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Diclofenac sodium gel is indicated for the topical treatment of actinic keratoses (AK). Diclofenac sodium gel is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the topical treatment of actinic keratoses (AK). ( 1 )

Diclofenac sodium gel is contraindicated in the following patients: With known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see Warnings and Precautions ( 5.1 , 5.3 , 5.10 ) and Description ( 11 )] With the history of asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions ( 5.1 , 5.2 )] Application on damaged skin resulting from any etiology, including exudative dermatitis, eczema, infected lesions, burns or wounds [see Warnings and Precautions ( 5.3 )] In the setting of coronary bypass graft (CABG) surgery [see Warnings and Precautions ( 5.4 )] Known hypersensitivity to diclofenac or any components of the drug product. ( 4 , 11 ) History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. ( 4 ) Use on damaged …

Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs. ( 5.1 ) Exacerbation of Asthma Related to Aspirin Sensitivity: Diclofenac sodium gel is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with pre-existing asthma (without aspirin sensitivity). ( 5.2 ) Serious Skin Reactions: Discontinue diclofenac sodium gel at first appearance of skin rash or other signs of hypersensitivity. ( 5.3 , 5.15 ) Hepatoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. ( 5.6 ) Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. ( 5.7 , 7 ) Heart Failure and Edema: Avoid use of diclofenac sodium gel in patients with severe heart failure. ( 5.8 ) Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of diclofenac sodium gel in patients with advanced renal disease. ( 5.9 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue diclofenac sodium gel and evaluate clinically. ( 5.10 ) Fetal Toxicity: Limit use of NSAIDs, including diclofenac sodium gel, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation …

8.1 Pregnancy Risk Summary Use of NSAIDs, including diclofenac sodium gel, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of diclofenac sodium gel use between about 20 and 30 weeks of gestation and avoid diclofenac sodium gel use at about 30 weeks of gestation and later in pregnancy. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Premature …