Voltaren Gel, a nonsteroidal anti-inflammatory medication in topical form, is used mostly on knees and hands to relieve arthritis pain and stiffness.
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Find a comprehensive guide to possible side effects when taking Voltaren Gel Diclofenac Sodium Gel for Professionals, Patients, and Caregivers.
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Voltaren Gel official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more.
Voltaren Gel (diclofenac sodium topical gel) is a topical gel nonsteroidal anti-inflammatory drug (NSAID) used to treat pain of osteoarthritis of joints that are amenable to topical treatment, such the hands and knees. Common side effects of Voltaren Gel are nausea, stomach pain, upset stomach, diarrhea, gas, ulcers, or itching, dryness, redness, scaling, or other skin irritation where the medicine was applied. The amount of Voltaren Gel should be measured using the dosing card supplied with the product. Potential drug interactions include aspirin, lithium (Eskalith, Lithobid), blood pressure medications, methotrexate (Rheumatrex, Trexall), certain antibiotics, other topical product treatments, and anticoagulants. Like other NSAIDs, Voltaren Gel is generally avoided during pregnancy because it may affect the cardiovascular system of the fetus. It is not known whether Voltaren Gel is excreted in breast milk. Our Voltaren Gel Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Read the entire detailed patient monograph for Voltaren Gel (Diclofenac Sodium Gel) Voltaren Gel FDA Prescribing Information: Side Effects (Adverse Reactions) SIDE EFFECTS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical development, 913 patients were exposed to VOLTAREN® GEL in randomized, double-blind, multicenter, vehicle-controlled, parallel-group studies in osteoarthritis of the superficial joints of the extremities. Of these, 513 patients received VOLTAREN® GEL for osteoarthritis of the knee and 400 were treated for osteoarthritis of the hand. Additionally, 583 patients were exposed to VOLTAREN® GEL in an uncontrolled, open-label, long-term safety trial in osteoarthritis of the knee. Of these, 355 patients were treated for osteoarthritis of 1 knee and 228 were treated for osteoarthritis of both knees. Duration of exposure ranged from 8 to 12 weeks for the placebo-controlled studies, and up to 12 months for the open-label safety trial. Short-Term Placebo-Controlled Trials Adverse reactions observed in at least 1% of patients treated with VOLTAREN® GEL: Non-serious adverse reactions that were reported during the short-term placebo-controlled studies comparing VOLTAREN® GEL and placebo (vehicle gel) over study periods of 8 to 12 weeks (16 g per day), were application site reactions. These were the only adverse reactions that occurred in > 1% of treated patients with a greater frequency in the VOLTAREN® GEL group (7%) than the placebo group (2%). Table 1 lists the types of application site reactions reported. Application site dermatitis was the most frequent type of application site reaction and was reported by 4% of patients treated with VOLTAREN® GEL, compared to 1% of placebo patients. Table 1: Non-serious Application Site Adverse Reactions ( ≥ 1% Voltaren® Gel Patients) - Short-term Controlled Trials In the placebo-controlled trials, the discontinuation rate due to adverse reactions was 5% for patients treated with VOLTAREN® GEL, and 3% for patients in the placebo group. Application site reactions, including application site dermatitis, were the most frequent reason for treatment discontinuation. Long-Term Open-Label Safety Trial In the open-label, long-term safety study, distribution of adverse reactions was similar to that in the placebo-controlled studies. In this study, where patients were treated for up to 1 year with VOLTAREN® GEL up to 32 g per day, application site dermatitis was observed in 11% of patients. Adverse reactions that led to the discontinuation of the study drug were experienced in 12% of patients. The most common adverse reaction that led to discontinuation of the study was application site dermatitis, which was experienced by 6% of patients. Read the entire FDA prescribing information for Voltaren Gel (Diclofenac Sodium Gel)','url':'http://www.rxlist.com/voltaren-gel-side-effects-drug-center.htm','og_descr':'Find a comprehensive guide to possible side effects when taking Voltaren Gel (Diclofenac Sodium Gel) for Professionals, Patients, and Caregivers.
Voltaren® Gel — Direct route to relief®
Indication. Voltaren Gel is a nonsteroidal anti-inflammatory drug NSAID used for the relief of joint pain of osteoarthritis in the knees, ankles, feet, elbows.
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: 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: if you have a history of ulcers or bleeding in the stomach or intestines, or kidney or liver problems, or heart failure about all of your medical conditions about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects if you are pregnant or breastfeeding. Voltaren® Gel should not be used late in pregnancy 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: Aspirin, which is an NSAID, can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines 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. Apply Voltaren® Gel to clean, dry skin that does not have any cuts, infections, or rashes Avoid exposing skin where you apply Voltaren® Gel to sunlight and artificial light, such as tanning booths Do not get Voltaren® Gel in your eyes, nose, and mouth 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. 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: 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: if you have a history of ulcers or bleeding in the stomach or intestines, or kidney or liver problems, or heart failure about all of your medical conditions about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects if you are pregnant or breastfeeding. Voltaren® Gel should not be used late in pregnancy 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: Aspirin, which is an NSAID, can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines 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.