May cause fat redistribution. In combination with ritonavir, may cause hepatitis and/or exacerbate pre-existing hepatic dysfunction (patients with chronic hepatitis B or C at increased risk). Protease inhibitors associated with a variety of hypersensitivity events, including rash, anaphylaxis, angioedema, bronchospasm, erythema multiforme, and/or Stevens-Johnson syndrome. Patients may develop immune reconstitution syndrome resulting in occurrence of inflammatory response to indolent or residual opportunistic infection. Increases in total cholesterol and triglycerides reported. Use in combination with ritonavir associated with rare reports of fatal and nonfatal intracranial hemorrhage (causal relationship not established). Use with caution in sulfonamide allergy. Changes in glucose tolerance, hyperglycemia, exacerbation of diabetes, DKA, and new-onset diabetes mellitus reported in patients receiving protease inhibitors). Use with caution in hemophilia A or B (increased bleeding during protease inhibitor therapy reported), and in mild hepatic impairment (contraindicated in moderate-to-severe impairment). May impair platelet aggregation, resulting in bleeding (use with caution in patients who may be at risk for increased bleeding (trauma, surgery or other medical conditions)). Anticoagulant and antiplatelet agent co-administration may increase risk of bleeding. Use with caution in patients taking strong CYP3A4 inhibitors and moderate CYP3A4 inducers. Concomitant use with selected major CYP3A4 substrates and strong CYP3A4 inducers contraindicated. Women receiving estrogens have increased incidence of rash. Co-administration with ritonavir required. Oral solution formulation contains vitamin E.