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Voltaren Gel

"Jan. 12, 2011 -- A new study weighs in on the debate over the relative safety of nonsteroidal anti-inflammatory medications (NSAIDs), commonly used to treat joint and muscle aches and pain.

The study, published online in the BMJ,"...

Voltaren Gel

Voltaren Gel Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Voltaren Gel (diclofenac sodium topical gel) is a topical gel medication that belongs to the nonsteroidal anti-inflammatory drug (NSAID) class. It is used for the treatment of pain of osteoarthritis of joints that are amenable to topical treatment, such the hands and knees. Most common side effects of Voltaren Gel are gastrointestinal disturbances including ulcer formation.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Voltaren Gel in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • chest pain, slurred speech, problems with vision or balance, and feeling weak or short of breath;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • pale or yellowed skin, dark colored urine, confusion;
  • swelling or rapid weight gain, urinating less than usual or not at all;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • bruising, severe tingling, numbness, pain, muscle weakness;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • the first sign of any skin rash, no matter how mild.

Less serious side effects may include:

  • mild nausea, stomach pain, upset stomach;
  • diarrhea, gas; or
  • mild itching, dryness, redness, scaling, or other skin irritation where the medicine was applied.

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) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Voltaren Gel FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies 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 (diclofenac sodium 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 (diclofenac sodium gel) for osteoarthritis of the knee and 400 were treated for osteoarthritis of the hand. Additionally, 583 patients were exposed to Voltaren® Gel (diclofenac sodium 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 (diclofenac sodium gel) :

Non-serious adverse reactions that were reported during the short-term placebo-controlled studies comparing Voltaren® Gel (diclofenac sodium 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 (diclofenac sodium 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 (diclofenac sodium gel) , compared to 1% of placebo patients.

Table 1 : Non-serious Application Site Adverse Reaction ( ≥ 1% Volteren® Gel Patients)- Short-term Controlled Trials

Adverse Reaction† Voltaren® Gel
N =913
Placebo (vehicle)
X = 876
N (%) N (%)
Anyapplication site reaction 62 (7) 19 (2)
Application site dermatitis 32 (4) 6 ( < 1)
Application site pruritus 7{ < 1) 1 ( < 1)
Application site erythema 6 ( < 1) 3 ( < 1)
Application site paresthesia 5 ( < 1) 3 ( < 1)
Application site dryness 4 ( < 1) 3 ( < 1)
Application site vesicles 3 ( < 1) 0
Application site irritation 2 ( < 1) 0
Application site papules 1 ( < 1) 0
Preferred Term according to MedDRA 9.1

In the placebo-controlled trials, the discontinuation rate due to adverse reactions was 5% for patients treated with Voltaren® Gel (diclofenac sodium 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 (diclofenac sodium 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) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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