Boxed-warning-level risk. Combination products carry the LABA risk of asthma-related death if used without a corticosteroid; the corticosteroid is part of the same inhaler.
Contraindications. Hypersensitivity, including severe milk protein allergy. Caution in active or quiescent tuberculosis.
Serious adverse effects. Adrenal suppression, pneumonia in COPD, cataract, glaucoma, reduced bone density, reduced growth velocity, paradoxical bronchospasm.
Common adverse effects. Oral candidiasis, headache, nasopharyngitis, hoarseness, arthralgia.
Interactions. Strong CYP3A4 inhibitors including ritonavir and cobicistat raise systemic exposure and lower cortisol; avoid unless the benefit outweighs the risk.
Common prescribing errors. Prescribing a second ICS or LABA inhaler on top. Using once daily dosing for twice daily products.
Special groups.
Pregnancy: use only if the benefit outweighs risk. Breastfeeding: no data; use with caution.
Older adults: monitor for pneumonia and bone effects.
Kidney impairment: no adjustment. Liver impairment: in moderate to severe impairment, use the 92/22 strength only and monitor for corticosteroid effects.
East Africa: avoid with ritonavir-boosted regimens where possible.