Causality assessment · Expected pharmacological effect

Corticosteroids (prednisolone) and Hyperglycaemia / steroid diabetes: is the FAERS signal real?

n=1,068 co-reports · PRR 3.5 · ROR 3.5

A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.

Expected pharmacological effect

Corticosteroids (prednisolone) ↔ Hyperglycaemia / steroid diabetes

n=1,068 co-reports · PRR 3.5 · ROR 3.5

Glucocorticoids such as prednisolone raise blood glucose by increasing liver glucose output and reducing peripheral insulin sensitivity, so steroid-induced hyperglycaemia and even frank diabetes are expected, dose-related effects rather than surprises. The problem is greatest in people with existing diabetes, in the afternoon and evening with once-daily morning dosing, and during high-dose therapy. The 1,068 co-reports (PRR 3.5) reflect the very large number of patients receiving corticosteroids for inflammatory disease.

Regulatory basis: corticosteroid prescribing information (hyperglycaemia; glucose monitoring advice). Established glucocorticoid-induced hyperglycaemia literature.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Glucose rises during steroid treatment and falls after withdrawal
Strength	met	PRR 4 with a large co-report count — a modest but broad signal
Consistency	met	Reproduced across the corticosteroid literature
Specificity	met	A recognised corticosteroid effect, not unique to prednisolone
Biological gradient	partial	Dose-related and worse in existing diabetes
Plausibility	met	Increased hepatic glucose output and insulin resistance are the mechanisms
Coherence	met	Coheres with the labelled glucose-monitoring advice
Experiment	partial	Dechallenge (steroid reduction/withdrawal) reverses it; no randomized trial
Analogy	met	Analogous to hyperglycaemia with other glucocorticoids and with some antipsychotics

This page's own qualitative read, not an automated/citation-gated assessment.

✗ No ClinicalTrials.gov results-posting trial in the top search hits for prednisolone captured hyperglycaemia as a coded event; steroid hyperglycaemia is managed by glucose monitoring in practice rather than recorded as a trial AE.