Understanding the Official Guidance: Why Can't You Use Voltaren Gel on Your Shoulder?

October 5, 2025 •

4 min read

Approximately 70% of adults aged 50–80 report experiencing joint pain, with many seeking topical relief. This raises a common question: Why can't you use Voltaren gel on your shoulder according to official FDA guidelines, and what does this mean for managing shoulder pain?

Quick Summary

While some sources mention using Voltaren for shoulder pain, it's not officially FDA-approved for this joint. This is because clinical trials for approval focused on more superficial joints, leaving its efficacy and safety for deeper joints like the shoulder and hip unevaluated.

Key Points

Official Approval: Voltaren Gel is not officially FDA-approved for use on the shoulder, hip, or spine because it was not evaluated for these joints in clinical trials.
Superficial Joints: Its approval is for joints amenable to topical treatment, like the hands, wrists, elbows, knees, ankles, and feet.
Penetration Concerns: The effectiveness of topical diclofenac is questioned for deeper joints like the shoulder, as the medication may not penetrate deeply enough to provide relief.
Low Systemic Risk: A key advantage of the gel is low systemic absorption (about 6% of an oral dose), which reduces the risk of side effects like stomach ulcers compared to pills.
Black Box Warning: Despite being topical, Voltaren Gel carries an FDA black box warning for increased risk of cardiovascular events and gastrointestinal bleeding, similar to oral NSAIDs.
Dosage Limits: Follow the specific application instructions and dosage limits provided on the product label or by a healthcare professional.
Alternative Treatments: Other options for shoulder pain include oral NSAIDs, physical therapy, ice, rest, and corticosteroid injections.

The Core Question: Deconstructing Voltaren's Use on Shoulders

The question of why can't you use Voltaren gel on your shoulder stems from the official prescribing information and FDA labels. According to the FDA, Voltaren Gel (diclofenac sodium topical gel, 1%) was not specifically evaluated for use on the joints of the spine, hip, or shoulder during its clinical trials. The over-the-counter (OTC) version is indicated for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle, and knee.

This doesn't necessarily mean it's inherently dangerous for the shoulder, but rather that its safety and effectiveness for these larger, deeper joints have not been formally established to meet FDA approval standards. The concern is that the medication may not penetrate deeply enough to be effective on a large joint like the shoulder, which is more complex and has more tissue to get through than a finger or wrist joint.

How Topical Diclofenac Works

Voltaren's active ingredient is diclofenac, a non-steroidal anti-inflammatory drug (NSAID). When applied to the skin, it is absorbed locally to reduce pain and inflammation in the underlying tissues. A key benefit of the topical form is its low systemic absorption—only about 6% of the active ingredient is absorbed into the bloodstream compared to the oral version. This significantly lowers the risk of systemic side effects, such as gastrointestinal issues, that are common with oral NSAIDs. However, this local action is also why its effectiveness is questioned for deeper joints.

Official Application Guidelines

Proper application is crucial for safety and efficacy. The medication comes with specific instructions to ensure the correct amount is used.

Upper Body Joints (Hands, Wrists, Elbows): Apply the directed amount of gel to the affected area, as advised by the product labeling or a healthcare professional. Follow guidelines for daily limits.
Lower Body Joints (Feet, Ankles, Knees): Apply the directed amount of gel to the affected area, as advised by the product labeling or a healthcare professional. Follow guidelines for daily limits.

Follow the specific instructions for the total amount that can be applied daily across all joints combined. It is also advised not to apply the gel to more than two body areas at the same time and to avoid use for more than a specified duration unless directed by a doctor.

The FDA Black Box Warning and Other Risks

Like all NSAIDs, Voltaren gel carries an FDA "black box warning," the most serious type of warning. This highlights two major risks:

Cardiovascular Events: NSAIDs can increase the risk of heart attack and stroke, which can be fatal. This risk may be higher for those with existing heart disease or who use the medication for a long time.
Gastrointestinal Bleeding: NSAIDs can cause serious GI problems like bleeding, ulcers, and perforation of the stomach or intestines.

Although the risk is lower with topical application due to minimal systemic absorption, it is not zero. Other potential side effects include skin irritation (redness, itching, dryness), high blood pressure, fluid retention, and in rare cases, severe skin reactions or liver damage. You should not use Voltaren gel on broken or infected skin, and avoid contact with eyes and mucous membranes.

Comparing Shoulder Pain Treatment Options

If you have shoulder pain and are hesitant to use Voltaren gel due to the lack of official FDA approval for that area, several other options exist.


Treatment Option	How It Works	Key Considerations
Oral NSAIDs (Ibuprofen, Naproxen)	Systemically reduces inflammation and pain throughout the body.	Higher risk of gastrointestinal and cardiovascular side effects compared to topical NSAIDs. Effective for various pain types.
Topical Menthol/Camphor (e.g., Icy Hot)	Creates a cooling or warming sensation on the skin that distracts from deeper pain. A counter-irritant.	Does not reduce underlying inflammation. Generally safe for most body areas. Recommended by Mayo Clinic as a first-line topical treatment.
Acetaminophen (Tylenol)	Reduces pain signals in the brain but has little anti-inflammatory effect.	Safer for those who cannot take NSAIDs due to stomach or heart issues. Overuse can cause liver damage.
Physical Therapy	Uses targeted exercises to improve shoulder strength, flexibility, and range of motion. Addresses the root mechanical cause of pain.	A long-term solution that helps prevent future injury. Requires commitment and professional guidance.
Corticosteroid Injections	A powerful anti-inflammatory steroid is injected directly into the shoulder joint by a healthcare provider.	Provides potent, but often temporary, pain relief. Too many injections can weaken tendons over time.
Rest and Ice	Resting the joint avoids re-injury, while ice helps numb the area and reduce acute inflammation and swelling.	Best for acute injuries like sprains or strains. Simple, effective, and has no medication side effects.

Conclusion: Navigating Pain Relief Safely

The primary reason you are officially advised not to use Voltaren gel on your shoulder is that it lacks specific FDA evaluation and approval for that joint. The gel's effectiveness is best documented for smaller, more superficial joints where the active ingredient can more easily reach the source of pain. While some people may use it "off-label" for shoulder pain, this should only be done after consulting a healthcare provider who can weigh the potential benefits against the risks. Given the availability of many other effective and approved treatments for shoulder pain, from other topical products and oral medications to physical therapy, it is wise to follow official guidelines and explore these proven alternatives first. Always discuss treatment options with your doctor to ensure you are choosing the safest and most effective path for your specific condition.

For more information on the safe use of NSAIDs, you can visit the FDA's resource page. Disclaimer: This information is for general knowledge and should not be taken as medical advice. Consult with a healthcare professional before starting any new supplement regimen.

Frequently Asked Questions

Using a medication for a purpose not listed on its official label is known as "off-label" use. While some doctors may suggest it, you should only do so after consulting a healthcare provider who can assess your specific situation. The primary concern is that it hasn't been proven effective for deep joints like the shoulder.

The FDA approval process was based on clinical studies that focused on joints amenable to topical treatment, such as the knees and hands. The knee joint, while large, is considered more superficial and accessible for topical treatment than the complex, deep structure of the shoulder joint.

Using more than the recommended amount can increase the absorption of diclofenac into your bloodstream, raising the risk of serious systemic side effects outlined in the black box warning, including heart attack, stroke, and stomach bleeding.

Voltaren gel may take up to 7 days to provide its full effect for arthritis pain. If you don't feel any relief after 7 days, or if you need to use it for more than 21 days, you should stop use and contact your doctor.

No, you should not apply external heat or cover the treated area with an occlusive dressing or bandage after applying Voltaren gel, as this has not been evaluated and could alter the medication's absorption and effects.

Topical NSAIDs like Voltaren gel have a lower risk of systemic side effects, particularly gastrointestinal issues, compared to oral NSAIDs like ibuprofen because less of the drug enters the bloodstream. However, risks are not eliminated, and the gel still carries serious warnings.

Effective alternatives include other topical products with menthol, oral NSAIDs like ibuprofen, acetaminophen, physical therapy exercises, rest, ice, and corticosteroid injections administered by a doctor.