Drug information for INCRELEX
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
INJECTABLE; SUBCUTANEOUS
40MG/4ML (10MG/ML)
Prescription
(Reference Drug)
MECASERMIN RECOMBINANT
myotrophin
TERCICA
21839
2011-02-24 Label
2011-02-18 Letter
2005-10-12 Review
2005-09-08 Letter
2005-08-31 Label
Drug Adverse Effects information for INCRELEX
Role code
Indications
Reaction
# Reports
PS
BODY HEIGHT BELOW NORMAL
DISTURBANCE IN ATTENTION
1
PS
BODY HEIGHT BELOW NORMAL
DIZZINESS
1
PS
BODY HEIGHT BELOW NORMAL
FATIGUE
1
PS
BODY HEIGHT BELOW NORMAL
GAIT DISTURBANCE
1
PS
BODY HEIGHT BELOW NORMAL
HEADACHE
2
PS
BODY HEIGHT BELOW NORMAL
HYPOGLYCAEMIA
1
PS
BODY HEIGHT BELOW NORMAL
INTRACRANIAL PRESSURE INCREASED
1
PS
BODY HEIGHT BELOW NORMAL
NEPHROLITHIASIS
1
PS
BODY HEIGHT BELOW NORMAL
POST PROCEDURAL HAEMORRHAGE
1
PS
BODY HEIGHT BELOW NORMAL
POST PROCEDURAL INFECTION
1
PS
BODY HEIGHT BELOW NORMAL
TONSILLECTOMY
1
PS
CONVULSION
ALOPECIA
4
PS
CONVULSION
CONDITION AGGRAVATED
3
PS
CONVULSION
CONVULSION
4
PS
DIABETES MELLITUS
CONVULSION
1
PS
FAILURE TO THRIVE
CONDITION AGGRAVATED
2
PS
FAILURE TO THRIVE
CONVULSION
2
PS
FAILURE TO THRIVE
DRUG DOSE OMISSION
1
PS
FAILURE TO THRIVE
NAUSEA
2
PS
FAILURE TO THRIVE
OFF LABEL USE
2
PS
FAILURE TO THRIVE
VOMITING
2
PS
FOETAL GROWTH RESTRICTION
ABDOMINAL DISTENSION
2
PS
FOETAL GROWTH RESTRICTION
ACTIVATED PARTIAL THROMBOPLASTIN TIME SHORTENED
1
PS
FOETAL GROWTH RESTRICTION
ANAEMIA
5
PS
FOETAL GROWTH RESTRICTION
ASCITES
2
PS
FOETAL GROWTH RESTRICTION
ASTHMA
2
PS
FOETAL GROWTH RESTRICTION
BLOOD THYROID STIMULATING HORMONE DECREASED
2
PS
FOETAL GROWTH RESTRICTION
BRONCHITIS
4
PS
FOETAL GROWTH RESTRICTION
CEREBRAL ATROPHY
3
PS
FOETAL GROWTH RESTRICTION
CEREBROVASCULAR DISORDER
1
PS
FOETAL GROWTH RESTRICTION
COLLATERAL CIRCULATION
1
PS
FOETAL GROWTH RESTRICTION
CULTURE URINE POSITIVE
4
PS
FOETAL GROWTH RESTRICTION
CYTOLYTIC HEPATITIS
2
PS
FOETAL GROWTH RESTRICTION
DIARRHOEA
3
PS
FOETAL GROWTH RESTRICTION
DRUG ADMINISTRATION ERROR
1
PS
FOETAL GROWTH RESTRICTION
EAR INFECTION
5
PS
FOETAL GROWTH RESTRICTION
EPSTEIN-BARR VIRUS INFECTION
2
PS
FOETAL GROWTH RESTRICTION
EPSTEIN-BARR VIRUS TEST POSITIVE
2
PS
FOETAL GROWTH RESTRICTION
ESCHERICHIA INFECTION
1
PS
FOETAL GROWTH RESTRICTION
ESCHERICHIA TEST POSITIVE
4
PS
FOETAL GROWTH RESTRICTION
FEBRILE CONVULSION
5
PS
FOETAL GROWTH RESTRICTION
GASTROENTERITIS
5
PS
FOETAL GROWTH RESTRICTION
GENERAL PHYSICAL HEALTH DETERIORATION
3
PS
FOETAL GROWTH RESTRICTION
HEPATIC CIRRHOSIS
5
PS
FOETAL GROWTH RESTRICTION
HEPATOMEGALY
2
PS
FOETAL GROWTH RESTRICTION
HYPERTHERMIA
1
PS
FOETAL GROWTH RESTRICTION
INFLAMMATION
4
PS
FOETAL GROWTH RESTRICTION
INTERSTITIAL LUNG DISEASE
1
PS
FOETAL GROWTH RESTRICTION
LUNG DISORDER
4
PS
FOETAL GROWTH RESTRICTION
MALNUTRITION
3
PS
FOETAL GROWTH RESTRICTION
NASOPHARYNGITIS
5
PS
FOETAL GROWTH RESTRICTION
PORTAL HYPERTENSION
3
PS
FOETAL GROWTH RESTRICTION
PROTHROMBIN TIME PROLONGED
1
PS
FOETAL GROWTH RESTRICTION
PYREXIA
1
PS
FOETAL GROWTH RESTRICTION
RENAL DISORDER
1
PS
FOETAL GROWTH RESTRICTION
SPLENIC VARICES
2
PS
FOETAL GROWTH RESTRICTION
SPLENOMEGALY
3
PS
FOETAL GROWTH RESTRICTION
TOXOPLASMOSIS
5
PS
FOETAL GROWTH RESTRICTION
VOMITING
3
PS
FOETAL GROWTH RESTRICTION
WEIGHT DECREASED
3
PS
GROWTH HORMONE DEFICIENCY
ALOPECIA
4
PS
GROWTH HORMONE DEFICIENCY
BETA HAEMOLYTIC STREPTOCOCCAL INFECTION
1
PS
GROWTH HORMONE DEFICIENCY
CONDITION AGGRAVATED
3
PS
GROWTH HORMONE DEFICIENCY
CONVULSION
4
PS
GROWTH HORMONE DEFICIENCY
GRAND MAL CONVULSION
1
PS
GROWTH HORMONE DEFICIENCY
HEADACHE
1
PS
GROWTH HORMONE DEFICIENCY
HYPOGLYCAEMIA
1
PS
GROWTH HORMONE DEFICIENCY
INTRACRANIAL PRESSURE INCREASED
1
PS
GROWTH HORMONE DEFICIENCY
PNEUMONIA
1
PS
GROWTH HORMONE DEFICIENCY
PNEUMONIA STREPTOCOCCAL
1
PS
GROWTH HORMONE DEFICIENCY
RHINORRHOEA
1
PS
GROWTH HORMONE DEFICIENCY
THYROID NEOPLASM
1
PS
GROWTH HORMONE DEFICIENCY
VOMITING
1
PS
GROWTH RETARDATION
ADVERSE EVENT
1
PS
GROWTH RETARDATION
AGGRESSION
1
PS
GROWTH RETARDATION
ANAEMIA
1
PS
GROWTH RETARDATION
DRUG DOSE OMISSION
1
PS
GROWTH RETARDATION
LEUKOPENIA
1
PS
GROWTH RETARDATION
THROMBOCYTOPENIA
1
PS
GROWTH RETARDATION
VAGINAL ABSCESS
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
ABDOMINAL DISTENSION
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
ABDOMINAL PAIN
3
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
ADENOIDAL HYPERTROPHY
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
ADENOTONSILLECTOMY
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
ASTHENIA
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
BACTERIAL TEST POSITIVE
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
BENIGN INTRACRANIAL HYPERTENSION
4
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
BETA HAEMOLYTIC STREPTOCOCCAL INFECTION
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
BODY MASS INDEX INCREASED
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
CHROMATURIA
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
CONSTIPATION
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
CONVULSION
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
CRYING
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
CSF WHITE BLOOD CELL COUNT POSITIVE
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
DEHYDRATION
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
DYSPNOEA
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
EMOTIONAL DISORDER
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
EXOSTOSIS
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
EYELID OEDEMA
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
HAEMATOCRIT DECREASED
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
HAEMATURIA
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
HAEMOGLOBIN DECREASED
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
HEADACHE
4
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
HETEROPHORIA
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
HYPERSENSITIVITY
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
HYPOGLYCAEMIA
3
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
IGA NEPHROPATHY
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
INJECTION SITE INDURATION
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
INJECTION SITE PRURITUS
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
INSOMNIA
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
LIP SWELLING
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
MENTAL DISORDER
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
MIGRAINE
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
MUSCULOSKELETAL PAIN
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
NASAL OEDEMA
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
NAUSEA
2
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
OPTIC NEURITIS
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
PAIN IN EXTREMITY
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
PAPILLOEDEMA
4
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
PARAESTHESIA
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
PORTAL SHUNT
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
POST PROCEDURAL COMPLICATION
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
PROTEIN URINE PRESENT
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
PYREXIA
2
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
REFRACTION DISORDER
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
SLEEP APNOEA SYNDROME
2
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
SNORING
2
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
TONSILLAR HYPERTROPHY
2
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
TREATMENT NONCOMPLIANCE
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
UNRESPONSIVE TO STIMULI
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
VIRAL INFECTION
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
VISUAL IMPAIRMENT
1
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
VOMITING
3
PS
INSULIN-LIKE GROWTH FACTOR DECREASED
WHITE BLOOD CELL COUNT DECREASED
1
PS
PRIMARY INSULIN LIKE GROWTH FACTOR-1 DEFICIENCY
CONVULSION
1
PS
PRIMARY INSULIN LIKE GROWTH FACTOR-1 DEFICIENCY
DRUG DOSE OMISSION
1
PS
PRIMARY INSULIN LIKE GROWTH FACTOR-1 DEFICIENCY
HYPERTROPHY
1
PS
PRIMARY INSULIN LIKE GROWTH FACTOR-1 DEFICIENCY
MENTAL DISORDER
1
PS
PRIMARY INSULIN LIKE GROWTH FACTOR-1 DEFICIENCY
OBESITY
1
PS
PRIMARY INSULIN LIKE GROWTH FACTOR-1 DEFICIENCY
PYELONEPHRITIS
1
PS
PRIMARY INSULIN LIKE GROWTH FACTOR-1 DEFICIENCY
SOFT TISSUE DISORDER
1
PS
PRIMARY INSULIN LIKE GROWTH FACTOR-1 DEFICIENCY
WEIGHT INCREASED
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ALOPECIA
3
PS
PRODUCT USED FOR UNKNOWN INDICATION
BODY MASS INDEX INCREASED
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
CONDITION AGGRAVATED
3
PS
PRODUCT USED FOR UNKNOWN INDICATION
CONVULSION
3
PS
PRODUCT USED FOR UNKNOWN INDICATION
GAIT DISTURBANCE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
OSTEONECROSIS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
UPPER LIMB FRACTURE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
WRONG TECHNIQUE IN DRUG USAGE PROCESS
1
PS
RETT'S DISORDER
EPILEPSY
1
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