Table 2.
Adverse Reaction | Male (n = 147) |
Female (n = 138) |
Total |
---|---|---|---|
Alanine aminotransferase increased | 72 | 27 | 99 |
Aspartate aminotransferase increased | 20 | 4 | 24 |
Hepatic enzyme increased (Combined AST and ALT) | 45 | 6 | 51 |
Hyperbilirubinemia | 20 | 21 | 41 |
Hypobilirubinemia | 0 | 1 | 1 |
Blood alkaline phosphatase increased | 1 | 9 | 10 |
Hyperamylasemia | 2 | 0 | 2 |
Blood lactate dehydrogenase increased | 2 | 0 | 2 |
Anemia | 106 | 203 | 309 |
Neutropenia | 3 | 4 | 7 |
Thrombocytopenia | 7 | 15 | 22 |
Leukopenia | 3 | 6 | 9 |
Dyslipidemia | 67 | 72 | 139 |
Blood creatinine increased | 114 | 23 | 137 |
Blood urea increased | 19 | 6 | 25 |
Hyperglycemia | 21 | 13 | 34 |
Hyponatremia | 0 | 1 | 1 |
Hypersensitivity | 0 | 1 | 1 |
Toxic optic neuropathy | 1 | 0 | 1 |
503 | 412 | 915 | |
Suspected Drugs | |||
Abacavir/Lamivudine | 13 (2.58%) | 0 | 13 (1.42%) |
Atazanavir/Ritonavir | 26 (5.16%) | 28 (6.79%) | 54 (5.90%) |
Dolutegravir | 67 (13.32%) | 27 (6.55%) | 94 (10.27%) |
Efavirenz | 18 (3.57%) | 7 (1.69%) | 25 (2.73%) |
Efavirenz/TLE | 6 (1.19%) | 3 (0.72%) | 9 (0.98%) |
Lamivudine | 86 (17.09%) | 42 (10.19%) | 128 (13.98%) |
Lamivudine/Abacavir | 2 (0.39%) | 0 | 2 (0.21%) |
Nevirapine | 1 (0.19%) | 0 | 1 (0.10%) |
Tenofovir | 234 (46.52%) | 276 (66.99%) | 510 (55.73%) |
Zidovudine | 32 (6.36%) | 20 (4.85%) | 52 (5.68%) |
Zidovudine/Lamivudine | 14 (2.78%) | 2 (0.48%) | 16 (1.74%) |
Ritonavir | 3 (0.59%) | 6 (1.45%) | 9 (0.98%) |
Amoxicillin | 0 | 1 (0.24%) | 1 (0.10%) |
Ethambutol | 1 (0.19%) | 0 | 1 (0.10%) |
503 | 412 | 915 |
The four most frequent ADRs and the five most commonly implicated drugs are presented in bold.