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Curr Med Res Opin. 2011 Mar;27(3):605-22. doi: 10.1185/03007995.2010.550606. Epub 2011 Jan 13.

Safety profile of topical diclofenac: a meta-analysis of blinded, randomized, controlled trials in musculoskeletal conditions.

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Peninsula College of Medicine & Dentistry, Universities of Exeter & Plymouth, Exeter, UK.



Topical non-steroidal anti-inflammatory drugs (NSAIDs) are clinically proven for the management of musculoskeletal conditions. It is important that prescribers and patients are aware of the safety profile of topical NSAIDs.


To evaluate the risk of adverse events (AEs) associated with topical diclofenac for the treatment of acute and chronic musculoskeletal conditions.


Systematic review and meta-analysis of blinded, randomized, placebo-, vehicle- or active-controlled trials.


The risk of any type of AE experienced with topical diclofenac was slightly higher compared with placebo/vehicle (RR 1.11), but was more than 50% lower than the risk observed with active topical comparators (RR 0.53). Absolute risk values indicated differences in the risk of AEs depending on the diclofenac formulation used; in particular, lower rates of local skin reactions were observed with diclofenac patches (e.g. 2.5% in placebo/vehicle-controlled studies) and gels (4.2%) compared with diclofenac solutions containing dimethylsulfoxide (34.2%). Dry skin/crusting and rash were the most common local skin reactions reported (9.0% and 3.0% of patients, respectively, in placebo/vehicle-controlled studies), which were usually mild-to-moderate and self-resolving. The discontinuation rate due to local skin reactions with topical diclofenac (1.9%) was low and comparable with non-active comparators (0.7%), and the tolerability of topical diclofenac treatment was rated as 'good' to 'excellent' by >90% physicians and patients.


Topical diclofenac appears to be generally well tolerated for cutaneous use in acute and chronic musculoskeletal conditions.

[Indexed for MEDLINE]

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