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Safety Concerns With Diclofenac Gel

General Diclofenac Gel Precautions and Warnings

Some precautions and warnings to be aware of with this product include:
 
  • All nonsteroidal anti-inflammatory drugs (NSAIDs), including diclofenac gel, have been linked to cardiovascular events, such as heart attack or stroke. People who have cardiovascular disease or cardiovascular risk factors appear to be at greater risk. To decrease the risk of these problems, you should take the smallest effective dose for the shortest period of time (using diclofenac gel is a good way to do this, since only 6 percent of the medication is absorbed to the rest of the body).
Be sure to call 911 if you notice heart attack symptoms or stroke symptoms, such as:
    • Chest pain
    • Shortness of breath
    • Weakness
    • Slurring of speech.

 

  • Even though this medication is a gel that is applied to the skin, some of the medication is absorbed into the bloodstream. Therefore, all of the standard warnings and precautions with other NSAIDs apply to diclofenac gel as well.
     
  • There is a "Medication Guide" (an FDA-approved handout) that should be dispensed along with diclofenac gel. Be sure to read the medication guide before using this medication and periodically thereafter.
     
  • All NSAIDs, including diclofenac gel, may cause high blood pressure or make it worse in people who already have it. Therefore, diclofenac gel should be used with caution in people with known high blood pressure.
     
  • All NSAIDs, including diclofenac gel, may cause congestive heart failure or fluid retention. Contact your healthcare provider if you notice unexplained weight gain or swelling while taking this drug. Also, diclofenac gel should be used with caution in people with heart failure.
     
  • All NSAIDs, including diclofenac gel, have been reported to cause problems in the stomach and intestines, including bleeding (known as gastrointestinal bleeding), stomach ulcers, or holes in the stomach or intestines (called perforations). These problems can lead to serious complications or even loss of life. Extreme caution should be used if diclofenac gel is prescribed for people with a history of ulcers or gastrointestinal bleeding.
To decrease the risk of these problems, you should take the smallest effective dose for the shortest period of time. Contact your healthcare provider immediately if you experience any signs or symptoms of stomach ulcers or bleeding, including:
    • Stomach pain
    • Indigestion
    • Black, tarry stools
    • Vomiting blood.
It is important to understand that diclofenac gel can cause this problem, even though it is not taken by mouth.
  • Diclofenac gel can interact with certain medications (see Drug Interactions With Diclofenac Gel).
     
  • Kidney damage can occur in people taking NSAIDs, including diclofenac gel. This occurrence is more common in the elderly, as well as in people with kidney disease, heart failure, liver problems, and those taking a diuretic or ACE inhibitor.
     
  • Liver damage can occur in people taking diclofenac gel. Contact your healthcare provider immediately if you notice things such as:

 

    • Nausea
    • Tiredness
    • Lethargy
    • Itchy or yellowing skin
    • Abdominal pain
    • Flu-like symptoms.

 

  • NSAIDs, including diclofenac gel, have been reported to cause allergic reactions. Seek emergency medical attention immediately if you notice things such as difficulty breathing or swelling of the face and throat.
     
  • In rare cases, people taking diclofenac gel can develop a serious rash. If you notice an unexplained rash or develop blisters, fever, or itchy skin, stop taking diclofenac gel and call your healthcare provider right away.
     
  • There have been reports of anemia in people taking NSAIDs. Therefore, if you are taking diclofenac gel for an extended period of time and show signs of anemia, talk to your healthcare provider.
     
  • It is possible that diclofenac gel could worsen asthma, especially in people with aspirin-sensitive asthma.
     
  • Avoid prolonged, unprotected sun exposure while using this medication, as animal studies indicate that it might increase the risk of skin cancers.
     
  • Diclofenac gel is a pregnancy Category B medication (for Solaraze) or a pregnancy Category C medicine (for Voltaren Gel). This means that it might not be safe during pregnancy, although the full risks are currently unknown (see Solaraze Gel and Pregnancy or Voltaren Gel and Pregnancy for more information).
     
  • It is unknown if diclofenac gel passes through breast milk. Therefore, if you are breastfeeding, check with your healthcare provider before using diclofenac gel (see Solaraze Gel and Breastfeeding or Voltaren Gel and Breastfeeding).
     
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