These reactions are usually mild to moderate gastrointestinal events.
Metabolism and nutrition disorders: Very common: hypophosphataemia. Rare: lactic acidosis.
Nervous system disorders: Very common: dizziness.
Respiratory, thoracic and mediastinal disorders: Very rare: dyspnoea.
Gastrointestinal disorders: Very common: diarrhoea, nausea, vomiting. Common: flatulence. Rare: pancreatitis.
Hepatobiliary disorders: Rare: increased transaminases. Very rare: hepatitis.
Musculoskeletal and connective tissue disorders: Not known: myopathy, osteomalacia (both associated with proximal renal tubulopathy).
Renal and urinary disorders: Rare: renal failure, acute renal failure, proximal tubulopathy (including Fanconi syndrome), increased creatinine. Very rare: acute tubular necrosis.
In addition, there have been post-marketing reports of nephritis and nephrogenic diabetes insipidus.
General disorders and administration site conditions: Very rare: asthenia.
Approximately 1% of tenofovir disoproxil fumarate treated patients discontinued treatment due to the gastrointestinal events.
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia.
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART). The frequency of this is unknown.
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