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Table 5 Number of adverse reactions related to antiretrovirals, nevirapine, and other medicines in 2011 and in the Previous Years (2008 - 2010)

From: Assessment of the nevirapine safety signal using data from the national antiretroviral dispensing database: a retrospective study

Adverse Reaction Reports 2011 2008–2010 (previous years) RR
n = 481 n = 593
Adverse reaction related to antiretroviral medicines 389 (80.9 %) 482 (81.3 %) 1
Total NVP reactions (related to skin and liver)
Adverse reactions attributed to NVP 208 (43.2 %) 99 (16.7 %) 2.6
NVP skin reactions
All skin reactions 150 (31.2 %) 70 (11.8 %) 2.6
Severe 109 (22.7 %) 33 (5.6 %) 4.1
Mild/moderate 41 (8.5 %) 37 (6.2 %) 1.4
NVP-liver reactions
All liver reactions 58 (12.1 %) 29 (4.9 %) 2.5
Severe 41 (8.5 %) 13 (2.2 %) 3.9
Mild/moderate 13 (2.7 %) 14 (2.4 %) 1.1
Unknown grade 4 (0.83 %) 2 (0.34 %) -
Other antiretroviral medicine reactions
Adverse reactions attributed to other medicines 273 (56.8 %) 494 (83.3 %) 0.7
  1. The severe skin reaction reports in 2011 included: Stevens-Johnson Syndrome (n = 54), Toxic Epidermal Necrolysis (n = 3), Erythema Multiforme Major (n = 1), Skin reactions with conjunctivitis and oral lesions (51). In the Previous Years the severe reactions included the same reactions but much fewer reports. Note: The adverse reaction reports that never provided any form of description of the type of reaction – e.g., skin rash, were regarded as mild or moderate. The severe liver reaction reports in 2011 included: High alanine aminotransferase i.e., above 5× the upper limit of normal (many were far above this), hyperbilirubinaemia, and some were reported as severe hepatotoxicity. Reports that never provided description of the liver reaction were considered to be mild or moderate