ospasm and angioedema
Rare
Anaphylaxis and Stevens Johnson syndrome
Metabolic and nutritional disorders
Uncommon
Dehydration, diabetes mellitus
Rare
Hyperglycaemia
Not known
Hypertriglyceridaemia, hypercholesterolaemia, hyperuricaemia
Nervous system disorders
Very common
Taste perversion, circumoral and peripheral paresthesia, headache
Common
Dizziness, paraesthesia, hyperaesthesia, somnolence, insomnia, anxiety
Not known
Seizure, syncope
Vascular disorders
Common
Vasodilation
Not known
Orthostatic hypotension
Respiratory, thoracic and mediastinal disorders
Common
Pharyngitis, cough increased
Gastrointestinal disorders
Very common
Abdominal pain, nausea, diarrhoea, vomiting
Common
Dyspepsia, anorexia, local throat irritation, flatulence, dry mouth, eructation, mouth ulcer
Hepatobiliary disorders
Uncommon
Hepatitis and jaundice
Skin and subcutaneous tissue disorders
Common
Rash, pruritus, sweating, lipodystrophy
Musculosketal and connective tissue disorders
Common
Increased CPK, myalgia
Uncommon
Myositis, rhabdomyolysis
Renal and urinary disorders
Not known
Acute renal failure
Reproductive system and breast disorders
Not known
Menorrhagia
General disorders and administration site conditions
Very common
Asthenia
Common
Fever, pain weight loss
Investigations
Common
Increased GGT, increased CPK, increased triglycerides, increased SGPT, increased SGOT, increased amylase, increased uric acid, decreased potassium, decreased free and total thyroxin
Uncommon
Increased glucose, decreased total calcium, increased magnesium, increased bilirubin, increased alkaline phosphatase
Hepatic transaminase elevations exceeding five times the upper limit or normal, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir alone or in combination with other antiretrovirals.
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).
Combination antiretroviral therapy has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
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 (see section 4.4).
Pancreatitis has been observed in patients receiving ritonavir therapy, including those who developed hypertriglyceridemia. In some cases fatalities have been observed. Patients with advanced HIV disease may be at risk of elevated triglycerides and pancreatitis (see section 4.4).
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretrovi |
