Tarlonib Adverse Reactions

Adverse reactions reported with monotherapy: Cardiovascular: Chest pain, peripheral edema.
Central nervous system: Anxiety, dizziness, fatigue, headache, insomnia, neurotoxicity, pain, paresthesia, voice disorder.
Dermatologic: Acne vulgaris, acneiform eruption, alopecia, bullous dermatitis, dermatitis, erythema, erythematous rash, exfoliative dermatitis, folliculitis, hypertrichosis, nail disease, palmar-plantar erythrodysesthesia, paronychia, pruritus, skin fissure, skin rash, xeroderma.
Endocrine & metabolic: Weight loss.
Gastrointestinal: Abdominal pain, anorexia, constipation, decreased appetite, diarrhea, dyspepsia, mucositis, nausea, stomatitis, taste disorder, vomiting, xerostomia.
Genitourinary: Urinary tract infection.
Hematologic & oncologic: Anemia, leukopenia, lymphocytopenia, thrombocytopenia.
Hepatic: Hepatic failure, hyperbilirubinemia, increased gamma-glutamyl transferase, increased serum ALT.
Infection: Increased susceptibility to infection.
Neuromuscular and skeletal: Arthralgia, back pain, muscle spasm, musculoskeletal pain (including chest), ostealgia, weakness.
Ophthalmic: Conjunctivitis, keratoconjunctivitis sicca, ophthalmic signs and symptoms.
Otic: Tinnitus.
Renal: Increased serum creatinine, renal failure.
Respiratory: Cough, dyspnea, epistaxis, nasopharyngitis, pneumonitis, pulmonary embolism, pulmonary fibrosis, respiratory tract infection.
Miscellaneous: Fever.
Rare but important or life-threatening: Interstitial lung disease.
Adverse reactions reported with combination (erlotinib plus gemcitabine) therapy: Cardiovascular: Cardiac arrhythmia, cerebrovascular accident (including cerebral hemorrhage), deep vein thrombosis, edema, myocardial infarction, syncope, thrombosis.
Central nervous system: Anxiety, depression, dizziness, fatigue, headache.
Dermatologic: Alopecia, skin rash.
Gastrointestinal: Abdominal pain, anorexia, diarrhea, dyspepsia, flatulence, intestinal obstruction, nausea, pancreatitis, stomatitis, vomiting, weight loss.
Hematologic & oncologic: Hemolytic anemia, microangiopathic hemolytic anemia with thrombocytopenia.
Hepatic: Hyperbilirubinemia, increased serum ALT, increased serum AST.
Infection: Increased susceptibility to infection.
Neuromuscular & skeletal: Myalgia, neuropathy, ostealgia, rigors.
Renal: Renal failure, renal insufficiency .
Respiratory: Cough, dyspnea, interstitial lung disease.
Miscellaneous: Fever.
Rare but important or life-threatening: Bullous dermatitis, exfoliative dermatitis, hepatic failure.
Mono- or combination therapy: Rare but important or life-threatening: Acute peptic ulcer with hemorrhage, bronchiolitis, corneal perforation, corneal ulcer, episcleritis, gastritis, gastrointestinal hemorrhage, gastrointestinal perforation, hearing loss, hematemesis, hematochezia, hepatorenal syndrome, hepatotoxicity, hirsutism, hyperpigmentation, hypokalemia, keratitis, melena, myopathy (in combination with statin therapy), peptic ulcer, rhabdomyolysis (in combination with statin therapy), skin photosensitivity, skin rash (acneiform; sparing prior radiation field), Stevens-Johnson syndrome, toxic epidermal necrolysis, tympanic membrane perforation.