Drug information for APIDRA SOLOSTAR
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
INJECTABLE; SUBCUTANEOUS
300 UNITS/3ML
Prescription
INSULIN GLULISINE RECOMBINANT
insulin glulisine
SANOFI AVENTIS US
21629
2009-03-17 Label
2009-02-27 Letter
2008-11-07 Label
2008-10-28 Letter
2007-04-20 Letter
2007-04-20 Label
2006-01-06 Label
2006-01-06 Label
2004-06-29 Review
2004-04-22 Label
2004-04-20 Letter
Drug Adverse Effects information for APIDRA SOLOSTAR
Role code
Indications
Reaction
# Reports
PS
DEVICE THERAPY
ANAEMIA
1
PS
DEVICE THERAPY
HYPOGLYCAEMIA
1
PS
DEVICE THERAPY
RESPIRATORY TRACT INFECTION
1
PS
DEVICE THERAPY
THROMBOCYTOPENIA
1
PS
DEVICE THERAPY
WHITE BLOOD CELL COUNT INCREASED
1
PS
DIABETES MELLITUS
ASTHENIA
2
PS
DIABETES MELLITUS
DIABETES MELLITUS INADEQUATE CONTROL
2
PS
DIABETES MELLITUS
EXPIRED DRUG ADMINISTERED
2
PS
DIABETES MELLITUS
HYPOGLYCAEMIA
8
PS
DIABETES MELLITUS
WRONG DRUG ADMINISTERED
8
PS
PRODUCT USED FOR UNKNOWN INDICATION
DEVICE BREAKAGE
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
DEVICE MALFUNCTION
14
PS
PRODUCT USED FOR UNKNOWN INDICATION
NO ADVERSE EVENT
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
PRODUCT QUALITY ISSUE
6
PS
PROPHYLAXIS
ANAEMIA
1
PS
PROPHYLAXIS
HYPOGLYCAEMIA
1
PS
PROPHYLAXIS
RESPIRATORY TRACT INFECTION
1
PS
PROPHYLAXIS
THROMBOCYTOPENIA
1
PS
PROPHYLAXIS
WHITE BLOOD CELL COUNT INCREASED
1
SS
ANTIDEPRESSANT THERAPY
ISCHAEMIC STROKE
1
SS
ANTIDEPRESSANT THERAPY
MOBILITY DECREASED
1
SS
ANTIDEPRESSANT THERAPY
MUSCULOSKELETAL PAIN
1
SS
ANTIDEPRESSANT THERAPY
PAIN IN EXTREMITY
1
SS
ANTIDEPRESSANT THERAPY
SPEECH DISORDER
1
SS
DEPRESSION
CYANOSIS
1
SS
DEPRESSION
DRUG INEFFECTIVE
1
SS
DEPRESSION
HYPERGLYCAEMIA
1
SS
DEPRESSION
INCORRECT STORAGE OF DRUG
1
SS
DEPRESSION
MALAISE
1
SS
DEPRESSION
PRODUCT QUALITY ISSUE
1
SS
DEPRESSION
THIRST
1
SS
DEVICE THERAPY
ANAEMIA
5
SS
DEVICE THERAPY
HYPOGLYCAEMIA
5
SS
DEVICE THERAPY
ISCHAEMIC STROKE
1
SS
DEVICE THERAPY
MOBILITY DECREASED
1
SS
DEVICE THERAPY
MUSCULOSKELETAL PAIN
1
SS
DEVICE THERAPY
PAIN IN EXTREMITY
1
SS
DEVICE THERAPY
RESPIRATORY TRACT INFECTION
5
SS
DEVICE THERAPY
SPEECH DISORDER
1
SS
DEVICE THERAPY
THROMBOCYTOPENIA
5
SS
DEVICE THERAPY
WHITE BLOOD CELL COUNT INCREASED
5
SS
DIABETIC NEUROPATHY
CYANOSIS
4
SS
DIABETIC NEUROPATHY
DRUG INEFFECTIVE
4
SS
DIABETIC NEUROPATHY
HYPERGLYCAEMIA
4
SS
DIABETIC NEUROPATHY
INCORRECT STORAGE OF DRUG
4
SS
DIABETIC NEUROPATHY
MALAISE
4
SS
DIABETIC NEUROPATHY
PRODUCT QUALITY ISSUE
4
SS
DIABETIC NEUROPATHY
THIRST
4
SS
HYPERTENSION
CYANOSIS
1
SS
HYPERTENSION
DRUG INEFFECTIVE
1
SS
HYPERTENSION
HYPERGLYCAEMIA
1
SS
HYPERTENSION
INCORRECT STORAGE OF DRUG
1
SS
HYPERTENSION
MALAISE
1
SS
HYPERTENSION
PRODUCT QUALITY ISSUE
1
SS
HYPERTENSION
THIRST
1
SS
INSOMNIA
ISCHAEMIC STROKE
1
SS
INSOMNIA
MOBILITY DECREASED
1
SS
INSOMNIA
MUSCULOSKELETAL PAIN
1
SS
INSOMNIA
PAIN IN EXTREMITY
1
SS
INSOMNIA
SPEECH DISORDER
1
SS
PROPHYLAXIS
ANAEMIA
5
SS
PROPHYLAXIS
HYPOGLYCAEMIA
5
SS
PROPHYLAXIS
RESPIRATORY TRACT INFECTION
5
SS
PROPHYLAXIS
THROMBOCYTOPENIA
5
SS
PROPHYLAXIS
WHITE BLOOD CELL COUNT INCREASED
5
C
DIABETES MELLITUS
ADRENAL DISORDER
2
C
DIABETES MELLITUS
ASTHENIA
2
C
DIABETES MELLITUS
DECREASED IMMUNE RESPONSIVENESS
2
C
DIABETES MELLITUS
DIARRHOEA
4
C
DIABETES MELLITUS
DIVERTICULITIS
2
C
DIABETES MELLITUS
ENDOCRINE DISORDER
2
C
DIABETES MELLITUS
HEADACHE
2
C
DIABETES MELLITUS
NAUSEA
4
C
DIABETES MELLITUS
OPTIC NEURITIS
4
C
MULTIPLE SCLEROSIS
ADRENAL DISORDER
1
C
MULTIPLE SCLEROSIS
ASTHENIA
1
C
MULTIPLE SCLEROSIS
DECREASED IMMUNE RESPONSIVENESS
1
C
MULTIPLE SCLEROSIS
DIARRHOEA
2
C
MULTIPLE SCLEROSIS
DIVERTICULITIS
1
C
MULTIPLE SCLEROSIS
ENDOCRINE DISORDER
1
C
MULTIPLE SCLEROSIS
HEADACHE
1
C
MULTIPLE SCLEROSIS
NAUSEA
2
C
MULTIPLE SCLEROSIS
OPTIC NEURITIS
2
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