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Of the 423 patients evaluable for safety in adequate and well-controlled trials, 211 were treated with Solaraze® drug product and 212 were treated with a vehicle gel. Eighty-seven percent (87%) of the Solaraze®-treated patients (183 patients) and 84% of the vehicle-treated patients (178 patients) experienced one or more adverse events (AEs) during the studies. The majority of these reactions were mild to moderate in severity and resolved upon discontinuation of therapy.
Of the 211 patients treated with Solaraze®, 172 (82%) experienced AEs involving skin and the application site compared to 160 (75%) vehicle-treated patients. Application site reactions (ASRs) were the most frequent AEs in both Solaraze®-and vehicle-treated groups. Of note, four reactions, contact dermatitis, rash, dry skin and exfoliation (scaling) were significantly more prevalent in the Solaraze® group than in the vehicle-treated patients.
Eighteen percent of Solaraze®-treated patients and 4% of vehicle-treated patients discontinued from the clinical trials due to adverse events (whether considered related to treatment or not). These discontinuations were mainly due to skin irritation or related cutaneous adverse reactions.
Table 1 below presents the AEs reported at an incidence of > 1% for patients treated with either Solaraze® Gel or vehicle (60- and 90-day treatment groups) during the phase 3 studies.
Table 1. Adverse Events Reported ( > 1% in Any Treatment
Group) During Solaraze® Phase 3 Clinical Trials Incidences for 60-Day and
|60-day Treatment||90-day Treatment|
|Solaraze® (%)||Gel Vehicle (%)||Solaraze® (%)||Gel Vehicle (%)|
|BODY AS A WHOLE||21||20||20||18|
|METABOLIC AND NUTRITIONAL DISORDERS||2||8||7||2|
|Creatine Phosphokinase Increased||0||0||4||1|
|SKIN AND APPENDAGES||75||86||86||71|
|Application Site Reaction||75||71||84||70|
Skin and Appendages Adverse Events Reported for Solaraze® at Less Than 1 % Incidence in the Phase 3 Studies: skin hypertrophy, paresthesia, seborrhea, urticaria, application site reactions (skin carcinoma, hypertonia, skin hypertrophy lacrimation disorder, maculopapular rash, purpuric rash, vasodilation).
Adverse Reactions Reported for Oral Diclofenac Dosage Form (not topical Solaraze® Gel): *Incidence greater than 1% marked with asterisk.
Body as a Whole: abdominal pain or cramps*, headache*, fluid retention*, abdominal distention*, malaise, swelling of lips and tongue, photosensitivity, anaphylaxis, anaphylactoid reactions, chest pain.
Digestive: diarrhea*, indigestion*, nausea*, constipation*, flatulence*, liver test abnormalities*, PUB*, i.e., peptic ulcer, with or without bleeding and/or perforation, or bleeding without ulcer, vomiting, jaundice, melena, esophageal lesions, aphthous stomatitis, dry mouth and mucous membranes, bloody diarrhea, hepatitis, hepatic necrosis, cirrhosis, hepatorenal syndrome, appetite change, pancreatitis with or without concomitant hepatitis, colitis, intestinal perforation.
Nervous System: dizziness*, insomnia, drowsiness, depression, diplopia, anxiety, irritability, aseptic meningitis, convulsions, paresthesia, memory disturbance, nightmares, tremor, tic, abnormal coordination, disorientation, psychotic reaction.
Skin and Appendages: rash*, pruritus*, alopecia, urticaria, eczema, dermatitis, bullous eruption, erythema multiforme major, angioedema, Stevens-Johnson syndrome, excess perspiration, exfoliative dermatitis.
Read the Solaraze (diclofenac sodium) Side Effects Center for a complete guide to possible side effects
Specific interaction studies between Solaraze® Gel and other topical or oral agents were not performed.
Oral Nonsteroidal Anti-Inflammatory Drugs
Although low, there is systemic exposure to diclofenac following labeled use of Solaraze® Gel. Therefore, concomitant administration of Solaraze® Gel with oral NSAIDS or aspirin may result in increased NSAID adverse effects.
Read the Solaraze Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 1/4/2012
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