Drug information for PREVACID 24 HR

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
CAPSULE, DELAYED REL PELLETS; ORAL	15MG	Over The Counter	(Reference Drug)	LANSOPRAZOLE	lansoprazole	NOVARTIS	22327 2012-04-25 Letter 2012-04-09 Letter 2011-12-20 Other Important Information from FDA 2011-11-02 Letter 2011-09-29 Letter 2011-04-20 Letter 2011-04-04 Label 2010-12-06 Letter 2010-12-06 Letter 2010-09-20 Letter 2009-08-03 Review 2009-08-03 Summary Review 2009-05-22 Letter 2009-05-20 Label

Drug Adverse Effects information for PREVACID 24 HR

Role code	Indications	Reaction	# Reports
PS	ABDOMINAL DISCOMFORT	HERPES ZOSTER	1
PS	ABDOMINAL DISCOMFORT	OFF LABEL USE	1
PS	ABDOMINAL DISTENSION	DIZZINESS	1
PS	ABDOMINAL DISTENSION	HYPERTENSION	1
PS	ABDOMINAL DISTENSION	INCORRECT DRUG ADMINISTRATION DURATION	1
PS	ABDOMINAL DISTENSION	MYOCARDIAL INFARCTION	1
PS	ABDOMINAL DISTENSION	NAUSEA	1
PS	ABDOMINAL DISTENSION	OFF LABEL USE	1
PS	ABDOMINAL DISTENSION	PAIN IN EXTREMITY	1
PS	ABDOMINAL DISTENSION	ROAD TRAFFIC ACCIDENT	1
PS	ABDOMINAL DISTENSION	VOMITING	1
PS	ANXIETY	DRUG INTERACTION	1
PS	ANXIETY	FEELING ABNORMAL	1
PS	ANXIETY	IMMUNE SYSTEM DISORDER	1
PS	ANXIETY	LYMPHOMA	1
PS	ANXIETY	MALAISE	1
PS	ANXIETY	OFF LABEL USE	1
PS	BLOOD CHOLESTEROL INCREASED	BREAST CANCER	1
PS	BLOOD CHOLESTEROL INCREASED	BREAST LUMP REMOVAL	1
PS	BLOOD CHOLESTEROL INCREASED	INCORRECT DRUG ADMINISTRATION DURATION	1
PS	BLOOD CHOLESTEROL INCREASED	OFF LABEL USE	1
PS	BLOOD CHOLESTEROL INCREASED	THERAPEUTIC RESPONSE UNEXPECTED	1
PS	BLOOD PRESSURE	COLON CANCER	1
PS	BLOOD PRESSURE	DRY MOUTH	1
PS	BLOOD PRESSURE	DYSPNOEA	1
PS	BLOOD PRESSURE	HERPES ZOSTER	2
PS	BLOOD PRESSURE	INCORRECT DRUG ADMINISTRATION DURATION	1
PS	BLOOD PRESSURE	OFF LABEL USE	2
PS	BLOOD PRESSURE	WRONG TECHNIQUE IN DRUG USAGE PROCESS	1
PS	CARDIAC DISORDER	HERPES ZOSTER	1
PS	CARDIAC DISORDER	OFF LABEL USE	1
PS	CARDIOVASCULAR DISORDER	COLON CANCER	1
PS	CARDIOVASCULAR DISORDER	DRY MOUTH	1
PS	CARDIOVASCULAR DISORDER	DYSPNOEA	1
PS	CARDIOVASCULAR DISORDER	INCORRECT DRUG ADMINISTRATION DURATION	1
PS	CARDIOVASCULAR DISORDER	WRONG TECHNIQUE IN DRUG USAGE PROCESS	1
PS	COLON CANCER STAGE IV	ADHESION	1
PS	COLON CANCER STAGE IV	DUODENAL STENOSIS	1
PS	COLON CANCER STAGE IV	INCORRECT DRUG ADMINISTRATION DURATION	1
PS	COLON CANCER STAGE IV	OFF LABEL USE	1
PS	COLON CANCER STAGE IV	OVERDOSE	1
PS	CONSTIPATION	DIZZINESS	1
PS	CONSTIPATION	HYPERTENSION	1
PS	CONSTIPATION	INCORRECT DRUG ADMINISTRATION DURATION	1
PS	CONSTIPATION	MYOCARDIAL INFARCTION	1
PS	CONSTIPATION	NAUSEA	1
PS	CONSTIPATION	OFF LABEL USE	1
PS	CONSTIPATION	PAIN IN EXTREMITY	1
PS	CONSTIPATION	ROAD TRAFFIC ACCIDENT	1
PS	CONSTIPATION	VOMITING	1
PS	DYSPEPSIA	CARDIAC OPERATION	1
PS	DYSPEPSIA	CHOLELITHIASIS	2
PS	DYSPEPSIA	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	2
PS	DYSPEPSIA	DYSPNOEA	2
PS	DYSPEPSIA	GALLBLADDER OPERATION	2
PS	DYSPEPSIA	INCORRECT DRUG ADMINISTRATION DURATION	3
PS	DYSPEPSIA	JAUNDICE	2
PS	DYSPEPSIA	MALAISE	2
PS	DYSPEPSIA	OFF LABEL USE	1
PS	DYSPEPSIA	STENT PLACEMENT	2
PS	FAECES HARD	DIZZINESS	1
PS	FAECES HARD	HYPERTENSION	1
PS	FAECES HARD	INCORRECT DRUG ADMINISTRATION DURATION	1
PS	FAECES HARD	MYOCARDIAL INFARCTION	1
PS	FAECES HARD	NAUSEA	1
PS	FAECES HARD	OFF LABEL USE	1
PS	FAECES HARD	PAIN IN EXTREMITY	1
PS	FAECES HARD	ROAD TRAFFIC ACCIDENT	1
PS	FAECES HARD	VOMITING	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	BARRETT'S OESOPHAGUS	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	BLOOD IRON DECREASED	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	BOWEL MOVEMENT IRREGULARITY	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	BREAST CANCER	2
PS	GASTROOESOPHAGEAL REFLUX DISEASE	BREAST LUMP REMOVAL	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	CARDIAC OPERATION	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	CHOLELITHIASIS	3
PS	GASTROOESOPHAGEAL REFLUX DISEASE	COLITIS MICROSCOPIC	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	CONCOMITANT DISEASE AGGRAVATED	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	CONDITION AGGRAVATED	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	DEAFNESS	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	DISEASE RECURRENCE	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	4
PS	GASTROOESOPHAGEAL REFLUX DISEASE	DRUG INTERACTION	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	DYSPHONIA	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	DYSPNOEA	2
PS	GASTROOESOPHAGEAL REFLUX DISEASE	EXPIRED DRUG ADMINISTERED	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	FALL	2
PS	GASTROOESOPHAGEAL REFLUX DISEASE	FEELING ABNORMAL	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	GALLBLADDER OPERATION	3
PS	GASTROOESOPHAGEAL REFLUX DISEASE	GASTRIC POLYPECTOMY	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	GASTRIC POLYPS	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	GASTRIC ULCER	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	GASTROOESOPHAGEAL REFLUX DISEASE	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	IMMUNE SYSTEM DISORDER	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	INCORRECT DRUG ADMINISTRATION DURATION	15
PS	GASTROOESOPHAGEAL REFLUX DISEASE	JAUNDICE	2
PS	GASTROOESOPHAGEAL REFLUX DISEASE	LOWER LIMB FRACTURE	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	LYMPHOMA	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	MALAISE	3
PS	GASTROOESOPHAGEAL REFLUX DISEASE	MALIGNANT BREAST LUMP REMOVAL	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	NEPHROLITHIASIS	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	NEUROPATHY PERIPHERAL	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	OFF LABEL USE	12
PS	GASTROOESOPHAGEAL REFLUX DISEASE	OVERDOSE	4
PS	GASTROOESOPHAGEAL REFLUX DISEASE	ROTATOR CUFF SYNDROME	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	SARCOIDOSIS	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	STENT PLACEMENT	3
PS	GASTROOESOPHAGEAL REFLUX DISEASE	THERAPEUTIC RESPONSE UNEXPECTED	4
PS	GASTROOESOPHAGEAL REFLUX DISEASE	TREATMENT NONCOMPLIANCE	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	UPPER LIMB FRACTURE	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	VOMITING	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	WRONG TECHNIQUE IN DRUG USAGE PROCESS	2
PS	HYPERTENSION	BREAST CANCER	1
PS	HYPERTENSION	BREAST LUMP REMOVAL	1
PS	HYPERTENSION	DIZZINESS	1
PS	HYPERTENSION	DRUG INTERACTION	1
PS	HYPERTENSION	FEELING ABNORMAL	1
PS	HYPERTENSION	HYPERTENSION	1
PS	HYPERTENSION	IMMUNE SYSTEM DISORDER	1
PS	HYPERTENSION	INCORRECT DRUG ADMINISTRATION DURATION	2
PS	HYPERTENSION	LYMPHOMA	1
PS	HYPERTENSION	MALAISE	1
PS	HYPERTENSION	MYOCARDIAL INFARCTION	1
PS	HYPERTENSION	NAUSEA	1
PS	HYPERTENSION	OFF LABEL USE	3
PS	HYPERTENSION	PAIN IN EXTREMITY	1
PS	HYPERTENSION	ROAD TRAFFIC ACCIDENT	1
PS	HYPERTENSION	THERAPEUTIC RESPONSE UNEXPECTED	1
PS	HYPERTENSION	VOMITING	1
PS	MULTIPLE ALLERGIES	DEAFNESS	1
PS	MULTIPLE ALLERGIES	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	1
PS	MULTIPLE ALLERGIES	INCORRECT DRUG ADMINISTRATION DURATION	1
PS	MULTIPLE ALLERGIES	OVERDOSE	1
PS	MULTIPLE ALLERGIES	THERAPEUTIC RESPONSE UNEXPECTED	1
PS	NAUSEA	HIATUS HERNIA	1
PS	NAUSEA	INCORRECT DRUG ADMINISTRATION DURATION	1
PS	NAUSEA	OFF LABEL USE	1
PS	NAUSEA	OVERDOSE	1
PS	PULMONARY ARTERIAL HYPERTENSION	BOWEL MOVEMENT IRREGULARITY	1
PS	PULMONARY ARTERIAL HYPERTENSION	GASTRIC POLYPECTOMY	1
PS	PULMONARY ARTERIAL HYPERTENSION	GASTRIC POLYPS	1
PS	PULMONARY ARTERIAL HYPERTENSION	INCORRECT DRUG ADMINISTRATION DURATION	1
PS	PULMONARY ARTERIAL HYPERTENSION	OFF LABEL USE	1
PS	PULMONARY ARTERIAL HYPERTENSION	OVERDOSE	1
PS	PULMONARY ARTERIAL HYPERTENSION	THERAPEUTIC RESPONSE UNEXPECTED	1
PS	PULMONARY ARTERIAL HYPERTENSION	WRONG TECHNIQUE IN DRUG USAGE PROCESS	1
PS	THYROID DISORDER	DRUG INTERACTION	1
PS	THYROID DISORDER	FEELING ABNORMAL	1
PS	THYROID DISORDER	IMMUNE SYSTEM DISORDER	1
PS	THYROID DISORDER	LYMPHOMA	1
PS	THYROID DISORDER	MALAISE	1
PS	THYROID DISORDER	OFF LABEL USE	1
PS	ULCER	INCORRECT DRUG ADMINISTRATION DURATION	2
PS	ULCER	LUNG NEOPLASM MALIGNANT	1
PS	ULCER	OFF LABEL USE	2
PS	ULCER	OSTEOPOROSIS	1
PS	ULCER	OVERDOSE	1
SS	DYSPEPSIA	CARDIAC OPERATION	1
SS	DYSPEPSIA	CHOLELITHIASIS	2
SS	DYSPEPSIA	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	2
SS	DYSPEPSIA	DYSPNOEA	2
SS	DYSPEPSIA	GALLBLADDER OPERATION	2
SS	DYSPEPSIA	INCORRECT DRUG ADMINISTRATION DURATION	3
SS	DYSPEPSIA	JAUNDICE	2
SS	DYSPEPSIA	MALAISE	2
SS	DYSPEPSIA	OFF LABEL USE	1
SS	DYSPEPSIA	STENT PLACEMENT	2
SS	GASTROOESOPHAGEAL REFLUX DISEASE	BARRETT'S OESOPHAGUS	1
SS	GASTROOESOPHAGEAL REFLUX DISEASE	CARDIAC OPERATION	1
SS	GASTROOESOPHAGEAL REFLUX DISEASE	CHOLELITHIASIS	2
SS	GASTROOESOPHAGEAL REFLUX DISEASE	DEAFNESS	1
SS	GASTROOESOPHAGEAL REFLUX DISEASE	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	3
SS	GASTROOESOPHAGEAL REFLUX DISEASE	DYSPNOEA	2
SS	GASTROOESOPHAGEAL REFLUX DISEASE	FALL	1
SS	GASTROOESOPHAGEAL REFLUX DISEASE	GALLBLADDER OPERATION	2
SS	GASTROOESOPHAGEAL REFLUX DISEASE	INCORRECT DRUG ADMINISTRATION DURATION	6
SS	GASTROOESOPHAGEAL REFLUX DISEASE	JAUNDICE	2
SS	GASTROOESOPHAGEAL REFLUX DISEASE	MALAISE	2
SS	GASTROOESOPHAGEAL REFLUX DISEASE	NEUROPATHY PERIPHERAL	1
SS	GASTROOESOPHAGEAL REFLUX DISEASE	OFF LABEL USE	3
SS	GASTROOESOPHAGEAL REFLUX DISEASE	OVERDOSE	2
SS	GASTROOESOPHAGEAL REFLUX DISEASE	ROTATOR CUFF SYNDROME	1
SS	GASTROOESOPHAGEAL REFLUX DISEASE	STENT PLACEMENT	2
SS	GASTROOESOPHAGEAL REFLUX DISEASE	THERAPEUTIC RESPONSE UNEXPECTED	2
SS	GASTROOESOPHAGEAL REFLUX DISEASE	TREATMENT NONCOMPLIANCE	1
SS	GASTROOESOPHAGEAL REFLUX DISEASE	UPPER LIMB FRACTURE	1
SS	GASTROOESOPHAGEAL REFLUX DISEASE	WRONG TECHNIQUE IN DRUG USAGE PROCESS	1
SS	MULTIPLE ALLERGIES	DEAFNESS	1
SS	MULTIPLE ALLERGIES	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	1
SS	MULTIPLE ALLERGIES	INCORRECT DRUG ADMINISTRATION DURATION	1
SS	MULTIPLE ALLERGIES	OVERDOSE	1
SS	MULTIPLE ALLERGIES	THERAPEUTIC RESPONSE UNEXPECTED	1

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