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Calcium dobesilate is an antioxidant that has been used to treat diabetic retinopathy, in which it slows progression of the disease during long-term oral treatment by reducing microvascular permeability, leading to improved visual acuity [ ]. It not only acts as an antioxidant but also stimulates endothelial production of nitric oxide.
In early studies the most common adverse reactions to calcium dobesilate after oral administration were gastrointestinal disturbances and, occasionally, nervousness and fever [ , ].
In a systematic review of the published literature from 1970 to 2003, a postmarketing surveillance report covering the period 1974–1998, and periodic safety update reports covering the period 1995–2003 from the French regulatory authorities pharmacovigilance database, the following adverse reactions were reported: fever (26%), gastrointestinal disorders (12.5%), skin reactions (8.2%), arthralgia (4.3%), and agranulocytosis (4.3%) [ ].
Safety data from post-marketing surveillance over 25 years has been extensively summarized [ ]. The data suggest that most adverse events are rare and frequently unrelated to the drug. Fever, gastrointestinal intolerance, skin reactions, and arthralgia are the most frequent adverse reactions ascribed to calcium dobesilate. There have been a few reports of agranulocytosis, but its frequency is lower than in the general population and methodological bias is therefore suspected.
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