Moderate and severe side effects are given below with frequency (very often ≥1/10; often ≥1/100 but <1/10; not often ≥1/1000 but <1/100).
On the immune system:
Often: hypersensitivity reactions, including hives and angioedema; rarely: immune recovery syndrome.
On the digestive system:
Very often: diarrhoea, nausea, frequent: vomiting, stomach pain (upper and lower parts), gastroenteritis, colitis, dyspepsia, pancreatitis, gastroesophageal reflux, hemorrhoids, flatulence, bloating, hepatitis, hepatomegaly, cholangitis, steatosis of the liver; not often: constipation, stomatitis, oral mucous membrane ulcers, duodenitis, gastritis, gastrointestinal bleeding, including rectal bleeding, dry mouth, gastric and intestinal ulcers, fecal incontinence.
On the nervous system:
Often: headache, migraine, insomnia, neuropathy, peripheral neuropathy, dizziness, anxiety; rarely: agesia, seizures, tremor, cerebrovascular disorders, sleep disturbance, decreased libido.
On the cardiovascular:
Often: arterial hypertension; rarely: atherosclerosis, myocardial infarction, atrioventricular block, triple valve failure, deep vein thrombosis.
On the skin and subcutaneous fatty tissue:
Often: rash, including maculopapulosis, lipodystrophy, including the exhaustion of subcutaneous fat tissue in the face, dermatitis, eczema, seborrhea, increased sweating at night, itching; not often: alopecia, capillary, vasculitis.
On the musculoskeletal:
Often: skeletal-muscular pain, including arthralgia and back pain, myalgia, muscle weakness, muscle spasms; not often: rhabdomyolysis, osteonecrosis.
Metabolic and endocrine system disorders:
Often: hypercholesterolemia, hypertriglyceridemia, weight loss, reduced appetite, diabetes mellitus; not often: weight gain, lactatacidosis, increased appetite, male hypogonadism.
On the kidney and urinary tract:
Often: renal failure; not often: hematuria, nephritis.
On the reproductive system:
Often: erectile dysfunction, amenorrhea, menorrhea.
On sensory organs:
Not often: vestibular dizziness, tinnitus, visual impairment.
Infections:
Very often: upper respiratory tract infections; often: lower respiratory tract infections, skin and subcutaneous fatty tissue infections, including cellulite, folliculitis.
General:
Often: weakness, asthenia.
Changes in laboratory indicators:
Increased concentrations of glucose, uric acid, total cholesterol, total bilirubin, triglycerides, increased serum aspartate transferase (AST) activity, alanine transferase (ALT), gamma-glutamyltranspeptidase (GGTP), lipase, amylase, creatine phosphokines, reduction of inorganic phosphorus, hemoglobin, reduction of creatinine clearance.
Children:
The side effects in children aged 6 months to 12 years were similar to those in adults. Rashes, dysgeusia, vomiting and diarrhoea were the most frequently observed.
