What to Know About Voltaren Gel

Safety, side effects, dosage, and more

Table of Contents
View All

Voltaren Gel (diclofenac, 1%) is an FDA-approved over-the-counter topical nonsteroidal anti-inflammatory drug (NSAID) for temporary relief of osteoarthritis pain in the joints of hands, knees, and feet. An alternative formulation (3% diclofenac gel) is another FDA-approved prescription drug used to treat actinic keratoses (a skin disorder). 

How to use voltaren gel safely
Illustration by JR Bee, Verywell 

Before Taking

If you think you may be a candidate for Voltaren Gel, discuss it with your doctor to determine if it's appropriate for you. People who've experienced gastrointestinal side effects from oral NSAIDs are often considered as candidates for switching to Voltaren Gel.

The systemic absorption of Voltaren Gel, which is 1% diclofenac sodium in a topical gel formulation, is three times less than oral diclofenac (5% vs. 15%, respectively).  That means the risk of serious gastrointestinal and cardiovascular side effects that are associated with oral NSAIDs are considerably less with the topical formulation.

The initial FDA approval was based on several studies, including two randomized, double-blind, placebo-controlled efficacy studies, and a 12-month safety study. After six weeks of treatment in an efficacy study of people with hand osteoarthritis, pain levels were reduced by 46 percent. In a 12-week study of people with knee osteoarthritis, Voltaren Gel reduced pain levels by 53%.

Talk to your doctor about all medications, supplements, and vitamins that you currently take. While some drugs pose minor interaction risks, others may outright contraindicate use or prompt careful consideration as to whether the pros of treatment outweigh the cons in your case.

Black Box Warnings

Black box warnings alert physicians and patients to the most severe possible side effects. Voltaren Gel has the following black box warnings:

Warnings

  • Increased risk of serious or possibly fatal cardiovascular events, heart attack, or stroke.
  • Its use is contraindicated in coronary artery bypass graft (CABG) surgery.
  • Increased risk of serious gastrointestinal events including bleeding, ulcers, and perforation of the stomach and intestines. Serious GI events indicated in elderly patients with a history of peptic ulcer disease and/or GI bleeding.

Serious side effects can happen without warning. Your risk may be higher if you've been taking NSAIDs for a long time or at high dosages.

If you are at risk for cardiac events and stroke, you should not take this medication. 

Contraindications

Besides the groups at increased risk listed in the black box warnings, Voltaren Gel should not be used by:

  • people with known hypersensitivity to diclofenac
  • in eyes, nose, or mouth.
  • people who developed asthma, urticaria, or allergic reactions after taking aspirin or NSAIDs
  • people with sports injuries, sprains, bruises, strains, etc. as it is ineffective in these areas.
  • at more than 2 body areas simultaneously.
  • before or after heart surgery.

Ask a healthcare professional if pregnant or breast-feeding. Unless prescribed, do not use during the last 3 months of pregnancy as it may cause birth defects or complications during delivery.

Dosage

Voltaren Gel should be measured onto the reusable dosing card which is enclosed—measure to the appropriate 2-gram or 4-gram mark. Never use more than the prescribed amount.

The total dose of Voltaren Gel should not exceed 32 grams per day over all of the affected joints. Do not apply to more than two body areas simultaneously.

Application:

  • For each lower body area (foot, ankle, or knee), apply 4 grams of the gel to the affected area four times daily.
  • For each upper body area (hand, wrist, or elbow), apply 2 grams of the gel to the affected area four times daily.

How to Take and Store

Unless specified, you can use this gel for up to 21 days. Avoid getting this medication in your eyes, mouth, open wounds, or infected areas. Unless you're applying it to your hand joints, wash your hands immediately after application. Store at 20-25°C (68-77°F). Avoid freezing.

Precautions

  • Apply only on clean, dry skin without rashes, cuts, or infections.
  • Don't shower or rinse the treated area for at least an hour.
  • Do not place a bandage over the treated area.
  • Avoid sunlight and artificial sunlight after application.
  • Do not apply in combination with another product.
  • Don't heat the treated joint(s)

Side Effects

The most common adverse reactions reported in clinical trials were application site reactions and were more commonly observed in patients treated with Voltaren Gel compared with placebo.

Hypertension can also occur with NSAID treatment, making it important to monitor blood pressure. Fluid retention and edema may occur as well.

If an allergic reaction occurs, stop using it immediately.

Severe

The prescribing information for Voltaren Gel provides warnings and precautions for serious adverse reactions as well.

Long-term administration of NSAIDs can result in renal (kidney) papillary necrosis and another renal injury. NSAIDs can cause serious skin side effects, too, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal.

The elderly, people with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE inhibitors should be cautious when using Voltaren Gel.

Long-term treatment with diclofenac sodium can cause abnormal liver test results that could indicate severe hepatic conditions, including jaundice, liver necrosis, and liver failure, which might be fatal or require liver transplantation.

These elevated levels in liver tests generally occur even before the patient becomes symptomatic. Voltaren gel should be discontinued if systemic symptoms, such as rash, diarrhea, abdominal pain, dark urine, high eosinophil count, etc. are observed.

Interactions

Voltaren Gel should not be used together with oral NSAIDs or aspirin because of an increased risk of adverse events. The risk of side effects increases with the increased absorption of the active ingredients in NSAIDs.

Just as topical NSAID cream should not be used with oral NSAIDs, two different oral NSAIDs should not be taken together. Talk to your doctor about using low-dose aspirin.

Skin Products

If you're using cosmetics or sunscreen, don't use Voltaren Gel at the same time. The combinations have not been tested and, if topical agents are combined, there is the potential to change how Voltaren Gel is tolerated and absorbed. 

A Word From Verywell

The more treatment options there are for people with arthritis, the better. And the availability of a topical formulation of Voltaren is important for people who can't tolerate oral NSAIDs for one reason or another.

Just be aware that both oral and topical NSAIDs carry the same risks, and that Voltaren shouldn't be combined with other NSAIDs.

Was this page helpful?
Article Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Food and Drug Administration. FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process. Updated February 14, 2020.

  2. U.S. National Library of Medicine. SOLARAZE-diclofenac sodium gel. Updated May 15, 2016.

  3. Tieppo Francio V, Davani S, Towery C, Brown TL. Oral Versus Topical Diclofenac Sodium in the Treatment of Osteoarthritis. J Pain Palliat Care Pharmacother. 2017;31(2):113-120. doi:10.1080/15360288.2017.1301616

  4. U.S. National Library of Medicine. LABEL: VOLTAREN ARTHRITIS PAIN- diclofenac sodium gel. Updated May 11, 2020.

  5. Altman RD, Dreiser RL, Fisher CL, Chase WF, Dreher DS, Zacher J. Diclofenac sodium gel in patients with primary hand osteoarthritis: a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2009;36(9):1991-1999. doi:10.3899/jrheum.081316

  6. Baraf HS, Gold MS, Clark MB, Altman RD. Safety and efficacy of topical diclofenac sodium 1% gel in knee osteoarthritis: a randomized controlled trial. Phys Sportsmed. 2010;38(2):19-28. doi:10.3810/psm.2010.06.1779

  7. Food and Drug Administration. VOLTAREN GEL. Updated February 2018.