Drug information for EGRIFTA
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
POWDER; SUBCUTANEOUS
EQ 1MG BASE/VIAL
Prescription
(Reference Drug)
TESAMORELIN ACETATE
tesamorelin
THERATECHNOLOGIES
22505
2011-12-02 Label
2011-12-02 Label
2010-12-14 Review
2010-12-14 Summary Review
2010-11-15 Letter
2010-11-12 Label
Drug Adverse Effects information for EGRIFTA
Role code
Indications
Reaction
# Reports
PS
ACQUIRED IMMUNODEFICIENCY SYNDROME
HYPOTENSION
1
PS
ACQUIRED IMMUNODEFICIENCY SYNDROME
INJECTION SITE PAIN
1
PS
ACQUIRED IMMUNODEFICIENCY SYNDROME
VISION BLURRED
1
PS
BARRETT'S OESOPHAGUS
HEPATOMEGALY
1
PS
CARDIOVASCULAR EVENT PROPHYLAXIS
HYPOTENSION
1
PS
CARDIOVASCULAR EVENT PROPHYLAXIS
INJECTION SITE PAIN
1
PS
CARDIOVASCULAR EVENT PROPHYLAXIS
VISION BLURRED
1
PS
DIABETES MELLITUS
BLOOD GLUCOSE INCREASED
1
PS
DIABETES MELLITUS
GLYCOSYLATED HAEMOGLOBIN INCREASED
1
PS
HIV INFECTION
ABDOMINAL PAIN
1
PS
HIV INFECTION
AGEUSIA
1
PS
HIV INFECTION
ARTHRALGIA
1
PS
HIV INFECTION
BLOOD CHLORIDE DECREASED
1
PS
HIV INFECTION
BLOOD PH DECREASED
1
PS
HIV INFECTION
BLOOD SODIUM DECREASED
1
PS
HIV INFECTION
CONFUSIONAL STATE
1
PS
HIV INFECTION
DYSGEUSIA
1
PS
HIV INFECTION
GASTRIC INFECTION
1
PS
HIV INFECTION
HEPATOMEGALY
3
PS
HIV INFECTION
HYPERGLYCAEMIA
1
PS
HIV INFECTION
HYPERSENSITIVITY
1
PS
HIV INFECTION
HYPOAESTHESIA
1
PS
HIV INFECTION
HYPOKALAEMIA
1
PS
HIV INFECTION
MYALGIA
1
PS
HIV INFECTION
OEDEMA PERIPHERAL
1
PS
HIV INFECTION
PAIN IN EXTREMITY
1
PS
HIV INFECTION
PHARYNGITIS
1
PS
HIV INFECTION
RENAL FAILURE ACUTE
1
PS
HIV INFECTION
RENAL TUBULAR NECROSIS
1
PS
LENTIVIRUS TEST POSITIVE
BREAST CANCER
1
PS
LENTIVIRUS TEST POSITIVE
WEIGHT DECREASED
1
PS
LIPODYSTROPHY ACQUIRED
ABDOMINAL DISTENSION
4
PS
LIPODYSTROPHY ACQUIRED
ABDOMINAL PAIN
1
PS
LIPODYSTROPHY ACQUIRED
ABDOMINAL TENDERNESS
1
PS
LIPODYSTROPHY ACQUIRED
ADVERSE REACTION
1
PS
LIPODYSTROPHY ACQUIRED
ALOPECIA
1
PS
LIPODYSTROPHY ACQUIRED
ANAEMIA
1
PS
LIPODYSTROPHY ACQUIRED
ANGER
1
PS
LIPODYSTROPHY ACQUIRED
ANOGENITAL DYSPLASIA
1
PS
LIPODYSTROPHY ACQUIRED
ANXIETY
4
PS
LIPODYSTROPHY ACQUIRED
ARTHRALGIA
6
PS
LIPODYSTROPHY ACQUIRED
ARTHRITIS
2
PS
LIPODYSTROPHY ACQUIRED
ASTHENIA
4
PS
LIPODYSTROPHY ACQUIRED
BLOOD CHLORIDE DECREASED
1
PS
LIPODYSTROPHY ACQUIRED
BLOOD CHOLESTEROL INCREASED
1
PS
LIPODYSTROPHY ACQUIRED
BLOOD GLUCOSE ABNORMAL
2
PS
LIPODYSTROPHY ACQUIRED
BLOOD GLUCOSE DECREASED
1
PS
LIPODYSTROPHY ACQUIRED
BLOOD GLUCOSE INCREASED
5
PS
LIPODYSTROPHY ACQUIRED
BLOOD PH DECREASED
1
PS
LIPODYSTROPHY ACQUIRED
BLOOD PRESSURE INCREASED
5
PS
LIPODYSTROPHY ACQUIRED
BLOOD SODIUM DECREASED
1
PS
LIPODYSTROPHY ACQUIRED
BLOOD UREA INCREASED
1
PS
LIPODYSTROPHY ACQUIRED
BREAST CANCER
1
PS
LIPODYSTROPHY ACQUIRED
BRONCHITIS
1
PS
LIPODYSTROPHY ACQUIRED
BURNING SENSATION
1
PS
LIPODYSTROPHY ACQUIRED
CACHEXIA
1
PS
LIPODYSTROPHY ACQUIRED
CARPAL TUNNEL SYNDROME
3
PS
LIPODYSTROPHY ACQUIRED
CHEST DISCOMFORT
1
PS
LIPODYSTROPHY ACQUIRED
CHILLS
1
PS
LIPODYSTROPHY ACQUIRED
CHOLECYSTECTOMY
2
PS
LIPODYSTROPHY ACQUIRED
COLORECTAL CANCER STAGE IV
1
PS
LIPODYSTROPHY ACQUIRED
CONCUSSION
1
PS
LIPODYSTROPHY ACQUIRED
CONDITION AGGRAVATED
1
PS
LIPODYSTROPHY ACQUIRED
CONFUSIONAL STATE
1
PS
LIPODYSTROPHY ACQUIRED
CONSTIPATION
2
PS
LIPODYSTROPHY ACQUIRED
CONTUSION
2
PS
LIPODYSTROPHY ACQUIRED
COUGH
1
PS
LIPODYSTROPHY ACQUIRED
CYST
1
PS
LIPODYSTROPHY ACQUIRED
DECREASED APPETITE
1
PS
LIPODYSTROPHY ACQUIRED
DEPRESSED MOOD
1
PS
LIPODYSTROPHY ACQUIRED
DEPRESSION
3
PS
LIPODYSTROPHY ACQUIRED
DIABETES MELLITUS
4
PS
LIPODYSTROPHY ACQUIRED
DIARRHOEA
4
PS
LIPODYSTROPHY ACQUIRED
DIVERTICULITIS
1
PS
LIPODYSTROPHY ACQUIRED
DIZZINESS
8
PS
LIPODYSTROPHY ACQUIRED
DYSGEUSIA
1
PS
LIPODYSTROPHY ACQUIRED
DYSMORPHISM
1
PS
LIPODYSTROPHY ACQUIRED
DYSPEPSIA
1
PS
LIPODYSTROPHY ACQUIRED
DYSPNOEA
2
PS
LIPODYSTROPHY ACQUIRED
DYSURIA
1
PS
LIPODYSTROPHY ACQUIRED
EPIGASTRIC DISCOMFORT
1
PS
LIPODYSTROPHY ACQUIRED
EPSTEIN-BARR VIRUS INFECTION
1
PS
LIPODYSTROPHY ACQUIRED
ERYTHEMA
2
PS
LIPODYSTROPHY ACQUIRED
EUPHORIC MOOD
1
PS
LIPODYSTROPHY ACQUIRED
EXPIRED DRUG ADMINISTERED
1
PS
LIPODYSTROPHY ACQUIRED
FACIAL WASTING
1
PS
LIPODYSTROPHY ACQUIRED
FAECES DISCOLOURED
1
PS
LIPODYSTROPHY ACQUIRED
FAT TISSUE INCREASED
2
PS
LIPODYSTROPHY ACQUIRED
FATIGUE
7
PS
LIPODYSTROPHY ACQUIRED
FEELING ABNORMAL
3
PS
LIPODYSTROPHY ACQUIRED
FEELING HOT
2
PS
LIPODYSTROPHY ACQUIRED
FLUSHING
1
PS
LIPODYSTROPHY ACQUIRED
FREQUENT BOWEL MOVEMENTS
1
PS
LIPODYSTROPHY ACQUIRED
FURUNCLE
2
PS
LIPODYSTROPHY ACQUIRED
GASTRIC INFECTION
2
PS
LIPODYSTROPHY ACQUIRED
GLYCOSYLATED HAEMOGLOBIN INCREASED
3
PS
LIPODYSTROPHY ACQUIRED
GYNAECOMASTIA
1
PS
LIPODYSTROPHY ACQUIRED
HEADACHE
3
PS
LIPODYSTROPHY ACQUIRED
HEPATOMEGALY
1
PS
LIPODYSTROPHY ACQUIRED
HIP ARTHROPLASTY
1
PS
LIPODYSTROPHY ACQUIRED
HIP SURGERY
1
PS
LIPODYSTROPHY ACQUIRED
HOT FLUSH
4
PS
LIPODYSTROPHY ACQUIRED
HYPERGLYCAEMIA
1
PS
LIPODYSTROPHY ACQUIRED
HYPERHIDROSIS
3
PS
LIPODYSTROPHY ACQUIRED
HYPERSOMNIA
3
PS
LIPODYSTROPHY ACQUIRED
HYPERTENSION
1
PS
LIPODYSTROPHY ACQUIRED
HYPOAESTHESIA
1
PS
LIPODYSTROPHY ACQUIRED
HYPOGLYCAEMIA
1
PS
LIPODYSTROPHY ACQUIRED
HYPOKALAEMIA
1
PS
LIPODYSTROPHY ACQUIRED
HYPOTENSION
1
PS
LIPODYSTROPHY ACQUIRED
INCISION SITE PAIN
2
PS
LIPODYSTROPHY ACQUIRED
INCREASED APPETITE
1
PS
LIPODYSTROPHY ACQUIRED
INFECTION
1
PS
LIPODYSTROPHY ACQUIRED
INFLUENZA
1
PS
LIPODYSTROPHY ACQUIRED
INJECTION SITE HAEMATOMA
6
PS
LIPODYSTROPHY ACQUIRED
INJECTION SITE HAEMORRHAGE
3
PS
LIPODYSTROPHY ACQUIRED
INJECTION SITE MASS
2
PS
LIPODYSTROPHY ACQUIRED
INJECTION SITE PAIN
4
PS
LIPODYSTROPHY ACQUIRED
INSOMNIA
4
PS
LIPODYSTROPHY ACQUIRED
JOINT SWELLING
1
PS
LIPODYSTROPHY ACQUIRED
LARYNGITIS
1
PS
LIPODYSTROPHY ACQUIRED
LIPOSUCTION
2
PS
LIPODYSTROPHY ACQUIRED
MALAISE
4
PS
LIPODYSTROPHY ACQUIRED
MASS
1
PS
LIPODYSTROPHY ACQUIRED
MIGRAINE
2
PS
LIPODYSTROPHY ACQUIRED
MOOD SWINGS
1
PS
LIPODYSTROPHY ACQUIRED
MUSCLE ATROPHY
1
PS
LIPODYSTROPHY ACQUIRED
MUSCULAR WEAKNESS
1
PS
LIPODYSTROPHY ACQUIRED
MUSCULOSKELETAL CHEST PAIN
1
PS
LIPODYSTROPHY ACQUIRED
MYALGIA
2
PS
LIPODYSTROPHY ACQUIRED
MYOCARDIAL INFARCTION
1
PS
LIPODYSTROPHY ACQUIRED
NASOPHARYNGITIS
2
PS
LIPODYSTROPHY ACQUIRED
NAUSEA
4
PS
LIPODYSTROPHY ACQUIRED
NEURODERMATITIS
1
PS
LIPODYSTROPHY ACQUIRED
NEUROPATHY PERIPHERAL
1
PS
LIPODYSTROPHY ACQUIRED
NIGHT SWEATS
1
PS
LIPODYSTROPHY ACQUIRED
NO ADVERSE EVENT
1
PS
LIPODYSTROPHY ACQUIRED
OEDEMA PERIPHERAL
4
PS
LIPODYSTROPHY ACQUIRED
ORAL HERPES
1
PS
LIPODYSTROPHY ACQUIRED
ORAL SURGERY
2
PS
LIPODYSTROPHY ACQUIRED
OVERDOSE
1
PS
LIPODYSTROPHY ACQUIRED
PAIN
6
PS
LIPODYSTROPHY ACQUIRED
PAIN IN EXTREMITY
4
PS
LIPODYSTROPHY ACQUIRED
PALPITATIONS
4
PS
LIPODYSTROPHY ACQUIRED
PHARYNGEAL OEDEMA
1
PS
LIPODYSTROPHY ACQUIRED
POLLAKIURIA
1
PS
LIPODYSTROPHY ACQUIRED
PRURITUS
1
PS
LIPODYSTROPHY ACQUIRED
PULMONARY THROMBOSIS
2
PS
LIPODYSTROPHY ACQUIRED
PYREXIA
1
PS
LIPODYSTROPHY ACQUIRED
RENAL DISORDER
1
PS
LIPODYSTROPHY ACQUIRED
RENAL FAILURE
1
PS
LIPODYSTROPHY ACQUIRED
RENAL FAILURE ACUTE
1
PS
LIPODYSTROPHY ACQUIRED
RENAL TUBULAR NECROSIS
1
PS
LIPODYSTROPHY ACQUIRED
RESPIRATORY TRACT INFECTION
1
PS
LIPODYSTROPHY ACQUIRED
RHINORRHOEA
1
PS
LIPODYSTROPHY ACQUIRED
ROAD TRAFFIC ACCIDENT
1
PS
LIPODYSTROPHY ACQUIRED
SINUSITIS
1
PS
LIPODYSTROPHY ACQUIRED
SKIN BURNING SENSATION
1
PS
LIPODYSTROPHY ACQUIRED
SKIN INFECTION
2
PS
LIPODYSTROPHY ACQUIRED
SQUAMOUS CELL CARCINOMA
1
PS
LIPODYSTROPHY ACQUIRED
SUICIDAL BEHAVIOUR
1
PS
LIPODYSTROPHY ACQUIRED
SWELLING
2
PS
LIPODYSTROPHY ACQUIRED
T-LYMPHOCYTE COUNT INCREASED
1
PS
LIPODYSTROPHY ACQUIRED
TACHYPHRENIA
1
PS
LIPODYSTROPHY ACQUIRED
TENDONITIS
2
PS
LIPODYSTROPHY ACQUIRED
THINKING ABNORMAL
1
PS
LIPODYSTROPHY ACQUIRED
THROMBOSIS
2
PS
LIPODYSTROPHY ACQUIRED
THYROID DISORDER
1
PS
LIPODYSTROPHY ACQUIRED
TREMOR
2
PS
LIPODYSTROPHY ACQUIRED
UMBILICAL HERNIA REPAIR
1
PS
LIPODYSTROPHY ACQUIRED
URINE ABNORMALITY
1
PS
LIPODYSTROPHY ACQUIRED
URINE COLOUR ABNORMAL
1
PS
LIPODYSTROPHY ACQUIRED
URTICARIA
1
PS
LIPODYSTROPHY ACQUIRED
VERTIGO
1
PS
LIPODYSTROPHY ACQUIRED
VISION BLURRED
3
PS
LIPODYSTROPHY ACQUIRED
VISUAL IMPAIRMENT
1
PS
LIPODYSTROPHY ACQUIRED
VOMITING
4
PS
LIPODYSTROPHY ACQUIRED
WEIGHT DECREASED
1
PS
LIPODYSTROPHY ACQUIRED
WEIGHT INCREASED
7
PS
PRODUCT USED FOR UNKNOWN INDICATION
ABDOMINAL DISTENSION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ANXIETY
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
BACK PAIN
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
BLOOD GLUCOSE INCREASED
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
BONE PAIN
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
BREAST SWELLING
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
CHEST DISCOMFORT
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
CHEST PAIN
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
DIABETES MELLITUS
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
DIABETIC HYPEROSMOLAR COMA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
DIARRHOEA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
FATIGUE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
FOAMING AT MOUTH
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HEADACHE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HEART RATE INCREASED
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
HEPATOMEGALY
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HYPERHIDROSIS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HYPERTENSION
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
INCORRECT DOSE ADMINISTERED
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
INFLUENZA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
INFLUENZA LIKE ILLNESS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
JOINT SWELLING
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
NEUROPATHY PERIPHERAL
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
OEDEMA PERIPHERAL
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
PALPITATIONS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
SKIN PAPILLOMA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
SYNCOPE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
UNEVALUABLE EVENT
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
VIRAL LOAD INCREASED
1
PS
SMOKING CESSATION THERAPY
FATIGUE
1
PS
SMOKING CESSATION THERAPY
HYPOAESTHESIA
1
PS
SMOKING CESSATION THERAPY
THINKING ABNORMAL
1
PS
TYPE 1 DIABETES MELLITUS
DIABETES MELLITUS
1
PS
TYPE 1 DIABETES MELLITUS
DIABETIC HYPEROSMOLAR COMA
2
PS
TYPE 1 DIABETES MELLITUS
FOAMING AT MOUTH
1
PS
TYPE 2 DIABETES MELLITUS
BLOOD GLUCOSE INCREASED
2
PS
TYPE 2 DIABETES MELLITUS
GLYCOSYLATED HAEMOGLOBIN INCREASED
2
SS
LENTIVIRUS TEST POSITIVE
BREAST CANCER
1
SS
LENTIVIRUS TEST POSITIVE
WEIGHT DECREASED
1
SS
LIPODYSTROPHY ACQUIRED
BREAST CANCER
1
SS
LIPODYSTROPHY ACQUIRED
OVERDOSE
1
SS
LIPODYSTROPHY ACQUIRED
WEIGHT DECREASED
1
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