Soranib (Nexavar / Sorafenib) 200 Mg

>10%:

Cardiovascular: Hypertension (9% to 41%; grade 3: 3% to 4%; grade 4: <1%; grades 3/4: 10%, onset: ~3 weeks)

Central nervous system: Fatigue (37% to 46%), headache (≤10% to 17%), mouth pain (14%), voice disorder (13%), peripheral sensory neuropathy (≤13%), pain (11%)

Dermatologic: Palmar-plantar erythrodysesthesia (21% to 69%; grade 3: 6% to 8%; grades 3/4: 19%), alopecia (14% to 67%), skin rash (including desquamation; 19% to 40%; grade 3: ≤1%; grades 3/4: 5%), pruritus (14% to 20%), xeroderma (10% to 13%), erythema (≥10%)

Endocrine & metabolic: Hypoalbuminemia (≤59%), weight loss (10% to 49%), hypophosphatemia (35% to 45%; grade 3: 11% to 13%; grade 4: <1%), increased thyroid stimulating hormone level (>0.5 mU/L: 41%; due to impairment of exogenous thyroid suppression), hypocalcemia (12% to 36%), increased amylase (30% to 34% [usually transient])

Gastrointestinal: Diarrhea (43% to 68%; grade 3: 2% to 10%; grade 4: <1%), increased serum lipase (40% to 41% [usually transient]), abdominal pain (11% to 31%), decreased appetite (30%), anorexia (16% to 29%), stomatitis (24%), nausea (21% to 24%), constipation (14% to 16%), vomiting (11% to 16%)

Hematologic & oncologic: Lymphocytopenia (23% to 47%; grades 3/4: ≤13%), thrombocytopenia (12% to 46%; grades 3/4: 1% to 4%), increased INR (≤42%), neutropenia (≤18%; grades 3/4: ≤5%), hemorrhage (15% to 17%; grade 3: 2%), leukopenia

Hepatic: Increased serum ALT (59%; grades 3/4: 4%), increased serum AST (54%; grades 3/4: 2%), hepatic insufficiency (≤11%; grade 3: 2%; grade 4: 1%)

Infection: Infection

Neuromuscular & skeletal: Limb pain (15%), weakness (12%), myalgia

Respiratory: Dyspnea (≤14%), cough (≤13%)

Miscellaneous: Fever (11%)

1% to 10%:

Cardiovascular: Ischemic heart disease (including myocardial infarction; ≤3%), cardiac failure (2%, congestive), flushing

Central nervous system: Depression, glossalgia

Dermatologic: Hyperkeratosis (7%), acne vulgaris, exfoliative dermatitis, folliculitis

Endocrine & metabolic: Hypokalemia (5% to 10%), hyponatremia, hypothyroidism

Gastrointestinal: Dysgeusia (6%), dyspepsia, dysphagia, gastroesophageal reflux disease, mucositis, xerostomia

Genitourinary: Erectile dysfunction, proteinuria

Hematologic & oncologic: Squamous cell carcinoma of skin (3%; grades 3/4: 3%), anemia

Hepatic: Increased serum transaminases (transient)

Neuromuscular & skeletal: Muscle spasm (10%), arthralgia (≤10%), myalgia

Renal: Renal failure

Respiratory: Epistaxis (7%), flu-like symptoms, hoarseness, rhinorrhea

<1%, postmarketing, and/or case reports: Acute renal failure, anaphylaxis, angioedema, aortic dissection, amyotrophy, cardiac arrhythmia, cardiac failure, cerebral hemorrhage, cholangitis, cholecystitis, dehydration, eczema, erythema multiforme, gastritis, gastrointestinal hemorrhage, gastrointestinal perforation, gynecomastia, hepatic failure, hepatitis, hypersensitivity reaction (skin reaction, urticaria), hypertensive crisis, hyperthyroidism, increased serum alkaline phosphatase, increased serum bilirubin, interstitial pulmonary disease (acute respiratory distress, interstitial pneumonia, lung inflammation, pneumonitis, pulmonitis, radiation pneumonitis), jaundice, malignant neoplasm of skin (keratoacanthomas), nephrotic syndrome, ostealgia, osteonecrosis of the jaw, pancreatitis, pleural effusion, prolonged QT interval on ECG, respiratory tract hemorrhage, reversible posterior leukoencephalopathy syndrome, rhabdomyolysis, Stevens-Johnson syndrome, thromboembolism, tinnitus, toxic epidermal necrolysis, transient ischemic attacks, tumor lysis syndrome, tumor pain