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Diclofenac Sodium: Topical gel (3%)

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Diclofenac Sodium 3% Top Gel
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Diclofenac Sodium 3% Top Gel

What is this Medicine?

DICLOFENAC (dye KLOE fen ak) is a non-steroidal anti-inflammatory drug (NSAID). The 1% skin gel is used to treat osteoarthritis of the hands or knees. The 3% skin gel is used to treat actinic keratosis.

CVS Pharmacy Patient Statistics for Diclofenac Sodium: Topical gel(3%)
Generic vs. Brand Name Usage*
*Brand contains same active ingredient but may not represent FDA-approved generic equivalent
Usage By Strength
In-Depth Information
Select a Medication

Diclofenac Sodium 3% Topical Gel

NDC: 516721363
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Actinic Keratosis, Osteoarthritis

Storage Information
Store at controlled room temperature (between 68 and 77 degrees F)
Protect from extreme heat
Protect from freezing
Diclofenac Sodium 3% Topical Gel

Reported Side Effects for Diclofenac Sodium 3% Topical Gel

Conjunctivitis Incidence:
<10.0%*
Severity: MODERATE
Onset: DELAYED
Elevated Hepatic Enzymes Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Chills Incidence:
<3.0%*
Severity: MILD
Onset: RAPID
Hyperesthesia Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
Vomiting Incidence:
<10.0%*
Severity: MILD
Onset: EARLY
Drug-Induced Acne Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Inflamed Brain Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Weakness Incidence:
<3.0%*
Severity: MILD
Onset: DELAYED
Blurred Vision Incidence:
<10.0%*
Severity: MODERATE
Onset: EARLY
Peripheral Vasodilation Incidence:
<1.0%*
Severity: MODERATE
Onset: RAPID
Photosensitivity Incidence:
<3.0%*
Severity: MILD
Onset: DELAYED
Rhinitis Incidence:
<3.0%*
Severity: MILD
Onset: EARLY
Dandruff Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Paresthesias Incidence:
<2.0%*
Severity: MILD
Onset: DELAYED
Vesicular Rash Incidence:
<4.0%*
Severity: MILD
Onset: DELAYED
Visual Impairment Incidence:
<10.0%*
Severity: SEVERE
Onset: EARLY
Rash With Pustules Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Secretion Of Tears Incidence:
<30.0%*
Severity: MILD
Onset: EARLY
High Cholesterol Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Sinus Infection Incidence:
<5.0%*
Severity: MILD
Onset: DELAYED
Eye Pain Incidence:
<15.0%*
Severity: MILD
Onset: EARLY
Migraine Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Inability To Sleep Incidence:
<6.0%*
Severity: MILD
Onset: EARLY
Fever Incidence:
<3.0%*
Severity: MILD
Onset: EARLY
Allergic Skin Reaction Incidence:
<33.0%*
Severity: MODERATE
Onset: DELAYED
Blood In The Urine Incidence:
<2.0%*
Severity: MODERATE
Onset: DELAYED
Increased Blood Sugar Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Skin Rash Incidence:
>1.0%*
Severity: MILD
Onset: EARLY
Gas Incidence:
>1.0%*
Severity: MILD
Onset: EARLY
Heartburn Incidence:
>1.0%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
>1.0%*
Severity: MILD
Onset: EARLY
Swelling Incidence:
1.0-33.0%*
Severity: MODERATE
Onset: DELAYED
Stomach Ulcer Incidence:
>1.0%*
Severity: SEVERE
Onset: DELAYED
Infection Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Upset Stomach Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Constipation Incidence:
>1.0%*
Severity: MODERATE
Onset: DELAYED
Drowsiness Incidence:
1.0-2.6%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
>1.0%*
Severity: MILD
Onset: EARLY
Hair Loss Incidence:
1.0-2.0%*
Severity: MILD
Onset: DELAYED
Skin Ulcer Incidence:
1.0-2.0%*
Severity: MODERATE
Onset: DELAYED
Headache Incidence:
>1.0%*
Severity: MILD
Onset: EARLY
Hole In Intestines Incidence:
1.0-10.0%*
Severity: SEVERE
Onset: DELAYED
Intestinal Bleeding Incidence:
1.0-10.0%*
Severity: SEVERE
Onset: DELAYED
Stomach Pain Incidence:
>1.0%*
Severity: MILD
Onset: EARLY
High Blood Pressure Incidence:
1.0-3.0%*
Severity: MODERATE
Onset: EARLY
Fluid Retention Incidence:
>1.0%*
Severity: MODERATE
Onset: DELAYED
Itching Incidence:
>1.0%*
Severity: MILD
Onset: RAPID
Lightheadedness Incidence:
>1.0%*
Severity: MILD
Onset: EARLY
Bad Breath Incidence:
1.0%*
Severity: MILD
Onset: EARLY
Hypoesthesia Incidence:
1.0%*
Severity: MILD
Onset: DELAYED
Hyperkinesis Incidence:
1.0%*
Severity: MILD
Onset: DELAYED
Ringing In Ears Incidence:
>1.0%*
Severity: MILD
Onset: DELAYED
Metallic Taste Incidence:
2.0%*
Severity: MILD
Onset: EARLY
Sore Throat Incidence:
2.0-6.0%*
Severity: MILD
Onset: DELAYED
Muscle Pain Incidence:
2.0-3.0%*
Severity: MILD
Onset: EARLY
Shortness Of Breath Incidence:
2.0%*
Severity: MODERATE
Onset: EARLY
Flu Incidence:
3.0%*
Severity: MILD
Onset: DELAYED
Joint Pain Incidence:
3.0%*
Severity: MILD
Onset: DELAYED
Back Pain Incidence:
3.0%*
Severity: MILD
Onset: DELAYED
Inflamed Stomach Incidence:
3.0%*
Severity: MODERATE
Onset: DELAYED
Skin Discoloration Incidence:
4.0%*
Severity: MILD
Onset: DELAYED
Skin Irritation Incidence:
4.0%*
Severity: MILD
Onset: EARLY
Cough Incidence:
4.0%*
Severity: MILD
Onset: DELAYED
Thinning Of Skin Incidence:
4.0%*
Severity: SEVERE
Onset: DELAYED
Skin Redness Incidence:
4.0-9.0%*
Severity: MODERATE
Onset: EARLY
Low Blood Pressure Incidence:
5.0%*
Severity: MODERATE
Onset: RAPID
Dry Skin Incidence:
7.0-11.0%*
Severity: MILD
Onset: DELAYED
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Daily Life Interactions for Diclofenac Sodium 3% Topical Gel

Elements of your daily lifestyle may have an effect on the medications you are taking. Drug interactions can result in unwanted side effects, reduce the effectiveness of your medicine or possibly increase the action of a particular medicine.

Major Lifestyle Interaction
Alcohol and Diclofenac Sodium 3% Topical Gel(Diclofenac Sodium)
Alcohol and Nonsteroidal antiinflammatory drugs (systemic)(Diclofenac Sodium)
Side effects from this drug may get worse if you drink alcohol-containing drinks. If you have persistent stomach upset, vomit blood or what looks like coffee grounds, or have black, tarry stools, contact your health care provider immediately. It is best to limit or avoid alcohol containing drinks while taking this drug, even with short term use. Many non-prescription products for headaches, pain, arthritis, or sinus pain contain drugs that may cause stomach problems along with alcohol; closely read labels before taking any medicines with alcohol-containing drinks.
Moderate Lifestyle Interaction
Tobacco and Diclofenac Sodium 3% Topical Gel(Diclofenac Sodium)
Tobacco and Nonsteroidal antiinflammatory drugs (systemic)(Diclofenac Sodium)
Tobacco-smoking may increase the risk for ulcers and gastrointestinal problems with these drugs. Ask your health care provider about a plan to stop smoking. If you have persistent stomach upset, vomit blood or what looks like coffee grounds, or have black, tarry stools, contact your health care provider immediately.
Moderate Lifestyle Interaction
Marijuana and Diclofenac Sodium 3% Topical Gel(Diclofenac Sodium)
Marijuana and Nonsteroidal antiinflammatory drugs (systemic)(Diclofenac Sodium)
Although an interaction is possible, these drugs may be used together. In therory, the actions of Marijuana, Medical may be decreased if you take Nonsteroidal Antiinflammatory Drugs (NSAIDs). However, the importance of this interaction is not known. Patients receiving this drug combination may notice decreased euphoria and heart rate.
Pregnancy & Lactation Information
First Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Second Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Third Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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