Drug information for KETEK

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 300MG Prescription   TELITHROMYCIN telithromycin SANOFI AVENTIS US 21144
2012-02-14 Review
2011-06-29 Letter
2011-01-05 Other
2010-12-10 Letter
2010-12-10 Letter
2010-12-09 Label
2010-12-08 Label
2009-11-19 Medication Guide
2007-02-23 Letter
2007-02-12 Label
2006-07-03 Letter
2006-07-03 Label
2005-11-08 Letter
2005-11-03 Label
2005-04-12 Letter
2005-02-11 Label
2005-02-11 Label
2005-02-11 Letter
2005-02-11 Letter
2004-07-13 Other Important Information from FDA
2004-07-08 Review
2004-04-07 Letter
2004-04-05 Label
TABLET; ORAL 400MG Prescription  (Reference Drug) TELITHROMYCIN telithromycin SANOFI AVENTIS US   "

Drug Adverse Effects information for KETEK

Role code Indications Reaction # Reports
PS BRONCHITIS DIPLOPIA 1
PS BRONCHITIS DIZZINESS 1
PS BRONCHITIS FEELING ABNORMAL 1
PS BRONCHITIS MALAISE 1
PS SINUSITIS DIPLOPIA 3
PS SINUSITIS DIZZINESS 3
PS SINUSITIS FEELING ABNORMAL 3
PS SINUSITIS MALAISE 3
SS BRONCHITIS DIPLOPIA 1
SS BRONCHITIS DIZZINESS 1
SS BRONCHITIS FEELING ABNORMAL 1
SS BRONCHITIS MALAISE 1
SS SINUSITIS DIPLOPIA 3
SS SINUSITIS DIZZINESS 3
SS SINUSITIS FEELING ABNORMAL 3
SS SINUSITIS MALAISE 3
C ANTASTHMATIC DRUG LEVEL ANXIETY 1
C ANTASTHMATIC DRUG LEVEL MATERNAL EXPOSURE DURING PREGNANCY 1
C ANTASTHMATIC DRUG LEVEL POSTPARTUM DEPRESSION 1
C ANTASTHMATIC DRUG LEVEL STRESS 1
C ASTHMA ANXIETY 1
C ASTHMA MATERNAL EXPOSURE DURING PREGNANCY 1
C ASTHMA MIDDLE EAR EFFUSION 1
C ASTHMA POSTPARTUM DEPRESSION 1
C ASTHMA STRESS 1
C HEADACHE ANXIETY 1
C HEADACHE MATERNAL EXPOSURE DURING PREGNANCY 1
C HEADACHE POSTPARTUM DEPRESSION 1
C HEADACHE STRESS 1
C INCREASED UPPER AIRWAY SECRETION HEPATITIS B 2
C INCREASED UPPER AIRWAY SECRETION HEPATITIS FULMINANT 2
C INCREASED UPPER AIRWAY SECRETION LIVER TRANSPLANT 2
C LUNG DISORDER DISABILITY 1
C LUNG DISORDER FATIGUE 1
C LUNG DISORDER MUSCULAR WEAKNESS 1
C LUNG INFECTION DISABILITY 1
C LUNG INFECTION FATIGUE 1
C LUNG INFECTION MUSCULAR WEAKNESS 1
C MIGRAINE ANXIETY 1
C MIGRAINE MATERNAL EXPOSURE DURING PREGNANCY 1
C MIGRAINE POSTPARTUM DEPRESSION 1
C MIGRAINE STRESS 1
C NON-HODGKIN'S LYMPHOMA HEPATITIS B 15
C NON-HODGKIN'S LYMPHOMA HEPATITIS FULMINANT 15
C NON-HODGKIN'S LYMPHOMA LIVER TRANSPLANT 15
C PRODUCT USED FOR UNKNOWN INDICATION ANAEMIA 1
C PRODUCT USED FOR UNKNOWN INDICATION ANAEMIA NEONATAL 1
C PRODUCT USED FOR UNKNOWN INDICATION ANISOMETROPIA 2
C PRODUCT USED FOR UNKNOWN INDICATION ANXIETY 2
C PRODUCT USED FOR UNKNOWN INDICATION APGAR SCORE LOW 1
C PRODUCT USED FOR UNKNOWN INDICATION ASPIRATION 2
C PRODUCT USED FOR UNKNOWN INDICATION ATRIAL SEPTAL DEFECT 2
C PRODUCT USED FOR UNKNOWN INDICATION AUTISM 2
C PRODUCT USED FOR UNKNOWN INDICATION BODY DYSMORPHIC DISORDER 1
C PRODUCT USED FOR UNKNOWN INDICATION CARDIAC FAILURE CONGESTIVE 2
C PRODUCT USED FOR UNKNOWN INDICATION CEREBRAL CYST 1
C PRODUCT USED FOR UNKNOWN INDICATION COGNITIVE DISORDER 2
C PRODUCT USED FOR UNKNOWN INDICATION COLITIS 2
C PRODUCT USED FOR UNKNOWN INDICATION CONGENITAL ANOMALY 1
C PRODUCT USED FOR UNKNOWN INDICATION CONSTIPATION 2
C PRODUCT USED FOR UNKNOWN INDICATION COUGH 2
C PRODUCT USED FOR UNKNOWN INDICATION CRYPTORCHISM 2
C PRODUCT USED FOR UNKNOWN INDICATION DEAFNESS 2
C PRODUCT USED FOR UNKNOWN INDICATION DEFORMITY 2
C PRODUCT USED FOR UNKNOWN INDICATION DEHYDRATION 2
C PRODUCT USED FOR UNKNOWN INDICATION DELAYED FONTANELLE CLOSURE 2
C PRODUCT USED FOR UNKNOWN INDICATION DEVELOPMENTAL DELAY 2
C PRODUCT USED FOR UNKNOWN INDICATION DILATATION ATRIAL 1
C PRODUCT USED FOR UNKNOWN INDICATION DILATATION VENTRICULAR 1
C PRODUCT USED FOR UNKNOWN INDICATION DYSMORPHISM 1
C PRODUCT USED FOR UNKNOWN INDICATION DYSPHAGIA 2
C PRODUCT USED FOR UNKNOWN INDICATION EAR MALFORMATION 1
C PRODUCT USED FOR UNKNOWN INDICATION ECTOPIC KIDNEY 2
C PRODUCT USED FOR UNKNOWN INDICATION EMOTIONAL DISORDER 1
C PRODUCT USED FOR UNKNOWN INDICATION FAILURE TO THRIVE 2
C PRODUCT USED FOR UNKNOWN INDICATION FALLOT'S TETRALOGY 1
C PRODUCT USED FOR UNKNOWN INDICATION FEEDING DISORDER NEONATAL 1
C PRODUCT USED FOR UNKNOWN INDICATION FOETAL EXPOSURE DURING PREGNANCY 1
C PRODUCT USED FOR UNKNOWN INDICATION FOETAL GROWTH RESTRICTION 1
C PRODUCT USED FOR UNKNOWN INDICATION FOOD AVERSION 1
C PRODUCT USED FOR UNKNOWN INDICATION GASTRIC VOLVULUS 2
C PRODUCT USED FOR UNKNOWN INDICATION GASTROINTESTINAL HAEMORRHAGE 2
C PRODUCT USED FOR UNKNOWN INDICATION GASTROOESOPHAGEAL REFLUX DISEASE 2
C PRODUCT USED FOR UNKNOWN INDICATION HEART DISEASE CONGENITAL 1
C PRODUCT USED FOR UNKNOWN INDICATION HIP DYSPLASIA 1
C PRODUCT USED FOR UNKNOWN INDICATION HYPERTELORISM OF ORBIT 2
C PRODUCT USED FOR UNKNOWN INDICATION HYPOTONIA 2
C PRODUCT USED FOR UNKNOWN INDICATION IMPAIRED GASTRIC EMPTYING 1
C PRODUCT USED FOR UNKNOWN INDICATION INJURY 1
C PRODUCT USED FOR UNKNOWN INDICATION MATERNAL DRUGS AFFECTING FOETUS 1
C PRODUCT USED FOR UNKNOWN INDICATION MENTAL RETARDATION 2
C PRODUCT USED FOR UNKNOWN INDICATION MICROPENIS 2
C PRODUCT USED FOR UNKNOWN INDICATION MIDDLE EAR DISORDER 1
C PRODUCT USED FOR UNKNOWN INDICATION MOTOR DEVELOPMENTAL DELAY 1
C PRODUCT USED FOR UNKNOWN INDICATION MULTIPLE CONGENITAL ABNORMALITIES 1
C PRODUCT USED FOR UNKNOWN INDICATION MYOCARDIAL INFARCTION 1
C PRODUCT USED FOR UNKNOWN INDICATION NASAL SEPTUM DISORDER 1
C PRODUCT USED FOR UNKNOWN INDICATION NUCLEAR MAGNETIC RESONANCE IMAGING BRAIN ABNORMAL 1
C PRODUCT USED FOR UNKNOWN INDICATION OTITIS MEDIA 1
C PRODUCT USED FOR UNKNOWN INDICATION OTITIS MEDIA CHRONIC 1
C PRODUCT USED FOR UNKNOWN INDICATION PAIN 3
C PRODUCT USED FOR UNKNOWN INDICATION PATENT DUCTUS ARTERIOSUS 2
C PRODUCT USED FOR UNKNOWN INDICATION PETIT MAL EPILEPSY 1
C PRODUCT USED FOR UNKNOWN INDICATION PNEUMONIA 2
C PRODUCT USED FOR UNKNOWN INDICATION PREMATURE BABY 2
C PRODUCT USED FOR UNKNOWN INDICATION RESPIRATORY FAILURE 2
C PRODUCT USED FOR UNKNOWN INDICATION SCAR 2
C PRODUCT USED FOR UNKNOWN INDICATION SENSORY INTEGRATIVE DYSFUNCTION 1
C PRODUCT USED FOR UNKNOWN INDICATION SLEEP APNOEA SYNDROME 2
C PRODUCT USED FOR UNKNOWN INDICATION SPEECH DISORDER DEVELOPMENTAL 2
C PRODUCT USED FOR UNKNOWN INDICATION STARING 2
C PRODUCT USED FOR UNKNOWN INDICATION SURGERY 1
C PRODUCT USED FOR UNKNOWN INDICATION UNEVALUABLE EVENT 1
C PURULENCE HEPATITIS B 2
C PURULENCE HEPATITIS FULMINANT 2
C PURULENCE LIVER TRANSPLANT 2
C RESPIRATORY TRACT INFECTION ANXIETY 2
C RESPIRATORY TRACT INFECTION MATERNAL EXPOSURE DURING PREGNANCY 2
C RESPIRATORY TRACT INFECTION POSTPARTUM DEPRESSION 2
C RESPIRATORY TRACT INFECTION STRESS 2
C SECRETION DISCHARGE HEPATITIS B 1
C SECRETION DISCHARGE HEPATITIS FULMINANT 1
C SECRETION DISCHARGE LIVER TRANSPLANT 1
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