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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