Drug information for INTEGRILIN

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
INJECTABLE; INJECTION 2MG/ML Prescription  (Reference Drug) EPTIFIBATIDE eptifibatide SCHERING 20718
2011-04-04 Letter

2011-04-01 Label

2009-01-02 Label

2008-12-19 Letter

2005-10-14 Letter

2005-10-14 Label

2004-07-21 Letter

2003-06-22 Letter

2003-06-22 Label

2001-06-08 Letter

2001-06-08 Label

2001-06-08 Review

2001-06-08 Letter

2001-06-08 Label

2001-06-08 Review

1999-09-20 Review

1999-09-20 Letter

1999-09-20 Label

1998-05-18 Letter

1998-05-18 Label

1998-05-18 Review
INJECTABLE; INJECTION 75MG/100ML Prescription  (Reference Drug) EPTIFIBATIDE eptifibatide SCHERING   "

Drug Adverse Effects information for INTEGRILIN

Role code Indications Reaction # Reports
PS ACUTE CORONARY SYNDROME HAEMORRHAGE 1
PS ACUTE CORONARY SYNDROME UNEVALUABLE EVENT 1
PS COAGULOPATHY ACUTE MYOCARDIAL INFARCTION 3
PS COAGULOPATHY CEREBRAL HAEMORRHAGE 3
PS PRODUCT USED FOR UNKNOWN INDICATION ANAPHYLACTIC SHOCK 1
PS PROPHYLAXIS ANGIOEDEMA 1
C ACUTE CORONARY SYNDROME COLON CANCER 3
C ACUTE CORONARY SYNDROME HAEMORRHAGE INTRACRANIAL 3
C ACUTE CORONARY SYNDROME MELAENA 3
C ACUTE MYOCARDIAL INFARCTION LONG QT SYNDROME 8
C ACUTE MYOCARDIAL INFARCTION THROMBOSIS IN DEVICE 4
C CHEST PAIN ANHEDONIA 1
C CHEST PAIN ANXIETY 1
C CHEST PAIN DEATH 1
C CHEST PAIN DEPRESSION 1
C CHEST PAIN EMOTIONAL DISTRESS 1
C CHEST PAIN FEAR 1
C CHEST PAIN INJURY 1
C CHEST PAIN MULTI-ORGAN FAILURE 1
C CHEST PAIN PAIN 1
C CHEST PAIN RENAL FAILURE 1
C CHEST PAIN RENAL IMPAIRMENT 1
C CHEST PAIN RENAL INJURY 1
C CHEST PAIN STRESS 1
C CHEST PAIN UNEVALUABLE EVENT 1
C CORONARY ARTERY BYPASS ANHEDONIA 4
C CORONARY ARTERY BYPASS ANXIETY 8
C CORONARY ARTERY BYPASS CARDIAC DISORDER 2
C CORONARY ARTERY BYPASS CEREBROVASCULAR ACCIDENT 6
C CORONARY ARTERY BYPASS DEATH 8
C CORONARY ARTERY BYPASS DEPRESSION 3
C CORONARY ARTERY BYPASS EMOTIONAL DISTRESS 6
C CORONARY ARTERY BYPASS FEAR 8
C CORONARY ARTERY BYPASS INJURY 8
C CORONARY ARTERY BYPASS MULTI-ORGAN FAILURE 6
C CORONARY ARTERY BYPASS MYOCARDIAL INFARCTION 4
C CORONARY ARTERY BYPASS ORGAN FAILURE 2
C CORONARY ARTERY BYPASS PAIN 8
C CORONARY ARTERY BYPASS PSYCHOLOGICAL TRAUMA 1
C CORONARY ARTERY BYPASS RENAL FAILURE 8
C CORONARY ARTERY BYPASS RENAL IMPAIRMENT 8
C CORONARY ARTERY BYPASS RENAL INJURY 8
C CORONARY ARTERY BYPASS STRESS 6
C CORONARY ARTERY BYPASS UNEVALUABLE EVENT 8
C GASTROOESOPHAGEAL REFLUX DISEASE LONG QT SYNDROME 2
C HYPERCHOLESTEROLAEMIA LONG QT SYNDROME 2
C HYPERTENSION LONG QT SYNDROME 4
C INTRA-AORTIC BALLOON PLACEMENT ANHEDONIA 1
C INTRA-AORTIC BALLOON PLACEMENT ANXIETY 1
C INTRA-AORTIC BALLOON PLACEMENT DEATH 1
C INTRA-AORTIC BALLOON PLACEMENT DEPRESSION 1
C INTRA-AORTIC BALLOON PLACEMENT EMOTIONAL DISTRESS 1
C INTRA-AORTIC BALLOON PLACEMENT FEAR 1
C INTRA-AORTIC BALLOON PLACEMENT INJURY 1
C INTRA-AORTIC BALLOON PLACEMENT MULTI-ORGAN FAILURE 1
C INTRA-AORTIC BALLOON PLACEMENT PAIN 1
C INTRA-AORTIC BALLOON PLACEMENT RENAL FAILURE 1
C INTRA-AORTIC BALLOON PLACEMENT RENAL IMPAIRMENT 1
C INTRA-AORTIC BALLOON PLACEMENT RENAL INJURY 1
C INTRA-AORTIC BALLOON PLACEMENT STRESS 1
C INTRA-AORTIC BALLOON PLACEMENT UNEVALUABLE EVENT 1
C MAGNESIUM DEFICIENCY LONG QT SYNDROME 2
C METASTASES TO BONE ANAEMIA 3
C METASTASES TO BONE ANGINA UNSTABLE 3
C METASTASES TO BONE ANXIETY 3
C METASTASES TO BONE ARTERIOSCLEROSIS 3
C METASTASES TO BONE ASTHENIA 3
C METASTASES TO BONE BACK PAIN 2
C METASTASES TO BONE BLOOD GLUCOSE INCREASED 3
C METASTASES TO BONE BRONCHOSPASM 2
C METASTASES TO BONE BUNDLE BRANCH BLOCK RIGHT 3
C METASTASES TO BONE CONSTIPATION 2
C METASTASES TO BONE CORONARY ARTERY STENOSIS 3
C METASTASES TO BONE DEFORMITY 3
C METASTASES TO BONE DYSPHAGIA 3
C METASTASES TO BONE ELECTROCARDIOGRAM ST-T CHANGE 2
C METASTASES TO BONE EMOTIONAL DISTRESS 3
C METASTASES TO BONE FAILURE TO THRIVE 3
C METASTASES TO BONE HEPATIC STEATOSIS 3
C METASTASES TO BONE HYDRONEPHROSIS 3
C METASTASES TO BONE HYPERHIDROSIS 3
C METASTASES TO BONE HYPERPARATHYROIDISM 3
C METASTASES TO BONE INFECTION 3
C METASTASES TO BONE INTERVERTEBRAL DISC DEGENERATION 3
C METASTASES TO BONE LUNG NEOPLASM 1
C METASTASES TO BONE LYMPHOCYTE COUNT DECREASED 3
C METASTASES TO BONE NAUSEA 3
C METASTASES TO BONE NEOPLASM MALIGNANT 2
C METASTASES TO BONE NEOPLASM PROGRESSION 2
C METASTASES TO BONE NEUTROPHIL COUNT INCREASED 3
C METASTASES TO BONE OEDEMA PERIPHERAL 3
C METASTASES TO BONE OSTEONECROSIS OF JAW 3
C METASTASES TO BONE PAIN 3
C METASTASES TO BONE PROSTATIC SPECIFIC ANTIGEN INCREASED 3
C METASTASES TO BONE PULMONARY CONGESTION 3
C METASTASES TO BONE RENAL FAILURE ACUTE 3
C METASTASES TO BONE SINUS TACHYCARDIA 3
C METASTASES TO BONE SPINAL CORD COMPRESSION 3
C METASTASES TO BONE SPINAL OSTEOARTHRITIS 2
C METASTASES TO BONE SUBMANDIBULAR MASS 3
C METASTASES TO BONE TREMOR 2
C METASTASES TO BONE URETHRAL PAIN 3
C METASTASES TO BONE URINARY TRACT INFECTION 3
C METASTASES TO BONE VENOUS INSUFFICIENCY 3
C MITRAL VALVE REPAIR ANHEDONIA 1
C MITRAL VALVE REPAIR ANXIETY 1
C MITRAL VALVE REPAIR CARDIAC DISORDER 1
C MITRAL VALVE REPAIR CEREBROVASCULAR ACCIDENT 1
C MITRAL VALVE REPAIR DEATH 1
C MITRAL VALVE REPAIR DEPRESSION 1
C MITRAL VALVE REPAIR FEAR 1
C MITRAL VALVE REPAIR INJURY 1
C MITRAL VALVE REPAIR ORGAN FAILURE 1
C MITRAL VALVE REPAIR PAIN 1
C MITRAL VALVE REPAIR RENAL FAILURE 1
C MITRAL VALVE REPAIR RENAL IMPAIRMENT 1
C MITRAL VALVE REPAIR RENAL INJURY 1
C MITRAL VALVE REPAIR UNEVALUABLE EVENT 1
C MYOCARDIAL INFARCTION HAEMATEMESIS 1
C MYOCARDIAL INFARCTION HELICOBACTER INFECTION 1
C OSTEOPOROSIS LONG QT SYNDROME 2
C PAIN ANHEDONIA 1
C PAIN ANXIETY 1
C PAIN DEATH 1
C PAIN DEPRESSION 1
C PAIN EMOTIONAL DISTRESS 1
C PAIN FEAR 1
C PAIN INJURY 1
C PAIN MULTI-ORGAN FAILURE 1
C PAIN PAIN 1
C PAIN RENAL FAILURE 1
C PAIN RENAL IMPAIRMENT 1
C PAIN RENAL INJURY 1
C PAIN STRESS 1
C PAIN UNEVALUABLE EVENT 1
C PERCUTANEOUS CORONARY INTERVENTION COAGULATION TIME ABNORMAL 1
C PERCUTANEOUS CORONARY INTERVENTION CORONARY ARTERY THROMBOSIS 1
C PERCUTANEOUS CORONARY INTERVENTION INCORRECT DRUG ADMINISTRATION DURATION 1
C PERCUTANEOUS CORONARY INTERVENTION MEDICAL DEVICE COMPLICATION 1
C PERCUTANEOUS CORONARY INTERVENTION MYOCARDIAL INFARCTION 1
C PERCUTANEOUS CORONARY INTERVENTION NO THERAPEUTIC RESPONSE 1
C PERCUTANEOUS CORONARY INTERVENTION SURGICAL PROCEDURE REPEATED 1
C PRODUCT USED FOR UNKNOWN INDICATION ANXIETY 18
C PRODUCT USED FOR UNKNOWN INDICATION CEREBROVASCULAR ACCIDENT 18
C PRODUCT USED FOR UNKNOWN INDICATION COLON CANCER 7
C PRODUCT USED FOR UNKNOWN INDICATION DEATH 18
C PRODUCT USED FOR UNKNOWN INDICATION EMOTIONAL DISTRESS 18
C PRODUCT USED FOR UNKNOWN INDICATION FEAR 18
C PRODUCT USED FOR UNKNOWN INDICATION INJURY 18
C PRODUCT USED FOR UNKNOWN INDICATION MELAENA 7
C PRODUCT USED FOR UNKNOWN INDICATION MULTI-ORGAN FAILURE 18
C PRODUCT USED FOR UNKNOWN INDICATION MYOCARDIAL INFARCTION 18
C PRODUCT USED FOR UNKNOWN INDICATION PAIN 18
C PRODUCT USED FOR UNKNOWN INDICATION RENAL FAILURE 18
C PRODUCT USED FOR UNKNOWN INDICATION RENAL IMPAIRMENT 18
C PRODUCT USED FOR UNKNOWN INDICATION RENAL INJURY 18
C PRODUCT USED FOR UNKNOWN INDICATION STRESS 18
C PRODUCT USED FOR UNKNOWN INDICATION UNEVALUABLE EVENT 18
C PROPHYLAXIS LONG QT SYNDROME 10
C SPONDYLITIS ANXIETY 1
C SPONDYLITIS CEREBROVASCULAR ACCIDENT 1
C SPONDYLITIS DEATH 1
C SPONDYLITIS EMOTIONAL DISTRESS 1
C SPONDYLITIS FEAR 1
C SPONDYLITIS INJURY 1
C SPONDYLITIS MULTI-ORGAN FAILURE 1
C SPONDYLITIS MYOCARDIAL INFARCTION 1
C SPONDYLITIS PAIN 1
C SPONDYLITIS RENAL FAILURE 1
C SPONDYLITIS RENAL IMPAIRMENT 1
C SPONDYLITIS RENAL INJURY 1
C SPONDYLITIS STRESS 1
C SPONDYLITIS UNEVALUABLE EVENT 1
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