The following are undesirable phenomena noted when applying preparation Nexavar in the course of clinical (or ≥1 / 100 to <1/10) infrequently (from ≥1 / 1000 to <1/10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to < 1/100), rarely (from ≥1 / 10,000 to <1/1 000).
For undesirable effects revealed during post-marketing observations and for which it is not possible to reliably estimate the frequency or establish a causal relationship with taking the drug, "frequency is unknown" is indicated.
In each frequency group, unwanted phenomena are presented in order of decreasing their importance.
On the part of the hematopoiesis system:
Often - lymphopenia;
often - Lakopenia, neutropenia, anemia,
thrombocytopenia.
From the cardiovascular system:
Often - bleeding (including bleeding from the gastrointestinal tract *, respiratory tract * and cerebral hemorrhage *), increased blood pressure; often - chronic heart failure *, myocardial ischemia and / or myocardial infarction *, tides; infrequently - hypertensive crisis*; rarely - interval lengthening QT.
From the respiratory system:
often - rhinorrhea, dysphonia; infrequently - phenomena similar to interstitial lung diseases * (including pneumonitis, radiation pneumonitis, acute respiratory distress syndrome, interstitial pneumonia, pulmonitis, pneumonia).
From the skin and skin appendages:
Often - dry skin, skin rash, alopecia, palmar-plantar erythrodysesthesia, erythema, itchy skin; often - keratoacanthoma / squamous cell carcinoma of the skin, exfoliative dermatitis, acne, skin peeling, hyperkeratosis, folliculitis;
infrequently - eczema, erythema multiforme;
frequency unknown - return beam dermatitis, Stevens-Johnson syndrome, leukocytoclastic vasculitis, toxic epidermal necrolysis *.
On the part of the digestive system:
Often - diarrhea, nausea, vomiting, constipation, anorexia;
often - stomatitis (including dryness mucous membrane of the oral cavity and glossodynia), dyspepsia, dysphagia, gastroesophageal reflux;
infrequently - gastritis, pancreatitis, perforation gastrointestinal tract *, increased concentrations of bilirubin (including jaundice), cholecystitis, cholangitis;
rarely - medicinal hepatitis *.
From the nervous system:
often - peripheral sensory neuropathy, dysgeusia;
infrequently - backward reversible syndrome encephalopathy *.
Mental disorders:
often - Depression.
From the organ of hearing:
often - tinnitus.
From the musculoskeletal system:
Often - arthralgia;
often - myalgia, muscle spasms;
frequency unknown - rhabdomyolysis, necrosis jaws.
From the side of the urogenital system:
often - renal failure, proteinuria;
rarely - nephrotic syndrome.
On the part of reproductive function:
often - erectile disfunction;
infrequently - gynecomastia.
From the endocrine system:
often - hypothyroidism;
infrequently - hyperthyroidism.
From the immune system:
infrequently - anaphylactic reactions, reactions of hypersensitivity (including skin reactions and urticaria);
frequency unknown - angioedema edema.
Violations of laboratory indicators:
Often - hypophosphatemia, an increase activity of lipase and amylase;
often - transient boost activity of transaminases (aspartate aminotransferase, alanine aminotransferase), hypocalcemia, hypokalemia, hyponatremia;
infrequently - dehydration, transient an increase in the activity of alkaline phosphatase, a deviation from the normal value of the international normalized ratio (INR) and prothrombin.
Other:
Often - increased fatigue, pain syndrome of different localization (including pain in the oral cavity, abdominal pain, bone pain, pain in the area tumors, headache), weight reduction body, infection, fever body;
often - asthenia, flu-like syndrome, inflammation of the mucous membranes.
* - adverse reactions may occur life-threatening consequences or death. Such phenomena occurred either infrequently, or less often than infrequently.
In clinical studies in patients palmar-plantar erythrodysesthesia, diarrhea, alopecia, weight loss, fever, hypocalcaemia, keratoacanthoma / squamous cell carcinoma of the skin were significantly more frequent than in patients with renal cell carcinoma and hepatocellular carcinoma.