PREDNISONE

Clinical safety rating: avoid

Positive evidence of fetus risks but benefits may outweigh risks in some cases

How it works

Agonist at glucocorticoid receptors, leading to altered gene transcription that results in anti-inflammatory and immunosuppressive effects, including suppression of cytokines, prostaglandins, and leukotrienes.

What the body does with it

Metabolism	Hepatic, primarily via CYP3A4-mediated 6β-hydroxylation; also reduced by 20-ketosteroid reductases. Prednisone is a prodrug converted to active metabolite prednisolone.
Excretion	Renal: <10% as unchanged drug; hepatic metabolism to inactive glucuronide and sulfate conjugates; fecal: ~20-30% via biliary elimination.
Half-life	Terminal half-life: 2-3 hours (plasma); clinical effects persist for 12-36 hours due to intracellular actions and active metabolite prednisolone (half-life 3-4 hours).
Protein binding	Prednisone: 70-90% bound to albumin and corticosteroid-binding globulin (CBG); prednisolone: 60-70% bound.
Volume of Distribution	Vd: 0.5-1.0 L/kg; distributes widely, crosses placenta and enters breast milk; apparent Vd larger with hyperthyroidism.
Bioavailability	Oral: 70-80% (active prednisolone after hepatic conversion); IM: ~100%.
Onset of Action	Oral: 1-4 hours; IV: rapid (within 1 hour); IM: 1-2 hours.
Duration of Action	Oral/IV: 12-36 hours (duration of HPA suppression and anti-inflammatory effects); clinical duration longer than plasma half-life.

Classification & Brands

Dosing & administration

5-60 mg orally once daily or divided twice daily; for acute indications, initial dose 5-60 mg/day; for chronic conditions, lowest effective dose; route: oral, intravenous, intramuscular.

Dosage form	TABLET
Renal impairment	No dose adjustment required for renal impairment; consider alternative corticosteroid in severe renal disease if fluid retention is a concern.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B or C: use with caution; dose reduction may be considered due to decreased clearance; monitor for adverse effects.
Pediatric use	0.1-2 mg/kg/day orally divided 1-4 times daily; maximum 60 mg/day; use lowest effective dose; for acute asthma, 1-2 mg/kg/day for 3-5 days.
Geriatric use	Start at lower end of dosing range (5-7.5 mg/day) due to increased risk of osteoporosis, hyperglycemia, and infections; monitor glucose and bone density; taper slowly to avoid adrenal suppression.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

CYP3A4 inducers (eg phenytoin) may decrease efficacy and inhibitors may increase effects Can cause hyperglycemia and adrenal suppression with prolonged use.

Breastfeeding	Prednisone enters breast milk in low concentrations (M/P ratio ~0.25-0.5). Maternal doses ≤20 mg/day produce negligible infant exposure. Higher doses: Avoid breastfeeding for 4 hours after dose. Monitor infant for growth and adrenal suppression.
Teratogenic Risk	First trimester: Increased risk of cleft lip/palate (odds ratio 1.3-3.4). Second/third trimester: Fetal growth restriction, adrenal suppression, preterm delivery. Chronic use: Dose-dependent fetal hypothalamic-pituitary-adrenal axis suppression.

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Common Effects	immunosuppression
Serious Effects

Absolute Contraindications

["Systemic fungal infections","Hypersensitivity to prednisone or any component","Administration of live or live attenuated vaccines (due to immunosuppression)"]

Clinical Precautions

Precautions

["Adrenal suppression and HPA axis suppression with prolonged therapy","Increased risk of infections","Exacerbation of systemic fungal infections","Masking of signs of infection","Osteoporosis with long-term use","Gastrointestinal perforation (especially in patients with certain GI disorders)","Kaposi sarcoma reported","Cardiovascular effects (hypertension, fluid retention)","Behavioral disturbances (euphoria, depression, psychosis)","Posterior subcapsular cataracts and glaucoma","Thromboembolism risk","Vaccine response may be diminished; live vaccines contraindicated"]

Clinical Tips & Counseling

Drug interactions

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