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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