diarrhoea pancreatitis Gastrointestinal nausea stomatitis gastritis Disorders vomiting (including dry gastrointestinal constipation mouth and perforations* glossodynia) dyspepsia dysphagia gastrooesophageal reflux disease Hepato-biliary increase in bilirubin drug induced Disorders and jaundice, hepatitis* cholecystitis, cholangitis dry skin keratoacanthoma/ eczema Skin and rash squamous cell erythema multiforme Subcutaneous alopecia cancer of skin Tissue Disorders hand foot skin dermatitis reaction** exfoliative erythema acne pruritus skin desquamation hyperkeratosis Musculoskeletal, arthralgia myalgia Connective muscle spasms Tissue and Bone Disorders renal failure nephrotic Renal and proteinuria syndrome Genitourinary Disorders Reproductive erectile dysfunction gynaecomastia System and Breast Disorders fatigue asthenia General pain (including influenza like Disorders and mouth, abdominal, illness Administration bone, tumour pain mucosal Site Conditions and headache) inflammation weight decreased transient increase in transient increase in Investigations increased amylase transaminases blood alkaline increased lipase phosphatase INR abnormal, prothrombin level abnormal * The adverse reactions may have a life-threatening or outcome. ** palmar plantar erythrodysaesthesia syndrome in MedDRA
Gastrointestinal Disorders diarrhoea nausea vomiting constipation stomatitis (including dry mouth and glossodynia) dyspepsia dysphagia gastrooesophageal reflux disease pancreatitis gastritis gastrointestinal perforations* Hepato-biliary Disorders increase in bilirubin and jaundice, cholecystitis, cholangitis drug induced hepatitis* Skin and Subcutaneous Tissue Disorders dry skin rash alopecia hand foot skin reaction** erythema pruritus keratoacanthoma/ squamous cell cancer of skin dermatitis exfoliative acne skin desquamation hyperkeratosis eczema erythema multiforme Musculoskeletal, Connective Tissue and Bone Disorders arthralgia myalgia muscle spasms Renal and Genitourinary Disorders renal failure proteinuria nephrotic syndrome Reproductive System and Breast Disorders erectile dysfunction gynaecomastia General Disorders and Administration Site Conditions fatigue pain (including mouth, abdominal, bone, tumour pain and headache) asthenia influenza like illness mucosal inflammation Investigations weight decreased increased amylase increased lipase transient increase in transaminases transient increase in blood alkaline phosphatase INR abnormal, prothrombin level abnormal * The adverse reactions may have a life-threatening or outcome. ** palmar plantar erythrodysaesthesia syndrome in MedDRA
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