Pennsaid Warnings and Precautions

People who have high blood pressure should use Pennsaid with caution, as the medication can make hypertension worse. Warnings and precautions with Pennsaid also extend to people with asthma and women who are pregnant or breastfeeding. If you are allergic to aspirin or have recently had open heart surgery, you should not use this product.

What Should I Tell My Healthcare Provider?

Prior to using Pennsaid® (diclofenac sodium topical solution), talk to your healthcare provider if you have:
 
Also, let your healthcare provider know if you:
 
  • Are pregnant or thinking of becoming pregnant
  • Are breastfeeding
  • Have had heart surgery recently.
     
You should also be sure to tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medications, vitamins, and herbal supplements.
 

Specific Warnings and Precautions With Pennsaid

Various precautions and warnings to be aware of prior to using Pennsaid include the following:
 
  • Even though Pennsaid is a solution that is applied to the skin, some medication is absorbed into the bloodstream. Therefore, all of the standard precautions and warnings with other nonsteroidal anti-inflammatory drugs (NSAIDs) apply to Pennsaid as well.
     
  • There is a "Medication Guide" (a handout approved by the U.S. Food and Drug Administration) that should be dispensed along with Pennsaid. Be sure to read this guide before using this medication and periodically thereafter.
     
  • All NSAIDs, including diclofenac (the active ingredient in Pennsaid), 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 chances of these problems occurring, you should take the smallest effective dose for the shortest period. Using Pennsaid is a good way to do this, since only 6 percent of the medication is absorbed into 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.
  • All NSAIDs may cause high blood pressure or make it worse in people who already have it. Therefore, Pennsaid should be used with caution in people with known high blood pressure.
     
  • All NSAIDs may cause congestive heart failure or fluid retention. Contact your healthcare provider if you notice unexplained weight gain or swelling while using this drug. Pennsaid should be used with caution in people with heart failure.
     
  • All NSAIDs, including diclofenac (the active ingredient in Pennsaid), 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 Pennsaid is prescribed for people with a history of ulcers or gastrointestinal bleeding.
To decrease the risk of these problems, you should use the smallest effective dose for the shortest period. 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.
Pennsaid can cause this problem even though it is not taken by mouth.
  • Pennsaid can interact with certain medications (see Pennsaid Drug Interactions).
     
  • Kidney damage can occur in people taking NSAIDs. 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 angiotensin-converting enzyme (ACE) inhibitor.
     
  • Liver damage can occur in people taking Pennsaid. Contact your healthcare provider immediately if you notice things such as:
     
    • Nausea
    • Tiredness
    • Lethargy
    • Itchy or yellowing skin
    • Abdominal pain (stomach pain)
    • Flu-like symptoms.
 
  • NSAIDs 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 using Pennsaid can develop a serious rash. If you notice an unexplained rash or develop blisters, fever, or itchy skin, stop using this medication and call your healthcare provider right away.
     
  • There have been reports of anemia in people taking NSAIDs. Therefore, if you are using Pennsaid for an extended period and show signs of anemia, talk to your healthcare provider.
     
  • Pennsaid 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.
     
  • Pennsaid is a pregnancy Category C or D medicine, depending on the particular trimester, which means it might not be safe during pregnancy. If you become pregnant while using this drug, contact your healthcare provider immediately (see Pennsaid and Pregnancy).
     
  • It is unknown if Pennsaid passes through breast milk. Therefore, if you are breastfeeding a child, check with your healthcare provider (or your child's healthcare provider) before using this product (see Pennsaid and Breastfeeding).
     
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