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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