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
Ads by Google