Drug information for XALKORI

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE; ORAL 200MG Prescription   CRIZOTINIB crizotinib PFIZER 202570
2012-03-15 Label

2012-02-29 Letter

2012-02-29 Letter

2012-02-28 Label

2011-09-27 Review

2011-09-27 Summary Review

2011-08-30 Letter

2011-08-26 Label
CAPSULE; ORAL 250MG Prescription  (Reference Drug) CRIZOTINIB crizotinib PFIZER   "

Drug Adverse Effects information for XALKORI

Role code Indications Reaction # Reports
PS ANAPLASTIC LYMPHOMA RECEPTOR TYROSINE KINASE ASSAY ASTHENIA 1
PS ANAPLASTIC LYMPHOMA RECEPTOR TYROSINE KINASE ASSAY COUGH 1
PS ANAPLASTIC LYMPHOMA RECEPTOR TYROSINE KINASE ASSAY ERUCTATION 1
PS ANAPLASTIC LYMPHOMA RECEPTOR TYROSINE KINASE ASSAY FATIGUE 1
PS ANAPLASTIC LYMPHOMA RECEPTOR TYROSINE KINASE ASSAY WEIGHT DECREASED 1
PS ANXIETY DIARRHOEA 3
PS ANXIETY FATIGUE 3
PS ANXIETY INCREASED APPETITE 3
PS ANXIETY TREMOR 3
PS ANXIETY WEIGHT INCREASED 3
PS BLOOD CHOLESTEROL DIARRHOEA 1
PS BLOOD PRESSURE DIARRHOEA 1
PS BREAST CANCER DRY SKIN 1
PS BREAST CANCER FEMALE DRY SKIN 2
PS BREAST CANCER FEMALE PRURITUS 2
PS BREAST CANCER FEMALE RASH 2
PS BRONCHIAL CARCINOMA CONSTIPATION 1
PS BRONCHIAL CARCINOMA DEATH 1
PS BRONCHIAL CARCINOMA FATIGUE 1
PS BRONCHIAL CARCINOMA NAUSEA 1
PS BRONCHIAL CARCINOMA VOMITING 1
PS CONSTIPATION CONSTIPATION 1
PS CONSTIPATION ERUCTATION 1
PS CONSTIPATION THROAT TIGHTNESS 1
PS CONSTIPATION VISUAL IMPAIRMENT 1
PS CONVULSION DIARRHOEA 1
PS CONVULSION DRY SKIN 3
PS CONVULSION FATIGUE 1
PS CONVULSION INCREASED APPETITE 1
PS CONVULSION PRURITUS 2
PS CONVULSION RASH 2
PS CONVULSION TREMOR 1
PS CONVULSION WEIGHT INCREASED 1
PS DEEP VEIN THROMBOSIS DIARRHOEA 1
PS DEPRESSION DIARRHOEA 2
PS DEPRESSION FATIGUE 2
PS DEPRESSION INCREASED APPETITE 2
PS DEPRESSION TREMOR 2
PS DEPRESSION WEIGHT INCREASED 2
PS GASTROINTESTINAL DISORDER DRY SKIN 6
PS GASTROINTESTINAL DISORDER PRURITUS 4
PS GASTROINTESTINAL DISORDER RASH 4
PS HYPOTHYROIDISM FATIGUE 1
PS INSOMNIA DIARRHOEA 1
PS INSOMNIA FATIGUE 1
PS INSOMNIA INCREASED APPETITE 1
PS INSOMNIA TREMOR 1
PS INSOMNIA WEIGHT INCREASED 1
PS LUNG ADENOCARCINOMA METASTATIC CONSTIPATION 1
PS LUNG ADENOCARCINOMA METASTATIC DECREASED APPETITE 1
PS LUNG ADENOCARCINOMA METASTATIC MALAISE 1
PS LUNG ADENOCARCINOMA METASTATIC NAUSEA 1
PS LUNG ADENOCARCINOMA METASTATIC PLEURAL EFFUSION 1
PS LUNG ADENOCARCINOMA METASTATIC VISION BLURRED 1
PS LUNG ADENOCARCINOMA METASTATIC VOMITING 1
PS LUNG CANCER METASTATIC DISEASE PROGRESSION 1
PS LUNG CANCER METASTATIC LUNG CANCER METASTATIC 1
PS LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE 0 CONSTIPATION 2
PS LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE 0 DIARRHOEA 1
PS LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE 0 MALAISE 1
PS LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE 0 NAUSEA 2
PS LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE 0 VISION BLURRED 2
PS LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE 0 VOMITING 2
PS LUNG NEOPLASM DEATH 1
PS LUNG NEOPLASM FATIGUE 1
PS LUNG NEOPLASM NAUSEA 1
PS LUNG NEOPLASM RASH MACULAR 1
PS LUNG NEOPLASM VOMITING 1
PS LUNG NEOPLASM MALIGNANT ABDOMINAL PAIN UPPER 3
PS LUNG NEOPLASM MALIGNANT AGEUSIA 1
PS LUNG NEOPLASM MALIGNANT ARTHRALGIA 1
PS LUNG NEOPLASM MALIGNANT ASTHENIA 1
PS LUNG NEOPLASM MALIGNANT BACK PAIN 3
PS LUNG NEOPLASM MALIGNANT BLOOD GLUCOSE INCREASED 1
PS LUNG NEOPLASM MALIGNANT BLOOD POTASSIUM INCREASED 1
PS LUNG NEOPLASM MALIGNANT BREATH SOUNDS ABNORMAL 2
PS LUNG NEOPLASM MALIGNANT CHOKING SENSATION 1
PS LUNG NEOPLASM MALIGNANT CONSTIPATION 13
PS LUNG NEOPLASM MALIGNANT COUGH 7
PS LUNG NEOPLASM MALIGNANT DEATH 4
PS LUNG NEOPLASM MALIGNANT DECREASED APPETITE 9
PS LUNG NEOPLASM MALIGNANT DEHYDRATION 2
PS LUNG NEOPLASM MALIGNANT DIARRHOEA 21
PS LUNG NEOPLASM MALIGNANT DIPLOPIA 3
PS LUNG NEOPLASM MALIGNANT DISEASE PROGRESSION 5
PS LUNG NEOPLASM MALIGNANT DIZZINESS 4
PS LUNG NEOPLASM MALIGNANT DIZZINESS POSTURAL 3
PS LUNG NEOPLASM MALIGNANT DREAMY STATE 1
PS LUNG NEOPLASM MALIGNANT DRUG INTERACTION 1
PS LUNG NEOPLASM MALIGNANT DRY SKIN 3
PS LUNG NEOPLASM MALIGNANT DYSGEUSIA 6
PS LUNG NEOPLASM MALIGNANT DYSPEPSIA 6
PS LUNG NEOPLASM MALIGNANT DYSPHAGIA 1
PS LUNG NEOPLASM MALIGNANT DYSPNOEA 1
PS LUNG NEOPLASM MALIGNANT ERUCTATION 1
PS LUNG NEOPLASM MALIGNANT EYE SWELLING 3
PS LUNG NEOPLASM MALIGNANT EYELID OEDEMA 1
PS LUNG NEOPLASM MALIGNANT FATIGUE 19
PS LUNG NEOPLASM MALIGNANT FLATULENCE 1
PS LUNG NEOPLASM MALIGNANT FLUID RETENTION 2
PS LUNG NEOPLASM MALIGNANT GAIT DISTURBANCE 3
PS LUNG NEOPLASM MALIGNANT HEADACHE 3
PS LUNG NEOPLASM MALIGNANT HEART RATE DECREASED 1
PS LUNG NEOPLASM MALIGNANT HYPOTENSION 1
PS LUNG NEOPLASM MALIGNANT INFLUENZA LIKE ILLNESS 1
PS LUNG NEOPLASM MALIGNANT JOINT SWELLING 1
PS LUNG NEOPLASM MALIGNANT LUNG CANCER METASTATIC 1
PS LUNG NEOPLASM MALIGNANT LUNG NEOPLASM MALIGNANT 4
PS LUNG NEOPLASM MALIGNANT MALAISE 4
PS LUNG NEOPLASM MALIGNANT MENOPAUSAL DISORDER 1
PS LUNG NEOPLASM MALIGNANT NAUSEA 22
PS LUNG NEOPLASM MALIGNANT OCULAR DISCOMFORT 2
PS LUNG NEOPLASM MALIGNANT OEDEMA PERIPHERAL 5
PS LUNG NEOPLASM MALIGNANT OROPHARYNGEAL PAIN 3
PS LUNG NEOPLASM MALIGNANT OXYGEN SATURATION ABNORMAL 1
PS LUNG NEOPLASM MALIGNANT PAIN 3
PS LUNG NEOPLASM MALIGNANT PAIN IN EXTREMITY 3
PS LUNG NEOPLASM MALIGNANT PARAESTHESIA 3
PS LUNG NEOPLASM MALIGNANT PHOTOPHOBIA 8
PS LUNG NEOPLASM MALIGNANT PHOTOPSIA 5
PS LUNG NEOPLASM MALIGNANT PNEUMONIA 1
PS LUNG NEOPLASM MALIGNANT PRODUCTIVE COUGH 3
PS LUNG NEOPLASM MALIGNANT PRURITUS 2
PS LUNG NEOPLASM MALIGNANT RASH 3
PS LUNG NEOPLASM MALIGNANT RENAL FAILURE 1
PS LUNG NEOPLASM MALIGNANT RHINORRHOEA 3
PS LUNG NEOPLASM MALIGNANT SINUS CONGESTION 3
PS LUNG NEOPLASM MALIGNANT SYNCOPE 1
PS LUNG NEOPLASM MALIGNANT THROAT TIGHTNESS 1
PS LUNG NEOPLASM MALIGNANT THROMBOSIS 3
PS LUNG NEOPLASM MALIGNANT VISION BLURRED 5
PS LUNG NEOPLASM MALIGNANT VISUAL ACUITY REDUCED 1
PS LUNG NEOPLASM MALIGNANT VISUAL BRIGHTNESS 1
PS LUNG NEOPLASM MALIGNANT VISUAL IMPAIRMENT 5
PS LUNG NEOPLASM MALIGNANT VITREOUS FLOATERS 4
PS LUNG NEOPLASM MALIGNANT VOMITING 17
PS LUNG NEOPLASM MALIGNANT WEIGHT INCREASED 2
PS METASTASES TO CENTRAL NERVOUS SYSTEM DISEASE PROGRESSION 1
PS METASTASES TO CENTRAL NERVOUS SYSTEM METASTASES TO CENTRAL NERVOUS SYSTEM 1
PS NAUSEA COUGH 2
PS NAUSEA DECREASED APPETITE 2
PS NAUSEA DIARRHOEA 3
PS NAUSEA DIZZINESS 2
PS NAUSEA DYSGEUSIA 2
PS NAUSEA FATIGUE 5
PS NAUSEA INCREASED APPETITE 3
PS NAUSEA OROPHARYNGEAL PAIN 2
PS NAUSEA RHINORRHOEA 2
PS NAUSEA SINUS CONGESTION 2
PS NAUSEA TREMOR 3
PS NAUSEA WEIGHT INCREASED 3
PS NEOPLASM MALIGNANT DISEASE PROGRESSION 2
PS NEOPLASM MALIGNANT NEOPLASM MALIGNANT 1
PS NON-SMALL CELL LUNG CANCER ATRIAL FIBRILLATION 2
PS NON-SMALL CELL LUNG CANCER CONFUSIONAL STATE 1
PS NON-SMALL CELL LUNG CANCER DEATH 1
PS NON-SMALL CELL LUNG CANCER DIARRHOEA 1
PS NON-SMALL CELL LUNG CANCER FATIGUE 1
PS NON-SMALL CELL LUNG CANCER INCREASED APPETITE 1
PS NON-SMALL CELL LUNG CANCER MENTAL STATUS CHANGES 1
PS NON-SMALL CELL LUNG CANCER NAUSEA 1
PS NON-SMALL CELL LUNG CANCER TREMOR 1
PS NON-SMALL CELL LUNG CANCER WEIGHT INCREASED 1
PS PAIN CONSTIPATION 1
PS PAIN DRUG INTERACTION 1
PS PAIN FATIGUE 2
PS PAIN NAUSEA 1
PS PAIN PHOTOPHOBIA 1
PS PAIN PHOTOPSIA 1
PS PAIN VISION BLURRED 1
PS PAIN VOMITING 1
PS PANCREATIC CARCINOMA DIARRHOEA 1
PS PANCREATIC CARCINOMA JOINT SWELLING 1
PS PANCREATIC CARCINOMA NAUSEA 1
PS SLEEP DISORDER DIARRHOEA 3
PS SLEEP DISORDER FATIGUE 3
PS SLEEP DISORDER INCREASED APPETITE 3
PS SLEEP DISORDER TREMOR 3
PS SLEEP DISORDER WEIGHT INCREASED 3
PS TRACHEAL CANCER ASTHENIA 3
PS TRACHEAL CANCER BLOOD PRESSURE DECREASED 2
PS TRACHEAL CANCER CONSTIPATION 4
PS TRACHEAL CANCER DEATH 1
PS TRACHEAL CANCER DECREASED APPETITE 4
PS TRACHEAL CANCER FATIGUE 5
PS TRACHEAL CANCER HEART RATE DECREASED 2
PS TRACHEAL CANCER NAUSEA 6
PS TRACHEAL CANCER PULMONARY EMBOLISM 2
PS TRACHEAL CANCER VISUAL IMPAIRMENT 1
PS TRACHEAL CANCER VOMITING 5
PS TRACHEAL NEOPLASM DEATH 1
PS VOMITING COUGH 2
PS VOMITING DECREASED APPETITE 2
PS VOMITING DIARRHOEA 3
PS VOMITING DIZZINESS 2
PS VOMITING DYSGEUSIA 2
PS VOMITING FATIGUE 5
PS VOMITING INCREASED APPETITE 3
PS VOMITING OROPHARYNGEAL PAIN 2
PS VOMITING RHINORRHOEA 2
PS VOMITING SINUS CONGESTION 2
PS VOMITING TREMOR 3
PS VOMITING WEIGHT INCREASED 3
SS BRONCHIAL CARCINOMA DEATH 1
SS LUNG NEOPLASM MALIGNANT DEATH 1
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