Table 3.

Adverse events in studies comparing diclofenac sodium topical solution with oral diclofenac²⁶,²⁷

Adverse events (%)	Tugwell et al27		Simon et al26
	TDiclo	Oral diclofenac	TDiclo	Oral diclofenac
Application site
Dry skin	27	1a	18.2	2.6
Rash	12	2a	–	–
Paresthesia	0.6	0.6	–	–
Pruritus	6	0.6a	1.3	0.0
Urticaria	0.3	0.3	–	–
Vesiculobullous rash	5	0a	1.9	0.7
Contact dermatitis	–	–	2.6	0.7
Gastrointestinal
All GI events	35	48a	6.5	23.8
Abdominal pain	12	22a	3.2	7.3
Constipation	8	10	–	–
Diarrhea	9	17a	1.3	4.6
Dyspepsia	15	26a	2.6	4.0
Flatulence	10	17a	–	–
Melena	1	2	–	–
Nausea	8	13a	0.0	2.0
Vomiting	2	2	ND	ND
Laboratory parametersb
AST	2	10a	6.9	19.6
ALT	5	17a	4.1	18.8
Hemoglobin	2	10a	2.1	5.8
Creatinine	1	3	2.8	7.2

^aNotes: P < 0.05 vs TDiclo with DMSO. No statistical analysis was performed in Simon et al;²⁶

^bPercentage of patients changing from normal levels at baseline to abnormal levels during the study.

Abbreviations: GI, gastrointestinal; AST, aspartate aminotransferase; ALT, alanine aminotransferase; DMSO, dimethyl sulfoxide; TDiclo, diclofenac sodium topical solution.