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Diclofenac gel

Pronunciation

Generic Name: diclofenac (dye-KLOE-fen-ak)
Brand Name: Voltaren Gel

Diclofenac gel is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, a heart attack, stroke). The risk may be greater if you already have heart problems or if you use diclofenac gel for a long time. Do not use diclofenac gel right before or after bypass heart surgery.

Diclofenac gel may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.


Diclofenac gel is used for:

Treating pain in certain joints (eg, in the knees or hands) caused by osteoarthritis. It may also be used for other conditions as determined by your doctor.

Diclofenac gel is an NSAID. It may work by blocking certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Do NOT use diclofenac gel if:

  • you are allergic to any ingredient in diclofenac gel
  • you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or another NSAID (eg, celecoxib, ibuprofen)
  • you have recently had or will be having bypass heart surgery
  • you have severe kidney problems
  • you are in the last 3 months of pregnancy

Contact your doctor or health care provider right away if any of these apply to you.

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Before using diclofenac gel:

Some medical conditions may interact with diclofenac gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of kidney or liver problems, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)
  • if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation
  • if you have high blood pressure, blood disorders (eg, porphyria), bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk of any of these diseases
  • if you have poor health, dehydration or low fluid volume, low blood sodium levels, or you drink alcohol or have a history of alcohol abuse

Some MEDICINES MAY INTERACT with diclofenac gel. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin), aspirin, clopidogrel, corticosteroids (eg, prednisone), direct factor Xa inhibitors (eg, rivaroxaban), heparin, prasugrel, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of bleeding, including stomach bleeding, may be increased
  • Azole antifungals (eg, itraconazole, voriconazole), bisphosphonates (eg, risedronate), or probenecid because they may increase the risk of diclofenac gel's side effects
  • Rifamycins (eg, rifampin) because they may decrease diclofenac gel's effectiveness
  • Cyclosporine, lithium, methotrexate, oral NSAIDs (eg, ibuprofen), quinolones (eg, ciprofloxacin), or tenofovir because the risk of their side effects may be increased by diclofenac gel
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by diclofenac gel
  • Medicines that may harm the liver (eg, acetaminophen, ketoconazole, isoniazid, certain medicines for HIV infection, certain antibiotics or seizure medicines) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

This may not be a complete list of all interactions that may occur. Ask your health care provider if diclofenac gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use diclofenac gel:

Use diclofenac gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Diclofenac gel comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get diclofenac gel refilled.
  • Do not apply diclofenac gel to infected skin; open wounds; or red, swollen, or peeling skin.
  • Use the provided dosing card to measure your dose of diclofenac gel. Ask your pharmacist if you have any questions about how to use the dosing card or diclofenac gel.
  • Gently massage diclofenac gel into the skin of the affected area. Allow the medicine to dry for at least 10 minutes before you wear clothes or gloves over the treated area.
  • After using the dosing card, fold it in half (with the used side inside) and throw it away out of the reach of children and pets.
  • Wash your hands immediately after using diclofenac gel, unless your hands are part of the treated area.
  • Do not wrap, bandage, or apply heat to the treated area.
  • Do not shower, bathe, or wash the treated area for at least 1 hour after you use diclofenac gel.
  • If you miss a dose of diclofenac gel, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use diclofenac gel.

Important safety information:

  • Diclofenac gel may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use diclofenac gel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Diclofenac gel is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse at once with cool water.
  • Serious stomach ulcers or bleeding can occur with the use of diclofenac gel. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking diclofenac gel with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
  • Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Diclofenac gel is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Do not take aspirin while you are using diclofenac gel unless your doctor tells you to.
  • Do not use sunscreens, lotions, insect repellants, or other topical medicines on the treated area.
  • Do not expose the treated area to the sun, sunlamps, or tanning booths.
  • Diclofenac gel may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
  • Lab tests, including kidney and liver function, blood electrolyte levels, complete blood cell counts, and blood pressure, may be performed while you use diclofenac gel. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use diclofenac gel with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
  • Diclofenac gel should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Diclofenac gel may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using diclofenac gel while you are pregnant. It is not known if diclofenac gel is found in breast milk after topical use. Do not breast-feed while taking diclofenac gel.

Possible side effects of diclofenac gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild irritation at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent irritation at the application site; severe or persistent stomach pain or nausea; severe vomiting or diarrhea; shortness of breath; sudden or unexplained weight gain; swelling of the hands, legs, or feet; unusual bruising or bleeding; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, yellowing of the skin or eyes); unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea, vomiting, or stomach pain; slow or troubled breathing; tremor; unusual bleeding or bruising; vomit that looks like coffee grounds.

Proper storage of diclofenac gel:

Store diclofenac gel at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep diclofenac gel out of the reach of children and away from pets.

General information:

  • If you have any questions about diclofenac gel, please talk with your doctor, pharmacist, or other health care provider.
  • Diclofenac gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take diclofenac gel or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about diclofenac gel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to diclofenac gel. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using diclofenac gel.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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