Drug information for ROSIGLITAZONE MALEATE
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET; ORAL
2MG
Tentative Approval
ROSIGLITAZONE MALEATE
rosiglitazone
TEVA PHARMS
76747
2009-11-12 Other Important Information from FDA
TABLET; ORAL
4MG
Tentative Approval
ROSIGLITAZONE MALEATE
rosiglitazone
TEVA PHARMS
"
TABLET; ORAL
8MG
Tentative Approval
ROSIGLITAZONE MALEATE
rosiglitazone
TEVA PHARMS
"
TABLET; ORAL
2MG
Tentative Approval
ROSIGLITAZONE MALEATE
rosiglitazone
HIKMA PHARMS
78658
TABLET; ORAL
4MG
Tentative Approval
ROSIGLITAZONE MALEATE
rosiglitazone
HIKMA PHARMS
"
TABLET; ORAL
8MG
Tentative Approval
ROSIGLITAZONE MALEATE
rosiglitazone
HIKMA PHARMS
"
TABLET; ORAL
2MG
Tentative Approval
ROSIGLITAZONE MALEATE
rosiglitazone
SANDOZ
78674
2009-11-12 Other Important Information from FDA
TABLET; ORAL
4MG
Tentative Approval
ROSIGLITAZONE MALEATE
rosiglitazone
SANDOZ
"
TABLET; ORAL
8MG
Tentative Approval
ROSIGLITAZONE MALEATE
rosiglitazone
SANDOZ
"
TABLET; ORAL
2MG
Tentative Approval
ROSIGLITAZONE MALEATE
rosiglitazone
ROXANE
78695
2009-11-12 Other Important Information from FDA
TABLET; ORAL
2MG
Tentative Approval
ROSIGLITAZONE MALEATE
rosiglitazone
MYLAN PHARMA
78825
2009-11-12 Other Important Information from FDA
TABLET; ORAL
4MG
Tentative Approval
ROSIGLITAZONE MALEATE
rosiglitazone
MYLAN PHARMA
"
TABLET; ORAL
8MG
Tentative Approval
ROSIGLITAZONE MALEATE
rosiglitazone
MYLAN PHARMA
"
Drug Adverse Effects information for ROSIGLITAZONE MALEATE
Role code
Indications
Reaction
# Reports
PS
DIABETES MELLITUS
ABDOMINAL PAIN UPPER
1
PS
DIABETES MELLITUS
ACUTE MYOCARDIAL INFARCTION
2
PS
DIABETES MELLITUS
ADVERSE EVENT
2
PS
DIABETES MELLITUS
AMNESIA
1
PS
DIABETES MELLITUS
ANEURYSM
1
PS
DIABETES MELLITUS
ANGINA UNSTABLE
1
PS
DIABETES MELLITUS
ANGIOPLASTY
2
PS
DIABETES MELLITUS
AORTIC VALVE INCOMPETENCE
1
PS
DIABETES MELLITUS
APHAGIA
1
PS
DIABETES MELLITUS
ARRHYTHMIA
2
PS
DIABETES MELLITUS
ARTERIAL OCCLUSIVE DISEASE
3
PS
DIABETES MELLITUS
ARTERIOSCLEROSIS
3
PS
DIABETES MELLITUS
ARTERIOSCLEROSIS CORONARY ARTERY
1
PS
DIABETES MELLITUS
ARTHRALGIA
1
PS
DIABETES MELLITUS
ASTHENIA
1
PS
DIABETES MELLITUS
ATRIAL FIBRILLATION
3
PS
DIABETES MELLITUS
BLINDNESS
1
PS
DIABETES MELLITUS
BLINDNESS UNILATERAL
1
PS
DIABETES MELLITUS
CARDIAC DEATH
1
PS
DIABETES MELLITUS
CARDIAC DISORDER
11
PS
DIABETES MELLITUS
CARDIAC FAILURE
3
PS
DIABETES MELLITUS
CARDIAC FAILURE CHRONIC
1
PS
DIABETES MELLITUS
CARDIAC FAILURE CONGESTIVE
26
PS
DIABETES MELLITUS
CARDIAC OPERATION
4
PS
DIABETES MELLITUS
CARDIAC PACEMAKER INSERTION
2
PS
DIABETES MELLITUS
CARDIAC VALVE DISEASE
1
PS
DIABETES MELLITUS
CARDIO-RESPIRATORY ARREST
2
PS
DIABETES MELLITUS
CARDIOMYOPATHY
3
PS
DIABETES MELLITUS
CARDIOVASCULAR DISORDER
6
PS
DIABETES MELLITUS
CATHETER PLACEMENT
1
PS
DIABETES MELLITUS
CATHETERISATION CARDIAC
1
PS
DIABETES MELLITUS
CEREBRAL HAEMORRHAGE
2
PS
DIABETES MELLITUS
CEREBROVASCULAR ACCIDENT
26
PS
DIABETES MELLITUS
CHEST PAIN
10
PS
DIABETES MELLITUS
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
1
PS
DIABETES MELLITUS
COAGULOPATHY
1
PS
DIABETES MELLITUS
CONDITION AGGRAVATED
1
PS
DIABETES MELLITUS
CONVULSION
1
PS
DIABETES MELLITUS
COR PULMONALE
1
PS
DIABETES MELLITUS
CORONARY ARTERIAL STENT INSERTION
2
PS
DIABETES MELLITUS
CORONARY ARTERY BYPASS
9
PS
DIABETES MELLITUS
CORONARY ARTERY DISEASE
16
PS
DIABETES MELLITUS
CORONARY ARTERY OCCLUSION
2
PS
DIABETES MELLITUS
DEATH
10
PS
DIABETES MELLITUS
DEEP VEIN THROMBOSIS
1
PS
DIABETES MELLITUS
DEMENTIA
1
PS
DIABETES MELLITUS
DIASTOLIC DYSFUNCTION
1
PS
DIABETES MELLITUS
DILATATION VENTRICULAR
1
PS
DIABETES MELLITUS
DIZZINESS
2
PS
DIABETES MELLITUS
DYSPNOEA
7
PS
DIABETES MELLITUS
FALL
1
PS
DIABETES MELLITUS
FATIGUE
2
PS
DIABETES MELLITUS
FLUID RETENTION
2
PS
DIABETES MELLITUS
GASTRIC DISORDER
1
PS
DIABETES MELLITUS
HEART INJURY
1
PS
DIABETES MELLITUS
HEART RATE DECREASED
1
PS
DIABETES MELLITUS
HEART VALVE REPLACEMENT
1
PS
DIABETES MELLITUS
HEMIPARESIS
1
PS
DIABETES MELLITUS
HEMIPLEGIA
1
PS
DIABETES MELLITUS
HEPATIC CIRRHOSIS
1
PS
DIABETES MELLITUS
HEPATIC ENZYME INCREASED
1
PS
DIABETES MELLITUS
HYPERLIPIDAEMIA
8
PS
DIABETES MELLITUS
HYPERTENSION
12
PS
DIABETES MELLITUS
HYPOAESTHESIA
3
PS
DIABETES MELLITUS
HYPOAESTHESIA ORAL
1
PS
DIABETES MELLITUS
ILL-DEFINED DISORDER
2
PS
DIABETES MELLITUS
IMPLANTABLE DEFIBRILLATOR INSERTION
1
PS
DIABETES MELLITUS
INJURY
3
PS
DIABETES MELLITUS
INSOMNIA
1
PS
DIABETES MELLITUS
INTERVERTEBRAL DISC COMPRESSION
1
PS
DIABETES MELLITUS
ISCHAEMIC CARDIOMYOPATHY
2
PS
DIABETES MELLITUS
LACUNAR INFARCTION
1
PS
DIABETES MELLITUS
LERICHE SYNDROME
2
PS
DIABETES MELLITUS
LIVER INJURY
2
PS
DIABETES MELLITUS
MACULAR DEGENERATION
1
PS
DIABETES MELLITUS
MALAISE
2
PS
DIABETES MELLITUS
MOVEMENT DISORDER
1
PS
DIABETES MELLITUS
MYALGIA
1
PS
DIABETES MELLITUS
MYOCARDIAL INFARCTION
41
PS
DIABETES MELLITUS
MYOCARDIAL ISCHAEMIA
3
PS
DIABETES MELLITUS
OEDEMA
4
PS
DIABETES MELLITUS
OEDEMA PERIPHERAL
1
PS
DIABETES MELLITUS
PAIN
3
PS
DIABETES MELLITUS
PAIN IN EXTREMITY
1
PS
DIABETES MELLITUS
PALPITATIONS
1
PS
DIABETES MELLITUS
PANCREATIC CALCIFICATION
1
PS
DIABETES MELLITUS
PANCREATITIS
2
PS
DIABETES MELLITUS
PHYSICAL DISABILITY
1
PS
DIABETES MELLITUS
PNEUMONIA
1
PS
DIABETES MELLITUS
POST PROCEDURAL COMPLICATION
1
PS
DIABETES MELLITUS
PROSTATIC DISORDER
1
PS
DIABETES MELLITUS
PULMONARY HYPERTENSION
4
PS
DIABETES MELLITUS
PULMONARY OEDEMA
2
PS
DIABETES MELLITUS
RENAL DISORDER
1
PS
DIABETES MELLITUS
RENAL FAILURE
2
PS
DIABETES MELLITUS
RENAL INJURY
2
PS
DIABETES MELLITUS
SILENT MYOCARDIAL INFARCTION
1
PS
DIABETES MELLITUS
SPINAL DISORDER
1
PS
DIABETES MELLITUS
STENT PLACEMENT
2
PS
DIABETES MELLITUS
STRESS
1
PS
DIABETES MELLITUS
SURGERY
2
PS
DIABETES MELLITUS
TACHYCARDIA
2
PS
DIABETES MELLITUS
TRANSIENT ISCHAEMIC ATTACK
2
PS
DIABETES MELLITUS
VASCULAR GRAFT
2
PS
DIABETES MELLITUS
WEIGHT DECREASED
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ADVERSE EVENT
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ANKLE FRACTURE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
CARDIAC ARREST
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
CARDIAC FAILURE CONGESTIVE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
CARDIO-RESPIRATORY ARREST
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
CEREBROVASCULAR ACCIDENT
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
CHEST PAIN
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
CLOSTRIDIUM DIFFICILE SEPSIS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
CONVULSION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
CORONARY ARTERY DISEASE
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
HEMIPARESIS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
MYOCARDIAL INFARCTION
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
PERIPHERAL VASCULAR DISORDER
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
PROCEDURAL COMPLICATION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
RENAL FAILURE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
RENAL FAILURE ACUTE
1
PS
TYPE 2 DIABETES MELLITUS
ABDOMINAL PAIN UPPER
2
PS
TYPE 2 DIABETES MELLITUS
ANAEMIA
2
PS
TYPE 2 DIABETES MELLITUS
ARTHRITIS
2
PS
TYPE 2 DIABETES MELLITUS
BACK PAIN
2
PS
TYPE 2 DIABETES MELLITUS
CARDIAC FAILURE CONGESTIVE
1
PS
TYPE 2 DIABETES MELLITUS
CARDIOVASCULAR DISORDER
1
PS
TYPE 2 DIABETES MELLITUS
CEREBROVASCULAR ACCIDENT
2
PS
TYPE 2 DIABETES MELLITUS
CORONARY ARTERY DISEASE
1
PS
TYPE 2 DIABETES MELLITUS
DEATH
2
PS
TYPE 2 DIABETES MELLITUS
DECREASED APPETITE
2
PS
TYPE 2 DIABETES MELLITUS
ELECTROCARDIOGRAM ABNORMAL
1
PS
TYPE 2 DIABETES MELLITUS
FOOT FRACTURE
2
PS
TYPE 2 DIABETES MELLITUS
HEART VALVE INCOMPETENCE
1
PS
TYPE 2 DIABETES MELLITUS
MYOCARDIAL INFARCTION
3
PS
TYPE 2 DIABETES MELLITUS
NAUSEA
2
PS
TYPE 2 DIABETES MELLITUS
OEDEMA
2
PS
TYPE 2 DIABETES MELLITUS
OEDEMA PERIPHERAL
2
PS
TYPE 2 DIABETES MELLITUS
TRANSIENT ISCHAEMIC ATTACK
1
PS
TYPE 2 DIABETES MELLITUS
VOMITING
2
PS
TYPE 2 DIABETES MELLITUS
WEIGHT INCREASED
2
SS
DIABETES MELLITUS
ACUTE MYOCARDIAL INFARCTION
3
SS
DIABETES MELLITUS
ANGINA UNSTABLE
2
SS
DIABETES MELLITUS
AORTIC VALVE CALCIFICATION
3
SS
DIABETES MELLITUS
CARDIAC ARREST
3
SS
DIABETES MELLITUS
CARDIAC FAILURE CONGESTIVE
1
SS
DIABETES MELLITUS
CEREBROVASCULAR ACCIDENT
2
SS
DIABETES MELLITUS
CORONARY ARTERY DISEASE
2
SS
DIABETES MELLITUS
DEATH
1
SS
DIABETES MELLITUS
DIASTOLIC DYSFUNCTION
3
SS
DIABETES MELLITUS
LEFT VENTRICULAR HYPERTROPHY
3
SS
DIABETES MELLITUS
MYOCARDIAL INFARCTION
2
SS
DIABETES MELLITUS
PRESYNCOPE
2
C
CORONARY ARTERY BYPASS
ANHEDONIA
1
C
CORONARY ARTERY BYPASS
ANXIETY
1
C
CORONARY ARTERY BYPASS
CARDIAC DISORDER
1
C
CORONARY ARTERY BYPASS
CEREBROVASCULAR ACCIDENT
1
C
CORONARY ARTERY BYPASS
DEATH
1
C
CORONARY ARTERY BYPASS
DEPRESSION
1
C
CORONARY ARTERY BYPASS
FEAR
1
C
CORONARY ARTERY BYPASS
INJURY
1
C
CORONARY ARTERY BYPASS
ORGAN FAILURE
1
C
CORONARY ARTERY BYPASS
PAIN
1
C
CORONARY ARTERY BYPASS
RENAL FAILURE
1
C
CORONARY ARTERY BYPASS
RENAL IMPAIRMENT
1
C
CORONARY ARTERY BYPASS
RENAL INJURY
1
C
CORONARY ARTERY BYPASS
UNEVALUABLE EVENT
1
C
COUGH
DEHYDRATION
5
C
COUGH
DIARRHOEA
5
C
COUGH
VOMITING
5
C
MALIGNANT MELANOMA
DEHYDRATION
2
C
MALIGNANT MELANOMA
DIARRHOEA
2
C
MALIGNANT MELANOMA
VOMITING
2
C
TYPE 2 DIABETES MELLITUS
INTESTINAL ADENOCARCINOMA
1
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