While some of the adverse events caused by the administration of medic
ines are specifically attributable to the drug molecule, a proportion
arises because of the chemical, biological and physical nature of the
formulation. The effects may be compounded by certain patient factors,
an incomplete understanding of the behaviour of the formulation or th
e coadministration pf other drugs, This review examines adverse drug r
eactions and other adverse events arising from the nature of the dosag
e form or formulation used. These adverse effects may be the result of
local irritation/toxicity, hypersensitivity or allergic reactions, sy
stemic effects from essentially local therapies, or idiosyncratic reac
tions in a small number of individuals. In certain cases where the exa
ct nature of the formulation is unknown, adverse events cannot be attr
ibuted to any single ingredient. In addition, the total of all ingredi
ents of a formulation, even where details of the formulation are clear
, may give rise to abnormal behaviour of the formulation in vivo. Ofte
n the desired objective of a particular specialised formulation leads
to an unforseen but related adverse effect, and in certain instances t
hese events are completely unpredictable and at variance with the perc
eived objectives of the formulation.