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Table 2 Observed frequency of expected adverse reactions to anti-leishmanial drugs

From: Using focused pharmacovigilance for ensuring patient safety against antileishmanial drugs in Bangladesh’s National Kala-azar Elimination Programme

Serial No.

Adverse reaction

Frequency % (n/N)

Liposomal amphotericin B (L-AmB) mono therapy (n/N)

Miltefosine mono therapy (n/N)

Paromomycin mono therapy (n/N)

L-AmB and miltefosine combination therapy (n/N)

L-AmB and paromomycin combination therapy (n/N)

Miltefosine and paromomycin combination therapy (n/N)

1.

Fever

16.5 (176/1066)

20.4 (167/817)

4.7 (9/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

2.

Vomiting

4.8 (51/1066)

4.2 (34/817)

8.8 (17/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

3.

Chills

3.9 (42/1066)

4.9 (40/817)

0.5 (1/193)

0 (0/1)

4.2 (1/24)

0 (0/30)

0 (0/1)

4.

Rigor

3.1 (33/1066)

3.9 (32/817)

0 (0/193)

0 (0/1)

4.2 (1/24)

0 (0/30)

0 (0/1)

5.

Nausea

2.2 (23/1066)

1.5 (12/817)

5.7 (11/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

6.

Diarrhea

1.4 (15/1066)

1.8 (15/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

7.

Facial flushing

1.4 (15/1066)

1.7 (14/817)

0 (0/193)

0 (0/1)

4.2 (1/24)

0 (0/30)

0 (0/1)

8.

Back pain

1.2 (13/1066)

1.5 (12/817)

0 (0/193)

0 (0/1)

4.2 (1/24)

0 (0/30)

0 (0/1)

9.

Anorexia

1.0 (11/1066)

0.4 (3/817)

4.1 (8/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

10.

Chest pain

0.8 (9/1066)

1.0 (8/817)

0 (0/193)

0 (0/1)

4.2 (1/24)

0 (0/30)

0 (0/1)

11.

Abdominal pain

0.8 (8/1066)

0.7 (6/817)

1.0 (2/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

12.

Headache

0.8 (8/1066)

0.5 (4/817)

2.1 (4/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

13.

Death

0.8 (8/1066)

1.0 (8/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

14.

Heaviness of head

0.7 (7/1066)

0.9 (7/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

15.

Rash

0.7 (7/1066)

0.9 (7/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

16.

Sweating

0.6 (6/1066)

0.6 (5/817)

0 (0/193)

0 (0/1)

4.2 (1/24)

0 (0/30)

0 (0/1)

17.

Malaise

0.6 (6/1066)

0 (0/817)

3.1 (6/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

18.

Vertigo

0.4 (4/1066)

0.5 (4/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

19.

Hypotension

0.4 (4/1066)

0.5 (4/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

20.

Tachycardia

0.4 (4/1066)

0.4 (3/817)

0 (0/193)

0 (0/1)

4.2 (1/24)

0 (0/30)

0 (0/1)

21.

Dyspnea

0.4 (4/1066)

0.4 (4/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

22.

Chest tightness

0.3 (3/1066)

0.4 (3/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

23.

Weakness

0.3 (3/1066)

0.4 (3/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

24.

Cough

0.1 (1/1066)

0 (0/817)

0 (0/193)

0 (0/1)

4.2 (1/24)

0 (0/30)

0 (0/1)

25.

Dyspepsia

0.2 (2/1066)

0.2 (2/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

26.

Hypertension

0.1 (1/1066)

0.1 (1/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

27.

Jaundice

0.1 (1/1066)

0.1 (1/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

28.

Leucopenia

0.1 (1/1066)

0.1 (1/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

29.

Bone pain

0.1 (1/1066)

0.1 (1/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

30.

Arthralgia

0.1 (1/1066)

0.1 (1/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

31.

Allergic reaction

0.1 (1/1066)

0.1 (1/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

32.

Belching

0.1 (1/1066)

0.1 (1/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

33.

Injection site swelling

0.1 (1/1066)

0.1 (1/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

34.

Lymphadenopathy

0.1 (1/1066)

1 (1/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

35.

Salivation

0.1 (1/1066)

0.1 (1/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

36.

Respiratory insufficiency

0.1 (1/1066)

0.1 (1/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

37.

Pruritus

0.1 (1/1066)

0.1 (1/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

38.

Leucopenia

0.1 (1/1066)

0.1 (1/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

39.

Annular corneal ulcer

0.1 (1/1066)

0 (0/817)

0.5 (1/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

40.

Mooren’s ulcer

0.1 (1/1066)

0 (0/817)

0.5 (1/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

41.

Avascular necrosis of alae of nose

0.1 (1/1066)

0.1 (1/817)

0 (0/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)

42.

Cervical lymphonode

0.1 (1/1066)

0 (0/817)

0.5 (1/193)

0 (0/1)

0 (0/24)

0 (0/30)

0 (0/1)