Medical Editor: Melissa Conrad Stöppler, MD
What Is Voltaren Gel?
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.
What Are Side Effects of Voltaren Gel?
Common side effects of Voltaren Gel include:
- nausea,
- stomach pain,
- upset stomach,
- diarrhea,
- gas,
- ulcers, or
- itching,
- dryness,
- redness,
- scaling,
- numbness and tingling,
- cysts,
- pimples, or other
- skin irritation where the medicine was applied.
Dosage for Voltaren Gel
The amount of Voltaren Gel should be measured using the dosing card supplied with the product.
What Drugs, Substances, or Supplements Interact with Voltaren Gel?
Potential drug interactions include aspirin, lithium (Eskalith, Lithobid), blood pressure medications, methotrexate (Rheumatrex, Trexall), certain antibiotics, other topical product treatments, and anticoagulants.
Voltaren Gel During Pregnancy and Breastfeeding
Like other NSAIDs, Voltaren Gel is generally avoided during pregnancy because it may affect the cardiovascular system of the fetus. Voltaren Gel passes into breast milk and may harm a nursing baby. Breastfeeding while using Voltaren Gel topical is not recommended.
and may harm a nursing baby. Breastfeeding while using Voltaren Gel topical is not recommended.Additional Information
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.
QUESTION
What joints are most often affected by osteoarthritis? See AnswerGet emergency medical help if you have signs of an allergic reaction (hives, sneezing, runny or stuffy nose, wheezing or trouble breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Although the risk of serious side effects is low when diclofenac is applied to the skin, this medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.
Stop using diclofenac and seek emergency medical attention if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.
Also call your doctor at once if you have:
- a skin rash, no matter how mild;
- swelling, rapid weight gain;
- severe headache, blurred vision, pounding in your neck or ears;
- little or no urination;
- liver problems--nausea, diarrhea, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
- signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
Common side effects may include:
- heartburn, gas, stomach pain, nausea, vomiting;
- diarrhea, constipation;
- headache, dizziness, drowsiness;
- stuffy nose;
- itching, increased sweating;
- increased blood pressure; or
- skin redness, itching, dryness, scaling, or peeling 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.
SLIDESHOW
Slideshow: Exercises for Knee Osteoarthritis and Joint Pain See SlideshowSIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
- GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
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 placebocontrolled 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 : Non-serious Application Site Adverse Reactions (≥1% VOLTAREN GEL Patients) - Short-term Controlled Trials
| VOLTAREN GEL N=913 | Placebo (Vehicle) N=876 | |
| Adverse Reaction† | N (%) | N (%) |
| Any application 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, 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)
© Voltaren Gel Patient Information is supplied by Cerner Multum, Inc. and Voltaren Gel Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
Health Solutions From Our Sponsors