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Prevpac (Clarithromycin / Amoxicillin / Lansoprazole) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Prevpac 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 (12)
Death (1)
Life Threatening Events (2)

Reports by Reaction Type

Diarrhoea (4)Drug Eruption (3)Alanine Aminotransferase Increased (3)Agranulocytosis (3)Aspartate Aminotransferase Increased (3)Loss of Consciousness (2)Cardio-Respiratory Arrest (2)Erythema Multiforme (2)Rhabdomyolysis (1)Abasia (1)Disseminated Intravascular Coagulation (1)Fall (1)

Possible Prevpac side effects in female

Reported by a physician from Japan on 2012-07-19

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Drug Eruption, Erythema Multiforme

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amoxicillin
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2011-09-07
    End date: 2011-09-13

Clarithromycin
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2011-09-07
    End date: 2011-09-13

Lansoprazole
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2011-09-07
    End date: 2011-09-13

Prevpac
    Dosage: 400 mg 2 tablets in 2 divided doses
    Indication: Helicobacter Infection
    Start date: 2011-09-07
    End date: 2011-09-13

Other drugs received by patient: Rabeprazole Sodium; Rabeprazole Sodium



Possible Prevpac side effects in female

Reported by a physician from Japan on 2012-07-05

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Drug Eruption, Erythema Multiforme

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amoxicillin
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2011-09-07
    End date: 2011-09-13

Clarithromycin
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2011-09-07
    End date: 2011-09-13

Lansoprazole
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2011-09-07
    End date: 2011-09-13

Prevpac
    Dosage: 400 mg 2 tablets in 2 divided doses
    Indication: Helicobacter Infection
    Start date: 2011-09-07
    End date: 2011-09-13

Other drugs received by patient: Rabeprazole Sodium; Rabeprazole Sodium



Possible Prevpac side effects in 70 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-27

Patient: 70 year old male

Reactions: Cardio-Respiratory Arrest, Agranulocytosis, Diarrhoea, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Disseminated Intravascular Coagulation

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Lansoprazole
    Dosage: 30 mg (15 mg, 2 in 1 d), per oral
    Administration route: Oral
    Start date: 2012-02-21
    End date: 2012-02-22

Lansoprazole
    Dosage: 30 mg (15 mg, 2 in 1 d), per oral
    Administration route: Oral
    Start date: 2012-03-01

Prevpac
    Dosage: 1 card (0.5 car-2 in 1 d) per oral
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2012-02-23
    End date: 2012-02-23

Other drugs received by patient: Ferromia (Ferrous Sodium Citrate); Miya-BM (Clostridium Butyricum); Loperamide HCL



Possible Prevpac side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-15

Patient: 76 year old female

Reactions: Rhabdomyolysis, Abasia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prevpac

Other drugs received by patient: Metformin Hydrochloride; Loxonin (Loxoprofen Sodium); Amaryl; Miya-BM (Clostridium Butyricum); Evista; Magmitt (Magnesium Oxide); Selbex (Teprenone)



Possible Prevpac side effects in 64 year old male

Reported by a physician from Japan on 2012-05-25

Patient: 64 year old male

Reactions: Drug Eruption, Generalised Erythema, Oedema Peripheral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lansoprazole
    Dosage: 1 cap. (1 cap.,1 in 1 d) per oral ; 1 cap. (1 cap.,1 in 1 d) per oral
    Administration route: Oral
    Indication: Gastric Ulcer
    Start date: 2012-05-05
    End date: 2012-05-09

Lansoprazole
    Dosage: 1 cap. (1 cap.,1 in 1 d) per oral ; 1 cap. (1 cap.,1 in 1 d) per oral
    Administration route: Oral
    Indication: Gastric Ulcer
    Start date: 2012-04-25
    End date: 2012-05-02

Prevpac
    Dosage: 0.5 card (0.5 card,1 in 1 d) per oral
    Administration route: Oral
    Indication: Helicobacter Infection
    Start date: 2012-05-03
    End date: 2012-05-03

Other drugs received by patient: Selbex (Teprenone)



Possible Prevpac side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-04

Patient: female

Reactions: Pruritus Generalised, NO Therapeutic Response

Drug(s) suspected as cause:
Prevpac



Possible Prevpac side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-27

Patient: 50 year old male

Reactions: Chest Discomfort, Troponin Increased

Drug(s) suspected as cause:
Prevpac

Other drugs received by patient: Sleeping Pill (Diphenhydramine Hydrochloride)



Possible Prevpac side effects in 23 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-11

Patient: 23 year old female, weighing 74.4 kg (163.7 pounds)

Reactions: Migraine, Menorrhagia, Abdominal Pain Upper

Drug(s) suspected as cause:
Prevpac
    Dosage: 14 pt. cards
    Administration route: Oral
    Indication: Infection
    Start date: 2012-03-12
    End date: 2012-03-26

Prevpac
    Dosage: 14 pt. cards
    Administration route: Oral
    Indication: Gastritis
    Start date: 2012-03-12
    End date: 2012-03-26



Possible Prevpac side effects in 70 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-03-29

Patient: 70 year old male

Reactions: Agranulocytosis, Diarrhoea, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Respiratory Arrest, Cardiac Arrest, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lansoprazole
    Indication: Gastric Ulcer Haemorrhage
    Start date: 2012-02-21
    End date: 2012-02-23

Prevpac
    Dosage: per oral
    Administration route: Oral
    Start date: 2012-02-23
    End date: 2012-02-29

Other drugs received by patient: Fesin (Saccharated Iron Oxide); Ferrous Citrate



Possible Prevpac side effects in 70 year old male

Reported by a individual with unspecified qualification from Japan on 2012-03-15

Patient: 70 year old male

Reactions: White Blood Cell Count Decreased, Agranulocytosis, Cardio-Respiratory Arrest, Diarrhoea, Alanine Aminotransferase Increased, Gastric Ulcer Haemorrhage, Aspartate Aminotransferase Increased, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lansoprazole
    Indication: Gastric Ulcer Haemorrhage
    Start date: 2012-02-21
    End date: 2012-02-23

Prevpac
    Dosage: per oral
    Administration route: Oral
    Start date: 2012-02-23
    End date: 2012-02-29

Other drugs received by patient: Ferrous Citrate; Fesin (Saccharated Iron Oxide)



Possible Prevpac side effects in 39 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-03-13

Patient: 39 year old male

Reactions: Cardiac Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prevpac



Possible Prevpac side effects in 86 year old male

Reported by a physician from United States on 2011-10-18

Patient: 86 year old male, weighing 95.3 kg (209.6 pounds)

Reactions: Diarrhoea, Dizziness, Disorientation, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prevpac

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