S. No

Description of ADR

No. of ADRs n = 128 (%)

No. of Patients N = 2248 (%)

1

Constipation

22 (17.18)

22 (0.91)

2

Oliguria

18 (14.06)

18 (0.80)

3

Cold

17 (13.28)

17 (0.75)

4

Dysuria

16 (12.5)

16 (0.71)

5

Fever

14 (10.93)

14 (0.62)

6

Arthralgia

8 (6.25)

8 (0.35)

7

Blurred vision

8 (6.25)

8 (0.35)

8

Insomnia

6 (4.68)

6 (0.26)

9

Myalgia

5 (3.90)

5 (0.22)

10

Back pain

2 (1.56)

2 (0.08)

11

Diarrhea

1 (0.78)

1 (0.04)

12

Nausea

1 (0.78)

1 (0.04)

13

Abdominal pain

1 (0.78)

1 (0.04)

14

Flatulence

1 (0.78)

1 (0.04)

15

GI Cramps

1 (0.78)

1 (0.04)

16

Headache

1 (0.78)

1 (0.04)

17

Vertigo

1 (0.78)

1 (0.04)

18

Malaise

1 (0.78)

1 (0.04)

19

Skin rash

1 (0.78)

1 (0.04)

20

Pruritus

1 (0.78)

1 (0.04)

21

Hair Loss

1 (0.78)

1 (0.04)

22

Urticaria

1 (0.78)

1 (0.04)