Voltaren Arthritis Pain Safety Profile

Doctor and patient discussion

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

See Voltaren® Arthritis Pain gel OTC Drug Facts for NSAID class warnings.

  • Voltaren discontinuation comparable to placebo

    No statistically significant difference in discontinuation rates due to adverse events between Voltaren® Arthritis Pain gel OTC and placebo.1,2

  • Adverse events that led to discontinuation

    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%).

  • Low systemic exposure

    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.

Find out more about Voltaren® Arthritis Pain

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Voltaren® Arthritis Pain compared with oral and topical analgesics.

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How does Voltaren® Arthritis Pain gel OTC penetrate the skin?

The science behind Voltaren® Arthritis Pain and its MOA.

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Emulgel penetration

What is an emulgel?

Voltaren® Arthritis Pain gel OTC has a unique formulation.

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Drug Facts

Voltaren® Arthritis Pain gel OTC Drug Facts

The drug facts contain all you need to know about dosing and administration.

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A look at which patients suffer most often.

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The latest OA treatment guidelines from the American College of Rheumatology.

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