Drug information for BIAXIN XL

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, EXTENDED RELEASE; ORAL 500MG Prescription AB (Reference Drug) CLARITHROMYCIN Clarithromycin ABBOTT 50775
2012-05-07 Label

2012-05-07 Label

2011-05-31 Label

2011-05-31 Label

2011-05-31 Letter

2011-05-31 Letter

2009-11-20 Letter

2009-09-22 Label

2008-05-29 Letter

2008-01-09 Letter

2007-12-27 Label

2006-07-13 Letter

2006-03-03 Other Important Information from FDA

2005-10-20 Letter

2005-10-10 Label

2004-07-21 Letter

2004-06-29 Review

2003-04-18 Letter

2001-11-23 Review

2001-10-11 Review

2001-08-03 Label

2001-08-03 Letter

2000-03-03 Label

2000-03-03 Letter

Drug Adverse Effects information for BIAXIN XL

Role code Indications Reaction # Reports
PS BRONCHITIS CHRONIC HALLUCINATION 1
PS BRONCHITIS CHRONIC PARANOIA 1
PS BRONCHITIS CHRONIC PSYCHOTIC DISORDER 1
PS PRODUCT USED FOR UNKNOWN INDICATION HALLUCINATION 1
PS PRODUCT USED FOR UNKNOWN INDICATION PARANOIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION PSYCHOTIC DISORDER 1
C ARTHRITIS APPLICATION SITE RASH 1
C ARTHRITIS BLISTER 1
C ARTHRITIS CONVULSION NEONATAL 3
C ARTHRITIS FOETAL EXPOSURE DURING PREGNANCY 1
C ARTHRITIS MATERNAL EXPOSURE DURING PREGNANCY 1
C ARTHRITIS MATERNAL EXPOSURE TIMING UNSPECIFIED 2
C ARTHRITIS PARONYCHIA 1
C ARTHRITIS TALIPES 3
C ASTHMA APPLICATION SITE RASH 1
C ASTHMA BLISTER 1
C ASTHMA CONVULSION NEONATAL 5
C ASTHMA FOETAL EXPOSURE DURING PREGNANCY 1
C ASTHMA MATERNAL EXPOSURE DURING PREGNANCY 3
C ASTHMA MATERNAL EXPOSURE TIMING UNSPECIFIED 2
C ASTHMA PARONYCHIA 1
C ASTHMA TALIPES 5
C DEPRESSION APPLICATION SITE RASH 1
C DEPRESSION BLISTER 1
C DEPRESSION CONVULSION NEONATAL 5
C DEPRESSION FOETAL EXPOSURE DURING PREGNANCY 1
C DEPRESSION MATERNAL EXPOSURE DURING PREGNANCY 3
C DEPRESSION MATERNAL EXPOSURE TIMING UNSPECIFIED 2
C DEPRESSION PARONYCHIA 1
C DEPRESSION TALIPES 5
C DIALYSIS ACUTE MYOCARDIAL INFARCTION 1
C DIALYSIS ACUTE PULMONARY OEDEMA 1
C DIALYSIS ASTHENIA 1
C DIALYSIS ATRIOVENTRICULAR BLOCK COMPLETE 1
C DIALYSIS BLOOD COUNT ABNORMAL 1
C DIALYSIS BRADYCARDIA 1
C DIALYSIS CARDIAC ARREST 1
C DIALYSIS CARDIAC FAILURE CONGESTIVE 1
C DIALYSIS CARDIOMEGALY 1
C DIALYSIS CORONARY ARTERY DISEASE 1
C DIALYSIS DYSPNOEA 1
C DIALYSIS ENCEPHALOPATHY 1
C DIALYSIS FATIGUE 1
C DIALYSIS HEPARIN-INDUCED THROMBOCYTOPENIA 1
C DIALYSIS HYPOTENSION 1
C DIALYSIS HYPOXIA 1
C DIALYSIS MYOCARDIAL INFARCTION 1
C DIALYSIS PLEURAL EFFUSION 1
C DIALYSIS PNEUMONIA 1
C DIALYSIS PULMONARY HYPERTENSION 1
C DIALYSIS RENAL FAILURE CHRONIC 1
C DIALYSIS THROMBOSIS 1
C DIALYSIS TRICUSPID VALVE INCOMPETENCE 1
C DIALYSIS UNRESPONSIVE TO STIMULI 1
C DYSPEPSIA DEEP VEIN THROMBOSIS 2
C DYSPEPSIA PAIN 2
C DYSPEPSIA PULMONARY EMBOLISM 2
C HALLUCINATION APPLICATION SITE RASH 1
C HALLUCINATION BLISTER 1
C HALLUCINATION CONVULSION NEONATAL 2
C HALLUCINATION FOETAL EXPOSURE DURING PREGNANCY 1
C HALLUCINATION MATERNAL EXPOSURE TIMING UNSPECIFIED 2
C HALLUCINATION PARONYCHIA 1
C HALLUCINATION TALIPES 2
C HUNTINGTON'S DISEASE AFFECTIVE DISORDER 1
C HUNTINGTON'S DISEASE BALANCE DISORDER 1
C HUNTINGTON'S DISEASE COGNITIVE DISORDER 1
C HUNTINGTON'S DISEASE COMMUNICATION DISORDER 1
C HUNTINGTON'S DISEASE CRYING 1
C HUNTINGTON'S DISEASE DEPRESSION 1
C HUNTINGTON'S DISEASE DIZZINESS 1
C HUNTINGTON'S DISEASE DRUG EFFECT DECREASED 1
C HUNTINGTON'S DISEASE HYPOAESTHESIA 1
C MULTIPLE MYELOMA ADRENAL INSUFFICIENCY 1
C MULTIPLE MYELOMA ANHEDONIA 1
C MULTIPLE MYELOMA ANXIETY 1
C MULTIPLE MYELOMA ARTERIOSCLEROSIS CORONARY ARTERY 1
C MULTIPLE MYELOMA ATELECTASIS 1
C MULTIPLE MYELOMA BACK PAIN 1
C MULTIPLE MYELOMA BASAL CELL CARCINOMA 1
C MULTIPLE MYELOMA BONE DISORDER 1
C MULTIPLE MYELOMA BREAST MASS 1
C MULTIPLE MYELOMA CARDIOMEGALY 1
C MULTIPLE MYELOMA COUGH 1
C MULTIPLE MYELOMA DISCOMFORT 1
C MULTIPLE MYELOMA EAR PAIN 1
C MULTIPLE MYELOMA EMOTIONAL DISTRESS 1
C MULTIPLE MYELOMA FISTULA 1
C MULTIPLE MYELOMA FLANK PAIN 1
C MULTIPLE MYELOMA FOOT DEFORMITY 1
C MULTIPLE MYELOMA HAEMATOMA 1
C MULTIPLE MYELOMA HEADACHE 1
C MULTIPLE MYELOMA HYPERKERATOSIS 1
C MULTIPLE MYELOMA HYPERLIPIDAEMIA 1
C MULTIPLE MYELOMA HYPERTENSION 1
C MULTIPLE MYELOMA HYPOKALAEMIA 1
C MULTIPLE MYELOMA INFECTIOUS DISEASE CARRIER 1
C MULTIPLE MYELOMA INJURY 1
C MULTIPLE MYELOMA LICHENOID KERATOSIS 1
C MULTIPLE MYELOMA LIFE EXPECTANCY SHORTENED 1
C MULTIPLE MYELOMA LUNG INFILTRATION 1
C MULTIPLE MYELOMA MASTICATION DISORDER 1
C MULTIPLE MYELOMA MELANOCYTIC NAEVUS 1
C MULTIPLE MYELOMA MUCOSAL INFLAMMATION 1
C MULTIPLE MYELOMA NAUSEA 1
C MULTIPLE MYELOMA NEOPLASM MALIGNANT 1
C MULTIPLE MYELOMA NEPHROLITHIASIS 1
C MULTIPLE MYELOMA NEUROPATHY PERIPHERAL 1
C MULTIPLE MYELOMA OSTEONECROSIS OF JAW 1
C MULTIPLE MYELOMA OSTEOPENIA 1
C MULTIPLE MYELOMA OSTEOPOROSIS 1
C MULTIPLE MYELOMA PAIN 1
C MULTIPLE MYELOMA PAIN IN JAW 1
C MULTIPLE MYELOMA PANCYTOPENIA 1
C MULTIPLE MYELOMA PARAESTHESIA ORAL 1
C MULTIPLE MYELOMA PHYSICAL DISABILITY 1
C MULTIPLE MYELOMA PNEUMONIA 1
C MULTIPLE MYELOMA PRIMARY SEQUESTRUM 1
C MULTIPLE MYELOMA RENAL CYST 1
C MULTIPLE MYELOMA SCAR 1
C MULTIPLE MYELOMA SEPSIS 1
C MULTIPLE MYELOMA SINUS CONGESTION 1
C MULTIPLE MYELOMA SPINAL OSTEOARTHRITIS 1
C MULTIPLE MYELOMA SQUAMOUS CELL CARCINOMA 1
C MULTIPLE MYELOMA SYNCOPE 1
C MULTIPLE MYELOMA URETHRAL OBSTRUCTION 1
C MULTIPLE MYELOMA UTERINE PROLAPSE 1
C MULTIPLE MYELOMA VAGINITIS BACTERIAL 1
C MULTIPLE MYELOMA VOMITING 1
C MYOCARDIAL INFARCTION ACUTE MYOCARDIAL INFARCTION 2
C MYOCARDIAL INFARCTION ACUTE PULMONARY OEDEMA 2
C MYOCARDIAL INFARCTION ASTHENIA 2
C MYOCARDIAL INFARCTION ATRIOVENTRICULAR BLOCK COMPLETE 2
C MYOCARDIAL INFARCTION BLOOD COUNT ABNORMAL 2
C MYOCARDIAL INFARCTION BRADYCARDIA 2
C MYOCARDIAL INFARCTION CARDIAC ARREST 2
C MYOCARDIAL INFARCTION CARDIAC FAILURE CONGESTIVE 2
C MYOCARDIAL INFARCTION CARDIOMEGALY 2
C MYOCARDIAL INFARCTION CORONARY ARTERY DISEASE 2
C MYOCARDIAL INFARCTION DYSPNOEA 2
C MYOCARDIAL INFARCTION ENCEPHALOPATHY 2
C MYOCARDIAL INFARCTION FATIGUE 2
C MYOCARDIAL INFARCTION HEPARIN-INDUCED THROMBOCYTOPENIA 2
C MYOCARDIAL INFARCTION HYPOTENSION 2
C MYOCARDIAL INFARCTION HYPOXIA 2
C MYOCARDIAL INFARCTION MYOCARDIAL INFARCTION 2
C MYOCARDIAL INFARCTION PLEURAL EFFUSION 2
C MYOCARDIAL INFARCTION PNEUMONIA 2
C MYOCARDIAL INFARCTION PULMONARY HYPERTENSION 2
C MYOCARDIAL INFARCTION RENAL FAILURE CHRONIC 2
C MYOCARDIAL INFARCTION THROMBOSIS 2
C MYOCARDIAL INFARCTION TRICUSPID VALVE INCOMPETENCE 2
C MYOCARDIAL INFARCTION UNRESPONSIVE TO STIMULI 2
C PRODUCT USED FOR UNKNOWN INDICATION ACUTE MYOCARDIAL INFARCTION 20
C PRODUCT USED FOR UNKNOWN INDICATION ACUTE PULMONARY OEDEMA 20
C PRODUCT USED FOR UNKNOWN INDICATION ASTHENIA 20
C PRODUCT USED FOR UNKNOWN INDICATION ATRIOVENTRICULAR BLOCK COMPLETE 20
C PRODUCT USED FOR UNKNOWN INDICATION BLOOD COUNT ABNORMAL 20
C PRODUCT USED FOR UNKNOWN INDICATION BRADYCARDIA 20
C PRODUCT USED FOR UNKNOWN INDICATION CARDIAC ARREST 20
C PRODUCT USED FOR UNKNOWN INDICATION CARDIAC FAILURE CONGESTIVE 20
C PRODUCT USED FOR UNKNOWN INDICATION CARDIOMEGALY 20
C PRODUCT USED FOR UNKNOWN INDICATION CORONARY ARTERY DISEASE 20
C PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA 20
C PRODUCT USED FOR UNKNOWN INDICATION ENCEPHALOPATHY 20
C PRODUCT USED FOR UNKNOWN INDICATION FATIGUE 20
C PRODUCT USED FOR UNKNOWN INDICATION HEPARIN-INDUCED THROMBOCYTOPENIA 20
C PRODUCT USED FOR UNKNOWN INDICATION HYPOTENSION 20
C PRODUCT USED FOR UNKNOWN INDICATION HYPOXIA 20
C PRODUCT USED FOR UNKNOWN INDICATION MYOCARDIAL INFARCTION 20
C PRODUCT USED FOR UNKNOWN INDICATION PLEURAL EFFUSION 20
C PRODUCT USED FOR UNKNOWN INDICATION PNEUMONIA 20
C PRODUCT USED FOR UNKNOWN INDICATION PULMONARY HYPERTENSION 20
C PRODUCT USED FOR UNKNOWN INDICATION RENAL FAILURE CHRONIC 20
C PRODUCT USED FOR UNKNOWN INDICATION THROMBOSIS 20
C PRODUCT USED FOR UNKNOWN INDICATION TRICUSPID VALVE INCOMPETENCE 20
C PRODUCT USED FOR UNKNOWN INDICATION UNRESPONSIVE TO STIMULI 20
C THYROID DISORDER DEEP VEIN THROMBOSIS 2
C THYROID DISORDER PAIN 2
C THYROID DISORDER PULMONARY EMBOLISM 2
C VITAMIN SUPPLEMENTATION DEEP VEIN THROMBOSIS 2
C VITAMIN SUPPLEMENTATION PAIN 2
C VITAMIN SUPPLEMENTATION PULMONARY EMBOLISM 2
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