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Ketek (Telithromycin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ketek (Telithromycin) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (7)
Life Threatening Events (4)

Reports by Reaction Type

Tachycardia (2)Stevens-Johnson Syndrome (2)Confusional State (1)Haemorrhage (1)Rectal Haemorrhage (1)Drug Interaction (1)Headache (1)Lactic Acidosis (1)Tricuspid Valve Incompetence (1)Diplopia (1)Dizziness (1)Abdominal Distension (1)

Possible Ketek side effects in 65 year old male

Reported by a physician from South Africa on 2012-08-13

Patient: 65 year old male, weighing 77.0 kg (169.4 pounds)

Reactions: Abdominal Discomfort, Rectal Haemorrhage, Abdominal Distension

Drug(s) suspected as cause:
Ketek

Other drugs received by patient: Ezetimibe; Perindopril Erbumine; Crestor



Possible Ketek side effects in 46 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-23

Patient: 46 year old male

Reactions: Haptoglobin Decreased, Pancytopenia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Norvir
    Administration route: Oral
    Indication: HIV Infection
    End date: 2012-02-01

Risperdal
    Administration route: Oral
    Start date: 2009-01-01
    End date: 2011-02-01

Ketek
    Administration route: Oral
    Start date: 2011-01-24
    End date: 2011-02-01

Other drugs received by patient: Atazanavir Sulfate; Corticosteroid NOS; Trimeprazine Tartrate; Emtricitabine / Tenofovir Disoproxil Fumarate; Valium; Desmopressin Acetate; Tazobactam; Bactrim



Possible Ketek side effects in 40 year old female

Reported by a physician from Turkey on 2012-04-16

Patient: 40 year old female, weighing 75.0 kg (165.0 pounds)

Reactions: Confusional State, Angioedema, Dyspnoea, Tachycardia, Swollen Tongue, Tricuspid Valve Incompetence, Headache, Pericardial Effusion

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Ketek



Possible Ketek side effects in 26 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-22

Patient: 26 year old female

Reactions: Xerophthalmia, Trichorrhexis, Stevens-Johnson Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Naphazoline HCL
    Indication: Sinusitis
    Start date: 2008-06-21

Prednisolone
    Administration route: Oral
    Indication: Sinusitis
    Start date: 2008-06-21
    End date: 2008-06-24

Ketek
    Administration route: Oral
    Start date: 2008-06-01

Pneumorel
    Administration route: Oral
    Indication: Sinusitis
    Start date: 2008-06-21
    End date: 2008-06-30

Supradyn / ARG /
    Administration route: Oral
    Start date: 2008-06-01

Ibuprofen (Advil)
    Administration route: Oral
    Start date: 2008-06-01
    End date: 2008-06-01

Euphytose
    Administration route: Oral
    Start date: 2008-06-30

Vitamins NOS
    Administration route: Oral
    Start date: 2008-06-01

Other drugs received by patient: Acetaminophen; Acetaminophen; Nordette-21; Lexomil; Prazepam



Possible Ketek side effects in 26 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-17

Patient: 26 year old female

Reactions: Haemorrhage, Cytolytic Hepatitis, Tachycardia, Neutropenia, Blood Pressure Decreased, Stevens-Johnson Syndrome, Inflammation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ketek
    Dosage: unk
    Administration route: Oral
    Start date: 2008-06-01

Naphazoline HCL
    Dosage: unk
    Indication: Sinusitis
    Start date: 2008-06-21
    End date: 2008-01-01

Prednisolone
    Dosage: unk
    Administration route: Oral
    Indication: Sinusitis
    Start date: 2008-06-21
    End date: 2008-06-24

Pneumorel
    Dosage: unk
    Administration route: Oral
    Indication: Sinusitis
    Start date: 2008-06-21
    End date: 2008-06-30

Ferrous Carbonate
    Dosage: unk
    Administration route: Oral
    Start date: 2008-06-01

Ibuprofen (Advil)
    Dosage: one single dose
    Administration route: Oral
    Start date: 2008-06-01
    End date: 2008-06-01

Euphytose
    Dosage: unk
    Administration route: Oral
    Start date: 2008-06-30

Other drugs received by patient: Nordette-21; Paracetamol; Prazepam; Lexomil



Possible Ketek side effects in

Reported by a health professional (non-physician/pharmacist) from South Africa on 2011-12-12

Patient:

Reactions: Drug Interaction, Lactic Acidosis

Drug(s) suspected as cause:
Ketek

Metformin HCL



Possible Ketek side effects in 50 year old female

Reported by a physician from South Africa on 2011-10-07

Patient: 50 year old female

Reactions: Diplopia, Malaise, Dizziness, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketek
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2011-09-15
    End date: 2011-09-22

Ketek
    Administration route: Oral
    Indication: Sinusitis
    Start date: 2011-09-15
    End date: 2011-09-22

Other drugs received by patient: Fluticasone Propionate; Pulmison; Desloratadine; Clarithromycin

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