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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