Adverse drug reaction |
Patients |
Naranjo score |
Severity grading |
Regimen switch/drug substitution |
Outcome of treatment Number (%) |
Death |
Recovered with disability |
Recovered fully |
Skin rash |
100 (26.3) |
5-8 |
Mild |
None |
|
|
100 (26.3) |
Insomnia |
10 (2.6) |
5-8 |
Mild |
None |
|
|
10 (2.6) |
Somnolence |
7 (1.8) |
5-8 |
Mild |
None |
|
|
7 (1.8) |
Bad dreams |
6 (1.5) |
>9 |
Mild |
None |
|
|
6 (1.5) |
Discoloration of finger nails |
10 (2.6) |
>9 |
Moderate |
AZT/3TC/NVP to TDF/FTC/NVP |
|
10 (2.6) |
|
Proximal muscle pain and weakness |
2 (0.5) |
1-4 |
Moderate |
None |
|
9 (2.4) |
|
7 (1.9) |
1-4 |
Moderate |
AZT/3TC/NVP
to TDF/FTC/NVP |
Nausea, hypersalivation
and vomiting |
129 (33.9) |
> 9 |
Moderate |
None |
|
|
129 (33.9) |
Peripheral neuropathy |
12 (3.1) |
>9 |
Moderate |
D4T substituted with AZT |
|
12 (3.1) |
|
Facial lipodystrophy |
6 (1.5) |
>9 |
Moderate |
D4T substituted with AZT |
|
6 (1.5) |
|
Palm hyperpigmentation |
2 (0.6) |
>9 |
Moderate |
D4T/3TC/NVP to TDF/FTC/NVP |
|
2 (0.6) |
|
Anemia |
1 (0.2) |
> 9 |
Moderate |
None |
|
|
25 (6.5) |
24(6.3) |
> 9 |
Moderate |
AZT/3TC/NVP
to TDF/FTC/NVP |
2 (0.6) |
> 9 |
Severe |
Removed AZT from AZT+ TDF/FTC+
LPV/r |
2 (0.6) |
|
|
Steven-Johnson syndrome(SJS) |
27 (7.1) |
>9 |
Severe |
NVP substituted with EFV |
1 (0.3) |
|
26 (6.8) |
Diarrhea |
18 (4.7) |
5-8 |
Severe |
None |
|
|
18 (4.7) |
Jaundice |
16 (4.2) |
>9 |
Severe |
NVP substituted with EFV |
|
|
16 (4.2) |
Headache |
1 (0.3) |
1-4 |
Severe |
None |
|
|
1 (0.3) |
Total |
380 (100) |
|
|
|
3 (0.9) |
39 (10.2) |
338 (88.9) |