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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