Table 5

Incidence of adverse events

Adverse events

Placebo (n = 23)

100 mg/day 5-Loxin^® (n = 24)

250 mg/day 5-Loxin^® (n = 23)

Diarrhoea

3

2

2

Nausea

1

3

2

Vomiting

1

1

1

Abdominal pain

4

2

2

Pedal edema

0

1

0

Itching

2

1

4

General weakness

2

4

2

Constipation

0

0

1

Mild fever (up to 37.5°C)

1

2

2

Stomach burn

4

0

3

Allergy^a

3

0

1

Headache

0

0

1

Miscellaneous^b

9

2

6

Sum of events

30

18

27

^aAllergy includes redness of skin and sinus allergy. ^bMiscellaneous group includes body pain, loss of hair, chest pain and eye infection.

Sengupta et al. Arthritis Research & Therapy 2008 10:R85   doi:10.1186/ar2461