A randomized crossover trial to assess therapeutic efficacy and cost reduction of acid ursodeoxycholic manufactured by the university hospital for the treatment of primary biliary cholangitis

Table 4 Adverse events during the treatment period (n = 34). Description about adverse events during the treatment period in sequence A and B with UDCA 300 mg capsules and tablets manufactured by the university hospital during all 24 weeks

Adverse Event	Sequence A (n = 15) n (%)		Sequence B (n = 19) n (%)
Adverse Event	Tablets	Capsules	Capsules	Tablets
Headache	0	0	1 (4)	0
Diarrhea	0	0	3 (12)	0
Abdominal pain	0	0	1 (4)	0
Flatulence	2 (8)	1 (4)	1 (4)	0
Acute myocardial infarction^a	0	1 (4)	0	0
Urinary infection	0	0	1 (4)	0
Improvement in intestinal function	1 (4)	3 (12)	1 (4)	0
Nausea	0	0	1 (4)	0
Worsening of rosacea	1 (4)	1 (4)	0	0
Itch	3 (12)	1 (4)	1 (4)	0
Vomit	0	0	1 (4)	0

^a Occurred at the end of the study. Did not have it causal relationship established with the UDCA

ISSN: 1471-230X