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Can diclofenac be bought at OTC? Understanding Topical vs. Oral Availability

4 min read

In February 2020, the FDA approved the switch of diclofenac sodium 1% topical gel from a prescription-only medication to an over-the-counter (OTC) treatment. This made a prescription-strength topical pain reliever, now known as Voltaren Arthritis Pain, available without a doctor's order, directly addressing the question of whether can diclofenac be bought at OTC.

Quick Summary

Topical diclofenac sodium 1% gel is available over-the-counter under the brand name Voltaren Arthritis Pain for relieving osteoarthritis joint pain. Other forms, like oral tablets, solutions, and higher-strength gels, still require a prescription. The OTC gel works locally with a lower risk of systemic side effects compared to oral NSAIDs.

Key Points

  • Topical diclofenac is OTC: Diclofenac sodium 1% topical gel, branded as Voltaren Arthritis Pain, is available over-the-counter for arthritis joint pain.

  • Oral diclofenac is not OTC: Oral tablets and stronger topical formulations of diclofenac still require a prescription.

  • Targeted pain relief: The topical gel provides localized pain relief directly at the site of arthritis pain in the hands, wrists, elbows, knees, ankles, and feet.

  • Reduced systemic side effects: Compared to oral NSAIDs, the topical gel has a lower risk of systemic side effects like stomach bleeding and cardiovascular events.

  • Use as directed: Follow the dosing instructions and use the provided card. The gel should be applied four times daily for up to 21 days for arthritis pain.

  • Consult a doctor with certain conditions: Individuals with heart conditions, high blood pressure, stomach ulcers, or an aspirin allergy should consult a doctor before use.

  • Do not use with other NSAIDs: Avoid combining topical diclofenac with other oral NSAIDs like ibuprofen or naproxen to reduce the risk of serious side effects.

In This Article

Understanding the Availability of Diclofenac

For many years, the nonsteroidal anti-inflammatory drug (NSAID) diclofenac was only available via prescription in the United States. However, this changed in February 2020 when the FDA approved the transition of a specific formulation, diclofenac sodium 1% topical gel, to over-the-counter (OTC) status. Now widely available under the brand name Voltaren Arthritis Pain, this topical gel provides convenient access to a potent pain reliever for those with certain types of arthritis pain. It is crucial, however, to understand that this OTC availability applies only to the 1% topical gel. Other formulations, such as oral tablets, solutions, and stronger 3% topical gels, remain prescription-only.

How Topical Diclofenac Works

Diclofenac is an NSAID that functions by blocking the body's production of chemicals called prostaglandins, which are responsible for causing pain and inflammation. Unlike oral NSAIDs that circulate throughout the body, the topical gel delivers the active ingredient directly to the site of pain, such as the hands, wrists, elbows, knees, feet, and ankles. This localized application significantly limits systemic exposure, leading to a much lower risk of the systemic side effects associated with oral NSAIDs, such as gastrointestinal bleeding and cardiovascular complications. The gel's formula is designed to penetrate the skin and reach the inflamed joints below, providing targeted relief where it is needed most.

Proper Use of OTC Diclofenac Gel

Using OTC diclofenac gel correctly is essential for both effectiveness and safety. Adhering to the manufacturer's instructions ensures you get the most benefit while minimizing risks. The following are key steps for proper application:

  • Use the dosing card provided in the package to measure the correct amount of gel for the affected joint.
  • For joints in the upper body (hands, wrists, elbows), apply 2 grams of gel. For joints in the lower body (knees, ankles, feet), apply 4 grams.
  • Gently rub the gel into the affected area, ensuring it is fully absorbed.
  • Apply the gel four times a day, but do not exceed two treatment areas at the same time.
  • Do not wash the treated area for at least one hour after application.
  • Do not cover the area with clothing or gloves for at least 10 minutes.
  • It may take up to 7 days of consistent use to feel the full pain-relieving effects.
  • Avoid applying the gel to open wounds, infected areas, or rashes.

Potential Risks and Side Effects

Despite its lower risk profile compared to oral NSAIDs, topical diclofenac still carries potential risks and side effects, especially with prolonged use. The following is a list of potential issues:

  • Local Skin Reactions: These are the most common side effects and include dryness, redness, itching, swelling, or irritation at the application site.
  • Systemic Risks: While minimized, there is still a risk of systemic side effects, including serious cardiovascular issues like heart attack and stroke, and gastrointestinal problems like stomach bleeding and ulcers.
  • Severe Allergic Reactions: A severe allergic reaction is possible, particularly in individuals with an aspirin allergy.
  • Other Side Effects: Less common side effects may include stomach pain, nausea, and dizziness.

Consulting a healthcare provider is recommended before starting treatment, especially if you have a history of heart disease, high blood pressure, ulcers, or kidney disease.

Comparison: Topical vs. Oral Diclofenac

Feature OTC Diclofenac (Topical Gel 1%) Prescription Diclofenac (Oral Tablet)
Availability Over-the-Counter Prescription Only
Application Applied directly to the skin on affected joints Taken by mouth
Absorption Localized and minimal systemic absorption Systemic absorption throughout the body
Primary Use Temporary relief of osteoarthritis joint pain Broader pain management for various conditions (e.g., arthritis, migraines, menstrual cramps)
Systemic Side Effects Lower risk of systemic effects (cardiovascular, GI) Higher risk of systemic side effects (cardiovascular, GI, liver)
Local Side Effects Higher risk of skin reactions at the application site (e.g., dryness, irritation) No local skin reactions

Other Considerations Before Use

  • Avoid Other NSAIDs: Do not combine topical diclofenac with other oral NSAIDs like ibuprofen (Advil) or naproxen (Aleve) without consulting a doctor, as this increases the risk of serious side effects.
  • Pregnancy and Breastfeeding: Pregnant or breastfeeding individuals should consult a healthcare professional before use, especially after 20 weeks of pregnancy, as NSAIDs can harm the fetus.
  • Duration of Use: Do not use the gel for more than 21 days at a time for arthritis pain without speaking to a doctor. If pain persists after 7 days, discontinue use and consult a healthcare provider.
  • Off-Label Use: The FDA-approved OTC formulation is specifically for arthritis pain in certain joints. Using it for back pain, muscle soreness, or other conditions is considered off-label and not recommended.

Conclusion

In summary, the question of "Can diclofenac be bought at OTC?" has a clear answer: yes, but only in its 1% topical gel form under the brand Voltaren Arthritis Pain and its generic counterparts. This option provides a targeted, effective way to manage localized arthritis pain with a lower risk of systemic side effects compared to oral NSAIDs. However, it is not without risks and requires careful use, especially regarding dosage, duration, and potential interactions with other medications. For broader pain management or for individuals with underlying health concerns, oral formulations of diclofenac and other NSAIDs remain prescription-only and should be discussed with a healthcare provider.


For additional information on diclofenac, consult the comprehensive monograph on MedlinePlus: Diclofenac Topical (arthritis pain): MedlinePlus Drug Information.

Frequently Asked Questions

No, oral diclofenac in tablet or capsule form is not available over the counter and still requires a doctor's prescription in the United States.

The over-the-counter version of diclofenac sodium 1% topical gel is sold under the brand name Voltaren Arthritis Pain. Generic versions are also available.

OTC diclofenac gel is used for the temporary relief of arthritis pain specifically in the hands, wrists, elbows, knees, ankles, and feet.

Yes, the over-the-counter Voltaren Arthritis Pain gel contains the same active ingredient, diclofenac sodium 1%, and is the same strength as the previously available prescription gel.

No, the OTC diclofenac gel is not FDA-approved for treating back pain. It is intended only for arthritis pain in specific joints. Consult a doctor for appropriate treatment for back pain.

It is not recommended to use other oral NSAIDs like ibuprofen or naproxen while using diclofenac gel. Combining NSAIDs increases the risk of serious side effects, such as stomach bleeding.

While some people may feel relief sooner, it can take up to 7 days of continuous use for the full pain-relieving effects of the gel to be noticeable.

Yes, like all NSAIDs, topical diclofenac carries a boxed warning about potential cardiovascular and gastrointestinal risks, including heart attack, stroke, and stomach bleeding, especially with long-term use.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.