Drug information for ZANTAC 150
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
CAPSULE; ORAL
EQ 150MG BASE
Discontinued
RANITIDINE HYDROCHLORIDE
Ranitidine
GLAXOSMITHKLINE
20095
2004-07-01 Letter
2003-04-29 Review
2003-04-29 Review
2002-01-07 Letter
GRANULE, EFFERVESCENT; ORAL
EQ 150MG BASE/PACKET
Discontinued
RANITIDINE HYDROCHLORIDE
Ranitidine
GLAXOSMITHKLINE
20251
2009-11-12 Letter
2009-10-06 Label
2009-03-27 Label
2009-02-19 Letter
2006-07-21 Letter
2005-05-02 Letter
2005-05-02 Label
2004-07-01 Letter
2004-05-03 Label
2004-04-07 Letter
2003-04-29 Review
2002-01-07 Letter
TABLET, EFFERVESCENT; ORAL
EQ 150MG BASE
Discontinued
RANITIDINE HYDROCHLORIDE
Ranitidine
GLAXOSMITHKLINE
"
TABLET; ORAL
EQ 150MG BASE
Prescription
AB
RANITIDINE HYDROCHLORIDE
Ranitidine
GLAXOSMITHKLINE
18703
2009-11-12 Letter
2009-10-06 Label
2009-03-27 Label
2009-02-19 Letter
2006-07-21 Letter
2005-05-02 Letter
2005-05-02 Label
2004-07-01 Letter
2003-04-30 Review
2002-01-07 Letter
TABLET; ORAL
EQ 150MG BASE
Over The Counter
(Reference Drug)
RANITIDINE HYDROCHLORIDE
Ranitidine
BOEHRINGER INGELHEIM
21698
2007-06-04 Review
2007-03-15 Letter
2004-09-03 Label
2004-09-03 Letter
TABLET; ORAL
EQ 150MG BASE
Over The Counter
RANITIDINE HYDROCHLORIDE
Ranitidine
BOEHRINGER INGELHEIM
"
Drug Adverse Effects information for ZANTAC 150
Role code
Indications
Reaction
# Reports
PS
ABDOMINAL DISCOMFORT
ACCIDENTAL OVERDOSE
1
PS
ABDOMINAL PAIN UPPER
ABDOMINAL PAIN UPPER
1
PS
ABDOMINAL PAIN UPPER
DRUG INEFFECTIVE
1
PS
ABDOMINAL PAIN UPPER
INCORRECT DOSE ADMINISTERED
1
PS
ABDOMINAL PAIN UPPER
INTENTIONAL OVERDOSE
1
PS
ABDOMINAL PAIN UPPER
TONGUE DISCOLOURATION
1
PS
ACCIDENTAL DRUG INTAKE BY CHILD
ACCIDENTAL DRUG INTAKE BY CHILD
1
PS
ANTACID THERAPY
PRURITUS
1
PS
ANTIDEPRESSANT THERAPY
GASTRITIS EROSIVE
1
PS
ANXIETY
ABDOMINAL PAIN UPPER
3
PS
ANXIETY
DRUG INEFFECTIVE
3
PS
ANXIETY
ERUCTATION
1
PS
ANXIETY
HAEMATOCHEZIA
3
PS
ANXIETY
INCORRECT DOSE ADMINISTERED
3
PS
ANXIETY
INCORRECT DRUG ADMINISTRATION DURATION
3
PS
ARRHYTHMIA
ERUCTATION
1
PS
ARRHYTHMIA
FLATULENCE
1
PS
ARTHRITIS
BLOOD PRESSURE INCREASED
1
PS
ASTHMA
BALANCE DISORDER
1
PS
ASTHMA
DIZZINESS
1
PS
ASTHMA
GAIT DISTURBANCE
1
PS
ASTHMA
SOMNOLENCE
1
PS
BACK PAIN
CHEST DISCOMFORT
1
PS
BACK PAIN
CHEST PAIN
1
PS
BACK PAIN
FLATULENCE
1
PS
BIPOLAR DISORDER
AMPHETAMINES POSITIVE
3
PS
BLOOD CHOLESTEROL INCREASED
ABDOMINAL PAIN UPPER
2
PS
BLOOD CHOLESTEROL INCREASED
DYSGEUSIA
1
PS
BLOOD CHOLESTEROL INCREASED
DYSPEPSIA
1
PS
BLOOD CHOLESTEROL INCREASED
ERUCTATION
1
PS
BLOOD CHOLESTEROL INCREASED
GASTRITIS EROSIVE
1
PS
BLOOD CHOLESTEROL INCREASED
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
BLOOD CHOLESTEROL INCREASED
HAEMATOCHEZIA
2
PS
BLOOD CHOLESTEROL INCREASED
INCORRECT DRUG ADMINISTRATION DURATION
2
PS
BLOOD CHOLESTEROL INCREASED
TINNITUS
1
PS
BRAIN TUMOUR OPERATION
DRUG INEFFECTIVE
1
PS
BRONCHIECTASIS
ABDOMINAL PAIN UPPER
1
PS
BRONCHIECTASIS
DYSPEPSIA
1
PS
BRONCHIECTASIS
HIATUS HERNIA
1
PS
CEREBROVASCULAR ACCIDENT PROPHYLAXIS
DYSARTHRIA
1
PS
CEREBROVASCULAR ACCIDENT PROPHYLAXIS
FATIGUE
1
PS
CEREBROVASCULAR ACCIDENT PROPHYLAXIS
GAIT DISTURBANCE
1
PS
DEPRESSION
ABDOMINAL PAIN UPPER
3
PS
DEPRESSION
AMPHETAMINES POSITIVE
2
PS
DEPRESSION
DRUG INEFFECTIVE
1
PS
DEPRESSION
HAEMATOCHEZIA
3
PS
DEPRESSION
INCORRECT DOSE ADMINISTERED
1
PS
DEPRESSION
INCORRECT DRUG ADMINISTRATION DURATION
3
PS
DIABETES MELLITUS
DRUG INEFFECTIVE
1
PS
DYSPEPSIA
ABDOMINAL DISCOMFORT
1
PS
DYSPEPSIA
ABDOMINAL DISTENSION
2
PS
DYSPEPSIA
ABDOMINAL PAIN UPPER
7
PS
DYSPEPSIA
ACCIDENTAL OVERDOSE
1
PS
DYSPEPSIA
AMPHETAMINES POSITIVE
1
PS
DYSPEPSIA
BALANCE DISORDER
2
PS
DYSPEPSIA
CHILLS
2
PS
DYSPEPSIA
COUGH
1
PS
DYSPEPSIA
DIARRHOEA
2
PS
DYSPEPSIA
DIZZINESS
2
PS
DYSPEPSIA
DRUG INEFFECTIVE
14
PS
DYSPEPSIA
DRY MOUTH
1
PS
DYSPEPSIA
DYSARTHRIA
1
PS
DYSPEPSIA
DYSPEPSIA
9
PS
DYSPEPSIA
DYSPNOEA
1
PS
DYSPEPSIA
ERUCTATION
2
PS
DYSPEPSIA
FATIGUE
1
PS
DYSPEPSIA
FEELING HOT
1
PS
DYSPEPSIA
FLATULENCE
3
PS
DYSPEPSIA
GAIT DISTURBANCE
3
PS
DYSPEPSIA
GASTROOESOPHAGEAL REFLUX DISEASE
2
PS
DYSPEPSIA
HAEMATOCHEZIA
1
PS
DYSPEPSIA
HIATUS HERNIA
1
PS
DYSPEPSIA
INCORRECT DOSE ADMINISTERED
6
PS
DYSPEPSIA
INCORRECT DRUG ADMINISTRATION DURATION
2
PS
DYSPEPSIA
INCREASED UPPER AIRWAY SECRETION
1
PS
DYSPEPSIA
INTENTIONAL DRUG MISUSE
1
PS
DYSPEPSIA
MUSCLE SPASMS
2
PS
DYSPEPSIA
MUSCULAR WEAKNESS
1
PS
DYSPEPSIA
NERVOUSNESS
1
PS
DYSPEPSIA
PRURITUS
1
PS
DYSPEPSIA
PRURITUS GENERALISED
1
PS
DYSPEPSIA
RASH GENERALISED
1
PS
DYSPEPSIA
SOMNOLENCE
2
PS
DYSPEPSIA
SWELLING
1
PS
DYSPEPSIA
TACHYCARDIA
2
PS
DYSPEPSIA
TINNITUS
2
PS
DYSPEPSIA
URINE AMPHETAMINE POSITIVE
1
PS
DYSPEPSIA
WHEEZING
1
PS
DYSPHAGIA
GASTRITIS EROSIVE
1
PS
EROSIVE OESOPHAGITIS
BLOOD PRESSURE INCREASED
1
PS
EYE DISORDER
PRURITUS
2
PS
EYE PRURITUS
DRUG INEFFECTIVE
1
PS
EYE PRURITUS
DRY MOUTH
1
PS
EYE PRURITUS
INCORRECT DOSE ADMINISTERED
1
PS
FLATULENCE
ERUCTATION
1
PS
FLATULENCE
FLATULENCE
1
PS
GASTRIC ULCER
SKIN DISORDER
1
PS
GASTRITIS
ABDOMINAL PAIN UPPER
2
PS
GASTRITIS
CHEST DISCOMFORT
2
PS
GASTRITIS
DRUG INEFFECTIVE
2
PS
GASTRITIS
DYSPNOEA
2
PS
GASTRITIS
GASTRITIS
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
ABDOMINAL DISCOMFORT
2
PS
GASTROOESOPHAGEAL REFLUX DISEASE
BODY TEMPERATURE NORMAL
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
COLITIS
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
DIVERTICULITIS
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
DRUG INEFFECTIVE
2
PS
GASTROOESOPHAGEAL REFLUX DISEASE
DYSGEUSIA
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
EATING DISORDER
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
FEELING ABNORMAL
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
GASTROOESOPHAGEAL REFLUX DISEASE
6
PS
GASTROOESOPHAGEAL REFLUX DISEASE
INCORRECT DOSE ADMINISTERED
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
INTENTIONAL DRUG MISUSE
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
MALAISE
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
NAUSEA
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
SOMNOLENCE
1
PS
HIATUS HERNIA
NASAL CONGESTION
1
PS
HIATUS HERNIA
NAUSEA
1
PS
HYPERSENSITIVITY
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
HYPERTENSION
ABDOMINAL PAIN UPPER
2
PS
HYPERTENSION
BALANCE DISORDER
1
PS
HYPERTENSION
BLOOD PRESSURE INCREASED
2
PS
HYPERTENSION
CHILLS
2
PS
HYPERTENSION
COLITIS
1
PS
HYPERTENSION
DIVERTICULITIS
1
PS
HYPERTENSION
DIZZINESS
1
PS
HYPERTENSION
DYSARTHRIA
1
PS
HYPERTENSION
DYSGEUSIA
1
PS
HYPERTENSION
DYSPEPSIA
1
PS
HYPERTENSION
ERUCTATION
1
PS
HYPERTENSION
FATIGUE
1
PS
HYPERTENSION
FLATULENCE
1
PS
HYPERTENSION
GAIT DISTURBANCE
2
PS
HYPERTENSION
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
HYPERTENSION
INTENTIONAL DRUG MISUSE
1
PS
HYPERTENSION
RASH GENERALISED
1
PS
HYPERTENSION
SOMNOLENCE
1
PS
HYPERTENSION
TACHYCARDIA
2
PS
HYPERTENSION
TINNITUS
2
PS
HYPOTENSION
FLATULENCE
1
PS
HYPOTHYROIDISM
ABDOMINAL PAIN UPPER
1
PS
HYPOTHYROIDISM
CHILLS
1
PS
HYPOTHYROIDISM
COLITIS
1
PS
HYPOTHYROIDISM
DIVERTICULITIS
1
PS
HYPOTHYROIDISM
DRUG INEFFECTIVE
2
PS
HYPOTHYROIDISM
ERUCTATION
1
PS
HYPOTHYROIDISM
GASTRITIS EROSIVE
1
PS
HYPOTHYROIDISM
INCORRECT DOSE ADMINISTERED
2
PS
HYPOTHYROIDISM
INTENTIONAL DRUG MISUSE
1
PS
HYPOTHYROIDISM
TACHYCARDIA
1
PS
HYPOTHYROIDISM
TINNITUS
1
PS
INNER EAR DISORDER
DYSGEUSIA
1
PS
INNER EAR DISORDER
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
IRRITABLE BOWEL SYNDROME
DYSGEUSIA
1
PS
IRRITABLE BOWEL SYNDROME
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
LACTOSE INTOLERANCE
DRUG INEFFECTIVE
2
PS
LACTOSE INTOLERANCE
INCORRECT DOSE ADMINISTERED
2
PS
MINERAL SUPPLEMENTATION
GASTRITIS EROSIVE
1
PS
MUSCLE SPASMS
PRURITUS
2
PS
MYOCARDIAL INFARCTION
DRUG INEFFECTIVE
1
PS
NAUSEA
INCORRECT DOSE ADMINISTERED
1
PS
NERVOUS SYSTEM DISORDER
GASTROOESOPHAGEAL REFLUX DISEASE
1
PS
PAIN
DRUG INEFFECTIVE
1
PS
PARKINSON'S DISEASE
FLATULENCE
2
PS
PROPHYLAXIS
ABDOMINAL PAIN UPPER
1
PS
PROPHYLAXIS
ERUCTATION
3
PS
PROPHYLAXIS
FLATULENCE
3
PS
PROPHYLAXIS
HAEMATOCHEZIA
1
PS
PROPHYLAXIS
INCORRECT DRUG ADMINISTRATION DURATION
1
PS
SLEEP DISORDER
DRUG INEFFECTIVE
2
PS
SLEEP DISORDER
INCORRECT DOSE ADMINISTERED
2
PS
SUPPLEMENTATION THERAPY
DRUG INEFFECTIVE
2
PS
SUPPLEMENTATION THERAPY
GASTRITIS EROSIVE
1
PS
SUPPLEMENTATION THERAPY
GASTROOESOPHAGEAL REFLUX DISEASE
2
PS
THYROID DISORDER
ABDOMINAL DISCOMFORT
1
PS
THYROID DISORDER
DRUG INEFFECTIVE
1
PS
THYROID DISORDER
EATING DISORDER
1
PS
THYROID DISORDER
INCORRECT DOSE ADMINISTERED
1
PS
THYROID DISORDER
NAUSEA
1
PS
TRIGEMINAL NEURALGIA
DYSPNOEA
1
PS
TRIGEMINAL NEURALGIA
INTENTIONAL DRUG MISUSE
1
PS
TRIGEMINAL NEURALGIA
PRURITUS
1
PS
TRIGEMINAL NEURALGIA
WHEEZING
1
PS
VITAMIN SUPPLEMENTATION
DYSPNOEA
1
PS
VITAMIN SUPPLEMENTATION
INTENTIONAL DRUG MISUSE
1
PS
VITAMIN SUPPLEMENTATION
PRURITUS
1
PS
VITAMIN SUPPLEMENTATION
WHEEZING
1
SS
ABDOMINAL PAIN UPPER
INTENTIONAL OVERDOSE
1
SS
ANXIETY
DRUG INEFFECTIVE
2
SS
ANXIETY
ERUCTATION
1
SS
ANXIETY
INCORRECT DOSE ADMINISTERED
2
SS
ARRHYTHMIA
ERUCTATION
1
SS
ARRHYTHMIA
FLATULENCE
1
SS
ATRIAL FIBRILLATION
ABDOMINAL DISCOMFORT
1
SS
ATRIAL FIBRILLATION
DRUG INEFFECTIVE
1
SS
BLOOD CHOLESTEROL INCREASED
DYSPEPSIA
1
SS
BLOOD CHOLESTEROL INCREASED
ERUCTATION
1
SS
BRAIN TUMOUR OPERATION
DRUG INEFFECTIVE
1
SS
BRONCHIECTASIS
ABDOMINAL PAIN UPPER
1
SS
BRONCHIECTASIS
DYSPEPSIA
1
SS
BRONCHIECTASIS
HIATUS HERNIA
1
SS
DEPRESSION
DRUG INEFFECTIVE
1
SS
DEPRESSION
INCORRECT DOSE ADMINISTERED
1
SS
DIABETES MELLITUS
DRUG INEFFECTIVE
1
SS
DYSPEPSIA
ABDOMINAL DISCOMFORT
1
SS
DYSPEPSIA
ABDOMINAL PAIN UPPER
3
SS
DYSPEPSIA
ACCIDENTAL OVERDOSE
1
SS
DYSPEPSIA
CHILLS
2
SS
DYSPEPSIA
DIARRHOEA
2
SS
DYSPEPSIA
DRUG INEFFECTIVE
7
SS
DYSPEPSIA
DYSPEPSIA
7
SS
DYSPEPSIA
ERUCTATION
2
SS
DYSPEPSIA
FLATULENCE
1
SS
DYSPEPSIA
HIATUS HERNIA
1
SS
DYSPEPSIA
INCORRECT DOSE ADMINISTERED
2
SS
DYSPEPSIA
INCREASED UPPER AIRWAY SECRETION
1
SS
DYSPEPSIA
NERVOUSNESS
1
SS
DYSPEPSIA
TACHYCARDIA
2
SS
EYE PRURITUS
DRUG INEFFECTIVE
1
SS
FLATULENCE
ERUCTATION
1
SS
FLATULENCE
FLATULENCE
1
SS
GASTROOESOPHAGEAL REFLUX DISEASE
DRUG INEFFECTIVE
1
SS
GASTROOESOPHAGEAL REFLUX DISEASE
INCORRECT DOSE ADMINISTERED
1
SS
HYPERTENSION
ABDOMINAL PAIN UPPER
2
SS
HYPERTENSION
CHILLS
2
SS
HYPERTENSION
DYSPEPSIA
1
SS
HYPERTENSION
ERUCTATION
1
SS
HYPERTENSION
FLATULENCE
1
SS
HYPERTENSION
TACHYCARDIA
2
SS
HYPOTHYROIDISM
ABDOMINAL PAIN UPPER
1
SS
HYPOTHYROIDISM
CHILLS
1
SS
HYPOTHYROIDISM
DRUG INEFFECTIVE
1
SS
HYPOTHYROIDISM
ERUCTATION
1
SS
HYPOTHYROIDISM
INCORRECT DOSE ADMINISTERED
1
SS
HYPOTHYROIDISM
TACHYCARDIA
1
SS
LACTOSE INTOLERANCE
DRUG INEFFECTIVE
1
SS
LACTOSE INTOLERANCE
INCORRECT DOSE ADMINISTERED
1
SS
MYOCARDIAL INFARCTION
DRUG INEFFECTIVE
1
SS
NAUSEA
INCORRECT DOSE ADMINISTERED
1
SS
PAIN
DRUG INEFFECTIVE
1
SS
PROPHYLAXIS
ERUCTATION
3
SS
PROPHYLAXIS
FLATULENCE
3
SS
SLEEP DISORDER
DRUG INEFFECTIVE
1
SS
SLEEP DISORDER
INCORRECT DOSE ADMINISTERED
1
SS
SUPPLEMENTATION THERAPY
DRUG INEFFECTIVE
2
SS
THYROID DISORDER
DRUG INEFFECTIVE
1
SS
THYROID DISORDER
INCORRECT DOSE ADMINISTERED
1
C
ANXIETY
CARDIAC DISORDER
6
C
ANXIETY
CARDIAC FAILURE CONGESTIVE
6
C
ANXIETY
CYSTITIS
2
C
ANXIETY
GASTRIC DISORDER
6
C
ANXIETY
URETHRAL DISORDER
2
C
BLOOD CHOLESTEROL INCREASED
CARDIAC DISORDER
6
C
BLOOD CHOLESTEROL INCREASED
CARDIAC FAILURE CONGESTIVE
6
C
BLOOD CHOLESTEROL INCREASED
CYSTITIS
2
C
BLOOD CHOLESTEROL INCREASED
GASTRIC DISORDER
6
C
BLOOD CHOLESTEROL INCREASED
URETHRAL DISORDER
2
C
DIABETES MELLITUS
CARDIAC DISORDER
6
C
DIABETES MELLITUS
CARDIAC FAILURE CONGESTIVE
6
C
DIABETES MELLITUS
CYSTITIS
2
C
DIABETES MELLITUS
GASTRIC DISORDER
6
C
DIABETES MELLITUS
URETHRAL DISORDER
2
C
FIBROMYALGIA
CARDIAC DISORDER
6
C
FIBROMYALGIA
CARDIAC FAILURE CONGESTIVE
6
C
FIBROMYALGIA
CYSTITIS
2
C
FIBROMYALGIA
GASTRIC DISORDER
6
C
FIBROMYALGIA
URETHRAL DISORDER
2
C
GASTROOESOPHAGEAL REFLUX DISEASE
CARDIAC DISORDER
6
C
GASTROOESOPHAGEAL REFLUX DISEASE
CARDIAC FAILURE CONGESTIVE
6
C
GASTROOESOPHAGEAL REFLUX DISEASE
CYSTITIS
2
C
GASTROOESOPHAGEAL REFLUX DISEASE
GASTRIC DISORDER
6
C
GASTROOESOPHAGEAL REFLUX DISEASE
URETHRAL DISORDER
2
C
HIATUS HERNIA
CARDIAC DISORDER
6
C
HIATUS HERNIA
CARDIAC FAILURE CONGESTIVE
6
C
HIATUS HERNIA
CYSTITIS
2
C
HIATUS HERNIA
GASTRIC DISORDER
6
C
HIATUS HERNIA
URETHRAL DISORDER
2
C
HYPERTENSION
CARDIAC DISORDER
6
C
HYPERTENSION
CARDIAC FAILURE CONGESTIVE
6
C
HYPERTENSION
CYSTITIS
2
C
HYPERTENSION
GASTRIC DISORDER
6
C
HYPERTENSION
URETHRAL DISORDER
2
C
NEUROPATHY PERIPHERAL
CARDIAC DISORDER
6
C
NEUROPATHY PERIPHERAL
CARDIAC FAILURE CONGESTIVE
6
C
NEUROPATHY PERIPHERAL
CYSTITIS
2
C
NEUROPATHY PERIPHERAL
GASTRIC DISORDER
6
C
NEUROPATHY PERIPHERAL
URETHRAL DISORDER
2
C
SLEEP DISORDER
CARDIAC DISORDER
6
C
SLEEP DISORDER
CARDIAC FAILURE CONGESTIVE
6
C
SLEEP DISORDER
CYSTITIS
2
C
SLEEP DISORDER
GASTRIC DISORDER
6
C
SLEEP DISORDER
URETHRAL DISORDER
2
C
THYROID DISORDER
CARDIAC DISORDER
6
C
THYROID DISORDER
CARDIAC FAILURE CONGESTIVE
6
C
THYROID DISORDER
CYSTITIS
2
C
THYROID DISORDER
GASTRIC DISORDER
6
C
THYROID DISORDER
URETHRAL DISORDER
2
C
URINARY INCONTINENCE
CARDIAC DISORDER
6
C
URINARY INCONTINENCE
CARDIAC FAILURE CONGESTIVE
6
C
URINARY INCONTINENCE
CYSTITIS
2
C
URINARY INCONTINENCE
GASTRIC DISORDER
6
C
URINARY INCONTINENCE
URETHRAL DISORDER
2
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