Diclofenac

FDA label, Strand Health Group, transdermal, effective 2025-12-18. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Nonsteroidal Anti-inflammatory Drug

Dosing in kidney impairment

However, severe hepatic reactions can occur at any time during treatment with diclofenac. Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). To minimize potential risk for an adverse liver-related event in patients treated with diclofenac external, exercise caution when prescribing diclofenac external with concomitant drugs that are known to be potentially hepatotoxic (e.g., acetaminophen, antibiotics, antiepileptics). 5.4 Renal Toxicity and Hyperkalemia Renal Toxicity Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.

Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation.

Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors or ARBs, and the elderly. Discontinuation of NSAID therapy was usually followed by recovery to the pretreatment state. Avoid the use of diclofenac external in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function.

If diclofenac is used in patients with advanced renal disease, monitor patients for signs of worsening symptoms. Hyperkalemia Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state. 5.5 Anaphylactic Reactions Diclofenac has been associated with anaphylactic reactions in patients with and without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma.

Drug interactions

Check diclofenac against a medication list
Label text (3 paragraphs)

6. DRUG INTERACTIONS Drugs That Interfere with Hemostasis Monitor patients with concomitant use of diclofenac external with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding. Aspirin Concomitant use of diclofenac external and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment.

Diuretics During concomitant use of diclofenac external with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects. Digoxin During concomitant use of diclofenac external and digoxin, monitor serum digoxin levels. Lithium During concomitant use of diclofenac external and lithium, monitor patients for signs of lithium toxicity. Methotrexate During concomitant use of diclofenac external and methotrexate, monitor patients for methotrexate toxicity. Cyclosporine During concomitant use of diclofenac external and cyclosporine, monitor patients for signs of worsening renal function.

Pemetrexed Concomitant use of diclofenac external and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity.

Contraindications

4. CONTRAINDICATIONS Xiclo™ Transdermal Patch is contraindicated in patients with a known history of hypersensitivity to non-steroidal anti-inflammatory medications such as diclofenac. Diclofenac is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. History of asthma, uticaria, or allergic-type reactions after absorbing non-steroidal anti-inflammatory drugs (NSAIDs) should also be considered.

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