Drug information for ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET; ORAL
10MG;25MG
Prescription
AB
ENALAPRIL MALEATE
;
HYDROCHLOROTHIAZIDE
Vaseretic
MYLAN
75624
2004-06-03 Letter
2001-09-18 Letter
TABLET; ORAL
5MG;12.5MG
Prescription
AB
ENALAPRIL MALEATE
;
HYDROCHLOROTHIAZIDE
Vaseretic
MYLAN
"
TABLET; ORAL
10MG;25MG
Prescription
AB
ENALAPRIL MALEATE
;
HYDROCHLOROTHIAZIDE
Vaseretic
TEVA
75727
2004-06-24 Letter
2004-06-03 Letter
TABLET; ORAL
5MG;12.5MG
Prescription
AB
ENALAPRIL MALEATE
;
HYDROCHLOROTHIAZIDE
Vaseretic
TEVA
"
TABLET; ORAL
10MG;25MG
Discontinued
ENALAPRIL MALEATE
;
HYDROCHLOROTHIAZIDE
Vaseretic
IVAX SUB TEVA PHARMS
75736
TABLET; ORAL
5MG;12.5MG
Discontinued
ENALAPRIL MALEATE
;
HYDROCHLOROTHIAZIDE
Vaseretic
IVAX SUB TEVA PHARMS
"
TABLET; ORAL
10MG;25MG
Prescription
AB
ENALAPRIL MALEATE
;
HYDROCHLOROTHIAZIDE
Vaseretic
TARO PHARM INDS
75788
2004-06-24 Letter
2004-06-03 Letter
TABLET; ORAL
5MG;12.5MG
Prescription
AB
ENALAPRIL MALEATE
;
HYDROCHLOROTHIAZIDE
Vaseretic
TARO PHARM INDS
"
TABLET; ORAL
10MG;25MG
Prescription
AB
ENALAPRIL MALEATE
;
HYDROCHLOROTHIAZIDE
Vaseretic
DR REDDYS LABS LTD
75909
2004-06-03 Label
2003-08-04 Review
2003-04-17 Letter
TABLET; ORAL
5MG;12.5MG
Prescription
AB
ENALAPRIL MALEATE
;
HYDROCHLOROTHIAZIDE
Vaseretic
DR REDDYS LABS LTD
"
TABLET; ORAL
10MG;25MG
Discontinued
ENALAPRIL MALEATE
;
HYDROCHLOROTHIAZIDE
Vaseretic
SANDOZ INC
76116
TABLET; ORAL
5MG;12.5MG
Discontinued
ENALAPRIL MALEATE
;
HYDROCHLOROTHIAZIDE
Vaseretic
SANDOZ INC
"
TABLET; ORAL
10MG;25MG
Prescription
AB
ENALAPRIL MALEATE
;
HYDROCHLOROTHIAZIDE
Vaseretic
APOTEX INC
76486
TABLET; ORAL
5MG;12.5MG
Prescription
AB
ENALAPRIL MALEATE
;
HYDROCHLOROTHIAZIDE
Vaseretic
APOTEX INC
"
Drug Adverse Effects information for ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Role code
Indications
Reaction
# Reports
PS
BACK PAIN
BLOOD AMYLASE INCREASED
1
PS
BACK PAIN
CONDITION AGGRAVATED
1
PS
BACK PAIN
DEHYDRATION
1
PS
BACK PAIN
INTESTINAL OBSTRUCTION
1
PS
BACK PAIN
LIPASE INCREASED
1
PS
BACK PAIN
RENAL FAILURE
1
PS
HYPERTENSION
ASTHENIA
1
PS
HYPERTENSION
CONDITION AGGRAVATED
1
PS
HYPERTENSION
DEMENTIA
1
PS
HYPERTENSION
GENERAL PHYSICAL HEALTH DETERIORATION
1
PS
HYPERTENSION
HYPONATRAEMIA
1
PS
HYPERTENSION
HYPOTENSION
1
PS
HYPERTENSION
MUSCULOSKELETAL CHEST PAIN
1
PS
HYPERTENSION
MYOCARDIAL INFARCTION
1
PS
HYPERTENSION
NAUSEA
1
PS
HYPERTENSION
VOMITING
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ABDOMINAL PAIN UPPER
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
BLOOD AMYLASE INCREASED
8
PS
PRODUCT USED FOR UNKNOWN INDICATION
BLOOD GLUCOSE DECREASED
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
BLOOD PRESSURE DIASTOLIC INCREASED
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
CONDITION AGGRAVATED
9
PS
PRODUCT USED FOR UNKNOWN INDICATION
DEHYDRATION
8
PS
PRODUCT USED FOR UNKNOWN INDICATION
HEADACHE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HYPERKALAEMIA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HYPERTENSION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HYPOTENSION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
INTENTIONAL OVERDOSE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
INTESTINAL OBSTRUCTION
8
PS
PRODUCT USED FOR UNKNOWN INDICATION
LIPASE INCREASED
8
PS
PRODUCT USED FOR UNKNOWN INDICATION
METABOLIC DISORDER
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
REACTION TO DRUG EXCIPIENTS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
RENAL DISORDER
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
RENAL FAILURE
8
PS
PRODUCT USED FOR UNKNOWN INDICATION
RENAL IMPAIRMENT
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
SOMNOLENCE
1
SS
AUTOIMMUNE HEPATITIS
ANTINUCLEAR ANTIBODY POSITIVE
1
SS
AUTOIMMUNE HEPATITIS
AUTOIMMUNE HEPATITIS
2
SS
AUTOIMMUNE HEPATITIS
HEPATIC FIBROSIS
1
SS
AUTOIMMUNE HEPATITIS
SMOOTH MUSCLE ANTIBODY POSITIVE
1
SS
BACK PAIN
DEHYDRATION
1
SS
BACK PAIN
INTESTINAL OBSTRUCTION
1
SS
BACK PAIN
PANCREATIC ENZYMES INCREASED
1
SS
BACK PAIN
RENAL FAILURE
1
SS
CORONARY ARTERY DISEASE
LACTIC ACIDOSIS
2
SS
CORONARY ARTERY DISEASE
RENAL FAILURE ACUTE
2
SS
DIABETES MELLITUS
HEPATITIS ACUTE
1
SS
FOLATE DEFICIENCY
LACTIC ACIDOSIS
1
SS
FOLATE DEFICIENCY
RENAL FAILURE ACUTE
1
SS
HYPERTENSION
HEPATITIS ACUTE
2
SS
HYPERTENSION
LACTIC ACIDOSIS
3
SS
HYPERTENSION
RENAL FAILURE ACUTE
3
SS
HYPERURICAEMIA
LACTIC ACIDOSIS
1
SS
HYPERURICAEMIA
RENAL FAILURE ACUTE
1
SS
IRON DEFICIENCY
LACTIC ACIDOSIS
1
SS
IRON DEFICIENCY
RENAL FAILURE ACUTE
1
SS
PAIN
DEHYDRATION
1
SS
PAIN
INTESTINAL OBSTRUCTION
1
SS
PAIN
PANCREATIC ENZYMES INCREASED
1
SS
PAIN
RENAL FAILURE
1
SS
PRODUCT USED FOR UNKNOWN INDICATION
ANTINUCLEAR ANTIBODY POSITIVE
8
SS
PRODUCT USED FOR UNKNOWN INDICATION
AUTOIMMUNE HEPATITIS
8
SS
PRODUCT USED FOR UNKNOWN INDICATION
DEHYDRATION
8
SS
PRODUCT USED FOR UNKNOWN INDICATION
HEPATIC FIBROSIS
8
SS
PRODUCT USED FOR UNKNOWN INDICATION
INTESTINAL OBSTRUCTION
8
SS
PRODUCT USED FOR UNKNOWN INDICATION
PANCREATIC ENZYMES INCREASED
8
SS
PRODUCT USED FOR UNKNOWN INDICATION
RENAL FAILURE
8
SS
PRODUCT USED FOR UNKNOWN INDICATION
SMOOTH MUSCLE ANTIBODY POSITIVE
8
SS
TYPE 2 DIABETES MELLITUS
LACTIC ACIDOSIS
1
SS
TYPE 2 DIABETES MELLITUS
RENAL FAILURE ACUTE
1
C
ATRIAL FIBRILLATION
COUGH
3
C
ATRIAL FIBRILLATION
DYSPNOEA
3
C
ATRIAL FIBRILLATION
INTERSTITIAL LUNG DISEASE
3
C
BLOOD CHOLESTEROL
HYPERHIDROSIS
1
C
BLOOD CHOLESTEROL
MANIA
1
C
BLOOD CHOLESTEROL INCREASED
DISCOMFORT
1
C
BLOOD CHOLESTEROL INCREASED
GAIT DISTURBANCE
1
C
BLOOD CHOLESTEROL INCREASED
PAIN IN EXTREMITY
1
C
BLOOD PRESSURE
HYPERHIDROSIS
1
C
BLOOD PRESSURE
MANIA
1
C
CHRONIC MYELOID LEUKAEMIA
ECZEMA
1
C
DEPRESSION
HYPERHIDROSIS
1
C
DEPRESSION
MANIA
1
C
DIABETES MELLITUS
HEPATITIS ACUTE
1
C
DIPHTHERIA
ANXIETY
4
C
DIPHTHERIA
DEPRESSION
4
C
DIPHTHERIA
INSOMNIA
4
C
DIPHTHERIA
PANIC ATTACK
4
C
DIPHTHERIA
SUICIDE ATTEMPT
4
C
DIZZINESS
COUGH
1
C
DIZZINESS
DYSPNOEA
1
C
DIZZINESS
INTERSTITIAL LUNG DISEASE
1
C
DYSLIPIDAEMIA
BLOOD CREATINE PHOSPHOKINASE INCREASED
2
C
DYSLIPIDAEMIA
GLOMERULAR FILTRATION RATE DECREASED
2
C
DYSLIPIDAEMIA
MALAISE
1
C
DYSLIPIDAEMIA
PALPITATIONS
1
C
DYSLIPIDAEMIA
TACHYCARDIA
1
C
EYE DISORDER
DISCOMFORT
1
C
EYE DISORDER
GAIT DISTURBANCE
1
C
EYE DISORDER
PAIN IN EXTREMITY
1
C
HYPERCHOLESTEROLAEMIA
ATRIAL FIBRILLATION
2
C
HYPERCHOLESTEROLAEMIA
CAROTID ARTERY STENOSIS
1
C
HYPERCHOLESTEROLAEMIA
CEREBRAL INFARCTION
2
C
HYPERCHOLESTEROLAEMIA
DIZZINESS
2
C
HYPERCHOLESTEROLAEMIA
HAEMORRHAGIC STROKE
2
C
HYPERCHOLESTEROLAEMIA
ISCHAEMIC STROKE
1
C
HYPERCHOLESTEROLAEMIA
PETECHIAE
2
C
HYPERCHOLESTEROLAEMIA
TRANSIENT ISCHAEMIC ATTACK
2
C
HYPERCHOLESTEROLAEMIA
VISION BLURRED
2
C
HYPERSENSITIVITY
BACTERIAL INFECTION
1
C
HYPERSENSITIVITY
BRADYCARDIA
1
C
HYPERSENSITIVITY
INCORRECT DOSE ADMINISTERED
1
C
HYPERSENSITIVITY
LEUKOCYTOSIS
1
C
HYPERSENSITIVITY
MYOCARDIAL INFARCTION
1
C
HYPERSENSITIVITY
OESOPHAGEAL CANDIDIASIS
1
C
HYPERSENSITIVITY
PYREXIA
1
C
HYPERSENSITIVITY
SYNCOPE
1
C
HYPERSENSITIVITY
ULCER
1
C
HYPERSENSITIVITY
VOMITING
1
C
HYPERTENSION
ABDOMINAL PAIN UPPER
9
C
HYPERTENSION
AGITATION
9
C
HYPERTENSION
BLOOD CREATINE PHOSPHOKINASE INCREASED
2
C
HYPERTENSION
BLOOD GLUCOSE FLUCTUATION
1
C
HYPERTENSION
BLOODY DISCHARGE
1
C
HYPERTENSION
CARDIAC ARREST
6
C
HYPERTENSION
CARDIO-RESPIRATORY ARREST
3
C
HYPERTENSION
CATARACT
1
C
HYPERTENSION
COMA
9
C
HYPERTENSION
CONSTIPATION
9
C
HYPERTENSION
DIARRHOEA
1
C
HYPERTENSION
FEMUR FRACTURE
1
C
HYPERTENSION
GLOMERULAR FILTRATION RATE DECREASED
2
C
HYPERTENSION
HEPATITIS ACUTE
2
C
HYPERTENSION
HYPERTENSION
9
C
HYPERTENSION
INCISION SITE HAEMATOMA
1
C
HYPERTENSION
MALAISE
2
C
HYPERTENSION
MYOCARDIAL INFARCTION
3
C
HYPERTENSION
PALPITATIONS
1
C
HYPERTENSION
TACHYCARDIA
1
C
HYPERURICAEMIA
ECZEMA
1
C
HYPERURICAEMIA
MALAISE
1
C
HYPERURICAEMIA
PALPITATIONS
1
C
HYPERURICAEMIA
TACHYCARDIA
1
C
HYPOTHYROIDISM
BLOOD GLUCOSE FLUCTUATION
2
C
HYPOTHYROIDISM
CATARACT
2
C
HYPOTHYROIDISM
DIARRHOEA
2
C
HYPOTHYROIDISM
FEMUR FRACTURE
2
C
HYPOTHYROIDISM
MALAISE
2
C
INTERSTITIAL LUNG DISEASE
ANXIETY
4
C
INTERSTITIAL LUNG DISEASE
DEPRESSION
4
C
INTERSTITIAL LUNG DISEASE
INSOMNIA
4
C
INTERSTITIAL LUNG DISEASE
PANIC ATTACK
4
C
INTERSTITIAL LUNG DISEASE
SUICIDE ATTEMPT
4
C
METASTATIC RENAL CELL CARCINOMA
DYSPNOEA
1
C
MICTURITION DISORDER
EPISTAXIS
1
C
MICTURITION DISORDER
MYOCARDIAL INFARCTION
1
C
MULTIPLE SCLEROSIS
HAEMOLYTIC URAEMIC SYNDROME
1
C
MULTIPLE SCLEROSIS
RENAL FAILURE ACUTE
1
C
NEURALGIA
POTENTIATING DRUG INTERACTION
1
C
NEURALGIA
STUPOR
1
C
NEUROPATHY PERIPHERAL
BACTERIAL INFECTION
1
C
NEUROPATHY PERIPHERAL
BRADYCARDIA
1
C
NEUROPATHY PERIPHERAL
INCORRECT DOSE ADMINISTERED
1
C
NEUROPATHY PERIPHERAL
LEUKOCYTOSIS
1
C
NEUROPATHY PERIPHERAL
MYOCARDIAL INFARCTION
1
C
NEUROPATHY PERIPHERAL
OESOPHAGEAL CANDIDIASIS
1
C
NEUROPATHY PERIPHERAL
PYREXIA
1
C
NEUROPATHY PERIPHERAL
SYNCOPE
1
C
NEUROPATHY PERIPHERAL
ULCER
1
C
NEUROPATHY PERIPHERAL
VOMITING
1
C
OSTEOPOROTIC FRACTURE
MALAISE
2
C
OSTEOPOROTIC FRACTURE
PALPITATIONS
2
C
OSTEOPOROTIC FRACTURE
TACHYCARDIA
2
C
PAIN
BLOODY DISCHARGE
1
C
PAIN
INCISION SITE HAEMATOMA
1
C
PERTUSSIS
ANXIETY
4
C
PERTUSSIS
DEPRESSION
4
C
PERTUSSIS
INSOMNIA
4
C
PERTUSSIS
PANIC ATTACK
4
C
PERTUSSIS
SUICIDE ATTEMPT
4
C
PRODUCT USED FOR UNKNOWN INDICATION
EPISTAXIS
11
C
PRODUCT USED FOR UNKNOWN INDICATION
HAEMOLYTIC URAEMIC SYNDROME
10
C
PRODUCT USED FOR UNKNOWN INDICATION
MYOCARDIAL INFARCTION
11
C
PRODUCT USED FOR UNKNOWN INDICATION
RENAL FAILURE ACUTE
10
C
SMOKING CESSATION THERAPY
ANXIETY
4
C
SMOKING CESSATION THERAPY
DEPRESSION
4
C
SMOKING CESSATION THERAPY
INSOMNIA
4
C
SMOKING CESSATION THERAPY
PANIC ATTACK
4
C
SMOKING CESSATION THERAPY
SUICIDE ATTEMPT
4
C
TETANUS
ANXIETY
4
C
TETANUS
DEPRESSION
4
C
TETANUS
INSOMNIA
4
C
TETANUS
PANIC ATTACK
4
C
TETANUS
SUICIDE ATTEMPT
4
C
THROMBOSIS PROPHYLAXIS
BLOODY DISCHARGE
1
C
THROMBOSIS PROPHYLAXIS
INCISION SITE HAEMATOMA
1
C
TYPE 1 DIABETES MELLITUS
BLOOD GLUCOSE FLUCTUATION
2
C
TYPE 1 DIABETES MELLITUS
CATARACT
2
C
TYPE 1 DIABETES MELLITUS
DIARRHOEA
2
C
TYPE 1 DIABETES MELLITUS
FEMUR FRACTURE
2
C
TYPE 1 DIABETES MELLITUS
MALAISE
2
C
TYPE 2 DIABETES MELLITUS
ABDOMINAL PAIN UPPER
12
C
TYPE 2 DIABETES MELLITUS
AGITATION
12
C
TYPE 2 DIABETES MELLITUS
CARDIAC ARREST
8
C
TYPE 2 DIABETES MELLITUS
CARDIO-RESPIRATORY ARREST
4
C
TYPE 2 DIABETES MELLITUS
COMA
12
C
TYPE 2 DIABETES MELLITUS
CONSTIPATION
12
C
TYPE 2 DIABETES MELLITUS
HYPERTENSION
12
C
TYPE 2 DIABETES MELLITUS
MYOCARDIAL INFARCTION
4
I
FIBROMYALGIA
ATRIAL FIBRILLATION
1
I
FIBROMYALGIA
BLOOD CREATININE INCREASED
1
I
FIBROMYALGIA
BLOOD POTASSIUM INCREASED
1
I
FIBROMYALGIA
DIAPHRAGMALGIA
1
I
FIBROMYALGIA
DRUG INTERACTION
1
I
FIBROMYALGIA
HEART RATE DECREASED
1
I
FIBROMYALGIA
RENAL FAILURE ACUTE
1
I
PAIN
ATRIAL FIBRILLATION
1
I
PAIN
BLOOD CREATININE INCREASED
1
I
PAIN
BLOOD POTASSIUM INCREASED
1
I
PAIN
DIAPHRAGMALGIA
1
I
PAIN
DRUG INTERACTION
1
I
PAIN
HEART RATE DECREASED
1
I
PAIN
RENAL FAILURE ACUTE
1
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