Voltaren Arthritis Pain Safety Profile
Adverse events were comparable to placebo in placebo-controlled trials1,2
The only adverse reactions that occurred in >1% of patients with greater frequency with Voltaren® Arthritis Pain gel OTC vs placebo were application-site reactions (Voltaren® Gel 7%, placebo 2%).1,2
No statistically significant difference in discontinuation rates due to adverse events between Voltaren® Arthritis Pain gel OTC and placebo.1,2
Results of an open-label, long-term safety study of patients treated for up to 1 year with Voltaren® Arthritis Pain gel OTC (N=947)3*
In clinical trials of the hand and knee1,2
- The most frequent treatment-emergent adverse event was headache. Other relatively frequent treatment-emergent adverse events that occurred in similar proportions of subjects in each group were back pain and pain in extremity
- The incidence of serious adverse events was low in the Voltaren® Arthritis Pain gel OTC and placebo groups and none was suspected to be related to the study drug
*Uncontrolled, long-term safety trial in patients with OA of the knee.3 Duration of studies ranged from 12 weeks to 1 year. Total of all treated patients equals 947. Total treated patients: under 2 months, 137 (14%); 2-6 months, 422 (45%); 7-12 months, 328 (35%); not enough information to determine duration of exposure, 60 (6%).
Systemic exposure and maximum plasma concentrations of diclofenac are significantly lower with Voltaren® Arthritis Pain gel OTC than with oral diclofenac sodium.4
A highly effective, topical pain reliever for OA—targeting joint pain directly at the source.1,2
- The amount of diclofenac sodium that is systemically absorbed from Voltaren® Arthritis Pain gel OTC is on average 6% of the systemic exposure from an oral form of diclofenac sodium4
- With recommended use 4 x 4g daily (applied to 1 knee), average peak plasma concentration is 158 times lower than with oral diclofenac4
*Study also included analysis of a 4 x 12g dose of Voltaren® Arthritis Pain gel OTC, which is not an approved dose.