Voltaren® Gel is a nonsteroidal anti-inflammatory drug (NSAID) used for the relief of joint pain of osteoarthritis in the knees, ankles, feet, elbows, wrists, and hands. Voltaren® Gel has not been studied for use on the spine, hip, or shoulder.
IMPORTANT SAFETY INFORMATION
for Voltaren® Gel
What is the most important information you should know about medicines called Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines, like Voltaren® Gel, may increase the chance of a heart attack or stroke that can lead to death. This chance increases:
NSAID medicines, like Voltaren® Gel, should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”
NSAID medicines, like Voltaren® Gel, can cause ulcers and bleeding in the stomach and intestines at any time during treatment.
NSAID medicines should only be used:
Do not use Voltaren® Gel if you are allergic to diclofenac (the active ingredient in Voltaren® Gel) or if you have had asthma, hives, or other allergic-type reactions after taking aspirin or other NSAIDs.
Tell your healthcare provider:
NSAIDs, including Voltaren® Gel, can lead to high blood pressure or worsening of high blood pressure, which may add to the increased risk of heart attack and stroke.
Possible serious side effects include life-threatening skin and allergic reactions.
Get emergency help right away if you have any of the following symptoms: shortness of breath or trouble breathing, chest pain, weakness in one side of your body, slurred speech, or swelling of the face or throat. Stop using Voltaren® Gel and call your healthcare provider right away if you have: skin rash or fever with blisters.
Do not use Voltaren® Gel on the same skin site that was treated with other topical products, such as sunscreens, cosmetics, lotions, moisturizers, or insect repellents.
Other information about NSAIDs:
You should not use Voltaren® Gel with oral NSAIDs.
The most common side effects reported in studies using Voltaren® Gel were application site reactions, including dermatitis (reported in 7% of treated patients).
Use Voltaren® Gel exactly as prescribed by your healthcare provider.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For additional information about Voltaren® Gel, please see the
full Prescribing Information, including the Medication Guide for patients.