e-15 ✓	426.6 EB05 394.6 · IC025 +8.0 3/3 methods agree	Lab value / disease marker	serious n=454 · 96% clinician	no trial arm names this drug
Glossodynia (burning tongue/mouth pain)	5,549	566.1 552.3–580.3ROR 1,032.4 · calibrated p 2e-17 ✓	423.4 EB05 414.1 · IC025 +8.6 3/3 methods agree	Not in label — unassessed	serious PRR 369.5 · 92% clinician	no trial arm names this drug
Synovitis	4,441	559.6 543.6–576.1ROR 876.3 · calibrated p 1e-16 ✓	419.6 EB05 409.3 · IC025 +8.6 3/3 methods agree	Likely indication confounding term in indications	serious PRR 265.0 · 93% clinician	no trial arm names this drug
Seronegative arthritis	273	550.9 481.1–630.8ROR 563.4 · calibrated p 2e-14 ✓	403.6 EB05 365.0 · IC025 +7.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=273 · 95% clinician	no trial arm names this drug
Peripheral venous disease	951	535.7 499.1–575.0ROR 580.6 · calibrated p 1e-14 ✓	403.4 EB05 382.3 · IC025 +8.3 3/3 methods agree	Not in label — unassessed	serious n=951 · 95% clinician	no trial arm names this drug
Sleep disorder due to general medical condition, insomnia type	1,503	521.9 494.0–551.5ROR 594.6 · calibrated p 9e-15 ✓	396.7 EB05 380.2 · IC025 +8.4 3/3 methods agree	Not in label — unassessed	serious n=1,503 · 94% clinician	no trial arm names this drug
Folliculitis	2,393	516.8 495.4–539.1ROR 641.7 · calibrated p 4e-15 ✓	394.5 EB05 381.4 · IC025 +8.4 3/3 methods agree	Not in label — unassessed	serious PRR 280.1 · 93% clinician	no trial arm names this drug
Grip strength	51	482.8 353.8–658.7ROR 484.8 · calibrated p 3e-13 ✓	329.1 EB05 260.0 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=51 · 92% clinician	no trial arm names this drug
C-reactive protein abnormal	1,294	433.5 408.8–459.6ROR 484.4 · calibrated p 8e-14 ✓	343.2 EB05 327.8 · IC025 +8.2 3/3 methods agree	Lab value / disease marker	serious n=1,294 · 94% clinician	no trial arm names this drug
Hypocholesterolaemia	61	423.0 319.6–559.7ROR 425.1 · calibrated p 8e-13 ✓	305.8 EB05 246.7 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=61 · 97% clinician	no trial arm names this drug
Wound	4,979	373.5 364.3–383.0ROR 627.8 · calibrated p 5e-15 ✓	305.6 EB05 298.5 · IC025 +8.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 299.3 · serious PRR 219.3 · 92% clinician	no trial arm names this drug
Systemic lupus erythematosus	6,277	369.3 361.7–377.1ROR 754.9 · calibrated p 6e-16 ✓	302.8 EB05 296.6 · IC025 +8.2 3/3 methods agree	Likely indication confounding term in indications	age-adj. PRR 280.1 · serious PRR 187.3	no trial arm names this drug
Breast cancer stage iii	1,055	335.6 314.9–357.7ROR 367.1 · calibrated p 1e-12 ✓	278.6 EB05 264.8 · IC025 +7.8 3/3 methods agree	Not in label — unassessed	serious n=1,055 · 95% clinician	no trial arm names this drug
Polyglandular disorder	11	331.0 173.4–631.5ROR 331.3 · calibrated p 2e-10 ✓	187.4 EB05 111.6 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Onychomadesis	643	313.3 288.5–340.2ROR 330.6 · calibrated p 4e-12 ✓	262.3 EB05 245.7 · IC025 +7.6 3/3 methods agree	Not in label — unassessed	serious n=643 · 91% clinician	no trial arm names this drug
Ankle arthroplasty	55	309.9 232.6–413.0ROR 311.3 · calibrated p 2e-11 ✓	240.1 EB05 191.4 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=55 · 100% clinician	no trial arm names this drug
Cerebral salt-wasting syndrome	15	304.5 175.7–527.6ROR 304.9 · calibrated p 2e-10 ✓	194.5 EB05 125.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Contraindicated product administered	4,543	303.4 295.6–311.5ROR 481.2 · calibrated p 8e-14 ✓	257.0 EB05 250.8 · IC025 +7.9 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 246.9 · serious PRR 192.9 · 91% clinician	no trial arm names this drug
Sleep disorder due to general medical condition, hypersomnia type	15	300.9 173.7–521.0ROR 301.2 · calibrated p 2e-10 ✓	193.0 EB05 124.2 · IC025 +3.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=15	no trial arm names this drug
Lip dry	1,339	300.6 284.4–317.7ROR 337.3 · calibrated p 3e-12 ✓	254.3 EB05 243.1 · IC025 +7.8 3/3 methods agree	Not in label — unassessed	serious n=1,339 · 95% clinician	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
Liver injury	5,118	29.528.9–30.1	signal
Interstitial lung disease	992	17.816.8–18.9	signal
Hyperglycaemia / diabetes	2,814	14.013.6–14.5	signal
Serious infection	3,436	7.67.4–7.9	signal
Depression	1,123	6.86.5–7.2	signal
Pancreatitis	139	2.92.5–3.5	signal
Osteonecrosis	86	2.52.1–3.1	signal
Arrhythmia / qt	234	2.11.8–2.3	raised
Fall / fracture	442	2.01.8–2.2	raised
Gi bleeding	182	1.71.5–2.0	raised
Thrombocytopenia	194	1.51.3–1.7	raised
Anaphylaxis / angioedema	101	1.41.1–1.7	raised
Rhabdomyolysis / myopathy	65	1.41.1–1.7	raised
Tendon disorder	25	1.10.8–1.7	no difference
Severe cutaneous reaction	36	0.80.6–1.1	no difference
Venous thromboembolism	87	0.70.6–0.8	lower than other drugs

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Cortisone only as a background or rescue medication (NCT02883049, NCT00075725); 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
Systemic lupus erythematosus	6,277	369.3 361.7–377.1ROR 754.9 · calibrated p 6e-16 ✓	302.8 EB05 296.6 · IC025 +8.2 3/3 methods agree	Likely indication confounding term in indications	age-adj. PRR 280.1 · serious PRR 187.3	no trial arm names this drug
Pain	6,211	17.4 17.1–17.7ROR 34.2 · calibrated p 1e-4 ✓	17.2 EB05 16.9 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	age-adj. PRR 13.8 · serious PRR 16.4	no trial arm names this drug
Pemphigus	6,161	1,699.2 1,648.0–1,752.1ROR 3,410.8 · calibrated p 3e-24 ✓	844.3 EB05 826.7 · IC025 +9.6 3/3 methods agree	Likely indication confounding term in indications	serious PRR 511.2	no trial arm names this drug
Drug ineffective (drug did not work)	6,130	8.0 7.8–8.1ROR 15.0 · calibrated p 0.007 ✓	8.0 EB05 7.8 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 8.3 · serious PRR 13.4	no trial arm names this drug
Alopecia (hair loss)	6,061	54.3 53.3–55.3ROR 106.3 · calibrated p 7e-8 ✓	52.6 EB05 51.5 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	age-adj. PRR 40.4 · serious PRR 67.8	no trial arm names this drug
Rheumatoid arthritis	6,021	96.1 94.3–97.9ROR 187.7 · calibrated p 7e-10 ✓	90.9 EB05 89.0 · IC025 +6.5 3/3 methods agree	Likely indication confounding term in indications	age-adj. PRR 72.3 · serious PRR 67.0	no trial arm names this drug
Abdominal discomfort	5,958	63.1 62.0–64.3ROR 121.8 · calibrated p 2e-8 ✓	60.9 EB05 59.6 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	age-adj. PRR 50.1 · serious PRR 82.3	no trial arm names this drug
Fatigue (tiredness)	5,673	12.6 12.3–12.8ROR 22.5 · calibrated p 0.001 ✓	12.5 EB05 12.2 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	age-adj. PRR 10.1 · serious PRR 14.3 · 90% clinician	no trial arm names this drug
Glossodynia (burning tongue/mouth pain)	5,549	566.1 552.3–580.3ROR 1,032.4 · calibrated p 2e-17 ✓	423.4 EB05 414.1 · IC025 +8.6 3/3 methods agree	Not in label — unassessed	serious PRR 369.5 · 92% clinician	no trial arm names this drug
Swelling	5,415	105.2 103.0–107.4ROR 187.4 · calibrated p 7e-10 ✓	99.0 EB05 96.8 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	age-adj. PRR 82.2 · serious PRR 96.7 · 92% clinician	no trial arm names this drug
Hand deformity	5,139	1,113.8 1,080.4–1,148.3ROR 1,915.3 · calibrated p 8e-21 ✓	669.3 EB05 654.0 · IC025 +9.3 3/3 methods agree	Not in label — unassessed	serious PRR 439.3 · 92% clinician	no trial arm names this drug
Wound	4,979	373.5 364.3–383.0ROR 627.8 · calibrated p 5e-15 ✓	305.6 EB05 298.5 · IC025 +8.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 299.3 · serious PRR 219.3 · 92% clinician	no trial arm names this drug
Rash	4,954	19.7 19.3–20.2ROR 32.4 · calibrated p 2e-4 ✓	19.5 EB05 19.1 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	age-adj. PRR 17.6 · serious PRR 26.2 · 92% clinician	no trial arm names this drug
Arthropathy	4,802	161.0 157.2–164.9ROR 263.9 · calibrated p 3e-11 ✓	147.0 EB05 143.5 · IC025 +7.1 3/3 methods agree	Not in label — unassessed	age-adj. PRR 141.6 · serious PRR 107.9 · 92% clinician	no trial arm names this drug
Contraindicated product administered	4,543	303.4 295.6–311.5ROR 481.2 · calibrated p 8e-14 ✓	257.0 EB05 250.8 · IC025 +7.9 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 246.9 · serious PRR 192.9 · 91% clinician	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.

Deep vein thrombosis postoperative — n=1,016, PRR 1,860.7
Lupus vulgaris — n=611, PRR 1,825.3
Facet joint syndrome — n=1,354, PRR 1,297.7
Hand deformity — n=5,139, PRR 1,113.8
Helicobacter infection — n=3,453, PRR 880.3
Adjustment disorder with depressed mood — n=635, PRR 789.6
Swollen joint count — n=75, PRR 752.2
Hepatic enzyme — n=40, PRR 687.7
Dislocation of vertebra — n=608, PRR 645.1
Pericarditis — n=4,474, PRR 629.6

✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.

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 Cortisone?

In FDA FAERS, the most frequently co-reported reaction terms for Cortisone are systemic lupus erythematosus, pain, pemphigus, alopecia, rheumatoid arthritis, abdominal discomfort. 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 Cortisone have an FDA boxed warning?

No. The FDA label retrieved for Cortisone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Cortisone 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 cc158d11-f356-4696-8b73-5d2681dcbcf2, effective 20250606; matched on openfda.generic_name.exact:"CORTISONE ACETATE")
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, field patient.drug.openfda.generic_name.exact, 1,006 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 CORTISONE, 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.