Diclofenac sodium Oral Precautions and Side Effects

  • Precautions

    Before taking diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

    Before using this medication, tell your doctor or pharmacist your medical history, especially of:

    • asthma (including a history of worsening breathing after taking aspirin or other NSAIDs)
    • bleeding or clotting problems
    • dehydration
    • heart disease (such as congestive heart failure, previous heart attack)
    • high blood pressure
    • kidney disease
    • liver disease
    • growths in the nose (nasal polyps)
    • stomach/intestinal/esophagus problems (such as bleeding, ulcers, recurring heartburn)
    • stroke

    Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

    This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

    This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

    This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.

    Older adults may be at greater risk for stomach/intestinal bleeding and kidney effects while using this drug.

    Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor before using this medication.

    This drug passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

    Side Effects

    See also Warning section.

    Upset stomach, nausea, heartburn, diarrhea, constipation, gas, headache, tiredness, drowsiness, and dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

    Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

    Tell your doctor right away if any of these unlikely but serious side effects occur:

    • swelling of the hands or feet (edema)
    • sudden or unexplained weight gain
    • hearing changes (such as ringing in the ears)
    • mental/mood changes
    • difficult/painful swallowing

    Get medical help right away if any of these rare but very serious side effects occur:

    • change in the amount of urine
    • unexplained stiff neck

    This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including:

    • dark urine
    • persistent nausea/vomiting/loss of appetite
    • stomach/abdominal pain
    • yellowing eyes or skin
    • unusual/extreme tiredness

    A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

    • rash
    • itching/swelling (especially of the face/tongue/throat)
    • severe dizziness
    • trouble breathing

    This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

    In the US -

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

    Warning

    Nonsteroidal anti-inflammatory drugs (including diclofenac) may rarely increase the risk for a heart attack or stroke. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. This drug should not be taken right before or after heart bypass surgery (CABG).

    Also, this drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning symptoms at any time while taking this drug. Older adults may be at higher risk for this effect. (See also Precautions and Drug Interactions sections.)

    Stop taking diclofenac and get medical help right away if you notice any of the following rare but serious side effects: bloody or black/tarry stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, sudden vision changes, slurred speech.

    Talk with your doctor or pharmacist about the risks and benefits of treatment with this medication.